Device and system for enabling adjustment of tension on artificial chordae in the heart

Abstract

Devices, systems, and methods for adjusting and setting tension in artificial chordae, the artificial chordae being coupleable between leaflet clips and tissue anchors, and a locking assembly through which the artificial chordae extend that is shiftable between a tension-adjusting configuration in which the artificial chordae are movable to adjust leaflet tension, and a tension-setting or locking configuration in which the artificial chordae are blocked, prevented, or locked relative to the locking assembly to set or fix leaflet tension.

Description

[Technical Field]

[0001] The present disclosure generally relates to medical devices for cardiac repair. and More particularly, the present disclosure relates to a medical device for delivering and implanting artificial chordae in the heart. and Even more particularly, the present disclosure relates to a medical device for adjusting the tension of artificial chordae in the heart. and Regarding the system. [Background technology]

[0002] Heart diseases, including atrioventricular heart valve malfunctions, reduce a patient's cardiac output, thereby decreasing their quality of life and shortening their lifespan. Proper blood flow through the heart is regulated, among other things, by heart valves, such as the atrioventricular valves, which include soft tissue leaflets that open and close periodically to allow blood to flow in one direction. Healthy valve leaflets prevent blood from flowing in the opposite direction (regurgitation). Chordae tendineae, which extend from the valve leaflets to the papillary muscles, assist the proper function of the valve leaflets, for example, by distributing load to the papillary muscles during systolic closure and by preventing the leaflets from flailing into the atrium. Improper function of the chordae tendineae impairs the ability of the leaflets to form a seal in the heart valve. Various defects in chordae insufficiency, such as elongation, tearing, thickening, retraction, calcification, inelastic stretching or other changes in elasticity, can result in improper closure of the heart valve and / or fluttering leaflets, which may no longer be capable of forming a valve seal for normal heart function. Summary of the Invention

[0003] There is a need for minimally invasive solutions to repair heart valves, e.g., their leaflets, while preserving options for future intervention. Furthermore, there is a need for methods to reposition, repair, and / or replace one or more chordae tendineae in the heart to improve the treatment of heart disease. medical care Device and System Mu Improvements are needed.

[0004] This summary of the disclosure is provided to aid in understanding, and those skilled in the art will appreciate that each of the various aspects and features of the disclosure may be advantageously used separately in some cases or in combination with other aspects and features of the disclosure in other cases. No limitations on the scope of the claimed subject matter, either by the inclusion or exclusion of elements, components, etc., are intended in this summary.

[0005] In one aspect, the present subject matter provides a medical device for delivering artificial chordae within a patient and adjusting the tension of the artificial chordae. and Related to the field of systems. In various embodiments described or otherwise within the scope of the present disclosure, a system for adjusting tension in artificial chordae extending between the leaflets of a heart valve and a papillary muscle or a heart wall includes the artificial chordae, a leaflet clip configured to engage with the leaflets of the heart valve and the artificial chordae, an anchor configured to engage with the papillary muscle or the heart wall, and a locking assembly associated with the anchor. In various embodiments, the locking assembly is configured to be selectively shiftable between a tension-adjusting configuration that allows the artificial chordae to move relative to the locking assembly to increase or decrease the tension in the leaflets, and a tension-setting configuration that prevents movement of the artificial chordae relative to the locking assembly to set the tension in the leaflets.

[0006] In some embodiments, the locking assembly includes a housing and a movable locking element movable within a longitudinal cavity defined within the housing to shift the locking assembly between a tension adjustment configuration and a tension setting configuration. In some embodiments, the movable locking element includes one of a carriage, a roller, an auger, or a tissue engagement element axially movable within the longitudinal cavity within the housing. In some embodiments, a passage is defined along the movable locking element, and the artificial chordae extend along the passage. In some embodiments, the longitudinal cavity within the housing defines a locking region and a tension adjustment region, and when the movable locking element is within the tension adjustment region, the artificial chordae are movable relative to the movable locking element, a portion of the passage extends along an outer portion of the movable locking element, and a portion of the artificial chordae extending along the portion of the passage that extends along the outer portion of the movable locking element is sandwiched between the movable locking element and the tension adjustment region when the movable locking element is within the locking region to set the tension of the valve leaflets. In some embodiments, the system further includes a stylet engageable with the movable locking element to move the movable locking element to shift the locking assembly between the tension-adjusting configuration and the tension-setting configuration. In some embodiments, the system further includes a coupler configured to couple the stylet and the movable locking element, wherein the artificial chordae extend axially through the stylet, the coupler, and the movable locking element, traverse through the movable locking element to a portion of the passage extending along an outer portion of the movable locking element, and extend across the housing to the leaflet clip.

[0007] In some embodiments, the system further includes a stylet engageable with the movable locking element to move the movable locking element to shift the locking assembly between the tension-adjusting configuration and the tension-setting configuration.

[0008] In some embodiments, the anchor includes a body portion, a tissue engaging portion extending distally from the tissue engaging portion, and a locking portion extending proximally from the body portion, and the housing is a portion of the locking portion of the anchor.

[0009] In various embodiments described or otherwise within the scope of the present disclosure, an apparatus for adjusting tension in artificial chordae includes: an artificial chordae; a housing defining a longitudinal cavity therein; a locking assembly disposed within the housing and having a movable locking element axially movable within the longitudinal cavity of the housing between a tension-adjusting configuration that allows movement of the artificial chordae relative to the housing and a tension-setting configuration that prevents movement of the artificial chordae relative to the housing; and a coupler extending from the movable locking element and configured to engage an actuator to move the movable locking element relative to the housing.

[0010] In some embodiments, the device further includes a tissue engaging element configured to engage tissue of the heart to firmly anchor the ends of the artificial chordae to the heart. In some embodiments, the movable locking element includes one of a carriage, a roller, an auger, or a tissue-engaging element. In some embodiments, a passage is defined along the movable locking element, along which the artificial chordae extend. In some embodiments, a portion of the passage extends across the movable locking element. Alternatively, or in addition, in some embodiments, a portion of the passage extends along an outer portion of the movable locking element. In some embodiments, a longitudinal cavity in the housing defines a locking region and a tension adjustment region, and when the movable locking element is within the tension adjustment region, the artificial chordae are movable relative to the movable locking element, and a portion of the artificial chordae extending along a portion of the passage that extends along the outer portion of the movable locking element is sandwiched between the movable locking element and the tension adjustment region when the movable locking element is within the locking region to set the tension of the valve leaflets.

