Devices, systems, and methods for clamping leaflets of a heart valve

Abstract

The present disclosure relates generally to the field of medical devices for grasping leaflets of a heart valve. In particular, the present disclosure relates to medical devices, systems, and methods for delivering artificial chordae in a patient. In one embodiment, a system can include a clip having a plurality of arms at a first end. The plurality of arms can have a closed configuration in which the arms are oriented toward one another and an open configuration in which the arms are oriented away from one another. A spring portion can be coupled to the plurality of arms at a second end configured to bias the arms to the closed configuration. The arms of the clip can be configured to fixedly engage a leaflet of the heart valve. The second end of the clip can be configured to be coupled to an artificial chordae.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application 62 / 873,354, filed July 12, 2019, which is incorporated by reference herein in its entirety for all purposes. TECHNICAL FIELD

[0003] The present disclosure relates generally to the field of medical devices for clamping leaflets of a heart valve. In particular, the present disclosure relates to medical devices, systems, and methods for delivering artificial chordae to a patient. BACKGROUND

[0004] Mitral valve disease is often repaired through invasive surgical intervention or by complexly pinching the leaflets together to form a bilaterally smaller opening, or by replacing the native valve. These approaches involve a risky bypass surgery that can include openings into the patient’s chest and heart chambers to expose the mitral valve for direct observation and repair. Resection, partial removal, and / or repair of the patient’s leaflets and implantation of a surgical ring are complex techniques used by surgeons to reduce the diameter of the patient’s mitral annulus, allowing the leaflets to coapt properly and reducing mitral regurgitation flow. Some techniques can slightly reduce regurgitation flow, but can not provide a lasting solution and do not repair and / or replace the damaged chordae of the valve. Thus, there is a need for a transluminal solution for mitral valve disease.

[0005] A variety of advantageous medical outcomes can be achieved by the medical devices, systems, and methods of the present disclosure, including clamping of leaflets of a heart valve. SUMMARY

[0006] Embodiments of the present disclosure can generally assist in clamping a heart valve and provide a connection point for a filament. In one aspect, a system for clamping leaflets of a heart valve can include a clip. The clip can include a plurality of arms at a first end. The plurality of arms can have a closed configuration in which the arms are oriented toward one another and an open configuration in which the arms are oriented away from one another with an open distance between the arms that is greater than a closed distance between the arms of the closed configuration. The closed distance can be zero millimeters. A spring portion can be coupled to the plurality of arms at a second end. The spring portion can be configured to bias the arms to the closed configuration. The arms of the clip can be configured to fixedly engage a leaflet of a heart valve. The second end of the clip can be configured to be coupled to an artificial chordae.

[0007] In various embodiments described herein or otherwise, a dilator can be configured to transition a clip between a closed configuration and an open configuration. The dilator can include a base. A pin can extend from the base. A lever can be rotatably disposed about the pin. A first channel can extend through the base substantially parallel to a first aperture of one of the plurality of arms and can be configured to receive one of the plurality of arms. A second channel can extend through the lever substantially parallel to a second aperture of one of the plurality of arms and can be configured to receive one of the plurality of arms. A first filament can extend from the lever. The filament can be configured to move the lever and the clip between the closed configuration and the open configuration. A catheter can have a distal end of the catheter coupled to the base. A first pin can be disposed within the first aperture and the first channel. A second pin can be disposed within the second aperture and the second channel. A second filament can couple the first pin to the second pin. One or more protrusions can be disposed on one or more of the plurality of arms. The one or more protrusions can be selected from the group consisting of barbs, spikes, hooks, and tines. The one or more protrusions can be a plurality of protrusions arranged in columns that extend along at least one of the plurality of arms such that the plurality of protrusions are in different planes. The protrusions can extend through no more than 50% of a wall thickness of the leaflet, for example, the protrusions can not extend into the wall of the leaflet and can instead distort the tissue. The protrusions can extend a distance from the arm that can be about 0.5 mm to about 1.5 mm. The clip can have a weight of less than 0.08 grams.

[0008] In one aspect, a clip for clamping a leaflet of a heart valve can include a body. The body can include a plurality of arms at a first end. The plurality of arms can have a closed configuration in which the arms are oriented toward each other and an open configuration in which the arms are oriented away from each other. The arms of the clip can be configured to fixedly engage a leaflet of a heart valve. A second end of the clip can be configured to be coupled to a prosthetic chordae.

[0009] In various embodiments described herein or otherwise, the body can include a coil spring portion at the second end portion. The spring portion can be configured to bias the arms to the closed conformation. The longitudinal axis can extend through the first end portion and the second end portion. The clip can include a first cap disposed adjacent to a first arm of the plurality of arms and extending along the first arm to the longitudinal axis. A second cap can be disposed adjacent to a second arm of the plurality of arms and extending along the second arm to the longitudinal axis. A pin can extend through the first cap, the second cap, and the coil spring portion. A first channel can be disposed on the first cap having a central axis that is generally parallel to the first arm. A second channel can be disposed on the second cap having a central axis that is generally parallel to the second arm. The first channel and the second channel can be configured to generally align with the second aperture and the third aperture of the dilator. A first pin can extend into the first channel and the second aperture. A second pin can extend through the second channel and the third aperture. A filament couples the first pin to the second pin. A tab can be configured to transition the arms between the open conformation and the closed conformation. The open conformation and the closed conformation can each be a stable conformation.

