Device and method for septum puncture

Abstract

In some embodiments, a method includes inserting a shaft (320) into the inferior vena cava and the superior vena cava, the shaft having a side catheter introducer (330) attached to the shaft via an introducer coupler (340) such that the introducer coupler (340) is disposed in the right atrium; and applying a distal force to a proximal portion of the side catheter introducer (330) such that a distal end of the side catheter introducer (330) is deflected laterally toward the septum around the introducer coupler (340). The method also includes extending a side catheter (360) disposed within the side catheter introducer (330) distally from the side catheter introducer (330) toward the septum and into contact with the septum. The method further includes extending a septum penetrator (370) slidably disposed within the side catheter (360) distally from the side catheter (360) while the side catheter (360) is in contact with the septum, so that the septum penetrator (370) punctures the septum.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 62 / 735,410, filed on September 24, 2018, entitled “Device for Transseptal Puncture,” the entire disclosure of which is hereby incorporated by reference herein in its entirety.

[0003] This application is related to PCT Application Serial No. PCT / US2018 / 023800, entitled “Device and Method for Transseptal Puncture,” filed on March 22, 2018, which claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 62 / 474,939, entitled “Device and Method for Transseptal Puncture,” filed on March 22, 2017, and U.S. Provisional Patent Application Serial No. 62 / 580,165, entitled “Device and Method for Transseptal Puncture,” filed on November 1, 2017. The entire disclosure of each of the foregoing applications is hereby incorporated herein by reference in its entirety. Technical Field

[0004] Described herein are embodiments directed to devices and methods for accessing the left side of the heart. Background Art

[0005] Many diseases and disorders (such as heart failure, atrial fibrillation, mitral valve disease, and other diseases) particularly affect the left side of the heart or can be traced to the left side of the heart. Therefore, many interventional percutaneous cardiac procedures require access to the left side of the heart, including, for example, electrophysiology procedures, left atrial appendage closure procedures, mitral valve repair and replacement procedures, atrial shunt procedures, and many others. In addition to therapeutic interventional procedures, indications for access to the left side of the heart also include diagnostic procedures, including, for example, hemodynamic measurements (e.g., left atrial pressure, transmitral pressure gradient, etc.). Minimally invasive access to the left side of the heart is challenging and presents significant risks.

[0006] Some catheter-based surgeries access the left side of the heart by piercing the atrial septum ("AS") of the heart, which separates the left atrium ("LA") of the heart from the right atrium ("RA") of the heart. Such surgeries use a catheter that accommodates a sheathed needle, which is advanced from the femoral vein in the patient's groin through the RA of the heart to the superior vena cava ("SVC"). The sheathed needle is often a long steel wire needle with a roughly 20-degree bend near its tip. With the catheter assembly disposed in the SVC, the catheter assembly is then slowly withdrawn from below the SVC and withdrawn into the RA until the tip of the catheter assembly rests in the oval fossa ("fossa", "FO" or "F"). The FO is a thumbprint-sized depression in the wall of the RA, and is the thinnest part of the atrial septum (i.e., the wall between the RA and LA). Once the operator sees contact between the tip of the catheter assembly and the F, the needle is advanced so that the needle pierces the F. As the needle extends from the LA into the RA, a guidewire is advanced through the catheter and into the RA. The needle is then removed from the LA and a device (e.g., an AF ablation device, catheter, percutaneous mitral valve repair delivery system or catheter, as examples) may be inserted into the LA.

[0007] An alternative procedure involves using a blunt needle electrified by radiofrequency to puncture or perforate the atrial septum.

[0008] The above procedure has significant limitations. Puncture of the FO is difficult to learn, time intensive, and it is easy to puncture the FO prematurely, misaligned, and inadvertently. In addition, it is difficult to accurately and precisely find the F with the tip of the device, and if the catheter assembly is withdrawn too far from the SVC, the time-intensive surgical steps must be repeated because the device cannot be moved toward the tip. In addition, the shape of the needle may need to be customized or adjusted based on the patient's specific anatomy, further complicating the process.

[0009] In addition, such catheters are typically very flexible and not very stable within the SVC, and therefore can be easily manipulated out of the ideal position inadvertently, especially during normal dynamic cardiac activity. Furthermore, the needle is not secured to the catheter, resulting in accidental needle exposure and possibly inadvertent cardiac puncture, which can be fatal. Further complicating the procedure is the possibility of distorted or abnormal anatomy due to, for example, aortic or mitral valve disease, resulting in changes in the position of the FO and confusion of typical anatomical landmarks. Even more, in patients undergoing repeat procedures, the FO may become thickened or scarred, requiring greater penetration force and increasing the risk of inadvertent damage to adjacent anatomical structures.

[0010] It may be critical for many left heart surgeries to perform a septal puncture in a specific location within the FO. For example, for delivery of a replacement mitral valve, it may be important to puncture the inferior portion of the FO, while for an autologous valve leaflet clip implant procedure, it may be important to puncture the posterior / middle portion of the FO. Existing systems do not provide sufficiently accurate and precise targeting of an intended puncture site, such as a specific area within the FO. Failure to puncture the septum at the proper location may result in a prolonged, unsuccessful, or cancelled procedure.

[0011] Therefore, there is a need for improved devices and methods for faster, more stable, safer, more accurate, and more precise access to the LA. Summary of the invention

[0012] Devices and methods for minimally invasively accessing various portions of a patient's anatomy, such as, for example, accessing the left atrium of a heart via a transseptal puncture, are described herein. In some embodiments, a method includes inserting a shaft into the inferior vena cava of a patient's heart and the superior vena cava of the heart, the shaft having (1) a side catheter introducer attached to the shaft via an introducer coupler, and (2) an introducer stabilizer / actuator ("GSA") in a delivery configuration and slidably attached to the shaft such that the GSA is disposed in the right atrium of the heart. The method also includes applying a distal force to the side catheter introducer such that the distal end of the side catheter introducer deflects laterally about the introducer coupler toward the septum of the heart. The method also includes actuating the introducer stabilizer / actuator to transition the GSA from its delivery configuration to a deployed configuration while the GSA is in its delivery configuration in the right atrium of the heart. After initiating the application of the distal force and with the introducer stabilizer / actuator in its deployed configuration, the GSA is disposed in contact with the side catheter introducer to laterally stabilize the side catheter introducer relative to the axis. The method further includes extending a side catheter disposed within the side catheter introducer distally from the side catheter introducer toward the septum and into contact with the septum with the distal end of the side catheter deflected laterally toward the septum about the introducer coupler and laterally stabilized by the GSA. The method further includes extending a septum penetrator slidably disposed within the side catheter distally from the side catheter with the distal end of the side catheter in contact with the septum such that the septum penetrator punctures the septum. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1A is a schematic diagram of a septum piercing device arranged in a delivery configuration according to one embodiment.

[0014] Figure 1BIs to expand the configuration settings Figure 1A Schematic diagram of the septum puncture device.

[0015] Figure 2A yes Figure 1A A schematic diagram of a septal puncture device disposed in a delivery configuration within the right atrium ("RA") of a patient's heart and coupled to a first guidewire extending from the inferior vena cava ("IVC") of the heart, across the RA and into the superior vena cava ("SVC") of the heart.

[0016] Figure 2B yes Figure 1A Schematic diagram of a transseptal device arranged in a deployed configuration and allowing the transseptal device to be advanced over a second guidewire and delivered to the LA.

[0017] Figure 3 is a flow chart illustrating a method of using a septal puncture device to access the left atrium of a patient's heart, according to one embodiment.

[0018] Figure 4A and Figure 4B Septum piercing device 300 is shown in a perspective view and in a partially exploded view in a delivery configuration and a deployed configuration, respectively. Septum piercing device 300 is shown partially exploded to illustrate the lumen defined by body 310.

[0019] Figure 5A and Figure 5B The cross-sectional view is shown in perspective and front view respectively. Figure 4A and Figure 4B A portion of a septum piercing device 300 .

[0020] 6A to 6H A septum piercing device 300 is shown in side view and a deployment sequence at a distal end portion thereof, according to one embodiment.

[0021] Fig. 7A and Figure 7B A portion of septum piercing device 300 is shown in its delivery configuration and in its deployed configuration, respectively.

[0022] Figure 8 An introducer coupler 340 of septum puncture device 300 coupled to and between main shaft 320 and side catheter introducer 330 is shown in an assembled arrangement (on the right) and in a detailed partially assembled arrangement (on the left).

[0023] Fig. 9 is a flow chart illustrating a method of using a septal puncture device to access the left atrium of a patient's heart, according to one embodiment.

[0024] Figures 10 to 12 A portion of a septum piercing device 500 in a deployed configuration according to another embodiment is shown in perspective bottom view, perspective side view, and side view, respectively.

[0025] FIG. 13A to FIG. 13F shows the use according to one embodiment Figures 10 to 12 Partial delivery and deployment sequence of septum piercing device 500.

[0026] FIG. 14A to FIG. 14K An example deployment sequence of septum piercing device 600 is shown according to one embodiment.

[0027] Figures 15 to 17 A septum piercing device 700 according to one embodiment is shown in perspective, front and side views, respectively.

[0028] 18A to 18C A first introducer stabilizer / actuator ("GSA") 850A and a second GSA 850B of a septum puncture device 800 according to one embodiment are shown in a collapsed delivery configuration, a partially expanded, partially deployed configuration, and an expanded deployed configuration, respectively.

[0029] Figures 19 to 21 A septum puncture device 900 including two side catheters according to one embodiment is shown in perspective view, front view, and detailed partial perspective view, respectively.

[0030] Fig. 22 and Fig.23 A septum puncture device 1000 having a single GSA and two side conduits according to one embodiment is shown in front view and perspective view, respectively.

[0031] Fig.24 and Fig.25 A septum puncture device 1100 having a single GSA and a single side catheter according to one embodiment is shown in perspective front view and perspective side view, respectively.

[0032] Fig.26A and Fig.26B An example delivery and deployment sequence of septum puncture device 1100 in the context of a patient's heart is shown according to one embodiment.

[0033] Fig. 27 A septum piercing device 1200 is shown having a GSA with a concave shape, and a GSA with a convex shape, according to one embodiment.

[0034] Fig.28A septum piercing device 1300 having a GSA with a particular bend is shown according to one embodiment.

[0035] Fig.29 A septum puncture device 1400 having a three-lobed GSA is shown in top view, according to one embodiment.

[0036] Fig.30 A septum piercing device 1500 having a GSA with multiple lobes is shown in top view according to one embodiment.

[0037] Fig.31 A septal puncture device 1600 having a GSA configured to limit blood flow obstruction is shown in side view according to one embodiment.

[0038] Fig.32 A septum piercing device 1700 having GSAs that are rotationally offset and interlocked with one another is shown in side view, according to one embodiment.

[0039] Fig.33 A septum piercing device 1800 having an asymmetric GSA is shown in side and top views according to one embodiment.

[0040] Fig.34 A septum piercing device 1900 is shown in side view defining two pathways between GSAs according to one embodiment.

[0041] FIG. 35A to FIG. 35D The deployment sequence of septum piercing device 2000 is shown according to one embodiment.

[0042] Fig.36 A portion of a septal puncture device 2100 having an intracardiac echo ("ICE") sensor is shown according to one embodiment.

[0043] Fig.37 A portion of a septum puncture device 2200 with a camera is shown according to one embodiment.

[0044] Fig.38 and Fig.39 A portion of a septum piercing device 2300 according to one embodiment is shown in cross-sectional side and front views, respectively.

[0045] Fig.40A and Fig.40B A stylus 2310 is shown according to one embodiment.

[0046] Fig.41 A handle 2318 is shown according to one embodiment.

[0047] FIG. 42A to FIG. 42D An example deployment sequence of septum piercing device 2300 is shown according to one embodiment.

[0048] Fig.43A and Fig.43B A portion of septum piercing device 2300 is shown in side view and cross-sectional side view, respectively.

[0049] Fig.44 A portion of septum piercing device 2300 including an end effector is shown in perspective view.

[0050] FIG. 45A to FIG. 45D Shows Fig.44 end effector.

[0051] Fig.46A and Fig.46B A portion of the diaphragm device 2300 including a reinforcement element is shown in cross-sectional side view and front view, respectively.

[0052] FIG. 47A to FIG. 48D A segmented septum piercing device 2400 is shown according to one embodiment.

[0053] Figures 49 to 52 A septum piercing device 2500 is shown according to one embodiment.

[0054] FIG. 53A to FIG. 53C Various implementations of septum piercing device 2500 are shown.

[0055] FIG. 54A to FIG. 54C Various implementations of septum piercing device 2500 are shown.

[0056] Fig.55 A sheath for septum piercing device 2500 is shown.

[0057] Fig.56 Various implementations of septum piercing device 2500 are shown.

[0058] Fig.57 and Fig.58 A handle assembly 2680 is shown according to one embodiment.

[0059] FIG. 59A to FIG. 59D An example deployment sequence of a septum piercing device according to one embodiment is shown.

[0060] FIG. 60A to FIG. 60D A portion of a septum piercing device 2700 is shown according to one embodiment.

[0061] FIG. 61A to FIG. 62B Various implementations of septum piercing device 2700 are shown.

[0062] Figures 63A to 63C A portion of a septum piercing device 2800 is shown according to one embodiment.

[0063] Fig.64 A portion of a septum puncture device 2900 is shown having a balloon covered in mesh, according to one embodiment. DETAILED DESCRIPTION

[0064] Devices and methods are described herein for accessing the left side of the heart (e.g., LA) from the right side of the heart (e.g., RA) without the need for open-heart surgery. The methods described herein are minimally invasive and utilize a septal puncture device to access the left side of the heart in a safe (e.g., non-traumatic), effective, timely, accurately and precisely positioned, and repeatable manner. This is achieved in part by providing a steerable (e.g., translatable and rotatable) stable platform between the IVC and the SVC, from which a puncture member can extend distally and into a target puncture location (e.g., FO) of the atrial septum.

[0065] In some embodiments, a method includes inserting a shaft into the inferior vena cava of a patient's heart and the superior vena cava of the heart, the shaft having (1) a side catheter introducer attached to the shaft via an introducer coupler, and (2) an introducer stabilizer / actuator ("GSA") in a delivery configuration and slidably attached to the shaft, such that the introducer stabilizer / actuator is disposed in the right atrium of the heart. The method also includes applying a distal force to the side catheter introducer so that the distal end of the side catheter introducer is deflected laterally around the introducer coupler toward the septum of the heart. The method also includes actuating the introducer stabilizer / actuator to transition the introducer stabilizer / actuator from its delivery configuration to a deployed configuration while the introducer stabilizer / actuator is in its deployed configuration in the right atrium of the heart. After the distal force is initiated and while the introducer stabilizer / actuator is in its deployed configuration, the side catheter introducer is disposed in contact with the side catheter introducer to stabilize the side catheter introducer laterally relative to the shaft. The method further includes extending a side catheter disposed in the side catheter introducer distally from the side catheter introducer toward the septum and into contact with the septum while the distal end of the side catheter introducer is deflected laterally toward the septum about the introducer coupler and laterally stabilized by the introducer stabilizer / actuator. The method further includes extending a septum penetrator slidably disposed in the side catheter distally from the side catheter while the distal end of the side catheter is in contact with the septum so that the septum penetrator punctures the septum.

[0066] In some embodiments, a method includes inserting a shaft into an inferior vena cava of a patient's heart and a superior vena cava of the heart, the shaft having a side catheter introducer attached to the shaft via an introducer coupler, such that the introducer coupler is disposed in the right atrium of the heart. The method also includes applying a distal force to a proximal portion of the side catheter introducer such that a distal end of the side catheter introducer deflects laterally around the introducer coupler toward a septum of the heart. The method also includes extending a side catheter disposed in the side catheter introducer distally from the side catheter introducer toward the septum and extending to contact the septum while the distal end of the side catheter introducer deflects laterally around the introducer coupler toward the septum. The method also includes extending a septum penetrator slidably disposed in the side catheter distally from the side catheter while the side catheter is in contact with the septum so that the septum penetrator punctures the septum.

[0067] In some embodiments, a method includes inserting a shaft into the inferior vena cava of a patient's heart and the superior vena cava of the heart, the shaft having an introducer stabilizer / actuator in a delivery configuration and slidably attached to the shaft, such that the introducer stabilizer / actuator is disposed in the right atrium of the heart, and a side catheter introducer is coupled to the introducer stabilizer / actuator. The method also includes actuating the introducer stabilizer / actuator to transition the introducer stabilizer / actuator from its delivery configuration to a deployed configuration with the introducer stabilizer / actuator in its delivery configuration in the right atrium of the heart, such that a distal end of the side catheter introducer is laterally deflected about the shaft toward the septum of the heart and is laterally stabilized in part by the introducer stabilizer / actuator in its deployed configuration. With the introducer stabilizer / actuator in its deployed configuration, the side catheter introducer extends proximally from its distal end disposed outside of a first side of the shaft, across the shaft, and to a second side of the shaft opposite the first side of the shaft, then turns and extends proximally toward the proximal end of the shaft. The method also includes extending a side catheter disposed within the side catheter introducer from a distal end of the side catheter introducer distally toward the septum and into contact with the septum while the distal end of the side catheter introducer is deflected laterally about the shaft toward the septum and is partially laterally stabilized by the introducer stabilizer / actuator. The method also includes extending a septum penetrator slidably disposed within the side catheter distally from the side catheter while the side catheter is in contact with the septum so that the septum penetrator punctures the septum.

[0068] In some embodiments, a device includes: a body, the body defining a first lumen and a second lumen. The device also includes: a shaft, the shaft having: a first section, the first section fixedly coupled to the body and extending distally from the first lumen of the body; and a second section, the second section is partially disposed within the first section of the shaft and is retractable relative to the first section. The device also includes: a guidewire coupler, the guidewire coupler is coupled to the body and extends distally from within the lumen defined by the shaft. The guidewire coupler defines a guidewire lumen, the guidewire lumen being configured to slidably receive a first guidewire. The device also includes: a side catheter introducer, the side catheter introducer is coupled to the body and extends distally from within the second lumen of the body. The side catheter introducer is coupled to the first section of the shaft via an introducer coupler. The side catheter introducer is configured to transition between a delivery configuration and a deployment configuration, wherein when transitioning from its delivery configuration to its deployment configuration, the distal end of the side catheter introducer is laterally deflected around the introducer coupler. The device also includes: an introducer stabilizer / actuator, which is coupled to the second section of the shaft and is configured to transition between a delivery configuration and a deployment configuration to further deflect and laterally stabilize the distal end of the side catheter introducer around the introducer coupler. The side catheter introducer defines a lumen configured to slidably receive the side catheter. The side catheter defines a lumen configured to slidably receive the puncture member. The puncture member is configured to puncture the patient's tissue.

[0069] In some embodiments, a device includes: a body, the body defining a first lumen and a second lumen. The device also includes: a shaft, the shaft having: a first section, the first section fixedly coupled to the body and extending distally from the first lumen of the body; and a second section, the second section is partially disposed within the first section of the shaft and is retractable relative to the first section. The device also includes: a guidewire coupler, the guidewire coupler is coupled to the body and extends distally from within the lumen defined by the shaft. The guidewire coupler defines a guidewire lumen, the guidewire lumen being configured to slidably receive a first guidewire. The device also includes: a side catheter introducer, the side catheter introducer is coupled to the body and extends distally from within the second lumen of the body. The side catheter introducer is coupled to the first section of the shaft via an introducer coupler. The side catheter introducer is configured to transition between a delivery configuration and a deployment configuration, wherein when transitioning from its delivery configuration to its deployment configuration, the distal end of the side catheter introducer is laterally deflected around the introducer coupler. The side catheter introducer defines a lumen configured to slidably receive the side catheter. The side catheter defines a lumen configured to slidably receive the puncture member. The puncture member is configured to puncture tissue of a patient.

[0070] In some embodiments, a device includes: a shaft having: a proximal end and a distal end; and a lumen extending through the shaft. The shaft defines (1) a first aperture, and (2) a second aperture and a third aperture, both of which are disposed distally of the first aperture. The device also includes: a first introducer stabilizer / actuator ("GSA") and a second GSA, both of which (1) are disposed circumferentially around the shaft and (2) are configured to transition between a delivery configuration and a deployment configuration. The device also includes: a side catheter introducer coupled to the shaft and extending distally into the lumen at the proximal end of the shaft, exiting the shaft through the first aperture, and extending distally between the first GSA and the second GSA and into the second aperture, and then exiting the shaft through the third aperture. The first GSA and the second GSA are configured such that transitioning from the delivery configuration to the deployment configuration causes the distal end of the side catheter introducer to (1) deflect laterally about the central axis of the shaft and (2) stabilize relative to the central axis. The side catheter introducer defines a lumen configured to slidably receive the side catheter. The side catheter defines a lumen configured to slidably receive a puncture member configured to puncture tissue of a patient.