[0011] In accordance with various principles of the present disclosure, a method for adjusting tension in artificial chordae extending between the leaflets of a heart valve and the papillary muscles or heart wall is also disclosed, the method including extending the artificial chordae through a locking assembly of an artificial chordae tensioning and locking device, moving the artificial chordae relative to a housing to increase or decrease leaflet tension when the locking assembly is in a tension-adjusting configuration, and shifting the locking assembly to a tension-setting configuration to set the artificial chordae and leaflet tension when a desired leaflet tension is reached.

[0012] In one aspect, moving the artificial chordae relative to the housing further includes coupling the stylet with a movable locking element of the locking assembly to move the movable locking element. In some embodiments, the locking assembly includes a movable locking element, and the method further includes associating the movable locking element with the artificial chordae such that the artificial chordae are prevented from moving relative to the housing when the locking assembly is in the tension-setting configuration.

[0013] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention will be set forth in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be recognized that individual aspects may be claimed separately or in combination with aspects and features of that embodiment or any other embodiment.

[0014] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in each drawing may vary. For example, devices may be enlarged so that details can be appreciated, but are intended to be scaled relative to fitting into, for example, a delivery catheter or working channel of an endoscope. In each drawing, identical, nearly identical, or equivalent elements are generally represented by the same reference numeral, and similar elements are generally designated by similar reference numerals that are different and incremented by 100, to avoid redundant description. For clarity and conciseness, not every element is labeled in every drawing, nor every element of every embodiment is shown, unless explanation is necessary to enable those skilled in the art to understand the disclosure.

[0015] The detailed description is better understood in conjunction with the accompanying drawings, in which like reference numerals represent like elements and in which: [Brief explanation of the drawings]

[0016] [Figure 1] 1 is a cross-sectional schematic view of a human heart with an illustrative example heart valve repair device implanted to repair the mitral valve annulus with a prosthetic chordae tensioning and locking device formed in accordance with aspects of the present disclosure. [Figure 2A] FIG. 1 is a perspective view of an artificial chordae tensioning and locking device formed in accordance with the principles of the present disclosure with a housing portion shown in phantom; [Figure 2B] 2B is a cross-sectional view of the artificial chordae tensioning and locking device of FIG. 2A in an unlocked configuration with portions of the housing shown in phantom. [Figure 2C] 2C is a cross-sectional view of the artificial chordae tensioning and locking device similar to FIG. 2B, but shown in a locked configuration. [Figure 2D]2D is a cross-sectional view similar to that of FIG. 2C showing an actuator formed in accordance with the principles of the present disclosure disengaged from an artificial chordae tensioning and locking device. [Figure 3A] FIG. 1 is a perspective view of an artificial chordae tensioning and locking device formed in accordance with the principles of the present disclosure with a housing portion shown in phantom; [Figure 3B] 3B is a cross-sectional view of the artificial chordae tensioning and locking device of FIG. 3A in an unlocked configuration with portions of the housing shown in phantom. [Figure 3C] 3C is a cross-sectional view of an artificial chordae tensioning and locking device similar to that of FIG. 3B, but shown in a locked configuration. [Figure 4A] FIG. 1 is a perspective view of an artificial chordae tensioning and locking device formed in accordance with the principles of the present disclosure with a housing portion shown in phantom; [Figure 4B] 4B is a cross-sectional view of the artificial chordae tensioning and locking device of FIG. 4A in an unlocked configuration with portions of the housing shown in phantom lines, taken along line IVB-IVB. [Figure 4C] 4C is a cross-sectional view of an artificial chordae tensioning and locking device similar to that of FIG. 4B, but shown in a locked configuration. [Figure 5A] FIG. 1 is a perspective view of an artificial chordae tensioning and locking device formed in accordance with the principles of the present disclosure with a housing portion shown in phantom; [Figure 5B] 5B is a cross-sectional view of the artificial chordae tensioning and locking device of FIG. 5A in an unlocked configuration with portions of the housing shown in phantom lines, taken along line VB-VB. [Figure 5C] 5C is a cross-sectional view of an artificial chordae tensioning and locking device similar to that of FIG. 5B, but shown in a locked configuration. [Figure 6A] 1 is a perspective view of an artificial chordae tensioning and locking device formed in accordance with the principles of the present disclosure; FIG. [Figure 6B]6B is a cross-sectional view of the artificial chordae tensioning and locking device of FIG. 6A in an unlocked configuration, taken along line VIB-VIB, with portions of the housing shown in phantom. [Figure 6C] 6C is a cross-sectional view of an artificial chordae tensioning and locking device similar to that of FIG. 6B, but shown in a locked configuration. [Figure 6D] FIG. 6C is an elevational view of an artificial chordae tensioning and locking device as in FIGS. 6A-6C, with an alternative form of actuator. [Figure 6E] FIG. 6B is an elevational view of an artificial chordae tensioning and locking device as in FIGS. 6A-6D, with an alternative form of actuator. [Figure 7A] FIG. 1 is a perspective view of an artificial chordae tensioning and locking device made in accordance with the principles of the present disclosure, comprising multiple elements shown in phantom, with anchor portions in place within body tissue; [Figure 7B] 7B is a cross-sectional view taken along line VIIB-VIIB of the artificial chordae tensioning and locking device of FIG. 7A, with portions of the housing shown in phantom, in a locked position within body tissue. [Figure 7C] 7C is a cross-sectional view of the artificial chordae tensioning and locking device similar to that of FIG. 7B, but shown in an unlocked position within body tissue. [Figure 7D] 7B is an elevational view of an alternative embodiment of an anchor portion usable in an artificial chordae tensioning and locking device such as that of FIG. 7A, shown in an insertion configuration. [Figure 7E] FIG. 7E is an elevation view of the anchor portion of FIG. 7D shown in an anchoring configuration. [Figure 7F] 7B is an elevational view of an alternative embodiment of an anchor portion usable in an artificial chordae tensioning and locking device such as that of FIG. 7A, shown in an insertion configuration. [Figure 7G] FIG. 7F is an elevational view of the anchor portion of FIG. 7F shown in an anchoring configuration. DETAILED DESCRIPTION OF THE INVENTION

[0017] The following detailed description should be read with reference to the drawings, which show illustrative embodiments. It should be understood that the present disclosure is not limited to the particular embodiments described and may vary as such. All devices, systems, and methods described herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of this disclosure. Each example embodiment is provided for illustrative purposes and is merely an example, not the only way, to implement these principles. Therefore, references to elements or structures or features in the drawings should be understood as references to example embodiments of the present disclosure and should not be understood as limiting the disclosure to the particular elements, structures, or features shown. Upon reading this disclosure, other examples of ways to implement the principles of the disclosure will occur to those skilled in the art. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the present subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. It is therefore intended that the present subject matter cover all such modifications and variations to the extent that they come within the scope of the appended claims and their equivalents.

