Patent Description:
Mitral valve regurgitation has several causes. Functional mitral valve regurgitation (FMR) is characterized by structurally normal mitral valve leaflets that are nevertheless unable to properly coapt with one another to close properly due to other structural deformations of surrounding heart structures. Other causes of mitral valve regurgitation are related to defects of the mitral valve leaflets, mitral valve annulus, or other mitral valve tissues. In some circumstances, mitral valve regurgitation is a result of infective endocarditis, blunt chest trauma, rheumatic fever, Marfan syndrome, carcinoid syndrome, or congenital defects to the structure of the heart. Other cardiac valves, in particular the tricuspid valve, can similarly fail to properly close, resulting in undesirable regurgitation.

Heart valve regurgitation is often treated by replacing the faulty valve with a replacement valve implant or by repairing the valve through an interventional procedure. In many instances, a procedure for implanting a replacement heart valve is performed on a patient that has undergone a previous repair procedure for treating the targeted valve, and the targeted valve to be replaced is already associated with an interventional implant. For example, a clip device may have been deployed at the targeted heart valve to fix or approximate leaflets of the valve to reduce regurgitation at the valve. In some circumstances, however, further degradation of the treated heart valve or other clinical circumstances can necessitate that the valve be replaced. In such cases, the previously deployed interventional implant must first be unfixed and/or extracted to prepare the site for deployment and positioning of the replacement valve. As a result, challenges can arise related to the handling of the prior implant(s) and preparation of the targeted site.

In <CIT> there are described devices and methods for the treatment of heart conditions. In particular, devices and methods are described for treating heart failure with preserved ejection fraction, including diastolic heart failure, by performing a pericardial modification procedure.

In <CIT> there are described a medical catheter and methods for removing a defective valve from a patient endoluminally. The method may comprise inserting a medical catheter endoluminally to a site of the defective valve; deploying a coupling mechanism of the medical catheter to stabilize and immobilize a free edge of at least one valve leaflet; deploying a cutting mechanism of the medical catheter to cut a valve base of the defective valve; and removing the defective valve from the patient.

In <CIT> there is described a treatment device for an endoscope that is used for cutting body tissue while the treatment device is retractably projected from a catheter. The treatment device includes: a control wire inserted into the catheter; and a cutting electrode mounted at the distal end of the control wire with the cutting electrode being imparted in a bent configuration in advance. The cutting electrode elastically deforms in a state where the cutting electrode is retracted into the catheter, thereby assuming such a shape as to resemble the configuration of the catheter.

In <CIT> there are described endoscopic and laparoscopic surgical instruments. More specifically, there is described an open loop snare device including a means for securely closing the loop. In some examples, a snare device comprises a snare wire and a capture mechanism wherein, when the snare wire is advanced, the snare wire extends from a distal portion of the device along an arcuate path curving back toward the capture mechanism such that, after the snare wire is advanced, activation of the capture mechanism captures the snare wire, creating a formed loop around a target tissue. Retraction of at least one of the snare wire and capture mechanism contracts the formed loop, resecting the target tissue.

In <CIT> there is described a medical device for performing a therapeutic procedure on a patient. The medical device includes an elongate probe extending to an applicator end sized and shaped to be slidably received in an endoscope working channel. The device also includes an injection needle positioned adjacent the applicator end of the probe. The injection needle is communicatible with a fluid source for delivering fluid and an electrical energy source for delivering electrical energy to the needle when performing the therapeutic procedure on the patient. The needle also has a central axis. The device further includes an ablating loop positioned adjacent the applicator end of the probe. The ablating loop is communicatible with the electrical energy source for delivering electrical energy to the ablating loop when performing the therapeutic procedure. The ablating loop also has a central axis that is spaced from the central axis of the injection needle. During operation of the device, the injection needle and ablating loop have opposite charges for ablating tissue of the patient.

In <CIT> there is described a treatment instrument which has a longitudinal-axis member having a longitudinal axis, a curved portion formed on a distal end side of the longitudinal-axis member, a lumen formed along the longitudinal axis of the longitudinal-axis member, and a through hole that communicates with the lumen, and opens toward the inner side of a curve of the curved portion when the curved portion is curved.

The subject matter claimed herein is not limited to arrangements that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is provided to illustrate one exemplary technology area where some arrangements described herein may be practiced.

According to the present invention there is provided a device having the features of claim <NUM> for cutting tissue at a targeted cardiac valve, such as a mitral valve. One or more embodiments described herein enable detachment and/or removal of an implanted repair device from the cardiac valve in order to prepare the valve site to subsequently receive a replacement cardiac valve or other implant, or to receive other treatment.

