Ablation monitoring method and device

Abstract

The invention relates to an ablation monitoring method and device. The ablation monitoring method comprises the steps that a first body surface patch is fixed to a body surface target area; receiving a first state signal generated by the first body surface patch at a first sampling moment, and receiving a second state signal generated by the first body surface patch at a second sampling moment; determining first position information of the first body surface patch at the first sampling moment according to the first state signal, and determining second position information of the first body surface patch at the second sampling moment according to the second state signal; determining the displacement of the first body surface patch according to the first position information and the second position information; when the displacement exceeds a preset displacement threshold value, prompt information is sent out. The ablation monitoring can help an operator to judge whether the phrenic nerve is injured or not in time in the cryoablation process, and is beneficial to getting rid of the constraint of experience subjective judgment, so that the injury risk of the phrenic nerve in the cryoablation process is reduced.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to an ablation monitoring method and device. Background Art

[0002] Patients with atrial fibrillation have a high risk of stroke. When in atrial fibrillation, the atrium beats irregularly and rapidly, losing its systolic function. Blood is prone to stagnate in the atrium and form thrombus. When the thrombus detaches and enters the brain through the artery, stroke occurs. Ablation treatment is one of the most effective treatment measures at present. Through an interventional catheter, ablation energy (such as radiofrequency, cryoablation, and laser, etc.) is applied to the pulmonary veins for ablation to isolate the pulmonary vein potential, thereby achieving the treatment effect.

[0003] Cryoablation is based on anatomical considerations and uses the contact between the balloon and the tissue for cryoablation, with characteristics such as one-time and continuity. Among them, the balloon mainly realizes cryoablation based on the Joule-Thomson effect, that is, the throttling expansion effect. This effect means that when a high-pressure fluid passes through a fine capillary to reach a low-pressure area, the temperature drop caused by the expansion and heat absorption of the fluid. At the beginning of cryoablation, the refrigerant is pressurized and cooled and liquefied through the built-in device of the cryoablation equipment and then reaches the inside of the balloon through the capillary. After the liquefied refrigerant sprays out through the small holes on the surface of the capillary, it quickly vaporizes and expands, quickly taking away the temperature inside the balloon, so that the balloon cools down significantly to achieve the cryoablation effect.

[0004] However, during cryoablation, the ablation site is often close to the phrenic nerve, and too low temperature causes phrenic nerve injury. Phrenic nerve injury is one of the most common complications of cryoablation. According to the degree and duration of injury, it can be divided into: transient phrenic nerve dysfunction, phrenic nerve paralysis, and persistent or permanent phrenic nerve paralysis. In the vast majority of cases, the phrenic nerve injury that occurs during cryoablation is transient, and most can recover during or after the operation for a period of time. The occurrence of phrenic nerve injury is related to the right superior pulmonary vein, superior vena cava, and left atrial appendage. Taking the right phrenic nerve as an example, since it runs along the superior vena cava and the anterior lateral wall of the right atrium, and runs together with the right ventricular superior pulmonary vein, superior vena cava, and right superior pulmonary vein, during cryoablation, it is necessary to closely monitor the phrenic nerve through pacing stimulation to avoid injury. Therefore, how to reduce the risk of phrenic nerve injury during cryoablation and get rid of the bondage of empirical subjective judgment is an urgent problem to be solved currently. Summary of the Invention

[0005] Based on this, the embodiments of this application provide an ablation monitoring method and device, which can help the operator timely judge whether the phrenic nerve is damaged during cryoablation, is beneficial to getting rid of the bondage of empirical subjective judgment, and thus reduces the risk of phrenic nerve injury during cryoablation.

[0006] According to some embodiments, on the one hand, this application provides an ablation monitoring method, including:

[0007] Fix the first body surface patch on the target area of the body surface;

[0008] Receive the first status signal generated by the first body surface patch at the first sampling moment, and receive the second status signal generated by the first body surface patch at the second sampling moment;

[0009] Determine the first position information of the first body surface patch at the first sampling moment according to the first status signal, and determine the second position information of the first body surface patch at the second sampling moment according to the second status signal;

[0010] Determine the displacement of the first body surface patch according to the first position information and the second position information; when the displacement exceeds the preset displacement threshold, send a prompt message.

[0011] In some embodiments, the step of receiving the first status signal generated by the first body surface patch at the first sampling moment and receiving the second status signal generated by the first body surface patch at the second sampling moment includes:

[0012] The first body surface patch is powered on at the first sampling moment to generate a first magnetic field status signal, and is powered on at the second sampling moment to generate a second magnetic field status signal;

[0013] The step of determining the first position information of the first body surface patch at the first sampling moment according to the first status signal and determining the second position information of the first body surface patch at the second sampling moment according to the second status signal includes:

[0014] Construct an ambient magnetic field;

[0015] Determine the first position information according to the interference generated by the first magnetic field status signal on the ambient magnetic field, and determine the second position information according to the interference generated by the second magnetic field status signal on the ambient magnetic field.

[0016] In some embodiments, before receiving the first status signal generated by the first body surface patch at the first sampling moment, the monitoring method further includes:

[0017] Generate a test magnetic field; the first body surface patch is located within the coverage of the test magnetic field;

[0018] The step of receiving the first status signal generated by the first body surface patch at the first sampling moment and receiving the second status signal generated by the first body surface patch at the second sampling moment includes:

[0019] The first body surface patch generates a first induced voltage state signal in the test magnetic field at the first sampling moment and generates a second induced voltage state signal in the test magnetic field at the second sampling moment;

[0020] Determining the first position information of the first body surface patch at the first sampling moment according to the first state signal and determining the second position information of the first body surface patch at the second sampling moment according to the second state signal includes:

[0021] Determining a first magnetic field strength according to the first induced voltage state signal, determining the first position information according to the first magnetic field strength; and determining a second magnetic field strength according to the second induced voltage state signal, determining the second position information according to the second magnetic field strength.

