Device for progressive transcatheter valve repair or implantation

Abstract

Devices for performing valve replacement or repair, including systems. The device may include an outer catheter, one or more interchangeable inner catheters, a guidewire, and an expandable chordae deflector. The outer conduit and the inner conduit may be configured to engage to prevent clearance. The inner catheter may include a chordae deflector. The outer catheter may be configured as a fast pacing sheath, which may be used with any of these devices.

Description

Priority Claim

[0001] This patent application claims priority to U.S. Patent Application No. 18 / 151,414, filed on January 6, 2023, entitled "METHOD AND APPARATUS FOR ANTEGRADE TRANSCATHETER VALVE REPAIR OR IMPLANTATION" and U.S. Patent Application No. 18 / 448,888, filed on August 11, 2023, entitled "METHOD AND APPARATUS FOR ANTEGRADE TRANSCATHETER VALVE REPAIR OR IMPLANTATION", each of the above patent applications is incorporated herein by reference in its entirety. Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Field

[0003] The methods and devices described herein may relate to transcatheter aortic valve implantation procedures. More specifically, the methods and devices described herein may relate to devices that may enable a surgeon to implant an aortic valve into a patient's heart using an antegrade transaortic approach. Background

[0004] Cardiac valve surgery may include various surgical methods for repairing or replacing diseased heart valves. Some cardiac valve surgeries may be open-chest surgeries performed under general anesthesia. An incision is made through the patient's sternum (sternotomy), and the patient's heart stops beating while the blood flow is rerouted through a cardiopulmonary bypass machine. This valve replacement surgery is a highly invasive procedure and is accompanied by significant risks and complications.

[0005] Transcatheter aortic valve replacement (TAVR) is an alternative to open-chest aortic valve replacement surgery. The aortic valve is located between the left ventricle and the aorta. If the aortic valve does not function properly, the blood flow from the heart to the body may be impaired. In this procedure, a collapsed replacement aortic valve is delivered to the implantation site through a catheter. The catheter is typically inserted into the patient's artery through an incision away from the heart. Using the catheter, the surgeon guides the replacement valve into position in a retrograde approach. After confirming the position of the replacement valve, the surgeon implants the valve using the catheter.

[0006] Retrograde TAVR procedures (e.g., advancing a catheter in a direction opposite or relative to blood flow) are typically used because the path of the catheter to the aortic valve is much simpler. However, a retrograde approach can lead to negative outcomes such as significant bleeding at the arterial access site or stroke due to embolization debris from the aorta, especially when the patient's aortic valve has stenosis and / or may include calcification or other deposits. An antegrade TAVR procedure via a transseptal approach (e.g., advancing a catheter in the direction of blood flow) can reduce bleeding by using a venous access and reduce stroke by eliminating trauma to the aortic arch, thereby overcoming some of the drawbacks associated with retrograde TAVR procedures. Unfortunately, antegrade TAVR procedures have been more difficult to perform in the past. Difficulties include the need for transseptal crossing, potential damage to the mitral valve, and issues related to delivering a large-sized implant device through the left atrium to the left ventricle and aortic valve. These challenges have led to antegrade TAVR procedures being largely replaced by other methods.

[0007] Accordingly, there has long been a need for a method and device for performing successful antegrade TAVR procedures. Disclosure Overview

[0008] Devices, systems, and methods for performing antegrade aortic valve replacement are described herein. Exemplary devices (which may include systems, system devices, and / or software) may include an outer catheter, an inner catheter (or a plurality of interchangeable inner catheters), and a guidewire. Any inner catheter may be detachably coupled to the outer catheter. The inner catheter and the outer catheter may be disposed around the guidewire such that the inner catheter and the outer catheter may be advanced in a monorail manner within a patient.

[0009] Any of the devices and methods described herein may be configured to safely cross the mitral valve without engaging the chordal spaces. For example, any of these methods and devices may include an expandable deflector (e.g., an expandable balloon, cage, mesh, plurality of struts, etc.) that may be expanded to cross the mitral valve orifice without engaging the chordae tendineae within the left ventricle. In any of these methods and devices, the deflector may deflect the device away from the chordae tendineae.

[0010] Any of the devices and methods described herein may include a rapid pacing sheath configured to apply cardiac pacing stimulation during a procedure to allow pacing for bradycardia and / or rapid pacing to allow safe aortic valve deployment. Accordingly, these devices may be configured to apply rapid pacing or escape pacing.

[0011] Typically, these devices (e.g., systems) are configured to navigate in the venous vasculature cardiac anatomy for antegrade delivery of a heart valve (e.g., aortic valve, mitral valve, etc.). By utilizing venous delivery, these devices are configured to prevent scratching of the aorta and arterial vasculature that can cause complications when repairing a heart valve from a retrograde direction, as this can release substances (including clots and / or atherosclerotic material), which can lead to complications. Thus, these devices can generally include an outer catheter having a distal region that sealingly and releasably mates with a slightly proximal region of the inner catheter(s) to prevent any gap from being created between the two upon engagement. The outer catheter and / or inner catheter can also be configured to bend or turn from a region near the distal end. The inner catheter(s) can include a steerable, pre-curved, and / or bendable (deflectable) region positioned between a tapered distal region and a more proximal sealing region that joins the inner catheter to the distal end of the outer catheter. The steerable, pre-curved, and / or bendable region can be configured to provide a very sharp bend (e.g., a deflection between about 30 degrees and about 180 degrees (e.g., between about 40 - 180 degrees, between about 60 - 180 degrees, between about 80 - 180 degrees, between about 90 - 180 degrees, between about 100 - 180 degrees, between about 110 - 180 degrees, between about 120 - 180 degrees, greater than 120 degrees, etc.)). Additionally, the outer catheter can be particularly flexible and thin-walled to allow it to follow a curve or bend formed by the inner catheter and to follow a guidewire.

[0012] For example, a system for antegrade delivery of a replacement valve (e.g., aortic valve) can include an outer catheter and an inner catheter, the inner catheter including: a tapered distal region, an engagement surface near the distal end of the inner catheter, and a bend region between the engagement surface and the distal end, wherein the engagement surface is configured to detachably couple to the distal region of the outer catheter such that the outer surface of the first inner catheter is flush with the outer surface of the outer catheter without a gap, and the bend region is configured to present a bend greater than 120 degrees.

[0013] For example, a system for antegrade delivery of a replacement mitral valve can include an outer catheter and an inner catheter, the inner catheter including: a tapered distal region, an engagement surface near the distal end of the inner catheter, and a bend region between the engagement surface and the distal end, wherein the engagement surface is configured to detachably couple to the distal region of the outer catheter such that the outer surface of the first inner catheter is flush with the outer surface of the outer catheter without a gap, and the bend region is configured to present a bend greater than between about 60 degrees and 120 degrees.

[0014] Any of these devices and methods can be configured for valve repair, not limited to valve replacement. For example, any of these methods can be used to insert repair tools, implants, etc. Generally, the same devices described herein for valve replacement and the procedures for using them can be used for access and repair.

[0015] The distal region can taper from a large proximal opening to a narrow distal opening (e.g., can taper from about 3Fr or less to about 14Fr or more (e.g., 20Fr or more, etc.)).

[0016] As mentioned, the outer catheter can include a thin-walled flexible outer layer of 14Fr or greater, which is configured to follow the inner catheter when the inner catheter is in a bent configuration. The outer catheter can include a pre-bent distal region. In some examples, the outer catheter can be bendable.

[0017] The inner catheter can be steerable (e.g., controllably bent / deflected). For example, in some examples, the inner catheter includes a tendon or wire (e.g., pull wire) configured to bend a bent region. The wire can be attached to the distal end of the bent distal region. The distal region can include a flexure (e.g., incision, crease, etc.) to provide a predictable bending region. In any of these examples, the bent region can include a bending-setting material, such as a shape memory material configured to assume a bent shape (e.g., nitinol). The bent region can be manually bent (shape-set) prior to use to assume a bend once deployed from the outer catheter and into the vasculature. This bendable inner catheter can impart a primary bend to the distal section of the flexible outer catheter to allow the relatively large outer catheter to track through the mitral valve, and / or around the left ventricle to the left ventricular outflow tract.

[0018] Any device described herein can include a second inner catheter, which includes: a tapered distal region, a mating surface near the distal end of the inner catheter, and a bent region between the mating surface and the distal end, wherein the mating surface is configured to detachably couple to the distal region of the outer catheter such that the outer surface of the first inner catheter is flush with the outer surface of the outer catheter without a gap, and the bent region is configured to assume a bend greater than 30 degrees. Thus, the second (or subsequent) inner catheter can be similar to the first inner catheter, but can have a different bend angle or range of bend angles.

[0019] In any system described herein, the inner catheter can have a bent region between about 3 - 10 mm from the distal tip of the inner catheter. As described above, this bent region can be between the tapered distal tip region and the proximal region that mates with the outer catheter.

[0020] Typically, the (one or more) inner catheters may include a rapid exchange monorail connection for a guidewire. This may allow for rapid replacement of the inner catheter within the outer catheter. In some examples, the outer catheter does not include a rapid exchange monorail and may instead be enclosed along its entire length. Any of these systems may include one or more guidewires, such as a first guidewire and a second guidewire, where the first guidewire is stiffer than the second guidewire. It may also include a guidewire having side holes to allow for injection of contrast agent in the proximal aorta, thereby allowing for more precise valve positioning. Typically, these devices may include one or more hemostatic valves coupled to or configured to be coupled to the outer catheter.

[0021] The inner catheter may have a decreasing stiffness along the distal region. Typically, the distal end may be significantly more flexible than the proximal end.

[0022] In any of these devices, the inner catheter may include an inflatable balloon disposed near the distal region of the inner catheter. For example, the inflatable balloon may be configured to open and / or widen an opening through the atrial septum or other anatomical region.

[0023] The inner catheter may include a cut hypotube configured to have a decreasing stiffness in the distal direction. In any of these devices, the inner catheter may include a first section and a second section, and where the first section includes a braid configured to provide kink resistance and torsional resistance, and the second section includes a helical coil configured to provide a lower stiffness than the braid. The first section may be configured to have an outer diameter of approximately 25 French units (Fr) (e.g., between 14Fr and 35Fr, between 20Fr and 30Fr, between 22Fr and 28Fr, between 22Fr and 30Fr, etc.), and the second section may be configured to have an outer diameter of approximately 23Fr (e.g., between 1 - 5Fr smaller than the first section, etc.). For example, the first section may be configured to have an inner diameter of approximately 24Fr. And the second section is configured to have an inner diameter of approximately 22Fr. Since TAVR valve technology provides a smaller delivery diameter, smaller sheaths may be used. The outer catheter may include a coupler configured to engage a locking ring disposed on the first inner catheter.

[0024] The present invention also describes methods for percutaneous antegrade delivery and insertion (implantation) of valves such as aortic valves. These methods can use any of the systems described herein. For example, a method for percutaneous antegrade delivery and implantation of a valve in a patient can include: advancing a distally tapered first inner catheter through a transseptal puncture, wherein a region of the first inner catheter near the distal end of the first inner catheter is annularly engaged to an outer catheter at the distal region of the outer catheter such that the outer surface of the first inner catheter is flush with the outer surface of the outer catheter without a gap; deflecting the first inner catheter within the left atrium such that the distal region of the first inner catheter presents a first bend; advancing the outer catheter and the first inner catheter or a second inner catheter that has replaced the first inner catheter such that the first inner catheter or the second inner catheter is located within the left ventricle; advancing a guidewire out of the distal end of the first inner catheter or the second inner catheter and across a valve of the patient's heart; removing the first inner catheter or the second inner catheter, leaving the guidewire in place, and implanting a replacement valve into the patient's heart through the outer catheter.

[0025] In any of these methods, after advancing the guidewire out of the distal end of the first inner catheter or the second inner catheter, the first inner catheter or the second inner catheter within the left ventricle can be deflected such that the distal region of the first inner catheter or the second inner catheter presents a second bend and faces the left ventricular outflow tract of the patient. Implanting the replacement valve can include implanting an aortic valve. For example, implanting the replacement valve can include implanting a mitral valve.

[0026] For example, a method for percutaneous antegrade delivery and implantation of a valve in a patient can include: advancing a distally tapered first inner catheter through a transseptal puncture, wherein a region of the first inner catheter near the distal end of the first inner catheter is annularly engaged to an outer catheter at the distal region of the outer catheter such that the outer surface of the first inner catheter is flush with the outer surface of the outer catheter without a gap; deflecting the first inner catheter within the left atrium such that the distal region of the inner catheter presents a first bend; advancing the outer catheter and the first inner catheter or a second inner catheter that has replaced the first inner catheter such that the first inner catheter or the second inner catheter is located within the left ventricle; deflecting the first inner catheter or the second inner catheter within the left ventricle such that the distal region of the first inner catheter or the second inner catheter presents a second bend toward the left ventricular outflow tract; advancing a guidewire out of the distal end of the first inner catheter or the second inner catheter and across the aortic valve of the patient's heart; removing the first inner catheter or the second inner catheter, leaving the guidewire in place, and implanting a replacement aortic valve into the patient's heart through the outer catheter.

[0027] Any of these methods may include advancing an outer catheter and a first or second inner catheter such that the first or second inner catheter passes through the aortic valve of the patient's heart and at least partially enters the ascending aorta over a guidewire. Implanting a replacement aortic valve in the patient's heart may include implanting the replacement valve through the outer catheter and over the guidewire. If the aortic valve is delivered with the outer catheter straddling the aortic valve, the outer catheter will be retracted in the proximal direction to "unsheath" the valve prior to valve deployment.

[0028] Any of these methods may include advancing a second guidewire into the left ventricle after the first inner catheter has assumed a first bend. Implanting a replacement aortic valve may include advancing a transcatheter aortic valve replacement (TAVR) delivery system through the outer catheter.

[0029] In some examples, the method may include using an expandable member on the outer surface of the first inner catheter to expand the transseptal puncture site. For example, the expandable member may include a balloon.

[0030] (e.g., of the inner catheter) The first bend may be at least about 30 degrees (e.g., between about 30 - 100 degrees, between about 30 - 90 degrees, between about 30 - 80 degrees, between about 30 - 70 degrees, between about 30 - 60 degrees, between about 3 - 45 degrees, etc.). The second bend may be at least about 120 degrees (e.g., between about 120 - 190 degrees, between about 120 - 180 degrees, between about 120 - 170 degrees, between about 120 - 160 degrees, between about 120 - 150 degrees, between about 120 - 140 degrees, etc.). Deflecting the first inner catheter may include actuating a pull wire within the first inner catheter to deflect the bent region of the inner catheter. In some examples, deflecting the first inner catheter may include allowing the first inner catheter to assume a bent configuration (e.g., extending the inner catheter from the outer catheter, removing a stiffening member, etc.).

