Device for antegrade transcatheter valve repair or implantation - Patent Application 20070122997

Abstract

A device includes a system for performing valve replacement or repair. The device may include an outer catheter, one or more exchangeable inner catheters, a guidewire, and an expandable chordae tendineae deflector. The outer catheter and inner catheter may be configured to engage to prevent gapping. The inner catheter may include the chordae tendineae deflector. The outer catheter may be configured as a rapid pacing sheath that may be used with any of these devices.

Description

[Technical Field]

[0001] Priority claims

[0001] This patent application claims priority to U.S. patent application Ser. No. 18 / 151,414, entitled "Method and Apparatus for Antegrade Transcatheter Valve Repair or Implantation," filed January 6, 2023, and U.S. patent application Ser. No. 18 / 448,888, entitled "Method and Apparatus for Antegrade Transcatheter Valve Repair or Implantation," filed August 11, 2023, each of which is incorporated herein by reference in its entirety. Incorporation by Reference

[0002]

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

[0003] Field 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 in a patient's heart using an antegrade approach to the aorta. [Background technology]

[0004]

[0004] Heart valve surgery may encompass a variety of surgical approaches used to repair or replace diseased heart valves. Heart valve surgery may be an open-chest procedure performed under general anesthesia. An incision is made in the patient's sternum (sternotomy), and the patient's heart is stopped while blood flow is redirected through a cardiopulmonary bypass machine. This valve replacement surgery is a highly invasive procedure and carries significant risks and complications.

[0005]

[0005] Transcatheter aortic valve replacement (TAVR) is an alternative to open-chest aortic valve replacement. The aortic valve is located between the left ventricle and the aorta. If the aortic valve does not function properly, blood flow from the heart to the body can be impaired. In this procedure, a miniaturized 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 place using a retrograde approach. After confirming the replacement valve's location, the surgeon uses the catheter to implant the valve. Summary of the Invention [Problem to be solved by the invention]

[0006] Retrograde TAVR procedures (e.g., advancing the catheter against or in the opposite direction to blood flow) are often used because they provide a much easier route for the catheter to approach the aortic valve. However, retrograde approaches can be associated with negative outcomes, such as major bleeding at the arterial access site or stroke due to embolic debris from the aorta, especially if the patient's aortic valve is stenotic and / or contains calcification or other deposits. Antegrade TAVR procedures via a transseptal approach (e.g., advancing the catheter in the direction of blood flow) overcome some of the drawbacks associated with retrograde TAVR procedures, using venous access to reduce bleeding and eliminating trauma to the aortic arch, thereby reducing stroke. Unfortunately, antegrade TAVR procedures have historically been more difficult to perform. Difficulties include crossing the interatrial septum, potential damage to the mitral valve, and issues associated with delivering a large implanted device via the left atrium to the left ventricle and aortic valve. These challenges have caused the antegrade TAVR procedure to be largely superseded by other approaches.

[0007]

[0007] Thus, there has been a long-standing need for methods and devices for successfully performing antegrade TAVR procedures. [Means for solving the problem]

[0008]

[0008] Described herein are devices, systems, and methods for performing antegrade aortic valve replacement. An exemplary device (which may include a system, system device, and / or software) may include an outer catheter, an inner catheter (or multiple interchangeable inner catheters), and a guidewire. Any of the inner catheters may be removably coupled to the outer catheter. The inner and outer catheters may surround a guidewire such that the inner and outer catheters may be advanced in a monorail-like manner within a patient.

[0009] Any of the devices and methods described herein may be configured to safely pass through the mitral valve without engaging the gaps in the chordae. For example, any of these methods and devices may include an expandable deflector (e.g., an expandable balloon, cage, mesh, multiple struts, etc.) that may be expanded to pass through the mitral valve opening without engaging the chordae in the left ventricle. In any of these methods and devices, the deflector may deflect the device from the chordae.

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

[0011] Generally, these devices (e.g., systems) are configured to navigate the cardiac anatomy of the venous vasculature to deliver a heart valve (e.g., aortic valve, mitral valve, etc.) in an antegrade manner. By utilizing venous delivery, these devices are configured to prevent abrasion of the aortic and arterial vasculature, which may release material (including thrombus and / or atherosclerotic material) that may cause complications when repairing a heart valve from a retrograde direction. Accordingly, these devices generally may include an outer catheter having a distal end region that sealably and releasably engages a slightly proximal region of the inner catheter to prevent a gap between the two upon engagement. The outer and / or inner catheters may also be configured to be bent or steered from a region proximal to the distal end. The inner catheter may include a steerable, pre-bent, and / or bendable (deflectable) region disposed between the tapered distal end region and a more proximal sealing region that engages the inner catheter with the distal end of the outer catheter. The steerable, pre-bent, and / or bendable region may be configured to provide very sharp bends (e.g., about 30 to about 180 degrees of deflection, e.g., about 40 to 180 degrees, about 60 to 180 degrees, about 80 to 180 degrees, about 90 to 180 degrees, about 100 to 180 degrees, about 110 to 180 degrees, about 120 to 180 degrees, greater than 120 degrees). Additionally, the outer catheter may be particularly flexible and thin-walled so that it can follow curves or bends formed by the inner catheter and follow the guidewire.

[0012]

[0012] For example, a system for antegrade delivery of a replacement valve (e.g., an aortic valve) may include an outer catheter and an inner catheter having a tapered distal end region and an engagement surface proximal to the distal end of the inner catheter, the engagement surface configured to removably couple to the distal end region of the outer catheter so 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 between the engagement surface and the distal end configured to exhibit a bend of greater than 120 degrees.

[0013]

[0013] For example, a system for antegrade delivery of a replacement mitral valve may include an outer catheter, an inner catheter including a tapered distal end region, an engagement surface proximal to the distal end of the inner catheter, the engagement surface configured to removably couple to the distal end 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 a bend region between the engagement surface and the distal end configured to exhibit a bend of greater than about 60 to 120 degrees.

[0014]

[0014] None of these devices and methods are limited to valve replacement, but may also be configured for valve repair. For example, any of these methods may be for the insertion of repair tools, implants, etc. In general, the same devices and procedures for their use described herein for valve replacement may be used for access and repair.

[0015]

[0015] The distal end region may taper from a large proximal opening to a narrow distal opening (e.g., from about 3 Fr (1 mm) or less to about 14 Fr or more, e.g., 20 Fr or more).

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

[0017] The inner catheter may be steerable (e.g., controllably bendable / deflectable). For example, in some instances, the inner catheter includes a tendon or wire (e.g., a pull wire) configured to bend the bending region. The wire may be attached to the distal end of the bending distal region. The distal region may include a bend (e.g., a notch, a wrinkle, etc.) to provide a predictable bending region. In any of these instances, the bending region may include a bend-setting material, such as a shape-memory material (e.g., a nickel-titanium alloy), configured to exhibit a bend. The bending region may be manually bent (shape-set) prior to use to exhibit a bend once deployed from the outer catheter into the vasculature. This bendable inner catheter may impart a primary bend to the distal portion of the flexible outer catheter to allow the relatively larger outer catheter to follow through the mitral valve and / or around the left ventricle into the left ventricular outflow tract.

[0018] Any of the devices described herein may include a second, inner catheter including a tapered distal end region, an engagement surface proximal to the distal end of the inner catheter, the engagement surface configured to removably couple to the distal end 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 a bend region between the engagement surface and the distal end configured to exhibit a bend of greater than 30 degrees. Thus, the second (or subsequent) inner catheter may be similar to the first inner catheter but may have a different bend angle or a different range of bend angles.

[0019] In any of the systems described herein, the inner catheter may have a bend region between about 3-10 mm from the distal tip of the inner catheter. As noted above, this bend region may be between the tapered distal tip region and the proximal region that engages the outer catheter.

[0020] Generally, the inner catheter may include a rapid exchange monorail connection for a guidewire, allowing the inner catheter to be rapidly exchanged within the outer catheter. In some instances, the outer catheter does not include a rapid exchange monorail, but may be enclosed throughout its entire length. Any of these systems may include one or more guidewires, e.g., a first guidewire and a second guidewire, where the first guidewire is stiffer than the second guidewire. Also, a guidewire may include a side hole to allow for the injection of contrast into the proximal aorta and more precise valve positioning. Generally, these devices may include one or more hemostatic valves coupled to or configured to couple to the outer catheter.

[0021]

[0021] The inner catheter may have reduced stiffness along the distal end region. In general, the distal end may be significantly more flexible than the proximal end.

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

[0023] The inner catheter may include a squib hypotube configured to decrease in stiffness distally. In any of these devices, the inner catheter includes a first section and a second section, the first section including a braid configured to provide kink resistance and twist resistance, and the second section including a helical coil configured to provide less stiffness than the braid. The first section may be configured to have an outer diameter of approximately 25 French (Fr) (e.g., 14 Fr to 35 Fr, 20 Fr to 30 Fr, 22 Fr to 28 Fr, 22 Fr to 30 Fr, etc.), and the second section may be configured to have an outer diameter of approximately 23 Fr (e.g., 1 to 5 Fr smaller than the first section). For example, the first section may be configured to have an inner diameter of approximately 24 Fr, and the second section may be configured to have an inner diameter of approximately 22 Fr. TAVR valve technology provides a smaller delivery diameter, allowing the use of a smaller sheath. The outer catheter may include a coupler configured to engage with a locking ring disposed on the first, inner catheter.

[0024] Also described herein are methods for the percutaneous antegrade delivery and insertion (implantation) of valves, such as aortic valves. These methods may use any of the systems described herein. For example, a method for percutaneous antegrade delivery and implantation of a valve in a patient may include advancing a tapered first inner catheter distally through a transseptal puncture, wherein a region of the first inner catheter proximal to a distal end of the first inner catheter is annularly engaged to the outer catheter at a distal end region of the outer catheter so that an outer surface of the first inner catheter is flush with an outer surface of the outer catheter without a gap; deflecting the first inner catheter within the left atrium so that the distal end region of the first inner catheter exhibits a first bend; advancing the outer catheter and the first inner catheter or a second inner catheter replaced with the first inner catheter so that the first or second inner catheter is within the left ventricle; advancing a guidewire from the distal end of the first or second inner catheter across a valve of the patient's heart; removing the first or second inner catheter, leaving the wire 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 from the distal end of the first or second inner catheter, the first or second inner catheter within the left ventricle may be deflected so that the distal end region of the first or second inner catheter assumes a second bend and faces the patient's left ventricular outflow tract. Implanting a replacement valve may include implanting an aortic valve. For example, implanting a replacement valve may include implanting a mitral valve.

[0026] For example, a method for percutaneous antegrade delivery and implantation of a valve in a patient includes advancing a tapered first inner catheter distally through a transseptal puncture, wherein a region of the first inner catheter proximal to a distal end of the first inner catheter is annularly engaged with the outer catheter at a distal end region of the outer catheter such that an outer surface of the first inner catheter is flush with an outer surface of the outer catheter without a gap; deflecting the first inner catheter within the left atrium such that the distal end region of the inner catheter exhibits a first bend; and inserting the first or second inner catheter into the left ventricle. and advancing the outer catheter and either the first inner catheter or a second inner catheter that has been replaced with the first inner catheter, as in (a), deflecting the first or second inner catheter within the left ventricle such that the distal end of the first or second inner catheter assumes a second bend and is directed toward the left ventricular outflow tract, advancing a guidewire from the distal end of the first or second inner catheter across the aortic valve of the patient's heart, removing the first or second inner catheter, leaving the wire in place, and implanting the replacement aortic valve into the patient's heart through the outer catheter.

[0027] Any of these methods may include advancing the outer catheter and the 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 into the ascending aorta over the guidewire. Implanting a replacement aortic valve in the patient's heart may include implanting the replacement valve over the guidewire through the outer catheter. When the aortic valve is delivered across the outer catheter and the aortic valve, the outer catheter is withdrawn proximally to "expose" 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 exhibits the 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 expanding the transseptal puncture with an expandable member on an outer surface of the first inner catheter. For example, the expandable member may include a balloon.

[0030] The first bend (e.g., of the inner catheter) may be at least about 30 degrees (e.g., about 30-100 degrees, about 30-90 degrees, about 30-80 degrees, about 30-70 degrees, about 30-60 degrees, about 3-45 degrees, etc.). The second bend may be at least about 120 degrees (e.g., about 120-190 degrees, about 120-180 degrees, about 120-170 degrees, about 120-160 degrees, about 120-150 degrees, about 120-140 degrees, etc.). Deflecting the first inner catheter may include actuating a pull wire of the first inner catheter to deflect a 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 noted above, the first inner catheter may be distally tapered from 3 French or less to 14 French or more, which taper, in combination with the engagement region between the inner and outer catheters, prevents or reduces tissue trauma and prevents fishmouth formation (e.g., separation between the inner and outer catheters at their distal junction as they pass through a bend 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.

