Power supply device, perforation method, and perforation system

Abstract

To provide a power supply device and the like capable of reducing unnecessary energy application other than during perforation.SOLUTION: A power supply device 5 comprises: a power supply unit 51 that applies energy based on power output externally to a wall-like tissue AS in a body through a distal electrode 42 at a distal end of a perforation device 4 so as to form a hole H; a power monitoring unit 54 that monitors the power output from the power supply unit 51; and a power control unit 52 that reduces the power output from the power supply unit 51 when at least one of the monitored power and an increase amount thereof exceeds a predetermined reference value. The power control unit 52 reduces the power output from the power supply unit 51 when the increase amount of the monitored power is greater than 20% of the power before the increase.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to a power supply device and the like. [Background technology]

[0002] Patent Document 1 discloses a puncture device for creating a hole in the fossa ovalis in the atrial septum. The tip of this puncture device is provided with a tip electrode for applying energy to the fossa ovalis in contact with the tip. The applied energy alters the fossa ovalis, forming a desired hole connecting the right atrium and the left atrium. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 7078606 Summary of the Invention [Problem to be solved by the invention]

[0004] For example, immediately after drilling a hole from the right atrium to the left atrium, the tip electrode enters the left atrium, and at this time, there is a possibility that the tip electrode may apply unnecessary energy to the left atrium itself or the blood in the left atrium.

[0005] The present disclosure has been made in light of these circumstances, and aims to provide a power supply device and the like that can reduce the application of unnecessary energy other than during drilling. [Means for solving the problem]

[0006] In order to solve the above problems, a power supply device of one embodiment of the present disclosure includes a power supply unit that applies energy based on power output outside the body to wall tissue inside the body through an electrode at the tip of the perforation device to create a hole, a power monitoring unit that monitors the power output by the power supply unit, and a power control unit that reduces the power output by the power supply unit when at least one of the monitored power and its increase is greater than a predetermined reference value.

[0007] According to this aspect, by monitoring the power output by the power supply unit, it is possible to reduce the application of unnecessary energy other than during perforation. For example, this utilizes the phenomenon that when the electrode is in contact with or close to the wall-like tissue to be perforated during perforation, the output power of the power supply unit is relatively small, and when the electrode is in a space (typically where a body fluid such as blood is present) away from the wall-like tissue before and / or after perforation, the output power of the power supply unit is relatively large. Specifically, when at least one of the monitored output power and its increase is greater than a predetermined reference value, the state is treated as a non-perforation state (i.e., before or after perforation), and the output power of the power supply unit is reduced.

[0008] Another aspect of the present disclosure is a perforation method, which includes applying energy based on power output outside the body to wall-like tissue inside the body through electrodes at the tip of a perforation device to create a hole, monitoring the power, and reducing the power when at least one of the monitored power and its increase is greater than a predetermined reference value.

[0009] Yet another aspect of the present disclosure is a perforation system comprising: a power supply unit including a power supply unit that outputs power, a power monitoring unit that monitors the power output by the power supply unit, and a power control unit that reduces the power output by the power supply unit when at least one of the monitored power and its increase is greater than a predetermined reference value; and a perforation device that applies energy based on the power output from the power supply unit to wall-like tissue through an electrode on the distal side to create a hole.

[0010] Any combination of the above components, or any conversion of these expressions into methods, devices, systems, recording media, computer programs, etc., are also encompassed within the present disclosure. [Effects of the Invention]

[0011] According to the power supply device and the like of the present disclosure, it is possible to reduce the application of unnecessary energy other than during drilling. [Brief explanation of the drawings]

[0012] [Figure 1] 1 shows a schematic representation of a drilling system. [Figure 2] The procedure for transatrial septal puncture is shown. [Figure 3] The procedure for transatrial septal puncture is shown. [Figure 4] The procedure for transatrial septal puncture is shown. [Figure 5] 10A and 10B are diagrams illustrating a typical example of power control based on a power supply time set by a power supply time setting unit. [Figure 6] 10 is a diagram illustrating a typical example of power control based on a reference value for output power applied by a power monitoring unit. [Figure 7] A modification of FIG. 6 is shown. [Figure 8] A modification of FIG. 6 is shown. [Figure 9] 10 is a flowchart illustrating an example of power control by the drilling system. DETAILED DESCRIPTION OF THE INVENTION

