Apparatus and system for clamping an artificial chord to the leaflet of a heart valve

Abstract

To provide a system for clamping a leaflet of a heart valve.SOLUTION: A system comprises: a clamp; a clamp spreader; and a first filament. The clamp includes a first clamp arm and a second clamp arm on the first end of the clamp. The first and second clamp arms have the closed form and the opened form. The first and second clamp arms are fixedly engaged with a leaflet of a heart valve. The clamp spreader includes a base and a lever which is relatively rotatable with respect to the base. The lever moves the clamp between the closed form and the opened form. The first filament extends from the lever so as to move the clamp arms between the closed form and the opened form by relatively moving the lever with respect to the base.SELECTED DRAWING: Figure 13C

Description

Technical Field

[0001] The present invention generally relates to the field of medical devices for clamping the leaflets of heart valves. In particular, the present invention relates to medical devices, systems, and methods for delivering an artificial chordae tendineae into a patient.

Background Art

[0002] Mitral valve disease is typically repaired via invasive surgical intervention or by complex clamping or autologous mitral valve replacement that brings together and clamps the leaflets forming two small openings. These techniques can involve risky bypass surgery, which can include incisions in the patient's chest and heart cavity to expose the mitral valve for direct visualization and repair. Excision, partial removal, and / or repair of the patient's leaflets in combination with implantation of a surgical ring are complex techniques used to enable the surgeon to reduce the diameter of the patient's mitral valve annulus, thereby allowing the leaflets to join properly and reducing mitral valve regurgitation. Some techniques can reduce regurgitation slightly but may not provide a durable solution and do not repair and / or replace damaged chordae tendineae of the valve. Accordingly, a transcatheter solution for mitral valve disease is needed.

Summary of the Invention

[0003] The medical devices, systems, and methods of the present invention, which include clamping of the leaflets of a heart valve, can achieve various advantageous medical outcomes. Embodiments of the present invention can generally assist in providing connection points for filaments by clamping the leaflets of a heart valve. In one aspect, a system for clamping the leaflets of a heart valve can include a clamp. The clamp can include a plurality of arms at a first end. The plurality of arms can have a closed configuration in which the arms face each other and an open configuration in which the arms face away from each other at an open distance between the arms that is greater than a closed distance between the arms in 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 toward the closed configuration. The arms of the clamp can be configured to fixedly engage the leaflets of the heart valve. The second end of the clamp can be configured to couple to an artificial chordae tendineae.

[0004] In various embodiments described herein or otherwise, the spreader may be configured to move the clamp between a closed configuration and an open configuration. The spreader may include a base. A pin may extend from the base. A lever may be pivotally disposed about the pin. A first channel may extend through the base generally parallel to a first aperture of one of the plurality of arms and may be configured to receive one of the plurality of arms. A second channel may extend through the lever generally parallel to a second aperture of one of the plurality of arms and may be configured to receive one of the plurality of arms. A first filament may extend from the lever. The filament may be configured to move the lever and the clamp between a closed configuration and an open configuration. The catheter may have a distal end of the catheter coupled to the base. A first pin may be disposed within the first aperture and the first channel. A second pin may be disposed within the second aperture and the second channel. A second filament may couple the first pin to the second pin. One or more protrusions may be disposed on one or more of the plurality of arms. The one or more protrusions may be selected from the group consisting of spines, spikes, hooks, and tines. The one or more protrusions may be a plurality of protrusions disposed along a plurality of rows, the plurality of rows extending along at least one of the plurality of arms such that the plurality of protrusions are in different planes. The protrusion may extend through no more than 50% of the wall thickness of the valve leaflet, e.g., the protrusion may not extend into the wall of the valve leaflet and instead may deform tissue. The protrusion may extend by a distance from the arm. The distance may be from about 0.5 millimeter to about 1.5 millimeters. The clamp may have a weight of less than 0.08 grams.

[0005] In one aspect, a clamp for clamping a valve leaflet of a heart valve may include a body. The body may include a plurality of arms at a first end. The plurality of arms may have a closed configuration in which the arms face each other and an open configuration in which the arms face away from each other. The arms of the clamp may be configured to fixedly engage the valve leaflet of the heart valve. A second end of the clamp may be configured to couple to an artificial chordae tendineae.

[0006] In various embodiments described herein or otherwise, the body may include a coiled spring portion at a second end. The spring portion may be configured to bias the arm into a closed configuration. The longitudinal axis may extend through the first end and the second end. The clamp may include a first cover disposed adjacent to the first arm of the plurality of arms and extending along the longitudinal axis along the first arm. The second cover may be disposed adjacent to the second arm of the plurality of arms and may extend along the longitudinal axis along the second arm. The pin may extend through the first cover, the second cover, and the coiled spring portion. The first channel having a central axis generally parallel to the first arm may be provided in the first cover. The second channel having a central axis generally parallel to the second arm may be provided in the second cover. The first channel and the second channel may be configured to generally align with the second and third apertures of the spreader. The first pin may extend into the first channel and the second aperture. The second pin may extend through the second channel and the third aperture. A filament may couple the first pin to the second pin. The tab may be configured to transition the arm between an open configuration and a closed configuration. The open configuration and the closed configuration may each be a stable configuration.

