Defibrillation control device and defibrillation system

Abstract

A defibrillation control device (14) comprises: a power supply unit (48) that supplies electrical energy to an electrode catheter (12) inserted into a heart chamber; a waveform input unit (46) that has an input connector (70) to which an output connector (80) that outputs an electrocardiographic waveform is connected; a connection determination unit (52b) that determines a connection state between the input connector (70) and the output connector (80); and a control unit (52) that controls the supply of the electrical energy on the basis of the electrocardiographic waveform input to the input connector (70) and a determination result of the connection determination unit (52b).

Description

Defibrillation control device and defibrillation system

[0001] The present disclosure relates to a defibrillation control device and a defibrillation system.

[0002] There is known a defibrillation device that detects an electrocardiographic waveform of a patient using an electrode catheter inserted into an intracardiac cavity and directly supplies electrical energy for defibrillation to the heart. As a countermeasure against malfunction caused by false detection of external noise, a configuration in which a noise removing capacitor is connected between the electrodes of an electrode catheter is known.

[0003] Japanese Unexamined Patent Publication No. 2002-263201

[0004] When an electrocardiographic waveform is input via an input connector, noise caused by poor connection of the input connector may be falsely detected as an electrocardiographic waveform.

[0005] The present disclosure has been made in view of such circumstances, and an object of the present disclosure is to address false detection of noise caused by poor connection of an input connector.

[0006] A defibrillation control device according to an aspect of the present disclosure includes: a power supply unit that supplies electrical energy to an electrode catheter inserted into an intracardiac cavity; an input connector to which an output connector that outputs an electrocardiographic waveform is connected; a connection determination unit that determines a connection state between the output connector and the input connector; and a control unit that controls supply of the electrical energy based on the electrocardiographic waveform input to the input connector and a determination result of the connection determination unit.

[0007] Another aspect of the present disclosure is a defibrillation system. This defibrillation system includes: an electrode catheter inserted into an intracardiac cavity; and a defibrillation control device that supplies electrical energy to the electrode catheter. The defibrillation control device includes: a power supply unit that supplies electrical energy; an input connector to which an output connector that outputs an electrocardiographic waveform is connected; a connection determination unit that determines a connection state between the output connector and the input connector; and a control unit that controls supply of the electrical energy based on the electrocardiographic waveform input to the input connector and a determination result of the connection determination unit.

[0008] Furthermore, any combination of the above components, as well as any representations thereof converted into methods, apparatus, systems, recording media, computer programs, etc., are also included in this disclosure.

[0009] According to this disclosure, it is possible to address false detection of noise due to poor connection of the input connector.

[0010] This is a schematic diagram showing the configuration of a defibrillation system according to an embodiment. This is a schematic diagram showing the structure of an electrode catheter. This is a schematic diagram showing the circuit configuration of the power supply unit. This is a graph showing an example of a voltage waveform output from the power supply unit. This is a schematic diagram showing the transition of the operating modes of the defibrillation control device. This is a schematic diagram showing an example of the configuration of the waveform input unit. This is a schematic diagram showing another example of the configuration of the waveform input unit. This is a schematic diagram showing yet another example of the configuration of the waveform input unit. This is a diagram showing an example of the display screen of the defibrillation control device. This is a schematic flowchart showing the defibrillation method according to an embodiment.

[0011] The following describes in detail the forms (hereinafter also referred to as embodiments) for carrying out this disclosure, with reference to the drawings. In the description and / or drawings, identical or equivalent components, members, processes, etc., are denoted by the same reference numerals, and redundant descriptions are omitted. The scale and shape of the illustrated parts are set for convenience to simplify the description and are not to be interpreted restrictively unless otherwise specified. The embodiments are illustrative and do not limit the scope of this disclosure in any way. Not all features or combinations thereof described in the embodiments are necessarily essential to this disclosure.

[0012] Figure 1 is a schematic diagram showing the configuration of a defibrillation system 10 according to an embodiment. The defibrillation system 10 comprises an electrode catheter 12, a defibrillation control device 14, and a monitoring device 16.

[0013] The electrode catheter 12 is a so-called cardiac catheter. The electrode catheter 12 is inserted into the body of the patient 20 and used so that the tip 24 of the electrode catheter 12 is positioned in the heart 22 of the patient 20. Multiple electrodes are provided on the tip side of the electrode catheter 12 so as to be arranged in the longitudinal direction. The electrode catheter 12 can measure the electrocardiogram at multiple locations in the cardiac chambers using the multiple electrodes. By applying voltage to the multiple electrodes, the electrode catheter 12 can directly supply electrical energy for defibrillation to the heart 22.

[0014] The defibrillation control device 14 is connected to the electrode catheter 12. The defibrillation control device 14 operates in either an electrocardiogram measurement mode or a defibrillation mode. In electrocardiogram measurement mode, the defibrillation control device 14 acquires the electrocardiogram waveform measured by the multiple electrodes of the electrode catheter 12 and outputs it to the monitoring device 16. In defibrillation mode, the defibrillation control device 14 supplies electrical energy for defibrillation to the electrode catheter 12 by applying voltage to the multiple electrodes of the electrode catheter 12.

[0015] The monitoring device 16 acquires and monitors the electrocardiogram waveform of the patient 20. The monitoring device 16 acquires the electrocardiogram waveform measured by the electrode catheter 12 via the defibrillation control device 14. The monitoring device 16 acquires the electrocardiogram waveform of the patient 20 via electrocardiogram measurement means such as electrode pads 18 attached to the surface of the patient 20's body. The monitoring device 16 can also acquire the electrocardiogram waveform of the patient 20 acquired from an electrode catheter other than the electrode catheter 12 connected to the defibrillation control device 14. The monitoring device 16 provides at least one of the acquired electrocardiogram waveforms to the defibrillation control device 14. The electrocardiogram waveform provided from the monitoring device 16 to the defibrillation control device 14 is used to determine the timing (trigger point) at which the supply of electrical energy for defibrillation can be initiated.