The device includes a catheter having a proximal end and a distal end. The distal end is positionable at the targeted cardiac valve. A cutting mechanism is positionable at the distal end of the catheter. The cutting mechanism includes one or more cutting elements configured to cut valve tissue when engaged against the valve tissue. The device also includes a handle coupled to the proximal end of the catheter. The handle includes an electrical source for powering oscillating motion of the one or more cutting elements. The handle may include one or more cutting controls operatively coupled to the cutting mechanism to provide selective actuation of the cutting mechanism.

In some embodiments, the catheter is configured as a steerable catheter having a steerable distal end. The catheter may include one or more control lines extending from one or more steering controls of the handle to the distal end such that adjusting the tension of the one or more control lines causes deflection of the steerable distal end.

In some embodiments, the cutting mechanism is translatable within the catheter such that it is routable through the catheter to be passed beyond the distal end of the catheter and/or to be retracted proximally into the catheter. In some embodiments, the cutting mechanism includes blades arranged in a scissor-like fashion. In some embodiments, the cutting mechanism includes a cutting element configured as a needle structure and/or includes a cutting element configured as a blade structure. In some embodiments, the cutting mechanism is operatively coupled to the one or more cutting controls via one or more cutting control lines and/or an actuator rod.

In some embodiments, the cutting mechanism is configured to pass radio frequency electrical current and/or thermal energy to the targeted valve to cut the targeted valve.

In an example beyond the claims, the cutting mechanism may include a noose structure positionable around valve tissue, the noose structure being configured to be selectively tightened around valve tissue to cut the valve tissue. The noose structure may be formed from a hooked wire and a snare, the snare being configured to engage with the hooked wire to complete the noose structure, wherein one or both of the hooked wire and the snare are translatable relative to the distal end of the catheter. The cutting system may include a first wire and a second wire, each extending distally past the distal end of the catheter, and first and second magnets (e.g., permanent magnets or electromagnets) respectively attached to the distal ends of the first and second wires. The magnets may be coupled to one another such that the first and second wires form the noose. In some examples including a noose structure, the targeted leaflet tissue may be cut by mechanically tightening the noose. Alternately, the targeted leaflet may be cut by contacting the noose to the tissue and applying radio frequency electrical and/or thermal energy.

In some embodiments, the cutting system includes one or more stabilizing prongs extendable distally past the distal end of the catheter, the one or more stabilizing prongs being configured to engage against tissue at the targeted valve to stabilize the distal end of the catheter relative to the targeted valve. The cutting system includes a stabilizing cup which is extendable distally past the distal end of the catheter and is configured to engage with targeted leaflet tissue. The cup is configured to hold an interventional device implanted into the leaflet tissue such that the interventional device may be captured and removed from the patient after the surrounding and/or adjacent leaflet tissue has been cut.

There are also described non-claimed methods of cutting cardiac valve tissue at a targeted cardiac valve, such as a mitral valve. The method includes positioning a delivery catheter within a body so that a distal end of the delivery catheter is positioned near the targeted cardiac valve, routing a cutting mechanism through the delivery catheter so that the cutting mechanism at least partially extends distally beyond the distal end of the catheter to enable the cutting mechanism to engage with leaflet tissue of the targeted cardiac valve, and actuating the cutting mechanism to cut at least one leaflet of the approximated adjacent leaflets.

In some implementations, the targeted cardiac valve is associated with an interventional implant (such as an interventional clip) that approximates adjacent leaflets of the targeted cardiac valve. Performance of the method therefore results in the cutting mechanism detaching the interventional implant from the at least one cut leaflet. Some methods include cutting all leaflets to which the interventional implant is attached. For example, both the anterior and the posterior leaflet of a mitral valve may be cut. The excised implant may then be removed from the patient (e.g., using a stabilizing cup).

In some implementations, the targeted cardiac valve is a mitral valve, and the at least one cut leaflet is the anterior leaflet. In some implementations, the interventional device remains attached to the posterior leaflet. The targeted cardiac valve could also be the tricuspid, aortic, or pulmonic valve, for example.

Additional features and advantages will be set forth in part in the description that follows, and in part will be obvious from the description, or may be learned by practice of the examples and arrangements disclosed herein. The objects and advantages of the examples and arrangements will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing brief summary and the following detailed description are exemplary and explanatory only and are not restrictive of the arrangements disclosed herein or as claimed.

In order to describe the manner in which the above-recited and other advantages and features can be obtained, a more particular description of the subject-matter briefly described above will be rendered by reference to specific examples thereof which are illustrated in the appended drawings. Understanding that these drawings depict only exemplary arrangements and are not therefore to be considered to be limiting in their scope, these arrangements will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:.

