Intracorporeal docking of therapeutic and diagnostic catheters to existing guidewires

Abstract

Provided are methods and devices for facilitating the advancement of a catheter device, such as an intracardiac ultrasound examination catheter, through a body wall, such as the septum of the heart. The catheter device is advanced through a subject's vasculature to a first body cavity. The catheter device is coupled to a guidewire previously placed within the vasculature between the first and second cavities. The catheter device is then advanced from the first body cavity to the second body cavity through a body wall separating the first and second cavities. To facilitate this advancement, the catheter device can be magnetically coupled to the guidewire. The magnetic assembly can be provided on a distal portion of a sleeve through which the distal portion of the catheter is advanced. A malleable dilator element can also be provided on the distal portion of the sleeve.

Description

[Background technology]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 63 / 487,229, filed February 27, 2023, and U.S. Provisional Application No. 63 / 522,094, filed June 20, 2023, each of which is incorporated by reference herein in its entirety.

[0002] Transcatheter interventions for structural heart disease represent one of the fastest-growing segments of cardiovascular disease treatment. These procedures allow for the correction of valvular and structural abnormalities of the heart using minimally invasive techniques and are traditionally performed using transesophageal echocardiography (TEE) or two-dimensional (2D) intracardiac echocardiography (ICE) guidance. TEE is the preferred imaging modality for procedures performed within the left atrium, such as mitral valve transcatheter limbal contact repair (M-TEER) and left atrial appendage occlusion (LAAO), or for any complex imaging guidance where 2D ICE is not sufficient (e.g., tricuspid valve-TEER).

[0003] In recent years, three commercially available 3D ICE catheters (Philips VeriSight Pro, Biosense Webster NuVision, and Siemens AcuNav Volume) have been introduced that enable real-time 3D imaging of intracardiac structures. These catheters also have the capability to perform multiplanar reconstructions, which can provide image resolution comparable to or even exceeding that of TEE. These 3D ICE catheters have attracted significant interest from clinicians and patients because they can be placed percutaneously through the femoral vein, do not require general anesthesia and esophageal intubation, and result in faster postprocedure recovery times and less discomfort for patients. Summary of the Invention [Means for solving the problem]

[0004] The present disclosure relates to devices and methods for facilitating the advancement of a catheter device through a body wall. Aspects of the disclosure herein provide a method for advancing a catheter device from a first body cavity of a subject to a second body cavity of the subject. An exemplary method would generally include advancing the catheter device through the subject's vasculature to the first body cavity, coupling the catheter device to a guidewire positioned within the vasculature while the catheter device is advanced within the vasculature, and advancing the catheter device from the first body cavity to the second body cavity through a body wall separating the first and second body cavities. The guidewire is advanced through the vasculature to cross the first and second body cavities. The advancement of the catheter device through the body wall is facilitated by coupling the catheter device to the guidewire.

[0005] In some embodiments, the first body cavity is the right atrium of the subject's heart. In some embodiments, the second body cavity is the left atrium of the subject's heart. In some embodiments, the body wall is the septum of the subject's heart. In some embodiments, advancing the catheter device through the vasculature includes advancing the catheter device through the left femoral vein, the inferior vena cava, or both. In some embodiments, the catheter device comprises an intracardiac echocardiography (ICE) catheter. In some embodiments, the method further includes advancing a guidewire through the subject's vasculature to cross between the first and second body cavities. In some embodiments, advancing the guidewire includes advancing the guidewire through the right femoral vein into the right atrium of the heart and through the septum of the heart into the left atrium of the heart. In some embodiments, coupling the catheter device to the guidewire includes docking a magnet of the catheter device with the guidewire. In some embodiments, the magnet of the catheter device is positioned in a distal portion of the catheter device. In some embodiments, the magnet of the catheter device is positioned in a steerable or articulating portion of the catheter device. In some embodiments, the magnet of the catheter device is positioned distal to an imaging element of the catheter device. In some embodiments, docking the magnet of the catheter device with the guidewire includes bending a distal portion of the catheter device carrying the magnet and positioning the magnet adjacent to the guidewire so that the magnet magnetically attracts and contacts the guidewire. In some embodiments, the method further includes enclosing at least the distal portion of the catheter device with a sleeve carrying the magnet. In some embodiments, at least the distal portion of the catheter device is encased with the sleeve carrying the magnet prior to coupling the catheter device to the guidewire. In some embodiments, the catheter device is coupled to the guidewire in one or more of the vena cava, inferior vena cava, superior vena cava, right atrium, or left atrium.In some embodiments, the catheter device is coupled to a guidewire in the inferior vena cava or right atrium before advancing the catheter device from the right atrium through the septum into the left atrium.

[0006] Aspects of the disclosure herein also provide a method of advancing a catheter device from a first body cavity of a subject to a second body cavity of the subject using a sleeve device as provided herein. An exemplary method would generally include advancing the sleeve device through the subject's vasculature to the first body cavity, coupling the sleeve device to a guidewire positioned within the vasculature while the sleeve device is advanced within the vasculature, advancing the sleeve device from the first body cavity to the second body cavity through a body wall separating the first and second body cavities, inserting the catheter device into the sleeve device while the sleeve device is positioned within the vasculature, and advancing the catheter device from the first body cavity to the second body cavity through the body wall separating the first and second body cavities. The guidewire is advanced through the vasculature to cross the first and second body cavities. Advancement of the sleeve device through the body wall is facilitated by coupling the sleeve device to the guidewire. Advancement of the catheter device through the body wall is facilitated by coupling the sleeve device to the guidewire.