[0018] It will be appreciated that the present disclosure is described in this application with varying degrees of detail. In some cases, details that are not necessary for those skilled in the art to understand the disclosure or that would make other details difficult to grasp may be omitted. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the appended claims. Unless otherwise defined, the terminology used herein should be understood as commonly understood by one of ordinary skill in the art to which the present disclosure pertains. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0019] As used herein, "proximal" refers to a direction or location closest to a user (e.g., a medical professional or clinician or technician or operator or physician, etc. (these terms are used interchangeably and without limitation or otherwise)) such as when using the device (e.g., during introduction, implantation, placement, or delivery of the device into a patient's body), and "distal" refers to a direction or location furthest from a user (e.g., during introduction, implantation, placement, or delivery of the device into a patient's body). "Longitudinal" means extending along the longer or greater dimension of an element. "Central" means at least approximately bisecting through the center point, and "central axis" means, with respect to an opening, a line at least approximately bisecting through the center point of the opening and extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, strut, channel, cavity, or bore.

[0020] According to various principles and aspects of the present disclosure, one or more leaflets of a heart valve are repositioned and / or repaired by implanting artificial chordae in the heart, the artificial chordae extending between the leaflets and the ventricular wall and / or papillary muscles. Disclosed herein are various embodiments of devices and systems, including devices for adjusting and / or setting the tension of the artificial chordae, and / or methods (e.g., minimally invasive methods) of using such devices and / or systems to implant and / or adjust and / or set the tension of the artificial chordae, for use in heart valve repair. An example of an artificial chordae tensioning and locking system 100 is shown in FIG. 1 with reference to a mitral valve. It will be appreciated that the artificial chordae tensioning and locking system 100 may also be used in other contexts, such as tricuspid valve repair. One end of the artificial chordae 102 is attached to the free edge of the valve leaflet L to be repaired (e.g., by a leaflet clip 104, e.g., a spring clip), and the other end of the artificial chordae 102 is connected to the heart H (e.g., a ventricular wall or papillary muscle VW) (e.g., by an anchor 110, e.g., a ventricular anchor). The artificial chordae 102 (e.g., their length and / or tension) are adjusted to adjust the relative position of the leaflet clip 104 and anchor 110 (e.g., to move the leaflet clip 104 and anchor 110 closer together or further apart) to adjust / repair the valve leaflet L, e.g., to minimize backflow of blood through the valve V.

[0021] In some embodiments, devices and systems for repairing heart valves are delivered to a treatment site (e.g., mitral or bicuspid valve) by a catheter or other suitable delivery device. The system may have one or more controls located at its proximal end to allow a user to operate the disclosed device. As will be appreciated, the specific characteristics of the delivery device are not critical to the present disclosure, so long as the delivery device is configured to allow a user to deliver, implant, and operate the disclosed device at a target location within the heart. It will also be appreciated that delivery, engagement, and operation of the disclosed device may be facilitated by the use of known visualization techniques, such as fluoroscopy, ultrasound, intracardiac echocardiography (ICE), transesophageal echocardiography, etc.

[0022] The delivery catheter is advanced to the treatment site within the ventricle. A leaflet clip 104 (e.g., a spring clip) may be manufactured or otherwise provided on the side of the delivery catheter, e.g., housed within a leaflet grasping mechanism. Once the catheter reaches the treatment site, the leaflet clip 104 is opened and positioned to capture a leaflet L (e.g., the free edge of the leaflet) and secured therein. Medical images may be used to confirm the location of the leaflet clip 104 and the quality of its purchase on the leaflet L. If the grasping and / or location is undesirable, the leaflet clip 104 may be returned to the open position and the leaflet grasping step repeated until the placement of the leaflet clip 104 is satisfactory, after which the leaflet clip 104 is placed in position on the leaflet L as shown in FIG. 1 .

[0023] Artificial chordae 102, formed from any of a variety of suitable materials, including, but not limited to, a suture material such as polytetrafluoroethylene (PTFE) or ePTFE (expanded PTFE), extend between the leaflet clip 104 and a ventricular anchor 110 configured to firmly secure the artificial chordae 102 to the ventricular wall VW (e.g., a papillary muscle). In some embodiments, additional artificial chordae filaments 102a, 102b, etc. may extend between the artificial chordae 102 extending from the ventricular anchor 110 and the leaflet clip 104. To deploy and secure the ventricular anchor 110 to the ventricular wall VW, the distal catheter head is positioned above the valve V in the atrium. A working channel is advanced out of the delivery catheter, and medical imaging may be used to assist in positioning the working channel relative to the desired ventricular anchor location. A rod or actuator or stylet (these terms are used interchangeably herein, without limitation) attached to the ventricular anchor may be used to deploy the ventricular anchor into the cardiac tissue of the ventricle by pushing the ventricular anchor out of the working channel. Medical images may be used to confirm the location of the ventricular anchor and the quality of its grip on the cardiac tissue. If the grip and / or location are undesirable, a stylet may be used to retract the ventricular anchor into the working channel, and the ventricular anchor deployment steps are repeated until satisfactory placement of the ventricular anchor is achieved, after which the ventricular anchor is in place as shown in FIG. 1.

[0024] A final check, for example using medical imaging, may be performed to verify placement of ventricular anchor 110. Once placement of ventricular anchor 110 is satisfactory, the working channel may optionally be retracted into the catheter. It will be appreciated that the working channel may remain coupled to ventricular anchor 110 while applying tension, if desired. The stylet remains coupled to the ventricular anchor.

[0025] In accordance with the principles of the present disclosure, anchor 110 is associated with artificial chordae tensioning and locking system 100 formed in accordance with various aspects and principles of the present disclosure to adjust tension and / or set or lock or modify / fix (these terms are used interchangeably herein and are not intended to be limiting) the tension of artificial chordae 102. In various embodiments, anchor 110 includes tissue-engaging portion 112, body portion 114 (from which tissue-engaging portion 112 extends), and locking portion 116. Locking portion 116 may extend from, be formed by, or coupled to, or otherwise associated with (e.g., be separate from and coupled to) anchor body portion 114. The tensioning and locking device (or at least parts or components thereof), as shown in more detail in various embodiments illustrated in the accompanying drawings and described in more detail below, is disposed within a housing 118, which is associated with (e.g., is part of or is separate and coupled to) the locking portion 116 of the anchor 110 and may be coupleable with the artificial chordae 102.

