HK40105855A - Cardiac valve prosthesis delivery system and methods of use - Google Patents

Description

Heart valve prosthesis delivery system and usage

Cross-references to related applications

This application claims priority to U.S. Provisional Application No. 63/262,552, filed October 14, 2021, entitled “DELIVERY SYSTEM FOR CARDIACVALVE PROSTHESIS,” the entire contents of which are incorporated herein by reference for all purposes.

By incorporating references

All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety, as if each individual publication or patent application were specifically and individually incorporated by reference.

Background Technology

Blood flow between the heart chambers is regulated by the patient's own valves (mitral valve), aortic valve, pulmonary valve, and tricuspid valve. Each of these valves is a passive, one-way valve that opens and closes in response to a pressure gradient. Patients with valvular disease have an abnormal anatomy and/or function of at least one valve. For example, a valve may have a dysfunction problem, also known as regurgitation, when it does not close completely and allows blood to flow backward. Valvular stenosis can cause a valve to fail to open properly. Other conditions can also cause valvular dysfunction. While medication can be used to treat the disease, in many cases, it may be necessary to repair or replace the defective valve at some point in a patient's life. Existing valve repair and/or replacement procedures can have relatively high risks, limited lifespan, and/or be highly invasive. Some less invasive transcatheter options are feasible; however, these are generally limited to aortic valve surgery, have limited inter-patient flexibility, and typically take longer than implantation would require. Therefore, there is a desire to provide a less invasive surgical procedure, a faster surgical approach, and/or a prosthetic valve that can be adapted to a wide range of individual patients for the repair and replacement of heart valves (including the mitral valve).

Furthermore, existing valve repair/replacement surgeries are typically complex and time-consuming. Currently feasible procedures often require the placement of more than one component, such as a prosthetic valve and a mechanism for anchoring it to the patient's own anatomy. Such procedures may utilize multiple delivery catheters to carry various components. Moreover, delivery of each component may require separate access sites and pathways to the patient, which can be time-consuming (especially if components are delivered sequentially), complex, and/or dangerous. For example, it may be difficult to align components delivered via separate delivery systems along different access pathways to the heart. Additionally, it may be necessary to extrude some anchoring elements through the patient's own valve annulus in a low-profile (e.g., elongated) delivery configuration to achieve an expanded configuration at or near the patient's own valve. In at least some cases, the extrusion of anchoring elements can be complex and may not reliably unfold into the correct expanded configuration relative to the delivery device and/or the patient's own anatomy. Proper alignment between the prosthetic valve and any anchoring or docking components is essential to ensuring the proper performance of the prosthetic heart valve. Incorrect deployment can lead to additional time, more complex anchoring procedures, and/or damage to autologous tissue when retracting and re-deploying the anchoring element and/or prosthetic valve. Therefore, there is a need for a faster, simpler, safer, and more reliable deployable valve assembly for valve replacement and repair.

Summary of the Invention

This document describes a delivery system and method for delivering a valve anchor and/or valve prosthesis to an autologous valve annulus. The anchor may have a helical shape and unfold around the chordae tendineae and/or leaflets of the autologous valve annulus. A tether attached to the anchor may extend to the exterior of the heart and/or the patient's body. During one or more unfolding operations of the anchor and/or valve prosthesis, the tether may remain attached to the anchor. In some examples, a valve delivery catheter may be delivered along a guidewire adjacent to the tether while the tether remains attached to the anchor to unfold the valve prosthesis within the autologous valve annulus and the helical anchor. In other examples, the tether may be disconnected from the anchor before delivery of the valve delivery catheter along the guidewire. Once the valve prosthesis has been unfolded, the valve delivery catheter (and the tether, if not already removed) may be removed from the patient's body, leaving the valve prosthesis within the autologous valve annulus and secured in place by the surrounding anchor.

According to some aspects, a method for treating a diseased autologous valve in a patient includes: encircling the chordae tendineae and/or leaflets of the diseased autologous valve in a second chamber of the patient's heart with an anchor, the anchor having a tether attached to the anchor, the tether extending proximally from the second chamber through a first chamber of the patient's heart; advancing a portion of a guidewire from the first chamber of the patient's heart through the annulus of the diseased autologous valve to the second chamber of the patient's heart; advancing a valve delivery catheter along the guidewire, the valve delivery catheter including a valve prosthesis therein in a compressed configuration; and releasing the valve prosthesis from the valve delivery catheter to extend into the annulus of the diseased autologous valve and within the anchor.

The method may further include: acquiring images as the guidewire is advanced through the annulus of the diseased autologous valve; and deflecting a manipulatory catheter to manipulate the guidewire through the inner diameter of the anchor. Advancing this portion of the guidewire may include: advancing a guidewire delivery catheter through the manipulatory catheter, through the annulus of the diseased autologous valve, and through the 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. Manipulating the guidewire may further include manipulating the guidewire through the annulus of the diseased autologous valve. The guidewire may have a curvature that facilitates imaging of the guidewire. Releasing a valve prosthesis from the valve delivery catheter may include: partially deploying a portion of the valve prosthesis in a second chamber; pressing the partially deployed valve prosthesis against the anchor and pushing the anchor toward the annulus of the diseased autologous valve; and fully deploying the remaining portion of the valve prosthesis into the annulus of the diseased autologous valve and/or the first chamber. The method may also include: disconnecting the tether from the anchor; and retracting the tether and valve delivery catheter from the patient's body. The tether can be disconnected and retracted after guidewire placement. The tether can be disconnected and retracted while the valve delivery catheter is being advanced along the guidewire. The tether can be disconnected and retracted before the valve prosthesis is released from the valve delivery catheter. The method may also include delivering the valve delivery catheter and tether within the outer sheath. Advancing the valve delivery catheter along the guidewire may further include passing the tether through the single-rail lumen of the valve delivery catheter. The method may also include using the anchor to control the catheter to deliver the anchor to the diseased autologous valve.

According to some aspects, a delivery system for delivering a valve prosthesis to a diseased valve in the heart includes: a tether, the tether being sized and shaped to extend from outside the heart and through a loop of the diseased valve, the tether also being configured to connect to an anchor, the anchor being sized and shaped to surround an autologous leaflet and/or chordae tendineae of the heart; a guidewire, the guidewire being sized and shaped to extend from outside the heart and through a loop of the diseased valve; and a valve delivery catheter, the valve delivery catheter being configured to extend along the guidewire through a loop of the diseased valve, the valve delivery catheter being configured to hold a compressed valve prosthesis therein, and to release the valve prosthesis within the loop of the diseased valve and the anchor when the tether is connected to the anchor.