[0071] As used herein, the terms "proximal" and "distal" refer to directions closer to and farther from, respectively, an operator (e.g., a surgeon, physician, nurse, technician, etc.) who would insert the septum puncture device into a patient, with the tip of the device (i.e., the distal end) first inserted into the patient's body. Thus, for example, the end of the spindle described herein that is first inserted into the patient's body would be the distal end, and the opposite end of the spindle (e.g., the end of the spindle that is manipulated by the operator) would be the proximal end of the spindle.

[0072] As used herein, the terms "advance," "advanced," and "advancing" each refer to distal movement. Advancing a device within a patient's vasculature, for example, refers to causing at least a portion of the device to move distally within the patient's vasculature. Similarly, as used herein, the terms "withdraw," "withdrawn," and "withdrawing" each refer to proximal movement. Withdrawing a device within a patient's vasculature, for example, refers to causing at least a portion of the device to move proximally within the patient's vasculature. In some cases, advancement and withdrawal may refer to relative movement of the device itself. Advancing a side catheter, for example, may refer to causing the side catheter to move distally relative to a side catheter introducer to which the side catheter is movably coupled. Similarly, withdrawing a side catheter, for example, may refer to causing the side catheter to move proximally relative to a side catheter introducer to which the side catheter is movably coupled.

[0073] The septal puncture device 100 can be used to access the left side of the heart (e.g., the left atrium) from the right side of the heart (e.g., the right atrium) and deliver a guidewire to the left side of the heart. Figure 1A As shown, the septum puncture device 100 includes: a body 110, the body 110 is connected to the main shaft 120; a side catheter introducer 130; a side catheter 160; and a septum penetrator 170. Figure 1A As shown, the main shaft 120 is coupled to the side catheter introducer 130 via the introducer coupler 140, the side catheter introducer 130 is coupled to the side catheter 160, and the side catheter 160 is coupled to the septum penetrator 170. The side catheter introducer 130 is configured to define a path through or across which the side catheter 160 can travel (e.g., advance and / or withdraw). In other words, and as described in more detail herein, the side catheter introducer 130 can be manipulated (e.g., actuated from a delivery state to a deployed state) to guide the side catheter 160 in a desired direction, such as toward the left atrium ( Figure 1B ) shows an actuated or deployed state of side catheter introducer 130.

[0074] As described in more detail herein, the introducer coupler 140 can couple the side catheter introducer 130 to the main shaft 120 to minimize or prevent relative translational movement between the main shaft 120 and the side catheter introducer 130, but as Figure 1B As shown schematically, relative rotational movement between the main shaft 120 and the side catheter introducer 130 is allowed. In this way, the introducer coupler 140 can help the side catheter introducer 130 to transition from a delivery configuration (e.g., parallel to or substantially parallel to the main shaft 120) for insertion through the patient's vascular system and into the RA to a deployment configuration, such that the distal end of the side catheter introducer 130 is laterally deflected (e.g., vertically or substantially vertically) relative to the main shaft 120, such as toward the patient's left atrium (e.g., the FO of the atrial septum). In some embodiments, as described in more detail herein, the introducer coupler 140 can be a hinge to facilitate lateral deflection of the side catheter introducer 130 relative to the main shaft 120. In such embodiments, for example, a distal force may be applied to the proximal end portion of the side catheter introducer 130, thereby rotating the hinge and causing the distal end portion of the side catheter introducer (i.e., a portion of the side catheter introducer 130 that extends distally of the introducer coupler 140) to deflect laterally. In some implementations, the amount of lateral deflection, or the amount of lateral deflection defined between the side catheter introducer 130 and the main shaft 120 after such lateral deflection, may be adjusted by the operator intraoperatively, i.e., in real time, so that, for example, the operator has surgical flexibility in locating the target puncture location.

[0075] In some implementations, one or more of the main shaft 120, the side catheter introducer 130, or the side catheter 160 may have a circular cross-sectional shape, while in other implementations, one or more of the main shaft 120, the side catheter introducer 130, or the side catheter 160 may have a non-circular cross-sectional shape. In some cases, for example, the main shaft 120 and the side catheter introducer 130 may have a circular cross-sectional shape, and as discussed in more detail herein, can be operably coupled together so that the main shaft 120 and the side catheter introducer 130 are at least partially arranged side by side (e.g., during delivery). In other cases, for example, the main shaft 120 may have a non-circular cross-sectional shape (e.g., a half-moon shape, a c-shape, a convex or concave shape, or any other suitable non-circular cross-sectional shape) so that when coupled to the side catheter introducer 130, a portion of the side catheter introducer 130 may be nested within a space defined at least partially by the non-circular curved body of the main shaft 120. In this way, the common cross-sectional area, footprint, diameter, etc. of main shaft 120 and side catheter introducer 130 can be reduced. In some cases, main shaft 120 and side catheter 160 can have a similar relationship (e.g., in embodiments where the septum puncture device does not have a side catheter introducer).

[0076] In some embodiments, septum puncture device 100 includes a side catheter introducer stabilizer / actuator ("GSA") 150 (also referred to herein as an "introducer stabilizer / actuator"), and a GSA actuator 154 operably coupled to GSA 150 and configured to actuate GSA 150. In some implementations, GSA 150 can be configured to stabilize side catheter introducer 130 (e.g., laterally, axially (proximally or distally), e.g., relative to main axis 120) to facilitate engagement of side catheter 160 with the FO and penetration of the FO by septum penetrator 170. In this manner, introducer coupler 140 can deflect side catheter introducer 130 laterally, and GSA 150 can stabilize side catheter introducer 130 (and thereby stabilize side catheter 160, optional end effector 162, and septum penetrator 170) to optimize subsequent penetration of the septum and access to the left atrium. In some implementations, in addition to or in lieu of stabilizing side catheter introducer 130, GSA 150 can be configured to deflect side catheter introducer 130 laterally (e.g., in addition to the lateral deflection caused or facilitated by introducer coupler 140 as described above) (and thereby deflect side catheter 160 and septum penetrator 170 laterally because they are coupled to side catheter introducer 130). In this way, in some embodiments, the introducer connector 140 and the GSA 150 can jointly deflect and stabilize the side catheter introducer 130 laterally (and thereby deflect and stabilize the side catheter 160, optional end effector 162, and septum penetrator 170 laterally) to optimize subsequent penetration of the septum and access to the left atrium.

[0077] The GSA 150 may be capable of being manipulated in any manner suitable for providing the functionality described above. In some embodiments, for example, the GSA 150 may be a balloon, and therefore, it may be configured to be expandable and deflated. In such embodiments, the GSA 150 may be fluidly coupled to a lumen extending from the GSA 150 to the GA actuator 154, such that the GA actuator 154 may selectively deliver fluid to the GA actuator 154 to expand the GSA 150 (i.e., to deploy the GSA 150), and selectively withdraw fluid from the GSA 150 to deflate the GSA 150 to remove the GSA 150 from the heart (e.g., after left atrial access has been achieved).

[0078] In embodiments where the GSA 150 is a balloon, the balloon may have any shape and size suitable for performing the desired functions described herein. In some embodiments, for example, the balloon may be conical in shape, while in other embodiments, the balloon may be at least partially concave, convex, rounded, oval, and the like. Additionally, in some embodiments, the balloon may have one or more lobes, for example, the balloon may be bi-lobed or tri-lobed, for example, to allow blood flow to flow along the balloon and through the device. Additionally, the balloon may have additional features configured to increase the stability of the side catheter introducer 130 (e.g., to improve the connection between the balloon and the side catheter introducer 130). In some embodiments, for example, the balloon may have dimples, protrusions, ridges, adhesives, and the like.

[0079] The balloon can be formed of any material or combination of materials suitable for performing its function described herein. In some embodiments, for example, the balloon can be formed of one or more of the following: polyethylene, polyethylene terephthalate ("PET"), polymers, thermoplastic polymers, elastomers, nylon, polyurethane, any non-compliant material, etc. As an example, the balloon can be configured to expand to any suitable pressure, such as from about 2 ATM to about 20 ATM. In some cases, higher inflation pressures may bring greater or improved stiffness of the balloon, thereby providing better stability of a side catheter introducer, a side catheter, a septum penetrator, etc.

[0080] The GSA 150 may be formed of any material suitable for performing its functions as described herein. In some embodiments, the GSA 150 may include or be formed of a shape memory material (e.g., nitinol) and be configured to transition between a delivery / withdrawal configuration in which the GSA 150 is constrained, compressed, or otherwise placed in a relatively small arrangement and a deployed configuration in which the GSA 150 is unconstrained, expanded, or otherwise placed in a larger arrangement sufficient to laterally deflect or stabilize the side catheter introducer 130, as described in greater detail herein.

[0081] Similar to introducer coupler 140, in some embodiments, GSA 150 may include or be formed of a radiopaque material to assist an operator in positioning the portion of septal puncture device 100 before, during, or after deployment. In this manner, an operator may selectively position septal penetrator 170 in real time in a position suitable for penetrating the FO following actuation of septal penetrator 170. In embodiments where GSA 150 is a balloon, for example, in some cases, GSA 150 may be inflated with a contrast agent (or a combination of a contrast agent and another fluid, such as saline) to provide visualization to an operator (e.g., under any suitable imaging modality) while GSA 150 is positioned within a patient.

[0082] As described in more detail herein, with the side catheter introducer 130 laterally deflected and stabilized at an appropriate angle relative to the FO or main shaft 120, and with the operator able to view from outside the patient (1) one or more landmark portions of the septal puncture device 100, and (2) a desired puncture location on the septum (e.g., the FO), the operator can translate or rotationally manipulate the main shaft 120 in any manner suitable for aligning the side catheter introducer 130 with the FO.

[0083] In addition, if Figure 1A As shown, the septum puncture device 100 includes: a guide wire connector 122, which is configured to connect the main shaft 120 to the guide wire (not shown in Figure 1A ) to facilitate delivery of the septum puncture device 100 into the patient's body (e.g., through the patient's vascular system) and to the patient's heart; and a guidewire coupler 172 configured to couple a guidewire (not shown in Figure 1A ) is connected to the septum penetrator 170 to facilitate delivery of the guidewire to the left side of the heart (e.g., the left atrium).

[0084] In addition, if Figure 1A As shown, the septum puncture device 100 optionally includes a shaft actuator 124, which is operably connected to the main shaft 120 and is configured to actuate the main shaft 120 to advance or retract the main shaft 120 relative to the body 110. As described in more detail herein, the septum puncture device 100 also includes: (1) a side catheter actuator 164, which is operably connected to the side catheter 160 and is configured to actuate the side catheter to advance or retract the side catheter 160, thereby enabling the side catheter 160 to be deployed between a delivery configuration and a deployed configuration (the side catheter 160 is deployed between the delivery configuration and the deployed configuration). Figure 1Band (2) a septum penetrator actuator (or "penetrator actuator") 174 for actuating septum penetrator 170 to advance or retract septum penetrator 170 to transition between a delivery configuration and a deployed configuration (septum penetrator 170 is shown in the figure as being in an actuated or deployed configuration); and (3) a septum penetrator actuator (or "penetrator actuator") 174 for actuating septum penetrator 170 to advance or retract septum penetrator 170 to transition between a delivery configuration and a deployed configuration (septum penetrator 170 is shown in the figure as being in an actuated or deployed configuration); Figure 1B , shown in an actuated or deployed configuration).

[0085] In addition, if Figure 1A As shown, septum piercing device 100 optionally includes a GSA ("GA") 150 coupled to spindle 120. As described in greater detail herein, optional GSA 150 is operably coupled to a GA actuator 154 that is configured to actuate GSA 150.

[0086] In addition, if Figure 1A As shown, the septum puncture device 100 optionally includes an end effector 162, which is connected to the side catheter 160 and extends distally from the side catheter. The end effector 162 is configured to facilitate subsequent puncture of the FO through a target puncture location, such as the septum of the heart. As described in more detail herein, the end effector 162 can be configured to, for example, contact the FO or cause the FO to bulge. For example, such contact or bulge of the FO can reduce or minimize the force required to penetrate the FO and / or provide improved force distribution to the FO. The end effector 162 can be configured to prevent the end effector 162 from inadvertently puncturing and / or damaging the FO.

[0087] In some embodiments, the end effector 162 is formed of or includes a radiopaque material such that the end effector 162 can be visualized under any suitable imaging modality (e.g., fluoroscopy, echocardiography, etc.) while accessing the heart from outside the patient to assist the operator in deploying the end effector 162, for example, positioning the end effector 162 within the heart or relative to the FO in preparation for deployment of the septum penetrator 170.

[0088] In some embodiments, as described in more detail herein, the end effector 162 can include multiple configurations, such as a delivery or retraction configuration, in which the end effector 162 is configured to travel through the vasculature of the patient; and an expanded configuration, in which the end effector 162 is configured to facilitate subsequent penetration of the FO. In such embodiments, for example, the end effector 162 can be delivered to the heart in a compressed, contracted, or otherwise relatively small configuration and then transitioned to a deployed configuration, in which the end effector is expanded, inflated, or otherwise increased in size, and then contacts or bulges the FO. Additionally, in some embodiments, after the end effector 162 is deployed, the end effector 162 can transition to a retraction configuration (which can be the same or similar to its delivery configuration), in which the end effector 162 is in a compressed, contracted, or otherwise small configuration to assist in removing the end effector 162 from the patient.

[0089] The end effector 162 can be formed of any one or more materials suitable for facilitating its functions as described herein. In some embodiments, for example, the end effector 162 can be formed of one or more shape memory materials (e.g., nitinol), or a polymer, or a combination thereof (e.g., nitinol coated with a polymer), such that the end effector can be transformed between a constrained or compressed arrangement (e.g., a delivery or withdrawal configuration) and an unconstrained or expanded arrangement (deployed configuration). In some embodiments, for example, the end effector 152 can be or include a balloon, such that the end effector can be delivered to the heart in a collapsed arrangement and then expanded to a deployed configuration (e.g., via an inflation lumen fluidly coupled to the end effector 162 and extending proximally from the end effector, not shown). Various other embodiments of the end effector are described in more detail below.

[0090] Each of main shaft 120, guidewire coupler 122, side catheter introducer 130, introducer coupler 140, optional GSA 150, side catheter 160, septum penetrator 170, and guidewire coupler 172 can translate relative to body 110 (e.g., can be advanced and / or extended distally, and can be withdrawn and / or retracted proximally). As described in more detail herein, side catheter 160 can translate relative to side catheter introducer 130, and septum penetrator 170 can translate relative to side catheter 160.

[0091] The septum penetrator 170 can be sized, shaped, and formed of any material suitable for effectively penetrating and traversing a target tissue such as a FO. In some embodiments, for example, the septum penetrator 170 can be a needle. In some embodiments, the septum penetrator 170 can be a coreless needle (e.g., a needle with a sharp tip having a cutting edge, such as a Quincke-type needle). In some embodiments, the septum penetrator 170 can have variable material properties. In such embodiments, for example, a distal portion of the septum penetrator 170 can have a greater hardness than a portion proximal to the distal portion. In this way, the more rigid distal portion can be configured to penetrate the septum, while the proximal portion can be configured to be delivered through the patient's vascular system. In some embodiments, the septum penetrator 170 can have a solid tip and can be charged via radio frequency ("RF") energy to pierce the FO.

[0092] The septum penetrator 170 may have any suitable length, for example, any length suitable for reaching the LA. In some embodiments, for example, the septum penetrator 170 may have an effective length (i.e., a length that may extend from the distal end of the side catheter 160 (or from the distal end of the end effector 162) from about 5 mm to about 25 mm). In some cases, the effective length of the septum penetrator 170 may be about 8 mm or about 10 mm, or any length therebetween. In some embodiments, the septum penetrator 170 may accommodate or be configured to receive a stylet to limit or minimize tissue coring. In some embodiments, the septum penetrator 170 may include a pressure transducer (not shown) configured to monitor the pressure in the lumen of the septum penetrator 170. In some embodiments, a port or Luer lock may be incorporated into the septum puncture device 100 to flush the septum penetrator 170.

[0093] Go to Figure 2A and Figure 2B The septal puncture device 100 is described (1) in the context of a patient's anatomy and (2) in a sample procedure for accessing a patient's LA. Figure 2A is a schematic diagram of a septal puncture device 100 disposed in a delivery configuration within the RA of the heart and coupled to a first guidewire GW1 extending from the IVC, through the RA and into the SVC, and Figure 2B is a schematic diagram of a septal puncture device 100 arranged in a deployed configuration and arranged such that the septal puncture device has been accessed and delivered to the LA over a second guidewire, which may be used to provide subsequent access to the LA.

[0094] In use, before the septum puncture device 100 is introduced into the patient, the guidewire GW1 can be inserted through the patient's entry site (e.g., femoral vein puncture site) (not shown) using a known technique suitable for guidewire delivery and is advanced across the IVC and RA through the patient's vascular system, and is advanced into the SVC. In the case of setting the guidewire GW1 in this way, the septum puncture device 100 can be movably connected to the guidewire GW1 via the guidewire coupler 122, and is advanced toward the heart from the patient's entry site. In some embodiments, the guidewire coupler 122 can be a lumen defined by the main shaft 120, and the guidewire GW1 can be arranged in the lumen and the main shaft 120 can be slidably arranged around the guidewire GW1. The guidewire GW1 can be any suitable size. In some embodiments, for example, the guidewire GW1 can have a diameter of about 0.014 inches to about 0.035 inches in diameter. In some embodiments, the guidewire GW1 can have a diameter of about 0.025 inches. In the case where the guidewire coupler 122 is movably coupled to the delivered guidewire GW1, as Figure 2A As shown, septum puncture device 100 can be advanced into the heart along guidewire GW1. More specifically, with main shaft 120 coupled to (1) body 110 and (2) to side catheter introducer 130 via introducer coupler 140, body 110, main shaft 120, introducer coupler 140, side catheter introducer 130, side catheter 160, septum penetrator 170, and guidewire coupler 172 can all be connected as shown. Figure 2A 1 and 12. The main shaft 120 is shown advanced into the patient's heart such that the main shaft 110 extends through the IVC and into the RA, and the main shaft 120 extends into the SVC. As described in more detail herein, with the main shaft 120 spanning the IVC, RA, and SVC, the main shaft 120 can provide a base or support against which the side catheter introducer 130, the side catheter 160, and the septum penetrator 170 can be deployed and advanced toward the septum.

[0095] In some cases, (1) the distal end of main shaft 120, (2) side catheter introducer 130, (3) side catheter 160, and septum penetrator 170 (and accompanying couplers, such as guidewire coupler 122 and guidewire coupler 172) can be disposed within body 110 (e.g., within one or more lumens (not shown) defined by body 110). In this manner, during delivery, the patient's anatomy can be protected or sheltered by body 110 to avoid inadvertent trauma to or contact with the patient's anatomy by such components. With the distal end of body 110 disposed in or near the RA, body 110 can be retracted (and / or one or more of the components movably coupled to the body can be advanced) to expose side catheter introducer 130 and introducer coupler 140 within the RA.

[0096] In the case where the side catheter introducer 130 is exposed within the RA and is translationally fixedly coupled to the main shaft 120 via the introducer coupler 140, as shown in FIG. Figure 2B As shown, the side catheter introducer 130 can be actuated to cause the distal end of the side catheter introducer 130 to deflect laterally (and therefore, the side catheter 160, the septum penetrator 170, and the guidewire GW2 to deflect laterally as well, if disposed therein during the lateral deflection of the side catheter introducer 130). Figure 2B As shown, the side catheter introducer 130 can be adapted to laterally deflect the side catheter 160 and the septum penetrator 170, which are movably attached to the side catheter introducer 130, toward a target penetration site, such as any angle directed by the FO. In some cases, the optimal angle for entering the FO is 90 degrees or approximately 90 degrees relative to a surface line tangential to the FO, which may be approximately a similar angle relative to the central axis of the main shaft 120. This vertical (or substantially vertical) entry angle can minimize the force required to penetrate the FO because the entire or substantially the entire force vector is directed at the plane of the FO (rather than tangentially approaching). Additionally, given the nature of the patient's anatomical structure, this vertical (or substantially vertical) entry angle guides the septum penetrator to a relatively large open space within the LA, thereby minimizing the risk of inadvertent punctures within the LA (e.g., inadvertent punctures of the wall of the LA).

