KR102614479B1 - Method and device for assessinng renal denervation - Google Patents

Abstract

The embodiment includes acquiring first blood flow data in the first region after the vasodilator injected into the first region within the renal blood vessel is activated in the second region within the renal blood vessel; and acquiring second blood flow data in the first region after renal nerve ablation (denervation) is performed using a nerve ablation catheter.
In addition, the embodiment includes a first input unit for inputting first blood flow data obtained in the first region after the vasodilator injected into the first region within the renal blood vessel is activated in the second region; and a second input unit for inputting second blood flow data obtained in the first region after performing renal nerve ablation using a catheter.

Description

Method and device for evaluating renal nerve ablation results {METHOD AND DEVICE FOR ASSESSINNG RENAL DENERVATION}

The embodiment relates to a method and device for evaluating the results of renal nerve ablation. More specifically, it relates to a method and device for evaluating the results of renal nerve ablation that easily evaluates whether the renal nerve ablation of the sympathetic nerve is performed after injection of a vasodilator.

Abnormally high sympathetic nerve activation exists in patients with chronic diseases such as hypertension, kidney disease, heart failure, diabetes, etc. Resistant hypertension, which accounts for 20-30% of all hypertensive patients, does not control blood pressure below the target level even after taking three or more antihypertensive drugs, including diuretics. Therefore, to treat chronic diseases, sympathetic nerve treatment such as renal sympathetic depression is recommended. Control was used.

A representative treatment for resistant hypertension is nerve ablation, which involves cutting the renal nerves that transmit signals to the Renin-Angiotensin-Aldosterone System (RAAS), which is one of the important mechanisms related to blood pressure control. This is a treatment method that can lower blood pressure by reducing nervous system activity. At this time, the renal sympathetic nerves exist in the subdermal layer of the renal artery, and the afferent and efferent sympathetic nerves also exist in the renal artery, so renal nerve resection for the treatment of high blood pressure is performed in the renal artery.

Meanwhile, it is necessary to check whether the renal nerve ablation has been sufficiently achieved through the above-described renal nerve denervation procedure and, if insufficient, to ensure renal nerve ablation through re-treatment. However, if it takes too much time to check and evaluate the results of the procedure or makes the patient wait for a long time, it not only reduces the effectiveness of the procedure but also makes the patient suffer. Therefore, it is important to quickly and accurately confirm and evaluate the results of renal nerve resection procedures.

U.S. published patent 2018-0333204 (2018.11.22)

The method and device for evaluating renal nerve resection results according to the present invention inject a vasodilator (e.g., dopamine, dobutamine, adenosine, prostacyclin, nitric oxide, etc.) into the renal vasculature, while minimizing the direct effect on the renal artery. By determining the injection location of the vasodilator so that the vasodilator is activated in the renal arteriole or renal capillary (hereinafter collectively referred to as 'renal arteriole') connected to the renal artery, data on blood flow within the renal artery in a state of maximum vasodilation of the renal arteriole Provides a renal nerve ablation result evaluation method and device that obtains and accurately evaluates renal nerve ablation.

In other words, the method and device for evaluating renal nerve ablation results according to the present invention inject a vasodilator into a specific location of the renal artery (i.e., first region) to minimize the time it stays in the renal artery, thereby significantly reducing the diameter or size of the renal artery blood vessel. Assessment of renal nerve ablation is performed using blood flow data obtained through activated and dilated renal arterioles predominantly in the renal arterioles (i.e., zone 2) without affecting the renal arterioles.

At this time, when a vasodilator is injected into a specific location of the renal artery, the renal arterioles can be dilated to the maximum blood vessel level without affecting the vasodilation of the renal artery. And only by measuring the blood flow in the activated state can the blood flow in the renal artery be accurately measured. Here, blood flow refers to the amount of blood flowing through blood vessels per unit time. The blood flow in the renal artery must be measured while minimizing the effect of vasodilators on the renal artery and maximally dilating the blood vessels in the renal arterioles in order to accurately measure the maximum blood flow unique to each patient.

Accordingly, the method and device for evaluating the results of renal nerve ablation according to the present invention can obtain blood flow data in the same state as the state in which the sympathetic nerve was ablated from the renal artery.

Therefore, the method and device for evaluating renal nerve ablation results according to the present invention include the maximum blood flow data (first blood flow data) in the renal artery unique to each patient and the blood flow data (first blood flow data) in the renal artery obtained after renal nerve ablation by a catheter was performed. 2 blood flow data), evaluation and judgment on renal nerve resection can be made quickly and accurately, minimizing the burden on the patient.

In addition, based on the comparison results between the blood flow data (first and second blood flow data), if it is above a certain threshold, it can be judged that the procedure was successful, and if it is below a certain threshold, it can be determined that the procedure was not performed properly, so reoperation is necessary. You can judge whether it is.

In addition, the method and device for evaluating renal nerve resection results according to an embodiment can obtain information about blood flow in the renal artery in the state of maximum vasodilation by injecting a vasodilator into the renal vasculature before renal nerve resection. In other words, the method and device for evaluating nephrectomy results can obtain blood flow information that is not affected by the compound factors of blood vessels that occur after renal nerve ablation. For example, compound factors in blood vessels may include muscle cramps (spasm) due to stimulation of the pain nerve (ache nerve) after nerve resection, changes in blood pressure due to stimulation of the sympathetic nerve, etc. In other words, if information on blood flow in the state of maximum vasodilation is obtained by injecting a vasodilator into the renal blood vessels after renal nerve resection, the results will be different from those before renal nerve resection, making it impossible to obtain accurate comparison value information.

In addition, the method and device for evaluating the results of renal nerve resection according to another embodiment of the present invention additionally uses the usual blood flow data of different patients according to the patient's physical condition or stage of the disease in addition to the above-mentioned information to measure renal nerve ablation results through a catheter. Evaluation and judgment regarding nerve resection can be performed quickly and accurately.

Specifically, the method and device for evaluating renal nerve ablation results according to another embodiment acquires the patient's usual blood flow data (base blood flow data), so that even if the usual blood flow data is different for each patient, the method and device are based on the usual blood flow data for each patient. By comparing the first blood flow data and the second blood flow data, it is possible to accurately evaluate renal nerve ablation for each patient.

Furthermore, the renal nerve ablation result evaluation method and device according to the present invention compares the ratio of the difference between the usual blood flow data and each of the above-mentioned first and second blood flow data with a threshold value to determine whether the renal nerve ablation procedure was successful for each patient. can be judged easily and accurately. In addition, the method and device for evaluating the results of renal nerve resection can easily determine whether to perform a repeat procedure if the ratio is below a certain threshold, as this is a result of the procedure not being performed properly.

In addition, by obtaining the patient's usual blood flow data (base blood flow data) before administering the vasodilator, changes in blood flow data due to the vasodilator or renal nerve ablation can be eliminated. As a result, it is possible to obtain reference data (usual blood flow data) for more accurate evaluation of renal nerve resection results.

The problem to be solved in the embodiment is not limited to this, and it will also include means of solving the problem described below and purposes and effects that can be understood from the embodiment.

A method for evaluating renal nerve ablation results according to an embodiment includes the steps of acquiring first blood flow data in the first region after the vasodilator injected into the first region within the renal blood vessel is activated in the second region within the renal blood vessel; and acquiring second blood flow data in the first region after renal nerve denervation is performed using a nerve ablation catheter.

It may further include comparing the first blood flow data and the second blood flow data.

The renal nerve resection results can be evaluated according to the results of comparing the first blood flow data and the second blood flow data.

If the compared result is lower than a predetermined threshold, the step of re-performing renal nerve ablation can be repeated.

calculating a first difference value representing a difference value between the first blood flow data and base blood flow data; calculating a second difference value representing a difference between the second blood flow data and the base blood flow data; and comparing the first difference value and the second difference value.

The renal nerve ablation result can be evaluated according to the result of comparing the first difference value and the second difference value.

If the compared result is lower than a predetermined threshold, the step of re-performing renal nerve ablation can be repeated.

The base blood flow data may be acquired before injecting the vasodilator, or between the step of acquiring the first blood flow data and the step of performing the renal nerve denervation.

The base blood flow data or the second blood flow data may be acquired when the half-life has elapsed after the vasodilator is injected into the first region.

The second region may be a renal arteriole or a renal capillary.

The vasodilators include dopamine, dobutamine, adenosine, prostacyclin, nitric oxide, bradykinin, papaverine, dipyridamolum, diuretin, theophylline, and minoxidil ( minoxidil) or isosorbide nitrate.

An apparatus for evaluating renal nerve ablation results according to an embodiment includes: a first input unit for inputting first blood flow data obtained in the first region after the vasodilator injected into the first region within the renal blood vessel is activated in the second region; and a second input unit for inputting second blood flow data obtained in the first region after performing renal nerve ablation using a catheter.

It may further include a first calculation unit that calculates a ratio between the first blood flow data input by the first input unit and the second blood flow data input by the second input unit.

It may further include an evaluation unit that evaluates the renal nerve resection results by comparing the ratio between the first blood flow data and the second blood flow data calculated by the first calculation unit with a first threshold.

It may further include a third input unit for inputting base blood flow data in the first area before injection of the vasodilator.

It further includes a second calculation unit that calculates a ratio between the first difference value and the second difference value, wherein the first difference value is a difference value between the first blood flow data and the base blood flow data, and the second difference value is may be a difference value between the second blood flow data and the base blood flow data.

It may further include an evaluation unit that evaluates the renal nerve ablation result by comparing the ratio between the first difference value and the second difference value calculated by the second calculation unit with a second threshold value.

It may further include a display unit that displays the evaluation results of the evaluation unit.

It may further include an output unit that outputs an audio signal or a video signal according to the evaluation result of the evaluation unit.

The first blood flow data, the second blood flow data, and the base blood flow data may be obtained from blood flow information detected by a detection means disposed on the catheter.

The blood flow information may include at least one of blood flow volume, blood flow speed, and blood flow resistance.

The detection means may include any one of an ultrasonic sensor, an impedance sensor, and an optical sensor.

The ultrasonic sensor may include a Doppler sensor.

The impedance value may be detected by the electrode of the catheter or the impedance value may be detected by a separate sensor.

The catheter may include the vasodilator injection unit.

According to an embodiment, it is possible to obtain intravascular blood flow data of the renal artery immediately after renal nerve resection, thereby providing a method and device for evaluating renal nerve resection results that reduce the procedure time.