[0007] In one aspect, a method of clamping a leaflet of a heart valve may include inserting a catheter through the valve. The catheter may include a spreader disposed at a distal end of the catheter and reversibly coupled to the clamp. The clamp and the spreader may be positioned proximate to the leaflet. Tension on a first filament extending through the catheter may be released and coupled to the spreader such that the clamp transitions to a closed configuration around the leaflet. A plurality of pins may be removed from the spreader and the clamp such that the spreader releases the clamp. Tension may be applied to the first filament such that the spreader transitions the clamp from the closed configuration to the open configuration. The clamp may be repositioned around the leaflet. Tension on the first filament extending through the catheter may be released such that the clamp transitions to a closed configuration around the leaflet. An artificial chordae tendineae attached to the clamp may be secured to a papillary muscle. The leaflet may be a flail leaflet.

[0008] Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to an exact scale. In the figures, each identical or substantially identical component shown is generally represented by a single number. For the sake of clarity, not all components are labeled in all figures, and not all components of each embodiment are shown, when illustration is not necessary for one skilled in the art to understand the present invention.

Brief Description of the Drawings

[0009]

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[0010] The present invention is not limited to the specific embodiments described. The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting beyond the scope of the appended claims. All technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present invention pertains, unless otherwise defined.

[0011] Embodiments of the present invention may be specifically described with respect to medical devices and systems for selectively accessing a heart valve (e.g., a transcatheter device inserted through the femoral vein or the like), but it should be understood that such medical devices and systems can be used in various medical procedures that require clamping of the valve leaflets or clamping of tissue walls. The disclosed medical devices and systems can also be inserted via different access points and techniques, e.g., percutaneously, endoscopically, laparoscopically, or combinations thereof.

[0012] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. The terms "comprising," "consisting of," and / or "comprises," "consists of," and / or "including," "includes," as used herein, specify the presence of the stated features, regions, steps, elements, and / or components, but do not preclude the presence or addition of one or more other features, regions, wholes, steps, operations, elements, components, and / or groups thereof.

[0013] As used herein, "proximal end" refers to the end of the device that is closest to the healthcare provider along the device when introducing the device into the patient, and "distal end" refers to the end of the device or object that is farthest from the healthcare provider along the device during implantation, positioning, or delivery.

[0014] As used herein, the conjunction "and" includes each of the structures, components, features, etc. so combined, unless the context clearly dictates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so combined, individually and in any combination and number, unless the context clearly dictates otherwise.

[0015] In this specification, all numerical values are assumed to be modified by the term "about", whether or not explicitly indicated. In relation to a numerical value, the term "about" generally refers to the range of numbers that a person skilled in the art would consider to be equivalent (i.e., having the same function or result) to the recited value. In many cases, the term "about" may include numbers rounded to the nearest significant digit. Other uses of the term "about" (i.e., uses related to other than numerical values) are to be understood in the context of this specification and, unless otherwise indicated, may be assumed to have their ordinary and customary definitions consistent with the context. The recitation of a numerical range by endpoints includes all numbers within that range including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0016] References to "one embodiment", "some embodiments", "other embodiments", etc. in this specification are to be noted as indicating that the described embodiments may include certain features, structures, or characteristics, but not all embodiments necessarily include the certain features, structures, or characteristics. Further, such phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in relation to one embodiment, unless explicitly stated to the contrary, whether or not explicitly described, it is within the knowledge of those skilled in the art to relate such feature, structure, or characteristic to other embodiments. That is, various individual elements described below, even if not explicitly shown in a particular combination, are nevertheless assumed to be combinable or arrangeable with each other to form other additional embodiments or to complement and / or enhance the importance of the described embodiments as understood by those skilled in the art.

[0017] Heart diseases, including atrioventricular heart valve insufficiency, reduce the patient's cardiac output, thereby decreasing the patient's quality of life and shortening the lifespan. Referring to the heart 154 shown in FIG. 1, as the heart disease progresses, the chordae tendineae 155 that connect the papillary muscles 152 to the valve leaflets 151 may extend inelastically and may rupture. The extended and / or ruptured chordae tendineae 156 can result in a fluttering valve leaflet 150. The fluttering valve leaflet 150 may lose the ability to form a valve seal for normal heart function. For example, abnormal blood flow regurgitation may occur in the direction of vector 158. The regurgitation prevents an appropriate supply of blood from being delivered through the cardiovascular system.

