Devices, systems, and methods for adjustably tensioning artificial chordae between leaflets and papillary muscles or heart walls

Abstract

The present invention relates generally to the field of medical devices for delivering artificial chordae tendinae in a patient. A system for adjusting tension in an artificial chordae tendinae includes an artificial chordae tendinae couplable between a clip and an anchor. The clip is engageable with a leaflet of a heart valve and the anchor is engageable with a papillary muscle or heart wall. The anchor includes a body portion and a locking portion couplable with the artificial chordae tendinae and configured to allow movement of the artificial chordae tendinae in a first direction while preventing movement of the artificial chordae tendinae in a second direction opposite the first direction. An actuator is coupled to the locking portion to selectively release the locking portion to enable selective movement of the artificial chordae tendinae in the second direction.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 62 / 873,352, filed July 12, 2019; and U.S. Provisional Patent Application No. 62 / 870,343, filed July 3, 2019, the entire contents of which are incorporated herein by reference for all purposes. TECHNICAL FIELD

[0003] The present invention relates generally to the field of medical devices for anchoring to heart walls. In particular, the present invention relates to medical devices, systems, and methods for delivering artificial chordae tendinae in a patient. BACKGROUND

[0004] Mitral valve disease is often repaired via invasive surgical intervention or by complexly pinching the leaflets together, thereby creating two smaller openings or performing a mitral valve replacement of the native valve. These approaches involve risky bypass surgery, which 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 properly coapt and reducing mitral regurgitation. Some techniques can slightly reduce regurgitation, but can fail to provide a lasting solution and fail to repair and / or replace damaged valve chordae. Thus, there is a need for a transluminal solution to mitral valve disease.

[0005] A variety of advantageous medical outcomes can be achieved by the present invention relating to medical devices, systems, and methods for anchoring to heart walls. SUMMARY

[0006] Embodiments of the present invention can generally relate to systems and methods for tensioning an artificial chordae tendinae implanted within a patient’s heart. In one aspect, a system for adjusting tension in an artificial chordae tendinae includes an artificial chordae tendinae couplable between a clip and an anchor. The clip can be engaged with a leaflet of a heart valve, and the anchor can be engaged with a papillary muscle or heart wall. The anchor can include a body portion and a locking portion couplable with the artificial chordae tendinae and configured to allow movement of the artificial chordae tendinae in a first direction while preventing movement of the artificial chordae tendinae in a second direction opposite the first direction. An actuator can be coupled to the locking portion. The actuator is operable to selectively release the locking portion to enable selective movement of the artificial chordae tendinae in the second direction.

[0007] The anchor can include a housing portion. In some embodiments, the body portion, the locking portion, and the actuator are disposed in or on the housing portion. The actuator can be couplable to a filament disposed in or on the catheter such that a user can activate the actuator to release the locking portion by applying a force to the filament. The locking portion locks to prevent movement of the artificial chordae tendinae in a second direction when the artificial chordae tendinae applies a force to the locking portion in the second direction.

[0008] The locking portion can include a ball or a roller for pressing the artificial chordae tendinae between the ball or the roller and a surface of the locking portion to prevent movement of the artificial chordae tendinae in the second direction. The actuator can be coupled to the ball or the roller to move the ball or the roller away from the artificial chordae tendinae to enable movement of the artificial chordae tendinae in the second direction. The ball or the roller can be movably positioned in a slot having a first wall oriented at an angle "a" relative to an axis of the artificial chordae tendinae and a second wall oriented parallel to the axis of the artificial chordae tendinae. Movement of the artificial chordae tendinae in the second direction can tend to press the ball or the roller against the artificial chordae tendinae until a frictional force between the artificial chordae tendinae and the first and second surfaces prevents further movement of the artificial chordae tendinae in the second direction.

[0009] The system can also include a filament coupled to the ball or the roller to enable a user to manually move the ball or the roller in a first direction to reduce the frictional force between the artificial chordae tendinae, the ball or the roller, and the first and second walls of the slot to allow movement of the artificial chordae tendinae in the second direction. Moving the artificial chordae tendinae in the first direction can increase a tension between the clip and the anchor, and moving the artificial chordae tendinae in the second direction can decrease the tension between the clip and the anchor.

[0010] In some embodiments, the locking portion includes a spring element for coupling to the artificial chordae tendinae to prevent movement of the artificial chordae tendinae in the second direction. In other embodiments, the locking portion includes a clip for engaging the artificial chordae tendinae. The actuator can be coupled to the clip to disengage the clip from the artificial chordae tendinae. In further embodiments, the locking portion includes a flexible woven member coupled at a first end to the actuator and at a second end to the body portion. The flexible woven member can be disposed within the housing portion, and the artificial chordae tendinae can be disposed between the flexible woven member and a sidewall of the housing portion. So arranged, the flexible woven member can expand to press the artificial chordae tendinae against the sidewall to prevent movement of the artificial chordae tendinae in the first and second directions when the locking portion is in a locked configuration. In still further embodiments, the locking portion includes a rotatable locking body having an engagement surface for engaging the artificial chordae tendinae, wherein the rotatable locking body is rotatable to sandwich the artificial chordae tendinae between the engagement surface and the body portion of the locking portion to prevent movement of the artificial chordae tendinae.

[0011] A device for adjusting tension in an artificial chordae tendinae is disclosed. The device can include an anchor engageable with a papillary muscle or heart wall. The anchor can have a body portion and a locking portion couplable to the artificial chordae tendinae and configured to allow movement of the artificial chordae tendinae in a first direction while preventing movement of the artificial chordae tendinae in a second direction opposite the first direction. The device can also include an actuator coupled to the locking portion, where the actuator is configured for selectively releasing the locking portion to enable selective movement of the artificial chordae tendinae in the second direction.

[0012] The actuator can be coupled to a filament disposed in or on the catheter such that a user can activate the actuator to release the locking portion by applying a force to the filament. The locking portion can automatically lock to prevent movement of the artificial chordae tendinae in the second direction when the artificial chordae tendinae applies a force to the locking portion in the second direction. In some embodiments, the locking portion includes a ball or roller for pressing the artificial chordae tendinae between the ball or roller and a surface of the locking portion to prevent movement of the artificial chordae tendinae in the second direction. The actuator can be coupled to the ball or roller to move the ball or roller away from the artificial chordae tendinae to enable movement of the artificial chordae tendinae in the second direction.

[0013] In some embodiments, the locking portion includes a spring element for coupling to the artificial chordae tendinae to prevent movement of the artificial chordae tendinae in the second direction. In other embodiments, the locking portion includes a clamp for engaging the artificial chordae tendinae. The actuator can be coupled to the clamp to disengage the clamp from the artificial chordae tendinae.

[0014] A method for adjusting tension in an artificial chordae tendinae is disclosed. The method can include disposing the artificial chordae tendinae between a leaflet and a papillary muscle or heart wall and adjusting tension in the artificial chordae tendinae by applying a force to the artificial chordae tendinae to move the artificial chordae tendinae from a first position to a second position relative to an anchor engaged with the papillary muscle or heart wall. A locking portion of the anchor can prevent movement of the artificial chordae tendinae from the second position toward the first position. The method can include visualizing a regurgitation characteristic of the heart valve after the artificial chordae tendinae has been moved from the first position to the second position and moving the artificial chordae tendinae from the second position to a third position based on the visualization. Moving the artificial chordae tendinae from the second position to the third position can include applying a force to the artificial chordae tendinae. Moving the artificial chordae tendinae from the second position to the third position can include disengaging the locking portion to allow movement of the artificial chordae tendinae toward the first position. The method can also include visualizing a regurgitation characteristic of the heart valve after the artificial chordae tendinae has been moved from the second position to the third position and moving the artificial chordae tendinae from the third position to a fourth position based on the visualization. BRIEF DESCRIPTION OF DRAWINGS

[0015] The non-limiting embodiments of the present application 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: Where the same or nearly the same components are shown in each of the drawings, each of the components is generally designated by one numeral. For the sake of clarity, not every component is designated in every drawing, and not every component of each of the embodiments shown is necessary to understand the present application. In the drawings:

[0016] Figure 1 is a cross-sectional view of the flail-like leaflets of the mitral valve during blood flow regurgitation.

[0017] Figure 2 is a cross-sectional view of a system according to an embodiment of the present application in which several artificial chordae are engaged between a heart valve leaflet and a heart wall.

[0018] Figure 3A and Figure 3B are first and second transparent side views of an artificial chordae tensioning device according to an embodiment of the present application.

[0019] Figure 4A and Figure 4B are first and second transparent side views of an artificial chordae tensioning device according to an embodiment of the present application.

[0020] Figure 5A and Figure 5B are first and second transparent side views of an artificial chordae tensioning device according to an embodiment of the present application.

[0021] Figure 6A , Figure 6B and Figure 6C are perspective view, partially transparent perspective view and cross-sectional view, respectively, of an artificial chordae tensioning device according to an embodiment of the present application.

[0022] Figures 6D-6G is a perspective view and a partially transparent perspective view of an artificial chordae tensioning device engaged with an embodiment of an actuator. Figures 6A-6C

[0023] Figure 7A and Figure 7B are perspective view and cross-sectional view, respectively, of a locking portion according to an embodiment of the present application.

[0024] Figures 8A-8E is a transparent view of a locking portion according to an embodiment of the present application.

[0025] Figures 9A-9E is a perspective view of a clamp-type locking portion according to an embodiment of the present application.

[0026] Figure 10A and​Figure 10B is a perspective view of a clamp lock portion according to an embodiment of the present application.

[0027] Figure 10C and Figure 10D is a perspective view of a Figure 10A and Figure 10B artificial chordae tendinae tensioning device.

[0028] Figures 11A-11F is a transparent view of a spring lock portion according to an embodiment of the present application.

[0029] Figures 12A-12B is a transparent view of a plunger coil lock portion according to an embodiment of the present application.

[0030] Figure 13 is a transparent view of a sleeve lock portion according to an embodiment of the present application.

[0031] Figure 14 is a cross-sectional view of a spring wedge lock portion according to an embodiment of the present application.

[0032] Figure 15A and Figure 15B is a perspective view of a spring wind lock portion according to an embodiment of the present application.

[0033] Figure 16A and Figure 16B is a perspective view of a suture lock portion according to an embodiment of the present application. DETAILED DESCRIPTION

[0034] The present application is not limited to the particular embodiments described. The terminology used in the description 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 application belongs.

[0035] While embodiments of the present application can be described with particular reference to medical devices and systems for selective access to cardiac tissue (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 requiring anchoring to cardiac tissue. The disclosed medical devices and systems can also be inserted via different access points and modalities, e.g., percutaneously, endoscopically, laparoscopically, or combinations thereof.

[0036] 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. When used herein, the terms “comprising” and / or “including” or “containing” and / or “including” indicate the presence of the stated feature, region, step, element, and / or component, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups.

[0037] As used herein, “proximal” refers to the end of the device that is closest to the medical professional when the device is introduced into the patient, and “distal” refers to the end of the device or object that is furthest from the medical professional during implantation, positioning, or delivery.

[0038] As used herein, the conjunction “and” includes each of the structures, components, features, etc. so connected, unless the context clearly indicates otherwise, and the conjunction “or” includes one or more of the structures, components, features, etc. so connected individually and in any combination and number, unless the context clearly indicates otherwise.

[0039] All numerical values ​​herein are assumed to be modified by the term "about," whether or not explicitly stated. In the context of numerical values, the term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the referenced value (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. Unless otherwise specified, the term "about" (i.e., in contexts other than numerical values) may be assumed to have its common and customary definition, as understood and consistent with the context of this specification. References to ranges of numbers represented by endpoints include all numbers within that range, including the endpoint (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0040] It should be noted that the embodiments described by references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification may include specific features, structures, or characteristics, but each embodiment may not necessarily include that specific feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, whether explicitly described or not, implementation of such a feature, structure, or characteristic in conjunction with other embodiments is within the knowledge of those skilled in the art, unless the contrary is explicitly stated. That is, even if not explicitly shown in a specific combination, the various individual elements described below are still considered to be combinable or arranged together to form other additional embodiments or to supplement and / or enrich the described embodiments, as will be understood by those skilled in the art.