In addition, by comparing the maximum blood flow data unique to each patient with the blood flow data after performing renal nerve ablation, it is possible to provide a method and device for evaluating renal nerve ablation results that can more accurately perform patient-specific evaluation of the nerve ablation procedure.

In addition, it is possible to provide a method and device for evaluating renal nerve resection results that reduce the patient's physical burden by reducing the procedure time, including evaluation of renal nerve resection results.

Additionally, a method and device for evaluating renal nerve resection results that do not directly expand the blood vessels of the renal artery can be provided.

In addition, a renal nerve ablation result evaluation method and device that can quickly and accurately perform evaluation and judgment on renal nerve ablation through a catheter by additionally using the usual blood flow data of different patients depending on the patient's physical condition or disease stage can be provided. In other words, it is possible to provide a renal nerve resection result evaluation method and device that accurately evaluates the renal nerve resection results for each patient even if each patient's condition is different.

The various and beneficial advantages and effects of the present invention are not limited to the above-described content, and may be more easily understood through description of specific embodiments of the present invention.

1 is a schematic diagram of a renal nerve ablation system according to an embodiment;
Figure 2 is a diagram illustrating a method for evaluating renal nerve resection results according to an embodiment;
Figure 3 is a perspective view schematically showing the configuration of the distal end side of the catheter according to the embodiment;
Figure 4 is a diagram showing a portion of Figure 2,
Figure 5 is a flowchart of a method for evaluating renal nerve ablation results according to an embodiment;
Figure 6 is a flowchart of a method for evaluating renal nerve ablation results according to another embodiment;
Figure 7 is a flowchart of a method for evaluating renal nerve ablation results according to another embodiment;
Figure 8 is a diagram illustrating a method of acquiring base blood flow data in the method for evaluating renal nerve ablation results according to the present invention;
Figure 9 is a diagram illustrating an example of a method for obtaining blood flow data;
Figure 10 is a diagram showing another example explaining a method of acquiring blood flow data;
Figure 11 is a diagram showing another example explaining a method of acquiring blood flow data;
Figure 12 is a diagram illustrating vasodilator injection in the method for evaluating renal nerve ablation results according to an embodiment;
Figure 13 is a diagram illustrating a method of acquiring first blood flow data in the method for evaluating renal nerve ablation results according to an embodiment;
Figure 14 is a graph of the action of a vasodilator in the method for evaluating renal nerve ablation results according to an embodiment;
Figure 15 is a diagram illustrating a method of obtaining renal nerve ablation and second blood flow data using a catheter in the renal nerve ablation result evaluation method according to an embodiment;
16 is a flowchart illustrating comparison of first blood flow data and second blood flow data in the method for evaluating renal nerve ablation results according to an embodiment;
Figure 17 is a block diagram of an apparatus for evaluating renal nerve ablation results according to an embodiment.

Since the present invention can be subject to various changes and can have various embodiments, specific embodiments will be illustrated and described in the drawings. However, this is not intended to limit the present invention to specific embodiments, and should be understood to include all changes, equivalents, and substitutes included in the spirit and technical scope of the present invention.

Terms containing ordinal numbers, such as second, first, etc., may be used to describe various components, but the components are not limited by the terms. The above terms are used only for the purpose of distinguishing one component from another. For example, the second component may be referred to as the first component without departing from the scope of the present invention, and similarly, the first component may also be referred to as the second component. The term and/or includes any of a plurality of related stated items or a combination of a plurality of related stated items.

When a component is said to be “connected” or “connected” to another component, it should be understood that it may be directly connected or connected to the other component, but that other components may exist in between. something to do. On the other hand, when it is mentioned that a component is “directly connected” or “directly connected” to another component, it should be understood that there are no other components in between.

The terms used in this application are only used to describe specific embodiments and are not intended to limit the invention. Singular expressions include plural expressions unless the context clearly dictates otherwise. In this application, terms such as “comprise” or “have” are intended to designate the presence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, but are not intended to indicate the presence of one or more other features. It should be understood that this does not exclude in advance the possibility of the existence or addition of elements, numbers, steps, operations, components, parts, or combinations thereof.

Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by a person of ordinary skill in the technical field to which the present invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with the meaning in the context of the related technology, and unless explicitly defined in the present application, should not be interpreted in an ideal or excessively formal sense. No.

Hereinafter, embodiments will be described in detail with reference to the attached drawings, but identical or corresponding components will be assigned the same reference numbers regardless of reference numerals, and duplicate descriptions thereof will be omitted.

FIG. 1 is a schematic diagram of a renal nerve ablation system according to an embodiment, and FIG. 2 is a diagram illustrating a renal nerve ablation method according to an embodiment.

Referring to Figures 1 and 2, the renal nerve ablation system 10 according to the embodiment includes a catheter 110, a console 120, a renal nerve ablation result evaluation device 130, a handle 140, and an injection unit 150. ) may include.

The catheter 110 is connected to the console 120 through a cable (CB) and may include a plurality of electrodes 115 at the distal end 110a. This catheter 110 can be moved to a blood vessel (eg, artery) connected to an organ (eg, kidney or ureter).

In addition, when the plurality of electrodes 115 in the catheter 110 are located within a blood vessel (V, for example, a renal artery), the wall of the blood vessel (V) is connected to the wall of the blood vessel (V) according to manipulation by the user or operator through the handle 140. Energy may be transferred to the adjacent electrode 115 (eg, energy transfer that generates high temperature). Additionally, nerves (hereinafter referred to as renal nerves) may be located outside the blood vessels along the arteries. Hereinafter, the lumen of the artery and renal artery will be partially illustrated and explained as shown in the drawings. Through this, energy can also be transmitted to nerves outside the wall of the blood vessel (V) that are connected to or adjacent to the wall of the blood vessel (V). For example, heat energy transmitted through the plurality of electrodes 115 of the catheter 110 is transmitted to the outer or adjacent nerve (eg, renal nerve) of the blood vessel (V), and ablation of the renal nerve may occur due to the transmitted energy. You can. Hereinafter, the description will be based on the fact that renal nerve ablation is performed by the above-described method.

The console 120 may control and monitor the operation of the catheter 110 so that the above-described renal nerve denervation (eg, renal nerve ablation) is performed. For example, the console 120 may be configured to continuously or intermittently monitor blood flow data (eg, blood flow rate, blood flow volume) within the blood vessel V. For example, a renal nerve ablation result evaluation device 130 may be mounted in the console 120. However, the present invention is not limited to this, and the renal nerve resection result evaluation device 130 may be implemented as a handle or a single external device. Hereinafter, the description will be based on the fact that the renal nerve ablation result evaluation device 130 is mounted in the console 120.

The console 120 may provide the user with blood flow data in the blood vessel V or data on the degree of renal nerve ablation performed in the target area through the renal nerve resection result evaluation device 130. For example, when it is determined that the renal nerve resection was not performed properly or when it is determined that the renal nerve resection was properly performed, the renal nerve resection result evaluation device 130 provides the user with data (e.g., alarm) corresponding to the evaluation of the renal nerve resection. can be provided.

Additionally, the console 120 can adjust the size and form of energy provided to the electrode 115. For example, the console 120 can vary the size and form of energy depending on the target of renal nerve resection, etc.

Additionally, in the case of electrode-based or heat transfer-based, console 120 may include or be connected to an energy generator that generates energy (eg, ultrasound, heat), for example. Furthermore, the energy generator can provide various types of energy, such as pulse energy, ultrasonic energy, microwave energy, optical energy, heat energy, and radiation.

As described above, the renal nerve ablation result evaluation device 130 may be located within the console 120 and may determine the degree of renal nerve ablation performance and provide a corresponding alarm to the user. A detailed explanation of this will be provided later.

The handle 140 is located between the console 120 and the catheter 110 and may be connected to the console 120 and the catheter 110. In an embodiment, handle 140 may contact proximal end 110b of catheter 110.

Additionally, the handle 140, like the console 120, may be located outside the patient and may include a control unit for ease of operation by the user. For example, the control unit may be implemented in various ways, such as buttons or jogs.

Additionally, the user can control the operation of the catheter 110, etc. through the handle 140. That is, when a command corresponding to the user's operation is generated, the generated command is transmitted to the console 120 or the catheter 110, and operation corresponding to the command can be performed in the console 120 or the catheter 110. For example, energy is delivered to the electrode 115 of the catheter 110 by a user's manipulation (eg, turning on the energy injection button), and renal nerve ablation can be performed with the delivered energy. For example, by manipulating or driving the handle 140 by a user or operator, the electrodes of the catheter may be extended or de-extended into the outer or renal blood vessels. For example, when inserting the distal end 11a of the catheter into a blood vessel, the electrodes of the catheter may have a spine structure. The spine structure of this electrode can be inserted into a blood vessel in a non-expanded state (the spine structure is spread out in a straight line) depending on the operation of the user or operator.

And after the distal end of the catheter is inserted into the renal artery, the spine structure of the electrode is expanded by the user manipulating the handle 140 so that the electrode of the catheter makes good contact with the blood vessel wall when acquiring blood flow data or performing renal nerve ablation ( The spine structure can be bent into a 'ㄷ' shape, for example. Furthermore, as another example, the electrodes of the catheter may be attached to the spine structure. In the present invention, it can be understood that the catheter has a spine structure so that the electrode of the catheter easily contacts the blood vessel wall.

The injection unit 150 may be connected to the catheter 110. Additionally, the injection unit 150 may be coupled to the proximal end 110b of the catheter 110 to inject fluid into the catheter 110. In an embodiment, catheter 110 may deliver fluid (eg, indicator fluid) to blood vessel V. Accordingly, the indicator solution can be injected into an area close to the distal end (110a) of the catheter 110. Additionally, the catheter 110 may include various ports for injecting an indicator solution. Alternatively, the catheter 110 may further include another guide member and be combined with the guide member to deliver the indicator solution. Alternatively, the indicator solution may be delivered to the target through another delivery member that is distinct from the catheter 110.

Additionally, the injection unit 150 may contain a fluoroscopic contrast agent for use in imaging. Alternatively, the injection unit 150 may be made of various materials capable of identifying IVUS, OCT, and target treatment sites. Additionally, the injection unit 150 may deliver a treatment substance or a vasodilator to the target, including a treatment substance or a vasodilator described later.