[0016] Figure 2 is a schematic diagram showing the structure of the electrode catheter 12. The electrode catheter 12 comprises a tubular, flexible shaft 26 that is inserted into the body, and a handle portion 28 connected to the proximal end (outside the body) of the shaft 26. A physician or other user of the electrode catheter 12 operates the electrode catheter 12 while grasping the handle portion 28. While grasping the handle portion 28, the user can deflect (swivel) the tip portion 24 of the shaft 26 in a predetermined direction by rotating the knob portion 34, through a pull wire (not shown) inserted inside the shaft 26. The deflection direction of the tip portion 24 of the shaft 26 can also be adjusted by rotating the handle portion 28 in the circumferential direction. A cable 30 for connecting to a defibrillation control device 14 is connected to the end of the handle portion 28.

[0017] The tip of the shaft 26 is provided with a first electrode group 31G, a second electrode group 32G, and a third electrode group 33G. The positions and order of the first electrode group 31G, the second electrode group 32G, and the third electrode group 33G in the axial direction (longitudinal direction) of the shaft 26 are arbitrary, but in the example shown in Figure 2, they are arranged in the order of first electrode group 31G, second electrode group 32G, and third electrode group 33G from the tip to the proximal end. When defibrillation is performed in the cardiac chambers using an electrode catheter 12 with such an electrode arrangement, for example, the first electrode group 31G at the tip is located in the coronary sinus (CS), the second electrode group 32G at the proximal end is located in the right atrium (RA), and the third electrode group 33G at the proximal end is located in the superior vena cava (SVC).

[0018] The first electrode group 31G comprises a plurality of ring-shaped first electrodes 31 arranged at intervals in the axial direction. The second electrode group 32G comprises a plurality of ring-shaped second electrodes 32 arranged at intervals in the axial direction. The third electrode group 33G comprises a plurality of ring-shaped third electrodes 33 arranged at intervals in the axial direction. In the example shown in Figure 2, eight first electrodes 31, eight second electrodes 32, and four third electrodes 33 are provided, but the number of electrodes included in each electrode group 31G, 32G, and 33G is not particularly limited. The plurality of electrodes 31, 32, and 33 do not have to be arranged together as electrode groups 31G, 32G, and 33G, but may be distributed at any position in the axial direction.

[0019] Inside the shaft 26 are inserted first, second, and third groups of wires (not shown) that are electrically connected to each electrode group 31G, 32G, and 33G. The first group of wires comprises multiple (e.g., eight) first wires connected to multiple first electrodes 31 in the first electrode group 31G. The second group of wires comprises multiple (e.g., eight) second wires connected to multiple second electrodes 32 in the second electrode group 32G. The third group of wires comprises multiple (e.g., four) third wires connected to multiple third electrodes 33 in the third electrode group 33G. Each group of wires is electrically connected to the defibrillation control device 14 via a cable 30. In electrocardiogram measurement mode, the defibrillation control device 14 can acquire electrocardiogram waveforms measured at each of the multiple electrodes 31, 32, and 33 constituting each electrode group 31G, 32G, and 33G.

[0020] In defibrillation mode, the first electrode group 31G and the second electrode group 32G are subjected to voltages of different polarities by the defibrillation control device 14. When a positive voltage is applied to the first electrode group 31G, a negative voltage is applied to the second electrode group 32G. For example, a common positive voltage is applied to the multiple first electrodes 31 constituting the first electrode group 31G, and a common negative voltage is applied to the multiple second electrodes 32 constituting the second electrode group 32G. Conversely, when a negative voltage is applied to the first electrode group 31G, a positive voltage is applied to the second electrode group 32G. For example, a common negative voltage is applied to the multiple first electrodes 31 constituting the first electrode group 31G, and a common positive voltage is applied to the multiple second electrodes 32 constituting the second electrode group 32G. In this way, electrical energy for defibrillation can be directly supplied between the coronary sinus (CS) where the first electrode group 31G is located and the right atrium (RA) where the second electrode group 32G is located.

[0021] Returning to Figure 1, the defibrillation control device 14 will be described. The defibrillation control device 14 includes a catheter connection unit 40, a contact switching unit 42, a waveform output unit 44, a waveform input unit 46, a power supply unit 48, an operation unit 50, a control unit 52, and a display unit 54.

[0022] The catheter connection section 40 is to which a cable 30 connected to the electrode catheter 12 is attached. The catheter connection section 40 is equipped with a group of connection terminals that are electrically connected to each of the multiple electrodes 31, 32, and 33 that constitute each electrode group 31G, 32G, and 33G of the electrode catheter 12. The catheter connection section 40 is equipped with a first group of connection terminals electrically connected to the first electrode group 31G, a second group of connection terminals electrically connected to the second electrode group 32G, and a third group of connection terminals electrically connected to the third electrode group 33G. The first and second groups of connection terminals are connected to the contact switching section 42. The third group of connection terminals is connected to the waveform output section 44, not the contact switching section 42, as shown by the dashed line 40a.

[0023] The contact switching unit 42 is a 1-circuit, 2-contact changeover switch, configured to connect the common contact 42c to either the first contact 42a or the second contact 42b. The first and second connection terminal groups of the catheter connection unit 40 are connected to the common contact 42c. Therefore, the common contact 42c is connected to the first electrode group 31G and the second electrode group 32G of the electrode catheter 12. The first contact 42a is connected to the waveform output unit 44. The second contact 42b is electrically connected to the power supply unit 48.

