Multi-electrode array for intraoperative cardiac conduction mapping

Abstract

A system for mapping the cardiac conduction system during open-heart cardiac surgery includes an electrode support and electrodes held in a fixed position by the electrode support. The system also includes a flexible intermediate component. The electrodes and electrode support are fixed to the first end of the intermediate component. A rigid handle is located at the second end of the intermediate component and is attached to the opposite side of the first end.

Description

【Technical Field】 【0001】 Related Applications This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 63 / 451,35, Attorney Docket No. C1233.70270US00, filed on March 10, 2023, the entire disclosure of which is hereby incorporated by reference herein. 【Background Art】 【0002】 Field Aspects of the present application relate to multi-electrode arrays for intraoperative cardiac conduction mapping and methods of using the same. 【0003】 Related Art Open-heart surgery involves accessing the heart through an opening in the chest and may be performed to address problems including plaque buildup, heart valve defects, and cardiac rhythm abnormalities. In children, open-heart surgery may be necessary to address congenital heart disease. While open-heart surgery can be necessary and beneficial with respect to the problems to be addressed by the surgery, the surgery itself can cause further complications. For example, mechanical damage to special conduction tissues inside the heart during a procedure to address congenital heart disease in a child can cause iatrogenic heart block, which results in the child requiring a permanent pacemaker and lifelong ventricular pacing. The need for a permanent pacemaker can obligate the child to numerous reoperations and interventional procedures. In addition, the pacemaker can lead to complications that can lead to sudden death, such as infections, cardiac tamponade, and coronary artery compression due to the presence of the pacemaker lead wire. Chronic ventricular pacing can cause deterioration of ventricular function over time. Generally, the economic and personal burden imposed by heart block can be substantial. 【Summary of the Invention】 【0004】 According to one or more embodiments, a system for mapping the cardiac conduction system during open-heart cardiac surgery comprises an electrode support and electrodes held in a fixed position by the electrode support. The system also comprises a flexible intermediate component. The electrodes and electrode support are fixed to the first end of the intermediate component. A rigid handle is at the second end of the intermediate component and is attached to the opposite side of the first end. 【0005】 In addition, in one or more embodiments, the portable cardiac conduction mapping system includes a rigid handle and a flexible intermediate component connected to the handle. A set of probing parts comprises at least one probing part. Each probing part of the set of probing parts comprises an electrode array and an electrode support. The electrode array is enclosed within the electrode support. 【0006】 In another embodiment, a method for mapping the cardiac conduction system in a pediatric heart during open-heart cardiac surgery, using a portable device comprising a probing section comprising a rigid handle, a flexible intermediate component connected to the handle, and an array of electrodes held in a fixed position by conformal electrode supports connected to the intermediate component, comprises holding and moving the handle to position the array of electrodes of the probing section to contact a first position on the heart. The array of electrodes supplies a first set of signals to a processing circuit via wires connected to each electrode in the array of electrodes, the first set of signals indicating the level of electrical activity at the first position. The method also comprises moving the handle to lift the probing section from the first position to bring the array of electrodes of the probing section to contact a second position on the heart, and, based on the determination that the cardiac conduction system is not located at the first position, holding and moving the rigid handle to position the array of electrodes at the second position. The array of electrodes supplies a second set of signals to a processing circuit via wires, the second set of signals indicating the level of electrical activity at the second position. 