Figure 3 is a perspective view schematically showing the configuration of the distal end side of the catheter according to an embodiment.

In this specification, the distal end of the catheter refers to the end on the side that reaches the treatment site among both ends in the longitudinal direction of the catheter. The distal end of the catheter is used interchangeably with distal end and distal part. Additionally, the catheter has both ends extending long in one direction and may be configured to move along the internal space of a blood vessel or the like.

Therefore, the proximal end of the catheter refers to the user's side among both longitudinal ends of the catheter. At this time, the proximal end of the catheter located on the operator's side is used interchangeably with 'proximal end' or 'proximal part'.

In other words, the end that is located on the opposite side of the proximal end and reaches the treatment area first at the forefront can be called the distal end. The distal end is used interchangeably with ‘distal danup’ or ‘distal part’.

Additionally, the operator is positioned at the proximal end of the catheter and can adjust the movement of the distal end of the catheter. For example, the operator is positioned at the proximal end and can control the movement of the distal end of the catheter so that it is located in the desired target area in the body, and transfer the above-described energy to the electrode located at the distal end of the catheter at the target location. Thus, renal nerve resection can be performed. Additionally, the distal end of the catheter is also referred to as the catheter head.

Referring to FIG. 3, the catheter may include a first frame 111, a second frame 112, a driving tube 113, a support member 114, an electrode 115, and a shaft body 116. Furthermore, the catheter may further include a guide wire 117.

The first frame 111 may be located at the distal end of the catheter. That is, the first frame 111 may be located at an end of both ends of the catheter that faces the treatment area or target location rather than the operator's side. Additionally, the first frame 111 may have a hollow interior. This hollow may extend along the length of the catheter. Accordingly, the first frame 111 may have both ends open.

Furthermore, the hollow portion of the first frame 111 may extend parallel to the longitudinal direction of the catheter. Accordingly, the first frame 111 may have a structure in which each end facing in the longitudinal direction is open. That is, the first frame 111 may have openings disposed at each end facing in the longitudinal direction. By this configuration, certain components can be inserted or accommodated in the hollow of the first frame 111. In this specification, the hollow formed in the first frame 111 is referred to as the first hollow so as to be compared with the hollow formed in other components.

The second frame 112 may be located closer to the proximal end of the catheter than the first frame 111. That is, the second frame 112 may be located on the distal end side of the entire catheter, but may be located on the proximal side of the catheter rather than the first frame 111. For example, the second frame 112 and the first frame 111 may be positioned sequentially in the longitudinal direction of the catheter. However, the first frame 111 and the second frame 112 may be spaced apart in the longitudinal direction, and a driving tube 113 and a support member to be described later are provided between the first frame 111 and the second frame 112. (114) and electrode 115 may be located.

In an embodiment, the second frame 112 may be spaced apart from the first frame 111 by a predetermined distance and may be located on the right side of the catheter, which may be considered the proximal side of the first frame 111.

And, like the first frame 111, the second frame 112 may have a hollow interior. The hollow portion of the second frame 112 may extend along the longitudinal direction of the catheter. Accordingly, the second frame 112 may have hollow openings located at both ends. Alternatively, the second frame 112 may be configured to have both ends open. Predetermined components may be inserted into the hollow of the second frame 112. In particular, the driving tube 113 may be inserted into the hollow of the second frame 112. In this specification, the hollow formed in the second frame 112 is referred to as the second hollow to be compared with the hollow formed in other components. The second hollow may also be configured with both ends open.

The first frame 111 and the second frame 112 may be configured to be spaced a predetermined distance apart from each other along the longitudinal direction of the catheter. And the distance between the first frame 111 and the second frame 112 can be changed by the operator's manipulation. The configuration of the distance change between them will be described later.

Additionally, the first frame 111 and/or the second frame 112 may be made of various biocompatible materials. For example, these support members may be made of soft materials such as rubber or plastic, as well as hard materials such as metal. In particular, these support members are preferably made of soft and flexible materials. Furthermore, the first frame 111 is located at the front end of the catheter and is likely to come into contact with the inner wall of the blood vessel when the catheter moves along the blood vessel. Therefore, it is made of a soft and flexible material to prevent blood vessel damage, etc. Changes in direction can be made easily.

The driving tube 113 may be configured to extend long in one direction. Here, it can be said that the longitudinal direction of the driving tube 113 coincides with the longitudinal direction of the catheter. In particular, drive tube 113 may extend from the distal end of the catheter to the proximal end of the catheter. Accordingly, the distal end of the driving tube 113 may be located on the side of the treatment area, and the proximal end of the driving tube 113 may be located on the operator's side. Therefore, the operator can move the drive tube 113 longitudinally by manipulating the proximal end of the drive tube 113.

The driving tube 113 may be formed to extend approximately in the left and right directions, and both the hollow left and right ends may be open. In this specification, the hollow of the driving tube 113 is referred to as the third hollow to distinguish it from the hollow of other components. In this way, the driving tube 113 has a hollow interior, and since both ends of the hollow are open, certain components can be inserted or moved into the driving tube 113.

The driving tube 113 may be inserted into both the first hollow of the first frame 111 and the second hollow of the second frame 112. And the driving tube 113 may be fixed to the first frame 111 or the second frame 112. That is, the driving tube 113 may be fixed to the first frame 111 or the second frame 112 while being inserted into the hollow of the first frame 111 and the second frame 112, respectively.

Additionally, when the driving tube 113 is moved in the longitudinal direction, the first frame 111 and the second frame 112 can be moved in the longitudinal direction.

For example, the driving tube 113 may be inserted into the hollow of the second frame 112 and may be configured to freely move in the longitudinal direction, that is, in the left and right directions of the drawing. Furthermore, when the driving tube 113 is moved in one direction, the first frame 111 coupled and fixed to the driving tube 113 may move in the same direction as the one direction. That is, when the operator pulls the proximal end of the drive tube 113, the drive tube 113 may move toward the proximal end of the catheter. At this time, the driving tube 113 can freely move in the hollow of the second frame 112 in the longitudinal direction, so the position of the second frame 112 may not change. In contrast, the first frame 111 is fixed to the driving tube 113, so when the driving tube 113 moves in the proximal direction (one direction), the first frame 111 moves together with the driving tube 113. Can move in a proximal direction.

Conversely, when the operator grabs and pushes the proximal end of the drive tube 113, the drive tube 113 may move in a direction opposite to the proximal direction, that is, toward the distal end of the catheter. This may cause the first frame 111 to move in the distal direction together with the drive tube 113. Accordingly, the separation distance between the first frame 111 and the second frame 112 may increase.

In this way, the separation distance between the first frame 111 and the second frame 112 can be adjusted depending on the moving direction of the driving tube 113. Correspondingly, the positions of the support member 114 and the electrode 115 located between the first frame 111 and the second frame 112 and coupled to the first frame 111 and the second frame 112 may also change. You can.

The support member 114 may be configured to connect the first frame 111 and the second frame 112 to each other. That is, one end of the support member 114 may be connected and fixed to the first frame 111, and the other end of the support member 114 may be connected and fixed to the second frame 112. The support member 114 may be configured in the form of a rod or plate extending long in one direction.

When the distance between the first frame 111 and the second frame 112 narrows, the support member 114 may be configured to be bent at least in part as the distance between both ends becomes closer. As a result, the above-described bending area of the support member 114 can be moved away from the central axis of the catheter. That is, a part of the bending area may be located outside the first frame 111 or the second frame 112.

And when the first frame 111 and the second frame 112 become close to each other and the support member 114 is bent, the bending area may move away from the central axis of the driving tube 113.

As described above, in the catheter according to the present invention, the distance between the first frame 111 and the second frame 112 can be adjusted by the driving tube 113. That is, as the driving tube 113 moves in the longitudinal direction, the distance between the first frame 111 and the second frame 112 may vary. Therefore, in the case of the catheter according to the present invention, the support member 114 can be bent or straightened through movement of the driving tube 113.

Meanwhile, the support member 114 must be made of a material that can be bent when the distance between both ends narrows because a bending area must be formed according to the movement of the first frame 111 or the second frame 112. You can. For example, the support member 114 may be made of a material such as metal or polymer. However, the present invention is not limited to a specific material of the support member 114, and the support member 114 may be made of various materials as long as a bending area can be formed in some parts.

A plurality of support members 114 may be provided between the first frame 111 and the second frame 112. For example, as shown in FIG. 3, three support members 114 may be provided. However, the present invention is not limited to a specific number of support members 114, and the support members 114 may be configured in various numbers. When a plurality of support members 114 are provided in this way, each support member 114 is bent at least in part when the distance between the first frame 111 and the second frame 112 becomes closer, thereby forming a bending area. It may be configured in a direction away from the central axis of the driving tube 113.

The electrode 115 is mounted on the support member 114 and can generate heat by receiving power. And in this way, the heat generated by the electrode 115 can apply thermal stimulation to surrounding tissues. For example, the heat generated by the electrode 115 can ablate the surrounding tissue. At this time, the electrode 115 generates heat of approximately 40 to 80 degrees Celsius, which can resect the nerves around the blood vessels, thereby blocking the nerves. However, of course, the temperature of the heat generated by the electrode 115 can be implemented in various ways depending on the use or purpose of the catheter.

Since the electrode 115 can apply heat to the nerve tissue located around the blood vessel by contacting the blood vessel wall, it is preferable that the electrode 115 can be in close contact with the blood vessel wall. Accordingly, the electrode 115 may have a curved outer surface so that the surface in contact with the inner wall of the blood vessel can correspond to the shape of the inner wall. For example, the electrode 115 may have a circular, semicircular, or oval cross-sectional shape.

The electrode 115 may be provided in the bending area of the support member 114. The bending area of the support member 114 may be configured to be furthest from the central axis of the catheter according to a change in the distance between the first frame 111 and the second frame 112. Therefore, when the electrode 115 is provided in the bending area of the support member 114, the electrode 115 may be located closer to the inner wall of the blood vessel than other components (support member, first and second support members, etc.). .

In this configuration, when the degree of bending of the support member 114 becomes the most severe as the distance between the first frame 111 and the second frame 112 becomes shorter, the electrode 115 can approach the inner wall of the blood vessel. In this case, it can be said that the catheter head is open. Conversely, when the support member 114 is stretched or the degree of bending is weakened as the distance between the first frame 111 and the second frame 112 increases, the electrode 115 may be furthest from the inner wall of the blood vessel. In this case, it can be said that the catheter head is closed.