[0026] The tensioning and locking device has a tension adjustment feature that allows the artificial chordae 102 to move relative to the tensioning and locking device (e.g., to adjust the tension of the artificial chordae 102 on the valve leaflets). Adjusting the tension of the artificial chordae 102 includes paying out, releasing, or feeding additional lengths of the artificial chordae 102 (e.g., moving the artificial chordae 102 distally) to decrease the tension on or within the artificial chordae 102, or retracting or pulling the artificial chordae 102 (e.g., moving the artificial chordae 102 proximally) to increase the tension on or within the artificial chordae 102. The tensioning and locking device also has a tensioning or locking (these terms are used interchangeably herein, without limitation) configuration that inhibits, prevents, or locks movement of the artificial chordae 102 relative to the tensioning and locking device (e.g., to set, fix, or limit tension in the artificial chordae 102 of the valve leaflets). The tensioning and locking device is selectively shiftable or movable (in either direction) alternately between a tensioning configuration and a locking configuration. Actuators (shown and described in further detail in conjunction with various embodiments of the tensioning and locking device shown in the accompanying figures and described in further detail below) are coupled to or engaged with components of the tensioning and locking device to selectively shift or move the tensioning and locking device between the tensioning configuration and the locking configuration to enable selective movement and / or tensioning of the artificial chordae 102.

[0027] In some embodiments, the artificial chordae 102 extend continuously from the proximal end of the catheter, through or along the catheter, into and through the tensioning and locking device (and optionally through the anchors 110) to the leaflets L, where they are securely secured to the leaflets L using leaflet clips 104 or the like. The artificial chordae 102 can be tensioned from the proximal end of the catheter to shorten the distance between the leaflet clips 104 and the anchors 110 and restore function of the leaflets L. In some embodiments, the artificial chordae 102 can be tensioned from a location adjacent the proximal end of the delivery system. Such tensioning can be performed to shorten the distance between the leaflet clips 104 and the anchors 110. When it is desired to reduce the tension, the artificial chordae 102 can be selectively released to increase the length of the artificial chordae 102 and increase the distance between the leaflet clips 104 and the anchors 110, thereby reducing the tension therebetween. The tensioning and locking device allows the artificial chordae 102 to be locked and released to adjust the desired tension, e.g., to increase or decrease the amount of tension on or within the artificial chordae 102.

[0028] A locking stylet or actuator (these terms are used interchangeably herein and are not intended to be limiting) may be provided extending from the proximal catheter handle to the ventricular anchor. A coupling feature may be provided at the distal end of the stylet or actuator to engage the tensioning and locking device. Manipulating the locking stylet allows the operator to manipulate (e.g., lock or unlock) the tensioning and locking device to lock or unlock the artificial chordae 102, e.g., with or without tension on the artificial chordae 102, e.g., to adjust the tension of the artificial chordae 102. The stylet may be formed of a metal or a polymeric material (e.g., a relatively hard polymer such as PEBAX®). Optionally, a wire may be added to provide additional feedback to the user regarding the effect of manipulating (e.g., rotating) the stylet. The effect of the artificial chordae 102 tensioning the valve leaflets and valve function can be observed under medical imaging, and further tensioning or relaxation by manipulating the locking stylet and artificial chordae can be performed until the desired leaflet repair is achieved. If the artificial chordae are over-tensioned, as may be revealed by the visualized regurgitation characteristics of the affected heart valve, the tensioning and locking device can be released, and the distance between the leaflet clips 104 and the anchors 110 can be increased by increasing the length of the artificial chordae 102 therebetween, thereby reducing tension in the artificial chordae 102. The tension adjustment step can be repeated as needed or indicated. Once the tension of the artificial chordae 102 and the valve repair are satisfied, the artificial chordae 102 are detached from the catheter, and the catheter is removed from the heart. The procedure can then be terminated, or additional artificial chordae 102 can be implanted. In some embodiments, one or more artificial chordae 102 can be coupled to one or more leaflet clips 104. Once the procedure is complete, the locking stylet or actuator is removed from the tensioning and locking device.The act of retracting the locking stylet from the tensioning and locking device can sever the artificial chordae proximal to the tensioning and locking device. Alternatively, the locking stylet can be detached from the anchor and removed from the body along with the entire catheter. The artificial chordae can then be suspended on a new catheter that can sever the artificial chordae. An artificial chordae-severing catheter can then be deployed, for example, to sever the artificial chordae proximal to the tensioning and locking device. The excess artificial chordae and the artificial chordae-severing catheter can then be removed from the body. Alternatively, pre-cut artificial chordae (e.g., of a selected / predetermined length) can be used, so that post-placement cutting is not necessary, and after completion of the procedure, the proximal end of the pre-cut artificial chordae is simply left in place (e.g., leaving a tail). The procedure can be terminated, or additional artificial chordae can be implanted.

[0029] Various embodiments of artificial chordae tensioning and locking devices embodying various aspects of and formed in accordance with various principles of the present disclosure are illustrated in the accompanying drawings. For simplicity, these devices will be referred to herein simply as tensioning and locking devices, rather than artificial chordae tensioning and locking devices. Each of the tensioning and locking devices disclosed herein includes a locking assembly having tensioning and locking elements configured to affect the tension of the artificial chordae. The locking assembly shifts or moves between a tension adjustment configuration in which the artificial chordae are substantially free to move relative to other components of the locking assembly (e.g., to adjust the tension of the artificial chordae) and a tension setting or locking configuration in which movement of the artificial chordae relative to other components of the locking assembly is constrained, inhibited, prevented, or locked (these terms are used interchangeably herein and are not intended to be limiting). In some embodiments, the tensioning and locking element includes a movable locking element with which the artificial chordae are associated to adjust the tension of the artificial chordae. The movable locking element is selectively movable to shift the locking assembly between a locked configuration and a tension-adjusting configuration. In some embodiments, the movable locking element moves along a longitudinal axis LA of a housing in which the tensioning and locking device is disposed. In some embodiments, the locking element is shaped and configured to engage or interact with the artificial chordae to affect movement of the artificial chordae relative to other components of the locking assembly.

[0030] The tensioning and locking device may be associated with anchor 110, e.g., coupled thereto or formed therewith (e.g., sharing a housing component thereof). In embodiments in which the tensioning and locking device may be associated with anchor 110, locking portion 116 of anchor 110 may extend from, be coupled thereto, or be coextensive with (e.g., as an extension thereof) anchor body portion 114. The tensioning and locking device, or at least components thereof, e.g., the locking assembly thereof, may be housed within a housing 118, e.g., of locking portion 116. It will be appreciated that in some embodiments, housing 118 may be separate from, extend from, or otherwise associated with locking portion 116.