Certain arrangements described herein are directed to interventional devices configured for cutting a cardiac valve, such as to enable removal of an implanted repair device from the cardiac valve and/or to prepare the site of the valve to subsequently receive a replacement cardiac valve or other implant. Certain arrangements are configured to route and/or deliver a cutting mechanism to a targeted cardiac valve through a transcatheter approach, such as a transfemoral, radial, or transjugular approach. Alternatively, other implementations can utilize a transapical approach for reaching the targeted cardiac valve.

Although many of the exemplary arrangements described herein are described in the context of cutting a mitral valve and releasing one or more interventional clip devices, it will be understood that similar principles may be applied to other implementations in which other implanted interventional devices are cut away from a mitral valve and/or in which one or more clips or other interventional devices are removed/cut away from another cardiac valve, such as the tricuspid valve. More generally, the exemplary arrangements described herein may be applied in other implementations involving removal of a previously implanted or deployed device from tissue.

<FIG> illustrates an exemplary delivery system <NUM> that may be utilized for routing a cutting mechanism to the targeted cardiac valve. The delivery system <NUM> includes a guide catheter <NUM> operatively coupled to a handle <NUM>. The guide catheter <NUM> is configured to be steerable so as to enable guiding and orienting of the distal end <NUM> of the catheter. For example, the illustrated handle <NUM> includes a control <NUM> (e.g., dial, switch, slider, button, etc.) that can be actuated to control the curvature of the distal end <NUM> of the catheter <NUM>, as indicated by arrows <NUM>. As explained in more detail below with respect to other similar arrangements, the handle <NUM> can include one or more additional controls for actuating and/or adjusting one or more components of a cutting mechanism <NUM>. The cutting mechanism <NUM> is illustrated generically in <FIG>, and may represent any of the other cutting mechanism arrangements (along with corresponding controls and other associated components) described herein.

In some arrangements, the control <NUM> is operatively coupled to one or more control lines <NUM> (e.g., pull wires) extending from the handle <NUM> through the catheter <NUM> to the distal end <NUM> (e.g., through one or more lumens in the catheter <NUM>). Actuation of the control <NUM> adjusts the tensioning of a control line <NUM> so as to pull the guide catheter <NUM> in the corresponding direction. The illustrated arrangement is shown as having a single control <NUM> for providing steerability in two opposing directions. Alternative arrangements may include additional controls (and associated control lines) for providing control in one or more additional directions.

The catheter <NUM> includes a lumen <NUM> through which the cutting mechanism <NUM> may be routed. Accordingly, the delivery system <NUM> may be utilized by positioning the distal end <NUM> near a targeted cardiac valve, and then routing the cutting mechanism <NUM> through the catheter <NUM> and out of the distal end <NUM> so as to position the cutting mechanism <NUM> at the targeted valve. Alternatively, a cutting mechanism <NUM> can be coupled to the distal end <NUM> so that it is positioned at the targeted valve as the distal end <NUM> reaches the targeted valve. As described previously, the delivery system <NUM> may be utilized in a transfemoral, transjugular, radial, or transapical approach, for example. The delivery system <NUM> may be utilized to guide any of the cutting mechanisms described herein, or equivalents thereof.

<FIG> illustrate a targeted mitral valve having an attached interventional clip device <NUM>, showing cutting of one of the valve leaflets (anterior leaflet <NUM>) to effect detachment of the previously approximated leaflets. <FIG> illustrates the mitral valve and clip device <NUM> prior to leaflet cutting, and <FIG> illustrates the mitral valve and clip device <NUM> after leaflet cutting. One or more of the delivery system and/or cutting mechanism arrangements described herein may be utilized in such a procedure.

As shown, the clip device <NUM> is coupled to the anterior leaflet <NUM> and posterior leaflet <NUM>. In many instances, an implant such as the clip device <NUM> will be embedded with the leaflet tissue and/or other surrounding tissues as a result of tissue ingrowth, making it difficult to extract the implant. As shown in <FIG>, one of the leaflets is cut (the anterior leaflet <NUM>, in this example) in order to separate the leaflets. Such separation may be beneficial prior to deployment of a replacement valve, or to satisfy another clinical need to reverse or minimize the effects of the repair device <NUM>. In one preferred implementation, the anterior leaflet <NUM> is cut so that the clip device <NUM> remains attached to the posterior leaflet <NUM>. In this position, there is less risk that the clip device will interfere with functioning of the left ventricular outflow tract (LVOT).

