JP2023518729A - Apparatus and method for septal punch - Google Patents

Abstract

The apparatus includes a shaft and an angularly deflectable guide coupled to the shaft via a guide coupler. The guide is configured to transition between a delivery configuration and a deployed configuration in which the distal end of the guide points away from the centerline of the shaft. The device further includes an elongated member slidably displaceable within the lumen defined by the guide and configured to extend distally relative to the distal end of the guide. The elongated member defines a lumen. A penetrating member is slidably displaceable within the lumen of the elongate member and configured to extend distally relative to the distal end of the elongate member. The penetrating member defines a lumen configured to receive the guidewire and has a first inner diameter at the distal end portion and a portion proximal to the distal end portion from the first inner diameter. a second inner diameter that is greater than the [Selection drawing] Fig. 70B

Description

Cross-reference to related applications
[0001] This application claims priority to and benefit from U.S. Provisional Application No. 62/994,751, entitled "Apparatus and Method for Septal Punch," filed March 25, 2020, which is hereby incorporated by reference. The entire disclosure of the application is incorporated herein by reference in its entirety.

[0002] Described herein are embodiments of instruments and methods for use during access to the left side of the heart.

[0003] Many diseases and disorders such as heart failure, atrial fibrillation, mitral valve disease, and others specifically affect or are manageable on the left side of the heart. Accordingly, many interventional percutaneous cardiac surgeries provide access to the left side of the heart, including, for example, electrophysiological procedures, left atrial appendage occlusion procedures, mitral valve repair and replacement procedures, atrial shunt surgery, and many others. need. 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 (eg, left atrial pressure, transmitral pressure gradient, etc.). Minimally invasive access to the left side of the heart is difficult and is not without significant risks.

[0004] Some catheter-based procedures involve puncturing the atrial septum ("AS") of the heart, which separates the left atrium ("LA") of the heart from the right atrium ("RA") of the heart. , to access the left side of the heart. Such procedures use a catheter containing a coated needle, which is advanced through the RA of the heart from the femoral vein in the patient's groin to the superior vena cava (“SVC”). Coated needles are often long stiff wire needles with approximately a 20 degree bend near the tip. With the catheter assembly disposed within the SVC, the catheter assembly then moves from the SVC into the RA until the tip rests within the fossa ovalis (“fossa”, “FO”, or “F”). Slowly withdrawn downwards. The FO is a thumbprint-sized depression in the wall of the RA and is the thinnest portion of the atrial septum (ie, the wall between the RA and LA). Once the operator visualizes contact between the tip of the catheter assembly and F, the needle is advanced to puncture F. A guidewire is advanced through the catheter and into the RA, with the needle extending from the LA into the RA. The needle can then be removed from the LA and an instrument (eg, an AF ablation device, catheter, percutaneous mitral valve repair delivery system or catheter, etc.) can be inserted into the LA.

[0005] An alternative procedure involves the use of a blunt needle electrified by radio frequency to puncture or perforate the interatrial septum.

[0006] The above treatments have significant limitations. It is difficult to learn, time intensive, and prone to premature, misaligned, and unintentional puncture of the FO. Also, it is difficult to precisely and precisely locate F at the tip of the instrument, and time-intensive steps must be repeated if the catheter assembly is withdrawn too far from the SVC. This is because such devices cannot move cephalad. Additionally, the needle shape may need to be customized or adjusted based on the patient's specific anatomy, which further complicates the process.

[0007] And, such catheters are generally very flexible and not very stable within the SVC, and thus are easily displaced from an ideal position, especially during normal dynamic cardiac activity. Unintentionally kicked out. Furthermore, the needle is not secured to the catheter, thereby resulting in accidental needle exposure and possibly unintentional cardiac puncture, which can lead to death. Further complicating this procedure is the anatomical structure, which may be distorted or abnormal due to, for example, aortic or mitral valve disease, which includes changes in FO location and typical Leads to obfuscation of anatomical landmarks. Moreover, for patients undergoing repeated procedures, the FO may become thickened or scarred, necessitating the application of greater puncture forces and an increased risk of unintended damage to nearby anatomy. .

[0008] For many left heart procedures, it will be critical that the septal puncture be performed at a specific location within the FO. For example, it may be important to puncture the inferior portion of the FO for delivering a replacement mitral valve, whereas puncturing the posterior/middle portion of the FO may be required for the self-cusp clip implantation procedure. can be important. Existing systems do not provide for sufficiently accurate and precise targeting of the intended puncture site, such as a specific region within the FO. Failure to puncture the septum at the proper location can result in prolonged, unsuccessful, or discontinued treatment.

[0009] Thus, a need exists for improved instruments and methods for faster, more stable, safer, more accurate, and more precise access to the LA.

[0010] Described herein are instruments and methods for use in minimally invasive access to various portions of a patient's anatomy, such as accessing the left atrium of the heart through a transseptal puncture. be done. In some embodiments, the method includes (1) a side catheter guide attached via a guide coupler and (2) a guide stabilizer/actuator (“GSA”) slidably attached in a delivery configuration. into the patient's inferior and superior vena cava of the heart such that the GSA is disposed in the right atrium of the heart. The method further includes applying a distal force to the side catheter guide such that the distal end of the side catheter guide deflects laterally about the guide coupler toward the septum of the heart. The method further includes actuating the guide stabilizer/actuator to transition the GSA from the delivery configuration to the deployed configuration while the GSA is in the right atrium of the heart in the delivery configuration. Disposing the GSA in contact with the side catheter guide to laterally stabilize the side catheter guide with respect to the shaft with the guide stabilizer/actuator in the deployed configuration after the application of the distal force begins. . The method further includes removing the side disposed within the side catheter guide with the distal end of the side catheter guide laterally deflected toward the septum about the guide coupler and laterally stabilized by the GSA. Extending the catheter from the side catheter guide distally toward the septum and into contact with the septum. The method further includes moving a septal penetrator slidably disposed within the side catheter with the distal end of the side catheter in contact with the septum such that the septal penetrator pierces the septum. Extending distally from the catheter.

[0011] FIG. 1 is a schematic illustration of a septal puncture device arranged in a delivery configuration according to one embodiment; [0012] FIG. 1B is a schematic illustration of the septal puncture device of FIG. 1A disposed in a deployed configuration; [0013] Disposed within the right atrium ("RA") of the patient's heart in a delivery configuration from the inferior vena cava ("IVC") of the heart across the RA into the superior vena cava ("SVC") of the heart. 1B is a schematic illustration of the septal puncture device of FIG. 1A coupled to an extending first guidewire; FIG. [0014] Fig. 2 is a schematic illustration of the septal puncture device of Fig. 1 disposed in a deployed configuration and accessing the LA to deliver a second guidewire; [0015] A flow chart illustrating a method of accessing the left atrium of a patient's heart using a septal puncture device according to one embodiment. [0016] Septal puncture device 300 is shown in a partially exploded perspective view in a delivery configuration. Septal puncture device 300 is shown partially exploded to illustrate the lumen defined by body 310 . [0016] Septal puncture device 300 is shown in a partially exploded perspective view in a deployed configuration. Septal puncture device 300 is shown partially exploded to illustrate the lumen defined by body 310 . [0017] A portion of the septal puncture device 300 of Figures 4A and 4B is shown in perspective cross-section. [0017] A portion of the septal puncture device 300 of FIGS. 4A and 4B is shown in front cross-sectional view. [0018] The deployment sequence at the distal end portion of septal puncture device 300 is shown in side view according to one embodiment. [0018] The deployment sequence at the distal end portion of septal puncture device 300 is shown in side view according to one embodiment. [0018] The deployment sequence at the distal end portion of septal puncture device 300 is shown in side view according to one embodiment. [0018] The deployment sequence at the distal end portion of septal puncture device 300 is shown in side view according to one embodiment. [0018] The deployment sequence at the distal end portion of septal puncture device 300 is shown in side view according to one embodiment. [0018] The deployment sequence at the distal end portion of septal puncture device 300 is shown in side view according to one embodiment. [0018] The deployment sequence at the distal end portion of septal puncture device 300 is shown in side view according to one embodiment. [0018] The deployment sequence at the distal end portion of septal puncture device 300 is shown in side view according to one embodiment. [0019] A portion of septal puncture device 300 is illustrated in a delivery configuration. [0019] A portion of septal puncture device 300 is illustrated in a deployed configuration. [0020] The assembled arrangement (right) and the partially assembled detailed arrangement (left) of the guide coupler 340 of the septal puncture device 300 coupled to the main shaft 320 and the side catheter guide 330 therebetween. ). [0021] A flow chart illustrating a method of accessing the left atrium of a patient's heart using a septal puncture device according to one embodiment. [0022] A portion of a septal puncture device 500 in a deployed configuration is shown in perspective bottom view according to another embodiment. [0022] A portion of a septal puncture device 500 in a deployed configuration is shown in perspective side view, according to another embodiment. [0022] A portion of a septal puncture device 500 in a deployed configuration is shown in side view according to another embodiment. [0023] FIG. 12 illustrates a partial delivery and deployment sequence using the septal puncture device 500 of FIGS. 10-12 according to one embodiment. [0023] FIG. 12 illustrates a partial delivery and deployment sequence using the septal puncture device 500 of FIGS. 10-12 according to one embodiment. [0023] FIG. 12 illustrates a partial delivery and deployment sequence using the septal puncture device 500 of FIGS. 10-12 according to one embodiment. [0023] FIG. 12 illustrates a partial delivery and deployment sequence using the septal puncture device 500 of FIGS. 10-12 according to one embodiment. [0023] FIG. 12 illustrates a partial delivery and deployment sequence using the septal puncture device 500 of FIGS. 10-12 according to one embodiment. [0023] FIG. 12 illustrates a partial delivery and deployment sequence using the septal puncture device 500 of FIGS. 10-12 according to one embodiment. [0024] Illustrates an example deployment sequence for a septal puncture device 600, according to one embodiment. [0024] Illustrates an example deployment sequence for a septal puncture device 600, according to one embodiment. [0024] Illustrates an example deployment sequence for a septal puncture device 600, according to one embodiment. [0024] Illustrates an example deployment sequence for a septal puncture device 600, according to one embodiment. [0024] Illustrates an example deployment sequence for a septal puncture device 600, according to one embodiment. [0024] Illustrates an example deployment sequence for a septal puncture device 600, according to one embodiment. [0024] Illustrates an example deployment sequence for a septal puncture device 600, according to one embodiment. [0024] Illustrates an example deployment sequence for a septal puncture device 600, according to one embodiment. [0024] Illustrates an example deployment sequence for a septal puncture device 600, according to one embodiment. [0024] Illustrates an example deployment sequence for a septal puncture device 600, according to one embodiment. [0024] Illustrates an example deployment sequence for a septal puncture device 600, according to one embodiment. [0025] A septal puncture device 700 according to one embodiment is shown in perspective view. [0025] A septal puncture device 700 according to one embodiment is shown in front view. [0025] A septal puncture device 700 according to an embodiment is shown in side view. [0026] Illustrates a first guide stabilizer/actuator ("GSA") 850A and a second GSA 850B of septal puncture device 800 in a contracted delivery configuration, according to one embodiment. [0026] Illustrates first GSA 850A and second GSA 850B of septal puncture device 800 in a partially inflated, partially deployed configuration, according to one embodiment. [0026] Illustrates first GSA 850A and second GSA 850B of septal puncture device 800 in an expanded, deployed configuration, according to one embodiment. [0027] A septal puncture device 900 including two side catheters according to one embodiment is shown in perspective view. [0027] A septal puncture device 900 including two side catheters according to one embodiment is shown in front view. [0027] Septal puncture device 900 including two side catheters according to one embodiment is shown in detailed partial perspective view. [0028] Fig. 10 shows a front view of a septal puncture device 1000 with a single GSA and two side catheters according to one embodiment. [0028] Fig. 10 shows in perspective view a septal puncture device 1000 having a single GSA and two side catheters according to one embodiment. [0029] A septal puncture device 1100 having a single GSA and a single side catheter according to one embodiment is shown in perspective front view. [0029] Fig. 11 shows in perspective side view a septal puncture device 1100 having a single GSA and a single side catheter according to one embodiment. [0030] An example delivery and deployment sequence for a septal puncture device 1100 is illustrated in relation to a patient's heart, according to one embodiment. [0030] An example delivery and deployment sequence for a septal puncture device 1100 is illustrated in relation to a patient's heart, according to one embodiment. [0031] Illustrates a septal puncture device 1200 having a concave shaped GSA and a convex shaped GSA according to one embodiment. [0032] Illustrates a septal puncture device 1300 having a GSA of a particular curvature, according to one embodiment. [0033] A septal puncture device 1400 having a three-lobed GSA according to one embodiment is shown in top view. [0034] A septal puncture device 1500 having a multi-lobe GSA according to one embodiment is shown in top view. [0035] Fig. 16 illustrates in side view a septal puncture device 1600 having a GSA configured to limit blood flow occlusion according to one embodiment. [0036] Fig. 17 illustrates in side view a septal puncture device 1700 having rotatably offset and interlocking GSAs according to one embodiment. [0037] A septal puncture device 1800 with an asymmetric GSA is shown in side and top views, according to one embodiment. [0038] A septal puncture device 1900 that defines two conduction paths between the GSAs according to one embodiment is shown in side view. [0039] FIG. [0039] FIG. [0039] FIG. [0039] FIG. [0040] Illustrates a portion of a septal puncture device 2100 having an intracardiac echo ("ICE") sensor according to one embodiment. [0041] A portion of a septal puncture device 2200 with a camera is illustrated according to one embodiment. [0042] A portion of a septal puncture device 2300 is shown in cross-sectional side view, according to one embodiment. [0042] A portion of a septal puncture device 2300 is shown in cross-sectional front view, according to one embodiment. [0043] A stylus 2310 is illustrated according to one embodiment. [0043] A stylus 2310 is illustrated according to one embodiment. [0044] A handle 2318 is illustrated according to one embodiment. [0045] Illustrates an example deployment sequence for a septal puncture device 2300, according to one embodiment. [0045] Illustrates an example deployment sequence for a septal puncture device 2300, according to one embodiment. [0045] Illustrates an example deployment sequence for a septal puncture device 2300, according to one embodiment. [0045] Illustrates an example deployment sequence for a septal puncture device 2300, according to one embodiment. [0046] A portion of septal puncture device 2300 is shown in side view. [0046] A portion of septal puncture device 2300 is shown in cross-sectional side view. [0047] A portion of a septal puncture device 2300 including an end effector is shown in perspective view. [0048] Fig. 45 illustrates the end effector of Fig. 44; [0048] Fig. 45 illustrates the end effector of Fig. 44; [0048] Fig. 45 illustrates the end effector of Fig. 44; [0048] Fig. 45 illustrates the end effector of Fig. 44; [0049] A portion of a septal device 2300 including stiffening elements is shown in cross-sectional side view. [0049] A portion of a septal device 2300 including stiffening elements is shown in cross-sectional front view. [0050] A segmented septal puncture device 2400 is illustrated, according to one embodiment. [0050] A segmented septal puncture device 2400 is illustrated, according to one embodiment. [0050] A segmented septal puncture device 2400 is illustrated, according to one embodiment. [0050] A segmented septal puncture device 2400 is illustrated, according to one embodiment. [0050] A segmented septal puncture device 2400 is illustrated, according to one embodiment. [0050] A segmented septal puncture device 2400 is illustrated, according to one embodiment. [0050] A segmented septal puncture device 2400 is illustrated, according to one embodiment. [0050] A segmented septal puncture device 2400 is illustrated, according to one embodiment. [0051] A septal puncture device 2500 is illustrated, according to one embodiment. [0051] A septal puncture device 2500 is illustrated, according to one embodiment. [0051] A septal puncture device 2500 is illustrated, according to one embodiment. [0051] A septal puncture device 2500 is illustrated, according to one embodiment. [0052] Various embodiments of a septal puncture device 2500 are illustrated. [0052] Various embodiments of a septal puncture device 2500 are illustrated. [0052] Various embodiments of a septal puncture device 2500 are illustrated. [0053] Various embodiments of a septal puncture device 2500 are illustrated. [0053] Various embodiments of a septal puncture device 2500 are illustrated. [0053] Various embodiments of a septal puncture device 2500 are illustrated. [0054] The sheath of septal puncture device 2500 is illustrated. [0055] Various embodiments of a septal puncture device 2500 are illustrated. [0056] A handle assembly 2680 is illustrated according to one embodiment. [0056] A handle assembly 2680 is illustrated according to one embodiment. [0057] Fig. 10 illustrates an example deployment sequence for a septal puncture device, according to an embodiment. [0057] Fig. 10 illustrates an example deployment sequence for a septal puncture device, according to an embodiment. [0057] Fig. 10 illustrates an example deployment sequence for a septal puncture device, according to an embodiment. [0057] Fig. 10 illustrates an example deployment sequence for a septal puncture device, according to an embodiment. [0058] A portion of a septal puncture device 2700 is illustrated, according to one embodiment. [0058] A portion of a septal puncture device 2700 is illustrated, according to one embodiment. [0058] A portion of a septal puncture device 2700 is illustrated, according to one embodiment. [0058] A portion of a septal puncture device 2700 is illustrated, according to one embodiment. [0059] Various embodiments of a septal puncture device 2700 are illustrated. [0059] Various embodiments of a septal puncture device 2700 are illustrated. [0059] Various embodiments of a septal puncture device 2700 are illustrated. [0059] Various embodiments of a septal puncture device 2700 are illustrated. [0059] Various embodiments of a septal puncture device 2700 are illustrated. [0059] Various embodiments of a septal puncture device 2700 are illustrated. [0059] Various embodiments of a septal puncture device 2700 are illustrated. [0059] Various embodiments of a septal puncture device 2700 are illustrated. [0059] Various embodiments of a septal puncture device 2700 are illustrated. [0059] Various embodiments of a septal puncture device 2700 are illustrated. [0060] A portion of a septal puncture device 2800 is illustrated, according to one embodiment. [0060] A portion of a septal puncture device 2800 is illustrated, according to one embodiment. [0060] A portion of a septal puncture device 2800 is illustrated, according to one embodiment. [0061] Illustrates a portion of a septal puncture device 2900 having a mesh-covered balloon according to one embodiment. [0062] Fig. 10 is a schematic illustration of a septal puncture device arranged in a delivery configuration according to one embodiment; [0063] Fig. 65B is a schematic illustration of the septal puncture device of Fig. 65A disposed in a deployed configuration; [0064] Fig. 10 illustrates a portion of a septal puncture device arranged in a delivery configuration according to one embodiment. [0065] FIG. 66B illustrates a portion of the septal puncture device of FIG. 66A disposed in a deployed configuration. [0066] FIG. 11 illustrates a portion of a septal puncture device having an atraumatic tip arranged in a delivery configuration according to one embodiment. [0067] FIG. 10 illustrates a portion of a septal puncture device having an atraumatic tip arranged in a delivery configuration according to one embodiment. [0068] Fig. 68B illustrates a portion of the septal puncture device of Fig. 68A disposed in a deployed configuration. [0069] FIG. 16 illustrates a portion of a septal puncture device having an atraumatic tip arranged in a delivery configuration according to one embodiment. [0070] FIG. 69B illustrates a portion of the septal puncture device of FIG. 69A disposed in a deployed configuration. [0071] Fig. 11 depicts in side view a portion of a septal puncture device disposed in a deployed configuration according to one embodiment. [0072] Fig. 70A depicts the septal puncture device of Fig. 70A in perspective view. [0073] FIG. 11 illustrates a portion of a septal penetrator having a variable inner diameter according to one embodiment. [0073] FIG. 11 illustrates a portion of a septal penetrator having a variable inner diameter according to one embodiment. [0073] FIG. 11 illustrates a portion of a septal penetrator having a variable inner diameter according to one embodiment. [0073] FIG. 10 illustrates a portion of a septal penetrator having a variable inner diameter according to one embodiment. [0074] FIG. 12C depicts in side view a portion of a septal puncture device having an atraumatic tip arranged in a delivery configuration according to one embodiment. [0074] Fig. 12 shows in perspective view a septal puncture device having an atraumatic tip arranged in a delivery configuration according to one embodiment.

[0075] Described herein are instruments and methods for use in accessing the left side of the heart (eg, LA) from the right side (eg, RA) of the heart without requiring open-heart surgery. The methods described herein access the left side of the heart in a minimally invasive, safe (e.g., atraumatic), efficient, timely, accurately and precisely localized repeatable procedure. A septal puncture device is used to This is accomplished, in part, by providing a stable platform that is steerable (e.g., translatable and rotatable) between the IVC and SVC, from which the penetrating member can be laterally displaced into the atrial septum. It can extend into the target puncture location (eg, FO).

[0076] In some embodiments, the method includes (1) a side catheter guide attached via a guide coupler and (2) a guide stabilizer/actuator slidably attached in a delivery configuration ("GSA ) into the patient's inferior vena cava and superior vena cava of the heart such that the guide stabilizer/actuator is disposed in the right atrium of the heart. The method further includes applying a distal force to the side catheter guide such that the distal end of the side catheter guide deflects laterally about the guide coupler toward the septum of the heart. The method further includes actuating the guide stabilizer/actuator to transition the guide stabilizer/actuator from the delivery configuration to the deployed configuration, with the guide stabilizer/actuator in the delivery configuration in the right atrium of the heart. A side catheter guide is disposed in contact with the side catheter guide to laterally stabilize the side catheter guide relative to the shaft with the guide stabilizer/actuator in the deployed configuration after the application of the distal force begins. to do. The method further comprises disposing within the side catheter guide with the distal end of the side catheter guide laterally deflected about the guide coupler toward the septum and laterally stabilized by the guide stabilizer/actuator. extending the side catheter from the side catheter guide distally toward the septum and into contact with the septum. The method further includes moving a septal penetrator slidably disposed within the side catheter with the distal end of the side catheter in contact with the septum such that the septal penetrator pierces the septum. Extending distally from the catheter.

[0077] In some embodiments, the method includes placing a shaft having a side catheter guide attached via a guide coupler under the patient's heart such that the guide coupler is disposed in the right atrium of the heart. Contained within the vena cava and the superior vena cava of the heart. The method further includes applying a distal force to the proximal portion of the side catheter guide such that the distal end of the side catheter guide deflects laterally about the guide coupler toward the septum of the heart. The method further includes moving a side catheter disposed within the side catheter guide from the side catheter guide to the septum with the distal end of the side catheter guide laterally deflected about the guide coupler toward the septum. Extending distally toward and into contact with the septum. The method further includes, with the side catheter in contact with the septum, a septal penetrator slidably disposed within the side catheter, the septal penetrator piercing the septum distally from the side catheter. including stretching as

[0078] In some embodiments, the method includes providing a shaft having a guide stabilizer/actuator slidably mounted in a delivery configuration such that the guide stabilizer/actuator is disposed in the right atrium of the heart. A side catheter guide is coupled to a guide stabilizer/actuator, including insertion into the inferior and superior vena cava of the patient's heart. The method further includes laterally stabilizing the distal end of the side catheter guide in part by the guide stabilizer/actuator being in a deployed configuration while the distal end of the side catheter guide is laterally deflected about the shaft toward the septum of the heart. actuating the guide stabilizer/actuator to transition the guide stabilizer/actuator from the delivery configuration to the deployed configuration, with the guide stabilizer/actuator in the delivery configuration in the right atrium of the heart. With the guide stabilizer/actuator in the deployed configuration, the side catheter guide extends proximally from the distal end of the side catheter guide disposed over the first side of the shaft, traverses the shaft, and extends proximally of the shaft. It leads to a second side of the shaft opposite the first side, then bends and extends proximally toward the proximal end of the shaft. The method further includes placing the distal end of the side catheter guide laterally about the shaft toward the septum and laterally stabilized in part by a guide stabilizer/actuator. extending a side catheter disposed in the distal end of the side catheter guide distally toward the septum and into contact with the septum. The method further includes, with the side catheter in contact with the septum, a septal penetrator slidably disposed within the side catheter, the septal penetrator piercing the septum distally from the side catheter. including stretching as

[0079] In some embodiments, a device includes a body defining a first lumen and a second lumen. The device further includes a shaft having a first section fixedly connected to the body and extending distally from the first lumen of the body and partially disposed within the first section of the shaft. and a second compartment that is extendable relative to the first compartment. The device further includes a guidewire coupler coupled to the body and extending distally from within the lumen defined by the shaft. The guidewire coupler defines a guidewire lumen configured to slidably receive the first guidewire. The device further includes a side catheter guide coupled to the body and extending distally from within the second lumen of the body. A side catheter guide is connected to the first section of the shaft via a guide coupler. The side catheter guide is configured to be transitioned between a delivery configuration and a deployed configuration such that transitioning from the delivery configuration to the deployed configuration deflects the distal end of the side catheter guide laterally about the guide coupler. be. The device further includes a guide stabilizer/actuator coupled to the second section of the shaft for further laterally deflecting and laterally stabilizing the distal end of the side catheter guide about the guide coupler. It is configured to transition between a delivery configuration and a deployed configuration to allow for increased flexibility. A side catheter guide defines a lumen configured to slidably receive a side catheter. The side catheter defines a lumen configured to slidably receive the penetrating member. The piercing member is configured to pierce tissue of a patient.