[0033]

[0033] The methods described herein may include advancing a distally tapered initial inner catheter through the transseptal puncture before advancing the first inner catheter, the initial inner catheter annularly engaging the outer catheter at the distal end region of the outer catheter, and the outer catheter passing through the transseptal puncture 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 instances (as described above), a single outer catheter may be used in conjunction with two or more inner catheters. For example, a method of percutaneous antegrade delivery and implantation of an aortic valve in a patient described herein includes advancing a tapered inner catheter distally through a transseptal puncture, wherein a region of the inner catheter proximal to the distal end of the inner catheter is annularly engaged to the outer catheter at the distal end region of the outer catheter so 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 so that the distal end region of the inner catheter exhibits a first bend; advancing the outer and inner catheters so that the inner catheter is within the left ventricle; deflecting the inner catheter within the left ventricle so that the distal end region of the inner catheter exhibits a second bend, the distal end region bent to direct the catheter system toward the left ventricular outflow tract; advancing a guidewire from the distal end of the inner catheter across the aortic valve of the patient's heart; removing the first or second inner catheter, leaving the wire in place, and implanting a replacement aortic valve in the patient's heart through the outer catheter.

[0035]

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

[0036] Generally, implanting a replacement aortic valve in a patient's heart may involve implanting the replacement valve over a guidewire through an outer catheter.

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

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

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

[0040] As described above, deflecting the inner catheter may include actuating a pullwire of the inner catheter. In some instances, deflecting the inner catheter includes allowing the inner catheter to assume a bent configuration. The inner catheter may be distally tapered from 3 French or less to 14 French or greater. Any of these methods may include manually setting the first bend and / or the second bend before advancing the distal inner catheter through the transseptal puncture.

[0041]

[0041] The methods described herein may include advancing a distally tapered initial inner catheter through the transseptal puncture before advancing the inner catheter, the initial inner catheter annularly engaging the outer catheter at the distal end region of the outer catheter, and the outer catheter entering the left atrium through the transseptal puncture.

[0042] As noted above, in some instances, these methods may involve the use of a single outer catheter and two (or more) inner catheters that may be exchanged (including by rapid exchange) at different points during a procedure. For example, a method for percutaneous antegrade delivery and implantation of an aortic valve in a patient may include: advancing a tapered first inner catheter distally through a transseptal puncture, wherein a region of the first inner catheter proximal to a distal end of the first inner catheter annularly engages the outer catheter at a distal end region of the outer catheter such that an outer surface of the first inner catheter is flush with an outer surface of the outer catheter without a gap; deflecting the first inner catheter within the left atrium such that the distal end region of the first inner catheter exhibits a first bend; advancing the outer catheter and the first inner catheter such that the first inner catheter is in the left ventricle; and advancing the second inner catheter such that a region of the second inner catheter proximal to a distal end of the second inner catheter annularly engages the outer catheter. withdrawing the first inner catheter proximally from the outer catheter so as to annularly engage the outer catheter at a distal end region of the outer catheter and inserting the second inner catheter through the outer catheter and into the left ventricle; deflecting the second inner catheter so that the distal end region of the second inner catheter exhibits a second bend greater than the first bend and the distal end of the second inner catheter is bent to allow passage of the catheter system into the left ventricular outflow tract; advancing a guidewire from the distal end of the second inner catheter across the aortic valve of the patient's heart; removing the first or second inner catheter, leaving the wire in place, and implanting the replacement aortic valve in the patient's heart through the outer catheter.

[0043] The methods described herein may include advancing the second outer catheter and the 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 guidewire. Implanting the replacement aortic valve in the patient's heart may include implanting the replacement valve over the guidewire through the outer catheter.

[0044] Any of these methods may include advancing a guidewire into the left ventricle after the first inner catheter assumes the 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 expanding the transseptal puncture with an expandable member on the outer surface of the first inner catheter. As described above, the expandable member may include a balloon. Also, 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 pullwire within the first inner catheter. In some examples, deflecting the first inner catheter includes allowing the first inner catheter to assume the bent configuration. The first inner catheter may be distally tapered from 3 French or less to 14 French or more, as described above. 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.

[0045]

[0045] In some examples, the method includes advancing a distally tapered initial inner catheter through the transseptal puncture before advancing the first inner catheter, the initial inner catheter being annularly engaged to the outer catheter at the distal end region of the outer catheter, and the outer catheter entering the left atrium through the transseptal puncture.

[0046] As described herein, any of the catheters may have varying stiffness. For example, the stiffness of either the outer catheter or the 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 liner, a spiral liner, or a combination thereof to vary and / or control the stiffness of the catheter.

[0047] Any of the exchangeable inner catheters may include a differently shaped distal tip that may be used to position and / or guide a guidewire within a patient. Alternatively, or in addition, any of the exchangeable inner catheters may include a distally disposed dilatation balloon.

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

[0049] Any of the methods described herein may involve percutaneous antegrade delivery and implantation of an aortic valve. Any of the methods may include using a guidewire to puncture the atrial septum of the patient's heart, advancing a catheter across 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 using a catheter to advance a guidewire through the aortic valve of the patient's heart, positioning the catheter across the annulus of the aortic valve, and implanting the replacement aortic valve within the patient's heart.

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

[0051] In either method, the catheter may include a first inner catheter and an outer catheter, the first inner catheter being concentric with and detachably connected to the outer catheter, and the guidewire may be concentric with and 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 may include advancing a guidewire through the mitral valve of the patient's heart. In some examples, advancing the catheter from the left atrium to the left ventricle may 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 the curved distal tip, through the mitral valve, and into the left ventricle, and withdrawing the second inner catheter from the outer catheter. In some embodiments, the curved distal tip may have a curve of at least 30 degrees.

[0053] In any of the methods described herein, advancing the guidewire through the aortic valve may include using a third inner catheter having a sharply curved distal tip with a curve of at least 120 degrees. Further, positioning the catheter across the annulus of the aortic valve may further include withdrawing the third inner catheter.

[0054] In any of the methods described herein, advancing the guidewire through the aortic valve may include advancing the guidewire in an antegrade direction into the aorta of the patient's heart. In any of the methods, positioning the catheter across the aortic valve annulus may 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 may further include advancing a dilation balloon into the atrial septum. In any of the methods described herein, advancing the catheter across the atrial septum may include advancing a dilation balloon into the atrial septum. Any of the methods may also include inflating the dilation balloon to dilate the puncture in the atrial septum, deflating the dilation balloon, and withdrawing the dilation balloon. In any of the methods described herein, the dilation balloon may be coupled to the catheter.

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

[0057] The methods and devices described herein may further or additionally include a filter for capturing material during valve positioning and deployment. The filter may be an expandable filter that may be attached or affixed to a wire, such as a guidewire. Thus, any of the guidewires described herein may include a filter ("filter wire"). The filter may be held in a contracted state by a sleeve that may be stored proximally. The filter may be deployed from a wire, such as a guidewire, that extends antegrade distally beyond the valve to be replaced or repaired. For example, in some variations, the method may include advancing a guidewire from the distal end of the first or second inner catheter across the aortic valve of the patient's heart, and the guidewire may include a filter. Thus, 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 media through one or more side ports. These guidewires may be used in place of any of the guidewires described herein (including with the filters described above). The guidewires may include an array of side-facing ports or openings into a central lumen through which contrast media may be injected. These guidewires may be referred to herein as contrast agent-deploying guidewires. The contrast agent-deploying guidewires may have a solid distal tip / end region or may be hollow along the length of the contrast agent-deploying guidewire proximal to the distal tip region. The distal tip region of the contrast agent-deploying guidewire may extend to 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, about 0.5-10 cm, about 1-8 cm, about 0.5-7 cm, about 0.5-6 cm, about 0.5-5 cm, etc.). Any number of side-opening ports or holes may be used and may be positioned along the length of the contrast agent deployment guidewire. In some instances, the ports or holes may be positioned on the same side of the contrast agent deployment guidewire, and in some instances, 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 from one or more side-facing ports on the guidewire.

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

[0060] For example, a method for percutaneous antegrade delivery and implantation of a valve in a patient may include advancing a tapered first inner catheter distally through a transseptal puncture, wherein a region of the first inner catheter proximal to a distal end of the first inner catheter is annularly engaged with the outer catheter at a distal end region of the outer catheter such that an outer surface of the first inner catheter is flush with an outer surface of the outer catheter without a gap; deflecting the first inner catheter within the left atrium such that the distal end region of the first inner catheter exhibits a first bend; expanding an expandable deflector to deflect it from the chordae tendineae of the left ventricle; and The method may include advancing the outer catheter and either the first inner catheter or a second inner catheter replaced with the first inner catheter so that the catheter is in the left ventricle while deflected from the chordae tendineae; deflecting the first or second inner catheter within the left ventricle so that a distal end region of the first or second inner catheter assumes a second bend and faces the patient's left ventricular outflow tract; advancing a guidewire from the distal end of the first or second inner catheter across the aortic valve of the patient's heart; removing the first or second inner catheter, leaving the wire in place, and implanting the replacement aortic valve in the patient's heart through the outer catheter.

[0061] Any of these methods may include deflecting the first inner catheter within the left atrium so that a distal end region of the first inner catheter assumes 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 exchanged for 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 exchanged for the first inner catheter. Expanding the expandable deflector may include expanding the expandable deflector on a second inner catheter exchanged for the first inner catheter.

[0063] Any of these methods may include advancing a guidewire from the distal end of the first or second inner catheter, and then deflecting the first or second inner catheter within the left ventricle so that the distal end region of the first or second inner catheter assumes a second bend and faces the patient's left ventricular outflow tract. For example, the method may include deflecting the distal end region of the first or second inner catheter from the chordae tendineae of the left ventricle using an expandable deflector as the distal end region assumes the second bend. In any of these methods, advancing the outer catheter and either the first inner catheter or the second inner catheter may include advancing the expandable deflector in an expanded state.

[0064] The expandable deflector may be any suitable deflector, including an inflatable deflector (e.g., a balloon), a mechanical deflector (e.g., a strut, a cage, a mesh, etc.), etc. For example, expanding the expandable deflector includes expanding a balloon. These methods and devices may include one or more expandable deflectors. For example, the expandable deflector may be on an inner catheter, an outer catheter, and / or a guidewire (or, more generally, a guide element). As used herein, a guidewire may include a wire, a thin guide tube or catheter, etc. In some cases, the deflector may be specifically adapted to deflect chordae tendineae; for example, the deflector may have an outer diameter of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, etc.) and a length of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, etc.). The outer shape of the deflector may be rounded in the deployed configuration. The outer shape of the deflector may be symmetrical (e.g., the distal and proximal ends may be symmetrical in a radial plane that bisects the deflector). In some examples, the deflector comprises an expandable strut, cage, or mesh. The deflector may be positioned proximal to the distal end of the inner catheter by about 2 mm or more (e.g., 2.5 mm or more, 3 mm or more, 4 mm or more, etc.), or between 2 and 10 mm (e.g., 2 and 8 mm, 2 and 6 mm, etc.). These configurations may prevent the deflector from becoming entangled or trapped in the chordae tendineae as it is advanced through the ventricle.

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

[0066]

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

[0067] As mentioned above, any of these methods may include applying electrical pacing to the patient's heart during the procedures described herein. In any of these methods and devices, the outer catheter may be configured as a sheath (e.g., a pacing sheath) containing multiple electrodes. For example, any of these methods may include applying a pacing signal to the patient's heart from electrodes on the outer catheter (sheath) through which the inner catheter is inserted.

[0068]

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

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

[0070]

[0070] Accordingly, any of these methods and devices may include an outer catheter configured as a sheath, e.g., a pacing sheath adapted to quickly and easily apply pacing signals (a "rapid pacing sheath"). Also described herein are methods that include any of these outer catheters (pacing sheaths) and a pacing controller configured to electrically couple to multiple conductors of the sheath, the pacing controller including one or more processors and a non-transitory computing device-readable medium having stored thereon instructions executable by the one or more processors to cause the pacing controller to apply cardiac pacing stimuli from multiple electrodes.

[0071] Any of these devices (e.g., systems) may include an inner catheter having a tapered distal end region and an engagement surface proximal to the distal end of the inner catheter, the engagement surface sealably coupling to the distal end region of the 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 may be any of the inner catheters described herein. For example, as described above, the inner catheter may include a bend region between the engagement surface and the distal end configured to exhibit a bend of greater than 120 degrees.

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

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

[0074]

[0074] The conductor cables may form a bundle that extends helically around the elongate body from the multiple electrical connectors to the multiple electrodes. This configuration may be particularly advantageous for providing a thin profile for the device while allowing flexibility for the elongate body.

[0075]

[0075] An outer catheter configured as a pacing sheath as described herein may also include a yoke coupled to multiple electrical connectors.

[0076]

[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 end region and an engagement surface proximal to the distal end of the inner catheter, the engagement surface configured to sealably couple to the distal end region of the outer catheter such that an outer surface of a first inner catheter is flush with an outer surface of the outer catheter without a gap, the outer catheter configured to accommodate the inner catheter, the outer catheter being an elongate body having a lumen configured to accommodate the inner catheter, the elongate body being configured to extend from outside the body to the left ventricular apex of the heart, a hub at the proximal end of the elongate body, the hub including a hemostatic valve, and a hub positioned along the distal end region of the elongate body. the plurality of electrodes are spaced a standoff distance from the distal end region; a plurality of electrical connectors extending proximally from the elongate body; and a plurality of conductor cables forming a bundle that helically extends around the elongate body from the plurality of electrical connectors to the plurality of electrodes, such that each electrical connector electrically connects to a corresponding electrode of the plurality of electrodes; and a pacing controller configured to electrically couple to the plurality of conductors of the outer catheter, the pacing controller including one or more processors and a non-transitory computing device readable medium having instructions executable by the one or more processors stored thereon to cause the pacing controller to apply cardiac pacing stimuli from the plurality of electrodes.