[0041] Heart disease, including atrioventricular heart valve failure, impedes the patient's cardiac output, which reduces the patient's quality of life and life span. Referring to Figure 1 With the progression of heart disease, the chordae tendinae 155 that connect the papillary muscle or heart wall 152 to the valve leaflets 151 can stretch inelastically and can rupture, as shown with the heart 154. The stretched and / or ruptured chordae tendinae 156 can result in flail leaflets 150 that can no longer have the ability to form a valve seal for normal heart function. For example, abnormal blood flow regurgitation in the vector direction 158 can occur. The regurgitation can prevent sufficient blood supply from being delivered through the cardiovascular system.

[0042] Repositioning, repairing, and / or replacing one or more leaflets of a valve and / or chordae tendinae can be desirable for treating heart disease. The devices, systems, and methods of the present invention can be used alone or with other devices, systems, and methods to treat heart disease. Examples of devices, systems, and methods that can be used to implement embodiments of the present invention include, but are not limited to, those described in U.S. Patent Application entitled Devices, Systems, and Methods for Clamping a Leaflet of a Heart Valve, Attorney Docket No. 8150.0592; U.S. Patent Application entitled Devices, Systems, and Methods for Anchoring Artificial Chordae Tendinae to a Papillary Muscle or Heart Wall, Attorney Docket No. 8150.0593; and U.S. Patent Application entitled Devices, Systems, and Methods for Artificial Chordae Tendinae, Attorney Docket No. 8150.0594, each of which is filed on the same date and each of which is incorporated by reference herein in its entirety for all purposes. Examples of devices described herein can be modified to incorporate embodiments of the present invention or one or more features.

[0043] Repositioning, repairing, and / or replacing one or more leaflets of a valve and / or chordae tendinae can require securing one or more devices to the leaflets and a portion of heart tissue, such as a papillary muscle or heart wall, and coupling one or more artificial chordae tendinae therebetween. Embodiment devices described herein can be secured to the leaflets using a clip, while other embodiment devices can be secured to a papillary muscle, heart wall, or other portion of heart tissue by engaging an anchor thereto. Such devices can provide a point of fixation for other devices, systems, or tools to engage in order to manipulate the leaflets of a valve and / or deliver devices attached to a papillary muscle and / or heart wall.

[0044] Devices and minimally invasive methods for implanting artificial chordae tendinae in a beating heart for repair of a heart valve are disclosed. In some embodiments, a leaflet clip is attached to a heart valve leaflet. The valve leaflet can be attached to heart tissue, such as an anchor of a papillary muscle or heart wall, by an artificial chordae tendinae connection. The tension in the artificial chordae tendinae can be adjusted to bring the leaflet clip and anchor closer together or further apart to minimize regurgitation of blood through the valve.

[0045] In some embodiments, the artificial chordae tendinae can be tensioned from a location proximal to the catheter. This tensioning can be performed to reduce the distance between the leaflet clip and the anchor. As the artificial chordae tendinae is tensioned, the anchor constantly locks the position of the artificial chordae tendinae. The effect of artificial chordae tendinae tensioning on the leaflet can be observed under medical imaging, and further tensioning can be performed until leaflet repair is achieved. If the artificial chordae tendinae is over-tensioned, as evidenced by visualized regurgitation characteristics of the affected heart valve, the anchor lock can be released by pulling the actuator, and the distance between the leaflet clip and the anchor can be increased to reduce the tension in the artificial chordae tendinae. The tension adjustment steps can be repeated. When satisfied with the artificial chordae tendinae tensioning and valve repair, the artificial chordae tendinae is then detached from the catheter, and the catheter is removed from the heart. The procedure can then be concluded or additional artificial chordae tendinae can be implanted.

[0046] It will be appreciated that one or more aspects of the disclosed devices can be delivered to the leaflets and heart tissue, such as papillary muscles and / or heart wall, using a catheter or other suitable delivery device. The catheter can have one or more controls disposed at its proximal end to enable a user to manipulate the disclosed devices using one or more sutures, cables, wires, etc.

[0047] As should be appreciated, the specific nature of the delivery device is not critical to the present invention, so long as the delivery device is configured to allow a user to deliver, implant, and manipulate the disclosed devices at a target location within the heart.

[0048] It should also be appreciated that delivery, engagement, and manipulation of the disclosed devices can be facilitated through the use of known visualization techniques, such as fluoroscopy, ultrasound, intracardiac echos, etc.

[0049] Figure 2An embodiment of a system for connecting one or more filaments 200, 202 between leaflets 150 and papillary muscles or heart wall 152 of a heart valve in accordance with the present application is shown. As should be appreciated, the filaments 200, 202 (used as artificial chordae) can comprise sutures made of any of a variety of suitable materials, non-limiting examples of which include polytetrafluoroethylene (PTFE). Where the present application relates to filaments, it should be appreciated that such filaments include artificial chordae. Anchors 204 can be attached to the papillary muscles or heart wall 152 of the heart 154. Each of the anchors 204 can also be attached to one end of anchoring filaments 202 that are used as artificial chordae. The anchoring filaments 202 are attached to filaments 200, which are further attached to a plurality of leaflet clips 206 that are coupled to leaflets 150. A medical professional can adjust the length and tension of the filaments 200 and 202 so that they can replicate and / or replace the natural chordae of the heart 154 to function with the leaflets 150 of the valve. The medical professional can adjust the tension in the filaments 200, 202 in response to observations of heart valve regurgitation that can be observed via transesophageal echocardiogram, fluoroscopy, etc. The filaments 200, 202 can be secured at one end to the leaflets 150 by the leaflet clips 206 and can be secured at a second end to the papillary muscles or heart wall 152 by the anchors 204. The use of intermediate filaments and / or multiple filaments can be contemplated. For example, as shown in the illustrated embodiment, a single anchoring filament 202 can be coupled to one or more filaments 200 so that one anchoring filament 202 and one anchor 204 can be used with a plurality of leaflet clips 206. In some embodiments, the filaments 200 and anchoring filaments 202 can be coupled to one or more leaflet clips 206 and to anchors 204 during delivery of the system to the heart 154.

[0050] Referring now to Figures 3A-3B , an embodiment of a device 300 for adjusting the tension of an artificial chordae 302 in accordance with the present application is shown. The device 300 can comprise an anchor having a tissue engaging portion 306, a body portion 308, and a locking portion 310. As will be described, the locking portion 310 can be coupled to the artificial chordae 302 to allow the artificial chordae to move in a first direction (arrow“A”) while preventing the artificial chordae from moving in a second direction (arrow“B”) opposite the first direction. In this way, a user can move the artificial chordae in a direction that tends to increase the tension thereon (e.g., the first direction), and when movement stops, the artificial chordae will be held in place by the locking portion 310, thereby maintaining the applied tension.

[0051] Artificial chordae are used in Figure 3A , Figure 3BThe middle is shown as having a first end 324 and a second end 326. In some embodiments, the first end 324 can be coupled to a control filament (not shown) that passes through a catheter to a location where a user can manipulate tension in the artificial chordae tendinae 302. In some embodiments, the first end 324 can include a loop or other connection mechanism through which the control filament can be coupled. After the tensioning process is complete, the control filament can be decoupled from the first end 324 and removed via the catheter. The second end 326 of the artificial chordae tendinae 302 can extend within the heart to directly or indirectly couple to one or more leaflet clips 206 Figure 2 ) In some embodiments, the second end 326 can be coupled to a filament 200 Figure 2 ), which in turn is coupled to one or more leaflet clips 206.

[0052] In the illustrated embodiment, the locking portion 310 includes a fixed stop member 312, and a roller 314 that is movably positioned in a slot 316 disposed in the locking portion 310 and / or a housing portion 318 that surrounds the locking portion. The stop member 312 and the roller 314 are shown as being cylindrical, although this shape is not critical, and other shapes are contemplated. For example, the stop member 312 can be a protrusion or other surface feature that prevents the roller 314 from continuing to move in the direction of arrow "B" (a second direction) when the roller contacts the stop member. The roller 314 can be disposed in other shapes (tapered, curved, etc.), so long as it is movable along the slot 316, as will be described in more detail. In some embodiments, the locking portion 310 is disposed within the housing portion 318. In some embodiments, the body portion 308 and the locking portion 310 can be disposed in or on the housing portion 318.

[0053] As mentioned, the stop member 312 can be fixed within the locking portion 310 and the roller 314 can be movable within the slot 316. As can be seen, a first wall 320 of the slot 316 can be oriented at an angle "a" relative to an axis of the artificial chordae tendinae 302, while a second wall 322 of the slot can be oriented parallel to the axis of the artificial chordae tendinae. The roller 314 can contact the artificial chordae tendinae 302 to allow the artificial chordae tendinae to move in a first direction (arrow "A") relative to the roller 314, and to prevent the artificial chordae tendinae from moving in a second direction (arrow "B").

[0054] In use, the stop member 312 can be fixed relative to the slot 316. The roller 314 and the artificial tendon cable 302 can be disposed within the slot 316 such that the roller 314 engages the artificial tendon cable 302. In the illustrated configuration, referred to as the unlocking configuration, the roller 314 presses into the artificial tendon cable 302 to engage with the first wall 320 of the locking portion 310, but not to the extent that it prevents movement of the artificial tendon cable in the first direction (arrow "A"). In this configuration, the artificial tendon cable 302 can be moved in the first direction (arrow "A") by the user applying force to the first end 324 of the artificial tendon cable to apply tension between the second end 326 of the artificial tendon cable and one or more associated leaflet clips 206 (see [link]). Figure 2 Due to the friction between the two, roller 314 can move together with artificial tendon 302 in the first direction, but as mentioned, this friction will not prevent artificial tendon 302 from moving beyond roller 314. Once the target position and / or tension of artificial tendon 302 are reached, the tension in artificial tendon can naturally tend to move artificial tendon in the second direction (arrow "B"). The friction between artificial tendon 302 and roller 314 will therefore cause roller 314 to move together with artificial tendon in the second direction (arrow "B"). However, due to the angled nature of slot 316, the movement of roller 314 in the second direction will cause roller 314 to move toward artificial tendon 302, and thus roller will exert an increased force against artificial tendon, which in turn leads to increased friction between roller, artificial tendon, and the second wall 322 of slot 316. The movement of roller 314 can continue until the friction between the surfaces prevents artificial tendon 302 from moving further in the second direction (arrow "B").

[0055] In some embodiments, movement of the artificial chordae tendineae in the direction of arrow "A" tends to tighten the artificial chordae tendineae 302 between the device 300 and the leaflet 150 of the heart valve. When the device 300 is attached to the papillary muscle or the heart wall 152, tension can be achieved in the artificial chordae tendineae 302 to influence the regurgitation of blood through the heart valve. Observation of the regurgitation can be performed via transesophageal echocardiography, fluoroscopy, etc., to determine whether the effect on regurgitation has been achieved with the artificial chordae tendineae 302 in the appropriate position. If, after observation, the user determines that the tension in the artificial chordae tendineae 302 should be increased, the user can apply additional tension to the artificial chordae tendineae to move it further in the first direction (arrow "A"), and then perform further observations, and so on.

[0056] If, upon observation, the user determines that the tension in the artificial chordae 302 is to be reduced, the artificial chordae can be moved in a second direction (arrow "B"). However, as described, the arrangement of the locking portion can prevent movement of the artificial chordae 302 in the second direction. Thus, the locking portion 310 can include an actuator 328 configured to manually move the roller 314 in the first direction (arrow "A") to reduce the frictional force between the artificial chordae 302, the roller 314, and the second wall 322 of the slot 316 to allow the artificial chordae 302 to move in the second direction to reduce the tension in the artificial chordae 302 by a target amount. In the illustrated embodiment, the actuator 328 is a filament disposed through a central portion of the roller 314. The actuator 328 can pass through a catheter to a location where the user can actuate the actuator to "unlock" the locking portion 310.

[0057] Once the tension has been reduced, observation of regurgitation can again be observed via transesophageal echocardiogram, fluoroscopy, etc. to determine whether the target effect has been achieved. Additional adjustments can be made to the artificial chordae 302 in the first direction and / or the second direction until the target effect on the heart valve regurgitation is achieved. Upon completion of the tensioning process, the actuator 328 can be disengaged from the roller 314 and removed via the catheter.

[0058] Reference is now made to Figures 4A-4B , which shows an embodiment of a device 400 for adjusting the tension of an artificial chordae 402 in accordance with the present application. As will be described, a locking portion 410 can be coupled to the artificial chordae 402 to allow the artificial chordae to be moved in a first direction (arrow "A") while preventing the artificial chordae from being moved in a second direction (arrow "B") opposite the first direction. In this way, a user can move the artificial chordae 402 in a direction that tends to increase the tension thereon (e.g., the first direction), and when movement is stopped, the artificial chordae will be held in place by the locking portion 410, thereby maintaining the applied tension.