[0031] As described above, the first inner catheter may taper distally from 3Fr or less to 14Fr or greater. This tapering in combination with the junction region between the inner catheter and the outer catheter may prevent or reduce tissue damage, thereby preventing the fish - mouth phenomenon (e.g., at the distal connection between the two catheters, there is no separation between the inner catheter and the outer catheter even when navigating through a curved region).

[0032] Any of these methods may include manually setting the first bend and / or the second bend before advancing the distal first inner catheter through the transseptal puncture site.

[0033] The methods described herein may include advancing a distally - tapering initial inner catheter through the transseptal puncture site before advancing the first inner catheter, wherein the initial inner catheter is annularly joined to the outer catheter at the distal region of the outer catheter such that the outer catheter passes through the transseptal puncture site and into the left atrium.

[0034] In any of the methods described herein, the method may use a single inner catheter and a single outer catheter. In some examples (as described above), a single outer catheter may be used with two or more inner catheters. For example, methods are described herein for percutaneous antegrade delivery and implantation of an aortic valve in a patient, including: advancing a distally tapered inner catheter through a transseptal puncture site, wherein a region of the inner catheter near the distal end of the inner catheter annularly engages the outer catheter at the distal region of the outer catheter such that the outer surface of the inner catheter is flush with the outer surface of the outer catheter without a gap; deflecting the inner catheter within the left atrium such that the distal region of the inner catheter presents a first bend; advancing the outer catheter and the inner catheter such that the inner catheter is within the left ventricle; deflecting the inner catheter within the left ventricle such that the distal region of the inner catheter presents a second bend, and the distal region is bent in a manner that guides the catheter system into the left ventricular outflow tract; advancing a guidewire out of the distal end of the inner catheter and across the aortic valve of the patient's heart; removing the first inner catheter or the second inner catheter, leaving the guidewire in place, and implanting a replacement aortic valve into the patient's heart through the outer catheter.

[0035] Any of these methods may include advancing the outer catheter and the inner catheter such that the inner catheter passes through the aortic valve of the patient's heart and at least partially enters the ascending aorta over the guidewire.

[0036] Typically, implanting a replacement aortic valve into a patient's heart may include implanting the replacement valve through the outer catheter and over the guidewire.

[0037] Any of these methods may include advancing a second guidewire into the left ventricle after the inner catheter has presented the first bend.

[0038] For example, implanting a replacement aortic valve includes advancing a transcatheter aortic valve replacement (TAVR) delivery system through the outer catheter.

[0039] As mentioned, the methods described herein may include dilating the transseptal puncture site using an expandable member on the outer surface of the inner catheter. The first bend may be at least about 30 degrees (e.g., between about 30 - 100 degrees, between about 30 - 90 degrees, between about 30 - 80 degrees, between about 30 - 70 degrees, between about 30 - 60 degrees, between about 3 - 45 degrees, etc.). The second bend may be at least about 120 degrees (e.g., between about 120 - 190 degrees, between about 120 - 180 degrees, between about 120 - 170 degrees, between about 120 - 160 degrees, between about 120 - 150 degrees, between about 120 - 140 degrees, etc.).

[0040] As described above, deflecting the inner catheter can include actuating a pull wire within the inner catheter. In some examples, deflecting the inner catheter includes allowing the inner catheter to assume a curved configuration. The inner catheter can taper distally from 3Fr or less to 14Fr or greater. Any of these methods can include manually setting a first bend and / or a second bend before advancing the distal inner catheter through the transseptal puncture site.

[0041] The methods described herein can include advancing a tapered initial inner catheter through the transseptal puncture site before advancing the inner catheter, wherein the initial inner catheter is circumferentially engaged to the outer catheter at the distal region of the outer catheter such that the outer catheter passes through the transseptal puncture site and into the left atrium.

[0042] As mentioned in some examples, these methods can include using a single outer catheter and two (or more) inner catheters that can be exchanged at different points during the procedure (including by rapid exchange). For example, a method for percutaneous antegrade delivery and implantation of an aortic valve in a patient can include: advancing a tapered first inner catheter through the transseptal puncture site, wherein a region of the first inner catheter near the distal end of the first inner catheter is circumferentially engaged to the outer catheter at the distal region of the outer catheter such that the outer surface of the first inner catheter is flush with the outer surface of the outer catheter without a gap; deflecting the first inner catheter within the left atrium such that the distal region of the first inner catheter assumes a first bend; advancing the outer catheter and the first inner catheter such that the first inner catheter is within the left ventricle; withdrawing the first inner catheter proximally from the outer catheter and inserting a second inner catheter through the outer catheter and into the left ventricle such that a region of the second inner catheter near the distal end of the second inner catheter is circumferentially engaged to the outer catheter at the distal region of the outer catheter; deflecting the second inner catheter such that the distal region of the second inner catheter assumes a second bend greater than the first bend and the distal end of the second inner catheter is curved in a manner that allows the catheter system to enter the left ventricular outflow tract; pushing a guide wire out of the distal end of the second inner catheter and across the aortic valve of the patient's heart; removing the first inner catheter or the second inner catheter, leaving the guide wire in place, and implanting a replacement aortic valve into the patient's heart through the outer catheter.

[0043] The methods described herein can include advancing a second outer catheter and inner catheter such that the second inner catheter passes through the aortic valve of the patient's heart and at least partially into the ascending aorta before advancing the guide wire. Implanting a replacement aortic valve into the patient's heart can include implanting the replacement valve through the outer catheter and over the guide wire.

[0044] Any of these methods may include advancing a guide wire into the left ventricle after the first inner catheter has assumed a first bend. In some examples, implanting a replacement aortic valve includes advancing a transcatheter aortic valve replacement (TAVR) delivery system through the outer catheter. Any of these methods may include using an expandable member on the outer surface of the first inner catheter to dilate the transseptal puncture site. As described above, the expandable member may include a balloon. Additionally, as described above, the first bend may be at least about 30 degrees, and the second bend may be at least about 120 degrees. Deflecting the first inner catheter may include actuating a pull wire within the first inner catheter. In some examples, deflecting the first inner catheter includes allowing the first inner catheter to assume a curved configuration. As described above, the first inner catheter may taper distally from 3Fr or less to 14Fr or more. Any of these methods may include manually setting the first bend and / or the second bend before advancing the distal first inner catheter through the transseptal puncture site.

[0045] In some examples, the method includes advancing a distally tapered initial inner catheter through the transseptal puncture site before advancing the first inner catheter, wherein the initial inner catheter annularly engages the outer catheter at the distal region of the outer catheter such that the outer catheter passes through the transseptal puncture site and into the left atrium.

[0046] As described herein, any catheter may have varying stiffness. For example, the stiffness of the outer catheter and any inner catheter may decrease as the catheter extends away from the surgeon or other user. In some examples, any of the catheters may include a braided lining, a helical lining, or a combination thereof to vary and / or control the stiffness of the catheter.

[0047] Any interchangeable inner catheter may include distal tips of different shapes, which may be used to position and / or guide a guide wire within the patient. Alternatively or additionally, any interchangeable inner catheter may include a distally located dilation balloon.

[0048] In any of the methods described herein, the inner catheter and the outer catheter may be introduced percutaneously into the patient. The device may puncture and pass through the atrial septum. The catheter may be advanced from the left atrium into the left ventricle and anterogradely toward the aortic valve. From this position, a replacement aortic valve may be implanted.

[0049] Any of the methods described herein may effect percutaneous anterograde delivery and implantation of an aortic valve. Any method may include piercing the atrial septum of the patient's heart using a guide wire, advancing a catheter through the atrial septum into the left atrium of the patient's heart, and advancing the catheter from the left atrium into the left ventricle. Additionally, any of the methods described herein may include advancing the guide wire and the catheter through the aortic valve of the patient's heart, positioning the catheter across the aortic valve annulus, and implanting a replacement aortic valve within the patient's heart.

[0050] In any of the methods described herein, the puncture can include using a radiofrequency device disposed at the distal end of a guidewire. Any of the methods described herein can also include entering the femoral artery with a catheter and a guidewire prior to puncturing the atrial septum.

[0051] In any method, the catheter can include a first inner catheter and an outer catheter, wherein the first inner catheter is concentrically and removably coupled to the outer catheter. Additionally, the guidewire can be concentric with the first inner catheter and the outer catheter and be surrounded by the first inner catheter and the outer catheter.

[0052] In any of the methods described herein, advancing the catheter from the left atrium to the left ventricle can include advancing the guidewire through the mitral valve of the patient's heart. In some examples, advancing the catheter from the left atrium to the left ventricle can include replacing the first inner catheter with a second inner catheter having a curved distal tip, advancing the guidewire through the second inner catheter having a curved distal tip, through the mitral valve and into the left ventricle, and withdrawing the second inner catheter from the outer catheter. In some aspects, the curved distal tip can have a curve of at least 30 degrees.

[0053] In any of the methods described herein, advancing the guidewire through the aortic valve can include using a third inner catheter having an acute-curved distal tip with a curve of at least 120 degrees. Additionally, positioning the catheter across the aortic valve annulus can also include withdrawing the third inner catheter.

[0054] In any of the methods described herein, advancing the guidewire through the aortic valve can include advancing the guidewire in an antegrade direction into the aorta of the patient's heart. In any method, positioning the catheter across the aortic valve annulus can include positioning the distal tip of the outer catheter below the aortic valve annulus.

[0055] In any of the methods described herein, advancing the catheter across the atrial septum can also include advancing a dilation balloon into the atrial septum. In any of the methods described herein, advancing the catheter across the atrial septum can also include advancing a dilation balloon into the atrial septum. Additionally, any method can include inflating the dilation balloon to dilate the puncture of the atrial septum; deflating the dilation balloon; and withdrawing the dilation balloon. In any of the methods described herein, the dilation balloon can be coupled to the catheter.

[0056] In any of the devices described herein, the outer catheter can include a coupler configured to engage a locking ring disposed on a first interchangeable inner catheter. Any of the devices can also include a second interchangeable inner catheter configured to bend at least 30 degrees. Any of the devices described herein can also include a third interchangeable catheter configured to bend at least 120 degrees. In any of the devices described herein, the first interchangeable inner catheter and the outer catheter can include radiopaque markers.

[0057] The methods and devices described herein may also or alternatively include a filter for capturing material during valve positioning and deployment. The filter may be an expandable filter that may be attached or secured to a wire, such as a guidewire. Accordingly, any guidewire described herein may include a filter ("filter wire"). The filter may be held collapsed by a proximally retractable sheath. The filter may be deployed from a wire, such as a guidewire, that extends distally antegrade beyond the valve being replaced or repaired. For example, in some variations, the method may include advancing a guidewire from the distal end of a first inner catheter or a second inner catheter and across the aortic valve of a patient's heart, and the guidewire may include a filter. Accordingly, any of these methods may include deploying a filter attached to the guidewire distal to the aortic valve.

[0058] Also described herein are guidewires configured to deliver contrast agent material from one or more side ports. These guidewires may be used in place of any of the guidewires described herein (including those used in conjunction with a filter as described above). The guidewire may include an array of side-facing ports or openings that enter a central lumen through which the contrast agent may be injected. These guidewires may be referred to herein as contrast agent deployment guidewires. The contrast agent deployment guidewire may have a solid distal tip / distal region and may be hollow along the length of the contrast agent deployment guidewire proximal to the distal tip region. The distal tip region of the contrast agent deployment guidewire may extend any suitable length (e.g., about 0.5 cm or less, about 1 cm or less, about 2 cm or less, about 3 cm or less, about 4 cm or less, about 5 cm or less, between about 0.5 - 10 cm, between about 1 - 8 cm, between about 0.5 - 7 cm, between about 0.5 - 6 cm, between about 0.5 - 5 cm, etc.). Any number of side opening ports or holes may be used and may be arranged along the length of the contrast agent deployment guidewire. In some examples, the ports or holes may be arranged on the same side of the contrast agent deployment guidewire; in some examples, the ports or holes may be distributed around the width of the contrast agent deployment guidewire. For example, any of the methods described herein may include delivering contrast agent material out of one or more side-facing ports of the guidewire.

[0059] As described above, any method and apparatus described herein may include a deflector for deflecting the chordae tendineae of the ventricle during a procedure. For example, methods for percutaneous antegrade delivery and implantation of a valve in a patient are described herein, which include: advancing a distally tapered first inner catheter through a transseptal puncture site into the left atrium, wherein a distal region of the first inner catheter is flush with an outer catheter at a distal region of the outer catheter; expanding an expandable deflector to allow safe passage through the mitral valve without engaging the chordae tendineae of the left ventricle; advancing the outer catheter and the first inner catheter or a second inner catheter that has replaced the first inner catheter such that the first inner catheter or the second inner catheter is in the left ventricle while deviating from the chordae tendineae; pushing a guidewire out of the distal end of the first inner catheter or the second inner catheter and across a valve of the patient's heart; removing the first inner catheter or the second inner catheter, leaving the guidewire in place, and implanting a replacement valve into the patient's heart through the outer catheter.

[0060] For example, a method for percutaneous antegrade delivery and implantation of a patient valve may include: advancing a distally tapered first inner catheter through a transseptal puncture site, wherein a region of the first inner catheter near the distal end of the first inner catheter engages the outer catheter annularly at the distal region of the outer catheter such that the outer surface of the first inner catheter is flush without a gap with the outer surface of the outer catheter; deflecting the first inner catheter within the left atrium such that the distal region of the inner catheter presents a first bend; expanding an expandable deflector to deflect away from the chordae tendineae of the left ventricle; advancing the outer catheter and the first inner catheter or a second inner catheter that has replaced the first inner catheter such that the first or second inner catheter deviates from the chordae tendineae simultaneously within the left ventricle; deflecting the first or second inner catheter within the left ventricle such that the distal region of the first or second inner catheter presents a second bend and faces the left ventricular outflow tract of the patient; pushing a guidewire out of the distal end of the first inner catheter or the second inner catheter and across the aortic valve of the patient's heart; removing the first inner catheter or the second inner catheter, leaving the guidewire in place, and implanting a replacement aortic valve into the patient's heart through the outer catheter.

[0061] Any of these methods may include deflecting the first inner catheter within the left atrium such that the distal region of the first inner catheter presents a first bend.