【0007】 The above outlines some of the relevant features of the disclosed subject matter. These features are merely illustrative. [Brief explanation of the drawing] 【0008】 Some examples of the disclosed technology are described with reference to the following figures. In the figures, the reference numbers indicate the corresponding parts from various perspectives. [Figure 1] Figure 1 shows a system for mapping regions comprising cardiac conduction pathways according to one or more embodiments; [Figure 2] Figure 2 details aspects of a probing portion having exemplary and optional features according to one or more embodiments; [Figure 3A-3C] Figure 3A shows an exemplary embodiment of a probing section with three electrodes; Figure 3B shows an exemplary embodiment of a probing section with nine electrodes; Figure 3C shows an exemplary embodiment of a probing section with twelve electrodes; [Figure 4] Figure 4 details the side view of a portable device according to one or more embodiments, and the probe interface of an intermediate component to be attached to the probing portion; [Figure 5] Figure 5 details the side view of a portable device according to one or more embodiments, and the handle interface of an intermediate component to be attached to a handle; [Figure 6] Figure 6 shows a side view of a portable device according to one or more embodiments; [Figure 7] Figure 7 is a cross-sectional view of an exemplary intermediate component according to one or more embodiments; [Figure 8] Figure 8 is a cross-sectional view of a wire oriented along an intermediate component and through a handle according to an exemplary embodiment; [Figure 9] Figure 9 is a cross-sectional view of an exemplary intermediate component according to one or more embodiments; [Figure 10] Figure 10 is a cross-sectional view of a wire directed through an intermediate component and through a handle according to an exemplary embodiment; [Figure 11A-11B]Figure 11A shows a portable device placed inside the heart according to one or more embodiments; Figure 11B shows a portable device having a probing portion conforming to the heart; [Figures 12A-12B] Figure 12A shows a probing portion according to an exemplary embodiment; Figure 12B shows conformality of the probing portion of Figure 12A according to an exemplary embodiment; and [Figure 13] Figure 13 shows a process flow of a method for performing intraoperative intracardiac conduction mapping according to one or more embodiments. [Modes for carrying out the invention] 【0009】 This disclosure will now be described in detail with reference to the drawings. It should be understood that the drawings and illustrated embodiments are not limited to their details. Modifications may be made without departing from the spirit and scope of the disclosed subject matter. 【0010】 Open-heart cardiac surgery may be performed to address a multitude of problems. Even if the surgery successfully corrects the initial problem, if conduction tissue within the heart is damaged due to careless contact during the surgical procedure, the procedure itself can lead to lifelong complications. Because the cardiac conduction system is invisible, prior localization is unavoidable. Furthermore, predicting the location of conduction tissue becomes increasingly difficult in patients with complex forms of congenital heart disease. In children, the risks and effects of contact with conduction tissue can be exacerbated. Mapping the proximal conduction tissue encompassing the bundle of His can facilitate the avoidance of mechanical damage to the area during open-heart cardiac surgery. In addition, localized conduction pathways can be used to develop and / or further train predictive models of conduction location in patients with complex congenital heart disease. For example, by performing classification and regression tree (CART) analysis, specific anatomical factors (e.g., ventricular loop, visceroatrial situs) can be used to predict the location of the conduction system. 【0011】 One approach to localizing the His bundle involves localizing the cardiac conduction pathway using a catheter-based cardiac electrical mapping system. This approach involves an array of electrodes placed on a semi-rigid support at the distal end of the catheter. The surgeon must control the length of the catheter (e.g., 110 centimeters) and stabilize the electrodes against the tissue. The electrical signals obtained from the electrodes are used to determine whether the array is present on the conduction tissue. If not, the surgeon must move the electrodes to a different location and repeat the examination. The size and shape of the electrode array can make it difficult to ensure sufficient contact between the electrodes and the underlying tissue. This is because the signal quality from the tissue will be reduced if the region of interest inside the heart does not precisely match the shape of the array, or if the electrodes are not held firmly in contact. Furthermore, the spatiotemporal resolution of the data obtained by catheter-based devices is limited. 