Patent Description:
Systems and methods are provided for repairing heart valves using adjustable heart valve implants.

A human heart is a vital part of the body having four chambers, the left and right atria and the left and right ventricles. The chambers alternately expand and contract to pump blood through the body. Each chamber of the heart includes a heart valve that, when functioning properly, controls the flow of blood in only one direction through the heart. However, the heart valve can become diseased or otherwise deficient such that it fails to close properly during the contraction of the lower chamber.

Mitral regurgitation is an insufficiency of a mitral valve which occurs when the mitral valve separating the left atrium and the left ventricle does not close properly when the heart pumps out blood. As a result, upon contraction of the left ventricle, blood may abnormally leak (regurgitate) from the left ventricle back into the left atrium, rather than flowing properly to the aorta. Mitral regurgitation can cause dilation of the left-sided heart chambers which, if left untreated, can ultimately lead to potentially fatal heart-rhythm disturbances and heart failure.

Another common heart disorder is aortic insufficiency, such as, for example, aortic stenosis in which the aortic valve located between the left ventricle and the aorta can become abnormally narrowed or constricted (stenotic) and therefore does not open fully. This can decrease the blood flow from the heart and lead to serious heart complications.

Heart valve regurgitation and other heart valve conditions can be caused by a variety of disorders and often require a surgical intervention involving replacement of a natural heart valve or heart replacement. An open heart procedure has been typically performed to surgically repair or replace a diseased or deficient heart valve using, for example, a prosthetic heart valve. However, an open heart surgery has significant risks and can lead to many complications. Moreover, some patients (e.g., children, elderly, patients with chronic conditions, etc.) can be at particular risk for open heart surgery and cannot be treated using this approach.

More recent approaches have been developed that aim at avoiding invasive valve repair or replacement surgeries by delivering a prosthetic valve using a catheter. However, a natural heart valve, such as a mitral valve, has a complicated anatomy and deforms in a complicated manner with the cardiac rhythm. The existing approaches do not adequately mimic the functionality of the mitral valve and may not address such potential issues as, for example, tissue damage, cardiac remodelling and paravalvular leaking. Furthermore, the techniques developed up-to-date may not provide adequate ways for replacing a heart valve implant after its deployment.

One device which attempts to overcome some of these deficiencies is found in <CIT>.

Accordingly, there remains a need for improved methods and systems for delivering prosthetic heart valves in a non-invasive manner. The invention is for a system as defined in appended claims <NUM> - <NUM>.

A method of repairing a mitral valve is provided that in some embodiments includes advancing an outer shaft of an introducer assembly through an apex of a heart into a left atrium of the heart, deploying a prosthetic valve portion of an implant from the outer shaft in the left atrium such that the prosthetic valve portion moves from an unexpanded configuration to an expanded configuration and at least one positioning member on the prosthetic valve portion is disposed on opposite sides of an opening of the mitral valve to suspend the prosthetic valve portion within the opening of the mitral valve, retracting the outer shaft from the left atrium towards the apex of the heart such that an inner shaft of the introducer assembly and at least a portion of an anchor portion of the implant are exposed, and deploying proximal and distal deployable wings on the anchor portion to engage tissue therebetween to removably affix the anchor portion to the apex of the heart. The outer shaft can be advanced through the apex of the heart into the left atrium by directly puncturing the apex of the heart with a leading end of the introducer assembly. Removably affixing the anchor portion to the apex of the heart results in closure of the apex puncture.

The method can vary in any number of ways. In some embodiments, the inner shaft can include an adjustable tether configured to couple the prosthetic valve portion to the anchor portion. The tether can be coupled to the anchor portion using a tether lock. A portion of the tether can be retracted proximal to the proximal end of the anchor portion prior to attaching the tether to the anchor portion using the tether lock. In some embodiments, the tether lock can be recessed into a body of the anchor portion so as not to protrude into the pericardial space. In some embodiments, the tether can be formed of an absorbable or non-absorbable suture. In other embodiments, the tether can include a wire suture (e.g., a metal suture), or it can be formed from any other materials. The tether can have one or more portions.

The method can further include adjusting a distance between the prosthetic valve portion and the anchor portion of the implant. In some embodiments, the distance can be adjusted using the adjustable tether coupling prosthetic valve portion to the anchor portion. The method can also include accessing a proximal end of the anchor portion with an adjustment tool and employing the adjustment tool to adjust the distance. The proximal end of the anchor portion can be accessed percutaneously. The distance can be adjusted by retractably moving the inner shaft with respect to the anchor portion. The length of the inner shaft can be adjusted prior to affixing the anchor portion within the apex of the heart.

In some embodiments, the method can further include rotating a portion of the prosthetic valve portion suspended within the opening of the mitral valve. The method can further additionally or alternatively include rotating the implant when the prosthetic valve portion is suspended within the opening of the mitral valve. The method can further include removing the outer shaft.

In some embodiments, deploying the prosthetic valve portion can include deploying the prosthetic valve portion from the outer shaft in the left atrium, and subsequently retracting the outer shaft from the left atrium to engage the at least one positioning member with the mitral valve.

The prosthetic valve portion of the implant can have any number of variations. For example, in some embodiments, the prosthetic valve portion can include an expandable frame and the at least one positioning member can include an expandable ring circumferentially disposed at an end of the expandable frame. The method can include adjusting a diameter of the expandable frame after the prosthetic valve portion is deployed. In embodiments in which the inner shaft includes an adjustable tether, the diameter of the expandable frame can be adjusted by adjusting a length of the tether or otherwise manipulating the tether.

In some embodiments, the method can further include determining a position of the prosthetic valve portion using at least one radiopaque marker associated with the prosthetic valve portion.

The proximal and distal deployable wings can vary in any number of ways. For example, in some embodiments, the proximal and distal deployable wings can be deployed within tissue of the apex of the heart. In other embodiments, the proximal and distal deployable wings can be deployed at opposite sides of a wall of the apex of the heart. In some embodiments, deploying the proximal and distal deployable wings can include deploying the distal wings and, after the distal wings are deployed, retracting the outer shaft proximally away from the prosthetic valve body to deploy the proximal wings. In some embodiments, the distal wings can be deployed against the wall of the apex of the heart and the proximal wings can be deployed within the tissue. In other embodiments, the proximal wings can be deployed against the wall of the apex of the heart and the distal wings are deployed within the tissue.

In some embodiments, the method can further include mating a proximal end of the anchor portion with an actuator tool, deploying the actuator tool to move the proximal and distal wings from a deployed configuration to an undeployed configuration, advancing the introducer assembly over the actuator tool towards the prosthetic valve portion, deploying the actuator tool to move the prosthetic valve portion from the expanded configuration to the unexpanded configuration, and removing the prosthetic valve portion in the unexpanded configuration from the left atrium through the introducer assembly. The method can further include, after removing the prosthetic valve portion from the introducer sheath, retracting the introducer assembly towards the apex of the heart, inserting a second closure device into the sheath and deploying second proximal and distal wings of a second closure device to engage tissue therebetween at the puncture hole of the apex of the heart.

In other aspects, a method of repairing a heart valve is provided that in some embodiments can include delivering an outer shaft of an introducer assembly through an apex of a heart into an atrium of the heart, deploying a prosthetic valve from the outer shaft in the atrium such that the prosthetic valve moves from an unexpanded configuration to an expanded configuration and at least one positioning member on the prosthetic valve is disposed above an opening of the heart valve to suspend a body of the prosthetic valve within the opening, retracting the outer shaft from the atrium towards the apex of the heart such that the suture tether or inner shaft coupled to and extending between the prosthetic valve and an anchor is exposed, removably affixing the anchor to the apex of the heart, and adjusting a distance between the prosthetic valve and the anchor.

The method can vary in any number of ways. For example, in some embodiments, the inner shaft can include an adjustable tether, such as a flexible suture tether. In such embodiments, the distance between the prosthetic valve and the anchor can be adjusted by altering a length of the tether. For example, the tether can be retracted proximally.

In some embodiments, the method can further include removing the outer shaft through the apex of the heart. In some embodiments, the distance between the prosthetic valve and the anchor can be adjusted after the anchor is affixed to the apex of the heart. Removably affixing the anchor to the apex of the heart can include deploying proximal and distal deployable wings of the anchor to engage tissue therebetween.

The method can further include rotating the body of the prosthetic valve body within the opening of the heart valve. The heart valve can include a mitral valve and the atrium can include a left atrium. The method can further include removing the prosthetic valve from the atrium through the outer shaft.

In yet another aspect, a system for repairing a heart valve is provided that in some embodiments includes an outer shaft and an implant disposed within the outer shaft, the implant including an inner shaft, a prosthetic valve coupled to a distal end of the inner shaft and having a prosthetic valve body and at least one positioning member, the prosthetic valve being configured to be distally advanced from the outer shaft such that the prosthetic valve moves from an unexpanded configuration, and the at least one positioning member being configured to suspend the prosthetic valve within an opening in tissue, and an anchor portion coupled to a proximal end of the inner shaft and configured to be removably affixed to tissue. A distance between the prosthetic valve and the anchor portion can be adjustable.