[0024] In the electrocardiogram measurement mode, for example, the contact switching unit 42 connects the common contact 42c to the first contact 42a. By connecting the common contact 42c to the first contact 42a, the first electrocardiogram waveform measured by the first electrode group 31G and the second electrocardiogram waveform measured by the second electrode group 32G can be output to the monitoring device 16 via the waveform output unit 44. In the defibrillation mode, for example, the contact switching unit 42 connects the common contact 42c to the second contact 42b. By connecting the common contact 42c to the second contact 42b, the first electrode group 31G and the second electrode group 32G can be connected to the power supply unit 48, and electrical energy can be supplied from the power supply unit 48.

[0025] The waveform output unit 44 outputs the electrocardiogram waveform measured using the electrode catheter 12 to the monitoring device 16. The waveform output unit 44 includes, for example, a first output terminal group that outputs multiple first electrocardiogram waveforms measured by the first electrode group 31G, a second output terminal group that outputs multiple second electrocardiogram waveforms measured by the second electrode group 32G, and a third output terminal group that outputs multiple third electrocardiogram waveforms measured by the third electrode group 33G.

[0026] The waveform output unit 44 outputs a first electrocardiogram waveform and a second electrocardiogram waveform, for example in the electrocardiogram measurement mode. The first and second electrocardiogram waveforms output from the waveform output unit 44 pass through the contact switching unit 42. The waveform output unit 44 does not output the first and second electrocardiogram waveforms when the first contact 42a is disconnected from the common contact 42c, for example in the defibrillation mode. The waveform output unit 44 outputs a third electrocardiogram waveform in both the electrocardiogram measurement mode and the defibrillation mode. This is because the third electrocardiogram waveform output from the waveform output unit 44 does not pass through the contact switching unit 42.

[0027] The waveform input unit 46 receives the electrocardiogram waveform provided by the monitoring device 16. The waveform input unit 46 has, for example, an input connector 70 into which the electrocardiogram waveform provided by the monitoring device 16 is input. The electrocardiogram waveform input to the waveform input unit 46 is, for example, a surface electrocardiogram waveform measured by the electrode pads 18. The electrocardiogram waveform input to the waveform input unit 46 may also be an intracardiac electrocardiogram waveform measured by a different electrode catheter than the electrode catheter 12.

[0028] In the example shown in Figure 1, the electrocardiogram waveform is provided to the waveform input unit 46 from the monitoring device 16, but the electrocardiogram waveform may also be provided directly to the waveform input unit 46 from the electrode pads 18 (i.e., without going through the monitoring device 16). The waveform input unit 46 may have a first waveform input unit to which the electrocardiogram waveform is input from the monitoring device 16, and a second waveform input unit to which the electrocardiogram waveform is input from the electrode pads 18.

[0029] The power supply unit 48 is connected to the second contact 42b of the contact switching unit 42. The power supply unit 48 is connected to the catheter connection unit 40 in defibrillation mode and disconnected from the catheter connection unit 40 in electrocardiogram measurement mode. The power supply unit 48 is connected to the first electrode group 31G and the second electrode group 32G of the electrode catheter 12 in defibrillation mode and disconnected from the first electrode group 31G and the second electrode group 32G of the electrode catheter 12 in electrocardiogram measurement mode.

[0030] In defibrillation mode, the power supply unit 48 supplies the electrical energy necessary for defibrillation to the electrode catheter 12. The power supply unit 48 includes a measurement circuit 48a, a charging circuit 48b, a discharge circuit 48c, and a capacitor 48d.

[0031] The measurement circuit 48a measures the impedance between the first electrode group 31G and the second electrode group 32G. The impedance measured by the measurement circuit 48a is used to determine whether the first electrode group 31G and the second electrode group 32G are in proper contact with the tissues in the cardiac chambers and are in a state suitable for supplying electrical energy for defibrillation. For example, if the impedance measured by the measurement circuit 48a is between 21Ω and 99Ω, it is determined that the state is suitable for defibrillation.

[0032] The charging circuit 48b charges the capacitor 48d with electrical energy for defibrillation. The charging circuit 48b is composed of a boost circuit that generates a high voltage of, for example, 100V to 600V. The amount of energy charged to the capacitor 48d by the charging circuit 48b is configured to be variable according to user input.

[0033] The discharge circuit 48c supplies electrical energy charged in the capacitor 48d to the first electrode group 31G and the second electrode group 32G of the electrode catheter 12. The discharge circuit 48c is composed of, for example, an H-bridge circuit using four switching elements (e.g., transistors). By switching the four switching elements on and off, the discharge circuit 48c generates a first state in which a positive voltage is applied to the first electrode group 31G and a negative voltage is applied to the second electrode group 32G, and a second state in which a negative voltage is applied to the first electrode group 31G and a positive voltage is applied to the second electrode group 32G.

[0034] Figure 3 is a schematic diagram showing the circuit configuration of the power supply unit 48. The power supply unit 48 includes a first terminal 48e that can be connected to the first electrode group 31G and a second terminal 48f that can be connected to the second electrode group 32G. The measurement circuit 48a is connected to the first terminal 48e and the second terminal 48f via the first switch S1 and the second switch S2. The discharge circuit 48c includes a third switch S3, a fourth switch S4, a fifth switch S5, and a sixth switch S6 that constitute an H bridge.

[0035] When the impedance between the first terminal 48e and the second terminal 48f is measured by the measurement circuit 48a, the first switch S1 and the second switch S2 are turned on, and the four switches S3 to S6 of the discharge circuit 48c are turned off. When the capacitor 48d is charged by the charging circuit 48b, all switches S1 to S6 are turned off. When the capacitor 48d is discharged by the discharge circuit 48c, a first state is used in which the third switch S3 and the fourth switch S4 are turned on and the fifth switch S5 and the sixth switch S6 are turned off, and a second state is used in which the third switch S3 and the fourth switch S4 are turned off and the fifth switch S5 and the sixth switch S6 are turned on.