【0012】 The inventors recognized and appreciated the need for more customized multi-electrode arrays and more accurate intraoperative intracardiac conduction mapping. According to one or more embodiments, instead of a long catheter-based instrument, a portable device may be assembled with an array of electrodes at one end. A flexible intermediate component may connect a rigid handle to the electrode array to apply downward pressure to cardiac tissue partially flexed by the flexible component. The pressure can ensure sufficient contact between the electrodes and cardiac tissue, and the flexure can ensure that no damage occurs during probing. The device may be customized to meet various size and shape needs based on a number of different arrangements and sizes of electrode arrays that can be selectively placed at the end of the portable device. A given set of electrodes may be held in a fixed position by conformal supports according to one or more embodiments, allowing sufficient contact between each electrode in the array and the tissue beneath it. 【0013】 An aspect of exemplary embodiments is the intraoperative mapping that precisely localizes intracardiac conduction. As described in detail, the size, shape, and density of the electrode array used for mapping can be tailored to specific patients and applications. In addition, the operability of the device, the limitation of the deflection of the handle portion, and the conformality of the electrode support ensure sufficient contact between the electrode and the underlying tissue. Signals from the electrodes can be used to identify the presence of His bundle potentials corresponding to conduction leaving the atrioventricular node and entering the proximal conduction system. As detailed, identifying and marking areas can help surgeons avoid causing mechanical damage that could lead to iatrogenic heart block or other complications. Patch or suture placement, tissue excision, or other cardiac repair techniques can be planned with the location of the cardiac conduction pathway in mind to optimize the geometric outcome of the repair while minimizing the risk of damage to the conduction system. 【0014】 Figure 1 shows an exemplary system 100 for mapping cardiac conduction pathways according to one or more embodiments. System 100 comprises a portable device 101 and a processing circuit 140. The portable device 101 comprises a replaceable probing portion 110, which will be further discussed with reference to Figure 2. A flexible intermediate component 120 connects the probing portion 110 to a rigid handle 130. The overall length of the portable device 101 (from the probing portion 110 to the end of the handle 130) is not limited, but tends to be shorter than that of catheter-based probing devices and may be dimensioned for operability and controllability (e.g., about 12 centimeters (cm) to 20 cm, or generally less than 30 cm). According to the exemplary embodiment, a wire channel 125 extends the length of the intermediate component 120 from the probing portion 110 and passes one or more wires 135 between the probing portion 110 and the processing circuit 140. The wire channel 125 may be, for example, an insulating tube. The wire 135, guided through the wire channel 125, may be held in the insulating channel material in the form of a channel 137 to the processing circuit. According to additional exemplary embodiments considered with reference to Figures 8-10, the wire 135 may also pass through the intermediate component 120 and / or handle 130. 【0015】 The processing circuit 140, as detailed with reference to Figure 1, includes one or more processors 150 and memory 160 for processing signals received from the probing section 110. The memory 160 includes a non-temporary computer-readable medium 165 that can store instructions that can be processed by one or more processors 150. The instructions stored in the non-temporary computer-readable medium 165 may be processed to display signals from the probing section 110 and to perform one or more algorithms that use the signals, either alternately or additionally. The processing circuit 140 may also include an interface 170 for facilitating the display of signals or for outputting information obtained from signals in text or visual format. 【0016】 According to an exemplary aspect, the signal carried by wire 135 may be displayed via interface 170 (e.g., after amplification and filtering). The signal may be analyzed to determine whether the location of the probing portion 110 (where the signal was acquired) indicates the presence of a cardiac conduction pathway (e.g., by an electrophysiologist or other member of the medical team). The signal and identification process may be similar to that performed with a catheter-based approach. Alternatively, or additionally, the processing circuit may analyze the signal to determine whether the cardiac conduction pathway is located and output the result of that determination. 