[0010] In one aspect, a method of clamping a leaflet of a heart valve can include inserting a catheter through the valve. The catheter can include a dilator disposed on a distal end of the catheter and reversibly coupled to a clip. The clip and the dilator can be positioned proximate the leaflet. Tension on a first filament extending through the catheter can be released and connected to the dilator such that the clip transitions about the leaflet to a closed conformation. A plurality of pins can be removed from the dilator and the clip such that the dilator releases the clip. Tension can be applied to the first filament such that the dilator transitions the clip from the closed conformation to an open conformation. The clip can be repositioned about the leaflet. Tension can be released on the first filament extending through the catheter such that the clip transitions about the leaflet to the closed conformation. Artificial chordae attached to the clip can be anchored to a papillary muscle. The leaflet can be a flail leaflet. BRIEF DESCRIPTION OF DRAWINGS

[0011] The non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures is typically represented by a single numeral. For the purposes of clarity, not every component is called out in every drawing where it appears. In the figures:

[0012] Figure 1 A cross-sectional view of a flail leaflet of a mitral valve during blood flow regurgitation is shown;

[0013] Figure 2A A perspective view of a clip in a closed conformation is shown according to one embodiment of the present disclosure;

[0014] Figure 2Bis shown Figure 2A Another perspective view of the clamp in FIG. 1 1 ;

[0015] Figure 2C is shown Figure 2A and Figure 2B A side view of the clamp in FIG. 1 1 ;

[0016] Figure 2D is shown Figures 2A-2C A perspective view of the clamp in FIG. 1 1 ;

[0017] Figure 2E is shown Figures 2A-2D A side view of the clamp in FIG. 1 1 ;

[0018] Figure 3A is shown A perspective view of the clamp in FIG. 1 1 ;

[0019] Figure 3B is shown Figure 3A A side view of the clamp in FIG. 1 1 ;

[0020] Figure 4A is shown A perspective view of the clamp in FIG. 1 1 ;

[0021] Figure 4B is shown Figure 4A A side view of the clamp in FIG. 1 1 ;

[0022] Figure 5A is shown A perspective view of the clamp in FIG. 1 1 ;

[0023] Figure 5B is shown Figure 5A A side view of the clamp in FIG. 1 1 ;

[0024] Figure 6A is shown A perspective view of the clamp in FIG. 1 1 ;

[0025] Figure 6B is shown Figure 6A A side view of the clamp in FIG. 1 1 ;

[0026] Figure 7A is shown A perspective view of the clamp in FIG. 1 1 ;

[0027] Figure 7B is shown Figure 7A A front view of the clamp in FIG. 1 1 ;

[0028] Figure 8A is shown A perspective view of the clamp in FIG. 1 1 ;

[0029] Figure 8B is shown Figure 8A A front view of the clamp in FIG. 1 1 ;

[0030] Figure 9A A perspective view of a clip is shown, in accordance with one embodiment of the present disclosure;

[0031] Figure 9B A perspective view of a clip is shown, in accordance with one embodiment of the present disclosure; Figure 9A A front view of a clip is shown, in accordance with one embodiment of the present disclosure;

[0032] Figure 10A A perspective view of a clip is shown, in accordance with one embodiment of the present disclosure;

[0033] Figure 10B A perspective view of a clip is shown, in accordance with one embodiment of the present disclosure; Figure 10A A side view of a clip is shown, in accordance with one embodiment of the present disclosure;

[0034] Figure 11A A perspective view of a clip is shown, in accordance with one embodiment of the present disclosure;

[0035] Figure 11B A perspective view of a clip is shown, in accordance with one embodiment of the present disclosure; Figure 11A A top view of a clip is shown, in accordance with one embodiment of the present disclosure;

[0036] Figure 11C A bottom view of a clip is shown, in accordance with one embodiment of the present disclosure; Figure 11A A bottom view of a clip is shown, in accordance with one embodiment of the present disclosure; Figure 11B A bottom view of a clip is shown, in accordance with one embodiment of the present disclosure;

[0037] Figure 12A A side view of a clip in a closed configuration is shown, in accordance with one embodiment of the present disclosure;

[0038] Figure 12B A clip in an open configuration is shown, in accordance with one embodiment of the present disclosure; Figure 12A

[0039] Figure 13A A perspective view of a system for clipping a leaflet of a heart valve in a closed configuration is shown, in accordance with one embodiment of the present disclosure;

[0040] Figure 13B A side view of a system is shown, in accordance with one embodiment of the present disclosure; Figure 13A

[0041] A system is shown, in an open configuration, disposed on a catheter, in accordance with one embodiment of the present disclosure; Figure 13C Figure 13A Figure 13B A system is shown, in an open configuration, disposed on a catheter, in accordance with one embodiment of the present disclosure;

[0042] Figure 14A A cross-sectional view of a clip for clipping a leaflet of a heart valve is shown, in accordance with one embodiment of the present disclosure;

[0043] Figure 14B A cross-sectional view of a clip for clipping a leaflet of a heart valve is shown, in accordance with one embodiment of the present disclosure; Figure 14A

[0044] A cross-sectional view of a clip for clipping a leaflet of a heart valve is shown, in accordance with one embodiment of the present disclosure; Figure 14C Figure 14A ​​​​another cross-sectional view of the clip and alternative orientation of the leaflet;

[0045] Figure 15 a cross-sectional view of a system for clipping a leaflet is shown in accordance with one embodiment of the present disclosure;

[0046] Figure 16 a clip with an alternative tab is shown in accordance with one embodiment of the present disclosure Figures 2A-2E a perspective view of a clip in the middle. DETAILED DESCRIPTION

[0047] The present disclosure is not limited to the particular embodiments described. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0048] While embodiments of the present disclosure can be described with particular reference to medical devices and systems for selective access to heart valves (e.g., transluminal devices inserted through the femoral vein, etc.), it should be understood that such medical devices and systems can be used for a variety of medical procedures that require clipping of a leaflet of a valve or clipping of a tissue wall. The disclosed medical devices and systems can also be inserted via different access points and modalities (e.g., percutaneously, endoscopically, laparoscopically, or combinations thereof).

[0049] As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises", "comprising", "includes", "including" and / or "has", "having" when used herein, specify the presence of stated features, regions, steps, elements and / or components but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and / or groups thereof.

