Prosthetic heart valve delivery system and method of use

Abstract

A delivery system, device and method for delivering a prosthetic valve to a native valve annulus are provided. The prosthetic valve can be secured to the native valve via anchors that surround the native valve annulus and the prosthetic valve. The anchors can be deployed around the chordae tendineae and / or leaflets of the native valve. A tether can be connected to the anchors and extend outside the patient's body and maintain communication with the anchors. After the anchors are deployed, a guidewire can be advanced parallel to the tether through the patient's blood vessel and through the native valve annulus. A valve delivery catheter carrying the prosthetic valve can be advanced over the guidewire and into the native valve annulus where the prosthetic valve is released and deployed. The tether can be used to position the anchors and / or the prosthetic valve during one or more operations of the valve delivery process.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 262,552, filed October 14, 2021, entitled "DELIVERY SYSTEM FOR CARDIAC VALVE PROSTHESIS," the entirety of which is incorporated herein by reference for all purposes. Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Summary of the Invention [Problem to be solved by the invention]

[0002]

[0003] Blood flow between the heart chambers is regulated by native valves, namely the mitral, aortic, pulmonary, and tricuspid valves. Each of these valves is a passive one-way valve that opens and closes in response to pressure differences. Patients with valvular disease have abnormalities in the anatomy and / or function of at least one valve. For example, a valve may malfunction, also called regurgitation, when the valve does not close completely, thereby allowing blood to flow backwards. Valve stenosis may cause the valve to fail to open properly. Other diseases may also lead to valve dysfunction. Although drug therapy can be used to treat the disease, defective valves often need to be repaired or replaced at some point in the patient's life. Existing valves and surgical repair and / or replacement procedures can be relatively risky, have a limited useful life, and / or be highly invasive. Although some less invasive transcatheter options are available, these are generally limited to aortic valve procedures, limiting flexibility between patients and often taking longer than desired to implant. It would therefore be desirable to provide a less invasive procedure for repairing and replacing heart valves, including the mitral valve, a faster surgical method, and / or a prosthetic valve that can accommodate a variety of individual patients.

[0003]

[0004] Additionally, repair / replacement procedures for existing valves are often complex and time-consuming. Currently available procedures often require the placement of multiple components, e.g., a prosthetic valve and mechanisms for securing it to the native anatomy. Such procedures may utilize multiple delivery catheters to carry the various components. Additionally, delivering each component separately to the valve may require separate access sites, and paths through the patient, which can be time-consuming (especially if the components are delivered sequentially), complicated, and / or dangerous. For example, it may be difficult to align components delivered via separate delivery systems along different access paths to the heart. Additionally, such fixation elements may require extrusion through the native valve annulus from a low-profile (e.g., elongated) delivery configuration to an expanded configuration at or near the native valve. In at least some instances, extrusion of the fixation elements may be complicated and may not reliably deploy in the correct expanded configuration relative to the delivery device and / or the native anatomy. Proper alignment between the prosthetic valve and any fixation or docking components is necessary to ensure proper performance of the prosthetic heart valve. Incorrect deployment can result in additional time to retract and redeploy the fixation element and / or prosthetic valve, more complicated fixation procedures, and / or damage to native tissue. It is therefore desirable to provide a faster, less complicated, less risky, and more reliably deployable valve assembly for valve replacement and repair. [Means for solving the problem]

[0004]

[0005] Described herein are delivery systems and methods for delivering a valve anchor and / or prosthetic valve to a native valve annulus. The anchor can have a helical shape and be deployed around the chordae and / or leaflets of the native valve annulus. A tether connected to the anchor can extend outside the heart and / or patient's body. The tether can remain attached to the anchor during one or more of the deployment operations of the anchor and / or prosthetic valve. In some examples, the valve delivery catheter can be delivered over a guidewire adjacent to the tether while the tether remains attached to the anchor to deploy the prosthetic valve within the native valve annulus and the helical shaped anchor. In other examples, the tether can be decoupled from the anchor prior to delivering the valve delivery catheter over the guidewire. Once the prosthetic valve is deployed, the valve delivery catheter (and the tether, if not already removed) can be removed from the patient's body, leaving the prosthetic valve in the native valve annulus, secured in place by the surrounding anchors.

[0005]

[0006] According to some aspects, a method for treating a diseased native valve in a patient includes encircling chordae and / or leaflets of the diseased native valve with anchors in a second chamber of the patient's heart, the anchors having a tether attached to the anchor extending proximally from the second chamber of the patient's heart through a first chamber; advancing a portion of a guidewire from the first chamber of the patient's heart, through an annulus of the diseased native valve, to the second chamber of the patient's heart; tracking a valve delivery catheter over the guidewire, the valve delivery catheter including a prosthetic valve in a compressed configuration therein; and releasing the prosthetic valve from the valve delivery catheter to expand within the anchors and into the annulus of the diseased native valve.

[0006]

[0007] The method may further include acquiring images as the guidewire advances through the annulus of the diseased native valve, and deflecting the steerable catheter to steer the guidewire through an inner diameter of the anchor. Advancing a portion of the guidewire includes advancing a guidewire delivery catheter through the steerable catheter, through the annulus of the diseased native valve and through an inner diameter of the anchor, and advancing the guidewire through the guidewire delivery catheter. The method may further include inflating a distal portion of the guidewire delivery catheter to form a balloon to facilitate positioning and / or imaging of the guidewire. Steering the guidewire may further include steering the guidewire through the annulus of the diseased native valve. The guidewire may have a curvature to facilitate imaging of the guidewire. Releasing the prosthetic valve from the valve delivery catheter may include partially deploying a portion of the prosthetic valve in the second heart chamber, pushing the partially deployed prosthetic valve against the anchor to urge the anchor toward the annulus of the diseased native valve, and fully deploying a remaining portion of the prosthetic valve into the annulus of the diseased prosthetic valve and / or into the first heart chamber. The method may further include decoupling the tether from the anchor and retracting the tether and the valve delivery catheter from the patient's body. Decoupling and retracting the tether may occur following placement of the guidewire. Decoupling and retracting the tether may occur while tracking the valve delivery catheter over the guidewire. Decoupling and retracting the tether may occur prior to release of the prosthetic valve from the valve delivery catheter. The method may further include delivering the valve delivery catheter and the tether within the outer sheath. Tracking the valve delivery catheter over the guidewire may further include advancing the tether through a monorail lumen of the valve delivery catheter. The method may further include delivering the anchor to the diseased native valve with the anchor control catheter.