【0017】 Figure 2 details a side view of the probing portion 110 with exemplary and optional features according to one or more aspects. The exemplary probing portion 110 has twelve electrodes 210 held in a fixed arrangement by an electrode support 220. In general, the electrodes 210 may be arranged at a distance of about two millimeters or more from each other. The electrode support 220 may, for example, enclose the electrodes 210. The material and thickness of the electrode support 220 may be selected based on the degree of conformality required for the array of electrodes 210. For example, an array of electrodes 210 spanning a larger area may require a more conformal electrode support 220. This is because electrodes 210 spanning a larger area may need to contact the cardiac tissue at different levels or heights. 【0018】 On the other hand, an array of three electrodes 210 with close spacing may require a relatively more rigid electrode support 220 to ensure close contact with the underlying tissue. Adding rigidity to the probing portion 110 can be achieved in numerous ways. The wire 135 embedded in the electrode support 220 may be more rigid. In addition, or alternatively, the material of the electrode support 220 may be more rigid. Exemplary and non-limiting materials for the electrode support 220 may include flexible and conformal silicone or hydrogel, or flexible and film-like Mylar or polyimide. Furthermore, the spacing of the electrodes 210 itself may affect rigidity; that is, electrodes 210 with closer spacing may result in a more rigid probing portion 110. Exemplary and non-limiting examples of electrodes 210 may include platinum-iridium, silver, or stainless steel. The surface area of ​​each electrode 210 may be approximately 1 to 1.5 square millimeters, for example, to provide sufficient signal fidelity for use in the human heart. The exemplary number and arrangement of electrodes 210 in Figure 2 are not intended to limit alternative numbers or arrangements of electrodes 210, some of which are shown in Figures 3A, 3B, and 3C. Any exemplary arrangement of electrodes 210 ensures that the bipole pair can detect the signal wavefront. 【0019】 As shown in FIG. 2, wire 135 is connected to each electrode 210. Wire 135 transmits a signal indicating the electrical activity detected by electrode 210. As shown, the wires 135 from each electrode 210 may be sent to combination region 250 where they are combined and then guided through wire channel 125 to processing circuit 140. As discussed in reference to FIG. 4, different sets of wires 135 may alternatively be sent to and combined in different combination regions 250. Wire 135, which is part of probing portion 110, may be encapsulated by electrode support 220, similar to electrode 210. Electrode support 220 may optionally include marking cutout 230. Marking cutout 230 refers to the area where electrode support 220 is cut out to expose the heart tissue under probing portion 110 and facilitate marking of the heart conduction pathway with a surgical marking pen based on identification via system 100. 【0020】 Electromagnetic sensor 240 may optionally be included in a different region of electrode support 220. Wire 135 connects electromagnetic sensor 240 to processing circuit 140, similar to wire 135 that connects electrode 210 to processing circuit 140. The wire 135 from electromagnetic sensor 240 is also sent to combination region 250, as shown. The potential of electromagnetic sensor 240 can be utilized to track the array of electrodes 210 in three-dimensional space. That is, rather than collecting potentials like electrode 210, electromagnetic sensor 240 has a potential that indicates its position in space when detected. Thus, detection of those potentials through the placement of electromagnetic sensors 240 around electrode support 220 facilitates visualization of the position and orientation of probing portion 110 on the heart. 【0021】 Figures 3A, 3B, and 3C show exemplary embodiments of the probing section 110. Figure 3A shows an exemplary embodiment of the probing section with three electrodes 210. The electrode support 220 is triangular, and the electrodes 210 are located at the three corners. Figure 3B shows an exemplary embodiment of the probing section 110 with nine electrodes 210. The electrodes 210 are positioned around and in the center of the electrode support 220, where the wire 135 is fed into the combination region 250. Figure 3C shows an exemplary embodiment of the probing section 110 with twelve electrodes 210. According to the orientation shown in Figure 3C, the electrodes 210 are arranged in four rows of three. Increasing the number of electrodes can facilitate bipole pairing options and increase the coverage area, enhancing the characterization and localization of the conduction system. The overall shape of the probing section 110 according to the various embodiments can determine its suitability for different cardiac shapes and regions of interest. Suitability may refer, for example, to improved signal quality. Different regions of the heart may require probing portions 110 of different sizes and shapes. For example, a shape suitable for the apex of a ventricular septal defect (VSD) may be less suitable for use below a heart valve. 