[0022] In some embodiments, the first position information includes first position coordinates, and the second position information includes second position coordinates;

[0023] After determining the first position information of the first body surface patch at the first sampling moment according to the first state signal and determining the second position information of the first body surface patch at the second sampling moment according to the second state signal, the monitoring method further includes:

[0024] Determining the movement speed of the first body surface patch according to the first position coordinates and the second position coordinates; and sending a prompt message when the movement speed exceeds a preset movement speed threshold;

[0025] The first position coordinates are (x1, y1, z1), and the second position coordinates are (x2, y2, z2); the movement speed of the first body surface patch is determined based on the following formula:

[0026] Δx = x2 - x1; Δy = y2 - y1; Δz = z2 - z1;

[0027]

[0028] v = L1 / (t2 - t1);

[0029] Wherein, the first position coordinates are (x1, y1, z1), the second position coordinates are (x2, y2, z2); v is the movement speed; t1 is the first sampling moment, and t2 is the second sampling moment.

[0030] In some embodiments, before receiving the second state signal generated by the first body surface patch at the second sampling moment, the monitoring method further includes:

[0031] Taking the position coordinates of the center of the test magnetic field as the first coordinate base point and the first position coordinates as the second coordinate base point;

[0032] Measure the position of the first body surface patch at the first sampling moment and calculate the distance between the position and the center of the test magnetic field; calibrate the second coordinate base point according to the distance.

[0033] In some embodiments, before receiving the first status signal generated by the first body surface patch at the first sampling moment, the monitoring method further includes:

[0034] Sending a test electrical signal;

[0035] The receiving the first status signal generated by the first body surface patch at the first sampling moment and receiving the second status signal generated by the first body surface patch at the second sampling moment includes:

[0036] The first body surface patch receives the test electrical signal and generates a first electrical status signal at the first sampling moment, and receives the test electrical signal and generates a second electrical status signal at the second sampling moment;

[0037] The determining the first position information of the first body surface patch at the first sampling moment according to the first status signal and determining the second position information of the first body surface patch at the second sampling moment according to the second status signal includes:

[0038] Substituting the signal characteristics of the first electrical status signal into a preset positioning model to determine the first position information; and substituting the signal characteristics of the second electrical status signal into the preset positioning model to determine the second position information.

[0039] In some embodiments, the test electrical signal includes a plurality of test sub-signals sent by a plurality of signal transceivers;

[0040] The receiving the first status signal generated by the first body surface patch at the first sampling moment and receiving the second status signal generated by the first body surface patch at the second sampling moment further includes:

[0041] The first body surface patch generates a plurality of first sub-status signals corresponding to each of the test sub-signals at the first sampling moment, and generates a plurality of second sub-status signals corresponding to each of the test sub-signals at the second sampling moment;

[0042] The determining the first position information of the first body surface patch at the first sampling moment according to the first status signal and determining the second position information of the first body surface patch at the second sampling moment according to the second status signal further includes:

[0043] Determine a plurality of first distances between the first body patch and each of the signal transceivers according to the signal characteristics of each of the first sub-state signals; each of the signal transceivers constructs a plurality of first signal spaces centered on itself, and determines the position information of the overlapping region of the plurality of first signal spaces as the first position information of the first body patch at the first sampling moment;

[0044] Determine a plurality of second distances between the first body patch and each of the signal transceivers according to the signal characteristics of each of the second sub-state signals; each of the signal transceivers constructs a plurality of second signal spaces centered on itself, and determines the position information of the overlapping region of the plurality of second signal spaces as the second position information of the first body patch at the second sampling moment.

[0045] In some embodiments, the monitoring method further includes:

[0046] The first body patch emits a retest electrical signal;

[0047] Each of the signal transceivers receives the retest electrical signal at a third sampling moment respectively, and determines a plurality of third distances between the first body patch and each of the signal transceivers respectively according to the received plurality of retest electrical signals;

[0048] When the third sampling moment is the first sampling moment, compare the plurality of third distances with the plurality of first distances to review each of the first distances;

[0049] When the third sampling moment is the second sampling moment, compare the plurality of second distances with the plurality of first distances to review each of the second distances.

[0050] In some embodiments, the signal transceivers are integrated in second body patches; the monitoring method further includes:

[0051] Arrange the plurality of second body patches in a fixed body area.

[0052] According to some embodiments, on the other hand, the present application provides an ablation monitoring device, the ablation device includes; the ablation monitoring device includes:

[0053] A first body patch;

[0054] A state signal receiving unit, connected to the first body patch, for receiving a first state signal generated by the first body patch at a first sampling moment and receiving a second state signal generated by the first body patch at a second sampling moment;

[0055] A position information determining unit, connected to the state signal receiving unit, is configured to determine first position information of the first body surface patch at the first sampling moment according to the first state signal, and determine second position information of the first body surface patch at the second sampling moment according to the second state signal;

[0056] A judging unit, connected to the position information determining unit, is configured to determine a displacement amount of the first body surface patch according to the first position information and the second position information; and send a prompt message when the displacement amount exceeds a preset displacement threshold.