[0059] Figures 4A-4B The embodiment of Figures 3A-3B may be arranged and operated in the same or similar manner as the device 300, except that the locking portion 410 of the device 400 includes a ball member 414 for engaging and locking against the artificial chordae 402 in place of a roller. The remaining elements of the device 400 can be the same as the device 300, and are denoted by increasing the reference numerals in Figures 3A-3B by 100, and the operation of the device 400 can be substantially the same, for simplicity, reference is made to the above description of similar elements and operation.

[0060] Accordingly, the ball member 414 is positioned within the angled slot 416 such that it is operable to selectively lock and release the artificial chordae tendinae 402 in the same manner as described with respect to the roller 314. An actuator 428 can be provided through a portion of the ball member 414 and can be manipulated to manually move the ball member 414 to unlock the locking portion in the same or similar manner as the actuator 328 previously described.

[0061] Referring now to Figures 5A-5B , an embodiment of a device 500 for adjusting the tension of an artificial chordae tendinae 502 according to the present application is shown. The device 500 can include an anchor having a tissue engaging portion 506, a body portion 508, and a locking portion 510. As will be described, the locking portion 510 can be coupled to the artificial chordae tendinae 502 to allow the artificial chordae tendinae to move in a first direction (arrow“A”) while preventing the artificial chordae tendinae from moving in a second direction (arrow“B”) opposite the first direction. In this manner, a user can move the artificial chordae tendinae 502 in a direction tending to increase the tension thereon, and when movement stops, the artificial chordae tendinae will be held in place by the locking portion 510 to maintain the applied tension.

[0062] The artificial chordae tendinae is shown in Figure 5A , Figure 5B with a first end 524 and a second end 526. In some embodiments, the first end 524 can be coupled to a control filament (not shown) that passes through a catheter to a location where a user can manipulate (e.g., move) the artificial chordae tendinae 502. In some embodiments, the first end 524 can include a loop or other connection mechanism through which the control filament can be coupled. After the tensioning process is complete, the control filament can be decoupled from the first end 524 and removed via the catheter. The second end 526 of the artificial chordae tendinae 502 can extend within the heart to directly or indirectly couple to one or more leaflet clips 206 Figure 2 ). In some embodiments, the second end 526 can be coupled to a filament 200 Figure 2 , which in turn is coupled to one or more leaflet clips 206.

[0063] In the illustrated embodiment, the locking portion 510 includes a housing portion 512 within which a portion of the artificial chordae 502 is disposed. The housing portion 512 can include a flexible woven member 514 coupled to the actuator 520 at a first end 518 and to the body portion 508 at a second end 516. The flexible woven member 514 can be centrally disposed within the housing portion 512, while the artificial chordae 502 can be disposed between the flexible woven member 514 and a sidewall 522 of the housing portion 512. In some embodiments, the flexible woven member 514 includes Nitinol. In one example embodiment, the flexible woven member 514 has a friction-enhancing coating disposed on at least a portion thereof to enhance the frictional engagement between the flexible woven member and the artificial chordae 502.

[0064] The actuator 520 can be moved in a first direction and a second direction (arrows“A” and“B”, respectively) to move the flexible woven member 514 between the locked and unlocked configurations. When the flexible woven member 514 is in the unlocked configuration, the artificial chordae can be moved in the first direction (arrow“A”) or the second direction (arrow“B”). When the flexible woven member 514 is in the locked configuration, the artificial chordae can be moved in the first direction (arrow“A”) or the second direction (arrow“B”). In some embodiments, the actuator 520 (or a separate member coupled to the actuator) can extend through a catheter such that a user can manually adjust the position of the actuator and can selectively move the flexible woven member 514 between the locked and unlocked configurations from a location outside the patient.

[0065] In use, the second end 516 of the flexible woven member 514 can be fixed relative to the body portion 508, while the first end 518 of the flexible woven member can be moved with the actuator 520. Moving the actuator 520 in the first direction (arrow“A”) Figure 5A causes the flexible woven member 514 to assume the unlocked configuration in which the first outer diameter“OD1” of the flexible woven member does not impede movement of the artificial chordae 502 in the first direction (arrow“A”). Moving the actuator 520 in the second direction (arrow“B”) causes the flexible woven member 514 to assume the locked configuration in which the flexible woven member 514 expands to have a second outer diameter“OD2” that is greater than the first outer diameter“OD1”.

[0066] In some embodiments, the actuator 520 can be moved in the first direction (arrow“A”) such that the flexible woven member 514 assumes a second outer diameter“OD2” that is the same as an inner diameter“ID” of the housing portion 512. In Figure 5BIn the illustrated locked configuration, the outer diameter "OD2" of the flexible woven member 514 is large enough to press the artificial chordae 502 into engagement with the sidewall 522 of the housing portion 512. In some embodiments, the force of the flexible woven member 514 against the artificial chordae 502 results in friction between the artificial chordae 502, the flexible woven member 514, and the sidewall 522 of the housing portion 512, thereby preventing the artificial chordae 502 from moving in the first direction or the second direction.

[0067] In some embodiments, moving the artificial chordae in the direction of arrow "A" will tend to tighten the artificial chordae 502 between the device 500 and the leaflets 150 of the heart valve. Figure 2 ) between the device 500 and the leaflets 150 of the heart valve. With the device 500 coupled to the papillary muscle or heart wall 152 Figure 2 ), tension can be achieved in the artificial chordae 502 to effect a reduction in regurgitation of blood through the heart valve. Observations of the regurgitation can be made via transesophageal echocardiography, fluoroscopy, etc. to determine whether the target effect has been achieved with the artificial chordae 502 in place. If, upon observation, the user determines that the tension in the artificial chordae 502 is to be increased, the user can move the actuator 520 in the first direction (arrow "A") to release the artificial chordae 502 from the frictional lock against the sidewall 522. The user can then apply additional tension to the artificial chordae (e.g., using a control filament that can be manipulated from the proximal end of the catheter) to move it further in the first direction (arrow "A"). When the target tension is reached, the actuator 520 can be moved in the second direction (arrow "B") to lock the artificial chordae 502 against the sidewall 522. This can be followed by additional observations of the regurgitation, followed by additional tensioning, and so on.

[0068] If, upon observation, the user determines that the tension in the artificial chordae 502 is to be decreased, the artificial chordae can be moved in the second direction (arrow "B"). In this case, the user can move the actuator 520 in the first direction (arrow "A") to release the artificial chordae 502 from the frictional lock against the sidewall 522, and the tension in the artificial chordae 502 can be decreased to move it further in the first direction (arrow "A"). When the decreased tension is reached, the actuator 520 can be moved in the second direction (arrow "B") to lock the artificial chordae 502 against the sidewall 522. This can be followed by additional observations of the regurgitation, followed by additional tensioning / relaxing, and so on.

[0069] After the tensioning process is complete, the actuator 520 can be locked to the housing portion by, for example, crimping, cutting and bonding, swaging, or other mechanical techniques. The remaining portion of the actuator 520 (i.e., the portion that resides in the catheter) can be disconnected from the portion of the actuator that remains locked to the housing portion 512 and can be removed via the catheter. The control filament can similarly be detached from the first end 524 of the artificial chordae 502 and removed via the catheter.

[0070] Referring now to Figures 6A-6C , an embodiment of a device 600 for adjusting the tension of an artificial chordae 602 according to the present application is shown. The device 600 can include an anchor having a tissue-engaging portion 606, a body portion 608, and a locking portion 610. As will be described, the locking portion 610 can be coupled to the artificial chordae 602 to allow the artificial chordae to move when the locking portion is in an unlocked configuration, and to prevent the artificial chordae from moving when the locking portion is in a locked configuration. In this way, a user can move the artificial chordae 602 in a direction that tends to increase the tension thereon, and when movement stops, the artificial chordae can be held in place by the locking portion 610 to maintain the applied tension.

[0071] The artificial chordae 602 is shown in Figure 6A , 6B as having a first end 624 and a second end 626. In some embodiments, the first end 624 can be coupled to a control filament (not shown) that passes through a catheter to a location where a user can manipulate (e.g., move) the artificial chordae 602. In some embodiments, the first end 624 can include a loop or other connection mechanism (not shown) through which the control filament can be coupled. After the tensioning process is complete, the control filament can be detached from the first end 624 and removed via the catheter. The second end 626 of the artificial chordae 602 can extend within the heart to directly or indirectly couple to one or more leaflet clips 206 Figure 2 ). In some embodiments, the second end 626 can be coupled to a filament 200 Figure 2 , which in turn is coupled to one or more leaflet clips 206.

[0072] In the illustrated embodiment, the locking portion 610 includes a housing portion 612 and a coil portion 616, a bearing member 614 is disposed within the housing portion 612, and the coil portion 616 is coupled to an end of the housing portion 612 opposite the body portion 608. The bearing member 614 can be disposed within the housing portion 612 such that it is oriented perpendicular to the artificial chordae 602. The bearing member 614 can be coupled to opposite interior surfaces 618, 620 of the housing portion 612 at opposite ends to lock the bearing member to the housing portion. In some non-limiting example embodiments, the bearing member 614 can rotate about its axis relative to the housing portion 612. The artificial chordae 602 can be disposed through a longitudinal opening 622 in the coil portion 616 and can loop around the bearing member 614 such that first and second ends 624, 626 of the artificial chordae extend through an upper end 628 of the coil portion.

[0073] As can be best seen in Figure 6C FIG. 6, the longitudinal opening 622 in the coil portion 616 can have an inner diameter "CID" that is less than twice the diameter "D" of the artificial chordae 602 when the locking portion 610 is in the locked configuration. Thus, in the locked configuration, the coil portion 616 can exert an inward force on the two portions of the artificial chordae 602 to squeeze them together to prevent the artificial chordae from moving relative to the coil portion.

[0074] To arrange the locking portion 610 in the unlocked configuration, the actuator 630 can engage the coil portion 616 to selectively increase the inner diameter "CID" to reduce the force exerted on the two portions of the artificial chordae 602 by an amount that allows the artificial chordae to move through the coil portion 616. In some embodiments, the actuator 630 (or a separate member coupled to the actuator) can extend through the catheter such that a user can manually adjust the position of the actuator from a location outside the patient's body.

[0075] The actuator 630 can be a hollow pushrod having a lumen 632 and a tapered tip portion 634. The lumen 632 can be sized such that its inner diameter is greater than twice the diameter "D" of the artificial chordae 602 to enable the artificial chordae to move freely therein. The actuator 630 can also include a longitudinal slot 636 to allow the second end 626 of the artificial chordae to protrude therefrom to access the leaflet clip 206 Figure 2 ). The first end 624 can be received within the lumen 632 of the actuator 630 to be connected to the control filament in the manner previously described.

[0076] In use, the actuator 630 is moved in the first direction "C" to engage the tapered tip portion 634 with the upper end 628 of the coil portion 616. Further driving the actuator 630 in the first direction "C" unfolds the coil portion 616, thereby increasing the inner diameter "CID" of the coil portion 616. In use, the actuator 630 can be driven to engage with the coil portion 616 until the tapered tip portion 634 is positioned adjacent to the bearing member 614. Figure 6F and 6G In the position shown, the coil portion 616 is in an expanded state, preventing it from clamping the artificial chordae tendineae. The locking portion 610 is therefore shown in an unlocked state, allowing the user to adjust the position of the artificial chordae tendineae to adjust the device 600 and one or more attached leaflet clips 206. Figure 2 The tension between the two. Moving the actuator 630 in the second direction "D" allows the inner diameter "CID" of the coil portion 616 to return the locking portion 610 to the locked state, wherein the inner diameter "CID" of the coil portion is less than twice the diameter "D" of the artificial tendon chord 602, thereby preventing the artificial tendon chord from moving in the first direction "A" or the second direction "B".

