His-bundle mapping catheter

Abstract

Apparatus is provided for mapping a heart of a subject. The apparatus comprises a catheter (22, 42) dimensioned for percutaneous advancement through vasculature of the subject. One or more pacing electrodes 24 are coupled to the catheter (22, 42) at a first distal region of the catheter (22, 42) designated for positioning adjacent an apex of the heart. An array of sensing electrodes (26) are coupled to the catheter (22, 42) at a second distal region of the catheter (22, 42) designated for positioning adjacent a His-Bundle of the heart. The one or more pacing electrodes (24) and the array of sensing electrodes (26) are separated from each other by a distance of 20-160 mm. Other embodiments are also described.

Description

[0001] HIS-BUNDLE MAPPING CATHETER

[0002] CROSS-REFERENCE TO RELATED APPLICATION

[0003] The present application claims priority from US Provisional Application 63 / 776,570, filed March 24, 2025, entitled, "HIS-BUNDLE MAPPING CATHETER" which is incorporated herein by reference.

[0004] FIELD OF THE APPLICATION

[0005] The present invention relates to methods and devices of electrical cardiac catheters for minimally-invasive medical treatment of cardiac mapping.

[0006] BACKGROUND OF THE INVENTION

[0007] The His-Bundle is a critical component of the cardiac conduction system and serves as the electrical connection between the atria and the ventricles.

[0008] Regarding transcatheter aortic valve implantation (i.e., TAVI) as well for Mitral and Tricuspid valve replacement procedures, although tremendous technological improvements were implemented in the valve replacement field, conduction disturbances are still one of the most common adverse event post procedure damage the His-Bundle area, leading to Bundle branch block (i.e., BBB). BBB may lead to the need for permanent pacemaker implantation (i.e., PPI) during the first 30 days of the valve replacement procedure.

[0009] SUMMARY OF THE INVENTION

[0010] Applications of the invention are dedicated for His-Bundle mapping in conjunction with minimally-invasive procedures, e.g., TAVI (Trans-catheter aortic valve implantation) procedures or Mitral / Tricuspid valves replacement procedures, mostly for treating aortic valve stenosis or Mitral / Tricuspid valves regurgitation.

[0011] In conjunction with a dedicated mapping system, the His-Bundle mapping catheter of some embodiments of the present invention will enable the mapping of the His location, thus alerting the cardiologist of the area near the aortic valve that may be regarded as an incompatible, potentially dangerous, or unacceptable region for positioning the prosthetic valve in its final location.

[0012] Applications of the present invention are directed to apparatus and methods for mapping a heart of the subject. A His-Bundle mapping catheter comprising sensing and pacing electrodes areused for such mapping. In some applications of the present invention, the mapping occurs in conjunction with, e.g., during, implantation of an implant in the heart of a subject. Typically, the His-Bundle mapping catheter is used in conjunction with, e.g., during, a transcatheter aortic valve implantation (TAVI) procedure.

[0013] During a TAVI procedure, the His-Bundle mapping catheter is deployed into the right ventricle of the heart through the superior vena cava, e.g., using a transjugular approach, or through the inferior vena cava, e.g., using a transfemoral approach.

[0014] The catheter includes at least one pacing electrode and an array of sensing electrodes.

[0015] There is therefore provided, in accordance with some applications of the invention apparatus for mapping a heart of a subject, the apparatus including:

[0016] a catheter dimensioned for percutaneous advancement through vasculature of the subject; one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; and

[0017] an array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart,

[0018] the one or more pacing electrodes and the array of sensing electrodes are separated from each other by a distance of 20- 160 mm.

[0019] In an application, the apparatus further includes a handle including an electrical socket connector.

[0020] In an application:

[0021] the catheter is dimensioned for advancement through a superior vena cava, and

[0022] the array of sensing electrodes is closer to a distal tip of the catheter than the one or more pacing electrodes are to the distal tip of the catheter.

[0023] In an application, the apparatus further includes at least a first pressure sensor disposed between the one or more pacing electrodes and the array of sensing electrodes.

[0024] In an application, the apparatus further includes a second pressure sensor disposed proximally to the one or more pacing electrodes.

[0025] In an application, the apparatus further includes at least a first accelerometer disposed between the one or more pacing electrodes and the array of sensing electrodes.In an application, the apparatus further includes a second accelerometer disposed proximally to the one or more pacing electrodes.

[0026] In an application, the apparatus further includes at least a first radiopaque marker disposed between the one or more pacing electrodes and the array of sensing electrodes.

[0027] In an application, the apparatus further includes a second radiopaque marker disposed proximally to the one or more pacing electrodes.

[0028] In an application, the first and second radiopaque markers include asymmetrical radiopaque markers.

[0029] In an application, the one or more pacing electrodes are located at a distance of between 5 and 20 cm from the distal tip.

[0030] In an application, the one or more pacing electrodes are located at a distance of 10 cm from the distal tip.

[0031] In an application, the array of sensing electrodes is located at a distance of between of between 0.1 and 20 mm from the distal tip.

[0032] In an application, the array of sensing electrodes is located at a distance of 1 mm from the distal tip.

[0033] In an application:

[0034] the catheter is dimensioned for advancement through an inferior vena cava, and

[0035] the one or more pacing electrodes are closer to a distal tip of the catheter than the array of sensing electrodes is to the distal tip of the catheter.

