Heart valve repair

Abstract

A medical system includes a catheter that can be navigated through a patient's vasculature to introduce a valve clip configured to engage an edge of a heart valve leaflet. The valve clip includes a deformable wire configured to engage the valve leaflet, the wire extending from a first wire portion to a second wire portion. The catheter includes a handle having a control member, an elongated body defining a cavity extending from the handle to a distal opening, and first and second delivery devices operably coupled to the control member and extending through the cavity to the distal opening. Each delivery device is configured to releasably couple to a portion of the wire and be movable relative to the distal opening. The delivery devices are controllable at the handle to move the valve clip between an extended configuration and a contracted configuration to engage the valve leaflet.

Description

Technical Field

[0001] The present disclosure relates to heart valve repair, such as mitral valve repair. Background Art

[0002] Some patient conditions can produce valvular insufficiency or regurgitation in the patient's heart. Valvular insufficiency or regurgitation occurs when a valve in the patient's heart does not close completely, allowing blood to flow backward (e.g., from the left ventricle to the left atrium), which can adversely affect the function of the heart.

[0003] The mitral valve includes two leaflets (anterior and posterior) attached to the valve annulus (e.g., the annulus fibrosus). In a healthy heart, the mitral valve leaflets close during left ventricular contraction and prevent blood from flowing back into the left atrium. Mitral regurgitation is a condition in which a patient's mitral valve leaflets do not close properly, resulting in blood flowing back from the left ventricle into the left atrium. The backflow of blood into the left atrium can cause a decrease in the amount of blood ejected by the left ventricle, causing the patient's heart to work relatively harder to provide the required amount of blood to the body. Mitral regurgitation can occur due to different patient conditions. For example, secondary mitral regurgitation, also known as functional mitral regurgitation, can occur when the left ventricle is dilated and causes the patient's mitral valve annulus to dilate. Summary of the Invention

[0004] The present disclosure describes medical devices, systems, and techniques that can be used to assist in coapting tissue, such as the leaflets of a heart valve, to facilitate implantation of a valve clip configured to treat valvular regurgitation. The devices, systems, and techniques described herein can be used to treat mitral valve regurgitation or other patient conditions involving the valve. In some instances, the devices, systems, and techniques can include transcatheter repair solutions for degenerative mitral valve regurgitation.

[0005] In some examples, the present disclosure describes an example medical system comprising: a valve clip comprising a deformable wire configured to engage a patient's valve leaflets, wherein the deformable wire extends from a first wire portion to a second wire portion; and a catheter configured to introduce the valve clip into a native heart valve adjacent to the patient's body, the catheter comprising: a handle comprising a plurality of control members; an elongated body defining a cavity, wherein the elongated body extends from a proximal end mechanically coupled to the handle to a distal portion comprising a distal opening; a first delivery device operably coupled to at least one of the plurality of control members and extending through the cavity to the distal opening, wherein the first delivery device is configured to releasably couple to the first wire portion and be movable relative to the distal opening of the elongated body; and a second delivery device operably coupled to at least one of the plurality of control members and extending through the cavity to the distal opening, wherein the second delivery device is configured to releasably couple to the second wire portion, wherein the first and second delivery devices are configured to move the valve clip between an extended configuration and a contracted configuration to engage the valve leaflets.

[0006] In some examples, the present disclosure describes an example medical system comprising: a valve clip comprising: a deformable wire extending from a distal fixing structure to a proximal fixing structure, wherein the deformable wire is movable between an extended configuration and a preformed contracted configuration configured to engage the valve leaflets; a plurality of barbs extending from an exterior surface of the wire; and a fabric positioned exterior to the plurality of barbs, wherein the plurality of barbs are configured to at least partially protrude through the fabric when the wire engages the valve leaflets; and a catheter configured to introduce the valve clip into a native heart valve adjacent to a patient's body, the catheter comprising: a handle comprising a plurality of control members; an elongated body defining a cavity, wherein the elongated body extends from a proximal end mechanically coupled to the handle to a distal opening; a first A delivery device that is operably coupled to at least one of a plurality of control members and extends through the lumen to the distal opening, wherein a first delivery device is configured to releasably couple to a distal fixation member of the deformable wire and is movable relative to the distal opening of the elongated body; and a second delivery device of the plurality of delivery devices that is operably coupled to at least one of a plurality of control members and extends through the lumen to the distal opening, wherein the second delivery device is configured to releasably couple to a proximal fixation member of the deformable wire, wherein the first and second delivery devices are configured to pass a valve clip in an extended configuration through the distal opening of the elongated body and to move the valve clip between an extended configuration and a contracted configuration to engage the valve leaflets.

[0007] In some examples, the present disclosure describes example techniques that include: advancing a catheter through a patient's vasculature to a selected tissue site in a blood vessel or heart, wherein the catheter includes a lumen to house a valve clip, the valve clip including a deformable wire configured to engage a valve leaflet of the patient, wherein the deformable wire extends from a first wire portion to a second wire portion, and wherein the catheter further includes a handle, the handle including a plurality of control members; an elongated body defining a lumen, wherein the elongated body extends from a proximal end mechanically coupled to the handle to a distal portion including a distal opening; and a first delivery device operably coupled to one of the plurality of control members. at least one control member and extending through the lumen to the distal opening, wherein a first delivery device is configured to releasably couple to the first wire portion and be movable relative to the distal opening of the elongated body; and a second delivery device of the plurality of delivery devices operably coupled to at least one control member of the plurality of control members and extending through the lumen to the distal opening, wherein the second delivery device is configured to releasably couple to the second wire portion; advancing the first delivery device distally to the distal opening of the elongated body; and controlling the first delivery device and the second delivery device to move the valve clip from an extended configuration to a retracted configuration to engage the valve leaflets.

[0008] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1A and 1B is a schematic cross-sectional view of an example human heart.

[0010] Figures 2A-2D Schematic diagram illustrating example medical systems and techniques for introducing a valve clip into a selected tissue site.