[0018] In order to treat heart disease, it may be desirable to reposition, repair, and / or replace one or more leaflets of a valve and / or chordae tendineae. The devices, systems, and methods of the present invention can be used alone or in combination with other devices, systems, and methods to treat heart disease. Examples of devices, systems, and methods that can implement embodiments of the present invention together include, but are not limited to, devices, systems, and methods for adjustably tensioning an artificial chordae tendineae between a leaflet and a papillary muscle or heart wall (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. _, Specification [Attorney Docket No. 8150.0591], devices, systems, and methods for artificial chordae tendineae (Devices, Systems, and Methods for Artificial Chordae Tendineae), U.S. Patent Application No. _, Specification [Attorney Docket No. 8150.0594], and devices, systems, and methods for anchoring an artificial chordae tendineae to a papillary muscle or heart wall (Devices, Systems, and Methods for Anchoring an Artificial Chordae Tendineae to a Papillary Muscle or Heart Wall), U.S. Patent Application No. _, Specification [Attorney Docket No. 8150.0593], each of these applications being filed on the same date as this application and incorporated herein by reference in its entirety for all purposes. Examples of the devices described therein can be modified to incorporate embodiments or one or more features of the present invention.

[0019] The repositioning, repair, and / or replacement of one or more valve leaflets and / or chordae tendineae may include one or more devices that are fixed to one or more valve leaflets of a valve. Embodiments of the devices described herein can be fixed to a valve by clamping onto a valve leaflet. These devices can provide a fixed point for gripping or attaching other devices, systems, or instruments to manipulate the valve leaflets of the valve and / or to deliver devices attached to the valve leaflets.

[0020] Referring to FIGS. 2A - 2E, an embodiment of a clamp 200 for clamping the leaflets of a heart valve according to the present invention is shown. The clamp 200 includes two arms 202 at a first end 200p of the clamp 200. In FIGS. 2A - 2C, the arms 202 are in a closed configuration, in which the arms 202 face each other. A second end 200d of the clamp 200 can be a spring portion 204. The spring portion 204 can be configured to bias the arms 202 into the closed configuration. The spring portion 204 at the second end 200d is wider than the width of the clamp 200 at the location of the arms 202, reducing the stress on the clamp 200 as it transitions between the closed and open configurations. Each of the arms 202 has an aperture 208 at the end of each arm 202. Each aperture 208 has a central axis 208a that extends generally along each of the arms 202 and is configured to receive a locking pin for operating the clamp 200 between the closed and open configurations (as will be described later with respect to FIGS. 13A - 15). Each arm 202 includes a protrusion 206 that extends along each arm 202 and is configured to penetrate into the tissue. Each of the protrusions has a smooth surface 206p that faces towards the first end 200p of the clamp 200, and the smooth surface 206p is configured to receive tissue that moves between the arms 202 from the first end 200p towards the second end 200d. Each protrusion 206 also includes an engaging end 206d that is configured to penetrate into the tissue between the arms 202 towards the second end 200d. Since the engaging end 206d of each protrusion 206 can be angled towards the second end 200d of the clamp 200, the protrusion 206 can resist movement of the tissue between the arms 202 relative to the clamp 200 by engaging the engaging end 206d into the tissue and / or applying frictional force to the tissue. FIGS. 2D and 2E show the clamp 200 in the open configuration. In the open configuration, the arms 202 face away from each other. The open configuration can more easily receive tissue (e.g., leaflets) than the closed configuration and can more easily reposition the tissue to be clamped. In the open configuration, the arms 202 are separated from each other by an arc length α that can be various amounts of angles, such as about 50°, about 60°, about 90°, etc.The arc length α can be sufficient for the clamp 200 to be able to surround at least a portion of the valve tissue. The first thickness 210p of the first end 200p of the clamp can be generally equal to the second thickness 210d of the second end 200d. Alternatively, the first thickness 210p can be different from the second thickness 210d, and the difference in this thickness can vary gradually from the first thickness 210p to the second thickness 210d. For example, the first thickness 210p can be thinner than the second thickness 210d, and vice versa. For example, one or more of the thicknesses 210p, 210d of the clamp can be from about 0.1 mm to about 3.0 mm, such as a first thickness 210p of about 0.7 mm and a second thickness from about 0.1 mm to about 3.0 mm. The width 212 of the clamp can be generally uniform or can vary along the clamp and can be from about 2 mm to about 20 mm. The length 214 of the clamp can be, for example, from about 5 mm to about 20 mm. The height 216 of the clamp can be, for example, from about 0.7 mm to about 10 mm.

[0021] In various embodiments of the present invention, one or more arms of the clamp can have a locking mechanism for use with a device that can move the clamp between a closed configuration and an open configuration. The locking mechanism can include an aperture, an edge for a channel, a tab, etc. Additional devices such as a locking pin, a channel, a clamp, etc. can engage with these locking mechanisms. The additional device can engage with the locking mechanism to move the clamp between a closed configuration and an open configuration, and the additional device can disengage the locking mechanism to deliver the clamp into the patient from one or more devices.