The system can vary in any number of ways. For example, in some embodiments, the prosthetic valve body can include prosthetic valve leaflets and the at least one positioning member can include at least two arms coupled to the prosthetic valve body. In other embodiments, the prosthetic valve body can include an expandable frame and the at least one positioning member can include an expandable ring circumferentially disposed at a distal end of the expandable frame.

The anchor portion can vary in any number of ways. For example, the anchor portion can include proximal and distal deployable wings configured to engage tissue therebetween.

In the invention a system for repairing a heart valve is provided that in some embodiments can include an outer shaft and an implant disposed within the outer shaft, the implant including one or more tethers, a prosthetic valve coupled to a distal end of the one or more tethers and having a prosthetic valve body and at least one positioning member, the prosthetic valve being configured to be distally advanced from the outer shaft such that the prosthetic valve moves from an unexpanded configuration, and the at least one positioning member being configured to suspend the prosthetic valve within an opening in tissue, and an anchor portion coupled to a proximal end of the one or more tethers and configured to be removably affixed to tissue. A distance between the prosthetic valve and the anchor portion can be adjustable.

The system can vary in any number of ways. For example, the one or more tethers can be flexible tethers. The flexible tethers can be formed from a suture. In some embodiments, the prosthetic valve body includes prosthetic valve leaflets and the at least one positioning member can include at least two arms coupled to the prosthetic valve body. In other embodiments, the prosthetic valve body includes an expandable frame and the at least one positioning member can include an expandable ring circumferentially disposed at a distal end of the expandable frame.

The embodiments described above will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings. The drawings are not intended to be drawn to scale. In the drawings:.

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims.

Methods and devices are provided for repairing and replacing heart valves. In particular, the described techniques utilize a system for delivering an adjustable implant into a heart valve that includes a prosthetic valve portion configured to be positioned within an opening of a natural heart valve, such as a mitral valve, a tricuspid valve, or an aortic valve, and an anchor portion configured to secure the implant to an apex of the heart. The prosthetic valve can have a configuration that allows it to be removably suspended within an opening of a diseased or defective heart valve such that the prosthetic valve can repair abnormalities of the heart valve or completely replace the diseased valve.

In certain exemplary methods, the implant can be delivered to the heart valve through the apex of the heart. The transapical delivery allows delivering the implant in a minimally invasive manner, for example, percutaneously, which may allow high risk patients to be treated. In some cases, even a relatively non-invasive minithoracotomy procedure can be avoided. No additional sutures (e.g., purse-string sutures) are required to be placed in the apex, which can reduce trauma to cardiac tissue and thus decrease a risk of complications.

Furthermore, after the implant has been deployed within the heart, a distance between the prosthetic valve portion and anchor portion can be adjusted. In some embodiments, the implant or a portion thereof can be rotated. The adjustment can be performed in a non-invasive or minimally invasive manner and can allow reducing or eliminating potential post-implantation complications such as, for example paravalvular leaks, cardiac remodelling (undesirable structural modifications of tissue) and other potential conditions, without removing the implant from the implantation site. The deployed implant can be moved to an undeployed configuration and removed from the implantation site in a simple manner. Accordingly, the implant placement procedure in accordance with the described embodiments can be simple, repeatable, cost-effective, and it causes less discomfort to a patient.

<FIG> illustrate a system <NUM> for repairing a heart valve in accordance with one embodiment. The system <NUM> may include an implant <NUM> and an outer shaft <NUM> which can define a lumen extending therethrough configured to slidably receive the implant <NUM> therein. The outer shaft <NUM> can be a part of the introducer assembly configured to deliver the implant <NUM> into the heart. The outer shaft <NUM> is shown in <FIG> by way of example as a component separate from the implant <NUM>, to illustrate that the outer shaft <NUM> is configured to removably receive the implant <NUM>. The outer shaft <NUM> can be an elongate tubular member configured to be inserted into a heart through the apex.

As shown in <FIG>, the implant <NUM> can include a prosthetic valve portion <NUM>, an inner shaft <NUM>, and an anchor portion <NUM>. The prosthetic valve portion <NUM> can be coupled at a proximal end <NUM> thereof to a distal end <NUM> of the inner shaft <NUM>, and the anchor portion <NUM> can be coupled to a proximal end <NUM> of the inner shaft <NUM>. As used herein, the term "proximal" end or portion refers to an end or portion that is nearest to a person operating the outer shaft <NUM> (e.g., using a suitable actuator tool), and the term "distal" end or portion refers to an end or portion that is closer to a forward end <NUM> of the implant <NUM>.

In the illustrated embodiment, the inner shaft <NUM> can have distal, middle, and proximal portions <NUM>, <NUM>, <NUM>, which can be configured to slidably and fixedly mate with each other. For example, at least a portion of the distal portion <NUM> can be configured to be slidably received within the middle portion <NUM>. In some embodiments, as discussed in more detail below, the inner shaft <NUM> can be formed from an absorbable or non-absorbable suture extending between the prosthetic valve portion <NUM> and the anchor portion <NUM>. The suture may further extend through the anchor portion <NUM>. In some embodiments, at least a portion of the middle portion <NUM> of the inner shaft <NUM> can be configured to be slidably received within the proximal portion <NUM>. In this way, a distance between the distal and proximal ends <NUM>, <NUM> of the inner shaft <NUM> can be adjustable. A screw mechanism or any other suitable mechanism can be used to adjust a length of the inner shaft <NUM>. The proximal portion <NUM> of the inner shaft <NUM> can be configured to mate on an inner surface thereof with a suitable tool that can be manipulated to adjust the length of the inner shaft <NUM>.

In some embodiments, a diameter of the proximal portion <NUM> can be larger than diameter(s) of the distal and middle portions <NUM>, <NUM>. The distal and middle portions <NUM>, <NUM> can have diameter(s) that are appropriate for implantation within a chamber of the heart. The anchor portion <NUM> can be sized appropriately so as to close a hole or puncture in the apex of the heart. In the illustrated embodiment, the proximal portion <NUM> is mated with the anchor portion <NUM> and is the same or similar in size (e.g., diameter) to the anchor portion <NUM>. However, in other embodiments, the diameter of the proximal portion <NUM> can be smaller than that of the anchor portion <NUM>. The distal, middle, and proximal portions <NUM>, <NUM>, <NUM> can have any suitable lengths. In some embodiments, one or more portions of the inner shaft <NUM> can be rotatable with respect to other portions. For example, the distal and middle portions <NUM>, <NUM> can be configured to be able to rotate with respect to the proximal portion <NUM>. This can allow adjusting the implant <NUM> by rotating the prosthetic valve <NUM> or the entire implant <NUM> after it has been deployed. A person skilled in the art will appreciate that the inner shaft <NUM> can have various configurations and can include any number of components, as the embodiments described herein are not limited in this respect.

The anchor portion, which is configured to function as a closure device used for closing a hole or puncture in tissue, can also have a variety of configurations. As shown in <FIG>, the anchor portion <NUM> can include distal, middle, and proximal portions <NUM>, <NUM>, <NUM>. The distal portion <NUM> of the anchor portion <NUM> can be coupled to the proximal end <NUM> of the inner shaft <NUM>. The distal and proximal portions <NUM>, <NUM> of the anchor portion <NUM> can be configured to expand to form deployable wings <NUM>, <NUM> shown in <FIG>. The deployed wings <NUM>, <NUM> can be maintained in the expanded configuration until the anchor portion <NUM> is manipulated to cause the wings <NUM>, <NUM> to collapse to the undeployed configuration. It should be appreciated that the implant <NUM> can include any other components not shown herein that are configured such that the anchor portion <NUM> can reversibly form the wings <NUM>, <NUM>.

In some embodiments, which are discussed in more detail below, the inner shaft <NUM> can include one or more adjustable tethers (e.g., suture or suture-like tether(s)) extending between the prosthetic valve portion and the anchor portion. In such embodiments, the implant <NUM> can additionally or alternatively include components to provide a tether lock or clamp. This lock can be used to reversibly couple the one or more tethers to the implant <NUM> following adjustment of a length of the tether(s).

In some embodiments, the implant <NUM> can include components configured as described at least in <CIT>, <CIT>, <CIT>, and <CIT>.

The prosthetic valve portion <NUM> can also have a variety of configurations that allow it to be inserted into a heart through the outer shaft <NUM>. For example, the prosthetic valve <NUM> can be configured such that it can move between unexpanded and expanded configurations. In <FIG>, the prosthetic valve portion <NUM> is shown in the unexpanded configuration.

An embodiment of the prosthetic valve portion <NUM> in the expanded configuration is shown in more detail in <FIG> shows the implant <NUM> with the wings <NUM>, <NUM> undeployed, whereas <FIG> shows an example with the wings <NUM>, <NUM> of the implant <NUM> deployed. As schematically shown in <FIG>, a proximal end <NUM> of the anchor portion <NUM> can be configured to mate with an actuator tool <NUM> that can be used to manipulate the inner shaft <NUM> to adjust a length thereof. The same or different tool can be configured to mate with the anchor portion <NUM> through its proximal end <NUM> to deploy the wings <NUM>, <NUM>. Moreover, a suitable actuator tool can be mated with the anchor portion <NUM> to cause the deployed wings <NUM>, <NUM> to revert to the undeployed configuration.