[0007] In some embodiments, the first body cavity is the right atrium of the subject's heart. In some embodiments, the second body cavity is the left atrium of the subject's heart. In some embodiments, the body wall is the septum of the subject's heart. In some embodiments, advancing the sleeve device through the vasculature includes advancing the sleeve device through the left femoral vein, the inferior vena cava, or both. In some embodiments, advancing the catheter device through the vasculature includes advancing the catheter device into the sleeve device and into the left femoral vein, the inferior vena cava, or both. In some embodiments, the catheter device comprises an intracardiac echocardiography (ICE) catheter. In some embodiments, the method further includes advancing a guidewire through the subject's vasculature to cross between the first and second body cavities. In some embodiments, advancing the guidewire includes advancing the guidewire through the right femoral vein into the right atrium of the heart and through the septum of the heart into the left atrium of the heart. In some embodiments, coupling the sleeve device to the guidewire includes docking at least one magnet of the sleeve device with the guidewire. In some embodiments, docking the at least one magnet of the sleeve device with the guidewire comprises rotating the at least one magnet to align the poles of the at least one magnet toward the guidewire and magnetically attracting the guidewire. In some embodiments, the at least one magnet comprises a plurality of discrete magnetic elements. In some embodiments, the sleeve device comprises a distal magnet assembly comprising at least one magnet and a flexible shaft coupled to the at least one magnet. In some embodiments, the at least one magnet comprises a plurality of discrete magnetic elements arranged in series along the flexible shaft. In some embodiments, the distal magnet assembly further comprises a distal atraumatic tip. In some embodiments, the distal magnet assembly further comprises at least one support spring for the flexible shaft. In some embodiments, the distal magnet assembly is at least partially radiopaque or echogenic.In some embodiments, advancing the sleeve device through a body wall from a first body cavity to a second body cavity includes pushing a dilator positioned within a main lumen of the sleeve device through the body wall. In some embodiments, the dilator comprises a tapered distal tip. In some embodiments, at least one magnet is coupled to the tapered distal tip. In some embodiments, inserting a catheter device into the sleeve device with the sleeve device positioned within the vasculature includes advancing the catheter device through the main lumen of the sleeve device. In some embodiments, the method further includes removing the dilator from the main lumen of the sleeve device prior to advancing the catheter device through the main lumen of the sleeve device. In some embodiments, the sleeve device is coupled to a guidewire in one or more of the vena cava, inferior vena cava, superior vena cava, right atrium, or left atrium. In some embodiments, the sleeve device is coupled to a guidewire in the inferior vena cava or right atrium before advancing the sleeve device from the right atrium through the septum into the left atrium. In some embodiments, the catheter device is coupled to the sleeve device in one or more of the vena cava, inferior vena cava, superior vena cava, right atrium, or left atrium. In some embodiments, the catheter device is coupled to the sleeve device in the inferior vena cava or right atrium before advancing the catheter device from the right atrium through the septum into the left atrium. In some embodiments, the catheter device is coupled to the sleeve device in the inferior vena cava or right atrium with the sleeve device advanced from the right atrium through the septum into the left atrium.

[0008] Aspects of the disclosure herein also provide a device for facilitating the advancement of a catheter device through a body wall. An exemplary sleeve device will generally include a flexible tubular sleeve having a main lumen for advancement of a distal portion of the catheter device therethrough, a dilator removably advanced through the main lumen of the flexible tubular sleeve, and a magnet assembly including at least one magnet rotatably coupled to a distal portion of the dilator and configured to be magnetically attracted to a guidewire advanced through the body wall. The dilator has a main lumen.

[0009] In some embodiments, the catheter device comprises an intracardiac echocardiography (ICE) catheter. In some embodiments, the magnet assembly is rotatable within the main lumen of the dilator when advanced through the dilator. In some embodiments, rotation of the magnet assembly reorients the poles of at least one magnet. In some embodiments, the sleeve device is advanceable over the guidewire, and rotation of the magnet assembly results in movement of the magnet along the circumflex branch on the outer surface of the guidewire. In some embodiments, the sleeve device further comprises a steering knob coupled to the proximal end of the dilator and rotating one or more of the dilator or the magnet assembly. In some embodiments, the at least one magnet comprises a plurality of discrete magnetic elements. In some embodiments, the magnet assembly comprises a flexible shaft, and the plurality of discrete magnetic elements are arranged in series along the flexible shaft. In some embodiments, the distal magnet assembly further comprises at least one support spring for the flexible shaft. In some embodiments, the distal magnet assembly is at least partially radiopaque or echogenic. In some embodiments, the dilator comprises a tapered distal tip. In some embodiments, the flexible tubular sleeve is at least partially made from a polymeric material. In some embodiments, the polymeric material is one or more of HDPE, LDPE, PTFE, PEP, PEEK, or Pebax. In some embodiments, the sleeve device includes a proximal end, the proximal end coupled to a hub. In some embodiments, the hub includes an irrigation port. In some embodiments, the hub includes a hemostatic seal. In some embodiments, the diameter of the main lumen of the flexible tubular sleeve is 1 to 7 mm. In some embodiments, the distal portion of the dilator is malleable to adjust the bend radius of the distal portion. In some embodiments, the at least one magnet is cylindrical. In some embodiments, the at least one magnet is magnetized along the longitudinal axis of the at least one magnet. In some embodiments, the poles of the at least one magnet are oriented transverse to the longitudinal axis of the dilator when the dilator is in the neutral configuration.

[0010] Aspects of the disclosure herein also provide a system for facilitating the advancement of a catheter device through a body wall. An exemplary system would generally include a sleeve device as provided herein and a guidewire. [Brief explanation of the drawings]

[0011] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings.

[0012] [Figure 1] FIG. 1 is an elevational view of a standard intracardiac echocardiography (ICE) catheter device.

[0013] [Figure 2] FIG. 2 is an elevational view of an exemplary ICE catheter device having a magnetic distal tip.

[0014] [Figure 3] 3A-3C depict an exemplary "mag-sleeve" device of the present disclosure. Fig. 3A is an elevational view of an exemplary sleeve device comprising a hemostatic valve attached to a polymer sleeve and a toroidal magnet attached to the distal end of the polymer sleeve. Figs. 3B-3C are cross-sectional views of the exemplary sleeve device taken along the section line indicated in Fig. 3A.

[0015] [Figure 4] FIG. 4 depicts an elevational view of a standard ICE catheter device and an exemplary sleeve device configured to accommodate insertion of an ICE catheter device.

[0016] [Figure 5] FIG. 5 depicts, in an elevational view, the catheter device of FIG. 4 inserted into an exemplary sleeve device.

[0017] [Figure 6] FIG. 6 depicts, in an elevational view, an exemplary deflection of a standard ICE catheter device by a practitioner while the catheter device is within a sleeve device.