[0036] In an application, the apparatus further includes at least a first pressure sensor disposed between the one or more pacing electrodes and the array of sensing electrodes.

[0037] In an application, the apparatus further includes a second pressure sensor disposed proximally to the array of sensing electrodes.

[0038] In an application, the apparatus further includes at least a first accelerometer disposed between the one or more pacing electrodes and the array of sensing electrodes.

[0039] In an application, the apparatus further includes a second accelerometer disposed proximally to the array of sensing electrodes.In an application, the apparatus further includes at least a first radiopaque marker disposed between the one or more pacing electrodes and the array of sensing electrodes.

[0040] In an application, the apparatus further includes a second radiopaque marker disposed proximally to the array of sensing electrodes.

[0041] In an application, the first and second radiopaque markers include asymmetrical radiopaque markers.

[0042] In an application, the one or more pacing electrodes are located at a distance of between 0 and 5 cm from the distal tip.

[0043] In an application, the one or more pacing electrodes are located at a distance of 0.1 cm from the distal tip.

[0044] In an application, the array of sensing electrodes is located at a distance of between of between 20 and 200 mm from the distal tip.

[0045] In an application, the array of sensing electrodes is located at a distance of 100 mm from the distal tip.

[0046] There is additionally provided, in accordance with some applications of the invention method for mapping a heart of a subject, the method including:

[0047] mapping the heart of the subject in order to identify one or more regions of the heart not suitable for positioning of at least a portion of an implant, by:

[0048] percutaneously advancing a catheter through vasculature of the subject; positioning one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; and

[0049] positioning an array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart, the one or more pacing electrodes and the array of sensing electrodes are separated from each other by a distance of 20- 160 mm.

[0050] In an application, the method further includes delivering an implant within the heart in a vicinity of the His-Bundle, and wherein mapping the heart includes mapping a position of the His-Bundle in conjunction with delivering the implant.In an application, mapping the position of the His-Bundle includes identifying locations of superior and anterior ends of the His-Bundle.

[0051] In an application, positioning the array of sensing electrodes adjacent the His-Bundle of the heart includes positioning the array such that the array extended beyond the His-Bundle in a manner in which the superior and anterior ends of the His-Bundle do not extend beyond distal and proximal ends of the array of sensing electrodes.

[0052] In an application, the implant includes a prosthetic valve, and wherein mapping the heart includes identifying one or more regions of the heart not suitable for positioning of at least a portion of the prosthetic valve.

[0053] In an application:

[0054] percutaneously advancing the catheter includes percutaneously advancing the catheter through a superior vena cava of the subject, and

[0055] the array of sensing electrodes is closer to a distal tip of the catheter than the one or more pacing electrodes are to the distal tip of the catheter.

[0056] In an application, the catheter further includes at least a first pressure sensor disposed between the one or more pacing electrodes and the array of sensing electrodes.

[0057] In an application, the catheter includes a second pressure sensor disposed proximally to the one or more pacing electrodes.

[0058] In an application, the catheter includes at least a first accelerometer disposed between the one or more pacing electrodes and the array of sensing electrodes.

[0059] In an application, the catheter includes a second accelerometer disposed proximally to the one or more pacing electrodes.

[0060] In an application, the catheter includes at least a first radiopaque marker disposed between the one or more pacing electrodes and the array of sensing electrodes.

[0061] In an application, the catheter includes a second radiopaque marker disposed proximally to the one or more pacing electrodes.

[0062] In an application, the first and second radiopaque markers include asymmetrical radiopaque markers.In an application, the one or more pacing electrodes are located at a distance of between 5 and 20 cm from the distal tip.

[0063] In an application, the one or more pacing electrodes are located at a distance of 10 cm from the distal tip.

[0064] In an application, the array of sensing electrodes is located at a distance of between of between 0.1 and 20 mm from the distal tip.

[0065] In an application, the array of sensing electrodes is located at a distance of 1 mm from the distal tip.

[0066] In an application:

[0067] percutaneously advancing the catheter includes percutaneously advancing the catheter through an inferior vena cava of the subject, and

[0068] the one or more pacing electrodes are closer to a distal tip of the catheter than the array of sensing electrodes is to the distal tip of the catheter.

[0069] In an application, the catheter includes at least a first pressure sensor disposed between the one or more pacing electrodes and the array of sensing electrodes.

[0070] In an application, the catheter includes a second pressure sensor disposed proximally to the array of sensing electrodes.

[0071] In an application, the catheter includes at least a first accelerometer disposed between the one or more pacing electrodes and the array of sensing electrodes.

[0072] In an application, the catheter includes a second accelerometer disposed proximally to the array of sensing electrodes.

[0073] In an application, the catheter includes at least a first radiopaque marker disposed between the one or more pacing electrodes and the array of sensing electrodes.

[0074] In an application, the catheter includes a second radiopaque marker disposed proximally to the array of sensing electrodes.

[0075] In an application, the first and second radiopaque markers include asymmetrical radiopaque markers.

[0076] In an application, the one or more pacing electrodes are located at a distance of between 0 and 5 cm from the distal tip.In an application, the one or more pacing electrodes are located at a distance of 0.1 cm from the distal tip.

[0077] In an application, the array of sensing electrodes is located at a distance of between of between 20 and 200 mm from the distal tip.

[0078] In an application, the array of sensing electrodes is located at a distance of 100 mm from the distal tip.