The electrode 115 may generate heat or transmit high-frequency energy using radio frequency (RF). For example, the electrode 115 is electrically connected to a high-frequency generating unit and emits high-frequency energy, thereby enabling renal nerve ablation.

The shaft body 116 may extend long in one direction. For example, the shaft body 116 may extend in the longitudinal direction of the catheter.

Additionally, the shaft body 116 may extend approximately in the left and right directions, as shown in FIG. 3 . In particular, the shaft body 116 may extend long from the distal end of the catheter where the first frame 111 and the second frame 112 are located to the proximal end of the catheter where the operator is located.

As described above, the catheter 110 according to the present invention may further include a guide wire 117.

The guide wire 117 is a wire for guiding the catheter 110 to the treatment site, and may be configured to reach the treatment site before the catheter. This guide wire 117 may extend in one direction or in a longitudinal direction. And the guide wire 117 may be inserted into the hollow of the driving tube 113. In this configuration, the guide wire 117 moves along the inside of the blood vessel to reach the treatment site first, and the driving tube 113, the first frame 111, the second frame 112, the support member 114, etc. Can be guided to the treatment area with the guide wire 117 inserted into the hollow. Furthermore, there may be an ultrasonic sensor in the guide wire 117 that functions as a guide and at the same time as a detection means to be described later.

Additionally, an end tip 118 may be further included at the distal end of the catheter, that is, in front of the distal end of the catheter head.

The end tip 118 is configured in the form of a hollow tube and may be made of a soft and flexible material. In particular, the end tip 118 may be formed of a composition containing polyether block amide (PEBA).

According to this configuration of the present invention, when the distal end of the catheter moves along the blood vessel, etc., the end tip 118 made of a soft and flexible material is located at the front, thereby reducing damage to the blood vessel, etc. and facilitating direction changes. You can do it. Moreover, in the case of the end tip 118 made of the above material, X-ray imaging is possible, so it can be easy to determine the location of the catheter head.

FIG. 4 is a diagram illustrating a portion of FIG. 2.

Referring to Figure 4 (hereinafter additionally refer to Figures 1 and 3), the catheter 110 may further include a guide wire 117 disposed at the distal end 110a. Accordingly, the distal end 110a of the catheter 110 can be easily moved to the target location by the guide wire 117.

For example, the catheter 110 and the guide wire 117 move to the target within the blood vessel V according to the user's manipulation, and renal nerve ablation can be performed through the electrode. Additionally, evaluation of renal nerve ablation results may be performed. And for the evaluation of renal nerve ablation, detection means such as, for example, an ultrasonic sensor, an impedance sensor, and an optical sensor may be attached to the guide wire 117. The detection means may be placed on the catheter, and will be described below based on its placement at the distal end of the catheter. A detailed explanation of this will be provided later.

In addition, a plurality of electrodes 115 are present at the distal end of the catheter 110 without the above-described guide wire, and renal nerve resection and evaluation of renal nerve resection results can be performed through the plurality of electrodes 115.

Figure 5 is a flow chart of a method for evaluating renal nerve ablation results according to an embodiment, Figure 6 is a flow chart of a method for evaluating renal nerve ablation results according to another embodiment, and Figure 7 is a method for evaluating renal nerve ablation results according to another embodiment. is a flowchart, FIG. 8 is a diagram illustrating a method of acquiring base blood flow data in the method for evaluating renal nerve ablation results according to the present invention, and FIG. 9 is a diagram illustrating an example of a method of acquiring blood flow data. , FIG. 10 is a diagram showing another example explaining a method of acquiring blood flow data, FIG. 11 is a diagram showing another example explaining a method of acquiring blood flow data, and FIG. 12 is a diagram showing a kidney according to an embodiment. A diagram illustrating the injection of a vasodilator in a method for evaluating nerve ablation results, FIG. 13 is a diagram illustrating a method for obtaining first blood flow data in a method for evaluating renal nerve ablation results according to an embodiment, and FIG. 14 is a diagram illustrating a method for obtaining first blood flow data in a method for evaluating renal nerve ablation results according to an embodiment. It is a graph showing the action of a vasodilator in a method for evaluating renal nerve ablation results, and FIG. 15 is a diagram illustrating a method of obtaining renal nerve ablation using a catheter and second blood flow data in a method for evaluating renal nerve ablation results according to an embodiment. , FIG. 16 is a flow chart illustrating the comparison of first blood flow data and second blood flow data in the method for evaluating renal nerve ablation results according to an embodiment.

Referring to FIG. 5, the method for evaluating renal nerve ablation results according to an embodiment acquires first blood flow data in the first region after the vasodilator injected into the first region within the renal blood vessel is activated in the second region within the renal blood vessel. and acquiring second blood flow data in the first region after renal nerve ablation (denervation) is performed using a renal nerve ablation catheter. The renal blood vessels may include renal arteries, renal arterioles, renal capillaries, and renal veins. The first region may be the renal artery. The second region may be a renal arteriole or a renal capillary.

More specifically, the method for evaluating renal nerve ablation results includes injecting a vasodilator, activating the vasodilator in a second region (renal arteriole) (S1110), and acquiring first blood flow data in the first region (renal artery). (S1120), performing renal nerve ablation (denervation) with a catheter located in the first region (renal artery) (S1130) acquiring second blood flow data in the first region (renal artery) after performing renal nerve ablation. It may include a step of comparing the first blood flow data and the second blood flow data (S1150).

First, in the step (S1110) where the vasodilator is injected and the vasodilator is activated, the injection of the vasodilator may be performed in a specific area of the first region (renal artery) within the renal blood vessel. Inject vasodilators (e.g., Dopamine, Dobutamine, adenosine, prostacyclin, nitric oxide, etc.) into the renal vascular system, but minimize the direct effect on the renal artery and inject the drug into the renal arteriole connected to the renal artery. By determining the injection location of the vasodilator so that the vasodilator is activated, accurate evaluation of renal nerve ablation can be performed by obtaining data on blood flow within the renal artery while the renal arteriole is at maximum vasodilation.

That is, the vasodilator is injected into a specific location of the renal artery (i.e., first region) to minimize the time it stays in the renal artery, thereby injecting the vasodilator into the renal arteriole (i.e., second region) without significantly affecting the diameter or size of the renal artery vessels. ), the evaluation of renal nerve ablation is performed using blood flow data obtained primarily through activated and dilated renal arterioles.

At this time, when a vasodilator is injected into a specific location of the renal artery, the renal arterioles can be dilated to the maximum blood vessel level without affecting the vasodilation of the renal artery. And only by measuring the blood flow in the activated state can the blood flow in the renal artery be accurately measured. In other words, the blood flow in the renal artery must be measured while minimizing the effect of the vasodilator on the renal artery and maximally dilating the blood vessels in the renal arterioles in order to accurately measure the maximum blood flow unique to each patient.

Accordingly, it is possible to obtain blood flow data in the same state as when the sympathetic nerve was removed from the renal artery.

Therefore, evaluation of renal nerve ablation is performed by comparing the maximum blood flow data in the renal artery unique to each patient (first blood flow data) with the blood flow data in the renal artery obtained after catheter-assisted renal nerve ablation (second blood flow data). and judgments can be made quickly and accurately, minimizing the burden on patients.

In addition, based on the comparison results between the blood flow data (first and second blood flow data), if it is above a certain threshold, it can be judged that the procedure was successful, and if it is below a certain threshold, it can be determined that the procedure was not performed properly, so reoperation is necessary. You can judge whether it is.

The vasodilators include dopamine, dobutamine, adenosine, prostacyclin, nitric oxide, bradykinin, papaverine, dipyridamolum, diuretin, theophylline, and minoxidil ( minoxidil) or isosorbide nitrate.

In contrast, when dilators such as nitroglycerin are used, blood vessels such as the renal artery and renal arteriole are dilated. Accordingly, it may become difficult to obtain accurate blood flow data in the case of nitroglycerin. As a result, it may be difficult to obtain blood flow information, such as the same blood flow volume, as when the renal nerve is removed from the renal artery through injection of nitroglycerin.

As another example, when nitroglycerin is injected during a procedure, vasodilation (activation) by nitroglycerin must be maintained when first blood flow data, second blood flow data, and base blood flow data are acquired. Therefore, if activation by nitroglycerin decreases before blood flow data acquisition, nitroglycerin must be reinjected. This is because the first blood flow data, second blood flow data, and base blood flow data must be acquired while the variable factors caused by nitroglycerin are the same.

In nephrectomy according to the embodiment, the effect of the vasodilator upon activation and the site of activation are different from the above-described nitroglycerin. Furthermore, since the vascular tonic agent according to the embodiment has a shorter duration compared to nitroglycerin, evaluation and judgment on renal nerve resection can be performed quickly, minimizing the burden on the patient.

As described above, the renal nerve ablation result evaluation method and device according to the embodiment can easily obtain the patient's own maximum blood flow as blood flow data without vasodilation of the renal artery itself, and the vasodilator proposed in the present invention (e.g. dopamine, adenosine, etc.) have a short duration, which minimizes the acquisition time of blood flow data in a state that is not affected by activation, thereby reducing the procedure time for patients undergoing renal nerve ablation. Accordingly, the risk of the procedure can be reduced.

Additionally, by injecting a vasodilator into the renal vasculature before renal nerve resection, data on blood flow within the renal artery in the state of maximum vasodilation can be obtained. In other words, the method and device for evaluating renal resection results in the present invention can obtain blood flow data that is not affected by the compound factors of blood vessels that occur after renal nerve resection. For example, compound factors in blood vessels may include muscle cramps (spasm) due to stimulation of the pain nerve (ache nerve) after renal nerve resection, changes in blood pressure due to stimulation of the sympathetic nerve, etc. In other words, if data on blood flow in the state of maximum vasodilation is obtained by injecting a vasodilator into the renal blood vessels after renal nerve resection, the results will be different from those before renal nerve resection, making it impossible to obtain accurate comparison value data.

In addition, according to an embodiment, the vasodilator can be locally injected into the renal artery to minimize the time it stays in the renal artery, thereby dilating the renal arterioles to the maximum blood vessel level without affecting vasodilation of the renal arteries. As a result, the method and device for evaluating renal nerve ablation results according to the present invention can obtain blood flow data in the same state as the state in which the sympathetic nerve was ablated from the renal artery.