[0050] As used herein, "proximal end" refers to the end of a device that is closest to a medical professional when the device is introduced into a patient, while "distal end" refers to the end of a device or object that is farthest from the medical professional during implantation, positioning, or delivery.

[0051] As used herein, the conjunction "and" includes each of the conjunctive structures, components, features, etc., unless the context clearly indicates otherwise; while the conjunction "or" includes one or the other (singularly and in any combination and number) of the conjunctive structures, components, features, etc., unless the context clearly indicates otherwise.

[0052] All numerical values are assumed to be modified by the term "about" whether explicitly indicated or not. In the context of a numerical value, the term "about" is generally the range of values that a person of skill in the art would consider equivalent to the stated value (i.e., having the same function or result). In many instances, the term "about" can include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (i.e., in contexts other than numerical values) can be assumed to have its ordinary and customary definition, which is understood by those of ordinary skill in the art and in light of the specification disclosure, unless otherwise indicated. A range of values expressed in a hyphenated format includes all the individual intermediate values, including the endpoints (e.g., 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0053] It should be noted that the description of the "one embodiment", "some embodiments", "other embodiments", etc. has been presented for the purpose of providing additional context for various embodiments. Thus, it should be understood that person of ordinary skill in the art will be able to practice an embodiment or embodiments of the application without one or more of the specific details from a given figure or embodiment. Additionally, it should be noted that language of "one embodiment", "some embodiments", "other embodiments", etc. does not require that all embodiments include the specific feature, structure, or characteristic that is being described in connection with that specific use of the language. Terms describing related or similar elements do not preclude the presence or addition of other related or similar elements. Additionally, the terms "first", "second", etc. are used herein only to describe one element from another, irrespective of position or other relation as can be used in other contexts. Thus, these terms are used broadly, and are not necessarily used in reference to a specific position or other relation.

[0054] Heart disease, including atrioventricular heart valve dysfunction, impedes patient cardiac output, which reduces patient quality of life and life span. Referring to Figure 1 As the heart disease progresses, the chordae tendinae 155 that connect the papillary muscles 152 to the valve leaflets 151 can stretch inelastically and can rupture, as shown for the heart 154. The stretched and / or ruptured chordae tendinae 156 can cause the flail leaflet 150 can no longer have the ability to form a valve seal for normal heart function. For example, abnormal blood flow regurgitation in the direction of vector 158 can occur. The regurgitation impedes the delivery of sufficient blood supply through the cardiovascular system.

[0055] The repositioning, repair, and / or replacement of one or more leaflets and / or chordae tendineae of a valve can be desirable for treating heart disease. The devices, systems, and methods of the present disclosure can be used alone, or with other devices, systems, and methods, to treat heart disease. Examples of devices, systems, and methods that can be implemented with embodiments of the present disclosure include, but are not limited to, those described in U.S. Patent Application No. __________ [Attorney Docket No. 8150.0591], entitled "Devices, Systems, and Methods for Adjustably Tensioning an Artificial Chordae Tendineae Between a Leaflet and a Papillary Muscle or Heart Wall"; U.S. Patent Application No. __________ [Attorney Docket No. 8150.0594], entitled "Devices, Systems, and Methods for Artificial Chordae Tendineae"; and U.S. Patent Application No. __________ [Attorney Docket No. 8150.0593], entitled "Devices, Systems, and Methods for Anchoring an Artificial Chordae Tendineae to a Papillary Muscle or Heart Wall"; each of which was filed on the same date as the present document and each of which is incorporated by reference herein in its entirety and for all purposes. Examples of the devices described therein can be modified to incorporate embodiments of the present disclosure or one or more features.

[0056] The repositioning, repair, and / or replacement of one or more leaflets and / or chordae tendineae of a valve can include one or more devices to be secured to one or more leaflets of the valve. Embodiments of the devices described herein can be secured to a valve by clipping to a leaflet. These devices can provide a secure point for other devices, systems, or tools to grasp or attach to in order to manipulate a leaflet of a valve and / or to deliver a device attached to the leaflet.

[0057] Referring to Figures 2A-2E FIG. 1 shows one embodiment of a clip 200 for clipping to a leaflet of a heart valve according to the present disclosure, the clip 200 including two arms 202 at a first end 200p of the clip 200. The arms 202 are in a first position, and the clip 200 is in a first position. Figures 2A-2CThe clamp 200 is in a closed configuration in which the arms 202 are oriented toward each other. A spring portion 204 may be located at a second end 200d of the clamp 200. The spring portion 204 may be configured to bias the arms 202 into the closed configuration. The spring portion 204 at the second end 200d is wider than the clamp 200 at the position of the arms 202 to reduce stress on the clamp 200 while transitioning between the closed and open configurations. Each arm 202 has a hole 208 at the end of each arm 202. Each hole 208 has a central axis 208a that extends generally along each arm 202 and is configured to receive a locking pin for manipulating the clamp 200 between the closed and open configurations (as described below). Figures 13A-15 (The discussion will proceed as follows). Each arm 202 includes a protrusion 206 extending along each arm 202, the protrusion 206 configured to embed in tissue. Each protrusion has a smooth surface 206p facing a first end 200p of the clamp 200, the smooth surface 206p configured to receive tissue that moves between the arms 202 from the first end 200p toward a second end 200d. Each protrusion 206 also includes an engaging end 206d facing the second end 200d, the engaging end 206d configured to embed in tissue between the arms 202. Because the engaging end 206d of each protrusion 206 may be angled toward the second end 200d of the clamp 200, the protrusion 206 can prevent movement of tissue relative to the clamp 200 between the arms 202 by embedding the engaging end 206d into the tissue and / or providing frictional force to the tissue. Figure 2D and Figure 2EThe clip 200 is shown in an open configuration in which the arms 202 are oriented away from one another. The open configuration can more easily receive tissue (e.g., leaflets) and can more easily be repositioned to clamp the tissue as compared to the closed configuration. The open configuration has the arms 202 spaced apart from one another by an arc length a, which can be various degrees, e.g., about 50°, about 60°, about 90°, etc. The arc length a can be sufficient to allow the clip 200 to surround at least a portion of valve tissue. The first thickness 210p of the first end 200p of the clip can be substantially equivalent to the second thickness 210d of the second end 200d. Alternatively, the first thickness 210p can be different than the second thickness 210d, and this thickness difference can gradually change from the first thickness 210p to the second thickness 210d. For example, the first thickness 210p can be thinner than the second thickness 210d, or vice versa. For example, one or more thicknesses 210p, 210d of the clip can be about 0.1 mm to about 3.0 mm, such as a first thickness 210p of about 0.7 mm, and a second thickness 210d of about 0.1 mm to about 3.0 mm. The width 212 of the clip can be substantially uniform, or can vary along the clip, and can be, for example, about 2 mm to about 20 mm. The length 214 of the clip can be, for example, about 5 mm to about 20 mm. The height 216 of the clip can be, for example, about 0.7 mm to about 10 mm.