[0011] Figures 3A-3C Schematic diagram illustrating a plan view of an example valve clip defining a helical shape.

[0012] Figure 4A and 4B Schematic diagram illustrating an example valve clip having a non-planar side profile.

[0013] Figure 5 Schematic diagram illustrating an example anchor extending from an exterior surface of a valve clip.

[0014] Figure 6 Schematic diagram illustrating an example valve clip including an anchor and fabric.

[0015] Figure 7 A schematic diagram illustrating a portion of an example valve clip engaging tissue.

[0016] Figure 8 A flow chart illustrating an example technique for introducing a valve clip. DETAILED DESCRIPTION

[0017] The present disclosure describes devices, systems, and techniques for repairing heart valves (such as, but not limited to, the mitral valve) that are less invasive than some other techniques (such as open-heart surgery). In some cases, a patient's heart valve is repaired by clipping or suturing the leaflets of the heart valve together, effectively dividing the valve orifice into separate functional orifices (e.g., two semilunar valves). This may be referred to as an edge-to-edge valve repair.

[0018] The devices and systems described herein can be used as part of edge-to-edge valve repair and can facilitate the performance of such medical procedures via transcatheter techniques (e.g., eliminating the need for open-heart surgery or more invasive techniques). As discussed in further detail below, the devices and systems described herein are configured to facilitate the use of a valve clip comprising a deformable spiral shape to grasp the leaflets of a heart valve. The valve clip can be deformed into an extended configuration. In the extended configuration, the spiral shape of the valve clip can be straight or nearly straight to enable the valve clip to be delivered through the lumen of a delivery catheter. The delivery catheter can be navigated through the patient's vasculature and positioned at or near a selected valve of the heart. When positioned at a selected position, such as within the plane of the valve, the valve clip can be deployed from the delivery catheter. The valve clip can be retracted to a pre-formed shape (e.g., an undeformed configuration). When the valve clip is manipulated from the deformed configuration to the undeformed configuration, the spiral clip can engage and capture the valve leaflets. In this way, the spiral clip is configured to clamp the leaflets together.

[0019] In some instances, multiple valve clips may be used to clamp the leaflets together. In some instances, the valve clips may enable the leaflets to be subsequently sutured, clamped (e.g., with a second clip), or otherwise connected at or near the edge of the leaflets. In other instances, the valve clips alone may be sufficient to clamp the leaflets together. In some instances, grasping the leaflets simultaneously (e.g., simultaneously or nearly simultaneously) with the spiral clips may improve the placement of the spiral clips and / or reduce the amount of time required to achieve the desired placement of the spiral clips relative to the annulus and / or edges of the valve leaflets of the heart valve. In some instances, the disclosed devices, systems, and techniques may be able to assess the function of the valve clips while still having the ability to reposition or retrieve the valve clips. Assessing the function of the valve clips while still being able to reposition or retrieve the valve clips may improve the effectiveness of treatment.

[0020] Side-to-side heart valve repair can be used to treat heart valve regurgitation, for example, in patients with relatively normal leaflet motion (compared to healthy hearts without degenerative mitral regurgitation) and / or those with annular dilatation or leaflet prolapse. Leaflet prolapse may be due to chordae tendineae rupture or elongated papillary muscles. Although some regurgitation may persist after side-to-side heart valve repair, side-to-side heart valve repair may reduce regurgitation enough to slow or even prevent further progression to heart failure.

[0021] Figure 1A and 1Bis a schematic cross-sectional view of an example human heart 10. The human heart 10 is a four-chambered muscular organ that provides blood circulation through the human body during the cardiac cycle. The four chambers include the right atrium (RA) and right ventricle (RV), which supply the pulmonary circulation, and the left atrium (LA) and left ventricle (LV), which supply oxygenated blood received from the lungs to the body. To ensure that blood flows through the heart in one direction, the atrioventricular valves (tricuspid valve (TV) and mitral valve (MV)) are present between the junctions of the atria and ventricles, and the semilunar valves (pulmonary valve (PV) and aortic valve (AV)) govern the outlet of the ventricles to the lungs and other parts of the body, respectively. These valves contain leaflets (LF) or cusps that open and close in response to changes in blood pressure caused by the contraction and relaxation of the heart chambers. Figure 1B is a schematic cross-sectional view of the left ventricle LV of the heart 10 showing the anatomy and native mitral valve MV.

[0022] The left atrium LA receives oxygenated blood from the lungs via the pulmonary veins and pumps the oxygenated blood through the mitral valve MV into the left ventricle LV during ventricular diastole. The left ventricle LV contracts during systole and blood flows outward through the aortic valve AV, into the aorta and to the rest of the body. In a healthy heart, the leaflets LF of the native mitral valve MV meet or close evenly at the free edges to close and prevent blood from flowing back into the left atrium LA during contraction of the left ventricle LV. The tissue of the leaflets LF is attached to the surrounding heart structures via a dense fibrous ring of connective tissue called the annulus AN. The flexible tissue of the leaflets LF of the native mitral valve MV is connected to the papillary muscles PM extending upward from the inferior wall of the left ventricle LV and the interventricular septum IVS via branching tendons called chordae tendineae (CT).

[0023] Mitral regurgitation is a condition in which a patient's mitral valve leaflets do not close properly. As a result, blood flows backward from the left ventricle LV into the left atrium LA. This backflow of blood into the left atrium LA can result in a decrease in the amount of blood ejected by the left ventricle LV, causing the patient's heart to work relatively harder to supply the required amount of blood to the body. Mitral regurgitation can occur as a result of one or more patient conditions. For example, secondary mitral regurgitation, also known as functional mitral regurgitation, can occur when the left ventricle LV dilates and causes the patient's mitral valve annulus to dilate. As the left ventricle LV dilates, the leaflets LF of the valve can move apart, which can adversely affect the leaflets' ability to close properly.