Referring to FIG. 12 together, the vasodilator may be injected into the renal artery through a catheter or other member as described above (S1110). Specifically, when dopamine, a vasodilator, is injected into the renal artery, it can block sympathetic nerve signals to the renal small arteriole in the kidney, which is thinner (eg, smaller in diameter or thickness) than the renal artery. Accordingly, vasodilation of the renal arterioles may occur (EP), as described above. For example, the diameter or cross-sectional area (A1) of the renal arteriole before injection of the vasodilator may be smaller than the diameter or cross-sectional area (A2) of the renal arteriole after injection of the vasodilator. With this configuration, the blood flow to the renal arterioles increases, ultimately increasing the blood flow rate (F1) in the renal arteries (eg, blood vessels, V). This may correspond to a transient hyperemic state or a transient renal nerve ablation state and may be maintained for a predetermined period of time of 4 to 6 minutes (preferably within 5 minutes).

Referring to FIG. 13 together, first blood flow data in the first region (renal artery) can be acquired (S1120). In other words, blood flow in the renal artery can be increased by vasodilators corresponding to the state of complete renal nerve ablation (the same state as the state in which the sympathetic nerve is ablated in the renal artery). For example, blood flow may be maximum in the renal artery. At this time, the first blood flow data corresponds to blood flow data in the renal artery within a predetermined time after injection of the vasodilator, hereinafter referred to as “RAF _Vasodilator ”. This first blood flow data can be acquired within the predetermined time period described above. For example, it may be the maximum or average value among blood flow velocities obtained within a predetermined time.

In this way, by injecting the vasodilator locally into the renal artery rather than by intravascular injection, the renal arterioles are maximally dilated, thereby obtaining more accurate first blood flow data as data corresponding to the state in which renal nerve ablation was performed without changing the diameter of the renal artery. can do.

Referring to FIG. 14, the diameter of the renal arteriole increases during the first time (T1) due to the vasodilator, and then the diameter of the renal arteriole is maintained at the maximum from the first time (T1) to the second time (T2) (maximum dilatation). It can be. And at the second time (T2) to the third time (T3), the vasodilator such as dopamine is washed away, and the diameter of the renal arteriole finally returns to the state (0) before the vasodilator was injected. For example, the third time T3 may be within 30 minutes. However, this is a graph that removes other factors that cause vasodilation of renal arterioles.

In an embodiment, the vasodilator may be injected at 50 μg/kg or less, and the second time (T2) may vary depending on the amount, but may be 5 minutes (min) or less in consideration of half-life, etc. For example, a vasodilator may have a half-life of 1 to 2 minutes. Additionally, the first time T1 may be smaller than the difference between the second time T2 and the first time T1. Accordingly, first blood flow data can be acquired between 10 seconds and 5 minutes after injecting the vasodilator into the renal artery. Additionally, renal nerve denervation can be performed 5 minutes after injection of the vasodilator. If it deviates from this, there is a problem of obtaining inaccurate first blood flow data. However, there is room for variation depending on the amount of vasodilator injected, etc.

In this specification, blood flow data may be acquired by the acquisition means from blood flow information calculated by peak-to-peak, average, cross-sectional area comparison, blood flow, peak blood flow velocity, blood flow resistance, etc. of the signal received by the detection means. More specifically, blood flow information includes blood flow volume, blood flow speed, blood flow resistance, etc., and the acquisition means may acquire or receive any one of the blood flow information from the detection means. For example, the first blood flow data, the second blood flow data, and the base blood flow data acquired by the acquisition means may be the same category of blood flow information, for example, blood flow volume. For example, in the case of an impedance sensor, when the blood flow speed increases, the impedance may increase, and when the blood flow speed decreases, the impedance may decrease. Using this, the blood flow rate can be calculated as the impedance or peak-to-peak or average value per cycle of the impedance value. Furthermore, an ultrasonic sensor may have a signal graph opposite to that of an impedance sensor.

The detection means may be located within the renal artery. It may also be located within the area between the aorta and kidney.

And renal nerve denervation can be performed with a catheter located in the first region (renal artery) (S1130). Renal nerve ablation can be performed by means of the above-described electrodes on a catheter. At this time, the electrode of the catheter is in contact with the renal nerve (N) located in contact with or adjacent to the blood vessel (V), and the renal nerve (N) can be excised by transmitting heat, etc. to the renal nerve (N). The vasodilator is characterized by a half-life sufficiently short that it does not affect the step of performing renal nerve ablation.

Renal nerve ablation may be performed multiple times and may be performed multiple times at various locations within the renal artery. For example, the number of branches of the renal artery may vary depending on the patient, and renal nerve denervation may be performed multiple times depending on the number of branches of the renal artery.

Referring to FIG. 15 together, second blood flow data in the first region (renal artery) can be obtained after performing renal nerve ablation (S1140). If renal denervation is performed, vasodilatation (EP') of the renal arterioles can be permanently increased, as can dopamine infusion. That is, after renal nerve ablation (denervation), the vessel diameter or cross-sectional area of the renal arteriole increases compared to before renal nerve ablation (A1'->A2'). Here, 'A1'' represents the vessel diameter or cross-sectional area of the renal arteriole before renal nerve ablation, and 'A2'' represents the diameter or cross-sectional area of the renal arteriole after renal nerve ablation.

And the first blood flow data and the second blood flow data can be compared (S1150). For example, the renal nerves (N) may be placed outside the renal artery (V). At this time, part of the tissue is ablated by the energy delivered by the electrode 115, and the ablated tissue is formed. The adjacent renal nerve may also be resected. In an embodiment, if the second blood flow data is lower than a predetermined ratio of the first blood flow data, renal nerve ablation may be performed again. Alternatively, renal nerve ablation may be performed again when the ratio of the second blood flow data and the first blood flow data is lower than a predetermined threshold. And after re-performing the nerve resection, the first blood flow data and the second blood flow data can be compared again. At this time, a predetermined ratio may be set according to the patient's condition. And the second blood flow data corresponds to blood flow data in the renal artery after renal nerve resection, hereinafter referred to as “RAF _RDN ”.

Through this, when renal nerve resection of the kidney is completely (e.g., 100%) achieved, vasodilation of all renal arterioles is permanently achieved, and the blood flow rate in the renal arteries can be maximized according to vasodilation of renal arterioles. That is, the second blood flow data may be similar to the first blood flow data.

However, when the renal nerve resection is incomplete (e.g., less than 80%), partial vasodilation of the renal arterioles occurs, and the flow rate within the renal artery may be slower than when the renal nerve resection is complete. That is, the second blood flow data may be less than a predetermined ratio of the first blood flow data. In this case, the second blood flow data can be obtained again by returning to the above-described step (S1130) and re-performing the renal nerve resection in the renal artery. In addition, when the second blood flow data consists of a predetermined ratio or higher value of the first blood flow data, renal nerve ablation through the catheter can be completed and the catheter can be separated from the patient's body. In this way, by acquiring the second blood flow data after acquiring the first blood flow data, evaluation of renal nerve ablation can be performed even if the first blood flow data is performed once regardless of the number of renal nerve ablation. In other words, since there is no need to repeatedly acquire first blood flow data, which is the standard for evaluating renal nerve ablation, the procedure time can be reduced and complex fluctuation factors in blood vessels due to renal nerve ablation can be avoided.

In addition, the nephroscopy resection result evaluation method according to the embodiment may compare the first blood flow data and the second blood flow data as described above, and then evaluate the renal nerve resection results according to the comparison results. For example, if the comparison result is lower than a predetermined threshold, an alarm may be provided to re-perform renal nerve ablation. Here, the threshold is, for example, a threshold for the ratio of the second blood flow data to the first blood flow data (second blood flow data/first blood flow data After this, the step of acquiring the second blood flow data can be repeated. Furthermore, the method for evaluating renal nerve ablation results according to the embodiment is based on before injecting a vasodilator or performing renal nerve ablation (denervation) with a catheter located in the renal artery (or before acquiring second blood flow data). Blood flow data can be obtained. Each example will be described below.

Referring to FIG. 6, a method for evaluating renal nerve ablation results according to another embodiment includes the steps of acquiring base blood flow data within the first region of the renal nerve (renal artery), and the vasodilator injected into the first region within the renal blood vessel is intrarenal. acquiring first blood flow data in the first region after activation in the second region, and acquiring second blood flow data in the first region after renal nerve ablation (denervation) is performed with a renal nerve ablation catheter. It may include steps.

More specifically, the method for evaluating renal nerve ablation results includes acquiring base blood flow data in the first region (renal artery) (S2110), injecting a vasodilator and activating the vasodilator (S2120), and activating the vasodilator. Obtaining first blood flow data within the renal artery after the renal artery ablation (S2130), performing renal nerve ablation (denervation) with a catheter located within the artery (S2140) Second blood flow within the renal artery after renal nerve ablation It may include acquiring data (S2150) and comparing first blood flow data and second blood flow data (S2160).

The step of injecting a vasodilator and activating the vasodilator (S2120) is the same as the step of injecting a vasodilator and activating the vasodilator (S1110) described above in FIG. 5, and the first blood flow data in the renal artery is The acquisition step (S2130) is the same as the step (S1120) of acquiring the first blood flow data in the renal artery described above in FIG. 5, and is a step of performing renal nerve denervation with a catheter located in the renal artery. (S2140) is the same as the step (S1130) of performing renal nerve ablation with a catheter located in the renal artery described above in FIG. 5, and after performing renal nerve ablation, the second blood flow in the renal artery The step of acquiring data (S2150) may be identical to the step of acquiring second blood flow data in the renal artery (S1140) after performing the renal nerve ablation described above in FIG. 5. And in the method for evaluating renal nerve ablation results according to the embodiment, the step of acquiring base blood flow data (S2110) may be performed before the vasodilator is injected.

Referring to FIGS. 8 and 16 together, base blood flow data may be acquired within the first region (renal artery) before the vasodilator (eg, dopamine) is injected. In an embodiment, the base blood flow data may correspond to blood flow data in the renal artery before the vasodilator is injected, hereinafter referred to as “RAF _basal .”

At this time, in the step of comparing the first blood flow data and the second blood flow data (S2160), referring to FIG. 16, the ratio between the first difference value and the second difference value (e.g., corresponding to 'PEI') can be compared with the threshold value. There is (S1151).