[0058] In various embodiments of the present disclosure, one or more arms of a clip can have locking features for use with a device that can transition the clip between a closed configuration and an open configuration. The locking features can include holes, channel edges, tabs, etc. These locking features can be engaged by an additional device, such as a locking pin, channel, clip, etc. The additional device can engage the locking features to transition the clip between the closed configuration and the open configuration, and the additional device can disengage the locking features to deliver the clip from one or more devices into a patient.

[0059] Reference is made to Figure 3A and Figure 3BFIG. 1 shows one embodiment of a clip for clamping a leaflet of a heart valve according to the present disclosure, including two arms 301, 302 at a first end 300p of the clip. The arms 301, 302 are transformable between a closed configuration in which the arms 301, 302 are oriented toward one another, and an open configuration in which the arms 302 are oriented away from one another at a distance between the arms 301, 302 that is greater than the distance between the arms 301, 302 in the closed configuration. A spring portion 304 at a second end 300d of the clip is configured to bias the arms 301, 302 to the closed configuration. One arm 301 includes protrusions 306 extending along the arm 302, the protrusions 306 configured to embed into tissue. Each of the protrusions 306 can be angled toward the second end 300d of the clip 300 to resist movement of tissue relative to the clip between the arms 301, 302 by embedding the protrusions 306 into tissue and / or providing a frictional force to the tissue. One of the arms 302 includes a slot 307 extending along a portion of the length of the arm 302, the slot 307 can assist the protrusions 306 in embedding into tissue by providing a window defined by the strut of the arm 302 around the protrusions 306, and / or can reduce the weight of the clip 300 by reducing the amount of material used as compared to a clip without the slot 307. In Figure 4A and Figure 4B the protrusions 306 on the arm 301 are angled perpendicular to the arm 301. In Figures 5A-6B the protrusions 306 on one arm 302 extend along the longitudinal axis of the arm 302, while the protrusions 305 on the opposing arm 301 extend in two spaced-apart rows adjacent to the longitudinal axis of the opposing arm 301. The protrusions 305 can be oriented opposite the direction in which the clip can slide (e.g., oriented toward the end of the leaflet). In some embodiments, the protrusions 305 can each be in a different plane from one another to reduce tearing propagation from adjacent protrusions 305. In some embodiments, the protrusions can be barbs, spikes, hooks, tines, etc.

[0060] In various embodiments, the clip can be manufactured from a material sufficient to provide sufficient clamping force to secure the clip to the leaflet and sufficient to provide a generally anchoring body to the attached filament, such as an artificial chordae. In one aspect, the clip can be manufactured to provide sufficient force to allow the clip to be fixedly attached to the valve tissue without exerting undue weight that can compromise the valve repair work. As such, the clip has a mass that is not significantly greater than necessary, such that the weight of the clip does not adversely affect the leaflet or nearby tissue. For example, the weight of the clip can be less than about 0.10 grams, less than about 0.08 grams, etc., for example such that the weight of the clip does not cause undesirable interference with the operation of the leaflet. The clip can include various materials, such as, for example, nitinol, polymer, rubber, nylon, stainless steel, nickel titanium, platinum, combinations thereof, etc.

[0061] Referring to Figure 7A and Figure 7B , one embodiment of a clip for clipping a leaflet of a heart valve according to the present disclosure is shown, the clip including a first arm 701 and a second arm 702 at a first end 700p of the clip. The first arm 701 and the second arm 702 are transitionable between a closed configuration in which the first arm 701 and the second arm 702 are oriented toward one another and / or are generally aligned in the same plane, and an open configuration in which the first arm 701 and the second arm 702 are oriented away from one another in different relative planes. In the closed configuration, the second arm 702 extends within the first arm 701. A spring portion 704 is at a second end 700d of the clip, with each of the first arm 701 and the second arm 702 connected to one another as part of the same wire filament that makes up the clip. The spring portion 704 can be a coil spring and is configured to bias the first arm 701 and the second arm 702 to the closed configuration. The single wire filament makes up the clip and extends from the first arm 701 to the spring portion 704 and the second arm 702 without the wire filament terminating at an end, such that there is no sharp portion of the clip. Figure 8A and Figure 8B first and second arms 801, 802 are shown having a thinner width profile than the first and second arms 701, 702 of the clip in Figure 7A and Figure 7B . Figure 9A and Figure 9B first and second arms 910, 902 are shown having a wire filament that makes up the clip that terminates at two ends, the two ends making up an end 902p of the second arm 902. Figure 10A and Figure 10B a clip is shown having a first arm 1001 and a second arm 1002 at a first end 1000p of the clip. The single wire filament that makes up the clip terminates at an end 1002p of the second arm 1002. The clip includes a spring portion 1004 at a second end 1000d of the clip, the spring portion 1004 configured to bias the arms 1001, 1002 to a closed configuration.