[0018] [Figure 7] FIG. 7 depicts, in cross-section, a guidewire placed inside the left atrium for advancing a catheter device into the left atrium.

[0019] [Figure 8] FIG. 8 depicts, in cross-section, a standard ICE catheter device that lacks a magnetic tip and is unable to dock with a guidewire placed inside the left atrium.

[0020] [Figure 9] FIG. 9 depicts, in cross-section, the distal end of a standard ICE catheter device lacking a magnetic tip and being deflected by the practitioner toward a transseptal puncture.

[0021] [Figure 10] 10 depicts, in cross-section, an ICE catheter device with a magnetic distal tip and a guidewire placed inside the left atrium. The magnetic distal tip is docked to the guidewire and can then be advanced tangentially relative to the guidewire to cross the transseptal puncture.

[0022] [Figure 11] 11 depicts, in cross-section, a standard ICE catheter device lacking a magnetic distal tip inside a sleeve device of the present disclosure and a guidewire placed inside the left atrium. The magnetic distal tip of the sleeve device can be docked with the guidewire, and the ICE catheter device can be advanced tangentially within the sleeve device relative to the guidewire and cross the transseptal puncture.

[0023] [Figure 12] FIG. 12 is a cross-sectional view depicting a standard ICE catheter device inside an exemplary sleeve device placed inside the left atrium.

[0024] [Figure 13] FIG. 13 is an elevational view of an exemplary sheath configured for use within the system of the present disclosure.

[0025] [Figure 14] FIG. 14 is an elevational view of an exemplary dilator configured for use within the system of the present disclosure.

[0026] [Figure 15] 15A, 15B, and 15C are perspective, elevational, and cross-sectional views, respectively, of the distal end of an exemplary dilator.

[0027] [Figure 16] FIG. 16 depicts, in cross-sectional view, an exemplary sheath and dilator placed inside the right atrium and docked to a guidewire placed inside the left atrium.

[0028] [Figure 17] 17A-17B depict undesirable positioning of the distal magnet of an exemplary dilator on an exemplary guidewire. Fig. 17A depicts, in an elevational view, the distal magnet over the guidewire and not aligned with the puncture over the cavity. Fig. 17B depicts, in an elevational view, the distal magnet not crossing the opening in the cavity when advanced by the practitioner.

[0029] [Figure 18]18A-18B depict repositioning of the distal magnet of an exemplary dilator over a guidewire by turning the steering knob of the exemplary dilator. FIG. 18A depicts, in an elevational view, the distal magnet on top of the guidewire and not aligned with the transseptal puncture on the fossa. FIG. 18B depicts, in an elevational view, the distal magnet aligned with the transseptal puncture prior to crossing the transseptal puncture into the left atrium.

[0030] [Figure 19] FIG. 19 depicts, in cross-section, an exemplary sheath and dilator placed inside the left atrium.

[0031] [Figure 20] 20A-20B depict the exemplary sheath of FIG. 19 positioned inside the left atrium with the exemplary dilator removed and replaced with a standard ICE catheter device. FIG. 20A depicts, in a cross-sectional view, the exemplary sheath being aspirated through the flush port to remove air after insertion of the standard ICE catheter device into the exemplary sheath. FIG. 20B depicts, in a cross-sectional view, the standard ICE catheter device being readily inserted into the left atrium via the exemplary sheath positioned within the left atrium.

[0032] [Figure 21] 21A-21B are elevational views of an exemplary dilator having a radially and longitudinally movable drive shaft within the dilator outer shaft. Fig. 21A depicts the retracted position of the drive shaft within the dilator outer shaft. Fig. 21B depicts the advanced position of the drive shaft within the dilator outer shaft.

[0033] [Figure 22]22A-22B depict longitudinal movement of an exemplary dilator drive shaft to advance a distal magnet along a guidewire and across a transseptal puncture. FIG. 22A depicts, in a cross-sectional view, the withdrawn drive shaft and the distal magnet aligned with the opening of the transseptal puncture. FIG. 22B depicts, in a cross-sectional view, the operator advancing the drive shaft to advance the distal magnet across the transseptal puncture. DETAILED DESCRIPTION OF THE INVENTION

[0034] Detailed Description Although only recently commercially available, clinical adoption of 3D intracardiac ultrasound (ICE) catheters by practitioners has been robust, with an increasing number of 3D ICE-guided procedures being performed. Best practices for acquiring imaging planes, optimizing steering techniques, and steering catheters are rapidly evolving.

[0035] Mitral valve transcatheter marginal contact repair (M-TEER) and left atrial appendage occlusion (LAAO) procedures traditionally require catheter manipulation and implant deployment within the left atrium. Because far-field imaging with a 3D ICE catheter can be limited, these left atrial procedures traditionally require advancement of a 3D ICE catheter across the interatrial septum from the right atrium into the left atrium to enable imaging of left atrial structures.

[0036] Crossing from the right atrium to the left atrium with a 3D ICE catheter is not a trivial maneuver because the hole in the interatrial septum after transseptal puncture can be very small, and navigating the tip of the 3D ICE catheter through this hole under single-plane fluoroscopic guidance can be challenging. While practitioners prefer to utilize imaging during the procedure, spending additional time guiding the intervention and navigating the 3D ICE catheter to the left atrium can be undesirable and dangerous. Multiple unsuccessful attempts involving repeated deflection, advancement, and retraction of the ICE catheter tip can occur within the procedure, which can result in intracardiac injury or perforation. In some cases, a larger hole in the septum must be created with balloon dilation, which creates a larger hole in the septum that may not heal. The difficulty of crossing the interatrial septum with a 3D ICE catheter is well recognized.

[0037] Because crossing from the right atrium to the left atrium is a crucial intraprocedural step when using 3D ICE to perform procedures within the left atrium, a solution to make this step safe, easy, and reproducible is desired. To facilitate interatrial crossing of a 3D ICE catheter, or any imaging or therapy catheter, provided herein are methods and devices for safe and rapid docking of the catheter to an existing guidewire. The guidewire can be used to reliably guide the catheter across the interatrial septum using the methods and devices described herein.