In an embodiment, the renal nerve ablation result evaluation method includes calculating a first difference value representing the difference value between the first blood flow data and the base blood flow data prior to comparing the first difference value and the second difference value, and a second difference value. The method may further include calculating a second difference value representing the difference between the blood flow data and the base blood flow data. At this time, the calculation order of the first difference value and the second difference value may be simultaneously or reversed.

And the renal nerve ablation result may be evaluated according to the result of comparing the first difference value and the second difference value. For example, renal nerve ablation result evaluation may be performed through a ratio or ratio between the first difference value and the second difference value. Here, as described above, the first difference value means the difference value between the first blood flow data and the base blood flow data, and the second difference value means the difference value between the second blood flow data and the base blood flow data. And the ratio between the first difference value and the second difference value may mean a ratio between the second difference value to the first difference value or a ratio between the first difference value to the second difference value. Hereinafter, the description will be based on the ratio between the second difference value and the first difference value.

Furthermore, if the ratio between the first difference value and the second difference value is lower than a predetermined threshold value, an alarm may be provided to re-perform renal nerve ablation. Here, the threshold may be, for example, a threshold of the ratio of the second difference value to the first difference value. And after re-performing the renal nerve ablation, the second difference value can be calculated again and the comparison of the first difference value and the second difference value can be repeated. Additionally, the first blood flow data, second blood flow data, and base blood flow data may be acquired while the driving tube is moved distally or proximally as described above. For example, the first blood flow data, the second blood flow data, and the base blood flow data may be acquired while the driving tube is moved to either the distal or proximal side. The first blood flow data, the second blood flow data, and the base blood flow data are obtained while the catheter in the renal artery is in the same state, so that errors in each blood flow data can be minimized.

In addition, the first blood flow data, the second blood flow data, and the base blood flow data may be obtained by blood flow information detected in the first region within the renal artery by the above-described detection means. For example, the first blood flow data, the second blood flow data, and the base blood flow data may be acquired while the position of the driving tube is the same. In other words, the operator moves the drive tube in the longitudinal direction by manipulating the proximal end of the drive tube, and the first blood flow data is obtained while manipulating the proximal end of the drive tube by the same amount to move the drive tube by the same amount in the longitudinal direction. , second blood flow data and base blood flow data can be obtained. As a result, when the catheter is present at the same position within the renal blood vessel, especially within the first region, each of the first blood flow data, second blood flow data, and base blood flow data is acquired, thereby minimizing the influence on the shape, structure, etc. of the renal blood vessel for each patient. can do. In other words, an accurate assessment of renal nerve ablation can be performed.

In addition, in an embodiment, if the ratio between the first difference value and the second difference value is greater than the threshold value, it is determined that renal nerve ablation is greater than the target value, and the catheter can be separated from the patient's body. On the other hand, if the ratio (PEI) between the first difference value and the second difference value is less than the threshold value, the renal nerve ablation using the above-described catheter is re-performed (S1130), indicating that renal nerve ablation above the target value has not been achieved, The second blood flow data can be acquired again (S2150). Then, the re-acquired second blood flow data and the previously obtained first blood flow data may be re-compared, or the ratio between the first difference value and the second difference value may be compared with a threshold value as described above. Accordingly, as described above, the first blood flow data and the base blood flow data only need to be measured once. In other words, there is no need to repeatedly acquire first blood flow data and base blood flow data, which are standards for evaluating renal nerve ablation, and thus the procedure time can be reduced.

At this _time , the ratio (PEI) between the first difference value and the second difference value, which is the difference value between the first blood flow data (RAF _Vasodilator ) and the second blood flow data (RAF _RDN ) with respect to the base blood flow data (RAF basal), is Equation 1 is satisfied.

[Equation 1]

Ratio between the first and second difference values (procedural endpoint index, PEI) = (RAF _RDN - RAF _basal )/(RAF _Vasodilator - RAF _basal )

Here, RAF _RDN corresponds to the second blood flow data as renal artery blood flow data after performing the renal nerve ablation, RAF _basal corresponds to the base blood flow data as basic blood flow data for blood flow in the renal artery, and RAF _Vasodilator corresponds to the base blood flow data in the blood vessel. After injection of the dilator, the first blood flow data is corresponded to the blood flow data in the renal artery. Such blood flow data may include blood flow speed, blood flow volume, blood flow resistance, etc. Specifically, the first blood flow data, the second blood flow data, and the base blood flow data described later may be any one of blood flow information, such as blood flow rate, blood flow rate per unit time, peak velocity, blood flow resistance, etc. And the first blood flow data, the second blood flow data, and the base blood flow data described later may be the same category in blood flow information. For example, the first blood flow data, the second blood flow data, and the base blood flow data described later may all be blood flow. Alternatively, the first blood flow data, the second blood flow data, and the base blood flow data described later may be blood flow speeds. Based on this, it will be explained below. Furthermore, hereinafter, the threshold values (eg, first threshold value, second threshold value) may vary depending on the category of blood flow information. For example, the threshold for the ratio between the first difference value and the second difference value may be 0.8 for blood flow volume, but may be different from or equal to 0.8 for blood flow velocity.

And when the ratio between the first difference value and the second difference value is equal to or greater than the threshold value, renal nerve ablation through the catheter can be terminated and the catheter can be separated from the patient's body. Alternatively, if the ratio between the first difference value and the second difference value is less than the threshold value, renal nerve ablation through the catheter may be performed again as described above.

In addition, in this embodiment, the first blood flow data (RAF _Vasodilator ), the second blood flow data (RAF _RDN ), and the base blood flow data (RAF _basal ) are detected by detection means, for example, an ultrasonic sensor, an impedance sensor, or an optical sensor. It can be obtained from blood flow information.

As described above, the ultrasonic sensor, impedance sensor, and optical sensor may be located on a catheter or guide wire. In embodiments, the ultrasonic sensor may include a Doppler sensor. Furthermore, a Doppler sensor disposed on the above-described guide wire may be used as a detection means. Additionally, the impedance sensor may use the catheter electrode as is or may be located adjacent to the electrode of the catheter to obtain blood flow data. For example, the impedance value may be detected by a catheter electrode, or the impedance value may be detected by a separate impedance sensor.

In this way, by acquiring base blood flow data (RAF _basal ) in the method and device for evaluating renal nerve ablation results according to the embodiment, it is possible to accurately determine whether renal nerve ablation has been completely achieved for each patient.

For example, base blood flow data (RAF _basal ) may be different for each patient. In other words, patients with hypertension may have lower baseline blood flow data (RAF _basal ) than the general population. In other words, compared to the general population, hypertensive patients may have more capillary constriction caused by the sympathetic nerve, and hypertensive patients may experience greater changes in blood flow data due to renal nerve ablation based on base blood flow data (RAF _basal ) than the general population. . Conversely, in the case of a patient with high blood flow (normal times), the amount of change between the first blood flow data and the second blood flow data (hereinafter referred to as 'blood flow change amount') may be smaller than the amount of change in blood flow in a patient with high blood flow (normal times). At this time, the relative blood flow change due to renal nerve ablation according to the embodiment can be easily calculated by using base blood flow data (RAF _basal ). In other words, the method and device for evaluating renal nerve ablation results according to the embodiment can accurately evaluate renal nerve ablation by using base blood flow data (RAF _basal ) even if the physical condition of each patient is different.

Additionally, in the various embodiments above, the step of acquiring the second blood flow data may be performed a predetermined time after performing renal nerve ablation. Even if contraction of the renal artery occurs due to muscle stiffness due to pain during renal nerve resection, recovery time for the renal artery is given after a predetermined period of time, and then the second blood flow data is acquired, so that the second blood flow data is obtained after complex factors are removed. can be obtained. Therefore, more accurate blood flow data can be obtained.

And first blood flow data (RAF _Vasodilator ) and base blood flow data (RAF _basal ) can be performed before renal nerve ablation. As a result, it is possible to avoid being influenced by complex factors occurring in the renal artery after renal nerve resection.

In addition, in another embodiment, the step of acquiring the second blood flow data is performed by performing renal nerve ablation of the contralateral renal artery (third region) and then returning to the initial renal artery (first region) to measure the data. can do. Even if constriction of the renal artery occurs due to muscle stiffness due to pain during renal nerve resection, after performing renal nerve resection in the contralateral renal artery (third area), the renal artery is given some recovery time and then returns to the first area again. Since the second blood flow data is obtained by returning to , the second blood flow data can be obtained after the complex factors are removed. Therefore, more accurate blood flow data can be obtained. And the step of acquiring the second blood flow data is to acquire the 2-1 blood flow data within the renal artery (first region) and then sequentially acquire the 2-2 blood flow data within the other renal artery (third region). You can.

For example, after the renal nerve is resected in either the right renal artery or the left renal artery (first region), the catheter is moved to the opposite renal artery (third region) to perform ablation and then returned to the original location of the renal artery (third region). Returning to the first area, second blood flow data (RAF _RDN ) can be sequentially acquired from one artery and the other artery. Here, the second blood flow data acquired from one artery may correspond to the 2-1 blood flow data, and the second blood flow data acquired from the other artery may correspond to the 2-2 blood flow data.

In addition, in the various embodiments described above, the second blood flow data is acquired after the vasodilator is injected and the first blood flow data is acquired, so even when renal nerve resection is performed multiple times, the first blood flow data according to the injection of the vasodilator is obtained. Can be obtained once. In other words, by not acquiring the first blood flow data multiple times, the procedure time can be reduced and changes in the first blood flow data caused by various factors can be eliminated.

Referring to FIG. 9, blood flow data (e.g., first blood flow data (RAF _Vasodilator ), second blood flow data) in the renal artery through an ultrasonic sensor (DS) disposed adjacent to the end of the guide wire or the electrode 115 of the catheter. (RAF _RDN ) and base blood flow data (RAF _basal )) can be obtained. For example, the ultrasonic sensor may be a Doppler sensor, may be plural, and may be spaced apart along the flow of blood. Accordingly, each of the plurality of ultrasonic sensors detects the blood flow rate in the proximal part of the renal artery, the blood flow rate in the distal part of the renal artery (renal arteriole or a location adjacent to the kidney), and the blood flow between the proximal part and the distal part (e.g., the middle part) to determine the blood flow rate. accuracy can be improved.