[0022] Referring to FIGS. 3A and 3B, an embodiment of a clamp for clamping the leaflets of a heart valve according to the present invention is shown. The clamp includes two arms 301, 302 at a first end 300p of the clamp. The arms 301, 302 can transition between a closed configuration where the arms 301, 302 face each other and an open configuration where the arms 301, 302 move apart from each other with a distance between the arms 301, 302 in the open configuration being greater than the distance between the arms 301, 302 in the closed configuration. A spring portion 304 at a second end 300d of the clamp is configured to bias the arms 301, 302 towards the closed configuration. One arm 301 includes a protrusion 306 that extends along the arm 302 and is configured to penetrate into the tissue. Each of the protrusions 306 is angled towards the second end 300d of the clamp 300 and can resist movement of the tissue between the arms 301, 302 relative to the clamp by penetrating the protrusions 306 into the tissue and / or applying frictional force to the tissue. One of the arms 302 includes a slot 307 that extends along a portion of the length of the arm 302 and provides a window defined by struts of the arm 302 around the protrusion 306, which can help the protrusion 306 penetrate into the tissue and / or reduce the weight of the clamp 300 by reducing the material used compared to a clamp without the empty slot 307. In FIGS. 4A and 4B, the protrusion 306 of the arm 301 is angled perpendicular to the arm 301. In FIGS. 5A - 6B, the protrusion 306 of one arm 302 extends along the longitudinal axis of the arm 302, and the protrusions 305 of 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 such that they are opposite to the direction in which the clamp can slide (e.g., the direction towards the end of the leaflet). In some embodiments, the protrusions 305 are in different planes from each other and can reduce tear propagation from adjacent protrusions 305. In some embodiments, the protrusions can be spines, spikes, hooks, tines, etc.

[0023] In various embodiments, the clamp can be manufactured to provide sufficient clamping force to secure the clamp to the valve leaflet and to be composed of a material suitable to provide a substantial anchor to an attached filament, such as an artificial chordae tendineae. In one aspect, the clamp can be manufactured to provide sufficient force such that the clamp can be fixedly attached to the valve tissue without imparting excessive weight that could impede the effort of valve repair. Thus, the clamp has a mass that is not significantly greater than necessary such that the weight of the clamp does not adversely affect the valve leaflet or nearby tissue. For example, the clamp can have a weight of less than about 0.10 grams, less than about 0.08 grams, etc., such that the weight of the clamp, for example, does not interfere with valve leaflet movement in an undesirable manner. The clamp can include various materials such as, for example, nitinol, polymers, rubbers, nylon, stainless steel, nickel titanium, platinum, combinations thereof, and the like.

[0024] Referring to FIGS. 7A and 7B, an embodiment of a clamp for clamping the leaflets of a heart valve according to the present invention is shown. The clamp includes two arms 701, 702 at a first end 700p of the clamp. The arms 701, 702 can transition between a closed configuration where the arms 701, 702 face each other and / or are generally aligned in the same plane, and an open configuration where the arms 701, 702 face away from each other in relatively different planes. In the closed configuration, the second arm 702 extends within the first arm 701. A spring portion 704 at a second end 700d of the clamp, where each of the arms 701, 702 is connected to each other as part of the same wire filament forming the clamp. The spring portion 704 can be a coiled spring and is configured to bias the arm 702 into the closed configuration. A single wire filament forms the clamp, and the wire filament extends from the first arm 702 to the spring portion 704 and then to the second arm 702 without terminating at an end so that there are no sharp portions on the clamp. FIGS. 8A and 8B show a first arm 801 and a second arm 802 having a thinner width profile than the arms 701, 702 of the clamp of FIGS. 7A and 7B. FIGS. 9A and 9B show a first arm 901 and a second arm 902 where the wire filament forming the clamp terminates at two ends forming an end 902p of the second arm 902. FIGS. 10A and 10B show a clamp having a first arm 1001 and a second arm 1002 at a first end 1000p of the clamp. The single wire filament forming the clamp terminates at an end 1002p of the second arm 1002. The clamp includes a spring portion 1004 at a second end 1000d of the clamp configured to bias the arms 1001, 1002 into the closed configuration.