[0062] Expanding the expandable deflector may include expanding the expandable deflector on a guidewire extending through the first inner catheter or a second inner catheter that has replaced the first inner catheter. In some examples, expanding the expandable deflector includes expanding the expandable deflector on the first inner catheter or a second inner catheter that has replaced the first inner catheter. Expanding the expandable deflector may include expanding the expandable deflector on a second inner catheter that has replaced the first inner catheter.

[0063] Any of these methods can include, after advancing a guidewire distally from a distal end of a first inner catheter or a second inner catheter: deflecting the first inner catheter or the second inner catheter within the left ventricle such that a distal region of the first inner catheter or the second inner catheter assumes a second curvature and faces the left ventricular outflow tract of the patient. For example, the method can include deflecting chordae tendineae exiting the left ventricle with an expandable deflector when the distal region of the first or second inner catheter assumes the second curvature. In any of these methods, advancing the outer catheter and the first inner catheter or the second inner catheter can include advancing with the expandable deflector expanded.

[0064] The expandable deflector can be any suitable deflector, including an inflatable deflector (e.g., a balloon), a mechanical deflector (e.g., struts, cages, meshes, etc.), and the like. For example, expanding the expandable deflector includes inflating a balloon. These methods and devices can include one or more expandable deflectors. For example, the expandable deflector can be on the inner catheter, the outer catheter, and / or the guidewire (or more generally, a guiding member). As used herein, a guidewire can include a wire, a thin guiding tube, or a catheter, etc. In some cases, the deflector can be particularly adapted to deflect chordae tendineae; for example, the deflector can have an outer diameter of 10 mm or greater (e.g., 11 mm or greater, 12 mm or greater, 13 mm or greater, 14 mm or greater, 15 mm or greater, etc.) and a length of 10 mm or greater (e.g., 11 mm or greater, 12 mm or greater, 13 mm or greater, 14 mm or greater, 15 mm or greater, etc.). The outer profile of the deflector can be circular in the deployed configuration. The outer profile of the deflector can be symmetric (the distal and proximal ends can be symmetric, e.g., symmetric in a radial plane bisecting the deflector). In some examples, the deflector includes expandable struts, cages, or meshes. The deflector can be positioned proximally of the distal end of the inner catheter by about 2 mm or greater (e.g., 2.5 mm or greater, 3 mm or greater, 4 mm or greater, etc.), or between 2 - 10 mm (e.g., between 2 - 8 mm, between 2 - 6 mm, etc.). These configurations can prevent the deflector from becoming entangled in or captured by chordae tendineae when advancing within the ventricle.

[0065] The expandable deflector can be fully or partially expanded and / or can be expanded to a diameter suitable for the anatomy (e.g., the ventricle), such as between about 1 cm and 5 cm. The mechanical deflector can have a circular and / or smooth outer profile, which can help avoid pinching between chordae tendineae and / or trauma to the interior of the ventricle. For example, the expandable deflector can include an outer surface that can be configured as a cap or a sleeve. In some cases, the expandable deflector can include mechanical ribs or struts that can be covered by an elastic or elastomeric layer.

[0066] The expandable deflector can be expanded in a ventricle (e.g., in the left ventricle), including (but not limited to) expanding the expandable deflector at the mitral valve orifice, e.g., before or after insertion through the mitral valve orifice / mitral valve.

[0067] As described above, any of these methods can include applying electrical pacing to the patient's heart during the procedures described herein. In any of these methods and devices, the outer catheter can be configured as a sheath including a plurality of electrodes (e.g., a pacing sheath). For example, any of these methods can include applying a pacing signal from an electrode on the outer catheter (sheath) that inserts the inner catheter to the patient's heart.

[0068] In any of these methods and devices, implanting a replacement aortic valve can include advancing a transcatheter aortic valve replacement (TAVR) delivery system through the outer catheter.

[0069] Also described herein is a system for antegrade delivery of a replacement valve, which can be used in any of the methods described herein. For example, any of these devices and methods can include an outer catheter configured as a sheath for receiving an inner catheter, the outer catheter (sheath) including: an elongate body having a lumen configured to receive the inner catheter, wherein the elongate body is configured to extend from outside the body to the apex of the left ventricle of the heart; a hub at the proximal end of the elongate body, the hub including a hemostatic valve; a plurality of electrodes at the distal region of the elongate body; a plurality of electrical connectors extending proximally from the elongate body; and a plurality of conductor cables (which can form a bundle) extending from the plurality of electrical connectors to the plurality of electrodes such that each electrical connector is electrically connected to a corresponding electrode of the plurality of electrodes.

[0070] Thus, any of these methods and devices can include an outer catheter configured as a sheath, e.g., a pacing or sheath ("rapid pacing sheath") adapted to quickly and easily apply a pacing signal. Also described herein are methods including any of these outer catheters (pacing sheaths) and a pacing controller configured to be electrically coupled to the sheath, the pacing controller including one or more processors and a non-transitory computer-readable medium having instructions stored thereon, the instructions executable by the one or more processors to cause the pacing controller to apply cardiac pacing stimuli from the plurality of electrodes.

[0071] Any one of these devices (e.g., systems) may also include an inner catheter, where the inner catheter includes: a tapered distal region, a mating surface near the distal end of the inner catheter, where the mating surface is configured to be sealingly coupled to the distal region of an outer catheter (sheath) such that the outer surface of the first inner catheter is flush with the outer surface of the sheath without a gap. The inner catheter can be any inner catheter described herein. For example, as described above, the inner catheter may include a curved region between the mating surface and the distal end, and the curved region is configured to present a bend greater than 120 degrees.

[0072] The outer catheter (sheath) may include a side port at the proximal end of the elongated body, where the side port is in fluid communication with the lumen. The side port can be used to apply fluid (e.g., saline, etc.) or withdraw fluid (e.g., blood).

[0073] The plurality of electrodes can be any suitable electrodes. In some examples, the electrodes are annular electrodes circumferentially arranged around the distal region. In some examples, the electrodes can be arranged in series along the distal region. For example, the electrodes can be arranged adjacent to each other along the longitudinal length of the elongated body of the sheath. For example, the electrodes among the plurality of electrodes can be spaced apart between about 1 cm and 9 cm (e.g., between about 2 cm and 7 cm, between about 4 cm and 6 cm, etc.).

[0074] The conductor cable can form a bundle that spirally extends from a plurality of electrical connectors around the elongated body to the plurality of electrodes. This arrangement can particularly advantageously provide a thin profile for the device while allowing flexibility of the elongated body.

[0075] The outer catheter configured as the pacing sheath described herein may also include a yoke coupled to the plurality of electrical connectors.

[0076] For example, a system for antegrade delivery of a replacement valve may include: an outer catheter configured as a pacing sheath; an inner catheter including: a tapered distal region, a mating surface proximate the distal end of the inner catheter, wherein the mating surface is configured to sealingly couple to the distal region of the outer catheter such that the outer surface of the first inner catheter is flush with the outer surface of the outer catheter without a gap; wherein the outer catheter is configured to receive the inner catheter, the outer catheter including: an elongate body having a lumen configured to receive the inner catheter, wherein the elongate body is configured to extend from outside the body to the apex of the left ventricle of the heart; a hub at the proximal end of the elongate body, the hub including a hemostatic valve; a plurality of electrodes disposed along the distal region of the elongate body, wherein the plurality of electrodes are spaced apart from the distal region by an isolation distance; a plurality of electrical connectors extending proximally from the elongate body; and a plurality of conductor cables, the plurality of conductor cables forming a bundle that spirally extends from the plurality of electrical connectors around the elongate body to the plurality of electrodes such that each electrical connector is electrically connected to a corresponding one of the plurality of electrodes; and a pacing controller configured to be electrically coupled to the plurality of electrical conductors of the outer catheter, the pacing controller including one or more processors and a non-transitory computer-readable medium having instructions stored thereon, the instructions executable by the one or more processors to cause the pacing controller to apply cardiac pacing stimuli from the plurality of electrodes.

[0077] Also described herein are methods including pacing, including methods using any of the pacing sheaths described herein. For example, a method for percutaneous antegrade delivery and implantation of a valve in a patient may include: advancing a distally tapered first inner catheter through a transseptal puncture site into the left atrium, wherein the distal region of the first inner catheter is flush with the outer catheter at the distal region of the outer catheter, and further wherein the outer catheter is configured as a pacing sheath having a plurality of pacing electrodes; advancing the outer catheter and the first inner catheter or a second inner catheter that has replaced the first inner catheter such that the first inner catheter or the second inner catheter is located in the left ventricle; applying a pacing signal from the outer catheter to the heart to maintain sinus rhythm of the heart; advancing a guidewire out of the distal end of the first inner catheter or the second inner catheter and across the valve of the patient's heart; removing the first inner catheter or the second inner catheter, leaving the guidewire in place, and implanting a replacement valve into the patient's heart through the outer catheter.

[0078] A system for antegrade delivery of a replacement valve as described herein may include: an outer catheter and an inner catheter, the outer catheter configured as a sheath for the catheter, the outer catheter including: an elongate body having a lumen configured to receive the catheter, and a coupling region within the lumen at the distal region of the outer catheter; the inner catheter including: a tapered distal region; an engagement surface proximate the tapered distal end of the inner catheter, wherein the engagement surface is configured to removably couple to the coupling region of the outer catheter such that the outer surface of the inner catheter is flush with the outer surface of the outer catheter without a gap; a deflector on the outer surface of the inner catheter distal to the tapered distal region, wherein the deflector is configured to radially expand to deflect from the chordae tendineae of the left ventricle; a steering region between the engagement surface and the distal end, the steering region configured to bend; and a guidewire lumen extending through the inner catheter.

[0079] As described herein, the steering region may be a curved region and may be configured to present a bend of greater than 120 degrees. The steering region may include a line configured to bend the steering region. The steering region may include a pre-bent region. The steering region may include a bend-setting material. In any of these examples, the steering region may be steered by a pull wire. For example, the inner catheter may further include a pull wire configured to bend the steering region.

[0080] Generally, the outer catheter may be coupled to the inner catheter at the distal end of the outer catheter and in a region proximal to the distal end of the inner catheter. As described herein, the outer catheter and the inner catheter may be adapted to allow a smooth (gapless) coupling between the two outer surfaces. For example, the distal region of the outer catheter may have a tapered outer surface. The coupling region may include an inner diameter that is at least one French unit (1Fr) smaller than the inner diameter of the lumen in the proximally adjacent region of the lumen. In some examples, the coupling region may include a coupler configured to engage a locking ring on the engagement surface of the inner catheter.

[0081] The tapered distal region of the inner catheter may taper from 3Fr or less to 14Fr or more. The outer catheter may include a thin-walled flexible outer layer of 22Fr or greater, the thin-walled flexible outer layer configured to follow the inner catheter when the inner catheter is in a bent configuration. The distance between the steering region and the distal tip of the inner catheter may be between about 3-6 mm. The inner catheter may have a decreasing stiffness along the distal region.

[0082] Any of these systems may further include one or more guidewires, including a guidewire having a deflector. The guidewire lumen may include a rapid exchange monorail connection.

[0083] Any of these systems may further be configured to include an electrode (e.g., a pacing electrode) on the outer catheter as described herein, and may include a pacing controller (and / or may be configured to operate with a pacing controller).

[0084] All methods and apparatus described herein (in any combination) are contemplated herein and may be used to achieve the benefits described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0085] A better understanding of the features and advantages of the methods and apparatus described herein will be obtained by referring to the following detailed description which sets forth illustrative embodiments and the accompanying drawings, in which: Figure 1A is an exemplary transcatheter aortic valve replacement (TAVR) device.

[0086] Figure 1B yes Figure 1A An enlarged view of the tip region of , showing the expandable region in an expanded state.

[0087] Figure 2A Shown Figure 1A An exemplary distal tip segment of a TAVR device.

[0088] Figure 2B Example measurements associated with the distal tip segment are shown.

[0089] Figures 3A - 3C Shown Figure 1A Example distal tip region of a TAVR device.

[0090] Figures 4A - 4C Shown Figure 1A Example view of the midshaft section of a TAVR device.

[0091] Figure 5 Shown Figure 1A Proximal view of the TAVR device.

[0092] Figures 6A - 6B An exemplary detailed view of the outer catheter of the TAVR device of FIG. 1 is shown. Figure 6A An external view is shown; Figure 6B Shown through Figure 6A cross-section of the device.

[0093] Figure 7 An example detail view of the transition region of the outer catheter is shown.

[0094] Figure 8 An exemplary detail view of the inner catheter is shown.

[0095] Figure 9 An exemplary interior view of the inner catheter is shown.

[0096] Figure 10 An example of a skived hypotube is shown.

[0097] Figures 11A - 11C Shows an example of an inner catheter, particularly below the dilatation balloon.

[0098] Figure 12A Shows an exemplary inner catheter.

[0099] Figure 12B Shows a cross-section of the inner catheter.

[0100] Figure 13A Shows an exemplary distal end of any feasible inner catheter.

[0101] Figure 13B Shows another exemplary distal end.

[0102] Figures 14A - 14C Shows an example of the shape of the distal end of any feasible inner catheter.

[0103] Figure 15A Shows an exemplary distal end of the outer catheter.

[0104] Figure 15B Shows an exemplary distal end of the shaped outer catheter.

[0105] Figure 16 Shows a possible cross-section of the outer catheter.

[0106] Figures 17A - 17D Shows an exemplary outer catheter shape.

[0107] Figures 18A - 18L Shows the use of Figure 1A Exemplary steps of introducing a replacement aortic valve into a patient using the TAVR device 00.

[0108] Figure 19 Is a flowchart showing an exemplary method of transseptal implantation for replacing an aortic heart valve.

[0109] Figure 20A And Figure 20B Shows an example of the system as described herein.

[0110] Figure 21 Shows the use of, such as Figures 20A - 20B An example of a method of the system described therein.

[0111] Figure 22A [[ID=6۴]]Shows an example of a method of using a system including a filter (e.g., a filter wire or on-wire filter), which can be used with any of the methods and devices described herein.

[0112] Figure 22B Shows an example of a wire (e.g., a guide wire) that includes infusion openings in regions along the length of the wire.

[0113] Figures 23A - 23C An example of a mitral valve centering guidewire including an expandable deflector is shown. The example is a 0.035-inch diameter centering guidewire with a J-shaped tip. Figure 23A A lateral perspective view of the mitral valve centering guidewire is shown. Figure 23B A view through Figure 23A is shown. Figure 23C is Figures 23A - 23B A slightly magnified view of the distal region of the device, where the expandable deflector (e.g., balloon) is in a collapsed configuration.