The valve delivery catheter may also include a monorail lumen sized and shaped to accommodate a tether. The tether may also 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 also include a balloon catheter configured to extend along at least a portion of a guidewire, the balloon catheter including an inflatable distal portion sized and shaped to prevent it from passing between adjacent chordae tendineae of the heart. The balloon catheter may be adapted for visualization via imaging. The distal portion of the guidewire may have a curvature adapted for visualization via imaging. The valve prosthesis may include an expandable frame. The tether may be releasably attached to the anchor via a releasable connector.

According to some aspects, a method of delivering a valve prosthesis in a patient's heart includes: implanting a helical anchor near an autologous valve annulus in the patient's heart by using an anchor control catheter to surround the chordae tendineae and/or leaflets of the autologous valve, wherein the proximal end of the helical anchor is releasably connected to a tether extending through the annulus and accessible from outside the patient's heart; unfolding 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 autologous valve and through a central opening of the anchor; advancing a valve delivery catheter along the guidewire, wherein the valve delivery catheter carries a valve prosthesis in a compressed state; and expanding the valve prosthesis within the autologous valve annulus and into the central opening of the anchor.

Expanding a valve prosthesis may include extending the distal portion of the valve prosthesis distally relative to the anchor into the ventricle of the patient's heart, wherein the method may further include pulling the distal portion of the valve prosthesis proximally against the anchor to adjust the position of the anchor relative to the annulus of the native valve. The method may also include extending the proximal portion of the valve prosthesis proximally relative to the anchor into the atrium of the patient's heart, thereby fully expanding the valve prosthesis within the anchor and the native valve. The method may further include extending the intermediate segment of the valve prosthesis into the anchor. The method may further include confirming the position of the anchor relative to the annulus of the native valve before releasing the tether. Confirming the position of the anchor may include visualizing the anchor using ultrasound, fluoroscopy, and/or radiographic imaging. Encircling the chordae tendineae and/or leaflets may include rotating the anchor control catheter relative to the chordae tendineae and/or leaflets. The method may further include removing the tether from the patient's heart before advancing the guidewire.

According to some aspects, a method for treating a diseased autologous valve in a patient includes: encircling the chordae tendineae and/or leaflets of the diseased autologous valve with an anchor in the second chamber of the patient's heart, the anchor having a tether attached thereto, wherein the tether extends distally from the first chamber of the patient's heart, passes through the ring of the diseased autologous valve, and enters the second chamber of the patient's heart; releasing the tether from the anchor once the anchor has unwound around the chordae tendineae 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 ring of the diseased autologous valve, and into the second chamber of the patient's heart; and confirming that the guidewire is not tangled in the second chamber by advancing and retracting the guidewire catheter while visualizing the distal features of the guidewire catheter.

The method may further include: advancing a valve delivery catheter along a guidewire, the valve delivery catheter including a valve prosthesis therein in a compressed configuration; and releasing the valve prosthesis from the valve delivery catheter to extend within the annulus and anchor of the diseased autologous valve. The guidewire may be advanced through the inner circumference of the anchor, which is anchored to the diseased autologous valve in a second chamber of the patient's heart. Releasing the valve prosthesis from the valve delivery catheter may include releasing a distal portion of the valve prosthesis into the second chamber and using the distal portion of the valve prosthesis to adjust the position of the anchor relative to the annulus of the diseased autologous valve. The method may further include confirming the position of the anchor relative to the annulus of the diseased autologous valve by visualizing the anchor using ultrasound, fluoroscopy, and/or radiographic imaging prior to releasing the tether from the anchor.

According to some aspects, a method for treating a diseased autologous valve in a patient includes: advancing a guidewire through an annulus of the diseased autologous valve and the inner circumference of an anchor, the anchor being anchored to the diseased autologous valve in a second chamber of the patient's heart, wherein the anchor includes a tether attached thereto, the tether extending from the second chamber through the annulus and out of the patient's body; advancing a valve delivery catheter along the guidewire, the valve delivery catheter including a valve prosthesis therein in a compressed configuration; and deploying the valve prosthesis from the valve delivery catheter into the annulus and anchor of the diseased autologous valve, wherein the tether is released from the anchor during the deployment of the valve prosthesis.

Deploying the valve prosthesis may include: (a) releasing a distal portion of the valve prosthesis into a second chamber and using the distal portion of the valve prosthesis to adjust the position of the anchor relative to the annulus of the diseased autologous valve; and (b) releasing a proximal portion of the valve prosthesis into a first chamber of the patient's heart; wherein a tether is released from the anchor during (a), during (b), or between (a) and (b). The method may further include, before advancing the guidewire through the annulus of the diseased autologous valve and the inner circumference of the anchor: while the tether is attached to the anchor, surrounding the chordae tendineae and/or leaflets of the diseased autologous valve in the second chamber of the patient's heart with the anchor. The tether may extend proximally from the second chamber of the patient's heart, through the annulus of the diseased autologous valve, and into the first chamber of the patient's heart. The method may further include, prior to releasing the tether from the anchor, visualizing the anchor relative to the annulus of the diseased autologous valve using ultrasound, fluoroscopy, and/or radiographic imaging to confirm the position of the anchor relative to the annulus of the diseased autologous valve.

This article describes these and other aspects.

Attached Figure Description

The novel features of the present invention are set forth in the appended claims. The features and advantages of the invention will be better understood by referring to the following detailed description of exemplary embodiments, in which the principles of the invention are utilized, as illustrated in the accompanying drawings:

Figures 1A to 1J illustrate an exemplary method for delivering an anchor and a valve prosthesis near an autologous valve, wherein a tether remains connected to the anchor as the anchor deploys and the valve delivery catheter deploys.

Figure 2 shows an exemplary valve delivery catheter with a monorail lumen for tethering;

Figures 3A to 3G illustrate another exemplary method for delivering an anchor and valve prosthesis near an autologous valve, wherein a tether is attached to the anchor while it is deployed and removed prior to deployment of the valve delivery catheter; and

Figure 4 is a flowchart illustrating an exemplary method for deploying a prosthetic valve.

Detailed Implementation

This document describes apparatus and methods for delivering valve prostheses, for example, during mitral valve replacement. Delivery systems may include anchor delivery systems (e.g., subsystems) that deliver a spiral anchor around a patient's own valve, and valve delivery systems (e.g., subsystems) that deliver the valve prosthesis within an deployed anchor and the patient's own valve. Anchor delivery systems may include anchor control catheters for releasing and positioning the anchor within the heart. Valve delivery systems may include valve delivery catheters for positioning and releasing the valve prosthesis within a central opening of the patient's own valve annulus and anchor. A tether attached to the end of the anchor may be positioned parallel to the anchor control catheter and/or valve delivery catheter. The tether may be used to adjust the position of the anchor and/or valve prosthesis, or otherwise provide access to the anchor. Such methods can advantageously allow reliable control of the anchor and/or valve prosthesis during a variety of procedures. In some cases, anchor delivery systems and/or valve delivery systems may include one or more features to allow visualization (e.g., via ultrasound and/or fluoroscopy) to track the location of anchors and/or valve prostheses within the heart.