[0077]

[0077] Also described herein are methods involving 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 into the left atrium, a distal region of the first inner catheter being flush with the outer catheter at a distal end region of the outer catheter, the outer catheter being configured as a pacing sheath having a plurality of pacing electrodes; advancing the outer catheter and either the first inner catheter or a second inner catheter replaced with the first inner catheter so that the first or second inner catheter is within the left ventricle; applying a pacing signal to the heart from the outer catheter to maintain sinus rhythm of the heart; advancing a guidewire from the distal end of the first or second inner catheter across a valve of the patient's heart; removing the first or second inner catheter, leaving the guidewire in place, and implanting the replacement valve in the patient's heart through the outer catheter.

[0078]

[0078] A system for antegrade delivery of a replacement valve as described herein may include an outer catheter configured as a sheath for the catheter, the outer catheter including an elongate body having a lumen configured to accommodate the catheter and a coupler region within the lumen at a distal end region of the outer catheter; an inner catheter having a tapered distal end and an engagement surface proximal to the tapered distal end of the inner catheter, the engagement surface configured to removably couple to the coupler region of the outer catheter so 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 end region, the deflector configured to expand radially to deflect from the chordae tendineae of the left ventricle; a steering region between the engagement surface and the distal end configured to bend; and a guidewire lumen extending through the inner catheter.

[0079] The steering region may be a bending region, as described herein, and may be configured to exhibit a bend of greater than 120 degrees. The steering region may include a wire configured to bend the steering region. The steering region may include a pre-bend 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 couple to the inner catheter at the distal end of the outer catheter and at a region proximal to the distal end of the inner catheter. The outer and inner catheters may be adapted to allow a smooth (gap-free) connection between the two outer surfaces, as described herein. For example, the distal end region of the outer catheter may have a tapered outer surface. The coupler region may include an inner diameter at least 1 French (1 Fr) smaller than the inner diameter of the lumen in a region proximally adjacent to the lumen. In some examples, the coupler region may include a coupler configured to engage with a locking ring on an engagement surface of the inner catheter.

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

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

[0083]

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

[0084]

[0084] All of the methods and devices described herein, in any combination, are contemplated herein and can be used to achieve the advantages as described herein. [Brief explanation of the drawings]

[0085] A better understanding of the features and advantages of the methods and apparatus described herein can be obtained by reference to the following detailed description and accompanying drawings that set forth exemplary embodiments.

[0086] [Figure 1A] FIG. 1A is an exemplary transcatheter aortic valve replacement (TAVR) device. [Figure 1B]

[0087] FIG. 1B is an enlarged view of the distal region of FIG. 1A showing the expandable region in an expanded state. [Figure 2A]

[0088] FIG. 2A illustrates an exemplary distal tip section of the TAVR device of FIG. 1A. [Figure 2B]

[0089] FIG. 2B shows exemplary measurements associated with the distal tip section. [Figure 3]

[0090] 3A-3C show an exemplary distal tip region of the TAVR device of FIG. 1A. [Figure 4A]

[0091] 4A-4C are exemplary illustrations of the mid-shaft section of the TAVR device of FIG. 1A. [Figure 5]

[0092] FIG. 5 shows a proximal view of the TAVR device of FIG. 1A. [Figure 6]

[0093] 6A-6B show exemplary detailed views of the outer catheter of the TAVR device of FIG. 1. FIG. 6A shows an external view. FIG. 6B shows a cross-section of the device of FIG. 6A. [Figure 7]

[0094] FIG. 7 shows an exemplary detailed view of the transition area of ​​the outer catheter. [Figure 8]

[0095] FIG. 8 shows an exemplary detailed view of the inner catheter. [Figure 9]

[0096] FIG. 9 shows an exemplary inner view of the inner catheter. [Figure 10]

[0097] FIG. 10 shows an example of a squib hypotube. [Figure 11]

[0098] 11A-11C show examples of inner catheters, particularly under dilation balloons. [Figure 12A]

[0099] FIG. 12A shows an exemplary inner catheter. [Figure 12B]

[0100] FIG. 12B shows a cross-sectional view of the inner catheter. [Figure 13A]

[0101] FIG. 13A shows an exemplary distal end of any possible inner catheter. [Figure 13B]

[0102] FIG. 13B shows another exemplary distal end. [Figure 14]

[0103] 14A-14C show exemplary shapes of the distal end of any possible inner catheter. [Figure 15A]

[0104] FIG. 15A shows an exemplary distal end of an outer catheter. [Figure 15B]

[0105] FIG. 15B shows an exemplary distal end of a shaped outer catheter. [Figure 16]

[0106] FIG. 16 shows a possible cross section of the outer catheter. [Figure 17-1]

[0107] 17A-17B show exemplary outer catheter shapes. [Figure 17-2] 17C-17D show exemplary outer catheter shapes. [Figure 18-1]

[0108] 18A-18C illustrate exemplary steps for introducing a replacement aortic valve into a patient using the TAVR device 00 of FIG. 1A. [Figure 18-2] 18D-18F show exemplary steps for introducing a replacement aortic valve into a patient using the TAVR device 00 of FIG. 1A. [Figure 18-3] 18G-18I illustrate exemplary steps for introducing a replacement aortic valve into a patient using the TAVR device 00 of FIG. 1A. [Figure 18-4] 18J-L show exemplary steps for introducing a replacement aortic valve into a patient using the TAVR device 00 of FIG. 1A. [Figure 19]

[0109] FIG. 19 is a flow chart illustrating an exemplary method for transseptal implantation of a replacement aortic heart valve. [Figure 20]

[0110] 20A and 20B show an example of the system described herein. [Figure 21]

[0111] FIG. 21 illustrates an example of a method for using the system described in FIGS. 20A-20B. [Figure 22A]

[0112] FIG. 22A shows an example of a method of using a system including a filter (eg, a filter wire or filter on a wire) that may be used with any of the methods and devices described herein. [Figure 22B]

[0113] FIG. 22B shows an example of a wire (eg, a guidewire) that includes injection openings along regions of the length of the wire. [Figure 23]

[0114] FIG. 23A shows an example of a mitral valve centering guidewire including an expandable deflector. This example is a 0.035 inch (0.889 mm) diameter centering guidewire with a J-tip. FIG. 23A shows a side perspective view of the mitral valve centering guidewire. FIG. 23B shows a cross section through the view of FIG. 23A. FIG. 23C is a slightly enlarged view of the distal end region of the device of FIGS. 23A-B with the expandable deflector (e.g., balloon) in a collapsed configuration. [Figure 24A]

[0115] FIG. 24A shows the mitral valve centering guidewire of FIGS. 23A-23C with the expandable deflector expanded, including the proximal end region. [Figure 24B]

[0116] FIG. 24B shows a cross-sectional view of a proximal hub that may be coupled to the proximal end region of FIG. 24A (for inflation / deflation of the expandable deflector). [Figure 25A]

[0117] Figure 25A shows an example of a mitral valve centering guidewire that includes an expandable deflector. This example is a 0.035 inch diameter centering guidewire with a straight tip. Figure 25A shows a side perspective view of the mitral valve centering guidewire. [Figure 25B] FIG. 25B shows an example of a mitral valve centering guidewire that includes an expandable deflector. This example is a 0.035 inch diameter centering guidewire with a straight tip. FIG. 25B shows a cross section through the view of FIG. 25A. [Figure 25C] FIG. 25C shows an example of a mitral valve centering guidewire including an expandable deflector. This example is a 0.035 inch diameter centering guidewire with a straight tip. FIG. 25C is a slightly enlarged view of the distal end region of the device of FIGS. 25A-B with the expandable deflector (e.g., balloon) in a collapsed configuration. [Figure 25D] FIG. 25D shows an example of a mitral valve centering guidewire including an expandable deflector. This example is a 0.035 inch diameter centering guidewire with a straight tip. FIG. 25D shows the expandable deflector of FIGS. 25A-25C in an expanded configuration. [Figure 26A]

[0118] Figure 26A shows an example of an inner catheter including an expandable deflector. Figure 26A shows a side perspective view of the distal end region of the inner catheter. [Figure 26B] Figure 26B shows an example of an inner catheter including an expandable deflector. Figure 26B shows a cross section through the view of Figure 26A. [Figure 26C] Figure 26C shows an example of an inner catheter including an expandable deflector, which is a cross section (section C-C') across the distal end region of Figure 26B. [Figure 27]

[0119] 27A-27B show one example of a method for deflecting from chordae using a guidewire with an expandable deflector (similar to that shown in FIGS. 25A-25C). [Figure 28]

[0120] 28A-28B show one example of a method for deflecting from chordae using an inner catheter with an expandable deflector (similar to those shown in 26A-26C). [Figure 29]

[0121] FIG. 29 illustrates an example of a method for replacing a valve as described herein. [Figure 30A]

[0122] FIG. 30A shows an example of an outer catheter configured as a pacing sheath as described herein. [Figure 30B]

[0123] FIG. 30B shows a cross section through the distal end region of the outer catheter (pacing sheath) of FIG. 30A. [Figure 30C]

[0124] FIG. 30C shows a longitudinal cross section through a portion of the distal end region of the outer catheter of FIG. 30A (transverse to the cross section shown in FIG. 30B). [Figure 31]

[0125] FIG. 31 is a cross section through the proximal region of the outer catheter of FIG. 30A. DETAILED DESCRIPTION OF THE INVENTION

[0087]

[0126] The present disclosure describes apparatus (e.g., devices, systems, etc.) and methods for inserting, guiding, and implanting a replacement heart valve (e.g., an aortic valve, a mitral valve, etc.) using an antegrade approach. In some examples, a transcatheter valve replacement apparatus may include an outer catheter and at least one inner catheter, which may be detachably coupled to each other. The inner and outer catheters may decrease in stiffness distally, away from the surgeon or the handle of the apparatus. Either catheter may be pre-shaped or shaped by the surgeon. Also, or alternatively, either inner catheter may include a pre-shaped or shapeable distal tip. Either apparatus may include a dilatation balloon to assist in enlarging a puncture or hole, such as an atrial septal puncture.

[0088]

[0127] The devices and methods described herein may include or be configured for use 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 include pacing of the heart during the procedure. In particular, any of these methods and devices may include an outer catheter configured as a pacing sheath adapted to apply a pacing signal.

[0089]

[0128] FIG. 1A illustrates an exemplary transcatheter aortic valve replacement (TAVR) device 100. While described herein as a system, the TAVR device 100 may also be a device (e.g., an inner catheter). The TAVR device 100 may be configured as a system including an optional guidewire 110, an optional hemostasis valve 120, an outer catheter 130, an inner catheter 140, an optional three-way stopcock 150, and an inflation valve 160. The inner catheter may include a dilatation balloon 142 and a distal tip 145. Other exemplary TAVR devices may include fewer, more, or different components than the TAVR device 100 illustrated in FIG. 1A.

[0090]

[0129] The TAVR device 100 may be used to deliver a replacement valve percutaneously using an antegrade approach through the left ventricle. The TAVR device 100 may be suitable for percutaneous delivery through various blood vessels, including, but not limited to, the femoral artery. In some examples, the flexibility of the TAVR device 100 may vary from the proximal end (e.g., the end adjacent the hemostatic valve 120) to the distal end (e.g., the end adjacent the distal tip 145). For example, the flexibility of the outer catheter 130 and / or the inner catheter 140 may vary from relatively stiff near the hemostatic valve 120 to relatively flexible near the distal tip 145. The inner catheter 140 may be interchangeable with other inner catheters, for example, having distal tips with different shapes. These other inner catheters are described in detail in conjunction with FIGS. 18A-18L.

[0091]

[0130] One or more guidewires may be included as part of the system. In some examples, the guidewire 110 may be approximately 0.035 inches in diameter. In some other examples, the guidewire 110 may be any other larger diameter, such as a diameter greater than 0.035 inches (0.889 mm) (including, but not limited to, 0.040 (1.016 mm), 0.045 (1.143 mm), 0.050 (1.27 mm), or any other feasible larger diameter). In some other examples, the guidewire 110 may be any other smaller diameter, including a diameter less than 0.035 inches (0.889 mm) (including, but not limited to, 0.030 (0.762 mm), 0.025 (0.635 mm), 0.020 (0.508 mm), or any other feasible smaller diameter). The guidewire 110 may be formed from any feasible material, including Nitinol.