[0007]

[0008] According to some aspects, a delivery system for delivering a prosthetic valve to a diseased valve of a heart includes a tether (i.e., a string-like member) sized and shaped to extend from outside the heart through the annulus of the diseased valve, the tether further configured to connect to anchors sized and shaped to circumscribe the native leaflets and / or chordae of the heart; a guidewire sized and shaped to extend from outside the heart through the annulus of the diseased valve; and a valve delivery catheter configured to extend over the guidewire through the annulus of the diseased valve, the valve delivery catheter configured to hold the prosthetic valve in a compressed state therein and release the prosthetic valve within the annulus of the diseased valve and the anchors while the tether is connected to the anchors.

[0008]

[0009] The valve delivery catheter may further comprise a monorail (i.e., single track) lumen sized and shaped to accommodate the tether therein. The tether may further be configured to move within the monorail lumen to adjust the position of the anchor relative to the valve delivery catheter and / or the diseased valve. The system may further comprise a balloon catheter configured to extend over at least a portion of the guidewire, the balloon catheter including an inflatable distal portion sized and shaped to block its passage between adjacent chordae of the heart. The balloon catheter may be adapted for visualization via imaging. The distal portion of the guidewire may have a curved portion adapted for visualization via imaging. The prosthetic valve may include an expandable frame. The tether may be releasably attached to the anchor via a releasable connector.

[0009]

[0010] According to some aspects, a method of delivering a prosthetic valve into a patient's heart includes implanting a helical anchor near a native annulus of the patient's heart by encircling chordae and / or leaflets of the native valve with an anchor control catheter, where a proximal end of the helical anchor extends through the annulus and is releasably connected to a tether accessible outside the patient's heart; deploying the helical anchor from the anchor control catheter; releasing the tether from the proximal end of the helical anchor; advancing a guidewire through the annulus of the native valve and through a central opening of the anchor; and tracking a valve delivery catheter over the guidewire, where the valve delivery catheter carries the prosthetic valve in a compressed state therein; and expanding the prosthetic valve within the native annulus and into the central opening of the anchor.

[0010]

[0011] Expanding the prosthetic valve may include expanding a distal portion of the prosthetic valve into a ventricle of the patient's heart distally relative to the anchor, and the method may further include pulling the distal portion of the prosthetic valve proximally relative to the anchor to adjust the position of the anchor relative to the annulus of the native valve. The method may further include expanding a proximal portion of the prosthetic valve into the atrium of the patient proximally relative to the anchor, thereby fully deploying the prosthetic valve within the anchor and the native valve. The method may further include expanding a central section of the prosthetic valve into the anchor. The method may further include verifying the position of the anchor relative to the annulus of the native valve prior to releasing the tether. Verifying the position of the anchor may include visualizing the anchor using ultrasound, fluoroscopy, and / or radiography. Circumscribing the chordae and / or leaflets may include rotating the anchor control catheter relative to the chordae and / or leaflets. The method may further include removing the tether from the patient's heart prior to advancing the guidewire.

[0011]

[0012] According to some aspects, a method for treating a diseased native valve in a patient includes encircling chordae and / or leaflets of the diseased native valve with anchors in a second chamber of the patient's heart, the anchors having a tether attached thereto, the tether extending distally from a first chamber of the patient's heart, through an annulus of the diseased native valve, and into the second chamber of the patient's heart; releasing the tether from the anchors once the anchors are deployed around the chordae and / or leaflets in the second chamber of the patient's heart; retracting the released tether proximally from the second chamber of the patient's heart; advancing a guidewire catheter carrying a guidewire through the first chamber of the patient's heart, through the annulus of the diseased native valve, and into the second chamber of the patient's heart; and verifying that the guidewire is not tangled in the second chamber by advancing and retracting the guidewire catheter while visualizing distal features of the guidewire catheter.

[0012]

[0013] The method includes tracking a valve delivery catheter over a guidewire, the valve delivery catheter including a prosthetic valve in a compressed configuration therein, and releasing the prosthetic valve from the valve delivery catheter to expand within the anchor into the annulus of the diseased native valve. The guidewire can be advanced through an inner circumference of an anchor that is secured to the diseased native valve in a second chamber of the patient's heart. Releasing the prosthetic valve from the valve delivery catheter can include releasing a distal portion of the prosthetic valve into the second chamber and adjusting the position of the anchor with the distal portion of the prosthetic valve relative to the annulus of the diseased native valve. The method can further include verifying the position of the anchor relative to the annulus of the diseased native valve by visualizing the anchor using ultrasound, fluoroscopy, and / or radiography prior to releasing the tether from the anchor.

[0013]

[0014] According to some aspects, a method for treating a diseased native valve in a patient includes advancing a guidewire through an annulus of the diseased native valve and an inner circumference of an anchor, the anchor being secured to the diseased native valve in a second chamber of the patient's heart, the anchor including a tether attached to the anchor that extends from the second chamber, through the annulus, to the exterior of the patient; tracking a valve delivery catheter over the guidewire, the valve delivery catheter including a prosthetic valve in a compressed configuration therein; and deploying the prosthetic valve within the anchor from the valve delivery catheter into the annulus of the diseased native valve, the tether being released from the anchor during deployment of the prosthetic valve.

[0014]

[0015] Deploying the prosthetic valve includes (a) releasing a distal portion of the prosthetic valve into the second chamber and aligning the anchor with the distal portion of the prosthetic valve relative to the annulus of the diseased native valve, and (b) releasing a proximal portion of the prosthetic valve into the first chamber of the patient's heart, wherein the tether is released from the anchor during (a), during (b), or between (a) and (b). The method may further include encircling the chordae and / or leaflets of the diseased native valve with the anchor in the second chamber of the patient's heart while the tether is attached to the anchor before advancing the guidewire through the annulus of the diseased native valve and the inner circumference of the anchor. The tether may extend proximally from the second chamber of the patient's heart through the annulus of the diseased native valve into the first chamber of the patient's heart. The method may further include verifying the position of the anchor with respect to the annulus of the diseased native valve by visualizing the anchor using ultrasound, fluorescence, and / or radiological imaging before releasing the tether from the anchor.

[0015]

[0016] These and other aspects are described herein.