[0057] The embodiments of the present application may / at least have the following advantages:

[0058] In the embodiments of the present application, the first body surface patch is pre-fixed on a target body surface area (such as the bottom of the chest cavity near the diaphragm, the abdomen, the back, the armpit, etc.). During the cryoablation process, the first state signal generated by the first body surface patch can be received at the first sampling moment, and the second state signal generated by the first body surface patch can be received at the second sampling moment; then, the first position information of the first body surface patch at the first sampling moment is determined according to the first state signal, and the second position information of the first body surface patch at the second sampling moment is determined according to the second state signal, so that the displacement amount of the first body surface patch can be determined according to the first position information and the second position information. In this way, the quantification of the movement change of the diaphragm during the ablation process is realized. When the displacement amount exceeds the preset displacement threshold, it means that the motor function of the diaphragm has been affected to a certain extent, that is, the risk of phrenic nerve injury is about to exceed the controllable range, and a prompt message is sent, so as to help the operator judge whether the phrenic nerve is damaged in time during the cryoablation process, which helps the operator make a judgment on whether the phrenic nerve injury occurs and whether to abort the operation. To a certain extent, it can get rid of the bondage of empirical subjective judgment, simplify the ablation learning curve, reduce the dependence on the operator's experience during the cryoablation process, is beneficial to reducing the risk of phrenic nerve injury during the cryoablation process, and simplifies the cryoablation operation process. Description of the Drawings

[0059] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained according to these drawings.

[0060] Figure 1 It is a schematic structural diagram of an ablation device used in the cryoablation process in the embodiments of the present application;

[0061] Figure 2Schematic flowchart of the ablation monitoring method provided in some embodiments of the present application;

[0062] Figure 3 Schematic flowchart of the ablation monitoring method provided in some other embodiments of the present application;

[0063] Figure 4 Schematic diagram of magnetic field induction of the first body surface patch in an ambient magnetic field in the ablation monitoring method provided in some embodiments of the present application;

[0064] Figure 5 In figure (a), it is a schematic diagram of the pose expression of the first body surface patch when constructing a coordinate system with the magnetic field generator as the origin in the ablation monitoring method provided in some embodiments of the present application; Figure 5 In figure (b), it is a schematic diagram of the pose expression of the first body surface patch when constructing a coordinate system with the first position coordinate as the origin in the ablation monitoring method provided in some embodiments of the present application;

[0065] Figure 6 Schematic flowchart of the ablation monitoring method provided in still some other embodiments of the present application;

[0066] Figure 7 In figure (a), it is a schematic diagram of the structure of the coil provided in some embodiments of the present application; Figure 7 In figure (b), it is a schematic diagram of the structure of the coil provided in some other embodiments of the present application.

[0067] Explanation of reference numerals:

[0068] 1. Balloon catheter; 2. Handle; 3. Sheath; 4. Ablation medium supply unit; 5. First body surface patch; 6. Control device; 7. Display device; 8. Magnetic field generator; 9. First body surface patch substrate; 101. Vortex coil; 102. Spiral coil; 12. Weak magnetic field. Detailed implementation manners

[0069] To facilitate the understanding of the present application, the present application will be described more comprehensively below with reference to the relevant attached drawings. Embodiments of the present application are shown in the attached drawings. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present application more thorough and comprehensive.

[0070] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present application belongs. The terms used in the specification of the present application herein are only for the purpose of describing specific embodiments and are not intended to limit the present application.

[0071] It will be appreciated that the terms "first", "second", etc. used in the present application may be used herein to describe various elements, but these elements are not limited by these terms. These terms are only used to distinguish a first element from another element. For example, without departing from the scope of the present application, the first sampling moment may be referred to as the second sampling moment, and similarly, the second sampling moment may be referred to as the first sampling moment. Both the first sampling moment and the second sampling moment are sampling moments, but they are not the same sampling moment.

[0072] It will be appreciated that for "connection" in the following embodiments, if there is a transfer of electrical signals or data between the connected circuits, modules, units, etc., it should be understood as "electrical connection", "communication connection", etc.

[0073] As used herein, the singular forms "a", "an" and "the" may also include the plural forms unless the context clearly dictates otherwise. It should also be understood that the terms "comprise / include" or "have" etc. specify the presence of the stated features, wholes, steps, operations, components, parts or combinations thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts or combinations thereof. At the same time, the term "and / or" used in this specification includes any and all combinations of the related listed items.

[0074] Patients with atrial fibrillation have a high risk of stroke. When in atrial fibrillation, the atrium beats irregularly and rapidly, losing its systolic function. Blood is prone to stagnate in the atrium and form thrombi. When the thrombi break off and enter the brain through the artery, a stroke occurs. Ablation therapy is one of the most effective treatment measures at present. By means of an interventional catheter, energy is applied to the pulmonary veins for ablation to isolate the pulmonary vein potential and achieve the therapeutic effect.

[0075] Among them, cryoablation is based on anatomical considerations and uses the contact between the balloon and the tissue for freezing, with characteristics such as being disposable and continuous. Among them, the balloon mainly realizes cryoablation based on the Joule-Thomson effect, that is, the throttling expansion effect. This effect means that when a high-pressure fluid passes through a fine capillary to reach a low-pressure area, the temperature drop caused by the expansion and heat absorption of the fluid. At the beginning of cryoablation, the refrigerant is pressurized and cooled and liquefied through the built-in device of the cryoablation equipment and then reaches the inside of the balloon through the capillary. After the liquefied refrigerant is ejected through the small holes on the surface of the capillary, it quickly vaporizes and expands, quickly taking away the temperature inside the balloon, so that the balloon cools down significantly to achieve the cryoablation effect.