[0025] Referring to FIGS. 11A - 11C, an embodiment of a clamp for clamping the leaflets of a heart valve according to the present invention is shown. This clamp includes a body 1101, and there are two arms 1102, 1103 at the first end 1101p of the body 1101. The arms 1102, 1103 have a closed configuration in which the arms 1102, 1103 face each other, and an open configuration in which the arms 1102, 1103 face away from each other, as shown in FIGS. 11A - 11C. There may be a coiled spring portion 1104 at the second end 1101d of the body 1101. The spring portion 1104 is configured to bias the arms 1102, 1103 into the closed configuration. A longitudinal axis l may extend through the first end 1101p and the second end 1101d. A first cover 1110 can be disposed adjacent to the arm 1102, and the first cover 1110 can extend along the longitudinal axis l along the arm 1102. A second cover 1112 can be disposed adjacent to the opposing arm 1103, and the second cover 1112 can extend along the longitudinal axis l along the arm 1103. The covers 1110, 1112 include protrusions 1106, and the protrusions 1106 extend along the covers 1110, 1112 and are configured to penetrate into the tissue. A pin 1114 can extend through the first cover 1110, the second cover 1112, the coiled spring portion 1104, and the longitudinal axis l. A first channel 1108 extending along the first cover 1110 can be provided on the first cover 1110, and the first channel 1108 can have a central axis that is generally parallel to the arm 1102. A second channel 1109 extending along the second cover 1112 can be provided on the second cover 1112, and the second channel 1109 can have a central axis that is generally parallel to the opposing arm 1103. The channels 1108, 1109 accommodate the arms 1102, 1103, and each channel 1108, 1109 has a portion without the arms 1102, 1103. This portion extends away from each of the arms 1102, 1103 and can accommodate a pin (for example, a locking pin of a spreader as described later). The covers 1110, 1112 are rotatable about the pin 1114 and move with the opening and closing of the arms 1102, 1103.The cover includes a clearance space 1115 near the pin 1114 so that the covers 1110, 1112 can rotate without interfering with each other.

[0026] Referring to FIGS. 12A and 12B, an embodiment of a clamp for clamping the leaflets of a heart valve according to an embodiment of the present invention is shown. The clamp includes a frame body 1201 having two arms 1202 pivotally connected by a tab 1205. A first pin 1213 extends through the two arms 1202 and the tab 1205 of the frame body 1201, and the arms 1202 can rotate about the first pin 1213. A first cover 1210 can be disposed adjacent to the arm 1202, and the first cover 1210 can extend along the longitudinal axis l along the arm 1202. A second cover 1212 can be disposed adjacent to the opposing arm 1202, and the second cover 1212 can extend along the longitudinal axis l along the arm 1202. The covers 1210, 1212 include protrusions 1206, and the protrusions 1206 extend along the covers 1210, 1212 and are configured to penetrate into the tissue. A second pin 1214 can extend through the first cover 1210, the second cover 1212, and the longitudinal axis l. The arms 1202 have a stable closed configuration as shown in FIG. 12A, in which the arms 1202 are configured to engage the tissue, and a stable open configuration as shown in FIG. 12B, in which the arms 1202 are spaced apart from each other. The open configuration allows the arms 1202 to be pulled apart from each other by a given angle α, for example, about 50°, about 60°, about 90°, etc. The clamp transitions between the closed and open configurations by moving the tab 1205 along the longitudinal axis l such that the arms 1202 of the frame body 1201 move away from each other and towards each other together with the covers 1210, 1212. When the tab 1205 moves along the longitudinal axis l, the arms 1202 rotate about the first pin 1213, and the covers 1210, 1212 rotate about the second pin 1214. The tab 1205 can be operated through a tab aperture 1205a (e.g., via a filament, wire, tether, push member, catheter, Bowden cable, etc.). The tab 1205 can be moved a certain distance to transition the arms 1202 between the open and closed configurations, and the distance can be, for example, about 0.51 millimeters (about 0.02 inches), etc.Covers 1210 and 1212 include a clearance space 1215 adjacent to pin 1214 to enable rotation without interference between the covers 1210 and 1212.

[0027] Referring to FIGS. 13A - 13C, an embodiment of a system for clamping the leaflets of a heart valve according to the present invention is shown. This system includes a clamp 1300 having an arm 1302 with a first end and having a closed form and an open form as described throughout the present invention. The clamp 1300 is in the closed form in FIGS. 13A and 13B and in the open form in FIG. 13C. The clamp 1300 has a spring portion 1304 at the second end that biases the arm 1302 into the closed form. A spreader 1320 can be releasably coupled to the clamp 1300. The spreader 1320 can move the clamp 1300 between the closed form and the open form. The spreader 1320 includes a base 1322 from which a first pin 1324 extends. A lever 1326 can be 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 channel being configured to receive an arm 1302 of the clamp 1300. The end of each arm 1302 includes an aperture 1308. Each aperture 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 into the aperture 1308 of the arm 1302 and the other locking pin 1310 extends through the second channel 1342 into the aperture 1308 of the opposing arm 1302. The locking pins 1310 fix the arms 1302 to the base 1322 and the lever 1326 such that the spreader 1320 can operate the arms 1302 between the open form and the closed form, whereby the clamp 1300 cannot be released from the spreader 1320. Since the arms 1302 are locked within the channels 1341, 1342, the arms 1302 can move between the closed form and the open form by the movement of the lever 1326. The lever 1326 can move about the first pin 1324 by the movement of a first filament 1330 coupled to a slot 1332 of the lever 1326.When the lever 1326 rotates about the first pin 1324, it also moves the arm 1302 within the second channel 1342, while the opposing arm 1302 is fixed within the first channel 1341 of the base 1322. In some embodiments, the pin 1310 can extend through the respective third and fourth apertures of the base 1322 and the lever 1326, rather than through the first channel 1341 and the second channel 1342, while still extending within the aperture 1308. A second filament 1312 is coupled to each end of the locking pin 1310 to grip the second filament 1312 and pull the second filament 1312 so that the locking pin 1310 is removed from the aperture 1308 and the channels 1341, 1342, thereby releasing the arm 1302 from the base 1322 and the lever 1326. FIG. 13C shows the base 1322 of the spreader 1320 coupled to the distal end of the catheter 1334. The first filament 1330 extends proximally within the catheter 1334 to be operated by a healthcare provider. Since the base 1322 is coupled to the catheter 1334, the catheter 1334 can be inserted to a target position within the patient to deliver the clamp 1300. Also, since the base 1322 is fixed to the catheter 1334, when the first filament 1330 operates the lever 1326 that houses the arm 1302, the lever 1326 acts against the biasing of the spring portion 1304 and moves the arm 1302 within the lever 1326 away from the fixed arm 1302 within the base 1322, thereby moving the clamp 1300 from the closed configuration to the open configuration.