[0038] 1 , the distal end 14 of a standard ICE catheter device 10 typically has an ultrasound transducer and / or receiver 16 attached thereto. A standard ICE catheter device will also typically have a control handle 12 with one or more deflection knobs 18. The deflection knobs can be manipulated by a practitioner to deflect (e.g., deflect upward or downward) the distal end 14 of the catheter device. In some cases, a standard ICE catheter device has at least three deflection knobs for deflecting the distal end on at least three separate axes (e.g., X, Y, and Z axes).

[0039] A magnet 25 can be attached to the distal tip 14 of a standard ICE catheter device 10, as depicted in FIG. 2. In some cases, the standard ICE catheter device has a magnetic distal tip 24. In some embodiments, the magnet 25 is distal to the transducer 16. In some embodiments, a coil or spring can be attached distal to the transducer. In some embodiments, a coil or spring can be attached between the magnet and the transducer, or between a first magnet and a second magnet distal to the transducer. As used herein, the distal-most magnet attached to a catheter device is sometimes referred to as the "distal magnet."

[0040] Attachment of a magnet (e.g., a distal magnet) to a diagnostic or therapeutic device can be accomplished by standard manufacturing techniques, such as adhesive bonding or insert molding. In some cases, attaching a magnet to the distal end of a standard diagnostic or therapeutic catheter device may not be feasible, for example, if the practitioner wishes to employ a commercially available catheter device that does not require repair of the catheter device prior to use. For such cases, a "mag-sleeve" device is provided herein.

[0041] As depicted in FIG. 3 , an exemplary “mag-sleeve” (magnetic sleeve) device 30 comprises a polymer sleeve 31 attached to a hemostatic valve 32. The hemostatic valve can be configured to seal around a commercially available diagnostic or therapeutic catheter device (e.g., a standard ICE catheter device). The polymer sleeve can be attached to a flush port 38 for flushing and aspirating air within the polymer sleeve. Attached to the distal end 34 of the polymer sleeve 31 is a magnet 35. In some cases, the magnet comprises a toroidal magnet with a distal vent 37, as shown in the cross-sectional view of FIG. 3B . The vent 37 allows air or fluid to escape from the sleeve during insertion of the catheter device.

[0042] The polymer sleeve has a main lumen 33, as shown in cross section in FIG. 3C. The main lumen can be configured to mate with a diagnostic or therapeutic catheter device. The polymer sleeve can be thin-walled. In some embodiments, the polymer sleeve has a wall thickness of about 0.0005 to about 0.005 inches. In some embodiments, the polymer sleeve has a wall thickness of about 0.0005 to about 0.0007, about 0.0007 to about 0.0009, about 0.0009 to about 0.001, about 0.001 to about 0.003, or about 0.003 to about 0.005 inches. In some embodiments, the polymer sleeve has a thickness of about 0.0005, 0.0006, 0.0007, 0.0008, 0.0009, 0.001, 0.002, 0.003, 0.004, or 0.005 inches. Having a thin wall allows the distal end 34 of the polymer sleeve 31 to be flexible and deflectable. In some cases, the distal end 34 of the polymer sleeve can deflect with any deflection of a diagnostic or therapeutic catheter device inserted therein. The polymer sleeve can be made from a lubricious material to facilitate advancement of the sleeve through a subject's body lumen (e.g., a blood vessel). In some embodiments, the polymer sleeve comprises a polymer material. The polymer material can be one or more of HDPE, LDPE, PTFE, PEP, PEEK, or Pebax. In some embodiments, the polymer sleeve comprises a PTFE, ePTFE, FEP, or HDPE material.

[0043] In some embodiments, the main lumen 33 of the polymer sleeve 31 has a diameter of about 1 mm to about 7 mm, preferably about 3.3 mm.

[0044] Referring to FIG. 4 , a standard ICE catheter device 10 and an exemplary sleeve device 30 are depicted. The exemplary sleeve device is configured to accommodate insertion of a standard ICE catheter device. An elevational view of the standard ICE catheter device 10 inserted into the exemplary sleeve device 30 is shown in FIG. 5 . The distal end 14 of the standard ICE catheter device and the distal end of the exemplary sleeve device 34 can be deflected by a practitioner manipulating the deflection knob 18 on the control handle 12, as shown in FIG. 6 . In many embodiments, the exemplary sleeve device 30 will not affect the deflection of the distal end 14 of the catheter device, for example, for navigation through the vasculature and cardiac structures. In many embodiments, the thin-walled and flexible polymer sleeve 31 does not interfere with or degrade the normal function of the catheter device (e.g., does not degrade the quality of the imaging catheter).

[0045] Method for intracorporeal docking of a catheter to a pre-positioned guidewire - Patent Application 20070122

[0046] Provided herein is a method for accessing the left atrium through a transseptal puncture with a catheter for the treatment of structural heart disease (e.g., mitral valve repair, left atrial appendage closure, etc.). Aspects of the disclosure herein provide a method for docking a magnetic distal end of a catheter device to a guidewire that is pre-positioned within the left atrium. The guidewire can be made of a magnetic material (e.g., stainless steel) and can be used to assist in the placement of the catheter device within the left atrium.

[0047] 7-12 , the distal end 73 of a guidewire 72 can be placed inside the left atrium 76. In some cases, the guidewire can be placed inside the left atrium using standard catheterization laboratory (“cath lab”) techniques, such as the Seldinger technique. In some cases, the distal end of the guidewire can be placed inside the left atrium, as depicted in FIG. 7 . The distal end 73 of the guidewire 72 can first be inserted into the patient's right femoral vein 77 and then moved through the inferior vena cava 79 into the right atrium 74. To access the left atrium from the right atrium, a transseptal puncture 75 can be made, for example, at or near the fossa ovalis (i.e., the foramen ovale). The distal end of the guidewire can then be placed through the transseptal puncture 75 into the left atrium 76.

[0048] As depicted in FIG. 8 , a standard catheter device (e.g., an ICE catheter lacking a distal magnetic tip) 80 can be inserted into a patient's left femoral vein 78, and the distal end 81 of the standard catheter device 80 can be advanced into the right atrium 74. To access the left atrium 76 using the standard catheter device 80, the distal end 81 of the catheter device is manipulated using a deflection knob 88 to deflect it toward the opening of a transseptal puncture 75, as shown in FIG. 9 . While the distal end 81 is being deflected, the practitioner typically evaluates its position under fluoroscopy under different planes, for example, to locate the transseptal puncture 75 and carefully pass the distal end 81 therethrough. Such methods can add time to the procedure and expose the patient and / or practitioner to X-rays and / or other imaging radiation (e.g., contrast agents or elements).