[0092]

[0131] The hemostatic valve 120 may provide a hemostatic barrier for any attached catheters, including the outer catheter 130 and the inner catheter 140. The hemostatic valve 120 may be attached to or otherwise coupled to the outer catheter 130. The inner catheter 140 may be removably coupled to the outer catheter 130. The hemostatic valve 120 may also receive and direct air from the inflation valve 160. Alternatively, or in addition, the hemostatic valve 120 may accommodate the guidewire 110. Although not shown, the guidewire 110 may travel through one or more concentric lumens and exit through the distal tip 145. The surgeon may manipulate the guidewire 110 to assist in positioning the dilatation balloon 142 in the desired area. The inner catheter may include a rapid exchange monorail connection for the guidewire, which will be described in more detail herein.

[0093]

[0132] The outer catheter 130 may be concentric with the inner catheter 140. In some examples, the outer catheter 130 may include a first section 133 and a second section 136. The first section 133 may be more rigid (e.g., less flexible) than the second section 136. The configuration of the outer catheter 130 is described in more detail in conjunction with FIGS. 4A-4C. The inner catheter 140 may be coupled to a dilatation balloon 142 and an inflation valve 160. In some examples, the inner catheter 140 may easily slide relative to the outer catheter 130. The dilatation balloon 142 may be inflated by the introduction of air through the inflation valve 160. As shown, when uninflated, the dilatation balloon 142 may be shrunk to a size relatively close to that of the guidewire 110. FIG. 170 (FIG. 1B) shows the dilatation balloon 143 in an inflated state.

[0094]

[0133] Hemostasis valve 120 is shown connected to three-way stopcock 150 by connecting tube 155 via flush port 157. Three-way stopcock 150 may allow any feasible liquid to be percutaneously introduced into the patient through hemostasis valve 120.

[0095]

[0134] 2A shows an exemplary distal tip section 200 of the TAVR device 100 of FIG. 1A. The distal tip section 200 may 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 may be examples of the guidewire 110, the outer catheter 130, and the inner catheter 140, respectively, of FIG. 1A.

[0096]

[0135] The transition 220 from the outer catheter 130 to the inner catheter 140 may be relatively smooth and seamless. The smooth and seamless transition 220 may aid in the insertion and manipulation of the TAVR device 100 and may prevent gaps that may catch and / or chafe in the body lumen into which the system is inserted. The inner catheter 240 may include a tapered element 245. The tapered element 245 allows for a reduction in size (diameter) from the transition 220 to the guidewire 110.

[0097]

[0136] The inner catheter 240 may extend partially or entirely through the outer catheter 230. The distal tip 241 may be coupled to the inner catheter 240 or may be integral with the inner catheter 240. The distal tip 241 may have a low cross profile to aid in steering, manipulation, and insertion of the TAVR device 100. In some instances, the distal tip 241 may also be highly flexible. An expandable member (e.g., a dilatation balloon 242) may be disposed on the inner catheter 240. As shown, the dilatation balloon 242 may be collapsed and / or folded. Other expandable members may include an expandable frame or struts, etc.

[0098]

[0137] FIG. 2B shows exemplary measurements associated with the distal tip section 250. The outer catheter may be, for example, 28 French (Fr). In this example, the exposed portion of the inner catheter may be 4-5 centimeters (cm). The dilatation balloon may be between about 8-12 millimeters (mm) and about 10-20 mm long. The distal tip may taper from 4 Fr to 3 Fr.

[0099]

[0138] 3A-3C illustrate an exemplary distal tip region 300 of the TAVR device 100 of FIG. 1A. The distal tip region 300 shown in FIG. 3A may include an outer catheter 330 and an inner catheter 340. The outer catheter 330 and the inner catheter 340 may be examples of the outer catheter 230 and the inner catheter 240, respectively, of FIG. 2. The distal tip region 300 may include a transition area 320.

[0100]

[0139] In some examples, the transition from the outer catheter 330 to the inner catheter 340 may be achieved using an interference fit as shown in diagram 345 (FIG. 3B) of the transition area 320. For example, a mechanical interference may exist between the outer catheter 330 and the inner catheter 340 such that a tapered element 347 of the inner catheter 340 may compress a distal portion of the outer catheter 330. In some examples, the mechanical interference region may be 346.

[0101]

[0140] In some examples, the transition from the outer catheter 330 to the inner catheter 340 may include a gap 355, as shown in diagram 350 (FIG. 3C) of the distal tip region 300. Diagram 350 also shows a step 357 that may hide or occlude the outer edge of the outer catheter 330. The step 357 may help smooth the transition between the outer catheter 330 and the inner catheter 340. The gap 355 may also allow for tolerances and / or manufacturing variations between various parts of the TAVR device 100.

[0102]

[0141] 4A-4C show exemplary diagrams of the mid-shaft section of the TAVR device 100 of FIG. 1A. The mid-shaft region 410 is shown. FIG. 4B shows a cross-section through the device of FIG. 4A. The mid-shaft region 410 includes an outer catheter 430 and an inner catheter 440. In some examples, the outer catheter 430 may include a first section 431 and a second section 432. In some examples, the outer catheter 430 may be stiff (e.g., less flexible) proximally toward a hemostasis valve (not shown) and flexible distally from the hemostasis valve. In some examples, the first section 431 may be stiffer than the second section 432. Additionally, a transition 434 between the first section 431 and the second section 432 may be a transition between stiffness (e.g., durometer) and / or internal reinforcement.

[0103]

[0142] The inner catheter 440 may include a locking ring 441. The outer catheter 430 may include a coupler 435. When the inner catheter 440 is inserted into the proximal end of the outer catheter 430, the locking ring 441 may slide into a space formed in the coupler 435. In this manner, the inner catheter 440 may be captured and locked (e.g., removably coupled) to the outer catheter 430.

[0104]

[0143] A cross-sectional view 450 of the mid-shaft region 410 is shown, including the outer catheter 430, the inner catheter 440, the locking ring 441, and the coupler 435. In some examples, the outer catheter 430 may decrease in diameter at the transition section 434. For example, the first section 431 may be 2-3 Fr larger than the second section 432. In some other examples, the first section 431 may be 3 Fr larger than the second section 432. In still other examples, the first section 431 may be less than 1 Fr larger than the second section 432.

[0105]

[0144] In some examples, the inner catheter 440 may include a rapid exchange port 446 through which the guidewire 411 (which may be an example of the guidewire 110 of FIG. 1A) may pass.

[0106]

[0145] Diagram 460 in FIG. 4C shows details related to coupler 435. Coupler 435 may be formed from stainless steel, nitinol, or any other feasible material. In some examples, coupler 435 may be formed by laser cutting a feasible material. Coupler 435 may include a split ring 461 that allows for the passage of a locking ring (not shown). Coupler 435 may also include a solid ring 462 that prevents further distal movement of the locking ring. The locking ring may be captured in a space 463 within coupler 435. Coupler 435 may include two or more flared tabs 465 that allow coupler 435 to be welded or otherwise attached to outer catheter 430.

[0107]

[0146] Figure 5 shows a proximal view 500 of the TAVR device 100 of Figure 1A. View 500 shows a guidewire 510, a hemostatic valve 520, an outer catheter 530, an inner catheter 540, and an inflation valve 560, which may be examples of the guidewire 110, the hemostatic valve 120, the outer catheter 530, the inner catheter 540, and the inflation valve 160 of Figure 1A. The inflation valve 560 may include an air inlet 561.

[0108]

[0147] Hemostasis valve 520 may be coupled to outer catheter 530 and may rotate relative to outer catheter 530. Hemostasis valve 520 may include a seal 521 to prevent and / or limit the unintended passage of fluid from outer catheter 530. Flush port 527 may be coupled to connecting tube 525. Connecting tube 525 may be directly or indirectly coupled to any feasible fluid source. Thus, connecting tube 525 may deliver fluid to flush port 527 and outer catheter 530.

[0109]

[0148] 6A-6B show example detailed views of the outer catheter of the TAVR device 100 of FIG. 1A. A first example view 610 may include a hemostasis valve 620 and an outer catheter 630, which may be examples of the hemostasis valve 120 and outer catheter 130 of FIG. 1A. View 610 may also show an outer catheter distal tip 640 and a coupler 635. Coupler 635 may be an example of coupler 435 of FIG. 4A.

[0110]

[0149] The outer catheter 630 may include a first section 633 and a second section 636. As shown, there may be a transition 637 between the first section 633 and the second section 636. In some examples, the first section 633 may be more rigid than the second section 636. For example, the first section 633 may include a braid 634, which may provide stiffness, kink resistance, and kink resistance (e.g., torqueability). In contrast, the second section 636 may include a helical or spiral reinforcement 638. The helical or spiral reinforcement may provide less stiffness relative to the first section 633. However, the second section 636 may still have kink resistance and kink resistance. Also, the first section 633 may have a 30F diameter, and the second section 636 may have a 28F diameter. These diameters are exemplary and not meant to be limiting. First section 633 and second section 636 may be of any feasible diameter. In some examples, the diameter of second section 636 may be smaller than the diameter of first section 633. The smaller diameter may allow second section 636 to be more flexible relative to first section 633.

[0111]

[0150] The hemostasis valve 620 may be rotatable with respect to the outer catheter 630. In some examples, the hemostasis valve 620 may include a hub 621 that allows 360 degree rotation between the proximal and distal portions of the hemostasis valve 620. The hemostasis valve 620 may include a flush port 627.

[0112]

[0151] The outer catheter distal tip 640 may include any feasible radiopaque material (e.g., radiopaque markers) to allow a surgeon to visualize and / or position 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-filled polymer, such as tungsten-filled Pebax®.

[0113]

[0152] The second exemplary diagram 650 shows exemplary dimensions of the outer catheter 630. In some instances, the second section of the outer catheter 630 may be approximately 30-40 cm in length. 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. Furthermore, in some instances, the inner diameter of the outer catheter distal tip 640 may be approximately 23 Fr (or may be approximately 1 Fr reduced relative to the inner diameter of the second section). The inner diameter 651 of the outer catheter 630 may include any suitable lubricious liner, such as polytetrafluoroethylene (PTFE).

[0114]

[0153] 7 shows an exemplary detailed view of an outer catheter transition area 700. The transition area 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 of FIG. 4A.

[0115]

[0154] In some examples, the distal section 710 and / or the proximal section 720 may include overlapping layers of coil and / or braid reinforcement material to increase kink and twist resistance. In some examples, the distribution and / or type of coil and braid material may vary from proximal to distal along the outer catheter. In this manner, the stiffness of the outer catheter may be higher in the proximal section 720 and lower in the distal section 710.

[0116]

[0155] 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 increase flexibility and kink resistance.

[0117]

[0156] 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 to the coil of the distal section 710. A tab 735 of the coupler 730 may be welded to the coil 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 modify flexibility, stiffness, kink resistance, etc.

[0118]

[0157] 8 shows an exemplary detailed view of an inner catheter 800. The inner catheter 800 may include an inflation valve 810, a proximal shaft 815, a distal shaft 820, a locking ring 830, a proximal tapered element 840, a distal tapered shaft 850, a dilation balloon 860, an inner shaft 880, and a distal tip 890.

[0119]

[0158] An optional inflation valve 810 may be used to inflate an optional dilatation balloon 860 through a lumen contained in or formed by the inner catheter 800. In some examples, the proximal shaft 815 may be formed from a stainless steel shaft. In some other examples, the proximal shaft 815 may be formed from any other feasible material. The distal shaft 820 may include a braided inner layer and a durable outer layer. A locking ring 830, which may be an example of a locking ring 441, may be disposed on the distal shaft 820.

[0120]

[0159] Proximal tapered element 840 may be distal to locking ring 830 and / or distal shaft 820. Distal tapered shaft 850 may extend beyond proximal tapered element 840. As shown, distal tapered shaft 850 may be surrounded and / or enveloped by dilation balloon 860. Dilation balloon 860 is shown in possible inflated states. Radiopaque marker band 870 may be positioned on distal tapered shaft 850 to assist the surgeon in positioning dilation balloon 860 within the patient.

[0121]

[0160] The inner catheter 800 may include a coil or braid-reinforced microcatheter inner shaft. The distal tip 890 may also include radiopaque material (e.g., radiopaque markers).

[0122]

[0161] 9 shows an exemplary interior (cross-sectional) view of an inner catheter 900. The inner catheter 900 may include an inflation lumen 910, a squib hypotube 920, and a rapid exchange port 930. The inflation lumen allows for the transfer of air from the inflation valve to the dilatation balloon. The squib hypotube 920 may be adjacent to the inflation lumen 910. The skiving may be variable, as described in more detail in FIG. 10.

[0123]

[0162] The inner catheter 900 may also include a rapid exchange port 930 to allow for the insertion of a guidewire. In some examples, the inner catheter 900 may include an inner lumen 940. The inner lumen 940 may be coated with and / or include a lubricious coating of, for example, PTFE.

[0124]

[0163] FIG. 10 illustrates an example of a squib hypotube 1000. The squib hypotube 1000 may be an example of the squib hypotube 920 of FIG. 9. As shown, the squib hypotube 1000 may include a continuous, straight skive 1010 having more material proximally and less material distally. The transition of material from the proximal end to the distal end may be smooth and continuous. The continuous, straight skive 1010 may provide more flexibility toward the distal end of the squib hypotube 1000.