In some embodiments, the prosthetic valve portion can include a prosthetic valve body and at least one positioning member configured to suspend the prosthetic valve portion within an opening of a heart valve. As shown in <FIG>, the prosthetic valve portion <NUM> can include a valve body <NUM> and positioning members 204A, 204B coupled thereto. In this example, the positioning members 204A, 204B can be in the form of positioning arms extending in opposite directions from the valve body <NUM>. The prosthetic valve portion <NUM> can also include a valve shaft <NUM> extending between the proximal end <NUM> of the prosthetic valve portion <NUM> and the distal tip <NUM> of the implant <NUM>.

As shown in <FIG> illustrating an enlarged view of the prosthetic valve body portion <NUM>, the valve body <NUM> can include a spine <NUM> coupled to the distal end <NUM> of the inner shaft <NUM> and leaflets 206A, 206B hingeably coupled to the spine <NUM>. The leaflets 206A, 206B can be flexibly coupled to the spine <NUM> such that they can pivot or flap with respect to the spine <NUM> as the heart contracts and relaxes. In some embodiments, the leaflets 206A, 206B can come together at one end to form a spine such that opposite ends of the leaflets can be configured to pivot or flap with respect to the spine. The leaflets 206A, 206B can have any suitable dimensions that allow them to mimic the function of a native heart valve. The leaflets 206A, 206B, which can be elastic, can be made from any suitable biological or synthetic material, or any combination thereof.

The prosthetic valve portion <NUM>, when deployed within the heart, can move from the unexpanded configuration to the expanded configuration. In some embodiments, the valve body <NUM> having the positioning members 204A, 204B and leaflets 206A, 206B coupled thereto can slide over the valve shaft <NUM> such that the positioning members 204A, 204B and leaflets 206A, 206B can fold and unfold in an umbrella-like fashion. For example, in the unexpanded configuration, a member <NUM> located at the proximal end <NUM> of the prosthetic portion <NUM> can be pushed in any suitable manner (e.g., by an outer shaft used to insert the implant to the implantation site, discussed below) which can cause the leaflets 206A, 206B and positioning members 204A, 204B to move outward and thus unfold. Similarly, when the prosthetic valve portion <NUM> is in the expanded configuration, the member <NUM> can be pushed or otherwise actuated (e.g., pulled) depending on its configuration to cause the positioning members 204A, 204B and leaflets 206A, 206A to move inward and fold.

The prosthetic value portion <NUM> can be used to mitigate abnormalities of a diseased heart valve and/or it can entirely replace the natural heart valve by mimicking operation of the valve. For example, when the implant <NUM> is used to repair a diseased mitral valve, as the left ventricle contracts (ejecting oxygen-rich blood throughout the body) and a healthy mitral valve would close, the leaflets 206A, 206B can be spaced apart with respect to the longitudinal axis B <NUM> of the implant <NUM> to ensure a proper closure of the diseased mitral valve to thereby prevent an undesirable backflow of blood (regurgitation) into the left atrium. When the left ventricle relaxes and the mitral valve opens to allow the blood to flow from the left atrium to the left ventricle, the leaflets 206A, 206B can be maintained close together without interfering with the blood flow.

The positioning members 204A, 204B can be coupled to the spine <NUM>. For example, in some embodiments, the positioning members 204A, 204B can be formed integrally with the spine <NUM>. However, it should be appreciated that the positioning members 204A, 204B can be coupled to the spine <NUM> or other portion of the prosthetic valve portion <NUM> in any suitable manner, as embodiments are not limited in this respect.

The positioning members 204A, 204B can have any suitable configuration. For example, the positioning members 204A, 204B can be formed from one or more elongate wires having a shape that allows the positioning members 204A, 204B to retain the prosthetic valve portion <NUM> within a mitral valve. In one embodiment, as shown in <FIG>, each of the positioning members 204A, 204B can form a shoulder having a straight or flat portion (302A, 302B) extending from and coupled to the spine <NUM> and a curved portion (304A, 304B) coupled to the flat portion (302A, 302B). The straight or flat portions 302A, 302B can be formed from separate wires or other elements, or, in some cases, they can be formed from the same element (e.g., wire or other material(s)). Each of the portions 302A, 302B can be coupled to the spine <NUM> at the portion <NUM> thereof, at shown in <FIG>. It should be appreciated that the portions 302A, 302B may not necessarily be straight or flat along their entire lengths and can have other suitable shapes.

In the example of <FIG>, the curved portions 304A, 304B can be half-U-shaped portions coupled to the portions 302A, 302B at tops of the "half-Us" formed by the curved portions 304A, 304B. In some embodiments, the curved portions 304A, 304B can be integrally formed with the flat portions 302A, 302B. <FIG> shows the curved portions 304A, 304B that are curved outwardly away from the longitudinal axis B <NUM> of the implant <NUM>. However, other configurations of the curved portions 304A, 304B can be utilized as well. The positioning members 204A, 204B or part(s) thereof (e.g., curved portions 304A, 304B) can be at least partially flexible to accommodate anatomical features of an annulus of a heart valve which the positioning members 204A, 204B are configured to engage. The length of the positioning members 204A, 204B can correspond to the diameter of the annulus of the heart valve such that the members 204A, 204B extend beyond the valve opening.

In some embodiments, the positioning members 204A, 204B can have suitable features configured to facilitate engaging tissue above the opening of the heart valve. However, regardless of a specific configuration of the positioning members 204A, 204B, they can be configured to engage the tissue in an atraumatic manner to decrease or eliminate damage to the tissue.

As shown in <FIG>, when the prosthetic valve portion <NUM> is in the expanded configuration, the positioning members 204A, 204B can be configured to extend in the opposite directions from the portion <NUM> of the spine <NUM> along an axis that is perpendicular or approximately perpendicular to a longitudinal axis A (indicated by a numerical reference <NUM> in <FIG>) of the spine <NUM>. It should be appreciated that the positioning members 204A, 204B can have any suitable shape that allows them to suspend the prosthetic valve portion <NUM> within a heart valve, and the shape of the positioning members 204A, 204B in <FIG> is shown by way of example only. Furthermore, in some embodiments, the prosthetic valve portion can include more than two positioning members having any suitable configuration. For example, in some embodiments, additional positioning members similar to the members 204A, 204B can extend from the spine <NUM> in the same plane at the members 204A, 204B, at different angles from the members 204A, 204B. In addition, in some embodiments, a single positioning member can be employed.

Regardless of the specific configuration of the positioning members 204A, 204B and the way in which they are coupled to the spine <NUM>, the positioning members 204A, 204B can be foldably coupled to the spine <NUM> such that, when the prosthetic valve portion <NUM> moves from the unexpanded configuration to the expanded configuration (e.g., when the implant <NUM> is deployed), the positioning members 204A, 204B can be unfolded to extend at the opposite sides of the valve body <NUM> as shown in <FIG>. When the prosthetic valve portion <NUM> moves from the expanded configuration to the unexpanded configuration (e.g., when the implant <NUM> is undeployed to be subsequently removed from the implantation site) shown in <FIG>, the positioning members 204A, 204B can be folded such that they extend along the sides of the leaflets 206A, 206B which can also be configured to be folded in the undeployed position. In some embodiments, one or more portions of the prosthetic valve portion <NUM> can be stretchable such that the prosthetic valve portion <NUM> in the expanded configuration, when pulled proximally, can collapse like an umbrella.

In some embodiments, the implant (e.g., one or more positioning members and/or other elements of the implant) can have associated therewith one or more markers that may be used to determine a location of the prosthetic valve portion within the heart in a non-invasive manner. The markers can be useful to ensure proper positioning of the prosthetic valve portion during delivering of the implant into the heart and when the position of the prosthetic valve portion or the entire implant is adjusted. The markers can be radiopaque elements (e.g., made from platinum, gold, silver, tungsten, or tantalum) having any suitable shape and size (e.g., rings or other elements) that are visible using ultrasound, X-ray, computed tomography (CT) or any other suitable imaging technique. However, it should be appreciated that any other suitable types of markers can be utilized, including, in some cases, radiolucent markers.

<FIG> shows that the prosthetic valve portion <NUM> can include markers 210A, 210B on ends of positioning members 204A, 204B. A member <NUM> located at the proximal end <NUM> of the prosthetic portion <NUM> can also have coupled thereto markers 212A and 212B. Additionally or alternatively, one or both of the leaflets 206A, 206B can have markers coupled thereto. In <FIG>, a marker <NUM> coupled to an edge of the leaflet 206A is shown by way of example. It should be appreciated, however, that one or more markers can be coupled to one or both leaflets 206A, 206B at any location on a surface thereof. Furthermore, in some embodiments, a part or the entire area of the spine <NUM> or other portion of the prosthetic valve <NUM> can be radiopaque or otherwise detectable using various imaging techniques to additionally facilitate the determination of the location of the prosthetic valve.