[0062] Referring to Figures 11A-11C , one embodiment of a clip for clipping a leaflet of a heart valve according to the present disclosure is shown, the clip including a body 1101 having two arms 1102, 1103 at a first end 1101p of the body 1101. The arms 1102, 1103 have a closed configuration in which the arms 1102, 1103 are oriented toward one another (as shown in Figures 11A-11CThe arms 1102, 1103 can be oriented away from each other in the open configuration. The coil spring portion 1104 can be at the second end 1101d of the body 1101. The coil spring portion 1104 is configured to bias the arms 1102, 1103 to the closed configuration. A longitudinal axis I can extend through the first end 1101p and the second end 1101d. A first cap 1110 can be disposed adjacent to the arm 1102 and can extend along the arm 1102 to the longitudinal axis I. A second cap 1112 can be disposed adjacent to the opposite arm 1102 and can extend along the arm 1102 to the longitudinal axis I. The first cap 1110 and the second cap 1112 include a projection 1106 that extends along the first cap 1110 and the second cap 1112 and is configured to embed in tissue. A pin 1114 can extend through the first cap 1110, the second cap 1112, the coil spring portion 1104, and the longitudinal axis I. A first channel 1108 can be disposed on the first cap 1110 along which it extends and have a central axis that can be generally parallel to the arm 1102. A second channel 1109 can be disposed on the second cap 1112 along which it extends and have a central axis that can be generally parallel to the opposite arm 1103. The first channel 1108 and the second channel 1109 accommodate the arms 1102, 1103 and each of the first channel 1108 and the second channel 1109 has a portion that extends away from each of the arms 1102, 1103 that is free of the arms 1102, 1103 that can accommodate a pin (e.g., a locking pin of a dilator, as described below). The first cap 1110 and the second cap 1112 are rotatable about the pin 1114 to move with the opening and closing of the arms 1102, 1103. The caps include a gap space 1115 adjacent to the pin 1114 to allow such rotation without interference of the first cap 1110 and the second cap 1112 with each other.

[0063] Reference Figure 12A and Figure 12B, shows one embodiment of a clip for clipping a leaflet of a heart valve according to the present disclosure, the clip including a frame body 1201 having two arms 1202 pivotably connected via a tab 1205. A first pin 1213 extends through both arms 1202 and the tab 1205 of the frame body 1201 such that the arms 1202 are rotatable about the first pin 1213. A first cap 1210 can be disposed adjacent to the arms 1202 and extend along the arms 1202 to a longitudinal axis / . A second cap 1212 can be disposed adjacent to the opposing arms 1202 and extend along the arms 1202 to the longitudinal axis / . The first cap 1210 and the second cap 1212 include protrusions 1206 that extend along the first cap 1210 and the second cap 1212 and are configured to embed into tissue. A second pin 1214 can extend through the first cap 1210, the second cap 1212, and the longitudinal axis / . The arms 1202 have a stable closed configuration (as shown in Figure 12A ) and a stable open configuration (as shown in Figure 12B ), in which the arms 1202 are configured for engagement to tissue in the stable closed configuration and in which the arms 1202 are spaced apart from each other in the stable open configuration. The open configuration can separate the arms 1202 from each other by a given degree a, for example, about 50°, about 60°, about 90°, etc. The clip transitions between the closed configuration and the open configuration by translating the tab 1205 along the longitudinal axis e such that the arms 1202 of the frame body 1201 move away from and toward each other with the first cap 1210 and the second cap 1212. The transition occurs as the tab 1205 moves along the longitudinal axis / , the arms 1202 rotate about the first pin 1213, and the first cap 1210 and the second cap 1212 rotate about the second pin 1214. The tab 1205 can be manipulated through a tab aperture 1205a (e.g., via a filament, wire, tether, push member, catheter, Bowden cable, etc.). The tab 1205 can travel a distance to transition the arms 1202 between the open configuration and the closed configuration, which can be, for example, about 0.02 inches (about 0.51 millimeters), etc. The first cap 1210 and the second cap 1212 include a gap space 1215 adjacent to the second pin 1214 to allow rotation without interference of the first cap 1210 and the second cap 1212 from each other.