[0125]

[0164] 11A-11C show examples of an inner catheter, particularly below a dilatation balloon. The example shown here may be an example of the distal end of the inner catheter 800 of FIG. 8. FIG. 11A shows a first example of an inner catheter 1100. The inner catheter 1100 may include a dilatation balloon 1111 and a first tapered element 1112. As shown, the dilatation balloon 1111 may be deflated (not deployed or inflated). The inner catheter 1100 may include a second tapered element 1113 disposed substantially below the balloon region 1114. In particular, the second tapered element 1113 terminates near a region 1115 where the dilatation balloon 1111 may contact the first tapered element 1112.

[0126]

[0165] 11B shows a second example of an inner catheter 1120. The inner catheter 1120 may include a dilatation balloon 1131, a first tapered element 1132, and a second tapered element 1133. As shown, the second tapered element may taper below the balloon region 1134 and may have a constant outer diameter over the remainder of the length of the inner catheter 1135.

[0127]

[0166] 11C shows a third example of an inner catheter 1140. The inner catheter 1140 may include a dilatation balloon 1151 and a tapered element 1152. The tapered element 1152 may be thicker than the corresponding first tapered element of FIGS. 11A and 11B. In some examples, the inflation lumen 1135 integrated into the inner catheter 1140 may be thinner than the corresponding inflation lumen of the inner catheters 1100 and 1120.

[0128]

[0167] 12A shows an exemplary inner catheter 1200. The inner catheter 1200 may not include a dilatation 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 element 1218, an inner shaft 1220, and a distal tip 1222.

[0129]

[0168] The handle 1210 may allow a surgeon to insert the inner catheter 1200 into an outer catheter (such as the outer catheter 130 of FIG. 1 or any other feasible outer catheter). In some examples, the locking ring 1216 may engage with a coupler on the outer catheter (not shown). The proximal shaft 1212 may be formed from stainless steel and may be relatively rigid. The rigidity of the inner catheter 1200 may gradually increase in flexibility away from the handle 1210.

[0130]

[0169] 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. A locking ring 1216 may be disposed on the distal outer shaft 1214. The inner catheter 1200 may be inserted into any feasible outer catheter. In some examples, the locking ring 1216 may engage with a corresponding coupler, such as coupler 435 of FIG. 4A.

[0131]

[0170] A tapered element 1218 may be disposed at the distal end of the distal outer shaft 1214. The shape of the tapered element 1218 may allow for insertion of the inner catheter 1200 and enlarge an obstruction or puncture within a lumen, although other uses are possible. Distal to the tapered element 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 with respect to the outer catheter of FIGS. 6A-6B.

[0132]

[0171] The distal tip 1222 may be distal to the inner shaft 1220 and the tapered element 1218. In some examples, the distal tip 1222 may include radiopaque material (e.g., radiopaque markers) to allow a surgeon to position and track the inner catheter using fluoroscopy or other similar methods.

[0133]

[0172] 12B shows a cross section 1250 of the inner catheter 1200. The cross section 1250 may show a rapid exchange port 1260, a squib hypotube 1262, and a guidewire lumen 1264. The rapid exchange port 1260 may allow for insertion of a guidewire into the guidewire lumen 1264. The squib hypotube may be an example of the squib hypotube 1000 of FIG. 10. Because there is no dilatation balloon that needs to be inflated, the proximal shaft may be occluded (shown at 1266).

[0134]

[0173] FIG. 13A shows an exemplary distal end 1300 of any possible inner catheter. In some examples, the distal end 1300 may be the distal tapered shaft 850 of FIG. 8, any of the tapered elements of FIGS. 11A-11C, the tapered element 1218 of FIG. 12A, etc. The distal end 1300 may include a tapered element 1310, an embedded profile wire 1320, and a guidewire lumen 1330. The embedded profile wire 1320 may be laminated and / or encapsulated within the tapered element 1310. In some examples, the embedded profile wire 1320 may be stainless spring steel, nitinol, or any other possible material.

[0135]

[0174] The distal end 1300 may be shaped into any feasible shape, including a curve, as shown. The tapered element 1310 may be shaped, at least in part, by an embedded shape wire 1320. In some instances, the embedded shape wire 1320 may retain or maintain a shape, such that the tapered element 1310 maintains a desired shape.

[0136]

[0175] A cross section 1340 of the distal end 1300 is shown. The cross section 1340 shows the cross sections of the tapered element 1310, the embedded shape wire 1320, and the guidewire lumen 1330. As shown, the cross section of the embedded shape wire 1320 may be a flat oval, although other cross sections are possible. For example, the cross section of the embedded shape wire 1320 may be circular, flat / ribbon, square, or any other feasible shape.

[0137]

[0176] Additionally or alternatively, the distal end 1300 may be shaped by the application of heat. For example, the tapered element 1310 may be formed from or include a heat-set polymer. The tapered element 1310 may be placed in a heat-set die to form it into the desired shape. In other examples, the shape of the tapered element 1310 may be controlled via a pull wire. The pull wire may be secured to the tapered element 1310 and made available to the surgeon.

[0138]

[0177] In some examples, tapered element 1310 may include a stylet channel (not shown) so that stylets of different semi-rigid shapes can be inserted through the port, allowing tapered element 1310 to conform to the shape of the stylet.

[0139]

[0178] 13B shows another exemplary distal tip 1350. The configuration of distal tip 1350 may be similar to that of distal tip 1300, but in some examples, distal tip 1350 may include a shapeable embedded shape wire 1360. Shapeable embedded shape wire 1360 may be any feasible ductile material or metal that may be manually shaped by a surgeon or other user.

[0140]

[0179] 14A-14C show exemplary shapes of the distal end of any possible inner catheter. FIG. 14A shows a distal end 1400 including a tapered element 1410 and a distal outer shaft 1411. In this example, the tapered element 1410 may be shaped to have a bend of approximately 30 degrees. FIG. 14B shows a distal end 1420 including a tapered element 1421 and a distal outer shaft 1422. In this example, the tapered element 1421 may be shaped to have a bend of approximately 90 degrees. FIG. 14C shows a distal end 1430 including a tapered element 1431 and a distal outer shaft 1432. In this example, the tapered element 1431 may be shaped to have a bend of approximately 120 degrees.

[0141]

[0180] The bends shown in Figures 14A-14C are meant to be exemplary and not limiting. In other embodiments, the distal end of the inner catheter may have any feasible bend.

[0142]

[0181] In some instances, the distal end of the inner catheter may be curved but relatively flexible. When a guidewire is inserted, the distal end may straighten. Conversely, when the guidewire is withdrawn from the distal end (from the tapered element), the distal end may return to a predetermined shape.

[0143]

[0182] FIG. 15A shows an exemplary distal end of an outer catheter. The outer catheter may be any feasible outer catheter, including the outer catheter 130 of FIG. 1A. The outer catheter may include a shape-set coil 1500. The shape-set coil 1500 may provide a predetermined desired shape to the distal end of the outer catheter. In some examples, the shape-set coil 1500 may be made of nitinol, stainless steel, or any other feasible material. In some examples, the shape-set coil 1500 may be heat-set into the desired shape. In some examples, the initial shape of the shape-set coil 1500 may be “more aggressive” (e.g., have more curvature or angle) because some of the curvature or angle may be lost when the shape-set coil 1500 is layered to form the outer catheter.

[0144]

[0183] In some examples, the shape-setting coil 1500 may be transferred to a dowel, shaft, or other form. A low durometer polymer and a thin liner may be applied. The polymer and liner may allow the shape-setting coil 1500 to, at least in part, determine the shape of the distal end of the outer catheter.

[0145]

[0184] In some examples, a hybrid design may include a shape-setting coil 1500 and a non-shaped coil. The shape-setting coil 1500 may be positioned distal to the non-shaped coil. In this manner, the distal portion of the outer catheter may be shaped, and the proximal portion of the outer catheter may be relatively straight.

[0146]

[0185] 15B shows an exemplary distal end of a shaped outer catheter 1510. 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 its unconstrained shape.

[0147]

[0186] 16 illustrates possible cross sections 1600 of outer catheters. As described herein, the shape-set 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-set wire 1611 as part of outer catheter 1612. Exemplary cross section 1620 includes a circular shape-set wire 1621 as part of outer catheter 1622. Exemplary cross section 1630 includes a flat (ribbon) shape-set wire 1631 as part of outer catheter 1632.

[0148]

[0187] In some examples, any of the sections 1600 may include a heat-set polymer that forms all or part of the outer catheter. In some examples, any of the sections 1600 may include one or more pull wires to control the shape of the outer catheter. In some other examples, any of the sections 1600 may include a stylet channel.

[0149]

[0188] Figures 17A-17D show exemplary outer catheter shapes. Figure 17A shows an outer catheter 1700 with a sharp 30-degree bend. Figure 17B shows an outer catheter 1710 with a smooth 30-degree bend. Figure 17C shows an outer catheter 1720 with a smooth 120-degree bend. Figure 17D shows an outer catheter 1730 with a smooth 120-degree bend, with the distal tip 1731 of the inner catheter 1732 having a 45-degree bend. The examples in Figures 17A-17D are meant to be illustrative and not limiting. For example, any feasible combination of bends and / or bend angles is possible.

[0150]

[0189] 18A-18L illustrate exemplary steps for using the TAVR device 100 of FIG. 1A to introduce a replacement aortic valve into a patient. The steps described herein are merely exemplary and are not meant to be limiting. Other steps may be used, and in some cases, the steps may be performed in a different order. In particular, FIGS. 18A-18L illustrate various interchangeable inner catheters for use with the TAVR device 100.

[0151]

[0190] 18A, a guidewire 1801 is introduced into the left atrium of the heart via a transseptal puncture (through the atrial septum). For example, the guidewire 1801 may be introduced percutaneously into the patient's femoral artery, at least in part, using the TAVR device 100. The guidewire 1801 may be a 0.035 inch guidewire, although in other examples, the guidewire 1801 may be of other thicknesses or gauges. In some examples, the transseptal puncture may be performed using a radiofrequency device positioned on or near the distal end of the guidewire 1801.

[0152]

[0191] Next, in FIG. 18B, the first exchangeable inner catheter 1802 and the outer catheter 1803 may be advanced into the transseptal puncture. For example, the first exchangeable inner catheter 1802 and the outer catheter 1803 may use the guidewire 1801 as a monorail guide. For example, the first exchangeable inner catheter 1802 may be introduced over the guidewire 1801 and positioned into the inferior vena cava (IVC) and right atrium. A transseptal puncture may then be performed, and the first exchangeable inner catheter 1802 may be advanced through the puncture. Note that the distal tip of the first exchangeable inner catheter 1802 may be relatively straight.

[0153]

[0192] 18C illustrates an optional step of balloon septotomy. In this step, a dilation balloon 1804 may be advanced to the transseptal puncture and inflated to dilate (widen) the puncture. In some examples, the dilation balloon 1804 may have an inflated diameter of 6 mm. After septotomy, the dilation balloon 1804 may be removed. After dilation, the dilation balloon 1804 may be deflated and withdrawn.

[0154]

[0193] 18D shows the guidewire 1801 and outer catheter 1803 in place. For example, the first exchangeable inner catheter 1802 may be unlocked from the outer catheter 1803 and then removed / withdrawn from the patient. As shown, the guidewire 1801 remains in the left atrium.

[0155]

[0194] 18E illustrates the introduction of a second, exchangeable inner catheter 1805 through the outer catheter 1803. The second, exchangeable inner catheter 1805 may include a distal end and / or tip that is curved at an angle of more than about 30 degrees. The second, exchangeable inner catheter 1805 may be locked to the outer catheter 1803 (e.g., via a locking ring and coupler). The second, exchangeable inner catheter 1805 may use the guidewire 1801 as a monorail guide.

[0156]

[0195] 18F shows the second exchangeable inner catheter 1805 and the outer catheter 1803 advanced through the mitral valve into the left ventricle. The second exchangeable inner catheter 1805 and the outer catheter 1803 may be guided by a guidewire 1801 (not shown).

[0157]

[0196] 18G, the second, exchangeable inner catheter 1805 is then unlocked and withdrawn from the outer catheter 1803. The positions of the guidewire 1801 and outer catheter 1803 are maintained within the left ventricle.

[0158]

[0197] 18H shows a third exchangeable inner catheter 1806 being inserted and guided into the left ventricle. The third exchangeable inner catheter 1806 may include a distal end and / or tip that is curved at an angle of approximately 120 degrees or more. In some examples, the third exchangeable inner catheter 1806 may be inserted and locked within the outer catheter 1803. In some examples, the guidewire 1801 may optionally be removed. The third exchangeable inner catheter 1806 may be positioned such that the distal end of the third exchangeable inner catheter 1806 may be directed toward the aortic valve.

[0159]

[0198] Figure 181 shows guidewire 1801 advanced distally (antegrade in the direction of blood flow) through the left ventricular outflow tract (LVOT) and across the aortic valve. In some cases, guidewire 1801 may be a stiffer guidewire than the guidewires used earlier in the procedure (e.g., Figures 18A-18G).