The manner in which the markers are positioned can depend on a configuration of the prosthetic valve portion and any other factors. Regardless of the way in which the markers of a suitable size and shape are positioned on one or more portions of the implant described herein, the markers can be used to track a position of the implant and/or portions thereof when the implant is in use. Furthermore, in some embodiments, the markers may be omitted, and the position of the implant can be determined in any suitable manner, as embodiments described herein are not limited in this respect.

The implants in accordance with some embodiments can include a prosthetic valve portion having any suitable configuration. For example, in some embodiments, as shown in <FIG>, an implant <NUM> can include a prosthetic valve portion <NUM> including a valve body <NUM> comprising an expandable/collapsible frame. The frame <NUM> can have proximal and distal portions <NUM>, <NUM>, with the proximal portion <NUM> coupled to a distal end <NUM> of an inner shaft <NUM> having distal and proximal ends <NUM>, <NUM>. The inner shaft <NUM> can have a distal portion <NUM>, a middle portion <NUM>, and a proximal portion <NUM> coupled to an anchor portion <NUM>. In some embodiments, the inner shaft <NUM> can be configured as one or more tethers (e.g., formed from one or more sutures) that extend between the distal end of the prosthetic valve portion <NUM> and the anchor portion <NUM>. The tethers can be slidably connected to the anchor portion <NUM>, e.g., via a locking component coupled to the anchor <NUM>, to allow adjusting a distance between the prosthetic valve portion <NUM> and the anchor portion <NUM> by adjusting a length of the tethers.

Similar to anchor portion <NUM> shown in <FIG>, the anchor portion <NUM> may include distal, middle, and proximal portions <NUM>, <NUM>, <NUM>, and the distal and proximal portions <NUM>, <NUM> can be configured to expand to form deployable wings <NUM>, <NUM> shown in <FIG>. The deployable wings <NUM>, <NUM> can be configured to form similar to the deployable wings <NUM>, <NUM>, as shown in <FIG>.

As shown in <FIG>, the prosthetic valve portion <NUM> can have a positioning member <NUM> configured as a ring circumferentially coupled to the distal portion <NUM> of the valve body <NUM>. The positioning member <NUM> can be coupled to the valve body <NUM> via legs 438a-438f which can be bent, as shown in <FIG>, so that the prosthetic valve portion <NUM> conforms to the geometry and function of a native heart halve. It should be appreciated that six legs 438a-438f are shown by way of example only, as any suitable number of structural features of any suitable type can be used to couple the positioning member <NUM> to the valve body <NUM>.

It should also be appreciated that the positioning member <NUM> can be formed integrally with the valve body <NUM>. The positioning member <NUM> can have a configuration different from a ring and can additionally or alternatively include any number of features. For example, the positioning member <NUM> can have multiple features disposed circumferentially around the distal portion <NUM> of the valve body <NUM>. In some embodiments (e.g., in which the positioning member <NUM> is formed integrally with the valve body <NUM>), the positioning member <NUM> can be formed from the same elements or segments as those used to form the valve body <NUM>. The positioning member <NUM> can be formed from elements that can terminate at a distal-most end of the member <NUM> as a ring or as multiple structures having any suitable shape(s).

In some embodiments, the prosthetic valve portion <NUM> can include an insert (not shown) positioned inside a portion or an entire area of the valve body <NUM> and/or the positioning member <NUM>. The insert can be positioned so that it lines the interior of the valve portion <NUM> and can be used to provide additional integrity to the structure of the prosthetic valve portion <NUM> when it is in use. The insert can be formed from any suitable material. For example, the insert can be formed from a natural material, such as bovine and/or porcine pericardial tissue. Additionally or alternatively, the insert can be formed from a synthetic material, such as polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or any other suitable material(s).

The valve body <NUM> can be mated to the inner shaft <NUM> via struts 440A, 440B, 440C shown in <FIG>. It should be appreciated, however, that the valve body <NUM> can be mated to the inner shaft <NUM> using any number of any other structural elements. As shown in <FIG>, the distal end <NUM> of the inner shaft <NUM> can be configured to function as a junction of the struts 440A, 440B, 440C where the struts 440A, 440B, 440C are attached to the inner shaft <NUM>. The 440A, 440B, 440C can be attached to the junction fixedly or flexibly. For example, in some embodiments, the junction can be configured as a swivel joint or other similar mechanism that allows the valve body <NUM> to swivel or otherwise move in any direction with respect to the junction, without disturbing or changing the orientation of the inner shaft <NUM> and the anchor portion <NUM> to which it is attached.

The prosthetic valve portion <NUM> can be self-expanding or expandable using an additional device such that, in a pre-deployed configuration, a diameter of the prosthetic valve portion <NUM> allows it to be inserted into an outer shaft of an introducer assembly (not shown in <FIG>) and delivered through the outer shaft into an area of the heart (e.g., an atrium). When deployed, the prosthetic valve portion <NUM> can expand radially away from the distal end <NUM> of the inner shaft <NUM> and reversibly self-lock to remain in the expanded configuration to fit the geometry of the heart valve. Prosthetic valve portion <NUM> can be configured to expand in a manner that prevents its upward and downward migration when the valve <NUM> is suspended within the opening of the mitral valve. When deployed, the prosthetic valve portion <NUM> can expand and contract such that its diameter and the overall configuration change to adapt to the dynamic geometric environment of the heart valve (e.g., a mitral valve) as the heart pumps blood.

The positioning member <NUM> can be configured to be expandable in any suitable manner. For example, portions of the ring-shaped positioning member <NUM> between sites of attachment of legs 438a-438f can telescopically slide over each other such that the positioning member <NUM> can expand and contract. Regardless of its specific geometry and a wire pattern, the prosthetic valve portion <NUM> can be configured to expand and collapse in respective deployed and undeployed configurations.

Although not shown in <FIG>, in some embodiments, the prosthetic valve portion <NUM> or any other portion(s) of the implant <NUM> can include one or more markers that can help determine a position of, for example, the prosthetic valve portion <NUM>, and can therefore be used for guiding a cardiac surgeon/cardiologist through delivery, deployment, adjustment and/or removal of the implant <NUM>. Similarly to the markers described in connection with the prosthetic valve portion <NUM>, the markers positioned on the implant <NUM> can be radiopaque markers or markers otherwise detectable using any suitable imaging technique. The markers can have any suitable size and shape and can be positioned on the implant <NUM> in any suitable manner.

It should be appreciated that a specific wire pattern of the valve body <NUM> comprising two rows of hexagonal elements is shown in the embodiment of <FIG> by way of example only. The frame can be formed from any number of any suitable circular, oval, ellipsoidal, or any other types of elements or segments which can form any regular or irregular patterns.

The prosthetic valve portion in accordance with the described techniques can be flexible and it can maintain its structural integrity which allows it to be ergonomic, conform to the structure of a native heart valve, and mimic operation of the native valve. The prosthetic valve portion can have any suitable configuration which can depend on the anatomy of a heart valve, such as a mitral valve, a tricuspid valve, or an aortic valve. The prosthetic valve portion can be formed from stainless steel, Nitinol®, or other biocompatible material(s). For example, Cu-Al-Ni alloys or other shape memory alloys can be used. The prosthetic valve portion can also be formed from polymer(s). In some embodiments, one or more elements of the prosthetic valve portion can be flexible that allows the prosthetic valve portion to adapt to the dynamic geometric environment of the heart valve.

In some embodiments, the prosthetic valve portion can be configured such that it can be suspended within a heart valve using one or more positioning members, with or without penetrating tissue. In the example illustrated in connection with <FIG>, the positioning member <NUM> can be configured to engage with an annulus of a heart valve such that the positioning member <NUM> is disposed above an opening of the valve and the valve body <NUM> is suspended within the opening. The positioning member <NUM> can be configured to withstand dislodgment forces that can be exerted thereon (e.g., during systole) and to thereby maintain a proper position and reduce risks of migration of the valve body <NUM> suspended within an opening of the natural heart valve (e.g., the mitral valve).

As shown in <FIG>, the anchor portion <NUM> of the implant, which can be positioned within the apex of the heart when the implant <NUM> is inserted into the heart, can be removably mated with an actuator <NUM> which can be used to urge the deployable wings <NUM>, <NUM> (shown in <FIG>) to be deployed. <FIG> illustrates the implant <NUM> with the wings <NUM>, <NUM> deployed to engage tissue therebetween. <FIG> additionally illustrates that a proximal end of the anchor portion <NUM> can have a mating feature <NUM> for engaging a distal end <NUM> (<FIG>) of the actuator <NUM> or other instrument.

As mentioned above, in some embodiments, an inner shaft of the implant can include a tether portion having one or more tethers extending between a prosthetic valve portion and an anchor portion. The tether portion can be coupled to the anchor portion using a tether lock or clamp which can be any locking element. A proximal end of one or more tethers can be retracted proximal to the proximal end of the anchor portion prior to coupling the tethers to the anchor portion using the tether lock. In some embodiments, the tether portion is formed from an absorbable or non-absorbable material, such as, for example, suture. The tether portion can be formed from a suitable metal material and can be a wire suture (e.g., a metal suture). One skilled in the art will appreciate that the tether portion can include any number of tethers formed from any suitable material(s).