[0080] In some embodiments, a device includes a body defining a first lumen and a second lumen. The device further includes a shaft having a first section fixedly connected to the body and extending distally from the first lumen of the body and partially disposed within the first section of the shaft. and a second compartment that is extendable relative to the first compartment. The device further includes a guidewire coupler coupled to the body and extending distally from within the lumen defined by the shaft. The guidewire coupler defines a guidewire lumen configured to slidably receive the first guidewire. The device further includes a side catheter guide coupled to the body and extending distally from within the second lumen of the body. A side catheter guide is connected to the first section of the shaft via a guide coupler. The side catheter guide is configured to be transitioned between a delivery configuration and a deployed configuration such that transitioning from the delivery configuration to the deployed configuration deflects the distal end of the side catheter guide laterally about the guide coupler. be. A side catheter guide defines a lumen configured to slidably receive a side catheter. The side catheter defines a lumen configured to slidably receive the penetrating member. The piercing member is configured to pierce tissue of a patient.

[0081] In some embodiments, a device includes a shaft having proximal and distal ends and a lumen extending therethrough. The shaft defines (1) a first aperture and (2) a second aperture and a third aperture, both disposed distally of the first aperture. The device further includes a first guide stabilizer/actuator ("GSA ”) and the second GSA. The device is further coupled to the shaft, extends distally into the lumen at the proximal end of the shaft, exits the shaft through the first aperture, and connects the first GSA and the second GSA. It includes a side catheter guide extending in between into a second aperture and then exiting the shaft through a third aperture. The first GSA and the second GSA are such that the transition from the delivery configuration to the deployment configuration causes the distal end of the side catheter guide to (1) laterally deflect about the central axis of the shaft and (2) It is configured to be axially stabilized. A side catheter guide defines a lumen configured to slidably receive a side catheter. The side catheter defines a lumen configured to slidably receive a piercing member configured to pierce tissue of a patient.

[0082] As used herein, the terms "proximal" and "distal" respectively refer to the operator (e.g., surgeon, physician, nurse, technician) who will insert the septal puncture device into the patient. etc.) and the tip (ie, distal end) of the instrument is inserted first into the patient's body. Thus, for example, the end of the main shaft described herein that is first inserted into the patient's body would be the distal end, and the opposite end of that main shaft (e.g., the main shaft) would be manipulated by the operator. end) will be the proximal end of the main shaft.

[0083] As used herein, the terms "advance," "advanced," and "advancing" each refer to movement in a distal direction. . For example, advancing an instrument within a patient's vasculature refers to moving at least a portion of the instrument distally within the patient's vasculature. Similarly, as used herein, the terms "withdraw," "withdrawn," and "withdrawing" each refer to movement in the proximal direction. For example, withdrawing an instrument within a patient's vasculature refers to moving at least a portion of the instrument proximally within the patient's vasculature. In some cases, advancing and withdrawing may refer to relative movement of the instrument itself. For example, advancing a side catheter may refer to moving the side catheter distally relative to a side catheter guide to which the side catheter is movably coupled. Similarly, for example, withdrawing the side catheter may refer to moving the side catheter proximally relative to the side catheter guide to which the side catheter is movably coupled.

[0084] Septal puncture device 100 may be used to access the left side of the heart (eg, left atrium) from the right side (eg, right atrium) of the heart and to deliver guidewires to the left side of the heart. As shown in FIG. 1A, septal puncture device 100 includes body 110 coupled to main shaft 120, side catheter guide 130, side catheter 160, and septal penetrator 170. As shown in FIG. As shown in FIG. 1A, main shaft 120 is connected to side catheter guide 130 via guide coupler 140, side catheter guide 130 is connected to side catheter 160, and side catheter 160 is connected to septal penetrator 170. connected to Side catheter guide 130 is configured to define a conduction path through which side catheter 160 can be advanced (eg, advanced and/or withdrawn) through or across. Stated another way, and as described in more detail herein, side catheter guide 130 is manipulated (e.g., delivered) to guide side catheter 160 in a desired direction, e.g., toward the left atrium. from a deployed state) (side catheter guide 130 in an actuated or deployed state is shown in FIG. 1B).

[0085] As described in further detail herein, guide coupler 140 provides relative translational motion between main shaft 120 and side catheter guide 130, as schematically illustrated in FIG. 1B. Side catheter guide 130 may be coupled to main shaft 120 to minimize or prevent, but allow relative rotational movement between main shaft 120 and side catheter guide 130 . In this manner, the guide coupler 140 is removed from the side catheter guide 130 distally from the delivery configuration (e.g., parallel or substantially parallel to the main shaft 120) for insertion, e.g., through the patient's vasculature and into the RA. A side catheter guide 130 to a deployed configuration in which the distal tip is deflected laterally (e.g., perpendicular or substantially perpendicular) to the main shaft 120, e.g., toward the patient's left atrium (e.g., FO of the interatrial septum). can facilitate the transition of In some embodiments, guide coupler 140 can be a hinge to facilitate lateral deflection of side catheter guide 130 relative to main shaft 120, as described in further detail herein. In such embodiments, for example, a distal force may be applied to the proximal end portion of the side catheter guide 130, thereby rotating the hinge to rotate the distal end portion of the side catheter guide (ie, the side catheter guide). The portion of the distal end of 130 that extends distally beyond guide coupler 140) is deflected laterally. In some embodiments, the amount of lateral deflection or after such lateral deflection defined between the side catheter guide 130 and the main shaft 120 is, for example, the position of the target puncture location. It is adjustable by the operator within the procedure, ie in real time, so that the operator has procedural flexibility when locating.

[0086] In some embodiments, one or more of main shaft 120, side catheter guide 130, or side catheter 160 may have a circular cross-sectional shape, while in other embodiments , one or more of main shaft 120, side catheter guide 130, and side catheter 160 may have a non-circular cross-sectional shape. In some cases, for example, main shaft 120 and side catheter guide 130 may have a circular cross-sectional shape, and as described in more detail herein, main shaft 120 and side catheter guide 130 ( They may be operably linked so that they are disposed at least partially side-by-side (eg, during delivery). In other cases, for example, main shaft 120 may have a non-circular cross-sectional shape (e.g., half-moon shape, C-shape, convex or concave shape), thereby, when coupled to side catheter guide 130, A portion of side catheter guide 130 may be nested within a space defined at least partially by the non-circular curvature of main shaft 120 . In this way, the collective cross-sectional area, footprint, diameter, etc. of main shaft 120 and side catheter guide 130 may be reduced. In some cases, main shaft 120 and side catheter 160 may have a similar relationship (eg, in embodiments where the septal puncture device does not have a side catheter guide).

[0087] In some embodiments, the septal puncture device 100 includes a side catheter guide stabilizer/actuator ("GSA") 150 (also referred to herein as a "guide stabilizer/actuator") and a GSA 150 and a GSA actuator 154 operably coupled to and configured to actuate the GSA 150 . In some embodiments, the GSA 150 aligns the side catheter guide 130 (e.g., transversely to the main shaft 120) to facilitate engagement of the side catheter 160 with the FO and penetration of the FO by the septal penetrator 170. It can be configured to provide directional, axial (proximal or distal) stabilization. In this way, the guide coupler 140 can laterally deflect the side catheter guide 130, and the GSA 150 can guide the side catheter guide 130 (and thus the side catheter 160, optional end effector 162, and septal penetrator 170). can be stabilized to optimize subsequent septal penetration and access to the left atrium. In some embodiments, in addition to or instead of stabilizing the side catheter guide 130, the GSA 150 stabilizes the side catheter guide 130 (and thus the side catheter 160 if coupled to the side catheter guide 130). and septal penetrator 170) (e.g., in addition to the lateral deflection caused or facilitated by guide coupler 140, as described above). In this way, in some embodiments, guide coupler 140 and GSA 150 collectively traverse side catheter guide 130 (and thus side catheter 160, optional end effector 162, and septal penetrator 170). It can be directionally deflected or stabilized to optimize subsequent septal penetration and access to the left atrium.

[0088] GSA 150 may be operated in any suitable manner to provide the functionality described above. In some embodiments, for example, GSA 150 may be a balloon and thus be configured to be inflatable and deflatable. In such embodiments, the GSA 150 may be fluidly coupled to a lumen extending from the GSA 150 to the GA actuator 154, whereby the GA actuator 154 operates the GA to inflate the GSA 150 (i.e. deploy the GSA 150). Fluid can be selectively delivered to the actuator 154 and selectively withdrawn from the GSA 150 to contract the GSA 150 for removal from the heart (e.g., after left atrial access has been achieved).

[0089] In embodiments where the GSA 150 is a balloon, the balloon may have any shape and size suitable to perform the desired functions described herein. For example, in some embodiments the balloon may be conical, while in other embodiments the balloon may be at least partially concave, convex, circular, oval, or the like. Also, in some embodiments, the balloon may have one or more lobes, e.g. can be Additionally, the balloon may have additional features configured to improve stability of the side catheter guide 130 (eg, improve the coupling between the balloon and the side catheter guide 130). In some embodiments, for example, the balloon may have dimples, protrusions, ridges, adhesives, and the like.

[0090] The balloon may be formed of any material or combination of materials suitable to perform the functionality described herein. For example, in some embodiments, the balloon is made of one or more of polyethylene, polyethylene terephthalate (“PET”), polymers, thermoplastic polymers, elastomers, nylons, polyurethanes, any non-compliant material, and the like. can be formed. The balloon may be configured to be inflated to any suitable pressure, such as from about 2 ATM to about 20 ATM in one example. In some cases, higher inflation pressures can result in greater or improved stiffness of the balloon, thereby providing better stability of side catheter guides, side catheters, septal penetrators, and the like.

[0091] GSA 150 may be formed of any material suitable for performing the GSA functions described herein. In some embodiments, the GSA 150 may comprise or be formed of a shape memory material (eg, Nitinol) and a delivery/withdrawal configuration in which the GSA 150 is constrained, compressed, or placed in a relatively small configuration. and deployment in which the GSA 150 is unconstrained, stretched, or placed in a larger configuration sufficient to laterally deflect or stabilize the side catheter guide 130 as described in further detail herein. can be configured to be migrated between configurations.

[0092] As with the guide coupler 140, in some embodiments, the GSA 150 includes or is formed of a radiopaque material to allow the operator to adjust the position before, during, or after deployment. It may assist in locating that portion of the septal-puncture device 100 . In this way, the operator can selectively position the septal penetrator 170 in real-time at a position suitable for penetrating the FO when the septal penetrator 170 is actuated. For example, in embodiments where GSA 150 is a balloon, GSA 150 is optionally inflated with a contrast agent (or a combination of contrast agent and another fluid such as saline) to dispose GSA 150 within a patient. can provide visualization to the operator (eg, under any suitable imaging technique) when

[0093] With the side catheter guide 130 laterally deflected and stabilized at an appropriate angle relative to the FO or main shaft 120, and (1) during With one or more landmark portions of septal-puncture device 100 and (2) the desired puncture location (e.g., FO) in the septum visible to the operator from outside the patient, the operator pushes main shaft 120 to any position. The side catheter guide 130 can be aligned with the FO by manipulating translationally or rotationally in a suitable manner.

[0094] As further illustrated in FIG. 1A, the septal puncture device 100 connects the main shaft 120 to a guidewire (not shown in FIG. 1A) to connect the septal puncture device 100 (eg, the patient's vasculature). a guidewire coupler 122 configured to facilitate delivery into the patient and to the patient's heart (through the heart of the patient) and a guidewire (not shown in FIG. 1A) coupled to the septal penetrator 170 to connect the guidewire. and a guidewire coupler 172 configured to facilitate delivery to the left side of the heart (eg, left atrium).

[0095] As further illustrated in FIG. 1A, septal puncture device 100 is operably coupled to main shaft 120 and actuates main shaft 120 to advance or withdraw main shaft 120 relative to body 110. Optionally includes a shaft actuator 124 configured to. Septal puncture device 100 is further configured to: (1) be operably coupled to side catheter 160 and actuated to advance or withdraw side catheter 160, as described in further detail herein; , a side catheter actuator 164 (side catheter 160 is shown in FIG. 1B in an actuated or deployed configuration), thereby transitioning side catheter 160 between a delivery configuration and a deployed configuration; (2) a septal penetrator 170; A septal penetrator actuator (or "penetrator actuator") 174 and (septal penetrator 170 is shown in an actuated or deployed configuration in FIG. 1B).

[0096] As further illustrated in FIG. Optional GSA 150 is operably coupled to GA actuator 154 configured to actuate GSA 150 as described in further detail herein.

[0097] As further illustrated in FIG. 1A, septal puncture device 100 optionally includes an end effector 162 coupled to side catheter 160 and extending distally therefrom. End effector 162 is configured to facilitate subsequent puncture through a target puncture location, such as the FO of the septum of the heart. The end effector 162 may be configured, for example, to contact or tent the FO, as described in further detail herein. Such FO contacting or tenting can, for example, reduce or minimize the force required to penetrate the FO and/or provide improved force distribution to the FO. End effector 162 may be configured to prevent unintentional puncturing and/or damage to the FO by end effector 162 .

[0098] In some embodiments, the end effector 162 is visible under any suitable imaging technique (eg, fluoroscopy, echocardiography, etc.) from outside the patient when the end effector 162 is in the heart. In preparation for deployment of the end effector 162 by the operator, e.g., the septal penetrator 170, in the heart or against the FO. to facilitate locating the end effector 162.

[0099] In some embodiments, the end effector 162 is configured in multiple configurations, for example, as the end effector 162 is routed through the patient's vasculature, as described in further detail herein. and a deployment 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 is delivered to the heart in a compressed, deflated, or other relatively small configuration, and then expanded, expanded, or otherwise deployed to an increased size. Once transitioned to configuration, the FO may be touched or tented. Also, in some embodiments, after deployment of the end effector 162, the end effector 162 is in a withdrawal configuration (which can be the same as the delivery configuration or may be similar) to aid in removal of the end effector 162 from the patient.

[00100] End effector 162 may be formed of any suitable material or materials to facilitate the functionality described herein. In some embodiments, the end effector 162 can be transitioned between a constrained or compressed configuration (e.g., delivery or withdrawal configuration) and an unconstrained or extended configuration (deployed configuration) by one It may be formed of one or more shape memory materials (eg, nitinol) or polymers, or combinations thereof (eg, polymer-coated nitinol). For example, in some embodiments, end effector 152 is delivered to the heart in a contracted configuration and then (e.g., fluidly coupled to and extending proximally from end effector 162, not shown). It may be or include a balloon so that it can be inflated to a deployed configuration (via an inflation lumen). Various further embodiments of end effectors are described in greater detail below.

[00101] Each of main shaft 120, guidewire coupler 122, side catheter guide 130, guide coupler 140, optional GSA 150, side catheter 160, septal penetrator 170, and guidewire coupler 172 are positioned relative to body 110. Translatable (eg, distally advanceable and/or extendable and proximally retractable and/or retractable). The side catheter 160 is translatable relative to the side catheter guide 130 and the septal penetrator 170 is translatable relative to the side catheter 160, as described in greater detail herein.

[00102] The septal penetrator 170 may be sized, shaped, and formed of any suitable material to effectively penetrate and traverse the target tissue, such as the FO. For example, in some embodiments the septal penetrator 170 can be a needle. In some embodiments, the septal penetrator 170 can be a non-coring needle (eg, a sharp-tipped needle with a cutting edge, such as a Quincke-type needle). In some embodiments, septal penetrator 170 can have variable material properties. In such embodiments, for example, a distal portion of septal penetrator 170 may have a greater stiffness than portions proximal to the distal portion. In this way, the more rigid distal portion may be configured for septal penetration, while the proximal portion may be configured for delivery through the patient's vasculature. In some embodiments, septal penetrator 170 may be solid tipped and may be electrified with radio frequency (“RF”) energy to penetrate the FO.

[00103] The septal penetrator 170 may have any suitable length, eg, any length suitable for reaching the LA. For example, in some embodiments, the septal penetrator 170 has an effective length (i.e., extendable from the distal end of the side catheter 160 (or from the distal end of the end effector 162) of about 5 mm to about 25 mm. ). In some cases, the effective length of septal penetrator 170 can be about 8 mm or about 10 mm, or any length therebetween. In some embodiments, septal penetrator 170 may include or be configured to house a stylet to limit or minimize tissue coring. In some embodiments, septal penetrator 170 may include a pressure transducer (not shown) configured to monitor pressure through the lumen of septal penetrator 170 . In some embodiments, a port or luer lock may be incorporated into septal puncture device 100 to flush septal penetrator 170 .

[00104] Turning now to Figures 2A and 2B to illustrate the septal puncture device 100 (1) in relation to the patient's anatomy and (2) in a sample procedure to access the patient's LA. 2A is a schematic illustration 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 across the RA into the SVC; FIG. 2B; 1 is a schematic illustration of septal puncture device 100 disposed in a deployed configuration, thereby delivering a second guidewire that may be used to access and provide subsequent access to the LA.

[00105] In use, prior to introducing the septal puncture device 100 into a patient, a guidewire GW1 is inserted (not shown) through the patient's entry site (e.g., femoral vein puncture site) to provide a known guidewire delivery method. is advanced through the patient's vasculature across the IVC and RA into the SVC using any suitable technique. With guidewire GW1 so disposed, septal puncture device 100 can be movably coupled to guidewire GW1 via guidewire coupler 122 and can be movably coupled to guidewire GW1 from the patient's entry site toward the heart. can be advanced. In some embodiments, the guidewire coupler 122 may be a lumen defined by the main shaft 120 through which the guidewire GW1 may be disposed, whereby the main shaft 120 is connected to the guidewire GW1. may be slidably disposed about the . Guidewire GW1 may be of any suitable size. In some embodiments, for example, guidewire GW1 can have a diameter of about 0.014 inches to about 0.035 inches in diameter. In some embodiments, guidewire GW1 can be about 0.025 inches in diameter. With guidewire coupler 122 movably coupled to delivered guidewire GW1, septal puncture device 100 may be advanced into the heart along guidewire GW1, as illustrated in FIG. 2A. More specifically, with the main shaft 120 coupled to (1) the main body 110 and (2) the side catheter guide 130 via the guide coupler 140, as illustrated in FIG. 120, guide coupler 140, side catheter guide 130, side catheter 160, septal penetrator 170, and guidewire coupler 172 may all be advanced into the patient's heart, thereby extending body 110 through the IVC and into the RA. , and the main shaft 120 extends into the SVC. With the main shaft 120 spanning the IVC, RA, and SVC, the main shaft 120 can provide a foundation or reinforcement, as will be described in more detail herein, side catheter guide 130, side Catheter 160 and septal penetrator 170 can be deployed relative thereto and advanced toward the septum.

[00106] Optionally, (1) main shaft 120, (2) side catheter guide 130, (3) side catheter 160, and septal penetrator 170 (and associated couplers, such as guidewire coupler 122 and guidewire coupler 172). ) may be disposed within body 110 (within one or more lumens (not shown) defined by body 110). In this manner, the patient's anatomy may be protected or shielded by the body 110 during delivery to avoid unintended trauma or contact from such components to the patient's anatomy. . With the distal end of body 110 disposed within or near the RA, body 110 is withdrawn (and/or one or more of the components movably coupled to the body are advanced), Side catheter guide 130 and guide coupler 140 may thereby be exposed within the RA.

[00107] With the side catheter guide 130 exposed in the RA and rigidly translationally coupled to the main shaft 120 via the guide coupler 140, as illustrated in FIG. 2B, the side catheter guide 130: The distal end of side catheter guide 130 (and consequently, if disposed therein upon lateral deflection of side catheter guide 130, side catheter 160, septal penetrator 170, and guidewire GW2). also) can be actuated to deflect laterally. As shown in FIG. 2B, the side catheter guide 130 is any suitable guide for directing the side catheter 160 and septal penetrator 170 movably attached to the side catheter guide 130 toward the target penetration site, e.g., the FO. can be laterally deflected at an angle. In some cases, the optimum angle of entry into the FO will be 90 degrees or substantially 90 degrees to the surface line tangent to the FO, which will be about the same angle to the central axis of the main shaft 120. . Such a vertical (or substantially vertical) entry angle is required to penetrate the FO because the force vector is wholly or substantially wholly directed into the plane of the FO (rather than a tangential approach). force can be minimized. Also, such a vertical (or substantially vertical) entry angle, given the patient's anatomy, directs the septal penetrator 170 into a relatively large space within the LA, thereby Minimize the risk of unintentional puncture (eg, unintentional puncture of the LA wall).

[00108] In other cases, the angle of entry to the FO or to the central axis of the main shaft 120 can be anywhere from about 50 degrees to about 90 degrees. In some cases, the preferred entry angle may be selected based on the particular therapy planned for the left side of the heart. In some cases, the optimal angle and location of entry through the FO is based on the particular therapeutic instrument or procedure, as the angle of entry defines the trajectory of subsequent therapeutic instruments entering the left side of the heart, for example.

[00109] It is noted that guidewire GW2 may be delivered in any suitable manner. For example, in some cases the guidewire GW2 is disposed within the side catheter guide 130 during delivery of the side catheter guide 130, while in other cases the guidewire GW2 is placed later during the procedure, e.g. After the septal penetrator 170 penetrates the FO and reaches the LA, it is inserted.

[00110] With the side catheter guide 130 transitioned to the deployed configuration in which the side catheter guide 130 is laterally biased toward the FO, the side catheter actuator 164 is at least partially defined by the side catheter guide 130. It can be actuated to advance the side catheter 160 along the path towards the FO. Optionally, side catheter 160 is advanced until its distal end tents or contacts the FO. For embodiments that include 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 tents or contacts the FO.

[00111] In embodiments where the end effector 162 is expandable and compressible, the end effector 162 is delivered to the right atrium RA in a compressed or relatively small configuration, and then the end effector 162 is in a relatively large configuration. It can be transitioned to an extended deployed configuration and then advanced to engage the FO. After sufficient penetration of the atrial septum AS by septal penetrator 170, end effector 162 transitions to a retracted or compressed configuration suitable for withdrawal from the patient, as described in greater detail herein. can be In embodiments in which side catheter 160 is slidably disposed within the lumen defined by side catheter guide 130 , end effector 162 similarly slides within the lumen defined by side catheter guide 130 . The side catheter guide 130 may be movably disposed so that the side catheter guide 130 includes the end effector 162 in a constrained or compressed configuration for delivery, after which the side catheter actuator 164 is actuated to move the side catheter 160 into the side catheter. As distally advanced from the distal end of guide 130 , end effector 162 may transition to a stretched or unconstrained configuration while or after exiting the lumen of side catheter guide 130 .

[00112] With the side catheter 160 (or end effector 162) in sufficient contact with the FO, the penetrator actuator 174 is positioned at least partially against and along the path defined by the side catheter 160. It can be actuated to advance the septal penetrator 170 . Septal penetrator 170 may be advanced through the FO and across the atrial septum AS into the left atrium LA. In some embodiments, the side catheter 160 defines a lumen through which the septal penetrator 170 is slidably disposed, such that actuation of the penetrator actuator 174 causes the septal penetrator 170 to move to the side. It is advanced through the lumen of catheter 160 . Septal penetrator 170 may thus be advanced to penetrate the FO and extend into the left atrium LA. During such penetration, main shaft 120 may provide lateral or axial stability to septal penetrator 170 .

[00113] When the guidewire GW2 is coupled to the side catheter guide 130 during delivery of the side catheter guide 130, the guidewire GW2 passes the distal end of the septal penetrator 170 across the atrial septum AS to the left. It may follow the septal penetrator 170 via the guidewire coupler 172 as it is advanced into the chamber LA. In other cases, guidewire GW2 may be inserted later in the procedure, eg, after septal penetrator 170 has penetrated the FO and reached the LA. In some embodiments, guidewire coupler 172 is a lumen defined by septal penetrator 170 and through which guidewire GW2 may be slidably disposed. In such embodiments, guidewire GW2 may be disposed within the lumen of septal penetrator 170 during delivery and deployment of septal penetrator 170 into left atrium LA.

[00114] With septal penetrator 170 and guidewire GW2 disposed in left atrium LA, guidewire GW2 may be advanced further into left atrium LA by manipulation at the proximal end of guidewire GW2, and/or the septal penetrator 170 may be withdrawn from the left atrium LA across the FO puncture or entry site, leaving the guidewire GW2 within the left atrium LA.

[00115] A guidewire GW2 is delivered to the left atrial LA (for subsequent access to the left atrial AS), across the puncture or entry site of the FO from the left atrial LA, into the right atrial RA, the IVC, and the patient's pulse. While extending proximally through the vasculature to the patient's entry point, the septal puncture device 100 may be withdrawn proximally from the heart and out of the patient over guidewire GW2.

[00116] Guidewire GW2 may be any guidewire suitable for providing desired subsequent access to the left atrium LA. In some embodiments, for example, guidewire GW2 may be a pigtail, an atraumatic guidewire, or other suitable guidewire conventionally used in transseptal procedures. For example, guidewire GW2 may have a flexible, coiled tip, pigtail, and may be configured to anchor septal puncture device 100 to the LA, thereby allowing septal puncture. Limit or prevent unintentional withdrawal or removal of guidewire GW2 from the LA in response to or while instrument 100 is withdrawn from the patient along guidewire GW2. Another guide GW2 example can be ProTrack™ pigtail wire from Baylis Medical Company.