[0114] Figure 24A is shown Figures 23A - 23C of the mitral valve centering guidewire and also includes a proximal region where the expandable deflector is expanded.

[0115] <{ Figure 24B A cross-sectional view of the proximal hub that can be coupled to Figure 24A the proximal region (for inflation / deflation of the expandable deflector) is shown.

[0116] Figures 25A - 25D An example of a mitral valve centering guidewire including an expandable deflector is shown. The example is a 0.035-inch diameter centering guidewire with a straight tip. Figure 25A A lateral perspective view of the mitral valve centering guidewire is shown. Figure 25B A view through Figure 25A ' is shown. Figure 25C is Figures 25A - 25B A slightly magnified view of the distal region of the device, where the expandable deflector (e.g., balloon) is in a collapsed configuration. Figure 25D The expandable deflector of Figures 25A - 25C in an expanded configuration is shown.

[0117] Figures 26A - 26C An example of an inner catheter including an expandable deflector is shown. Figure 26A A lateral perspective view of the distal region of the inner catheter is shown. Figure 26B A view through Figure 26A is shown. Figure 26C is a cross-section (section C-C') taken transversely through Figure 26B the distal region.

[0118] Figures 27A - 27B An example of a method of deflecting a chordae tendineae using a guidewire having an expandable deflector (similar to that shown in Figures 25A - 25C ) is shown.

[0119] Figures 28A - 28B An example of a method of deflecting a chordae tendineae using an inner catheter having an expandable deflector (similar to that shown in 26A- Figure 26C ) is shown.

[0120] Figure 29 Shows an example of a method of replacing a valve as described herein.

[0121] Figure 30A Shows an example of an outer catheter of a pacing sheath configured as described herein.

[0122] Figure 30B Shows a cross-section through the distal region of the outer catheter (pacing sheath) through Figure 30A .

[0123] Figure 30C Shows a longitudinal section through a portion of the distal region of the outer catheter through Figure 30A (transverse to the section shown in Figure 30B ).

[0124] Figure 31 Is a cross-section through the proximal region of the outer catheter through Figure 30A . Detailed description

[0125] The present disclosure describes devices (e.g., apparatuses, systems, etc.) and methods for inserting, guiding, and implanting replacement heart valves (e.g., aortic valve, mitral valve, etc.) using an antegrade approach. In some examples, a transcatheter valve replacement device may include an outer catheter and at least one inner catheter, which may be removably coupled together. The inner catheter and the outer catheter may have reduced stiffness in a distal direction away from the surgeon or the handle of the device. Any catheter may be preformed or formed by the surgeon. Additionally or alternatively, any inner catheter may include a preformed or formable distal tip. Any device may include an inflatable balloon to assist in enlarging a puncture site or aperture, such as a transseptal puncture site.

[0126] The devices and methods described herein may include or may be configured to be used with an expandable deflector to prevent entanglement with the chordae tendineae. The expandable deflector may be integrated as part of the inner catheter and / or guidewire. Any of these methods and devices may also include pacing of the heart during the procedure. In particular, any of these methods and devices may include an outer catheter of a pacing sheath configured to be adapted to apply a pacing signal.

[0127] Figure 1Ais an exemplary transcatheter aortic valve replacement (TAVR) device 100. Although described herein as a system, the TAVR device 100 can be a device (e.g., an inner catheter). The TAVR device 100 can be configured as a system including an optional guidewire 110, an optional hemostatic valve 120, an outer catheter 130, an inner catheter 140, an optional three-way stopcock 150, and a balloon 160. The inner catheter can include an inflatable balloon 142, a distal tip 145. Other example TAVR devices can include fewer, more, or different components than the Figure 1A TAVR device 100 shown in

[0128] The TAVR device 100 can be used for percutaneous delivery of a replacement valve via the left ventricle using an antegrade approach. The TAVR device 100 can be well-suited for percutaneous delivery through a variety of blood vessels, including but not limited to the femoral artery. In some instances, the flexibility of the TAVR device 100 can vary from proximal (e.g., the end adjacent to the hemostatic valve 120) to distal (e.g., the end adjacent to the distal tip 145). For example, the flexibility of the outer catheter 130 and / or the inner catheter 140 can vary from relatively rigid near the hemostatic valve 120 to relatively flexible near the distal tip 145. The inner catheter 140 can be interchanged with other inner catheters having, for example, different shaped distal tips. These other inner catheters are described in more detail in conjunction with Figures 18A - 18L more detail.

[0129] One or more guidewires can be included as part of the system. In some examples, the diameter of the guidewire 110 can be about 0.035 inches. In some other examples, the guidewire 110 can be any other larger diameter, such as a diameter greater than 0.035 inches (including but not limited to 0.040, 0.045, 0.050, or any other viable larger diameter). In some other examples, the guidewire 110 can be any other smaller diameter, including a diameter less than 0.035 inches (including but not limited to 0.030, 0.025, 0.020, or any other viable smaller diameter). The guidewire 110 can be formed of any viable material, including nitinol.

[0130] The hemostatic valve 120 can provide a hemostatic barrier for any attached catheter, including the outer catheter 130 and the inner catheter 140. The hemostatic valve 120 can be attached to or otherwise coupled to the outer catheter 130. The inner catheter 140 can be removably coupled to the outer catheter 130. The hemostatic valve 120 can also receive and direct air from the inflation balloon 160. Alternatively or additionally, the hemostatic valve 120 can receive the guidewire 110. Although not shown, the guidewire 110 can travel through one or more concentric lumens and can exit through the distal tip 145. The surgeon can manipulate the guidewire 110 to assist in positioning the dilation balloon 142 in the desired region. The inner catheter can include a rapid exchange monorail connection for the guidewire, as will be described in more detail herein.

[0131] The outer catheter 130 can be concentric with the inner catheter 140. In some examples, the outer catheter 130 can include a first section 133 and a second section 136. The first section 133 can be stiffer (e.g., less flexible) relative to the second section 136. The construction of the outer catheter 130 will be described in more detail in conjunction Figures 4A - 4C with. The inner catheter 140 can be coupled to the dilation balloon 142 and the inflation balloon 160. In some examples, the inner catheter 140 can slide relative to the outer catheter 130 easily. Introducing air through the inflation balloon 160 can cause the dilation balloon 142 to expand. As shown, when not inflated, the dilation balloon 142 can collapse and be relatively close in size to the guidewire 110. View 170( Figure 1B ) shows the dilation balloon 143 in its expanded state.

[0132] The hemostatic valve 120 is shown coupled to the three-way stopcock 150 through the flush port 157 by the connecting tube 155. The three-way stopcock 150 can enable any viable liquid to be introduced percutaneously into the patient through the hemostatic valve 120.

[0133] Figure 2A Shown is Figure 1A an exemplary distal tip section 200 of the TAVR device 100. The distal tip section 200 can include a guidewire 210, an outer catheter 230, and an inner catheter 240. The guidewire 210, the outer catheter 230, and the inner catheter 240 can be examples of Figure 1A the guidewire 110, the outer catheter 130, and the inner catheter 140, respectively.

[0134] The transition portion 220 from the outer catheter 130 to the inner catheter 140 can be relatively smooth and seamless. The smooth and seamless transition portion 220 can facilitate the insertion and manipulation of the TAVR device 100 and can prevent gaps that may get stuck on and / or scratch the lumen of the body into which the system is inserted. The inner catheter 240 can include a tapered member 245. The tapered member 245 allows for a decrease in size (diameter) from the transition portion 220 to the guide wire 110.

[0135] The inner catheter 240 can extend partially or fully through the outer catheter 230. The distal tip 241 can be coupled to or integral with the inner catheter 240. The distal tip 241 can have a low crossing profile to assist in the manipulation, operation, and insertion of the TAVR device 100. Additionally, in some examples, the distal tip 241 can be highly flexible. An expandable member (e.g., the expansion balloon 242) can be disposed on the inner catheter 240. As shown, the expansion balloon 242 can be collapsed and / or folded. Other expandable members can include expandable frames or struts, etc.

[0136] Figure 2B Example measurements associated with the distal tip section 250 are shown. The outer catheter can be, for example, 28 French units (Fr). In this example, the exposed portion of the inner catheter can be between 4 and 5 centimeters (cm). The length of the expansion balloon can be between approximately 8 and 12 millimeters (mm) and between approximately 10 and 20 mm. The distal tip can taper from 4 Fr to 3 Fr.

[0137] Figures 3A - 3C Shown is Figure 1A an example distal tip region 300 of the TAVR device 100. Figure 3A The distal tip region 300 shown in can include an outer catheter 330 and an inner catheter 340. The outer catheter 330 and the inner catheter 340 can be examples of the outer catheter 230 and the inner catheter 240 of FIG. 2, respectively. The distal tip region 300 can include a transition region 320.

[0138] In some examples, the transition from the outer catheter 330 to the inner catheter 340 can be achieved by an interference fit as shown in view 345 of the transition region 320 ( Figure 3B ). For example, there can be a mechanical interference between the outer catheter 330 and the inner catheter 340 such that the tapered member 347 of the inner catheter 340 can compress the distal section of the outer catheter 330. In some examples, the mechanical interference region can be 346.

[0139] In some examples, the transition from the outer catheter 330 to the inner catheter 340 can include a gap 355, as shown in view 350 of the distal tip region 300 ( Figure 3C) as shown. View 350 also shows a step 357 that can hide or obscure the outer edge of the outer catheter 330. The step 357 can help smooth the transition between the outer catheter 330 and the inner catheter 340. Additionally, the gap 355 can accommodate tolerances and / or manufacturing variations between the various components of the TAVR device 100.

[0140] Figures 4A - 4C shows Figure 1A An exemplary view of an intermediate shaft section of the TAVR device 100 is shown. The intermediate shaft region 410 is shown. Figure 4B shows a cross-section through Figure 4A the device. The intermediate shaft region 410 includes an outer catheter 430 and an inner catheter 440. In some examples, the outer catheter 430 can include a first section 431 and a second section 432. In some examples, the outer catheter 430 can be stiffer (e.g., less flexible) proximally towards a hemostatic valve (not shown) and more flexible distally away from the hemostatic valve. In some examples, the first section 431 can be stiffer than the second section 432. The transition 434 between the first section 431 and the second section 432 can also be a transition between stiffness (e.g., hardness) and / or internal reinforcement.

[0141] The inner catheter 440 can include a locking ring 441. The outer catheter 430 can include a coupler 435. When the inner catheter 440 is inserted into the proximal end of the outer catheter 430, the locking ring 441 can slide into a space formed within the coupler 435. In this way, the inner catheter 440 can be captured and locked (e.g., detachably coupled) to the outer catheter 430.

[0142] A cross-sectional view 450 of the intermediate shaft region 410 including the outer catheter 430, the inner catheter 440, the locking ring 441, and the coupler 435 is shown. In some examples, the outer catheter 430 can decrease in diameter at the transition 434. For example, the first section 431 can be 2-3 Fr larger than the second section 432. In some other examples, the first section 431 can be 3 Fr larger than the second section 432.. In other examples, the first section 431 can be 1 Fr larger than the second section 432.

[0143] In some examples, the inner catheter 440 can include a rapid exchange port 446 through which a guide wire 411 (which can be Figure 1A an example of the guide wire 110) can pass.

[0144] Figure 4C460 in FIG shows details associated with the coupler 435. The coupler 435 can be formed from stainless steel, nitinol, or any other feasible material. In some examples, the coupler 435 can be formed by laser cutting a feasible material. The coupler 435 may include an open ring 461 that allows a locking ring (not shown) to pass therethrough. The coupler 435 may also include a solid ring 462 that prevents the locking ring from advancing further distally. The locking ring may be captured in a space 463 within the coupler 435. The coupler 435 may include two or more flared tabs 465 that allow the coupler 435 to be welded or otherwise attached to the outer catheter 430.

[0145] Figure Shown ​ A proximal view 500 of the TAVR device 100 is shown. The view 500 shows a guide wire 510, a hemostatic valve 520, an outer catheter 530, an inner catheter 540, and an inflation balloon 560, which may be ​ 1 , the guidewire 110 , the hemostatic valve 120 , the outer catheter 530 , the inner catheter 540 , and the inflation ball 160 . The inflation ball 560 may include an air inlet 561 .

[0146] The hemostatic valve 520 can be coupled to the outer catheter 530 and can also rotate relative to the outer catheter 530. The hemostatic valve 520 can include a seal 521 to prevent and / or limit the unintended passage of fluid from the outer catheter 530. The flush port 527 can be coupled to the connecting tube 525. The connecting tube 525 can be directly or indirectly coupled to any feasible fluid source. Thus, the connecting tube 525 can deliver fluid to the flush port 527 and the outer catheter 530.

[0147] ​ Shown ​ Detailed views of the outer catheter of the TAVR device 100 are shown in FIG. The first example view 610 may include a hemostatic valve 620 and an outer catheter 630, which may be ​ An example of a hemostatic valve 120 and an outer catheter 130. In addition, view 610 can show the outer catheter distal tip 640 and the connector 635. The connector 635 can be ​ Example of connector 435.

[0148] The outer catheter 630 may include a first section 633 and a second section 636. As shown, a transition 637 may exist between the first section 633 and the second section 636. In some examples, the first section 633 may be stiffer relative to the second section 636. For example, the first section 633 may include a braid 634, and the braid 634 may provide stiffness, kink resistance, and torsional resistance (e.g., anti-twistability). In contrast, the second section 636 may include a helical or spiral reinforcement 638. Relative to the first section 633, the helical or spiral reinforcement may provide less stiffness. However, the second section 636 may still have kink resistance and torsional resistance. Additionally, the diameter of the first section 633 may be 30F, and the diameter of the second section 636 may be 28F. These diameters are exemplary and not restrictive. The first section 633 and the second section 636 may be any feasible diameters. In some examples, the diameter of the second section 636 may be less than the diameter of the first section 633. The smaller diameter may enable the second section 636 to be more flexible relative to the first section 633.

[0149] The hemostatic valve 620 may be rotatable relative to the outer catheter 630. In some examples, the hemostatic valve 620 may include a hub 621 that is capable of rotating 360 degrees between the proximal section and the distal section of the hemostatic valve 620. The hemostatic valve 620 may include a flush port 627.

[0150] The outer catheter distal tip 640 may include any feasible radiopaque material (e.g., a radiopaque marker) to enable a surgeon to visualize and / or locate the distal end of the outer catheter 630 using fluoroscopy or other feasible or similar procedures. In some examples, the outer catheter distal tip 640 may include a tungsten-containing polymer, such as tungsten-containing Pebax®.