【0022】 In exemplary embodiments, the arrangement of the wires 135 and the material of the electrode support 220 may facilitate dynamic modification (e.g., resizing and / or reshaping) of the probing portion 110. That is, as shown in Figure 3C, one or more outer electrodes 210, along with at least some of the wires 135 extending from those electrodes 210, may be cut, resulting in a dynamically modified probing portion 310. As shown, six outer electrodes 210 and some of the wires 135 from the six electrodes 210 may be cut, resulting in a modified probing portion 310. 【0023】 Relevant exemplary factors that can be used in selecting the probing portion 110 are time and resolution, along with size and shape. That is, a small, closely spaced set of electrodes 210 can locate cardiac conduction pathways with higher resolution. However, a larger array with more electrodes 210 may facilitate faster intracardiac conduction mapping. Completing the mapping as quickly as possible ensures that the overall time of the surgery is not significantly prolonged, which can generally be safer for the patient. According to exemplary embodiments, a larger probing portion 110 with more electrodes 210 may be initially desirable, but once the area of ​​conduction activity has been identified, smaller probing portions 110 that provide higher resolution may be used. There is no limit to the maximum number of electrodes 210, but generally 30 to 100 electrodes 210 may be the upper limit. 【0024】 Figure 4 details a side view of a portable device 100 according to one or more embodiments, and a probe interface 410 of an intermediate component 120 to be attached to a probing section 110. Figure 4 shows an exemplary probing section 110 encompassing an array of 16 electrodes 210. According to the orientation illustrated in Figure 4, wires 135 from the eight electrodes 210 on the left are combined in combination region 250a, and wires 135 from the eight electrodes 210 on the right are combined in combination region 250b (generally referred to as combination region 250). The two combinations of wires 135 are guided to a processing circuit 140 via a wire channel 125. In another embodiment, any number of different subsets of wires 135 may be combined in any number of combination regions 250. Alternatively, individual wires 135 may be directed to the wire channel 125. The flexibility of the wire arrangement facilitates flexibility in the configuration of the array electrodes 210 and also facilitates dynamic modification of the probing portion 110. 【0025】 Figure 4 also shows the probe interface 410 of an intermediate component 120 attached to the probing portion 110. More specifically, as shown in the figure, the probe interface 410 of the intermediate component 120 may be fixed to the electrode support 220 of the probing portion 110. By separating the probing portion 110 in the combination region 250 and the probe interface 410, another probing portion 110 may be selected and fixed to the intermediate component 120. According to the exemplary embodiment, a real-time three-dimensional model of the heart undergoing surgery can be generated. Size and shape matching may be performed to select the probing portion 110 best suited for a particular operation between the three-dimensional model of the heart and the different configurations of the electrodes 210 of the different probing portions 110. 【0026】 Alternatively, size and shape matching may involve different configurations of electrodes 210 for different (complete) portable devices 101. As described with reference to Figures 5 and 6, in yet another alternative embodiment, size and shape matching may involve selecting a specific combination of probing portion 110 and flexible component 120 to be attached to the handle 130. In addition to size and shape, electrode density may be another consideration in the selection of the probing portion 110, regardless of whether the probing portion 110 is selected alone, in combination with the intermediate component 120, or as a complete portable device 101. Multiple electrode densities may be required to maintain the minimum number of electrodes 210 needed to optimize signal integrity and ensure the discriminability of His bundle potentials in various cardiac shapes. As previously described with reference to Figure 3C, size and shape matching may involve dynamically modifying (e.g., cutting) the probing portion 110 to obtain a modified probing portion 310. 【0027】 Figure 5 details a side view of a portable device 100 according to one or more embodiments, and the handle interface 510 of an intermediate component 120 that attaches to the handle 130. The probing portion 110 shown in Figure 5 is the same as that shown in Figure 4. Thus, as described with reference to Figure 4, there are two combined regions 250a, 250b for the wires 135 from various electrodes 210 used to transmit all the wires 135 to the wire channel 125. Figure 5 shows the intermediate component 120 detached from the handle 130 and exposing the handle interface 510, which is the end of the intermediate component 120 opposite to the end of the intermediate component 120 that contains the probe interface 410 shown in Figure 4. 