[0064] Referring to Figures 13A-13C , shows an embodiment system for clipping a leaflet of a heart valve according to the present disclosure, the system including a clip 1300 having arms 1302 at a first end, the arms 1302 having a closed configuration and an open configuration as described throughout the present disclosure. The clip 1300 is in the closed configuration of Figure 13A and Figure 13B , and the clip 1300 is in the open configuration of Figure 13Copen configuration. The clip 1300 has a spring portion 1304 at the second end that biases the arms 1302 to the closed configuration. A spreader 1320 is releasably coupled to the clip 1300. The spreader 1320 can transition the clip 1300 between the closed configuration and the open configuration. The spreader 1320 includes a base 1322 and a first pin 1324 extending from the base 1322. A lever 1326 is rotatably disposed about the first pin 1324. The base 1322 includes a first channel 1341 and the lever 1326 includes a second channel 1342, each configured to receive an arm 1302 of the clip 1300. The end of each arm 1302 includes a hole 1308. Each hole 1308 has a central axis extending generally along each of the arms 1302 and is configured to receive one of two locking pins 1310. One locking pin 1310 extends through the first channel 1341 and into the hole 1308 of one arm 1302, while the other locking pin 1310 extends through the second channel 1342 and into the hole 1308 of the opposite arm 1302. The locking pins 1310 secure the arms 1302 to the base 1322 and the lever 1326 so that the spreader 1320 can manipulate the arms 1302 between the open and closed configurations and so that the clip 1300 cannot be released from the spreader 1320. Because the arms 1302 are locked within the first and second channels 1341, 1342, the arms 1302 can be transitioned between the closed and open configurations with movement of the lever 1326. The lever 1326 can be moved about the first pin 1324 via translation of a first filament 1330 that can be coupled to a slot 1332 of the lever 1326. As the lever 1326 rotates about the first pin 1324, it also moves the arm 1302 that is within the second channel 1342, while the opposite arm 1302 is secured within the first channel 1341 of the base 1322. In some embodiments, the locking pins 1310 can extend through third and fourth holes in each of the base 1322 and the lever 1326, rather than through the first and second channels 1341, 1342, while still extending into the holes 1308. A second filament 1312 can be coupled to the locking pins 1310 at each end, so that the second filament 1312 can be grasped and pulled so that the locking pins 1310 are removed from the holes 1308 and the first and second channels 1341, 1342, releasing the arms 1302 from the base 1322 and the lever 1326. Figure 13CA base 1322 of a dilator 1320 is shown coupled to a distal end of a catheter 1334. A first filament 1330 extends proximally into the catheter 1334 for manipulation by a medical professional. Because the base 1322 is coupled to the catheter 1334, the catheter 1334 can be inserted into a patient to a target location to deliver the clip 1300. Additionally, because the base 1322 is fixed to the catheter 1334, as the first filament 1330 manipulates the lever 1326 including the arms 1302, the lever 1326 acts against the bias of the spring portion 1304 and moves the clip 1300 from the closed configuration to the open configuration by moving the arms 1302 in the lever 1326 away from the fixed arms 1302 in the base 1322.

[0065] Still referring to Figures 13A-13C One embodiment of a method of clamping a leaflet of a heart valve according to the present disclosure can include inserting a catheter 1334 toward a valve (e.g., through the valve). In some embodiments, the catheter 1334 can include a dilator 1320 disposed on a distal end of the catheter 1334, the dilator 1320 reversibly coupled to a clip 1300 in a closed configuration for navigation through a patient and / or working channel. Once the catheter 1334 is in the vicinity of a target location of the valve, the clip 1300 can be transitioned to an open configuration by proximally pulling a first filament 1330 and maintaining tension on the first filament 1330, the first filament 1330 coupled to a lever 1326. The lever 1326 rotates about a first pin 1324 and moves the arms 1302 within the lever 1326 apart from the opposing arms 1302 in the base 1322. With the clip 1300 in the open configuration, the catheter 1334 can move the clip to a location proximal to the leaflets of the valve (e.g., near the flail leaflet) such that the arms 1302 are on either side of the leaflets (e.g., see FIG. 13B). The clip 1300 can then be released from the catheter 1334 and the catheter 1334 can be removed from the patient. Figures 14A-15). With the clip 1300 in the leaflet-adjacent position, tension can be released on the first filament 1330, allowing the biased spring portion 1304 of the clip 1300 to cause the clip 1300 to transition to a closed configuration about the leaflet. If desired, the medical professional can optionally reopen the dilator 1320 and the clip 1300 by again pulling the first filament 1330 proximally to reposition the clip 1300. It can be desirable to reposition the clip 1300, for example, if released accidentally, if a better position is achieved after the clip 1300 is deployed, or to configure tension in the artificial chordae attached to the clip 1300. Once the clip 1300 is in the appropriate position, the second filament 1312 attached to the locking pin 1310 can be pulled (e.g., by a grasper, a third filament, etc.) such that the locking pin 1310 is removed from the aperture 1308 of the arm 1302. With the locking pin 1310 removed, the clip is no longer fixed to the dilator 1320 and the dilator 1320 releases the clip 1300. The clip 1300 can be delivered over the leaflet to the left, and the catheter 1334 and the dilator 1320 can be withdrawn from the patient (e.g., by a spring within the dilator 1320 to bias the lever 1326 toward the base 1322) in the open configuration (e.g., within an outer sheath) or the closed configuration. Additionally or alternatively, the clip can be delivered on a fourth filament (e.g., artificial chordae), which can extend from the clip 1300 (e.g., from the spring portion 1304) to another device (e.g., an anchor) that will be used for the medical treatment (e.g., anchoring the artificial chordae to the leaflet and to the papillary muscle).

[0066] Referring to Figure 14A and Figure 14B , according to the present disclosure Figures 2A-2Eembodiments, the arms 202 and / or the spring portion 204 can be configured to embed into the leaflet 150 by a distance of about 25% or less of the wall of the leaflet, about 10% or less of the wall of the leaflet, about 50% or more of the wall of the leaflet, etc. For example, with reference to FIG. 2A, the arms 202 and / or the spring portion 204 can be configured to embed into the leaflet 150 by a distance of about 0.1 mm or more, about 0.5 mm or more, about 1.0 mm or more, about 1.5 mm or more, about 2.0 mm or more, etc. In some embodiments, the arms 202 and / or the spring portion 204 can be configured to embed into the leaflet 150 by a distance of about 0.1 mm to about 2.0 mm, about 0.5 mm to about 1.5 mm, about 0.7 mm, etc. In some embodiments, the arms 202 and / or the spring portion 204 can be configured such that tissue is not pierced by the arms 202 and / or the spring portion 204, such that the clip can be repositioned from a first delivery position to a second delivery position without significant impact to the first delivery position. In the present delivery position, the arms 202 of the clip 200 fixedly engage the leaflet 150, and the second end 200d of the clip 200 can be coupled to a filament, e.g., one or more artificial chordae tendinae, such as described and shown with respect to FIG. 2B. Figure 14C In some embodiments, the protrusions 206 can not extend into the wall of the leaflet 150 and can instead distort the leaflet between the protrusions 206 such that the clip engages the leaflet 150 without the protrusions 206 extending into the leaflet. The shape of the clip (e.g., the spring portion 204 and / or the arms 202 of the clip) can provide an amount of force that does not pierce the protrusions 206 into and / or through the leaflet 150, thereby leaving room for distortion of the leaflet 150 within the clip. In some embodiments, the protrusions can extend a distance from the arms that can be about 0.1 mm to about 2.0 mm, about 0.5 mm to about 1.5 mm, about 0.7 mm, etc. In some embodiments, the protrusions and / or the spring portion can be configured such that tissue is not pierced by the protrusions, such that the clip can be repositioned from a first delivery position to a second delivery position without significant impact to the first delivery position. In the present delivery position, the arms 202 of the clip 200 fixedly engage the leaflet 150, and the second end 200d of the clip 200 can be coupled to a filament, e.g., one or more artificial chordae tendinae, such as described and shown with respect to FIG. 2B. Figure 15