[0031] The tensioning and locking devices of the presently disclosed embodiments are configured to allow adjustment and / or locking (e.g., setting or fixing) of tension acting on or within the artificial chordae (these terms are used interchangeably herein, without limitation), such as to apply a desired tension, for example, between the valve leaflets and the papillary muscles / heart wall. In some embodiments, the artificial chordae 102 may enter the housing 118 substantially along the longitudinal axis LA of the housing 118 and exit through the side of the housing 118, via a delivery catheter and actuator. In some embodiments, other components extend through the delivery catheter, and the artificial chordae 102 instead extend along the delivery catheter (e.g., outside, optionally within an overtube) and enter the housing 118 through the side of the housing 118. In various presently disclosed embodiments, the tensioning and locking devices allow for reversible locking and unlocking, for example, by using a control element or actuator, to allow setting and releasing of the tension so that the tension can be readjusted as needed or desired. The tensioning and locking can be adjusted while the heart is actively beating. It is recognized that various features of one embodiment can be used in conjunction with or in place of features of another embodiment. Accordingly, the features described herein are shown in various combinations as examples of how such features can be combined and provided in an artificial chordae tensioning and locking device to provide the various benefits disclosed herein.

[0032] Referring now to the drawings, an example embodiment of a tensioning and locking device 200 formed in accordance with the principles of the present disclosure is shown in FIG. 2A as associated with an anchor 210 (although other configurations are within the scope of the present disclosure). Anchor 210 includes a tissue engaging portion 212 (configured to engage and / or securely anchor into tissue, e.g., cardiac tissue) at a distal end 211 of anchor 210 extending distally from a body portion 214 of anchor 210. A locking portion 216 extends proximally from body portion 214 of anchor 210. A locking assembly 230 of tensioning and locking device 200 may be housed within housing 218. The locking assembly 230, in some embodiments, is associated with locking portion 216 of anchor 210, as shown in FIGS. 2B, 2C, and 2D and described in further detail below. The artificial chordae 202 extend into the proximal end 203 of the tensioning and locking device 200 to engage or interact with tensioning and locking device components (these terms are used interchangeably herein and are not intended to be limiting) of the locking assembly 230 within the housing 218 (to allow for adjustment and / or setting of the tension of the artificial chordae 202), and out of exit openings, apertures, or windows 217 in the housing 218 to the cardiac valve leaflets, where the free ends of the artificial chordae 202 can be securely secured by leaflet clips or the like, as described with reference to FIG. 1 . In the illustrated embodiment, the artificial chordae 202 extend substantially axially along the longitudinal axis LA of the housing 218 and through the catheter 220 and stylet 222 into the housing 218. However, as noted above, other entry points for the artificial chordae 202 are within the scope and spirit of the present disclosure.As will now be described with reference to Figures 2B, 2C, and 2D, which show the various components of the tensioning and locking device 200 and locking assembly 230 and their interaction with the artificial chordae tendineae 202, the stylet 222 is engaged with a longitudinal bore or cavity 219 (these terms are used interchangeably herein without any limitation intended, and the term bore is not limited to a circular cross-sectional shape) within the housing 218 to actuate the locking assembly 230 of the tensioning and locking device 200.

[0033] 2B , the stylet 222 includes a threaded distal end 223 that is threadedly engaged within a threaded portion of a proximal portion of a longitudinal bore or cavity 219 in the housing 218. The stylet 222 also engages a movable element of a locking assembly 230 of the tensioning and locking device 200, such as a coupler 232 that extends from (and is optionally coupled to) a carriage 234. The coupler 232 may also be threadably engaged within the longitudinal cavity 219 of the housing 218 such that it can be rotationally advanced distally or retracted proximally by the stylet 222. As such, the stylet 222 and coupler 232 are engaged such that rotation of the stylet 222 can be transferred to the coupler 232, thereby rotating the coupler 232 within the longitudinal cavity 219. Examples of such engagement include, but are not limited to, locking features in a key, such as a non-circular protrusion on one of the stylet 222 and coupler 232 engaging a corresponding non-circular bore on the other of the stylet 222 and coupler 232, a slot on one of the stylet 222 and coupler 232 and a longitudinally extending rib on the other of the stylet 222 and coupler 232, and other engagements that lock against relative rotational movement as known in the art or conventionally known. Additionally, coupler 232 is coupled to carriage 234 such that axial advancement or retraction of coupler 232 causes axial advancement or retraction of carriage 234, but does not cause relative rotation between carriage 234 and housing 218 (for reasons that will become apparent). Examples of such engagement include, but are not limited to, a circumferentially extending rib along a distally extending portion of coupler 232 (e.g., extending distally from the threaded portion of coupler 232) engaging into a circumferentially extending groove in carriage 234 and receiving the distally extending portion of coupler 232, as well as other engagements that lock against relative rotational movement. In the illustrated embodiment, carriage 234 is disposed within a portion of longitudinal cavity 219 within housing 218 distal to the threaded portion of longitudinal cavity 219.The longitudinal cavity 219 may include a tensioning adjustment region 219a having a first diameter and a locking region 219b having a second diameter, the first diameter being larger than the second diameter to allow for adjustment of tension on or within the artificial chordae 202 (as described in more detail below). As used herein, the term "diameter" is generally understood to refer to a dimension perpendicular to the longitudinal dimension, e.g., a width dimension, and is not limited to a circular shape or cross-sectional dimension. The locking region 219b may be formed by narrowing the diameter of the longitudinal cavity 219 relative to the tensioning adjustment region 219a, for example, by a shoulder or other protrusion extending into the longitudinal cavity 219 at the locking region 219b and narrowing its diameter. In the illustrated embodiment, the tensioning adjustment region 219a is located closer to the distal end 201 of the tensioning and locking device 200 than to the proximal end 203 of the tensioning and locking device 200. However, the reverse configuration is within the scope of this disclosure.

[0034] Once tensioning and locking device 200 is delivered (and anchor 210 is deployed or secured to tissue), carriage 234 is positioned within tension adjustment region 219a, as shown in Figure 2B. Artificial chordae 202 extend along a passageway 236 formed partially through and partially along an outer portion of carriage 234, where they are coupled to carriage 234, and then exit housing 218 via exit 217 located within housing 218. For example, the artificial chordae 202 may extend along the distal portion 236b (e.g., along an outer portion of the carriage 234) and through the transverse portion 236c (e.g., extending transversely across the carriage 234 so that when the carriage 234 moves axially along the longitudinal cavity 229 within the housing 218, the artificial chordae 202 moves axially along the longitudinal axis LA of the housing 218) to engage with the carriage 234 (e.g., by passing through the stylet 222 into the longitudinal cavity 229 and through the coupler 232 out of the longitudinal cavity 239). When carriage 234 is in tension adjustment region 219a, artificial chordae 202 are generally freely movable along path 236 and relative to carriage 234 and locking assembly 230 and anchor 210, allowing adjustment of the tension in, or acting on, artificial chordae 202. The tension in artificial chordae 202 can be adjusted by retracting artificial chordae 202 proximally (e.g., to increase tension) or by feeding or unfeeding or otherwise releasing or feeding additional artificial chordae 202 distally (e.g., to decrease tension) (these terms are used interchangeably herein and are not intended to be limiting).