[0013] Hereinafter, embodiments for carrying out the present disclosure (hereinafter also referred to as embodiments) will be described in detail with reference to the drawings. In the description and / or drawings, identical or equivalent components, members, processes, etc. are designated by the same reference numerals, and redundant description will be omitted. The scale and shape of each part shown in the drawings are set for convenience to simplify the description and should not be construed as limiting unless otherwise specified. The embodiments are merely examples and do not limit the scope of the present disclosure in any way. Not all features and combinations thereof presented in the embodiments are necessarily essential to the present disclosure. For convenience, the embodiments are presented by breaking them down into components for each function and / or functional group that realize them. However, one component in an embodiment may actually be realized by a combination of multiple separate components, or multiple components in an embodiment may actually be realized by a single integrated component. Furthermore, although multiple embodiments and variants may be disclosed in parallel, any components of each embodiment and / or each variant may be combined in any manner as long as they do not interfere with each other's functions.

[0014] Fig. 1 schematically shows a drilling system 1 according to an embodiment of the present disclosure. The drilling system 1 is a system or device that drills a hole H in wall-like tissue AS inside the body, such as the atrial septum. In Fig. 1, the external appearance of the distal end side of the drilling system 1 is shown schematically, and the functional blocks and the like of the proximal end side of the drilling system 1 are shown schematically.

[0015] The distal end of the drilling system 1 is inserted into the body where the wall-like tissue AS to be drilled is located. Thus, in this embodiment, the distal end and the inside of the body have the same meaning. On the other hand, the proximal end of the drilling system 1 or the power supply device 5 is located outside the body so that an operator such as a doctor can operate it electrically and / or mechanically. Thus, in this embodiment, the proximal end and the outside of the body have the same meaning.

[0016] In this embodiment, the direction in which the distal end (inside the body) and the proximal end (outside the body) are connected by the drilling system 1 is conveniently referred to as the axial direction, the length direction, the insertion direction, etc. The drilling system 1, at least a portion of which is flexible, typically bends inside the body to reach the target site such as wall-like tissue AS. For this reason, the drilling system 1, which determines the axial direction, length direction, insertion direction, etc., is typically at least partially curved. In other words, the axial direction, length direction, insertion direction, etc. may differ for each portion of the drilling system 1.

[0017] The perforation system 1 mainly includes a sheath 2, a dilator 3, a perforation device 4, and a power supply 5. Fig. 1 exemplarily and schematically illustrates a state in which the perforation system 1 is used in a procedure on the human body or the like. In this exemplary state, the sheath 2, the dilator 3, and at least the distal ends of the perforation device 4 are inserted into the body. The power supply 5, which serves as the proximal end of the perforation system 1, is outside the body.

[0018] The sheath 2 is a flexible tube. In the state shown in Fig. 1, the sheath 2 connects the power supply unit 5 outside the body of the drilling system 1 to the distal end portion inside the body.

[0019] As will be described later, the dilator 3 is an expander that assists in perforating the wall-like tissue AS (i.e., forming a hole H) and / or entering the hole H. To enhance its function as such an expander, the dilator 3 has a tapered shape that tapers from the base end, which has a relatively large outer diameter, to the tip end, which has a relatively small outer diameter. The dilator 3 is also formed in a tubular shape that allows the perforation device 4 to be inserted therethrough.

[0020] The dilator 3 in the state shown in FIG. 1 is provided on the distal side of the sheath 2. For example, the proximal side (not shown) of the dilator 3 (hidden by the sheath 2 and not visible) is housed within the tubular sheath 2. In other words, the outer diameter of the proximal side of the dilator 3 is equal to or smaller than the inner diameter of at least the distal side of the sheath 2. As shown in FIG. 1, the distal side of the dilator 3 protrudes or extends from the distal end of the tubular sheath 2 toward the distal side.