[0097] In other cases, the angle of entry relative to the FO or relative to the central axis of the main shaft 120 can be any degree within the range of about 50 degrees to about 90 degrees. In some cases, the preferred angle of entry can be selected based on the specific treatment planned for the left side of the heart. The angle of entry defines, for example, the trajectory of subsequent treatment devices entering the left side of the heart, and thus, in some cases, the optimal angle of entry and position through the FO is based on the specific treatment device or procedure.

[0098] It should be noted that guidewire GW2 can be delivered in any suitable manner. In some cases, for example, guidewire GW2 is disposed in side catheter introducer 130 during delivery of side catheter introducer 130, while in other cases, guidewire GW2 is inserted at a later time during the operation, for example, after septum penetrator 170 has penetrated FO and reached LA.

[0099] With the side catheter introducer 130 transitioning to its deployed configuration (wherein the side catheter introducer 130 is deflected laterally toward the FO), the side catheter actuator 164 can be actuated to advance the side catheter 160 along a path at least partially defined by the side catheter introducer 130 and toward the FO. In some cases, the side catheter 160 is advanced until the distal end of the side catheter 160 bulges or otherwise contacts the FO. In embodiments including an end effector 162, the side catheter 160 can be advanced until the end effector 162 extending from the distal end of the side catheter 160 bulges or otherwise contacts the FO.

[0100] In embodiments where the end effector 162 is both expandable and compressible, the end effector 162 can be delivered to the right atrium RA in a compressed or relatively small configuration, then transitioned to a deployed configuration (where the end effector 162 is expanded to a relatively larger configuration), and then advanced to engage the FO. After the atrial septum AS is sufficiently penetrated with the septal penetrator 170, as described in greater detail herein, the end effector 162 can be transitioned to a retracted or compressed configuration in which it is suitable for withdrawal from the patient. In an embodiment in which the side catheter 160 is slidably disposed within a lumen defined by the side catheter introducer 130, the end effector 162 may be similarly slidably disposed within the lumen defined by the side catheter introducer 130 such that the side catheter introducer 130 accommodates the end effector 162 in its constrained or compressed configuration during delivery, and then when the side catheter actuator 164 is actuated to advance the side catheter 160 distally from the distal end of the side catheter introducer 130, the end effector 162 may be transitioned to its expanded or unconstrained configuration as or after it exits the lumen of the side catheter introducer 130.

[0101] With the side catheter 160 (or end effector 162) in full contact with the FO, the penetrator actuator 174 can be actuated to advance the septum penetrator 170 relative to the side catheter 160 and along a path at least partially defined by the side catheter. The septum penetrator 170 can be advanced through the FO and across the atrial septum AS and into the left atrium LA. In some embodiments, the side catheter 160 defines a lumen in which the septum penetrator 170 is slidably disposed, so that actuating the penetrator actuator 174 causes the septum penetrator 170 to be advanced through the lumen of the side catheter 160. The septum penetrator 170 can be advanced in this manner to penetrate the FO and extend into the left atrium LA. During such penetration, the main shaft 120 can provide lateral or axial stability to the septum penetrator 170.

[0102] When the distal end of the septum penetrator 170 is advanced across the atrial septum AS and into the left atrium LA, the guidewire GW2 can follow up via the guidewire coupler 172 and the septum penetrator 170 when the guidewire GW2 is coupled to the side catheter introducer 130 during the delivery of the side catheter introducer 130. In other cases, the guidewire GW2 can be inserted at a later time during the operation, for example, after the septum penetrator 170 has penetrated the FO and reached the LA. In some embodiments, the guidewire coupler 172 is a lumen defined by the septum penetrator 170, and the guidewire GW2 can be slidably disposed in the lumen. In such embodiments, the guidewire GW2 can be disposed in the lumen of the septum penetrator 170 during the delivery and deployment of the septum penetrator 170 into the left atrium LA.

[0103] With the septum penetrator 170 and guidewire GW2 disposed within the left atrium LA, the guidewire GW2 may be further advanced into the left atrium LA by manipulating the guidewire GW2 at its proximal end, and / or the septum penetrator 170 may be withdrawn from the left atrium LA, across the puncture or access site of the FO, thereby leaving the guidewire GW2 within the left atrium LA.

[0104] The septal puncture device 100 may be proximally withdrawn from the heart and from the patient over the guidewire GW2 after the guidewire GW2 is delivered to the left atrium LA and from the left atrium LA, across the puncture or access site of the FO, into the right atrium RA, the IVC and extending proximally through the patient's vasculature to the patient's access point (for subsequent access to the left atrium AS).

[0105] The guidewire GW2 may be any guidewire suitable for providing the desired subsequent access to the left atrium LA. In some embodiments, for example, the guidewire GW2 may be a twisted wire, an atraumatic guidewire, or other suitable guidewire conventionally used in transseptal surgery. For example, the guidewire GW2 may have a flexible twisted wire with a spiral tip, and may be configured to anchor the septal puncture device 100 to the LA, thereby limiting or preventing the guidewire GW2 from being withdrawn from the patient along the guidewire GW2 in response to the septal puncture device 100, or from being inadvertently withdrawn or removed from the LA when so operated. Another example introducer GW2 may be the ProTrack from Baylis Medical Company, Inc. TM Twisted wire.

[0106] The septum puncture device 100 can be configured to be withdrawn from the patient in any suitable order (e.g., after the guidewire GW2 has been delivered to the left atrium LA). With the guidewire GW2 disposed within the left atrium LA, for example, the septum penetrator 170 and the portion of the guidewire coupler 172 disposed within the left atrium LA can be withdrawn relative to the guidewire GW2 and through the puncture site in the FO, and withdrawn into the right atrium RA. In an embodiment in which the side catheter 160 defines a lumen in which the septum penetrator is slidably disposed, the septum penetrator 170 can be withdrawn relative to the lumen defined by the side catheter 160 and withdrawn into the lumen. In this way, the septum penetrator 170 and particularly its distal end designed to penetrate tissue can be sheathed or shielded by the side catheter 160 to facilitate safe withdrawal from the patient and avoid inadvertent contact with the patient's heart or vascular system during removal of the septum puncture device 100 from the patient.

[0107] Similarly, the side catheter 160 can be withdrawn relative to the side catheter introducer 130. For example, in embodiments where the side catheter introducer 130 defines a lumen in which the side catheter 160 is slidably disposed, the side catheter 160 can be withdrawn into the lumen of the side catheter introducer 130. In embodiments where the septum puncture device 100 includes an end effector 162, the side catheter introducer 160 can be withdrawn relative to and into the lumen of the side catheter introducer 130 such that the end effector 162 is also withdrawn into the lumen of the side catheter introducer 130. In embodiments where the end effector 162 has an expanded configuration having a diameter greater than the inner diameter of the side catheter introducer 130, the end effector 162 can be configured to transition from its expanded configuration to its withdrawn (or delivered) configuration. For example, if the end effector 162 is a balloon, the balloon can be deflated and then withdrawn into the lumen of the side catheter introducer 130. As another example, if end effector 162 includes or is formed from a shape memory material, end effector 162 may be compressed, constrained, or otherwise transitioned to a smaller arrangement such that the end effector may be withdrawn into side catheter introducer 130. In some instances, withdrawing end effector 162 into side catheter introducer 130 may transition end effector 162 to its constrained or compressed configuration.

[0108] Additionally, the side catheter introducer 130 can be configured to transition from its deployed configuration, in which the distal portion of the side catheter introducer is deflected laterally relative to the main axis 120, to its withdrawn (or delivered) configuration, in which the side catheter introducer 130 is at least substantially linear and parallel to the main axis 120. In some embodiments, for example, a proximal force can be applied to the proximal end portion of the side catheter introducer 130 to withdraw the side catheter introducer 130 relative to the main axis.

[0109] In the septum puncture device 100, for example, after the guide wire GW2 is delivered, Figure 2A As shown, the septum puncture device 100 can be withdrawn from the heart and from the patient. For example, the body 110 and all components connected thereto can be withdrawn from the heart, through the patient's vascular system, and out through the initial entry site (e.g., femoral puncture site) into the patient.

[0110] Although the embodiments described herein refer to introducing a guidewire and septum puncture device into the patient's vasculature and across the IVC and RA and into the SVC, access to the RA for the purpose of deploying a septum penetrator can be accomplished in a variety of ways. In some embodiments, for example, a guidewire and septum puncture device can be inserted into the patient's internal jugular vein (e.g., the right internal jugular vein) and then advanced into and across the SVC and RA and into the IVC such that the distal end of the septum puncture device is disposed in (or outside of) the IVC.

[0111] Although the embodiments described herein refer to a single FO puncture for delivering a single guidewire to the LA, it should be understood that the septal puncture device described herein can be used to perform multiple punctures and deliver multiple guidewires. In some cases, for example, a double puncture and delivery of two guidewires may be desired, such as when desired in conjunction with an atrial fibrillation ablation procedure. In such cases, the septal puncture device described herein can be deployed twice to puncture the septum twice, with each puncture providing an access for delivering a guidewire as described herein. In some procedures requiring multiple punctures and delivery of multiple guidewires to the LA, for example, it may be critical that the punctures are in specific locations and positioned a specific distance from each other, and as described in the present disclosure, the septal puncture device described herein provides just that.

[0112] In addition, instead of using the septum puncture device described herein to continuously implement multiple punctures (e.g., with a single puncture device, a single side catheter, a single side catheter introducer, etc.), in some embodiments, any of the septum puncture devices described herein can be modified to incorporate additional components. For example, in some cases, the septum puncture device may include a main body and a main shaft (similar to the septum puncture device 100), and includes two side catheter introducers, two side catheters, two end effectors, two septum penetrators and two guide couplers (for the guide wires delivered), and optionally one or two guide couplers and one or two guide stabilizers / actuators. In this way, two side catheter introducers can be deployed simultaneously (i.e., laterally deflected and stabilized), and then two side catheters (optionally with end effectors) can be optionally simultaneously advanced to contact the septum, and then two septum penetrators can be optionally simultaneously advanced to penetrate the septum. In the case of two puncture holes in the septum, two guide wires can be optionally delivered simultaneously afterwards. In such cases, the preferred distance between the two puncture holes may be selectively defined by the distance between the side catheters through which the septum penetrator is advanced.

[0113] Figure 3 A method 200 of using a septal puncture device 100 to access the left atrium of a patient's heart according to one embodiment is shown. At 201, a guidewire GW1 is inserted through the IVC, across the RA, and the guidewire is inserted into the SVC of the heart (e.g., via a femoral vein puncture and through the patient's vascular system disposed between the femoral vein puncture site and the IVC). At 202, the septal puncture device 100 is delivered through the guidewire GW1 until the distal end of the main shaft 110 is disposed within the SVC. At 204, the GSA 150 is actuated to deflect the side catheter introducer 130 laterally and guide the side catheter introducer toward the FO. Optionally, at 206, the main shaft 110 and the side catheter introducer 130 are selectively positioned (e.g., translated or rotated) relative to the FO. Optionally, at 208, the end effector 162 is deployed. At 210, the end effector 162 (or the distal end of the side catheter) is advanced against the FO and into contact with the FO (e.g., to bulge the FO). Optionally, at 212, the end effector 162 (or the distal end of the side catheter 130) is visualized from outside the patient, and if necessary, the main shaft 110 or the side catheter introducer 130 is adjusted to selectively reposition the end effector 162 (or the distal end of the side catheter 130) relative to the FO.

[0114] At 214, septum penetrator 170 is advanced through the FO and into the LA. Optionally, at 216, visualization techniques are used to confirm that septum penetrator 170 has crossed into the LA. At 220, guidewire GW2 is advanced relative to septum penetrator 170 and the guidewire is advanced into the LA, or septum penetrator 170 is withdrawn relative to septum penetrator 170, thereby leaving a portion of guidewire GW2 in the LA. At 222, septum penetrator 170 is withdrawn, end effector 162 is optionally withdrawn, main shaft 120 is withdrawn, introducer actuator 150 is deactivated, and device 100 is withdrawn through guidewire GW1 and removed from the patient.

[0115] Although not shown, in some embodiments, any of the spindles described herein can define a channel in which an intracardiac echogenic device can be disposed or slidably coupled to the channel to assist in navigation through a patient.

[0116] Figure 4A and Figure 4B The septum piercing device 300 is shown in perspective views in a delivery configuration and a deployed configuration, respectively; Figure 5A and Figure 5B A cross-sectional view of a portion of a septum piercing device 300 is shown in perspective and front view, respectively; and 6A to 6H A deployment sequence at a distal end portion of a septum piercing device 300 is shown according to another embodiment.

[0117] Septal puncture device 300 may be used to access the left side of the heart (e.g., the left atrium) from the right side of the heart (e.g., the right atrium) and deliver a guidewire to the left side of the heart, similar or identical to that described with respect to septal puncture device 100. Septal puncture device 300 may be constructed in the same or similar manner as septal puncture device 100 and may function in the same or similar manner as the septal puncture device. Therefore, the various portions of septal puncture device 300 will not be described in further detail herein.

[0118] In this embodiment, as described in more detail herein, the septum puncturing device 300 includes a body 310 defining a first lumen 311 and a second lumen 312 in which various portions of the septum puncturing device 300 are disposed or slidably disposed. Coupled to the body 310 are a main shaft 320 and a side catheter introducer 330, and the main shaft 320 is coupled to the side catheter introducer 330 via an introducer coupler 340. Figure 5A and Figure 5BAs shown, the proximal end portion of the side catheter introducer 330 is disposed in the second lumen 312 of the body 310. The side catheter introducer 330 defines a lumen in which the side catheter 360 is slidably disposed, the side catheter 360 defines a lumen in which the septum penetrator 370 is slidably disposed, and the septum penetrator 370 defines a lumen in which the guidewire GW2 can be slidably disposed (e.g., Figure 5A , Figure 5B and Figure 6H Extendable from the distal end portion of the side catheter 360 is an end effector 362.

[0119] The main shaft 320 is retractable, i.e., it can be expanded / stretched / advanced and retracted / withdrawn in sections. The main shaft 320 includes a proximal section 320A, and an expansion section 320B, which is partially disposed within the proximal section 320A and can be retracted distally relative to the proximal section. Although not shown, in some embodiments, the septum puncture device 300 may include a locking member that is operably coupled to the expansion section 320B of the main shaft 320 and is configured to fix the expansion section 320B and the proximal section 320A translationally to at least temporarily limit or prevent relative movement therebetween. In this way, as described in more detail herein, the operator can selectively enable and disable the retractable feature of the main shaft 320.

[0120] The proximal section 320A of the main shaft 320 is coupled to and disposed within the first lumen 311 of the body 310 and extends distally from the distal end of the body 310. In some implementations of this embodiment, the proximal section 320A of the main shaft 320 is fixedly coupled to the body 310 (e.g., welded within the first lumen 311 of the body). Circumferentially disposed around the expansion section 320B of the main shaft 320 and fluidly coupled to the expansion section (the expansion section 320B is fluidly and slidably coupled to the proximal section 320A) is a introducer stabilizer / actuator ("GSA") 350. In this embodiment, the GSA 350 is a balloon configured to be inflated for deployment and deflated for delivery or withdrawal. To inflate, the GSA 350 is configured to receive one or more fluids (e.g., one or more of saline, air, or contrast media for visualization) via the expansion section 320B. In use, for example, one or more fluids may be delivered from the lumen defined by the proximal segment 320A to the lumen defined by the expansion segment 320B and into the volume defined by the GSA 350. The one or more fluids may be withdrawn from the GSA 350 (e.g., via the same pathway used to deliver the one or more fluids) to deflate the GSA 350 so that the GSA 350 may be withdrawn from the patient. The balloon may be of any size suitable for performing the desired functions disclosed herein, for example, in some embodiments, the balloon may have a diameter of about 10 mm to about 60 mm when inflated. In some embodiments, for example, the balloon may have a diameter of 20 mm or about 20 mm when inflated. In some implementations of this embodiment, the septum puncture device 300 may include a GA actuator (not shown, but, for example, disposed at or operably coupled to the handle 380) configured to inflate or deflate the GSA 350.

[0121] As shown, the expansion segment 320B includes an expansion portion 326 around which the GSA 350 is circumferentially disposed, and a distal portion 327 extending distally from the GSA 350. In use, for example, with the GSA 350 deployed within the right atrium of the patient's heart, the distal portion 327 extends into the patient's SVC to provide stability between the IVC and the SVC for subsequent puncture of the FO. Although not shown, in some embodiments, the distal portion 327 may have a diameter that is greater than the diameter of the expansion portion 326. In this way, the cross-sectional area or footprint collectively occupied by the GSA 350 and the expansion portion 326 around which the GSA 350 is coupled within the atrium of the heart can be minimized, while the diameter of the distal portion 327 can be relatively large to provide additional stability (e.g., by having a relatively large stiffness) to ensure that a stable platform is bridged between the IVC and the SVC. In other embodiments, other design considerations (eg, thickness, material, etc.) may be employed to increase the stiffness or stability of the distal portion 327 relative to the expansion portion 326 for similar purposes.

[0122] Disposed within the first lumen defined by the main shaft 320 is a guidewire coupler 322. The guidewire coupler 322 extends distally from the body 310 and is configured to extend from the body 310 to the patient's SVC during use. The guidewire coupler 322 defines a lumen in which the guidewire GW1 can be laid and slidably disposed. In some implementations of this embodiment, the guidewire coupler 322 is fixedly coupled (e.g., welded) to the inner surface of the main shaft 320. As best shown in Figure 5B In the embodiment of the present invention, an expansion volume IV (e.g., a crescent-shaped void or volume) is defined between an outer surface of a portion of the guidewire coupler 322 and an inner surface of the main shaft 320. The volume is fluidly coupled to the GSA 350 disposed about the main shaft 320 such that the volume provides a conduit through which fluid can be delivered from outside the patient to the interior of the GSA 350 when the GSA 350 is disposed within the patient's heart.

[0123] In this embodiment, introducer coupler 340 is formed of a single suture (although in other embodiments, introducer coupler 340 may be formed of any suitable number of sutures, such as two or more sutures). Any suture suitable for fixedly coupling main shaft 320 with side catheter introducer 330 in translation, but allowing relative rotational movement between main shaft 320 and side catheter introducer 330 may be used. In some embodiments, for example, a polymer such as Dacron may be used.

[0124] To couple the introducer coupler 340 with the main shaft 320 and the side catheter introducer 330, the suture may be wrapped circumferentially around each of the side catheter introducer 330 and the main shaft 320 separately and may be wrapped circumferentially around the side catheter introducer 330 and the main shaft 320 collectively. For additional securement, in some embodiments, an adhesive may be applied between the introducer coupler 340 and the main shaft 320, between the introducer coupler 340 and the side catheter introducer 330, or between the side catheter introducer 330 and the main shaft 320, or any combination thereof.

[0125] Like many minimally invasive surgical procedures performed in the cardiac space, it may be important to minimize the size of one or more devices inserted into the patient's body, and in particular the cross-sectional area occupied. Forming the introducer coupler 340 with sutures achieves this goal by allowing flush or substantially flush contact (e.g., direct or substantially direct contact) between the main shaft 320 and the side catheter introducer 330. In some embodiments, for example, the suture can be wrapped around each of the main shaft 320 and the side catheter introducer 330 so that the distance between the outer surface of the main shaft 320 and the outer surface of the side catheter introducer 330 is equal to or substantially equal to the outer diameter of the suture. In such embodiments, using, for example, a suture with an outer diameter of 0.15 mm with a U.S. Pharmacopeia rating ("USP") of 4-0 can allow the distance between the main shaft 320 and the side catheter introducer 330 to be 0.15 mm. In some implementations, other suture sizes may be used, such as, for example, USP 2-0, USP 3-0, USP 5-0, USP 6-0, or USP 7-0.

[0126] Although in this embodiment, the introducer coupler 340 is formed by a suture, in other embodiments, the introducer coupler may be additionally or alternatively formed by other materials, such as, for example, textiles, polymers, filaments, metals, or braided materials. As another example, in some embodiments, the introducer coupler may be a sleeve (e.g., a textile sleeve), and in some implementations, the sleeve may function in conjunction with the suture (e.g., formed as a double knot), and the free end of the suture may be stabilized with an adhesive coating.