[0160]

[0199] 18J illustrates a first optional positioning of the third exchangeable inner catheter 1806 and the outer catheter 1803 within the patient's heart. Note that the curve of the third exchangeable inner catheter 1806 may be at least partially straightened by the guidewire 1801. As shown, the distal tip of the outer catheter 1803 may be below the annulus of the aortic valve.

[0161]

[0200] 18K illustrates a second optional positioning within the patient's heart of the third exchangeable inner catheter 1806 and the outer catheter 1803. As shown, the distal tip of the outer catheter 1803 may be advanced across the aortic valve.

[0162]

[0201] 18L shows the TAVR device 100 as the third exchangeable inner catheter 1806 is being withdrawn. For example, the third exchangeable inner catheter 1806 may be unlocked from the outer catheter 1803 and fully withdrawn from the patient. In this position, the outer catheter 1803 is ready to deliver the replacement aortic valve. Optionally, once the distal tip of the outer catheter 1803 has crossed the aortic valve, the surgeon may optionally withdraw or position the distal tip of the outer catheter 1803 below the aortic valve annulus to aid in positioning and deployment of the replacement aortic valve.

[0163]

[0202] It should be noted that the position of any of the elements of the TAVR device 100 during any step may be confirmed using any feasible technique, including but not limited to echocardiography, transesophageal echocardiography, aortic contrast injection, etc. The positioning of the TAVR device 100 may be enhanced by implanted and / or included radiopaque elements (e.g., radiopaque markers).

[0164]

[0203] 19 is a flowchart illustrating an exemplary method 1900 for transseptal implantation of a replacement aortic heart valve. Some examples may perform the operations described herein using additional operations, fewer operations, operations in a different order, operations in parallel, and some operations in different ways. Although method 1900 is described below with respect to TAVR device 100 of FIG. 1A, method 1900 may be performed by any other suitable system or device.

[0165]

[0204] The method 1900 may optionally include performing a transseptal puncture. The TAVR device may place a guidewire into the heart. 1902 For example, the TAVR device may introduce the guidewire percutaneously into an artery, such as the femoral artery, although other arteries or veins may be used. In some instances, the transseptal puncture may be performed using a radiofrequency device. The TAVR device may be advanced through the atrial septum and positioned within the left atrium of the heart. 1904 The inner and outer catheters may be advanced across the atrial septum. For example, a first exchangeable 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 exchangeable inner catheter may include a dilation balloon that may be used to dilate or enlarge the septal puncture. After dilation, the dilation balloon and / or the first exchangeable inner catheter may be removed. Optionally, the same inner catheter may be used. Either the same or a different inner catheter may be deflected (e.g., bent, twisted, tilted, etc.) within the left atrium so that the distal end region of the inner catheter exhibits a first bend. 1904 A guidewire may then be directed distally from the inner catheter into the left ventricle.

[0166]

[0205] The inner and outer catheters may then be advanced into the left ventricle. 1906 For example, the inner and outer catheters may be advanced through the atrial valve. In some instances, a second, exchangeable inner catheter 1805 may be inserted and locked into the outer catheter 1803. Alternatively, the same inner catheter may be used (e.g., particularly if the inner catheter is steerable or deflectable greater than 120 degrees, as described below). In this manner, the inner catheter (or a new inner catheter) and outer catheter 1803 may be advanced into the left ventricle. Once in the left ventricle, the inner catheter (either the same inner catheter or a new inner catheter) may be deflected within the left ventricle such that the distal end region of the inner catheter assumes a second bend (typically >120 degrees) and faces the left ventricular outflow tract 1907.

[0167]

[0206] The guidewire may then be advanced through the aortic valve. 1908 In some instances, the guidewire may be advanced through the aortic valve and into the aorta. Additionally, in some instances, the inner catheter used in the previous step may be removed and replaced with another interchangeable inner catheter.

[0168]

[0207] The catheters may then be advanced and positioned across the aortic valve annulus. 1910 For example, the inner and outer catheters may be positioned at or near (or, in some instances, across) the aortic valve annulus. In some instances, the distal end of the outer catheter may be above the aortic valve annulus. In some other instances, the distal end of the outer catheter may be below the aortic valve annulus.

[0169]

[0208] A guidewire (or a second guidewire having a different stiffness) may be advanced from the distal end of the inner catheter and across the aortic valve of the patient's heart.

[0170]

[0209] The replacement aortic valve may then be implanted. 1912 In some instances, the inner catheter may be unlocked and withdrawn from the outer catheter prior to placement and implantation of the replacement aortic valve.

[0171]

[0210] 20A and 20B show another example of a system 2000 for antegrade delivery of a replacement aortic valve. In this example, the system includes an outer catheter and an inner catheter. The inner catheter is inserted into the outer catheter hub 2021 (shown in FIG. 20A) of the outer catheter 2030. The inner catheter 2040 in this example is deflectable or bendable at its distal end region (shown in FIG. 20B). Deflection may be controlled by actuation of a deflection control 2056 on an inner catheter deflection handle 2055. In this example, moving the control forward or backward (indicated by arrow 2057) may deflect a deflectable region 2061 of the inner member, distal to the connection region 2063 with the outer catheter and proximal to the distal (tapered) end 2065 of the inner catheter. In this example, the inner catheter is configured to deflect greater than 120 degrees when coupled to the distal end of the outer catheter (e.g., in FIG. 20B , the deflection is greater than 180 degrees, as indicated by arrow 2058). Thus, a bending region 2061 between the engagement surface and the distal end is configured to exhibit a bending greater than 120 degrees. In some examples, the bending may be actuated by a wire or tendon (e.g., a pull wire) that may extend through or through the wall of the inner catheter. Any suitable actuation mechanism may be used. For example, the catheters described herein may be tendon-actuated catheters, magnetic navigation catheters, soft material-actuated catheters (e.g., shape memory effect catheters, steerable needles, concentric tubes, conductive polymer-actuated catheters, hydraulically actuated catheters, etc.), and hybrid actuation catheters. These catheters may have a single section or multiple sections.

[0172]

[0211] As shown in FIG. 20B, the distal end region of the inner catheter is tapered 2065, and the proximal region of the inner catheter includes an engagement surface proximal to the distal end of the inner catheter, the engagement surface forming part of a coupling region 2063, which is configured to removably and sealably couple to the distal end 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 any gaps.

[0173]

[0212] 20A-20B is just one example of an inner catheter, and other examples may include smaller bending angles (e.g., 20-90 degrees, 30-90 degrees, etc.) The outer catheter may be steerable.

[0174]

[0213] FIG. 21 illustrates an example of a method for using a system including a steerable inner catheter such as that shown in FIGS. 20A-20B. In this example, the system is shown with inner and outer catheters extending from an antegrade direction (e.g., through the septal opening into the left atrium and then into the left ventricle), similar to that shown in FIGS. 18A-18L. A relatively rigid guidewire 2110 is shown extending from the inner catheter 2140 into the ascending aorta. The inner and outer catheters (linked as shown) may be advanced so that the outer catheter is adjacent to the aortic valve; the inner catheter may then be removed, leaving the outer catheter in place to deliver the replacement valve (along with the guidewire). As mentioned above, in any of these examples, the outer catheter (which may be referred to as an outer sheath) can be delivered through the diseased aortic valve or placed just proximal to the inferior surface of the aortic valve. Thus, the guidewire may be extended across the valve or pushed across the replacement valve without driving the sheath across the valve.

[0175]

[0214] While the examples described above and shown in Figures 18A-18L illustrate methods for replacing an aortic valve, similar techniques may be used to replace a mitral valve from an antegrade approach. For example, the same basic steps described above may be followed, but the outer and inner catheters may be advanced only to the mitral valve (e.g., without the need to deflect the inner catheter within the left ventricle). For example, the variations of Figures 18A-18G may be implemented to place the distal end of the outer catheter adjacent to or through (e.g., beyond) the mitral valve. After delivery of the outer catheter (e.g., a sleeve), a percutaneous mitral valve interventional device (e.g., a mitral valve replacement device, mitral valve repair device, clip, etc.) may be advanced, positioned, and deployed through the outer catheter into the mitral valve or an area adjacent to the valve.

[0176]

[0215] In general, the methods and devices described herein may include one or more features that enhance their use for valve replacement. For example, the inner catheter may be configured for rapid exchange over a guidewire (e.g., a monorail), while the outer catheter is not. Generally, the inner and outer catheters may sealably lock together as described, and the inner catheter may be steered when locked to (and extending distally from) the outer catheter, such that the inner catheter may be freely steered without interference from the outer catheter while remaining locked to the inner catheter in a predictable and safe manner. The inner catheter may also have a steeply tapered distal end (e.g., 3F-20F in some examples), and this tapered region may be relatively short (e.g., extending 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 may prevent damage to tissue and allow for navigation within the heart. Additionally, in steerable inner catheters, the deflection region may stop proximal to the distal end of the inner catheter, allowing the distal, highly flexible tip to follow the guidewire. For example, the steerable region may terminate approximately 4-5 mm behind the distal tip. In general, the devices and methods described herein are configured to prevent abrasion that may otherwise damage blood vessels and cause material (e.g., thrombus, plaque, calcified material, etc.) to be released from the heart valves and / or walls.

[0177] filter

[0216] Generally, any of the devices and methods described herein may include one or more filters that may be configured to be positioned distally from the device when (or after) it is positioned relative to the valve. The filter 2371 may be a filter wire, such as that shown in FIG. 22A, configured to capture loose material during valve positioning and deployment. FIG. 22A illustrates placement of a filter 2371 as part of the system described above. For example, the filter may be coupled to a wire 2375 (e.g., a 0.035 inch wire) and deployed within the ascending aorta to capture debris from valve deployment and replacement. The filter may be self-expanding and may be deployed as part of (e.g., attached to) a guidewire, or may be applied using (e.g., over) or adjacent to a guidewire, and may be advanced into place in a collapsed configuration with a sheath (not shown) over the self-expanding filter 2271. Once in a distal position at the distal end of the outer catheter and further antegrade, the filter sheath may be removed and the filter deployed as shown. Once deployed, the filter may capture any debris resulting from the procedure. Following the procedure, the sheath may be reattached and the filter removed, for example, and withdrawn to remove any trapped debris.

[0178]

[0217] In some instances, the filter wire may act as a 0.035 inch guide wire to deliver the valve. In some instances, the filter may be deployed in the ascending aorta, and the sheath for the filter may be completely removed (e.g., withdrawn completely from the body) so that a replacement valve (e.g., a TAVR valve) may be advanced over the filter wire. Once the valve is deployed, debris may be trapped within the filter and removed to retrieve the filter and any debris trapped during the procedure and reduce the risk of embolic embolism to other more distal arterial intracerebral vessels.

[0179]

[0218] Any suitable wire may be used for the filter wire and / or guidewire. For example, in some cases, the distal end of the wire may be, for example, an A3J guidewire (e.g., the distal end may have a predetermined curve or shape) and may be of any suitable length. In some instances, a filter region may be attached or poisoned in a region proximal to the distal end. For example, 15 cm proximal to the tip of the wire may include a filter attached to the wire. The filter may be, for example, an expandable nitinol filter that may be delivered constrained by an outer sheath. Pulling the sheath may expand the filter (e.g., to a diameter of 3 cm or more) and, in some instances, contact the wall of the ascending aorta (e.g., approximately 8 cm above the valve and before the first branch of the aortic arch). Thus, any of the methods and devices described herein may involve users of such filters (and antegrade filters).

[0180]

[0219] Alternatively, or in addition, a wire (e.g., a filter wire, a guidewire, etc.) may be used to deliver contrast agent distal to the proximal aorta (e.g., a contrast agent-deploying guidewire). For example, any of the wires described herein (e.g., a guidewire, a filter wire, etc.) may be hollow and include one or more distal openings (holes, slits, etc.) through which contrast agent may be used. For example, any of these devices may include a wire to deliver contrast agent (and optionally deliver and / or control a filter). In some examples, the wire may include one or more side holes in the wire through which contrast agent may be delivered, e.g., a syringe may be applied to the proximal end of the wire to inject contrast agent through the wire. Contrast agent may be delivered in this manner with or without the use of a filter. Alternatively, or in addition, contrast agent may be used through the outer catheter to aid in accurate placement of the valve.

[0181]

[0220] FIG. 22B shows an example of a contrast agent deployment guidewire 2377 that includes multiple injection holes 2379 disposed along the lateral length of the guidewire. The distal tip region of the contrast agent deployment guidewire can be solid (e.g., does not allow contrast agent to pass through the distal end). Alternatively, in some examples, the distal tip region can be open instead of or similar to the lateral openings. The length of the region of the contrast agent deployment guidewire that includes multiple openings can be, for example, between 0.5 cm and 10 cm (e.g., 0.5 cm or more, 0.75 cm or more, 1 cm or more, 1.5 cm or more, 2 cm or more, 3 cm or more, 4 cm or more, 5 cm or more, about 0.5-10 cm, about 0.5-8 cm, about 0.5-7 cm, about 0.5-6 cm, about 0.5-5 cm, about 0.5-3 cm, etc.). The solid 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, about 0.5-10 cm, about 1-8 cm, about 0.5-7 cm, about 0.5-6 cm, about 0.5-5 cm, etc.).