[0024] In addition to or instead of being caused by left ventricle LV dilation, mitral valve regurgitation (or other valve regurgitation) can be caused by the accumulation of calcified plaque in the heart 10. For example, the leaflets LF of a valve (e.g., aortic valve AV or mitral valve MV) may become stiff and may not close sufficiently, causing regurgitation where the valve does not close completely, allowing blood to flow backward (e.g., from the left ventricle LV to the left atrium LA). Due to the higher pressures generated, the left side of the heart 10 (e.g., mitral valve MV and aortic valve AV) may be more likely to become calcified.

[0025] The medical devices, systems, and techniques described herein can be used to repair a valve of the heart 10 via a minimally invasive medical procedure. For example, the medical procedure can include delivering a valve clip via a transcatheter, transseptal, or left ventricular approach that is less invasive than open heart surgery. Although open heart surgery, such as annuloplasty preformed via open heart surgery, can produce positive results, minimally invasive medical procedures can also result in positive results and a shorter recovery time for some patients compared to open heart surgery. Although the devices, systems, and techniques are described herein primarily with reference to the repair of the mitral valve MV, in other instances, the devices, systems, and techniques described herein can be used to repair other heart valves or other valves outside of a patient's heart. In addition, the devices, systems, and techniques can be used in conjunction with other medical devices or medical procedures, such as in conjunction with an annuloplasty ring for annular stabilization around the annulus of the mitral valve MV.

[0026] Figures 2A-2D Schematic diagram illustrating an example medical system 100 and technique for introducing a valve clip 102 to a selected tissue site. Figure 2A A schematic diagram of a partially cutaway section of an example medical system 100 is shown, illustrating a catheter 104 and a valve clip 102. The catheter 104 includes a handle 106, an elongated body 108, a first delivery device 110A, and a second delivery device 110B. For illustrative purposes, the distal portion 105 of the catheter 104 is enlarged relative to the handle 106 and the proximal portion 107 of the catheter 104. In practice, the outer diameter of the distal portion 105 can be substantially similar to the outer diameter of the proximal portion 107.

[0027] The valve clip 102 includes a deformable wire configured to engage a patient's tissue, such as the leaflets LF of a heart valve. The valve clip 102 may include a biocompatible material configured to apply or maintain a force on the tissue. For example, the valve clip 102 may be configured to apply a force to the leaflets LF to join at least a portion of the leaflets LF or to push at least a portion of the leaflets LF toward each other to improve the engagement of the leaflets LF. In some examples, the valve clip 102 may include a biocompatible metal or alloy, such as nitinol, stainless steel, cobalt-chromium alloy, etc. In other examples, the valve clip 102 may include a polymer, suture, a composite material, or any combination of suitable materials. For example, the valve clip 102 may be primarily composed of a metal or alloy. In some cases, the valve clip 102 may include a biocompatible shape memory alloy. In addition to or in place of a metal or alloy, in some examples, the valve clip 102 may include a polymer. For example, the valve clip 102 may be primarily composed of a polymer or may be formed from a composite material of a metal or polymer. As another example, the valve clip 102 can be formed from polyterephthalamide (eg, Kevlar, DuPont, Wilmington, Delaware).

[0028] In some instances, the valve clip 102 may have a collapsed (e.g., undeformed) configuration that defines a preformed shape. For example, a heat treatment may be used to define or set the preformed shape. The preformed shape is the shape toward which the valve clip 102 returns in the absence of an applied force. In some instances, the preformed shape may include a substantially planar spiral (e.g., planar within manufacturing tolerances), a helix, a tapered spiral, or other spring-like shape. The preformed shape is configured to cause the valve clip 102 to engage tissue. In some instances, the preformed shape may cause the valve clip 102 to engage tissue via a capstan effect. For example, when the valve clip 102 engages tissue, the preformed shape may cause the tissue to conform to the cross-sectional shape of the valve clip 102, thereby generating friction between the tissue and the valve clip 102. In some instances, as discussed below, tissue engagement may be generated or increased by other features of the valve clip 102, such as anchors.

[0029] The valve clip 102 can also be deformed from a pre-formed shape. For example, applying a force can push the pre-formed shape toward an extended (e.g., deformed) configuration. In the extended configuration, the valve clip 102 can be configured to pass through the cavity 114 and / or the distal opening 112 of the elongated body 108. In this way, deforming the valve clip 102 into the extended configuration can enable the valve clip 102 to be loaded into the catheter 104 for delivery to a selected tissue site. In some examples, the pre-formed shape of the valve clip 102 (e.g., the collapsed configuration) can have at least one dimension, such as width or height, that is larger than the cross-section of the cavity 114 and / or the distal opening 112.

[0030] The valve clip 102 extends from a distal end 116 to a proximal end 118. In some examples, the distal end 116 and / or the proximal end 118 can include respective securing structures 120 and / or 122. As discussed in further detail below, the securing structures 120 and 122 are configured to releasably engage the first delivery device 110A and the second delivery device 110B, respectively. For example, the securing structures 120 and 122 can include loops, hooks, spherical structures such as balls, etc., in the wires of the valve clip 102.

[0031] In some instances, the valve clip 102 may include at least one anchor. The anchor may include any structure configured to engage the valve clip 102 with tissue at a selected tissue site, such as the leaflet LF, and to help maintain the valve clip 102 generally in an appropriate position relative to the selected tissue site. For example, the anchor may be configured to penetrate at least a portion of the tissue at the selected tissue site, increase the coefficient of friction at the selected tissue site (e.g., improve the capstan effect) and / or promote tissue ingrowth. The anchor may be positioned at one or more selected locations along the length of the valve clip 102 and extend from or cover the outer surface of the wire of the valve clip 102. In some instances, the anchor may include fabric, one or more barbs, one or more hooks, one or more spiral coils, or one or more tapered spiral coils. In some instances, the anchor may include a biocompatible metal or alloy, such as nitinol, stainless steel, cobalt-chromium alloy, etc. In some cases, the anchor may include a biocompatible shape memory alloy. In addition to or in place of metal, in some instances, the anchor may be at least partially formed of a polymer. For example, the anchor can include a biocompatible polymeric fabric, such as Dacron, etc. In some examples, the anchor can be fluorescent, echogenic, or both.