During various procedures of anchor and/or valve delivery, the tether can be used for one or more purposes. For example, when the anchor control catheter is pulled proximally out of the heart, the tether can facilitate the retraction of the anchor control catheter. Once the anchor control catheter has been removed from the heart, the tether can be used additionally or alternatively to adjust the position of the anchor. This can include pulling the tether proximally and/or pushing the tether distally to reposition the anchor closer to the native valve ring and/or to achieve an anchor orientation coplanar with respect to the native valve ring. The tether can be used additionally or alternatively in conjunction with the valve prosthesis (e.g., before the valve prosthesis is fully deployed) to adjust the position of the anchor and the valve prosthesis.

The tether can be released from the anchor at different times during the anchor and/or valve prosthesis delivery procedure. For example, the tether can be released from the anchor after the catheter has been positioned by the anchor. In other examples, the tether can be released from the anchor after the guidewire has been introduced through the anchor and/or after the valve prosthesis has been partially deployed within the heart. In yet another example, the tether can be released from the anchor after the valve prosthesis has been fully deployed within the heart.

Figures 1A through 1J illustrate exemplary methods of delivering a prosthetic valve according to some embodiments. Figure 1A shows a transseptal puncture portion 102 created by a puncture device 103 to provide an entrance into a first chamber of the heart (in this case, the left atrium 104). The puncture device 103 may advance through a manipulable catheter (e.g., 111 in Figure 1B) and/or an anchor control catheter (e.g., 108 in Figure 1B), or may advance through a portion of a manipulable catheter and/or an anchor control catheter, or may be a separate device that retracts before advancing the manipulable catheter and/or anchor delivery catheter. In some cases, the puncture device 103 may include a dilator configured to expand the transseptal puncture portion 102, for example, to accommodate the entry of the anchor delivery catheter and/or valve delivery catheter.

Figure 1B illustrates a manipulable catheter 111 and an anchor control catheter 108 (also referred to as an anchor delivery catheter) passing through the transseptal puncture site 102 and positioned for delivery of an anchor 114. The manipulable catheter 111 and the anchor control catheter 108 may be part of an anchor delivery system. At least a portion (e.g., distal) of the manipulable catheter 111 may be manipulable (e.g., deflectable) to manipulate the anchor control catheter 108 and/or the anchor 114 to a desired position and orientation relative to the autologous valve ring 110. In some examples, the manipulable catheter 111 and/or the anchor control catheter 108 may include one or more concentric catheters (e.g., sub-catheters) each configured to deflect along a plane in 3D space. Therefore, a maneuverable conduit 111 and/or an anchor control conduit 108 having a single planar deflectable conduit can allow the maneuverable conduit 111 to deflect along one plane in 3D space, two concentric planar deflectable conduits (e.g., sub-conduits) can allow the maneuverable conduit 111 to deflect along two planes in 3D space, and three concentric planar deflectable conduits (e.g., sub-conduits) can allow the maneuverable conduit 111 and/or an anchor control conduit 108 to deflect along three planes in 3D space, and so on. The maneuverable conduit 111 and/or an anchor control conduit 108 can be configured to be maneuverable in any number of planes and dimensions in 3D space. The maneuverable conduit 111 and/or an anchor control conduit 108 can bend between a straight configuration and a curved (deflecting) configuration. This bending can be controlled, for example, at a handle operably coupled to the maneuverable conduit 111 and/or an anchor control conduit 108. In some cases, each inner conduit in the concentric conduits can be advanced through the distal end of its corresponding outer conduit.

Once the anchor control catheter 108 is in the first chamber of the heart (e.g., left atrium 104), it can be advanced through the maneuverable catheter 111, and the anchor 114 can be advanced through the distal guide arm portion 112 of the anchor control catheter 108. The guide arm portion 112 may be integrally formed with the remainder of the anchor control catheter 108. The anchor 114 and the guide arm portion 112 of the anchor control catheter 108 may be positioned to pass through the autologous valve ring 110 and into the second chamber of the heart (in this case, left ventricle 106). Once in the second chamber of the heart (e.g., 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 autologous valve ring 110. Engagement and positioning of the anchor 114 may include rotating the anchor control catheter 108 (which rotates the anchor 114) relative to the chordae tendineae 116 and/or leaflets. This may include rotating the anchor control catheter 108 relative to the steerable catheter 111. The delivered anchor 114 may reside only in the second chamber of the heart (e.g., the left ventricle 106).

As shown, anchor 114 may be configured in a helical shape. The anchor may have one or more bends in its deployed state. In some embodiments, the bends of the deployed anchor are substantially in a plane (e.g., radial). In some embodiments, the bends of the deployed anchor at least partially overlap each other (e.g., in a direction perpendicular to the radial plane). In some embodiments, the anchor is sized and shaped to be able to deploy in a single chamber of the heart and reside in (e.g., different) single chambers of the heart. For example, the anchor may deploy (e.g., completely) in the atrium of the heart and be implanted (e.g., individually) in the ventricle of the heart. In some examples, anchor 114 comprises a shape memory material (e.g., nitinol, nitinium). Guide arm portion 112 may be configured in a predetermined curved shape to facilitate the winding of the bends of the helical anchor 114, such that the helical arm of anchor 114 surrounds chordae tendineae 116 and/or leaflets. The geometry (e.g., curvature) of guide arm portion 112 may induce torsion on anchor 114 during deployment. In other cases, the guide arm portion 112 may be configured to be curved when activated (e.g., via control at the handle). For example, once the guide arm portion 112 advances from the steerable catheter 111, the guide arm portion 112 may take on its shape through “self-assembly.” The curved shape of the arm portion 112 may maintain the planar orientation of the anchor 114 relative to the autologous valve ring 110. The guide arm portion 112 may be positioned and/or oriented around the chordae tendineae 116 and/or leaflets as needed by manipulating (e.g., deflecting, bending) the steerable catheter 111 and/or rotating the anchor to control the catheter 108 and/or the guide arm portion 112. In some embodiments, reverse rotation of the anchor 114 (via the anchor to control the reverse rotation of the catheter 108 and/or the guide arm portion 112) may help advance the anchor 114 through the autologous valve ring 110 without tangling the chordae tendineae 116 and/or the leaflets. In some cases, imaging (e.g., ultrasound and/or fluoroscopy) can be used to determine whether the anchor 114 surrounds sufficient chordae tendineae 116 and/or leaflets, and if necessary, to reverse and rotate the anchor 114 to capture sufficient chordae tendineae 116 and/or leaflets.

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 controlling the forward rotation of the catheter 108 and/or guide arm portion 112) allows the anchor 114 to surround the mitral valve leaflets and chordae tendineae 116 and/or leaflets. In some embodiments, the anchor 114 is deployed toward the ventricular apex (e.g., initially) to help avoid interfering with the leaflet movement of the autologous valve 110.