[0077] In some embodiments, moving the artificial chordae tendineae in the direction of arrow "A" will tend to tighten the device 600 and the leaflet 150 of the heart valve. Figure 2 Artificial tendineae 602 between the papillary muscles and the cardiac wall 152. The device 600 is connected to the papillary muscles or the cardiac wall 152. Figure 2 In the case of [a specific condition], a target tension can be achieved in the artificial chordae tendineae 602 to achieve the target effect of suppressing blood regurgitation through the heart valves. Observation of the regurgitation can be performed via transesophageal echocardiography, fluoroscopy, etc., to determine whether the target effect has been achieved with the artificial chordae tendineae 602 in the appropriate position. If, after observation, the user determines that the tension in the artificial chordae tendineae 602 needs to be increased, the user can move the actuator 630 to enlarge the inner diameter "CID" of the coil portion 616 to release the segments of the artificial chordae tendineae from frictional lock against each other and the inner surface of the coil portion, allowing the user to apply additional tension to the artificial chordae tendineae to move it further in the first direction (arrow "A"). When the target tension is reached, the actuator 630 can move to return the inner diameter "CID" of the coil portion 616 to its original position, thereby locking the segments of the artificial chordae tendineae 602 against each other and to the inner surface of the coil portion. Further regurgitation observations can then be performed, followed by further tensioning, and so on.

[0078] If, upon observation, the user determines to reduce the tension in the artificial chordae 602, the artificial chordae can be caused to move in a second direction (arrow "B"). In this case, the user can move the actuator 630 to release the segments of the artificial chordae 602 from the frictional lock against each other and the inner surface of the coil portion 616, so that the user can reduce the tension in the artificial chordae to cause it to move in the second direction (arrow "B"). When the target reduced tension is reached, the actuator 630 can be moved to return the inner diameter "CID" of the coil portion 616 to its original position, thereby locking the segments of the artificial chordae 602 to each other and to the inner surface of the coil portion. This can be followed by additional retrograde observation, followed by additional tensioning / relaxing, and so on.

[0079] Upon completion of the tensioning process, the actuator 630 can be locked to the housing portion by, for example, crimping, cutting and gluing, swaging, or other mechanical techniques. The remaining portion of the actuator 630 (i.e., the portion that resides in the catheter) can be severed and can be removed via the catheter.

[0080] Reference is now made to Figures 7A-7B , which shows an embodiment of a locking portion 700 for adjusting the tension of an artificial chordae 702, in accordance with the present application. The locking portion 700 can be interchanged with any of the locking portions disclosed with respect to the devices 300-600, as appropriate. Thus, the locking portion 700 can be combined with any of the tissue engagement portions, body portions, and housing portions previously described, in order to provide an anchor that includes features that enable a user to tension and / or relax, as well as lock, the artificial chordae between the anchor, which can be coupled to the papillary muscle or heart wall, and the clip, which can be coupled to the leaflets of the heart valve. Figures 3A-6A

[0081] As will be described, the locking portion 700 can be coupled to the artificial chordae 702 to allow the artificial chordae to move in a first direction (arrow "A"), while preventing the artificial chordae from moving in a second direction (arrow "B") that is opposite the first direction. In this manner, the user can move the artificial chordae 702 in a direction that tends to increase the tension thereon, and when movement is stopped, the artificial chordae will be held in place by the locking portion 700, in order to thereby maintain the applied tension.

[0082] The artificial chordae are in Figure 7A , 7B ​The artificial tendon chord 702 is shown having a first end 724 and a second end 726. In some embodiments, the first end 724 may be coupled to a control filament (not shown) that passes through a catheter to a location where the user can manipulate (e.g., move) the artificial tendon chord 702. In some embodiments, the first end 724 may include a loop or other connecting mechanism through which the control filament can be coupled. After the tensioning process is completed, the control filament can be detached from the first end 724 and removed via the catheter. The second end 726 of the artificial tendon chord 702 may extend within the heart to be coupled directly or indirectly to one or more leaflet clips 206. Figure 2 In some embodiments, the second end 726 may be connected to the filament 200. Figure 2 The filament 200 is then connected to one or more leaf clips 206.

[0083] In the illustrated embodiment, the locking portion 700 includes a body portion 701 having openings 703A, 703B through which the artificial tendon chord 702 is disposed. The body portion 701 may accommodate a locking body 704 having a hole 706 for receiving the artificial tendon chord 702. The locking body 704 may be a generally rectangular member (although the specific shape is not critical) coupled to an actuator 708 for moving the locking body within the body portion 701.

[0084] The locking body 704 can be received within an opening 710 in the body portion 701. The opening 710 may have a first wall 712 and a second wall 714. In the illustrated embodiment, when the locking portion 700 is in the unlocked state ( Figure 7A When the first wall 712 is in place, it is oriented parallel to the first side 716 of the locking body 704. The second wall 714 may be oriented at an oblique angle relative to the first wall 712.

[0085] exist Figure 7A In the unlocked configuration, the artificial tendon chord 702 is arranged along a substantially linear path passing through openings 703A and 703B in the main body portion 701 and holes 706 in the locking body 704. In this configuration, the artificial tendon chord 702 can move in a first direction and a second direction (arrows “A” and “B”, respectively) to increase or decrease the tension in the artificial tendon chord.

[0086] To lock the artificial tendon 702 in place, the actuator 708 can move in a first direction (arrow "A"). This movement causes the locking body 704 to move in the first direction (arrow "A") until the locking body engages with the angled second wall 714 of the opening 710 in the body portion 701. Upon engagement with the angled second wall 714, the lower portion of the locking body 704 can stop moving, while the upper portion of the locking body can continue moving until it approaches the angled second wall, causing the locking body to rotate to present... Figure 7B The inclined configuration is shown. In this configuration (referred to as the locking configuration), the hole 706 in the locking body 704 is oriented at an oblique angle relative to the first opening 703A and the second opening 703B of the body portion 701. In this orientation, the locking body 704 clamps the artificial tendon chord 702, preventing it from moving freely through the hole 706 or the first opening 703A and the second opening 703B.

[0087] With this arrangement, by moving the actuator 708 in the first and second directions (arrows "A" and "B"), a user can selectively lock and unlock the locking portion 700. In some embodiments, the actuator 708 (or a separate component coupled to the actuator) may extend through a catheter, allowing the user to manually adjust the position of the actuator from a location outside the patient's body.

[0088] Locking portion 700 can be locked and unlocked even without an actuator. Therefore, in some embodiments, when the artificial tendon chord 702 moves in the first direction "A", the friction between the artificial tendon chord and the locking body 704 causes the locking body to move toward the first wall 712, thereby aligning the hole 706 with the openings 703A, 703B in the body portion 701 and unlocking the locking portion 700. Similarly, when the artificial tendon chord 702 moves in the second direction "B", the friction between the artificial tendon chord and the locking body 704 causes the locking body 704 to move toward the second wall 714, thereby tilting the locking body. Figure 7B ), and clamp the artificial tendon chord within the hole 706 and prevent the artificial tendon chord from moving further through the hole.

[0089] The tension and relaxation of the artificial chordae tendineae 702 can be achieved by unlocking the locking part 700, adjusting the tension, and then relocking the locking part. This can be done as previously discussed... Figures 1-6C The visualization is performed in the manner described in the embodiments, and then the tension in the artificial tendon 702 is readjusted.

[0090] After the tensioning process is completed, the actuator 708 can be locked in place by means of, for example, crimping, cutting and bonding, forging or other mechanical techniques. The remaining portion of the actuator 708 (i.e., the portion residing in the conduit) can be disconnected from the actuator portion and can be removed via the conduit.

[0091] Reference is now made to Figure 8A , which shows an embodiment of a locking portion 800 for adjusting tension of an artificial chordae 802 according to the present application. The locking portion 800 can be interchanged with any of the locking portions disclosed with respect to the devices 300-600 as appropriate. Thus, the locking portion 800 can be combined with any of the tissue engaging portions, body portions, and housing portions previously described in order to provide an anchor that includes features that enable a user to tension and / or relax, as well as lock the artificial chordae between the anchor that can be coupled to a papillary muscle or heart wall and the clip that can be coupled to a leaflet of a heart valve. Figures 3A-6A

[0092] As will be described, the locking portion 800 can be coupled to the artificial chordae 802 to allow the artificial chordae to move in a first direction (arrow“A”) while preventing the artificial chordae from moving in a second direction (arrow“B”) opposite the first direction. In this manner, a user can move the artificial chordae 802 in a direction that tends to increase the tension thereon, and when movement stops, the artificial chordae will be held in place by the locking portion 800, thereby maintaining the applied tension.

[0093] The artificial chordae is shown in Figure 8A as having a first end 824 and a second end 826. In some embodiments, the first end 824 can be coupled to a control filament (not shown) that passes through a catheter to a location where a user can manipulate (e.g., move) the artificial chordae 802. In some embodiments, the first end 824 can include a loop or other connection mechanism through which the control filament can be coupled. After the tensioning process is complete, the control filament can be decoupled from the first end 824 and removed via the catheter. The second end 826 of the artificial chordae 802 can extend within the heart to directly or indirectly couple to one or more leaflet clips 206 Figure 2 ). In some embodiments, the second end 826 can be coupled to a filament 200 Figure 2 that in turn couples to one or more leaflet clips 206.

[0094] ​In the illustrated embodiment, the locking portion 800 includes a body portion 801 having an opening 803 through which the artificial tendon chord 802 is disposed. The body portion 801 may accommodate a rotatable locking body 804 having an engagement surface 806 for selectively engaging the artificial tendon chord 802. In some embodiments, the engagement surface 806 may have a curved shape and may also include surface textures or surface features configured to enhance engagement between the engagement surface and the artificial tendon chord. The rotatable locking body 804 may also be coupled to a pin 805, which in turn is coupled to the body portion 801, thereby allowing the rotatable locking body to rotate relative to the body portion 801.

[0095] With this arrangement, when the artificial tendon chord 802 moves in the first direction (arrow "A"), the contact between the artificial tendon chord and the engagement surface 806 of the rotatable locking body 804 causes the rotatable locking body to rotate about the pin 805, preventing the rotatable locking body from clamping the artificial tendon chord. When the artificial tendon chord 802 moves in the second direction (arrow "B"), the contact between the artificial tendon chord and the engagement surface 806 of the rotatable locking body 804 causes the rotatable locking body to rotate in the opposite direction about the pin 805, clamping the artificial tendon chord between the engagement surface and the body portion 801, thereby preventing further movement of the artificial tendon chord.

[0096] In some embodiments, movement of the artificial chordae tendineae in the direction of arrow "A" will tend to increase the distance between the artificial chordae tendineae and the leaflet 150 of the heart valve. Figure 2 The tension between the artificial chordae tendineae and the chordae tendineae. When the locking portion 800 is incorporated into the device connected to the papillary muscle or the heart wall 152, the target tension can be achieved in the artificial chordae tendineae 802 to achieve the target effect of inhibiting blood regurgitation through the heart valves. The regurgitation can be observed via transesophageal echocardiography, fluoroscopy, etc., to determine whether the target effect has been achieved with the artificial chordae tendineae 802 in the appropriate position. If, after observation, the user determines that the tension in the artificial chordae tendineae 802 needs to be increased, the user can apply additional tension to the artificial chordae tendineae to move it further in the first direction (arrow “A”), and then perform further observations, and so on.

[0097] If, after observation, the user determines that a reduction in tension in the artificial chord 802 is desired, the artificial chord can be moved in the second direction (arrow "B"). However, as described, the arrangement of the locking portion 800 prevents movement of the artificial chord 802 in the second direction. Therefore, the locking portion 800 may include an actuator 808 configured to manually rotate the rotatable locking body 804 away from the artificial chord to reduce friction between the artificial chord 802, the rotatable locking body, and the body portion 801, allowing the artificial chord 802 to move in the second direction (arrow "B"), resulting in a targeted reduction in tension in the artificial chord. In the illustrated embodiment, the actuator 808 is a filament disposed through the central portion of the rotatable locking body 804. The actuator 808 can be routed through a conduit to a position where the user can actuate the actuator to "unlock" the locking portion 800.

[0098] Once tension has been reduced, regurgitation can be observed via transesophageal echocardiography, fluoroscopy, etc., to determine if the target effect has been achieved. Additional adjustments can be made to the artificial chordae tendineae 802 in the first and / or second directions until the target effect on valvular regurgitation is achieved. After the tensioning process is complete, the actuator 808 can be disengaged from the rotatable locking body 804 and removed via a catheter.

[0099] Figure 8B An alternative embodiment of the locking portion 800 is described, which includes first and second opposing rotatable locking bodies 804A, 804B, between which an artificial chordae tendineae 802 can be received. Operation of this embodiment is compatible with... Figure 8A The operation of the embodiments is the same or similar. For example, when the artificial tendon cord attempts to move in the "B" direction, it will rotate the two locking bodies 804A, 804B, which will clamp the artificial tendon cord between them.