[0035] Once the desired tension in or on the artificial chordae 202 is reached, the tension may be fixed, set, or locked (these terms are used interchangeably herein and are not intended to be limiting). The stylet 222 is actuated (e.g., rotated) to actuate the coupler 232 to move proximally (toward the proximal end 203 of the tensioning and locking device 200), thereby moving the carriage 234 proximally. As shown in FIG. 2C , when the carriage 234 is advanced within the longitudinal cavity 219 toward the locking region 219b, such that the portion of the artificial chordae 202 extending along the outer surface portion of the passageway 236 of the carriage 234 faces the locking region 219b, that portion of the artificial chordae 202 is captured or held between the carriage 234 and the locking region 219b. The tension in the artificial chordae 202 may thereby be fixed. If further tension adjustment is desired, the stylet 222 can be actuated (e.g., rotated) to move the carriage 234 distally (toward the distal end 201 of the tensioning and locking device 200), releasing the hold of the locking region 219b on the artificial chordae 202 and allowing the tension of the artificial chordae 202 to be adjusted (e.g., by paying out, releasing, or feeding in additional lengths of artificial chordae 202 to decrease tension, or by pulling or retracting the artificial chordae 202 proximally to increase tension). Once it is determined that the desired tension on the artificial chordae 202 has been reached, the stylet 222 can be decoupled from the coupler 232 (e.g., by continuously rotating the stylet 222 to disengage it from the threads of the threaded portion of the longitudinal cavity 219 in the housing 218) and removed. Thus, a portion of the artificial chordae 202 can be locked within the locking portion 216 of the housing 218, and the artificial chordae 202 extending proximally from the housing 218 can be cut, and the artificial chordae 202 will be firmly secured in place between the cardiac tissue and the valve leaflets, functioning as chordae.

[0036] In the embodiment of Figures 2A-2D, the carriage 234 may have a substantially rectangular cross-section. An alternative form of locking assembly similar to the locking assembly 230 of Figures 2A-2D but having a carriage of a substantially rounded cross-section is shown in connection with the tensioning and locking device 300 shown in Figures 3A-3C. The carriage 334 of the locking assembly 330 functions substantially the same as or similar to the carriage 234 of the locking assembly 230 shown in and described with reference to Figures 2A-2D, with certain additional features or advantages. It will be appreciated that, other than certain differences in the carriages 234, 334, the tensioning and locking devices 200 and 300 of Figures 2A-2D and 3A-3C, respectively, may be arranged and operate in substantially the same or similar manner. For example, tensioning and locking device 300 is shown in association with anchor 310 having tissue engaging portion 312, body portion 314, and locking portion 316. For brevity, convenience, and without any intended limitation, like elements with like functionality will be designated by the same reference numerals, altered by 100, and reference will be made to the above description of those like elements and their function and operation.

[0037] Like the artificial chordae 202 of Figures 2A-2C, the artificial chordae 302 shown in Figures 3A-3C may extend through the stylet 322 and catheter 320 into the proximal end 303 of the locking device 300, through the coupler 332, and through the longitudinal cavity 339 to enter into engagement with the carriage 334. Also like the artificial chordae 202 and carriage 234 shown in Figures 2A-2D, the artificial chordae 302 shown in Figures 3A-3C extend along a passageway 336 formed partially along and partially across an outer portion of the carriage 334, such that the artificial chordae 302 are moved axially along the longitudinal axis LA of the housing 318 as the carriage 334 moves axially within the housing 318 along the longitudinal cavity 319. However, in contrast to the carriage 234 shown in the locking assembly 230 shown in Figures 2A-2D, the carriage 334 of the locking assembly 330 shown in Figures 3A-3C has a circumferential groove 335 between the exit point from the longitudinal portion 336a of the passageway 336 (e.g., a longitudinal bore in the carriage 334) into the outer surface portion 336b of the passageway 336 and the entry point from the outer surface portion 336b of the passageway 336 into the transverse portion 336c of the passageway 336 through the carriage 334. The circumferential groove 335 may provide or define two pinch points 337a, 337b at which the artificial chordae 302 may become pinched between the carriage 334 and the locking region 319b of the longitudinal cavity 319 in the housing 318. As the carriage 334 moves from the tension adjustment region 319a (which allows for adjustment of the tension of the artificial chordae 302 by relatively unrestrained movement of the artificial chordae 302 within the passage 336) to the locking region 319b (e.g., towards the distal end 301 of the tensioning and locking device 300 in the illustrated example), the artificial chordae 302 becomes pinched between the pinch points 337a, 337b and the inner wall of the longitudinal cavity 319, thereby fixing the tension within the artificial chordae 302.

[0038] In some embodiments, a clocking mechanism 340 may be provided to prevent rotation of the carriage 334 within the longitudinal cavity 319, for example, to guide the path of the artificial chordae 302 through the housing 318 (e.g., by locating a passageway 336 for the artificial chordae 302 along or around the carriage 334 with an exit 317 in the housing 318). For example, a detent or rib or protrusion 342 (these terms are used interchangeably herein and are not intended to be limiting) may be provided on the carriage 334 to engage a corresponding groove 344 and / or window 346 in the housing 318. It will be appreciated that other configurations are within the scope of this disclosure.

[0039] An alternative form of tensioning and locking device 400 is shown in Figures 4A-4C, which includes a locking assembly similar to locking assembly 330 of tensioning and locking device 300 of Figures 3A-3C, but with a different path for the artificial chordae to extend relative to the carriage. Tensioning and locking device 400 may have an associated anchor 410 that includes a tissue-engaging portion 412, a body portion 414, and a locking portion 416 similar to anchor 310 associated with tensioning and locking device 300. For brevity, convenience, and without intended limitation, like elements of the example embodiment shown in Figures 4A-4C that have similar functionality as in the example embodiment shown in Figures 3A-3C are designated with the same reference numerals, changed by 100, and reference is made to the above description of those like elements and their function and operation.