<FIG> illustrate examples of implants and a method of their use in accordance with embodiments in which the inner shaft is formed by one or more tethers.

<FIG> illustrate a system <NUM> for repairing a heart valve in accordance with some embodiments. As shown in <FIG>, the system <NUM> may include an implant <NUM> and an outer shaft <NUM> which can define a lumen extending therethrough configured to slidably receive the implant <NUM> therein. Similar to outer shaft <NUM> (<FIG>), the outer shaft <NUM> can be a part of an introducer assembly configured to deliver the implant <NUM> into the heart.

As shown in <FIG>, the implant <NUM> can include a prosthetic valve portion <NUM>, a tether portion <NUM>, and an anchor portion <NUM>. The prosthetic valve portion <NUM> can be coupled at a proximal end <NUM> thereof to a distal end <NUM> of the tether portion <NUM>, and the anchor portion <NUM> can be coupled to a proximal end <NUM> of the tether portion <NUM>.

As shown in <FIG>, which illustrates the prosthetic valve portion <NUM> in a deployed or expanded configuration, the valve portion <NUM> can have a valve body <NUM> including an expandable/collapsible frame. The frame <NUM> can be similar to valve body or expandable/collapsible frame <NUM> shown in <FIG>. Further, similar to valve body <NUM>, the prosthetic valve portion <NUM> can have a positioning member <NUM> configured as a ring and/or multiple elements or segments circumferentially coupled to a distal portion of and/or being integrally formed with the valve body <NUM> so that they can conform to the geometry of a native heart halve. It should be appreciated that the valve portion <NUM> can have any number of elements having any suitable configuration(s).

<FIG> shows that the anchor portion <NUM> can include distal, middle, and proximal portions <NUM>, <NUM>, <NUM>. The distal and proximal portions <NUM>, <NUM> of the anchor portion <NUM> can be configured to expand to form deployable wings <NUM>, <NUM> shown in <FIG>, and <FIG>. The deployed wings <NUM>, <NUM> can be maintained in the expanded configuration until the anchor portion <NUM> is manipulated to cause the wings <NUM>, <NUM> to collapse to the undeployed configuration. It should be appreciated that the implant <NUM> can include any other components not shown herein that are configured such that the anchor portion <NUM> can reversibly form the wings <NUM>, <NUM>.

As shown in <FIG> by way of a non-limiting example, the tether portion <NUM> can include one or more tethers <NUM> extending between the prosthetic valve portion <NUM> and the anchor portion <NUM>. The tethers <NUM> can extend between the prosthetic valve portion <NUM> and the anchor portion <NUM> so that they also extend through the anchor portion <NUM> and protrude beyond the proximal end 532b of the anchor portion <NUM>. <FIG> and <FIG> illustrate proximal ends <NUM> of the tethers <NUM> extending from the proximal end 532b of the anchor portion <NUM>.

As shown in <FIG>, the tethers <NUM> can be coupled to the prosthetic valve portion <NUM> at respective attachment points 516A, 516B, 516C, which can be done in any suitable manner. For example, the tethers <NUM> can be passed through one or more openings or apertures formed in the structural elements of the valve portion <NUM>. In one exemplary embodiment, the tethers <NUM> can be integrally formed with the valve portion <NUM>. Additionally or alternatively, the valve portion <NUM> can clamp the tether <NUM>, and/or any retaining feature can be used to attach the tethers <NUM> to the prosthetic valve portion <NUM>. It should be appreciated that three tethers <NUM> are shown in <FIG> as an example only, as the tether portion <NUM> can include any number of tethers (e.g., one, two, four, or more) that can be attached to the prosthetic valve portion <NUM> in any suitable manner.

The tether portion <NUM> can be formed from one or more absorbable or non-absorbable sutures (or any combination thereof) extending between the prosthetic valve portion <NUM> and the anchor portion <NUM>. Thus, the tethers <NUM> can be flexible and/or elastic so that they can be tensioned at the distance between the prosthetic valve portion <NUM> and the anchor portion <NUM> is adjusted. Furthermore, the flexible and/or elastic nature of the tethers <NUM> can provide flexibility in the position of the valve portion <NUM> as the heart contracts and relaxes, so that the valve portion <NUM> can mimic the function of a native heart valve.

The tethers <NUM> can be retained in the implant <NUM> in a number of ways. In the illustrated embodiment, as shown in <FIG>, the anchor portion <NUM> can be coupled to or can include at the proximal end 532b thereof a tether lock <NUM> configured to reversibly lock the tethers <NUM> therein. The tether lock <NUM> can be a clamp or any other device configured to reversibly retain the tethers <NUM> in a fixed position. Although not illustrated, in some embodiments, the implant <NUM> can include a tether lock that is recessed into a body of the anchor portion <NUM> so that the lock does not protrude into the pericardial space.

In use, after the implant <NUM> is delivered transapically to the heart through outer shaft <NUM> of the introducer assembly, the prosthetic valve portion <NUM> can move from the undeployed or collapsed configuration (e.g., shown in <FIG> and SD) to a deployed or expanded configuration (e.g., shown in <FIG> and <FIG>). The prosthetic valve portion <NUM> can be seated within the opening of a valve (e.g., a mitral valve) such that the valve body <NUM> is suspended off the tip of the mitral valve. The proximal end 532b of the anchor portion <NUM> can be mated with an actuator <NUM> (<FIG>) which can be used to manipulate the anchor portion <NUM> to cause the deployable distal and proximal wings <NUM>, <NUM> to expand, as shown in <FIG>, to thereby anchor the implant <NUM> within the apex of the heart.

In some embodiments, prior to or after deploying the wings <NUM>, <NUM>, a length of the tether portion <NUM> can be adjusted. The adjustment can be made at any time point following the placement of the implant <NUM>. For example, the actuator <NUM> (<FIG>) or any other suitable instrument can be mated to the tether lock <NUM> at the proximal end 532b and used to adjust the length of the tethers <NUM> so that the distance between the prosthetic valve portion <NUM> and the anchor portion <NUM> is adjusted to ensure a proper position of the valve portion <NUM> within a natural valve. In this way, the position of the prosthetic valve portion <NUM> in an expanded configuration, as shown in <FIG> and <FIG>, can be adjusted. Additionally, in some embodiments, the prosthetic valve portion <NUM> and/or other portion(s) of the implant <NUM> can be rotated to adjust the position of the prosthetic valve portion <NUM>.

The length of the tether portion <NUM> can be adjusted in any suitable manner. For example, an actuator, which can be any suitable adjustment tool configured to mate with the proximal end of the anchor portion <NUM>, can be used to release a locking mechanism of the tether lock <NUM>. In this way, one or more of the tethers <NUM> can be released to increase the length of the tether portion <NUM>, or retracted (e.g., by being pulled) proximally to decrease the length of the tether portion <NUM>. All of the tethers <NUM> can be adjustable together or one or more of the tethers <NUM> can be manipulated and adjusted separately from the other tethers of the tether portion <NUM>, for example, to adjust a position of the prosthetic valve portion <NUM> within a natural heart valve.

It should be appreciated that the locking mechanism of the tether lock <NUM> can be manipulated in any suitable manner to adjust the length of the tether portion <NUM>. After a desirable adjustment is complete, the tether lock <NUM> can be manipulated to lock the tethers <NUM> at the fixed position.

After the adjustment is complete, the actuator <NUM> can be removed, as shown in <FIG>. It should be appreciated that any portion of the tethers <NUM> can extend beyond the anchor <NUM> as the proximal portion <NUM>, and, in some cases, some or all of the tethers <NUM> may not protrude beyond the proximal end 532b of the anchor portion <NUM>.

<FIG> illustrate other exemplary embodiments of an implant having an adjustable tether portion. In the exemplary embodiment of an implant <NUM>' shown in <FIG>, a tether portion <NUM>' has first and second portions <NUM>, <NUM> formed from a flexible suture. The first, distal, portion <NUM> is attached to a prosthetic valve portion <NUM>', whereas the second, proximal, portion <NUM> is slidably attached to an anchor portion <NUM>'. As shown in <FIG>, the first and second portions <NUM>, <NUM> can loop through each other at a junction <NUM>. Proximal ends <NUM>' of the tethers of the second portion <NUM> can extend through the anchor portion <NUM>' and protrude beyond the proximal end thereof. Similar to the embodiment of <FIG>, the distance between the prosthetic valve portion <NUM>' and the anchor portion anchor portion <NUM>' can be adjusted by manipulating a tether lock <NUM>'.

In use, because the first and second portions <NUM>, <NUM> can slide relative to each other at the junction <NUM>, this loop arrangement of the portions <NUM>, <NUM> allows the prosthetic valve portion <NUM>' to swivel in any direction without disturbing the orientation of the anchor portion <NUM>'(e.g., after its proximal and distal wings are deployed).