[0151] The second example view 650 shows an example size of the outer catheter 630. In some examples, the length of the second section of the outer catheter 630 may be between approximately 30 cm and 40 cm. The inner diameter of the first section of the outer catheter 630 may be approximately 26 Fr. The inner diameter of the second section of the outer catheter 630 may be approximately 24 Fr. Additionally, in some examples, the inner diameter of the outer catheter distal tip 640 may be approximately 23 Fr (or decreased by approximately 1 Fr relative to the inner diameter of the second section). The inner diameter 651 of the outer catheter 630 may include any feasible lubricious liner, such as any feasible polytetrafluoroethylene (PTFE).

[0152] ​ An example detailed view of the transition region 700 of the outer catheter is shown. The transition region 700 may include a distal section 710 and a proximal section 720. A coupler 730 may be included in the distal section 710. The coupler 730 may be ​ an example of the coupler 435.

[0153] In some examples, the distal section 710 and / or the proximal section 720 may include overlapping layers of coils and / or braid reinforcements to increase kink resistance and torsional resistance. In some examples, the distribution and / or type of coil and braid materials may vary from proximal to distal along the outer catheter. In this way, the stiffness of the outer catheter may become stiffer in the proximal section 720 and weaker in the distal section 710.

[0154] In some examples, the distal section 710 and / or the proximal section 720 may include overlapping coils wound in opposite directions (clockwise and counterclockwise). This configuration of overlapping coils may allow for increased flexibility and torsional resistance.

[0155] In some examples, the coil section from the distal section 710 may be welded to the coil section from the proximal section 720 via a coupler 730. For example, the coupler 730 may be integral with the coils of the distal section 710. The tabs 735 of the coupler 730 may be welded to the coils of the proximal section 720. The coils of the distal section 710 and the proximal section 720 may be laser cut to control and / or vary flexibility, stiffness, torsional resistance, etc.

[0156] ​ An example detailed view of the inner catheter 800 is shown. The inner catheter 800 may include a balloon 810, a proximal shaft 815, a distal shaft 820, a locking ring 830, a proximal tapering member 840, a distal tapering shaft 850, an inflatable balloon 860, an inner shaft 880, and a distal tip 890.

[0157] The optional balloon 810 may be used to inflate the optional inflatable balloon 860 through a lumen included or formed by the inner catheter 800. In some examples, the proximal shaft 815 may be formed of a stainless steel shaft. In some other examples, the proximal shaft 815 may be formed of any other suitable material. The distal shaft 820 may include a braided inner layer and a durable outer layer. The locking ring 830, which may be an example of the locking ring 441, may be disposed on the distal shaft 820.

[0158] The proximal tapering member 840 may be distal relative to the locking ring 830 and / or the distal shaft 820. The distal tapering shaft 850 may extend beyond the proximal tapering member 840. As shown, the distal tapering shaft 850 may be surrounded and / or encircled by the inflatable balloon 860. The inflatable balloon 860 is shown in a possible inflated state. A radiopaque marker band 870 may be disposed on the distal tapering shaft 850 to assist the surgeon in positioning the inflatable balloon 860 within the patient.

[0159] The inner catheter 800 may include a coiled or braided-reinforced microcatheter inner shaft. The distal tip 890 may also include a radiopaque material (e.g., a radiopaque marker).

[0160] ​ An exemplary internal (cross-sectional) view of the inner catheter 900 is shown. The inner catheter 900 may include an inflation lumen 910, a cut hypotube 920, and a rapid exchange port 930. The inflation lumen enables air to be transmitted from an inflation balloon to an expandable balloon. The cut hypotube 920 may be adjacent to the inflation lumen 910. The cut may be variable, as ​ described in more detail below.

[0161] The inner catheter 900 may also include a rapid exchange port 930 to allow the insertion of a guide wire. In some examples, the inner catheter 900 may include an internal lumen 940. For example, the internal lumen 940 may be coated with and / or include a lubricious coating of PTFE.

[0162] ​ An example of a cut hypotube 1000 is shown. The cut hypotube 1000 may be an example of the cut hypotube 920 for ​ as shown. The cut hypotube 1000 may include a continuous linear cut 1010 that has more material proximally and less material distally. The transition of the material from the proximal end to the distal end may be smooth and continuous. The continuous linear cut 1010 may provide more flexibility to the distal end of the cut hypotube 1000.

[0163] ​ An example of the inner catheter particularly under the expandable balloon is shown. The example shown here may be ​ an example of the distal end of the inner catheter 800. ​ A first example of an inner catheter 1100 is shown. The inner catheter 1100 may include an expandable balloon 1111 and a first tapered member 1112. As shown, the expandable balloon 1111 may be collapsed (not deployed or inflated). The inner catheter 1100 may include a second tapered member 1113 that is disposed substantially below the balloon region 1114. Notably, the second tapered member 1113 ends approximately near the region 1115 where the expandable balloon 1111 may contact the first tapered member 1112.

[0164] ​Shows a second example of the inner catheter 1120. The inner catheter 1120 may include an inflatable balloon 1131, a first tapered member 1132, and a second tapered member 1133. As shown, the second tapered member may taper below the balloon region 1134 and have a constant outer diameter for the remainder of the length of the inner catheter 1135.

[0165] ​ Shows a third example of the inner catheter 1140. The inner catheter 1140 may include an inflatable balloon 1151 and a tapered member 1152. The tapered member 1152 may be thicker than ​ and ​ the corresponding first tapered member. In some examples, the inflation lumen 1135 integral with the inner catheter 1140 may be thinner than the corresponding inflation lumens of the inner catheters 1100 and 1120.

[0166] ​ Shows an exemplary inner catheter 1200. The inner catheter 1200 may not include an inflatable balloon. The inner catheter 1200 may include a handle 1210, a proximal shaft 1212, a distal outer shaft 1214, a locking ring 1216, a tapered member 1218, an inner shaft 1220, and a distal tip 1222.

[0167] The handle 1210 may enable a surgeon to insert the inner catheter 1200 into an outer catheter (such as the outer catheter 130 of FIG. 1 or any other suitable outer catheter). In some examples, the locking ring 1216 may engage a coupler (not shown) of the outer catheter. The proximal shaft 1212 may be formed of stainless steel and be relatively rigid. The further away from the handle 1210, the more flexible the stiffness of the inner catheter 1200 may become.

[0168] The distal outer shaft 1214 may be distal to the proximal shaft 1212. In some cases, the distal outer shaft 1214 may cover the proximal shaft 1212. The locking ring 1216 may be disposed on the distal outer shaft 1214. The inner catheter 1200 may be inserted into any suitable outer catheter. In some examples, the locking ring 1216 may engage a corresponding coupler (such as ​ the coupler 435) of

[0169] The tapered member 1218 may be disposed at the distal end of the distal outer shaft 1214. The shape of the tapered member 1218 may enable the inner catheter 1200 to be inserted and expand a blockage or perforation in a lumen, but other uses are also possible. Distal to the tapered member 1218 is the inner shaft 1220. In some examples, the inner shaft 1220 may be reinforced with coils and / or braids similar to those described for ​ the outer catheter of

[0170] The distal tip 1222 can be distal relative to the inner shaft 1220 and the tapered member 1218. In some examples, the distal tip 1222 can include a radiopaque material (e.g., a radiopaque marker) to enable a surgeon to use fluoroscopy or other similar methods to locate and track the inner catheter.

[0171] ​ A cross-section 1250 of the inner catheter 1200 is shown. The cross-section 1250 can show a rapid exchange port 1260, a cut hypotube 1262, and a guidewire lumen 1264. The rapid exchange port 1260 can enable a guidewire to be inserted into the guidewire lumen 1264. The cut hypotube can be ​ an example of the cut hypotube 1000. The proximal shaft can be blocked (shown at 1266) since there is no dilation balloon that needs to be inflated.

[0172] ​ An exemplary distal end 1300 of any viable inner catheter is shown. In some examples, the distal end 1300 can be ​ the distally tapered shaft 850 of ​ any one of the tapered members of ​ the tapered member 1218, etc. The distal end 1300 can include a tapered member 1310, an embedded forming wire 1320, and a guidewire lumen 1330. The embedded forming wire 1320 can be laminated and / or encapsulated within the tapered member 1310. In some examples, the embedded forming wire 1320 can be stainless steel spring steel, nitinol, or any other viable material.

[0173] The distal end 1300 can be formed into any viable shape, including the curve shown. The tapered member 1310 can be formed at least in part by the embedded forming wire 1320. In some examples, the embedded forming wire 1320 can hold or retain its shape such that the tapered member 1310 maintains the desired shape.

[0174] A cross-section 1340 of the distal end 1300 is shown. The cross-section 1340 shows the cross-sections of the tapered member 1310, the embedded forming wire 1320, and the guidewire lumen 1330. As shown, the cross-section of the embedded forming wire 1320 can be a flat oval, however other cross-sections are possible. For example, the cross-section of the embedded forming wire 1320 can be circular, flat / ribbon-shaped, square, or any other viable shape.

[0175] Additionally or alternatively, the distal end 1300 can be shaped by applying heat. For example, the tapered member 1310 can be formed of a heat-set polymer or include a heat-set polymer. The tapered member 1310 can be placed in a heat-setting mold to be shaped into a desired shape. In some other examples, the shape of the tapered member 1310 can be controlled by pulling a wire. The wire can be anchored to the tapered member 1310 and made available for use by the surgeon.

[0176] In some examples, the tapered member 1310 can include a stylet channel (not shown). Different semi-rigid shaped stylets can be inserted through the port such that the tapered member 1310 conforms to the shape of the stylet.

[0177] ​ Another example distal end 1350 is shown. The construction of the distal end 1350 can be similar to the construction of the distal end 1300, however in some examples, the distal end 1350 can include a formable embedded shaping wire 1360. The formable embedded shaping wire 1360 can be any viable malleable material or metal that can be manually shaped by the surgeon or other user.

[0178] ​ An example shape of the distal end of any viable inner catheter is shown. ​ A distal end 1400 including a tapered member 1410 and a distal outer shaft 1411 is shown. In this example, the tapered member 1410 can be shaped to have a bend of approximately 30 degrees. ​ A distal end 1420 including a tapered member 1421 and a distal outer shaft 1422 is shown. In this example, the tapered member 1421 can be shaped to have a bend of approximately 90 degrees. ​ A distal end 1430 including a tapered member 1431 and a distal outer shaft 1432 is shown. In this example, the tapered member 1431 can be shaped to have a bend of approximately 120 degrees.

[0179] ​ The bends shown are exemplary and not limiting. In other embodiments, the distal end of the inner catheter can have any viable bend.

[0180] In some examples, the distal end of the inner catheter can be bent but relatively flexible. When inserted, the guide wire can straighten the distal end. Conversely, when the guide wire is withdrawn from the distal end (from the tapered member), the distal end can return to a predetermined shape.

[0181] ​ An exemplary distal end of an outer catheter is shown. The outer catheter can be any viable outer catheter, including ​The outer catheter 130. The outer catheter may include a shape-setting coil 1500. The shape-setting coil 1500 may provide a predetermined desired shape to the distal end of the outer catheter. In some examples, the shape-setting coil 1500 may be made of nitinol, stainless steel, or any other suitable material. In some examples, the shape-setting coil 1500 may be heat-set to a desired shape. In some examples, the initial shape of the shape-setting coil 1500 may be "more aggressive" (e.g., having more curvature or angles) because some of the curvature or angles may be lost when the shape-setting coil 1500 is laminated to form the outer catheter.

[0182] In some examples, the shape-setting coil 1500 may be converted into pins, shafts, or other forms. Low-hardness polymers and thin liners may be applied. The polymers and liners may enable the shape-setting coil 1500 to at least partially define the shape of the distal end of the outer catheter.

[0183] In some examples, a hybrid design may include a shape-setting coil 1500 and a non-forming coil. The shape-setting coil 1500 may be located distally relative to the non-forming coil. In this way, the distal portion of the outer catheter may be shaped while the proximal section of the outer catheter may be relatively straight.

[0184] ​ An exemplary distal end of a shaped outer catheter 1510 is shown. As shown, the shaped outer catheter 1510 may include an unshaped coil 1520 and a shaped coil 1530. The shaped outer catheter 1510 is shown in an unconstrained shape.

[0185] ​ A possible cross-section 1600 of the outer catheter is shown. As described herein, the shape-setting wire may be incorporated, encapsulated, or laminated within the outer catheter. Cross-section 1600 includes an exemplary cross-section 1610 having a rectangular (ribbon) shape-setting wire 1611 as part of the outer catheter 1612. Exemplary cross-section 1620 includes a circular shape-setting wire 1621 as part of the outer catheter 1622. Exemplary cross-section 1630 includes a flat (ribbon) shape-setting wire 1631 as part of the outer catheter 1632.

[0186] In some examples, any cross-section 1600 may include a heat-set polymer to form all or part of the outer catheter. In some examples, any cross-section 1600 may include one or more pull wires to control the shape of the outer catheter. In some other examples, any cross-section 1600 may include a stylet channel.

[0187] ​ An exemplary outer catheter shape is shown. ​ An outer catheter 1700 with a 30-degree sharp bend is shown. ​The outer catheter 1710 with a smooth 30-degree bend is shown. ​ The outer catheter 1720 with a smooth 120-degree bend is shown. ​ The distal tip 1731 of the outer catheter 1730 with a smooth 120-degree bend and the inner catheter 1732 with a 45-degree bend is shown. ​ The examples are intended to be exemplary and not restrictive. For example, any feasible combination of bends and / or bend angles is possible.

[0188] ​ The use of ​ exemplary steps of introducing a replacement aortic valve into a patient using the TAVR device 100 are shown. The steps described herein are merely exemplary and are not meant to be restrictive. Other steps may be used, and in some cases, these steps may be performed in a different order. Specifically, ​ Various interchangeable inner catheters for use with the TAVR device 100 are shown.

[0189] In ​ , a guide wire 1801 is introduced into the left atrium of the heart via a transseptal puncture site (through the atrial septum). For example, the guide wire 1801 can be introduced percutaneously into the femoral artery of the patient at least in part using the TAVR device 100. The guide wire 1801 can be a 0.035-inch guide wire. However, in other examples, the guide wire 1801 can be of other thicknesses or specifications. In some examples, a radiofrequency device disposed on or near the distal end of the guide wire 1801 can be used to perform the transseptal puncture.