[0036] Figure 4 is a graph showing an example of the voltage waveform output from the power supply unit 48, illustrating the time variation of the voltage applied between the first electrode group 31G and the second electrode group 32G. First, voltage application begins after a waiting period T0 has elapsed from the defibrillation start timing (trigger point). The waiting period T0 is, for example, about 10 to 50 ms (milliseconds), and one example is 10 ms. The first period T1 is a first state in which a positive voltage is applied to the first terminal 48e and a negative voltage is applied to the second terminal 48f. In the first period T1, the first peak voltage V Ａ The magnitude of the applied voltage decreases over time. First peak voltage V Ａ The magnitude of the voltage corresponds to the charging voltage of capacitor 48d, and is approximately 100V to 600V. The second period T2 is a second state in which a negative voltage is applied to the first terminal 48e and a positive voltage is applied to the second terminal 48f. In the second period T2, the second peak voltage V Ｂ The magnitude of the applied voltage decreases over time. Second peak voltage V Ｂ The magnitude of is the voltage V at the end of the first period T1. Ｃ Its size is approximately the same as that of [the other component]. The interval period ΔT between the first period T1 and the second period T2 is the short time required to switch the switches S3 to S6 of the discharge circuit 48c on and off. The discharge period T, including the first period T1 and the second period T2, is, for example, about 6 to 30 ms, and one example is 20 ms.

[0037] Returning to Figure 1, the operation unit 50 is a switch such as a push button that accepts user input. The operation unit 50 includes a mode switching button 50a, a charging button 50b, and a discharge button 50c. The mode switching button 50a is used to switch the operating mode between the electrocardiogram measurement mode and the defibrillation mode. The charging button 50b is used in the defibrillation mode to start charging the capacitor 48d by the charging circuit 48b. The discharge button 50c is used in the defibrillation mode to start discharging from the capacitor 48d by the discharge circuit 48c.

[0038] The control unit 52 controls the overall operation of the defibrillation control device 14. The control unit 52 comprises a mode control unit 52a, a connection determination unit 52b, and a trigger detection unit 52c.

[0039] The mode control unit 52a switches the operating mode of the defibrillation control device 14 in response to user operation of the operation unit 50. The connection determination unit 52b determines the connection status of the input connector 70 of the waveform input unit 46. The trigger detection unit 52c detects the trigger point for initiating a discharge for defibrillation based on the electrocardiogram waveform provided by the monitoring device 16.

[0040] Figure 5 is a schematic diagram showing the transitions in the operating modes of the defibrillation control device 14. As described above, the defibrillation control device 14 includes an electrocardiogram measurement mode 66 and a defibrillation mode 68 as operating modes. The defibrillation mode 68 has a measurement mode 68a, a charging mode 68b, and a discharge mode 68c.

[0041] In the electrocardiogram measurement mode 66, when the mode switching button 50a is pressed, the mode control unit 52a switches to the defibrillation mode 68 and shifts to the measurement mode 68a. In the measurement mode 68a, the impedance between the first electrode group 31G and the second electrode group 32G is measured by the measurement circuit 48a. When shifting to the measurement mode 68a, the mode control unit 52a switches the contact of the contact switching unit 42, and connects the common contact 42c to the second contact 42b. When the impedance measurement by the measurement circuit 48a is completed, the mode control unit 52a switches the contact of the contact switching unit 42, and returns the common contact 42c to the first contact 42a. When the measured impedance value is within a predetermined range (for example, 21Ω or more and 99Ω or less), the mode control unit 52a shifts to the charging mode 68b. When the measured impedance value is outside the predetermined range, the mode control unit 52a shifts to the electrocardiogram measurement mode 66. When the impedance value is outside the predetermined range, for example, the position of the electrode catheter 12 in the cardiac cavity is adjusted by the user so that the first electrode group 31G and the second electrode group 32G appropriately contact the tissue in the cardiac cavity.

[0042] In the charging mode 68b, the capacitor 48d is charged by the charging circuit 48b. When the charging button 50b is pressed in the charging mode 68b, the mode control unit 52a causes the charging circuit 48b to start charging the capacitor 48d. When the charging button 50b is not pressed in the charging mode 68b, the mode control unit 52a does not cause the charging circuit 48b to start charging the capacitor 48d. In the charging mode 68b, the mode control unit 52a does not switch the contact of the contact switching unit 42, and the common contact 42c remains connected to the first contact 42a. When the charging of the capacitor 48d is completed, the mode control unit 52a shifts to the discharge mode 68c.

[0043] In discharge mode 68c, the discharge circuit 48c discharges from the capacitor 48d to the electrode catheter 12. When the discharge button 50c is pressed in discharge mode 68c, the mode control unit 52a checks the connection of the input connector 70 using the connection determination unit 52b. If the connection determination unit 52b confirms a normal connection, the mode control unit 52a enters a state of waiting for the trigger detection unit 52c to detect a trigger point. Subsequently, when the trigger detection unit 52c detects a trigger point, the mode control unit 52a switches the contacts of the contact switching unit 42 to connect the common contact 42c to the second contact 42b, and then operates the discharge circuit 48c to supply electrical energy to the electrode catheter 12. Alternatively, the mode control unit 52a may switch the contacts of the contact switching unit 42 to connect the common contact 42c to the second contact 42b when the discharge button 50c is pressed, and then operate the discharge circuit 48c to supply electrical energy to the electrode catheter 12 when a trigger point is detected. After the discharge by the discharge circuit 48c is completed, the mode control unit 52a switches the contacts of the contact switching unit 42 to return the common contact 42c to the first contact 42a and transitions to the electrocardiogram measurement mode 66.