[0028] Referring further to FIGS. 13A - 13C, one embodiment of a method for clamping the leaflets of a heart valve according to the present invention may include inserting a catheter 1334 towards (e.g., through) the valve. In some embodiments, the catheter 1334 can include a spreader 1320 disposed at the distal end of the catheter 1334, and the spreader 1320 can be reversibly coupled to the clamp 1300 in a closed configuration for advancement through the patient and / or working channel. When the catheter 1334 is near the target side of the valve, pulling the first filament 1330 coupled to the lever 1326 proximally and holding the tension on the first filament 1330 can shift the clamp 1300 to an open configuration. The lever 1326 rotates about the first pin 1324 and moves the arm 1302 within the lever 1326 away from the opposing arm 1302 within the base 1322. With the clamp 1300 in the open configuration, the catheter 1334 can be moved to a position proximate to (e.g., around the fluttering leaflet) the leaflet of the valve such that the arm 1302 is on either side of the leaflet (see, e.g., FIGS. 14A - 15 described below). With the clamp 1300 in place around the leaflet, releasing the tension on the first filament 1330 can cause the biased spring portion 1304 of the clamp 1300 to shift the clamp 1300 to a closed configuration around the leaflet. The healthcare provider can optionally re - open the spreader 1320 and the clamp 1300 by pulling the first filament 1330 proximally again to re - position the clamp 1300 as needed. For example, it may be desirable to re - position the clamp 1300 if it is accidentally released, if a more appropriate position is found after deploying the clamp 1300, or to configure the tension in an artificial chord attached to the clamp 1300. Once the clamp 1300 is in place, pulling the second filament 1312 attached to the locking pin 1310 (e.g., by a grasping tool, a third filament, etc.) can cause the pin 1310 to be removed from the aperture 1308 of the arm 1302.When pin 1310 is removed, the clamp becomes unsecured to spreader 1320, and spreader 1320 releases clamp 1300. Clamp 1300 can be left delivered on the valve tip and the catheter 1334 and spreader 1320 can be withdrawn from within the patient in an open configuration (e.g., within the outer sheath) or in a closed configuration (e.g., by a spring within spreader 1320 that biases lever 1326 towards base 1322). Additionally or alternatively, the clamp can be delivered with a fourth filament (e.g., an artificial chordae tendineae), which can extend from clamp 1300 (e.g., spring portion 1304) to another device (e.g., an anchor) used in a medical procedure (e.g., to secure the artificial chordae tendineae to the valve tip and to the papillary muscle).

[0029] Referring to FIGS. 14A and 14B, an embodiment of the clamp 200 of FIGS. 2A-2E clamping the leaflet 150 of the heart valve according to the present invention is shown. The clamp 200 is shown in a closed configuration where its two arms 202 are adjacent to the leaflet 150 and there is one arm 202 on each side of the leaflet 150. The spring portion 204 at the second end 200d of the clamp 200 biases the two arms 202 towards each other in this closed configuration. In the illustrated embodiment, the clamp 200 is positioned around the leaflet with the first end 200p leading, and the leaflet 150 is received between the two arms 202. The clamp 200 can be delivered over the leaflet 150 using another device, such as a spreader, that can articulate the arms 202 between an open configuration for receiving the leaflet 150 and a closed configuration for engaging the leaflet 150. The clamp 200 can be unlocked from the spreader for delivery, for example, by removing a locking pin from an aperture 208. When the clamp 200 is delivered over the leaflet 150, the leaflet 150 may engage one or more smooth surfaces 206p of the protrusions 206. In the closed configuration, the engaging ends 206d of most of the protrusions can at least partially penetrate into the leaflet 150. The penetrated protrusions 206 penetrate by less than about 50% of the wall thickness of the leaflet 150. The spring portion 204 is configured to press the arms 202 and / or the protrusions 206 against the leaflet 150 and provide a clamping force that allows the protrusions 206 to penetrate. In some embodiments, the protrusions and / or the spring portion can be configured to penetrate by less than about 25% of the leaflet wall, less than 10% of the leaflet wall, more than 50% of the leaflet wall, etc. For example, referring to FIG. 14C, the protrusions 206 may not extend into the wall of the leaflet 150, and instead, the clamp can deform the leaflet between the protrusions 206 such that the protrusions 206 do not extend into the leaflet 150 while the clamp engages the leaflet 150. The shape of the clamp, such as the shape of the spring portion 204 and / or the arms 202 of the clamp, can provide an amount of force that does not pierce the protrusions 206 into and / or through the leaflet 150, leaving room for the leaflet 150 to deform within the clamp.In some embodiments, the protrusion can extend only the distance from the arm, which can be from about 0.1 millimeter to about 2.0 millimeters, from about 0.5 millimeter to about 1.5 millimeters, about 0.7 millimeter, etc. In some embodiments, the protrusion and / or spring portion can be configured so that tissue is not impaled by the protrusion such that the clamp can be repositioned from the first delivery site to the second delivery site without significant effect on the first delivery site. At this delivery position, the arm 202 of the clamp 200 is fixedly engaged with the valve tip 150, and the second end 200d of the clamp 200 can be coupled to a filament, such as one or more artificial chordae tendineae, as described and illustrated with respect to FIG. 15.