[0040] 4A-4C may be more suitable for use with stiffer artificial chordae 402 than those used in the embodiment of FIGS. 3A-3C. More particularly, the artificial chordae 402 may be inserted into position relative to the locking assembly 430 by inserting first and second free ends of the artificial chordae 402 through inlet 415. One end of the artificial chordae 402 extends through a longitudinal cavity 439 in the coupler 432 and through the stylet 422 and catheter 420. The other end of the artificial chordae 402 extends through the carriage 434 (through a transverse passage 436c therethrough) and exits through an outlet 417 in the housing 418 substantially opposite the inlet 415. Angled passage 436a may guide artificial chordae 402 from inlet 415 to longitudinal cavity 439 in coupler 432 and / or to transverse passage 436c, and out through outlet 417.

[0041] The longitudinal extent of the artificial chordae 402 through the longitudinal cavity 439 in the coupler 432 transitions along connecting passage 436b through the carriage 434 to a lateral extent of the artificial chordae 402 extending along a transverse passage 436c and exiting at an outlet 417 in the housing 418. The connecting passage 436b is angled relative to the axial extent of the housing 418 and may provide a relatively large radius of curvature to transition the orientation of the artificial chordae 402 from an axial extent through the carriage 434 to a lateral extent and out at the outlet 417.

[0042] 4A-4C, the carriage 434 of the locking assembly 430 has a rounded cross-section similar to the carriage 334 of the locking assembly 330. Therefore, the carriage 434 may similarly benefit from a clocking mechanism 440 to prevent rotation of the carriage 434 within the longitudinal cavity 419 of the housing 418. Also, as in the example embodiment shown in FIGS. 3A-3C, the carriage 434 of the locking assembly 430 shown in FIGS. 4A-4C has a circumferential groove 435 over which the artificial chordae 402 extend (generally perpendicularly or orthogonally) when the carriage 434 is shifted from the tension adjustment region 419a to the locking region 419b of the longitudinal cavity 419 in the housing 418. The circumferential groove 435 may provide or define two pinch points 437a, 437b at which the artificial chordae 402 may be pinched between the carriage 434 and a locking region 419b of the longitudinal cavity 419 within the housing 418. When the carriage 434 moves from the tension adjustment region 419a (where the tension of the artificial chordae 402 may be adjusted by relatively unrestrained movement of the artificial chordae 402 within the passageway 436) to the locking region 419b (e.g., toward the distal end 401 of the tensioning and locking device 400 in the illustrated example), the artificial chordae 402 becomes pinched between the pinch points 437a, 437b and the inner wall of the longitudinal cavity 419, thereby fixing the tension within the artificial chordae 402.

[0043] In the tensioning and locking device 200, 300, 400, the locking assembly 230, 330, 430 includes a movable element in the form of a carriage. The movable element is moved relative to the housing 218, 318, 418 of the tensioning and locking device 200, 300, 400 to shift the locking assembly 230, 330, 430 between a tension adjustment configuration in which the artificial chordae 202, 302, 402 are selectively movable relative to the locking assembly 230, 330, 430 (e.g., to allow adjustment of the tension of the artificial chordae 202, 302, 402) and a tension setting or locking configuration in which movement of the artificial chordae 202, 302, 402 relative to the locking assembly 230, 330, 430 is inhibited or prevented (these terms are used interchangeably herein and not with any limitation) to fix, set or lock the tension of the artificial chordae 202, 302, 402 (these terms are used interchangeably herein and not with any limitation). It will be appreciated that the movable elements of the locking assemblies 230, 330, 430 of tensioning and locking devices formed in accordance with the principles of the present disclosure may have other configurations than those described with respect to the examples shown in Figures 2A-2D, 3A-3C, and 4A-4C.

[0044] 5A-5C, the locking assembly 530 may have movable elements in the form of rolling elements, such as rollers 534. The rolling elements roll with the movement of the artificial chordae 502 (e.g., during the adjustment of tension in the artificial chordae 502) and may be substantially cylindrical or substantially spherical. The locking assembly 530 of the tensioning and locking device 500 functions substantially the same as or similar to the locking assemblies 230, 330 of the tensioning and locking devices 200, 300, despite the variations in the configuration of the movable elements and housing. In particular, the artificial chordae 502 extend into the proximal end 503 of the tensioning and locking device 500, into a longitudinal cavity 519 of the housing 518 for interaction with the locking assembly 530, and exit the housing 518 via an outlet 517 in the housing 518 for anchoring to the valve leaflet in a manner similar to that described above with respect to the tensioning and locking devices 200, 300. The movable element of the locking assembly 530 can be moved between a tensioning region 519a and a locking region 519b within the housing 518 (e.g., between the proximal end 503 and the distal end 501 of the tensioning and locking device 500) by an actuator, such as a stylet 522 at the end of a catheter 520. For brevity, convenience, and without intending to be limiting, elements similar to those shown in Figures 2A-2D, 3A-3C, and 4A-4C having similar functionality are designated with the same reference numerals, changed by 100, and reference is made to the above description of those similar elements and their functionality and operation. The locking and tensioning features of the tensioning and locking device 500 of Figures 5A-5C are substantially the same or similar to the locking and tensioning features of the tensioning and locking devices 200, 300, 400 of Figures 2A-2D, 3A-3C, and 4A-4C, respectively, although the movable elements of the locking assemblies 230, 330, 430 are configured differently and their functionality will be described in more detail below.