[0049] 10 , a catheter device 100 as provided herein can have a magnet 105 attached to the distal tip 104 of the catheter device. The magnet 105 of the catheter device allows a practitioner to dock the distal tip 104 with a guidewire 72. In some cases, the magnet 105 is docked with the guidewire in the inferior vena cava 79 or the right atrium 74. In some embodiments, docking the magnet 105 of the catheter device with the guidewire 72 includes bending a distal portion of the catheter device carrying the magnet and positioning the magnet adjacent to the guidewire so that the magnet magnetically attracts and contacts the guidewire. In some embodiments, one or more deflection knobs 108 can be used by the practitioner to bend the distal tip 104 and position the magnet 105 adjacent to the guidewire 72.

[0050] The distal tip 104, while remaining docked to the guidewire, can be advanced by the practitioner through the inferior vena cava and right atrium, and from there to the opening of the transseptal puncture 75. From the right atrium 74, the docked distal tip 104 can cross the transseptal puncture 75 tangentially to the guidewire 72 into the left atrium 76. In this manner, advancing the catheter through the transseptal puncture can be performed easily and with minimal x-ray exposure to the patient and practitioner.

[0051] Provided herein is a method of advancing a catheter device from a first body cavity (e.g., the right atrium) of a subject to a second body cavity (e.g., the left atrium) of the subject, the method including: advancing the catheter device through the subject's vasculature to the first body cavity; while the catheter device is advanced within the vasculature, coupling the catheter device to a guidewire positioned within the vasculature, the guidewire being advanced through the vasculature to cross the first and second body cavities; and advancing the catheter device from the first body cavity to the second body cavity through a body wall separating the first and second body cavities, wherein advancement of the catheter device through the body wall is facilitated by coupling the catheter device to the guidewire.

[0052] Aspects of the disclosure herein also provide a method for docking the magnetic distal end of the magsleeve device to a guidewire that is pre-positioned within the left atrium, where the guidewire can be used to assist in placement of the magsleeve device within the left atrium.

[0053] 11-12 , the mag-sleeve 110 as provided herein can allow a practitioner to use the magnetic distal tip 115 of the mag-sleeve 110 to dock any catheter device (e.g., a commercially available catheter device lacking a magnetic distal tip) with a pre-placed guidewire 72. In some cases, the magnetic distal tip 115 of the mag-sleeve 110 is docked with the guidewire 72 in the inferior vena cava 79 or in the right atrium 74. In some embodiments, a standard catheter device 80 is inserted into the mag-sleeve 110 before inserting the mag-sleeve into the left femoral vein 78. In some embodiments, a standard catheter device 80 is inserted into the mag-sleeve 110 before docking the mag-sleeve with the guidewire. In some embodiments, a standard catheter device 80 is inserted into the mag-sleeve 110 after docking the mag-sleeve with the guidewire. In some cases, the distal end 81 of the standard catheter 80 and the magnetic distal tip 115 of the mag sleeve 110 are advanced together by the practitioner (e.g., through the inferior vena cava to the right atrium) while the magnetic distal tip remains docked to the guidewire. The distal end 81 of the standard catheter 80 and the docked magnetic distal tip 115 of the mag sleeve 110 can be advanced along the guidewire 72 to the opening of the transseptal puncture 75 in the right atrium 74, as shown in FIG. 11 . From the right atrium 74, the docked mag sleeve is advanced into the left atrium 76 by crossing the transseptal puncture 75 tangentially to the guidewire 72, as shown in FIG. 12 . Advancing an existing diagnostic or therapeutic catheter through a transseptal puncture in this manner can be done easily and with minimal x-ray or other radiation exposure to the patient and practitioner.

[0054] Provided herein is a method for advancing a catheter device from a first body cavity (e.g., the right atrium) of a subject to a second body cavity (e.g., the left atrium) of the subject, the method comprising: advancing a sleeve device through the subject's vasculature to the first body cavity; with the sleeve device advanced within the vasculature, coupling the sleeve device to a guidewire positioned within the vasculature; advancing the sleeve device from the first body cavity to the second body cavity through a body wall separating the first and second body cavities; with the sleeve device positioned within the vasculature, inserting the catheter device into the sleeve device; and advancing the catheter device from the first body cavity to the second body cavity through the body wall separating the first and second body cavities. The guidewire is advanced through the vasculature to cross the first and second body cavities. Advancement of the sleeve device through the body wall is facilitated by coupling the sleeve device to the guidewire. Advancement of the catheter device through the body wall is facilitated by coupling the sleeve device to the guidewire.

[0055] system

[0056] Referring to Figures 13-14, provided herein is a system for accessing a second body cavity (e.g., left atrium) of a subject from a first body cavity (e.g., right atrium) of the subject using a guidewire, the system comprising a sheath 130 and a dilator 140.

[0057] Sheath 130 comprises a tubular body 131 attached to a hub 132, as depicted in FIG. 13. In some cases, tubular body 131 has a radiopaque marker 137 in distal section 134 for easy visualization of the location of the distal tip inside the body cavity. In some embodiments, a hemostatic valve 139 is attached to the proximal end of tubular body 131. Hub 132 can include a flush port 138 for flushing and aspirating the sheath lumen free of air.

[0058] The tubular body 131 of the sheath 130 can be made from a thin-walled polymeric material (e.g., HDPE, LDPE, PTFE, FEP, PEP, PEEK, or Pebax). The inner diameter of the tubular body can be about 1 mm to about 7 mm, preferably about 3.3 mm. The tubular body 131 has a main lumen 133 configured to receive the dilator 140.