[0021] As will be described later, a hole H of the minimum necessary size is formed through the small-diameter tip 31 of the dilator 3 (and the tip electrode 42 of the perforation device 4, which will be described later). Furthermore, the dilator 3 can easily enter the hole H that it has formed through the small-diameter tip 31. As shown in FIG. 1 , as the dilator 3 advances further through the hole H, the outer diameter of the dilator 3 at the position of the hole H gradually increases, and therefore the hole H is effectively expanded by the dilator 3 as an expansion tool.

[0022] A through-hole 32 through which a punching device 4 (described later) can be inserted is provided at the tip 31 of the dilator 3. Although not shown in the drawings, the through-hole 32 extends over the entire length of the dilator 3.

[0023] The perforation device 4 is a tubular or linear elongated member. In the state shown in Fig. 1, the perforation device 4 extends from an external power supply unit 5 in the perforation system 1 to a distal end within the body. The perforation device 4 includes a tubular main body 41, a distal electrode 42 provided at the distal end of the main body 41, and a conductor 43 that electrically connects the distal electrode 42 to a power supply unit 51 (described later) in the proximal power supply unit 5.

[0024] 1, the distal end of the tubular main body 41 can be pulled out from the distal ends of the sheath 2 and the dilator 3. Therefore, the total axial length of the main body 41 is longer than the total axial length of the sheath 2 and the dilator 3 combined together.

[0025] The main body 41 is a tubular member having flexibility at least in a portion of its entire length. For example, the desired flexibility can be imparted by spirally winding the wire that forms the main body 41. Flexibility may be imparted over substantially the entire length of the main body 41, or to a portion in the axial direction that is required to be flexibly bent (for example, the tip portion that is pulled out from the tip 31 of the dilator 3 in FIG. 1).

[0026] It is preferable that at least the tip of the main body 41 is visible to an operator such as a doctor during a procedure inside the body. For example, the tip of the main body 41 may be formed of a material that is visible under X-ray fluoroscopy when the procedure is performed (for example, a material that is opaque to X-rays). Also, such a visible marker may be provided on the tip of the main body 41. Although not shown, a covering tube made of resin or the like is provided over substantially the entire length of the main body 41 to cover and protect the outer periphery of the main body 41. This covering tube is insulating and is therefore electrically insulated from the tip electrode 42, which will be described later.

[0027] A tip electrode 42 made of a conductive metal or the like is provided at the tip of the perforation device 4. This tip electrode 42 is disposed at the tip of the tubular body 41 and is exposed without being covered by the covering tube. The shape of the tip electrode 42 is arbitrary, but for example, it is exposed in a hemispherical shape.

[0028] 1 is electrically connected to a power supply unit 51 (described later) of the power supply device 5 by a conductor 43 that extends from the distal end (inside the body) to the proximal end (outside the body) within the tubular body 41. In other words, the conductor 43 constitutes a current path or a current path between the distal end electrode 42 and the power supply unit 51. The current that flows to the distal end electrode 42 through the conductor 43 is returned to the power supply device 5 through a return electrode plate (not shown) that is attached to an appropriate site on the human body of the procedure target. Alternatively, a current return conductor (not shown) may be provided in addition to the conductor 43.

[0029] The perforation device 4 as described above is movable in the axial direction relative to the entire dilator 3 (and sheath 2) in response to manipulation by a doctor or the like, as schematically shown by the solid double-headed arrow in FIG.

[0030] In the exemplary state shown in Fig. 1, the distal end side of the perforation device 4 is pulled out distally beyond the distal end 31 of the dilator 3. Meanwhile, as will be described later, the entire distal end side of the perforation device 4 (or substantially the entirety excluding the distal end portion including the distal electrode 42, which will be described later) may be housed within the dilator 3 and / or the sheath 2. In this manner, the distal end side of the perforation device 4 (particularly the distal electrode 42) can be inserted and removed through the distal end 31 of the dilator 3 in response to manipulation by a doctor or the like. Note that, at the proximal end side, where the dilator 3 may not be provided, the linear perforation device 4 extends through the tubular sheath 2 to the power supply 5 outside the body.