[0044] The mode control unit 52a prevents electrical energy from being supplied to the electrode catheter 12 if, in discharge mode 68c, the connection determination unit 52b does not confirm a normal connection when the discharge button 50c is pressed. The mode control unit 52a may terminate discharge mode 68c and switch to electrocardiogram measurement mode 66 if the connection determination unit 52b does not confirm a normal connection in discharge mode 68c. The mode control unit 52a may maintain discharge mode 68c and wait for the next press of the discharge button 50c if the connection determination unit 52b does not confirm a normal connection in discharge mode 68c.

[0045] In the charging mode 68b, when the charging button 50b is pressed, the mode control unit 52a may be configured not to start charging the capacitor 48d by the charging circuit 48b if normal connection is not confirmed by the connection determination unit 52b. In the charging mode 68b, when the charging button 50b is pressed, the mode control unit 52a may start charging the capacitor 48d by the charging circuit 48b if normal connection is confirmed by the connection determination unit 52b.

[0046] The connection determination unit 52b determines the connection state of a connector provided in the waveform input unit 46. The waveform input unit 46 includes an input connector 70 to which an electrocardiographic waveform is input. For example, an output connector 80 that outputs an electrocardiographic waveform provided from the monitoring device 16 is connected to the input connector 70. The output connector 80 is provided, for example, at a distal end of a cable extending from the monitoring device 16. The output connector 80 may be provided at a distal end of a cable extending from the electrode pad 18. For example, the input connector 70 is a female connector, and the output connector 80 is a male connector. The connection determination unit 52b determines whether the output connector 80 is appropriately connected to the input connector 70.

[0047] FIG. 6 is a diagram schematically illustrating an example of a configuration of the waveform input unit 46. The waveform input unit 46 includes an input connector 70. The input connector 70 has a plurality of input terminals 72a to 72h. The first input terminal 72a, the second input terminal 72b, and the third input terminal 72c are connected in parallel to the first input line 74. The fourth input terminal 72d, the fifth input terminal 72e, and the sixth input terminal 72f are connected in parallel to the second input line 76. The seventh input terminal 72g and the eighth input terminal 72h are connected to a measurement circuit 78. The electrocardiographic waveform input to the input connector 70 is sent to the control unit 52 via the first input line 74 and the second input line 76.

[0048] For example, the first input line 74 is a signal line for inputting an electrocardiogram waveform, and the second input line 76 is a ground line. In this case, the first input terminal 72a, the second input terminal 72b, and the third input terminal 72c are signal terminals, the fourth input terminal 72d, the fifth input terminal 72e, and the sixth input terminal 72f are ground terminals, and the seventh input terminal 72g and the eighth input terminal 72h are connection confirmation terminals. The input connector 70 has three or more terminals, including signal terminals, ground terminals, and connection confirmation terminals.

[0049] The input connector 70 is connected to the output connector 80. The output connector 80 has a plurality of output terminals 82a to 82h. Each of the plurality of output terminals 82a to 82h is connected to the corresponding input terminals 72a to 72h. The first output terminal 82a, the second output terminal 82b, and the third output terminal 82c are connected in parallel to the first output line 84. The fourth output terminal 82d, the fifth output terminal 82e, and the sixth output terminal 82f are connected in parallel to the second output line 86. The seventh output terminal 82g and the eighth output terminal 82h are short-circuited. The first output line 84 and the second output line 86 are connected to the monitoring device 16 and output electrocardiogram waveforms provided by the monitoring device 16.

[0050] For example, the first output line 84 is a signal line for outputting an electrocardiogram waveform, and the second output line 86 is a ground line. In this case, the first output terminals 82a, 82b, and 82c are signal terminals, the fourth output terminals 82d, 82e, and 82f are ground terminals, and the seventh output terminals 82g and 8th output terminals 82h are connection confirmation terminals. The output connector 80 has three or more terminals, including signal terminals, ground terminals, and connection confirmation terminals.

[0051] When the output connector 80 is properly connected to the input connector 70, the first input line 74 is connected to the first output line 84, and the second input line 76 is connected to the second output line 86. The first input line 74 and the first output line 84 are connected in parallel via three input terminals 72a to 72c and three output terminals 82a to 82c, thereby improving the reliability of the connection. Similarly, the second input line 76 and the second output line 86 are connected in parallel via three input terminals 72d to 72f and three output terminals 82d to 82f, thereby improving the reliability of the connection. This reduces the possibility of noise due to poor contact being superimposed on the electrocardiogram waveforms provided to the first input line 74 and the second input line 76.

[0052] When the output connector 80 is properly connected to the input connector 70, a short circuit occurs between the seventh input terminal 72g and the eighth input terminal 72h. On the other hand, when the output connector 80 is disconnected from the input connector 70, an open circuit occurs between the seventh input terminal 72g and the eighth input terminal 72h. The measurement circuit 78 measures the impedance value between the seventh input terminal 72g and the eighth input terminal 72h (i.e., the impedance value between the seventh output terminal 82g and the eighth output terminal 82h) and transmits the measured impedance value to the control unit 52. The connection determination unit 52b determines the connection status based on the acquired impedance value. If the impedance value is less than a predetermined value, the connection determination unit 52b determines that the output connector 80 is properly connected to the input connector 70. If the impedance value is greater than or equal to the predetermined value, the connection determination unit 52b determines that the output connector 80 is not properly connected to the input connector 70.