[0079] In an application, the catheter includes a handle including an electrical socket connector. There is yet additionally provided, in accordance with some applications of the invention, apparatus for mapping a heart of a subject, the apparatus including:

[0080] a catheter dimensioned for percutaneous advancement through vasculature of the subject; one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; and

[0081] an array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart,

[0082] the catheter is dimensioned for advancement through a superior vena cava, and

[0083] the array of sensing electrodes is closer to a distal tip of the catheter than the one or more pacing electrodes are to the distal tip of the catheter.

[0084] There is further additionally provided, in accordance with some applications of the invention, apparatus for mapping a heart of a subject, the apparatus including:

[0085] a catheter dimensioned for percutaneous advancement through vasculature of the subject; one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; and

[0086] an array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart,

[0087] wherein the catheter is dimensioned for advancement through an inferior vena cava, and wherein the one or more pacing electrodes are closer to a distal tip of the catheter than the array of sensing electrodes is to the distal tip of the catheter.

[0088] There is further provided, in accordance with some applications of the invention, a method for mapping a heart of a subject, the method including:

[0089] mapping the heart of the subject in order to identify one or more regions of the heart not suitable for positioning of at least a portion of an implant, by:percutaneously advancing a catheter through vasculature of the subject and through a superior vena cava of the subject;

[0090] positioning one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; and

[0091] positioning an array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart, the array of sensing electrodes is closer to a distal tip of the catheter than the one or more pacing electrodes are to the distal tip of the catheter.

[0092] There is also provided, in accordance with some applications of the invention, a method for mapping a heart of a subject, the method including: mapping the heart of the subject in order to identify one or more regions of the heart not suitable for positioning of at least a portion of an implant, by:

[0093] percutaneously advancing a catheter through vasculature of the subject and through an inferior vena cava of the subject;

[0094] positioning one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; and

[0095] positioning an array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart, wherein the one or more pacing electrodes are closer to a distal tip of the catheter than the array of sensing electrodes is to the distal tip of the catheter.

[0096] The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:

[0097] BRIEF DESCRIPTION OF THE DRAWINGS

[0098] Fig. 1 is a schematic illustration of a His-Bundle mapping catheter inside the right ventricle using a transjugular approach, in accordance with an application of the present invention;

[0099] Fig. 2 is a schematic illustration of a His-Bundle mapping catheter inside the right ventricle using a transfemoral approach, in accordance with an application of the present invention;

[0100] Fig. 3 is a schematic illustration of the His-Bundle mapping catheter of Fig. 1, in accordance with an application of the present invention;Fig. 4 is a schematic illustration of the His-Bundle mapping catheter of Fig. 2, in accordance with an application of the present invention;

[0101] Fig. 5 is a schematic illustration of an array of intra-cardiac sensing electrodes of the His-Bundle mapping catheters of Figs. 2 and 3, in accordance with an application of the present invention; and

[0102] Fig. 6 is a schematic illustration of a radiopaque marker of the His-Bundle mapping catheters of Figs. 1 and 2, in accordance with an application of the present invention.

[0103] DETAILED DESCRIPTION OF APPLICATIONS

[0104] Reference is now made to Figs. 1, 3, and 5-6, which are schematic illustrations of a system 20 comprising a His-Bundle mapping catheter 22 comprising pacing electrodes 24 and an array of intracardiac (IC) sensing electrodes 26 being advanced into a right ventricle of a patient through the superior vena cava, e.g., using a transjugular approach, in accordance with some applications of the present invention. It is to be noted any suitable access point or method of access into the right ventricle via the superior vena cava can be used. The one or more pacing electrodes 24 are coupled to catheter 22 at a first distal region of catheter 22 designated for positioning adjacent an apex of the heart, and the array of sensing electrodes 26 is coupled to catheter 22 at a second distal region of catheter 22 designated for positioning adjacent the His-Bundle of the heart.

[0105] The body of catheter 22 has a tube diameter between 1 and 10 Fr, e.g., 7 Fr and has a length between 100 to 300 cm, e.g., 160 cm. The body of catheter 22 is made of a non-galvanic biocompatible material such as polyether block amide.

[0106] Catheter 22 is shaped so as to define one or more internal lumens for threading all the wires connected to the electrodes, sensors, and / or accelerometers of catheter 22, and for threading one or more pullwires for controlling the bending of the body of catheter 22.

[0107] For some applications of the present invention, a guide sheath is used to deliver the catheter into the right ventricle. Typically, but not necessarily, the guide sheath is sized larger than catheter 22, e.g., an additional Fr measurement.

[0108] During the transjugular approach, catheter 22 passes through the superior vena cava, thus pacing electrodes 24 are located at a first distance from a distal tip 21 of catheter 22, and the array of intracardiac (IC) sensing electrodes 26 is located at a second distance, nearer to distal tip 21 of catheter22, as shown in Figs. 1 and 3. As shown, for catheter 22, the first distance is greater than the second distance.

[0109] Catheter 22 includes between 1 to 20 (e.g., 2 as shown) annular pacing electrodes 24. Pacing electrodes 24 are located at a distance DI (e.g., between 5 and 20 cm, e.g., 10 cm) from tip 21 of catheter 22.

[0110] Pacing electrodes 24 are coupled to the catheter at a distal region of catheter 22 at a portion of catheter 22 designated for positioning at the apex of the heart, as shown in Fig. 1.

[0111] Pacing electrodes 24 are connected to at least one of the contacts of the socket connector (at the handle 28) using a conductive shielded or unshielded wire via the lumen of the catheter.