[0067] With reference to FIG. 2B, the clip 200 is shown in a delivery position, in which the arms 202 of the clip 200 are positioned on either side of the leaflet 150. The clip 200 can be delivered to the leaflet 150 using a delivery device, e.g., a dilator, which can be used to deploy the arms 202 between the leaflet 150 and the dilator. The clip 200 can be deployed from the dilator by removing a locking pin from the hole 208, for example. As the clip 200 is delivered to the leaflet 150, the leaflet 150 can engage one or more of the smooth surfaces 206p of the protrusions 206. In the delivery position, the engagement ends 206d of most of the protrusions can be embedded at least partially into the leaflet 150. The protrusions 206 can be configured to embed into the leaflet 150 by a distance of about 25% or less of the wall of the leaflet, about 10% or less of the wall of the leaflet, about 50% or more of the wall of the leaflet, etc. For example, with reference to FIG. 2A, the arms 202 and / or the spring portion 204 can be configured to embed into the leaflet 150 by a distance of about 0.1 mm or more, about 0.5 mm or more, about 1.0 mm or more, about 1.5 mm or more, about 2.0 mm or more, etc. In some embodiments, the arms 202 and / or the spring portion 204 can be configured to embed into the leaflet 150 by a distance of about 0.1 mm to about 2.0 mm, about 0.5 mm to about 1.5 mm, about 0.7 mm, etc. In some embodiments, the arms 202 and / or the spring portion 204 can be configured such that tissue is not pierced by the arms 202 and / or the spring portion 204, such that the clip can be repositioned from a first delivery position to a second delivery position without significant impact to the first delivery position. In the present delivery position, the arms 202 of the clip 200 fixedly engage the leaflet 150, and the second end 200d of the clip 200 can be coupled to a filament, e.g., one or more artificial chordae tendinae, such as described and shown with respect to FIG. 2B. Figure 15 ​FIG. 1 1 shows one embodiment of a system for clamping a leaflet 150 of a heart valve in accordance with the present disclosure, the system including four clips 1500 attached to the leaflet 150. Each of the clips 1500 is attached to an end of a filament 1550, which is an artificial chordae. The filament 1550 is attached to an anchoring filament 1552, which is also attached to an anchor 1554. The anchor 1554 is embedded in a papillary muscle 152 of a heart 154. By changing the length of the filaments 1550, 1552 between the clips 1500 and the anchor 1554, a medical professional can adjust the length and tension of the filaments 1550 and the anchoring filament 1552 so that they can replicate and / or replace chordae of the heart 154 for working with the leaflet 150 of the valve. The medical professional can adjust the filaments 1550, 1552 in response to heart valve regurgitation observations, which can be observed via transesophageal echocardiography and / or fluoroscopy. The filaments 1550, 1552 are fixed at one end to the leaflet 150 by the clips 1500 and at a second end to the papillary muscle 152 by the anchor 1554. A single anchoring filament 1552 can be coupled to one or more filaments 1550 so that one anchoring filament 1552 and one anchor 1554 can be used for multiple clips 1500. In some embodiments, the filaments 1552 and the anchoring filament 1552 can be coupled to one or more clips 1500 and to each other during delivery of the system to the heart 154.

[0068] Figure 16 FIG. 16 shows a perspective view of a clip with alternative first, second, third, and fourth protrusions 1606a, 1606b, 1606c, and 1606d in accordance with one embodiment of the present disclosure. The clip includes first, second, third, and fourth protrusions 1606a, 1606b, 1606c, and 1606d oriented at various angles that are offset from each other and / or from the first and second arms 1601 and 1602. The first protrusion 1606a is oriented at a first angle relative to the longitudinal axis of the first arm 1601. The second protrusion 1606b is oriented at a second angle relative to the longitudinal axis of the second arm 1602, the second angle being greater than the first angle. The third protrusion 1606c is oriented at a third angle relative to the longitudinal axis of the second arm 1602, the third angle being greater than the second angle. The fourth protrusion 1606d is oriented at a fourth angle relative to the longitudinal axis of the second arm 1602, the fourth angle being greater than the third angle. Various embodiments can include multiple protrusions at various angles. Some protrusions can engage tissue at alternative angles to other protrusions along the same arm or opposite arm of the clip. Figures 2A-2D

[0069] ​All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While this disclosure has described and illustrated devices and methods presently accepted as preferred embodiments, those skilled in the art will understand that alternative and / or equivalent devices and / or methods described and practiced in the art can be utilized as modifications of the devices and methods described herein without departing from the spirit and scope of the present disclosure. Accordingly, all such modifications and equivalents are intended to be included within the scope of the present disclosure as defined by the following claims.