[00117] Septal puncture device 100 may be configured to be withdrawn from the patient in any suitable order (eg, after guidewire GW2 has been delivered to left atrium LA). With the guidewire GW2 disposed in the left atrium LA, for example, the portion of the septal penetrator 170 and the guidewire coupler 172 disposed in the left atrium LA is withdrawn from the guidewire GW2 to perform FO. can be drawn into the right atrium RA through the puncture site. Side catheter 160 is slidably disposed through the septal penetrator. can be withdrawn and drawn into this lumen. In this manner, the septal penetrator 170, and the distal portion of septal penetrators specifically designed to penetrate tissue, may be covered and shielded by the side catheter 160 to facilitate safe withdrawal from the patient and may be , may avoid unintentional contact with the patient's heart or vascular system upon removal of the septal puncture device 100 from the patient.

[00118] Similarly, the side catheter 160 may be withdrawn relative to the side catheter guide 130. FIG. For example, in embodiments in which side catheter guide 130 defines a lumen through which side catheter 160 is slidably disposed, side catheter 160 is positioned within the lumen of side catheter guide 130. can be drawn in. In embodiments where septal puncture device 100 includes an end effector 162 , side catheter guide 160 may be withdrawn from and drawn into the lumen of side catheter guide 130 , thereby causing end effector 162 to move. are also drawn into the lumen of side catheter guide 130 . In embodiments in which the end effector 162 has a deployed configuration with a diameter greater than the inner diameter of the side catheter guide 130, the end effector 162 can be configured to transition from the deployed configuration to the withdrawal (or delivery) configuration. For example, if end effector 162 is a balloon, it can be deflated and then drawn into the lumen of side catheter guide 130 . As another example, if the end effector 162 includes or is formed of a shape memory material, the end effector 162 may be compressed, constrained, or more rigid so that it can be drawn into the side catheter guide 130 . It can be migrated to a smaller arrangement. In some cases, retraction of end effector 162 into side catheter guide 130 may cause end effector 162 to transition to a constrained or compressed configuration.

[00119] Also, the side catheter guide 130 is at least substantially straight and parallel to the main shaft 120 from a deployed configuration in which the distal portion is laterally biased relative to the main shaft 120. It can be configured to transition to a withdrawal (or delivery) configuration. In some embodiments, for example, a proximal force can be applied to the proximal end portion of the side catheter guide 130 to withdraw the side catheter guide 130 relative to the main shaft.

[00120] With septal puncture device 100 positioned as shown in Figure 2A, for example, after delivery of guidewire GW2, septal puncture device 100 may be withdrawn from the heart and out of the patient. For example, the body 110 and all of the components connected thereto may be withdrawn from the heart, through the patient's vasculature, and through an initial entry site into the patient (eg, a femoral puncture site).

[00121] Although the embodiments described herein refer to introducing a guidewire and septal puncture device into the patient's vasculature, across the IVC and RA, and into the SVC, Access to the RA for the purpose of deploying a septal penetrator can be achieved in various ways. In some embodiments, for example, a guidewire and septal puncture device are inserted into the patient's jugular vein (eg, right internal jugular vein) and then into and across the SVC and RA into the IVC. , thereby disposing the distal end of the septal puncture device at (or beyond) the IVC.

[00122] Although the embodiments described herein refer to a single FO puncture for delivering a single guidewire to the LA, the septal puncture device described herein It should be understood that it can be used to perform multiple punctures and to deliver multiple guidewires. For example, in some cases, such as in the context of an atrial fibrillation ablation procedure, double puncture and delivery of two guidewires may be desirable. In such a case, the septal puncture device described herein may be deployed twice to puncture the septum twice, each puncture as described herein. , to provide access for delivering the guidewire. For example, in some procedures requiring multiple punctures and guidewires delivered to the LA, it may be critical that the punctures are at specific locations and at specific distances from each other, and the present disclosure As described throughout, the septal puncture device described herein provides just that.

[00123] Multiple punctures may also be made in series using the septal puncture device described herein (e.g., with a single penetrator, single side catheter, single side catheter guide, etc.). Alternatively, in some embodiments, any of the septal puncture devices described herein may be modified to incorporate additional components. For example, in some cases, a septal puncture device (similar to septal puncture device 100) may include a body and a main shaft, but with two side catheter guides, two side catheters, two end effectors, two septum Also includes a penetrator and two guide couplers (for the guidewires to be delivered), and optionally one or two guide couplers and one or two guide stabilizers/actuators. In this way, two side catheter guides can be deployed (i.e. laterally deflected and stabilized) simultaneously, and then the two side catheters (optionally with end effectors) are optionally advanced simultaneously. can be applied to contact the septum, and then the two septal penetrators can optionally be advanced simultaneously to penetrate the septum. With two punctures in the septum, two guidewires can then optionally be delivered simultaneously. In such cases, the preferred distance between the two punctures may optionally be defined by the distance between the side catheters from which the septal penetrator is advanced.

[00124] Figure 3 illustrates a method 200 of accessing the left atrium of a patient's heart using the septal puncture device 100, according to one embodiment. At 201, a guidewire GW1 is passed through the IVC, across the RA, and into the SVC of the heart (e.g., through the femoral venipuncture and through the patient's vasculature disposed between the femoral venipuncture site and the IVC). through). At 202, septal puncture device 100 is delivered over guidewire GW1 until the distal end of main shaft 110 is disposed within the SVC. At 204, the GSA 150 is actuated to laterally deflect the side catheter guide 130 toward the FO. Optionally, at 206, main shaft 110 and side catheter guide 130 are selectively positioned (eg, 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 relative to and contacts the FO (eg, to tent 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 side catheter guide 130 is aligned with the end effector 162 (or the distal end of the side catheter 130). or distal end of side catheter 130) to selectively reposition relative to the FO.

[00125] At 214, the septal penetrator 170 is advanced through the FO into the LA. Optionally, at 216, visualization techniques are used to confirm crossing of the septal penetrator 170 into the LA. At 220, guidewire GW2 is advanced relative to septal penetrator 170 into LA, or septal penetrator 170 is withdrawn relative to septal penetrator 170, thereby leaving a portion of guidewire GW2 within LA. At 222, septal penetrator 170 is withdrawn, end effector 162 is optionally withdrawn, main shaft 120 is withdrawn, guide actuator 150 is stopped, and instrument 100 is withdrawn over guidewire GW1 and removed from the patient. be done.

[00126] Although not shown, in some embodiments, any of the main shafts described herein may define a channel through which intracardiac echo is disposed or It may be slidably coupled to aid navigation within the patient.

[00127] FIGS. 4A and 4B respectively show septal puncture device 300 in a delivery configuration and a deployed configuration in perspective view, and FIGS. Viewed from the front, FIGS. 6A-6H illustrate the deployment sequence at the distal end portion of septal puncture device 300 according to another embodiment.

[00128] Similar to or similar to that described with respect to septal-puncture device 100, septal-puncture device 300 provides access and guidance from the right side of the heart (eg, right atrium) to the left side of the heart (eg, left atrium). It can be used to deliver wires to the left side of the heart. Septal puncture device 300 may be constructed the same or similar to intermediate puncture device 100 and may function the same or similar. Accordingly, portions of septal puncture device 300 are not described in greater detail herein.

[00129] In this embodiment, the septal puncture device 300 includes a body 310 defining a first lumen 311 and a second lumen 312, and as described in further detail herein, the septal puncture device 300 includes a body 310 that Various portions of puncture device 300 are disposed or slidably disposed through these lumens. Coupled to body 310 are main shaft 320 and side catheter guide 330 , with main shaft 320 coupled to side catheter guide 330 via guide coupler 340 . As shown in FIGS. 5A and 5B, the proximal end portion of side catheter guide 330 is disposed within second lumen 312 of body 310 . Side catheter guide 330 (as shown in FIGS. 5A, 5B, and 6H) defines a lumen through which side catheter 360 is slidably disposed, side catheter 360 enclosing the septal penetrator. 370 defines a lumen through which guidewire GW2 may be slidably disposed, and septal penetrator 370 defines a lumen through which guidewire GW2 may be slidably disposed. Extendable from the distal end portion of side catheter 360 is an end effector 362 .

[00130] The main shaft 320 is telescopic, ie it can be extended/stretched/advanced and contracted/withdrawn segment by segment. Main shaft 320 includes a proximal section 320A and an expansion section 320B partially disposed within proximal section 320A and telescopically distal to the proximal section. Although not shown, in some embodiments, septal puncture device 300 is inflated by being operably coupled to inflation section 320B of main shaft 320 and translationally locking inflation section 320B by proximal section 320A. A lock configured to at least temporarily limit or prevent relative movement between the compartment and the proximal compartment is included. In this manner, the telescopic feature of main shaft 320 can be selectively enabled and disabled by the operator, as described in further detail herein.

[00131] 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. As shown in FIG. In some implementations of this embodiment, the proximal section 320A of the main shaft 320 is rigidly coupled to the body 310 (eg, welded within the first lumen 311 of the body). Circumferentially disposed about and fluidly connected to expansion section 320B of main shaft 320 (inflation section 320B is fluidly slidably connected to proximal section 320A). ), a guide stabilizer/actuator (“GSA”) 350 . In this embodiment, GSA 350 is a balloon configured to be inflated for deployment and deflated for delivery or withdrawal. For inflation, GSA 350 is configured to receive one or more fluids (eg, saline, air, or a contrast agent for visualization) via inflation compartment 320B. In use, for example, one or more fluids may be conveyed from the lumen defined by proximal section 320A to the lumen defined by inflation section 320B and into the volume defined by GSA 350. FIG. The one or more fluids are delivered (eg, via the same conduction path used to deliver the one or more fluids) to contract GSA 350 so that GSA 350 can be withdrawn from the patient. ) can be withdrawn from the GSA 350 . The balloon can be of any size suitable to perform the desired functionality disclosed herein, for example, in some embodiments the balloon has a diameter of about 10 mm when inflated. from about 60 mm. In some embodiments, for example, the balloon may be 20 mm or about 20 mm in diameter when inflated. In some implementations of this embodiment, septal puncture device 300 includes a GA actuator (not shown, for example, disposed on handle 380 and operable thereon) configured to inflate or deflate GSA 350 . linked).

[00132] As shown, inflation section 320B includes an inflation portion 326 about which GSA 350 is circumferentially disposed, and a distal portion 327 that extends distally from GSA 350. As shown in FIG. In use, for example, with the GSA 350 deployed in the right atrium of the patient's heart, the distal portion 327 extends into the patient's SVC to provide space between the IVC and SVC for subsequent puncture of the FO. Provides stability. Although not shown, in some embodiments distal portion 327 may have a diameter greater than the diameter of dilating portion 326 . In this way, the cross-sectional area or footprint collectively envisioned within the atrium of the heart by the GSA 350 and the expanded portion 326 around which the GSA 350 is connected may be minimized, while the Distal portion 327 may be relatively large in diameter to provide additional stability (eg, by having a relatively greater stiffness) to ensure a stable platform that spans across. In other embodiments, other design considerations (eg, thickness, materials, etc.) may be employed to increase the stiffness or stability of distal portion 327 relative to expansion portion 326 for similar purposes.

[00133] Disposed within a first lumen defined by the main shaft 320 is a guidewire coupler 322. As shown in FIG. Guidewire coupler 322 extends distally from body 310 and is configured to extend from body 310 to the patient's SVC in use. Guidewire coupler 322 defines a lumen through which guidewire GW1 may be routed and slidably disposed. In some implementations of this embodiment, guidewire coupler 322 is rigidly coupled (eg, welded) to the inner surface of main shaft 320 . An expansion volume IV (eg, a crescent-shaped gap or volume) is defined between an outer surface portion of guidewire coupler 322 and an inner surface of main shaft 320, as best shown in FIG. 5B. This volume is fluidly connected to GSA 350, which is disposed about main shaft 320, such that when GSA 350 is disposed within a patient's heart, fluid passes through it from outside the patient to the interior of GSA 350. provides a conduit that can be delivered to

[00134] In this embodiment, guide coupler 340 is formed from a single suture (although in other embodiments, guide coupler 340 is formed from any number of sutures, such as two or more sutures). can be). Any suture suitable for rigidly coupling main shaft 320 translationally with side catheter guide 330 but allowing relative rotational movement between main shaft 320 and side catheter guide 330 may be used. can be In some embodiments, for example, polymers such as Dacron may be used.

[00135] To couple guide coupler 340 with main shaft 320 and side catheter guide 330, sutures may be separately circumferentially wrapped around each of side catheter guide 330 and main shaft 320, and the side catheters The guide 330 and the main shaft 320 may be collectively wrapped circumferentially. For additional fixation, in some embodiments, between the guide coupler 340 and the main shaft 320, between the guide coupler 340 and the side catheter guide 330, or between the side catheter guide 330 and the main shaft 320. An adhesive may be applied between them, or any combination thereof.

[00136] As with many minimally invasive surgical procedures in the epigastrium, it may be important to minimize the size, and particularly the cross-sectional footprint, of the instrument or instruments inserted into the patient. Forming guide coupler 340 with sutures allows for flush or substantially flush contact (e.g., direct or substantially direct contact) between main shaft 320 and side catheter guide 330. addresses this goal by In some embodiments, for example, the suture is attached to main shaft 320 such that the distance between the outer surface of main shaft 320 and the outer surface of side catheter guide 330 is equal or substantially equal to the outer diameter of the suture. and side catheter guide 330 . In such an embodiment, for example, a United States Pharmacopoeia (“USP”) 4-0 suture having an outer diameter of 0.15 mm is used as a 0.15 mm suture between the main shaft 320 and the side catheter guide 330. distance can be enabled. In some embodiments, other suture sizes may be used, such as USP2-0, USP3-0, USP5-0, USP6-0, or USP7-0.

[00137] Although in this embodiment the guide coupler 340 is formed of suture, in other embodiments the guide coupler may additionally or alternatively be made of, for example, fabric, polymer, fine wire, metal, Or it may be formed of other materials, such as braided materials. As another example, in some embodiments the guide coupler may be a sleeve (e.g., a woven sleeve), and in some embodiments, the sleeve may cooperate with the suture (e.g., tied into a lark knot). , the free ends of the suture may be stabilized by an adhesive application.

[00138] In addition, in this embodiment, as shown in FIG. 4B, the side catheter guide 330 is arranged on the right side of the main shaft 320 in top view. Given the general anatomic location of the FO relative to the IVC, SVC, and RA, offsetting the side catheter guide 330 relative to the central axis of the main shaft 320 in this manner often results in side catheter guide 330 is aligned with the FO. Since the FO is often offset from the central axis defined from IVC to SVC, aligning side catheter guide 330 offset from the central axis of main shaft 320 may result in side catheter guide 330 may be placed in a more suitable location for subsequent punctures. In this way, the placement of the side catheter guide 330 and main shaft 332 makes it easier for the operator to locate the FO with the side catheter 360 (or end effector 362) for subsequent puncture of the FO with the septal penetrator 370. The required time and number of steps can be optimized.

[00139] As described elsewhere herein, in this embodiment, the septal puncture penetrator 370 has a variable stiffness. More specifically, the distal end portion of septal penetrator 370 is configured to be stiffer/less flexible than the proximal end portion of septal penetrator 370, which is optimized for penetrating the FO. and the proximal end portion is optimized (due to flexibility) to advance through the curved side catheter guide 330 . Given the anatomical space constraints within the heart, an inflexible septal penetrator that is suitable for puncturing the septum and can bend appropriately from the central axis of the main shaft 320 in the RA and towards the FO. Accommodating the 370 would be difficult.

[00140] To address such constraints, side catheter guide 330, when deployed, assumes a curved shape as it extends distally from body 310, as illustrated in FIG. 4B. More specifically, when viewed from the front, the side catheter guide 330 extends proximally from its distal end and below the main shaft 320 across the central axis of the main shaft 320 and above the central axis of the main shaft 320 . , then curves to the left toward the second lumen 312 of the body 310 and inwardly thereof. In this way, the straight section of the distal end portion of the side catheter guide 360 can have sufficient length to slidably contain or house the septal penetrator 370 when deployed. Its length may, for example, be greater than the thickness of the FO. In some embodiments, the length can be from about 5 mm to about 15 mm, or even greater. In this embodiment, its length is greater than the diameter of GSA 350 when deployed. This curved configuration also provides a more gradual lateral deflection towards the FO than would otherwise be obtained, e.g. Allows lateral deflection/bending.

[00141] In use, avoiding traumatic contact with the patient's anatomy, for example, when advancing the main shaft 320 from patient entry through the patient's vasculature and into the IVC, RA, and SVC is desirable. To limit or prevent undesired trauma from septal-puncture device 300 to the patient, in this embodiment, septal-puncture device 300 is provided with a flexible atraumatic sheath coupled to and extending from main shaft 320. A sex distal component 328 is included. Although this embodiment illustrates the atraumatic distal component 328 as a separate component coupled to the main shaft 320, in other embodiments, a distal end portion of the main shaft 320 (e.g., distal tip) may be configured to be atraumatic (eg, flexible, soft, or any other design feature configured to avoid unwanted trauma to the patient). Atraumatic distal component 328 may be tapered, in some embodiments, such that its proximal end portion has a larger cross-sectional area than its distal end portion. In some cases, the portion having the largest cross-sectional area, diameter, or width of the atraumatic distal component 328 is the same, about the same, or a greater cross-section than the GSA 350 (when the GSA 350 is in the delivery configuration). It can have an area, diameter, or width. In this way, the atraumatic distal component 328 can facilitate smooth delivery within the patient.

[00142] Also, as shown, septal puncture device 300 is coupled to body 310 and manipulated by an operator to deliver and deploy septal puncture device 300 as described in further detail herein. It includes a handle 380 configured to. Handle 380 may include or be coupled to one or more shaft actuators (if included; not shown), GA actuator 354, side catheter actuator (not shown), and penetrator actuator (not shown). obtain. Additionally, the handle may be operable to actuate one or more of the actuators.

[00143] Turning now to an exemplary deployment sequence, FIGS. 6A-6H illustrate an exemplary deployment sequence at the distal end portion of septal puncture device 300 in side view, according to one embodiment.

[00144] FIG. 6A illustrates a portion of septal puncture device 300 prior to deployment. A septal puncture device 300 is inserted into a patient (e.g., via a femoral vein puncture) and passes through the patient's vasculature and into the patient's heart, whereby a main shaft 320 extending distally from body 310 is formed. It is this configuration that provides a stable platform across the IVC, RA, and SVC against which septal puncture device 300 can be deployed to puncture the FO. As shown, during delivery, septal puncture device 300 is in a delivery configuration in which main shaft 320 and side catheter guide 330 are parallel or substantially parallel to each other. In this manner, for example, the cross-sectional footprint of septal puncture device 300 may be minimized or optimized for minimally invasive delivery within a patient.

[00145] As shown in FIG. 6A, the distal end of side catheter guide 330 is in physical contact with the proximal side of GSA 350 during delivery. In some cases, for example, the proximal side of GSA 350 and the distal end of side catheter guide 330 may be such that a portion of the distal end of side catheter guide 330 may be partially nested within the proximal side of GSA 350 or It can be so close that it can be partially covered by its proximal side. In this way, the GSA 350 can protect the distal end of the side catheter guide 330 from unintentional contact with the patient's anatomy. In such a case, a subsequent step is to advance the inflation section 320B of the main shaft 320 to separate the distal end of the side catheter guide 330 from the GSA 350 or unarmor the distal end of the side catheter guide 330. including extending and retracting the main shaft 320 . In other cases, the septal puncture device 300 may be delivered spaced between the side catheter guide 330 and the GSA 350 such that the unarmoring step is unnecessary.

[00146] With the main shaft 320 extending from the IVC to the SVC and the GSA 350 and guide coupler 340 disposed within the RA, the side catheter guide 330 may be deployed as shown in Figure 6B. More specifically, a distal force is applied to the proximal end portion of the side catheter guide 330 and the force is transmitted to the guide coupler to rotate or deflect the guide coupler 340, causing the guide coupler 340 of the side catheter guide 330 to move. provides rotation or deflection about the guide coupler 340 of the portion extending distally from the . In this embodiment, the deflection occurs such that the distal end portion of the side catheter guide 330 deflects laterally approximately 90 degrees and approximately perpendicular to the central axis of the main shaft 320, as illustrated in FIG. 6B. . In alternative embodiments, the lateral deflection may be less than 90 degrees, such as about 15 degrees, about 30 degrees, about 45 degrees, about 60 degrees, about 75 degrees, or any angle therebetween. and so on. 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 may be greater than 90 degrees, such as about 105 degrees, about 120 degrees, about 135 degrees, or any angle therebetween. In this embodiment, actuation of side catheter guide 330 is sufficient to laterally deflect a portion of side catheter guide 330 such that that portion is substantially perpendicular to the central axis of main shaft 320; For example, in other embodiments where the lateral deflection is less than about 90 degrees, additional lateral deflection/rotation may be applied by GSA 350 as described in further detail herein.

[00147] Next, the GSA 350 is activated. That is, in this embodiment, it is inflated as illustrated in FIG. 6C. More specifically, fluid is applied to GSA 350 to expand GSA 350 . With the GSA 350 inflated, the inflation section 320B, around which the GSA 350 is disposed, is stretched proximally, including withdrawn relative to the proximal section 320A, whereby the proximal side of the GSA 350 is expanded in the FIG. It makes physical contact with the side catheter guide 350 as shown in 6D. Inflation section 320B is withdrawn relative to proximal section 320A with an amount of force that can be safely applied any distance suitable to sufficiently contact or stabilize side catheter guide 330. obtain. In some cases, such withdrawal may apply a force to the side catheter guide 350 to further laterally displace the side catheter guide 350 (although, as shown and described in this embodiment, side The catheter guide 350 is laterally deflected about 90 degrees before being physically contacted by the GSA 350), so that the distal end portion of the side catheter guide 350 is aligned with, for example, the central axis of the main shaft 320 or the FO or It is perpendicular or nearly perpendicular to the surface line tangent to the main shaft 320 . Such withdrawal forces may also cause the GSA 350 to contact or abut the distal end portion of the side catheter guide 350 and be pulled (e.g., laterally, axially (proximal or distal) relative to the main shaft 320). to) stabilize. Although not shown, in some cases the withdrawal force may be sufficient to recess the GSA 350 in the imprint of the side catheter guide 330 or cause the GSA to envelop a portion of the side catheter guide 330 . In this manner, side catheter guide 330 may be sufficiently stabilized and temporarily sufficiently coupled to GSA 350 . In some embodiments, GSA 350 may be configured to possess variable amounts of flexibility. In some embodiments, for example, a proximal portion of GSA 350 configured to contact side catheter guide 330 may have a first level of flexibility, while another portion of GSA 350 may have a first level of flexibility. A portion may have a second level of flexibility that is different from the first level of flexibility. Additionally, in some embodiments, the proximal side of GSA 350 may include features configured to further stabilize side catheter guide 330 relative to GSA 350 . These features may include, for example, dimples, protrusions, adhesives, and the like.

[00148] With the GSA 350 actuated and in sufficient contact with the side catheter guide 330 to provide sufficient stability of the side catheter guide 330 relative to the main shaft 320, the end effector 350, as illustrated in FIG. 362 is deployed. To deploy end effector 362 , side catheter 360 , from which end effector 362 extends distally, is advanced relative to side catheter guide 330 , whereby end effector 362 is positioned within side catheter guide 330 . As it is released from the constrained configuration within the lumen, it can be extended to an extended/deployed configuration.

[00149] With the end effector 362 deployed, the end effector 362 may be advanced toward and contact the FO to tent the FO. As described elsewhere herein, the operator has the ability to measure both the end effector and the tenting of the FO (or other portion of the septum) externally to the patient, e.g. It can be viewed through a variety of imaging techniques, including any suitable imaging technique. To advance the end effector 362 toward the FO and into contact with the FO, the side catheter 360 is moved (relative to the side catheter guide 330, for example by actuating a side catheter actuator (not shown)) or the main shaft 320. can be advanced by manipulating (i.e. translating or rotating) the .

[00150] If the operator is not satisfied with the location of the septum contacted or tented by the end effector 362, e.g., if the end effector 362 is misaligned with the FO, the end effector 362 may The catheter 360 can be withdrawn from contact with the FO or septum (either by withdrawing the catheter 360 against the side catheter guide 330 or by manipulating the main shaft 320), and the operator can then maneuver the FO sufficiently for subsequent puncture. Another approach to landing the end effector 362 on the FO may be taken. This process can be repeated until the operator is satisfied.

[00151] With the FO properly tented by the end effector 362, the septal penetrator 370 moves relative to the side catheter 360 and the end effector 362 and through the FO into the LA as shown in FIG. 6G. can be advanced to With the FO fully penetrated by the septal penetrator 370 and the distal end of the septal penetrator 370 disposed within the LA, the guidewire GW2 is inserted into the lumen defined by the septal penetrator 370. It is advanced through the lumen, thereby advancing at least the distal end portion of guidewire GW2 out the distal end of septal penetrator 370 (as shown in FIG. 6H) and into LA. This can be confirmed by the operator under imaging techniques. Once GW2 is confirmed to be fully positioned within the LA, septal penetrator 370 is withdrawn relative to and retracted into the lumen of side catheter 360, causing GSA 350 to contract (e.g., GSA ) and the side catheter guide 330 may be retracted into a straight, pre-deployed delivery configuration suitable for removal from the patient. Also, in some cases, the end effector 362 may be withdrawn relative to and drawn into the lumen defined by the side catheter 360 .

[00152] With the septal penetrator 370 pulled out from the LA, the operator operates the septal-puncture device 300 (for example, the handle 380, the main body 310, or the main shaft 320) so that the septal-puncture device 300 is inserted into the patient. Withdraw the entire septal puncture device 300 along the guidewire GW2 until it exits the septum.