[0100] Figures 8C-8D Another alternative embodiment of a locking portion 800, including a single rotatable locking body 804 and an alignment member 809, is shown. The alignment member 805 may be secured to the rotatable locking body 804 to hold the rotatable locking body in a target orientation during operation. The alignment member 809 may include a bearing member 807 around which an artificial tendon 802 is disposed, thereby forcing the artificial tendon 802 through a predetermined serpentine path through the locking portion 800. Thus, when the artificial tendon 802 moves in a first direction (arrow “A”), in addition to the force applied to the engagement surface 811 of the rotatable locking body 804, the artificial tendon also applies a force to the bearing member 807, thereby tending to pull the alignment member 809 upwards to remove the rotatable locking body from a locked position. Figure 8D Rotate to unlocked position. Figure 8ESimilarly, when the artificial tendon 802 moves in the second direction (arrow "B"), in addition to the force applied to the engagement surface 811 of the locking body, the artificial tendon also applies a force to the bearing member 807, thereby tending to pull the alignment member 809 downwards to move the rotatable locking body from the unlocked position. Figure 8E Rotate to locked position. Figure 8D ).

[0101] Now for reference Figures 9A-9E Various embodiments of locking portions 900A-E according to the invention for adjusting the tension of an artificial tendon chord 902 are shown. In some embodiments, the artificial tendon chord 902 may have a first end 924 which may be coupled to a control filament (not shown) that passes through a catheter to a position where the user can manipulate (e.g., move) the artificial tendon chord 902. The artificial tendon chord may have a second end 926 which may extend within the heart to be coupled directly or indirectly to one or more leaflet clips 206 ( Figure 2 In some embodiments, the second end 926 may be connected to the filament 200. Figure 2 The filament 200 is then connected to one or more leaf clips 206. The locking portions 900A-E can be adjusted as appropriate with respect to... Figures 3A-6A Any of the locking portions disclosed in devices 300-600 are interchangeable. Thus, locking portions 900A-E can be combined with any of the previously described tissue engagement portions, body portions, and housing portions to provide an anchor, the anchor including features that allow the user to tension and / or relax, and lock the artificial chordae tendineae between an anchor that can be coupled to the papillary muscle or the heart wall and a clip that can be coupled to the leaflets of the heart valve.

[0102] Embodiments of the locking portions 900A-E include several common features. For example, each of the locking portions 900A-E may include a body portion 901A-E and a clamping element 904A-E, wherein the clamping element is biased to engage with the body portion 901A-E to clamp a portion of the artificial tendon chord 902 therebetween. In some non-limiting example embodiments, the clamping element 904A-E may be biased to engage with the body portion 901A-E via a hinge 905A-E, which in some embodiments is a movable hinge comprising a thin, flexible hinge made of the same material as the clamping element and the body portion. The clamping element 904A-E may be an integrally formed part of the body portion 901A-E, or it may be a separate part joined to the body portion by any suitable technique (e.g., welding, gluing, press fitting).

[0103] The clamping elements 904A-E can have clamping faces 906A-E that engage the artificial chordae tendinae 902 and press the artificial chordae tendinae 902 against engagement faces 910A-E of the respective body portions 901A-E. The clamping faces 906A-E can have any of a variety of shapes and can also or instead include surface texturing or coatings to enhance engagement between the clamping faces and the artificial chordae tendinae 902. The engagement faces 910A-E can have shapes that correspond or mate with the shapes of the associated clamping faces 906A-E, and can also include surface texturing or coatings to enhance engagement between the engagement faces and the artificial chordae tendinae 902.

[0104] Figure 9A The locking portion 900A of FIG. 1 includes a clamping face 906A having a plurality of barbs 907A that are receivable within corresponding recesses 909A in the engagement face 910A of the body portion 901A. Figure 9B The locking portion 900B of FIG. 2 includes a clamping face 906B having a curved geometry that is receivable by a corresponding curved surface of the engagement face 910B of the body portion 901B. Figure 9C The locking portion 900C of FIG. 3 includes a clamping face 906C having a plurality of barbs 907C that are engageable with a flat surface of the engagement face 910C of the body portion 901C. Figure 9D The locking portion 900D of FIG. 4 includes a clamping face 906D that includes a plurality of curved portions 907D that are receivable within corresponding recesses 909D in the engagement face 910D of the body portion 901D. Figure 9E The locking portion 900E of FIG. 5 includes a clamping face 906E that includes a plurality of protrusions 907E that are receivable within corresponding recesses 909E in the engagement face 910E of the body portion 901E.

[0105] The locking portions 900A-E are shown in a locked configuration. Thus, in the illustrated configuration, the locking portions 900A-E allow the artificial chordae tendinae 902 to move in a first direction (arrow“A”) and prevent the artificial chordae tendinae from moving in a second direction (arrow“B”) opposite the first direction. As should be appreciated, moving the artificial chordae tendinae 902 in the first direction (arrow“A”) tends to move the clamping elements 904A-E away from the body portions 901A-E, thereby reducing friction between the components and allowing the artificial chordae tendinae to pass. In contrast, moving the artificial chordae tendinae 902 in the second direction (arrow“B”) tends to move the clamping elements 904A-E toward the associated body portions 901A-E, which increases friction between the components and locks the artificial chordae tendinae to the locking portions 900A-E.

[0106] In some embodiments, moving the artificial chordae tendineae 902 in the direction of arrow "A" will tend to increase the space between the artificial chordae tendineae and the leaflet 150 of the heart valve. Figure 2 The tension between the artificial chordae tendineae (902 and 900A-E) is considered. When the locking portions 900A-E are incorporated into the device connected to the papillary muscle or the heart wall 152, the target tension can be achieved in the artificial chordae tendineae 902 to achieve the target effect of suppressing blood regurgitation through the heart valves. The regurgitation can be observed via transesophageal echocardiography, fluoroscopy, etc., to determine whether the target effect has been achieved with the artificial chordae tendineae 902 in the appropriate position. If, after observation, the user determines that the tension in the artificial chordae tendineae 902 needs to be increased, the user can apply additional tension to the artificial chordae tendineae to move it further in the first direction (arrow “A”), and then conduct further observations, and so on.

[0107] If, after observation, the user determines that a reduction in tension in the artificial chord 902 is desired, the artificial chord can be moved in the second direction (arrow "B"). However, as described, the arrangement of the locking portions 900A-E prevents movement of the artificial chord 902 in the second direction. Therefore, the locking portions 900A-E may include an actuator 908 configured to manually rotate the clamping elements 904A-E about the hinges 905A-E to move the clamping elements away from the artificial chord and the body portions 901A-E, reducing friction between the artificial chord 902, the clamping elements 904A-E, and the body portions 901A-E, to allow movement of the artificial chord 902 in the second direction (arrow "B"). Movement of the artificial chord 902 in the second direction can result in a targeted reduction in tension in the artificial chord. In the illustrated embodiment, the actuator 908 is a filament coupled to the clamping elements 904A-E of the locking portions 900A-E. Actuator 908 can pass through a conduit to the location where the user can actuate the actuator to “unlock” the locking section 900A-E.

[0108] Once tension has been reduced, regurgitation can be monitored via transesophageal echocardiography, fluoroscopy, etc., to determine if the target effect has been achieved. Additional adjustments can be made to the artificial chordae tendineae 902 in the first and / or second directions until the target effect on valvular regurgitation is achieved. After the tensioning process is complete, the actuator 908 can disengage from the locking portions 900A-E and can be removed via a catheter.

[0109] Now for reference Figure 10A and 10B An embodiment of a locking portion 1000 for adjusting the tension of an artificial tendon chordae 1002 according to the present invention is shown. The locking portion 1000 may be used as appropriate with respect to... Figures 3A-6AThe locking portion 1000 can be interchanged with any of the locking portions 300-600 disclosed above. Thus, the locking portion 1000 can be combined with any of the tissue engagement portions, body portions, and housing portions described above to provide an anchor that includes features that enable a user to tension and / or relax, as well as lock, the artificial chordae tendinae between the anchor that can be coupled to the papillary muscle or heart wall and the clip that can be coupled to the leaflet of the heart valve.

[0110] The locking portion 1000 can include a first clip member 1004A and a second clip member 1004B coupled at one end by a hinge 1006, which in one non-limiting example embodiment is a living hinge. The first clip member 1004A and the second clip member 1004B can be biased toward one another by the living hinge (e.g., in the closed configuration shown). Figure 10B The first clip member 1004A and the second clip member 1004B can each have a clamping face 1000A, 1000B for engaging the artificial chordae tendinae 1002 therebetween. In the embodiment shown, the clamping faces 1000A, 1000B include a plurality of protrusions 1006A, 1006B; 1008A, 1008B. Each of the plurality of protrusions can be received between adjacent protrusions of the opposing clamping face 1000A, 1000B.

[0111] The upper ends 1010A, B of each of the first clip member 1004A and the second clip member 1004B can combine to form an opening 1012 for receiving the artificial chordae tendinae 1002 therethrough. An opening 1014 can also be provided in the hinge 1006 for receiving the artificial chordae tendinae 1002 therethrough.

[0112] Figure 10A The locking portion 1000 is shown in the unlocked configuration, which can allow the artificial chordae tendinae to move relative to the locking portion. In contrast, Figure 10B The locking portion 1000 is shown in the locked configuration, in which the artificial chordae tendinae 1002 is prevented from moving relative to the locking portion. As should be appreciated, in the locked configuration, the artificial chordae tendinae 1002 is forced to conform to the shape of the plurality of protrusions 1006A, 1006B; 1008A, 1008B. The frictional forces between the protrusions and the artificial chordae tendinae 1002 can prevent the artificial chordae tendinae from moving in the first direction or the second direction.

[0113] In some embodiments, moving the artificial chordae tendinae 1002 in the direction of arrow “A” will tend to increase the tension between the artificial chordae tendinae and the leaflet 150 of the heart valve. Figure 2 In this case, the user can reconfigure the locking portion 1000 to assume the unlocked configuration Figure 10B) to allow the artificial chordae 1002 to move in a first direction (arrow“A”) to increase tension in the artificial chordae. In the case where the locking portion 1000 is incorporated into a device that is coupled to the papillary muscle or heart wall 152, a target tension can be achieved in the artificial chordae 1002 to achieve a target effect on regurgitation of blood through the heart valve. Observations of regurgitation can be made via transesophageal echocardiogram, fluoroscopy, etc. to determine whether the target effect has been achieved with the artificial chordae 1002 in place. If, after observation, the user determines that the tension in the artificial chordae 1002 is to be increased, the locking portion can be unlocked and the user can apply additional tension to the artificial chordae to move it further in the first direction (arrow“A”), followed by additional observation, and so on.

[0114] If, after observation, the user determines that the tension in the artificial chordae 1002 is to be decreased, the artificial chordae can be moved in a second direction (arrow“B”). In this case, the user can reconfigure the locking portion 1000 to assume an unlocked configuration Figure 10B ) to allow the artificial chordae 1002 to move in a second direction (arrow“B”) to decrease tension in the artificial chordae. When a target decreased tension is achieved, the locking portion 1000 can be reconfigured to assume a locked configuration Figure 10A ), to lock the artificial chordae 1002 to the locking portion 1000. This can be followed by additional observation of regurgitation, followed by additional tensioning / relaxing, and so on.

[0115] To arrange the locking portion 1000 in the unlocked configuration, the actuator 1030 can engage the first and second clamp members 1004A, 1004B to move them apart, thereby reducing or eliminating the clamping force applied to the artificial chordae (not shown) so that the artificial chordae 1002 can move through the locking portion. In some embodiments, the actuator 1030 (or a separate member coupled to the actuator) can extend through a catheter so that the user can manually adjust the position of the actuator from a location outside the patient’s body.

[0116] The actuator 1030 can be a hollow pushrod having a lumen 1032 and a tapered tip portion 1034. The lumen 1032 can be sized to accommodate the artificial chordae 1002 and to enable the artificial chordae to move freely therein.