[0076] However, during cryoablation, since the ablation site is often close to the phrenic nerve, too low a temperature can cause phrenic nerve injury. Phrenic nerve injury is one of the most common complications of cryoablation, and can be divided into: transient phrenic nerve dysfunction, phrenic nerve palsy, and persistent or permanent phrenic nerve palsy according to the degree and duration of the injury. In the vast majority of cases, the phrenic nerve injury that occurs during cryoablation is transient, and most can recover during or some time after the operation. The occurrence of phrenic nerve injury is related to the right superior pulmonary vein, superior vena cava, and left atrial appendage. Taking the right phrenic nerve as an example, since it runs along the anterior side wall of the superior vena cava and the right atrium, and runs together with the right ventricular superior pulmonary vein, superior vena cava, and right superior pulmonary vein, during cryoablation, it is necessary to closely monitor the phrenic nerve through pacing stimulation to avoid injury. Therefore, how to reduce the risk of phrenic nerve injury during cryoablation and get rid of the bondage of empirical subjective judgment is an urgent problem to be solved at present.

[0077] Based on this, the embodiments of the present application provide an ablation monitoring method and device, which can timely judge whether the phrenic nerve is damaged during cryoablation, and is beneficial to reducing the risk of phrenic nerve injury during cryoablation.

[0078] In the embodiments of the present application, a cryoablation device can be used for cryoablation surgery. Please refer to Figure 1 , the ablation device used in the cryoablation process involved in the embodiments of the present application may include the following components: balloon catheter 1, handle 2, sheath 3, and ablation medium supply unit 4.

[0079] Among them, the handle 2 can be connected to the balloon catheter 1 through a cable or other connection means, and the balloon catheter 1 is inserted into the patient's body through the sheath 3. The ablation medium supply unit 4 can be connected to the balloon catheter 1 through the handle 2, so that the ablation medium can flow through the balloon catheter 1 into the patient's body to achieve cryoablation. The first body surface patch 5 can be connected to the monitoring device through a cable or other connection means to monitor and record physiological parameters during the treatment process.

[0080] Please refer to Figure 2 , according to some embodiments, on the one hand, the embodiments of the present application provide an ablation monitoring method, including the following steps:

[0081] S100: Fix the first body surface patch 5 on the target area of the body surface.

[0082] S200: Receive the first status signal generated by the first body surface patch 5 at the first sampling moment, and receive the second status signal generated by the first body surface patch 5 at the second sampling moment.

[0083] S300: Determine the first position information of the first body surface patch 5 at the first sampling moment according to the first status signal, and determine the second position information of the first body surface patch 5 at the second sampling moment according to the second status signal.

[0084] S400: Determine the displacement of the first body surface patch 5 based on the first position information and the second position information; and send a prompt message when the displacement exceeds a preset displacement threshold.

[0085] In the ablation monitoring method provided in the above embodiment, the first body surface patch 5 is pre-fixed to the body surface target area (such as the bottom of the chest near the diaphragm, the abdomen, the back, and the armpit, etc.). During the cryoablation process, the first state signal generated by the first body surface patch 5 can be received at the first sampling moment, and the second state signal generated by the first body surface patch 5 can be received at the second sampling moment. Then, the first position information of the first body surface patch 5 at the first sampling moment is determined according to the first state signal, and the second position information of the first body surface patch 5 at the second sampling moment is determined according to the second state signal. Thus, the displacement of the first body surface patch 5 can be determined based on the first position information and the second position information. In this way, the quantification of the diaphragmatic movement change during the ablation process is realized. When the displacement exceeds the preset displacement threshold, it means that the motor function of the diaphragm has been affected to a certain extent, that is, the risk of phrenic nerve injury is about to exceed the controllable range, and then a prompt message is sent to help the operator judge whether the phrenic nerve is damaged in time during the cryoablation process, and to a certain extent, it can get rid of the bondage of subjective judgment based on experience and simplify the ablation learning curve. Compared with the current method that only relies on the operator's subjective experience to judge whether to stop cryoablation, the above monitoring method reduces the dependence on the operator's experience during the cryoablation process, which is beneficial to reducing the risk of phrenic nerve injury during the cryoablation process and simplifying the cryoablation surgical process.

[0086] Exemplarily, as Figure 3 shown, after the prompt message is sent in this ablation monitoring method, the operator can judge whether to continue ablation; if so, continue ablation, if not, stop the operation. If the displacement does not exceed the preset displacement threshold, continue ablation until the operation stops.

[0087] It should be understood that although Figure 2 the steps in the flowchart of Figure 2 are shown in sequence according to the arrows, these steps are not necessarily executed in the order indicated by the arrows. Unless there is a clear indication in this article, the execution of these steps has no strict order limit, and these steps can be executed in other orders. Moreover,

[0088] In step S100, the target area can be, for example, the bottom of the chest cavity near the diaphragm, the abdomen, the back, the armpit, etc., but is not limited thereto. The number of target areas can be one or multiple, both are allowed.

[0089] The phrenic nerve is mainly responsible for controlling the movement of the diaphragm. The diaphragm is a respiratory muscle located between the chest cavity and the abdominal cavity. Therefore, it is possible to judge whether the phrenic nerve is damaged by monitoring the contraction and relaxation of the diaphragm. The first body patch 5 is fixed to the bottom of the chest cavity, the abdomen, the back, the armpit and other parts of the body surface near the diaphragm, so that the contraction and relaxation of the diaphragm can be monitored by observing the movement of the first body patch 5, and whether there is a risk of damage to the phrenic nerve can be judged accordingly.

[0090] As an example, after the first body patch 5 is fixed to the target area, information can be transmitted through a wire.

[0091] In some embodiments, step S200 can be specifically embodied as the following steps:

[0092] The first body patch 5 is energized at the first sampling moment to generate a first magnetic field state signal, and is energized at the second sampling moment to generate a second magnetic field state signal.

[0093] As an example, the first body patch 5 can include a dischargeable electrode.

[0094] In the above embodiments, step S300 can be specifically embodied as the following steps:

[0095] Construct an environmental magnetic field; determine the first position information according to the interference generated by the first magnetic field state signal on the environmental magnetic field, and determine the second position information according to the interference generated by the second magnetic field state signal on the environmental magnetic field.