[00153] Figures 7A and 7B further illustrate the actuation of the side catheter guide 340 and the guide coupler 340 and the transition between their respective delivery configuration (Figure 7A) and deployment configuration (Figure 7B). . With septal puncture device 300 disposed in the delivery configuration, as shown in FIG. 7A, main shaft 320 and side catheter guide 330 extend distally from body 310 and relatively parallel or nearly parallel. They extend and are connected to each other via guide couplers 340 . More specifically, guide coupler 340 is coupled to side catheter guide 330 and proximal section 320A of main shaft 320 therebetween. With the guide coupler 340 coupled to the proximal section 320A of the main shaft 320, the expansion section 320B of the main shaft 320 can move the proximal section, possibly without interference to or by the guide coupler 340, for example. 320A can be advanced.

[00154] As described in further detail herein, the side catheter guide 340 has a distal force (e.g., It may be configured to transition from a delivery configuration (FIG. 7A) to a deployed configuration (FIG. 7B) in response to a distal force applied at handle 380). With a portion of side catheter guide 340 translationally fixed but rotationally coupled to proximal section 320A of main shaft 320 via guide coupler 340, side catheter guide 330 is shown in FIG. 7B. , so that the portion of the side catheter guide 330 disposed distal to the guide coupler 340 rotates clockwise about the guide coupler 340 .

[00155] The distal force applied to the side catheter guide 340 also causes the portion of the guide coupler 340 disposed about the side catheter guide 340 to move, as illustrated in FIG. It rotates around a portion disposed around the main shaft 320 . Stated another way, the distal force applied to side catheter guide 340 is at least partially transmitted to guide coupler 340, thereby actuating the hinging feature of guide coupler 340 and causing side catheter guide 330 to deliver. Allows transition from configuration to deployment configuration.

[00156] In this embodiment, the guide coupler 340 is formed of sutures to limit or limit relative translational movement between the main shaft 320 and the side catheter guide 330 as described in further detail herein. It is threaded or routed around and between the main shaft 320 and the side catheter guide 330 to prevent but allow relative rotational movement. Sutures may be threaded or routed around and between the main shaft 320 and side catheter guides 330 in any suitable manner to provide the intended functionality. In some embodiments, fasteners may be added to the sutures to improve their fixation to the main shaft 320 and side catheter guides 330 . The fastener may be, for example, an adhesive, which is optionally used to adhere the suture wraps/loops and the free ends of the suture.

[00157] FIG. 8 illustrates an example placement of the suture (guide coupler 340). As shown (left in FIG. 8), the suture is initiated in a lark knot 340CH around the side catheter guide 330 and then the first working end of the suture is tied about the main shaft 320 in a first direction. D1 to coil or loop around main shaft 320 such that the second working end of the suture is centered about main shaft 320 in a second direction (opposite to first direction D1). It is routed to D2 and spirals or loops around the main shaft 320 in the same manner as the first working end. Each end of the suture may be secured by being sandwiched under, between, or threaded through one or more of the loops, or the suture may be secured, e.g. It may be secured by additional fasteners.

[00158] Figure 9 illustrates a method 400 of accessing the left atrium of a patient's heart using a septal puncture device 300, according to one embodiment. At 401, a guidewire GW1 is passed through the IVC, across the RA, and into the SVC of the heart (e.g., through the femoral venipuncture and through the patient's vasculature disposed between the femoral venipuncture site and the IVC). through). At 402, septal puncture device 300 is delivered over guidewire GW1 until the distal end of main shaft 320 is disposed within the SVC. In some cases, guidewire GW1 is advanced or wedged to the uppermost aspect of the SVC (e.g., the bifurcation of the SVC into the left and right brachiocephalic (unnamed) veins) to advance main shaft 520 and associated components ( For example, it may provide additional stability for the side catheter guide 530). At 404, the side catheter guide 330 is actuated to direct the distal end of the side catheter guide 330 toward the FO of the septum of the heart. At 406, balloon 550 disposed about main shaft 320 is inflated and inflation section 320B of main shaft 320 is withdrawn relative to proximal section 320B of main shaft 320, thereby displacing balloon 350 from side catheter guide 330. abut on.

[00159] At 408, optionally, main shaft 320 and side catheter guide 330 are precisely positioned (eg, translated, rotated, etc.) with respect to the FO. At 410, the side catheter 360 is advanced and the end effector 362 is deployed from the distal end portion of the side catheter guide 330 so that the side catheter 360 contacts and tents the FO. At 412, the operator optionally visualizes the tenting of the FO. At 414, the septal penetrator 370 is advanced relative to the side catheter 360 through the FO and into the LA. At 416, the operator optionally visualizes septal penetrator 370 to confirm that septal penetrator 370 has traversed into the LA. At 418, a second guidewire GW2 is advanced relative to the septal penetrator 370 and into the LA. At 420, septal penetrator 370 is withdrawn from and retracted into the lumen defined by side catheter 360, inflation section 320B of main shaft 320 is advanced relative to proximal section 320A, Side catheter guide 330 is withdrawn relative to main shaft 320 and balloon 350 is deflated. Optionally, at 420 the end effector 362 is withdrawn relative to the side catheter guide 330 . In some cases, withdrawing the end effector 362 relative to the side catheter guide 330 includes retracting the end effector 362 into the lumen defined by the side catheter guide 330 to return the end effector 362 to the delivery configuration.

[00160] Although the septal-puncture device 300 is illustrated and described as having a GSA 350, in alternative embodiments, the septal-puncture device is similar to the septal-puncture device 300 but without a GSA, for example. It does not have to be included. In such embodiments, the septal puncture device may rely on the guide coupler for both lateral deflection and stabilization of, for example, side catheter guides, side catheters, and septal penetrators. 7A and 7B are referenced as an illustrative example of such an alternative embodiment, given that these figures show only a portion of septal puncture device 300 and do not include GSA 350. obtain.

[00161] Figures 10-12 illustrate a portion of a septal puncture device 500 in a deployed configuration in perspective bottom, side, and side views, respectively, according to another embodiment. Septal-puncture device 500 is located on the right side of the heart, similarly or similarly as described with respect to other septal-puncture devices described herein (eg, septal-puncture device 100, septal-puncture device 300, etc.). It can be used to access the left side of the heart (eg, the left atrium) from (eg, the right atrium) and to deliver guidewires to the left side of the heart. Septal puncture device 500 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 500 are not described in greater detail herein.

[00162] In this embodiment, as shown, septal puncture device 500 includes a main shaft 520 defining a lumen therethrough (eg, through which a guidewire may be routed). Main shaft 520 includes a proximal section 520A at its proximal end, a distal section 520C at its distal end, and an inflation section 520B disposed therebetween. The proximal section 520A defines a first aperture AP1, and the expansion section 520B defines a second aperture AP2, both of which are in fluid communication with the lumen of the main shaft 520, and a second aperture AP2 disposed opposite the second aperture AP2. Define 3 apertures AP3. As best shown in FIG. 12, in this embodiment, the proximal end of inflation section 520B is inserted into proximal section 520A and the distal end of inflation section 520B is inserted into distal section 520C. However, in alternate embodiments, other main shaft designs suitable for providing stability for lateral puncture may be used. In some embodiments, for example, two or three of the proximal section, the expansion section, and the distal section may be monolithically formed, rather than formed separately and then joined together.

[00163] Septal puncture device 500 further includes a side catheter guide 530 that extends distally into the lumen of main shaft 520 at the proximal end of proximal section 520A of main shaft 520, as shown. It extends in the lateral direction, exits the first aperture AP1 (see for example FIG. 11), enters towards the second aperture AP2 and exits the third aperture AP3.

[00164] The expansion section 520B of the main shaft 520 includes (1) a first first expansion section 526A having a first stabilizer/actuator guide ("GSA") 550A disposed therearound; defines a second expansion portion 526B in which a second stabilizer/actuator guide (“GSA”) 550B is disposed. In this embodiment, the first GSA 550A and the second GSA 550B are balloons arranged circumferentially about the main shaft 520. As shown in FIG. The distal portion of the side catheter guide 530 translates directly to (relative to) the main shaft 520 (eg, using any suitable fasteners) between the first GSA 550A and the second GSA 550B. Alternatively, the distal portion of the side catheter guide 530 may be separated from the distal surface of the first GSA 550A and the proximal surface of the second GSA 550B by contact, abutment, interference fit, etc. , may be translationally fixed relative to the main shaft 520 . In some embodiments, the distal portion of side catheter guide 530 can be attached to one or both of first GSA 550A or second GSA 550B.

[00165] The first GSA 550A and the second GSA 550B are configured to be inflated for deployment and deflated for delivery or withdrawal. To inflate, the first GSA 550A passes one or more fluids (eg, one or more of saline, air, or contrast agents for visualization) to the fluid defined by the first inflatable portion 526A. It is configured to receive from and through an opening O (FIG. 12). Similarly, second GSA 550B is configured to receive one or more fluids from and through openings O (FIG. 12) defined by second inflatable portion 526B. In use, for example, one or more fluids pass through the lumen of the main shaft 320, into the volume defined by the first GSA 550A (via the opening O of the first inflatable portion 526A) and into the volume defined by the second GSA 550A. 526B) into the volume defined by the second GSA 550B. The same one or more fluids are used to deliver the one or more fluids from the first GSA 550A and the second GSA 550B to contract the first GSA 550A and the second GSA 550B (e.g., withdrawn), thereby reducing the cross-sectional area or footprint of the first GSA 550A and the second GSA 550B to facilitate removal from the patient. The balloon can be of any size suitable to perform the desired functionality disclosed herein, for example, in some embodiments the balloon has a diameter of 20 mm or 20 mm when inflated. It can be about 20mm. In some implementations of this embodiment, septal puncture device 500 includes a GSA actuator (not shown, e.g., also not shown) configured to expand or contract first GSA 550A and second GSA 550B. disposed on or operably connected to the handle of the septal puncture device).

[00166] As shown, and as with other embodiments described herein, the side catheter guide 530 extends distally around the first GSA 550A and then through the first GSA 550A and the second GSA 550A. As routed through the conduction path defined between them by GSA 550B, side catheter guide 530 extends from the length of side catheter guide 530 across the first side of main shaft 520 to the second side of main shaft 520. Curvature is envisioned to extend beyond (e.g., at least a distance equal to the diameter of the first GSA 550A or the second GSA 550B when inflated), thereby further describing other embodiments herein. A linear or substantially linear length (eg, about 3 cm to about 4 cm in some cases) suitable to accommodate the septal penetrator (or rigid portion of the septal penetrator), as described in detail. I will provide a.

[00167] As noted above, some components of septal puncture device 500 are similar or identical (in shape or function) to components of other septal puncture devices described herein, and they will not be described or illustrated again with respect to septal puncture device 500. For example, in some embodiments, septal puncture device 500 includes a body, a handle, a side catheter (with or without an end effector extending therefrom), a septal penetrator, one or more guidewire couplers, or actuators (eg, shaft actuators, GSA actuators, side catheter actuators, penetrator actuators), none of which are shown in FIGS. 10-12. The following examples of how to use septal puncture device 500 refer to some of those components.

[00168] In use, septal puncture device 500 is inserted into a patient (eg, via a femoral venipuncture) and is inserted into the patient's vascular system, eg, as described herein with respect to other embodiments. into the patient's heart, whereby the main shaft 520 spans the IVC, RA, and SVC and provides a stable platform against which the septal puncture device 300 deploys to puncture the FO. can do. In some cases, septal puncture device 500 is inserted over a guidewire (not shown) routed through the lumen of main shaft 520 (or optionally through a guidewire coupler, not shown). obtain. Upon such delivery, septal puncture device 500 is in a delivery configuration (not shown) with first GSA 550A and second GSA 550B retracted. In this manner, for example, the cross-sectional area or footprint of septal puncture device 500 may be minimized or optimized for minimally invasive delivery within a patient.

[00169] With the main shaft 520 extended from the IVC to the SVC and the distal end portions of the first GSA 550A, second GSA 550B, and side catheter guide 530 disposed within the RA, the first GSA 550A and The second GSA 550B can be inflated to deploy the side catheter guide 530, as shown in FIGS. 10-12. Inflating first GSA 550A and second GSA 550B in this manner causes the distal end portion of side catheter 530 to (1) deflect laterally toward the FO to a suitable angle and (2) The distal end portion of side catheter 530 is stabilized to facilitate subsequent tenting or puncture of the FO. In this embodiment, the deflection is such that the distal end portion of the side catheter guide 530 is perpendicular to the central axis of the main shaft 520 or to the FO or surface line tangent to the main shaft 520, as illustrated in FIG. It occurs to deflect laterally until it is nearly vertical. In alternate embodiments, the lateral deflection may optionally be less or greater than about 90 degrees, as described with respect to other embodiments. Although not shown, in some cases, the first GSA 550A or the second GSA 550B may be recessed in the vestiges of the distal end portion of the side catheter guide 530 or the distal end portion of the side catheter guide. It can be inflated to envelop a portion of the distal portion. In this manner, side catheter guide 530 may be sufficiently stabilized and temporarily sufficiently coupled to first GSA 550A or second GSA 550B. In some embodiments, GSA 550A or GSA 550B can be configured to possess variable amounts of flexibility. In some embodiments, for example, the distal portion of the first GSA 550A and the proximal portion of the second GSA 550B may have a first level of flexibility while the first GSA 550A Another portion of the GSA 550B and another portion of the second GSA 550B may have a second level of flexibility different from the first level of flexibility. Additionally, in some embodiments, the distal side of first GSA 550A and the proximal side of second GSA 550B include features configured to further stabilize side catheter guide 530 relative to GSA 550. obtain. These features may include, for example, dimples, protrusions, adhesives, and the like.

[00170] With the first GSA 550A and the second GSA 550B actuated and in sufficient contact with the side catheter guide 530 to provide sufficient stability of the side catheter guide 530 relative to the main shaft 520, another implementation An end effector (not shown) may be deployed from the side catheter guide 530, similar or similar to that described in the configuration. To deploy the end effector, for example, a side catheter (not shown) from which the end effector extends distally is positioned relative to the side catheter guide 530 (defined by the side catheter guide 530). through a lumen extending therethrough), whereby the end effector extends to an extended/deployed configuration as it is released from a constrained or delivery configuration within the lumen of the side catheter guide 530. can do.

[00171] With the end effector deployed, the end effector may be advanced toward and contact the FO to tent the FO. As described elsewhere herein, the operator has the ability to measure both the end effector and the tenting of the FO (or other portion of the septum) externally to the patient, e.g. It can be viewed through a variety of imaging techniques, including any suitable imaging technique. The side catheter manipulates (relative to side catheter guide 530, e.g., by actuating a side catheter actuator (not shown)) or main shaft 520 to advance the end effector toward the FO until it contacts the FO. It can be advanced by moving (i.e., translating or rotating).

[00172] If the operator is not satisfied with the location of the septum contacted or tented by the end effector, e.g., if the end effector is misaligned with the FO, the end effector (e.g., side catheter It can be withdrawn from contact with the FO or septum (either by withdrawing against the catheter guide 530 or by manipulating the main shaft 520), and the operator then pulls the end effector sufficiently to suffice for subsequent puncture of the FO. Another approach to landing on the FO can be done. This process can be repeated until the operator is satisfied.

[00173] With the FO properly tented by the end effector, a septal penetrator (not shown) is inserted (eg, through a lumen defined by and extending through the side catheter) to the side catheter and the end effector. to and through FO into LA. With the FO fully penetrated by the septal penetrator and the distal end of the septal penetrator disposed within the LA, a second guidewire is defined by and extends through the septal penetrator. to and through the lumen, thereby advancing at least the distal end portion of the guidewire out of the distal end of the septal penetrator and into the LA. This can be confirmed by the operator under imaging techniques.

[00174] Once it is confirmed that the second guidewire is sufficiently positioned within the LA, the septal penetrator may be withdrawn relative to and drawn into the lumen of the side catheter. , first GSA 550A and second GSA 550B may be deflated in preparation for removal of septal puncture device 500 from the patient. Also, in some cases, the end effector may be withdrawn relative to and drawn into the lumen defined by the side catheter.

[00175] With the septal penetrator withdrawn from the LA, the operator manipulates the septal puncture device 500 (e.g., handle, body, or main shaft 520) (e.g., without further penetration of the FO). Leaving the second guidewire within the patient for subsequent access to the left atrium, the septal puncture device 500 is withdrawn entirely along the second guidewire until the septal puncture device 500 exits the patient.

[00176] In some embodiments, during delivery, the side catheter guide 530 (or any component disposed therein) is prevented from premature deployment or advancement or into the patient's anatomy. can be protected from unintentional and undesired contact of In some cases, for example, the side catheter guide 530 (or the side catheter and end effector extending or projecting from the distal end of the side catheter guide 530) can be in the delivery configuration or the contracted configuration, the first GSA 550A and the second GSA 550A. It may be at least partially encased within the GSA550B. As an illustrative example, Figures 13A-13F show a partial delivery and deployment sequence. 13A shows septal puncture device 500 in a delivery configuration with first GSA 550A and second GSA 550B retracted and circumferentially disposed about side catheter guide 530. FIG. FIG. 13B shows first GSA 550A and second GSA 550B in a deployed and inflated configuration with side catheter guide 530 laterally deflected relative to main shaft 520, thereby causing side catheter guide 530 to flex. The distal end is directed toward the FO and extends linearly proximally between the first GSA 550A and the second GSA 550B toward and beyond the main shaft 520 . Arrows L and R represent the linear and angular axes, respectively, along which the main shaft 520 aligns the distal end of the side catheter guide (or end effector of the side catheter) with the FO. Can be adjusted by the operator.

[00177] FIG. 13C shows a side catheter 560 with an end effector 562 advanced from the side catheter guide 530 into contact with and tenting the FO. Side catheter 560 may be advanced any suitable distance to probe the FO. In some cases, for example, side catheter 560 may be advanced from side catheter guide 530 about 1 cm to about 4 cm. In other cases, as another example, side catheter 560 may be advanced from side catheter guide 530 about 2 cm to about 3 cm.

[00178] FIG. 13D shows a septal penetrator 570 advanced from the side catheter 560 through the FO and into the LA, and a guidewire (with a pigtail configuration) advanced from the septal penetrator 570 through the FO and into the LA. GW2. The septal penetrator 570 may be advanced any suitable distance from the side catheter 560 to penetrate the FO and enter the LA. Optionally, for example, septal penetrator 570 may be advanced from side catheter 560 about 0.5 cm to about 1 cm.

[00179] With guidewire GW2 disposed within the LA, the septal penetrator 570 may be withdrawn from the LA as described in further detail herein and as illustrated in Figure 13E. Also, as illustrated in FIG. 13F, the first GSA 550A and the second GSA 550B can be contracted to extend from within the LA through the FO puncture and into the LA for subsequent minimally invasive access to the LA. Septal puncture device 500 may be withdrawn over and along guidewire GW2, leaving guidewire GW2 exiting the patient through the patient's vasculature.

[00180] Although the septal puncture device 500 is shown and described as having a second aperture AP2 and a third aperture AP3 in the main shaft 520 through which the side catheter guide 530 may be disposed; In other embodiments, a similar septal puncture device may include a side catheter guide that extends or is routed along the outer surface of the main shaft rather than through the main shaft. In such embodiments, for example, the septal puncture device may include a guide coupler similar or identical in shape or function to any of the guide couplers described herein with respect to other embodiments. A guide coupler is disposed, for example, between the first GSA and the second GSA to connect (eg, rigidly and rotationally connect) the side catheter guide to the main shaft. , whereby the side catheter guide can deflect laterally about the guide coupler in response to inflation/deployment of the first GSA and the second GSA. The guide coupler can in some examples be a hinge, such as a suture-formed hinge, similar or identical to those described in other embodiments herein.

[00181] Septal puncture device 500 has a side catheter guide 530 through which side catheter 560 (and end effector 562), septal penetrator 570, and guidewire GW2 may be slidably disposed. Although shown and described as such, in alternate embodiments, the septal puncture device may not include, for example, a side catheter guide. Figures 14A-14K illustrate one such alternative embodiment. More specifically, FIGS. 14A-14K illustrate an example deployment sequence for the distal end portion of the septal puncture device 600 according to one embodiment.

[00182] Similar to or similar to that described with respect to other septal-puncture devices described herein, septal-puncture device 600 extends from the right side of the heart (e.g., right atrium) to the left side of the heart (e.g., right atrium). left atrium) and to deliver guidewires to the left side of the heart. Septal puncture device 600 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 600 are not described in greater detail herein.

[00183] In this embodiment, as illustrated in FIG. 14A, prior to deployment, septal puncture device 600 includes a portion of main shaft 620, first GSA 650A, second GSA 650B, and side catheters. A portion of 660 has a protective sleeve 629 connected to and circumferentially disposed thereabout. Protective sleeve 629 may protect the aforementioned components of septal-puncture device 600 prior to use of septal-puncture device 600, for example. In such cases, protective sleeve 629 may be removed prior to insertion of septal puncture device 600 into the patient. Also, in some cases, protective sleeve 629 may protect the aforementioned components of septal puncture device 600 during delivery of septal puncture device 600 into and within a patient. As an example, the septal puncture device 600 can be inserted into the patient's vascular system through the IVC and into the RA, similar to those described herein with respect to other embodiments. In such cases, protective sleeve 629 may be configured to prevent unintended contact or trauma to the patient's surrounding tissue. Additionally or alternatively, protective sleeve 629 constrains first GSA 650A, second GSA 650B, or side catheter 660 to define a cross-sectional profile or footprint suitable for delivery within a patient. can be configured as In this manner, the protective sleeve 629 and components disposed therein can be delivered to the RA of the heart, whereupon the protective sleeve 629 is withdrawn along the main shaft 620 (or, as the case may be, is pulled along the main shaft 620). ) to expose first GSA 650A, second GSA 650B, and a portion of side catheter 660.

[00184] With the protective sleeve 629 withdrawn or advanced, the side catheter 630 may assume a curved orientation as described in other embodiments herein and illustrated in FIG. 14B. Also, as illustrated in FIG. 14B, an end effector 662 may optionally be disposed between the first GSA 650A and the second GSA 650B such that the end effector 662 is at least partially shielded. be. Stated another way, end effector 662 is spaced from the central axis of main shaft 620 by a distance less than the radius of first GSA 650A and second GSA 650B. Furthermore, the side catheter 660 is slidably disposed with respect to the main shaft 620, the first GSA 650A, and the second GSA 650B. Thus, the side catheter 660 (and end effector 662) are attached to the main shaft 620 to provide sufficient space for the first GSA 650A and the second GSA 650B to extend or expand, as illustrated in FIG. 14C. can be advanced against.

[00185] With the end effector 662 thus advanced, the first GSA 650A and the second GSA 650B are inflated, as illustrated in Figure 14D. Inflation of first GSA 650A and second GSA 650B also laterally deflects and stabilizes the distal end portion of side catheter 660 relative to main shaft 620, as shown. Lateral deflection was measured during the experiment and is shown in FIGS. 14E and 14F as an illustrative example. As shown in FIG. 14E, prior to inflation of first GSA 650A and second GSA 650B, (1) side catheter 660 (a) central axis of main shaft 620 and (b) first GSA 650A and second GSA 650A. The angle between the central axis of the portion extending distally from the GSA 650B and (2) the central axis of the main shaft 620 is about 65 degrees to about 70 degrees. As the first GSA 650A and the second GSA 650B expand, the angle changes to about 90 degrees as illustrated in Figure 14F.

[00186] With the side catheter 660 thus laterally deflected, the side catheter 660 may optionally be further advanced relative to the main shaft 620, thereby increasing the effective length (e.g., first and The length of the side catheter extending distally from the closest outer surface of the second GSA 650A, 650B) is increased to the desired amount for tenting the FO, as illustrated in FIG. 14G. A septal penetrator 670 is then advanced relative to the end effector 662 to, for example, penetrate the FO, as illustrated in FIG. 14H. Also, as described in other embodiments herein, guidewire GW2 passes through the lumen defined by septal penetrator 670 to end effector 662, as illustrated in FIG. 14I. can be advanced.

[00187] With guidewire GW2 fully advanced, septal penetrator 670 is positioned (e.g., between the sharp blade of septal penetrator 670 and guidewire GW2, and septal penetrator 670, as shown in FIG. 14J). It may be retracted into the lumen defined by the side catheter 670 to prevent unintentional contact (and risk of injury) between the sharp edge of the penetrator 670 and surrounding patient anatomy). Also, as shown in FIG. 14J, the first GSA 650A and second GSA 650B can be retracted, and the side catheter (and end effector 662) can be pulled from the main shaft around the guidewire GW2, as shown in FIG. 14K. With respect to 620, it can be withdrawn toward the delivery position.

[00188] (1) Septal puncture device 500 passes through a lumen defined by main shaft 520 (or a central axis of main shaft 520), or more specifically, through a second aperture of main shaft 520. (2) the septal puncture device 600 passes through the lumen or central axis of the main shaft 620; Although shown and described as having a side catheter 660 routed therethrough, in other embodiments, a side catheter guide or side catheter is positioned along the outer surface of the main shaft, i.e., along the central axis of the main shaft. may be routed offset from A side catheter guide or side catheter, for example, may be disposed on one side of the main shaft in top view. Given the general anatomical location of the FO relative to the IVC, SVC, and RA (e.g., measured laterally from the central longitudinal axis from the IVC to the SVC), often such a side catheter guide or side By offsetting the catheter with respect to the central axis of the main shaft, the distal end of the side catheter guide or side catheter is better aligned with the FO. Since the FO is often offset from about 4 mm to about 6 mm from the central axis defined from IVC to SVC, by aligning the side catheter guides at an equivalent distance offset from the central axis of the main shaft, the A side catheter guide or side catheter will be placed in a more suitable position for subsequent puncture. In this manner, a side catheter guide or placement of the side catheter and main shaft is required by the operator to locate the FO by the side catheter (or end effector) for subsequent puncture of the FO by the septal penetrator. The time and number of steps taken can be optimized.