[0117] In use, moving the actuator 1030 in the first direction "C" causes the tapered tip portion 1034 to engage the opening 1012 formed by the first clamp member 1004A and the second clamp member 1004B. Further driving the actuator 1030 in the first direction "C" causes the first clamp member 1004A and the second clamp member 1004B to spread apart an amount such that the artificial chordae tendinae 1002 can move in the first direction and the second direction ("A", "B") (FIGS. 10A-10B). A user can then adjust the position of the artificial chordae tendinae 1002 to adjust the tension between the anchor and the one or more attached leaflet clips 206 (FIGS. 10C-10D). Moving the actuator 1030 in the second direction "D" allows the first clamp member 1004A and the second clamp member 1004B to return the locking portion 1000 to the locked configuration, where the first clamp member 1004A and the second clamp member 1004B clamp the artificial chordae tendinae 1002, thereby preventing the artificial chordae tendinae from moving in the first direction "A" or the second direction "B". Figure 10A Figure 2 Figure 10D

[0118] Referring now to Figure 11A and Figure 11B , embodiments of a locking portion 1100 for adjusting the tension of an artificial chordae tendinae 1102 according to the present application are shown. The locking portion 1100 can be interchanged with any of the locking portions disclosed with respect to the devices 300-600 as appropriate. Thus, the locking portion 1100 can be combined with any of the tissue engagement portions, body portions, and housing portions previously described in order to provide an anchor that includes features that enable a user to tension and / or relax, as well as lock, the artificial chordae tendinae between the anchor, which can be coupled to a papillary muscle or heart wall, and a clip that can be coupled to a leaflet of a heart valve. Figures 3A-6A

[0119] The artificial chordae tendinae is shown in Figure 11A , Figure 11B with a first end 1124 and a second end 1126. In some embodiments, the first end 1124 can be coupled to a control filament (not shown) that passes through a catheter to a location where a user can manipulate (e.g., move) the artificial chordae tendinae 1102. In some embodiments, the first end 1124 can include a loop or other connection mechanism through which the control filament can be coupled. After the tensioning process is complete, the control filament can be decoupled from the first end 1124 and removed via the catheter.

[0120] ​​​​The locking portion 1100 can include a body portion 1104, a plunger 1106, a spring member 1108, and an end cap 1110. In the illustrated embodiment, the spring member 1108 can be made of silicone or other compressible material. The spring member can be molded into a shape that elastically engages the plunger 1106 to bias the locking portion 1100 into a locked position. Due to the compressibility of the spring member 1108, applying a force to the plunger 1106 can compress the spring member 1108 to move the locking portion 1100 from the locked position to an unlocked position. The body portion 1104 can include a first lateral opening 1112 and a second lateral opening 1114 for receiving the artificial chordae tendinae 1102 therethrough. The plunger 1106 can include an opening 1116 for receiving the artificial chordae tendinae 1102 therethrough.

[0121] Figure 11A The locking portion 1100 is shown in an unlocked configuration, with the first lateral opening 1112 and the second lateral opening 1114 aligned with the opening 1116 in the plunger 1106. This can allow the artificial chordae tendinae 1102 to move relative to the locking portion in either of the first and second directions (arrows “A” and “B”). In contrast, Figure 11B The locking portion 1100 is shown in a locked configuration, with the plunger 1106 moved in the direction of arrow “C” such that the opening 1116 is not aligned with the first lateral opening 1112 and the second lateral opening 1114 of the body portion 1104. This arrangement can clamp the artificial chordae tendinae 1102 between the surfaces of the plunger and the body portion, thereby preventing the artificial chordae tendinae from moving relative to the locking portion in either of the first and second directions (arrows “A” and “B”). In some embodiments, the end cap 1110 can provide a fixed surface against which the spring member 1108 can press to bias the plunger in the direction of arrow “C” such that the locking portion 1100 is biased in the locked configuration. Figure 11B The locking portion 1100 is shown in an unlocked configuration, with the first lateral opening 1112 and the second lateral opening 1114 aligned with the opening 1116 in the plunger 1106. This can allow the artificial chordae tendinae 1102 to move relative to the locking portion in either of the first and second directions (arrows “A” and “B”). In contrast, Figure 11B The locking portion 1100 is shown in an unlocked configuration, with the first lateral opening 1112 and the second lateral opening 1114 aligned with the opening 1116 in the plunger 1106. This can allow the artificial chordae tendinae 1102 to move relative to the locking portion in either of the first and second directions (arrows “A” and “B”). In contrast, Figure 11A The locking portion 1100 is shown in an unlocked configuration, with the first lateral opening 1112 and the second lateral opening 1114 aligned with the opening 1116 in the plunger 1106. This can allow the artificial chordae tendinae 1102 to move relative to the locking portion in either of the first and second directions (arrows “A” and “B”). In contrast,

[0122] In some embodiments, moving the artificial chordae tendinae 1102 in the direction of arrow “A” will tend to increase the tension in the artificial chordae tendinae and the leaflets 150 of the heart valve (Figure 2 ) between the locking portion 1100 and the artificial chordae 1102. In the case where the locking portion 1100 is incorporated into a device that is coupled to a papillary muscle or heart wall 152, a target tension can be achieved in the artificial chordae 1102 to achieve a target effect on regurgitation of blood through a heart valve. Observations of regurgitation can be made via transesophageal echocardiography, fluoroscopy, etc. to determine whether the target effect has been achieved with the artificial chordae 1102 in place. If, upon observation, the user determines that the tension in the artificial chordae 1102 is to be increased, the user can reconfigure the locking portion 1100 to assume an unlocked configuration Figure 11A ) to allow the artificial chordae 1102 to move in a first direction (arrow “A”) to increase the tension in the artificial chordae.

[0123] If, upon observation, the user determines that the tension in the artificial chordae 1102 is to be decreased, the artificial chordae can be moved in a second direction (arrow “B”). In this case, the user can reconfigure the locking portion 1100 to assume an unlocked configuration Figure 11A ), to allow the artificial chordae 1102 to move in a second direction (arrow “B”) to decrease the tension in the artificial chordae.

[0124] When the target decreased tension is achieved, the locking portion 1100 can be reconfigured to assume a locked configuration Figure 11B ) to lock the artificial chordae 1102 to the locking portion 1100. This can be followed by additional observations of regurgitation, followed by additional tensioning / relaxing, and so on.

[0125] The actuator 1118 can pass through a catheter to a location where the user can actuate the actuator to “unlock” the locking portion 1100. Upon completion of the tensioning process, the actuator 1118 can be disengaged from the locking portion 1100 and can be removed via a catheter.

[0126] Figure 11C -F shows alternative embodiments of the concepts described with respect to Figure 11A -B. Accordingly, each of these embodiments includes a body portion 1104C-F, a plunger 1106C-F, a spring member 1108C-F, and an end cap 1110C-F. The body portion 1104C-F can include a first lateral opening 1112C-F and a second lateral opening 1114C-F for receiving the artificial chordae 1102 therethrough. The plunger 1106C-F can include a corresponding opening 1116C-F for receiving the artificial chordae 1102 therethrough.

[0127] Figure 11C-F illustrates the locking portion 1100C-F in the unlocked configuration, which allows the artificial tendon chord 1102 to move relative to the locking portion in either the first or second direction (arrows "A" and "B"). In the locked configuration (not shown), the plunger 1106C-F moves in the direction of arrow "C" under the force of the spring member 1108C-F, such that the opening 1116C-F is not aligned with the corresponding first lateral opening 1112C-F and second lateral opening 1114C to F of the body portion 1104C-F. This clamps the artificial tendon chord 1102 between the surfaces of the plunger and the body portion, thereby preventing movement of the artificial tendon chord in either the first or second direction (arrows "A" and "B"). In some embodiments, the end cap 1110 may provide a fixing surface against which the spring member 1108C-F may press to bias the plunger 1106C-F in the direction of arrow "C," thereby biasing the locking portion 1100C-F in the locked configuration. Actuator 1118C-F can be coupled to plunger 1106 to pass through as previously mentioned Figure 11A and Figure 11B The method described overcomes the bias of the spring member 1188C-F, causing the plunger to move from the locked state to the unlocked state. This can be achieved by... Figure 11A The tension in the artificial tendineae 1102 is adjusted in the same manner as described in B.

[0128] Now for reference Figure 12A and Figure 12B An embodiment of a locking portion 1200 for adjusting the tension of an artificial tendon 1202 according to the present invention is shown. The locking portion 1200 may be used as appropriate with respect to... Figures 3A-6A The locking portions of the devices 300-600 are interchangeable. Thus, the locking portion 1200 can be combined with any of the previously described tissue engagement portions, body portions, and housing portions to provide an anchor, the anchor including features that allow the user to tension and / or relax, and to lock the artificial chordae tendineae between an anchor that can be coupled to the papillary muscle or the heart wall and a clip that can be coupled to the leaflets of the heart valve.

[0129] Artificial tendineae in Figure 12A The device is shown having a first end 1224 and a second end 1226. In some embodiments, the first end 1224 may be coupled to a control filament (not shown) that passes through a conduit to a position through which the user can manipulate (e.g., move) the artificial tendon chord 1202. In some embodiments, the first end 1224 may include a loop or other connecting mechanism through which the control filament may be coupled. After the tensioning process is completed, the control filament may be disengaged from the first end 1224 and removed via the conduit.

[0130] The locking portion 1200 can include a body portion 1204, a plunger 1206, a spring member 1208, and an end cap 1210. The body portion 1204 can include a lateral opening 1212 for receiving the artificial chordae tendinae 1202 therethrough. The plunger 1206 can include a corresponding opening 1216 for receiving the artificial chordae tendinae 1202 therethrough and for leading the artificial chordae tendinae out through an upper end 1217 of the plunger.

[0131] Figure 12A The locking portion 1200 is shown in a locked configuration, which can prevent the artificial chordae tendinae 1202 from moving in either of the first and second directions (arrows“A,”“B”) relative to the locking portion. In this arrangement, the artificial chordae tendinae 1202 are compressed against an inner surface 1218 of the body portion 1204, which prevents the artificial chordae tendinae from moving in either of the first and second directions (arrows“A” and“B”) relative to the locking portion 1200. In some embodiments, the end cap 1210 can provide a fixed surface against which the spring member 1208 can compress to bias the plunger 1206 in the direction of arrow“A” such that the locking portion 1200 is biased in the locked configuration. Figure 12A The actuator 1220 can be coupled to the plunger 1206 to move the plunger from the locked configuration shown in Figure 12A to the unlocked configuration shown in Figure 12B For example, exerting a force on the plunger 1206 via the actuator 1220 to move the plunger in the direction of arrow“B” can overcome the bias of the spring member 1208, thereby causing the plunger to move such that the artificial chordae tendinae 1202 are no longer compressed between the plunger 1206 and the inner surface 1218 of the body portion 1204. In this unlocked configuration of Figure 12B , the artificial chordae tendinae 1202 can be pulled through the locking portion 1200 to adjust tension between the associated anchor and one or more leaflet clips 206 Figure 2 .

[0132] In some embodiments, moving the artificial chordae tendinae 1202 in the direction of arrow“A” will tend to increase tension in the artificial chordae tendinae and the leaflets 150 Figure 2The tension between the artificial chordae tendineae and the chordae tendineae. When the locking portion 1200 is incorporated into the device connected to the papillary muscle or the heart wall 152, a target tension can be achieved in the artificial chordae tendineae 1202 to achieve the target effect of inhibiting blood regurgitation through the heart valves. The regurgitation can be observed via transesophageal echocardiography, fluoroscopy, etc., to determine whether the target effect has been achieved with the artificial chordae tendineae 1202 in the appropriate position. If, after observation, the user determines that the tension in the artificial chordae tendineae 1202 needs to be increased, the user can reconfigure the locking portion 1200 to present an unlocked state, allowing the artificial chordae tendineae 1202 to move in the first direction to increase the tension in the artificial chordae tendineae.

[0133] If, after observation, the user determines that the tension in the artificial chordae tendineae 1202 needs to be reduced, the artificial chordae tendineae can be moved in the second direction (arrow "B"). In this case, the user can reconfigure the locking portion 1200 to present an unlocked position to allow the artificial chordae tendineae 1202 to move in the second direction (arrow "B") to reduce the tension in the artificial chordae tendineae. When the target tension reduction is achieved, the locking portion 1200 can be reconfigured to present a locked position to lock the artificial chordae tendineae 1202 to the locking portion 100. Further backflow observation can then be performed, followed by further tension / relaxation, and so on.

[0134] Actuator 1220 can pass through a conduit to a position where the user can actuate the actuator to “unlock” locking part 1200. After the tensioning process is complete, actuator 1220 can be disengaged from locking part 1200 and can be removed via the conduit.