[0016]

[0017] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [Brief description of the drawings]

[0017] [Figure 1A]

[0018] An exemplary method of delivering an anchor and prosthetic valve near a native valve is shown, where the tether remains connected to the anchor while the anchor is deployed and the valve delivery catheter is deployed. [Figure 1B] An exemplary method of delivering an anchor and prosthetic valve near a native valve is shown, where the tether remains connected to the anchor while the anchor is deployed and the valve delivery catheter is deployed. [Figure 1C] An exemplary method of delivering an anchor and prosthetic valve near a native valve is shown, where the tether remains connected to the anchor while the anchor is deployed and the valve delivery catheter is deployed. [Figure 1D] An exemplary method of delivering an anchor and prosthetic valve near a native valve is shown, where the tether remains connected to the anchor while the anchor is deployed and the valve delivery catheter is deployed. [Figure 1E] An exemplary method of delivering an anchor and prosthetic valve near a native valve is shown, where the tether remains connected to the anchor while the anchor is deployed and the valve delivery catheter is deployed. [Figure 1F] An exemplary method of delivering an anchor and prosthetic valve near a native valve is shown, where the tether remains connected to the anchor while the anchor is deployed and the valve delivery catheter is deployed. [Figure 1G] An exemplary method of delivering an anchor and prosthetic valve near a native valve is shown, where the tether remains connected to the anchor while the anchor is deployed and the valve delivery catheter is deployed. [Figure 1H]An exemplary method of delivering an anchor and prosthetic valve near a native valve is shown, where the tether remains connected to the anchor while the anchor is deployed and the valve delivery catheter is deployed. [Figure 1I] An exemplary method of delivering an anchor and prosthetic valve near a native valve is shown, where the tether remains connected to the anchor while the anchor is deployed and the valve delivery catheter is deployed. [Figure 1J] An exemplary method of delivering an anchor and prosthetic valve near a native valve is shown, where the tether remains connected to the anchor while the anchor is deployed and the valve delivery catheter is deployed. [Diagram 2]

[0019] 1 shows an exemplary valve delivery catheter having a monorail lumen for a tether. [Figure 3A]

[0020] 13 illustrates another exemplary method of delivering an anchor and prosthetic valve near a native valve, where a tether is connected to the anchor while the anchor is deployed and removed prior to deployment of the valve delivery catheter. [Figure 3B] 13 illustrates another exemplary method of delivering an anchor and prosthetic valve near a native valve, where a tether is connected to the anchor while the anchor is deployed and removed prior to deployment of the valve delivery catheter. [Figure 3C] 13 illustrates another exemplary method of delivering an anchor and prosthetic valve near a native valve, where a tether is connected to the anchor while the anchor is deployed and removed prior to deployment of the valve delivery catheter. [Figure 3D] 13 illustrates another exemplary method of delivering an anchor and prosthetic valve near a native valve, where a tether is connected to the anchor while the anchor is deployed and removed prior to deployment of the valve delivery catheter. [Figure 3E] 13 illustrates another exemplary method of delivering an anchor and prosthetic valve near a native valve, where a tether is connected to the anchor while the anchor is deployed and removed prior to deployment of the valve delivery catheter. [Figure 3F]13 illustrates another exemplary method of delivering an anchor and prosthetic valve near a native valve, where a tether is connected to the anchor while the anchor is deployed and removed prior to deployment of the valve delivery catheter. [Figure 3G] 13 illustrates another exemplary method of delivering an anchor and prosthetic valve near a native valve, where a tether is connected to the anchor while the anchor is deployed and removed prior to deployment of the valve delivery catheter. [Figure 4]

[0021] 1 is a flow chart illustrating an exemplary method of deploying a prosthetic valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018]

[0022] Described herein are devices and methods for use in delivering a prosthetic valve, for example during mitral valve replacement. The delivery system can include an anchor delivery system (e.g., subsystem) for delivering a spiral-shaped anchor around the patient's native valve, and a valve delivery system (e.g., subsystem) for delivering the deployed anchor and the prosthetic valve into the patient's native valve. The anchor delivery system can include an anchor control catheter for releasing and positioning the anchor within the heart. The valve delivery system can include a valve delivery catheter for positioning and releasing the prosthetic valve within the native valve annulus and the central opening of the anchor. A tether connected to an end of the anchor can be positioned parallel to the anchor control catheter and / or the valve delivery catheter. The tether can be used to adjust the position of the anchor and / or the prosthetic valve or otherwise provide access to the anchor. Such methods can advantageously allow for reliable control of the anchor and / or the prosthetic valve during various operations. In some cases, the anchor delivery system and / or the valve delivery system can include one or more features that allow visualization (e.g., via ultrasound and / or fluoroscopy) to track the position of the anchor and / or the prosthetic valve within the heart.

[0019]

[0023] The tether can serve one or more purposes during various operations of the anchor and / or valve delivery process. For example, the tether can facilitate retraction of the anchor control catheter as it is being withdrawn proximally from the heart. Additionally or alternatively, the tether may be used to adjust the position of the anchor once the anchor control catheter is removed from the heart. This can include pulling the tether proximally and / or pushing the tether distally to reposition the anchor near the native annulus and / or achieve a coplanar anchor orientation relative to the native annulus. Additionally or alternatively, the tether can also be used in conjunction with the prosthetic valve (e.g., before the prosthetic valve is fully deployed) to adjust the position of the anchor and the prosthetic valve.

[0020]

[0024] The tether may be released from the anchor at different times during the anchor and / or prosthetic valve delivery operation. For example, the tether may be released from the anchor after the anchor is positioned by the anchor control catheter. In other examples, the tether may be released from the anchor after a guidewire is introduced through the anchor and / or after the prosthetic valve is partially deployed within the heart. In further examples, the tether may be released from the anchor after the prosthetic valve is fully deployed within the heart.

[0021]

[0025] 1A-1J show an exemplary method of delivering a prosthetic valve, according to some embodiments. FIG. 1A shows a transseptal puncture 102 made by a puncture device 103 to provide access to a first chamber of the heart (in this case, the left atrium 104). The puncture device 103 may be advanced through the steerable catheter (e.g., 111 in FIG. 1B) and / or the anchor control catheter (e.g., 108 in FIG. 1B), or may be a separate device that is retracted prior to advancing the steerable catheter and / or anchor delivery catheter. In some cases, the puncture device 103 may include a dilator configured to expand the transseptal puncture 102, e.g., to accommodate entry of the anchor delivery catheter and / or the valve delivery catheter.