Figure 1C shows the anchor 114 deployed around the chordae tendineae 116 and/or leaflets, and the anchor control catheter 108 (including the guide arm portion 112) retracted into the maneuverable catheter 111 (Figure 1B). As shown, the proximal end of the anchor 114 can be connected to a tether 118 extending out of the patient's body to maintain communication with the anchor 114. The connector 120 can be adapted to releasably connect the distal end of the tether 118 to the proximal end of the anchor 114. For example, the locking mechanism of the connector 120 can be configured to lock the anchor 114 to the tether 118 and unlock (and disconnect) the anchor 114 from the tether 118 when the handle at the proximal end of the tether 118 is actuated.

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 shaped in a predetermined way) so that it can be pushed distally (e.g., instead of being pulled proximally or otherwise) to adjust the position of the anchor 118 closer to the autologous valve ring 110 and/or adjust the orientation of the anchor 118 to be coplanar with the autologous valve ring 110. In some examples, the tether 118 can be stiffened (and/or shaped in a predetermined way) so that it can be pushed distally (instead of being pulled proximally or otherwise) to adjust the position of the anchor 114 closer to the autologous valve ring 110 and/or adjust the orientation of the anchor 114 relative to the autologous valve ring 110. Exemplary embodiments of suitable tethers may be described in International Application No. PCT/US2022/075931, filed September 2, 2022, the entire disclosure of which is incorporated herein by reference.

Figure 1D illustrates guidewire 122, which advances through a manipulable catheter 111 adjacent to tether 118, through the autologous valve annulus 110, through the inner circumference of anchor 114, and into the second chamber of the heart (e.g., left ventricle 106). In some cases, guidewire 112 can be delivered via guidewire delivery catheter 126, which itself can be delivered via manipulable catheter 111. For example, guidewire delivery catheter 126 can be advanced through manipulable catheter 111, through the autologous valve annulus 110, and through the inner diameter of anchor 114; and guidewire 123 can be advanced through guidewire delivery catheter. In some examples, manipulating (e.g., deflecting) manipulable catheter 111 is used to position guidewire 122 (and guidewire delivery catheter 126) through the inner diameter of valve annulus 110 and anchor 114. In some examples, the distal end 123 of guidewire 122 may have a curvature (e.g., pigtail shape) that facilitates visualization of guidewire 122 during positioning (e.g., via fluoroscopic imaging). Guidewire 114 may be made of any of a variety of materials, such as one or more metals and/or one or more polymeric materials. In some examples, guidewire 122 has a diameter ranging from about 0.02 inches to about 0.05 inches (e.g., 0.02, 0.025, 0.03, 0.035, 0.04, 0.045, or 0.05 inches).

Figure 1E illustrates a balloon 124 (e.g., an exploratory balloon), which may optionally be used to aid in the visualization of the guidewire 122. In some cases, the balloon 124 may be attached to or be part of the guidewire delivery catheter 126. For example, the balloon 124 may be an inflatable portion of the guidewire delivery catheter 126. The balloon 124 may deploy (e.g., inflate) at any desired point along the guidewire 122. For example, the balloon 124 may be located at the distal end of the guidewire delivery catheter 126 and advance along the guidewire 122 toward the distal end 123 of the guidewire 122, where the balloon 124 may deploy (e.g., inflate). The curvature (e.g., pigtail shape) of the distal end 123 of guidewire 122 and/or balloon 124 can be visualized (e.g., via ultrasound and/or fluoroscopic imaging) to ensure that guidewire 122 is properly positioned substantially through the center of autologous valve 110, within the inner circumference of anchor 114, and/or within the second chamber of the heart (e.g., left ventricle 106). Alternatively or additionally, the expanded balloon and its visualization can be used to identify undesirable placement of guidewire 122, such as ensuring that guidewire 122 is not entangled within or between chordae tendineae 116 and/or leaflets, passes through bends in anchor 114, or is not properly engaged with chordae tendineae 116 and/or leaflets. For example, the shape and size of the balloon can be configured to prevent passage between adjacent chordae tendineae, thus a freely moving balloon provides confirmation that the guidewire is not mispositioned between chordae tendineae or around the papillary muscle. Other imaging techniques may also be used. For example, the 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 ensures the correct positioning of the subsequently introduced valve delivery catheter and/or valve prosthesis, which can travel over guidewire 122. If misposition of guidewire 122 is detected, its position can be adjusted. For example, guidewire 122 can be pulled proximally, pushed distally, and/or manipulated by activating manipulable catheter 111. After guidewire 122 is correctly positioned, manipulable catheter 111 and guidewire delivery catheter 126 can be retracted from the heart (e.g., before insertion of valve delivery catheter 128 as described below).

Figure 1F illustrates a valve delivery catheter 128 (as part of a valve delivery system) advancing through a transseptal puncture site 102 and positioned for delivery of a prosthetic valve. In the example shown, the valve delivery catheter 128 is advanced adjacent to a tether 118. The valve delivery catheter 128 can be maneuverable because it can be bent in any direction in various orientations to guide the distal end of the valve delivery catheter 128 through the autologous valve ring 110. For example, the valve delivery catheter 128 can be configured to bend along one or more planes in 3D space, similar to the maneuverable catheter 111 of an 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, this outer sheath can be a safety feature to minimize tissue damage at the puncture site and/or along the vessels through which the catheter passes. In some examples, the valve delivery catheter 128 may include a single-track lumen (e.g., FIG. 2) extending parallel to the central lumen of the valve delivery catheter 128 (e.g., for retaining the valve prosthesis), the size and shape of which may be configured to accommodate the tether 118 therein. This configuration can provide greater control over the tether 118 (e.g., to prevent tether tangling).

Figure 1G illustrates how tension is applied to the tether 118 to maintain the position of the anchor 114 during the advancement and manipulation of the valve delivery catheter 128. For example, it is desirable to keep the anchor 114 as close as possible to the autologous valve ring 110. This tension can be applied by pulling the tether 118 in the proximal direction 130.