[00189] One such example is illustrated in Figures 15-17, which respectively show a septal puncture device 700 in perspective, front and side views, according to one embodiment. Similar to or similar to that described with respect to other septal-puncture devices described herein, septal-puncture device 700 extends from the right side of the heart (eg, right atrium) to the left side of the heart (eg, left atrium). and to deliver guidewires to the left side of the heart. Septal puncture device 700 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 700 are not described in greater detail herein.
[00190] In this embodiment, the septal puncture device 700 is configured around or around the main shaft 720, the first GSA 750A, the second GSA 750B, the first GSA 750A, and then the second GSA 750A, as shown. and a side catheter 760 routed between one GSA 750A and a second GSA 750B and along the outer surface of the main shaft 720 (offset from the central axis of the main shaft 720). In this manner, side catheter 760 may be better aligned with the patient's FO in some cases. Although not shown in FIGS. 15-17, in some embodiments side catheter 760 may be slidably attached to main shaft 720 via a guide coupler (not shown). The guide coupler slidably and rotatably attaches the side catheter 760 to the main shaft 720, for example, to prevent the side catheter 760 from separating from the main shaft 720 or between the first GSA 750A and the second GSA 750B. It can be configured to allow attachment. In other embodiments, for example, the guide coupler may be attached to, be part of, or extend from the first GSA 750A or the second GSA 750B. An illustrative example of a guide coupler 840 of a septal puncture device 800 according to one embodiment is shown in FIGS. 18A-18C.

[00191] Similar to or similar to that described with respect to other septal-puncture devices described herein, septal-puncture device 800 extends from the right side of the heart (e.g., right atrium) to the left side of the heart (e.g., right atrium). left atrium) and to deliver guidewires to the left side of the heart. Septal puncture device 800 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 700 are not described in greater detail herein.

[00192] FIGS. 18A-18C respectively show a contracted delivery configuration (side catheter 860 is at least partially axially aligned with main shaft 820), a first power, lateral and (side catheter 860 laterally deflected a second degree greater than the first degree, stabilized, representative of FO). 8A illustrates first GSA 850A and second GSA 850B in an inflated deployed configuration (facing the model).

As shown, the guide coupler 840 of this embodiment extends from the main shaft 820 to circumferentially surround or engage the side catheter 860 . More specifically, guide coupler 840 defines an eyelet through which side catheter 860 is threaded. In this way, the side catheter 860 is free to translate (advance or be withdrawn) through the grommet. In some embodiments, the grommets can be sized to have an at least partial interference fit, thereby providing a tight fit between guide coupler 840 and side catheter 860 such that side catheter 860 is not unintentionally translated. provide some friction to the Guide coupler 840 also connects first GSA 850A and second GSA 850B to allow lateral deflection of side catheter 860 toward its target location (eg, FO), as shown in FIG. 18C. is configured to rotate about main shaft 820 in response to expansion of the . After delivery of guidewire GW2 (not shown), first GSA 850A and second GSA 850B may be retracted and guide coupler 840 may be retracted during deployment, as described with respect to other embodiments herein. can be rotated in the direction opposite to the direction it is rotated to.

[00194] Although various embodiments of the septal puncture device described herein disclose a single side catheter guide or single side catheter (with a single end effector), In some embodiments, the septal puncture device may include two side catheter guides or two side catheters (with or without one or more side catheter guides). One such embodiment is illustrated in Figures 19-21. Figures 19-21 respectively show a septal puncture device 900 including two side catheters in perspective, front and detailed partial perspective views.

[00195] Similar to or similar to that described with respect to other septal-puncture devices described herein, septal-puncture device 900 extends from the right side of the heart (e.g., right atrium) to the left side of the heart (e.g., right atrium). left atrium) and to deliver guidewires to the left side of the heart. Septal puncture device 900 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 900 are not described in greater detail herein.

[00196] In this embodiment, the septal puncture device 900 comprises a first device, each configured to be delivered and deployed within a patient, as described herein with respect to other embodiments. It includes a side catheter 960A and a second side catheter 960B. Septal puncture device 900 further includes a first end effector 962A extending from a first side catheter 960A and a second end effector 962B extending from a second side catheter 960B. As shown, the main shaft 920 includes a lumen through which the first side catheter 960A and the second side catheter 960B may be slidably disposed, and a lumen for the first side catheter 960A and the second side catheter 960B. Define an aperture AP through which the side catheter 960B may be advanced or withdrawn. The septal puncture device 900 further includes a first GSA 950A circumferentially centered on the main shaft 920, proximal to the aperture, and a first GSA 950A circumferentially centered on the main shaft 920, distal to the aperture AP. and a second GSA 950B disposed on the posterior side. In this manner, the first side catheter 960A and the second side catheter 960B extend distally from the AP through a conduction path defined between the first GSA 950A and the second GSA 950B. obtain.

[00197] In use, the first GSA 950A and the second GSA 950B traverse the first side catheter 960A and the second side catheter 960B, similar to those described herein with respect to other embodiments. It can be inflated to deflect in a direction (e.g., laterally, axially (proximal, distal)) and stabilize, whereby the first and second septal penetrators (not shown) are positioned there. can be advanced or withdrawn through and first and second guidewires (not shown) can be advanced and withdrawn through the first and second septal penetrators thereof. When accessing the LA, for example, a first GSA 950A and a second GSA 950B are disposed within the RA in an inflated deployed configuration, and a first side catheter 960A and a second side catheter 960B are directed toward the septum. While directed, the first side catheter 960A and the second side catheter 960B are advanced to tent the FO, and then the first and second septal penetrators are advanced (optionally simultaneously). can puncture the FO or other target location or locations in the septum. The puncture sites may be separated by a predetermined distance set by the distance between the side catheter lumens. With two punctures in the septum, two guidewires may then be advanced (optionally simultaneously) into the LA, one through each puncture.

[00198] Although the septal puncture device 900 is shown and described as having two GSAs, in other embodiments, the septal puncture device may be similar or identical to the septal puncture device 900. but contains only a single GSA. An exemplary embodiment is shown in Figures 22 and 23, which show front and perspective views, respectively, of a septal puncture device. Similar to or similar to that described with respect to other septal-puncture devices described herein, septal-puncture device 1000 is directed from the right side of the heart (eg, right atrium) to the left side of the heart (eg, left atrium). It can be used to access and deliver two guidewires to the left side of the heart. Septal puncture device 1000 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 1000 are not described in greater detail herein.

[00199] In this embodiment, the septal puncture device 1000 comprises a first device, each configured to be delivered and deployed within a patient, as described herein with respect to other embodiments. It includes a side catheter 1060A and a second side catheter 1060B. Septal puncture device 1000 further includes a first end effector 1062A extending from first side catheter 1060A and a second end effector 1062B extending from second side catheter 1060B. As shown, the main shaft 1020 includes a lumen through which the first side catheter 1060A and the second side catheter 1060B may be slidably disposed, and a lumen for the first side catheter 1060A and the second side catheter 1060B. Define an aperture AP through which the side catheter 1060B may be advanced or withdrawn. Septal puncture device 1000 further includes GSA 1050 disposed circumferentially about main shaft 1000 distal to aperture AP. In this manner, first side catheter 1060A and second side catheter 1060B may extend distally from the AP along the proximal end surface of GSA 1050 as shown.

[00200] Although not shown, in the delivery configuration in which the GSA 1050 is contracted, the first side catheter 1060A and the second side catheter 1060B are in a more convenient position for delivery, e.g., generally parallel to the central axis of the main shaft 1020. can be oriented along the outer surface of the contracted GSA 1050. As described in further detail with respect to other embodiments herein, the GSA 1050 is attached to the main shaft 1020 by a first side catheter 1060A and a second side catheter 1060B, as illustrated in FIGS. can be configured to be inflated or deployed to laterally deflect the . GSA 1050 may also be configured to stabilize first side catheter 1060A and second side catheter 1060B relative to main shaft 1020, as described in further detail with respect to other embodiments herein. . In some embodiments, for example, GSA 1050 can include dimples, protrusions, ridges, adhesives, etc. configured to improve stability of first side catheter 1060A and second side catheter 1060B. .

[00201] With the first side catheter 1060A and the second side catheter 1060B thus laterally deflected and stabilized, the first side catheter 1060A and the second side catheter 1060B are connected to the main shaft. A first septal penetrator may be advanced relative to 1020 toward a target tissue (e.g., septum or FO), e.g., to penetrate the septum and deliver a first guidewire and a second guidewire. , a second septal penetrator, a first guidewire, and a second guidewire (none of which are shown in FIGS. 19 and 20) may be deployed.

[00202] Although septal puncture device 1000 is illustrated and described as having two side catheters, in other embodiments, septal puncture device 1000 may be similar or identical to septal puncture device 1000. It is possible but contains only a single GSA. An exemplary embodiment is shown in FIGS. 24 and 25, which show perspective front and side perspective views of a septal puncture device, respectively. Similar to or similar to that described with respect to other septal-puncture devices described herein, septal-puncture device 1100 passes from the right side of the heart (eg, right atrium) to the left side of the heart (eg, left atrium). It can be used to access and deliver two guidewires to the left side of the heart. Septal puncture device 1100 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 1100 are not described in greater detail herein.

[00203] In this embodiment, septal puncture device 1100 includes a side catheter configured to be delivered and deployed within a patient as described herein with respect to other embodiments. Septal puncture device 1100 further includes an end effector 1162 extending from side catheter 1160 . As shown, main shaft 1120 has a lumen through which side catheter 1160 and second side catheter 1160 may be slidably disposed, and a lumen through which side catheter 1160 and second side catheter 1160 pass. Define an aperture AP that can be advanced or withdrawn. Septal puncture device 1100 further includes GSA 1150 disposed circumferentially about main shaft 1100 and distal to aperture AP. In this manner, the side catheter 1160 may extend distally from the AP along the proximal end surface of the GSA 1150 as shown.

[00204] Although not shown, with the GSA 1150 in the contracted delivery configuration, the side catheter 1160 is positioned along the outer surface of the contracted GSA 1150, generally parallel to the central axis of the main shaft 1120, for example. can be oriented As described in further detail with respect to other embodiments herein, the GSA 1150 may be inflated to laterally deflect the side catheter 1160 relative to the main shaft 1120, as illustrated in FIGS. It can be configured to be deployed. GSA 1150 may also be configured to stabilize side catheter 1160 relative to main shaft 1120, as described in further detail with respect to other embodiments herein. In some embodiments, for example, GSA 1150 can include dimples, protrusions, ridges, adhesives, etc. configured to improve stability of first side catheter 1160 .

[00205] With the side catheter 1160 thus laterally deflected and stabilized, the side catheter can be advanced relative to the main shaft 1120 toward the target tissue (e.g., septum or FO), e.g. a first septal penetrator, a second septal penetrator, a first guidewire, and a second guidewire ( 24 and 25) can be deployed.

[00206] An example of delivery and deployment of septal puncture device 1100 in relation to a patient's heart is illustrated in FIGS. 26A and 26B. As shown in FIG. 26A, septal puncture device 1100 is positioned within the RA of the heart such that main shaft 1120 spans the IVC, RA, and SVC, and GSA 1150 and side catheter 1160 are disposed within the RA. can be set. As described in further detail with respect to other embodiments herein, the GSA 1150 laterally deflects and stabilizes the side catheter 1160 relative to the main shaft 1120 toward the FO, as illustrated in FIG. 26B. can be inflated to a deployed configuration for As further illustrated in FIG. 26B, the side catheter 1160 may be advanced such that the end effector 1162 contacts or tents the FO, after which the septal penetrator 1170 is oriented against the end effector 1162. Guidewire GW2 may be advanced into the LA by advancing distally from the .

[00207] Various embodiments of septal puncture devices are described herein as having one or more GSAs, some of which may be balloons having particular shapes, sizes, etc. , any of the embodiments described herein are suitable to be inflatable and deflatable coupled to the main shaft, and one or more side catheter guides or one or more side catheters (and any shape, size, expansion volume suitable for laterally deflecting and stabilizing any components disposed therein, such as end effectors, septal penetrators, and guidewires; It can be modified to have one or more GSAs with one or more materials, one or more surface features, and the like. Various embodiments of the GSA are described below with respect to FIGS. 27-34 by way of illustrative examples and are referenced as being part of septal puncture devices 1200-1900. All of these may be the same or similar and function in the same or similar manner as the other septal puncture devices described herein. Accordingly, some of the septal puncture devices 1200-1900 are not described in greater detail herein.

[00208] In some embodiments, for example, the GSA can have a concave or convex shape. One such embodiment is illustrated in FIG. 27, which shows a first GSA 1250A having a concave shape at its distal end and a first GSA 1250A disposed distally and proximally to the first GSA 1250A. A portion of a septal puncture device 1200 including a second GSA 1250B having a convex shape at the end is shown. As shown, such a shape combination provides a conduction channel through which the side catheter 1260 may be slidably disposed (or in an alternate embodiment, a side catheter guide may be disposed therethrough). can define a path.

[00209] In another embodiment, the GSA is configured to define an optimal conduction path along which a side catheter guide or side catheter may extend from the proximal end of the GSA to the distal end of the GSA. obtain. One such embodiment is illustrated in FIG. 28, which shows a portion of a septal puncture device 1300 including a first GSA 1350A having a particular curvature C along which side Catheter 1360 (or side catheter guide in other embodiments) may be extended to engage the first GSA. As shown, in this embodiment the curvature C is different than the corresponding section of the second GSA 1350B.

[00210] In some embodiments, a septal puncture device may include one or more GSAs that are multi-lobe (2-lobes, 3-lobes, etc.). Multilobes can, for example, reduce or limit the footprint of the GSA, thereby reducing the risk of unwanted occlusion within the patient. When the GSA is disposed within the patient's RA, it is advantageous to minimize the cross-sectional area or footprint of the GSA, for example, to allow blood to flow in line with the normal functioning of the heart. Will. For example, a three-lobe GSA is shown in top view in FIG. As shown, main shaft 1420 (of septal puncture device 1400) extends axially between first lobe GSA 1450A, second lobe GSA 1450B, and third lobe GSA 1450C; One lobe GSA1450A defines a conduction path through which a side catheter or side catheter guide may be routed.

[00211] In some embodiments, as illustrated in top view in FIG. 30, the septal puncture device is a multi-lobe GSA in which at least two of the plurality of lobes are dissimilar in size or shape. can include As illustrated in FIG. 30, septal puncture device 1500 includes first lobe GSA 1550A, second lobe GSA 1550B, and third lobe GSA 1550C, wherein first lobe GSA 1550A is connected to second lobe GSA 1550A. It has a different size than the GSA1550B.

[00212] In some embodiments, one or more GSAs may have a particular aspect ratio to further reduce the risk of blood flow occlusion. For example, a portion of septal puncture device 1600 is shown in side view in FIG. 31, where first GSA 1650A and second GSA 1650A have a collective height of L1. Minimizing L1 can help limit the risk of blood flow occlusion in some cases. In this embodiment, for example, L1 is less than the collective width or collective diameter of first GSA 1650A and second GSA 1650B indicated by L2.

[00213] In some embodiments, a septal puncture device may include an associated GSA. For example, as illustrated in side view in FIG. 32, first three-lobed GSA 1750A and second three-lobed GSA 1750B of septal puncture device 1700 are rotatably offset relative to each other about main shaft 1750 and then engaged and interlocked. In some embodiments, for example, first three-lobe GSA 1750A can be rotated about 60 degrees about main shaft 1750 relative to second three-lobe GSA 1750B and then geared. Other rotation angles may be used in other embodiments.

[00214] In some embodiments, a septal puncture device may include an asymmetric GSA. For example, as illustrated in side and top views in FIG.

[00215] In some embodiments, the septal puncture device may include two side catheters (or side catheter guides) disposed extending between the GSAs in different or opposite directions, Thereby, the main shaft can be rotated to selectively align one side catheter (or side catheter guide) with the target location to be penetrated, but not the other. For example, as illustrated in side view in FIG. 34, septal puncture device 1900 includes a first GSA 1950A and a second GSA 1950B that collectively define two conductive paths in opposite directions therebetween. In this manner, the first side catheter 1960A is disposed within or routed through a first conductive path defined between the first GSA 1950A and the second GSA 1950B, as shown. and a second side catheter 1960B may be disposed in or routed through a second conductive path defined between the first GSA 1950A and the second GSA 1950B. In use, for example, the operator rotates the main shaft 1920 about its central axis to select only one of the first GSA 1950A or the second GSA 1950B (at a time) as the target location (eg, septum or FO). can be aligned.

[00216] In some embodiments, the septal puncture device includes a side catheter guide or a guide configured to couple a side catheter (without a side catheter guide in some embodiments) to the main shaft. A coupler may be included whereby the guide coupler along with the side catheter is slidable relative to the main shaft. An exemplary embodiment is illustrated in Figures 35A-35D, in which septal puncture device 2000 is shown in various stages of a deployment sequence.

[00217] Similar to or similar to that described with respect to other septal-puncture devices described herein, septal-puncture device 2000 extends from the right side of the heart (e.g., right atrium) to the left side of the heart (e.g., right atrium). left atrium) and to deliver guidewires to the left side of the heart. Septal puncture device 2000 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 2000 are not described in greater detail herein.

[00218] In this embodiment, septal puncture device 2000 includes a body (not shown) slidably disposed about side catheter guide 2030 and extendable main shaft 2020. As shown in FIG. A side catheter guide 2030 is coupled to the main shaft 2020 via a guide coupler 2040 as shown in Figure 35A. Guide coupler 2040 is slidable relative to main shaft 2020 . Disposed distally of the body (not shown) is a pusher 2096 slidably circumferentially disposed about the main shaft 2020 . Main shaft 2020 includes GSA 2050 disposed distal to guide coupler 2040 . Pusher 2096 is configured to be advanced relative to main shaft 2020 into contact with guide coupler 2040 and push/advance guide coupler 2040 and attached side catheter guide 2030 toward GSA 2050 into contact therewith. , whereby the distal end portion of side catheter guide 2030 is connected to guide coupler 2040 and guide coupler 2040, as described in other embodiments herein and as illustrated across FIGS. 35A-35D. Deflect laterally around GSA 2050 .

[00219] In some procedures involving a septal-puncture device, sensing various parameters such as pressure, flow, temperature, oxygen, etc. at or near the patient's heart, e.g. would be desirable. In procedures to access the LA of the heart, it may be desirable to determine the pressure within the heart, eg, within the RA or within the LA. Accordingly, a sensor may be coupled to the septal puncture device in any of the embodiments described herein. In some embodiments, for example, a septal puncture device may include an intracardiac echo (“ICE”) sensor configured to enhance visualization capabilities for the operator during the procedure. An illustrative example is shown in FIG. 36 illustrates a portion of a septal puncture device 2100 having an ICE sensor disposed within catheter C. FIG. A catheter may represent a main shaft, a side catheter guide, a side catheter, or a septal penetrator. In this way, the ICE sensor can provide visualization from various orientations and positions within the patient, for example, depending on the location within the septal puncture device in which the ICE is disposed.

[00220] In some embodiments, the septal puncture device may include a camera in addition to or instead of the ICE sensor or other suitable sensor. An illustrative example is shown in FIG. FIG. 37 illustrates a portion of septal puncture device 2200 having camera 2295 disposed within GSA 2250 . Camera 2295 may be configured to communicate wirelessly in some embodiments, but in other embodiments, camera 2295 is positioned proximally from camera 2295 in the main direction of septal puncture device 2200 . There may be physical connections (eg, wires, optical fibers, etc.) that extend through the shaft 2220 and out of the patient. The camera 2295 may be disposed at various locations within the GSA 2250, such as contacting and coupled to an inner wall of the GSA 2250, or (as described with respect to various embodiments herein). It may be attached to a catheter disposed therein. With the camera 2295 disposed within the GSA 2250, the camera 2295 can provide direct visualization of the septal or FO treatment, eg, before, during, or after puncture.

[00221] In some procedures involving a septal puncture device, it may be desirable to flush the area adjacent to the septal penetrator, side catheter, or end effector, e.g., before, during, or after the puncture. deaf. As such, any of the septal puncture devices described herein have an exit near the septal penetrator, side catheter, or end effector to allow an area at or adjacent to that location to be An irrigator (not shown) may be included, configured to flush (eg, with saline) during or after. The septal puncture device may also include a pressure transducer configured to measure pressure, eg, within the RA or LA, before or after puncture, eg, to verify successful puncture.

[00222] Referring now to Figures 38 and 39, an exemplary septal puncture device (also referred to herein as "the device") 2300 is illustrated. In contrast to many of the embodiments described above, this embodiment does not have a body containing a main shaft and side catheters side-by-side, but instead has a cannula 2306 with a central lumen and a catheter within the lumen of the cannula 2306. and a stylus 2310 disposed in the . Cannula 2306 extends from distal end 2302 to proximal end 2304 . Cannula 2306 has an elongated hollow tubular shape with a lumen therethrough. Cannula 2306 includes an opening in distal end 2302 and at least one elongated window 2308 adjacent distal end 2302, with both the opening and at least one window 2308 fluidly connected to the lumen of cannula 2306. there is Cannula 2306 may have any suitable dimensions. For example, the cannula 2306 can have an outer diameter of about 14 to 22 French (about 5mm to 7mm). In some embodiments, cannula 2306 can have one or more surface coatings. Suitable surface coatings may reduce friction or irritation and may include anticoagulants such as heparin, ethylenediaminetetraacetic acid (EDTA), oxalic acid, and the like.

[00223] Instrument 2300 further includes an elongated flexible tubular stylus 2310 sized to fit within the lumen of cannula 2306. As shown in FIG. The stylus 2310 is functionally equivalent to the combined side catheter guide and side catheter in the embodiments described above. In some embodiments, stylus 2310 has an articulated structure, such as in FIGS. 40A and 40B. The joint may extend the entire length of stylus 2310 or only a section of stylus 2310 . In some embodiments, stylus 2310 is articulated from distal end 2302 over a length of approximately 2 cm to 4 cm. Stylus 2310 includes a first lumen sized to receive hollow needle 2312, which corresponds to the septal penetrator in the embodiments described above. Hollow needle 2312 also has a guidewire lumen (corresponding to the guidewire coupler in the embodiments described above) sized to fit any suitable guidewire 2314, such as a 0.035 inch guidewire. In some embodiments, stylus 2310 includes one or more additional lumens, each additional lumen sized to accommodate cable 2316 .

[00224] Instrument 2300 further includes a handle 2318 at its proximal end 2304 (see, eg, FIG. 41). Handle 2318 includes an extension knob 2320 and at least one angulation screw 2322 . An extension knob 2320 is connected to the proximal end of stylus 2310 and is operable to extend and retract stylus 2310 within cannula 2306 . Each of the at least one angulation screw is connected to a proximal end of cable 2316 and is operable to extend and retract the connected cable 2316 within stylus 2310 . In some embodiments, handle 2318 further includes one or more actuatable knobs or screws connectable to needle 2312 and guidewire 2314, thereby actuating needle 2312 and guidewire 2314 within stylus 2310. Stretching and retraction can be realized with precision.
42A-42D, instrument 2300 is shown at several stages of stylus 2320 deployment. 42A, stylus 2320 lies flush within cannula 2316 and does not protrude through window 2318. In FIG. In this configuration (delivery configuration), the cannula 2316 will be manipulated to the desired location without the stylus 2320 interfering. For example, instrument 2300 may be delivered to a desired location over a first delivery guidewire (not shown) disposed within the guidewire lumen of hollow needle 2322 . After delivery to the desired location, the delivery guidewire may be withdrawn from instrument 2300 and a second guidewire may be disposed through instrument 2300 and the guidewire lumen of hollow needle 2322 .

[00225] In FIGS. 42B-24D, cable 2326 is retracted into stylus 2320, such as by angulation screw 2332 connected to handle 2328. In FIGS. Retracting the cable 3226 causes the stylus 20 to exit the window 2318 in the direction of the retracted cable 2326, angling toward the deployed configuration. For example, a stylus 2320 having two or more cables 2326 may have its distal tip angled toward either of the cables 2326 by retracting one or more cables 2326 . The angle of angulation can be varied between approximately 0 and 90 degrees with respect to the axis of cannula 2316 by adjusting the amount of retraction of cable 2326 in connected angulation screw 2332 . In various embodiments, stylus 2320 can be repositioned within cannula 2316 by adjusting extension knob 2330, as in FIG. 42D. The combination of angulation and position control of stylus 2320 relative to cannula 2316 allows instrument 2300 to precisely aim needle 2322 toward the FO. In certain embodiments, the instrument 2300 can be aimed at specific locations on the FO. The FO may be divided into quadrants, with punctures in each quadrant being advantageous for certain procedures. For example, the instrument 2300 may be aimed to puncture slightly above, behind, and 3.5 cm to 4.5 cm above the mitral valve for a typical mitra clip instrument; A left atrial appendage obturator is configured to puncture posteriorly and slightly below the FO.