[0182]

[0221] The contrast agent deployment guidewire may be formed from any suitable material, including polymeric and / or metallic materials (eg, stainless steel, nitinol, etc.).

[0183] Expandable deflector

[0222] The methods and devices for replacing a valve described herein may include an expandable deflector that deflects the chordae to prevent any of the components (e.g., guidewire, inner catheter, outer catheter, etc.) from becoming entangled within the chordae during the procedure. For example, any of the methods and devices described herein may include an expandable deflector configured to deflect the chordae to prevent damage to the valve and / or chordae, including preventing severing of the chordae that might otherwise result in mitral valve regurgitation.

[0184]

[0223] The expandable deflector may include any expandable member, such as a balloon, basket, mesh, or the like, that may be controllably expanded and contracted. In some examples, the device may include one or more expandable deflectors at the distal end region of the guidewire, inner catheter, and / or outer catheter. The expandable deflector may expand before, during, or immediately after inserting the device into a cardiac chamber (e.g., the left ventricle) as described above, displacing it away from the device and away from the chordae tendineae to prevent it from becoming trapped between the chordae tendineae and the ventricular wall. In some examples, the expandable deflector may act to center the device in the mitral valve apparatus and / or left ventricle.

[0185]

[0224] 23A-23C show a first example of a device including an expandable deflector. FIG. 23A shows a guidewire 2300 including an expandable deflector 2307 configured as a flexible balloon extending across the distal region of the device. In FIG. 23A, the guidewire is configured as a mitral valve centering guidewire. The expandable deflector 2307 may be expanded (as shown in FIG. 24A) to deflect from the chordae tendineae when in the ventricle. In FIG. 23A, the guidewire has a J-tip 2305 having a diameter of approximately 0.035 inches, which may be atraumatic and may include radiopaque markers. The expandable member may be formed of a flexible tube forming a balloon that is connected to the outer surface of the guidewire by a polymer jacket 2309. The more proximal outer surface region 2311 of the guidewire may be configured with a textured surface that may provide additional grip for the inflation hub Tuohy region, as shown in FIG. 24B.

[0186]

[0225] As shown in the cross-sectional view of FIG. 23B, the guidewire may be cut (e.g., laser cut) at the distal end region 2313 to increase and / or enhance flexibility. The guidewire in this example may be formed from a hypotube 2315 that has been laser cut and coated, laminated, or otherwise configured to seal the inner lumen, which may be configured as an inflation lumen for inflating an expandable deflector (e.g., a balloon). For example, as shown in FIG. 23C, the guidewire may be a cut hypotube sealed by a laminated polymer jacket 2327. FIG. 23C shows a slightly enlarged view of the guidewire distal section shown in FIG. 23B. In FIG. 23C, the distal tip 2317 is shown as an atraumatic distal tip that is attached (e.g., soldered, welded, etc.) to a J-shaped distal region 2319, which may include a shape-set inner core (e.g., a nickel titanium inner core) to have a J-shape. As shown in this example, the distal end (J-shaped) may be hermetically welded between the hypotube and the core wire 2321. The expandable deflector 2307 may be expanded by filling it with inflation fluid which may flow through the inner lumen of the guide wire. The distal end 2329 of the expandable deflector and the proximal end of the expandable deflector 2325 may be sealed to the guide wire as shown.

[0187]

[0226] FIG. 24A shows an example of a guidewire device 2400 similar to that shown in FIGS. 23A-23C. As shown in FIG. 24A, the expandable member 2307 may be expanded, for example, between about 4 mm and about 25 mm (e.g., between about 12 mm and about 20 mm, etc.). FIG. 23C is a slightly enlarged view of the device of FIGS. 23A-23B with the expandable deflector (e.g., balloon) in a collapsed configuration. FIG. 24A also includes a proximal end 2425 that may be coupled to a seal-removable inflation hub having a rotating Tuohy Borst seal 2424 (which may be used as a handle). The hub in this example may include a positioning window 2420 for aligning the guidewire, as well as an inflation port 2422 (e.g., a balloon inflation port). FIG. 24B shows a close-up of this handle of FIG. 24A (inflation hub with rotating Tuohy Borst seal 2424) including a Tuohy Borst seal 2430 sealed around the proximal end region of the guidewire.

[0188]

[0227] 25A-25D show another example of a guidewire including an expandable deflector 2507 (also configured as a flexible tip in this example). As shown in FIG. 25A, the guidewire 2500 of FIGS. 25A-25D has a straight distal end 2505 (shown as an atraumatic radiopaque tip) rather than the J-shaped distal end region of FIGS. 23A-23C. However, other features may be the same, including the polymer jacket region 2509 and the proximal textured surface 2511. As described above with respect to FIGS. 23A-23C, the guidewire may be formed from a hypotube 2515 that may be cut (e.g., laser cut) to increase the flexibility of the distal end region 2513. The guidewire 2500 may also include a machined platinum tip 2517, which may be an atraumatic tip, and a solder / adhesive joint 2520 connecting the sealed tip to the hypotube. The expandable deflector may be inflated by injecting fluid 2523 through the hypotube to inflate the balloon 2507 (as shown in FIG. 25D). The balloon may be seated in fluid communication with the lumen of the guidewire at proximal balloon seal 2525 and distal balloon seal 2529. As mentioned above, the laser-cut hypotube may be sealed by laminating a polymer jacket over the laser-cut hypotube 2527, for example, as shown in FIG. 25C.

[0189]

[0228] 26A-26C show an example of an inner catheter 2605 including an expandable deflector 2607. As shown in FIG. 26A, the inner catheter may be engaged with the outer catheter 2603 as described above. The expandable deflector (balloon 2607) may be disposed at the distal end region of the inner member and may be in fluid communication with an inflation lumen 2627, as shown in FIG. 26C. The distal end region of the inner catheter in FIGS. 26A-26C may be bendable or steerable using a pull wire within a pull wire lumen 2621, the distal end of which may be anchored 2617 within the distal end region, as shown in FIG. 26B. A guide wire 2611 may extend in and out of the guide wire lumen 2623. Thus, the inner catheter in this example may include a multi-lumen shaft 2625.

[0190]

[0229] In operation, the chordae tendineae of the ventricle may be avoided as part of any of the methods described herein for valve replacement. For example, FIGS. 27A-27B illustrate the use of a guidewire 2700 having an expandable deflector 2707 similar to that shown in FIGS. 25A-25D. The expandable deflector 2707 may be inflated while at the mitral valve, just proximal to the mitral valve, or in some instances just distal to the mitral valve. In some instances, inflation of the expandable deflector may aid in the advancement and centering of the guidewire away from the chordae tendineae. For example, expansion of the expandable deflector may act as a sail, allowing blood flow within the ventricle to pull the expanded deflector forward and retract the expandable deflector into the ventricle and valve during expansion. Once positioned, the expandable member may be deflated, or in some instances, may remain inflated while performing other steps of the method.

[0191]

[0230] 28A-28B show the same operation using an inner catheter 2805 (extending from an outer catheter 2803) that includes an expandable deflector 2707 similar to that shown in Figures 27A-27B. In Figure 28B, the expandable deflector 2807' is shown in an unexpanded state.

[0192]

[0231] In any of the drawings shown herein, the dimensions are for illustrative purposes only and other dimensions (e.g., + / - 5%, 10%, 15%, 20%, 25%, 50% or more) may be used.

[0193]

[0232] Figure 29 illustrates one example of a method for replacing a heart valve using an expandable deflector. In general, the expandable deflector may be used for any step of the procedure in which the device is maneuvered within the heart chamber. In Figure 29, the procedure may be performed while a pacing signal is applied to the heart to generate a pacing rhythm. 2901 This may be performed in any of the methods described herein using an outer catheter configured as a pacing sheath, as described in more detail below.

[0194]

[0233] The method 2900 may optionally include performing a transseptal puncture. 2903 As described above, the TAVR device may place a guidewire into the heart. For example, the TAVR device may 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, the transseptal puncture may be performed using a radiofrequency device. The TAVR device may be advanced through the atrial septum and positioned within the left atrium of the heart. The inner and outer catheters may be advanced across the atrial septum. 2905 For example, a first exchangeable 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 exchangeable inner catheter may include a dilation balloon that may be used to dilate or enlarge the septal puncture. After dilation, the dilation balloon and / or the first exchangeable inner catheter may be removed. Optionally, the same inner catheter may be used. Either the same or a different inner catheter may be deflected (e.g., bent, rotated, tilted, etc.) within the left atrium so that the distal end region of the inner catheter assumes a first bend. A guidewire may then be directed distally from the inner catheter into the left ventricle.

[0195]

[0234] Before advancing the guidewire and / or inner catheter into the ventricle, the system may prepare the expandable deflector by expanding it to deflect it from the chordae tendineae. 2907 As shown in FIG. 27A or 28A, the expandable deflector may be expanded (e.g., by inflating a balloon) at the mitral valve orifice. The expandable deflector may be on the guidewire (a straight or J-tip guidewire) and / or may be at the distal portion of the inner catheter. In some instances, the inner catheter (or inner catheter and guidewire) may be advanced into the ventricle such that the expandable deflector advances first 2909, and as described above, the expanded expandable deflector may be advanced by blood flow into the ventricle, for example, toward the ventricular apex.

[0196]

[0235] Thus, the inner (and outer) catheters may be advanced into the left ventricle while deflecting away from the chordae tendineae. 2909 In some instances, a second, interchangeable inner catheter may be inserted into and locked into the outer catheter. Alternatively, the same inner catheter may be used (e.g., particularly if the inner catheter is steerable or deflectable more than 120 degrees). In this manner, the inner catheter (or a new inner catheter) and outer catheter may be advanced into the left ventricle. Once in the left ventricle, the inner catheter (either the same inner catheter or a new inner catheter) may be deflected within the left ventricle so that the distal end region of the inner catheter assumes a second bend (typically >120 degrees) and faces the left ventricular outflow tract 2911.

[0197]

[0236] The expandable deflector may be used to maneuver within the ventricle, including steering or bending the inner catheter to face the outflow tract, and may be used to prevent entanglement of the chordae tendineae. The expandable deflector may be retracted once a pathway through the ventricle is established.

[0198]

[0237] A guidewire (the same or a different guidewire) may then be advanced through the aortic valve. 2913 In some instances, the guidewire may be advanced through the aortic valve and into the aorta. Additionally, in some instances, the inner catheter used in the previous step may be removed and replaced with another interchangeable inner catheter.

[0199]

[0238] The catheters may then be advanced and positioned across the aortic valve annulus. 2915 For example, the inner and outer catheters may be positioned at or near (or in some instances across) the aortic valve annulus. In some instances, the distal end of the outer catheter may be above the aortic valve annulus. In other instances, the distal end of the outer catheter may be below the aortic valve annulus and placed near the left ventricular apex.

[0200]

[0239] A guidewire (or a second guidewire having a different stiffness) may be advanced from the distal end of the inner catheter and across the aortic valve of the patient's heart. The replacement aortic valve may then be implanted. 2917 In some examples, the inner catheter may be unlocked and withdrawn from the outer catheter prior to placement and implantation of the replacement aortic valve.

[0201] Pacing sheath

[0240] In any of these methods, pacing may be performed using a single vascular entry point. As mentioned above, any of the methods and devices (e.g., systems) described herein may include an outer catheter configured as a pacing sheath, which may simplify procedural operation. A pacing electrode may be part of the distal portion of the sheath, which may be positioned at the left ventricular apex to enable escape pacing or rapid pacing during valve implantation. A pacing controller may apply a pacing signal to provide pacing when the heart's sinus rhythm is disrupted, avoiding the need for a pacemaker. In general, an outer catheter configured as a pacing sheath (also referred to herein as a "rapid pacing sheath") may include any of the features described above, particularly including a distal end region for sealably engaging the inner catheter.

[0202]

[0241] To ensure pacing capture and establish periodicity and predictability of cardiac cycles during the procedure, pacing signals may be applied to the heart to electrically pace the heart. Either atrial pacing, ventricular pacing, or both may be applied. The pacing signals may be controlled by a pacing controller (e.g., a pacing sheath) that may be part of the pacing device. The controller may include a signal generator and one or more processors. The pacing device may be appropriately coupled to the patient and configured to provide device-generated cardiac pacing signals for cardiac stimulation and to enable rapid ventricular pacing during valve implantation.

[0203]

[0242] As mentioned above, the same sheath (outer catheter) may be used to insert multiple inner catheters and may be used to provide electrical pacing.

[0204]

[0243] For example, Figure 30A shows an example of a pacing sheath described herein. This pacing sheath may be particularly advantageous because it simplifies the control of pacing and the performance of a valve replacement procedure while also being adapted for rapid use with the retrograde system described herein, including engagement with a catheter (e.g., one or more inner catheters). In Figure 30A, the pacing sheath 3000 has an elongate body having a proximal end with a hub and a distal end with multiple electrodes for applying pacing signals to the heart (e.g., the apex of the ventricle).