Figure 1H illustrates the distal portion 132 of a valve prosthesis extending from the valve delivery catheter 128 into the central opening of the autologous valve ring 110 and anchor 114. In some examples, the valve prosthesis 132 has an expandable frame structure configured to expand when pushed out from the distal end of the valve delivery catheter 128. The valve prosthesis 132 may define a central lumen through which blood flows and include prosthetic leaflets. Figure 1H illustrates the partial deployment of the valve prosthesis 132, with the distal portion of the valve prosthesis 132 expanding. In some examples, the partially expanded valve prosthesis can be pulled proximally 134 (e.g., by pulling the valve delivery catheter 128 proximally and/or pulling the tether 118 proximally) to hold or adjust the position of the distal portion 132 of the valve prosthesis and/or the anchor 114 closer to the autologous valve ring 110, as shown in Figure 1I. For example, the distal portion 132 of the valve prosthesis can be pressed against the anchor 114 and pushed towards the autologous valve ring 110. Figure 1J shows the proximal portion 136 of the valve prosthesis unfolding over the autologous valve ring 110 into the first chamber (e.g., left atrium 104), thus fully unfolding the valve prosthesis 150. As shown, the valve prosthesis 150 can have an hourglass shape, wherein the distal portion 132 and the proximal portion 136 each have a diameter wider than the central segment of the valve prosthesis 150. When fully unfolded, the anchor 114 can surround (e.g., enclose) the central segment of the valve prosthesis 150. After the valve prosthesis 150 is fully unfolded, the valve delivery catheter 128 can be pulled proximally and withdrawn from the patient's body. The anchor 114 can be disconnected from the tether 118 by unlocking the connector 120. The tether 118 can then be removed by pulling it proximally and pulling it out of the patient's body.

U.S. Patent Publication No. published on September 24, 2020.

Exemplary embodiments of valve prostheses/anchors are described in US2020/0297491A1 and US Patent No. 10,912,644, published on February 9, 2021, the entire disclosure of which is incorporated herein by reference.

Figure 2 illustrates an exemplary valve delivery catheter 228 as a variation of the valve delivery catheter 128 shown in Figures 1F to 1J. In this variation, the valve delivery catheter 228 includes a single-rail lumen 252 sized and shaped to accommodate a tether 118. As shown, the single-rail lumen 252 may extend along one side of the valve delivery catheter 228 parallel to a central lumen 250 that accommodates the guidewire 122. The single-rail lumen 252 may restrict movement of the tether 118, for example, to prevent the tether 118 from twisting or tangling. The central lumen 250 may define a distal opening at which the guidewire 122 may exit the valve delivery catheter 228. The valve delivery catheter 228 includes an internal volume 254 adapted (e.g., in size and shape) to hold a prosthetic valve 132 in a compressed configuration (e.g., before the prosthetic valve 132 is released and expanded). When the prosthetic valve 132 is placed within the valve delivery catheter 228, the central lumen 250 can extend through the center of the valve delivery catheter 228 and the prosthetic valve 132.

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

Figures 3A through 3G illustrate another exemplary method for delivering a prosthetic valve in this scenario. The operation shown in Figures 3A through 3G is similar to that in Figures 1B through 1J, except that a tether is attached during the deployment of the anchor 314 but removed before the deployment of the valve delivery catheter. Figure 3A shows a manipulable catheter 311 and an anchor control catheter 308 passing through the transseptal puncture portion 302 and positioned for delivery of the anchor 314. Once the anchor control catheter 308 is in the first chamber of the heart (e.g., the left atrium 304), the anchor control catheter 308 can be advanced through the manipulable catheter 311, and then the anchor 314 can be advanced through the anchor control catheter 308 and exit from the distal guide arm portion 312 of the anchor control catheter 308. The anchor 314 and the guide arm portion 312 can be positioned through the autologous valve ring 310 and into the second chamber of the heart (e.g., the left ventricle 306). Once within the second chamber of the heart (e.g., left ventricle 306), the chordae tendineae 316 and/or leaflet guide anchors 314 can be positioned and/or oriented around the autologous valve ring 310. The catheter 308 (e.g., guide arm portion 312) can be manipulated (e.g., deflected, bent) as needed by manipulating the catheter 311 and/or the anchors to control the positioning and/or orientation of the anchors 314, as described above with respect to Figure 1B. In Figure 3A (similar to Figure 1B), the tether can be connected to the anchors 314 via a connector within the catheter 308 controlled by the anchors.

Figure 3B shows the anchor 314 positioned closer to the plane of the autologous valve ring 310 and oriented in a planar configuration relative to the plane of the autologous valve ring 310. The distal guide arm portion 312 of the anchor control catheter 308 may be curved to maintain the planar orientation of the anchor 314 relative to the autologous valve ring 310. In some cases, the anchor control catheter 308 transitions from a straight shape when in the maneuverable catheter 311 to a curved shape when released from the maneuverable catheter 311. For example, the anchor control catheter 308 may be made of a shape memory material (e.g., nitinol) that is pre-treated to present a curved shape. Alternatively or additionally, the anchor control catheter 308 may be configured to present a curved shape when activated (e.g., by control of a handle). In some cases, a tether (e.g., 118) that may be pulled proximally (and/or pushed distally) within the anchor control conduit 308 can provide traction on the anchor 314 and alter the shape of the anchor control conduit 308. This traction can hold the anchor in place when the anchor control conduit 308 is retracted proximally through the maneuverable conduit 311. In some examples, imaging (e.g., ultrasound and/or fluoroscopy) can be used to visualize the anchor 314 during or after deployment. This imaging can be used to confirm the correct placement and/or orientation of the anchor 314. Once the anchor 314 is properly positioned and oriented, the tether can be released from the anchor 314 by releasing the releasable connector (e.g., 120).

Figure 3C illustrates a guidewire delivery catheter 326, in which a guidewire 322 advances through an internal opening of a manipulable catheter 311, an autologous valve ring 310, an anchor 314, and into the second chamber of the heart (e.g., the left ventricle 306), similar to that previously described with reference to Figure 1D. Figure 3D illustrates an optional balloon 324 (e.g., attached to or part of the guidewire delivery catheter 326), which may optionally be used to aid in visualization of the guidewire 322, similar to that previously described with reference to Figure 1E. Figure 3E illustrates the advancement of a valve delivery catheter 328 (e.g., as part of a valve delivery system), which passes through a transseptal puncture portion 302 and is positioned for delivery of a prosthetic valve, similar to that previously described with reference to Figure 1F.

Figure 3F shows the distal portion 332 of the valve prosthesis, which is unfolding from the valve delivery catheter 328 into the central opening of the autologous valve ring 310 and the anchor 314, similar to what was described previously with reference to Figure 1H. In some examples, if desired, the distal portion 332 of the valve prosthesis can be pulled proximally (e.g., by pulling the valve delivery catheter 328 proximally) to hold or move the anchor 314 close to the autologous valve ring 310. Figure 3G shows the proximal portion 336 of the valve prosthesis unfolding over the autologous valve ring 310, thus fully unfolding the valve prosthesis 350. After the valve prosthesis 350 is fully unfolded, the valve delivery catheter 328 can be pulled proximally and withdrawn from the patient's body.