Referring to FIG. 10, the impedance is measured using the electrode 115 of the catheter to measure blood flow data (e.g., first blood flow data (RAF _Vasodilator ), second blood flow data (RAF _RDN ), and base blood flow data (RAF) in the renal artery. _basal )) can be obtained. Or in another embodiment, blood flow data (e.g., first blood flow data (RAF _Vasodilator )), second blood flow data ( RAF _RDN ) and base blood flow data (RAF _basal )) can be obtained

And the impedance sensor detects changes in blood flow impedance, from which the blood flow speed can be obtained.

Referring to Figure 11, blood flow data (e.g., first blood flow data (RAF _Vasodilator ), second blood flow data (RAF _RDN ), and base blood flow data (RAF _basal ) within the renal artery can be acquired by an optical sensor.

Specifically, the optical sensor may include a light emitting unit (LE) and a light receiving unit (LR), and the light emitting unit (LE) and the light receiving unit (LR) may be disposed below the electrode described above. Accordingly, when the electrode is extended toward the inner wall of the renal artery, the light emitting unit (LE) irradiates light to the blood inside the renal artery and the light receiving unit (LR) can receive the light reflected from the blood. The light emitting unit LE may be made of an element that emits light. For example, the light emitting unit LE may include a light emitting diode (LED) that is harmless to the human body. Additionally, the light receiver LR may include an image sensor that receives light emitted from the light emitter reflected from blood cells (eg, red blood cells, RBC) or a diffraction pattern or shadow. The image sensor may include a CMOS image sensor.

The above-described method of acquiring blood flow data can be equally applied to acquiring first blood flow data (RAF _Vasodilator ), second blood flow data (RAF _RDN ), and base blood flow data (RAF _basal ) within the present specification.

Referring to FIG. 7 , a method for evaluating renal nerve ablation results according to another embodiment provides first blood flow data in the first region after the vasodilator injected into the first region within the renal blood vessel is activated in the second region within the renal blood vessel. Obtaining base blood flow data in a first region (renal artery) and acquiring second blood flow data in the first region after renal nerve ablation (denervation) is performed with a renal nerve ablation catheter. May include steps.

More specifically, the method for evaluating renal nerve ablation results includes the steps of injecting a vasodilator and activating the vasodilator (S3110), acquiring first blood flow data in the first region (renal artery) (S3120), and base blood flow data. Obtaining (S3130), performing renal nerve ablation (denervation) with a catheter located in the first region (renal artery) (S3140), and performing renal nerve ablation with a catheter located in the first region (renal artery). It may include acquiring 2 blood flow data (S3150) and comparing the first blood flow data and the second blood flow data (S3160). That is, unlike the description in the previous embodiment, the step of acquiring base blood flow data within the renal artery can be performed between the step of injecting a vasodilator and the step of performing renal nerve denervation with a catheter located within the renal artery. there is.

And, except for the details described later, the step (S3110) in which the vasodilator is activated is the same as the steps (S1110, S2120) in which the vasodilator is activated, and the first region (kidney) In the step (S3120) of acquiring the first blood flow data in the first region (renal artery), the contents of the steps (S1120, S2130) of acquiring the first blood flow data in the first region (renal artery) are applied identically, and the steps of acquiring the base blood flow data are applied in the same way. The step (S3130) is the same as the step (S2110) of acquiring the base blood flow data described above, and the step (S3140) of performing renal nerve denervation with a catheter located in the first region (renal artery) The contents of the steps (S1130, S2140) of performing renal nerve denervation with a catheter located within the first region (renal artery) are equally applied, and after performing renal nerve ablation, within the first region (renal artery) In the step of acquiring the second blood flow data (S3150), the contents of the steps of acquiring the second blood flow data in the first region (renal artery) (S1140, S2150) after performing renal nerve resection are applied in the same way, The step of comparing the first blood flow data and the second blood flow data (S3160) may be identical to the steps of comparing the first blood flow data and the second blood flow data (S1150, S2160).

In this embodiment, the vasodilator is characterized by a sufficiently short half-life so as not to affect the base blood flow data acquisition step. For example, the vasodilator is injected into the first region and activated in the second region, and the base blood flow data or the second blood flow data may be acquired after the half-life of the vasodilator has passed. In other words, the base blood flow data or the second blood flow data may be acquired after the half-life of the vasodilator has elapsed after the vasodilator is injected into the first region or the second region. As will be described later, when the base blood flow data is acquired before the first blood flow data, the base blood flow data may be acquired regardless of the half-life. However, if the second blood flow data or base blood flow data is acquired after the first blood flow data is acquired, the second blood flow data or base blood flow data may be acquired after the half-life has elapsed after injection of the vasodilator. In addition, in the embodiment, the vasodilator is injected into the first region, but is provided to the second region according to movement, and it should be understood that this is expressed as 'injection'. In addition, since the vasodilator quickly moves to the second region after being injected into the first region, the base blood flow data or the second blood flow data can be obtained after the half-life has elapsed after the vasodilator moves to the second region. there is.

The step of acquiring base blood flow data (S3130) may be performed a predetermined time after the vasodilator is injected. In other words, the vasodilation of the renal arterioles, which is similar to the state of renal nerve ablation due to the vasodilator, may return to the state before the vasodilator was injected (all recovered) after a predetermined period of time. In this recovered state, base blood flow data can be obtained. According to this embodiment, it is preferable that the first blood flow data and the base blood flow data only have an acquisition time difference, and that there is no change in the position of the catheter, etc., as described above.

That is, the first blood flow data, the second blood flow data, and the base blood flow data can be acquired while the driving tube is moved distally or proximally, as described above. For example, the first blood flow data, the second blood flow data, and the base blood flow data may be acquired while the driving tube is moved to either the distal or proximal side. In other words, the first blood flow data, the second blood flow data, and the base blood flow data are obtained while the catheter in the renal artery is in the same state, so that errors in each blood flow data can be minimized.

In addition, the first blood flow data, the second blood flow data, and the base blood flow data may be obtained by blood flow information detected in the first region within the renal artery by the above-described detection means. For example, the first blood flow data, the second blood flow data, and the base blood flow data may be acquired while the position of the driving tube is the same. In other words, the operator moves the drive tube in the longitudinal direction by manipulating the proximal end of the drive tube, and the first blood flow data is obtained while manipulating the proximal end of the drive tube by the same amount to move the drive tube by the same amount in the longitudinal direction. , second blood flow data and base blood flow data can be obtained. Thereby, when the catheter is present at the same position within the renal blood vessel, particularly within the first region, each of the first blood flow data, the second blood flow data, and the base blood flow data can be acquired so that an accurate evaluation of renal nerve ablation can be performed.

Figure 17 is a block diagram of an apparatus for evaluating renal nerve ablation results according to an embodiment.

Referring to FIG. 17, the renal nerve ablation result evaluation device 130 according to the embodiment includes a first input unit 131, a second input unit 132, a third input unit 133, a first calculation unit 134, and a first input unit 134. 2 It may include a calculation unit 135 and an evaluation unit 136.

The renal nerve ablation result evaluation device 130 according to the embodiment includes a first input unit 131 for inputting first blood flow data in the first region after injection of a vasodilator into a first region within a renal blood vessel, and a first input unit 131 in the first region. It may be configured as the second input unit 132 to input second blood flow data after performing renal nerve ablation using a catheter. It may further include the third input unit 133 for inputting base blood flow data in the first area before injection of the vasodilator.

Blood flow information can be detected from a detection means disposed at the distal end of the catheter. As described above, blood flow information includes blood flow volume, blood flow speed, blood flow resistance, etc., and the acquisition means may acquire or receive any one of the blood flow information from the detection means. For example, the first blood flow data, the second blood flow data, and the base blood flow data acquired by the acquisition means may be the same category of blood flow information, for example, blood flow volume. And the detection means may include any one of an ultrasonic sensor, an impedance sensor, and an optical sensor. Additionally, as described above, the acquisition means may acquire the first blood flow data, the second blood flow data, and the base blood flow data based on the blood flow information detected by the detection means. The catheter may include the acquisition means described above. And the catheter may include the vasodilator injection unit.

First, the first input unit 131 may input first blood flow data in the first region (renal artery). For example, the first input unit 131 may be connected to the above-described detection means to input blood flow data obtained from the acquisition means. At this time, the detection means is connected to the acquisition means as described above, measures the blood flow information measured by the detection means and transmits it to the acquisition means, and the acquisition means can obtain the measured blood flow information by processing it as blood flow data. there is. This detection means includes an ultrasonic sensor, etc., and acquires blood flow data (e.g., first blood flow data, second blood flow data, and base blood flow data) measured within the first region (renal artery) and the blood flow obtained by the acquisition means. Data can be received. Accordingly, hereinafter, the second input unit 132 and the third input unit 133, like the first input unit 131, are connected to the acquisition means and input the blood flow data acquired by the acquisition means to evaluate renal nerve ablation. You can.

For example, the first input unit 131 may receive first blood flow data, which is blood flow data within the first region (renal artery), from the acquisition means within a predetermined time after injecting the vasodilator, and input it for evaluation of the renal nerve ablation results. there is.

The second input unit 132 may input second blood flow data in the first region (renal artery). That is, the second input unit 132 may input second blood flow data, which is blood flow data in the first area, to evaluate renal nerve ablation after performing renal nerve denervation using a catheter. Additionally, the second input unit 132 is connected to the above-described detection means and can input blood flow data obtained from the acquisition means. At this time, the detection means may include an ultrasonic sensor, etc. as described above.

The third input unit 133 may input base blood flow data, which is blood flow data in the first region (renal artery), to evaluate renal nerve ablation before injecting a vasodilator or performing renal nerve ablation. For example, the third input unit 133 may input base blood flow data received from the acquisition means before injecting the vasodilator. Alternatively, the third input unit 133 may input the base blood flow data received from the acquisition means after a predetermined time has elapsed after the vasodilator is injected and the first blood flow data is input.

As described above, the evaluation of renal nerve ablation can be performed even if the base blood flow data and the first blood flow data are performed once, unlike the second blood flow data that can be input multiple times. Accordingly, in the renal nerve ablation result evaluation device according to the embodiment, there is no need to repeatedly acquire first blood flow data and base blood flow data, which are standards for evaluation of renal nerve ablation, so the procedure time can be reduced and the ablation result The evaluation can be made free from the complex factors of vascular fluctuations associated with renal nerve resection.

Furthermore, as described above, the first input unit 131 to the third input unit 133 receive blood flow data including blood flow rate and blood flow volume in the renal artery from the acquisition means, and receive the data from the same device with a predetermined time difference. This can be input into each calculation unit described later.