In contrast, cutting the posterior leaflet <NUM> so that the clip device <NUM> remains on the anterior leaflet <NUM>, can result in weighing down of the anterior leaflet <NUM>, which in turn can lead to detrimental interference with the LVOT. However, certain applications may allow for leaving the clip device <NUM> on the anterior leaflet <NUM> with little or acceptable risk of LVOT interference and/or may involve subsequent removal/extraction of the clip device <NUM> from the anterior leaflet <NUM>. Accordingly, methods in which a posterior valve is cut are also included within this disclosure.

<FIG> illustrates an example of a cutting system having a cutting mechanism <NUM> that may be utilized to cut a targeted valve to unfix/detach previously approximated valve leaflets. In this example, the cutting mechanism <NUM> is configured as a scissor-like mechanism having opposing blade cutting elements <NUM> for cutting tissue. In the illustrated arrangement, the cutting mechanism <NUM> extends through or is attached to a distal end of a catheter <NUM>. The cutting mechanism <NUM> is operatively connected to a handle <NUM>, and the handle <NUM> is configured to enable selective actuation of the cutting mechanism <NUM>. For example, the handle <NUM> may include one or more controls <NUM>, and at least one of such controls <NUM> may be operatively coupled to the cutting mechanism <NUM>. The control <NUM> may be, for example, a button, switch, dial, slider, or other suitable actuation mechanism providing a user with selective control over the cutting mechanism <NUM>.

As shown by arrow <NUM>, the cutting system shown in <FIG> is also configured to allow rotational adjustment of the cutting mechanism <NUM> about a longitudinal axis that extends through the catheter <NUM>. Rotational adjustment may be accomplished, for example, by rotating the handle <NUM>, with the rotational torque from turning the handle <NUM> being transferred distally to the cutting mechanism <NUM>. Additionally, or alternatively, the cutting mechanism <NUM> may be rotated relative to the handle <NUM> through actuation of a control <NUM> of the handle <NUM>. The ability to rotate the cutting mechanism <NUM> beneficially allows an operator to properly orient the cutting mechanism <NUM> relative to a targeted cardiac valve or other targeted anatomy so that a desired cut may be made.

As shown in the expanded views of <FIG>, the cutting mechanism <NUM> may be joined to one or more control lines <NUM> (e.g., passing through a lumen of the catheter <NUM>) that control actuation of the cutting mechanism <NUM> through adjustments to the tension of the one or more control lines <NUM>.

In one configuration, shown in <FIG>, the opposing blades <NUM> are operatively coupled to the control line <NUM> such that adjusting tension (shown by arrows <NUM>) of the control line <NUM> allows the blades <NUM> to move between the closed position shown in <FIG> and the open position shown in <FIG>. In this configuration, the application of tension to control line <NUM> moves the blades <NUM> to the open position and the release of tension moves the blades <NUM> to the closed position. The blades <NUM> may, for example, be biased toward the closed position shown in <FIG>. The blades <NUM> may be operated by applying tension to the control line <NUM> to move the blades <NUM> toward the open position shown in <FIG>, then releasing tension in the control line <NUM> to cause the blades <NUM> to close and provide a cutting motion.

<FIG> show another configuration in which the blades <NUM> close through the application of tension to the control line <NUM> and open upon release of tension (shown by arrows <NUM>). The blades <NUM> may, for example, be biased toward the open position shown in <FIG>. The blades <NUM> may be operated by releasing tension to the control line <NUM> to move the blades <NUM> toward the open position shown in <FIG>, then reapplying tension in the control line <NUM> to cause the blades <NUM> to close and provide a cutting motion.

<FIG> illustrates another example in which the cutting mechanism includes a control rod <NUM> operatively coupled to the cutting blades <NUM>. Translation of the control rod <NUM> (shown by arrows <NUM>) provides control over opening and closing of the blades <NUM>. In some configurations, distal translation of the control rod <NUM> causes the blades <NUM> to open while proximal translation of the control rod <NUM> causes the blades <NUM> to close. In other configurations, distal translation of the control rod <NUM> causes the blades <NUM> to close while proximal translation of the control rod <NUM> causes the blades <NUM> to open. One or more push rods such as control rod <NUM> may be used in addition to or as an alternative to the one or more control lines <NUM> for controlling the cutting blades <NUM>. The control elements and configurations shown in <FIG>, including the control line(s) <NUM>, the control rod(s) <NUM>, and their mechanical and operational relationship with the cutting mechanism, may be utilized in any of the other arrangements described herein.