[0127] In addition, in this embodiment, and if Figure 4BAs shown, the side catheter introducer 330 is disposed on the right side of the main shaft 320 from a top view. Considering the common anatomical position of the FO relative to the IVC, SVC, and RA, offsetting the side catheter introducer 330 relative to the central axis of the main shaft 320 in this way will align the distal end of the side catheter introducer 330 with the FO in many cases. The FO tends to deviate from the central axis defined from the IVC to the SVC, so aligning the side catheter introducer 330 to deviate from the central axis of the main shaft 320 can place the side catheter introducer 330 in a position more suitable for subsequent puncture in some cases. In this way, the arrangement of the side catheter introducer 330 and the main shaft 332 can optimize the time and number of steps required for the operator to find the FO with the side catheter 360 (or the end effector 362) to subsequently puncture the FO with the septum penetrator 370.

[0128] Similar to what is described elsewhere herein, in this embodiment, septum piercing member 370 has a variable stiffness. More specifically, the distal end portion of septum piercing member 370 is configured to be stiffer / more rigid than the proximal end portion of septum piercing member 370, wherein the distal end portion is optimized to penetrate the FO and the proximal end portion is optimized to be advanced (have flexibility) through the curved side catheter introducer 330. Given the anatomical space constraints within the heart, it may be challenging to accommodate a rigid septum piercing member 370 that is suitable for piercing the septum and that is able to properly bend within the RA relative to the central axis of the main shaft 320 and toward the FO.

[0129] To address such constraints, Figure 4B As shown, when deployed, the side catheter introducer 330 presents a curved shape when it extends distally from the main body 310. More specifically, in the front view, the side catheter introducer 330 extends proximally from its distal end and from below the central axis of the main shaft 320, extends across the central axis of the main shaft 320 and extends above the central axis of the main shaft 320, and then bends to the left and toward the second lumen 312 of the main body 310 and turns into the second lumen. In this way, the linear section at the distal end portion of the side catheter introducer 360 can have a length sufficient to slidably accommodate or accommodate the septum puncture member 370 when deployed. For example, the length can be greater than the thickness of the FO. In some embodiments, the length can be about 5mm to about 15mm, or greater. In this embodiment, the length is greater than the diameter of the GSA 350 when it is deployed. Additionally, this curved configuration allows for a more gradual lateral deflection / turn toward the FO than would otherwise be possible, for example rather than lateral deflection toward the FO from a linear axis parallel to the central axis of the main shaft 320 .

[0130] In use, for example, when the main shaft 320 is advanced from an entry point into a patient, through the patient's vasculature and into the IVC, RA and SVC, it is desirable to avoid any traumatic contact with the patient's anatomical structures. In order to limit or prevent undesirable trauma to the patient by the septum puncture device 300, in this embodiment, the septum puncture device 300 includes a flexible atraumatic distal component 328 that is coupled to the main shaft 320 and extends from the main shaft. Although this embodiment shows the atraumatic distal component 328 as a separate component coupled to the main shaft 320, in other embodiments, the distal end portion (e.g., distal tip) of the main shaft 320 can be configured to be atraumatic (e.g., flexible, soft, or any other design feature configured to avoid undesirable trauma to the patient). In some implementations, the atraumatic distal component 328 can be tapered so that the proximal end portion of the atraumatic distal component has a cross-sectional area greater than its distal end portion. In some cases, the portion of the atraumatic distal component 328 having the largest cross-sectional area, diameter, or width can have the same, about the same, or larger cross-sectional area, diameter, or width as the GSA 350 (when the GSA 350 is in its delivery configuration). In this way, the atraumatic distal component 328 can facilitate smooth delivery within the patient.

[0131] In addition, as shown, the septum puncture device 300 includes a handle 380, as described in more detail herein, which is coupled to the body 310 and is configured to be manipulated by an operator to deliver and deploy the septum puncture device 300. The handle 380 may include or be coupled to one or more shaft actuators (if included, not shown), GA actuator 354, side catheter actuators (not shown), and penetrator actuators (not shown). In addition, the handle may be capable of being manipulated to actuate one or more of the actuators.

[0132] Turning now to an exemplary deployment sequence, 6A to 6H A septum piercing device 300 is shown in side view and an exemplary deployment sequence at a distal end portion thereof, according to one embodiment.

[0133] Fig. 6AA portion of the septum puncture device 300 is shown prior to deployment. In this configuration, the septum puncture device 300 can be inserted into a patient (e.g., via a femoral vein puncture), through the patient's vasculature, and into the patient's heart such that a main shaft 320 extending distally from the body 310 spans the IVC, RA, and SVC to provide a stable platform against which the septum puncture device 300 can be deployed to puncture the FO. As shown, during delivery, the septum puncture device 300 is in its delivery configuration, wherein the main shaft 320 and the side catheter introducer 330 are parallel or substantially parallel to each other. In this manner, for example, the cross-sectional footprint of the septum puncture device 300 can be minimized or optimized for minimally invasive delivery within a patient.

[0134] like Fig. 6A As shown, during delivery, the distal end of the side catheter introducer 330 is in physical contact with the proximal side of the GSA 350. In some cases, for example, the proximal side of the GSA 350 and the distal end of the side catheter introducer 330 may be in close contact, so that a portion of the distal end of the side catheter introducer 330 may be partially nested within or partially covered by the proximal side of the GSA 350. In this way, the GSA 350 can shield the distal end of the side catheter introducer 330 from inadvertent contact with the patient's anatomical structure. In such cases, subsequent steps may include telescoping the main shaft 320, including advancing the expansion section 320B of the main shaft 320, to separate the distal end of the side catheter introducer 330 from the GSA 350 or to expose the distal end of the side catheter introducer 330. In other cases, septum puncture device 300 may be delivered with a space between side catheter introducer 330 and GSA 350, such that the deployment step is unnecessary.

[0135] With the main shaft 320 extending from the IVC to the SVC, and the GSA 350 and introducer coupler 340 disposed within the RA, the Figure 6B More specifically, a distal force is applied to the proximal end portion of the side catheter introducer 330 so that the force is transmitted to the introducer coupler 340, thereby rotating or deflecting the introducer coupler 340, thereby causing a portion of the side catheter introducer 330 extending distally from the introducer coupler 340 to rotate or deflect around the introducer coupler 340. In this embodiment, as shown in FIG. Figure 6B320 , the distal end portion of the side catheter introducer 330 is deflected laterally by about 90 degrees and is deflected laterally to be approximately perpendicular to the central axis of the main shaft 320. In alternative embodiments, the lateral deflection can be less than about 90 degrees, such as about 15 degrees, about 30 degrees, about 45 degrees, about 60 degrees, about 75 degrees or any degree therebetween. In some cases, the lateral deflection can be about 75 degrees to about 85 degrees, such as about 80 degrees. In further embodiments, the lateral deflection can be greater than about 90 degrees, such as about 105 degrees, about 120 degrees, about 135 degrees or any degree therebetween. Although in this embodiment, actuating the side catheter introducer 330 is enough to deflect a part of the side catheter introducer 330 laterally, so that the part is approximately perpendicular to the central axis of the main shaft 320, but in other embodiments such as the lateral deflection is less than about 90 degrees, as discussed in more detail herein, additional lateral deflection / rotation can be applied by GSA 350.

[0136] Then, if Figure 6C As shown, the GSA 350 is actuated, i.e., in this embodiment, the GSA is expanded. More specifically, a fluid is applied to the GSA 350 to expand the GSA 350. When the GSA 350 is expanded, as shown in FIG. Fig.6DAs shown, the GSA 350 telescopes proximally around the expansion segment 320B disposed therefrom, including being withdrawn relative to the proximal segment 320A such that the proximal side of the GSA 350 is brought into physical contact with the side catheter introducer 350. The expansion segment 320B may be withdrawn any distance relative to the proximal segment 320A, and with any safely applicable amount of force suitable to adequately contact or stabilize the side catheter introducer 330. In some cases, such withdrawal may apply a force to the side catheter introducer 350 to further deflect the side catheter introducer 350 laterally (although as shown and described in this embodiment, the side catheter introducer 350 deflects laterally approximately 90 degrees before being physically contacted by the GSA 350), thereby causing the distal end portion of the side catheter introducer 350 to be, for example, perpendicular or approximately perpendicular to the central axis of the main shaft 320, or a surface line tangent to the FO or the main shaft 320. In addition, this withdrawal force causes the GSA 350 to contact or abut the distal end portion of the side catheter introducer 350 to stabilize relative to the main shaft 320 (e.g., laterally, axially (proximally or distally)). Although not shown, in some cases, this withdrawal force can be sufficient to cause the GSA 350 to become recessed due to the indentation of the side catheter introducer 330, or to surround a portion of the side catheter introducer 330. In this way, the side catheter introducer 330 can be sufficiently stabilized and temporarily fully coupled to the GSA 350. In some embodiments, the GSA 350 can be configured to have different degrees of compliance. In some embodiments, for example, a proximal portion of the GSA 350 configured to contact the side catheter introducer 330 can have a first degree of compliance, while another portion of the GSA 350 can have a second degree of compliance that is different from the first degree of compliance. Additionally, in some embodiments, the proximal side of the GSA 350 can include features configured to further stabilize the side catheter introducer 330 relative to the GSA 350. These features can include, for example, dimples, protrusions, adhesives, and the like.

[0137] When the GSA 350 is actuated and in full contact with the side catheter introducer 330 and provides sufficient stability of the side catheter introducer 330 relative to the main shaft 320, as shown in FIG. Fig. 6E The end effector 362 is shown deployed. To deploy the end effector 362, the side catheter 360 from which the end effector 362 extends distally is advanced relative to the side catheter introducer 330 so that the end effector 362 is allowed to expand to its expanded / deployed configuration when it is released from its constrained configuration within the lumen of the side catheter introducer 330.

[0138] With the end effector 362 deployed, the end effector 362 can be advanced toward the FO and into contact with the FO to cause the FO to bulge. As described elsewhere herein, the operator can see both the end effector and the bulge of the FO (or other portion of the septum) from outside the patient via various imaging techniques, such as ultrasound or related suitable imaging techniques. To advance the end effector 362 toward the FO and into contact with the FO, the side catheter 360 can be advanced (e.g., by actuating a side catheter actuator (not shown) relative to the side catheter introducer 330, or by manipulating (i.e., translating or rotating) the main shaft 320).

[0139] In the event that the operator is not satisfied with the position on the septum contacted by or elevated by the end effector 362, for example, if the end effector 362 is not aligned with the FO, the end effector 362 may be withdrawn from contact with the FO or septum (e.g., by withdrawing the side catheter 360 relative to the side catheter introducer 330, or by manipulating the main shaft 320), and the operator may then make another approach with respect to landing the end effector 362 on the FO in a manner sufficient to achieve subsequent puncture of the FO. This process may be repeated until the operator is satisfied.

[0140] With the FO properly raised via the end effector 362, the Figure 6G As shown, the septum penetrator 370 is advanced relative to the side catheter 360 and the end effector 362, and the septum penetrator is advanced through the FO and into the LA. With the FO fully penetrated by the septum penetrator 370 and the distal end of the septum penetrator 370 disposed within the LA, the guidewire GW2 is advanced relative to the lumen defined by the septum penetrator 370 and advanced through the lumen, such that at least the distal end portion of the guidewire GW2 leaves the distal end of the septum penetrator 370 (as shown in FIG. Figure 6H 360) and advanced into the LA, which can be confirmed by the operator under imaging techniques. Once it is confirmed that GW2 is sufficiently disposed within the LA, the septum penetrator 370 can be withdrawn relative to and into the lumen of the side catheter 360, the GSA 350 can be collapsed (e.g., collapsed to its delivery configuration), and the side catheter introducer 330 can be withdrawn to its linear, pre-deployed delivery configuration suitable for removal from the patient. Additionally, in some cases, the end effector 362 can be withdrawn relative to and into the lumen defined by the side catheter 360.

[0141] With septum penetrator 370 withdrawn from LA, the operator may manipulate septum puncturing device 300 (eg, handle 380, body 310, or main shaft 320) to withdraw the entire septum puncturing device 300 along guidewire GW2 until septum puncturing device 300 exits the patient.

[0142] Fig. 7A and Figure 7B Also shown are the side catheter introducer 340 and the actuation of the introducer coupler 340 or both in their respective delivery configurations ( Fig. 7A ) and expansion configuration ( Figure 7B ). Fig. 7A As shown, with the septum puncture device 300 disposed in its delivery configuration, the main shaft 320 and the side catheter introducer 330 extend distally and relatively parallel or approximately parallel from the body 310 and are coupled to each other via an introducer coupler 340. More specifically, the introducer coupler 340 is coupled to and between the side catheter introducer 330 and the proximal section 320A of the main shaft 320. With the introducer coupler 340 coupled to the proximal section 320A of the main shaft 320, in some cases, for example, the expansion section 320B of the main shaft 320 can be advanced relative to the proximal section 320A without interfering with or being interfered with by the introducer coupler 340.

[0143] As described in more detail herein, the side catheter introducer 340 can be configured to deliver a configuration ( Fig. 7A ) to its expanded configuration ( Figure 7B ). Where a portion of the side catheter introducer 340 is translationally fixed but rotationally movably coupled to the proximal section 320A of the main shaft 320 via the introducer coupler 340, the side catheter introducer 330 is configured as Figure 7B The side catheter introducer 330 is deformed as shown, and the portion of the side catheter introducer 330 disposed distally of the introducer coupler 340 is caused to rotate clockwise around the introducer coupler 340.

[0144] In addition, if Figure 7B As shown, the distal force applied to the side catheter introducer 340 causes the portion of the introducer coupler 340 disposed around the side catheter introducer 340 to rotate around the portion of the introducer coupler 340 disposed around the main axis 320. In other words, the distal force applied to the side catheter introducer 340 is at least partially transmitted to the introducer coupler 340, so that the articulation feature of the introducer coupler 340 is activated to allow the side catheter introducer 330 to transition from its delivery configuration to its deployed configuration.

[0145] In this embodiment, as described in more detail herein, the introducer coupler 340 is formed of a suture and shuttles or travels around and between the main shaft 320 and the side catheter introducer 330 to limit or prevent relative translational movement, but allow relative rotational movement between the main shaft 320 and the side catheter introducer 330. The suture can shuttle or travel around and between the main shaft 320 and the side catheter introducer 330 in any manner suitable for providing its intended function. In some implementations, fasteners can be added to the suture to improve its fixation to the main shaft 320 and the side catheter introducer 330. The fastener can be, for example, an adhesive, which is used in some cases to bond the wrap / loop of the suture and the loose end of the suture.

[0146] Figure 8 An example arrangement of suture (introducer coupling 340) is shown. Figure 8 ), the suture begins with a double knot 340CH around the side catheter introducer 330, and then the first working end of the suture is laid around the main shaft 320 in a first direction D1, thereby forming a spiral or loop around the main shaft 320, and the second working end of the suture is laid around the main shaft 320 in a second direction D2 (opposite to the first direction D1), thereby forming a spiral or loop around the main shaft 320 in a similar manner to the first working end. Each end of the suture can be fastened by tucking under or between one or more of the loops, or passing through one or more of the loops, or the suture can be fastened by additional fasteners, such as, for example, an adhesive coating.

[0147] Fig. 9 A method 400 of using a septum puncture device 300 to access the left atrium of a patient's heart according to one embodiment is shown. At 401, a guidewire GW1 is inserted through the IVC, across the RA, and the guidewire is inserted into the SVC of the heart (e.g., via a femoral vein puncture and through the patient's vascular system disposed between the femoral vein puncture site and the IVC). At 402, the septum puncture device 300 is delivered by the guidewire GW1 until the distal end of the main shaft 320 is disposed within the SVC. In some cases, the guidewire GW1 may be advanced or wedged into the uppermost side of the SVC (e.g., the bifurcation of the SVC into the left and right brachiocephalic (innominate) veins) to provide additional stability to the main shaft 520 and associated components (e.g., the side catheter introducer 530). At 404, the side catheter introducer 330 is actuated to guide the distal end of the side catheter introducer 330 toward the FO of the septum of the heart. At 406 , the balloon 550 disposed about the main shaft 320 is inflated, and the inflated section 320B of the main shaft 320 is withdrawn relative to the proximal section 320B of the main shaft 320 such that the balloon 350 abuts the side catheter introducer 330 .

[0148] At 408, optionally, the main shaft 320 and the side catheter introducer 330 are finely positioned relative to the FO (e.g., translated, rotated, etc.). At 410, the side catheter 360 is advanced, and the end effector 362 is deployed from the distal end portion of the side catheter introducer 330 so that the side catheter 360 contacts the FO and bulges the FO. At 412, optionally, the operator visualizes the bulge of the FO. At 414, the septum penetrator 370 is advanced through the FO and into the LA relative to the side catheter 360. At 416, optionally, the operator visualizes the septum penetrator 370 to confirm that the septum penetrator 370 has crossed into the LA. At 418, the second guidewire GW2 is advanced into the LA relative to the septum penetrator 370. At 420, septum penetrator 370 is withdrawn relative to and into the lumen defined by side catheter 360, expansion section 320B of main shaft 320 is advanced relative to proximal section 320A, side catheter introducer 330 is withdrawn relative to main shaft 320, and balloon 350 is deflated. Optionally, at 420, end effector 362 is withdrawn relative to side catheter introducer 330. In some instances, withdrawing end effector 362 relative to side catheter introducer 330 includes withdrawing end effector 362 back into the lumen defined by side catheter introducer 330 to return end effector 362 to its delivery configuration.

[0149] Although septum puncture device 300 is shown and described as having GSA 350, in alternative embodiments, for example, the septum puncture device may be similar to septum puncture device 300, but does not include a GSA. In such embodiments, the septum puncture device may, for example, rely on an introducer coupler to achieve both lateral deflection and stabilization of the side catheter introducer, the side catheter, and the septum penetrator. Considering Fig. 7A and Figure 7B Only a portion of septum piercing device 300 excluding GSA 350 is shown, and these figures may be considered illustrative examples of such alternative embodiments.

[0150] Figures 10 to 12A portion of a septum puncture device 500 in an expanded configuration according to another embodiment is shown in a perspective bottom view, a perspective side view, and a side view, respectively. Similar or identical to that described with respect to other septum puncture devices described herein (e.g., septum puncture device 100, septum puncture device 300, etc.), septum puncture device 500 can be used to access the left side of the heart (e.g., left atrium) from the right side of the heart (e.g., right atrium) and deliver a guidewire to the left side of the heart. The septum puncture device 500 can be constructed in the same or similar manner as any of the septum puncture devices described herein and can function in the same or similar manner as any of the described ones. Therefore, the portions of the septum puncture device 500 will not be described in further detail herein.

[0151] In this embodiment, as shown, the septum puncture device 500 includes a main shaft 520 that defines a lumen therethrough (e.g., through which a guidewire may be laid). The main shaft 520 includes a proximal segment 520A at its proximal end, a distal segment 520C at its distal end, and an expansion segment 520B disposed therebetween. The proximal segment 520A defines a first aperture AP1, and the expansion segment 520B defines a second aperture AP2 and a third aperture AP3 disposed opposite the second aperture AP2, both of which are in fluid communication with the lumen of the main shaft 520. As best shown in Fig.12 In this embodiment, the proximal end of the expansion segment 520B is inserted into the proximal segment 520A, and the distal end of the expansion segment 520B is inserted into the distal segment 520C. However, in alternative embodiments, other spindle designs suitable for providing stability for lateral puncture can be used. In some embodiments, for example, two or three of the proximal segment, the expansion segment, and the distal segment can be formed integrally, rather than formed separately and then coupled together.

[0152] As shown, the septum puncture device 500 also includes a side catheter introducer 530 that extends distally into the lumen of the main shaft 520 at the proximal end of the proximal section 520A of the main shaft 520, away from the first aperture AP1 (see, e.g., Fig.11 ), toward the second pore AP2 and enters the second pore, and leaves the third pore AP3.

[0153] The expansion section 520B of the main shaft 520 defines (1) a first expansion portion 526A, around which a first stabilizer / actuator introducer ("GSA") 550A is disposed; and (2) a second expansion portion 526B, around which a second stabilizer / actuator introducer ("GSA") 550B is disposed. In this embodiment, the first GSA 550A and the second GSA 550B are balloons disposed circumferentially around the main shaft 520. The distal portion of the side catheter introducer 530 may be directly coupled to the main shaft 520 (e.g., using any suitable fastener) for translation (relative to the main shaft 520) between the first GSA 550A and the second GSA 550B, or the distal portion of the side catheter introducer 530 may be translationally secured relative to the main shaft 520 from a distal side surface of the first GSA 550A and a proximal side surface of the second GSA 550B by means of contact, abutment, interference fit, etc. In some implementations, the distal portion of the side catheter introducer 530 may be fastened to one or both of the first GSA 550A or the second GSA 550B.