[0022]

[0026] 1B shows steerable catheter 111 and anchor control catheter 108 (also referred to as anchor delivery catheters) threaded through transseptal puncture 102 and positioned for delivery of anchor 114. Steerable catheter 111 and anchor control catheter 108 can be part of an anchor delivery system. At least a portion (e.g., a distal end) of steerable catheter 111 can be steerable (e.g., deflectable) to steer anchor control catheter 108 and / or anchor 114 into a desired position and orientation relative to native valve annulus 110. In some examples, steerable catheter 111 and / or anchor control catheter 108 can include one or more concentric catheters (e.g., sub-catheters), each concentric catheter configured to deflect along a plane in 3D space. Thus, a steerable catheter 111 and / or anchor control catheter 108 having a one-plane deflectable catheter can allow the steerable catheter 111 to deflect along one plane in 3D space, two concentric one-plane deflectable catheters (e.g., sub-catheters) can allow the steerable catheter 111 to deflect along two planes in 3D space, three concentric one-plane deflectable catheters (e.g., sub-catheters) can allow the steerable catheter 111 and / or anchor control catheter 108 to deflect along three planes in 3D space, etc. The steerable catheter 111 and / or anchor control catheter 108 can be configured to be steerable in any number of planes and dimensions in 3D space. The steerable catheter 111 and / or anchor control catheter 108 may be bendable between a straight configuration and a bent (deflected) configuration. Such bending can be controlled, for example, in a handle operatively coupled to the steerable catheter 111 and / or anchor control catheter 108. In some cases, each inner catheter of a concentric catheter may be advanceable through the distal end of a corresponding outer catheter.

[0023]

[0027] Once in the first chamber of the heart (e.g., the left atrium 104), the anchor control catheter 108 can be advanced through the steerable catheter 111 and the anchor 114 can be advanced through a distal guide arm portion 112 of the anchor control catheter 108. The guide arm portion 112 can be integrally formed with the remainder of the anchor control catheter 108. The anchor 114 and guide arm portion 112 of the anchor control catheter 108 can be positioned through the native annulus 110 and into a second chamber of the heart (in this case, the left ventricle 106). Once in the second chamber of the heart (e.g., the left ventricle 106), the anchor 114 can be released from the anchor control catheter 108 and guided around the chordae tendineae 116 and / or leaflets of the native annulus 110. Engagement and positioning of the anchor 114 can involve rotating the anchor control catheter 108 (thereby rotating the anchor 114) relative to the chordae tendineae 116 and / or leaflets. This may involve rotating the anchor control catheter 108 relative to the steerable catheter 111. The delivered anchor 114 may be only in the second chamber of the heart (eg, the left ventricle 106).

[0024]

[0028] As shown, the anchor 114 can be configured to assume a helical shape. The anchor can have one or more turns in a deployed state. In some embodiments, the turns of the deployed anchor are substantially in a (e.g., radial) plane. In some embodiments, the turns of the deployed anchor at least partially overlap one another (e.g., in a direction perpendicular to the radial plane). In some embodiments, the anchor is deployed in a single chamber of the heart and is sized and shaped to reside in a (e.g., different) single chamber of the heart. For example, the anchor may be deployed (e.g., entirely) in the atrium and implanted (e.g., alone) in the ventricle. In some examples, the anchor 114 includes a shape-memory material (e.g., Nitinol, NiTi). The guide arm portion 112 can be configured to assume a predetermined curved shape to facilitate winding of the turns of the helical-shaped anchor 114 such that the helical arms of the anchor 114 encircle the chordae tendineae 116 and / or leaflets. The geometry (e.g., curvature) of the guide arm portion 112 may induce torsion in the anchor 114 during deployment. In other cases, the guide arm portion 112 may be configured to assume a curved shape when actuated (e.g., by a control at a handle). For example, the guide arm portion 112 may assume its shape by "self-assembly" upon advancement from the steerable catheter 111. The curved shape of the arm portion 112 may maintain a planar orientation of the anchor 114 relative to the native annulus 110. The guide arm portion 112 may be positioned and / or oriented as desired by steering the steerable catheter 111 (e.g., by deflecting, bending) and / or rotating the anchor control catheter 108 and / or the guide arm portion 112 to encircle the chordae 116 and / or leaflets. In some embodiments, counter-rotation of the anchor 114 (via counter-rotation of the anchor control catheter 108 and / or guide arm portion 112) can assist in advancing the anchor 114 across the native annulus 110 without entangling the chordae 116 and / or leaflets.In some cases, imaging (e.g., ultrasound and / or fluoroscopy) can be used to determine whether the anchors 114 sufficiently surround the chords 116 and / or leaflets, and, if necessary, the anchors 114 can be de-rotated and rotated to sufficiently capture the chords 116 and / or leaflets.

[0025]

[0029] Once the anchor 114 is at a selected depth within the second chamber of the heart (e.g., the left ventricle 106), forward rotation of the anchor 114 (via forward rotation of the anchor control catheter 108 and / or guide arm portion 112) can allow the anchor 114 to encircle the mitral valve leaflets and chordae 116 and / or leaflets. In some embodiments, the anchor 114 can be deployed (e.g., initially) toward the apex of the ventricle to help avoid interference with leaflet movement of the native valve 110.

[0026]

[0030] FIG. 1C shows anchor 114 deployed around chordae tendineae 116 and / or leaflets, and anchor control catheter 108 (including guide arm portion 112) (FIG. 1B) retracted back into steerable catheter 111. As shown, the proximal end of anchor 114 can be connected to a tether 118 that extends out of the patient's body and maintains communication with anchor 114. A connector 120 can be adapted to releasably connect the distal end of tether 118 to the proximal end of anchor 114. For example, a locking mechanism of connector 120 can be configured to lock and / or unlock (and disconnect) anchor 114 from tether 118 upon actuation of a handle at the proximal end of tether 118.

[0027]

[0031] In some cases, the tether 118 can be configured to have different shapes and / or stiffness. For example, the tether 118 can be stiffened (and / or have a predetermined shape) such that the tether 118 can be pushed distally (e.g., instead of or in addition to being pulled proximally) to adjust the position of the anchor 114 closer to the native annulus 110 and / or adjust the orientation of the anchor 114 to be in the same plane as the native annulus 110. In some examples, the tether 118 can be stiffened (and / or have a predetermined shape) such that the tether 118 can be pushed distally (e.g., instead of or in addition to being pulled proximally) to adjust the position of the anchor 114 closer to the native annulus 110 and / or adjust the orientation of the anchor 114 relative to the native annulus 110. Exemplary embodiments of suitable tethers may be described in International Patent Application No. PCT / US2022 / 075931, filed September 2, 2022, the entire disclosure of which is incorporated by reference into this specification.