[0112] Pacing electrodes 24 are made of a biocompatible conductive material such as platinum or platinum-iridium alloy.

[0113] The body of catheter 22 is shaped so as to define a bending region 25 near the location of pacing electrodes 24. This bending region 25 is particularly important for catheter 22 since it is used during the transjugular approach, as shown in Fig. 1. Bending region 25 is located at or adjacent (e.g., proximally adjacent or distally adjacent) the region of pacing electrodes 24 so as to ensure that pacing electrodes 24 are positioned at the apex of the heart, as shown in Fig. 1. As shown in Fig. 3, bending region 25 has a bending angle alpha a that is between 20 and 180 degrees, e.g., 30 degrees, for applications in which catheter 22 is delivered from the superior vena cava and advances such that pacing electrodes 24 are positioned at the apex, and catheter 22 bends back up toward the His-Bundle such that the array of IC sensing electrodes 26 is positioned adjacent the His-Bundle, as shown in Fig.

[0114] 1.

[0115] Reference is now made to Figs. 2 and 4-6, which are schematic illustrations of a system 40 comprising a His-Bundle mapping catheter 42 comprising pacing electrodes 24 and an array of intracardiac (IC) sensing electrodes 26 being advanced into the right ventricle through the inferior vena cava, e.g., using a transfemoral approach, in accordance with some applications of the present invention. It is to be noted any suitable access point or method of access into the right ventricle via the inferior vena cava can be used. The one or more pacing electrodes 24 are coupled to catheter 42 at a first distal region of catheter 42 designated for positioning adjacent an apex of the heart, and the array of sensing electrodes 26 is coupled to catheter 42 at a second distal region of catheter 42 designated for positioning adjacent the His-Bundle of the heart.The body of catheter 42 has a tube diameter between 1 and 10 Fr, e.g., 7 Fr and has a length between 100 to 300 cm, e.g., 160 cm. The body of catheter 42 is made of a non-galvanic biocompatible material such as polyether block amide.

[0116] Catheter 42 is shaped so as to define one or more internal lumens for threading all the wires connected to the electrodes, sensors, and / or accelerometers of catheter 42, and for threading one or more pullwires for controlling the bending of the body of catheter 42.

[0117] For some applications of the present invention, a guide sheath is used to deliver the catheter into the right ventricle. Typically, but not necessarily, the guide sheath is sized larger than catheter 42, e.g., an additional Fr measurement.

[0118] During the transfemoral approach, catheter 42 passes through the inferior vena cava, thus pacing electrodes 24 are located in proximity to distal tip 21, e.g., at distal tip 21, at a first distance from a distal tip 21 of catheter 22, and the array of intracardiac (IC) sensing electrodes 26 is located at a second distance, farther from distal tip 21 of catheter 22, as shown in Figs. 2 and 4. As shown, for catheter 22, the first distance is smaller than the second distance.

[0119] Catheter 42 includes between 1 to 20 (e.g., 2 as shown) annular pacing electrodes 24. Pacing electrodes 24 are located at a distance D2 (e.g., between 0 and 5 cm, e.g., 0.1 cm) from tip 21 of catheter 22.

[0120] Pacing electrodes 24 are connected to at least one of the contacts of the socket connector (at the handle 28) using a conductive shielded or unshielded wire via the lumen of the catheter.

[0121] Pacing electrodes 24 are made of a biocompatible conductive material such as platinum or platinum-iridium alloy.

[0122] The body of catheter 42 is shaped so as to define a bending region 27 near the location of pacing electrodes 24. Bending region 27 is particularly important for catheter 42 since it is used during the transfemoral approach, as shown in Fig. 2. Bending region is located at or adjacent (e.g., proximally) the region of array of intracardiac (IC) sensing electrodes 26 so as to ensure that pacing electrodes are positioned at the His-Bundle, as shown in Fig. 2. As shown in Fig. 4, bending region 27 has a bending angle beta 0 that is between 20 and 180 degrees, e.g., 30 degrees, for applications in which catheter 42 is delivered from the inferior vena cava and advances such that the array of IC sensing electrodes 26 is positioned adjacent the His-Bundle and pacing electrodes 24 are positioned at the apex, as shown in Fig. 2.

[0123] Reference is now made to Figs. 1 -2. At the end of the insertion procedure, pacing electrode(s) 24 are positioned at the apex of the right ventricle, and the array of intracardiac (IC) sensing electrodes26 are placed in proximity with the His-Bundle. In either approach, catheters 22 and 42 are each positioned in a manner in which the superior and anterior ends of the His-Bundle do not extend beyond the distal and proximal ends of the array of IC sensing electrodes 26.

[0124] Pacing electrode(s) 24 deliver a bipolar / unipolar pacing stimulation signal, for facilitating stabilizing of the aortic valve area during the implantation process and / or for assisting in pacing the heart. The IC sensor signals acquired by the array of the intracardiac sensing electrodes 26 provide identification of the locations of the superior and anterior ends of the His-Bundle.

[0125] For applications in which a prosthetic valve is delivered proximate the His-Bundle, the His-Bundle mapping catheters 22 and 42 provide the identification of a region that is not suitable for positioning at least a portion of the prosthetic valve or any other implant and / or for applying radial forces by the prosthetic valve or any other implant to the identified region.