[0059] The dilator 140 includes a drive shaft 148 inside the lumen of the outer shaft 141. A distal segment 144 is at the distal end of the drive shaft 148. The distal segment includes one or more magnets 145, one or more springs 146, and an atraumatic tip 147. In some cases, the poles of the one or more magnets are oriented transversely to the longitudinal axis of the dilator when the dilator is in the neutral configuration. The drive shaft 148 further includes a magnet steering knob 149 attached to the proximal end of the drive shaft. The magnet steering knob can move the drive shaft 148 and the attached distal segment 144 radially and longitudinally. By rotating the magnet steering knob, the magnet and spring assembly on the distal segment of the drive shaft can be rotated accordingly. In some embodiments, rotating the magnet assembly reorients the poles of the one or more magnets.

[0060] The proximal end of the outer shaft may further comprise a hub 142. The hub of the dilator 140 provides an ergonomic means for holding the dilator during manipulation of the magnet and spring assembly and is secured to the outer shaft 141.

[0061] In some embodiments, the distal end of the outer shaft 141 can be tapered to allow it to cross into an opening such as a transseptal puncture.

[0062] The dilator 140 can be made of a polymer material (eg, HDPE, LDP, Pebax). The inner diameter of the outer shaft 141 can be about 0.1 mm to about 3.0 mm, preferably about 1.0 mm.

[0063] In some embodiments, the distal section 144 comprises one or more discrete magnets 145 connected in series by a coil or spring 146, as shown in FIGS. 15A-15B. The magnets and springs can be mounted in series on the distal section 144 of the drive shaft, making the distal section malleable and allowing the practitioner to increase or decrease the bending radius of the distal section 144 of the dilator 140. In some embodiments, the magnets can be electromagnets. The magnets can also be magnetized along different axes of the magnet geometry. In some embodiments, the distal section comprises one, two, or three magnets and one, two, or three springs. In some embodiments, the magnets are magnetized along the long axis of a cylindrical magnet, as depicted in FIG. 15B. The magnets can be made into different shapes, such as a cylinder or a cylinder with a hole in the center, as shown in cross section in FIG. 15C. In some embodiments, the magnetic assembly of the distal section 144 is at least partially radiopaque or echogenic.

[0064] 16 , a system as provided herein can allow a practitioner to dock one or more magnets of a distal segment 144 of a drive shaft of a dilator 140 with a pre-placed guidewire 72. The dilator 140 is inserted into the sheath 130 before inserting both the dilator and sheath into the left femoral vein 78. In some cases, the magnetic distal segment 144 is docked with the guidewire 72 in the inferior vena cava 79 or the right atrium 74. The distal segment 144 of the drive shaft and the distal segment 134 of the sheath 130 can be advanced together (e.g., through the inferior vena cava to the right atrium) by the practitioner while the magnet of the distal segment remains docked with the guidewire. In some cases, the distal segment 134 of the sheath 130 has a radiopaque marker 137 to visualize the location of the advanced system. The distal segment 144 of the dilator 140 can be advanced along the guidewire 72 to the opening of the transseptal puncture 75 in the right atrium 74, as shown in FIG. 17A. If the distal magnet 173 is positioned on the side of the guidewire 72 away from the opening of the transseptal puncture 75, the distal magnet will not be aligned with the opening and will not be able to cross the transseptal puncture into the left atrium, as shown in FIG. 17B. In some cases, advancing the distal segment when the distal magnet is positioned away from the opening can undock the distal magnet from the guidewire. The spring 146 of the distal segment 144 allows deflection of the distal segment, preventing damage to tissue and providing a visual indication for the practitioner that the magnet's orientation must be adjusted relative to the guidewire. The position of the distal magnet 173 can be easily adjusted under fluoroscopy to align it with the opening by turning the magnet steering knob 149, as depicted in FIGS. 18A-B. By turning the magnet steering knob 149, the distal magnet can be rotated around the guidewire 72, encircling the guidewire and aligning it with the opening of the transseptal puncture 75 for safe and easy crossing into the left atrium.The dilator 140 and sheath 130 can be advanced tangentially relative to the guidewire 72 through the transseptal puncture 75 and placed within the left atrium 76, as depicted in FIG.

[0065] After placing the distal segment 144 of the dilator 140 in the left atrium, the dilator can be removed from the left atrium 76 while the distal segment 134 of the sheath 130 remains in the left atrium, maintaining access to the left atrium, as depicted in FIG. 20A . A transducer and / or receiver 216 attached to the distal end of an existing diagnostic or therapy catheter 200 (e.g., an ICE catheter device) can be advanced through the tubular body 131 of the sheath 130 into the left atrium 76, as shown in FIG. 20B . In some cases, the sheath 130 can be aspirated through the flush port 138 before inserting the existing catheter device 200 into the tubular body 131. Advancing an existing diagnostic or therapy catheter through a transseptal puncture in this manner can be performed easily and with minimal x-ray exposure to the patient and the practitioner.

[0066] 21A-21B depict the use of a magnetic steering knob 149 to move the drive shaft 148 radially and longitudinally within the dilator outer shaft 141. Figure 21A depicts the retracted position of the drive shaft within the dilator outer shaft. Figure 21B depicts the fully advanced position of the drive shaft within the dilator outer shaft.

[0067] 22A-22B depict advancing the distal section 144 of the drive shaft 148 by advancing the drive shaft longitudinally within the dilator outer shaft 141. FIG. 22A depicts the drive shaft in the withdrawn position just before the operator advances the drive shaft longitudinally within the dilator outer shaft, with the distal magnet 173 aligned with the opening of the transseptal puncture 75. In some cases, the drive shaft was moved radially by turning the magnet steering knob 149 to position the distal magnet 173 on the desired side of the guidewire 72. FIG. 22B depicts the operator advancing the distal magnet 173 across the transseptal puncture 75 by advancing the drive shaft longitudinally within the dilator.

[0068] Provided herein is a sleeve device for facilitating advancement of a catheter device through a body wall, the sleeve device comprising: a flexible tubular sleeve having a main lumen for advancement of a distal portion of the catheter device therethrough; a dilator removably advanced through the main lumen of the flexible tubular sleeve; and a magnet assembly rotatably coupled to a distal portion of the dilator and comprising at least one magnet configured to be magnetically attracted to a guidewire advanced through the body wall. The dilator has a main lumen.

[0069] definition

[0070] Unless otherwise defined, all terms used herein are intended to be understood as they are understood by one of ordinary skill in the art. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains.