[0032] The catheter 104 is configured to introduce the valve clip 102 into a patient at a selected tissue site, such as the mitral valve MV. The catheter 104 includes a handle 106, an elongated body 108, a first delivery device 110A, and a second delivery device 110B ("delivery devices 110").

[0033] The handle 106 can be configured to control the movement of the catheter 104 and / or the deployment of the valve clip 102. The handle 106 includes a first control member 124A and a second control member 124B ("control members 124"). The control members 124 can include any suitable device that can be manipulated by a clinician, such as a button, a sliding lever, a dial, etc. The control members 124 can be operably coupled, such as mechanically coupled or fluidically connected, to enable control of other components of the catheter 104, such as the delivery device 110.

[0034] The clinician can position the medical system 100 by advancing the distal portion 105 of the catheter 104 through the patient's vasculature, for example, from a femoral vein entry site and upward through the inferior vena cava IVC or a radial artery entry site. In some instances, to facilitate positioning of the catheter 104, the valve clip 102, or both within the treatment location, the distal portion of the catheter 104 can include at least one radiographic and / or echogenic marker configured to be visualized using radiographic and / or ultrasound techniques. In some instances, the distal portion 105 of the catheter 104 is configured to puncture the patient's cardiac septum so that the catheter 104 can enter the left atrium LA through the septum. For example, delivering the valve clip 102 through the septum to the mitral valve MV can include puncturing the septum between the right atrium RA and the left atrium LA. The delivery tool 106 can include an articulation feature to facilitate navigation of the distal portion 105 of the catheter 104. For example, the catheter 104 can include a pull wire assembly (not shown) integrated therein and coupled to one of the control members 124 that, when moved, causes the distal portion 105 of the catheter 104 to bend in a selected direction.

[0035] The elongated body 108 defines a lumen 114 and extends from a proximal end 126 that is mechanically coupled to the handle 106 to the distal portion 105. The distal portion 105 defines a distal opening 112 that provides access to the lumen 114. The distal opening 112 can be disposed at the distal end of the distal portion or extend through a sidewall 109 of the elongated member 108. The lumen 114 can be configured to accommodate the valve clip 102 during percutaneous introduction of the catheter 104 into the patient's vasculature and advancement of the distal portion 105 to a selected tissue site. In some examples, the lumen 114 can be configured for use with a guidewire, a guide catheter, or the like to facilitate introduction of the catheter 104 into the patient's vasculature and advancement of the distal portion 105 of the catheter 104 to a selected tissue site.

[0036] During use, the valve clip 102 is loaded into the catheter 104 for deployment to a selected tissue site (e.g., the mitral valve MV). The valve clip 102 can be loaded through the distal opening 112 of the elongated body 108 or an opening in the proximal portion 107 of the catheter 104. In some examples, loading the valve clip 102 can include releasably coupling the valve clip 102 to the delivery device 110. For example, the distal tips of the first and second delivery devices 110A and 110B can include respective clamshell-shaped clamps 126A and 126B ("clamps 126"). In other examples, the clamps 126 can include any suitable structure to releasably couple to at least a portion of the valve clip 102. In some examples, the clamps 126 can be controllable at the control member 124 to engage or disengage the clamps 126 with the valve clip 102, such as the fixation members 120 and 122.

[0037] The catheter 104 is also configured to deploy the valve clip 102 at a selected tissue site (e.g., the mitral valve MV) to engage the leaflets LF. For example, a first delivery device 110A is operably coupled to a control member 124A of the plurality of control members and extends through the lumen 114 to the distal opening 112. Similarly, a second delivery device 110B is operably coupled to the control member 124B and extends through the lumen 114 to the distal opening 112. The first delivery device 110A is configured to releasably connect to the first wire portion of the valve clip 102. In some examples, the first delivery device 110A is releasably coupled to the fixation structure 120. The second delivery device 110B is configured to releasably connect to the second wire portion of the valve clip 102. In some examples, the second delivery device 110B is releasably coupled to the fixation structure 122. The delivery device 110 is movable relative to the distal opening 112 of the elongated body 104 to deploy the valve clip 102 from the lumen 114. For example, actuation of a control member 124 operably coupled to the delivery device 110 can move the delivery device relative to the distal opening 112. In this manner, the delivery device 110 can be used to move the valve clip relative to the distal opening 112 and between the extended and retracted configurations.

[0038] like Figure 2B As illustrated, after positioning the distal portion 105 of the catheter 104 at a selected tissue site, such as adjacent to a native heart valve within a patient, a clinician can actuate one or both of the control members 124 to control the corresponding delivery device(s) 110, deploying the valve clip 102 and extending it through the distal opening 112. In some examples, during deployment, the valve clip 102 can be in an extended configuration. When in the extended configuration, the valve clip 102 is configured to pass through the lumen 114 of the elongated body 104 and the distal opening 112.