[0030] Referring to FIG. 15, an embodiment of a system for clamping the valve leaflets 150 of a heart valve according to the present invention is shown. This system includes four clamps 1500 attached to the valve leaflets 150. Each of the clamps 1500 is attached to the end of a filament 1550 that is an artificial chordae tendineae. The filament 1550 is attached to a tether filament 1552 that is further attached to an anchor 1554. The anchor 1554 is embedded in the papillary muscle 152 of the heart 154. The medical practitioner can adjust the length and tension of the filaments 1550 and the tether filament 1552 by changing the length of the filaments 1550, 1552 between the clamps 1500 and the anchor 1554 so that the filaments 1550 and the tether filament 1552 can reproduce and / or replace the chordae tendineae of the heart 154 to function with the valve leaflets 150 of the valve. The medical practitioner can adjust the filaments 1550, 1552 in response to observing heart valve regurgitation that can be observed via transesophageal echocardiography and / or fluoroscopy. The filaments 1550, 1552 are fixed to the valve leaflets 150 by the clamps 1500 at one end and fixed to the papillary muscle 152 by the anchor 1554 at the second end. It is possible to combine a single tether filament 1552 with one or more filaments 1550 so that one tether filament 1552 and one anchor 1554 can be used for a plurality of clamps 1500. In some embodiments, the filament 1552 and the tether filament 1552 can be coupled to one another and to one or more of the clamps 1500 during delivery of the system into the heart 154.

[0031] FIG. 16 shows a perspective view of the clamp of FIGS. 2A-2D having alternative protrusions 1606a, 1606b, 1606c, and 1606d, according to an embodiment of the present invention. The clamp includes protrusions 1606a, 1606b, 1606c, and 1606d oriented at various angles offset from each other and / or from the arms 1601, 1602. The first protrusion 1606a is oriented at a first angle with respect to the longitudinal axis of the first arm 1601. The second protrusion 1606b is oriented at a second angle greater than the first angle with respect to the longitudinal axis of the second arm 1602. The third protrusion 1606c is oriented at a third angle greater than the second angle with respect to the longitudinal axis of the second arm 1602. The fourth protrusion 1606d is oriented at a fourth angle greater than the third angle with respect to the longitudinal axis of the second arm 1602. Various embodiments may include multiple protrusions at various angles. Some protrusions may engage tissue at alternative angles from other protrusions along the same or opposing arms of the clamp. (Appendix) As a preferred embodiment, the technical idea understood from the above embodiment will be described below. [Item 1] A system for clamping the leaflets of a heart valve, comprising: a clamp, wherein the clamp includes a plurality of arms at a first end, the arms having a closed configuration in which the arms face each other and an open configuration in which the arms face away from each other at an open distance greater than a closed distance between the arms in the closed configuration; the clamp includes a spring portion coupled to the plurality of arms at a second end, the spring portion configured to bias the arms into the closed configuration; the arms of the clamp are configured to fixedly engage the leaflets of the heart valve, and the second end of the clamp is configured to couple to an artificial chordae tendineae; the system further includes a spreader configured to transition the clamp between the closed configuration and the open configuration, the spreader including: a base, A pin extending from the base, A lever pivotally arranged about the pin, A first filament extending from the lever and configured to move the lever and the clamp between the closed configuration and the open configuration A system comprising. [Item 2] The spreader, A first channel extending through the base generally 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 generally parallel to a second aperture of one of the plurality of arms and configured to receive one of the plurality of arms, A first pin disposed within the first aperture and the first channel, A second pin disposed within the second aperture and the second channel The system according to item 1, further comprising. [Item 3] The system according to item 1 or 2, further comprising a catheter having a distal end coupled to the base. [Item 4] The system according to item 2, further comprising a second filament coupling the first pin to the second pin. [Item 5] The system according to any one of items 1 to 4, further comprising one or more protrusions disposed on one or more of the plurality of arms. [Item 6] The system according to item 5, wherein the one or more protrusions are selected from the group consisting of spines, spikes, hooks, and barbs. [Item 7] The system according to item 5 or 6, wherein the one or more protrusions are a plurality of protrusions arranged along a plurality of rows, the plurality of rows extending along at least one of the plurality of arms such that the plurality of protrusions are in different planes. [Item 8] The system according to any one of items 5 to 7, wherein the protrusion extends from one or more of the arms by about 0.5 millimeter to about 1.5 millimeters. [Item 9] The system according to any one of items 1 to 8, wherein the clamp has a weight of less than 0.08 grams.