Figure 4 is a flowchart illustrating an exemplary method of implanting a valve prosthesis for treating a diseased valve. Example operation 402 includes a chordae tendineae and/or leaflet positioning anchor around the diseased autologous valve. This may include an anchor that is spirally wound around the chordae tendineae and/or leaflets. In some examples, the anchor is delivered to the heart via a manipulable catheter and/or an anchor control catheter. A guide arm portion of the anchor control catheter may extend from the manipulable catheter and has a curved shape designed to guide the anchor around the chordae tendineae and/or leaflets as the anchor advances beyond the anchor guide. The manipulable catheter may be manipulable (e.g., deflectable) to maneuver the anchor control catheter and/or anchor into place. Alternatively or additionally, the anchor control catheter may be manipulable (e.g., deflectable) to maneuver the anchor into place. The guide arm portion may rotate relative to the manipulable catheter to facilitate anchor positioning. A tether may be attached to the anchor during the unfolding of the anchor around the chordae tendineae/leaflets. In some examples, the tether can be pulled proximally to provide traction on the anchor. This traction can alter the shape of the anchor control conduit (e.g., compress its curvature) and/or hold the anchor in place when the anchor control conduit 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 confirm its proper placement and/or orientation.

Once the anchor has been deployed, at operation 403, the tether can optionally be released from the anchor. For example, once the tether has been used to apply tension to the anchor control catheter and/or to hold the anchor in place when the anchor control catheter is retracted proximally, the tether can be disconnected from the anchor and pulled proximally out of the patient's body. In some cases, releasing the tether from the anchor earlier (e.g., before operation 404) can prevent the tether from interfering with the anchor's position. Furthermore, once the anchor's position and/or orientation is properly positioned at operation 402, it may not be necessary to access the anchor via the tether.

Example operation 404 includes advancing at least a portion of the guidewire through the central opening of the annulus and helical anchor of the diseased autovalve. The guidewire can be routed from a first cardiac chamber (e.g., the left atrium) to a second cardiac chamber (e.g., the left ventricle). In some cases, the dextrous catheter can be manipulated (e.g., deflected) to maneuver the guidewire through the annulus and anchor of the diseased autovalve.

Example operation 406 includes optionally using imaging (e.g., ultrasound and/or fluoroscopy) while positioning the guidewire through the diseased autologous valve annulus and anchor. In some examples, the guidewire may have a distinctive shape (e.g., a pigtail tip) to facilitate the use of imaging techniques to identify the guidewire and its position relative to the anchor and/or autologous valve annulus. Alternatively or additionally, the guidewire may include a balloon to facilitate identification of the guidewire and its position. Imaging can be performed in real time during guidewire placement to prevent the guidewire from becoming entangled within the chordae tendineae and/or leaflets, extending through bends in the anchor, or being positioned outside the chordae tendineae and/or leaflets. As the guidewire extends from the manipulable catheter, the manipulable catheter can be manipulated to control the movement of the guidewire. In some cases, the guidewire is manipulated by a combination of advancing and retracting it relative to the manipulable catheter. Once the guidewire has passed through the valve annulus, imaging can also be used to confirm proper guidewire placement. Once the guidewire is properly positioned, the manipulable catheter can be retracted.

Example operation 408 involves advancing the valve delivery catheter along the guidewire. In some examples, the tether may 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 vessel and passes through the transseptal puncture site. With the tether still attached to the anchor, the valve delivery catheter and the tether may be located within the outer sheath of the valve delivery catheter. The outer sheath minimizes tissue damage at the puncture site and/or along the vessel through which the valve delivery catheter (and tether) passes. In some examples, the valve delivery catheter is maneuverable. In some examples, the valve delivery catheter may include a single-rail lumen to receive the tether (if the tether is still present). This allows control over the position and movement of the tether, for example, preventing tether tangling.

Example operation 410 involves deploying the distal portion of the valve prosthesis from the valve delivery catheter to a second side (e.g., the ventricular side) of the autologous valve annulus. The release of the valve prosthesis from the valve delivery catheter can be controlled such that the distal portion of the valve prosthesis extends into the second side (e.g., the ventricular side) of the autologous valve, without releasing/expanding the proximal portion of the valve prosthesis within the atrial side of the autologous valve annulus. In some examples, the distal portion of the valve prosthesis is pulled proximally against an anchor to position the anchor and the distal portion of the valve prosthesis as close as possible to the plane of the autologous valve annulus and/or achieve a coplanar orientation relative to the plane of the autologous valve annulus. Once the anchor and the distal portion of the valve prosthesis are properly positioned relative to the autologous valve annulus, the proximal portion of the valve prosthesis can be deployed, thereby fully deploying the valve prosthesis.

If the tether has not been released from the anchor at operation 403, at operation 405, the tether may optionally be disconnected and released from the anchor at any of operations 404 to 410 (or between any of operations 404 to 410). For example, the tether may be pulled proximally and/or pushed distally at any of operations 404 to 410 (or between any of operations 404 to 410) to reposition the anchor as close as possible to the autologous valve ring and/or achieve a coplanar anchor orientation relative to the autologous valve ring. In some cases, releasing the tether from the anchor at or between operations 404 to 410 may prevent the tether from interfering with the anchor's position during these operations. Furthermore, after one of operations 404 to 410, it may not be necessary to access the anchor via the tether.

At operation 412, the proximal portion of the valve prosthesis is deployed within the first cardiac chamber (e.g., the atrium on the atrial side of the autologous valve annulus), thereby fully deploying the valve prosthesis. At operation 414, the valve delivery catheter and guidewire can be retracted from the patient's body and removed. If the tether has not been released from the anchor at 403 or 405, the tether can be disconnected and released from the anchor after operation 410, at any of operations 412 to 414 (or between any of operations 412 to 414), or after operation 414.

Any method described herein may include visualizing any of the catheters (e.g., manipulable catheters, anchor-controlled catheters, valve delivery catheters, and/or outer sheaths) while they are positioned in the patient's heart. Visualization may include using one or more imaging techniques, such as (but not limited to) ultrasound, fluoroscopy, and/or radiofrequency imaging. Imaging may be used to visualize the position of any of the catheters (e.g., anchors, valve prostheses, tethers, and/or catheters) at any point in operations 402 to 414 or between operations 402 to 414.

As described herein, any of the valve prostheses may include a frame structure. The frame structure may be configured as a strut. The frame structure may, for example, include a rhomboid-shaped stent formed of a shape memory material (e.g., nitinol, nitinium). Those skilled in the art will understand that many other structures, materials, and configurations can be used for the frame structure. For example, the frame structure may be formed of a polymer with sufficient elasticity. The frame structure may be formed of a combination of metal and polymer, such as a metal (e.g., a shape memory material) coated within a polymer. The frame structure may include various forms other than rhomboid. In some embodiments, the frame structure is a closed frame that forces blood flow through the valve segment therein. One or more skirts and/or seals may help force blood through the valve segment.

Those skilled in the art will recognize from the description herein that any of the valve prostheses described herein may, as needed, include any combination of the following: frame structure shape, frame structure design, frame structure material, anchor shape, anchor winding method, anchor material, free end tip, leaflet configuration, or any other variation thereof.