[0031] The power supply device 5 of the drilling system 1 includes a power supply unit 51, a power control unit 52, a power supply time setting unit 53, and a power monitoring unit 54. Some of these functional blocks may be omitted as long as the power supply device 5 can achieve at least some of the actions and / or effects described below. At least some of these functional blocks may be realized by cooperation of hardware resources such as a computer's central processing unit, memory, input devices, output devices, and peripheral devices connected to the computer, and software executed using them.

[0032] The power supply unit 51 outputs or supplies power to the power supply device 5 outside the body in the perforation system 1. Specifically, the power supply unit 51 supplies high frequency or alternating current having any frequency and / or amplitude suitable for perforating the wall-like tissue AS (i.e., forming a hole H). The frequency of the high frequency is, for example, 300 kHz-5 MHz, and the maximum output of the high frequency is, for example, 50 W. Because the power supply unit 51 generates high frequency or other electric power in this way, the power supply device 5 is also called a generator.

[0033] The high-frequency or other electric power supplied by power supply unit 51 is delivered to the aforementioned tip electrode 42 through conductor 43. Then, at the tip end portion inside the body, tip electrode 42 applies energy (which may be expressed as cauterization energy) based on the high-frequency or other electric power supplied from power supply unit 51 to wall-like tissue AS to open hole H. Details of the specific procedure will be described later.

[0034] The power control unit 52 controls the power supply or current flow to the tip electrode 42 via the power supply unit 51. The power supply time setting unit 53 sets the power supply time during which the power supply unit 51 outputs high-frequency or other power. As a power supply time suitable for perforating the wall-like tissue AS by the tip electrode 42, for example, a power supply time of less than 1 second (typically, 0.3 to 0.6 seconds) is set by the power supply time setting unit 53. The power supply time setting unit 53 may autonomously set such a power supply time suitable for perforation as an initial value or a recommended value. Alternatively, the power supply time setting unit 53 may set the power supply time according to manual operation by an operator such as a doctor.

[0035] Power monitoring unit 54 monitors the power output by power supply unit 51. For example, power monitoring unit 54 monitors or constantly measures the current and voltage in at least one of conductor 43 (or the electrodes (not shown) of power supply unit 51 electrically connected thereto), and monitors the output power as the product of the two (current x voltage). As described above, the maximum value (maximum output) of power monitored by power monitoring unit 54 is, for example, 50 W.

[0036] As will be described in detail later, when at least one of the power and its increase monitored by the power monitoring unit 54 is greater than a predetermined reference value, the power control unit 52 reduces the power output by the power supply unit 51. For example, when at least one of the power and its increase monitored by the power monitoring unit 54 is greater than a reference value, the power control unit 52 stops the power output by the power supply unit 51 (i.e., application of energy by the tip electrode 42). Furthermore, when the power control unit 52 does not stop the power output by the power supply unit 51 based on the reference value (power monitoring unit 54), it stops the power output by the power supply unit 51 after the power supply time (e.g., 0.3 to 0.6 seconds) set by the power supply time setting unit 53 has elapsed. As will be described later, stopping the power supply based on the reference value is considered sufficient in typical cases, and therefore the power supply time setting unit 53 may not be provided.

[0037] Next, an example of a procedure using the drilling system 1 configured as described above will be shown. Specifically, the flow of a transatrial septal puncture method, sometimes called the Brockenbrough method, is shown schematically in Figures 2 to 4. Figures 2 to 4 show a heart having a right ventricle RV, a right atrium RA, a left atrium LA, and a left ventricle LV, and the drilling system 1 according to this embodiment introduced therein.

[0038] As shown in Fig. 2, the dilator 3 constituting the distal end of the perforation system 1 is guided to the right atrium RA through the right ventricle RV. The distal dilator 3 and the proximal sheath 2 may be introduced to the state shown in Fig. 2 via a guide wire (not shown). Note that the linear perforation device 4 itself may function as a guide wire to guide the sheath 2 and dilator 3 to the state shown in Fig. 2.