[0053] Alternatively, instead of short-circuiting the seventh output terminal 82g and the eighth output terminal 82h, a reference resistor may be connected. In this case, the connection determination unit 52b may determine that the output connector 80 is properly connected to the input connector 70 if the impedance value measured by the measurement circuit 78 falls within a predetermined range corresponding to the resistance value of the reference resistor. The connection determination unit 52b may determine that the output connector 80 is not properly connected to the input connector 70 if the impedance value measured by the measurement circuit 78 falls outside a predetermined range corresponding to the resistance value of the reference resistor. The connection determination unit 52b can determine the connection status based on the impedance values ​​between multiple terminals of the input connector 70 or the output connector 80 (for example, between multiple input terminals or between multiple output terminals).

[0054] The input connector 70 and output connector 80 shown in Figure 6 are 8-pin connectors, but the number of pins in the connector is not particularly limited. For example, the number of pins in the input terminals connected in parallel to the first input line 74 and the second input line 76 may be 2 or less, or 4 or more. The input connector 70 and output connector 80 shown in Figure 6 are shown with multiple input terminals 72a to 72h and multiple output terminals 82a to 82h arranged in a line, but the arrangement of multiple input terminals and multiple output terminals is not particularly limited.

[0055] As a modification of Figure 6, a measurement circuit 78 may be connected between the seventh output terminal 82g and the eighth output terminal 82h, and a short-circuit wire or reference resistor may be connected between the seventh input terminal 72g and the eighth input terminal 72h. In this case, the measurement circuit 78 measures the impedance value between the seventh output terminal 82g and the eighth output terminal 82h (i.e., the impedance value between the seventh input terminal 72g and the eighth input terminal 72h) and transmits the measured impedance value to the control unit 52. The measurement circuit 78 may transmit the impedance value to the control unit 52 through another terminal in the input connector 70 and the output connector 80, or it may transmit the impedance value to the control unit 52 through a different signal line than the input connector 70 and the output connector 80. The connection determination unit 52b can determine the connection state based on the impedance values ​​between multiple terminals of the input connector 70 or the output connector 80 (for example, between multiple input terminals or between multiple output terminals).

[0056] Figure 7 is a schematic diagram showing another example of the configuration of the waveform input unit 46. The configuration in Figure 7 differs from the configuration in Figure 6 in that a memory element 88A is connected between the seventh output terminal 82g and the eighth output terminal 82h of the output connector 80A, and a reading circuit 78A is connected between the seventh input terminal 72g and the eighth input terminal 72h of the input connector 70A. The memory element 88A stores predetermined authentication information. The predetermined authentication information may be unique identification information or encrypted digital signature information. The reading circuit 78A acquires the authentication information stored in the memory element 88A and detects whether or not it matches the predetermined authentication information. If the predetermined authentication information is detected by the reading circuit 78A, the connection determination unit 52b determines that the output connector 80 is properly connected to the input connector 70. If the predetermined authentication information is not detected by the reading circuit 78A, the connection determination unit 52b determines that the output connector 80 is not properly connected to the input connector 70.

[0057] Figure 8 is a schematic diagram showing yet another example of the configuration of the waveform input unit 46. The configuration in Figure 8 differs from the configuration in Figure 6 in that a connection confirmation pin 88B is provided on the output connector 80B, and a switch 78B for detecting the insertion of the connection confirmation pin 88B is provided on the input connector 70B. The connection confirmation pin 88B is a connection confirmation terminal provided, for example, in place of the seventh output terminal 82g and the eighth output terminal 82h. The switch 78B has a receiving portion 78c into which the connection confirmation pin 88B is inserted, and a displacement portion 78d provided behind the receiving portion 78c. When the displacement portion 78d is pushed and displaced by the connection confirmation pin 88B, the switch 78B outputs an insertion detection signal. The connection determination unit 52b determines the connection status based on the state of the switch 78B. When the connection determination unit 52b outputs an insertion detection signal from the switch 78B, it determines that the output connector 80 is properly connected to the input connector 70. The connection determination unit 52b determines that the output connector 80 is not properly connected to the input connector 70 if no insertion detection signal is output from the switch 78B.

[0058] Returning to Figure 1, the trigger detection unit 52c detects trigger points based on the electrocardiogram waveform input to the waveform input unit 46. The trigger detection unit 52c detects, for example, the position of the peak of the R wave in the electrocardiogram waveform as a trigger point. The trigger detection unit 52c measures the peak height of the R wave in the electrocardiogram waveform and detects the next R wave peak position when the potential reaches 80% of the measured peak height. The trigger detection unit 52c may also generate a filtered waveform by extracting the high-frequency components of the electrocardiogram waveform using a bandpass filter and detect trigger points based on the peak positions of the filtered waveform. The trigger detection unit 52c may also exclude peak positions that are thought to be caused by arrhythmias from the trigger points based on the intervals between the peak positions of the R waves.

[0059] Figure 9 shows an example of the display screen of the defibrillation control device 14, and is an example of the screen displayed on the display unit 54. In the example shown in Figure 9, the display unit 54 displays the input electrocardiogram waveform 90, the filter waveform 92, the heart rate 94a, the impedance 94b, the joules 94c, the input type 96a, and the mode 96b. The display unit 54 is composed of a liquid crystal display or an organic display, etc.

[0060] The input electrocardiogram waveform 90 is the electrocardiogram waveform input to the waveform input unit 46. The filtered ECG waveform 92 is the waveform of the high-frequency components of the input electrocardiogram waveform 90 and is displayed below the input electrocardiogram waveform 90. Trigger markers 90a, 90b, 90c, 90d, and 90e, which indicate the positions of trigger points detected by the trigger detection unit 52c, are superimposed on the input electrocardiogram waveform 90. The positions of the trigger markers 90a to 90e correspond to the peak positions of the R wave in the input electrocardiogram waveform 90. In the example in Figure 9, a skip marker 90s, which indicates the peak position of the R wave that was not detected as a trigger point, is displayed. In the example in Figure 9, because the time interval from the position of the previous trigger marker 90b to the skip marker 90s is shorter than the heartbeat, the peak waveform corresponding to the skip marker 90s is excluded from the trigger point.