The first calculation unit 134 may calculate the ratio between first blood flow data and second blood flow data. And the second calculation unit 135 can calculate the ratio between the first difference value and the second difference value. As described above, here, the first difference value may be a difference value between the first blood flow data and the base blood flow data, and the second difference value may be a difference value between the second blood flow data and the base blood flow data. In an embodiment, the first calculation unit 134 and the second calculation unit 135 calculate the first blood flow data, second blood flow data, and base blood flow data input from the first input unit 131 to the third input unit 133. The above-mentioned ratio or ratio can be calculated using.

The evaluation unit 136 may receive the ratio or ratio calculated from the first calculation unit 134 and the second calculation unit 135 and use it to evaluate renal nerve ablation.

More specifically, the evaluation unit 136 may compare first blood flow data and second blood flow data. For example, the evaluation unit 136 may compare the ratio or proportion of the first blood flow data and the second blood flow data with a threshold value (eg, a first threshold value). Exemplarily, it may be determined whether the ratio of the second blood flow data and the first blood flow data is lower or higher than the first threshold. Alternatively, it may be determined whether the ratio of the second blood flow data and the first blood flow data is lower or higher than a predetermined ratio. For example, when the ratio between the second blood flow data and the first blood flow data is lower than the first threshold, the evaluation unit 136 may evaluate that renal nerve ablation should be performed again. Accordingly, information or an alarm that renal nerve ablation must be re-performed may be output to the operator by the output unit. Additionally, when the ratio between the second blood flow data and the first blood flow data is higher than the first threshold, the evaluation unit 136 may evaluate that renal nerve ablation was performed correctly. Accordingly, the evaluation unit 136 can provide an alarm about the completeness of the resection to the operator through the output unit indicating that the renal nerve resection has been appropriately performed.

In addition, the evaluation unit 136 compares the ratio or proportion between the first difference value and the second difference value with a threshold value, and the ratio between the first difference value and the second difference value (e.g., corresponding to the 'PEI' described above) It may be determined whether is greater than or less than a threshold value (eg, a second threshold value).

For example, the evaluation unit 136 may evaluate that renal nerve ablation should be performed again when the ratio between the first difference value and the second difference value is less than the second threshold value. Accordingly, information or an alarm that renal nerve ablation must be re-performed may be output to the operator by the output unit.

The evaluation unit 136 may evaluate that renal nerve ablation has been performed correctly when the ratio between the first difference value and the second difference value is higher than the first threshold, and then sends an alarm about the completeness of the ablation to the operator through the output unit. can be provided.

The output unit (not shown) may output or provide an output (eg, an alarm) corresponding to the evaluation of the renal nerve resection results to the user. The output unit (not shown) may provide the user with the adequacy or evaluation of renal nerve resection through various output methods such as a display. For example, the output unit (not shown) includes a display unit, and the evaluation results of the evaluation unit (ratio between the first difference value and the second difference value, ratio between the first blood flow data and the second blood flow data, etc.) are displayed on the display unit. You can. Additionally, the output unit (not shown) may display at least one of first blood flow data, second blood flow data, and base blood flow data. For example, the output unit (not shown) may output the above-described peak-to-peak value, average value, or first blood flow data, second blood flow data, and base blood flow data acquired over a predetermined time in real time.

And, if the evaluation unit 136 determines that the second blood flow data is less than a predetermined ratio of the first blood flow data or the ratio between the first difference value and the second difference value is less than the threshold as described above, the output unit (not shown) ) can provide the user with information that renal nerve resection is incomplete. For example, an output unit (not shown) may display that renal nerve ablation is not complete (corresponding to renal nerve ablation being re-performed) or provide a specific sound to the user. At this time, the specific sound may be different from the sound output when renal nerve resection is completed. Additionally, an output unit (not shown) may provide the user with completion of renal nerve ablation. That is, according to the judgment of the evaluation unit 136, the output unit (not shown) may output the evaluation of renal nerve resection or provide an alarm to the operator. The term '~unit' used in this embodiment refers to software or hardware components such as FPGA (field-programmable gate array) or ASIC, and the '~unit' performs certain roles. However, '~part' is not limited to software or hardware. The '~ part' may be configured to reside in an addressable storage medium and may be configured to reproduce on one or more processors. Therefore, as an example, '~ part' refers to components such as software components, object-oriented software components, class components, and task components, processes, functions, properties, and procedures. , subroutines, segments of program code, drivers, firmware, microcode, circuitry, data, databases, data structures, tables, arrays, and variables. The functions provided within the components and 'parts' may be combined into a smaller number of components and 'parts' or may be further separated into additional components and 'parts'. Additionally, components and 'parts' may be implemented to regenerate one or more CPUs within a device or a secure multimedia card.

Although the above description focuses on the examples, this is only an example and does not limit the present invention, and those skilled in the art will be able to You will see that various variations and applications are possible. For example, each component specifically shown in the examples can be modified and implemented. And these variations and differences in application should be construed as being included in the scope of the present invention as defined in the appended claims.

Claims (25)

A first input unit inputting first blood flow data from the first region after the vasodilator injected into the first region within the renal blood vessel is activated in the second region within the renal blood vessel;
A second input unit inputting second blood flow data from the first region after renal nerve denervation is performed with a nerve ablation catheter; And
The evaluation unit compares the first blood flow data and the second blood flow data, and determines the comparison result, including a ratio or a difference value corresponding to each of the first blood flow data and the second blood flow data, with a predetermined threshold value. A step of comparing and evaluating the result of renal nerve resection, which is whether or not to re-perform renal nerve resection, depending on whether the compared result is greater or less than the predetermined threshold,
The predetermined threshold value is set corresponding to the patient,
The first input unit inputs the first blood flow data within a half-life after injecting the vasodilator,
It is performed by a renal nerve ablation result evaluation device, which acquires base blood flow data or the second blood flow data when a half-life has elapsed after the vasodilator is injected into the first region,
A method for evaluating renal nerve ablation results wherein the vasodilator is not injected into the first region between input of the first blood flow data and input of the second blood flow data.
delete delete According to paragraph 1,
A renal nerve ablation result evaluation method performed by a renal nerve ablation result evaluation device, comprising an output unit outputting that renal nerve ablation is to be re-performed when the compared result is lower than the predetermined threshold.
According to paragraph 1,
A first calculation unit calculating a first difference value representing a difference value between the first blood flow data and base blood flow data;
A second calculation unit calculating a second difference value representing a difference between the second blood flow data and the base blood flow data; and
A renal nerve ablation result evaluation method performed by a renal nerve ablation result evaluation apparatus further comprising: the evaluation unit comparing the first difference value and the second difference value.
According to clause 5,
A renal nerve ablation result evaluation method performed by a renal nerve ablation result evaluation device in which the evaluation unit evaluates the renal nerve ablation result according to a result of comparing the first difference value and the second difference value.
According to clause 6,
A renal nerve ablation result evaluation method performed by a renal nerve ablation result evaluation device in which the output unit repeats the step of outputting to re-perform renal nerve ablation if the compared result is lower than the predetermined threshold.
According to clause 5,
The base blood flow data is obtained before injecting the vasodilator, or between the step of inputting the first blood flow data and the step of performing the renal nerve ablation. It is performed by a renal nerve ablation result evaluation device. Methods for evaluating renal nerve ablation outcomes.
delete According to paragraph 1,
A method for evaluating renal nerve ablation results performed by a renal nerve ablation result evaluation device, wherein the second region is a renal arteriole or renal capillary.
According to paragraph 1,
The vasodilators include dopamine, dobutamine, adenosine, prostacyclin, nitric oxide, bradykinin, papaverine, dipyridamolum, diuretin, theophylline, and minoxidil ( A renal nerve ablation outcome evaluation method performed by a renal nerve ablation outcome evaluation device containing any one of minoxidil) and isosorbide nitrate (isosorbide).
a first input unit for inputting first blood flow data obtained in the first region after the vasodilator injected into the first region within the renal blood vessel is activated in the second region;
a second input unit for inputting second blood flow data obtained in the first region after performing renal nerve ablation using a catheter; and
Comparing the first blood flow data and the second blood flow data, and comparing a comparison result including a ratio or a difference value corresponding to each of the first blood flow data and the second blood flow data with a predetermined threshold value. An evaluation unit that evaluates the result of renal nerve ablation, which is whether or not to re-perform renal nerve ablation, depending on whether the compared result is greater or smaller than the predetermined threshold;
The predetermined threshold value is set corresponding to the patient,
The first input unit inputs the first blood flow data within a half-life after injecting the vasodilator,
Base blood flow data or the second blood flow data are obtained when the half-life has elapsed after the vasodilator is injected into the first region,
A renal nerve ablation result evaluation device wherein the vasodilator is not injected into the first region between input of the first blood flow data and input of the second blood flow data.

According to clause 12,
A renal nerve ablation result evaluation device further comprising a first calculation unit that calculates a ratio between the first blood flow data input by the first input unit and the second blood flow data input by the second input unit.
According to clause 13,
The evaluation unit is a renal nerve ablation result evaluation device wherein the evaluation unit evaluates the renal nerve ablation result by comparing the ratio between the first blood flow data and the second blood flow data calculated by the first calculation unit with a first threshold.
According to clause 13,
A renal nerve ablation result evaluation device further comprising a third input unit for inputting base blood flow data in the first region before injection of the vasodilator.
According to clause 15,
It further includes a second calculation unit that calculates the ratio between the first difference value and the second difference value,
The first difference value is a difference value between the first blood flow data and the base blood flow data, and the second difference value is a difference value between the second blood flow data and the base blood flow data. Renal nerve ablation result evaluation device.
According to clause 16,
The evaluation unit is a renal nerve ablation result evaluation device wherein the evaluation unit compares the ratio between the first difference value and the second difference value calculated by the second calculation unit with a second threshold value to evaluate the renal nerve ablation result.
delete delete According to clause 15,
The first blood flow data, the second blood flow data, and the base blood flow data are obtained from blood flow information detected by a detection means disposed on the catheter.
According to clause 20,
The blood flow information includes at least one of blood flow volume, blood flow rate, and blood flow resistance.
According to clause 20,
A renal nerve ablation result evaluation device wherein the detection means includes any one of an ultrasonic sensor, an impedance sensor, and an optical sensor.
delete delete delete

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