When a feature or element is referred to herein as being "on" another feature or element, it may be directly on the other feature or element, or there may be an intervening feature and/or element. Conversely, when a feature or element is referred to as being "directly on" another feature or element, there is no intervening feature or element. It should also be understood that when a feature or element is referred to as being "connected," "attached," or "joined" to another feature or element, it may be directly connected, attached, or joined to the other feature or element, or there may be an intervening feature or element. Conversely, when a feature or element is referred to as being "directly connected," "directly attached," or "directly joined" to another feature or element, there is no intervening feature or element. Although described or illustrated with respect to one embodiment, the features and elements thus described or illustrated can be applied to other embodiments. Those skilled in the art will also understand that references to structures or features disposed "adjacent" to another feature may have portions overlapping with or located below the adjacent feature.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the 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 indicates otherwise. It will also be understood that the terms “comprise” and/or “comprising”, when used in this specification, indicate the presence of the stated features, steps, operations, elements, and/or components, but do not exclude the presence or inclusion of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.

Spatial terms such as “below,” “under,” “below,” “below,” “above,” and “above” are used herein to conveniently describe the relationship between one element or feature and another, as shown in the figures. It should be understood that, in addition to the orientations shown in the figures, spatial terms are intended to cover different orientations of the device in use or operation. For example, if the device in the figure is inverted, an element described as “below” or “below” other elements or features would be oriented “above” other elements or features. Thus, the exemplary term “below” can cover both above and below orientations. The device may be oriented in other ways (rotated 90 degrees or otherwise), and the spatial descriptive terms used herein will be interpreted accordingly. Similarly, the terms “upward,” “downward,” “vertically,” “horizontally,” etc., are used herein for their intended purpose unless otherwise specifically indicated.

Although the terms "first" and "second" may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms unless the context otherwise requires. These terms may be used to distinguish one feature/element from another. Therefore, the first feature/element discussed below may be referred to as the second feature/element, and similarly, the second feature/element discussed below may be referred to as the first feature/element, without departing from the teachings of the invention.

In this specification and the appended claims, unless the context otherwise requires, the word "comprise" and variations thereof, such as "comprises" and "comprising," mean various components that can be used together in a method and article (e.g., a composition and apparatus that includes means and methods). For example, the term "comprising" will be understood to imply the inclusion of any of the stated elements or steps, but does not exclude any other elements or steps.

As used herein in the specification and claims, including as in the examples, and unless otherwise expressly stated, all figures may be interpreted as if they begin with the words “about” or “approximately,” even if the term is not explicitly stated. When describing values and/or locations, the phrase “about” or “approximately” may be used to indicate that the described value and/or location is within a reasonably expected range of the value and/or location. For example, a numerical value may be +/- 0.1% of the value (or range of values), +/- 1% of the value (or range of values), +/- 2% of the value (or range of values), +/- 5% of the value (or range of values), or +/- 10% of the value (or range of values). Any numerical value given herein should also be understood to include the value of about or approximately that value, unless the context otherwise requires. For example, if the value “10” is disclosed, “about 10” is also disclosed. Any numerical ranges listed herein are intended to include all subranges contained therein. It should also be understood that when numerical values are disclosed, as those skilled in the art will understand appropriately, the terms "less than or equal to" the value, "greater than or equal to" the value, and possible ranges between the values are also disclosed. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and these data represent endpoints and starting points, as well as ranges of any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, as well as values between 10 and 15, are disclosed. It should also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

Although various exemplary embodiments have been described above, any of the many changes that may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be changed, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various apparatus and system embodiments may be included in some embodiments but not in others. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention, which is set forth in the claims.

The examples and descriptions included herein are illustrated in an illustrative and not limiting manner, showing specific embodiments in which the invention may be practiced. As stated, other embodiments may be utilized and derived therefrom, allowing for structural and logical substitutions and changes without departing from the scope of the invention. Where more than one inventive or inventive concept is disclosed, these embodiments of the subject matter may herein be referred to individually or collectively by the term "inventive," merely for convenience and not intended to voluntarily limit the scope of this application to any single inventive or inventive concept. Therefore, although specific embodiments are shown and described herein, any arrangement suitable for achieving the same purpose may replace the specific embodiments shown. The invention is intended to cover any embodiments and modifications or variations of all embodiments in the various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art upon reading the above description.

Claims (40)