[0154] The first GSA 550A and the second GSA 550B are configured to expand for deployment and to contract for delivery or withdrawal. To expand, the first GSA 550A is configured to expand from the opening O ( Fig.12 ) and receives one or more fluids (e.g., one or more of saline, air, or contrast agent for visualization) through the opening; and similarly, the second GSA 550B is configured to flow from the opening O ( Fig.12) and receive one or more fluids through the opening. In use, for example, one or more fluids may be delivered through the lumen of the main shaft 320 and delivered into the volume defined by the first GSA 550A (via the opening O in the first expansion portion 526A), and delivered into the volume defined by the second GSA 550B (via the opening O in the second expansion portion 526B). The one or more fluids may be withdrawn from the first GSA 550A and the second GSA 550B (e.g., via the same path used to deliver the one or more fluids) to cause the first GSA 550A and the second GSA 550B to contract so that the cross-sectional area or footprint of the first GSA 550A and the second GSA 550B is reduced to facilitate removal from the patient. The balloon may be of any size suitable for performing the desired functions disclosed herein, for example, in some embodiments, the balloon may have a diameter of 20 mm or about 20 mm when inflated. In some implementations of this embodiment, the septum puncture device 500 may include a GSA actuator (not shown, but, for example, disposed at or operably coupled to a handle of the septum puncture device, also not shown), the GSA actuator being configured to expand or contract the first GSA 550A and the second GSA 550B.

[0155] As shown, and similar to other embodiments described herein, the side catheter introducer 530 is laid distally around the first GSA 550A and then through a path defined by and between the first GSA 550A and the second GSA 550B, with the side catheter introducer 530 presenting a bend such that, as described in more detail herein relative to other embodiments, the length of the side catheter introducer 530 extends from outside the first side of the main shaft 520 to outside the second side of the main shaft 520 (e.g., a distance that is at least equal to the diameter of the first GSA 550A or the second GSA 550B when expanded), thereby providing a suitable straight or substantially straight length (e.g., in some cases, about 3 cm to about 4 cm) to accommodate the septum penetrator (or the rigid portion of the septum penetrator).

[0156] As described above, some components of septum piercing device 500 are similar or identical (in form or function) to components of other septum piercing devices described herein, and some of these components will not be described or illustrated again with respect to septum piercing device 500. For example, in some embodiments, septum piercing device 500 includes a body, a handle, a side catheter (with or without an end effector extending from the side catheter), a septum penetrator, one or more guidewire couplers or actuators (e.g., a shaft actuator, a GSA actuator, a side catheter actuator, a penetrator actuator), none of which are described herein. Figures 10 to 12The following exemplary method of using septum piercing device 500 mentions some of these components.

[0157] In use, for example and similar to that described herein with respect to other embodiments, the septum puncture device 500 can be inserted into a patient (e.g., via femoral vein puncture), through the patient's vasculature, and into the patient's heart such that the main shaft 520 spans the IVC, RA, and SVC to provide a stable platform against which the septum puncture device 300 can be deployed to puncture the FO. In some cases, the septum puncture device 500 can be inserted over a guidewire (not shown) that is laid through the lumen of the main shaft 520 (or in some cases, laid over a guidewire coupler, not shown). During such delivery, the septum puncture device 500 is in its delivery configuration, wherein the first GSA 550A and the second GSA 550B are retracted (not shown). In this manner, for example, the cross-sectional area or footprint of the septum puncture device 500 can be minimized or optimized for minimally invasive delivery in a patient.

[0158] With the main shaft 520 extending from the IVC to the SVC, and the distal end portions of the first GSA 550A, the second GSA 550B, and the side catheter introducer 530 disposed within the RA, as shown in FIG. Figures 10 to 12 As shown, the first GSA 550A and the second GSA 550B can be expanded to deploy the side catheter introducer 530. Inflating the first GSA 550A and the second GSA 550B in this manner causes the distal end portion of the side catheter 530 to (1) deflect laterally to a preferred angle and deflect laterally toward the FO, and (2) stabilize the distal end portion of the side catheter 530 to facilitate subsequent inflation or puncture of the FO. In this embodiment, as shown in FIG. Fig.11As shown, deflection occurs so that the distal end portion of the side catheter introducer 530 is deflected laterally to be perpendicular to or approximately perpendicular to the central axis of the main shaft 520, or a surface line tangent to the FO or the main shaft 520. In alternative embodiments, as described with respect to other embodiments, the lateral deflection may be selectively less than about or greater than about 90 degrees. Although not shown, in some cases, the first GSA 550A or the second GSA 550B may be expanded so that the first GSA 550A or the second GSA 550B becomes recessed or surrounds a portion of the side catheter introducer because of the indentation of the distal end portion of the side catheter introducer 530. In this way, the side catheter introducer 530 can be fully stabilized and temporarily fully connected to the first GSA 550A or the second GSA 550B. In some embodiments, the GSA 550A or the GSA 550B may be configured to have different degrees of compliance. In some embodiments, for example, a distal portion of the first GSA 550A and a proximal portion of the second GSA 550B may have a first degree of compliance, while another portion of the first GSA 550A and another portion of the second GSA 550B may have a second degree of compliance that is different from the first degree of compliance. Additionally, in some embodiments, the distal portion of the first GSA 550A and the proximal portion of the second GSA 550B may include features configured to further stabilize the side catheter introducer 530 relative to the GSA 550. These features may include, for example, dimples, protrusions, adhesives, and the like.

[0159] With the first GSA 550A and the second GSA 550B actuated and in full contact with the side catheter introducer 530 and providing sufficient stability of the side catheter introducer 530 relative to the main shaft 520, an end effector (not shown) can be deployed from the side catheter introducer 530 in a manner similar or identical to that described in other embodiments. To deploy the end effector, for example, a side catheter (not shown) from which the end effector extends distally can be advanced relative to the side catheter introducer 530 (e.g., through a lumen defined by and extending through the side catheter introducer 530) such that the end effector is allowed to expand to its expanded / deployed configuration when it is released from its constrained or delivery configuration within the lumen of the side catheter introducer 530.

[0160] With the end effector deployed, the end effector can be advanced toward the FO and into contact with the FO to cause the FO to bulge. As described elsewhere herein, the operator can see both the end effector and the bulge of the FO (or other portion of the septum) from outside the patient via various imaging techniques, such as ultrasound or related suitable imaging techniques. To advance the end effector toward the FO and into contact with the FO, the side catheter can be advanced (e.g., by actuating a side catheter actuator (not shown) relative to the side catheter introducer 530, or by manipulating (i.e., translating or rotating) the main shaft 520).

[0161] In the event that the operator is not satisfied with the position on the septum contacted by or elevated by the end effector, for example, if the end effector is not aligned with the FO, the end effector may be withdrawn from contact with the FO or septum (e.g., by withdrawing the side catheter relative to the side catheter introducer 530, or by manipulating the main shaft 520), and the operator may then make another approach with respect to landing the end effector on the FO in a manner sufficient to achieve a subsequent puncture of the FO. This process may be repeated until the operator is satisfied.

[0162] With the FO appropriately domed via the end effector, a septum penetrator (not shown) may be advanced relative to the side catheter (e.g., through a lumen defined by and extending through the side catheter) and the end effector and advanced through the FO and into the LA. With the FO sufficiently penetrated by the septum penetrator and the distal end of the septum penetrator disposed within the LA, a second guidewire may be advanced relative to and through the lumen defined by and extending through the septum penetrator such that at least a distal end portion of the guidewire exits the distal end of the septum penetrator and is advanced into the LA, which may be confirmed by the operator under imaging techniques.

[0163] Once it is confirmed that the second guidewire is adequately disposed within the LA, the septum penetrator can be withdrawn relative to and into the lumen of the side catheter, and the first GSA 550A and the second GSA 550B can be retracted to prepare for removal of the septum puncturing device 500 from the patient. Additionally, in some cases, the end effector can be withdrawn relative to and into the lumen defined by the side catheter.

[0164] With the septum penetrator retracted from the LA, the operator can manipulate the septum puncture device 500 (e.g., the handle, body, or main shaft 520) to withdraw the entire septum puncture device 500 along the second guidewire until the septum puncture device 500 exits the patient, thereby leaving the second guidewire in the patient for subsequent access to the left atrium (e.g., without additionally penetrating the FO).

[0165] In some implementations, during delivery, the side catheter introducer 530 (or any components disposed therein) can be protected from premature deployment or advancement, or from inadvertent, undesirable contact with the patient's anatomy. In some cases, for example, the side catheter introducer 530 (or a side catheter and end effector extending or protruding from the distal end of the side catheter introducer 530) can be at least partially enclosed within the first GSA 550A and the second GSA 550B in its delivery or collapsed configuration. As an example illustration, FIG. 13A to FIG. 13F A partial delivery and deployment sequence is shown. Fig.13A The septum puncture device 500 is shown in a delivery configuration, wherein the first GSA 550A and the second GSA 550B are collapsed and circumferentially disposed about the side catheter introducer 530 . Fig. 13B A first GSA 550A and a second GSA 550B are shown in a deployed, expanded configuration, wherein the side catheter introducer 530 is deflected laterally relative to the main shaft 520 such that the distal end of the side catheter introducer 530 is directed toward the FO and extends proximally toward and beyond the main shaft 520 in a linear manner between the first GSA 550A and the second GSA 550B. Arrows L and R represent linear and angular axes, respectively, along which the main shaft 520 can be adjusted by an operator to align the distal end of the side catheter introducer (or the end effector of the side catheter) with the FO.

[0166] Fig. 13C A side catheter 560 having an end effector 562 is shown, which is advanced from the side catheter introducer 530 and contacts and bulges the FO. The side catheter 560 can be advanced any suitable distance to detect the FO. In some cases, for example, the side catheter 560 can be advanced from the side catheter introducer 530 by about 1 cm to about 4 cm. In other cases, as another example, the side catheter 560 can be advanced from the side catheter introducer 530 by about 2 cm to about 3 cm.

[0167] Fig.13DA septum penetrator 570 is shown advanced from the side catheter 560, through the FO and into the LA, and a guidewire GW2 (having a twisted wire configuration) is advanced from the septum penetrator 570, through the FO and into the LA. The septum penetrator 570 may be advanced any suitable distance from the side catheter 560 to penetrate the FO and enter the LA. In some cases, for example, the septum penetrator 570 may be advanced from the side catheter 560 by about 0.5 cm to about 1 cm.

[0168] In the case where the guidewire GW2 is disposed within the LA, as described in more detail herein and as Fig.13E As shown, the septum penetrator 570 can be withdrawn from the LA. Fig.13F As shown, the first GSA 550A and the second GSA 550B can be retracted, and the septum puncture device 500 can be withdrawn relative to and along the guidewire GW2, so that the guidewire GW2 extends from within the LA, through the puncture hole in the FO, into the LA, and through the patient's vascular system and out of the patient for subsequent minimally invasive access to the LA.

[0169] Although the septum puncture device 500 is shown and described as having a second aperture AP2 and a third aperture AP3 in the main shaft 520 which may be provided with a side catheter introducer 530, in other embodiments, a similar septum puncture device may include a side catheter introducer extending or laid along the outer surface of the main shaft, rather than through the main shaft. In such embodiments, for example, the septum puncture device may include an introducer coupler similar or identical in form or function to any one of the introducer couplers described herein with respect to other embodiments. For example, the introducer coupler may be arranged between the first GSA and the second GSA, and is used to couple the side catheter introducer (e.g., fixedly coupled in translation, and rotatably coupled) to the main shaft so that the side catheter introducer can be deflected laterally around the introducer coupler in response to the expansion / deployment of the first GSA and the second GSA. In some implementations, similar or identical to that described herein in other embodiments, the introducer coupler may be a hinge, such as a hinge formed by a suture.

[0170] Although the septum puncture device 500 is shown and described as having a side catheter introducer 530 that can be slidably provided with a side catheter 560 (and an end effector 562), a septum penetrator 570, and a guidewire GW2, in alternative embodiments, the septum puncture device may, for example, not include a side catheter introducer. FIG. 14A to FIG. 14K This alternative embodiment is shown. More specifically, FIG. 14A to FIG. 14K A septum piercing device 600 is shown along with an exemplary deployment sequence at a distal end portion thereof, according to one embodiment.

[0171] Similar or identical to that described with respect to other septal puncture devices described herein, septal puncture device 600 can be used to access the left side of the heart (e.g., the left atrium) from the right side of the heart (e.g., the right atrium) and deliver a guidewire to the left side of the heart. Septal puncture device 600 can be constructed in the same or similar manner as any of the septal puncture devices described herein and can function in the same or similar manner as any of the described. Therefore, the various parts of septal puncture device 600 will not be described in further detail herein.

[0172] In this embodiment, if Fig.14A As shown, prior to deployment, septum puncture device 600 has a protective sleeve 629 coupled to and circumferentially disposed about a portion of main shaft 620, first GSA 650A, second GSA 650B, and a portion of side conduit 660. For example, protective sleeve 629 may shield the aforementioned components of septum puncture device 600 prior to use of septum puncture device 600. In such cases, protective sleeve 629 may be removed prior to inserting septum puncture device 600 into a patient. Additionally, in some cases, protective sleeve 629 may shield the aforementioned components of septum puncture device 600 during delivery of septum puncture device 600 into and through the patient. As an example, similar to that described herein with respect to other embodiments, septum puncture device 600 may be inserted into the vasculature of a patient, through the IVC, and into the RA. In such cases, protective sleeve 629 may be configured to prevent inadvertent contact or trauma to surrounding tissue of the patient. Additionally or alternatively, the protective sleeve 629 can be configured to constrain the first GSA 650A, the second GSA 650B, or the side catheter 660 to define a cross-sectional profile or footprint suitable for delivery within a patient. In this manner, the protective sleeve 629 and the components disposed therein can be delivered to the RA of the heart, and then the protective sleeve 629 can be withdrawn along the main axis 620 (or in some cases advanced along the main axis 620) to expose a portion of the first GSA 650A, the second GSA 650B, and the side catheter 660.

[0173] In the case of withdrawing or advancing the protective sleeve 629, as described in other embodiments herein and as Fig. 14B As shown, the side conduit 630 can assume its curved orientation. Fig. 14BAs shown, in some cases, the end effector 662 can be disposed between the first GSA 650A and the second GSA 650B such that the end effector 662 is at least partially shielded. In other words, the distance between the end effector 662 and the central axis of the main shaft 620 is less than the radius of the first GSA 650A and the second GSA 650B. In addition, the side conduit 660 is slidably disposed relative to the main shaft 620 and the first GSA 650A and the second GSA 650B. Thus, as shown in FIG. Fig. 14C As shown, the side catheter 660 (and end effector 662) can be advanced relative to the main shaft 620 to provide sufficient space within which the first GSA 650A and the second GSA 650B can be expanded or inflated.

[0174] When the end effector 662 is advanced in this manner, Fig.14D As shown, the first GSA 650A and the second GSA 650B are expanded. In addition, as shown, the expansion of the first GSA 650A and the second GSA 650B causes the distal end portion of the side catheter 660 to deflect and stabilize laterally relative to the main axis 620. The lateral deflection was measured during the experiment, and as an illustrative example, Fig.14E and Fig.14F The measurements are shown in Fig.14E As shown, before the first GSA 650A and the second GSA 650B are expanded, the angle between (1) the central axis of the portion of the side conduit 660 extending distally from (a) the central axis of the main shaft 620 and (b) the first GSA 650A and the second GSA 650B, and (2) the central axis of the main shaft 620 is about 65 degrees to about 70 degrees. When the first GSA 650A and the second GSA 650B are expanded, as shown in FIG. Fig.14F As shown, the angle becomes about 90 degrees.

[0175] When the side conduit 660 is deflected laterally in this manner, as shown in FIG. Figure 14G As shown, the side catheter 660 can optionally be further advanced relative to the main shaft 620 so that the effective length (e.g., the length of the side catheter extending distally from the closest outer surfaces of the first GSA 650A and the second GSA 650B) is increased to a desired amount to achieve FO bulging. Fig.14H As shown, the end effector 662 is advanced relative to the end effector 662 to, for example, penetrate the FO. In addition, and as described in other embodiments herein, as Fig.14I As shown, guidewire GW2 can be advanced through the lumen defined by septum penetrator 670 and relative to end effector 662.

[0176] When the guide wire GW2 is fully advanced, Fig.14JAs shown, the septum penetrator 670 can be withdrawn into the lumen defined by the side catheter 670 (e.g., to prevent any inadvertent contact (and risk of injury) between the sharp edge of the septum penetrator 670 and the guidewire GW2, and between the sharp edge of the septum penetrator 670 and the patient's surrounding anatomical structures). Fig.14J As shown, the first GSA 650A and the second GSA 650B can be collapsed, and as shown Figure 14K As shown, the side catheter (and end effector 662) can be retracted around the guidewire GW2 relative to the main shaft 620 and toward its delivery position.

[0177] Although (1) the septum puncture device 500 is shown and described as having a side catheter introducer 530 laid through a lumen defined by the main shaft 520 (or the central axis of the main shaft 520), or more specifically laid into the second aperture AP2 and out of the third AP3 of the main shaft 520, and (2) the septum puncture device 600 is shown and described as having a side catheter 660 laid through the lumen or central axis of the main shaft 620, in other embodiments, the side catheter introducer or side catheter may be laid along the outer surface of the main shaft, i.e., offset from the central axis of the main shaft. For example, from a top view, the side catheter introducer or side catheter may be set relative to one side of the main shaft. Considering the common anatomical position of the FO relative to the IVC, SVC and RA (e.g., measured laterally relative to the central longitudinal axis from the IVC to the SVC), offsetting the side catheter introducer or side catheter relative to the central axis of the main shaft in this way will in many cases better align the distal end of the side catheter introducer or side catheter with the FO. The FO tends to deviate from the central axis defined from the IVC to the SVC by about 4 mm to about 6 mm, so aligning the side catheter introducer to deviate from the central axis of the main shaft by a comparable distance can in some cases place the side catheter introducer or side catheter in a position more suitable for subsequent puncture. In this way, the arrangement of the side catheter introducer or side catheter with the main shaft can optimize the time and number of steps required for the operator to find the FO with the side catheter (or end effector) for subsequent puncture of the FO with the septum penetrator.

[0178] One such example is shown in Figures 15 to 17 , which illustrate a septum puncture device 700 according to one embodiment in perspective, front and side views, respectively. Similar or identical to that described with respect to other septum puncture devices described herein, the septum puncture device 700 can be used to access the left side of the heart (e.g., the left atrium) from the right side of the heart (e.g., the right atrium) and deliver a guidewire to the left side of the heart. The septum puncture device 700 can be constructed in the same or similar manner as any of the septum puncture devices described herein and can function in the same or similar manner as any of the described ones. Therefore, the various parts of the septum puncture device 700 will not be described in further detail herein.

[0179] In this embodiment, as shown, the septum puncture device 700 includes a main shaft 720, a first GSA 750A, a second GSA 750B, and a side conduit 760 that is laid around or around the first GSA 750A, then between the first GSA 750A and the second GSA 750B, and along the outer surface of the main shaft 720 (and offset from the central axis of the main shaft 720). In this way, in some cases, the side conduit 760 can be better aligned with the patient's FO. Although not shown in FIG. Figures 15 to 17 , but in some implementations, the side catheter 760 may be slidably attached to the main shaft 720 via an introducer coupler (not shown). For example, the introducer coupler may be configured to slidably and rotatably attach the side catheter 760 to the main shaft 720 to prevent the side catheter 760 from being separated from the main shaft 720 or from being separated from between the first GSA 750A and the second GSA 750B. In other implementations, for example, the introducer coupler may be attached to, be a part of, or extend from the first GSA 750A or the second GSA 750B. 18A to 18C An illustrative example of an introducer coupler 840 of a septum puncturing device 800 according to one embodiment is shown in FIG.

[0180] Similar or identical to that described with respect to other septal puncture devices described herein, septal puncture device 800 can be used to access the left side of the heart (e.g., the left atrium) from the right side of the heart (e.g., the right atrium) and deliver a guidewire to the left side of the heart. Septal puncture device 800 can be constructed in the same or similar manner as any of the septal puncture devices described herein and can function in the same or similar manner as any of the described. Therefore, the various portions of septal puncture device 700 will not be described in further detail herein.