[0039] In the state shown in FIG. 2, the tip 31 of the dilator 3 faces the atrial septum (e.g., the fossa ovalis) as the wall tissue AS to be perforated. At this time, the linear perforation device 4 may be completely housed within the dilator 3 and sheath 2 (or may not be introduced at all), or its tip portion including the tip electrode 42 may slightly protrude from the tip 31 of the dilator 3 (not shown). In either case, the perforation device 4 is handled so as not to interfere with the introduction of the sheath 2 and dilator 3 into the heart. Note that the sheath 2 and dilator 3 are introduced into the heart in response to manipulation by a physician or the like, as schematically shown by the dotted double-headed arrow in FIG. 1.

[0040] Next, as shown in Fig. 3, in response to the operation of a physician or other such person, the dilator 3 and / or the tip electrode 42, which serve as the tip of the perforation system 1, are pressed against the atrial septum AS, which is the target of perforation. The pressed atrial septum AS bends from the right atrium RA, which serves as the source of perforation, toward the left atrium LA, which serves as the destination of perforation, a process also known as tenting, but at this point, a hole has not yet been created. Furthermore, for the subsequent application of ablation energy (Fig. 4), the tip electrode 42, which serves as the tip of the perforation device 4, protrudes or is exposed from the tip 31 of the dilator 3 and comes into contact with or close to the atrial septum AS, which is the target of perforation.

[0041] When an operator, such as a doctor, performs an operation to start current application (e.g., pressing a current application start button on an operation panel, not shown) while appropriate tenting is being performed as shown in FIG. 3 , the power control unit 52 starts supplying current from the power supply unit 51. As shown in FIG. 4 , the tip electrode 42, which has been in contact with or in close proximity to the atrial septum AS, applies ablation energy based on the high frequency supplied from the power supply unit 51 to the atrial septum AS, thereby creating a hole H. The perforation device 4 (particularly the tip electrode 42) and / or at least the tip of the dilator 3 that performed the perforation advances into the newly created hole H with the momentum of tenting. As exemplarily shown in FIG. 4 , the tip of the perforation device 4 and the tip of the dilator 3 pass through the hole H and enter the left atrium LA, which is the perforation destination.

[0042] As shown in Fig. 4, when perforation of the atrial septum AS is completed, the power control unit 52 reduces the power output by the power supply unit 51. This effectively prevents the distal electrode 42, which has entered the left atrium LA immediately after perforation, from applying unnecessary high-frequency or cauterizing energy to the left atrium LA itself or the blood within the left atrium LA. For example, the power control unit 52 stops the output of power by the power supply unit 51 when the power supply time (e.g., 0.3 to 0.6 seconds) set by the power supply time setting unit 53 has elapsed since the time the power application start operation was performed. This power supply time is preferably optimized in advance as a time necessary and sufficient for perforating the wall-like tissue AS to be perforated.

[0043] 5 is a diagram illustrating a typical example of power control based on the power supply time T set by the power supply time setting unit 53. In this figure, the horizontal axis represents time, and the vertical axis represents the output power of the power supply unit 51 (this also applies to the following figures).

[0044] As described above, power supply or energization by the power supply unit 51 begins when appropriate tenting is being performed, as shown in FIG. 3 . This energization start point is set as the origin of the horizontal axis in FIG. 5 . At this time, the tip electrode 42, which is the main current source, is in contact with the atrial septum AS, which is a difficult target for electrical current to flow through, and therefore the output power of the power supply unit 51 is relatively low. As described above, if the maximum output of the power supply unit 51 is 50 W, the output power at the start of energization while the tip electrode 42 is in contact with the atrial septum AS, which is the target for perforation, is, for example, approximately 35 W (in practice, the output power rises sharply from 0 W to approximately 35 W in a short period of time immediately after the start of energization). Thereafter, the output power remains approximately constant at approximately 35 W while the tip electrode 42 is in contact with the atrial septum AS for perforation. In this manner, the output power of the power supply unit 51 remains approximately constant from the start of energization until perforation is completed, and is hereinafter referred to as the pre-perforation power WL.