[0135] Now for reference Figure 13 An embodiment of a locking portion 1300 for adjusting the tension of an artificial tendon 1302 according to the present invention is shown. The locking portion 1300 may be used as appropriate with respect to... Figures 3A-6A The locking portions of the devices 300-600 are interchangeable. Thus, the locking portion 1300 can be combined with any of the previously described tissue engagement portions, body portions, and housing portions to provide an anchor, the anchor including features that allow the user to tension and / or relax, and to lock the artificial chordae tendineae between an anchor that can be coupled to the papillary muscle or the heart wall and a clip that can be coupled to the leaflets of the heart valve.

[0136] Artificial tendineae in Figure 13The middle is shown as having a first end 1324 and a second end 1326. In some embodiments, the first end 1324 can be coupled to a control filament (not shown) that passes through a catheter to a location where a user can manipulate (e.g., move) the artificial chordae tendinae 1302. In some embodiments, the first end 1324 can include a loop or other connection mechanism through which the control filament can be coupled. After the tensioning process is complete, the control filament can be decoupled from the first end 1324 and removed via the catheter. The second end 1326 of the artificial chordae tendinae 1302 can extend within the heart to directly or indirectly couple to one or more leaflet clips 206 Figure 2 ) In some embodiments, the second end 1326 can be coupled to a filament 200 Figure 2 ), which in turn is coupled to one or more leaflet clips 206.

[0137] In the illustrated embodiment, the locking portion 1300 includes a housing portion 1312 having a longitudinal opening 1314 within which a spring element 1316 and a plunger 1318 are disposed. The spring element 1316 can be disposed between a shoulder 1320 of the housing portion and a face 1322 of the plunger 1318 to bias the plunger away from the shoulder. The spring element and the plunger can be movable within the longitudinal opening 1314. A tube element 1328 can be disposed within the spring element 1316 and can have a first end 1328A coupled to the plunger 1318 and a second end 1328B coupled to the housing portion near a first end 1330 of the locking portion 1300. In one non-limiting example embodiment, the tube element 1328 is formed of a resilient material such as silicone. A portion of the artificial chordae tendinae 1302 can be disposed within the tube element 1328 such that a first end of the artificial chordae tendinae extends from the first end 1330 of the locking portion 1300 and a second end extends from the second end of the locking portion 1332.

[0138] The tube element 1328 can be configured such that its inner diameter "TID" is sized in the unlocked configuration to allow the artificial chordae tendinae 1302 to move in the first and second directions (arrows "A" and "B", respectively). The tube element 1328 can be configured to assume a locked configuration in which the inner diameter "TID" is reduced such that it pinches the artificial chordae tendinae 1302 to prevent the artificial chordae tendinae from moving relative to the tube element. In some embodiments, the tube element 1328 is moved to the locked configuration by moving the first end 1328A of the tube element in the second direction (arrow "B") and is moved to the unlocked configuration by moving the first end of the tube element in the first direction (arrow "A").

[0139] Figure 13The locking portion 1300 (and tube element 1328) is shown in a locked configuration, with the spring element 1316 exerting a bias to move the plunger 1318 toward the second end 1332 of the housing portion 1312 (i.e., in the second direction (arrow “B”)). This causes the tube element 1328 to extend such that its inner diameter “TID” is pressed tightly against the artificial chordae to create a frictional lock, preventing the artificial chordae 1302 from moving through the locking portion.

[0140] The actuator 1334 can be coupled to the plunger 1318 to selectively move the plunger toward the first end 1330 of the housing portion 1312 (i.e., in the first direction (arrow “A”)) such that the inner diameter “TID” reduces the force from the artificial chordae, reducing the friction to allow the artificial chordae 1302 to move through the locking portion 1300. In some embodiments, the actuator 1334 (or a separate member coupled to the actuator) can extend through the catheter such that a user can manually adjust the actuator to move the locking portion 1300 between the locked and unlocked configurations from a location outside the patient’s body.

[0141] The actuator 1334 can move in the first and second directions (arrows “A” and “B”, respectively) to move the plunger 1318 and tube element 1328 between the locked and unlocked configurations. When the tube element 1328 is in the unlocked configuration, the artificial chordae can be moved in the first direction (arrow “A”) or the second direction (arrow “B”). When the tube element 1328 is in the locked configuration, the artificial chordae are prevented from moving in the first direction (arrow “A”) or the second direction (arrow “B”).

[0142] In some embodiments, moving the artificial chordae 1302 in the direction of arrow “A” will tend to increase the tension between the artificial chordae and the leaflets 150 of the heart valve. Adjusting the tension in the artificial chordae 1302 can achieve a target effect on the regurgitation of blood through the heart valve. Observations of the regurgitation can be made via transesophageal echocardiogram, fluoroscopy, etc. to determine whether the target effect has been achieved with the artificial chordae 1302 in place. If, upon observation, the user determines that the tension in the artificial chordae 1302 is to be increased, the user can move the actuator 1334 in the first direction (arrow “A”) to release the artificial chordae 1302 from the frictional lock within the tube element 1328. The user can then apply additional tension to the artificial chordae (e.g., using a control filament that can be manipulated from the proximal end of the catheter) to move it further in the first direction (arrow “A”). When the target tension is reached, the actuator 1334 can be moved in the second direction (arrow “B”) by an amount to lock the artificial chordae 1302 within the tube element 1328. This can be followed by additional observations of the regurgitation, followed by additional tensioning, and so on. Figure 2 ) between the artificial chordae and the leaflets 150 of the heart valve. Adjusting the tension in the artificial chordae 1302 can achieve a target effect on the regurgitation of blood through the heart valve. Observations of the regurgitation can be made via transesophageal echocardiogram, fluoroscopy, etc. to determine whether the target effect has been achieved with the artificial chordae 1302 in place. If, upon observation, the user determines that the tension in the artificial chordae 1302 is to be increased, the user can move the actuator 1334 in the first direction (arrow “A”) to release the artificial chordae 1302 from the frictional lock within the tube element 1328. The user can then apply additional tension to the artificial chordae (e.g., using a control filament that can be manipulated from the proximal end of the catheter) to move it further in the first direction (arrow “A”). When the target tension is reached, the actuator 1334 can be moved in the second direction (arrow “B”) by an amount to lock the artificial chordae 1302 within the tube element 1328. This can be followed by additional observations of the regurgitation, followed by additional tensioning, and so on.

[0143] If, after observation, the user determines that the tension in the artificial tendon chord 1302 needs to be reduced, the artificial tendon chord can be moved in the second direction (arrow "B"). In this case, the user can move the actuator 1334 in the first direction (arrow "A") to release the artificial tendon chord 1302 from the friction lock within the tubular element 1328, and the tension in the artificial tendon chord can be reduced to allow it to move further in the first direction (arrow "A"). When the target tension reduction is achieved, the actuator 1334 can move a certain amount in the second direction (arrow "B") to lock the artificial tendon chord 1302 within the tubular element 1328. Further backflow observation can then be performed, followed by further tensioning / relaxation, and so on.

[0144] After the tensioning process is complete, the actuator 1334 can be locked to the housing portion by, for example, crimping, cutting and bonding, forging, or other mechanical techniques. The remaining portion of the actuator 1334 (i.e., the portion residing in the conduit) can be disconnected and removed via the conduit. Similarly, the control filament can be disengaged from the first end 1324 of the artificial tendon 1302 and removed via the conduit.

[0145] Now for reference Figure 14 An embodiment of a locking portion 1400 for adjusting the tension of an artificial tendon 1402 according to the present invention is shown. The locking portion 1400 may be used as appropriate with respect to... Figures 3A-6A The locking portion 1400 is interchangeable with any of the locking portions disclosed in devices 300-600. Therefore, the locking portion 1400 can be combined with any of the previously described tissue engagement portion, body portion, and housing portion to provide an anchor, which includes features enabling the user to tension and / or relax, and for locking the artificial tendineae to an anchor that can be coupled to the papillary muscle or the heart wall and to a leaflet 150 that can be coupled to a heart valve. Figure 2 The characteristics between the clips.

[0146] The locking portion 1400 may include a housing portion 1404 that receives the floating block portion 1406 and the locking element 1408. The floating block portion 1406 may have a triangular shape and may be movable within the housing portion 1404. The locking element 1408 may also be movable within the housing portion 1404 and may include a protrusion 1410 oriented toward a first side of the floating block portion 1406.

[0147] The housing portion 1404 can also include a groove 1412 for guiding the artificial chordae from a first side 1414 of the housing portion to a second side 1416 of the housing portion. The groove 1412 can be configured to guide the artificial chordae against the beveled side 1418 of the floating block portion 1406 and then against the second side 1420 of the floating block portion. Thus, the groove 1412 can guide the artificial chordae 1402 around both sides of the floating block portion 1406 and then out of the housing portion 1404.

[0148] The locking element 1408 can be positioned such that the protrusion 1410 can engage the artificial chordae 1402 to press it against the second side 1420 of the floating block portion 1406. At the same time, the protrusion 1410 forces the floating block portion 1406 downward such that the beveled side 1418 of the floating block portion presses the artificial chordae 1402 against the opposite surface of the groove 1412. Movement of these elements locks the artificial chordae to the locking portion 1400 such that the artificial chordae is prevented from moving in the first and second directions. Figure 14 This locked configuration is shown in the middle.

[0149] An actuator 1422 can be coupled to the locking element 1408 to move the protrusion 1410 away from the artificial chordae 1402 such that the artificial chordae is allowed to move in the first and second directions (arrows“A” and“B”, respectively). In some embodiments, the actuator 1422 (or a separate member coupled to the actuator) can extend through a catheter such that a user can manually adjust the actuator to move the locking portion 1400 between the locked and unlocked configurations from a location outside of the patient’s body.

[0150] In some embodiments, moving the artificial chordae 1402 in the direction of arrow“A” will tend to increase the tension in the artificial chordae and the leaflets 150 Figure 2) between the protrusion 1410 and the block portion 1406. Additional regurgitation observations can be made after this, followed by additional tensioning, and so on.

[0151] If, after observation, the user determines that the tension in the artificial chordae 1402 is to be reduced, the artificial chordae can be moved in a second direction (arrow "B"). In this case, the user can move the actuator 1422 to release the artificial chordae 1402 from between the protrusion 1410 and the block portion 1406, and can reduce the tension in the artificial chordae to move it further in the second direction (arrow "B"). When the target reduced tension is reached, the actuator 1422 can be moved so that the protrusion 1410 engages the artificial chordae 1402 to prevent further movement. Additional regurgitation observations can be made after this, followed by additional tensioning / relaxing, and so on.

[0152] After the tensioning process is complete, the actuator 1422 can be locked to the housing portion by, for example, crimping, cutting and gluing, swaging, or other mechanical techniques. The remaining portion of the actuator 1422 (i.e., the portion that resides in the catheter) can be disconnected and removed via the catheter. The control filament can similarly be decoupled from the first end 1424 of the artificial chordae 1402 and removed via the catheter. The second end 1426 of the artificial chordae 1402 can extend within the heart to directly or indirectly couple to one or more leaflet clips 206 Figure 2 ) in some embodiments, the second end 1426 can be coupled to a filament 200 Figure 2 , which in turn is coupled to one or more leaflet clips 206.

[0153] Referring now to Figure 15A and Figure 15B , embodiments of a locking portion 1500 for adjusting tension of an artificial chordae 1502 according to the present application are shown. The locking portion 1500 can be used with the artificial chordae 1502 as described with respect to Figures 3A-6AThe locking portions of the devices 300-600 are interchangeable. Thus, the locking portion 1500 can be combined with any of the previously described tissue engagement portions, body portions, and housing portions to provide an anchor, the anchor including features that allow the user to tension and / or relax, and to lock the artificial chordae tendineae between an anchor that can be coupled to the papillary muscle or the heart wall and a clip that can be coupled to the leaflets of the heart valve.

[0154] Artificial tendineae in Figure 15A , 15B The artificial tendon chord 1502 is shown having a first end 1524 and a second end 1526. In some embodiments, the first end 1524 may be coupled to a control filament (not shown) that passes through a catheter to a location where the user can manipulate the tension in the artificial tendon chord 1502. In some embodiments, the first end 1524 may include a loop or other connecting mechanism through which the control filament may be coupled. After the tensioning process is completed, the control filament may be detached from the first end 1524 and removed via the catheter. The second end 1526 of the artificial tendon chord 1502 may extend within the heart to be coupled directly or indirectly to one or more leaflet clips 206. Figure 2 In some embodiments, the second end 1526 may be connected to the filament 200. Figure 2 The filament 200 is then connected to one or more leaf clips 206.