<FIG> illustrates another example of a cutting system having a cutting mechanism <NUM> operatively coupled to a handle <NUM>. In this example, the cutting mechanism <NUM> is configured as a blade, needle, or other sharp member capable of cutting through cardiac valve leaflet tissue. The illustrated cutting mechanism <NUM> is further configured to provide an oscillating or translating motion to enable cutting of tissue against which the cutting mechanism <NUM> is engaged. As shown, the handle <NUM> includes a power source <NUM>, such as a battery source or other source of electricity. Power may additionally or alternatively be provided by an external source such as through electrical cable <NUM> (e.g., AC or DC power). The cutting mechanism <NUM> is thereby powered to provide an oscillating, rotating, or other cutting motion through power transmission means known in the art. For example, the cutting mechanism <NUM> can include or can be operatively coupled to one or more motors <NUM> (e.g., servomotors) or other means of converting the delivered electrical power into the mechanical work of actuating the cutting mechanism <NUM>.

As illustrated, motor <NUM> can be associated with the handle <NUM> and connected to linkage(s) <NUM> extending to the cutting mechanism <NUM> and thereby mechanically coupling the motor <NUM> to the cutting mechanism <NUM>. The motor <NUM> can transfer, through the linkage(s) <NUM>, rotative (as shown by arrow <NUM>) and/or longitudinally oscillating (as shown by arrow <NUM>) motion. This motion powers the cutting mechanism <NUM> and allows it to cut through targeted cardiac tissue or other targeted tissue.

<FIG> illustrate cutting of an anterior leaflet <NUM> to detach a clip device <NUM> from the anterior leaflet <NUM> using a cutting mechanism <NUM> having a blade structure, and <FIG> illustrate a cutting procedure accomplished using a cutting mechanism 512b having a needle structure.

<FIG> illustrates another example of a cutting system including a cutting mechanism <NUM> operatively coupled to a handle <NUM>. In this example, the cutting mechanism includes a tip <NUM> capable of transmitting radio frequency (RF) energy to the targeted valve leaflets in order to provide tissue cutting functionality. The tip <NUM> may be configured as a blade, needle, or other relatively sharp component; however, the tip structure need not necessarily be inherently sharp enough to cut targeted tissue in applications in which RF electrical current is used to provide the cutting functionality.

The illustrated handle <NUM> includes an RF energy source <NUM>. The RF energy from the RF energy source <NUM> may be transmitted distally along the length of the catheter <NUM> to the tip <NUM> of the cutting mechanism <NUM>. For example, the RF energy may be transmitted through a conductor <NUM>, which may be formed as a metallic cable or other structure suitable for transmitting RF energy. The handle <NUM> also includes a control <NUM> configured to enable control of the cutting mechanism <NUM> and/or adjustment to the RF energy source <NUM> and the applied RF energy.

In an alternative arrangement, the tip <NUM> of the cutting mechanism <NUM> is configured as a heat-transmitting structure capable of transmitting sufficient thermal energy (not induced using RF electrical current) to the targeted valve tissue to ablate and cut the valve tissue. In such arrangements, the cutting mechanism <NUM> is thermally coupled to a source of thermal energy at the handle <NUM>, and the thermal energy is transmitted through the length of the catheter <NUM> (e.g., through conductor <NUM>) and sufficiently concentrated at the tip <NUM> of the cutting mechanism <NUM> to provide tissue cutting functionality.

<FIG> illustrate another example of a cutting system that may be utilized in a valve cutting procedure. In this example, the cutting mechanism is configured as a noose structure <NUM> for wrapping around a targeted valve leaflet to enable cutting of the leaflet upon tightening of the noose structure. As shown, the cutting system includes a handle <NUM> and a catheter <NUM> extending distally from the handle <NUM> to a distal end <NUM>. As shown by the progressive succession from <FIG>, the noose structure <NUM> includes a snare <NUM> (including a distal loop and a wire <NUM> extending proximally therefrom) and a wire <NUM> (including a hook at its distal end) that is passable through the snare <NUM> to form the closed noose structure <NUM>.

The illustrated cutting system may also include a collet <NUM> through which both the first wire <NUM> and the second wire <NUM> pass. The collet <NUM> may be configured to lock onto the wires <NUM> and <NUM> and may be translatable with respect to the catheter <NUM>. In this manner, the diameter of the exposed portion of the noose structure <NUM> may be adjusted by translating the collet <NUM> after the collet <NUM> has been locked to the wires <NUM> and <NUM>. For example, the diameter of the noose structure <NUM> may be enlarged by pushing the collet <NUM> distally to move more of the wires <NUM> and <NUM> distally beyond the catheter <NUM>, and may be reduced by retracting the collet <NUM> proximally to pull more of the wires <NUM> and <NUM> within the catheter <NUM>.