In the exemplary embodiment of <FIG>, the first and second portions <NUM>, <NUM> each form one loop. One skilled in the art will appreciate that any number of loops can be included in the first and second portions of the tether portion. For example, <FIG> shows an implant <NUM>" having a tether portion <NUM>" which is similar to the tether portion <NUM>' of the implant <NUM>' in <FIG>. A first portion <NUM>"of the tether portion <NUM>" includes two loops 515A, 515B. As shown in <FIG>, the first portion <NUM>" is coupled to a second portion <NUM>" of the tether portion <NUM>" at a junction <NUM>". Similar to the embodiment of <FIG>, proximal ends <NUM>" of the tethers of the second portion <NUM>" can extend through the anchor portion <NUM>" and protrude beyond the proximal end thereof. The distance between the prosthetic valve portion <NUM>" and the anchor portion <NUM>" can be adjusted by manipulating a tether lock <NUM>" to adjust the length of the tether portion <NUM>".

It should be appreciated that the implants in the embodiments described in connection with <FIG> can include any other components that can additionally or alternatively be used to adjust a position of a prosthetic valve within a natural heart valve. For example, in some embodiments, the tether portion of the implant can be used to manipulate the tethers to rotate the prosthetic valve or otherwise adjust its position. Furthermore, the tether locks <NUM>, <NUM>', <NUM>" are shown by way of example only, as any other mechanism can be used to adjust the distance between the prosthetic and anchor portions.

Regardless of the particular configuration of an inner shaft and a tether portion that can extend between a prosthetic valve portion and an anchor portion, an actuator tool (e.g., the tool <NUM>, <NUM>, <NUM>, or other suitable instrument) can be used to manipulate an implant (e.g., the implant <NUM>, <NUM>, <NUM>', or <NUM>") such that a distance between the prosthetic valve portion and the anchor portion is adjusted. Additionally or alternatively, the actuator or other suitable instrument can be used to rotate the entire implant or a portion thereof (e.g., the prosthetic valve portion). The actuator or other device that can be coupled to the anchor portion can be inserted percutaneously. Fluoroscopy or other suitable technique can be used to guide the adjustment process.

<FIG> illustrate a method for repairing a heart valve of a patient using the exemplary system <NUM> described above in connection with <FIG>. Cross-sectional views of a patient's heart <NUM> are shown in <FIG>.

<FIG> illustrates a cross-sectional view of a heart having a mitral valve <NUM> positioned between a left ventricle <NUM> and a left atrium <NUM>. The mitral valve <NUM>, which includes leaflets <NUM>, <NUM>, may become diseased such that it does not close properly when the heart <NUM> pumps out blood. In such condition, when the left ventricle <NUM> contracts, the blood leaks back (regurgitates) from the left ventricle <NUM>, through the mitral valve <NUM>, into the left atrium <NUM> in a direction shown by an arrow <NUM> in <FIG>. The mitral valve <NUM> can also have other defects which can be mitigated using the techniques described herein.

The system <NUM>, which may be used to repair the regurgitated mitral valve <NUM>, can include an introducer assembly <NUM> having an outer shaft <NUM> (also shown in <FIG>) having proximal and distal ends <NUM>, <NUM>. As shown in <FIG>, the outer shaft <NUM> (a portion of which is shown in <FIG>) may be introduced into the left ventricle <NUM> through an apex <NUM> of the heart <NUM> at an implantation site <NUM>. The introducer assembly <NUM> can be manipulated to insert and advance the outer shaft <NUM> towards the left atrium <NUM> using, for example, a catheter system, or any other system.

The outer shaft <NUM>, introduced through the apex <NUM>, can be distally advanced further towards the left atrium <NUM>. In this way, the shaft <NUM> can be manipulated to pass through an opening <NUM> of the mitral valve <NUM> until the distal end <NUM> of the outer shaft <NUM> is positioned within the left atrium <NUM>, as shown in <FIG> illustrates that the distal end <NUM> can protrude above the opening <NUM> of the mitral valve <NUM>. It should be appreciated that the outer shaft <NUM> can protrude into the left atrium <NUM> to any suitable distance, which allows the prosthetic valve to be deployed within the atrium.

In some embodiments, an implant can be delivered to the patient's heart through the outer shaft <NUM>. The outer shaft <NUM> can have a lumen defined therein that can receive various components therethrough. The implant in accordance with some embodiments, such as the implant <NUM> in <FIG>, can be configured such that it can be removably inserted into the outer shaft <NUM> through its proximal end <NUM> and passed through the lumen of the outer shaft <NUM> towards the left atrium <NUM>. The implant <NUM> can be passed through the outer shaft <NUM> such that its forward end <NUM> enters and exits the outer shaft <NUM> first. As shown in <FIG>, the implant <NUM> can be configured such that it can be collapsed, or folded, and it can be inserted through the outer shaft <NUM> in this unexpanded configuration.

Accordingly, as a result of advancing the implant <NUM> through the outer shaft <NUM>, the prosthetic valve <NUM> located on the distal end of the implant <NUM> can be advanced in the undeployed configuration from the distal end <NUM> of the outer shaft <NUM> into the left atrial space, as shown in <FIG>. The prosthetic valve <NUM> can be coupled to the distal end <NUM> of the inner shaft <NUM> inserted through the outer shaft <NUM>, a portion of which is shown protruding from the outer shaft <NUM> in <FIG>. In some embodiments, the prosthetic valve <NUM> can be integrally formed with the inner shaft <NUM>.

As shown in <FIG>, the prosthetic valve <NUM> can be deployed such that it moves from the undeployed configuration to the deployed configuration and its valve body <NUM> and positioning members 204A, 204B (shown in <FIG>) are unfolded or expanded. Any suitable mechanism can be used to unfold the prosthetic valve <NUM>. For example, the prosthetic valve <NUM> can operate like a spring-loaded umbrella that unfolds when actuated. However, other mechanisms can be used additionally or alternatively.

<FIG> illustrates that, prior to deployment of the prosthetic valve <NUM>, the outer shaft <NUM> can be retracted from the left atrium <NUM> such that the distal end <NUM> thereof is positioned in the opening <NUM> of the mitral valve <NUM> between the leaflets <NUM> and <NUM>. It should be appreciated that the described techniques are not limited to a specific position of the distal end <NUM> of the outer shaft <NUM>, as the outer shaft <NUM> can be positioned differently depending on specifics of the patient's heart anatomy, the configuration of the prosthetic valve, and other factors.

<FIG> shows that the deployed prosthetic valve <NUM> can be initially positioned within the left atrium <NUM> such that its positioning members 204A, 204B are disposed within the left atrium <NUM> at a distance from the annulus <NUM> of the mitral valve <NUM>. Next, the implant <NUM> can be manipulated such that the position of the prosthetic valve <NUM> with respect to the mitral valve <NUM> is adjusted to ensure proper positioning of the prosthetic valve <NUM>. Thus, as shown in <FIG>, the outer shaft <NUM> carrying the implant <NUM> can be retracted from the left atrium <NUM> to the left ventricle <NUM>. In this way, the prosthetic valve <NUM> can be moved proximally towards the mitral annulus <NUM> so that the positioning members 204A, 204B are disposed on opposite sides of the opening <NUM> of the mitral valve <NUM> and the valve body <NUM> is suspended within the opening <NUM>. <FIG> shows that the leaflets 206A, 206B of the prosthetic valve <NUM> are positioned within the opening <NUM> of the mitral valve <NUM> between the native leaflets <NUM>, <NUM>.

The positioning members 204A, 204B can engage tissue of the mitral annulus <NUM> without penetrating therethrough. For example, the positioning members 204A, 204B, which may be at least partially flexible, can have a shape that allows them to frictionally engage the tissue of the mitral annulus. The positioning members 204A, 204B can thereby engage the tissue of the mitral annulus such that the valve body <NUM> is seated within the opening of the mitral valve <NUM>. The positioning members 204A, 204B can be configured to engage tissue such that they resist dislodgment forces from the cardiac muscles and do not cause excessive disturbance to the tissue of the mitral annulus. As another advantageous characteristic of the described techniques, the prosthetic valve can be configured and deployed such that a risk of a left ventricular outflow tract (LVOT) obstruction can be reduced or eliminated, and the left ventricular (LV) function can be preserved. Accordingly, the risk of clotting can be reduced or eliminated.

In some embodiments, the location of the prosthetic valve <NUM> can be determined using suitable markers, such as, for example, one or more of the radiopaque markers 210A, 210B, 212A, 212B, and <NUM> shown in <FIG>. The markers can be tracked using a suitable imaging technique and can thus be used to guide a surgeon when the implant <NUM> is delivered, deployed, adjusted, and/or removed.

As shown in <FIG>, after the prosthetic valve <NUM> is suspended within the opening <NUM> of the mitral valve <NUM>, the outer shaft <NUM> can be retracted proximally towards the apex <NUM> of the heart <NUM> such that a portion of the inner shaft <NUM> can be exposed within the left ventricle <NUM>. As discussed above, the inner shaft <NUM> can include distal, middle, and proximal portions <NUM>, <NUM>, <NUM>. As the outer shaft <NUM> is retracted further towards the apex <NUM> such that it is eventually completely retracted from the left ventricle <NUM>, as shown in <FIG>, the anchor portion <NUM> of the implant <NUM> can also be exposed. As shown in <FIG>, the implant <NUM> can be delivered to the heart <NUM> such that the anchor portion <NUM> can be positioned within the apex <NUM>. As also shown in <FIG>, the anchor portion <NUM> can include distal, middle, and proximal portions <NUM>, <NUM>, <NUM>.