[0039] When deployed, the valve clip 102 can be in an extended configuration and across the mitral valve MV. After the valve clip 102 in the extended configuration is positioned across the mitral valve MV, the clinician can manipulate one or both of the control members 124 to control the corresponding (one or more) delivery devices to move the valve clip 102 between the extended configuration and the collapsed configuration. For example, Figure 2CAs illustrated in FIG, a clinician can actuate the first control member 124A to move the first delivery device 110A in the proximal direction without actuating the second control member 124B, which causes the second delivery device 110B to remain stationary relative to the distal opening 112 and / or the mitral valve MV. In this manner, the clinician can control the distal tip 116 of the valve clip 102 to move toward the proximal tip 118 of the valve clip 102 to return the valve clip 102 toward the collapsed configuration. In some instances, the clinician can actuate the first control member 124A to move the first delivery device 110A in the proximal direction while actuating the second control member 124B to move the second delivery device 110B in the distal direction. In this manner, the clinician can control the distal tip 116 of the valve clip and the proximal tip 118 of the valve clip 102 to move toward each other simultaneously to return the valve clip 102 toward the collapsed configuration. In some instances, the clinician can actuate the second control member 124B to move the second delivery device 110B in the distal direction without actuating the first control member 124A, which causes the first delivery device 110A to remain stationary relative to the distal opening 112 and / or the mitral valve MV. In this manner, the clinician can control the proximal end 118 of the valve clip 102 to move toward the distal end 116 of the valve clip 102 to return the valve clip 102 toward the collapsed configuration. After returning the valve clip 102 to the collapsed configuration, such as to allow for extension when engaging the leaflets LF, the clinician can actuate one or both control members 124 or another control unit to release the valve clip 102 from one or both delivery devices 110. In some examples, in addition to or in lieu of actuating the first and / or second control members 124A and 124B to move one or both delivery devices 110, the clinician may actuate one or both control members 124 or another control unit to release the valve clip 102 from one or both delivery devices 110, causing the valve clip 102 to return in an uncontrolled manner toward the collapsed configuration. For example, when in the extended configuration or a configuration between the extended and collapsed configurations, the clinician may release the valve clip 102, causing the valve clip 102 to rebound or rapidly and uncontrollably return to the collapsed configuration, such as to allow for extension when engaging the leaflets LF.

[0040] As the valve clip 102 moves from the extended configuration to the retracted configuration, the valve clip 102 can engage the leaflets LF. Figure 2C As described in [ 15 ], the valve clip 102 can be coiled around the free edge of the leaflet LF. By coiling around the leaflet LF, the valve clip 102 engages the tissue of the leaflet LF. In some instances, engaging the leaflet LF with the valve clip 102 can be relatively easier than clamping the leaflet LF alone. For example, the valve clip 102 can be deployed and moved from an extended configuration to a collapsed configuration without requiring precise positioning to capture the free edge of the leaflet LF (compared to clamping the edge of the leaflet LF alone).

[0041] In some examples, the design of the valve clip 102 and delivery device 110 can allow for assessment of the placement of the valve clip 102 before releasing the valve clip 102 from the delivery device 110. For example, after placement of the valve clip 102, a radiofluorescent dye can be injected into the patient's beating heart to visualize apposition. In some examples, the valve clip 102 can be repositioned by manipulating the control member 124 to move the delivery device 110 to return the valve clip 102 to the extended configuration, repositioning the valve clip 102, and manipulating the control member 124 to move the delivery device 110 to maneuver the valve clip 102 toward the collapsed configuration.

[0042] like Figure 2D As illustrated, once the valve clip 102 has substantially returned to the collapsed configuration, the clinician can control one or both of the control members 124 to control the corresponding delivery device(s) to release the valve clip 102. When engaged with the selected tissue, the valve clip 102 can be at least partially deformed such that the valve clip 102 applies a force to the tissue to engage the tissue. In some instances, the valve clip 102 can still be removable even after the valve clip 102 is released. For example, the clinician can control one or both of the control members 124 to engage the corresponding delivery device(s) 110 with the valve clip 102 to move the valve clip 102 toward the extended configuration to retrieve the valve clip 102. Retrieving the valve clip 102 can be beneficial, for example, when engagement becomes unsatisfactory over time or when a different means of treating valvular insufficiency or regurgitation is used at the valve.

[0043] As discussed above, the pre-formed shape of the valve clip may include a substantially planar helix (eg, planar within manufacturing tolerances), a non-planar helix, a helical wire, or other spring-like shapes. Figures 3A-3C Schematic diagram illustrating a plan view of example valve clips 302A, 302B, and 302C. Figure 3A As illustrated, valve clip 302A defines a helix extending from a proximal end 304A to a distal end 306A. Figure 3B As illustrated, valve clip 302B defines a double helix extending from a proximal portion 303B including a proximal end 304B to a distal portion 305B including a distal end 306B. In some examples, the double helix can improve the capstan effect by positioning the proximal portion 303B and the distal portion 305B on opposite sides of the valve when in the collapsed configuration. In general, the preformed shape can define any suitable shape. For example, Figure 3C As illustrated, valve clip 302C defines an elongated double helix.

[0044] The pre-formed shape of the valve clip may be planar or non-planar. Figure 4A and 4BSchematic diagram illustrating example valve clips 402A and 402B having non-planar side profiles. In some examples, the valve clips can be substantially planar within common manufacturing tolerances. Figure 4A As illustrated in the side view of FIG, the valve clip 402B defines a helix. Although illustrated as a single tapered helix, in some instances, the valve clip may include a double helix or a non-tapered helix. In some instances, the preformed shape of the valve clip may be selected to correspond to the shape of an anatomical surface. For example, Figure 4B As illustrated by the positive rise of the valve clip 402B, the preformed shape of the valve clip 402B may be selected to define a saddle shape, similar to the saddle shape of the native mitral valve.

[0045] As mentioned above about Figures 2A-2D As discussed, valve clip 102 may optionally include at least one anchor. Figure 5 Schematic diagram illustrating example anchors 504A, 504B, 504C, and 504D ("anchors 504") extending from an exterior surface 503 of a valve clip 502. Anchors 504 comprise structures configured to engage the valve clip 502 to tissue at a selected tissue site, such as leaflets LF, and to help substantially maintain the valve clip 502 in position relative to the selected tissue site. For example, anchors 504 are configured to at least one of: penetrate at least a portion of the tissue at the selected tissue site, increase the coefficient of friction at the selected tissue site (e.g., improve the capstan effect), and / or promote tissue ingrowth.