[0190] Next, in ​ , a first interchangeable inner catheter 1802 and an outer catheter 1803 can be advanced to the transseptal puncture site. For example, the first interchangeable inner catheter 1802 and the outer catheter 1803 can use the guide wire 1801 as a monorail guide. For example, the first interchangeable inner catheter 1802 can be introduced above the guide wire 1801 and positioned in the inferior vena cava (IVC) and the right atrium. Then the transseptal puncture can be performed, and the first interchangeable inner catheter 1802 is advanced through the puncture site. Note that the distal tip of the first interchangeable inner catheter 1802 can be relatively straight.

[0191] ​ Optional steps of balloon septostomy are shown. In this step, an inflated balloon 1804 can be advanced to the transseptal puncture site and inflated to dilate (enlarge) the puncture site. In some examples, the inflated balloon 1804 can have an inflated diameter of 6 mm. After septostomy, the inflated balloon 1804 can be removed. After dilation, the inflated balloon 1804 can be deflated and withdrawn.

[0192] ​ The guide wire 1801 and the outer catheter 1803 are shown in place. For example, the first interchangeable inner catheter 1802 can be unlocked from the outer catheter 1803 and then removed / withdrawn from the patient. As shown, the guide wire 1801 remains in the left atrium.

[0193] ​ The introduction of the second interchangeable inner catheter 1805 through the outer catheter 1803 is shown. The second interchangeable inner catheter 1805 can include a distal end and / or tip that is bent at an angle of more than about 30 degrees. The second interchangeable inner catheter 1805 can be locked (e.g., via a locking ring and a coupler) to the outer catheter 1803. The second interchangeable inner catheter 1805 can use the guide wire 1801 as a monorail guide.

[0194] ​ The second interchangeable inner catheter 1805 and the outer catheter 1803 being advanced through the mitral valve and into the left ventricle are shown. The second interchangeable inner catheter 1805 and the outer catheter 1803 can be guided by the guide wire 1801 (not shown).

[0195] Next, in ​ the second interchangeable inner catheter 1805 is unlocked from the outer catheter 1803 and withdrawn. The positions of the guide wire 1801 and the outer catheter 1803 are maintained in the left ventricle.

[0196] ​ The third interchangeable inner catheter 1806 inserted and guided into the left ventricle is shown. The third interchangeable inner catheter 1806 can include a distal end and / or tip that is bent at or more than about 120 degrees. In some examples, the third interchangeable inner catheter 1806 can be inserted and locked into the outer catheter 1803. In some examples, the guide wire 1801 can optionally be removed. The third interchangeable inner catheter 1806 can be positioned such that the distal end of the third interchangeable inner catheter 1806 can point towards the aortic valve.

[0197] ​ The guide wire 1801 being advanced distally (antegrade along the blood flow direction) through the left ventricular outflow tract (LVOT) and across the aortic valve is shown. In some cases, the guide wire 1801 can optionally be a stiffer guide wire than the guide wire used earlier in the procedure (e.g., ​ )

[0198] ​ The first alternative positioning of the third interchangeable inner catheter 1806 and the outer catheter 1803 within the patient's heart is shown. Note that the curve of the third interchangeable inner catheter 1806 can be at least partially straightened by the guide wire 1801. As shown, the distal tip of the outer catheter 1803 can be below the aortic valve annulus.

[0199] ​Illustrates a second alternative positioning of the third interchangeable inner catheter 1806 and the outer catheter 1803 within a patient's heart. As shown, the distal tip of the outer catheter 1803 can be advanced across the aortic valve.

[0200] ​ Illustrates the TAVR device 100 when the third interchangeable inner catheter 1806 is withdrawn. For example, the third interchangeable inner catheter 1806 can be unlocked from the outer catheter 1803 and withdrawn completely from the patient. In this position, the outer catheter 1803 is ready to deliver a replacement aortic valve. In some cases, if the distal tip of the outer catheter 1803 is across the aortic valve, the surgeon can optionally withdraw or position the distal tip of the outer catheter 1803 below the aortic annulus to assist in positioning and deploying the replacement aortic valve.

[0201] Note that the position of any component of the TAVR device 100 during any step can be confirmed using any feasible technique, including but not limited to echocardiography, transesophageal echocardiography, aortic contrast agent injection, etc. The positioning of the TAVR device 100 can be enhanced by embedded and / or included radiopaque elements (e.g., radiopaque markers).

[0202] ​ Is a flowchart illustrating an exemplary method 1900 for transseptal implantation for replacing an aortic heart valve. Some examples may perform the operations described herein with additional operations, fewer operations, different orders of operations, parallel operations, and different sets of operations. The method 1900 is described below with respect to ​ the TAVR device 100, however, the method 1900 can be performed by any other suitable system or device.

[0203] Method 1900 may optionally include performing a transseptal puncture. The TAVR device may position a guidewire within the heart 1902. For example, the TAVR device may percutaneously introduce the guidewire into an artery, such as the femoral artery, although the use of other arteries or veins is possible. In some examples, a transseptal puncture may be performed using a radiofrequency device. The TAVR device may be advanced through the septum and positioned within the left atrium of the heart 1904. The inner catheter and the outer catheter may be advanced through the septum. For example, the first interchangeable inner catheter may be coupled (locked) to the outer catheter and advanced over the guidewire using the guidewire as a monorail. In some cases, the first interchangeable inner catheter may include an inflatable balloon that can be used to dilate or enlarge the septal puncture. After dilation, the inflatable balloon and / or the first interchangeable inner catheter may be removed. Optionally, the same inner catheter may be used. The same or a different inner catheter may be deflected (e.g., bent, rotated, angled, etc.) within the left atrium such that the distal region of the inner catheter presents a first bend 1904. The guidewire may then be guided distally from the inner catheter and into the left ventricle.

[0204] Next, the inner catheter and the outer catheter can be advanced into the left ventricle 1906. For example, the inner catheter and the outer catheter can be advanced through the atrial valve. In some examples, the second interchangeable inner catheter 1805 can be inserted and locked within the outer catheter 1803. Alternatively, the same inner catheter can be used (e.g., especially in cases where the inner catheter is steerable or deflectable by greater than 120 degrees, as described below). In this manner, the inner catheter (or the new inner catheter) and the outer catheter 1803 can be advanced into the left ventricle. Once in the left ventricle, the inner catheter (the same inner catheter or the new inner catheter) can be deflected within the left ventricle such that the distal region of the inner catheter assumes a second bend (generally > 120 degrees) and faces the left ventricular outflow tract 1907.

[0205] Then, the guidewire can be advanced through the aortic valve 1908. In some examples, the guidewire can be advanced through the aortic valve and into the aorta. Additionally, in some examples, the inner catheter used in the previous step can be removed and replaced with another interchangeable inner catheter.

[0206] Then the catheter can be advanced and positioned across the aortic valve annulus 1910. For example, the inner catheter and the outer catheter can be positioned at or near the aortic valve annulus (or in some examples, across the aortic valve). In some examples, the distal end of the outer catheter can be above the aortic valve annulus. In some other examples, the distal end of the outer catheter can be below the aortic valve annulus.

[0207] The guidewire (or a second guidewire with a different stiffness) can be pushed out from the distal end of the inner catheter and across the aortic valve of the patient's heart.

[0208] Then the replacement aortic valve 1912 can be implanted. In some examples, the inner catheter can be unlocked and withdrawn from the outer catheter before placing and implanting the replacement aortic valve.

[0209] ​ and ​ Another example of a system 2000 for antegrade delivery of a replacement aortic valve is shown. In this example, the system includes an outer catheter and an inner catheter. The inner catheter is inserted into the outer catheter hub 2021 of the outer catheter 2030 (as ​ shown). In this example, the inner catheter 2040 is deflectable or bendable at the distal region (as ​as shown). Deflection can be controlled by actuating a deflection controller 2056 on the inner catheter deflection handle 2055. In this example, moving the controller forward or backward (shown by arrow 2057) can deflect a deflectable region 2061 of the inner member, which is distal to the coupling region 2063 to the outer catheter but proximal to the distal (tapered) end 2065 of the inner catheter. In this example, the inner catheter is configured to deflect more than 120 degrees when coupled to the distal end of the outer catheter (e.g., in ​ it deflects more than 180 degrees, as shown by arrow 2058). Thus, the curved region 2061 between the engagement surface and the distal end is configured to present a bend greater than 120 degrees. In some examples, the bend can be actuated by a wire or pull wire (e.g., a pull wire) that can extend through the inner catheter or through the wall of the inner catheter. Any suitable actuation mechanism can be used. For example, the catheters described herein can be pull-wire driven catheters, magnetic navigation catheters, soft material driven catheters (such as shape memory effect catheters, steerable needles, concentric tubes, electro-conductive polymer driven catheters, and hydraulic driven catheters, etc.), and hybrid actuation catheters. These catheters can have a single section or multiple sections.

[0210] As ​ shown, the distal region of the inner catheter is tapered 2065, and the proximal region of the inner catheter includes an engagement surface near the distal end of the inner catheter, where the engagement surface forms part of a coupling region 2063 that is configured to removably and sealingly couple to the distal region of the outer catheter 2030 such that the outer surface of the first inner catheter is flush with the outer surface of the outer catheter without a gap.

[0211] ​ The example shown in

[0212] ​ is merely one example of an inner catheter; other examples can include smaller bend angles (e.g., between 20 - 90 degrees, between 30 - 90 degrees, etc.). The outer catheter can also be steerable. ​ An example of a method of using a system that includes a steerable inner catheter such as that shown in ​As shown. The relatively rigid guidewire 2110 is shown extending from the inner catheter 2140 and into the ascending aorta. The inner catheter and the outer catheter (coupled together as shown) can be advanced such that the outer catheter is adjacent to the aortic valve, but then the inner catheter can be removed, leaving the outer catheter in place to deliver (along with the guidewire) the replacement valve. As described above, in any of these examples, the outer catheter (which may also be referred to as an outer sheath) can be delivered through the diseased aortic valve or placed proximal to the lower surface of the aortic valve. Thus, the guidewire can extend across the valve, and the replacement valve can be pushed across the valve without driving a sheath across the valve.

[0213] Although the examples above and ​ shown illustrate methods for replacing the aortic valve, similar techniques can be used to replace the mitral valve in an antegrade manner. For example, the same basic steps can be followed as described above, but the outer catheter and the inner catheter can be advanced only to the mitral valve (e.g., no deflection of the inner catheter within the left ventricle is required). For example, a ​ variant can be performed such that the distal end of the outer catheter is adjacent to or passes through the mitral valve (e.g., beyond the mitral valve). After delivering the outer catheter (e.g., cannula), a percutaneous mitral valve intervention device (e.g., mitral valve replacement device, mitral valve repair device, clip, etc.) can be advanced, positioned, and deployed through the outer catheter to the mitral valve or an area near the valve.

[0214] Generally, the methods and devices described herein can include one or more features that enhance their use for valve replacement. For example, the inner catheter can be configured for rapid exchange over a guidewire (e.g., monorail), while the outer catheter is not, but is a complete catheter. Generally, as described, the inner catheter and the outer catheter can be sealed and locked to each other, and the inner catheter can be steered while being locked by the outer catheter (and extending distally from the outer catheter), such that the inner catheter can be freely steered without interference from the outer catheter, while the outer catheter remains locked to the inner catheter in a predictable and safe manner. In addition, the inner catheter can have a distal end that rapidly tapers (e.g., in some examples, from 3F to 20F); this tapered region can be relatively short (e.g., can extend about 4 cm or less, about 3.5 cm or less, about 3 cm or less, about 2.5 cm or less, about 2 cm or less, about 1.5 cm or less, etc.), which can both prevent damage to tissue and allow manipulation within the heart. In addition, in a steerable inner catheter, the deflection region can stop proximal to the distal end of the inner catheter such that the distal highly flexible tip can track the guidewire. For example, the steerable region can end about 4 - 5 mm behind the distal tip. Generally, the devices and methods described herein are configured to prevent scratching, which could otherwise damage blood vessels and could cause substances (e.g., clots, plaques, calcified substances, etc.) to be released from the valves and / or walls of the heart. Filter

[0215] Generally, any device and method described herein may include one or more filters that may be configured to be positioned distally of the device when (or after) the device is positioned relative to the valve. The filter 2371 may be a filter wire, such as ​ the filter wire shown in, which is configured to capture loose material during valve positioning and deployment. ​ The placement of the filter 2371 as part of the system as described above is shown. For example, the filter may be coupled to a wire 2375 (e.g., a 0.035-inch wire) and may be deployed into the ascending aorta to capture debris from valve deployment and replacement. The filter may be self-expanding and may be deployed as part of a guide wire (e.g., attached to the guide wire), or applied using a guide wire (e.g., on the guide wire), or adjacent to the guide wire, and may be advanced into place in a collapsed configuration with a sheath (not shown) over the self-expanding filter 2271. Once in a position distal to the distal end of the outer catheter and further anterograde, the filter sheath may be removed and the filter deployed as shown. Once deployed, the filter may capture any debris generated by the procedure. After the procedure, the filter may be removed, e.g., re-sheathed, and withdrawn to remove any captured debris.

[0216] In some examples, the filter wire may act as a 0.035' guide wire to deliver the valve. In some examples, the filter may be deployed into the ascending aorta and the sheath used for the filter may be completely removed (e.g., pulled all the way out of the body) such that the replacement valve (e.g., a TAVR valve) may be advanced over the filter wire. Once the valve is deployed, debris may be captured in the filter, and the filter may be removed to retrieve the filter and any debris captured during the procedure in order to reduce the risk of embolization to intracranial vessels of other more distal arteries.

[0217] Any suitable wire may be used for the filter wire and / or guide wire. For example, in some cases, the distal end of the wire may be an A3J guide wire (e.g., the distal end may have a preset curve or shape) and may be any suitable length. In some examples, the filter region may be mounted or positioned in an area near the distal end. For example, 15 cm near the tip of the wire may include a filter mounted on the wire. The filter may be, for example, an expandable nitinol filter that may be delivered constrained by an outer sheath. Pulling on the sheath may cause the filter to expand (e.g., to a diameter of 3 cm or greater) and, in some examples, may contact the wall of the ascending aorta, e.g., about 8 cm above the valve but before the first branch of the aortic arch). Thus, any method and device described herein may include a user of the filter (and anterograde filter) as described.