[00226] In various embodiments, instrument 2300 may further include one or more modifications to enhance its performance. For example, in some embodiments, instrument 2300 includes one or more sensors positioned within the lumen of stylus 2320, such as an endoscope assembly, an ultrasound transducer, a temperature sensor, an oxygen probe, a flow sensor, a cauterizer, and the like. additional equipment. In another example, instrument 2310 may include one or more radiopaque or echo-bright markers positioned on cannula 2316, stylus 2320, or both. The markers allow the position of instrument 2310 to be monitored via fluoroscopy or echocardiography and include, but are not limited to, the distal tips of cannula 2316 and stylus 2320 and at least one window 2318. It can be installed on or near the structure.

[00227] In some embodiments, the device 2300 can include an atraumatic support 2334, as shown in Figures 43A and 43B. Atraumatic support 2334 has an elongated tubular shape and can fit within the first lumen of stylus 2320 around needle 2322 . Atraumatic support 2334 further comprises a blunt tip at the distal end. In some embodiments, the blunt tip includes an inflatable balloon. In yet another embodiment, the blunt tip is a flattened end effector. In yet another embodiment, the blunt tip is an annular end effector. The blunt end of the atraumatic support 2334 provides a greater surface area to the distal end of the stylus 2320 to minimize injury and stabilize by providing uniform pressure when placed against a tissue surface such as the FO. enhance sexuality. In FIG. 44, an instrument 2310 has an atraumatic support 2336 with a bell-tip configured to be foldable and retractable within a sheath 2338 attached to the distal end of a stylus 2320. is illustrated as Similar to atraumatic support 2334, atraumatic support 2336 generally increases the surface area of stylus 2320 in contact with the FO tissue (before puncturing the FO) to reduce pressure on the tissue and premature puncture. or configured to reduce or prevent the likelihood of injury. The collapsible design allows the instrument 2310 to support a wide trumpet tip, such as about 8 mm to 15 mm wide, within the confines of the cannula 2316 . 45A-45D, the geometry of the atraumatic support 2336 is shown in detail. Atraumatic support 2336 includes a trumpet tip with a plurality of scalloped folds at its distal end. As the atraumatic support 2336 is drawn into the sheath 2338 , the trumpet tips bundle in a controlled manner to fit within the sheath 2338 while maintaining space for passage of the needle 2322 . The needle 2322 can thereby be extended and retracted past the bell tip of the atraumatic support 2336 regardless of whether the trumpet tip is in the folded or open configuration.

[00228] In some examples, the instrument 2300 can include a stiffening element configured to modify the inflexibility of a segment of the instrument 2323. Increasing the stiffness of a section of instrument 2300, such as a section of cannula 2316 with at least one window 2318, provides instrument 2300 with a stable backbone against which stylus 2320 and needle are stretched. 2322 can push through tissue.

[00229] Referring now to FIGS. Spine 2340 is positioned within the second lumen of cannula 2316 and extends at least to the location of at least one window 2318 . Spine 2340 is configured to be flexible when loose and rigid when compacted. For example, in some embodiments spine 2340 is an elongated tubular member constructed from a compressible polymer. In other embodiments, the spine 2340 is made from a long chain of interlocking segments or a series of hollow tubules positioned loosely next to each other, constructed from, for example, plastic or metal. Cable 2342 runs the length of spine 2340 and has a wider tip than spine 2340 at its distal end. Retracting the cable 2342 forces the tip against the distal end of the spine 2340, thereby compacting the overall length of the spine 2340 and increasing the stiffness of the spine 2340 and the length of the cannula 2316 with the spine 2340 therein. become. Extending the cable 2342 releases the pressure that the tip exerts on the distal end of the spine 2340, which relaxes the spine 2340 and the length of the cannula 2316 with the spine 2340 therein.

[00230] Referring now to FIGS. 47A-47D, an exemplary segmented septal puncture device 2400 is illustrated. Instrument 2400 comprises a plurality of interlocking segments 2456 between distal end 2452 and proximal end 2454 . Interlocking segments 2456 may have any configuration suitable for forming a flexible elongated member. For example, in some embodiments, each interlocking segment 2456 has a first end with a small hollow sphere and a second end with a large hollow sphere, thereby providing a A first end of an interlocking segment 2456 fits flush within a second end of another interlocking segment 2456 to form a ball joint. A plurality of interlocking segments 2456 connected in this manner thereby form a series of elongated articulated ball joints. In other embodiments, interlocking segment 2456 may form a gooseneck member, a snake chain member, or the like. Instrument 2400 further includes at least one first cable 2458a, one second cable 2458b, and one third cable 2458c along its length, each cable 2458a, 2458b, and 2458c being connected to each other. They are arranged in a radiation pattern at regular intervals. Each cable 2458a, 2458b, and 2458c is attached to a distal-most interlock segment 2456 such that retraction of any one or two of cables 2458a, 2458b, or 2458c causes distal movement of instrument 50. The proximal end 2452 curls in the direction of the retracted cable. Retracting all of cables 2458a, 2458b, and 2458c with the same amount of force causes device 2450 to stiffen and retain its instantaneous shape.

[00231] Referring now to Figures 48A-48D, two exemplary configurations of instrument 2450 are shown. 48A-48D, instrument 2450 fits within the lumen of cannula 2462 and includes needle 2460 extending through the hollow interior. 48C and 48D, instrument 2450 fits within a first lumen of cannula 2462 and needle 2460 fits within a second lumen of cannula 2462. In FIGS. In this configuration, the hollow interior of instrument 2450 is for housing additional equipment such as endoscope assemblies, ultrasonic transducers, any number of sensor probes (including temperature probes, oxygen sensors, flow sensors), and the like. can be used for

[00232] Referring now to FIGS. 49-52, an exemplary septal puncture device 2500 is illustrated. As with other septal puncture devices described herein, device 2500 includes cannula 2506 (which corresponds to the body of the embodiments described above) extending from proximal end 2502 to distal end 2504 . Cannula 2506 has an elongated hollow tubular shape with a lumen extending between an opening in proximal end 2502 and distal end 2504 . In some embodiments, cannula 2506 can be described as having two segments, proximal cannula 206a and distal cannula 2506b. Instrument 2500 includes a relaxed-to-stretched inflatable balloon 2508 positioned near distal end 2504 between proximal cannula 2506a and distal cannula 2506b. equivalent). Balloon 2508 may be elastic and waterproof. Balloon 2508 may be inflatable to pressures of approximately 2 to 20 atmospheres using any suitable fluid, including liquids (such as saline) and gases (such as air). Higher inflation pressures generally increase the inflexibility of balloon 2508 due to increased stability (ie vertical and horizontal). In some embodiments, the balloon 2508 may be supported by one or an external arm, or wrapped in mesh for additional stability, such as during inflation or tissue puncture. Balloon 2508 may be inflated to any desired diameter. In some embodiments, the inflated diameter of balloon 2508 is determined by its relationship to the anatomical space in which it is positioned. For example, balloon 2508 may be inflated to a diameter that may or may not impinge on the wall of the right atrium or inferior vena cava to provide additional stability, e.g., for extending stylus 2512 to puncture the FO. (possibly reducing the need for image guidance in general).

[00233] FIG. The lumen of the cannula 2506 is sized to receive an elongated tubular sheath 2510 (corresponding to the side catheter guide in the embodiments described above), which in turn fits an elongated tubular stylus 2512 (corresponding to the side catheter guide in the embodiments described above). ) and the stylus has a lumen sized to fit the hollow needle 2514 (which corresponds to the septal penetrator in the embodiments described above) and has a hollow The needle has a lumen sized to fit a guidewire 2516 (eg, a transseptally delivered guidewire corresponding to guidewire GW2 in the embodiments described above). Cannula 2506 was also sized to fit a second guidewire GW1 (eg, a guidewire corresponding to guidewire GW1 in the embodiments described above, over which instrument 2500 was delivered to a desired location). A second guidewire lumen 2517 is provided. Guidewire 2516 may be any suitable guidewire, such as a 0.035 inch guidewire, a 0.025 inch guidewire, a curlycue wire (eg, Baylis left atrial wire), and the like. An inflation tube 209 is provided within the lumen of cannula 2506 and has an interior lumen fluidly connected to balloon 2508 for inflation and deflation. In some embodiments, cannula 2506 may include one or more stiffening rods 2518 having lengths selected to provide instrument 2500 with greater stiffness in desired compartments.

[00234] The distal tip of sheath 2510 is secured to the outer surface of balloon 2508 by balloon grommet 2507. As shown in FIG. In this configuration, balloon 2508 can be inflated and deflated without leakage from balloon grommet 2507 or sheath 2510 , and sheath 5210 provides access to the exterior of balloon 2508 . The grommet 2507 has a smooth interior surface (or other surface) to reduce friction between the stylus 2512 and the grommet 2507, such as when inflating or deflating the balloon 2508 or retracting the stylus 2512 through the sheath 2510. surface treatment). Grommet 2507 may be constructed from any suitable material including plastics, metals, composites, ceramics, and the like. The grommet 2507 may also be configured with a particular shape or edging whereby the interior surface has a bevel or chamfer. In one embodiment, grommet 2507 is positioned at the widest radial point or circumference on balloon 208, although grommet 2507 is not limited by placement at other locations.

[00235] In some embodiments, the stylus 2512 has an atraumatic end effector 2511 positioned at its distal tip (e.g., similar or identical to that shown in FIG. 59B), Effector 2511 has a disk shape configured to tent tissue (such as FO) and apply pressure without unintentional puncture. End effector 2511 may have a flaring tip configured to be foldable and retractable within sheath 2510 . The collapsible design allows the instrument 2500 to support a wide trumpet tip within the sheath 2510, such as about 8mm to 15mm wide. The end effector 2511 may comprise a flaring tip with a plurality of wavy folds. As the end effector 2511 is drawn into the sheath 2510 , the trumpet tips bundle in a controlled manner to fit within the sheath 2510 while maintaining space for passage of the needle 2514 . The needle 2514 can thereby be extended and retracted past the tip of the end effector 2511, regardless of whether the tip is in a folded or open configuration. In some embodiments, the lumen of stylus 1510 can receive a radio frequency probe with a rounded metal tip that is driven by an electric current to pierce tissue instead of a needle. It can be electrified (eg radiation ablation).

[00236] Instrument 2500 is configured to increase lateral stability of needle 214 during penetration of tissue, such as the FO. Balloon 2508 has a stretched state (FIG. 49) and a low profile, relaxed state (FIG. 52). The relaxed state defines the delivery configuration of the instrument 2500 and allows the instrument 2500 to be guided into the right atrium of the patient's heart such that the distal end 2504 of the instrument 2500 can be positioned within the subject's superior vena cava. to In some embodiments, the relaxed balloon 2508 may be folded over the end effector 2511, stylus 2512, and sheath 2510, the folded configuration (or delivery configuration) being ( maintained during insertion and advancement of device 2500 into the right atrium (similar to an intra-aortic balloon pump). Thus, instrument 2500 is generally inserted or withdrawn such that the "sheath" catheter is positioned over the assembly of folded balloon 2508, end effector 2511, stylus 2512, and sheath 2510 (i.e., these covering) is not required. In some embodiments, the device 2500 can include an outer wrap or sleeve that slides over the relaxed balloon 2508 . In the stretched state, balloon 2508 is configured to be sufficiently inflexible to enhance stability (eg, lateral stability). In some embodiments, the balloon 2508 is configured to selectively press against the wall of the right atrium adjacent the FO to further enhance stability (eg, lateral stability). The instrument 2500 thereby provides stability in the area directly behind the stylus 2512 by stretching to provide more room for FO access.

[00237] In some embodiments, the balloon 2508 is configured to increase the stability and accuracy of tissue puncture (ie, the maneuverability of the stylus 2512). For example, grommet 2507 may be positioned at one point on balloon 2508 as described above such that stylus 2512 projects through balloon 2508 at an angle to the longitudinal axis of cannula 206 by sheath 2510 when balloon 2508 is in an extended state. can be placed in Balloon 2508 thus functions similarly to the GSA of the previously described embodiments. In some embodiments, the angle is between about 60 degrees and 180 degrees. In some embodiments, the angle is between about 60 degrees and 140 degrees. In some embodiments, the angle is between about 60 degrees and 100 degrees. In some embodiments, the angle is between about 80 degrees and 120 degrees. In some embodiments the angle is approximately 90 degrees. In some embodiments, the angle is approximately 80 degrees (see, eg, 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.

[00238] Balloon 2508 may also be configured to affect the angle of stylus 2512 when inflated. For example, balloon 2508 may have a generally spherical-like shape, while in other embodiments, balloon 2508 has an oval-like shape. Also, balloon 2508 may be generally symmetrical or asymmetrical (see FIG. 53A). For example, an asymmetric balloon 2508 may have a larger inflated radius at the grommet 2507 than at the portion of the balloon 2508 opposite the grommet 2507 . In another example, an asymmetric balloon 2508 can have a different inflated radius at the grommet 2507 than at the portion of the balloon 2508 circumferentially adjacent the grommet 2507 . When viewed in cross-section, this would cause cannula 2506 to be non-concentric with inflated balloon 2508 . Grommet 2507 thus provides a preferred angle for stylus 2512 over balloon 2508 (which has an inflated radius) when balloon 2508 is in an extended state to enhance stability and maneuverability of stylus 2512. can be positioned.

[00239] In some examples, the balloon 2508 may be shaped to allow blood flow around the balloon 2508. FIG. For example, balloon 2508 may have multiple lobes, such as longitudinally oriented (or axially oriented) lobes (see FIG. 53B). In the stretched state, the lobes of balloon 2508 provide lateral stability by positioning stylus 2512 at a preferred angle, while the various inflated radii of balloon 2508 (e.g., when balloon 2508 or in the inferior vena cava) to allow blood to flow around portions of balloon 2508 . Also, the lobes of balloon 2508 may have a lateral aspect to further enhance lateral stability of stylus 2512 . For example, multiple lobes may form a spiral or spiral shape or pattern.

[00240] In some examples, the balloon 2508 can be positioned adjacent to the cannula 2506. As shown in FIG. Sheath 2510 can be cradled within a groove in cannula 2506 with balloon 208 folded around sheath 210, as illustrated in FIG. 53C. Inflating balloon 2508 pushes sheath 2510 away from cannula 2506, thereby positioning stylus 2512 therein at a desired angle. In some embodiments, the angle can be adjusted by changing the amount of inflation of balloon 2508 .

[00241] In some examples, the balloon 2508 can be shaped to have a concave or convex surface. For example, Figures 54A-54C illustrate a device 2500 having a balloon 2508 with a concave proximal surface. Sheath 2510 is configured to attach to and curve in accordance with a concave proximal surface, thereby pointing stylus 2512 laterally outward. In some embodiments, sheath 2510 can be external or partially external to balloon 2508 . For example, FIG. 55 illustrates a cross-sectional view of a sheath 2510 partially embedded in the outer surface of balloon 2508. FIG. It should be appreciated that the sheath 2510 may have any desired cross-sectional shape including, but not limited to, the oval and arcuate cross-sections illustrated in FIG.

[00242] In various embodiments, instrument 2500 may further include one or more modifications to enhance its performance. For example, instrument 2500 may be modified to include an additional sheath 2510, stylus 2512, needle 2514, and guidewire 2516, similar to the embodiments shown in FIGS. 19-23 and described above. As illustrated in FIG. 56, additional sheaths 2510, styluses 2512, needles 2514, and guidewires 2516 may be secured to balloon 2508 to provide separate puncture sites. In this manner, the stylus 2512 is used to perform separate punctures for different procedures, such as a first needle 2514 for a first procedure or step and a second needle 2514 for a second procedure or step. Or it can allow different steps of the procedure to be performed. Each needle 2514 is positioned (eg, positioning stylus 2512 in the right atrium, stylus 2512 and adjusting the angle of the stylus 2512) relative to each other on the FO. Thus, instrument 2500 can be configured to have multiple extendable elements that are closely spaced to allow simultaneous puncture.

[00243] In another example, the instrument 2500 may comprise one or more waveforms or radiopaque, echobright, or sonopaque markers. The markers allow the position of instrument 2500 to be monitored via fluoroscopy or echocardiography and include, but are not limited to, at least a portion of cannula 2506, stylus 2512, end effector 2511, balloon 2508, and the like. It may be installed at or near the structure of interest.

[00244] The various components of the embodiments described herein may be constructed using any suitable method. Methods of fabrication will vary depending on the materials used. For example, components substantially comprising metal may be rolled from large blocks of metal or may be cast from molten metal. Similarly, components substantially comprising plastics or polymers may be milled, cast, or injection molded from large blocks. In some embodiments, the device may be made using three-dimensional (“3D”) printing or other additive manufacturing techniques. Also, it should be understood that descriptions applicable to one embodiment of the invention are equally applicable to all embodiments described elsewhere herein.

[00245] The septal puncture devices described herein may be used in conjunction with any suitable handle adapted to the components of the device. Referring now to Figure 57, an exemplary handle assembly 2680 is illustrated. Handle assembly 2600 comprises main shaft handle 2602 engaged to side catheter handle 304 by side catheter deflection knob 2606 . Knob 2606 can be tightened to secure handle 2604 to handle 2602 and loosened to allow handle 2604 to be actuated relative to handle 2602 . Handle assembly 2680 further includes a plurality of lumens connected to the openings, the lumens and openings sized to accommodate guidewires and needles. Handle 2602 includes a lumen and opening connected to balloon inflation syringe 2608 . A valve or stopcock 2610 is provided at the engagement between handle 2602 and syringe 2608 . Handle assembly 2680 further includes needle tube handle 2612 and needle safety tab 2614 .

[00246] Handle assembly 2680 is connectable to any of the septal puncture devices described herein, but will be described in relation to device 2500 as an example. Handle 2602 is connectable to the proximal end of a cannula of a septal puncture device, such as cannula 2506, to manipulate, rotate, advance, and withdraw the cannula. Handle 2604 is connectable to the proximal end of a stylus of a septal puncture device, such as stylus 2512, to manipulate, rotate, advance, and withdraw the stylus. A venous guidewire 2516 inserted into the distal opening of instrument 2500 is configured to exit handle assembly 2680 through a side opening in handle 2602 . Syringe 2608 is fluidly connected to inflation lumen 2509 to inflate and deflate balloon 2508 and stopcock 2610 can be actuated to maintain or release balloon 2508 in its inflated state. A needle 2514 is connected at its proximal end to a handle 2612 and a needle safety tab 2614 may be clipped to the proximal end of the needle 2514 between the handles 2604 and 2612 to prevent unintentional extension of the needle 2514. . An atrial guidewire 2516 contained within needle 2514 may extend proximally from handle 2612 . In various embodiments, handle assembly 2680 further includes one or more actuatable knobs or screws connectable to cannulas, styluses, needles, and guidewires to allow extension and retraction of components. It can be realized with high accuracy. In some embodiments, handle assembly 2600 may include components configured to further steer the components, such as pull cables.

[00247] Referring now to Figures 58 and 59A-59D, operation of device 2500 using handle assembly 2680 will be described. In FIG. 59A, balloon 2508 is inflated to a stretched state using syringe 2608 and maintained in the stretched state by closing stopcock 2610 . Inflation of balloon 2508 angles sheath 2510 away from cannula 2506 , such as at an 80 degree angle relative to the long axis of cannula 2506 . 59B, knob 2606 is loosened to advance handle 604 toward handle 2602 and extend stylus 2512 out of sheath 2510 to expose end effector 2511. In FIG. The stylus 2512 can be extended any desired length, such as about 3-4 cm, and held in place by tightening the knob 2606 . In FIG. 59C, instrument 2500 is positioned adjacent the atrial septum such that end effector 2511 bears against the FO to tent the FO. In FIG. 59D, needle safety tab 2614 is removed to allow handle 2612 to be advanced toward handle 304 and extend needle 2514 out of stylus 2512 to puncture the FO. Needle 2514 may be extended any desired length, such as about 4-10 mm. Atrial guidewire 2516 may then be advanced distally through needle 2514 and FO into the left atrium.

[00248] Another embodiment of an instrument 2700 is shown in Figures 60A-60D. Instrument 2700 has a plurality of slits 2775 positioned near its distal end and evenly distributed around the body, defining a plurality of arms 2776 therebetween. Compressing instrument 2700 on either side of plurality of slits 2775 causes arms 2776 to extend outwardly, exposing stylet catheter section 2778 . The stylet catheter section may have an inflexible structure formed of either hard plastic or metal such that at least the distal end 2771 of the cannula 2774 is advanced proximally over the catheter section 2778. Allows extension of arm 2776 to be achieved. In certain embodiments, distal end 2771 of cannula 2774 is manipulated using one or more pull cables that run the length of device 2700 . For example, the one or more pull cables may be equally retracted to uniformly stretch each arm 2776 and to form an equally sized opening between each arm 2776 . In another example, one or more pull cables may be selectively retracted, thereby causing pull cables exposed to more tension to cause greater stretch in arms 2776 closest to those pull cables. , changes the geometry of the opening between each arm 2776 . Extended arm 2776 provides room for extension of stylet 80 out of catheter compartment 78, as well as extension of hollow needle 82 out of stylet 80 and any desired guidewire out of hollow needle 2782. .

[00249] Device 2700 has a relaxed state (or a delivery configuration shown in Figure 60A) and an extended state (or a deployed configuration shown in Figure 60B). The relaxed state allows instrument 2700 to be guided into the right atrium of the patient's heart such that the distal end of instrument 2700 rests in the patient's superior vena cava. In the extended state, multiple arms 2776 are configured to selectively bear against the wall of the right atrium adjacent the FO to enhance stability (eg, lateral stability). Instrument 2700 thereby provides at least two stable platforms for septal puncture using stylet 2780 : arms 2776 that directly press against heart tissue, and arms 2776 between arms 2776 . A suspended catheter section 2778 is provided. Selective retraction of the pull cables of instrument 2700 to unevenly stretch instrument 2700 may be desirable in certain circumstances. For example, the instrument 2770 can be stretched such that the arm 2776 adjacent to the stylet 2780 is stretched more to provide more room for FO access, while the arm 2776 behind the stylet 2780 is , can be stretched to a lesser extent to increase stability in the area immediately behind the stylet 2780 .

[00250] Referring now to Figures 61A-61H, further examples of various configurations of instrument 2700 are illustrated. Although exemplary instruments 2700 are illustrated with three and six arms 2776, instruments 2700 may have any suitable number of arms 2776, such as from about three to ten arms. In certain embodiments, multiple arms 2776 may each be connected by one or more bands 2786, as illustrated in FIGS. 61E and 61F. By connecting each arm 2776 to the adjacent arm 2776, the band 2786 increases the stability of the instrument 2700 by reducing lateral movement of each arm 2776 and prevents injury due to overstretching of the arms 2776. . In certain embodiments, multiple arms 2776 may be wrapped in a jacket 2788, as illustrated in FIGS. 61G and 61H. The jacket 2788 can be both elastic and waterproof to guide the instrument 2700 smoothly in the relaxed state, and to provide a larger surface area to spread pressure and reduce trauma in the stretched state. The jacket 2788 also provides the same benefits as the band 86 in that the jacket 88 reduces lateral movement and overstretching of the arm 76 to improve stability. In FIG. 61H, stylet 2780 and needle 2782 are shown as being able to pierce jacket 2788 to access and puncture the FO.

[00251] Referring now to Figures 62A and 62B, an exemplary embodiment of an instrument 2700 having a loop guide 2789 is illustrated. Loop guide 2789 provides additional stability by tethering extended stylus 2780 to extended arm 2776 . In some embodiments, the loop guide 2789 is attached to the distal end of the stylus 2780 such that after extending the plurality of arms 2776 the loop guide 2789 slides over the extended arms 2776. As the stylus 2780 is extended along the extended arm 2776 . In other embodiments, the loop guide 2789 is welded to both the distal end of the stylus 2780 and the extended arm 2776 such that the extension action of the arm 2776 extends the stylus 2780 while simultaneously extending the stylus 2780 . toward FO.

[00252] Referring now to Figures 63A-63C, an exemplary hinged septal puncture device 90 is illustrated. Instrument 2800 has a distal end 2891 , a proximal end 2892 and a cannula 2894 therethrough. Instrument 2800 has a hinged arm 2895 near distal end 2891 that rests within cannula 2894 adjacent window 2896 . A hinged arm 2895 is attached to the distal end of the stylus 2898 such that rotating the hinged arm 2895 out of the window 2896 causes the stylus 2898 to extend out of the cannula 2894 and face the FO. Although FIGS. 63B and 63C illustrate exemplary embodiments of instrument 2800 with one and two articulation points, respectively, hinged arm 2895 can be any suitable joint, such as from about one to ten. It should be understood that it can have any number of articulation points. Hinged arm 2895 may 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, and the like.

[00253] In general, devices such as catheters that are introduced into a patient's vascular system also carry the risk of unintended trauma to the patient's vessel walls and/or associated tissues, organs, and the like. For example, the sharp edges of the instrument can tear the vessel wall. In the context of the present disclosure, the main shaft (e.g., main shaft 120) and/or side catheter guide (e.g., side catheter guide 130) of the septal puncture device may exert traumatic forces on curved or tortuous vessel walls. There is This can be of particular concern, for example, when relatively stiff main shafts are used (eg, to provide stability between the IVC and SVC). Additionally, having side catheter guides adjacent to the main shaft may present additional similar risks. To address such risks, any suitable portion of the septal puncture devices described herein may have an atraumatic design. Figures 65A and 65B illustrate such a septal puncture device 2900 according to one embodiment. Similar to or similar to that described with respect to the septal puncture devices described herein, septal puncture device 2900 accesses the left side of the heart (eg, left atrium) from the right side of the heart (eg, right atrium). and to deliver guidewires to the left side of the heart. Septal puncture device 2900 may be constructed the same or similar to and function the same or similar to any of the intermediate puncture devices described herein (eg, septal puncture device 100). Accordingly, portions of septal puncture device 2900 are not described in greater detail herein.