[0028]

[0032] 1D shows a guidewire 122 advanced through the steerable catheter 111 adjacent to the tether 118, through the native annulus 110, through the inner diameter of the anchor 114, and into a second chamber of the heart (e.g., the left ventricle 106). In some cases, the guidewire 112 can be delivered through a guidewire delivery catheter 126, which itself can be delivered through the steerable catheter 111. For example, the guidewire delivery catheter 126 can be advanced through the steerable catheter 111, through the native annulus 110, and through the inner diameter of the anchor 114, and the guidewire 123 can be advanced through the guidewire delivery catheter. In some examples, the steerable catheter 111 is steered (e.g., deflected) to position the guidewire 122 (and guidewire delivery catheter 126) through the annulus 110 and the inner diameter of the anchor 114. In some examples, the distal end 123 of the guidewire 122 can include a curved portion (e.g., a pigtail) that can facilitate visualization of the guidewire 122 during positioning of the guidewire 122 (e.g., via fluoroscopic imaging). The guidewire 114 can be made from any of a number of materials, such as one or more metals and / or one or more polymeric materials. In some examples, the guidewire 122 has a diameter in the range of about 0.02 inches to about 0.05 inches (e.g., 0.05, 0.06, 0.08, 0.09, 0.10, 0.11, 0.13 cm (0.02, 0.025, 0.03, 0.035, 0.04, 0.045, or 0.05 inches)).

[0029]

[0033] FIG. 1E shows a balloon 124 (e.g., a scout balloon) that can optionally be used to facilitate visualization of the guidewire 122. In some cases, the balloon 124 can be attached to or part of the guidewire delivery catheter 126. For example, the balloon 124 can be an inflatable portion of the guidewire delivery catheter 126. The balloon 124 can be deployed (e.g., inflated) at any desired location along the guidewire 122. For example, the balloon 124 can be at the distal end of the guidewire delivery catheter 126 and advanced over the guidewire 122 toward the distal end 123 of the guidewire 122 to deploy (e.g., inflate) the balloon 124 at the distal end 123. The curved portion (e.g., pigtail) and / or balloon 124 at the distal end 123 of the guidewire 122 can be visualized (e.g., via ultrasound and / or fluoroscopy imaging) to ensure proper positioning of the guidewire 122 within the inner circumference of the anchor 114 and / or through substantially the center of the native valve 110 within the second chamber of the heart (e.g., left ventricle 106). Additionally or alternatively, the expanded balloon and its visualization can be used to identify undesirable placement of the guidewire 122, for example, to ensure that the guidewire 122 is not entangled in or between the chordae tendineae 116 and / or leaflets, is threaded through turns of the anchor 114, or is not properly engaged with the chordae tendineae 116 and / or leaflets. For example, the balloon can be shaped and sized to prevent passing between adjacent chordae, thereby ensuring that a free-floating balloon does not misposition the guidewire between the chordae or around the papillary muscles. Other imaging techniques can also be used. For example, guidewire delivery catheter 126, balloon 124 and / or guidewire 122 may additionally or alternatively include one or more radiopaque markers visible using radiographic imaging. Proper positioning of guidewire 122 can ensure proper positioning of a subsequently introduced valve delivery catheter and / or prosthetic valve, which can be tracked over guidewire 122.If guidewire 122 is found to be malpositioned, the position of guidewire 122 can be adjusted. For example, guidewire 122 can be pulled proximally, pushed distally, and / or steered by actuating steerable catheter 111. After guidewire 122 is properly positioned, steerable catheter 111 and guidewire delivery catheter 126 can be retracted from the heart (e.g., prior to insertion of valve delivery catheter 128, as described below).

[0030]

[0034] FIG. 1F illustrates the advancement of a valve delivery catheter 128 (as part of a valve delivery system) through the transseptal puncture 102 and positioned for delivery of a prosthetic valve. In the illustrated example, the valve delivery catheter 128 is advanced adjacent to the tether 118. The valve delivery catheter 128 may be steerable such that it can bend in any of a variety of directions that direct the distal end of the valve delivery catheter 128 through the native valve annulus 110. For example, the valve delivery catheter 128 may be configured to bend along one or more planes in 3D space, similar to the steerable catheter 111 of the anchor delivery system. In some examples, an outer sheath (not shown) surrounds both the valve delivery catheter 128 and the tether 118. In some examples, such an outer sheath may be a safety element to minimize tissue damage at the puncture site and / or along the blood vessel that the catheter traverses. In some examples, the valve delivery catheter 128 can include a monorail (i.e., single track) lumen (e.g., FIG. 2) that runs parallel to a central lumen of the valve delivery catheter 128 (e.g., that holds the prosthetic valve), which can be sized and shaped to accommodate the tether 118 therein. This configuration can provide additional control over the tether 118 (e.g., prevent the tether from becoming tangled).

[0031]

[0035] 1G illustrates how tension can be placed on the tether 118 to maintain the position of the anchor 114 during advancement and manipulation of the valve delivery catheter 128. For example, it may be desirable for the anchor 114 to be maintained as close as possible to the native valve annulus 110. Such tension can be applied by pulling the tether 118 in a proximal direction 130.

[0032]

[0036] FIG. 1H shows the distal portion 132 of the prosthetic valve being deployed from the valve delivery catheter 128 into the central opening of the native annulus 110 and the anchors 114. In some examples, the prosthetic valve 132 has an expandable frame structure configured to expand when pushed out of the distal end of the valve delivery catheter 128. The prosthetic valve 132 defines a central lumen through which blood flows and may include artificial leaflets. FIG. 1H shows a partial deployment of the prosthetic valve 132 in which the distal portion of the prosthetic valve 132 is expanded. In some examples, the partially expanded prosthetic valve can be pulled proximally (134) (e.g., by pulling the valve delivery catheter 128 proximally and / or by pulling the tether 118 proximally) to maintain or adjust the position of the anchors 114 and / or the distal portion 132 of the prosthetic valve closer to the native annulus 110, as shown in FIG. 1I. For example, the distal portion 132 of the prosthetic valve can be pressed against the anchor 114, forcing the anchor 114 towards the native annulus 110. FIG. 1J shows the proximal portion 136 of the prosthetic valve being deployed into the first heart chamber (e.g., the left atrium 104) above the native annulus 110, thereby fully deploying the prosthetic valve 150. As shown, the prosthetic valve 150 can have an hourglass shape, where the distal portion 132 and the proximal portion 136 each have a larger diameter than the midsection of the prosthetic valve 150. When fully deployed, the anchor 114 can surround (e.g., encircle) the midsection of the prosthetic valve 150. After the prosthetic valve 150 is fully deployed, the valve delivery catheter 128 can be pulled proximally and outwardly from the patient's body. The anchor 114 can be detached from the tether 118 by disengaging the connector 120. Tether 118 can then be removed by pulling tether 118 proximally, outward from the patient's body.