[0181] 18A to 18C The first GSA 850A and the second GSA 850B are shown in the following configurations, respectively: a contracted delivery configuration (in which the side catheter 860 is at least partially aligned axially with the main axis 820); a partially expanded, partially deployed configuration (in which the side catheter 860 has been laterally deflected a first degree); and an expanded deployment configuration (in which the side catheter 860 has been laterally deflected a second degree greater than the first degree, stabilized, and directed toward a representative mode of FO).

[0182] As shown, the introducer coupler 840 in this embodiment extends from the main shaft 820 and circumferentially surrounds or engages the side catheter 860. More specifically, the introducer coupler 840 defines an eyelet through which the side catheter 860 passes. In this way, the side catheter 860 can freely translate (advance or withdraw) through the eyelet. In some implementations, the eyelet can be sized to have at least a partial interference fit, thereby providing a certain friction between the introducer coupler 840 and the side catheter 860 so that the side catheter 860 will not be inadvertently translated. In addition, as shown in FIG. Fig.18C As shown, the introducer coupler 840 is configured to rotate about the main axis 820 in response to the expansion of the first GSA 850A and the second GSA 850B to allow the side catheter 860 to be deflected laterally toward its target location (e.g., FO). After delivering the guidewire GW2 (not shown), as discussed herein with respect to other embodiments, the first GSA 850A and the second GSA 850B can be retracted and the introducer coupler 840 can be rotated in a direction opposite to the direction in which it was rotated during deployment.

[0183] Although various embodiments of the septum puncture device described herein are disclosed as having a single side catheter introducer or a single side catheter (with a single end effector), in some embodiments, the septum puncture device may include two side catheter introducers or two side catheters (with or without one or more side catheter introducers). Figures 19 to 21 Such an embodiment is shown in . Figures 19 to 21 A septum puncture device 900 including two side catheters is shown in perspective view, front view, and detailed partial perspective view, respectively.

[0184] Similar or identical to that described with respect to other septal puncture devices described herein, septal puncture device 900 can be used to access the left side of the heart (e.g., the left atrium) from the right side of the heart (e.g., the right atrium) and deliver a guidewire to the left side of the heart. Septal puncture device 900 can be constructed in the same or similar manner as any of the septal puncture devices described herein and can function in the same or similar manner as any of the described. Therefore, the various parts of septal puncture device 900 will not be described in further detail herein.

[0185] In this embodiment, the septum puncture device 900 includes a first side catheter 960A and a second side catheter 960B, each of which is configured to be delivered and deployed in a patient's body as described herein with respect to other embodiments. The septum puncture device 900 also includes a first end effector 962A extending from the first side catheter 960A, and a second end effector 962B extending from the second side catheter 960B. As shown, the main shaft 920 defines a lumen in which the first side catheter 960A and the second side catheter 960B can be slidably disposed, and an aperture AP through which the first side catheter 960A and the second side catheter 960B can be advanced or withdrawn. The septum puncture device 900 also includes: a first GSA 950A, which is circumferentially disposed around the main shaft 920 and disposed proximally of the aperture AP; and a second GSA 950B, which is circumferentially disposed around the main shaft 920 and disposed distally of the aperture AP. In this manner, the first and second side conduits 960A, 960B may extend distally from the AP and through a pathway defined between the first and second GSAs 950A, 950B.

[0186] In use, similar to that described herein with respect to other embodiments, the first and second GSAs 950A, 950B may be expanded to laterally deflect and stabilize the first and second side catheters 960A, 960B (e.g., laterally, axially (proximally, distally)) such that first and second septum penetrators (not shown) may be advanced or withdrawn through the side catheters, and first and second guidewires (not shown) may be advanced and withdrawn via the first and second septum penetrators. Upon accessing the LA, for example, with the first and second GSAs 950A, 950B disposed within the RA in an expanded, deployed configuration, and the first and second side catheters 960A, 960B directed toward the septum, the first and second side catheters 960A, 960B may be advanced to bulge the FO, and then the first and second septum penetrators may be (optionally simultaneously) advanced to puncture the FO, or one or more other target locations of the septum. The puncture sites may be separated by a predetermined distance, which is set by the distance between the side catheter lumens. After two punctures have been achieved in the septum, two guidewires may then be advanced (optionally simultaneously) into the LA, one guidewire through each puncture.

[0187] Although septum piercing device 900 is shown and described as having two GSAs, in other embodiments, a septum piercing device may be similar or identical to septum piercing device 900 but include only a single GSA. Fig. 22 and Fig.23An example embodiment is shown in , wherein the septum puncture device is shown in a front view and a perspective view, respectively. Similar or identical to that described with respect to other septum puncture devices described herein, the septum puncture device 1000 can be used to enter the left side of the heart (e.g., the left atrium) from the right side of the heart (e.g., the right atrium) and deliver two guide wires to the left side of the heart. The septum puncture device 1000 can be constructed in the same or similar manner as any of the septum puncture devices described herein and can function in the same or similar manner as any of the described ones. Therefore, the various parts of the septum puncture device 1000 will not be described in further detail herein.

[0188] In this embodiment, the septum puncture device 1000 includes a first side catheter 1060A and a second side catheter 1060B, each of which is configured to be delivered and deployed in a patient's body as described herein with respect to other embodiments. The septum puncture device 1000 also includes a first end effector 1062A extending from the first side catheter 1060A, and a second end effector 1062B extending from the second side catheter 1060B. As shown, the main shaft 1020 defines a lumen in which the first side catheter 1060A and the second side catheter 1060B can be slidably disposed, and an aperture AP through which the first side catheter 1060A and the second side catheter 1060B can be advanced or withdrawn. The septum puncture device 1000 also includes a GSA 1050, which is circumferentially disposed around the main shaft 1000 and is disposed distal to the aperture AP. In this manner, as shown, the first and second side conduits 1060A, 1060B may extend distally from the AP and along the proximal end surface of the GSA 1050.

[0189] Although not shown, with the GSA 1050 in its collapsed delivery configuration, the first and second side conduits 1060A, 1060B can be oriented in a more delivery-friendly position along the outer surface of the collapsed GSA 1050, such as being oriented approximately parallel to the central axis of the main shaft 1020. As described in greater detail herein with respect to other embodiments, Fig. 22 and Fig.23 As shown, the GSA 1050 can be configured to expand or deploy to deflect the first and second side conduits 1060A, 1060B laterally relative to the main axis 1020. As described in more detail herein with respect to other embodiments, the GSA 1050 can also be configured to stabilize the first and second side conduits 1060A, 1060B relative to the main axis 1020. In some implementations, for example, the GSA 1050 can include dimples, protrusions, ridges, adhesives, etc. configured to improve the stability of the first and second side conduits 1060A, 1060B.

[0190] With the first and second side catheters 1060A, 1060B laterally deflected and stabilized in this manner, the first and second side catheters 1060A, 1060B can be advanced relative to the main axis 1020 and toward the target tissue (e.g., the septum or FO), and the first septum penetrator, the second septum penetrator, the first guidewire, and the second guidewire (none of which is in the Fig.19 and Fig. 20 ), for example to penetrate the septum and deliver a first guide wire and a second guide wire.

[0191] Although septum puncture device 1000 is shown and described as having two side catheters, in other embodiments, the septum puncture device may be similar or identical to septum puncture device 1000 but include only a single GSA. Fig.24 and Fig.25 An example embodiment is shown in , wherein the septum puncture device is shown in a perspective front view and a perspective side view, respectively. Similar or identical to that described with respect to other septum puncture devices described herein, the septum puncture device 1100 can be used to enter the left side of the heart (e.g., the left atrium) from the right side of the heart (e.g., the right atrium) and deliver two guide wires to the left side of the heart. The septum puncture device 1100 can be constructed in the same or similar manner as any of the septum puncture devices described herein and can function in the same or similar manner as any of the described ones. Therefore, the various parts of the septum puncture device 1100 will not be described in further detail herein.

[0192] In this embodiment, as described herein with respect to other embodiments, the septum puncture device 1100 includes a side catheter configured to be delivered and deployed in a patient. The septum puncture device 1100 also includes an end effector 1162 extending from the side catheter 1160. As shown, the main shaft 1120 defines a lumen in which the side catheter 1160 and the second side catheter 1160 can be slidably disposed, and an aperture AP through which the side catheter 1160 and the second side catheter 1160 can be advanced or withdrawn. The septum puncture device 1100 also includes a GSA 1150 that is circumferentially disposed around the main shaft 1100 and disposed distally of the aperture AP. In this way, as shown, the side catheter 1160 can extend distally from the AP and along the proximal end surface of the GSA 1150.

[0193] Although not shown, with the GSA 1150 in its collapsed delivery configuration, the side conduit 1160 can be oriented in a more delivery-friendly position along the outer surface of the collapsed GSA 1150, such as oriented approximately parallel to the central axis of the main shaft 1120. As described in more detail herein with respect to other embodiments, Fig.24 and Fig.25As shown, the GSA 1150 can be configured to expand or deploy to deflect the side conduit 1160 laterally relative to the main axis 1120. As described in more detail herein with respect to other embodiments, the GSA 1150 can also be configured to stabilize the side conduit 1160 relative to the main axis 1120. In some implementations, for example, the GSA 1150 can include dimples, protrusions, ridges, adhesives, etc. configured to increase the stability of the first side conduit 1160.

[0194] With the side catheter 1160 laterally deflected and stabilized in this manner, the side catheter can be advanced relative to the main axis 1120 and toward the target tissue (e.g., the septum or FO), and the first septum penetrator, the second septum penetrator, the first guidewire, and the second guidewire (none of which is in the Fig.24 and Fig.25 ), for example to penetrate the septum and deliver a first guide wire and a second guide wire.

[0195] exist Fig.26A and Fig.26B An example delivery and deployment of the septum puncture device 1100 in the context of a patient's heart is shown in FIG. Fig.26A As shown, the septal puncture device 1100 can be disposed within the RA of the heart such that the main axis 1120 spans the IVC, RA, and SVC, and the GSA 1150 and the side catheter 1160 are disposed within the RA. As described in more detail herein with respect to other embodiments, Fig.26B As shown, the GSA 1150 can be expanded to its deployed configuration to deflect and stabilize the side conduit 1160 laterally relative to the main axis 1120 and toward the FO. Fig.26B As shown, the side catheter 1160 can be advanced so that the end effector 1162 contacts or bulges the FO, after which the septum penetrator 1170 can be advanced distally relative to and from the end effector 1162, and the guidewire GW2 can be advanced into the LA.

[0196] Although various embodiments of the septum puncture device are described herein as having one or more GSAs, some of which may be balloons of particular shapes, sizes, etc., any of the embodiments described herein may be modified to have one or more GSAs having any shape, size, expansion volume, one or more materials, one or more surface features, etc., suitable for expandably and retractably coupling to the main shaft and laterally deflecting and stabilizing one or more side catheter introducers or one or more side catheters (and any components disposed therein, such as end effectors, septum penetrators, and guidewires). As an illustrative example, the following description with respect to Figures 27 to 34Various embodiments of GSAs are described, and the GSAs are considered to be a portion of septum piercing devices 1200-1900, all of which may function the same or similarly to other septum piercing devices described herein and in the same or similar manner as the other septum piercing devices described herein. Therefore, the various portions of septum piercing devices 1200-1900 will not be described in further detail herein.

[0197] In some embodiments, for example, the GSA may have a concave or convex shape. Fig. 27 , which shows a portion of a septum puncture device 1200 including: a first GSA 1250A having a concave shape at its distal end; and a second GSA 1250B disposed distally of the first GSA 1250A and having a convex shape at its proximal end. As shown, this combination of shapes can define a path that can be slidably provided with a side catheter 1260 (or, in an alternative embodiment, a side catheter introducer).

[0198] In another embodiment, the GSA can be configured to define an optimal path along which a side catheter introducer or side catheter can extend from the proximal end of the GSA to the distal end of the GSA. Fig.28 , which shows a portion of a septum puncture device 1300 that includes a first GSA 1350A having a particular bend C along which a side catheter 1360 (or side catheter introducer in other implementations) can extend and engage with the first GSA. As shown, in this embodiment, bend C is different from a corresponding section of a second GSA 1350B.

[0199] In some embodiments, the septal puncture device may include one or more GSAs having multiple lobes (bilobed, trilobed, etc.). For example, the multiple lobes may reduce or limit the footprint of the GSA, thereby reducing the risk of undesired blockage in the patient. In the case where the GSA is disposed within the patient's RA, for example, it may be desirable to minimize the cross-sectional area or footprint of the GSA to allow blood to flow in a manner consistent with the normal functioning of the heart. For example, in Fig.29 A three-lobed GSA is shown in top view in As shown, the main shaft 1420 (of the septum puncture device 1400) extends axially between a first lobe GSA 1450A, a second lobe GSA 1450B, and a third lobe GSA 1450C, wherein the first lobe GSA 1450A defines a path in which a side catheter or side catheter introducer may be laid.

[0200] In some embodiments, the septum piercing device may include a GSA having multiple lobes, wherein Fig.30 In top view, at least two of the plurality of lobes differ in size or shape. Fig.30 As shown, septum puncture device 1500 includes a first lobe GSA 1550A, a second lobe GSA 1550B, and a third lobe GSA 1550C, wherein first lobe GSA 1550A has a size different from that of second lobe GSA 1550B.

[0201] In some embodiments, to further reduce the risk of blood flow obstruction, one or more GSAs may have a specific aspect ratio. Fig.31 16 shows a portion of septum puncture device 1600 in side view, where first GSA 1650A and second GSA 1650B have an overall height L1. In some cases, minimizing L1 can help limit any risk of blood flow obstruction. In this implementation, for example, L1 is less than the overall width or overall diameter of first GSA 1650A and second GSA 1650B as shown by L2.

[0202] In some embodiments, the septum piercing device may include an interlocking GSA. Fig.32 As shown in side view, first three-lobed GSA 1750A and second three-lobed GSA 1750B of septum piercing device 1700 are rotatably offset relative to each other about main axis 1750 and then enter into engagement and interlock. In some implementations, for example, first three-lobed GSA 1750A may be rotated about main axis 1750 and relative to second three-lobed GSA 1750B about 60 degrees and then interlock. In other implementations, other degrees of rotation may be used.

[0203] In some embodiments, the septum piercing device may include an asymmetric GSA. For example, Fig.33 As shown in side and top views, septum piercing device 1800 includes an asymmetric GSA 1850 disposed circumferentially about a major axis 1820 .

[0204] In some embodiments, the septum puncture device may include two side catheters (or side catheter introducers) extending in different or opposite directions and disposed between the GSAs such that the main shaft may be rotated to selectively align one, but not the other, side catheter (or side catheter introducer) with the target site to be penetrated. Fig.34As shown in side view, septum puncture device 1900 includes a first GSA 1950A and a second GSA 1950B, which together define two paths in opposite directions between them. In this way, as shown, a first side conduit 1960A can be disposed in or laid through a first path defined between the first GSA 1950A and the second GSA 1950B, and a second side conduit 1960B can be disposed in or laid through a second path defined between the first GSA 1950A and the second GSA 1950B. In use, for example, an operator can rotate spindle 1920 about its central axis to selectively align only one (at a time) of the first GSA 1950A or the second GSA 1950B with a target location (e.g., septum or FO).

[0205] In some embodiments, the septum puncture device may include an introducer coupler configured to couple a side catheter introducer or a side catheter (in some embodiments without a side catheter introducer) to the main shaft such that the introducer coupler can slide with the side catheter and relative to the main shaft. FIG. 35A to FIG. 35D An exemplary embodiment is shown in FIG. 2 , in which a septum piercing device 2000 is shown at various stages of a deployment sequence.

[0206] Similar or identical to that described with respect to other septal puncture devices described herein, septal puncture device 2000 can be used to access the left side of the heart (e.g., the left atrium) from the right side of the heart (e.g., the right atrium) and deliver a guidewire to the left side of the heart. Septal puncture device 2000 can be constructed in the same or similar manner as any of the septal puncture devices described herein and can function in the same or similar manner as any of the described. Therefore, the various parts of septal puncture device 2000 will not be described in further detail herein.

[0207] In this embodiment, the septum puncture device 2000 includes a body (not shown) that is slidably disposed about a side catheter introducer 2030 and a retractable main shaft 2020. Fig.35A As shown, the side catheter introducer 2030 is coupled to the main shaft 2020 via an introducer coupler 2040. The introducer coupler 2040 is slidable relative to the main shaft 2020. Disposed distally of the body (not shown) is a push rod 2096 that is slidably and circumferentially disposed around the main shaft 2020. The main shaft 2020 includes a GSA 2050 disposed distally of the introducer coupler 2040. Similar to that described in other embodiments herein, and as spanning FIG. 35A to FIG. 35DAs shown, the push rod 2096 is configured to be advanced relative to the main shaft 2020 and advanced into contact with the guide connector 2040 to push / advance the guide connector 2040 and the attached side catheter introducer 2030 toward the GSA 2050 and contact the GSA 2050 so that the distal end portion of the side catheter introducer 2030 is laterally deflected around the guide connector 2040 and the GSA 2050.

[0208] In some procedures involving a septal puncture device, it may be desirable to sense various parameters such as pressure, flow, temperature, oxygen, etc., within the patient's heart at or near the septal puncture device. In procedures accessing the LA of the heart, for example, it may be desirable to determine the pressure within the heart, such as within the RA or LA. Thus, in any of the embodiments described herein, a sensor may be coupled to the septal puncture device. In some implementations, for example, the septal puncture device may include an intracardiac echo ("ICE") sensor configured to enhance the operator's visualization capabilities during the procedure. Fig.36 An illustrative example is shown in . Fig.36 A portion of a septum puncture device 2100 is shown with an ICE sensor disposed within a catheter C. The catheter may represent a main shaft, a side catheter introducer, a side catheter, or a septum penetrator. In this manner, the ICE sensor may provide visualization from various orientations and locations within the patient, depending on, for example, where within the septum puncture device the ICE is disposed.

[0209] In some embodiments, the septum piercing device may include a camera in addition to or in lieu of an ICE sensor or other suitable sensor. Fig.37 An illustrative example is shown in . Fig.37 A portion of a septum puncture device 2200 is shown having a camera 2295 disposed within a GSA 2250. In some implementations, the camera 2295 may be configured to communicate wirelessly, while in other implementations, the camera 2295 may have a physical connection (e.g., a wire, an optical fiber, etc.) extending proximally from the camera 2295, through the main shaft 2220 of the septum puncture device 2200, and out of the patient. The camera 2295 may be disposed in various locations within the GSA 2250, such as, for example, disposed in contact with and coupled to an inner wall of the GSA 2250, or attached to a catheter disposed within the GSA 2250 (as described herein with respect to various embodiments). With the camera 2295 disposed within the GSA 2250, the camera 2295 may provide direct visualization of the procedure, such as the septum or FO, before, during, or after puncture.

[0210] In some procedures involving a septum puncture device, it may be desirable to flush an area adjacent to a septum penetrator, side catheter, or end effector, for example, before, during, or after puncture. To this end, any of the septum puncture devices described herein may include an irrigator (not shown) having an outlet near the septum penetrator, side catheter, or end effector and configured to flush an area at or adjacent to the irrigator location (e.g., with saline) before, during, or after puncture. The septum puncture device may also include a pressure transducer configured to measure pressure within, for example, the RA or LA, before or after puncture, for example, to verify successful puncture.

[0211] Reference Fig.38 and Fig.39 , an exemplary septum puncture device (also referred to herein as a "device") 2300 is shown. In contrast to many of the embodiments described above, instead of having a body that accommodates the main shaft and the side catheter side by side, this embodiment includes a cannula 2306 having a central lumen, and a stylus 2310 disposed in the lumen of the cannula 2306. The cannula 2306 extends from the distal end 2302 to the proximal end 2304. The cannula 2306 has an elongated hollow tubular shape having a lumen running therethrough. The cannula 2306 includes an opening at its distal end 2302, and at least one elongated window 2308 adjacent to its distal end 2302, wherein both the opening and the at least one window 2308 are fluidly connected to the lumen of the cannula 2306. The cannula 2306 may have any suitable size. For example, the cannula 2306 may have an outer diameter between about 14 and 22 French (about 5 mm to 7 mm). In some implementations, the cannula 2306 can have one or more surface coatings. Suitable surface coatings can reduce friction or irritation, and can include anticoagulants such as heparin, ethylenediaminetetraacetic acid (EDTA), oxalates, and the like.