[0205]

[0244] The distal end region of the pacing sheath may include multiple electrodes 3006, 3008, 3010, 3012 at or near the distal tip. The electrodes may be circumferential, as shown in FIG. 30A, or the electrodes may be located on only a portion of the circumference. The ring electrodes shown in FIG. 30A may be spaced about 1 to about 10 cm (e.g., about 3 to 7 cm) apart in FIG. 30A. The electrodes are spaced about 5 cm apart, about 2 cm from the distal end of the elongate body. In some examples, the distal tip of the device shown in FIG. 30A may be configured to lock onto the outer diameter of the inner catheter, as described above. The electrodes may 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. The connector may be coupled to a controller (not shown), as described above. In some examples, the leads may be helically wound around the elongate body to extend the length of the sheath. In the example shown in FIG. 30A , the leads include a coiled conductor wire 3014 that is helically wound around the elongate body and couples to an overmolded yoke 3016 at the proximal end of the sheath. The leads (individual cables 3024) may be integrated into a conductor cable bundle 3032 that couples to the yoke 3016 and carries connectors (e.g., pins) for connecting to a controller. The conductive cables (e.g., wires, leads, etc.) may be bundled together and extend helically together around the length of the elongate body.

[0206]

[0245] The proximal end of the sheath may also include a hub 3002 with a hemostatic valve for accommodating and sealing the inner catheter (or multiple nested catheters and / or guidewires). The hub may also include a side port 3004 that may be used to apply and / or remove materials through the central lumen 3015 of the sheath.

[0207]

[0246] 30B and 30C show cross sections through the distal end region of the sheath illustrating one configuration of electrodes that may be used. In FIG. 30C, the portion of the distal end region shown includes an exposed ring electrode 3008 coupled to a conductive wire or lead 3038 that is insulated except for an exposed region 3042 that contacts the electrode. As described above, the conductive lead may be helically wound around the elongate body of the sheath. In this example, the insulated wire is embedded and / or covered by an outer polymer jacket that covers the wire 3040.

[0208]

[0247] The elongate body of the sheath may be reinforced, for example, by a coil or braid 3044. The coil or braid may be supported by one or more layers, including being sandwiched between two or more layers. As shown in FIG. 30C, the sheath also includes an inner or base polymer jacket 3048 that may insulate (and may smooth) the inner wall of the sheath lumen 3015. In some examples, the sheath may include a lubricious layer, such as a lubricious inner liner 3046. Alternatively, in some examples, the base polymer layer may be lubricious.

[0209]

[0248] Figure 31 shows an enlarged view of the proximal end of the pacing sheath of Figures 30A-30C. The hub 3002 includes a hemostatic valve, a side port 3004, and a port for a bundle of conductor cables 3032, as described above. The hub may be, or alternatively be configured as, a handle. In Figure 31, the conductor cables may be coupled to a yolk 3015 that supports individual connectors (e.g., pins 3016, 3018, 3220, 3022).

[0210]

[0249] It will be understood that all combinations of the concepts discussed above, and additional concepts described in more detail below (unless the concepts are mutually inconsistent), are contemplated as part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0211]

[0250] The process parameters and sequence of steps described and / or illustrated herein are provided by way of example only and can be modified as desired. For example, although the steps illustrated and / or described herein may be shown or described in a particular order, these steps do not necessarily have to be performed in the order illustrated or described. Also, various exemplary methods described and / or illustrated herein may omit one or more of the steps described.

[0212]

[0251] Those skilled in the art will recognize that any process or method disclosed herein can be varied in many ways. The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be changed as desired. For example, although the steps illustrated and / or described herein may be shown or described in a particular order, these steps do not necessarily have to be performed in the order illustrated or described.

[0213]

[0252] Also, the various exemplary methods described and / or illustrated herein may omit one or more of the steps described or illustrated herein, or may include additional steps in addition to those disclosed. Furthermore, the steps of any method disclosed herein may be combined with any one or more steps of any other method disclosed herein.

[0214]

[0253] The processors described herein can be configured to perform one or more steps of any of the methods disclosed herein. Alternatively, or in combination, the processors can be configured to combine one or more steps of one or more of the methods disclosed herein.

[0215]

[0254] As used herein, when a feature or element is referred to as being "on" another feature or element, it may be directly on the other feature or element, or there may be intervening features and / or elements present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, features and elements so described or illustrated may also be applicable to other embodiments. It will also be understood by those skilled in the art that a reference to a structure or feature being located "adjacent" to another feature may have portions that overlap or underlie the adjacent feature.

[0216]

[0255] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting of the present invention. For example, as used herein, the singular forms "a," "an," and "the" are also intended to include the plural forms unless the context clearly dictates otherwise. It will be further understood that, as used herein, the terms "comprises" and / or "comprising" specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude 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 associated listed items and may be abbreviated as " / ."

[0217]

[0256] Spatially relative terms such as "below," "lower," "lower side," "top," and "upper" may be used herein to describe the relationship of one element or feature to another, as shown in the figures, for ease of description. It will be understood that spatially relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation shown in the figures. For example, if a device in the figures were inverted, an element described as "below" or "below" another element or feature would be oriented "above" that other element or feature. Thus, the exemplary term "below" can encompass both an orientation of above and below. The device may be in other orientations (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein may be interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless specifically indicated otherwise.

[0218]

[0257] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element described below could be referred to as a second feature / element, and similarly, a second feature / element described below could be referred to as a first feature / element without departing from the teachings of the present invention.

[0219]

[0258] Unless the context requires, throughout this specification and the claims that follow, the term "comprises" and variations such as "comprises" and "comprising" mean that various components can be simultaneously employed in methods and articles (e.g., compositions and apparatuses that include devices and methods). For example, the term "comprising" will be understood to mean the inclusion of any stated element or step, but not the exclusion of any other element or step.

[0220]

[0259] In general, any of the apparatus and methods described herein should be understood to be inclusive, although all or a subset of the components and / or steps may alternatively be exclusive and may be expressed as "consisting of" or "consisting essentially of" various components, steps, sub-components, or sub-steps.

[0221]

[0260] Unless otherwise expressly specified, as used in the specification and claims, including those used in the examples, all numbers may be read as if preceded by the term "about" or "approximately," even if the term does not explicitly appear. The phrase "about" or "approximately" may be used when describing a magnitude and / or location to indicate that the stated value and / or location is within a reasonably expected range of value and / or location. For example, a numerical value may have a value 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. Additionally, any numerical value provided herein will be understood to include about or approximately that value unless the context dictates otherwise. For example, if a value of "10" is disclosed, "about 10" is also disclosed. Any numerical ranges described herein are intended to include all subranges subsumed therein. It will also be appreciated by those skilled in the art that when a value is disclosed, "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between those values ​​are also disclosed. For example, if a value of "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a number) are also disclosed. It is also understood that throughout the application, data are provided in a number of different formats, and that this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a specific data point of "10" and a specific data point of "15" are disclosed, it is understood that values ​​greater than, greater than, less than, less than, less than, and equal to 10 and 15, as well as values ​​between 10 and 15, are considered to be disclosed. It is also understood that each unit between two specified units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0222]

[0261] While various exemplary embodiments have been described above, numerous modifications may be made to the various embodiments without departing from the scope of the present invention, as set forth in the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional features of the various device and system embodiments may be included in some embodiments and not in other embodiments. As such, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the present invention, as set forth in the claims.

[0223]

[0262] The examples and figures included herein illustrate, by way of illustration, and not limitation, specific embodiments in which the subject matter may be practiced. As noted above, 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. Such embodiments of the inventive subject matter may be referred to herein, individually or collectively, by the term "invention" merely for convenience, but are not intended to spontaneously limit the scope of this application to any single invention or inventive concept, if in fact more than one is disclosed. Thus, while specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to cover all adaptations or variations of the various embodiments. Combinations of the above-described embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing the above description.

Claims

1. 1. A system for antegrade delivery of a replacement valve, comprising: An outer catheter configured as a sheath that houses an inner catheter, the sheath comprising: an elongate body having a lumen configured to accommodate the inner catheter, the elongate body configured to extend from an exterior of the body to the left ventricular apex of the heart; a hub at a proximal end of the elongate body, the hub including a hemostatic valve; a plurality of electrodes at a distal end region of the elongate body; a plurality of electrical connectors extending proximally from the elongate body; a plurality of conductor cables extending from the plurality of electrical connectors to the plurality of electrodes, each electrical connector being electrically connected to a corresponding one of the plurality of electrodes; an outer catheter comprising: a pacing controller configured to electrically couple to the plurality of electrical conductors of the sheath, the pacing controller including one or more processors and a non-transitory computing device readable medium having stored thereon instructions executable by the one or more processors to cause the pacing controller to apply cardiac pacing stimuli from the plurality of electrodes; A system including:

2. an inner catheter including a tapered distal end region and an engagement surface proximal to the distal end of the inner catheter, the engagement surface configured to sealably couple to the distal end region of the sheath such that an outer surface of the inner catheter is flush with an outer surface of the sheath without a gap; The system of claim 1 further comprising:

3. the inner catheter includes a bend region between the engagement surface and the distal end configured to exhibit a bend of greater than 120 degrees; The system of claim 2 .

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

5. the plurality of electrodes being ring electrodes arranged circumferentially around the distal end region; The system of claim 1 .

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

7. the plurality of electrodes are arranged in series along the distal end region; The system of claim 1 .

8. the electrodes of the plurality of electrodes are spaced apart from one another by about 1 cm to 9 cm; The system of claim 1 .

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

10. 1. A system for antegrade delivery of a replacement valve, comprising: an outer catheter configured as a pacing sheath; an inner catheter including a tapered distal end region and an engagement surface proximal to the distal end of the inner catheter, the engagement surface configured to sealably couple to the distal end region of the outer catheter such that an outer surface of the inner catheter is flush with an outer surface of the outer catheter without a gap; The outer catheter is configured to receive the inner catheter, the outer catheter comprising: an elongate body having a lumen configured to accommodate the inner catheter, the elongate body configured to extend from an exterior of the body to the left ventricular apex of the heart; a hub at a proximal end of the elongate body, the hub including a hemostatic valve; a plurality of electrodes disposed along a distal end region of the elongate body, the plurality of electrodes being spaced apart from the distal end region by a standoff distance; a plurality of electrical connectors extending proximally from the elongate body; a plurality of conductor cables forming a bundle that extends helically around the elongate body from the plurality of electrical connectors to the plurality of electrodes, each electrical connector being electrically connected to a corresponding one of the plurality of electrodes; Including, a pacing controller configured to electrically couple to the plurality of electrical conductors of the outer catheter, the pacing controller including one or more processors and a non-transitory computing device readable medium having stored thereon instructions executable by the one or more processors to cause the pacing controller to apply cardiac pacing stimuli from the plurality of electrodes; A system including:

11. the inner catheter includes a bend region between the engagement surface and the distal end configured to exhibit a bend of greater than 120 degrees; The system of claim 10.

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

13. the plurality of electrodes being ring electrodes arranged circumferentially around the distal end region; The system of claim 10.

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

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

16. the electrodes of the plurality of electrodes are spaced apart from one another by about 1 cm to 9 cm; The system of claim 10.

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

18. 1. A system for antegrade delivery of a replacement valve, comprising:

1. An outer catheter configured as a sheath for a catheter, the outer catheter comprising: an elongate body having a lumen configured to receive the catheter; an engagement region within the lumen at a distal end region of the outer catheter; an outer catheter including: An inner catheter, the inner catheter comprising: a tapered distal end region; an engagement surface proximal to the tapered distal end of the inner catheter, the engagement surface configured to removably couple to the engagement region of the outer catheter such that an outer surface of the inner catheter is flush with an outer surface of the outer catheter without a gap; a deflector on an outer surface of the inner catheter distal to the tapered distal end region, the deflector 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 of the inner catheter, the steering region being configured to bend; a guidewire lumen; an inner catheter including: A system including:

19. The steering region is configured to exhibit greater than 120 degrees of flexion.

20. The system of claim 18.

20. the steering region includes a wire configured to bend the steering region; 20. The system of claim 18.

21. the steering region includes a pre-curved region; 20. The system of claim 18.

22. the steering region includes a bend-setting material; 20. The system of claim 18.

23. the inner catheter further includes a pull wire configured to deflect the steering region.

20. The system of claim 18.

24. the distal end region of the outer catheter having a tapered outer surface; 20. The system of claim 18.

25. the engagement region includes an inner diameter at least 1 French (1 Fr) smaller than the inner diameter of the lumen in a region proximally adjacent the lumen; 20. The system of claim 18.

26. the engagement region includes a coupler configured to engage a locking ring on the engagement surface of the inner catheter.

20. The system of claim 18.

27. The tapered distal end region tapers from 3 Fr or less to 14 Fr or more.

20. The system of claim 18.

28. the outer catheter includes a thin-walled flexible outer layer of 22 Fr or greater configured to conform to the inner catheter when the inner catheter is in a bent configuration; 20. The system of claim 18.

29. the steering region is 3-6 mm from the distal tip of the inner catheter; 20. The system of claim 18.

30. the guidewire lumen includes a rapid exchange monorail connection; 20. The system of claim 18.

31. Guidewire 20. The system of claim 18, further comprising:

32. the inner catheter having reduced stiffness along the distal end region; 20. The system of claim 18.

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