[0126] Reference is now made to Figs. 3 and 4. Each catheter 22 and 42 comprises a handle 28 at a proximal end thereof. Handle 28 is designed for the operator for convenient control of the insertion, steering and orientation of catheters 22 and 42, and for controlling the bending capability of catheters 22 and 42.

[0127] Handle 28 comprises an electrical socket connector with a suitable number of contacts, electrically connected to all electrodes 24 and 26, pressure sensors 52, and accelerometers 54 of catheters 22 and 42.

[0128] For some applications, handle 28 may comprise a digital storage feature, e.g., erasable programmable read-only memory (EPROM). For some applications, the digital storage feature assists in calibration of data of the exact positions of all electrodes 24 and 26, sensors 52, and accelerometers 54 of each catheter 22 and 42. For some applications, handle 28 comprises an authentication component for digital signature. Both components are electrically connected to specific pins of the socket connector.

[0129] Reference is now made to Fig. 5. Each catheter 22 and 42 comprises an array of annular intracardiac (IC) sensing electrodes 26. Each array comprises between 10 and 100 electrodes 26, e.g., 40 electrodes. The array of IC electrodes 26 is typically between 0.1 and 200 mm from distal tip 21 of each catheter 22 and 42.

[0130] As illustrated in Fig. 3, for catheter 22 used to access the right ventricle from the superior vena cava, the array of intracardiac electrodes 26 is located at a distance D3 of between 0.1 and 20 mm, e.g., approximately 1 mm, from distal tip 21.As illustrated in Fig. 4, for catheter 42 used to access the right ventricle from the inferior vena cava, the array of intracardiac electrodes 26 is located at a distance D4 of between 20 and 200 mm, e.g., approximately 100 mm, from distal tip 21.

[0131] Reference is again made to Fig. 5. Each electrode 26 has a width wl between 0.1 and 3 mm, e.g., approximately 1 mm. A pitch pl between any consecutive sensing electrodes 26 is between 0.1 and 5 mm, e.g., approximately 2 mm.

[0132] The array of IC sensing electrodes 26 is coupled to each catheter 22 and 42 at a distal region of catheter 22 and 42 at a portion of catheter 22 and 42 designated for positioning in a vicinity of the His-Bundle of the heart, such that the first and last IC electrodes 26 are configured to be disposed beyond the His-Bundle region.

[0133] Each IC electrode 26 is annular and comprises biocompatible conductive material such as platinum or platinum-iridium alloy.

[0134] The surface of each electrode 26 is raised above the surface of the body of catheter 22 and 42 by a height hl between 0.01 to 1 mm, e.g., 0.1 mm, for enabling contact between electrodes 26 and the cardiac tissue with minimal resistance.

[0135] By analyzing the bipolar IC signals recorded by the array of IC electrodes 26, mapping of the location of the His-Bundle is achieved by verifying whether specific electrodes 26 are in close contact with the His-Bundle tissue. As such, the length and location of the His-Bundle can be determined.

[0136] Reference is now made to Figs. 3-5. Typically, for either catheter 22 and 42, the one or more pacing electrodes 24 and the array of sensing electrodes 26 are separated from each other by a distance D5 of approximately 20-160 mm, e.g., 80 mm.

[0137] Each catheter 22 and 42 may comprise up to 5, e.g., up to 2, small, low power accelerometers 54 and / or up to 5, e.g., up to 2, two radiopaque markers, e.g., asymmetric radiopaque markers 50.

[0138] Accelerometers 54 are located inside the lumen of each catheter 22 and 42 at locations distal and proximal to bending regions 25 and 27 of catheters 22 and 42, respectively. One accelerometer 54 is embedded between sensing electrodes 26 and pacing electrodes 24. The second accelerometer 54 is embedded between 2 and 20 cm, e.g., 10 cm, proximal to bending regions 25 and 27. Both accelerometers 54 are wired to the contacts of the electrical socket connector on handle 28 for applying electrical power and communication line (e.g., I2C) with accelerometers 54.For some applications of the present invention, each catheter 22 and 42 may comprise up to 5, e.g., up to 2, small pressure sensors 52a and 52b, located on the outer surface of catheter 22 and 42, and positioned in the vicinity of accelerometers 54 and asymmetric radiopaque markers 50.

[0139] Both pressure sensors 52a and 52b are wired to the contacts of the electrical socket connector on handle 28, for applying electrical power and receiving the outputs of the pressure readings. The wiring between sensors 52 and handle 28 is threaded inside the lumen of each catheter 22 and 42 in order to prevent leakage of blood into the lumen of catheter 22 and 42.

[0140] Pressure sensors 52, accelerometers 54, and markers 50 provide indications for visualizing the position, orientation, and rotation of catheters 22 and 42.

[0141] Reference is now made to Figs 3, 4, and 6. Asymmetric radiopaque markers 50 are positioned on the circumference of the body of each catheter 22 and 42 and are electrically insulated from the outer surface of the body of catheters 22 and 42. One marker 50a is located near but distal to the first accelerometer 54a, and the second marker 50b is located near but proximal to the second accelerometer 54b.

[0142] The markers 50 are designed as generally annular platinum stripes shaped so as to define a spiral structure. The width w2 of the stripe of each marker 50 is between 2 and 5 mm, e.g., 3 mm, and the overall length or height h2 of each marker 50 between 5 and 50 mm, e.g., 25 mm. The diameter dial of each marker 50 is generally similar to the diameter of the body of catheter 22 and 42.