[00254] As shown in FIG. 65A, a septal puncture device 2900 includes a body 2910 coupled to a main shaft 2920, a side catheter guide 2930, and a side catheter 2960 (with an optional end effector 2962 extending therefrom). ), a septal penetrator 2970 and an atraumatic tip 2945 . Main shaft 2920 is coupled to side catheter guide 2930 via guide coupler 2940, which is coupled to side catheter 2960, which in turn is connected to septal penetrator 2970, as shown in FIG. 65A. connected to The side catheter guide 2930 is configured to define a conductive pathway through which the side catheter 2960 can be advanced (eg, advanced and/or withdrawn). Stated another way, and as described in greater detail herein, side catheter guide 2930 is manipulated (e.g., delivered) to guide side catheter 2960 in a desired direction, e.g., toward the left atrium. 65B) (the side catheter guide 2930 in the actuated or deployed state is shown in FIG. 65B).

[00255] Atraumatic tip 2945 is caused by a portion of side catheter guide 2930, for example, the distal end portion of side catheter guide 2930 that is guided into the patient's vascular system by main shaft 2920 during insertion. It is designed to protect the patient from unintended trauma. Atraumatic tip 2945 may be formed of any suitable material and may have any suitable shape. In some embodiments, atraumatic tip 2945 can be mounted and/or coupled to main shaft 2920 . In some embodiments, for example, the atraumatic tip 2945 comprises a tapered leading edge and a radiused trailing edge (eg, to eliminate sharp edges from the atraumatic tip 2945). A nosecone (eg, a blunt nosecone) mounted to and/or coupled to shaft 2920 . In some embodiments, the atraumatic tip 2945 may be asymmetrically mounted or coupled to the main shaft 2945 such that the atraumatic tip 2945 is positioned along the entire length of the main shaft 2920 and side catheter guide 2930. Protect the distal end portion of the side catheter guide 2930 while limiting its diameter, cross-sectional area, and/or profile.

[00256] In some embodiments, the atraumatic tip 2945 can be formed separately and then coupled to the main shaft 2920 and/or the side catheter guide 2930, while in other embodiments, the atraumatic tip 2945 can be formed separately. Tip 2945 and main shaft 2920 may be monolithically formed.

[00257] As described in further detail in other embodiments herein, the guide coupler 2940 connects the main shaft 2920 and the side catheter guide 2930, as schematically illustrated in FIG. 65B. Side catheter guide 2930 is coupled to main shaft 2920 to minimize or prevent relative translational movement, but to allow relative rotational movement between main shaft 2920 and side catheter guide 2930. obtain. In this manner, the guide coupler 2940 is removed from the side catheter guide 2930 distally from the delivery configuration (eg, parallel or substantially parallel to the main shaft 2920) for insertion, eg, through the patient's vasculature and into the RA. To facilitate transition of the side catheter guide 2930 to a deployed configuration in which the proximal end is deflected angularly and/or laterally relative to the main shaft 2920, e.g., toward the patient's left atrium (e.g., FO of the interatrial septum) can do.

[00258] Atraumatic tip 2945 may be configured to facilitate such transition of side catheter guide 2930 to the deployed configuration. In some embodiments, the atraumatic tip 2945 may define one or more apertures and/or slots through which the distal end portion of the side catheter guide 2930 is angularly and/or laterally oriented. and/or a portion of side catheter guide 2930 proximal to the distal end of side catheter guide 2930 may be stretched and/or deflected (e.g., , the proximal portion is on a first side of the central axis of the shaft, while the distal portion is on a second side of the central axis, opposite the first side of the central axis). In this way, the side catheter guide 2930 is shielded prior to deployment and free to deflect to assume an increased profile upon deployment.

[00259] In some embodiments, the entire atraumatic tip 2945 may be disposed distally of the guide coupler 2940, although in some embodiments, the atraumatic tip 2945 may extend beyond the guide coupler 2940. can extend across and beyond.

[00260] Atraumatic tip 2945 may be of any suitable size. For example, in some embodiments, the atraumatic tip 2945 can have an outer diameter of approximately 14F. As another example, in some embodiments the atraumatic tip 2945 can have a length ranging from about 1 mm to about 150 mm. In some embodiments, the atraumatic tip 2945 can have a length of about 10-30 times the diameter, such lengths being, for example, 75 mm, 100 mm, 150 mm, or therebetween. It can be any value.

[00261] In some embodiments, the atraumatic tip 2945 is positioned within the heart to facilitate the deployment of the side catheter guide 2930 and/or the side catheter 2960 by the operator. Radiopaque material and/or markers (e.g. bands and/or grooves) so that they can be visualized under any suitable imaging technique (e.g. fluoroscopy, echocardiography, etc.) from outside the patient at one time. may contain

[00262] As further illustrated in FIG. 65A, septal puncture device 2900 connects main shaft 2920 to a guidewire (not shown in FIG. 65A) to connect septal puncture device 2900 (eg, a patient's vascular system). a guidewire coupler 2922 configured to facilitate delivery into the patient and to the patient's heart (through the heart of the patient) and a guidewire (not shown in FIG. 65A) coupled to the septal penetrator 2970 to connect the guidewire. and a guidewire coupler 2972 configured to facilitate delivery to the left side of the heart (eg, left atrium).

[00263] As further illustrated in FIG. 65A, septal puncture device 2900 is operably coupled to main shaft 2920 and actuates main shaft 2920 to advance or withdraw main shaft 2920 relative to body 2910. Optionally includes a shaft actuator 2924 configured to. Septal puncture device 2900 is further configured to: (1) be operably coupled to side catheter 2960 and actuated to advance or withdraw side catheter 2960, as described in further detail herein; , a side catheter actuator 2964 (side catheter 2960 is shown in an actuated or deployed configuration in FIG. 65B), thereby transitioning side catheter 2960 between a delivery configuration and a deployed configuration; (2) a septal penetrator 2970; A septal penetrator actuator (or "penetrator actuator") 2974 and (septal penetrator 2970 is shown in an actuated or deployed configuration in FIG. 65B).

[00264] As further illustrated in FIG. 65A, septal puncture device 2900 optionally includes an end effector 2962 coupled to side catheter 2960 and extending distally therefrom. End effector 2962 is configured to facilitate subsequent puncture through a target puncture location, eg, the FO of the septum of the heart. The end effector 2962 may be configured, for example, to contact or tent the FO, as described in further detail herein. Such FO contacting or tenting can, for example, reduce or minimize the force required to penetrate the FO and/or provide improved force distribution to the FO. End effector 2962 may be configured to prevent unintentional puncturing and/or damage to the FO by end effector 2962 .

[00265] Each of main shaft 2920, guidewire coupler 2922, side catheter guide 2930, guide coupler 140, side catheter 2960, septal penetrator 2970, and guidewire coupler 2972 are translatable (e.g., distal) relative to body 2910. proximally advanceable and/or extendable, and proximally retractable and/or retractable). The side catheter 2960 is translatable relative to the side catheter guide 2930 and the septal penetrator 2970 is translatable relative to the side catheter 2960, as described in further detail herein.

[00266] Figures 66A and 66B illustrate a portion of a septal puncture device 3000 in a delivery configuration and a deployed configuration, respectively, according to one embodiment.

[00267] As with the other septal puncture devices described herein, septal puncture device 3000 provides access from the right side of the heart (eg, right atrium) to the left side of the heart (eg, left atrium) and a guidewire. to the left side of the heart. Septal puncture device 3000 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 3000 are not described in greater detail herein.

[00268] In this embodiment, septal puncture device 3000 is coupled to main shaft 3020 via guide coupler 3040, similar to that described in connection with other embodiments. A side catheter guide 3030 is included. The septal puncture device 3000 is further coupled to and disposed about the main shaft 3020 and abuts a distal end portion of the side catheter guide 3030 when the side catheter guide 3030 is in the delivery configuration. Includes tip 3045 . The distal end of the side catheter guide 3030 is shielded or at least partially covered by an atraumatic tip 3045, as shown in FIG. 66A. In this manner, upon insertion of septal puncture device 3000 into a patient, with side catheter guide 3030 in the delivery configuration, atraumatic tip 3045 penetrates the patient's vasculature and associated anatomy to Protects against unintended trauma from the side catheter guide 3030. When deployed, as illustrated in FIG. 66B, the distal end of side catheter guide 3030 is angularly deflected relative to main shaft 3020, as described in other embodiments herein. , thereby allowing a side catheter (not shown) to be extended distally through the main shaft. In this embodiment, the atraumatic tip 3045 abuts the distal end portion of the side catheter guide 3030 when the side catheter guide 3030 is in the delivery configuration, although in other embodiments the atraumatic tip It may be axially offset from the distal end portion of the side catheter guide so that the atraumatic tip does not contact the side catheter guide.

[00269] Also, in this embodiment, the atraumatic tip 3045 has an asymmetrical shape such that, upon delivery, the atraumatic tip 3045 has a non-traumatic profile, as illustrated in FIG. 66A. It protects the entire distal end of the side catheter guide 3030 while limiting the overall footprint of the distal tip 3045 . More specifically, in this embodiment the atraumatic tip 3045 has a reduced cross-sectional area from its proximal end to its distal end.

[00270] The atraumatic tip 3045 also includes a radiopaque (eg, fluoroscopic) marker band 3046 circumferentially disposed about the outer surface of the atraumatic tip 3045. As shown in FIG. Atraumatic tip 3045 is provided with a radiopaque marker band 3046 such that band 3046 does not increase the overall profile, cross-sectional area, and/or diameter of the remainder of atraumatic tip 3045. Define grooves.

[00271] In some embodiments, the atraumatic tip may define or include a slot or recess through which a side catheter guide may deflect. FIG. 67 illustrates a portion of a septal puncture device 3100 in a delivery configuration according to one such embodiment.

[00272] As with the other septal puncture devices described herein, septal puncture device 3100 provides access from the right side of the heart (eg, right atrium) to the left side of the heart (eg, left atrium) and a guidewire. to the left side of the heart. Septal puncture device 3100 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 3100 are not described in greater detail herein.

[00273] In this embodiment, a septal puncture device 3100 is connected to a main shaft 3120 and a main shaft 3120 via a guide coupler 3140, similar to that described in connection with other embodiments. and a side catheter guide 3130 extending distally from 3110 . The septal puncture device 3100 is further coupled to and disposed about the main shaft 3120 to abut against the distal end portion of the side catheter guide 3130 when the side catheter guide 3130 is in the delivery configuration, an atraumatic Includes tip 3145 . In this embodiment, the atraumatic tip 3145 abuts the distal end portion of the side catheter guide 3130 when the side catheter guide 3130 is in the delivery configuration, although in other embodiments the atraumatic tip It may be axially offset from the distal end portion of the side catheter guide so that the atraumatic tip does not contact the side catheter guide.

[00274] The atraumatic tip 3145 may be constructed the same or similar and may function in the same or similar manner as the atraumatic tip 3045, although as shown, the atraumatic tip 3145 is located at the proximal end. a slot through which the distal end of the side catheter guide 3130 is disposed during delivery and through and/or over which the distal end of the side catheter guide 3130 passes during deployment; can be stretched.

[00275] In some embodiments, the atraumatic tip extends distally from a location proximal to the guide coupler, across the guide coupler, and distal to the distal end of the side catheter guide. and define one or more slots or recesses through which the side catheter guide can be deployed and/or deflected. Figures 68A and 68B illustrate a portion of a septal puncture device 3200 in a delivery configuration and a deployed configuration, respectively, according to one such embodiment.

[00276] As with the other septal puncture devices described herein, septal puncture device 3200 provides access from the right side of the heart (eg, right atrium) to the left side of the heart (eg, left atrium) and a guidewire. to the left side of the heart. Septal puncture device 3200 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 3200 are not described in greater detail herein.

[00277] In this embodiment, the septal puncture device 3200 includes a main shaft 3220 and a side catheter guide 3230 coupled to the main shaft 3220 via a guide coupler 3240. Septal puncture device 3200 further includes an atraumatic tip 3245 coupled to and disposed about main shaft 3220 and side catheter guide 3230 when side catheter guide 3230 is in the delivery configuration (FIG. 68A). . As best shown in FIG. 68B, the atraumatic tip 3245 defines a first slot 3246A and a second slot 3256B (collectively referred to herein as "slots 3246"). During delivery, the side catheter guide 3230 remains within the profile defined by the atraumatic tip 3245 such that the side catheter guide 3230 passes through and/or over the slot 3246 as shown in FIG. 68A. not stretched. When deployed, the side catheter guide 3230 is angularly deflected such that the distal end portion of the side catheter guide 3230 points in a first direction (eg, toward the septum), as shown in FIG. 68B. , the portion of the side catheter guide 3230 proximal to the distal end portion and opposite to the central axis of the main shaft 3220 relative to the distal end portion is oriented in a second direction different from the first direction. Angular and lateral deflection. In this manner, the atraumatic tip 3245 covers and/or wraps the side catheter guide 3230 to prevent side catheter guide 3230 from unintentionally coming into contact with surrounding anatomy and/or avoiding surrounding anatomy. Protect against unintentional trauma to structures. Also, as shown, the distal end of the atraumatic tip 3245 is tapered to be atraumatic (eg, similar to a warhead or nosecone).

[00278] In various embodiments described herein, upon deployment, the distal end portion of the side catheter guide deflects laterally with respect to the central axis of the main shaft, thereby disposed laterally beyond the outer surface of the main shaft (eg, toward the septum). In some cases, it is desirable to minimize and/or avoid such lateral deflection, so that during deployment (e.g., in applicable embodiments where the septal puncture device includes an atraumatic tip), the lateral The distal end of the catheter guide does not extend beyond the outer surface of the main shaft when viewed in side view and/or does not extend beyond the outer surface of the atraumatic tip when viewed in side view. to the angular direction.

[00279] Figures 69A and 69B illustrate a portion of a septal puncture device 3300 in a delivery configuration and a deployed configuration, respectively, according to one such embodiment. As with other septal puncture devices described herein, septal puncture device 3300 provides access from the right side of the heart (eg, right atrium) to the left side of the heart (eg, left atrium) and guidewires through the heart. It can be used to deliver to the left side. Septal puncture device 3300 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 3300 are not described in greater detail herein.

[00280] In this embodiment, the septal puncture device 3300 includes a main shaft 3320 and a side catheter guide 3330 coupled to the main shaft 3320 via a guide coupler 3340. As shown in FIG. Septal puncture device 3300 further includes an atraumatic tip 3345 coupled to and disposed about main shaft 3320 and side catheter guide 3330 when side catheter guide 3330 is in the delivery configuration (FIG. 69A). . As best shown in FIG. 69B, the atraumatic tip 3345 defines a first slot 3346A and a second slot 3356B (collectively referred to herein as "slots 3346").

[00281] In this embodiment, the guide coupler 3340 is configured such that when the side catheter guide 3330 is deployed, its distal end deflects angularly without substantial lateral deflection. Disposed proximate the distal end of guide 3330, whereby the distal end of side catheter guide 3330 when deployed increases the collective cross-sectional area of main shaft 3320 and atraumatic tip 3345. don't let Stated another way, the distal end of side catheter guide 3330, when deployed, is less than or equal to the shortest distance from the central axis of the main shaft to the outer surface of the atraumatic tip to the central axis. extend the distance. Stated another way, the distal end of the side catheter guide 3330 does not extend laterally beyond the exterior surface of the atraumatic tip in side view when deployed.

[00282] Similarly, in any of the embodiments described herein, including, for example, embodiments described without an atraumatic tip, the guide coupler similarly abuts the distal end of the side catheter guide. so that the distal end of the side catheter guide deflects angularly without substantial lateral deflection when deployed. Thus, for example, in some embodiments, when deployed, the distal end of the side catheter guide is positioned between the central axis of the main shaft and a tangent to the outer surface of the main shaft when viewed from the side. so that deployment of the side catheter guide does not increase the collective cross-sectional area of the side catheter guide and the main shaft at the distal end of the side catheter guide. In some embodiments, for example, the distal end of the side catheter guide, when deployed, is a distance from the central axis equal to or less than the radius of the main shaft (this radius is defined as the guide coupler at or adjacent to the main shaft radius). In some embodiments, for example, the distal end of the side catheter guide extends a lateral distance from the nearest external surface of the main shaft when deployed a lateral distance that is less than the radius of the main shaft.

[00283] Although the various atraumatic tips described herein are shown as materials that are separately formed and then connected to the main shaft, in some embodiments, the atraumatic tip ( For example, the functionality of the atraumatic tip 3245) may be incorporated into and provided by the main shaft. Figures 70A and 70B show in side and perspective views, respectively, a portion of a septal puncture device in a deployed configuration according to one such embodiment.

[00284] As with the other septal puncture devices described herein, septal puncture device 3400 provides access from the right side of the heart (eg, right atrium) to the left side of the heart (eg, left atrium) and a guidewire. to the left side of the heart. Septal puncture device 3400 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 3400 are not described in greater detail herein.

[00285] In this embodiment, septal puncture device 3400 includes a main shaft 3400 and a side catheter guide 3430 coupled to main shaft 3420 via a guide coupler (not shown). A portion of the side catheter guide 3430 disposed proximal to the guide coupler is slidably disposed within the lumen defined by the main shaft 3420 and is positioned proximal to the guide coupler of the side catheter guide 3430. The distally disposed portion is disposed within and is deflectable relative to the lumen of main shaft 3420 . Slidably disposed within side catheter guide 3430 is side catheter 3460 and slidably disposed within side catheter 3460 is septal penetrator 3460 . Although not shown in this embodiment, as can be in any of the embodiments described herein, in some examples, a septal puncture device (e.g., septal puncture device 3400) includes) can include an end effector (eg, similar or identical in shape and/or function to any of the end effectors described herein). As best shown in FIG. 70B, main shaft 3420 defines a first slot 3446A and a second slot 3446B (both in communication with the lumen of main shaft 3420). During deployment, the side catheter guide 3430 can deflect and pass through the first slot 3446A and the second slot 3446B in a manner similar to that described above with respect to the septal puncture device 3200 and septal puncture device 3330. can be stretched.

[00286] Although various embodiments described herein include a side catheter guide disposed adjacent to the main shaft and coupled to the main shaft via a guide coupler, any of these embodiments but a side catheter guide is disposed within the lumen defined by the main shaft (e.g., through a guidewire coupler defined by or associated with the main shaft, or through a separate lumen defined by the main shaft). It should be understood that it can be modified as In such modified embodiments, the main shaft may define slots and/or apertures through which the side catheter guide may extend or traverse upon deployment of the side catheter guide.

[00287] Various configurations and methods of using a septal puncture device to puncture one or more holes through the atrial septum have been described herein. In some cases, verifying that the puncture was actually performed at the desired location, e.g., verifying communication with the left atrium, as well as communication through the septal penetrator between the left atrium and the exterior of the patient's body It would be desirable to verify lumen establishment. For example, it may be desirable to identify an erroneous puncture (eg, in aortic or atrial tissue) while the puncture is relatively small (eg, before reaming the hole).

[00288] Once communication is established between the target area (e.g., the left atrium) and the patient's exterior via a lumen defined by a septal penetrator extended into the left atrium, various verification techniques are performed. can be used. For example, one or more of the following verification techniques may be used. : measuring the pressure within the septal penetrator lumen, drawing a blood sample through the septal penetrator lumen, and visualizing it through the septal penetrator lumen by imaging techniques such as fluoroscopy and/or echocardiography. injecting a contrast agent composed into

[00289] In some embodiments where verification is desired, there are multiple competing design goals. The first goal is obviously to provide a communicating lumen from outside the patient to the target area (eg the left atrium). This goal can be achieved by providing a septal penetrator with a lumen defined therein, as described in various embodiments herein. A second goal is to limit the cross-sectional area and/or overall profile of the septal penetrator, thereby limiting the hole the septal penetrator creates. The goal is to closely match the outer diameter of the guidewire inserted into the left atrium to the inner diameter of the septal penetrator, thereby providing no or substantially no annular space between the inner surface of the septal penetrator and the outer surface of the guidewire. This can be achieved by ensuring that there are no gaps. A third goal is to preload the guidewire to minimize the time required for the guidewire to be inserted into the left atrium following puncture. Stated another way, with the guidewire preloaded or deployed in the septal penetrator lumen before the septal penetrator lumen punctures the FO, the guidewire needs to advance to reach the left atrium. Some remaining distance is less than if the guidewire was introduced into the septal penetrator lumen only after the septal penetrator had punctured the FO.

[00290] With these goals in mind, in some embodiments, the annular gap between the outer surface of the guidewire and the inner surface of the septal penetrator still preloads the guidewire and the septal penetrator. It would be desirable to design a septal penetrator with a lumen of varying diameter so that it can be provided while keeping the diameter to a minimum.

[00291] Figures 71A-71D are schematic illustrations of a portion of a septal penetrator of a septal penetrating member 3500 according to one such embodiment. As with other septal puncture devices described herein, septal puncture device 3500 is used to access the left side of the heart (eg, left atrium) from the right side of the heart (eg, right atrium) and to guide a guidewire through the heart. It can be used to deliver to the left side. Septal puncture device 3500 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 3500 are not described in greater detail herein.

[00292] As illustrated in cross-sectional and linear side views in FIGS. 71A and 71B, respectively, septal-piercing member 3500 includes a septal penetrator 3560 defining a lumen therethrough. In this embodiment, septal penetrator 3560 is divided into three segments, including a first segment L1, a second segment L2 and a third segment L3. At the distal end of septal penetrator 3560 is a sharp end portion of septal penetrator 3560 configured to puncture the target tissue (eg, FO of the septum). The sharp end portion defines the first segment L1 such that there is little or no annular gap between its inner diameter and the outer diameter of the guidewire, while the sharp end portion crosses the septum. It has a sufficiently strong wall thickness to maintain sufficient inflexibility for puncture. The second segment L2 is disposed immediately proximal to the first segment L1 and has an inner diameter that is larger than the outer diameter of the guidewire GW2, so that the inner wall of the second segment L2 and the outer surface of the guidewire GW2 are in contact with each other. providing an annular gap therebetween. A second segment L2 is also defined by a side catheter (not shown) within which the second segment is slidably disposed when deflected with a side catheter guide (not shown). It is sufficiently flexible that curved orientations can be assumed. Additionally, the second segment L2 is configured to have a length sufficient to extend the full bending distance. A third segment L3 is disposed immediately proximal to the second segment L2 and also has an inner diameter larger than the outer diameter of the guidewire GW2, but not necessarily with the same characteristics as the second segment L2 ( flexibility, material, etc.). The third segment L3 extends proximally from the second segment L2 and out of the patient when the second segment L2 is disposed within the patient's heart (and is coupled to, for example, a handle). ).

[00293] FIG. 71C illustrates in cross-sectional side view a septal penetrator 3560 having guidewire GW2 preloaded within third segment L3, the distal end of guidewire GW2 being within third segment L3. is terminated with FIG. 71D shows septal penetrator 3560 in cross-sectional side view with guidewire GW2 extending distally to the preloaded position and distally of septal penetrator 3560. FIG. In use, the septal penetrator 3560 is disposed in the left atrium with the guidewire GW2 delivered distally from the septal penetrator 3560 into the left atrium, as described in various embodiments. GW2 may be withdrawn in a proximal direction with respect to guidewire GW2, leaving guidewire GW2 in the closed position. Referring to FIG. 71C, where the distal end of guidewire GW2 is disposed proximal to first segment L1 in the context of this embodiment, the proximal end of septal penetrator 3560 passes through the lumen. is in fluid communication with the distal end portion of the septal penetrator (e.g., the first segment L1 and the second segment L2) via the septal penetrator, thereby utilizing its lumen for verification as described herein. techniques can be used. For example, in some cases, a contrast agent is introduced into the lumen at the proximal end of the septal penetrator 3560 (e.g., from outside the patient) and around the guidewire GW2 (i.e., the inner surface of the septal penetrator 3560 and the guidewire GW2). external surface), exiting through the distal end of the septal penetrator 3560, and into the left atrium, thereby providing contrast to fluoroscopy and /or can be viewed via similar imaging techniques. After verification, the annular space is no longer needed and guidewire GW2 can be extended distally to septal penetrator 3560 and delivered to the left atrium.

[00294] Although guidewire GW2 is shown preloaded within third segment L3, but proximal to second segment L2, in other embodiments, guidewire GW2 Into the second segment L2, but proximal to the first segment L2, may be preloaded so that fluid communication is likewise from the first segment L1 to the second segment L2 and the third segment L2. and further proximally through the septal penetrator 3560 out of the patient to, for example, a handle assembly (not shown).

[00295] Although the septal penetrator 3560 is shown and described as having three segments, in some embodiments, the septal penetrator 3560 has any suitable number of segments (e.g., one segment, two segments, or more than three segments). For example, in some embodiments, the distal-most segment of the septal penetrator may have a first lumen having a first diameter and may be more proximal than the distal-most segment. A second segment of the side may have a second lumen having a second diameter that is greater than the first diameter. In this manner, a guidewire may be disposed within the second lumen upstream of the first lumen, thereby disposing the first lumen in a manner similar to that described with respect to septal penetrator 3560 and guidewire GW2. Fluid communication is provided (eg, via a handle assembly to which the proximal end portion of the septal penetrator is coupled) between the lumen and the second lumen, and thus to the exterior of the patient.