[0046] Anchor 504A includes a point 506A and a barb 508A. Point 506A is configured to penetrate tissue, such as the leaflet LF. After the tissue has penetrated to a selected depth, barb 508A is configured to engage the tissue to substantially hold the valve clip 502 in place. Anchor 504B includes a tine having a point 506B configured to penetrate tissue and a curved portion 510B configured to engage tissue to substantially hold the valve clip 502 in place. Anchor 504C includes a helical coil having a point 506C configured to penetrate tissue and a plurality of curved portions 510C configured to engage tissue to substantially hold the valve clip 502 in place. In some examples, the helical coil may include other helical shapes, such as a double helix or a tapered helix. Anchor 504D includes a hook having a point 506D configured to penetrate tissue and a plurality of curved portions 510C configured to engage tissue to substantially hold the valve clip 502 in place. In some examples, the anchor 504D can be formed by machining the exterior surface 503 of the valve clip 502. For example, the exterior surface 503 can be laser ablated to at least partially metallize a portion of the exterior surface 503, forming the recess 512D and the anchor 504D.

[0047] In some examples, the anchor may comprise fabric. Figure 6 Schematic diagram illustrating an example valve clip 602 including an anchor 604 and a fabric 606. Figure 6 In an example of , the anchor 604 may extend around the periphery of the valve clip 602 defined by the outer surface 603. For example, the first side 601A of the valve clip 602 may be positioned adjacent to (e.g., in contact with) tissue at a selected tissue site. The second side 601B of the valve clip 602 may be positioned opposite the tissue contacting side of the valve clip 602. In some examples, the fabric 606 may be positioned outside the anchor 604 before the valve clip 602 is deployed from a delivery catheter (e.g., catheter 104). During deployment, the anchor 604 may penetrate the fabric 606 and subsequently penetrate the tissue at the selected tissue site. For example, the force applied to the tissue by moving the valve clip 602 from an extended configuration to a contracted configuration may cause the anchor 602 to penetrate the fabric 606 and the tissue 602. As Figure 6 As illustrated, the anchors 604 on the first side 601A (e.g., the tissue-contacting side) may penetrate the fabric 606 and at least a portion of the tissue, such as the leaflet LF. The anchors 604 on the second side 601B (e.g., opposite the tissue-contacting side) may not penetrate the fabric 606. In this way, the fabric 606 can reduce interference between the anchors 604 and the sidewall of the delivery catheter and / or anatomical surfaces other than the selected tissue site during deployment.

[0048] Figure 7 Schematic diagram illustrating a portion of an example valve clip 702 engaged with tissue. The valve clip 702 includes a first portion 704 extending on the atrial side of the leaflet LF and a second portion 706 extending on the ventricular side of the leaflet LF. The valve clip 702 includes a plurality of anchors 708 extending from an outer surface of the valve clip 702. The valve clip 702 also includes a fabric 710 extending above the anchors 708. As described above with reference to Figure 6 As discussed, the anchor 708 can penetrate at least a portion of the fabric 710 and the leaflets LF along the tissue-contacting side of the valve clip 702. Furthermore, by alternating between the atrial side of the leaflets LF and the ventricular side of the leaflets LF, the first portion 704 and the second portion 706 can cause a capstan effect with frictional forces that, alone or in conjunction with the anchor 708 and the fabric 710, are sufficient to retain the valve clip 702 on the leaflets LF.

[0049] Figure 8 A flow chart illustrating an example technique for introducing a valve clip. Figures 2A-2D The valve clip 102 is described Figure 8 technology, but it should be understood Figure 8 The techniques described herein may be used to introduce the other valve clips described herein, and the valve clips described herein may be introduced using other techniques.

[0050] The distal portion 105 of the catheter 104 can be advanced through the patient's vasculature to a selected tissue site (802). For example, a clinician can percutaneously introduce the distal portion 105 of the catheter 104 into the patient's vasculature. For example, the distal portion 105 of the catheter 104 can be introduced into the femoral artery or the radial artery. The distal portion 105 of the catheter 104 can be advanced through the patient's vasculature to the selected tissue site by the clinician manipulating a handle 106 of the distal portion 105 of the catheter 104. In some examples, the distal portion 105 of the catheter 104 can include a steerable shaft or tip to allow the clinician to guide the distal portion 105 of the catheter 104 through bends, curves, and branch points of the vasculature.

[0051] In some examples, the selected tissue site may include the mitral valve MV, and the distal portion 105 of the catheter 104 may be advanced to the left atrium LA. In other examples, the selected tissue site may include another heart valve. In other examples, the selected tissue site may include other vascular valves or other anatomical tissues that can be engaged using the valve clip described herein. The distal portion 105 of the catheter 104 may enter the left atrium through the septum, through the aorta, or through the apex. In some examples, as the distal portion 105 of the catheter 104 is advanced to the selected tissue site, the distal portion 105 of the catheter 104 may be tracked over a guidewire, through a guide catheter, etc. The distal portion 105 of the catheter 104 may include one or more radioactive markers at or near the distal end of the distal portion 105 of the catheter 104 to assist in visualizing the distal portion 105 as the distal portion 105 of the catheter 104 is advanced to the selected tissue site.

[0052] Once the distal portion 105 of the catheter 104 (e.g., the distal opening 112) has been advanced to the selected tissue site, the delivery device 110 can be manipulated to move the valve clip 102 in the extended configuration distally to the distal opening 112 (804). For example, the clinician can control the delivery device 110 to move the valve clip 102 into the plane of the mitral valve MV.

[0053] After positioning the valve clip 102 in the extended configuration, the delivery device 110 can be manipulated to move the valve clip 102 from the extended configuration to the collapsed configuration to engage tissue at the selected tissue site (806). In some instances, the placement of the valve clip 102 while engaged with the tissue can be assessed. For example, a radiofluorescent dye can be injected into the left atrium LA and / or the left ventricle LV to assess coaptation of the mitral valve. After moving the valve clip 102 to the collapsed configuration, the delivery device 110 can be controlled to release the valve clip 102 (808).