[0218] Alternatively or additionally, a wire (e.g., a filter wire, a guide wire, etc.) can also be used to deliver contrast distally to the proximal aorta (e.g., a contrast deployment guide wire). For example, any wire described herein (e.g., a guide wire, a filter wire, etc.) can be hollow and can include one or more distal openings (holes, slits, etc.) through which contrast can be applied. For example, any of these devices can include a wire for delivering contrast (and optionally for delivering and / or controlling a filter). In some examples, the wire can include one or more side holes in the wire such that contrast can be delivered from the side holes; for example, a syringe can be applied to the proximal end of the wire and contrast can be injected through the wire. Contrast can be delivered in this manner with or without a filter. Alternatively or additionally, contrast can be applied through an outer catheter to assist in the accurate placement of the valve.

[0219] ​ An example of a contrast deployment guide wire 2377 is shown, which includes a plurality of infusion holes 2379 arranged along the length of the side of the guide wire. The distal tip region of the contrast deployment guide wire can be solid (e.g., not allowing contrast material to flow out from the distal end). Alternatively, in some examples, the distal tip region can be open, or open like the side openings. The length of the region of the contrast deployment guide wire that includes a plurality of openings can be, for example, between 0.5 cm and 10 cm (e.g., 0.5 cm or greater, 0.75 cm or greater, 1 cm or greater, 1.5 cm or greater, 2 cm or greater, 3 cm or greater, 4 cm or greater, 5 cm or greater, between about 0.5 - 10 cm, between about 0.5 - 8 cm, between about 0.5 - 7 cm, between about 0.5 - 6 cm, between about 0.5 - 5 cm, between about 0.5 - 3 cm, etc.). The solid distal tip region of the contrast deployment guide wire can extend any suitable length (e.g., about 0.5 cm or less, about 1 cm or less, about 2 cm or less, about 3 cm or less, about 4 cm or less, about 5 cm or less, between about 0.5 - 10 cm, between about 1 - 8 cm, between about 0.5 - 7 cm, between about 0.5 - 6 cm, between about 0.5 - 5 cm, etc.).

[0220] The contrast deployment guide wire can be formed from any suitable material, including polymer and / or metal (e.g., stainless steel, nitinol, etc.) materials. Expandable deflector

[0221] The methods and devices for replacement valves described herein may include an expandable deflector to deflect the chordae tendineae to prevent any component (e.g., guidewire, inner catheter, outer catheter, etc.) from becoming entangled in the chordae tendineae during surgery. For example, any method and device described herein may include an expandable deflector configured to deflect the chordae tendineae to prevent damage to the valve and / or chordae tendineae, including preventing cutting of the chordae tendineae, which could otherwise result in mitral regurgitation.

[0222] The expandable deflector may include any expandable member, such as a balloon, basket, net, etc., which can be controllably expanded and contracted. In some examples, the device may include one or more expandable deflectors in the distal region of the guidewire, inner catheter, and / or outer catheter. As described above, the expandable deflector may be expanded before, during, or shortly after inserting the device into the ventricle (e.g., left ventricle) to deflect away from the chordae tendineae, away from the device displacement, and prevent the device from getting stuck between the chordae tendineae and the ventricular wall. In some examples, the expandable deflector may be used to center the device within the mitral valve apparatus and / or the left ventricle.

[0223] ​ A first example of a device including an expandable deflector is shown. ​ A guidewire 2300 is shown, which includes an expandable deflector 2307 configured as a compliant balloon that extends in the distal region of the device. In ​ , the guidewire is configured as a mitral centering guidewire. When in the ventricle, the expandable deflector 2307 can be expanded (as ​ shown) to deflect away from the chordae tendineae. In ​ , the guidewire has a diameter of approximately 0.035 inches and has a J-shaped tip (J-tip) 2305, which can be atraumatic and may include radiopaque markers. The expandable member may be formed by a compliant tube forming a balloon, which is coupled to the outer surface of the guidewire by a polymeric outer sheath 2309. The more proximal outer surface region 2311 of the guidewire may be configured to have a textured surface, which can provide additional gripping force for the inflation hub Tuohy region, as ​ shown.

[0224] As ​ shown in the cross-sectional view, the guidewire may be cut (e.g., laser cut) in the distal region 2313 to increase and / or enhance flexibility. The guidewire in this example may be formed by a Hypotube 2315, which may be laser cut and coated, laminated, or otherwise configured to seal the inner lumen such that the inner lumen of the Hypotube can be configured as an inflation lumen for inflating the expandable deflector (e.g., balloon). For example, as ​ shown, the guidewire may be a cut Hypotube sealed by a laminated polymeric outer sheath 2327. ​ Shown is ​A slightly enlarged view of the distal section of the guide wire shown in. In ​ In, the distal tip 2317 is shown attached (e.g., welded, brazed, etc.) to the atraumatic distal tip of the J-shaped distal region 2319, which may include a shape-setting inner core (e.g., nitinol inner core) to have a J-shape. The distal end (J-shape) may be hermetically brazed between the hypotube and the core wire 2321. As shown in this example, the expandable deflector 2307 may be expanded by filling it with an inflation fluid, and the inflation fluid may flow through and into the internal lumen of the guide wire. As shown, the distal end 2329 of the expandable deflector and the proximal end 2325 of the expandable deflector may be sealed to the guide wire.

[0225] ​ An example similar to the guide wire device 2400 shown in ​ is shown. As ​ shown, the expandable member 2307 may be expanded to, for example, between about 4 mm and about 25 mm (e.g., between about 12 mm and about 20 mm, etc.). ​ is ​ a slightly enlarged view of the device in which the expandable deflector (e.g., balloon) is in a collapsed configuration. ​ It also includes a proximal end 2425, which may be coupled to a sealed removable inflation hub by rotating a Tuohy Borst seal 2424 (which may serve as a handle). The hub in this example may include a positioning window 2420 for aligning the guide wire and a filling port 2422 (e.g., a balloon filling port). ​ A magnified view of ​ this handle (inflation hub with rotating Tuohy Borst seal 2424) is shown, including a Tuohy Borst seal 2430 sealed around the proximal region of the guide wire.

[0226] ​ Another example of a guide wire including an expandable deflector 2507 is shown (also configured as a compliant view in this example). As ​ shown, ​ the guide wire 2500 has a straight distal end 2505 (shown as an atraumatic, radiopaque tip), rather than the ​ J-shaped distal region. However, other features may be the same, including a polymer outer sheath region 2509 and a proximal textured surface 2511. As described above for ​As described, the guidewire can be formed from a hypotube 2515, which can be cut (e.g., laser cut) to increase the flexibility of the distal region 2513. The guidewire 2500 can also include a machined platinum tip 2517, which can be an atraumatic tip, and a solder / adhesive joint 2520 that couples the sealed tip to the hypotube. The expandable deflector can be inflated by injecting fluid 2523 via the hypotube to inflate the balloon 2507 (as ​ shown). The balloon can be in fluid communication with the lumen of the guidewire at the proximal balloon seal 2525 and the distal balloon seal 2529. As described above, the laser-cut hypotube can be sealed, for example, by laminating a polymeric outer sheath over the laser-cut hypotube 2527, as ​ shown.

[0227] ​ An example of an inner catheter 2605 that includes an expandable deflector 2607 is shown. As ​ shown, as described above, the inner catheter can be joined to the outer catheter 2603. The expandable deflector (balloon 2607) can be positioned at the distal region of the inner member and can be in fluid communication with the inflation lumen 2627, as ​ shown. ​ The distal region of the inner catheter of ​ can be bendable or steerable using a pull wire within the pull wire lumen 2621; the distal end of the pull wire can be anchored 2617 within the distal region, as

[0228] shown. The guidewire 2611 can extend into and out of the guidewire lumen 2623. Thus, the inner catheter in this example can include a multi-lumen shaft 2625. ​ ​ shown. The guidewire 2700 having an expandable deflector 2707 similar to that shown in

[0229] ​ Figures 27A - 27B shown. The expandable deflector 2707 can be inflated at or proximal to the mitral valve, or in some examples only distal to the mitral valve. In some examples, inflation of the expandable deflector can assist in advancing and centering the guidewire, thereby avoiding the chordae tendineae. For example, inflation of the expandable deflector can also allow the expandable deflector to be pulled into the ventricle and to the valve during diastole, as it can act as a sail and the blood flow within the ventricle can pull the inflated deflector forward. Once positioned, the expandable member can be discharged 2707', or in some examples, can be kept inflated while performing other steps of the method. Figures 27A - 27BThe same operation of the inner catheter 2805 (extending from the outer catheter 2803) of the expandable deflector 2707 shown in the figure. In Figure 28B the expandable deflector 2807' is shown as not expanded.

[0230] In any of the figures shown herein, the dimensions may be illustrative only, and other dimensions may be used (e.g., + / −5%, 10%, 15%, 20%, 25%, 50% or more).

[0231] Figure 29 An example of a method of replacing a heart valve using an expandable deflector is shown. Generally, an expandable deflector can be used in any step of a procedure where the device is manipulated within the ventricle. In Figure 29 the procedure 2901 can be performed while applying a pacing signal to the heart to create a pacing rhythm. In any of the methods described herein, this can be performed using an outer catheter configured as a pacing sheath, as will be described in more detail below.

[0232] Method 2900 can optionally include performing a transseptal puncture 2903. As described above, a TAVR device can position a guidewire in the heart. For example, a TAVR device can percutaneously introduce a guidewire into a vein or artery, such as the femoral vein or artery, although the use of other arteries or veins is possible. In some examples, a transseptal puncture can be performed using a radiofrequency device. The TAVR device can be advanced through the septum and positioned within the left atrium of the heart. The inner catheter and the outer catheter can be advanced through the septum 2905. For example, a first interchangeable inner catheter can be coupled (locked) to the outer catheter and advanced over the guidewire as a monorail. In some cases, the first interchangeable inner catheter can include an expandable balloon, which can be used to dilate or enlarge the septal perforation. After dilation, the expandable balloon and / or the first interchangeable inner catheter can be removed. Optionally, the same inner catheter can be used. The same or a different inner catheter can be deflected (e.g., bent, rotated, angled, etc.) within the left atrium such that the distal region of the inner catheter presents a first bend. Then, the guidewire can be guided distally from the inner catheter and into the left ventricle.

[0233] Before advancing the guidewire and / or the inner catheter into the ventricle, the system can prepare the deviating chordae 2907 by expanding the expandable deflector. As Figure 27A or Figure 28AAs shown, the expandable deflector can be expanded at the mitral valve orifice (e.g., by inflating a balloon). The expandable deflector can be on a guide wire (straight guide wire or J-tip guide wire) and / or it can be on the distal section of the inner catheter. In some examples, the inner catheter (or the inner catheter and the guide wire) can be advanced into the ventricle such that the expandable deflector is first advanced 2909; as described above, the expanded expandable deflector can be advanced into the ventricle by the blood flow, e.g., towards the apex of the ventricle.

[0234] Thus, the inner (and outer) catheter can be advanced into the left ventricle while deviating from the chordae tendineae 2909. In some examples, a second interchangeable inner catheter can be inserted and locked within the outer catheter. Alternatively, the same inner catheter can be used (e.g., especially when the inner catheter is steerable or deflectable by more than 120 degrees). In this way, the inner catheter (or the new inner catheter) and the outer catheter can be advanced into the left ventricle. Once in the left ventricle, the inner catheter (the same inner catheter or the new inner catheter) can be deflected within the left ventricle such that the distal region of the inner catheter presents a second bend (usually >120 degrees) and faces the left ventricular outflow tract 2911.

[0235] When manipulating within the ventricle, including steering or bending the inner catheter to face the outflow tract, the expandable deflector can be used and it can be used to prevent entanglement of the chordae tendineae. Once the path through the ventricle has been established, the expandable deflector can be collapsed.

[0236] Then, a guide wire (the same or a different guide wire) can be advanced through the aortic valve 2913. In some examples, the guide wire can be advanced through the aortic valve and into the aorta. Additionally, in some examples, the inner catheter used in the previous step can be removed and replaced with another interchangeable inner catheter.

[0237] Then the catheter can be advanced and positioned across the aortic valve annulus 2915. For example, the inner catheter and the outer catheter can be positioned at or near the aortic valve annulus (or in some examples, across the aortic valve). In some examples, the distal end of the outer catheter can be above the aortic valve annulus. In some other examples, the distal end of the outer catheter can be below the aortic valve annulus, or even closer to the apex of the left ventricle.

[0238] A guide wire (or a second guide wire with different stiffness) can be pushed out from the distal end of the inner catheter and across the aortic valve of the patient's heart. Then a replacement aortic valve can be implanted 2917. In some examples, before placing and implanting the replacement aortic valve, the inner catheter can be unlocked and withdrawn from the outer catheter. Pacing sheath

[0239] In any of these methods, a single vascular entry point can be used for pacing. As described above, any method and device (e.g., system) described herein can include an outer catheter configured as a pacing sheath, which can simplify the operation of the procedure. The pacing electrode can be part of the distal portion of the sheath, which can be positioned at the left ventricular apex to allow escape pacing or rapid pacing during valve implantation. The pacing controller can apply a pacing signal to provide pacing in the event that the sinus rhythm of the heart is disrupted and avoid the need for pacemaker insertion. Generally, an outer catheter configured as a pacing sheath (also referred to herein as a "rapid pacing sheath") can include any of the above features, particularly including a distal region for sealing engagement with an inner catheter.

[0240] A pacing signal can be applied to the heart such that the heart can be electrically paced to ensure pacing capture and establish the periodicity and predictability of the cardiac cycle during the procedure. One or both of atrial and ventricular pacing can be applied. The pacing signal can be controlled by a pacing controller, which can be part of a pacing device (e.g., a pacing sheath). The controller can include a signal generator and one or more processors. The pacing device can be suitably coupled to the patient and configured to provide a cardiac pacing signal generated by the device for cardiac stimulation and also allow rapid ventricular pacing during valve implantation.

[0241] As described above, the same sheath (outer catheter) can be used to insert multiple inner catheters and can be used to provide electrical pacing.

[0242] For example, Figure 30A An example of a pacing sheath as described herein is shown. The pacing sheath can be particularly advantageous because it can be adapted for rapid use with the retrograde systems described herein, including engagement with catheters (e.g., one or more inner catheters), while simplifying the control of pacing and the performance of valve replacement procedures. In Figure 30A FIG., the pacing sheath 3000 has an elongate body with a hub at its proximal end and a plurality of electrodes at its distal end for applying a pacing signal to the heart (e.g., to the apex of the ventricle).