【0028】 Figure 6 shows a side view of the portable device 100 according to one or more embodiments. The probing portion 110 shown in Figure 6 is different from the one shown in Figure 5. Because the probing portion 110 shown in Figure 6 includes only three electrodes 210, only three wires 135 are guided through the wire channel 125 of the intermediate component 120. In Figure 6, it is shown that the handle interface 510 of the intermediate component 120 is attached to the handle 130. The attachment can be completed in one of several ways. According to an exemplary embodiment, the handle interface 510 is hollow and fits onto a protrusion 610 of the handle 130. According to another exemplary embodiment, the protrusion 610 of the handle 130 is hollow and the handle interface 510 of the intermediate component 120 fits onto the protrusion 610. In either case, the intermediate component 120 is easily removed from the handle 130. Therefore, different combinations of probing portions 110 and intermediate components 120 (for example, the probing portions 110 and intermediate components 120 shown in Figures 4 and 5) may be used selectively with the same handle 130. In another embodiment, the handle interface 510 of the intermediate portion 120 is fixed to the protrusion 610 of the handle 130 or to a handle 130 without the protrusion 610. 【0029】 Figure 7 is a cross-sectional view of an exemplary intermediate component 120 according to one or more embodiments. The cross-sectional view in Figure 7 details a wire 135 within a wire channel 125 of the intermediate component 120. As shown, the wire 135 from the combination region 250 of the probing portion 110 extends through the wire channel 125. According to the exemplary embodiments, the wire 135 is directed from the intermediate component 120 to the processing circuit 140 (as shown, for example, in Figure 1). According to the alternative embodiments shown in Figures 8 and 10, the wire 135 may extend over the length of the handle 130. 【0030】 Figure 8 is a cross-sectional view of a wire 135 directed along an intermediate component 120 and through a handle 130 according to an exemplary embodiment. The wire 135 may also be directed through a wire channel 125, as shown in Figures 1 and 7. The wire 135 may also be directed from the combination region 250 of the probing portion 110 along the intermediate component 120. The wire 135 emerging through the handle 130 may be directed to the processing circuit 140, as shown. 【0031】 Figure 9 is a cross-sectional view of an exemplary intermediate component 120 according to one or more embodiments. The cross-sectional view in Figure 9 details a wire 135 extending through the intermediate component 120. The wire 135 from the combined region 250 of the probing portion 110 extends through the intermediate component 120 rather than the wire channel 125, as shown, for example, in Figures 1 and 7. 【0032】 Figure 10 is a cross-sectional view of a wire 135 directed through an intermediate component 120 and a handle 130 according to an exemplary embodiment. The wire 135 may be directed from the combination region 250 of the probing portion 110 to the intermediate component 120. The wire coming out of the handle 130 may be directed to the processing circuit 140 as shown in the figure. Although not specifically shown, the wire may be directed through a channel along the handle 130 in a similar manner to how it is directed through the wire channel 125 of the intermediate component 120. 【0033】 Figures 11A and 11B show a portable device 101 in use in a heart with a ventricular septal defect (VSD) according to one or more exemplary embodiments. Figure 11A shows the portable device 101 with a probing portion 110 inserted through the tricuspid valve orifice of the heart in preparation for conduction mapping. Figure 11B shows the portable device 101 with a probing portion 110 conformally in contact with the apex of the VSD. As shown in Figure 11A, the portable device 101 may be held so that no part of the portable device 101 is in contact with any part of the patient. Even during probing, only the probing portion 110 may be in contact with any part of the heart or patient, but this is not the case with catheter-based devices. Generally, to probe various regions of the heart and position the conduction system, the probing portion 110 may be moved along the inner surface of the heart while remaining in contact with the heart, but the probe portion 110 can be kept from complete contact with the heart via the control of the handle 130. 