[0054] The following clauses present examples of subject matter described herein.

[0055] Item 1. A medical system comprising: a valve clip comprising a deformable wire configured to engage a patient's valve leaflet, wherein the deformable wire extends from a first wire portion to a second wire portion; and a catheter configured to introduce the valve clip into a native heart valve adjacent to the patient's body, the catheter comprising: a handle comprising a plurality of control members; an elongated body defining a cavity, wherein the elongated body extends from a proximal end mechanically coupled to the handle to a distal portion comprising a distal opening; a first delivery device operably coupled to at least one of the plurality of control members and extending through the cavity to the distal opening, wherein the first delivery device is configured to releasably couple to the first wire portion and be movable relative to the distal opening of the elongated body; and a second delivery device operably coupled to at least one of the plurality of control members and extending through the cavity to the distal opening, wherein the second delivery device is configured to releasably couple to the second wire portion, wherein the first and second delivery devices are configured to move the valve clip between an extended configuration and a contracted configuration to engage the valve leaflet.

[0056] Item 2. A medical system according to Item 1, wherein the valve clip is configured to pass through the cavity and the distal opening of the slender body when in the extended configuration, and wherein the valve clip defines a pre-formed shape configured to engage the valve leaflet when in the contracted configuration.

[0057] Clause 3. A medical system according to clause 1 or 2, wherein the first wire portion is a distal portion of the deformable wire, wherein the second wire portion is a proximal portion of the deformable wire, wherein at least one of the proximal end or the distal end includes a fixed structure, and wherein at least one of the first or second delivery devices is configured to be releasably connected to the fixed structure.

[0058] Clause 4. The medical system of any one of Clauses 1 to 3, wherein the deformable wire comprises at least one of a biocompatible shape memory alloy or a nickel-titanium alloy.

[0059] Clause 5. The medical system of any one of Clauses 1 to 4, wherein the valve clip comprises at least one anchor extending from an exterior surface of the deformable wire and configured to engage the valve leaflet.

[0060] Clause 6. The medical system of Clause 5, wherein the at least one anchor comprises fabric, one or more barbs, one or more hooks, one or more helical coils, or one or more tapered helical coils.

[0061] Clause 7. The medical system of Clause 5 or 6, wherein the at least one anchor comprises at least one of a biocompatible shape memory alloy or a nickel-titanium alloy.

[0062] Clause 8. A medical system according to any one of clauses 1 to 7, wherein the valve clip comprises a plurality of barbs extending from the exterior of the deformable line and a fabric positioned above the plurality of barbs, wherein the barbs are configured to protrude at least partially through the fabric when the valve clip engages the valve leaflet.

[0063] Clause 9. The medical system of any one of Clauses 1 to 8, wherein the valve leaflets comprise leaflets of a mitral valve of the heart.

[0064] Item 10. A medical system comprising: a valve clip, the valve clip comprising: a deformable wire extending from a distal fixing structure to a proximal fixing structure, wherein the deformable wire is movable between an extended configuration and a preformed contracted configuration configured to engage a valve leaflet; a plurality of barbs extending from an outer surface of the wire; and a fabric positioned outside the plurality of barbs, wherein the plurality of barbs are configured to at least partially protrude through the fabric when the wire engages the valve leaflet; and a catheter configured to introduce the valve clip into a native heart valve adjacent to a patient's body, the catheter comprising: a handle comprising a plurality of control members; an elongated body defining a cavity, wherein the elongated body extends from a proximal end mechanically coupled to the handle to a distal opening; a first delivery device operably coupled to the at least one of the plurality of control members and extending through the lumen to the distal opening, wherein the first delivery device is configured to releasably couple to the distal fixation member of the deformable wire and be movable relative to the distal opening of the elongated body; and a second delivery device of the plurality of delivery devices, which is operably coupled to at least one of the plurality of control members and extending through the lumen to the distal opening, wherein the second delivery device is configured to releasably couple to the proximal fixation member of the deformable wire, wherein the first and second delivery devices are configured to pass the valve clip in the extended configuration through the distal opening of the elongated body and move the valve clip between the extended configuration and the retracted configuration to engage the valve leaflets.

[0065] Clause 11. The medical system of Clause 10, wherein the deformable wire comprises at least one of a biocompatible shape memory alloy or a nickel-titanium alloy.

[0066] Clause 12. The medical system of Clause 10 or 11, wherein the valve leaflets comprise leaflets of a mitral valve of the heart.

[0067] Clause 13. A method comprising: advancing a catheter through the vasculature of a patient to a selected tissue site in a blood vessel or heart, wherein the catheter comprises a cavity for accommodating a valve clip, the valve clip comprising a deformable wire configured to engage a valve leaflet of the patient, wherein the deformable wire extends from a first wire portion to a second wire portion, and wherein the catheter further comprises: a handle comprising a plurality of control members; an elongated body defining the cavity, wherein the elongated body extends from a proximal end mechanically coupled to the handle to a distal portion comprising a distal opening; and a first delivery device operably coupled to at least one of the plurality of control members and extending through the cavity. the lumen to the distal opening, wherein the first delivery device is configured to releasably couple to the first wire portion and be movable relative to the distal opening of the elongated body; and a second delivery device of the plurality of delivery devices, which is operably coupled to at least one control member of the plurality of control members and extends through the lumen to the distal opening, wherein the second delivery device is configured to releasably couple to the second wire portion; advancing the first delivery device distally to the distal opening of the elongated body; and controlling the first and second delivery devices to move the valve clip from an extended configuration to a retracted configuration to engage the valve leaflets.

[0068] Clause 14. A method according to clause 13, wherein the valve clip is configured to pass through the cavity and the distal opening of the slender body when in the extended configuration, and wherein the valve clip defines a pre-formed shape configured to engage the valve leaflet when in the contracted configuration.