[0096] As an example, as Figure 4 shown, a magnetic field generator 8 can be used, but is not limited thereto, to construct an environmental magnetic field. The coverage area of the environmental magnetic field can be called a strong magnetic field area. The environmental magnetic field can be constructed first, and then step S200 is executed to generate the first magnetic field state signal and the second magnetic field state signal.

[0097] Please continue to combine Figure 4It is understood that the ablation monitoring method provided in the above embodiments mainly uses the electro-magnetic principle to construct a weak magnetic field 12, and determines the position information of the weak magnetic field 12 by disturbing the shape and / or distribution of the magnetic induction lines in the strong magnetic field region with the weak magnetic field 12. Specifically, in the strong magnetic field region, each first body surface patch 5 is energized to form a weak magnetic field 12, and the magnetic induction lines of the ambient magnetic field will be disturbed by the weak magnetic field 12, resulting in changes in the shape and / or distribution of the magnetic induction lines of the ambient magnetic field. Based on this, by observing the changes in the magnetic induction lines of the ambient magnetic field, the interference caused by the weak magnetic field 12 can be monitored and analyzed, so that the existence and location of the weak magnetic field 12 can be known accordingly, and then the position information of the first body surface patch 5 can be determined.

[0098] In the above ablation monitoring method, the weak magnetic field 12 formed by energizing the first body surface patch 5 at the first sampling moment can be defined as the first magnetic field state signal, and the weak magnetic field 12 formed by energizing the first body surface patch 5 at the second sampling moment can be defined as the second magnetic field state signal. Thus, the first position information can be determined according to the interference generated by the first magnetic field state signal on the ambient magnetic field, and the second position information can be determined according to the interference generated by the second magnetic field state signal on the ambient magnetic field.

[0099] In some other embodiments, a test magnetic field can be generated before step S200 is executed.

[0100] As an example, by setting the position of the test magnetic field, the first body surface patch 5 can be made to fall within the coverage of the test magnetic field.

[0101] Exemplarily, the magnetic field generator 8 can be installed under the operating table to construct a test magnetic field.

[0102] In some other embodiments, step S200 can be specifically embodied as the following steps:

[0103] The first body surface patch 5 generates a first induced voltage state signal in the test magnetic field at the first sampling moment and generates a second induced voltage state signal in the test magnetic field at the second sampling moment.

[0104] In the above embodiments, step S300 can be specifically embodied as the following steps:

[0105] Determine the first magnetic field strength according to the first induced voltage state signal, and determine the first position information according to the first magnetic field strength; and determine the second magnetic field strength according to the second induced voltage state signal, and determine the second position information according to the second magnetic field strength.

[0106] In the ablation monitoring method provided in the above embodiments, the first body surface patch 5 functions as a magnetic induction positioning sensor, and can determine the position information by using the change in the magnetic field strength. Specifically, when the first body surface patch 5 is within the coverage range of the test magnetic field, an induced voltage will be generated. Therefore, the magnetic field strength and the position of the first body surface patch 5 itself in the test magnetic field can be determined by measuring the magnitude of the induced voltage.

[0107] In the above ablation monitoring method, when the first body surface patch 5 is within the coverage range of the test magnetic field, a first induced voltage state signal is generated at the first sampling moment. By measuring the magnitude of the first induced voltage state signal, the magnetic field strength at the position of the first body surface patch 5 at the first sampling moment is determined, so as to determine the position of the first body surface patch 5 in the test magnetic field at this time. A second induced voltage state signal is generated at the second sampling moment. By measuring the magnitude of the second induced voltage state signal, the magnetic field strength at the position of the first body surface patch 5 at the second sampling moment is determined, so as to determine the position of the first body surface patch 5 in the test magnetic field at this time.

[0108] As an example, the magnetic field strength of the test magnetic field generated by the magnetic field generator 8 in the target area can be recorded in advance and stored in the database. During actual use, after obtaining the magnetic field strength at the position of the first body surface patch 5 by measuring the magnitude of the induced voltage, a matching algorithm can be used to match this magnetic field strength with the information in the database, so as to determine the specific position where the first body surface patch 5 is currently located.

[0109] As an example, the first position information may include first position coordinates, and the second position information may include second position coordinates. Exemplarily, as shown in FIG. (a) Figure 5 shown, a three-dimensional coordinate system is established with the center of the magnetic field generator 8 as the reference point, and the position coordinates of the center of the magnetic field generator 8 are defined as (0, 0, 0).

[0110] In some embodiments, after determining the first position information of the first body surface patch 5 at the first sampling moment and the second position information of the first body surface patch 5 at the second sampling moment, the monitoring method may further include the following steps:

[0111] Determine the movement speed of the first body surface patch 5 according to the first position coordinates and the second position coordinates; and send a prompt message when the movement speed exceeds the preset movement speed threshold.

[0112] Since the phrenic nerve will be stimulated during cryoablation, resulting in periodic contraction and relaxation of the diaphragm, the movement speed of the diaphragm is within the preset movement speed threshold during this process. The main manifestation of phrenic nerve injury during cryoablation is diaphragmatic paralysis. When diaphragmatic paralysis occurs, the periodic contraction and relaxation of the diaphragm decrease, resulting in a decrease in the movement speed. As shown in Figure 6As shown, when the movement speed drops below the preset movement speed threshold, it indicates that the diaphragm movement is abnormal at this time and there is a risk of phrenic nerve injury.

[0113] In the ablation monitoring method provided in the above embodiment, when the movement speed of the first body surface patch 5 exceeds the preset movement speed threshold, it indicates that the movement speed of the diaphragm has dropped below the preset movement speed threshold, and thus it can be determined that the diaphragm is paralyzed and the phrenic nerve is damaged.