[0045] Once the perforation is complete, as shown in Figure 4, the tip electrode 42 enters the left atrium LA, which is the space distal to the atrial septum AS and foramen H. At this time, the tip electrode 42, which continues to be energized, is in contact with body fluids in the left atrium LA, such as blood, which conducts electricity easily, and the output power of the power supply unit 51 becomes relatively high. As described above, if the maximum output or rated output of the power supply unit 51 is 50 W, the post-perforation power WH will be approximately equal to that.

[0046] In this way, when the power supply time T set by the power supply time setting unit 53 (the time from the start of power supply as the origin of the horizontal axis in FIG. 5 ) elapses while the tip electrode 42 is applying energy based on the post-perforation power WH that is approximately equal to the maximum output to the blood, etc. in the left atrium LA, the power control unit 52 stops the output of power by the power supply unit 51 (i.e., the application of energy by the tip electrode 42). As shown schematically as the "power supply period after completion of perforation" in FIG. 5 , power supply at the maximum output (post-perforation power WH) continues until the power supply time T has elapsed, even after perforation is completed and power supply is no longer necessary.

[0047] In addition to or instead of the power control based on the predetermined power supply time T as described above, in this embodiment, power control is performed using the power monitoring unit 54. Fig. 6 schematically shows a typical example of power control based on a reference value WS for output power applied by the power monitoring unit 54.

[0048] The reference value WS is set so that the power monitoring unit 54 and / or the power control unit 52 can determine that drilling by the tip electrode 42 has been completed. Therefore, the reference value WS is preferably set to a value equal to or less than the post-punching power WH (e.g., 50 W) and significantly greater than the pre-punching power WL (e.g., 35 W). Specifically, the reference value WS is set to a value greater than the expected fluctuation range or maximum value of the pre-punching power WL to prevent erroneous determination. For example, if the expected fluctuation range of the pre-punching power WL, which is 35 W on average, is 20%, i.e., 7 W (= 35 W * 20%), the reference value WS is preferably set to a value greater than the expected maximum value of the pre-punching power WL, 42 W (= 35 W + 7 W).

[0049] When the pre-drilling power WL and its fluctuation range are known to some extent in advance, the reference value WS for the output power applied by the power monitoring unit 54 may be preset as a fixed value (for example, a value slightly greater than 42 W).

[0050] Alternatively, the power monitoring unit 54 may derive the reference value WS to be applied in real time based on the pre-drilling power WL monitored in real time after the start of energization. For example, if the average pre-drilling power WL over a predetermined period (e.g., 0.1 to 0.3 seconds) after the start of energization (but before the completion of drilling) is 35 W, the power monitoring unit 54 may derive and apply in real time as the reference value WS a value slightly larger than the value obtained by multiplying this by a predetermined fluctuation range (e.g., 20%) (e.g., a value slightly larger than 42 W). Note that the power monitoring unit 54 may also measure the fluctuation range of the pre-drilling power WL after the start of energization in real time in the form of statistics such as deviation, standard deviation, and variance, and use this to derive the reference value WS.

[0051] Alternatively, if the instantaneous value of the pre-drilling power WL is 35 W after a predetermined period (e.g., 0.1 to 0.3 seconds) has elapsed since the start of energization (but before drilling is completed), the power monitoring unit 54 may derive and apply in real time as the reference value WS a value slightly larger than the value obtained by multiplying this by a predetermined fluctuation range (e.g., 20%) (e.g., a value slightly larger than 42 W). In this way, if the increase in output power monitored by the power monitoring unit 54 is larger than the fluctuation range (e.g., 20%) of the reference value WS of the pre-drilling power WL before the increase (e.g., 35 W), the power control unit 52 reduces the power output by the power supply unit 51.

[0052] The reference value WS may be set as an absolute value of output power, such as "42W" (a slightly larger value), or as a relative value or increase to the pre-perforation power WL (e.g., 35W), such as "20%" (a slightly larger value) or "7W" (a slightly larger value).