[0069] Clause 15. A method according to clause 13 or 14, wherein the first wire portion is a distal portion of the deformable wire, wherein the second wire portion is a proximal portion of the deformable wire, and wherein at least one of the proximal end or the distal end includes a fixed structure, the method further comprising connecting at least one of the first or second delivery devices to the fixed structure.

[0070] Clause 16. The method of any one of Clauses 13 to 15, wherein the deformable wire comprises at least one of a biocompatible shape memory alloy or a nickel-titanium alloy.

[0071] Clause 17. A method according to any one of clauses 13 to 16, wherein the valve clip comprises at least one anchor extending from an outer surface of the deformable wire, and wherein moving the valve clip from an extended configuration to a contracted configuration comprises engaging the at least one anchor with the valve leaflet.

[0072] Clause 18. The method of Clause 17, wherein the at least one anchor comprises fabric, one or more barbs, one or more hooks, one or more helical coils, or one or more tapered helical coils.

[0073] Clause 19. A method according to any one of clauses 13 to 18, wherein the valve clip comprises a plurality of barbs extending from the exterior of the deformable wire and a fabric positioned above the plurality of barbs, wherein the barbs are configured to protrude at least partially through the fabric when the valve clip engages the valve leaflet.

[0074] Clause 20. A method according to any one of clauses 13 to 19, wherein the valve leaflet comprises a leaflet of a mitral valve of a heart, and wherein advancing the catheter through the patient's vasculature to a selected tissue site in a blood vessel or heart comprises: advancing the catheter through the patient's vasculature to the patient's right atrium; and advancing the catheter through the septum of the heart to the left atrium.

[0075] Various examples have been described. Any combination of the described systems, devices, operations, or functions is contemplated. These and other examples are within the scope of the following claims.

Claims

1. A medical system comprising: a valve clip comprising a deformable wire configured to engage a valve leaflet of a patient, wherein the deformable wire extends from a first wire portion to a second wire portion; and a catheter configured to introduce the valve clip adjacent to a native heart valve in a patient, the catheter comprising: a handle comprising a plurality of control members; an elongated body defining a lumen, wherein the elongated body extends from a proximal end mechanically coupled to the handle to a distal end containing a distal opening; a first delivery device operably coupled to at least one of the plurality of control members and extending through the lumen to the distal opening, wherein the first delivery device is configured to releasably couple to the first wire portion and be movable relative to the distal opening of the elongated body; and a second delivery device operably coupled to at least one of the plurality of control members and extending through the lumen to the distal opening, wherein the second delivery device is configured to releasably couple to the second wire portion, Wherein the first and second delivery devices are configured to move the valve clip between an extended configuration and a contracted configuration to engage the valve leaflets.

2. A medical system according to claim 1, wherein the valve clip is configured to pass through the cavity and the distal opening of the slender body when in the extended configuration, and wherein the valve clip defines a pre-formed shape configured to engage the valve leaflet when in the contracted configuration.

3. The medical system of claim 1 , wherein the first wire portion is a distal portion of the deformable wire, wherein the second wire portion is a proximal portion of the deformable wire, wherein at least one of the proximal end or the distal end of the elongated body comprises a fixation structure, and wherein at least one of the first or second delivery devices is configured to releasably couple to the fixation structure.

4. The medical system of claim 1, wherein the deformable wire comprises a biocompatible shape memory alloy.

5. The medical system of claim 1, wherein the deformable wire comprises a nickel-titanium alloy.

6. The medical system of claim 1, wherein the valve clip comprises at least one anchor extending from an exterior surface of the deformable wire and configured to engage the valve leaflet.

7. The medical system of claim 6, wherein the at least one anchor comprises fabric, one or more hooks, or one or more helical coils.

8. The medical system of claim 6, wherein the at least one anchor comprises one or more barbs or one or more tapered helical coils.

9. The medical system of claim 7 or 8, wherein the at least one anchor comprises a biocompatible shape memory alloy.

10. The medical system of claim 7 or 8, wherein the at least one anchor comprises a nickel-titanium alloy.

11. A medical system according to claim 1, wherein the valve clip includes a plurality of barbs extending from the exterior of the deformable wire and a fabric positioned above the plurality of barbs, wherein the barbs are configured to protrude at least partially through the fabric when the valve clip engages the valve leaflet.

12. The medical system of claim 1, wherein the valve leaflets comprise leaflets of a mitral valve of the heart.

13. A medical system comprising: A valve clip comprising: a deformable wire extending from the distal fixation structure to the proximal fixation structure, wherein the deformable wire is movable between an extended configuration and a preformed contracted configuration configured to engage the valve leaflets; a plurality of barbs extending from an exterior surface of the wire; and a fabric positioned exteriorly of the plurality of barbs, wherein the plurality of barbs are configured to at least partially protrude through the fabric when the wire engages the valve leaflet; and a catheter configured to introduce the valve clip adjacent to a native heart valve in a patient, the catheter comprising: a handle comprising a plurality of control members; an elongated body defining a lumen, wherein the elongated body extends from a proximal end mechanically coupled to the handle to a distal opening; a first delivery device operably coupled to at least one of the plurality of control members and extending through the lumen to the distal opening, wherein the first delivery device is configured to releasably couple to the distal fixation structure of the deformable wire and be movable relative to the distal opening of the elongated body; and a second delivery device of the plurality of delivery devices operably coupled to at least one control member of the plurality of control members and extending through the lumen to the distal opening, wherein the second delivery device is configured to releasably couple to the proximal fixation structure of the deformable wire, The first and second delivery devices are configured to pass the valve clip in the extended configuration through the distal opening of the elongated body and move the valve clip between the extended configuration and the collapsed configuration to engage the valve leaflets.

14. The medical system of claim 13, wherein the deformable wire comprises a biocompatible shape memory alloy.

15. The medical system of claim 13, wherein the deformable wire comprises a nickel-titanium alloy.

16. The medical system of claim 13, wherein the leaflets comprise leaflets of a mitral valve of the heart.

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