【0034】 Figure 12A shows an exemplary probing portion 110 that may be used in a portable device 101 according to an exemplary embodiment described herein. The exemplary probing portion 110 includes 12 electrodes, as in the embodiment shown in Figure 3C. According to the orientation shown in Figure 12A, the intermediate component 120 is invisible (for example, behind the wire channel 125). As shown, the electrode support 220 is flat (i.e., each of the electrodes 210 is at the same level). Figure 12B shows the conformality of the probing portion 110 of Figure 12A according to an exemplary embodiment. As shown in Figure 12B, each of the electrodes 210 may be at a different level compared to the base level shown in Figure 12A, based on the flexibility of the electrode support 220. This conformality of the electrode array 210, facilitated by the conformality of the electrode support 220, promotes sufficient contact between each electrode 210 and the tissue beneath it. The material composition and thickness of the electrode support 220 may be controlled to control the degree of conformity of the electrode array 210. 【0035】 Figure 13 shows a process flow of a method for performing intraoperative intracardiac conduction mapping according to one or more embodiments. In 1310, preparation may involve an arterial cannula to supply oxygenated blood and bypass the heart, as well as inducing ventricular fibrillation (i.e., the heart pumping blood) to eliminate cardiac output. The heart may then be opened via an atrialotomy (i.e., opening of the atria) or a ventricularotomy (incision into one or both ventricles). Once a cardiotomy aspirator is placed over the ventricular valves to ensure that the heart is not compressing or draining blood, a defibrillator is attached to return the heart to normal sinus rhythm (resumption of cardiac conduction). 【0036】 In 1320, intracardiac conduction mapping generally refers to the process involving the use of a portable device 101 and system 100 to locate cardiac conduction pathways. In 1322, selecting a probing portion 110 may refer to selecting from a set of portable devices 101, selecting from a set of combinations of probing portions 110 fixed to a handle 130 and intermediate components 120, or selecting from a set of intermediate components 120 and probing portions 110 fixed to a handle 130. The selection may be based on the patient's size or age. According to an exemplary embodiment, the selection may be based on matching the size and shape of the available probing portions 110 to a desired size and shape determined from a three-dimensional model of the patient's heart. 【0037】 In 1324, positioning the probing portion 110 (selected in 1322) to acquire a signal may refer to a signal from the electrodes 210 of the probing portion 110 that is transmitted to the processing circuit 140 via the wire 135 while the electrodes 210 are in a specific location on the heart. Positioning to a specific location is achieved by the surgeon holding the handle 130 of the portable device 101, the electrode support 220 being conformally draped over the specific location on the heart, and positioning the probing portion 110 in a specific location so that each of the electrodes 210 is in contact with the heart at that specific location. In 1326, the process includes determining whether a conduction pathway was detected at the location where the probing portion 110 was positioned when the signal was acquired (in 1322). For example, a signal indicating the level of electrical activity supplied by the electrodes 210 may be displayed via the interface 170 to determine whether any of the signals meet a criterion indicating His bundle potential (e.g., based on signal amplitude and temporal position in the electrograph). 【0038】 If the confirmation in 1326 indicates that no conduction pathway is detected, the process of positioning the probing portion 110 in a different location and acquiring a signal (in 1324) may be repeated iteratively. If the confirmation in 1326 indicates that a conduction pathway is detected, marking the conduction pathway in 1328 may then involve marking the underlying cardiac tissue with a surgical pen using the marking cutout 230 on the electrode support 220. Once the conduction pathway is marked or otherwise identified (in 1328), proceeding with the surgical procedure in 1330 refers to completing the corrective procedure in the heart while avoiding the conduction pathway mapped according to the intracardiac conduction mapping process (in 1320). Once it can be determined (by confirmation in 1326) that the cardiac conduction pathway is located and marked as desired, the portable device 100 may be easily detached / removed from the heart and the procedure may continue (in 1330). 【0039】 Even if descriptive embodiments are described, other embodiments are possible. Variations of exemplary methods, including rearrangements, omissions, or modifications of some processes, are intended and such variations are within the scope and spirit of the embodiments detailed herein.