Claims

1. A system for clamping a leaflet of a heart valve, the system comprising: a clip, the clip comprising: a plurality of arms at a first end, the plurality of arms having a closed configuration in which the arms are oriented toward one another and an open configuration in which the arms are oriented away from one another with an open distance between the arms that is greater than a closed distance between the arms in the closed configuration; and a spring portion coupled to the plurality of arms at a second end, the spring portion configured to bias the arms to the closed configuration; wherein the arms of the clip are configured to fixedly engage the leaflet of the heart valve and the second end of the clip is configured to be coupled to an artificial chordae tendineae; and a dilator configured to transition the clip between the closed configuration and the open configuration, the dilator comprising: a base; a pin extending from the base; a lever rotatably disposed about the pin; a first channel extending through the base substantially parallel to a first aperture of one of the plurality of arms and configured to receive one of the plurality of arms; a second channel extending through the lever substantially parallel to a second aperture of one of the plurality of arms and configured to receive one of the plurality of arms; and a first filament extending from the lever, the filament configured to move the lever and the clip between the closed configuration and the open configuration.

2. The system of claim 1, further comprising a catheter having a distal end of the catheter coupled to the base.

3. The system of claim 1 or 2, further comprising a first pin disposed within the first aperture and the first channel and a second pin disposed within the second aperture and the second channel.

4. The system of claim 3, further comprising a second filament coupling the first pin to the second pin.

5. The system of claim 1 or 2, further comprising one or more protrusions disposed on one or more of the plurality of arms.

6. The system of claim 5, wherein the one or more protrusions are selected from the group consisting of barbs, spikes, hooks, and tines.

7. The system of claim 5, wherein the one or more protrusions are a plurality of protrusions arranged in a column, the column extending along at least one of the plurality of arms such that the plurality of protrusions are in different planes.

8. The system of claim 5, wherein the protrusions extend about 0.5 millimeters to about 1.5 millimeters from one or more of the arms.

9. The system of claim 1 or 2, wherein the clip weighs less than 0.08 grams.

10. A system for clamping a leaflet of a heart valve, the system comprising: a clip, the clip comprising: a body, the body comprising: a plurality of arms at a first end, the plurality of arms having a closed configuration in which the arms are oriented toward one another and an open configuration in which the arms are oriented away from one another, the arms of the clip being configured to fixedly engage the leaflets of the heart valve, while a second end of the clip is configured to be coupled to a prosthetic chordae; a dilator configured to transition the clip between the closed configuration and the open configuration, the dilator comprising: a base; a pin extending from the base; a lever rotatably disposed about the pin; a first channel extending through the base substantially parallel to a first aperture of one of the plurality of arms and configured to receive one of the plurality of arms; a second channel extending through the lever substantially parallel to a second aperture of one of the plurality of arms and configured to receive one of the plurality of arms; and a first filament extending from the lever, the filament configured to move the lever and the clip between the closed configuration and the open configuration.

11. The system of claim 10, wherein the body further comprises: a coil spring portion at a second end, the spring portion configured to bias the arms to the closed configuration; and a longitudinal axis extending through the first end and the second end; wherein the clip further comprises: a first cap disposed adjacent to and extending along a first arm of the plurality of arms to the longitudinal axis; a second cap disposed adjacent to and extending along a second arm of the plurality of arms to the longitudinal axis; a pin extending through the first cap, the second cap, and the coil spring portion; a first channel disposed on the first cap, the first cap having a central axis that is substantially parallel to the first arm; and a second channel disposed on the second cap, the second cap having a central axis that is substantially parallel to the second arm.

12. The system of claim 11, wherein the first channel and the second channel are configured to substantially align with a second aperture and a third aperture of a dilator.

13. The system of claim 12, further comprising: a first pin extending into the first channel and the second aperture; a second pin extending through the second channel and the third aperture; and a filament coupling the first pin to the second pin.

14. The system of any one of claims 10 to 13, further comprising a tab configured to transition the arms between the open configuration and the closed configuration; and wherein the open configuration and the closed configuration are each stable configurations.

15. The system of any one of claims 10 to 14, wherein the plurality of arms are configured to be biased to the closed configuration by a coil spring portion of the body.

16. The system of any one of claims 10 to 15, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

17. The system of any one of claims 10 to 16, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

18. The system of any one of claims 10 to 17, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

19. The system of any one of claims 10 to 18, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

20. The system of any one of claims 10 to 19, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

21. The system of any one of claims 10 to 20, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

22. The system of any one of claims 10 to 21, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

23. The system of any one of claims 10 to 22, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

24. The system of any one of claims 10 to 23, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

25. The system of any one of claims 10 to 24, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

26. The system of any one of claims 10 to 25, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

27. The system of any one of claims 10 to 26, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

28. The system of any one of claims 10 to 27, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

29. The system of any one of claims 10 to 28, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

30. The system of any one of claims 10 to 29, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

31. The system of any one of claims 10 to 30, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

32. The system of any one of claims 10 to 31, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

33. The system of any one of claims 10 to 32, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

34. The system of any one of claims 10 to 33, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

35. The system of any one of claims 10 to 34, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

36. The system of any one of claims 10 to 35, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

37. The system of any one of claims 10 to 36, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

38. The system of any one of claims 10 to 37, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

39. The system of any one of claims 10 to 38, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

40. The system of any one of claims 10 to 39, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

41. The system of any one of claims 10 to 40, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

42. The system of any one of claims 10 to 41, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

43. The system of any one of claims 10 to 42, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

44. The system of any one of claims 10 to 43, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

45. The system of any one of claims 10 to 44, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

46. The system of any one of claims 10 to 45, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

47. The system of any one of claims 10 to 46, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

48. The system of any one of claims 10 to 47, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

49. The system of any one of claims 10 to 48, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

50. The system of any one of claims 10 to 49, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

51. The system of any one of claims 10 to 50, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

52. The system of any one of claims 10 to 51, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

53. The system of any one of claims 10 to 52, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

54. The system of any one of claims 10 to 53, wherein the plurality of arms are configured to be biased to the open configuration by a coil spring portion of the body.

55. The system of any one of

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