Although the illustrated collet <NUM> is shown as being disposed within the catheter <NUM>, alternative arrangements position the collet <NUM> further proximally, such as at the handle <NUM>. In some arrangements, the collet <NUM> and/or wires <NUM>, <NUM> may be operatively coupled to a control <NUM> disposed at the handle <NUM>, with the wires <NUM> and <NUM> extending proximally to the control <NUM> at the handle <NUM>. As with other arrangements described herein, the control <NUM> may be configured as a button.

<FIG> illustrates an alternative configuration in which the noose structure <NUM> includes a first magnet <NUM> and second magnet <NUM> attached at the distal ends of respective wires <NUM> and <NUM>. The magnets <NUM> and <NUM> may independently be electromagnets (e.g., powered by power source <NUM>) or permanent magnets. The magnets <NUM> and <NUM> are configured to attract and magnetically couple to one another to form the noose structure <NUM>.

<FIG> illustrate use of the noose structure <NUM> shown in <FIG> to cut a targeted cardiac valve leaflet <NUM>. As shown in <FIG>, the noose structure <NUM> may first be positioned around the targeted leaflet <NUM>. This may be accomplished by positioning the distal end <NUM> of the catheter <NUM> near the targeted leaflet <NUM>, and then forming the noose structure <NUM> around the leaflet <NUM> by extending the wires <NUM> and <NUM> (see <FIG>) around opposite sides of the leaflet <NUM>. After the noose structure <NUM> has been formed around the targeted leaflet <NUM>, the leaflet may be cut by mechanically tightening the noose structure <NUM> such that the noose structure <NUM> cuts into the tissue. Alternatively, the leaflet <NUM> may be cut by tightening the noose structure <NUM> to bring it into contact with the targeted leaflet <NUM> and then applying radio frequency electrical and/or thermal energy to the noose structure <NUM> (e.g., using RF and/or thermal energy source <NUM> as shown in <FIG>). In <FIG>, the leaflet <NUM> is shown having been cut so as to separate the clip device <NUM> from the leaflet.

<FIG> illustrates an example of a cutting system that includes a plurality of stability components which may be utilized to engage with or against tissue at or near the targeted valve. The stabilizing prongs <NUM> and associated components may be included in other cutting system arrangements described herein, including the arrangements shown in <FIG> and <FIG>.

In the illustrated example, a pair of prongs <NUM> extend distally from a distal end <NUM> of the catheter <NUM> along with the cutting mechanism <NUM>. Other examples may include a different number of prongs (e.g., three, four, or more). Similar to other examples described above, the cutting mechanism <NUM> may be controlled using one or more control elements operatively coupled to the cutting mechanism <NUM> and to a control <NUM> of the handle <NUM>. As with the cutting mechanism <NUM>, the prongs <NUM> may be controllable via one or more controls <NUM> of the handle <NUM>, such as by adjusting the tension in one or more control lines <NUM> extending through the catheter <NUM> to the prongs <NUM>, through the translation of an actuator rod or catheter relative to the prongs <NUM>, and/or through another control mechanism that operatively connects the handle <NUM> to the prongs <NUM>. In some arrangements, the prongs <NUM> may be replaced by or may be used in conjunction with a stabilizing cup (see <FIG>).

The described stabilization components may be utilized in conjunction with one or more components of any of the other cutting mechanism arrangements described herein in order to stabilize the position of the distal end <NUM> of the catheter <NUM> relative to the targeted valve tissue. For example, <FIG> illustrates engagement of the prongs <NUM> against a targeted leaflet <NUM> to stabilize the position of the blade <NUM> relative to the leaflet <NUM>. The blade <NUM> and/or prongs <NUM> may then be actuated to move the blade <NUM> across the leaflet <NUM>. <FIG> illustrates the cut leaflet and the separated clip device <NUM>.

The arrangements and examples described herein are described in the context of cutting leaflet tissue around a single deployed clip device, such as by cutting a single leaflet in a mitral valve (preferably the anterior leaflet). In other implementations, both leaflets may be cut so as to completely free the clip device. In such applications, prongs (such as the prongs <NUM> illustrated in <FIG>) and/or a cup (such as the cup <NUM> or <NUM> illustrated in <FIG>) may be utilized to grasp the clip device as it is cut free. The extracted clip device may then be removed by retracting the prongs and/or cup through the catheter, carrying the extracted clip device away from the targeted valve. Additionally, or alternatively, a vacuum may be applied to the catheter (such as by applying suction at the proximal end and/or handle) to enable the extracted clip device to be pulled into the catheter and removed.