[0053] The reference value WS (e.g., a value slightly greater than 42 W) set as the absolute value of the output power is greater than the pre-perforation power WL (e.g., 35 W) monitored by the power monitoring unit 54 when the tip electrode 42 in contact with the atrial septum AS before the hole H is created is applying energy (before perforation is completed in Figure 5), and is less than the post-perforation power WH (e.g., 50 W) monitored by the power monitoring unit 54 when the tip electrode 42 in the space beyond the hole H (left atrium LA) is applying energy (after perforation is completed in Figure 5).

[0054] The reference value WS (e.g., a value slightly greater than 20% or 7 W) set as a relative value or increase amount relative to the pre-perforation power WL (e.g., 35 W) is less than the increase amount (e.g., 43% or 15 W) from the pre-perforation power WL (e.g., 35 W) monitored by the power monitoring unit 54 when the tip electrode 42 in contact with the atrial septum AS before the hole H is opened is applying energy (before the perforation is completed in Figure 5) to the post-perforation power WH (e.g., 50 W) monitored by the power monitoring unit 54 when the tip electrode 42 in the space beyond the hole H (left atrium LA) is applying energy (after the perforation is completed in Figure 5).

[0055] 6, when power monitoring unit 54 detects that the output power of power supply unit 51 has increased from pre-drilling power WL (e.g., 35 W) to reference value WS (e.g., 42 W) after drilling is completed, power control unit 52 stops the output of power by power supply unit 51 (i.e., application of energy by tip electrode 42). When the output power of power supply unit 51 and / or its increase amount reaches reference value WS in this way, power control unit 52 may, instead of stopping the output of power by power supply unit 51, reduce the output power below reference value WS or may limit the increase in output power above reference value WS (not shown).

[0056] As described above, according to this embodiment, the power monitoring unit 54 monitors the output power of the power supply unit 51, so that application of unnecessary energy through the tip electrode 42 after perforation is completed can be reduced or prohibited.

[0057] 7, if the output power does not reach reference value WS and power control unit 52 does not stop the output of power by power supply unit 51 based on reference value WS, power output by power supply unit 51 is stopped in response to the elapse of power supply time T set by power supply time setting unit 53, as in the case of FIG. 5. This effectively prevents power from continuing to flow for a long period of time while the output power does not exceed reference value WS.

[0058] FIG. 6 illustrates an example in which energization after perforation completion is stopped based on the reference value WS. However, as illustrated in FIG. 8, energization before perforation completion may also be stopped based on the reference value WS. In the example of FIG. 8, due to poor tenting of the atrial septum AS (FIG. 3), the tip electrode 42 immediately after energization begins comes into contact with body fluids in the right atrium RA, such as blood, which easily conducts electricity. Therefore, the output power of the power supply unit 51 immediately after energization begins becomes the post-perforation power WH, which is the maximum output or rated output that should be achieved after perforation completion. However, when the power monitoring unit 54 detects a maximum output WH (e.g., 50 W) that is greater than the reference value WS (e.g., 42 W), the power control unit 52 immediately stops the output of power from the power supply unit 51. As described above, according to this embodiment, the power monitoring unit 54 monitors the output power of the power supply unit 51, thereby reducing or preventing unnecessary application of energy through the tip electrode 42 before perforation completion.

[0059] 6, after perforation of the atrial septum AS is completed and current supply to the distal electrode 42 is terminated, the perforation device 4 may be removed from the body through the dilator 3 and the sheath 2. Furthermore, a treatment tool such as an ablation catheter for performing a medical treatment such as ablation (cauterization) may be introduced into the left atrium LA through the hole H formed in the atrial septum AS (or the dilator 3 inserted therein).

[0060] 9 is a flowchart showing an example of power control by the drilling system 1 according to this embodiment. "S" in the flowchart denotes a step or a process.