[0061] Heart rate 94a indicates the heart rate calculated from the input electrocardiogram waveform 90. Impedance 94b indicates the impedance value measured by the measurement circuit 48a. Joules 94c indicates the value of electrical energy charged in the capacitor 48d. Input type 96a indicates the type of input electrocardiogram waveform 90. In the example shown in Figure 9, "PAD" is displayed to indicate that it is an electrocardiogram waveform from the electrode pad 18. Mode 96b indicates the current operating mode of the defibrillation control device 14. In the example shown in Figure 9, "ECG" is displayed to indicate that it is in electrocardiogram measurement mode. Note that "DC" is displayed when it is in defibrillation mode.

[0062] Returning to Figure 1, the monitoring device 16 will be described. The monitoring device 16 comprises a waveform acquisition unit 60, a waveform provision unit 62, and a waveform selection unit 64. The monitoring device 16 may be an electrocardiograph or a laboratory device.

[0063] The waveform acquisition unit 60 acquires the electrocardiogram waveform of the patient 20. The waveform acquisition unit 60 acquires the intracardiac electrocardiogram waveform output from the waveform output unit 44 of the defibrillation control device 14. The waveform acquisition unit 60 acquires the surface electrocardiogram waveform of the patient 20 measured using the electrode pads 18. If a different electrode catheter than the electrode catheter 12 is used on the patient 20, the waveform acquisition unit 60 acquires the electrocardiogram waveform measured using the different electrode catheter.

[0064] The waveform providing unit 62 provides at least one of the electrocardiogram waveforms acquired by the waveform acquisition unit 60 to the waveform input unit 46 of the defibrillation control device 14. The waveform providing unit 62 outputs the electrocardiogram waveform to the output connector 80, 80A, or 80B through, for example, the first output line 84 and the second output line 86 shown in Figures 6 to 8. The waveform selection unit 64 selects the electrocardiogram waveform provided by the waveform providing unit 62 according to the user's operation. For example, if the waveform selection unit 64 selects the surface electrocardiogram waveform from the electrode pads 18, the waveform providing unit 62 provides the selected surface electrocardiogram waveform to the defibrillation control device 14.

[0065] Figure 10 is a flowchart schematically showing the defibrillation method according to the embodiment. First, in electrocardiogram measurement mode, the mode switching button 50a is pressed to switch to defibrillation mode (step S10). Next, the impedance between the electrodes of the electrode catheter 12 is measured (step S12). If the impedance is within a predetermined range, the system waits for the charging button 50b to be pressed (step S14, N), and upon pressing the charging button 50b (step S14, Y), electrical energy is charged (step S16). After the electrical energy is fully charged, the system waits for the discharge button 50c to be pressed (step S18, N).

[0066] If the discharge button 50c is pressed (Y in step S18), the connection determination unit 52b determines the connection status of the input connector 70 of the waveform input unit 46. In step S20, if the connection determination unit 52b confirms the connection of the connector (Y in step S20) and the trigger detection unit 52c detects a trigger point (Y in step S22), electrical energy is supplied to the electrode catheter 12 in synchronization with the trigger point (step S24). After the supply of electrical energy is complete, the system switches to electrocardiogram measurement mode (step S26). If no trigger point is detected in step S22 (N in step S22), the system returns to step S20. In step S20, if the connection determination unit 52b does not confirm the connection of the connector (N in step S20), steps S22 to S24 are skipped and the system switches to electrocardiogram measurement mode (step S26).

[0067] In addition, in the modified flow of Figure 10, if the connection determination unit 52b does not confirm the connection of the connector (N in step S20), the process may return to before step S18. In other words, if the connection of the connector is not confirmed, the defibrillation mode may be maintained without terminating the defibrillation mode. When the contacts of the contact switching unit 42 are switched to connect to the second contact 42b triggered by the pressing of the discharge button 50c (Y in step S18), the contacts of the contact switching unit 42 may be returned to their original position and connected to the first contact 42a triggered by the connection determination unit 52b not confirming the connection of the connector (N in step S20).

[0068] According to this embodiment, by checking the connection status of the connector of the waveform input unit 46 after the discharge button 50c is pressed, it is possible to prevent the detection of trigger points caused by noise due to poor connector connection. In particular, by checking the connection status of the connector before detecting the trigger point, electrical energy can be supplied at an appropriate timing synchronized with the trigger point based on the patient's electrocardiogram waveform.

[0069] The present disclosure has been described above based on embodiments. Various modifications are possible for each component and each combination of processes in the exemplary embodiments, and it will be obvious to those skilled in the art that such modifications are included in the scope of the present disclosure.

[0070] Certain aspects of this disclosure are as follows:

[0071] The first embodiment is a defibrillation control device comprising: a power supply unit that supplies electrical energy to an electrode catheter inserted into the cardiac chamber; a waveform input unit having an input connector to which an output connector that outputs an electrocardiogram waveform is connected; a connection determination unit that determines the connection status between the input connector and the output connector; and a control unit that controls the supply of electrical energy based on the electrocardiogram waveform input to the waveform input unit and the determination result of the connection determination unit. According to the first embodiment, by determining the connection status of the connector to which the electrocardiogram waveform is input, it is possible to prevent the supply of electrical energy due to false detection of noise caused by poor connection of the connector.