[0114] For the sake of description, as shown in FIG. (a) in Figure 5 , the first position coordinate is H(x1, y1, z1), and the second position coordinate is K(x2, y2, z2). As an example, the movement speed of the first body surface patch 5 can be determined based on the following formula:

[0115] Δx = x2 - x1; Δy = y2 - y1; Δz = z2 - z1;

[0116]

[0117] v = L1 / (t2 - t1);

[0118] where v is the movement speed; t1 is the first sampling moment, t2 is the second sampling moment, and t2 - t1 can be referred to as a position information recording period.

[0119] As an example, according to the artificial respiration frequency of 10 times / minute and the adult respiration frequency of 16 times / minute to 20 times / minute, the position information recording period can be set to 3 s / time to 6 s / time. In this way, a complete diaphragm contraction and relaxation process can be included in one position information recording period.

[0120] Please continue to refer to Figure 5 FIG. (b) in. In some embodiments, before receiving the second state signal generated by the first body surface patch 5 in step S200, the monitoring method may further include the following steps:

[0121] Taking the position coordinate O(0, 0, 0) of the test magnetic field center as the first coordinate base point and the first position coordinate H(x1, y1, z1) as the second coordinate base point; measuring the position of the first body surface patch 5 at the first sampling moment t1 and calculating the distance between the position and the test magnetic field center O; calibrating the second coordinate base point H(x1, y1, z1) according to the distance.

[0122] It can be understood that Figure 5 the coordinate system shown in FIG. (b) in (H x , H y , H z)(It) is a coordinate system formed with the second coordinate base point H(x1, y1, z1) as the origin. In the ablation monitoring method provided in the above embodiment, before obtaining the second state signal and determining the second position information according to the second state signal, the second coordinate base point H(x1, y1, z1) is calibrated according to the distance between the initial position of the first body patch 5 (the position corresponding to the first position coordinate H(x1, y1, z1)) and the center O of the test magnetic field, so that the pose change of the first body patch 5 can be calculated more accurately.

[0123] In some other embodiments, a test electrical signal may be issued before performing step S200.

[0124] In some other embodiments, step S200 may specifically be the following steps:

[0125] The first body patch 5 receives the test electrical signal at the first sampling moment t1 and generates a first electrical state signal, and receives the test electrical signal at the second sampling moment t2 and generates a second electrical state signal.

[0126] In the above embodiment, step S300 may specifically be the following steps:

[0127] Substitute the signal characteristics of the first electrical state signal into the preset positioning model to determine the first position information; and substitute the signal characteristics of the second electrical state signal into the preset positioning model to determine the second position information.

[0128] In the ablation monitoring method provided in the above embodiment, the first body patch 5 can be used to implement the electrical positioning function, integrating the functions of electrodes and sensor elements. As an example, the signal characteristics described in the above steps may include but are not limited to signal strength, phase, arrival time, and so on.

[0129] As an example, the test electrical signal may include multiple test sub-signals emitted by multiple signal transceivers.

[0130] In some embodiments, step S200 may also specifically be the following steps:

[0131] The first body patch 5 generates a plurality of first sub-state signals corresponding to each test sub-signal at the first sampling moment t1, and generates a plurality of second sub-state signals corresponding to each test sub-signal at the second sampling moment t2.

[0132] In the above steps, each test sub-signal received by the first body patch 5 at the first sampling moment t1 is defined as a plurality of first sub-state signals, and each test sub-signal received by the first body patch 5 at the second sampling moment t2 is defined as a plurality of second sub-state signals.

[0133] In the above embodiments, the following steps may be adopted to determine the first position information of the first body surface patch 5 at the first sampling moment t1:

[0134] Determine a plurality of first distances between the first body surface patch 5 and each signal transceiver according to the signal characteristics of each first sub-state signal; each signal transceiver constructs a plurality of first signal spaces centered on itself, and determines the position information of the overlapping area of the plurality of first signal spaces as the first position information of the first body surface patch 5 at the first sampling moment t1.

[0135] Moreover, the following steps may be adopted to determine the second position information of the first body surface patch 5 at the second sampling moment t2:

[0136] Determine a plurality of second distances between the first body surface patch 5 and each signal transceiver according to the signal characteristics of each second sub-state signal; each signal transceiver constructs a plurality of second signal spaces centered on itself, and determines the position information of the overlapping area of the plurality of second signal spaces as the second position information of the first body surface patch 5 at the second sampling moment t2.

[0137] In the ablation monitoring method provided in the above embodiments, the first body surface patch 5 can receive a plurality of test sub-signals with different intensities simultaneously in the target area, and calculate the distances between each signal transceiver and the first body surface patch 5 according to the time, signal intensity and / or phase at which each test sub-signal is received. A plurality of signal transceivers can construct signal spaces centered on themselves according to the distances, and the position where the plurality of signal spaces intersect and is within the target area is the actual position of the first body surface patch 5.

[0138] In some embodiments, the ablation monitoring method may further include the following steps:

[0139] The first body surface patch 5 emits a retest electrical signal;

[0140] Each signal transceiver receives the retest electrical signal at the third sampling moment respectively, and determines a plurality of third distances between the first body surface patch 5 and each signal transceiver according to the received plurality of retest electrical signals respectively;

[0141] When the third sampling moment is the first sampling moment t1, compare the plurality of third distances with the plurality of first distances to review each first distance;

[0142] When the third sampling moment is the second sampling moment t2, compare the plurality of second distances with the plurality of first distances to review each second distance.