[00296] In some embodiments, instead of or in addition to a septal penetrator having a variable lumen diameter, the septal penetrator may include multiple different or partially different lumens. In such embodiments, for example, the septal penetrator may have two different lumens extending through the septal penetrator, one for a guidewire as further described herein. and the other is designated for fluid communication for verification purposes. As another example, the septal penetrator may have a single lumen extending proximally from the distal-most end and then bifurcated into two lumens, the two lumens One of the lumens may be designated for a guidewire and the other of the two lumens may be designated for fluid communication for verification purposes. Thus, in use, the guidewire can be preloaded within one of the bifurcated lumens as the septal penetrator penetrates the septum, and the verification technique traverses the other of the bifurcated lumens. A guidewire can then be advanced distally into a single lumen and delivered distally from the septal penetrator into the left atrium (or other target area). .

[00297] Figures 72A and 72B show a portion of a septal puncture device 3600 in a delivery configuration in side and perspective views, respectively, according to one embodiment.

[00298] As with other septal puncture devices described herein, septal puncture device 3600 uses a guidewire to access the left side of the heart (eg, left atrium) from the right side of the heart (eg, right atrium) and a guidewire. to the left side of the heart. Septal puncture device 3600 may be constructed the same or similar and may function the same or similar to any of the intermediate puncture devices described herein. Accordingly, portions of septal puncture device 3600 are not described in greater detail herein.

[00299] In this embodiment, a septal puncture device 3600 is coupled to the main shaft 3620 via a main shaft 3620 and a guide coupler 3640, similar to that described in connection with other embodiments. A side catheter guide 3630 is included. Septal puncture device 3600 is further coupled to and disposed about main shaft 3620 and is axially slightly offset from the distal end portion of side catheter guide 3030 when side catheter guide 3030 is in the delivery configuration. atraumatic tip 3645. The distal end of the side catheter guide 3630 is shielded or at least partially covered by an atraumatic tip 3645, as shown in FIG. 72A. In this manner, upon insertion of septal puncture device 3600 into a patient, with side catheter guide 3630 in the delivery configuration, atraumatic tip 3645 penetrates the patient's vasculature and associated anatomy to Protects against unintended trauma from the side catheter guide 3630. When deployed (not shown), the distal end of side catheter guide 3630 is angularly deflected relative to main shaft 3620, as described in some embodiments herein, thereby allows a side catheter (not shown) to be extended distally through the main shaft. As shown, in this embodiment the collective cross-sectional area of main shaft 3620 and side catheter guide 3630 is less than the cross-sectional area at the proximal end of atraumatic tip 3645 (ie, its largest cross-sectional area). Thus, the atraumatic tip 3645 protects the distal end portion of the side catheter guide 3630. Stated another way, when viewed from the front, side catheter guide 3645 is invisible because its profile is smaller than that of atraumatic tip 3645 .

[00300] Also, in this embodiment, the atraumatic tip 3645 has an asymmetrical shape such that, upon delivery, the atraumatic tip 3645 has a non-traumatic profile, as illustrated in FIG. 72A. It protects the entire distal end of side catheter guide 3630 while limiting the overall footprint of distal tip 3645 . More specifically, in this embodiment the atraumatic tip 3645 has a reduced cross-sectional area from its proximal end to its distal end.

[00301] The atraumatic tip 3645 also includes a radiopaque (eg, fluoroscopic) marker band 3646 circumferentially disposed about the outer surface of the atraumatic tip 3645. As shown in FIG. Atraumatic tip 3645 is provided with a radiopaque marker band 3646 such that band 3646 does not increase the overall profile, cross-sectional area, and/or diameter of the remainder of atraumatic tip 3645. Define grooves.

[00302] In some embodiments, the needle may be aimed at a specific area of the FO for puncture. For example, the FO may be divided into quadrants, and puncturing in each quadrant may be advantageous for certain procedures. The needle is thereby positioned to penetrate slightly above, posterior, and 3.5-4.5 cm above the mitral valve for a Mitra Clip device, or within the FO for a typical left atrial appendage closure device. After successful puncture and insertion of the guidewire, the septal puncture device may be aimed to puncture behind and slightly below. It can be completely removed to clear the way for guidance into the left atrium of the heart to perform desired procedures such as closure surgery and valve replacement.

[00303] Various embodiments described herein employ a distal force applied to a portion of the side catheter guide disposed proximal to the guide coupler (e.g., distal force applied with a handle). ), a side catheter guide configured to transition from a delivery configuration to a deployed configuration in response to a . In some instances of such embodiments described herein, instead of or in addition to such distal force, a proximal force is applied to cause similar deployment of the side catheter guide. It can be applied to the main shaft (eg, proximal to the guide coupler). Stated another way, deployment of the side catheter guide can be accomplished only by relative movement between the main shaft and the side catheter guide, which can be achieved by proximal force applied to the main shaft and/or It may include a distal force applied to the side catheter guide.

[00304] In various embodiments described herein, the side catheter guide is angularly oriented and/or the distal end portion of the side catheter guide relative to the central axis of the main shaft to which the side catheter guide is coupled. Or deflected laterally by about 90 degrees. In any of the embodiments described herein, in some examples, such deflection may be greater than 90 degrees or less than 90 degrees. In such embodiments, the deflection may 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 angle therebetween. . In some embodiments, the deflection can be about 75 degrees to about 85 degrees, such as about 80 degrees. In further embodiments, the deflection is greater than 90 degrees, such as about 95 degrees, about 105 degrees, about 110 degrees, about 115 degrees, about 120 degrees, about 135 degrees, or any angle therebetween. could be. In yet another embodiment, the deflection can be from about 50 degrees to about 90 degrees.

[00305] Various embodiments described herein include a GSA or balloon configured to transition between a delivery configuration and a deployed configuration. In some examples of any of the various embodiments described herein, one or more GSAs or balloons are made from any suitable material (e.g., nylon, polymer, etc.). can be partially or completely covered with a mesh. The mesh may be coupled to the balloon, for example, to facilitate a preferred predetermined shape of the balloon when inflated, or to provide additional stability, for example, to inflate the balloon. Multiple steps can be facilitated. An illustrative example of mesh covering a balloon is shown in FIG. 64, which shows GSA 2950 covered by mesh GSA 2955, both of which are circumferentially disposed about main shaft 2920. FIG. In some embodiments, the mesh may be used to secure (slidably or rigidly) one or more balloons to a side catheter guide or side catheter.

[00306] Although the various embodiments described herein focus on puncturing the septum of the heart with a puncture device, the various puncture devices described herein The functionality provided may also be desirable in other procedures and in other areas of the patient. For example, there are many procedures in which it would be desirable to be able to provide a stable, accurate, safe and repeatable lateral puncture. In some cases, for example, any of the puncture devices described herein can be used to facilitate tricuspid annuloplasty. The puncture device may, for example, be positioned so that the central axis of its main shaft is parallel to the plane of the tricuspid valve, and thus the puncture device may be, for example, a suture, screw, or other device for tricuspid annuloplasty. Lateral or vertical access to the tricuspid annulus may be provided for delivery of anchoring devices.

[00307] As another example, the puncture device described herein is a coronary implant of the heart, e.g., for inserting or delivering wires, catheters, mitral valve repair devices, pacemaker leads, etc. into the coronary sinus. It may provide access to the sinus or a direct vector.

[00308] As another example, the puncture devices described herein can be used to deliver therapeutic repair or replacement devices to the mitral valve in the heart. For example, if the side catheter guide or side catheter disclosed herein is further extended beyond about 90 degrees, the side catheter can be directed into the LA and toward the mitral valve. Optionally, the natural trajectory of the side catheter in some of the embodiments described herein is angled or directed toward the mitral valve if extended or advanced the appropriate distance. Will. For example, since the side catheter assumes a laterally-biased shape or orientation, it may be curved or have an arcuate portion, whereby further advancement relative to the main shaft results in side catheter will advance along such a curvature or arc, thus bending or deflecting the distal end of the side catheter further laterally toward the mitral valve. Stated another way, optionally advancing the side catheter from the delivery configuration to the advanced/deployed configuration includes laterally deflecting the distal end of the side catheter up to about 180 degrees. obtain.

[00309] As another example, the puncture devices described herein may incorporate an intracardiac echo catheter to allow acceleration of the transseptal puncture.

[00310] As another example, the lancing device described herein may be used in the context of cardiac arrest. In such cases, for example, a guidewire can be directed or delivered from the femoral vein across the FO, through the mitral valve, and out the left ventricular outflow tract (“LVOT”)/aortic valve. One or more puncture devices may be used in combination with a wide, curved catheter so as to do so. In some embodiments, a balloon/flow direct catheter will be advanced across the FO, into the LA, across the mitral valve, and then across the LVOT/aortic valve. A balloon, for example, may help to "flow direct" the catheter out of the LVOT, across the aortic valve and into the aorta. Once positioned, the wire can be used as a conduit for extracorporeal membrane oxygenation (“ECMO”) and a small catheter that can provide oxygen to the brain. The distal end of the catheter in the aorta will be the outflow channel and the more proximal port (eg in the RA or IVC) will be the inflow channel to the pump.

[00311] As another example, the puncture devices described herein are used in the aorta to facilitate delivery of branch vessel stents, to deliver coils to branch vessels, or for cerebral embolism protection. It can be used to deliver a screen for blood flow to the cranial vessels.

[00312] Detailed embodiments of the present disclosure have been disclosed herein for the purpose of describing and illustrating the claimed structures and methods. These may be embodied in various forms and 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. Terms used herein are used to best describe the principles, practical applications, or technical improvements of one or more of the embodiments, or to enhance an understanding of the embodiments disclosed herein. selected to allow As noted above, details of well-known features and techniques may be omitted to avoid unnecessarily obscuring the embodiments of the disclosure.

[00313] References herein to "an embodiment," "an embodiment," "exemplary embodiment," and the like refer to the implementation in which the described embodiment includes one or more of the specified features, structures, or characteristics. However, it is understood that such specific features, structures, or characteristics may or may not be common to each individual disclosed embodiment disclosed herein. It must be. Moreover, such phrases do not necessarily refer to any one particular embodiment per se. Thus, when one or more particular features, structures, or characteristics are described in connection with one embodiment, such one or more features, structures, or characteristics are implemented in the context of other embodiments. It is considered within the knowledge of one of ordinary skill in the art to do, where applicable, whether explicitly stated or not.

[00314] The parameters, dimensions, materials, and configurations described herein are intended to be examples, and the actual parameters, dimensions, materials, and/or configurations may vary depending on the specifics in which the teachings of the invention are used. will depend on the intended use or uses. It is therefore intended that the foregoing embodiments be presented as examples only, and that the embodiments are particularly described and claimed within the scope of the following claims and their equivalents. can be implemented differently. Embodiments of the present disclosure are directed to each and every feature, system, article, material, kit, and/or method described herein. Also, any combination of two or more such features, systems, articles, materials, kits, and/or methods shall not be construed as such features, systems, articles, materials, kits, and/or methods contradict each other. Otherwise, it falls within the scope of this disclosure.

[00315] As used herein, the phrase "and/or" refers to "either or both" of the elements joined by them, i. should be understood as meaning Multiple elements listed with "and/or" should be construed in the same manner, ie, "one or more" of the elements conjoined thereby. Other elements are optionally present other than the elements specifically identified by the "and/or" clause, whether related or unrelated to those specifically identified elements. good too. Thus, as a non-limiting example, when used in connection with open-ended language such as "comprising" or "including," when referring to "A and/or B" , which in some embodiments only A (optionally including elements other than B), in some other embodiments only B (optionally including elements other than A), and in some other embodiments A form may refer to both A and B (optionally including other elements), and so on.

[00316] As used herein, the term "or" should be understood to have the same meaning as "and/or" as defined above. For example, when separating listed items, "or" or "and/or" is intended to be inclusive, i.e., including at least one of several or the listed elements but not one or more. It should be construed as including more, and optionally additional, unlisted items. Only terms that are otherwise specified, such as "only one of" or "only one of", or "consisting of" when used in the claims , including only one of several or the listed elements. Generally, the term "or" as used herein is preceded by "either," "one of," "only one of," or "only one of." Any exclusivity term is to be construed only as indicating exclusive alternatives (ie, "one or the other but not both"). "consisting essentially of" when used in the claims shall have its ordinary meaning as used in the field of patent law.

[00317] As used herein, the terms "about" and/or "approximately" when used in conjunction with values and/or ranges generally refer to values and/or values around the stated value/range. point to the range. In some cases, the terms "about" and "approximately" can mean within ±10% of the stated value. For example, in some cases "about the diameter of the instrument" can mean within ±10% of the diameter of the instrument. The terms "about" and "approximately" can be used interchangeably. Similarly, the term "substantially" when used in conjunction with one or more physical and/or geometric features, structures, properties, relationships, etc., means one or more so defined. It is intended to convey that a plurality of features, structures, properties, relationships, etc. are nominally one or more of the features, structures, properties, relationships, etc. As an example, a first quantity described as "substantially equal" to a second quantity is intended to convey that although equality may be desirable, some differences may occur. . Such differences may result from manufacturing tolerances, limitations, approximations, and/or other practical considerations. Hence the term "substantially".

[00318] While various embodiments have been described above, it should be understood that they are presented by way of example only, and not limitation. Where the diagrams and/or embodiments described above show certain components arranged in particular orientations or locations, the arrangement of the components may be modified. While embodiments have been individually shown and described in detail, it will be understood that various changes in form and detail may be made. Although various embodiments have been described as having particular combinations of features and/or components, any combination of features and/or components of any of the embodiments described herein may be Other embodiments with are possible.

[00319] The specific arrangement of the various components may also vary. For example, the sizes and specific shapes of various components may differ from the illustrated embodiments while still providing the functionality described herein. More specifically, the sizes and shapes of the various components may be specifically selected for desired or intended uses. Thus, the size, shape, and/or arrangement of an embodiment and/or its components may be adapted for a given use unless the context clearly indicates otherwise.

[00320] Where the methods and/or events described above indicate specific events and/or procedures occurring in a particular order, the ordering of the specific events and/or procedures may be modified. Also, certain events and/or procedures may be performed concurrently in parallel processing where possible, or may be performed serially as described above.

Claims (50)

a shaft;
coupled to the shaft via a guide coupler and angularly deflectable and configured to be transitioned between a delivery configuration and a deployed configuration; a guide that, when translated, points a distal end of the guide away from the centerline of the shaft and defines a lumen;
an elongate member slidably disposable within the lumen of the guide and configured to extend distally relative to the distal end of the guide and defining a lumen;
A penetrating member slidably disposable within the lumen of the elongate member and configured to extend distally relative to a distal end of the elongate member for penetrating tissue of a patient. A penetrating member configured to puncture and defining a lumen configured to receive a guidewire, said lumen having a first inner diameter at its distal end portion and said distal end portion. a second inner diameter greater than the first inner diameter at a portion proximal to the distal portion;
A device comprising: An end effector disposed about the elongate member, the delivery configuration having a first cross-sectional area and the end effector having a second cross-sectional area greater than the first cross-sectional area. 11. The apparatus of Claim 1, further comprising an end effector configured to transition between deployed configurations. 2. The apparatus of claim 1, further comprising an end effector centered about the elongate member and having a cross-sectional area greater than a cross-sectional area of the elongate member. 2. The apparatus of claim 1, wherein said guide coupler permits rotational movement of said guide relative to said shaft and limits relative linear movement between said guide coupler and said guide. 3. The apparatus of claim 1, wherein the guide coupler is formed from suture. the guide is the deployed configuration;
When the elongate member is at least partially disposed within the lumen of the guide, the guide extends proximally from its distal end across at least a portion of the shaft, and 2. The device of claim 1, over the side of a shaft and then bending to extend proximally toward the proximal end of said shaft. a handle operably coupled to the shaft and the guide, the shaft and the guide extending distally from the handle;
2. A length of the guide disposed between the distal end of the handle and the guide coupler increases in response to the guide being transitioned from the delivery configuration to the deployment configuration. equipment. 2. The apparatus of claim 1, wherein the guide coupler is spaced proximally from the distal end of the shaft. the shaft defines at least one lumen;
3. The device of Claim 1, wherein the at least one lumen is configured to accommodate a guidewire. The guide moves between the delivery configuration and the deployment configuration in response to relative movement between (1) a portion of the guide disposed proximal to the guide coupler and (2) the shaft. 2. The apparatus of claim 1, configured to be transitioned between. the elongated member is a side catheter;
2. The device of Claim 1, wherein the guide is a side catheter guide. the shaft defines at least one lumen;
the at least one lumen configured to receive at least a portion of the guide;
the shaft defines a first lateral opening and a second lateral opening;
the guide is configured to extend through the first lateral opening when in the deployed configuration;
2. The device of claim 1, wherein the elongate member and the penetrating member are configured to extend through the second lateral opening when the guide is in the deployed configuration. 2. The apparatus of claim 1, wherein said guide coupler is disposed within a lumen defined by said shaft. the penetrating member defines a lumen configured to slidably receive a guidewire;
4. The lumen has a first inner diameter at its distal end portion and a second inner diameter at a portion proximal to said distal end portion, which is greater than said first inner diameter. 1 device. further comprising an atraumatic member coupled to the shaft and spaced (1) distally from the guide and (2) proximally from a distal end of the shaft;
2. The device of claim 1, wherein the atraumatic member tapers to reduce cross-sectional area from its proximal end to its distal end. further comprising an atraumatic member defining a lumen therethrough, a first lateral opening, and a second lateral opening;
at least a portion of the shaft and the guide are disposed within the lumen of the atraumatic member;
A portion of the guide disposed proximally of the guide coupler is configured to extend through the first lateral opening when the guide transitions from the delivery configuration to the deployment configuration. has been
2. The apparatus of claim 1, wherein the elongated member member is configured to extend distally through the second lateral opening when the guide is in the deployed configuration. 3. The apparatus of Claim 1, wherein the atraumatic member comprises a radiopaque, echobright or sonopaque marker. the deployed configuration is a first deployed configuration;
the distal end of the guide is configured to deflect a first amount relative to the centerline of the shaft when transitioned from the delivery configuration to the first deployed configuration;
The guide is configured to deflect a second amount different than the first amount relative to the centerline of the shaft when transitioned from the delivery configuration to the second deployed configuration. , the apparatus of claim 1. inserting a shaft having a guide attached via a guide coupler into a patient's heart such that a distal end of the guide is disposed in the right atrium of the heart;
deflecting the distal end of the guide about the guide coupler so that the distal end of the guide points toward the heart septum;
extending an elongated member disposed within the guide distally from the guide toward the septum;
extending a septal penetrator slidably disposed within the elongate member distally from the elongate member such that the septal penetrator punctures the septum; the septum penetrator defines a lumen configured to slidably receive the guidewire;
verifying that a distal end portion of the septal penetrator is disposed in the left atrium of the heart after the septal penetrator punctures the septum;
A method. The verifying includes (1) measuring pressure representative of the left atrium from outside the patient through the lumen defined by the septal penetrator; or (2) 20. The method of claim 19, comprising at least one of: delivering fluid to the left atrium through the defined lumen. 20. The method of Claim 19, wherein during said verification, said guidewire is disposed within said lumen of said septal penetrator. 22. The method of claim 21, wherein during said verification a distal end of said guidewire is disposed within said right atrium. the lumen of the septal penetrator having a first inner diameter at a distal end portion thereof and a second inner diameter at a portion proximal to the distal end portion greater than the first inner diameter; and
20. The method of Claim 19, wherein the guidewire is disposed within the portion having the second inner diameter and not disposed within the portion having the first inner diameter. The inserting of the shaft includes inserting the shaft into the heart's inferior vena cava (IVC) and the heart's superior vena cava (SVC) such that the shaft is disposed in both the IVC and SVC. including making
20. The method of Claim 19, wherein said deflecting and said extending said elongate member occur with said shaft disposed in both said IVC and said SVC. The extending the septal penetrator distally from the elongate member extends the septal penetrator distally from the elongate member such that the septal penetrator punctures the fossa ovalis of the heart. 20. The method of claim 19, comprising causing. the extending the septal penetrator so that the septal penetrator punctures the septum comprises extending the septal penetrator into the left atrium of the heart;
The method further comprises:
With the septal penetrator disposed in the left atrium, extending a guidewire from within a lumen defined by the septal penetrator distally from the septal penetrator into the left atrium. 20. The method of claim 19, comprising: 20. The method of claim 19, wherein the deflecting comprises increasing a length of the guide disposed within the heart proximal to the guide coupler. the guide coupler is a hinge rotatably coupled to the shaft;
20. The method of claim 19, allowing rotational movement of the distal end of the guide relative to the shaft while limiting relative linear movement between the hinge and the distal end of the guide. said elongated member includes an end effector at its distal end;
The extending the elongate member distally from the guide toward the septum extends the elongate member distally from the guide such that the septum is tented by the end effector. 20. The method of claim 19, comprising contacting the septum with a force. 20. The method of claim 19, wherein the deflecting comprises causing relative movement between (1) a portion of the guide disposed proximal to the guide coupler and (2) the shaft. Method. the elongated member is a side catheter;
20. The method of Claim 19, wherein the guide is a side catheter guide. 20. The method of claim 19, wherein said extending said elongate member distally from said guide comprises extending said elongate member through a lateral opening defined by said shaft. the lateral opening is a first lateral opening;
33. The method of claim 32, wherein the deflecting comprises extending a portion of the guide disposed proximally of the guide coupler through a second lateral opening. a shaft;
coupled to the shaft via a guide coupler and angularly deflectable and configured to be transitioned between a delivery configuration and a deployed configuration; a guide that, when translated, points a distal end of the guide away from the centerline of the shaft and defines a lumen;
an elongate member slidably disposable within the lumen of the guide and configured to extend distally relative to the distal end of the guide and defining a lumen;
A penetrating member slidably disposable within the lumen of the elongate member and configured to extend distally relative to a distal end of the elongate member for penetrating tissue of a patient. a piercing member configured to pierce;
an atraumatic member defining a lumen therethrough, a first lateral opening, and a second lateral opening, wherein at least a portion of the shaft and the guide are connected to the atraumatic member; an atraumatic member disposed within the lumen of
A device comprising: An end effector disposed about the elongate member, the delivery configuration having a first cross-sectional area and the end effector having a second cross-sectional area greater than the first cross-sectional area. 35. The apparatus of Claim 34, further comprising an end effector configured to transition between deployed configurations. 35. The apparatus of claim 34, further comprising an end effector centered about the elongate member and having a cross-sectional area greater than the cross-sectional area of the elongate member. 35. The apparatus of claim 34, wherein said guide coupler permits rotational movement of said guide relative to said shaft and limits relative linear movement between said guide coupler and said guide. 35. The apparatus of Claim 34, wherein the guide coupler is formed from suture. the guide is the deployed configuration;
When the elongate member is at least partially disposed within the lumen of the guide, the guide extends proximally from its distal end across at least a portion of the shaft, and 35. The device of claim 34, over the side of a shaft and then bending to extend proximally toward the proximal end of said shaft. a handle operably coupled to the shaft and the guide, the shaft and the guide extending distally from the handle;
35. A length of said guide disposed between a distal end of said handle and said guide coupler increases in response to said guide being transitioned from said delivery configuration to said deployed configuration. equipment. 35. The apparatus of claim 34, wherein the guide coupler is spaced proximally from the distal end of the shaft. the shaft defines at least one lumen;
35. The device of Claim 34, wherein the at least one lumen is configured to accommodate a guidewire. The guide moves between the delivery configuration and the deployment configuration in response to relative movement between (1) a portion of the guide disposed proximal to the guide coupler and (2) the shaft. 35. The apparatus of claim 34, configured to be transitioned between. the elongated member is a side catheter;
35. The apparatus of Claim 34, wherein said guide is a side catheter guide. the shaft defines at least one lumen;
the at least one lumen configured to receive at least a portion of the guide;
the shaft defines a first lateral opening and a second lateral opening;
the guide is configured to extend through the first lateral opening when in the deployed configuration;
35. The device of Claim 34, wherein the elongate member and the penetrating member are configured to extend through the second lateral opening when the guide is in the deployed configuration. 35. The apparatus of Claim 34, wherein said guide coupler is disposed within a lumen defined by said shaft. the penetrating member defines a lumen configured to slidably receive a guidewire;
4. The lumen has a first inner diameter at its distal end portion and a second inner diameter at a portion proximal to said distal end portion, which is greater than said first inner diameter. 34 devices. 35. The device of claim 34, wherein the atraumatic member tapers to reduce cross-sectional area from its proximal end to its distal end. A portion of the guide disposed proximally of the guide coupler is configured to extend through the first lateral opening when the guide transitions from the delivery configuration to the deployment configuration. has been
35. The apparatus of claim 34, wherein the elongate member is configured to extend distally through the second lateral opening when the guide is in the deployed configuration. the deployed configuration is a first deployed configuration;
the distal end of the guide is configured to deflect a first amount relative to the centerline of the shaft when transitioned from the delivery configuration to the first deployed configuration;
The guide is configured to deflect a second amount different than the first amount relative to the centerline of the shaft when transitioned from the delivery configuration to the second deployed configuration. 35. The apparatus of claim 34.

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