[0072] A second embodiment is a defibrillation control device according to the first embodiment, further comprising an operating unit that receives input operations from a user, wherein the connection determination unit determines the connection state in response to an input operation from the operating unit. According to the second embodiment, the connection state can be determined in response to an input operation for charging or discharging electrical energy.

[0073] A third embodiment is a defibrillation control device according to the first or second embodiment, wherein the input connector is connected to a monitoring device via the output connector. According to the third embodiment, the connection status of the input connector can be determined even when an electrocardiogram waveform is input from the monitoring device.

[0074] A fourth embodiment is a defibrillation control device according to any one of the first to third embodiments, wherein the input connector is connected to the electrode pads via the output connector. According to the fourth embodiment, the connection status of the input connector can be determined even when an electrocardiogram waveform is input from the electrode pads.

[0075] A fifth embodiment is a defibrillation control device according to any one of the first to fourth embodiments, wherein the input connector or the output connector has a plurality of terminals, and the connection determination unit determines the connection state based on the impedance values ​​between the plurality of terminals of the input connector or the output connector. According to the fifth embodiment, the connection state of the input connector can be electrically detected.

[0076] A sixth embodiment is a defibrillation control device according to any one of the first to fifth embodiments, wherein the input connector is equipped with a switch for detecting the insertion of the output connector, and the connection determination unit determines the connection state based on the state of the switch. According to the sixth embodiment, the connection state of the input connector can be mechanically detected.

[0077] A seventh embodiment is a defibrillation control device according to any one of the first to sixth embodiments, wherein the output connector includes a memory element for storing authentication information, and the connection determination unit determines the connection status based on the authentication information obtained via the input connector. According to the seventh embodiment, it is possible to detect whether or not an authenticated connector is connected.

[0078] The eighth aspect is a defibrillation control device according to any one of the first to seventh aspects, wherein the input connector or the output connector has three or more terminals, and the three or more terminals include a signal terminal, a ground terminal, and a connection confirmation terminal. According to the eighth aspect, by providing a connection confirmation terminal, the connection status of the input connector can be determined more appropriately.

[0079] A ninth embodiment is a defibrillation system comprising an electrode catheter inserted into a cardiac chamber and a defibrillation control device that supplies electrical energy to the electrode catheter, wherein the defibrillation control device comprises a power supply unit that supplies the electrical energy, a waveform input unit having an input connector to which an output connector that outputs an electrocardiogram waveform is connected, a connection determination unit that determines the connection status between the input connector and the output connector, and a control unit that controls the supply of electrical energy based on the electrocardiogram waveform input to the waveform input unit and the determination result of the connection determination unit. According to the ninth embodiment, by determining the connection status of the connector to which the electrocardiogram waveform is input, it is possible to prevent the supply of electrical energy due to false detection of noise caused by poor connection of the connector.

[0080] The configuration, operation, and function of each of the above-described devices and methods can be realized by hardware resources or software resources, or by the cooperation of hardware and software resources. Hardware resources include, for example, various integrated circuits, such as processors (CPU - Central Processing Unit) and memory (ROM - Read Only Memory - RAM - Random Access Memory). Software resources include, for example, operating systems and application programs.

[0081] According to this disclosure, it is possible to address false detection of noise due to poor connection of the input connector.

[0082] 10... Defibrillation system, 12... Electrode catheter, 14... Defibrillation control device, 16... Monitoring device, 48... Power supply unit, 50... Operation unit, 52... Control unit, 52b... Connection determination unit, 52c... Trigger detection unit, 70, 70A, 70B... Input connectors, 80, 80A, 80B... Output connectors.

Claims

1. A defibrillation control device comprising: a power supply unit that supplies electrical energy to an electrode catheter inserted into the cardiac chamber; a waveform input unit having an input connector to which an output connector that outputs an electrocardiogram waveform is connected; a connection determination unit that determines the connection status between the input connector and the output connector; and a control unit that controls the supply of electrical energy based on the electrocardiogram waveform input to the waveform input unit and the determination result of the connection determination unit.

2. The defibrillation control device according to claim 1, further comprising an operation unit for receiving input operations from a user, wherein the connection determination unit determines the connection state in response to an input operation from the operation unit.

3. The defibrillation control device according to claim 1 or 2, wherein the input connector is connected to a monitoring device via the output connector.

4. The defibrillation control device according to any one of claims 1 to 3, wherein the input connector is connected to an electrode pad via the output connector.

5. The defibrillation control device according to any one of claims 1 to 4, wherein the input connector or the output connector has a plurality of terminals, and the connection determination unit determines the connection state based on the impedance values ​​between the plurality of terminals of the input connector or the output connector.

6. The defibrillation control device according to any one of claims 1 to 5, wherein the input connector is equipped with a switch for detecting the insertion of the output connector, and the connection determination unit determines the connection state based on the state of the switch.

7. The defibrillation control device according to any one of claims 1 to 6, wherein the output connector is equipped with a memory element for storing authentication information, and the connection determination unit determines the connection status based on the authentication information obtained via the input connector.

8. The defibrillation control device according to any one of claims 1 to 7, wherein the input connector or the output connector has three or more terminals, and the three or more terminals include a signal terminal, a ground terminal, and a connection confirmation terminal.

9. A defibrillation system comprising: an electrode catheter inserted into a cardiac chamber; and a defibrillation control device that supplies electrical energy to the electrode catheter, wherein the defibrillation control device comprises: a power supply unit that supplies the electrical energy; a waveform input unit having an input connector to which an output connector that outputs an electrocardiogram waveform is connected; a connection determination unit that determines the connection state between the input connector and the output connector; and a control unit that controls the supply of electrical energy based on the electrocardiogram waveform input to the waveform input unit and the determination result of the connection determination unit.

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