[0143] In the ablation monitoring method provided in the above embodiment, the first body patch 5 can send a retest electrical signal in the target area, and the multiple signal transceivers described above receive the retest electrical signal to review the first distance and / or the second distance, so as to timely detect measurement errors caused by the loss or interference of the test electrical signal during transmission.

[0144] In some embodiments, each signal transceiver can be integrated into the second body patch.

[0145] As an example, multiple second body patches can be arranged in a fixed area on the body surface.

[0146] According to some embodiments, on the other hand, the present application embodiment also provides an ablation monitoring device, which can be used to execute the ablation monitoring method provided in some of the foregoing embodiments. Therefore, the technical effects that can be achieved by the foregoing ablation monitoring method can also be achieved by this ablation monitoring device, and will not be elaborated here.

[0147] In some embodiments, the ablation monitoring device may include a first body patch 5, as well as a status signal receiving unit, a position information determining unit, and a judgment unit.

[0148] The status signal receiving unit is connected to the first body patch 5, and is configured to receive the first status signal generated by the first body patch 5 at the first sampling moment t1 and receive the second status signal generated by the first body patch 5 at the second sampling moment t2. The position information determining unit, which is connected to the status signal receiving unit, is configured to determine the first position information of the first body patch 5 at the first sampling moment t1 according to the first status signal, and determine the second position information of the first body patch 5 at the second sampling moment t2 according to the second status signal. The judgment unit is connected to the position information determining unit, and is configured to determine the displacement amount of the first body patch 5 according to the first position information and the second position information; and send a prompt message when the displacement amount exceeds a preset displacement threshold.

[0149] It should be noted that the ablation monitoring devices in the embodiments of the present application can all be used to implement the corresponding ablation monitoring method. Therefore, the technical features between the method embodiments and the device embodiments can be mutually replaced and supplemented without conflict, so that those skilled in the art can learn the technical content of the present invention.

[0150] In some embodiments, the ablation monitoring device can pre-record the magnetic field intensity of the test magnetic field generated by the magnetic field generator 8 in the target area and store it in the internal database. During actual use, after obtaining the magnetic field intensity at the position of the first body patch 5 by measuring the magnitude of the induced voltage, a matching algorithm can be used to match the magnetic field intensity with the information in the database, so as to determine the specific position where the current first body patch 5 is located.

[0151] In some embodiments, the first body surface patch 5 is used to implement the electropositioning function, integrating the functions of electrodes and sensor elements, and can use the change in magnetic field strength to determine the position information.

[0152] As an example, the first body surface patch 5 may include a coil. When a test magnetic field passes through the coil, the first body surface patch 5 generates an induced voltage. Therefore, the magnetic field strength and the position of the first body surface patch 5 itself in the test magnetic field can be determined by measuring the magnitude of the induced voltage. Among them, the coils in the first body surface patch 5 may be arranged in a vortex shape, as shown in Figure 7 Figure (a) in; or may be arranged in a spiral shape, as shown in Figure 7 Figure (b) in.

[0153] Exemplarily, the first body surface patch 5 may further include a magnetoresistive sensor (made of a magnetosensitive material, which generates a corresponding resistance change when the test magnetic field changes) and a magnetic force measurement sensor (which can measure the magnetic force it receives in the test magnetic field to determine its own position information), etc.

[0154] As an example, as shown in Figure 1 , the ablation monitoring device may further include a control device 6.

[0155] The control device 6 may include a test electrical signal generator and an electrical state signal receiver. Among them, the test electrical signal generator is used to emit a test electrical signal, and the electrical state signal receiver is used to obtain a first electrical state signal and a second electrical state signal. The judgment unit may be integrated in the control device 6, so that the control device 6 can be used to substitute the signal characteristics of the first electrical state signal into a preset positioning model to determine the first position information, and substitute the signal characteristics of the second electrical state signal into the preset positioning model to determine the second position information.

[0156] Exemplarily, a test electrical signal may also be emitted by an external electrical signal generator provided at other fixed positions, and it is not limited to the above embodiments.

[0157] As an example, as shown in Figure 1 , the ablation monitoring device may further include a display device 7. The display device 7 may be connected to the judgment unit and is used to display the prompt information sent by the judgment unit for the surgeon to view.

[0158] In the description of this specification, the descriptions referring to terms such as "some embodiments", "other embodiments", "ideal embodiments", etc. mean that the specific features, structures, materials or features described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic description of the above terms does not necessarily refer to the same embodiment or example.

[0159] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as falling within the scope described in this specification.

[0160] The above-described embodiments merely represent several implementation manners of the present application. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. An ablation monitoring method, characterized in that, Including: Fix the first body surface patch on the target area of the body surface; Receive the first status signal generated by the first body surface patch at the first sampling moment, and receive the second status signal generated by the first body surface patch at the second sampling moment; Determine the first position information of the first body surface patch at the first sampling moment according to the first status signal, and determine the second position information of the first body surface patch at the second sampling moment according to the second status signal; Determine the displacement of the first body surface patch according to the first position information and the second position information; when the displacement exceeds the preset displacement threshold, a prompt message is sent.

2. The ablation monitoring method according to claim 1, characterized in that, The step of receiving the first status signal generated by the first body surface patch at the first sampling moment and receiving the second status signal generated by the first body surface patch at the second sampling moment includes: The first body surface patch is powered on at the first sampling moment to generate a first magnetic field status signal, and is powered on at the second sampling moment to generate a second magnetic field status signal; The step of determining the first position information of the first body surface patch at the first sampling moment according to the first status signal and determining the second position information of the first body surface patch at the second sampling moment according to the second status signal includes: Construct an ambient magnetic field; Determine the first position information according to the interference generated by the first magnetic field status signal on the ambient magnetic field, and determine the second position information according to the interference generated by the second magnetic field status signal on the ambient magnetic field.