[0143] As shown in the middle image of Fig. 6, each radiopaque marker 50 may be shaped so as to define include up to 10 structural cuts or indentations 51 along its annular stripe design, creating an asymmetric visual pattern. The depth of each vertical cut of indentation 51 is up to 50% of the width 2w of marker 50.

[0144] Reference is now made to Figs. 1-6. It is to be noted that although apparatus and techniques described herein relate to a transfemoral or transjugular approach, any other suitable approach using suitable vasculature may be used. It is to be noted that although apparatus and techniques described herein relate to positioning of catheter 22 and 42 in the right ventricle for electrical mapping of the His-Bundle position, the scope of the present invention includes positioning catheters 22 and 42 in the left ventricle for electrical mapping of the His-Bundle position from within the left ventricle using any suitable approach through any suitable vasculature.It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

CLAIMS1. Apparatus for mapping a heart of a subject, the apparatus comprising:a catheter dimensioned for percutaneous advancement through vasculature of the subject; one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; andan array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart,wherein the one or more pacing electrodes and the array of sensing electrodes are separated from each other by a distance of 20-160 mm.

2. The apparatus according to claim 1, further comprising a handle comprising an electrical socket connector.

3. The apparatus according to any one of claims 1-2, wherein:the catheter is dimensioned for advancement through a superior vena cava, andthe array of sensing electrodes is closer to a distal tip of the catheter than the one or more pacing electrodes are to the distal tip of the catheter.

4. The apparatus according to claim 3, further comprising at least a first pressure sensor disposed between the one or more pacing electrodes and the array of sensing electrodes.

5. The apparatus according to claim 4, further comprising a second pressure sensor disposed proximally to the one or more pacing electrodes.

6. The apparatus according to claim 3, further comprising at least a first accelerometer disposed between the one or more pacing electrodes and the array of sensing electrodes.

7. The apparatus according to claim 6, further comprising a second accelerometer disposed proximally to the one or more pacing electrodes.

8. The apparatus according to claim 3, further comprising at least a first radiopaque marker disposed between the one or more pacing electrodes and the array of sensing electrodes.

9. The apparatus according to claim 8, further comprising a second radiopaque marker disposed proximally to the one or more pacing electrodes.

10. The apparatus according to claim 9, wherein the first and second radiopaque markers comprise asymmetrical radiopaque markers.

11. The apparatus according to claim 3, wherein the one or more pacing electrodes are located at a distance of between 5 and 20 cm from the distal tip.

12. The apparatus according to claim 11, wherein the one or more pacing electrodes are located at a distance of 10 cm from the distal tip.

13. The apparatus according to claim 3, wherein the array of sensing electrodes is located at a distance of between of between 0.1 and 20 mm from the distal tip.

14. The apparatus according to claim 13, wherein the array of sensing electrodes is located at a distance of 1 mm from the distal tip.

15. The apparatus according to any one of claims 1-2, wherein:the catheter is dimensioned for advancement through an inferior vena cava, andthe one or more pacing electrodes are closer to a distal tip of the catheter than the array of sensing electrodes is to the distal tip of the catheter.

16. The apparatus according to claim 15, further comprising at least a first pressure sensor disposed between the one or more pacing electrodes and the array of sensing electrodes.

17. The apparatus according to claim 16, further comprising a second pressure sensor disposed proximally to the array of sensing electrodes.

18. The apparatus according to claim 15, further comprising at least a first accelerometer disposed between the one or more pacing electrodes and the array of sensing electrodes.

19. The apparatus according to claim 18, further comprising a second accelerometer disposed proximally to the array of sensing electrodes.

20. The apparatus according to claim 15, further comprising at least a first radiopaque marker disposed between the one or more pacing electrodes and the array of sensing electrodes.

21. The apparatus according to claim 20, further comprising a second radiopaque marker disposed proximally to the array of sensing electrodes.

22. The apparatus according to claim 21, wherein the first and second radiopaque markers comprise asymmetrical radiopaque markers.

23. The apparatus according to claim 15, wherein the one or more pacing electrodes are located at a distance of between 0 and 5 cm from the distal tip.

24. The apparatus according to claim 23, wherein the one or more pacing electrodes are located at a distance of 0.1 cm from the distal tip.

25. The apparatus according to claim 15, wherein the array of sensing electrodes is located at a distance of between of between 20 and 200 mm from the distal tip.

26. The apparatus according to claim 25, wherein the array of sensing electrodes is located at a distance of 100 mm from the distal tip.

27. A method for mapping a heart of a subject, the method comprising:mapping the heart of the subject in order to identify one or more regions of the heart not suitable for positioning of at least a portion of an implant, by:percutaneously advancing a catheter through vasculature of the subject; positioning one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; andpositioning an array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart, wherein the one or more pacing electrodes and the array of sensing electrodes are separated from each other by a distance of 20-160 mm.

28. The method according to claim 27, further comprising delivering an implant within the heart in a vicinity of the His-Bundle, and wherein mapping the heart comprises mapping a position of the His-Bundle in conjunction with delivering the implant.

29. The method according to claim 28, wherein mapping the position of the His-Bundle comprises identifying locations of superior and anterior ends of the His-Bundle.

30. The method according to claim 27, wherein positioning the array of sensing electrodes adjacent the His-Bundle of the heart comprises positioning the array such that the array extended beyond the His-Bundle in a manner in which the superior and anterior ends of the His-Bundle do not extend beyond distal and proximal ends of the array of sensing electrodes.