[0155] The locking portion 1500 may include a helical spring element 1504 having a first spring end 1506 and a second spring end 1508, and a central ring portion 1510 through which the artificial tendon chord 1502 is disposed. The first spring end 1506 and the second spring end 1508 may be secured within corresponding first recess 1507 and second recess 1509 in the main body portion 1511 of the locking portion 1500. An actuator 1512 may be coupled to a portion of the central ring portion 1510 such that the central ring portion can be rotated by rotating the actuator. The actuator 1512 may be coupled to a control element 1514, such as a filament operable from the proximal end of a catheter, such that when the control element is moved, the actuator and the central ring portion 1510 are rotated.

[0156] The helical spring element 1504 can be naturally biased to twist in a first rotational direction (arrow "RDA") or a second rotational direction (arrow "RDB"). In the illustrated embodiment, the helical spring element 1504 is biased to twist in the first rotational direction ("RDA"), such that the resting state of the spring is relative to the locking portion 1500 ( Figure 15A The artificial tendon chord 1502 is associated with the locking configuration. In the locking configuration, the artificial tendon chord 1502 is wrapped around the central loop portion 1510, thereby preventing the artificial tendon chord from moving in the first direction "A" or the second direction "B".

[0157] In order to move the locked part 1500 to the unlocked state ( Figure 15B The control element 1514 can move in the actuation direction (arrow "C"). This movement causes the actuator 1512 and the central ring portion 1510 to rotate in the second rotation direction "RDB", which unfolds the artificial tendon chord 1502 from the central ring portion until the artificial tendon chord passes straight through the central ring portion, as shown. Figure 15B As shown.

[0158] In some embodiments, moving the artificial chordae tendineae 1502 in the direction of arrow "A" will tend to increase the space between the artificial chordae tendineae and the leaflets 150 of the heart valve. Figure 2 The tension between the artificial chordae tendineae 1502 and the target effect of blood regurgitation through the heart valves can be achieved by adjusting the tension in the artificial chordae tendineae 1502. The regurgitation can be observed via transesophageal echocardiography, fluoroscopy, etc., to determine whether the target effect has been achieved with the artificial chordae tendineae 1502 in the appropriate position. If, after observation, the tension in the artificial chordae tendineae 1502 is to be increased, the helical spring element 1504 can be rotated as appropriate in the first or second direction (“RDA”, “RDB”) to allow the artificial chordae tendineae 1502 to pass through. The user can then apply additional tension to the artificial chordae tendineae 1502 (e.g., using a control filament that can be manipulated from the proximal end of the catheter) to allow it to move further in the first direction (arrow “A”). When the target tension is reached, the helical spring element 1504 can be rotated as appropriate in the first or second direction (“RDA”, “RDB”) to clamp the artificial chordae tendineae to prevent further movement of the artificial chordae tendineae in the first or second direction (arrows “A” and “B”, respectively). After this, additional backflow observations can be conducted, followed by additional tensioning, and so on.

[0159] If, after observation, the user determines that the tension in the artificial chordae tendineae 1502 needs to be reduced, the artificial chordae tendineae can be moved in the second direction (arrow "B"). In this case, the locking portion 1500 can move to the unlocked position as described above, and the user can then reduce the tension in the artificial chordae tendineae to allow it to move further in the second direction (arrow "B"). When the target tension reduction is achieved, the locking portion 1500 can return to the locked position as described above to prevent further movement. Additional backflow observation can then be performed, followed by additional tension / relaxation, and so on.

[0160] Now for reference Figure 16A and 16B An embodiment of a locking portion 1600 for adjusting the tension of an artificial tendon 1602 according to the present invention is shown. The locking portion 1600 may be used as appropriate with respect to... Figures 3A-6AThe locking portions of the devices 300-600 are interchangeable. Thus, the locking portion 1600 can be combined with any of the previously described tissue engagement portions, body portions, and housing portions to provide an anchor, the anchor including features that allow the user to tension and / or relax, and to lock the artificial chordae tendineae between an anchor that can be coupled to the papillary muscle or the heart wall and a clip that can be coupled to the leaflets of the heart valve.

[0161] The locking portion 1600 can be coupled to a first end 1604 of the artificial tendon chord 1602. In one embodiment, the first end 1604 is knotted or otherwise secured to a protrusion 1606 in the body portion 1608 of the locking portion 1600. A portion of the artificial tendon chord 1602 may be disposed in a recess 1610 within the body portion 1612 and may exit through the upper surface 1614 of the locking portion.

[0162] like Figure 16B As shown, the second end 1616 of the artificial tendon chord 1602 can be strung internally and around the corresponding bottom and sides 1618, 1620 of the recess 1610 within the body portion 1612, such that the second end can extend away from the locking portion 1600. In some embodiments, the artificial tendon chord 1602 includes a plurality of filaments (e.g., which may be braided or twisted) to enable it to be strung internally in the manner described above. Figure 16B As shown, the artificial tendineae 1602 can thus form a loop 1622, which can be directly or indirectly connected to one or more leaflet clips 206. Figure 2 The second end 1616 of the artificial tendon chord 1602 can be connected to a filament disposed in or on a catheter, allowing the user to manipulate the artificial tendon chord 1602 by applying force to the filament. Alternatively, the second end 1616 of the artificial tendon chord 1602 can be disposed within a catheter, allowing the user to directly manipulate the second end.

[0163] When a force is applied to the second end 1616 of the artificial tendon chord (or the filament attached thereto), the artificial tendon chord 1602 can move in the first direction (arrow "A"). However, due to the friction generated by the artificial tendon chord 1602 strung together internally, along with the interaction between the artificial tendon chord and the corners 1624, 1626 of the recess 1610 of the adjacent locking portion 1600, the reverse movement of the artificial tendon chord in the second direction (arrow "B") is prevented.

[0164] To unlock the locking portion 1600 (i.e., to allow the artificial tendon chord 1602 to move in the second direction "B"), a force can be applied to the eyelet 1628 of the artificial tendon chord 1602, which is directly adjacent to the locking portion. A separate control element (e.g., a filament) can be attached to the eyelet 1628, allowing the user to unlock the locking portion 1600 by applying force to the individual control filament. Applying force to the eyelet in this manner overcomes frictional and other forces that tend to prevent movement in the second direction (arrow "B").

[0165] In some embodiments, moving the artificial chordae tendineae 1602 in the direction of arrow "A" will tend to increase the space between the artificial chordae tendineae and the leaflets 150 of the heart valve. Figure 2 The tension between the artificial chordae tendineae 1602 and the chordae tendineae 1602 can be adjusted to achieve the desired effect of reducing blood regurgitation through the heart valves. The regurgitation can be observed via transesophageal echocardiography, fluoroscopy, etc., to determine whether the desired effect has been achieved with the artificial chordae tendineae 1602 in the appropriate position. If, after observation, the user determines that the tension in the artificial chordae tendineae 1602 needs to be increased, a force can be applied to the second end 1616 (or the filament attached to it) to move the artificial chordae tendineae in the first direction (arrow “A”) to apply additional tension to the artificial chordae tendineae 1602. Further observation of regurgitation can then be performed, followed by further tensioning, and so on.

[0166] If, after observation, the user determines that the tension in the artificial tendon chord 1602 needs to be reduced, the artificial tendon chord can be moved in the second direction (arrow "B") by applying force to the eyelet 1628. This can be followed by additional backflow observation, then additional tension / relaxation, and so on.

[0167] According to the present invention, all the apparatuses and / or methods disclosed and claimed herein can be manufactured and performed without requiring extensive experimentation. While the apparatuses and methods of the present invention have been described with reference to preferred embodiments, it will be apparent to those skilled in the art that variations can be made to the apparatuses and / or methods and to the steps or sequences of steps described herein without departing from the concept, spirit, and scope of the invention. All such similar substitutions and modifications that will be apparent to those skilled in the art are considered to be within the spirit, scope, and concept of the invention as defined by the appended claims.

Claims

1. A system for adjusting tension in artificial chordae tendineae, the system comprising: Artificial tendon chords that can connect between clamps and anchors; The clip capable of engaging with the leaflets of a heart valve; as well as The anchor, capable of engaging with the papillary muscle or the heart wall, comprises: Main body, A locking portion, which can be connected to the artificial tendon chord and is configured to allow movement of the artificial tendon chord in a first direction while preventing movement of the artificial tendon chord in a second direction opposite to the first direction; as well as An actuator is coupled to the locking portion for selectively releasing the locking portion to enable selective movement of the artificial tendon in the second direction; wherein the actuator is coupled to a filament disposed in or on the catheter, allowing a user to activate the actuator to release the locking portion by applying force to the filament.

2. The system of claim 1, wherein the anchor further comprises a housing portion, the main body portion, the locking portion, and the actuator disposed in the housing portion or on the housing.

3. The system of claim 1, wherein the locking portion locks to prevent the artificial tendon from moving in the second direction when a force is applied to the locking portion in the second direction.

4. The system of claim 1, wherein the locking portion comprises a ball or roller for pressing the artificial tendon between the ball or roller and the wall of the locking portion to prevent the artificial tendon from moving in the second direction.

5. The system of claim 4, wherein the actuator is coupled to the ball or roller to move the ball or roller away from the artificial tendon chord, so that the artificial tendon chord can move in the second direction.

6. The system of claim 4, wherein the ball or roller is movably positioned in a slot having a first wall oriented at an angle "α" relative to the axis of the artificial tendon, and a second wall oriented parallel to the axis of the artificial tendon.

7. The system of claim 6, wherein the movement of the artificial tendon in the second direction tends to press against the ball or roller until the frictional force between the artificial tendon and the first and second walls prevents further movement of the artificial tendon in the second direction.

8. The system of claim 7, further comprising a filament coupled to the ball or roller to enable a user to manually move the ball or roller in the first direction to reduce the frictional forces between the artificial tendon, the ball or roller, and the first and second walls to allow the artificial tendon to move in the second direction.

9. The system of claim 1, wherein moving the artificial tendon in the first direction increases the tension between the clamp and the anchor, and moving the artificial tendon in the second direction reduces the tension between the clamp and the anchor.

10. The system of claim 1, wherein the locking portion includes a spring element for coupling to the artificial tendon chord to prevent movement of the artificial tendon chord in the second direction.

11. The system of claim 1, wherein the locking portion includes a clamp for engaging the artificial tendon chord, and the actuator is coupled to the clamp to disengage the clamp from the artificial tendon chord.

12. The system of claim 2, wherein the locking portion includes a flexible braided member coupled to an actuator at a first end and to a body portion at a second end, wherein the flexible braided member is disposed within the housing portion, and the artificial tendon is disposed between the flexible braided member and the sidewall of the housing portion.

13. The system of claim 12, wherein when the locking portion is in the locked position, the flexible braided member expands to press the artificial tendon against the sidewall of the housing portion to prevent the artificial tendon from moving in the first and second directions.

14. The system of claim 1, wherein the locking portion includes a rotatable locking body having an engagement surface for engaging the artificial tendon chord, wherein the rotatable locking body is rotatable to clamp the artificial tendon chord between the engagement surface and a body portion of the locking portion to prevent movement of the artificial tendon chord.

15. A device for adjusting tension in artificial chordae tendineae, the device comprising: Anchors that can engage with the papillary muscles or the heart wall. The anchor includes: Main body, A locking portion, which is connectable to the artificial tendon chord and configured to allow movement of the artificial tendon chord in a first direction while preventing movement of the artificial tendon chord in a second direction opposite to the first direction; and An actuator is coupled to the locking portion for selectively releasing the locking portion to allow selective movement of the artificial tendon in a second direction; wherein the actuator is coupled to a filament disposed in or on a catheter, allowing a user to activate the actuator to release the locking portion by applying force to the filament.

16. The apparatus of claim 15, wherein the locking portion locks to prevent the artificial tendon from moving in the second direction when a force is applied to the locking portion in the second direction.

17. The apparatus of claim 15, wherein the locking portion comprises a ball or roller for pressing the artificial tendon between the ball or roller and the wall of the locking portion to prevent the artificial tendon from moving in the second direction.

18. The apparatus of claim 17, wherein the actuator is coupled to the ball or roller to move the ball or roller away from the artificial tendon chord, such that the artificial tendon chord is movable in the second direction.

19. The apparatus of claim 15, wherein the locking portion includes a spring element for coupling to the artificial tendon chord to prevent movement of the artificial tendon chord in the second direction.

20. The apparatus of claim 15, wherein the locking portion includes a clamp for engaging the artificial tendon chord, and the actuator is coupled to the clamp to disengage the clamp from the artificial tendon chord.

Images