[0033]

[0037] Exemplary embodiments of the prosthetic valve / anchor are described in U.S. Patent Application Publication No. 2020 / 0297491A1, published September 24, 2020, and U.S. Patent No. 10,912,644, issued February 9, 2021, the entire disclosures of which are incorporated by reference herein.

[0034]

[0038] FIG. 2 illustrates an exemplary valve delivery catheter 228 that is a variation of the valve delivery catheter 128 illustrated in FIGS. 1F-1J. In this variation, the valve delivery catheter 228 includes a monorail lumen 252 sized and shaped to accommodate the tether 118. As shown, the monorail lumen 252 can extend along one side of the valve delivery catheter 228 parallel to a central lumen 250 that accommodates the guidewire 122. The monorail lumen 252 can constrain the movement of the tether 118, for example, to prevent the tether 118 from kinking or tangling. The central lumen 250 can define a distal opening through which the guidewire 122 can exit the valve delivery catheter 228. The valve delivery catheter 228 includes an interior volume 254 adapted (e.g., sized and shaped) to hold the prosthetic valve 132 in a compressed configuration (e.g., prior to release and expansion of the prosthetic valve 132). The central lumen 250 can extend through the center of the valve delivery catheter 228 and the prosthetic valve 132 when the prosthetic valve 132 is disposed within the valve delivery catheter 228 .

[0035]

[0039] An example of a valve delivery catheter having a monorail lumen is described in International Patent Application No. PCT / US2021 / 026463, filed April 8, 2021, and published as WO2021 / 207545 on October 14, 2021, the entire disclosure of which is incorporated herein by reference.

[0036]

[0040] 3A-3G show another exemplary method of delivering, in this case, a prosthetic valve. The operations shown in FIGS. 3A-3G are similar to those in FIGS. 1B-1J, except that a tether is connected during deployment of anchor 314, but is removed prior to deployment of the valve delivery catheter. FIG. 3A shows steerable catheter 311 and anchor control catheter 308 threaded through transseptal puncture 302 and positioned for delivery of anchor 314. Once in a first chamber of the heart (e.g., left atrium 304), anchor control catheter 308 can be advanced through steerable catheter 311, and then anchor 314 can be advanced through anchor control catheter 308 and out of distal guide arm portion 312 of anchor control catheter 308. Anchor 314 and guide arm portion 312 can be positioned through native valve annulus 310 and into a second chamber of the heart (e.g., left ventricle 306). Once within the second chamber of the heart (e.g., left ventricle 306), anchor 314 may be guided around the chordae tendineae 316 and / or leaflets of native valve annulus 310. As described above with respect to, for example, FIG. 1B, anchor 314 may be positioned and / or oriented as desired by steering steerable catheter 311 (e.g., by deflecting, bending) and / or anchor control catheter 308 (e.g., guide arm portion 312). In FIG. 3A (similar to FIG. 1B), a tether may be connected to anchor 314 by a connector within anchor control catheter 308.

[0037]

[0041] FIG. 3B illustrates a position of the anchor 314 oriented closer to and in a planar configuration relative to the plane of the native annulus 310. The distal guide arm portion 312 of the anchor control catheter 308 can assume a curved shape to maintain the orientation of the plane of the anchor 314 relative to the native annulus 310. In some cases, the anchor control catheter 308 transitions from a straight shape when within the steerable catheter 311 to a curved shape when released from the steerable catheter 311. For example, the anchor control catheter 308 can be made from a shape memory material (e.g., Nitinol) that has been pretreated to assume a curved shape. Alternatively or additionally, the anchor control catheter 308 can be configured to assume a curved shape when actuated (e.g., by a control at a handle). In some cases, a tether (e.g., 118) that can be at least partially present within the anchor control catheter 308 can provide traction to the anchor 314 and can be pulled proximally (and / or pushed distally) to change the shape of the anchor control catheter 308. This traction can hold the anchor in place as anchor control catheter 308 is retracted proximally back through steerable catheter 311. In some examples, imaging (e.g., ultrasound and / or fluoroscopy) can be used to visualize anchor 314 during or after deployment of anchor 314. Such imaging can be used to confirm the placement and / or orientation of anchor 314. Once anchor 314 is properly positioned and oriented, the tether can be released from anchor 314 by releasing the releasable connector (e.g., 120).

[0038]

[0042] FIG 3C shows a guidewire delivery catheter 326 having a guidewire 322 advanced through the steerable catheter 311, the native annulus 310, the inner opening of the anchor 314, and into the second chamber of the heart (e.g., left ventricle 306), similar to that described above with reference to FIG 1D. FIG 3D shows an optional balloon 324 (e.g., attached to or part of the guidewire delivery catheter 326) that can optionally be used to facilitate visualization of the guidewire 322, similar to that described above with reference to FIG 1E. FIG 3E shows the advancement of a valve delivery catheter 328 (e.g., as part of a valve delivery system) threaded through the transseptal puncture 302 and positioned for delivery of a prosthetic valve, similar to that described above with reference to FIG 1F.

[0039]

[0043] FIG. 3F shows the distal portion 332 of the prosthetic valve being deployed from the valve delivery catheter 328 into the native annulus 310 and into the central opening of the anchor 314, similar to that described above with reference to FIG. 1H. In some instances, the distal portion 332 of the prosthetic valve can be pulled proximally (334) (e.g., by pulling the valve delivery catheter 328 proximally) to maintain or move the position of the anchor 314 proximal to the native annulus 310, if necessary. FIG. 3G shows the proximal portion 336 of the prosthetic valve being deployed above the native annulus 310, thereby fully deploying the prosthetic valve 350. After the prosthetic valve 350 is fully deployed, the valve delivery catheter 328 can be pulled proximally outwardly from the patient's body.