<FIG> illustrates an example of a cutting system having a catheter <NUM> extending distally from a handle (not shown; see, e.g., <FIG>), a cutting mechanism <NUM> that extends through or is attached to a distal end of the catheter <NUM>, and a stabilizing cup <NUM> capable of extending distally from the distal end of the catheter <NUM>. The cutting mechanism <NUM> is shown here in generic form as a dashed line, and cutting mechanism <NUM> therefore represents any of the cutting mechanism arrangements described herein, including the noose structure <NUM> of <FIG>, cutting mechanism <NUM> of <FIG>, cutting mechanism <NUM> of <FIG>, cutting mechanism 512b of <FIG>, or cutting mechanism <NUM> of <FIG>. In accordance with the claims, the cutting mechanism includes one or more cutting elements. Each of the one or more cutting elements are configured as a blade structure or a needle structure.

In the illustrated example, the cup <NUM> is attached to an inner member <NUM> which extends proximally from the cup <NUM> toward the handle. By advancing or retracting the inner member <NUM> relative to the catheter <NUM>, the cup <NUM> may be respectively advanced past the distal end of the catheter <NUM> or retracted into the catheter <NUM>. The inner member <NUM> may be formed, for example, as a hypotube, push rod, catheter, or other suitable structure capable of transmitting longitudinal movement to the cup <NUM>.

The cup <NUM> may be formed as an expandable structure capable of moving between a collapsed, lower profile configuration and an expanded, fully open configuration. For example, the cup <NUM> may be biased toward the expanded, fully open position such that when the cup <NUM> is advanced past the distal end of the catheter <NUM> (and/or the catheter <NUM> is retracted to expose the cup <NUM>) the cup <NUM> self-expands from the collapsed configuration to the open, expanded position. As shown in <FIG>, as the cup <NUM> is advanced relative to the catheter <NUM>, the distal-most portion of the cup <NUM> begins to open and expand, while the more proximal portion remaining within the lumen of the catheter <NUM> remains in a collapsed configuration. In some arrangements, the cup <NUM> includes a frame structure made of a suitable self-expanding material, such as nitinol. The frame structure may also be covered in a membrane (e.g., formed from a suitable medical-grade polymer) to further define the shape of the cup <NUM>.

As shown in <FIG>, the cup <NUM> is configured to contact and cup the implanted interventional device <NUM> and/or leaflet tissue adjacent the implanted interventional device <NUM>. In procedures where the interventional device <NUM> is completely cut free from the targeted cardiac valve <NUM> (e.g., where both leaflets of the mitral valve are cut), the cup <NUM> can function to hold and receive the excised interventional device <NUM>. In the illustrated example, the cup <NUM> is coupled to an adjustment wire <NUM> which extends proximally to the handle (e.g., through the inner member <NUM>). The application and release of tension in the adjustment wire <NUM> causes the cup <NUM> to tighten and loosen, respectively, around the targeted valve <NUM>. For example, the adjustment wire <NUM> may wrap around the periphery <NUM> of the cup <NUM> such that the application of tension to the adjustment wire <NUM> causes the periphery <NUM> of the cup <NUM> to "cinch" to a smaller diameter. For purposes of clarity,
<FIG> illustrate the cup <NUM> with a somewhat loose grasp to the targeted valve <NUM>, it will be understood that the cup <NUM> may be adjusted to a desired fit or tightness against the targeted valve <NUM>.

In preferred arrangements, the catheter <NUM> is a multi-lumen catheter including a lumen for the cutting mechanism <NUM> and a separate lumen for the cup <NUM> and inner member <NUM>. Alternatively, the catheter <NUM> may be a single-lumen catheter. In such a single-lumen catheter, the cutting system may additionally include a tether <NUM> coupling the cup <NUM> to the cutting mechanism <NUM>, as shown in <FIG>. For example, in a single-lumen catheter, the cup <NUM> may be deployed first, then detached from the inner member <NUM>. The cutting mechanism <NUM> may then be deployed to cut the valve <NUM>. The tether <NUM> maintains connection of the cutting system to the cup <NUM>.

As shown in <FIG>, after the cutting mechanism <NUM> has cut the targeted valve <NUM>, the cup <NUM> remains in contact with the cut portion of the leaflet tissue which includes the excised interventional device <NUM>. As shown in <FIG>, the cup <NUM> may then be retracted into the catheter <NUM> to allow the excised interventional device <NUM> to be withdrawn from the patient. The cup <NUM> may be included with other cutting system arrangements described herein, including the arrangements shown in <FIG> and <FIG>.