[0243] The distal region of the pacing sheath can include a plurality of electrodes 3006, 3008, 3010, 3012 at or near the distal tip. The electrodes can be circumferential, as Figure 30A shown, or they can be located only on a portion of the circumference. Figure 30A The annular electrodes shown in FIG. can be spaced apart by about 1 to about 10 cm (e.g., about 3 to 7 cm, etc.). In Figure 30A FIG., the electrodes are spaced apart by about 5 cm and are spaced about 2 cm from the distal end on the elongate body. In some examples, Figure 30AThe distal tip of the device shown in can be configured to lock onto the outer diameter of the inner catheter, as described above. The electrodes can each be coupled to a helical lead that electrically couples the electrode to a connector (e.g., pins 3016, 3018, 3020, 3022) extending from the proximal end of the device. As described above, the connector can be coupled to a controller (not shown). In some examples, the leads can be helically wound around the elongate body to extend the length of the sheath. In Figure 30A the example shown, the lead includes coiled wire 3014 that is helically wound around the elongate body and coupled to a molded-over yoke 3016 at the proximal end of the sheath. The leads (individual cables 3024) can be combined into a conductor cable bundle 3032 that is coupled to the yoke 3016 and supports connectors (e.g., pins) for connection to the controller. The conductive cables (e.g., wires, leads, etc.) can be bundled together and extend helically together around the length of the elongate body.

[0244] The proximal end of the sheath can also include a hub 3002 having a hemostatic valve for receiving and sealing the inner catheter (or nested catheters and / or guidewires). The hub can also include a side port 3004 that can be used to apply and / or remove materials through the central lumen 3015 of the sheath.

[0245] Figure 30B and Figure 30C shows a cross-section through the distal region of the sheath, showing one configuration of electrodes that can be used. In Figure 30C it, the portion of the distal region shown includes an exposed annular electrode 3008 that is coupled to a wire or lead 3038 that is insulated except for the exposed area 3042 that contacts the electrode. As described above, the conductive leads can be helically wound around the elongate body of the sheath. In this example, the insulated wire is embedded in and / or covered by an outer polymer jacket 3040 that covers the wire.

[0246] The elongate body of the sheath can be reinforced, for example, by a coil or braid 3044. The coil or braid can be supported by one or more layers, including being sandwiched between two or more layers. As Figure 30C shown, the sheath also includes an inner or base polymer jacket 3048 that can insulate (and smooth) the inner wall of the lumen 3015 of the sheath. In some examples, the sheath can also include a lubricating layer, such as a lubricious liner 3046. Alternatively, in some instances, the base polymer layer can be lubricious.

[0247] Figure 31 shows Figures 30A - 30CAn enlarged view of the proximal end of the pacing sheath. The hub 3002 includes the hemostatic valve as described above, as well as a side port 3004 and a port for the conductor cable bundle 3032. The hub may also or alternatively be configured as a handle. In Figure 31 , the conductor cables may be coupled to a yoke 3015 that supports respective connectors (e.g., pins 3016, 3018, 3220, 3022).

[0248] It should be understood that all combinations of the foregoing concepts and additional concepts discussed in more detail below (provided that such concepts are not mutually inconsistent) are considered to be part of the inventive subject matter disclosed herein and can be used to achieve the benefits described herein.

[0249] The process parameters and the order of steps described and / or illustrated herein are given by way of example only and may be varied as needed. For example, although the steps shown and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order shown or discussed. Various example methods described and / or illustrated herein may also omit one or more of the steps described.

[0250] One of ordinary skill in the art will recognize that any process or method disclosed herein may be modified in a variety of ways. The process parameters and the order of steps described and / or illustrated herein are given by way of example only and may be varied as needed. For example, although the steps shown and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order shown or discussed.

[0251] Various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein, or include additional steps in addition to those disclosed steps. Further, the steps of any method disclosed herein may be combined with any one or more steps of any other method disclosed herein.

[0252] A processor as described herein may be configured to perform one or more steps of any method disclosed herein. Alternatively or in combination, the processor may be configured to combine one or more steps of one or more methods disclosed herein.

[0253] When a feature or component is referred to herein as being "on" another feature or component, it can be directly on the other feature or component, or intervening features or components may also be present. In contrast, when a feature or component is referred to as being "directly on" another feature or component, there are no intervening features or components present. It will also be understood that when a feature or component is referred to as being "connected", "attached" or "coupled" to another feature or component, it can be directly connected, attached or coupled to the other feature or component, or intervening features or components may be present. In contrast, when a feature or component is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or component, there are no intervening features or components present. Although described or shown with respect to one embodiment, the features and elements so described or shown can be applied to other embodiments. Those skilled in the art will also recognize that structures or features referred to as "adjacent" to another feature may have portions that overlap or are below the adjacent feature.

[0254] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be further understood that the terms "comprises" and / or "comprising", when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated to " / ".

[0255] For ease of description, spatial - related terms such as "under", "below", "lower", "over", "upper", etc. may be used in this text to describe the relationship of one component or feature to other components or features as illustrated in the accompanying drawings. It will be understood that the spatial - related terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if the device in the drawings is inverted, a component described as "under" or "below" other components or features will then be oriented "over" the other components or features. Thus, the exemplary term "under" can encompass both the orientation of "over" and "under". The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial - related descriptive terms used herein are to be interpreted accordingly. Similarly, unless otherwise specifically stated, terms such as "upwardly", "downwardly", "vertical", "horizontal", etc. are used herein for illustrative purposes.

[0256] Although the terms "first" and "second" may be used in this text to describe various features / components (including steps), these features / components should not be limited by these terms unless the context otherwise indicates. These terms can be used to distinguish one feature / component from another. Thus, without departing from the teachings of the present invention, a first feature / component discussed below can be referred to as a second feature / component, and similarly, a second feature / component discussed below can be referred to as a first feature / component.

[0257] In this specification and the appended claims, unless the context otherwise requires, the term "comprise" and its variants such as "comprises" and "comprising" mean that various components can be used together in a method and an article (e.g., a composition and a device, including apparatuses and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated component or step, but not the exclusion of any other component or step.

[0258] Generally, any device and method described herein should be understood as inclusive, but all or a subset of the components and / or steps can optionally be exclusive and can be expressed as "consisting of various components, steps, sub - components or sub - steps" or alternatively "consisting essentially of various components, steps, sub - components or sub - steps".

[0259] As used herein in the specification and claims, including in the examples, and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or "approximately", even if the term does not expressly appear. The phrase "about" or "approximately" may be used when describing magnitudes and / or positions to indicate that the described value and / or position are within a reasonable expectation range of the value and / or position. For example, a numerical value can have values of + / −0.1% of the stated value (or range of values), + / −1% of the stated value (or range of values), + / −2% of the stated value (or range of values), + / −5% of the stated value (or range of values), + / −10% of the stated value (or range of values), etc. Any numerical value given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It should also be understood that when a value is disclosed, "less than or equal to" that value, "greater than or equal to" that value, and the possible ranges between values are also disclosed, as appropriately understood by one of ordinary skill in the art. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" are also disclosed (e.g., where X is a numerical value). It should also be understood that throughout this application, data is provided in a variety of different formats, and that this data represents endpoints and starting points and ranges for any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, then it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, and between 10 and 15 are considered to be disclosed. It should also be understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0260] While various illustrative embodiments have been described above, various changes among the several changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, generally the order in which the various described method steps are performed may be altered, and in other alternative embodiments, one or more of the method steps may be skipped altogether. Optional features of the various apparatus and system embodiments may be included in some embodiments and not included in other embodiments. Accordingly, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0261] The examples and illustrations included in this document show, by way of illustration and not limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. For convenience only, such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention", and if more than one is actually disclosed, the scope of this application is not intended to be actively limited to any single invention or inventive concept. Thus, while specific embodiments have been illustrated and described herein, any arrangement that is recognized to achieve the same purpose may be substituted for the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of various embodiments. After reading the above description, those skilled in the art will appreciate the combinations of the above embodiments and other embodiments not specifically described herein.

Claims

1. A system for antegrade delivery of a replacement valve, the system comprising: -- An outer catheter configured as a sheath for receiving an inner catheter, the sheath comprising: --- An elongate body having a lumen configured to receive the inner catheter, wherein the elongate body is configured to extend from outside the body to the apex of the left ventricle of the heart; --- A hub at the proximal end of the elongate body, the hub comprising a hemostatic valve; --- A plurality of electrodes at the distal region of the elongate body; --- A plurality of electrical connectors extending proximally from the elongate body; and --- A plurality of conductor cables extending from the plurality of electrical connectors to the plurality of electrodes such that each electrical connector is electrically connected to a corresponding one of the plurality of electrodes; and -- A pacing controller configured to be electrically coupled to the plurality of electrical conductors of the sheath, the pacing controller comprising one or more processors and a non-transitory computer-readable medium having instructions stored thereon that are executable by the one or more processors to cause the pacing controller to apply cardiac pacing stimuli from the plurality of electrodes.

2. The system according to claim 1 further comprises: An inner catheter, wherein the inner catheter comprises: a tapered distal region, an engagement surface near the distal end of the inner catheter, wherein the engagement surface is configured to sealingly couple to the distal region of the sheath such that the outer surface of the inner catheter is flush with the outer surface of the sheath without a gap.

3. The system according to claim 2, wherein, The inner catheter comprises a curved region between the engagement surface and the distal end, the curved region being configured to present a bend greater than 120 degrees.

4. The system according to claim 1, wherein the sheath further comprises a side port at the proximal end of the elongate body, wherein the side port is in fluid communication with the lumen.

5. The system according to claim 1, wherein The plurality of electrodes are annular electrodes circumferentially arranged around the distal region.

6. The system according to claim 1, wherein, The plurality of conductor cables form a bundle that spirally extends from the plurality of electrical connectors around the elongate body to the plurality of electrodes.

7. The system according to claim 1, wherein the plurality of electrodes are arranged in series along the distal region.

8. The system according to claim 1, wherein the electrodes among the plurality of electrodes are spaced apart by about 1 cm to 9 cm.

9. The system according to claim 1, further comprising a yoke coupled to the plurality of electrical connectors.

10. A system for antegrade delivery of a replacement valve, the system comprising: -- An outer catheter configured as a pacing sheath; -- An inner catheter, which comprises: a tapered distal region, an engagement surface near the distal end of the inner catheter, wherein the engagement surface is configured to sealingly couple to the distal region of the outer catheter such that the outer surface of the first inner catheter is flush with the outer surface of the outer catheter without a gap; -- wherein the outer catheter is configured to receive the inner catheter, the outer catheter comprising: --- An elongate body having a lumen configured to receive the inner catheter, wherein the elongate body is configured to extend from outside the body to the apex of the left ventricle of the heart; --- A hub at the proximal end of the elongate body, the hub including a hemostatic valve; --- A plurality of electrodes disposed along a distal region of the elongate body, wherein the plurality of electrodes are spaced apart from the distal region by an isolation distance; --- A plurality of electrical connectors extending proximally from the elongate body; and --- A plurality of conductor cables forming a bundle that spirally extends around the elongate body from the plurality of electrical connectors to the plurality of electrodes such that each electrical connector is electrically connected to a corresponding electrode of the plurality of electrodes; and -- A pacing controller configured to be electrically coupled to the plurality of electrical conductors of the outer catheter, the pacing controller including one or more processors and a non-transitory computer-readable medium having instructions stored thereon that are executable by the one or more processors to cause the pacing controller to apply cardiac pacing stimuli from the plurality of electrodes.

11. The system according to claim 10, wherein, The inner catheter includes a curved region between the engagement surface and the distal end, the curved region being configured to exhibit a curvature greater than 120 degrees.

12. The system of claim 10, wherein the sheath further includes a side port at the proximal end of the elongate body, wherein the side port is in fluid communication with the lumen.

13. The system according to claim 10, wherein, The plurality of electrodes are annular electrodes circumferentially disposed around the distal region.

14. The system according to claim 10, wherein The plurality of conductor cables form a bundle that spirally extends around the elongate body from the plurality of electrical connectors to the plurality of electrodes.

15. The system of claim 10, wherein the plurality of electrodes are arranged in series along the distal region.

16. The system of claim 10, wherein the electrodes of the plurality of electrodes are spaced apart from each other by about between 1 cm and 9 cm.

17. The system of claim 10, further including a yoke coupled to the plurality of electrical connectors.

18. A system for antegrade delivery of a replacement valve, the system including: -- An outer catheter configured as a sheath for a catheter, the outer catheter including: --- An elongate body having a lumen configured to receive the catheter, and --- An engagement region within the lumen located in the distal region of the outer catheter; and -- An inner catheter, including: --- A tapered distal region, --- An engagement surface near the tapered distal end of the inner catheter, wherein the engagement surface is configured to be detachably coupled to the engagement region of the outer catheter such that the outer surface of the inner catheter is flush with the outer surface of the outer catheter without a gap, --- A deflector located on the outer surface of the inner catheter distal to the tapered distal region, wherein the deflector is configured to radially expand to deflect chordae tendineae away from the left ventricle, --- a deflection region between the engagement surface and the distal end of the inner catheter, the deflection region being configured to bend, and --- a guidewire lumen.

19. The system according to claim 18, wherein, The deflection region is configured to present a bend greater than 120 degrees.

20. The system according to claim 18, wherein, The deflection region includes a wire configured to bend the deflection region.

21. The system according to claim 18, wherein, The deflection region includes a pre-bent region.

22. The system according to claim 18, wherein, The deflection region includes a bend-setting material.

23. The system according to claim 18, wherein, The inner catheter further includes a pull wire configured to bend the deflection region.

24. The system of claim 18, wherein the distal region of the outer catheter has a tapered outer surface.

25. The system according to claim 18, wherein, The engagement region includes an inner diameter that is at least one French unit (1 Fr) smaller than the inner diameter of the lumen in the proximally adjacent region of the lumen.

26. The system according to claim 18, wherein The engagement region includes a connector configured to engage a locking ring on the engagement surface of the inner catheter.

27. The system according to claim 18, wherein, The tapered distal region tapers from 3 Fr or less to 14 Fr or more.

28. The system according to claim 18, wherein The outer catheter includes a thin-walled flexible outer layer of 22 Fr or greater configured to follow the inner catheter when the inner catheter is in a bent configuration.

29. The system according to claim 18, wherein, The distance between the deflection region and the distal tip of the inner catheter is between 3-6 mm.

30. The system of claim 18, wherein the guidewire lumen includes a rapid exchange monorail connection.

31. The system of claim 18, further comprising a guidewire.

32. The system according to claim 18, wherein, The inner catheter has a decreasing stiffness along the distal region.

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