Claims

[Claim 1] A system for mapping the cardiac conduction system during open-heart cardiac surgery: electrode support; Electrodes held in a fixed position by an electrode support; A flexible intermediate component wherein an electrode and an electrode support are fixed to the first end of the intermediate component; and, The second end of the intermediate component, a rigid handle attached to the opposite side of the first end: The system including the above. [Claim 2] The system according to claim 1, wherein the combined length of the handle and the intermediate component is 30 centimeters or less. [Claim 3] The system according to claim 1, wherein the number of electrodes is in the range of 3 to 100. [Claim 4] The system according to claim 1, further comprising wires, each electrode being connected to one of the wires, and the electrodes and wires being enclosed by an electrode support. [Claim 5] The system according to claim 4, wherein the electrode support material is conformal. [Claim 6] The system according to claim 1, further comprising a wire, each electrode being connected to one of the wires, and the wire being connected to a processing circuit. [Claim 7] The system according to claim 6, wherein the wire is directed along or through an intermediate component in a channel of the intermediate component. [Claim 8] The system according to claim 6, wherein the wire is directed through a handle. [Claim 9] The system according to claim 1, wherein adjacent electrodes are separated from each other by 2 millimeters or more. [Claim 10] A portable cardiac conduction mapping system: Rigid handlebars; Flexible intermediate components connected to the handle; and, A set of probing parts that encompasses at least one probing part, where each probing part of the set of probing parts is: Electrode array, and An electrode support, wherein an array of electrodes is enclosed within the electrode support: The set of the probing parts, including the set of the probing parts, The portable cardiac conduction mapping system, including the following. [Claim 11] The portable cardiac conduction mapping system according to claim 10, wherein each probing portion of the set of probing portions further includes a wire, and each electrode of the electrode array is connected to one of the wires. [Claim 12] The portable cardiac conduction mapping system according to claim 11, wherein the intermediate component includes a channel for directing wires from an array of electrodes to a processing circuit. [Claim 13] The portable cardiac conduction mapping system according to claim 11, wherein the wire is directed to a processing circuit through an intermediate component and a handle. [Claim 14] The portable cardiac conduction mapping system according to claim 11, wherein the electrode support is conformal. [Claim 15] A method for mapping the cardiac conduction system in a pediatric heart during open-heart cardiac surgery, using a portable device comprising a probing portion containing a rigid handle, a flexible intermediate component connected to the handle, and an array of electrodes held in a fixed position by conformal electrode supports connected to the intermediate component, the method being: By holding and moving the handle, the array of electrodes on the probing part is positioned to make contact with a first position on the heart, the array of electrodes supplies a first set of signals to a processing circuit via wires connected to each electrode in the array, the first set of signals indicating the level of electrical activity at the first position; and, By moving the handle to lift the probing portion from the first position, the electrode array of the probing portion is brought into contact with a second position on the heart. Based on the determination that the cardiac conduction system is not in the first position, the rigid handle is held and moved to position the electrode array in the second position, where the electrode array supplies a second set of signals to the processing circuit via wires, and the second set of signals indicates the level of electrical activity at the second position. The method, including the method described above. [Claim 16] The method according to claim 15, further comprising selecting a probing portion from a set of probing portions based on the determination that the probing portion more accurately matches the size and shape of a three-dimensional model of the heart than the other probing portions of the set of probing portions. [Claim 17] The method according to claim 15, wherein determining that the cardiac conduction system is not in a first position is based on a first set of signals. [Claim 18] The method according to claim 15, further comprising moving a rigid handle to lift the probing portion so as not to contact the first position, and continuing open-heart cardiac surgery based on the determination that the cardiac conduction system is located in the first position. [Claim 19] The method according to claim 15, further comprising sequentially moving the array of electrodes of the probing portion to contact additional locations on the heart until it is determined that the cardiac conduction system has been identified, and generating an additional set of signals from the array of electrodes. [Claim 20] The method according to claim 19, wherein determining that the cardiac conduction system has been identified comprises comparing a first set of signals, a second set of signals, and an additional set of signals.

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