As shown in <FIG>, a proximal end <NUM> of the anchor <NUM> is coupled (e.g., slidably or in other manner) to the distal end <NUM> of the outer shaft <NUM>. The proximal end <NUM> is mated with an actuator, such as the actuator <NUM>, (not shown), which can be used to manipulate the anchor <NUM> to cause it to deploy the deployable distal and proximal wings <NUM>, <NUM> (<FIG> and <FIG>) to thereby anchor the implant <NUM> within the apex of the heart. In this way, as shown in <FIG>, the distal portion <NUM> of the anchor <NUM> can first be expanded to form the distal wings <NUM>. The proximal portion <NUM> of the anchor <NUM> can then be expanded to form the proximal wings <NUM>, as shown in <FIG>. It should be appreciated that the distal wings <NUM> are shown to be deployed prior to deploying the proximal wings <NUM> by way of example only, and, in some embodiments, the proximal wings <NUM> can be deployed before the distal wings <NUM> are deployed. Also, in some embodiments, the distal and proximal wings <NUM>, <NUM> can be deployed simultaneously or substantially simultaneously.

In some embodiments, prior to or after deploying the wings <NUM>, <NUM>, a length of the inner shaft <NUM> can be adjusted. The distal and middle portions <NUM>, <NUM> of the inner shaft <NUM> can be configured to slide within each other. For example, the middle portion <NUM> can slide over the distal portion <NUM> to receive at least part of the distal portion <NUM> therein and reversibly lock in that configuration. In this way, the combined length of the middle and distal portions <NUM>, <NUM> can be changed to thereby allow the length of the inner shaft <NUM> to be changed. Additionally, in some embodiments, the proximal portion <NUM> of the inner shaft <NUM> can be configured to receive a portion of the middle portion <NUM>. After the length of the inner shaft <NUM> of the implant <NUM> is adjusted as desired, the implant <NUM> can be affixed within the apex of the heart.

The middle portion <NUM> of the anchor <NUM> can be positioned in tissue of the apex <NUM> and the wings <NUM>, <NUM> can engage the tissue therebetween. The middle portion <NUM> can have a fixed length or, in some cases, the length of the middle portion <NUM> can be adjustable such that the middle portion <NUM> can traverse tissue walls having different thickness. <FIG> illustrates that the distal and proximal wings <NUM>, <NUM> are positioned within tissue of the apex <NUM> of the heart <NUM>. However, in some embodiments, the wings <NUM>, <NUM> can be positioned at opposite sides of the apex wall, as the embodiments described herein are not limited to a specific way in which the deployable wings <NUM>, <NUM> are positioned to anchor the implant <NUM> to the apex of the heart. In some embodiments, the distal wings <NUM> can be deployed against the wall of the apex of the heart and the proximal wings <NUM> can be deployed within the tissue. In other embodiments, the proximal wings <NUM> can be deployed against the wall of the apex of the heart and the distal wings <NUM> can be deployed within the tissue. In both of the above cases, the distal wings <NUM> can be deployed before, after, or simultaneously with deploying the proximal wings <NUM>, as the described techniques are not limited in this respect.

Regardless of the manner and specific locations at which the distal and proximal wings <NUM>, <NUM> are deployed, after the wings <NUM>, <NUM> are deployed, the outer shaft <NUM> including suitable actuator tool(s) used to deploy the prosthetic valve <NUM> and the anchor <NUM> can then be removed from the implantation site such that the implant <NUM> having the prosthetic valve <NUM> suspended in the mitral valve is anchored within the apex of the heart, as shown in <FIG>.

Accordingly, the implant <NUM> can be removably deployed within the heart in a simple and cost-effective manner. The transapical delivery of the implant allows simplifying the surgical procedure and can lead to reducing trauma to the patient. An open heart surgery and the reliance on a cardiac bypass system can be avoided. The implant can be anchored in the apex of the heart without using sutures, purse strings or other additional attachment features. The site of the insertion of the implant can be closed in a clean manner, and a blood loss can be decreased.

In some embodiments, after the implant is anchored in the apex of the heart and the prosthetic valve is suspended off the annulus of a heart valve (e.g., a mitral valve), the distance between the prosthetic valve and the anchor can be adjusted. The anchor can be configured such that a proximal end thereof can receive a suitable adjustment tool which can then be used to adjust a length of the inner shaft to thereby adjust the position of the prosthetic valve within the mitral valve. In some embodiments, additionally or alternatively, the prosthetic valve only or the entire implant can be rotated while the implant is deployed.

In embodiments where one or more tethers can be used to couple the prosthetic valve portion to the anchor portion (e.g., as shown in <FIG>), a suitable adjustment tool can mate with the proximal end of the anchor portion and can be used to unlock the tether clamp to thereby adjust the position of the prosthetic valve within the heart valve (e.g., the mitral valve). When the adjustment is complete, the tether clamp can be manipulated to lock the tether to the anchor portion.

The implant can be adjusted to correct for a variety of conditions, and the adjustment can be made at any time point following the placement of the implant. For example, in cases when any part of the implant migrates from its position such that blood flows through a space between a structure of the implanted valve and cardiac tissue (e.g., a paravalvular leak occurs), the implant may need to be readjusted. The described techniques can allow treating the paravalvular leak or other conditions after the implant has been delivered into the heart. The implant can be adjusted (e.g., by adjusting the distance between the prosthetic valve and the anchor portion and/or rotating the implant or a portion thereof), or it can be completely removed which may be followed by a replacement of the prosthetic valve. Accordingly, the described techniques can provide a simplified and repeatable prosthetic valve implantation procedure which can reduce trauma to tissue and decrease risks associated with open heart surgery.

<FIG> and <FIG> illustrate that an adjustment tool <NUM> can be mated with the anchor <NUM> at the proximal end <NUM> of thereof. The adjustment tool <NUM> can be a screw driver or any other suitable tool. The screw driver can have a hollow shaft. A distal end of the adjustment tool <NUM> can be inserted into the anchor <NUM> and the adjustment tool <NUM> can be used to adjust the length of the inner shaft <NUM> to thereby raise or lower the prosthetic valve <NUM> relative to the mitral valve <NUM> to adjust a position of the implant during the movement of the mitral valve <NUM> upon beating of the heart.

In embodiments including a tether portion configured to adjust a distance between the prosthetic valve and anchor portions (e.g., embodiments shown in <FIG>), the adjustment tool <NUM> can be placed over one or more tethers extending beyond the proximal end of the anchor portion and the tool <NUM> can be used to manipulate a locking portion (e.g., the tether lock <NUM>) configured to reversibly retain the tether(s). In this way, the distance between the prosthetic valve portion and the anchor portion can be adjusted.

As discussed above, the implant in accordance with some embodiments can be removed from the implantation site in a simple, time-efficient, and non-invasive manner. Following the removal, another implant can be inserted to the site of the deficient native valve, for example, when an implant needs to be positioned differently, a different type of an implant is desired, or for any other reasons. Accordingly, the implant placement procedure in accordance with some embodiments can be repeatable without causing trauma to the cardiac tissue.

<FIG> illustrate a reverse process of removing the implant <NUM> delivered and deployed as shown in connection with <FIG>. <FIG> shows that a reversal tool <NUM>, which can be any suitable instrument, can be mated with the proximal end <NUM> of the deployed implant <NUM>. The tool <NUM> can be any suitable instrument and can be locked into position when inserted through the proximal end <NUM> to move the deployed wings <NUM>, <NUM> from the expanded configuration to the unexpanded configuration. In <FIG>, the anchor <NUM> is shown with the wings <NUM>, <NUM> collapsed, such that distal and proximal portions <NUM>, <NUM> of the anchor <NUM> are shown in a pre-deployed configuration, without the wings formed. Next, as also shown in <FIG>, the outer shaft <NUM> can be inserted over the reversal tool <NUM> and advanced distally over the implant <NUM> having the wings <NUM>, <NUM> collapsed, towards the left atrium <NUM>. The outer shaft <NUM> can be advanced into the left ventricle <NUM> until the distal end <NUM> thereof is located in proximity to the proximal end <NUM> of the prosthetic valve <NUM>, as shown in <FIG>. In some embodiments, as shown in this example, the outer shaft <NUM> can be advanced distally until only the distal end <NUM> of the inner shaft <NUM> is exposed.

<FIG> demonstrates that the outer shaft <NUM> can be inserted further such that its distal end <NUM> is positioned within the left atrium <NUM>. The prosthetic valve <NUM> can then be collapsed in a suitable manner. For example, in one embodiment, the prosthetic valve portion <NUM> can be pulled proximally or otherwise manipulated which causes the positioning members 204A, 204B and leaflets 206A, 206A to collapse like a reverse umbrella. In this way, the prosthetic valve <NUM> can move from the expanded configuration to the unexpanded configuration in which the valve <NUM> is compressed and can fit into the outer shaft <NUM> for removal. It should be appreciated that the mechanism of collapsing the prosthetic valve <NUM> is shown by way of example only, as the prosthetic valve <NUM> can have any other structure which can allow the valve to expand/collapse in any suitable manner.