31. The method according to claim 27, wherein the implant includes a prosthetic valve, and wherein mapping the heart comprises identifying one or more regions of the heart not suitable for positioning of at least a portion of the prosthetic valve.

32. The method according to claim 27, wherein:percutaneously advancing the catheter comprises percutaneously advancing the catheter through a superior vena cava of the subject, andthe array of sensing electrodes is closer to a distal tip of the catheter than the one or more pacing electrodes are to the distal tip of the catheter.

33. The method according to claim 32, wherein the catheter further comprises at least a first pressure sensor disposed between the one or more pacing electrodes and the array of sensing electrodes.

34. The method according to claim 33, wherein the catheter comprises a second pressure sensor disposed proximally to the one or more pacing electrodes.

35. The method according to claim 32, wherein the catheter comprises at least a first accelerometer disposed between the one or more pacing electrodes and the array of sensing electrodes.

36. The method according to claim 35, wherein the catheter comprises a second accelerometer disposed proximally to the one or more pacing electrodes.

37. The method according to claim 32, wherein the catheter comprises at least a first radiopaque marker disposed between the one or more pacing electrodes and the array of sensing electrodes.

38. The method according to claim 37, wherein the catheter comprises a second radiopaque marker disposed proximally to the one or more pacing electrodes.

39. The method according to claim 38, wherein the first and second radiopaque markers comprise asymmetrical radiopaque markers.

40. The method according to claim 32, wherein the one or more pacing electrodes are located at a distance of between 5 and 20 cm from the distal tip.

41. The method according to claim 40, wherein the one or more pacing electrodes are located at a distance of 10 cm from the distal tip.

42. The method according to claim 32, wherein the array of sensing electrodes is located at a distance of between of between 0.1 and 20 mm from the distal tip.

43. The method according to claim 42, wherein the array of sensing electrodes is located at a distance of 1 mm from the distal tip.

44. The method according to claim 27, wherein:percutaneously advancing the catheter comprises percutaneously advancing the catheter through an inferior vena cava of the subject, andthe one or more pacing electrodes are closer to a distal tip of the catheter than the array of sensing electrodes is to the distal tip of the catheter.

45. The method according to claim 44, wherein the catheter comprises at least a first pressure sensor disposed between the one or more pacing electrodes and the array of sensing electrodes.

46. The method according to claim 45, wherein the catheter comprises a second pressure sensor disposed proximally to the array of sensing electrodes.

47. The method according to claim 44, wherein the catheter comprises at least a first accelerometer disposed between the one or more pacing electrodes and the array of sensing electrodes.

48. The method according to claim 47, wherein the catheter comprises a second accelerometer disposed proximally to the array of sensing electrodes.

49. The method according to claim 44, wherein the catheter comprises at least a first radiopaque marker disposed between the one or more pacing electrodes and the array of sensing electrodes.

50. The method according to claim 49, wherein the catheter comprises a second radiopaque marker disposed proximally to the array of sensing electrodes.

51. The method according to claim 50, wherein the first and second radiopaque markers comprise asymmetrical radiopaque markers.

52. The method according to claim 49, wherein the one or more pacing electrodes are located at a distance of between 0 and 5 cm from the distal tip.

53. The method according to claim 52, wherein the one or more pacing electrodes are located at a distance of 0.1 cm from the distal tip.

54. The method according to claim 44, wherein the array of sensing electrodes is located at a distance of between of between 20 and 200 mm from the distal tip.

55. The method according to claim 54, wherein the array of sensing electrodes is located at a distance of 100 mm from the distal tip.

56. The method according to claim 27, wherein the catheter comprises a handle comprising an electrical socket connector.

57. Apparatus for mapping a heart of a subject, the apparatus comprising:a catheter dimensioned for percutaneous advancement through vasculature of the subject; one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; andan array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart,wherein the catheter is dimensioned for advancement through a superior vena cava, and wherein the array of sensing electrodes is closer to a distal tip of the catheter than the one or more pacing electrodes are to the distal tip of the catheter.

58. The apparatus according to claim 57, wherein the one or more pacing electrodes and the array of sensing electrodes are separated from each other by a distance of 20-160 mm.

59. The apparatus according to claim 57, further comprising a handle comprising an electrical socket connector.

60. The apparatus according to any one of claims 57-59, further comprising at least a first pressure sensor disposed between the one or more pacing electrodes and the array of sensing electrodes.

61. The apparatus according to claim 60, further comprising a second pressure sensor disposed proximally to the one or more pacing electrodes.

62. The apparatus according to any one of claims 57-61, further comprising at least a first accelerometer disposed between the one or more pacing electrodes and the array of sensing electrodes.

63. The apparatus according to claim 62, further comprising a second accelerometer disposed proximally to the one or more pacing electrodes.

64. The apparatus according to any one of claims 57-63, further comprising at least a first radiopaque marker disposed between the one or more pacing electrodes and the array of sensing electrodes.

65. The apparatus according to claim 64, further comprising a second radiopaque marker disposed proximally to the one or more pacing electrodes.

66. The apparatus according to claim 65, wherein the first and second radiopaque markers comprise asymmetrical radiopaque markers.

67. The apparatus according to any one of claims 57-66, wherein the one or more pacing electrodes are located at a distance of between 5 and 20 cm from the distal tip.