[0040]

[0044] FIG. 4 is a flow chart illustrating an exemplary method of implanting a prosthetic valve to treat a diseased valve. An exemplary operation 402 includes positioning anchors around chordae and / or leaflets of a diseased native valve. This may involve winding a helical shaped anchor around the chordae and / or leaflets. In some examples, the anchors are delivered to the heart via a steerable catheter and / or an anchor control catheter. A guide arm portion of the anchor control catheter may extend from the steerable catheter and have a curved shape designed to guide the anchor around the chordae and / or leaflets as the anchor advances out of the anchor guide. The steerable catheter may be steerable (e.g., deflectable) to steer the anchor control catheter and / or anchors in place. Additionally or alternatively, the anchor control catheter may be steerable (e.g., deflectable) to steer the anchors in place. The guide arm portion may be rotatable relative to the steerable catheter to facilitate positioning of the anchors. A tether may be attached to the anchors during deployment of the anchors around the chordae / leaflets. In some instances, the tether can be pulled proximally to provide traction to the anchor, which changes the shape of the anchor control catheter (e.g., compresses the curvature) and / or holds the anchor in place as the anchor control catheter is retracted proximally. In some cases, imaging (e.g., ultrasound and / or fluoroscopy) can be used to visualize the anchor during or after deployment and / or to ensure proper placement and / or orientation of the anchor.

[0041]

[0045] Once the anchor is deployed, the tether is optionally released from the anchor in operation 403. For example, if the tether is used to tension the anchor control catheter and / or hold the anchor in place as the anchor control catheter is retracted proximally, the tether can be detached from the anchor and pulled proximally out of the patient's body. In some cases, releasing the tether from the anchor early (e.g., before operation 404) can prevent the tether from interfering with the position of the anchor. Additionally, once the anchor is properly positioned and / or oriented in operation 402, access to the anchor via the tether may not be necessary.

[0042]

[0046] An exemplary operation 404 includes advancing at least a portion of a guidewire through the diseased native valve annulus and a central opening of the helical-shaped anchor. The guidewire can be passed from a first heart chamber (e.g., the left atrium) to a second heart chamber (e.g., the left ventricle). In some cases, a steerable catheter may be steered (e.g., deflected) to steer the guidewire through the diseased native valve annulus and the anchor.

[0043]

[0047] Exemplary operations 406 include optionally using imaging (e.g., ultrasound and / or fluoroscopy) while positioning the guidewire through the diseased native annulus and anchors. In some instances, the guidewire can have a unique shape (e.g., a pigtail end) to facilitate identification of the guidewire and its location relative to the anchors and / or native annulus using imaging techniques. Additionally or alternatively, the guidewire can include a balloon to facilitate identification of the guidewire and its location. Imaging can be performed in real-time during placement of the guidewire to prevent the guidewire from becoming tangled within the chordae and / or leaflets, passing through the turns of the anchors, or being positioned outside of the chordae and / or leaflets. The steerable catheter can be steered to control the movement of the guidewire as it is extended from the steerable catheter. In some cases, the guidewire is manipulated by a combination of advancing the guidewire and retracting the guidewire relative to the steerable catheter. Once positioned through the annulus, imaging can also be used to confirm proper placement of the guidewire. Once the guidewire is properly positioned, the steerable catheter can be retracted.

[0044]

[0048] An exemplary operation 408 includes tracking the valve delivery catheter over the guidewire. In some examples, the tether can remain attached to the anchor such that the valve delivery catheter extends parallel to the tether along at least a portion of the patient's blood vessel and through the transseptal puncture. If the tether is still attached to the anchor, the valve delivery catheter and tether can be within an outer sheath of the valve delivery catheter. The outer sheath can minimize tissue damage at the puncture site and / or along the blood vessel that the valve delivery catheter (and tether) traverses. In some examples, the valve delivery catheter is steerable. In some examples, the valve delivery catheter can include a monorail lumen to house the tether therein (if the tether is still present). This can control the position and movement of the tether, for example, to prevent the tether from becoming tangled.

[0045]

[0049] An exemplary operation 410 includes deploying a distal portion of the prosthetic valve from the valve delivery catheter to a second side (e.g., ventricular side) of the native valve annulus. Release of the prosthetic valve from the valve delivery catheter can be controlled such that the distal portion of the prosthetic valve expands into the second side (e.g., ventricular side) of the native valve without releasing / expanding the proximal portion of the prosthetic valve within the atrial side of the native valve annulus. In some examples, the distal portion of the prosthetic valve is pulled proximally relative to the anchor to position the anchor and the distal portion of the prosthetic valve as close as possible to the plane of the native valve annulus and / or achieve the same planar orientation relative to the plane of the native valve annulus. Once the anchor and the distal portion of the prosthetic valve are properly positioned relative to the native valve annulus, the proximal portion of the prosthetic valve can be deployed, thereby fully deploying the prosthetic valve.

[0046]

[0050] If the tether was not already released from the anchor in operation 403, then in operation 405 the tether can optionally be decoupled and released from the anchor during (or between) any of operations 404-410. For example, the tether can be pulled proximally and / or pushed distally during (or between) any of operations 404-410 to reposition the anchor as close as possible to the native annulus and / or achieve a co-planar anchor orientation relative to the native annulus. In some cases, releasing the tether from the anchor during or between operations 404-410 can prevent the tether from interfering with the position of the anchor during these operations. Additionally, access to the anchor via the tether may not be necessary after one of operations 404-410.

[0047]

[0051] In operation 412, a proximal portion of the prosthetic valve is deployed in a first heart chamber (e.g., the atrium on the atrial side of the native valve annulus), thereby fully deploying the prosthetic valve. In operation 414, the valve delivery catheter and guidewire can be retracted and removed from the patient's body. If the tether was not already released from the anchor in operation 403 or 405, the tether can be decoupled and released from the anchor after operation 410, in any of operations 412-414, or after operation 414.

[0048]

[0052] Any of the methods described herein may include visualizing any of the anchors, prosthetic valves, tethers, and / or catheters (e.g., steerable catheters, anchor control catheters, valve delivery catheters, and / or outer sheaths) while in the patient's heart. Visualizing may include using one or more imaging techniques, such as (but not limited to) ultrasound, fluoroscopy, and / or radio frequency imaging techniques. Imaging may be used to visualize the position of any of the anchors, prosthetic valves, tethers, and / or catheters during or between any of acts 402-414.

[0049]

[0053] As described herein, any of the prosthetic valves may include a framework. The framework may be configured like a stent. The framework may include, for example, a diamond patterned scaffolding formed from a shape memory material (e.g., Nitinol, NiTi). Those skilled in the art will recognize that many other structures, materials, and configurations may be utilized for the framework. For example, the framework may be formed from a sufficiently elastic polymer. The framework may be formed from a combination of metal and polymer, such as a metal (e.g., a shape memory material) covered with a polymer. The framework may include a wide variety of patterns in addition to the diamond shape. In some embodiments, the framework is a closed frame such that blood flow is forced through the internal valve segments. One or more skirts and / or seals may assist in forcing blood flow through the valve segments.