[0071] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0072] Throughout this application, various embodiments may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the present disclosure. Thus, the description of a range should be construed as including all specifically disclosed subranges as well as individual numerical values ​​within that range. For example, a description of a range such as 1 to 6 should be construed as including specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numerical values ​​within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the scope of the range.

[0073] As used herein, the term "about" when referring to a number refers to a number plus or minus 20% of that number. The term "about" when referring to a range refers to a range from -20% of the lowest value to +20% of the highest value.

[0074] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, the term "a sample" includes a plurality of samples, including mixtures thereof.

[0075] As used herein, the term "mag-sleeve" or "mag sleeve" refers to a sleeve device for facilitating the advancement of a catheter device through a body wall. In some cases, the mag-sleeve includes a distal magnetic tip (e.g., one or more magnets at the distal end of a polymer sleeve).

[0076] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. It is not intended that the present disclosure be limited by the specific examples provided herein. While embodiments of the present disclosure have been described with reference to the foregoing specification, the description and illustration of the embodiments herein are not meant to be construed in a limiting sense. Numerous variations, modifications, and substitutions will now occur to those skilled in the art without departing from the scope of the present disclosure. Furthermore, it should be understood that all aspects of the present disclosure are not limited to the specific depictions, configurations, or relative proportions set forth herein, which depend upon a variety of conditions and variables. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the embodiments of the present disclosure. It is therefore contemplated that the present disclosure also covers any such alternatives, modifications, variations, or equivalents. It is intended that the following claims define the scope of the invention, and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. 1. A method of advancing a catheter device from a first body cavity of a subject to a second body cavity of the subject, the method comprising: advancing the catheter device through the subject's vasculature to the first body cavity; With the catheter device advanced within the vasculature, coupling the catheter device to a guidewire positioned within the vasculature, the guidewire being advanced through the vasculature to cross the first and second body cavities; advancing the catheter device from the first body cavity to the second body cavity through a body wall separating the first and second body cavities, the advancement of the catheter device through the body wall being facilitated by the coupling of the catheter device to the guidewire; A method comprising:

2. The method of claim 1 , wherein the first body cavity is the right atrium of the subject's heart.

3. The method of claim 1 or 2, wherein the second body cavity is the left atrium of the subject's heart.

4. The method of any one of claims 1-3, wherein the body wall is the septum of the subject's heart.

5. The method of any one of claims 1-4, wherein advancing the catheter device through the vascular system comprises advancing the catheter device through the left femoral vein, the inferior vena cava, or both.

6. The method of any one of claims 1-5, wherein the catheter device comprises an intracardiac echocardiography (ICE) catheter.

7. The method of any one of claims 1-6, further comprising advancing the guidewire through the vasculature of the subject so as to cross between the first and second body cavities.

8. 8. The method of claim 7, wherein advancing the guidewire comprises advancing the guidewire through the right femoral vein into the right atrium of the heart and through the septum of the heart into the left atrium of the heart.

9. The method of any one of claims 1-8, wherein coupling the catheter device to the guidewire comprises docking a magnet of the catheter device with the guidewire.

10. The method of claim 9 , wherein the magnet of the catheter device is positioned in a distal portion of the catheter device.

11. The method of claim 9 or 10, wherein the magnet of the catheter device is positioned in a steerable or articulating portion of the catheter device.

12. The method of any one of claims 9-11, wherein the magnet of the catheter device is positioned distal to an imaging element of the catheter device.

13. 13. The method of any one of claims 9-12, wherein docking the magnet of the catheter device with the guidewire comprises bending a distal portion of the catheter device carrying the magnet and positioning the magnet adjacent to the guidewire so that the magnet magnetically attracts and contacts the guidewire.

14. The method of any one of claims 9-13, further comprising enclosing at least a distal portion of the catheter device with a sleeve carrying the magnet.

15. 15. The method of claim 14, wherein at least the distal portion of the catheter device is surrounded with the sleeve carrying the magnet prior to coupling the catheter device to the guidewire.

16. The method of any one of claims 1-15, wherein the catheter device is coupled to the guidewire in one or more of the vena cava, the inferior vena cava, the superior vena cava, the right atrium, or the left atrium.

17. 17. The method of claim 16, wherein the catheter device is coupled to the guidewire in the inferior vena cava or the right atrium before advancing the catheter device from the right atrium through the septum into the left atrium.

18. 1. A method of advancing a catheter device from a first body cavity of a subject to a second body cavity of the subject, the method comprising: advancing a sleeve device through the subject's vasculature to the first body cavity; With the sleeve device advanced within the vasculature, coupling the sleeve device to a guidewire positioned within the vasculature, the guidewire being advanced through the vasculature to cross the first and second body cavities; advancing the sleeve device from the first body cavity to the second body cavity through a body wall separating the first and second body cavities, the advancement of the sleeve device through the body wall being facilitated by the coupling of the sleeve device to the guidewire; inserting the catheter device into the sleeve device while the sleeve device is positioned within the vasculature; advancing the catheter device from the first body cavity to the second body cavity through the body wall separating the first and second body cavities, the advancement of the catheter device through the body wall being facilitated by the coupling of the sleeve device to the guidewire; A method comprising:

19. 20. The method of claim 18, wherein the first body cavity is the right atrium of the subject's heart.

20. 20. The method of claim 18 or 19, wherein the second body cavity is the left atrium of the subject's heart.

21. The method of any one of claims 18-20, wherein the body wall is the septum of the subject's heart.

22. 22. The method of any one of claims 18-21, wherein advancing the sleeve device through the vascular system comprises advancing the sleeve device through the left femoral vein, the inferior vena cava, or both.

23. 23. The method of any one of claims 18-22, wherein advancing the catheter device through the vascular system comprises advancing the catheter device into the sleeve device and into the left femoral vein, the inferior vena cava, or both.

24. The method of any one of claims 18-23, wherein the catheter device comprises an intracardiac echocardiography (ICE) catheter.

25. 25. The method of any one of claims 18-24, further comprising advancing the guidewire through the vasculature of the subject so as to cross between the first and second body cavities.

26. 26. The method of claim 25, wherein advancing the guidewire comprises advancing the guidewire through the right femoral vein into the right atrium of the heart and through the septum of the heart into the left atrium of the heart.