3. The ablation monitoring method according to claim 1, characterized in that, Before receiving the first status signal generated by the first body surface patch at the first sampling moment, the monitoring method further includes: Generate a test magnetic field; the first body surface patch is located within the coverage of the test magnetic field; The step of receiving the first status signal generated by the first body surface patch at the first sampling moment and receiving the second status signal generated by the first body surface patch at the second sampling moment includes: The first body surface patch generates a first induced voltage status signal in the test magnetic field at the first sampling moment, and generates a second induced voltage status signal in the test magnetic field at the second sampling moment; The step of determining the first position information of the first body surface patch at the first sampling moment according to the first status signal and determining the second position information of the first body surface patch at the second sampling moment according to the second status signal includes: Determine the first magnetic field intensity according to the first induced voltage status signal, determine the first position information according to the first magnetic field intensity; and determine the second magnetic field intensity according to the second induced voltage status signal, determine the second position information according to the second magnetic field intensity.

4. The ablation monitoring method according to claim 3, characterized in that, The first position information includes first position coordinates, and the second position information includes second position coordinates; After determining the first position information of the first body surface patch at the first sampling moment according to the first status signal and determining the second position information of the first body surface patch at the second sampling moment according to the second status signal, the monitoring method further includes: Determine the movement speed of the first body surface patch according to the first position coordinate and the second position coordinate; when the movement speed exceeds a preset movement speed threshold, a prompt message is sent. The first position coordinate is (x1, y1, z1), and the second position coordinate is (x2, y2, z2); the movement speed of the first body surface patch is determined based on the following formula: Δx = x2 - x1; Δy = y2 - y1; Δz = z2 - z1; v = L1 / (t2 - t1); wherein, the first position coordinate is (x1, y1, z1), the second position coordinate is (x2, y2, z2); v is the movement speed; t1 is the first sampling moment, and t2 is the second sampling moment.

5. The ablation monitoring method according to claim 4, characterized in that, Before receiving the second state signal generated by the first body surface patch at the second sampling moment, the monitoring method further includes: Using the position coordinate of the center of the test magnetic field as the first coordinate base point, and using the first position coordinate as the second coordinate base point; Measure the position of the first body surface patch at the first sampling moment, and calculate the distance between the position and the center of the test magnetic field; calibrate the second coordinate base point according to the distance.

6. The ablation monitoring method according to claim 1, characterized in that, Before receiving the first state signal generated by the first body surface patch at the first sampling moment, the monitoring method further includes: Sending a test electrical signal; Receiving the first state signal generated by the first body surface patch at the first sampling moment and receiving the second state signal generated by the first body surface patch at the second sampling moment includes: The first body surface patch receives the test electrical signal and generates a first electrical state signal at the first sampling moment, and receives the test electrical signal and generates a second electrical state signal at the second sampling moment; Determining the first position information of the first body surface patch at the first sampling moment according to the first state signal, and determining the second position information of the first body surface patch at the second sampling moment according to the second state signal includes: Substituting the signal characteristics of the first electrical state signal into a preset positioning model to determine the first position information; and substituting the signal characteristics of the second electrical state signal into the preset positioning model to determine the second position information.

7. The ablation monitoring method according to claim 6, wherein The test electrical signal includes multiple test sub-signals sent by multiple signal transceivers; Receiving the first state signal generated by the first body surface patch at the first sampling moment and receiving the second state signal generated by the first body surface patch at the second sampling moment further includes: The first body surface patch generates multiple first sub-state signals corresponding to each of the test sub-signals at the first sampling moment, and generates second sub-state signals corresponding to each of the test sub-signals at the second sampling moment; Determining the first position information of the first body surface patch at the first sampling moment according to the first state signal, and determining the second position information of the first body surface patch at the second sampling moment according to the second state signal further includes: Determine a plurality of first distances between the first body patch and each of the signal transceivers according to the signal characteristics of the first sub-state signals; each of the signal transceivers constructs a plurality of first signal spaces centered on itself, and determines the position information of the overlapping region of the plurality of first signal spaces as the first position information of the first body patch at the first sampling moment; Determine a plurality of second distances between the first body patch and each of the signal transceivers according to the signal characteristics of the second sub-state signals; each of the signal transceivers constructs a plurality of second signal spaces centered on itself, and determines the position information of the overlapping region of the plurality of second signal spaces as the second position information of the first body patch at the second sampling moment.

8. The ablation monitoring method according to claim 7, wherein The monitoring method further includes: The first body patch emits a retest electrical signal; Each of the signal transceivers receives the retest electrical signal at the third sampling moment, and respectively determines a plurality of third distances between the first body patch and each of the signal transceivers according to the received plurality of retest electrical signals; When the third sampling moment is the first sampling moment, compare the plurality of third distances with the plurality of first distances to verify each of the first distances; When the third sampling moment is the second sampling moment, compare the plurality of second distances with the plurality of first distances to verify each of the second distances.

9. The ablation monitoring method according to claim 7, wherein The signal transceivers are integrated in the second body patches; the monitoring method further includes: Arrange a plurality of the second body patches in a body surface fixed area.

10. An ablation monitoring device, wherein The ablation monitoring device includes: A first body patch; A state signal receiving unit connected to the first body patch; configured to receive a first state signal generated by the first body patch at a first sampling moment and receive a second state signal generated by the first body patch at a second sampling moment; A position information determining unit connected to the state signal receiving unit, configured to determine first position information of the first body patch at the first sampling moment according to the first state signal and determine second position information of the first body patch at the second sampling moment according to the second state signal; A judgment unit connected to the position information determining unit, configured to determine a displacement amount of the first body patch according to the first position information and the second position information; and emit a prompt message when the displacement amount exceeds a preset displacement threshold.

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