[0212] Device 2300 also includes an elongated flexible tubular feeler 2310 sized to fit within the lumen of cannula 2306. Feeler 2310 corresponds functionally to the combination of the side catheter introducer and side catheter in the embodiments described above. In some implementations, feeler 2310 has a configuration such as Fig.40A and Fig.40B23. The articulated portion may extend over the entire length of the feeler 2310, or only over a portion of the feeler 2310. In some embodiments, the feeler 2310 is articulated at a length between about 2 cm and 4 cm from the distal end 2302. The feeler 2310 includes a first lumen sized to fit a hollow needle 2312, which corresponds to the septum penetrator in the embodiments described above. The hollow needle 2312 also has a guidewire lumen sized to fit any suitable guidewire 2314, such as a 0.035" guidewire (corresponding to the guidewire connector in the embodiments described above). In some embodiments, the feeler 2310 includes one or more additional lumens, each of which is sized to fit a cable 2316.

[0213] The device 2300 also includes a handle 2318 at its proximal end 2304 (see, e.g., Fig.41 ). The handle 2318 includes an extension knob 2320 and at least one angle screw 2322. The extension knob 2320 is connected to the proximal end of the stylus 2310 and can be actuated to extend and retract the stylus 2310 within the sleeve 2306. Each of the at least one angle screw is connected to the proximal end of the cable 2316 and can be actuated to extend and retract the connected cable 2316 within the stylus 2310. In some implementations, the handle 2318 also includes one or more actuatable knobs or screws that can be connected to the needle 2312 and the guide wire 2314 so that the extension and retraction of the needle 2312 and the guide wire 2314 within the stylus 2310 can be accurately achieved.

[0214] Reference FIG. 42A to FIG. 42D , the device 2300 is shown in several stages of deployment of the stylus 2320. Fig.42A 2318, the stylus 2320 lies flat within the cannula 2316 and does not protrude from the window 2318. In this configuration (delivery configuration), the cannula 2316 can be manipulated to a desired location without being obstructed by the stylus 2320. For example, the device 2300 can be delivered to a desired location by a first delivery guidewire (not shown) disposed in the guidewire lumen of the hollow needle 2322. After delivery to the desired location, the delivery guidewire can be withdrawn from the device 2300, and a second guidewire can be disposed through the guidewire lumens of the device 2300 and the hollow needle 2322.

[0215] exist Figure 42B to Figure 24D, the cable 2326 is retracted within the stylus 2320, such as by a connected angle screw 2332 on the handle 2328. Retracting the cable 3226 causes the stylus 20 to angle away from the window 2318 in the direction of the retracted cable 2326 toward the deployed configuration. For example, a stylus 2320 having two or more cables 2326 can have its distal tip angled in the direction of any of the cables 2326 by retracting one or more cables 2326. The degree of angulation can be varied between approximately 0 and 90 degrees relative to the axis of the cannula 2316 by adjusting the amount of retraction of the cable 2326 at the connected angle screw 2332. In various implementations, such as in Fig.42D , the stylus 2320 can be repositioned within the cannula 2316 by adjusting the extension knob 2330. The combination of angulation control and position control of the stylus 2320 relative to the cannula 2316 enables the device 2300 to accurately aim the needle 2322 at the FO. In certain implementations, the device 2300 can aim at a specific location of the FO. The FO can be divided into a plurality of quadrants, wherein the puncture in each quadrant facilitates a specific procedure. For example, the device 2300 can be intended to slightly puncture the upper posterior side, and 3.5 cm to 4.5 cm above the mitral valve for a typical Mitraclip device, and is also configured to puncture the slightly lower posterior side within the FO for a typical left atrial appendage occlusion device.

[0216] In various implementations, the device 2300 may also include one or more modifications to enhance its performance. For example, in some embodiments, the device 2300 may include one or more additional instruments positioned within the lumen of the stylus 2320, such as an endoscopic assembly, an ultrasonic transducer, a temperature sensor, an oxygen probe, a flow sensor, a cauterizer, and the like. In another example, the device 2310 may include one or more radiopaque or highly echogenic markers positioned on the cannula 2316, the stylus 2320, or both. The markers enable the position of the device 2310 to be monitored via fluoroscopy or echocardiography, and the markers may be placed at or near a target structure, including but not limited to the distal tips of the cannula 2316 and the stylus 2320 and at least one window 2318.

[0217] In some embodiments, the device 2300 may include Fig.43A and Fig.43BThe atraumatic support 2334 is shown. The atraumatic support 2334 has an elongated tubular shape and can be assembled around the needle 2322 within the first lumen of the stylus 2320. The atraumatic support 2334 also includes a blunt tip at its distal end. In some embodiments, the blunt tip includes an inflatable balloon. In another embodiment, the blunt tip is a flat end effector. In yet another embodiment, the blunt tip is a ring-shaped end effector. The blunt tip of the atraumatic support 2334 provides a larger surface area for the distal end of the stylus 2320 to minimize damage, and improves stability by providing uniform pressure when placed against a tissue surface, such as a FO. Fig.44 , the device 2310 is shown as having an atraumatic support 2336 having a bell-shaped tip that is configured to be collapsible and retractable into a sheath 2338 attached to the distal end of the feeler 2320. Similar to the atraumatic support 2334, the atraumatic support 2336 is generally configured to increase the surface area of ​​the feeler 2320 in contact with the FO tissue (before puncturing the FO) to reduce pressure on the tissue and reduce or prevent the possibility of premature puncture or injury. The collapsible design enables the device 2310 to support a wide bell-shaped tip within the boundaries of the cannula 2316, such as a width of between about 8 mm and 15 mm. Now refer to FIG. 45A to FIG. 45D , showing in detail the geometry of the atraumatic support 2336. The atraumatic support 2336 includes a bell-shaped tip at its distal end having a plurality of undulating corrugations. Drawing the atraumatic support 2336 back into the sheath 2338 causes the bell-shaped tip to come together in a controlled manner to fit within the sheath 2338 while maintaining a space for the needle 2322 to pass through. The needle 2322 can thereby be extended and retracted through the bell-shaped tip of the atraumatic support 2336, regardless of whether the bell-shaped tip is in a collapsed configuration or an open configuration.

[0218] In some implementations, the device 2300 can include a stiffening element configured to modify the stiffness of a section of the device 2323. Increasing the stiffness of a section of the device 2300, such as a section of the cannula 2316 that includes the at least one window 2318, provides the device 2300 with a stable support against which the extended stylus 2320 and needle 2322 can be pushed to penetrate tissue.

[0219] Reference Fig.46A and Fig.46B, the device 2300 is shown as having a reinforcing element, which includes a ridge 2340 and a cable 2342. The ridge 2340 is positioned within the second lumen of the sleeve 2316 and extends at least to the location of the at least one window 2318. The ridge 2340 is constructed so that the ridge is flexible when relaxed and rigid when compressed. For example, in some implementations, the ridge 2340 is an elongated tubular member composed of a compressible polymer. In other implementations, the ridge 2340 is made of a long series of interlocking segments or a series of hollow tubules that are loosely positioned next to each other, such as composed of plastic or metal. The cable 2342 extends over the entire length of the ridge 2340 and includes a tip at its distal end that is wider than the ridge 2340. Retracting the cable 2342 presses its tip against the distal end of the ridge 2340, thereby compacting the entire length of the ridge 2340 and strengthening the ridge 2340 and the length of the cannula 2316 where the ridge 2340 resides. Extending the cable 2342 releases the pressure applied by its tip on the distal end of the ridge 2340, which causes the ridge 2340 and the length of the cannula 2316 where the ridge 2340 resides to become relaxed.

[0220] Reference FIG. 47A to FIG. 47D , an exemplary segmented septum puncture device 2400 is shown. The device 2400 includes a plurality of interlocking segments 2456 between a distal end 2452 and a proximal end 2454. The interlocking segments 2456 may have any suitable configuration to form an elongated flexible member. For example, in some implementations, each interlocking segment 2456 includes a first end having a small hollow spherical shape and a second end having a large hollow spherical shape, such that the first end of one interlocking segment 2456 fits flush within the second end of another interlocking segment 2456 to form a ball joint. The plurality of interlocking segments 2456 connected in this manner thereby form a series of elongated articulated ball joints. In other implementations, the interlocking segments 2456 may form a gooseneck member, a snake chain member, and the like. The device 2400 also includes at least a first cable 2458a, a second cable 2458b, and a third cable 2458c that runs through its entire length, each cable 2458a, 2458b, and 2458c being arranged equidistant from each other in a radial pattern. Each cable 2458a, 2458b, and 2458c is attached to the most distal interlocking section 2456, so that retracting any one or both of the cables 2458a, 2458b, or 2458c causes the distal end 2452 of the device 50 to curl in the direction of the retracted cable. Retracting all of the cables 2458a, 2458b, and 2458c with the same amount of force causes the device 2450 to strengthen and maintain its instant shape.

[0221] Reference FIG. 48A to FIG. 48D , two exemplary configurations of the device 2450 are shown. FIG. 48A to FIG. 48DIn , the device 2450 fits within the lumen of a cannula 2462 and includes a needle 2460 extending through the hollow interior thereof. Fig.48C and Fig.48D 24, the device 2450 fits within a first lumen of a cannula 2462, and the needle 2460 fits within a second lumen of the cannula 2462. In this configuration, the hollow interior of the device 2450 can be used to house additional instrumentation, such as an endoscope assembly, an ultrasound transducer, any number of sensor probes (including temperature probes, oxygen sensors, flow sensors), and the like.

[0222] Reference Figures 49 to 52 , an exemplary septum puncture device 2500 is shown. Similar to other septum puncture devices described herein, device 2500 includes a cannula 2506 (corresponding to the body of the embodiments described above) extending from a proximal end 2502 to a distal end 2504. The cannula 2506 has an elongated hollow tubular shape having a lumen extending between its proximal end 2502 and an opening at its distal end 2504. In some embodiments, the cannula 2506 can be described as having two sections, namely a proximal cannula 206a and a distal cannula 2506b. Near the distal end 2504 and positioned between the proximal cannula 2506a and the distal cannula 2506b, the device 2500 includes a balloon 2508 (corresponding to the GSA in the embodiments described above) that can be expanded from a relaxed state to an expanded state. The balloon 2508 is elastic and can be waterproof. Balloon 2508 may be expanded to a pressure between about 2 and 20 atmospheres using any suitable fluid, including liquids (such as saline) and gases (such as air). Higher expansion pressures generally increase the stiffness of balloon 2508 to improve stability (i.e., vertically and laterally). In some embodiments, balloon 2508 may be supported by one or more outer arms, or surrounded by a mesh, such as to achieve additional stability during expansion or tissue puncture. Balloon 2508 may be expanded to any desired diameter. In some embodiments, the diameter of the expansion of balloon 2508 depends on the anatomical space in which the balloon is positioned. For example, balloon 2508 may be expanded to have a diameter that presses against or does not press against the wall of the right atrium or inferior vena cava, such as to provide further stability to extend the stylus 2512 to pierce the FO (usually reducing image guidance requirements in some cases).

[0223] exist Fig.502508, an exemplary internal arrangement of the device 2500 is shown in a cross-sectional view of the device 2500 taken proximal to the balloon 2508. The lumen of the cannula 2506 is sized to fit an elongated tubular sheath 2510 (corresponding to the side catheter introducer of the embodiment described above), which has a lumen sized to fit an elongated tubular feeler 2512 (corresponding to the side catheter of the embodiment described above), which in turn has a lumen sized to fit a hollow needle 2514 (corresponding to the septum penetrator of the embodiment described above), which in turn has a lumen sized to fit a guidewire 2516 (e.g., a guidewire to be delivered across the septum, corresponding to guidewire GW2 in the embodiment described above). The sleeve 2506 also includes a second guidewire lumen 2517 sized to fit a second guidewire GW1 (e.g., a guidewire utilized to deliver the device 2500 to a desired location, corresponding to the guidewire GW1 in the embodiments described above). The guidewire 2516 may be any suitable guidewire, such as a 0.035" guidewire, a 0.025" guidewire, a flower body wire (e.g., a Baylis left atrium wire), and the like. The expansion tube 209 is disposed within the lumen of the sleeve 2506, wherein the expansion tube 2509 has an inner lumen that is fluidically connected to the balloon 2508 for expansion and contraction. In some embodiments, the sleeve 2506 may include one or more reinforcing rods 2518 having a selected length to provide greater stiffness to the device 2500 in a desired section.

[0224] The distal tip of the sheath 2510 is fastened to the outer surface of the balloon 2508 by the balloon grommet 2507. In this configuration, the balloon 2508 can be expanded and deflated without leaking from the balloon grommet 2507 or the sheath 2510, and the sheath 2510 can provide access to the outside of the balloon 2508. The grommet 2507 can include a smooth inner surface (or other surface treatment) to reduce friction between the stylus 2512 and the grommet 2507, such as when inflating or deflation of the balloon 2508 or when advancing or retracting the stylus 2512 through the sheath 2510. The grommet 2507 can be constructed of any suitable material including plastic, metal, composite material, ceramic, etc. The grommet 2507 can also be configured to have a specific shape or edge, so that the inner surface has a bevel or chamfer. In one embodiment, the grommet 2507 is positioned at the widest radial point or perimeter on the balloon 208, but the grommet 2507 is not limited to placement at other locations.

[0225] In some implementations, the stylus 2512 has an atraumatic end effector 2511 positioned at the distal tip (e.g., with Fig.59B2510 ), wherein the end effector 2511 has a disc shape configured to bulge tissue (such as FO) and apply pressure without inadvertent puncture. The end effector 2511 may have a bell-shaped tip configured to be collapsible and withdrawn into the sheath 2510. The collapsible design enables the device 2500 to support a wide bell-shaped tip within the sheath 2510, such as a width of between about 8 mm and 15 mm. The end effector 2511 may include a bell-shaped tip having a plurality of undulating folds. Withdrawing the end effector 2511 into the sheath 2510 causes the bell-shaped tip to come together in a controlled manner to fit within the sheath 2510 while maintaining a certain space for the needle 2514 to pass through. The needle 2514 can thereby extend and retract through the tip of the end effector 2511, regardless of whether the tip is in a collapsed configuration or an open configuration. In some embodiments, the lumen of the stylus 1510 can receive a radiofrequency probe having a rounded metal tip, where the metal tip can be electrified via an electrical current (eg, radiofrequency ablation) to penetrate tissue in lieu of a needle.

[0226] The device 2500 is configured to improve the lateral stability of the needle 214 when piercing tissue, such as FO. The balloon 2508 has an expanded state ( Fig.49 ) and the relaxed state with a thin profile ( Fig.52 ). The relaxed state defines the delivery configuration of the device 2500 and permits the device 2500 to be introduced into the right atrium of the patient's heart so that the distal end 2504 of the device 2500 can be positioned within the superior vena cava of the subject. In some embodiments, the balloon 2508 in the relaxed state can be folded over the end effector 2511, the stylus 2512, and the sheath 2510, wherein the folded configuration (or delivery configuration) is maintained during insertion of the device 2500 and advancement of the device into the right atrium (similar to an intra-aortic balloon pump). Therefore, the device 2500 does not typically require a "sheath" catheter to be positioned over (i.e., covering) the assembly of the folded balloon 2508, the end effector 2511, the stylus 2512, and the sheath 2510 during insertion or withdrawal. In some implementations, the device 2500 may be provided with a cannula or sleeve that slides over the balloon 2508 in the relaxed state. In the expanded state, the balloon 2508 is configured to be sufficiently rigid to enhance stability (e.g., lateral stability). In some embodiments, the balloon 2508 is configured to selectively press against the wall of the right atrium adjacent to the FO to further enhance stability (e.g., lateral stability). The device 2500 thereby provides stability in the area immediately behind the stylus 2512 by expansion to provide a larger clearance for FO access.

[0227] In some embodiments, the balloon 2508 is configured to improve the stability and accuracy of piercing tissue (i.e., the maneuverability of the feeler 2512). For example, the grommet 2507 may be placed at a point on the balloon 2508 as described above, such that the feeler 2512 protrudes through the balloon 2508 through the sheath 2510 at an angle relative to the long axis of the cannula 206 when the balloon 2508 is in an expanded state. Thus, the balloon 2508 functions in a manner similar to the GSA in the embodiments described above. In some embodiments, the angle is between about 60 and 180 degrees. In some embodiments, the angle is between about 60 and 140 degrees. In some embodiments, the angle is between about 60 and 100 degrees. In some embodiments, the angle is between about 80 and 120 degrees. In some embodiments, the angle is approximately 90 degrees. In some embodiments, the angle is approximately 80 degrees (e.g., see Fig.59A ). In some embodiments, the angle is approximately 110 degrees. In some embodiments, the stylus 2512 may protrude approximately 3-4 cm from the balloon 2508, such that the protruding portion of the stylus 2512 is generally straight.

[0228] The balloon 2508 can also be configured to affect the angle of the stylus 2512 when inflated. For example, the balloon 2508 can have a generally spherical shape, while in other implementations, the balloon 2508 has an elliptical shape. Further, the balloon 2508 can be generally symmetrical or asymmetrical (see Fig.53A ). For example, the asymmetric balloon 2508 may have a larger expansion radius at the grommet 2507 than at a portion of the balloon 2508 opposite the grommet 2507. In another example, the asymmetric balloon 2508 may have a different expansion radius at the grommet 2507 than at a portion of the balloon 2508 circumferentially adjacent to the grommet 2507. According to the cross-sectional view, the sleeve 2506 will thus be non-concentric with the expanded balloon 2508. Therefore, the grommet 2507 can be positioned at a point on the balloon 2508 (having a certain expansion radius) that provides a preferred angle for the stylus 2512 when the balloon 2508 is in an expanded state to improve the stability and maneuverability of the stylus 2512.

[0229] In some implementations, the balloon 2508 can be shaped to allow blood to flow around the balloon 2508. For example, the balloon 2508 can have multiple lobes, such as longitudinally oriented (or axially oriented) lobes (see Fig.53B). In the expanded state, the lobes on the balloon 2508 provide lateral stability by positioning the stylus 2512 at a preferred angle, while the varying expansion radius of the balloon 2508 permits blood to flow around portions of the balloon 2508 (e.g., if the balloon 2508 were to be wedged into the superior or inferior vena cava). Additionally, the lobes on the balloon 2508 may have lateral faces to further enhance the lateral stability of the stylus 2512. For example, the plurality of lobes may form a shape or pattern resembling a spiral or helix.

[0230] In some implementations, the balloon 2508 can be positioned adjacent to the cannula 2506. Fig.53C As shown, the sheath 2510 can be placed in a groove in the sleeve 2506, with the balloon 208 folded around the sheath 210. Inflating the balloon 2508 pushes the sheath 2510 away from the sleeve 2506, thereby positioning the stylus 2512 at a desired angle. In some implementations, the angle can be adjusted by changing the amount of inflation of the balloon 2508.

[0231] In some implementations, the balloon 2508 can be shaped to have a concave or convex surface. For example, FIG. 54A to FIG. 54C Device 2500 is shown having a balloon 2508 with a concave proximal surface. A sheath 2510 can be attached to the concave proximal surface and bend accordingly, thereby being configured to direct the stylus 2512 outward in a lateral direction. In some implementations, the sheath 2510 can be external to the balloon 2508 or partially external to the balloon. For example, Fig.55 A cross-sectional view of a sheath 2510 partially embedded within the outer surface of the balloon 2508 is shown. It should be understood that the sheath 2510 can have any desired cross-sectional shape, including but not limited to Fig.55 Oval and arcuate cross-sections are shown.

[0232] In various implementations, the device 2500 may also include one or more modifications to enhance its performance. Figures 19 to 23 As shown and described above, the device 2500 can be modified to include an additional sheath 2510, a stylus 2512, a needle 2514, and a guidewire 2516. Fig.56As shown, additional sheaths 2510, styluses 2512, needles 2514, and guidewires 2516 may be secured to balloon 2508 to provide separate puncture sites. In this way, styluses 2512 may be used to allow separate punctures to perform different procedures or to perform different steps of a procedure, such as a first needle 2514 for a first procedure or step, and a second needle 2514 for a second procedure or step, etc. Each needle 2514 may be positioned on the FO relative to one another (e.g., by positioning stylus 2512 within the right atrium, rotating stylus 2512, and adjusting the angle of stylus 2512) to more desirably position each of the needles on the FO for each respective procedure or surgical step in which the needle 2514 is being used. Thus, device 2500 may be configured with multiple extendable elements in close proximity to allow simultaneous punctures.