[0061] In S1, preferably with appropriate tenting being performed as shown in Fig. 3, in response to an operation to start power supply performed by an operator such as a doctor (for example, pressing a power supply start button provided on an operation panel, not shown), power control unit 52 starts power supply from power supply unit 51. In S2, power monitoring unit 54 continuously monitors the output power from power supply unit 51, which started power supply in S1.

[0062] In S3, the power control unit 52 determines whether the output power monitored in S2 has exceeded a predetermined reference value WS. If the determination in S3 is "Yes," the process proceeds to S5, where the power control unit 52 stops the output of power from the power supply unit 51 (i.e., the application of energy by the tip electrode 42) that began in S1, as shown in FIGS.

[0063] If the determination in S3 is "No," the process proceeds to S4, where the power control unit 52 determines whether the power supply time T set by the power supply time setting unit 53 has elapsed since the start of power supply in S1. If the determination in S4 is "Yes," the process proceeds to S5, where the power control unit 52 stops the output of power by the power supply unit 51 (i.e., the application of energy by the tip electrode 42) that began in S1, as shown in Fig. 7. If the determination in S4 is "No," the process returns to S2.

[0064] The present disclosure has been described above based on the embodiments. Various modifications are possible to the combinations of the components and processes in the exemplary embodiments, and it will be obvious to those skilled in the art that such modifications are included within the scope of the present disclosure.

[0065] The configuration, operation, and function of each device and method described in the embodiments can be realized by hardware resources, software resources, or a combination of hardware and software resources. Examples of hardware resources include processors, ROMs, RAMs, and various integrated circuits. Examples of software resources include operating systems, applications, and other programs. [Explanation of symbols]

[0066] 1 perforation system, 2 sheath, 3 dilator, 4 perforation device, 5 power supply, 42 tip electrode, 51 power supply unit, 52 power control unit, 53 power supply time setting unit, 54 power monitoring unit.

Claims

1. a power supply unit that applies energy based on power output outside the body to wall-like tissue inside the body through an electrode at the tip of the perforation device to create a hole; a power monitoring unit that monitors the power output by the power supply unit; a power control unit that reduces the power output by the power supply unit when at least one of the monitored power and the increase in the power is greater than a predetermined reference value; A power supply device comprising:

2. The power supply device according to claim 1 , wherein the power control unit stops the power output by the power supply unit when at least one of the monitored power and an increase in the monitored power is greater than the reference value.

3. a power supply time setting unit that sets a power supply time during which the power supply unit outputs power, When the power control unit does not stop outputting power based on the reference value, the power control unit stops outputting power based on the reference value. The power supply device according to claim 2 .

4. When the electrode in contact with the wall-like tissue before the hole is formed is applying the energy, the pre-perforation power monitored by the power monitoring unit is smaller than the reference value; When the electrode in the space after the hole is drilled is applying the energy, the post-punching power monitored by the power monitoring unit is greater than the reference value.

3. The power supply device according to claim 1 or 2.

5. 3. The power supply device according to claim 1, wherein the increase from the pre-perforation power monitored by the power monitoring unit when the electrode in contact with the wall-like tissue before the hole is created is applying the energy to the post-perforation power monitored by the power monitoring unit when the electrode in the space where the hole is created is applying the energy is greater than the reference value.

6. 4. The power supply device according to claim 1, wherein the power control unit reduces the power output by the power supply unit when the increase in the monitored power is greater than 20% of the power before the increase.

7. The power supply device according to claim 1 , wherein the wall-like tissue is the atrial septum.

8. applying energy based on the power output outside the body to the wall-like tissue inside the body through an electrode at the tip of the perforation device to create a hole; monitoring the power; reducing the power when at least one of the monitored power and its increase is greater than a predetermined reference value; To perform drilling method.

9. a power supply unit that outputs power; a power monitoring unit that monitors the power output by the power supply unit; a power control unit that reduces the power output by the power supply unit when at least one of the monitored power and the increase in the power is greater than a predetermined reference value; a power supply device comprising: a perforation device that applies energy based on the power output from the power supply unit to wall-like tissue through an electrode on the distal end side to create a hole; A drilling system comprising:

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