<FIG> illustrate an alternative arrangement of a cutting system including a catheter <NUM> (shown here as a multi-lumen catheter), cutting mechanism <NUM>, inner member <NUM>, and cup <NUM>. The cutting system shown in <FIG> may be configured similar to the cutting system of <FIG>. However, whereas the cup <NUM> is oriented to open in a direction transverse to the longitudinal axis of the catheter <NUM>, the cup <NUM> is oriented to open in a direction substantially aligned with the longitudinal axis of the catheter <NUM>. <FIG> illustrates that the interventional device <NUM> and surrounding tissue is grasped within the cup <NUM> as the valve <NUM> is cut by the cutting mechanism <NUM>, <FIG> illustrates the excised interventional device <NUM> held within the cup <NUM> after the valve <NUM> has been cut, and <FIG> illustrates tightening and/or "cinching" of the cup <NUM> to more fully hold the excised interventional device <NUM>. After receiving the excised interventional device <NUM>, the cup <NUM> may be retracted into the catheter <NUM> and the system removed from the patient.

<FIG> further illustrate closing mechanics related to the cup <NUM> of <FIG> and the cup <NUM> of <FIG>, respectively. <FIG> illustrates a cross-sectional view of the distal portion of the catheter <NUM>, showing the opening/rim of the cup <NUM>. As the inner member <NUM> is retracted relative to the catheter <NUM>, the cup <NUM> is brought into contact against the distal end of the catheter <NUM>. The peripheral curvature of the cup <NUM> at the point where the cup <NUM> abuts the catheter <NUM> allows the cup <NUM> to collapse into a more oblong and lower profile shape as it is forced against the distal end of the catheter <NUM>. Further proximal retraction of the inner member <NUM> forces the cup <NUM> to a correspondingly lower profile until it can be retracted fully within the catheter <NUM>. In the illustrated example, the frame of the cup <NUM> may include one or more pivot points <NUM> that aid in folding of the cup <NUM> toward the collapsed position. Other arrangements may omit pivot points <NUM> and may instead utilize an inherent flexibility of the frame to allow collapse of the cup <NUM>.

<FIG> illustrates a cross-sectional view of the catheter <NUM> and cup <NUM>. Similar to the example of <FIG>, proximal retraction of the inner member <NUM> relative to the catheter <NUM> brings the cup <NUM> into contact against the distal end of the catheter <NUM>. The peripheral curvature of the cup <NUM> at the point where the cup <NUM> contacts the catheter <NUM> allows the distal rim of the cup <NUM> to collapse radially inward as the cup <NUM> is forced against the distal end of the catheter <NUM>.

The terms "approximately," "about," and "substantially" as used herein represent an amount or condition close to the stated amount or condition that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," and "substantially" may refer to an amount or condition that deviates by less than <NUM>%, or by less than <NUM>%, or by less than <NUM>%, or by less than <NUM>%, or by less than <NUM>% from a stated amount or condition.

Claim 1:
A device for cutting tissue at a targeted cardiac valve, the device comprising:
a catheter (<NUM>) having a proximal end and a distal end (<NUM>), the distal end (<NUM>) of the catheter (<NUM>) being positionable at the targeted cardiac valve;
a cutting mechanism (<NUM>) positionable at the distal end (<NUM>) of the catheter (<NUM>), the cutting mechanism (<NUM>) including one or more cutting elements configured to cut leaflet tissue of the targeted cardiac valve when engaged against the leaflet tissue, wherein each of the one or more cutting elements are configured as a blade structure or a needle structure, and wherein the cutting mechanism (<NUM>) is translatable within the catheter (<NUM>) such that it is routable through the catheter (<NUM>) to be passed beyond the distal end (<NUM>) of the catheter (<NUM>) and/or to be retracted proximally into the catheter (<NUM>);
a handle (<NUM>) coupled to the proximal end of the catheter (<NUM>), the handle (<NUM>) including an electrical source for powering oscillating motion of the one or more cutting elements;
a stabilizing assembly extendable distally past the distal end (<NUM>) of the catheter (<NUM>), the stabilizing assembly being configured to engage against the targeted cardiac valve to stabilize the distal end (<NUM>) of the catheter (<NUM>) relative to the targeted valve, wherein the stabilizing assembly includes a cup (<NUM>); and
wherein the cup (<NUM>) is attached to an inner member (<NUM>) which extends proximally from the cup (<NUM>) toward the handle (<NUM>), wherein the inner member is configured to be advanced or retracted relative to the catheter (<NUM>) to advance the cup past the distal end (<NUM>) of the catheter (<NUM>) or to retract the cup into the catheter (<NUM>), respectively, the cup (<NUM>) being configured to engage with the leaflet tissue and to receive cut leaflet tissue and/or an interventional device implanted into the cut leaflet tissue, the cup (<NUM>) including one or more pivot points (<NUM>) that allow the cup (<NUM>) to collapse into a more oblong and lower profile shape as a peripheral curvature of the cup (<NUM>) is forced against the distal end (<NUM>) of the catheter (<NUM>).