[0233] In another example, the device 2500 may include one or more corrugations, or radiopaque, echogenic, or acoustically opaque markers. The markers enable the position of the device 2500 to be monitored via fluoroscopy or echocardiography, and the markers may be placed at or near a target structure, including but not limited to at least a portion of the cannula 2506, the stylus 2512, the end effector 2511, the balloon 2508, and the like.

[0234] The various components of the embodiments described herein can be constructed using any suitable method. Depending on the materials used, the manufacturing method may be different. For example, a component substantially comprising metal can be milled from a larger block of metal, or can be cast from molten metal. Similarly, a component substantially comprising plastic or polymer can be milled from a larger block, cast or injection molded. In some embodiments, the device can be manufactured using 3-dimensional ("3D") printing or other additive manufacturing techniques. In addition, it should be understood that any description applicable to one embodiment of the present invention is equally applicable to all embodiments described elsewhere herein.

[0235] The septum piercing devices described herein may be used in conjunction with any suitable handle suitable for the components of the device. Fig.57, an exemplary handle assembly 2680 is shown. The handle assembly 2600 includes a main shaft handle 2602 that is coupled to the side catheter handle 304 by a side catheter deflection knob 2606. The knob 2606 can be tightened to secure the handle 2604 to the handle 2602, and loosened to permit the handle 2604 to be actuated relative to the handle 2602. The handle assembly 2680 also includes a plurality of lumens connected to the opening, the lumens and the opening being sized to receive a guidewire and a needle. The handle 2602 includes a lumen and an opening connected to a balloon inflation syringe 2608. A valve or stopcock 2610 is provided at the junction between the handle 2602 and the syringe 2608. The handle assembly 2680 also includes a needle handle 2612 and a needle safety lug 2614.

[0236] Although handle assembly 2680 can be connected to any septum puncture device described herein, the handle assembly is now described with respect to device 2500 by way of example. Handle 2602 can be connected to the cannula of the septum puncture device, such as the proximal end of cannula 2506, to manipulate, rotate, advance and withdraw the cannula. Handle 2604 can be connected to the stylus of the septum puncture device, such as the proximal end of stylus 2512, to manipulate, rotate, advance and withdraw the stylus. The venous guidewire 2516 inserted into the distal opening of device 2500 is configured to leave handle assembly 2680 through the side opening on handle 2602. Syringe 2608 is fluidly connected to expansion lumen 2509 to expand and contract balloon 2508, wherein stopcock 2610 can be actuated to maintain or release the expanded state of balloon 2508. Needle 2514 is connected to handle 2612 at the proximal end, wherein needle safety lug 2614 can be clamped between handle 2604 and handle 2612 on the proximal end of needle 2514 to prevent the inadvertent extension of needle 2514. Atrial guidewire 2516 residing in needle 2514 can extend proximally from handle 2612. In various embodiments, handle assembly 2680 also includes one or more actuable rotations or screws that can be connected to sleeve, stylus, needle and guidewire, so that the extension and retraction of the parts can be accurately achieved. In some embodiments, handle assembly 2600 may include a part configured to further manipulate components, such as a pull cable.

[0237] Reference Fig.58 and FIG. 59A to FIG. 59D , describes the operation of the device 2500 using the handle assembly 2680. Fig.59A In FIG. 2 , the balloon 2508 is inflated to an expanded state using a syringe 2608 and maintained in the expanded state by closing the stopcock 2610. The inflation of the balloon 2508 causes the sheath 2510 to be angled away from the cannula 2506, such as by being angled 80 degrees relative to the long axis of the cannula 2506. Fig.59BIn the embodiment, the knob 2606 is loosened to advance the handle 604 toward the handle 2602 and extend the stylus 2512 from the sheath 2510, thereby exposing the end effector 2511. The stylus 2512 can be extended to any desired length, such as about 3-4 cm, and is held in place by tightening the knob 2606. Fig.59C In FIG. 2 , the device 2500 is positioned adjacent to the atrial septum such that the end effector 2511 presses against the FO and bulges the FO. Fig.59D In the embodiment of the present invention, the needle safety lug 2614 is removed to allow the handle 2612 to be advanced toward the handle 304 and the needle 2514 to be extended from the contact needle 2512 to puncture the FO. The needle 2514 can extend any desired length, such as about 4-10 mm. The atrial guidewire 2516 can then be advanced in the distal direction to pass through the needle 2514, the FO and into the left atrium.

[0238] exist FIG. 60A to FIG. 60D Another embodiment of a device 2700 is shown in FIG. The device 2700 has a plurality of slits 2775 evenly distributed around the body near the distal end of the device, thereby defining a plurality of arms 2776 therebetween. Compressing the device 2700 on either side of the plurality of slits 2775 causes the arms 2776 to expand outwardly, thereby exposing a stylet needle catheter segment 2778, which may be of rigid construction, formed of a hard plastic or metal, and permits at least the distal end 2771 of the cannula 2774 to be proximally advanced over the catheter segment 2778 to effect expansion of the arms 2776. In certain embodiments, the distal end 2771 of the cannula 2774 is manipulated using one or more pull cables extending through the length of the device 2700. For example, the one or more pull cables may be retracted equally to cause each arm 2776 to expand evenly and form an opening of equal size between each arm 2776. In another example, one or more puller cables can be selectively retracted so that puller cables that are under greater tension cause greater expansion of the arms 2776 closest to those puller cables, thereby changing the geometry of the opening between each arm 2776. The expanded arms 2776 provide clearance for the stylet 80 to extend from the catheter segment 78, and also for the hollow needle 82 to extend from the stylet 80, as well as any desired guidewire to extend from the hollow needle 2782.

[0239] Device 2700 has a relaxed state (or delivery configuration, shown in FIG. Fig.60A ) and the expanded state (or unfolded configuration, shown in Fig.60B). The relaxed state permits the device 2700 to be introduced into the right atrium of the patient's heart so that the distal end of the device 2700 rests in the patient's superior vena cava. In the expanded state, the plurality of arms 2776 are configured to selectively press against the wall of the right atrium adjacent to the FO to enhance stability (e.g., lateral stability). The device 2700 thus provides at least two stable platforms for septal puncture using a stylet 2780: the plurality of arms 2776 press directly against the heart tissue, and the catheter segment 2778 is suspended between the plurality of arms 2776. It may be desirable in some cases to selectively retract the pull cables in the device 2700 so that the device 2700 expands unevenly. For example, the device 2770 may be expanded so that the arms 2776 adjacent to the stylet 2780 are greatly expanded to provide a larger gap for FO access, while the arms 2776 behind the stylet 2780 may be expanded to a lesser extent to improve the stability of the area immediately behind the stylet 2780.

[0240] Reference Figures 61A to 61H , showing additional implementations of various configurations of the device 2700. Although the exemplary device 2700 is shown as having three and six arms 2776, it should be understood that the device 2700 may have any suitable number of arms 2776, such as between about three and ten arms. In certain embodiments, as Fig.61E and Fig.61F As shown, each of the multiple arms 2776 can be connected by one or more straps 2786. By connecting each arm 2776 to its adjacent arm 2776, the straps 2786 improve the stability of the device 2700 by moderating the lateral movement of each arm 2776 and preventing injury from over-expansion of the arms 2776. In certain embodiments, as Figure 61G and Fig.61H As shown, the plurality of arms 2776 may be encased in a cover 2788. The cover 2788 is elastic and may be waterproof to smoothly guide the device 2700 into a relaxed state and provide a larger surface area in the expanded state, which distributes pressure and reduces trauma. The cover 2788 also provides the same benefits of the strap 86, in that the cover 88 mitigates lateral movement and over-expansion of the arms 76 to improve stability. Fig.61H , stylet 2780 and needle 2782 are shown as being able to penetrate covering 2788 to access and puncture the FO.

[0241] Reference Fig.62A and Fig.62B, an exemplary implementation of the device 2700 is shown with a cuff introducer 2789. The cuff introducer 2789 provides additional stability by coupling the extended stylus 2780 to the expanded arms 2776. In some embodiments, the cuff introducer 2789 is attached to the distal end of the stylus 2780 so that after the plurality of arms 2776 are expanded, the stylus 2780 can extend along the expanded arms 2776 as the cuff introducer 2789 slides over the expanded arms 2776. In other embodiments, the cuff introducer 2789 is welded to both the distal end of the stylus 2780 and the expanded arms 2776 so that the expansion action of the arms 2776 simultaneously extends the stylus 2780 and bends the stylus 2780 toward the FO.

[0242] Reference Figures 63A to 63C , shows an exemplary articulated septum puncture device 90. The device 2800 has a distal end 2891, a proximal end 2892, and a cannula 2894 extending therethrough. The device 2800 has an articulated arm 2895 near its distal end 2891, which rests within the cannula 2894 adjacent to a window 2896. The articulated arm 2895 is attached to the distal end of a stylus 2898 such that rotating the articulated arm 2895 out of the window 2896 causes the stylus 2898 to extend out of the cannula 2894 to face the FO. Although the exemplary embodiment of the device 2800 is Fig.63B and Fig.63C 2895 are shown as having one and two articulation points, respectively, but it should be understood that the articulated arm 2895 can have any suitable number of articulation points, such as between about one and ten. The articulated arm 2895 can be rotated using any suitable means, including but not limited to one or more pull cables, one or more servo motors, one or more hydraulic pistons, etc.

[0243] In some embodiments, the needle can be aimed at a specific area of ​​the FO for puncture. For example, the FO can be divided into multiple quadrants, where puncture in each quadrant is conducive to a specific operation. Therefore, for the Mitraclip device, it can be aimed to slightly puncture the upper posterior side, and 3.5cm to 4.5cm above the mitral valve, or for a typical left atrial appendage occlusion device, puncture the posterior side slightly lower in the FO. After a successful puncture and insertion of a guidewire, the septal puncture device can be completely removed to make room for any suitable instrument or device to be introduced into the left atrium of the heart to perform the desired operation, such as atrial fibrillation ablation, left atrial appendage occlusion, and valve replacement.

[0244] Various embodiments described herein include GSAs or balloons that are configured to transition between a delivery configuration and a deployed configuration. In some implementations of any of the embodiments described herein, one or more GSAs or balloons may be partially or completely covered by a mesh made of any suitable material (e.g., nylon, polymers, etc.). For example, the mesh coupled to the balloon may facilitate a preferred predetermined shape of the balloon when inflated, or may assist in one or more steps of inflating the balloon by, for example, providing additional stability. Fig.64 An example illustration of a mesh covering a balloon is shown in , which shows a GSA 2950 covered by a mesh GSA 2955, both of which are disposed circumferentially around a main axis 2920. In some embodiments, the mesh can be used to secure (slidably or fixedly) one or more balloons to a side catheter introducer or side catheter.

[0245] Although the various embodiments described herein focus on the use of puncture devices to puncture the septum of the heart, the functionality provided by the various puncture devices described herein may be desirable in other procedures and in other locations on a patient. For example, there are many procedures in which it is desirable to be able to provide a stable, precise, safe, and repeatable lateral puncture. In some cases, for example, any of the puncture devices described herein may be used to facilitate a tricuspid valvuloplasty. For example, the puncture device may be arranged such that the central axis of the main shaft of the puncture device is parallel to the plane of the tricuspid valve, and thus, the puncture device may provide lateral or vertical access to the annulus of the tricuspid valve, such as to deliver sutures, screws, or other anchoring devices to achieve the purpose of a tricuspid valvuloplasty.

[0246] As another example, the puncture devices described herein can provide access and a direct vector to the coronary sinus of the heart to, for example, insert or deliver a wire, catheter, mitral valve repair device, pacemaker lead, etc. into the coronary sinus.

[0247] As another example, the puncture device described herein can be used to deliver a therapeutic repair or replacement device to the mitral valve in the heart. If, for example, the side catheter introducer or side catheter disclosed herein is further extended and extends beyond about 90 degrees, the side catheter can be guided into the LA and guided toward the mitral valve. In some cases, the natural trajectory of the side catheter will be angled toward the mitral valve or guided toward the mitral valve in some embodiments described herein when extending or advancing a suitable distance. For example, when the side catheter presents its laterally deflected shape or orientation, the side catheter may be bent or have an arc so that further advancement relative to the main axis will cause the side catheter to advance along this bend or arc, so that the distal end of the side catheter turns or further deflects laterally toward the mitral valve. In other words, in some cases, the side catheter is advanced from its delivery configuration to the advancement / deployment configuration, which may include the distal end of the side catheter being laterally deflected up to about 180 degrees.

[0248] As another example, the puncture devices described herein may be incorporated with an intracardiac echogenic catheter to achieve accelerated transseptal puncture.

[0249] As another example, the puncture devices described herein may be used in conjunction with cardiac arrest. In such cases, for example, one or more puncture devices may be used in conjunction with a wide curved catheter to enable a guidewire to be guided or delivered from the femoral vein, across the FO, through the mitral valve and out of the left ventricular outflow tract ("LVOT") / aortic valve. In some embodiments, the balloon / flow guiding catheter will be advanced across the FO into the LA, across the mitral valve, and then across the LVOT / aortic valve; for example, the balloon will be used to "flow guide" the catheter, leading out of the LVOT and across the aortic valve into the aorta. Once in place, the wire can be used as a track for a small catheter that can provide extracorporeal membrane oxygenation ("ECMO") and oxygen to the brain. The distal end of the catheter in the aorta will be the outflow portion, and the more proximal port (e.g., in the RA or IVC) will be the inflow portion of the pump.

[0250] As another example, the puncture devices described herein may be used in the aorta to facilitate delivery of branch vessel stents, to deliver coils to branch vessels, or to deliver mesh for cerebral embolic protection to vessels of the head.

[0251] Detailed embodiments of the present disclosure have been disclosed herein for the purpose of describing and illustrating the claimed structures and methods that may be embodied in various forms, and the detailed embodiments are not intended to be exhaustive or limited to the disclosed embodiments in any way. Many modifications and variations will be apparent without departing from the scope of the disclosed embodiments. The terms used herein are selected to best explain the principles, practical applications, or technical improvements over current technologies of one or more embodiments, or to enable understanding of the embodiments disclosed herein. As described, in order to avoid unnecessarily obscuring the embodiments of the present disclosure, details of well-known features and technologies may be omitted.

[0252] References in this specification to "one embodiment," "an embodiment," "an example embodiment," etc. indicate that the described embodiment may include one or more particular features, structures, or characteristics, but it should be understood that such particular features, structures, or characteristics may or may not be common to every disclosed embodiment disclosed herein. In addition, such phrases themselves do not necessarily refer to any one particular embodiment. Therefore, when one or more particular features, structures, or characteristics are described in conjunction with an embodiment, whether or not explicitly described, it should be recognized that it is within the knowledge of those skilled in the art to implement such one or more features, structures, or characteristics in conjunction with other embodiments when applicable.

[0253] The parameters, dimensions, materials, and configurations described herein are intended as examples, and the actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications in which the creative teachings are used. Therefore, it should be understood that the foregoing embodiments are presented by way of example only and are within the scope of the appended claims and their equivalents; and the embodiments may be practiced in a manner different from that specifically described and claimed. The embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods (if such features, systems, articles, materials, kits, and / or methods are not mutually contradictory) is included within the scope of the present disclosure.

[0254] As used herein, the phrase "and / or" should be understood to mean "either or both" of the elements so combined, i.e., appearing jointly in some cases and separately in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so combined. Other elements may optionally appear in a manner different from the elements specifically identified by the "and / or" phrase, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to "A and / or B" when used in conjunction with open language such as "comprising" or "including" may refer to only A (optionally including elements other than B) in one embodiment; to only B (optionally including elements other than A) in another embodiment; to both A and B (optionally including other elements) in yet another embodiment, etc.

[0255] As used herein, the term "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating the items in a list, "or" or "and / or" should be interpreted as inclusive, i.e., including at least one of a plurality of elements or a list of elements, and including more than one, and optionally additional unlisted items. Only terms that are clearly indicated to the contrary, such as "only one of..." or "exactly one of..." or "consisting of..." when used in the claims will refer to the inclusion of exactly one element in a plurality of elements or a list of elements. In general, when there are exclusive terms in front, such as "any one", "one of...", "only one of..." or "exactly one of...", the term "or" as used herein should only be interpreted as indicating an exclusive alternative (i.e., "one or the other, not both"). "Substantially consisting of..." when used in the claims should have its ordinary meaning as used in the field of patent law.

[0256] As used herein, the terms "about" and / or "approximately" when used in conjunction with values ​​and / or ranges generally refer to those values ​​and / or ranges that are close to the values ​​and / or ranges. In some cases, the terms "about" and "approximately" may mean within ±10% of the values. For example, in some cases, "approximately the diameter of the device" may mean within ±10% of the diameter of the device. The terms "about" and "approximately" are used interchangeably. Similarly, the term "substantially" when used in conjunction with one or more physical and / or geometric features, one or more structures, one or more characteristics, one or more relationships, etc., is intended to convey that the one or more features, one or more structures, one or more characteristics, one or more relationships, etc. defined so are nominally one or more features, one or more structures, one or more characteristics, one or more relationships, etc. As an example, a first quantity is described as "substantially equal to" a second quantity to convey that there may be some variation, but the equality may be expected. Such variation may be caused by manufacturing tolerances, limitations, approximations, and / or other practical considerations. Therefore, the term "substantially".

[0257] Although various embodiments have been described above, it will be understood that the various embodiments are presented by way of example only and not limitation. Where the schematic diagrams and / or embodiments described above indicate that a particular component is arranged in a particular orientation or position, the arrangement of the components may be modified. Although embodiments have been specifically shown and described, it will be understood that various changes may be made in form and detail. Although various embodiments have been described as having specific features and / or combinations of components, other embodiments having any combination of features and / or components from any of the embodiments described herein are possible.

[0258] The specific configuration of the various components may also vary. For example, the size and specific shape of the various components may differ from the embodiment shown while still providing the functionality as described herein. More specifically, the size and shape of the various components may be specifically selected for a desired or intended use. Therefore, it should be understood that the size, shape, and / or arrangement of an embodiment and / or its components may be suitable for a given use unless the context clearly indicates otherwise.

[0259] In the case where the methods and / or events described above indicate that specific events and / or operations occur in a specific order, the sequencing of specific events and / or operations may be modified. In addition, specific events and / or operations may be performed simultaneously in parallel processes when possible, or may be performed sequentially as described above.

Claims

1. A device for septal puncture, the device comprising: axis; a side catheter introducer coupled to the shaft, the side catheter introducer defining a lumen; a side catheter slidably disposed within the lumen of the side catheter introducer and configured to extend distally relative to a distal end of the side catheter introducer, the side catheter defining a lumen and having an end effector at a distal end thereof, the end effector configured to contact and bulge the septum of the patient's heart; as well as A puncture member is slidably disposed within the lumen of the side catheter and is configured to extend distally relative to a distal end of the side catheter, the puncture member being configured to puncture a septum of a patient's heart.

2. The apparatus of claim 1, wherein: The side catheter introducer is configured to transition between a delivery configuration of the side catheter introducer and a deployed configuration of the side catheter introducer.

3. The apparatus of claim 1 or 2, wherein: The piercing member defines a lumen configured to slidably receive a guidewire.

4. The device according to claim 1 or 2, wherein: The end actuator is configured to transition between a delivery configuration in which the end actuator has a first cross-sectional area and a deployment configuration in which the end actuator has a second cross-sectional area greater than the first cross-sectional area.

5. The apparatus of claim 1 or 2, wherein: The end effector is formed from a shape memory material.

6. The apparatus of claim 1 or 2, wherein: The piercing member is configured to be charged via radio frequency energy to pierce the septum.

7. A device for septal puncture, the device comprising: axis; a side catheter introducer coupled to the shaft, the side catheter introducer defining a lumen; a side catheter slidably disposed within the lumen of the side catheter introducer and configured to extend distally relative to a distal end of the side catheter introducer, the side catheter defining a lumen; as well as an atraumatic end effector extending from a distal-most end of the side catheter, the atraumatic end effector configured to press against and bulge the fossa ovalis of the patient's heart; A puncture member is slidably disposed within the lumen of the side catheter and is configured to extend distally relative to a distal-most end of the side catheter, the puncture member being configured to be charged via radio frequency energy to puncture a target puncture site.

8. The apparatus of claim 7, wherein: The piercing member defines a lumen.

9. The device of claim 8, wherein the lumen of the piercing member is configured to slidably receive a guide wire.

10. The apparatus of any one of claims 7 to 9, wherein: The atraumatic end effector is formed from a shape memory material.

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