68. The apparatus according to claim 67, wherein the one or more pacing electrodes are located at a distance of 10 cm from the distal tip.

69. The apparatus according to any one of claims 57-68, wherein the array of sensing electrodes is located at a distance of between of between 0.1 and 20 mm from the distal tip.

70. The apparatus according to claim 69, wherein the array of sensing electrodes is located at a distance of 1 mm from the distal tip.

71. Apparatus for mapping a heart of a subject, the apparatus comprising:a catheter dimensioned for percutaneous advancement through vasculature of the subject; one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; andan array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart,wherein the catheter is dimensioned for advancement through an inferior vena cava, and wherein the one or more pacing electrodes are closer to a distal tip of the catheter than the array of sensing electrodes is to the distal tip of the catheter.

72. The apparatus according to claim 71, wherein the one or more pacing electrodes and the array of sensing electrodes are separated from each other by a distance of 20-160 mm.

73. The apparatus according to claim 71, further comprising a handle comprising an electrical socket connector.

74. The apparatus according to any one of claims 71-73, further comprising at least a first pressure sensor disposed between the one or more pacing electrodes and the array of sensing electrodes.

75. The apparatus according to claim 74, further comprising a second pressure sensor disposed proximally to the array of sensing electrodes.

76. The apparatus according to any one of claims 71-75, further comprising at least a first accelerometer disposed between the one or more pacing electrodes and the array of sensing electrodes.

77. The apparatus according to claim 76, further comprising a second accelerometer disposed proximally to the array of sensing electrodes.

78. The apparatus according to any one of claims 71-77, further comprising at least a first radiopaque marker disposed between the one or more pacing electrodes and the array of sensing electrodes.

79. The apparatus according to claim 78, further comprising a second radiopaque marker disposed proximally to the array of sensing electrodes.

80. The apparatus according to claim 79, wherein the first and second radiopaque markers comprise asymmetrical radiopaque markers.

81. The apparatus according to any one of claims 71-80, wherein the one or more pacing electrodes are located at a distance of between 0 and 5 cm from the distal tip.

82. The apparatus according to claim 81, wherein the one or more pacing electrodes are located at a distance of 0.1 cm from the distal tip.

83. The apparatus according to any one of claims 71-82, wherein the array of sensing electrodes is located at a distance of between of between 20 and 200 mm from the distal tip.

84. The apparatus according to claim 83, wherein the array of sensing electrodes is located at a distance of 100 mm from the distal tip.

85. A method for mapping a heart of a subject, the method comprising:mapping the heart of the subject in order to identify one or more regions of the heart not suitable for positioning of at least a portion of an implant, by:percutaneously advancing a catheter through vasculature of the subject and through a superior vena cava of the subject;positioning one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; andpositioning an array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart, wherein the array of sensing electrodes is closer to a distal tip of the catheter than the one or more pacing electrodes are to the distal tip of the catheter.

86. The method according to claim 85, wherein the one or more pacing electrodes and the array of sensing electrodes are separated from each other by a distance of 20-160 mm.

87. The method according to claim 85, further comprising delivering an implant within the heart in a vicinity of the His-Bundle, and wherein mapping the heart comprises mapping a position of the His-Bundle in conjunction with delivering the implant.

88. The method according to claim 87, wherein mapping the position of the His-Bundle comprises identifying locations of superior and anterior ends of the His-Bundle.

89. The method according to claim 85, wherein positioning the array of sensing electrodes adjacent the His-Bundle of the heart comprises positioning the array such that the array extended beyond the His-Bundle in a manner in which the superior and anterior ends of the His-Bundle do not extend beyond distal and proximal ends of the array of sensing electrodes.

90. The method according to claim 85, wherein the implant includes a prosthetic valve, and wherein mapping the heart comprises identifying one or more regions of the heart not suitable for positioning of at least a portion of the prosthetic valve.

91. A method for mapping a heart of a subject, the method comprising:mapping the heart of the subject in order to identify one or more regions of the heart not suitable for positioning of at least a portion of an implant, by:percutaneously advancing a catheter through vasculature of the subject and through an inferior vena cava of the subject;positioning one or more pacing electrodes coupled to the catheter at a first distal region of the catheter designated for positioning adjacent an apex of the heart; andpositioning an array of sensing electrodes coupled to the catheter at a second distal region of the catheter designated for positioning adjacent a His-Bundle of the heart, wherein the one or more pacing electrodes are closer to a distal tip of the catheter than the array of sensing electrodes is to the distal tip of the catheter.

92. The method according to claim 91, wherein the one or more pacing electrodes and the array of sensing electrodes are separated from each other by a distance of 20-160 mm.

93. The method according to claim 91, further comprising delivering an implant within the heart in a vicinity of the His-Bundle, and wherein mapping the heart comprises mapping a position of the His-Bundle in conjunction with delivering the implant.

94. The method according to claim 93, wherein mapping the position of the His-Bundle comprises identifying locations of superior and anterior ends of the His-Bundle.

95. The method according to claim 91, wherein positioning the array of sensing electrodes adjacent the His-Bundle of the heart comprises positioning the array such that the array extended beyond the His-Bundle in a manner in which the superior and anterior ends of the His-Bundle do not extend beyond distal and proximal ends of the array of sensing electrodes.

96. The method according to claim 91, wherein the implant includes a prosthetic valve, and wherein mapping the heart comprises identifying one or more regions of the heart not suitable for positioning of at least a portion of the prosthetic valve.

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