[0032] All of the devices and / or methods disclosed in this specification and claimed in the claims can be made and executed without undue experimentation in view of the present invention. Although the devices and methods of the present invention are described with reference to preferred embodiments, it should be apparent to those skilled in the art that variations can be applied to the devices and / or methods and to the steps or series of steps of the methods described herein without departing from the concept, spirit, and scope of the present invention. All such similar substitutions and modifications that are apparent to those skilled in the art are considered to be within the spirit, scope, and concept of the present invention as defined by the appended claims.

Claims

1. A system for clamping the leaflets of a heart valve, the system comprising: a clamp having a first end and a second end; a clamp spreader; a first filament; and wherein: the clamp includes a first clamp arm and a second clamp arm at the first end of the clamp; the first clamp arm and the second clamp arm have a closed configuration in which the two clamp arms are disposed at a closed distance from each other and an open configuration in which the two clamp arms are disposed at an open distance greater than the closed distance from each other; the first clamp arm and the second clamp arm are configured to fixedly engage the leaflets of the heart valve; the clamp spreader includes a base and a lever rotatable relative to the base; the lever is configured to move the clamp between the closed configuration and the open configuration; the first filament extends from the lever to move the lever relative to the base and to move the two clamp arms between the closed configuration and the open configuration; a first channel extends through the base and is configured to receive the first clamp arm; a second channel extends through the lever and is configured to receive the second clamp arm.

2. a first aperture is defined in the first clamp arm to align with the first channel extending through the base; a second aperture is defined in the second clamp arm to align with the second channel extending through the lever; The system according to claim 1.

3. a pin disposed in an aperture and channel aligned with the first clamp arm and the base, or an aperture and channel aligned with the second clamp arm and the lever, to couple the clamp and the clamp spreader to each other; a release filament coupled to the pin to operate the pin to pull at least one of the first clamp arm out of the base or the second clamp arm out of the lever to release at least one of them; The system according to claim 2.

4. Further comprising a second filament, the second filament being coupled to at least one of the first clamping arm or the second clamping arm and operable to release at least one of the first clamping arm or the second clamping arm from the clamp spreader. The system according to claim 1.

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

6. The system according to claim 1, further comprising one or more protrusions disposed on one or both of the clamping arms, the one or more protrusions being selected from the group consisting of spines, spikes, hooks, and tines.

7. The system according to claim 6, wherein the one or more protrusions comprise a plurality of protrusions disposed in a row extending along one of the first clamping arm and the second clamping arm in a first plane and a plurality of protrusions disposed in a row extending along the other of the first clamping arm and the second clamping arm in a second plane different from the first plane.

8. The system according to claim 1, wherein the second end of the clamp is configured to couple to an artificial chord.

9. The system according to claim 1, wherein the clamp has a weight of less than 0.08 grams.

10. The system according to claim 1, wherein the clamp further comprises a spring portion disposed to bias the first clamping arm and the second clamping arm into the closed configuration.

11. A clamp spreader for transitioning from an open configuration to a closed configuration to clamp a leaflet of a heart valve, The clamp spreader comprises a base configured to be coupled to a first clamping arm of the clamp, The clamp spreader comprises a lever rotatable relative to the base, the lever being coupled to a second clamping arm of the clamp, and a filament configured to be coupled to the lever and operable to move the second clamping arm from a closed configuration in which the second clamping arm is at a closed distance relative to the first clamping arm to an open configuration in which the second clamping arm is at an open distance greater than the closed distance relative to the first clamping arm. configured to be coupled to A first channel extends through the base and is configured to receive the first clamping arm. A clamp spreader in which a second channel extends through and along the lever and is configured to receive the second clamp arm. **Claim 12** The clamp spreader according to claim 11, wherein the lever has a first end configured to couple with the filament and a second end swingably coupled to the first end of the base. **Claim 13** The first channel passing through the base is configured to substantially align with the aperture of the first clamp arm and to receive a first pin extending through the aperture of the first clamp arm. The clamp spreader according to claim 11, wherein the second channel passing through the lever is configured to substantially align with the aperture of the second clamp arm and to receive a second pin extending through the aperture of the second clamp arm.

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