After the prosthetic valve <NUM> is collapsed, the implant <NUM> can be removed from the implantation site through the outer shaft <NUM> (e.g., using the reversal tool <NUM> or other instrument). Thus, <FIG> shows a cross-section of the heart <NUM> where the prosthetic valve <NUM> has been pulled into the outer shaft <NUM> and only the outer shaft <NUM> is visible.

After the implant <NUM> is removed from the left atrium <NUM> through the outer shaft <NUM>, the outer shaft <NUM> can be moved further from the left atrium <NUM> through the mitral valve <NUM> into the left ventricle <NUM>. While still being located within the left ventricle <NUM>, the outer shaft <NUM> can be positioned such that its distal end <NUM> extends above the apex <NUM> of the heart <NUM>, as shown in <FIG>. In some embodiments, the outer shaft <NUM> can be completely removed from the implantation site. Furthermore, in some embodiments, the site <NUM> of implantation of the implant <NUM> can then be closed, as shown in <FIG>.

<FIG> shows that an additional implant, referred to herein as a closure implant or closure device <NUM>, can be introduced through the outer shaft <NUM>, advanced distally through the lumen of the shaft <NUM>, and released from the distal end <NUM> of the shaft <NUM>. The closure device <NUM> can be configured similarly to the anchor portion <NUM> or in any other suitable manner.

In the embodiment of <FIG>, the closure implant <NUM> can include proximal, middle, and distal portions <NUM>, <NUM>, <NUM>, and the proximal and distal portions <NUM>, <NUM> can be configured to expand to form proximal and distal deployable wings <NUM>, <NUM>, both shown in <FIG> and <FIG>. The proximal and distal deployable wings <NUM>, <NUM> can be deployed to engage tissue therebetween and to thereby seal the hole in the apical tissue at the implantation site <NUM> created by the implant <NUM>.

While the distal end <NUM> of the outer shaft <NUM> is positioned within the left ventricle <NUM>, a suitable actuator tool that can be received through the outer shaft <NUM>, which can be the same or different from the reversal tool <NUM>, can be used to deploy the distal wings <NUM> of the closure implant <NUM>, as shown in <FIG>. The outer shaft <NUM> can then be pulled proximally towards the apex <NUM> of the heart <NUM> such that it entirely or partially exits the apex <NUM>, as shown in <FIG>. This movement of the outer shaft <NUM> can bring the closure implant <NUM> in proximity to the apex <NUM> and the closure implant <NUM> having the distal wings <NUM> deployed can be positioned within tissue of the apex <NUM> as shown by way of example in <FIG>. However, it should be appreciated that, in some embodiments, the distal wings <NUM> can be positioned in the left ventricle <NUM> outside of the wall of the apex <NUM> and the middle portion <NUM> can span the apical wall. Furthermore, in some cases, the distal wings <NUM> can be deployed after the closure implant <NUM> is inserted at least partially within the apex <NUM> in a ready-to-deploy position.

<FIG> shows that after the distal wings <NUM> are deployed, the proximal wings <NUM> can be deployed to engage tissue between the wings <NUM>, <NUM>. In this way, the puncture in the apical wall created by the implant <NUM> can be sealed. Following the completion of the deployment of the closure implant <NUM>, the outer shaft <NUM> can be separated from the closure implant <NUM> and removed, as shown in <FIG>.

The implant in accordance with the described techniques can include a prosthetic valve having any suitable configuration that allows the prosthetic valve to have an unexpanded, or collapsed, configuration for delivery and removal to/from a heart valve and an expanded configuration adopted when the prosthetic valve is deployed within the deficient heart valve.

Depending on its structure, the prosthetic valve can alternatively or additionally be described as configured to be able to move between folded and unfolded configurations. The structure of the prosthetic valve can be selected based on an anatomic environment of a natural valve to be repaired or replaced, patient's characteristics, and/or any other factors.

<FIG> is a cross-sectional view of the heart <NUM> illustrating the implant <NUM> of <FIG>, <FIG> transapically delivered to the heart <NUM> to repair or replace the mitral valve <NUM>. The implant <NUM> can be deployed within the heart <NUM> as shown in <FIG> removably and replaceably. The implant <NUM> can have the inner shaft <NUM> and anchor portion <NUM> similar to the inner shaft <NUM> and anchor portion <NUM> of the implant <NUM> (shown in a fully deployed configuration in <FIG>). However, the implant <NUM> can also have a prosthetic valve portion <NUM> configured as an expandable/collapsible wire frame (e.g., a woven wire or other flexible structure). In some embodiments, the prosthetic valve portion <NUM> can include an insert and lines one or more portions of the valve portion <NUM> and is configured to provide a seal against the opening of the natural valve or other body opening into which the prosthetic valve portion <NUM> is inserted. Furthermore, in some embodiments, the expandable/collapsible wire frame can be coupled to the anchor portion <NUM> by a suture/tether, for example, as shown in <FIG>.

The prosthetic valve portion <NUM> can be configured to self-expand upon being released from an introducer assembly (e.g., the outer shaft <NUM>, not shown in <FIG>) used to deliver the implant <NUM> to the mitral valve <NUM>. As shown in <FIG>, the prosthetic valve portion <NUM> can be seated within the opening of the mitral valve <NUM> such that the positioning member <NUM>, shaped in this example as an expandable/collapsible ring, is configured to engage the tissue of the mitral annulus <NUM> to suspend the valve body <NUM> off the tip of the mitral valve <NUM>. The distal and proximal portions <NUM>, <NUM> of the anchor portion <NUM> are configured to expand to form deployable wings <NUM>, <NUM> to anchor the implant <NUM> to the apex <NUM>, as shown in <FIG>. In some cases, a proximal end <NUM> of the implant <NUM> can be located in the pericardial space. The proximal end <NUM> can be accessed to adjust the distance between the prosthetic valve and the anchor portion affixed to the apex by adjusting a length of the inner shaft <NUM> or one or more tethers, such as suture tether(s).

After being deployed, the prosthetic valve portion <NUM> can expand and contract to thereby assist in proper operation of the mitral valve <NUM>. Accordingly, the prosthetic valve portion <NUM> can be configured to operate so as to eliminate mitral regurgitation during systole. Furthermore, the prosthetic valve portion <NUM> can operate without impeding the blood flow from the left atrium to the left ventricle during diastole. After the implant <NUM> is deployed, it can be manipulated such that a distance between the prosthetic valve portion <NUM> and the anchor portion <NUM> is adjusted and/or the implant <NUM> or a portion thereof is rotated.

In embodiments in which the implant includes a tether portion extending between the prosthetic valve portion and the anchor portion (e.g., implant <NUM>, <NUM>', or <NUM>" in <FIG>), the distance between the prosthetic valve portion and the anchor portion can be adjusted by adjusting a length of one or more tethers of the tether portion. The adjustment can be performed at any time point following the implantation (e.g., to adjust the position of the implant after it migrates from an appropriate location), and can also be performed during the placement of the implant. In some cases, the adjustment can decrease or eliminate paravalvular leaks and can treat any other conditions that can be caused by an improper positioning of the implant. <FIG> illustrates the mating component <NUM> (e.g., the distal end <NUM> of the actuator <NUM> in <FIG>) for engaging a suitable adjustment tool used to adjust the deployed implant <NUM>. The implant <NUM> can be accessed for adjustment percutaneously and the adjustment process can be guided using a suitable non-invasive technique, such as, for example, fluoroscopy.

It should be appreciated that although illustrated embodiments provide techniques for repairing or replacing a mitral valve, the techniques can be adapted for repairing or replacing other heart valves as well, or for treating any other conditions. For example, a tricuspid valve or an aortic valve can be repaired using an implant in accordance with some embodiments. Also, a left atrial appendage may be repaired using an implant in accordance with some embodiments. As another example, an enlarged ventricle may be reduced in volume using an implant in accordance with some embodiments, and/or a flail valve leaflet may be repaired using an implant in accordance with some embodiments.

Claim 1:
A system (<NUM>) for repairing a heart valve, comprising:
an outer shaft (<NUM>); and
an implant (<NUM>) disposed within the outer shaft, the implant (<NUM>) including:
at least one tether (<NUM>),
a prosthetic valve portion (<NUM>) coupled to a distal end of the at least one tether and having at least one positioning member (<NUM>), the prosthetic valve portion (<NUM>) being configured to be distally advanced from the outer shaft (<NUM>) so as to move from an unexpanded configuration to an expanded configuration such that at least a portion of the prosthetic valve portion (<NUM>) is positioned within an opening in tissue,
an anchor portion (<NUM>) coupled to a proximal end of the at least one tether and configured to be removably affixed to tissue, and
a tether lock (<NUM>) that is either (i) recessed into a body of the anchor portion or (ii) coupled to a proximal end of the anchor portion, the tether lock (<NUM>) being configured to reversibly lock the at least one tether;
wherein the tether lock (<NUM>) is configured to be released to allow the at least one tether to be adjusted relative to the anchor portion to cause a distance between the prosthetic valve portion (<NUM>) and the anchor portion to increase or decrease.