1. A method for treating a diseased autologous valve in a patient, the method comprising: An anchor is used to surround the chordae tendineae and/or leaflets of the diseased autologous valve in the second chamber of the patient's heart, the anchor having a tether attached to the anchor, the tether extending proximally from the second chamber through the first chamber of the patient's heart; A portion of the guidewire is advanced from the first chamber of the patient's heart through the annulus of the diseased autologous valve into the second chamber of the patient's heart; The valve delivery catheter is advanced along the guidewire, the valve delivery catheter including a valve prosthesis in a compression configuration therein; and The valve prosthesis is released from the valve delivery catheter to extend into the annulus of the diseased autologous valve and within the anchor. 2. The method according to claim 1, further comprising: Images are acquired as the guidewire is advanced through the annulus of the diseased autologous valve; and The deflection maneuverable conduit can be used to manipulate the guide wire through the inner diameter of the anchor. 3. The method of claim 2, wherein advancing the portion of the guidewire comprises: The guidewire delivery catheter is advanced through the maneuverable catheter, through the ring of the diseased autologous valve, and through the inner diameter of the anchor; and The guidewire is advanced through the guidewire delivery catheter. 4. The method of claim 3, further comprising inflating a distal portion of the guidewire delivery catheter to form a balloon for positioning and/or imaging of the guidewire. 5. The method of claim 2, wherein manipulating the guidewire further comprises manipulating the guidewire through a loop of the diseased autologous valve. 6. The method of claim 2, wherein the guidewire has curvature to facilitate imaging of the guidewire. 7. The method of claim 1, wherein releasing the valve prosthesis from the valve delivery catheter comprises: A portion of the valve prosthesis is partially deployed in the second chamber; The partially expanded valve prosthesis is pressed against the anchor, and the anchor is pushed toward the annulus of the diseased autologous valve; and The remaining portion of the valve prosthesis is fully extended into the annulus and/or first chamber of the diseased autologous valve. 8. The method according to claim 1, further comprising: Disconnect the mooring rope from the anchor; and The tether and the valve delivery catheter are retracted from the patient's body. 9. The method of claim 8, wherein the tether is disconnected and retracted after the guide wire is placed. 10. The method of claim 8, wherein the tether is disconnected and retracted while the valve delivery catheter is being advanced along the guidewire. 11. The method of claim 8, wherein the tether is disconnected and retracted before the valve prosthesis is released from the valve delivery catheter. 12. The method of claim 1, further comprising delivering the valve delivery catheter and the tether within an outer sheath. 13. The method of claim 1, wherein advancing the valve delivery catheter along the guidewire further comprises passing the tether through the monorail lumen of the valve delivery catheter. 14. The method of claim 1, further comprising using an anchor to control the delivery of the anchor to the diseased autologous valve via a catheter. 15. A delivery system for delivering a valve prosthesis to a diseased valve of the heart, the delivery system comprising: A tether, the size and shape of which are designed to extend from the outside of the heart and pass through the loop of the diseased valve, the tether also being configured to connect to an anchor, the size and shape of which are designed to surround the autologous leaflet and/or chordae tendineae of the heart. A guidewire, the size and shape of which are designed to extend from the outside of the heart and pass through a loop of the diseased valve; and A valve delivery catheter configured to extend over a guidewire through a loop of the diseased valve, the valve delivery catheter being configured to hold the valve prosthesis in a compressed state therein, and to release the valve prosthesis within the loop of the diseased valve and the anchor when the tether is connected to the anchor. 16. The system of claim 15, wherein the valve delivery catheter further comprises a monorail lumen, the size and shape of which are designed to accommodate the tether therein. 17. The system of claim 16, 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. 18. The system of claim 15, 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 it from passing between adjacent chordae tendineae of the heart. 19. The system of claim 18, wherein the balloon catheter is adapted for visualization via imaging. 20. The system of claim 15, wherein the distal portion of the guidewire has a curvature adapted for visualization via imaging. 21. The system of claim 15, wherein the valve prosthesis includes an expandable frame. 22. The system of claim 15, wherein the tether is releasably attached to the anchor via a releasable connector. 23. A method of delivering a valve prosthesis in a patient's heart, the method comprising: A helical anchor is implanted near the autologous valve ring of a patient’s heart by using an anchor to control a catheter to surround the chordae tendineae and/or leaflets of the autologous valve, wherein the proximal end of the helical anchor is releasably connected to a tether that extends through the ring and is accessible from outside the patient’s heart. The spiral anchor is deployed from the anchor control conduit; Release the tether from the proximal end of the helical anchor; The guidewire is advanced through the annulus of the autologous valve and through the central opening of the anchor. The valve delivery catheter is advanced along the guidewire, wherein the valve delivery catheter carries the valve prosthesis in a compressed state; and The valve prosthesis expands within the autologous valve annulus and enters the central opening of the anchor. 24. The method of claim 23, wherein extending the valve prosthesis comprises extending a distal portion of the valve prosthesis distally relative to the anchor into the ventricle of the patient's heart, wherein the method further comprises pulling the distal portion of the valve prosthesis in a proximal direction against the anchor to adjust the position of the anchor relative to the annulus of the autologous valve. 25. The method of claim 24, further comprising extending the proximal portion of the valve prosthesis proximally into the atrium of the patient's heart relative to the anchor, thereby causing the valve prosthesis to fully unfold within the anchor and the autologous valve. 26. The method of claim 25, further comprising extending the intermediate segment of the valve prosthesis into the anchor. 27. The method of claim 23, further comprising confirming the position of the anchor relative to the loop of the autologous valve before releasing the tether. 28. The method of claim 27, wherein confirming the location of the anchor includes visualizing the anchor using ultrasound, fluorescence imaging, and/or radiographic imaging. 29. The method of claim 23, wherein surrounding the chordae tendineae and/or leaflets includes rotating the anchorage control catheter relative to the chordae tendineae and/or leaflets. 30. The method of claim 23, further comprising removing the tether from the patient's heart before advancing the guidewire. 31. A method for treating a diseased autologous valve in a patient, the method comprising: An anchor is used to encircle the chordae tendineae and/or leaflets of the diseased autologous valve in the second chamber of the patient's heart. The anchor has a tether attached to the anchor, wherein the tether extends distally from the first chamber of the patient's heart, passes through the loop of the diseased autologous valve, and enters the second chamber of the patient's heart. Once the anchor has unfurled around the chordae tendineae and/or leaflets within the second chamber of the patient's heart, the tether is released from the anchor. The tether released from the second chamber of the patient's heart and retracted proximally; The guidewire catheter, carrying the guidewire, is advanced through the first chamber of the patient's heart, through the annulus of the diseased autologous valve, and into the second chamber of the patient's heart; and The guidewire was confirmed to be free of tangles in the second chamber by advancing and retracting the guidewire catheter while visualizing the distal features of the guidewire catheter. 32. The method according to claim 31, further comprising: The valve delivery catheter is advanced along the guidewire, the valve delivery catheter including a valve prosthesis in a compression configuration therein; and The valve prosthesis is released from the valve delivery catheter to extend into the annulus of the diseased autologous valve and within the anchor. 33. The method of claim 31, wherein the guidewire is advanced through the inner circumference of the anchor, the anchor being anchored to the diseased autologous valve in the second chamber of the patient's heart. 34. The method of claim 32, wherein releasing the valve prosthesis from the valve delivery catheter comprises releasing a distal portion of the valve prosthesis into the second chamber, and using the distal portion of the valve prosthesis to adjust the position of the anchor relative to the annulus of the diseased autologous valve. 35. The method of claim 31, further comprising, prior to releasing the tether from the anchor, visualizing the anchor relative to the ring of the diseased autologous valve using ultrasound, fluorescence examination, and/or radiographic imaging. 36. A method for treating a diseased autologous valve in a patient, the method comprising: The guidewire is advanced through the annulus of the diseased autologous valve and the inner circumference of the anchor, which is anchored to the diseased autologous valve in the second chamber of the patient's heart, wherein the anchor includes a tether attached to the anchor, which passes through the annulus from the second chamber and extends out of the patient's body. The valve delivery catheter is advanced along the guidewire, the valve delivery catheter including a valve prosthesis in a compression configuration therein; and The valve prosthesis is deployed from the valve delivery catheter into the annulus of the diseased autologous valve and into the anchor, wherein the tether is released from the anchor during the deployment of the valve prosthesis. 37. The method of claim 36, wherein unfolding the valve prosthesis comprises: (a) Releasing the distal portion of the valve prosthesis into the second chamber, and using the distal portion of the valve prosthesis to adjust the position of the anchor relative to the annulus of the diseased autologous valve; and (b) Deploying the proximal portion of the valve prosthesis into the first chamber of the patient's heart; The tether is released from the anchor during (a), during (b), or between (a) and (b). 38. The method of claim 36, further comprising: before advancing the guidewire through the annulus of the diseased autologous valve and the inner circumference of the anchor: When the tether is attached to the anchor, the anchor is used to surround the chordae tendineae and/or leaflets of the diseased autologous valve in the second chamber of the patient's heart. 39. The method of claim 36, wherein the tether extends proximally from the second chamber of the patient's heart, passes through the ring of the diseased autologous valve, and enters the first chamber of the patient's heart. 40. The method of claim 36, further comprising, prior to releasing the tether from the anchor, visualizing the anchor relative to the ring of the diseased autologous valve using ultrasound, fluorescence examination, and/or radiographic imaging.