27. The method of any one of claims 18-26, wherein coupling the sleeve device to the guidewire comprises docking at least one magnet of the sleeve device with the guidewire.

28. 28. The method of claim 27, wherein docking the at least one magnet of the sleeve device with the guidewire comprises rotating the at least one magnet to align the poles of the at least one magnet toward the guidewire and magnetically attract the guidewire.

29. 29. The method of claim 27 or 28, wherein the at least one magnet comprises a plurality of discrete magnetic elements.

30. 30. The method of any one of claims 27-29, wherein the sleeve device comprises a distal magnet assembly comprising the at least one magnet and a flexible shaft coupled to the at least one magnet.

31. 31. The method of claim 30, wherein the at least one magnet comprises a plurality of discrete magnetic elements arranged in series along the flexible shaft.

32. 32. The method of claim 30 or 31, wherein the distal magnet assembly further comprises a distal atraumatic tip.

33. The method of any one of claims 30-32, wherein the distal magnet assembly further comprises at least one support spring for the flexible shaft.

34. The method of any one of claims 30-33, wherein the distal magnet assembly is at least partially radiopaque or echogenic.

35. The method of any one of claims 18-34, wherein advancing the sleeve device through the body wall from the first body cavity to the second body cavity comprises pushing a dilator positioned within a main lumen of the sleeve device through the body wall.

36. 36. The method of claim 35, wherein the dilator comprises a tapered distal tip.

37. 37. The method of claim 36, wherein the at least one magnet is coupled to the tapered distal tip.

38. The method of any one of claims 18-37, wherein inserting the catheter device into the sleeve device while the sleeve device is positioned within the vasculature comprises advancing the catheter device through a main lumen of the sleeve device.

39. 39. The method of claim 38, further comprising removing a dilator from the main lumen of the sleeve device prior to advancing the catheter device through the main lumen of the sleeve device.

40. 40. The method of any one of claims 18-39, wherein the sleeve device is coupled to the guidewire in one or more of the vena cava, the inferior vena cava, the superior vena cava, the right atrium, or the left atrium.

41. 41. The method of claim 40, wherein the sleeve device is coupled to the guidewire in the inferior vena cava or the right atrium before advancing the sleeve device from the right atrium through the septum and into the left atrium.

42. 42. The method of any one of claims 18-41, wherein the catheter device is coupled to the sleeve device in one or more of the vena cava, the inferior vena cava, the superior vena cava, the right atrium, or the left atrium.

43. 43. The method of claim 42, wherein the catheter device is coupled to the sleeve device in the inferior vena cava or the right atrium before advancing the catheter device from the right atrium through the septum into the left atrium.

44. 44. The method of claim 42 or 43, wherein the catheter device is coupled to the sleeve device in the inferior vena cava or the right atrium, with the sleeve device advanced from the right atrium through the septum and into the left atrium.

45. 1. A sleeve device for facilitating advancement of a catheter device through a body wall, said sleeve device comprising: a flexible tubular sleeve having a main lumen for advancement of a distal portion of said catheter device therethrough; a dilator removably advanced through the main lumen of the flexible tubular sleeve, the dilator having a main lumen; a magnet assembly rotatably coupled to a distal portion of the dilator, the magnet assembly comprising at least one magnet configured to be magnetically attracted to a guidewire advanced through the body wall; A sleeve device comprising:

46. 46. ​​The sleeve device of claim 45, wherein the catheter device comprises an intracardiac echocardiography (ICE) catheter.

47. 47. The sleeve device of claim 45 or 46, wherein the magnet assembly is rotatable within the main lumen of the expander when advanced through the main lumen.

48. 48. The sleeve device of claim 47, wherein rotation of the magnet assembly reorients the poles of the at least one magnet.

49. 49. The sleeve device of claim 47 or 48, wherein the sleeve device is advanceable over a guidewire and rotation of the magnet assembly results in movement of the magnet along the circumflex branch of the outer surface of the guidewire.

50. The sleeve device of any one of claims 47-49, further comprising a steering knob coupled to a proximal end of the expander for rotating one or more of the expander or the magnet assembly.

51. A sleeve device according to any one of claims 45 to 50, wherein the at least one magnet comprises a plurality of discrete magnetic elements.

52. 52. The sleeve device of claim 51, wherein the magnet assembly comprises a flexible shaft, and the plurality of discrete magnetic elements are arranged in series along the flexible shaft.

53. 53. The sleeve device of claim 52, wherein the distal magnet assembly further comprises at least one support spring for the flexible shaft.

54. A sleeve device according to any one of claims 45-53, wherein the distal magnet assembly is at least partially radiopaque or echogenic.

55. The sleeve device of any one of claims 45-54, wherein the dilator comprises a tapered distal tip.

56. The sleeve device of any one of claims 45-55, wherein the flexible tubular sleeve is made at least in part from a polymeric material.

57. 57. The sleeve device of claim 56, wherein the polymeric material is one or more of HDPE, LDPE, PTFE, PEP, PEEK, or Pebax.

58. A sleeve device according to any one of claims 45-57, wherein the sleeve device comprises a proximal end, the proximal end being coupled to a hub.

59. 59. The sleeve device of claim 58, wherein the hub includes a flush port.

60. 60. The sleeve device of claim 58 or 59, wherein the hub includes a hemostatic seal.

61. A sleeve device according to any one of claims 45 to 60, wherein the diameter of the main lumen of the flexible tubular sleeve is between 1 and 7 mm.

62. The sleeve device of any one of claims 45-61, wherein the distal portion of the expander is malleable to adjust the bend radius of the distal portion.

63. A sleeve device according to any one of claims 45 to 62, wherein the at least one magnet is cylindrical in shape.

64. A sleeve device according to any one of claims 45 to 63, wherein the at least one magnet is magnetised along a longitudinal axis of the at least one magnet.

65. 65. The sleeve device of any one of claims 45-64, wherein the poles of the at least one magnet are oriented transverse to the longitudinal axis of the dilator when the dilator is in a neutral configuration.

66. 66. A system for facilitating the advancement of a catheter device through a body wall, comprising a sleeve device according to any one of claims 45-65 and said guidewire.

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