[0050]

[0054] Those skilled in the art will recognize, based on the description herein, that any of the prosthetic valves described herein can include any of the framework shape, framework design, framework material, anchor shape, anchor windings, anchor material, free end tips, leaflet configurations, or any other of the variable features described herein in any combination thereof as desired.

[0051]

[0055] As used herein, when a feature or element is said to be "on" another feature or element, it can be directly on the other feature or element, or there may be intervening features and / or elements. In contrast, when a feature or element is said to be "directly on" another feature or element, there are no intervening features or elements. Also, when a feature or element is said to be "connected," "attached," or "coupled" to another feature or element, it should be understood that it can be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is said to be "directly connected," "directly attached," or "directly coupled," there are no intervening features or elements. Although described and illustrated in connection with one embodiment, the features and elements so described or illustrated are applicable to other embodiments. Also, when a structure or feature is said to be "adjacent" to another feature, one skilled in the art will understand that it may have portions that overlap or underlie the adjacent feature.

[0052]

[0056] The terms used herein are only intended to describe particular embodiments and are not intended to be limiting of the present invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural unless the context dictates otherwise. Furthermore, when the terms "comprise" and / or "comprises" are used herein, they are understood to specify the presence of the described features, steps, operations, elements and / or components, but not to preclude the presence or addition of one or more other features, steps, operations, elements, components and / or groups thereof. As used herein, the term "and / or" includes any or all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0053]

[0057] Spatially relative terms such as "below," "down," "lower," "upper," "top," and the like may be used herein for ease of description to describe the relationship of one element or feature to another element or feature as depicted in the drawings. It should be understood that these spatially relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation depicted in the drawings. For example, if the device in the figures were flipped over, an element described as being "below" or "below" the other element or feature would be in an orientation "above" that other element or feature. Thus, the illustrative term "below" may encompass both an orientation above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless specifically indicated otherwise.

[0054]

[0058] In this specification, the terms "first" and "second" may be used 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 may be referred to as a second feature / element, and similarly, a second feature / element described below may be referred to as a first feature / element, without departing from the teachings of the present invention.

[0055]

[0059] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "comprises" and "comprising" mean that various components may be employed together in methods and articles (e.g., devices and compositions and apparatuses that include methods). For example, the term "comprising" is understood to imply the inclusion of any recited elements or steps, but not to exclude other elements or steps.

[0056]

[0060] Unless expressly specified, all numerical values ​​used in the specification and claims, including those used in the examples, can be read as if they were preceded by the term "about" or "approximately" even if these terms are not explicitly stated. The phrase "about" or "approximately" can be used when describing a magnitude and / or location to indicate that the stated value and / or location is within a reasonable expected range of values ​​and / or locations. For example, a numerical value can have a value that is + / -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), or + / -10% of the stated value (or range of values). Any numerical value provided herein should also be interpreted as including about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any range described herein is intended to include all subranges encompassed herein. It is also to be understood that when a value is disclosed, "less than or equal to," "more than or equal to," and possible ranges between the values ​​are also disclosed, as would be properly understood by one of ordinary skill in the art. It is also to be understood that when a value "X" is disclosed, "less than or equal to X" and "more than or equal to X" (e.g., where X is a numeric value) are also disclosed, as would be properly understood by one of ordinary skill in the art. It is also to be understood that throughout this application, data are presented in several different formats, and that these data represent endpoints and starting points, and ranges for any combination of these data points. For example, when a specific data point "10" and a specific data point "15" are disclosed, it is to be understood that values ​​greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than or equal to 10 and 15, and equal to 10 and 15 are also considered to be disclosed, as are values ​​between 10 and 15. It is also to be understood that each unit amount between two specific unit amounts is also disclosed. For example, when 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0057]

[0061] Although various exemplary embodiments have been described above, any of many modifications may be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which the various method steps described are performed can often be changed in alternative embodiments, and one or more method steps may be skipped entirely in other alternative embodiments. Optional features of the various device and system embodiments may be included in some embodiments and not in others. Thus, the above description has been presented primarily for purposes of illustration and should not be construed as limiting the scope of the invention as described in the claims.

[0058]

[0062] The examples and illustrations contained herein are for illustrative purposes, not for limiting purposes, and show specific embodiments in which the subject matter may be practiced. As mentioned above, other embodiments are available and can be derived in such a manner that structural and logical substitutions and changes can be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention may be referred to herein, individually or collectively, under the term "invention" for convenience only, without intending to spontaneously limit the scope of the present application to any single invention or inventive concept when in fact more than one is disclosed. Thus, although specific embodiments are illustrated and described herein, any configuration intended to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to cover any modifications or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to one of ordinary skill in the art upon reviewing the above description.

Claims

1. 1. A delivery system for delivering a prosthetic valve to a diseased heart valve, comprising: a tether sized and shaped to extend from outside the heart through the annulus of the diseased valve, the tether further configured to connect to anchors sized and shaped to circumscribe the native leaflets and / or chordae of the heart; a guidewire sized and shaped to extend from outside the heart through the annulus of the diseased valve; a valve delivery catheter configured to extend over the guidewire through the annulus of the diseased valve, the valve delivery catheter configured to hold the prosthetic valve in a compressed state therein and to release the prosthetic valve within the annulus of the diseased valve and the anchor while the tether is connected to the anchor; and A delivery system comprising:

2. The system of claim 1 , wherein the valve delivery catheter further comprises a monorail lumen sized and shaped to accommodate the tether therein.

3. The system of claim 2 , wherein the tether is further configured to move within the monorail lumen to adjust the position of the anchor relative to the valve delivery catheter and / or the diseased valve.

4. 10. The system of claim 1, further comprising a balloon catheter configured to extend over at least a portion of the guidewire, the balloon catheter including an inflatable distal portion sized and shaped to prevent its passage between adjacent chordae of the heart.

5. The system of claim 4 , wherein the balloon catheter is adapted for visualization via imaging.

6. The system of claim 1 , wherein the distal end of the guidewire has a curve adapted for visualization via imaging.

7. The system of claim 1 , wherein the prosthetic valve comprises an expandable frame.

8. The system of claim 1 , wherein the tether is releasably attached to the anchor via a releasable connector.

Images