[0045] 5B and 5C , it will be appreciated that the housing 518 of the tensioning and locking device 500 (shown in the illustrative embodiment as associated with an anchor 510 having a tissue-engaging portion 512, a body portion 514, and a locking portion 516) has a tension adjustment region 519a that has at least one dimension that is larger than a corresponding dimension (e.g., in substantially the same direction) of the locking region 519b. When the roller 534 is positioned within the tension adjustment region 519a, the artificial chordae 502 may move substantially freely around the roller 534 (e.g., around a central section of the roller 534) along the passageway 536, allowing for tension adjustment. When the roller 534 is moved into the locking region 519b, for example, by actuation of the stylet 522, the artificial chordae 502 are pinched or trapped between the narrow interior walls of the longitudinal cavity 519, preventing further movement and thereby setting the tension of the artificial chordae 502. The rollers 534 may rotate as the tension in the artificial chordae 502 is adjusted, so that the rollers 534 are engaged by (e.g., contacted by) the stylet 522, for example, by abutting the distal end 521 of the stylet 522 against the end 538 of the roller 534 (e.g., the end having a larger diameter than the mid-section where the artificial chordae 502 extend along the passageway 536) so as not to straddle or otherwise interfere with the artificial chordae 502 as they extend around the rollers 534. Thus, the stylet 522 may hold the rollers 534 in a particular position against tension from the artificial chordae 502 that would tend to pull the rollers 534 proximally.In some embodiments, the distal end 521 extends from a coupler 532 that is rotatably coupled to the distal end of the stylet 522, such that rotation of the stylet 522 to adjust the tension in the artificial chordae 502 (to advance the stylet 522 distally toward the distal end 501 of the tensioning and locking device 500 or to retract the stylet 522 proximally toward the proximal end 503 of the tensioning and locking device 500) does not cause rotation of the distal end 521 relative to the roller 534. As the stylet 522 is actuated (e.g., by being withdrawn proximally) to set the tension in the artificial chordae 502, the roller 534 moves toward the locking region 519b (by being pulled by the tension of the artificial chordae 502 extending around the roller 534) until the artificial chordae 502 are retained between the roller 534 and the longitudinal cavity 519. As with the tensioning and locking devices 200, 300, 400 of Figures 2A-2D, 3A-3C, and 4A-4C, respectively, the tensioning and locking device 500 of Figures 5A-5C allows for adjustment of the tension of the artificial chordae 502 until a desired tension is achieved, at which point the tensioning and locking device 500 can be shifted to a tension setting or locking configuration (e.g., by moving a locking element, e.g., roller 534 of locking assembly 530, to locking region 519b), and the stylet 522 can be disengaged or removed from the tensioning and locking device 500.

[0046] The tensioning and locking device 600 of Figures 6A-6C has a different form of movable element of the locking assembly 630 than that of the tensioning and locking devices 200, 300, 400, 500 of Figures 2A-2D, 3A-3C, 4A-4C, and 5A-5C, respectively. In particular, the movable element of the locking assembly 630 of the tensioning and locking device 600 of Figures 6A-6C is in the form of a coil auger 634. For brevity, convenience, and without intended limitation, elements similar to those of Figures 2A-2D, 3A-3C, 4A-4C, and 5A-5C that have similar functionality are designated with the same reference numerals, changed by 100, and reference is made to the above description of those similar elements and their function and operation. The locking and tensioning features of the tensioning and locking device 600 of Figures 6A-6C are substantially the same as or similar to the locking and tensioning features of the tensioning and locking devices 200, 300, 400, 500 of Figures 2A-2D, 3A-3C, 4A-4C, and 5A-5C, respectively, although the movable elements of the locking assemblies 230, 330, 430, 530, 630 are configured differently and will be described in more detail below.

[0047] 6A-6C, and as can be more clearly appreciated with reference to FIGS. 6B and 6C, the artificial chordae 602 extend laterally into a housing 618 of the tensioning and locking device 600 (which, in the exemplary embodiment, is shown as being associated with an anchor 610 having a tissue-engaging portion 612, a body portion 614, and a locking portion 616), e.g., via an entrance 615. Instead of extending around the periphery or outer portion of the movable element of the locking assembly 630, the artificial chordae 602 extend through the coils of the auger 634. As in the tensioning and locking devices 200, 300 described above, the stylet 622 is coupled to the locking assembly 630 via a coupler 632. Coupler 632 may be fixed against axial movement (along longitudinal axis LA of tensioning and locking device 600) but allows rotation relative to housing 618 (e.g., circumferential rib and groove engagement between coupler 632 and housing 618). Rotation of stylet 622 (shown in this example embodiment extending from catheter 620) actuates and rotates auger 634 to carry portions of artificial chordae 602 proximally (toward proximal end 603 of tensioning and locking device 600) or distally (toward distal end 601 of tensioning and locking device 600). In the tensioning configuration, artificial chordae 602 are free to move through the housing as well as through and across auger 634. However, when the auger 634 is rotated to move the portion of the artificial chordae 602 extending away from the outlet 617, the artificial chordae 602 is pinched between the auger 634 and the longitudinal cavity 619 in the housing 618 into a locking position where its tension is substantially fixed. In some embodiments, the entrance 615 is in the form of a slot to allow the artificial chordae 602 to pass therethrough without being pinched when the auger 634 is actuated or moved between a tension adjustment configuration and a tension setting or locking configuration.

[0048] To facilitate rotational movement of the stylet 622 to the coupler 632, a railcar-type coupling may be used, as shown. In particular, the stylet 622 and coupler 632 may have ends shaped to interlock or interlock with one another, locking the stylet 622 and coupler 632 against relative rotational movement. The stylet 622 and coupler 632 may be secured against relative movement, causing their coupled ends to disengage (e.g., movement of the ends perpendicular to the longitudinal axes of the stylet 622 and coupler 632) by using a locking stylet 624 extending through lumens in the stylet 622 and coupler 632, as shown in FIG. 6B . Alternatively, as shown in FIGURE 6D, a locking stylet 624' extending over the stylet 622 and coupler 632 can secure the stylet 622 and coupler 632 against relative movement that would cause their coupled ends to disengage. An alternative configuration of the mating locking ends of the stylet 622 and coupler 632 is shown in FIGURE 6E. It will be appreciated that the illustrated configurations are non-limiting examples and that other configurations are within the scope of this disclosure.

[0049] Another form of the movable element of the locking assembly 730 is shown in Figures 7A-7C. For brevity, convenience, and without intending to be limiting, elements similar to those shown in Figures 2A-2D, 3A-3C, 4A-4C, 5A-5C, and 6A-6C that have similar functionality are designated with the same reference numerals, changed by 100, and reference is made to the above description of those similar elements and their function and operation.

[0050] 7A-7C, the movable element of the locking assembly 730 includes a tissue-engaging movable element 734 configured to move relative to a housing 718 of the tensioning and locking device 700 (which, in the exemplary embodiment, is shown as being associated with an anchor 710 having a tissue-engaging portion 712, a body portion 714, and a locking portion 716). An actuator, such as in the form of an actuator shaft 720, extends through a longitudinal cavity 719 in the housing 718 to move the tissue-engaging movable element 734 (extending from the distal end 701 of the tensioning and locking device 700) between a tension-setting or locking configuration, in which the tension in the artificial chordae 702 is substantially fixed, and a tension-adjustment configuration, in which the tension in the artificial chordae 702 can be adjusted. More specifically, the artificial chordae 702 extend laterally into the housing 718 of the tensioning and locking device 700, for example, via inlet 715, pass through a passage 736 through (in this example, transversely) the tissue engaging movable element 734, and exit the housing 718 through outlet 717 to the leaflet where the artificial chordae 702 are to be secured. As can be appreciated by comparing Figures 7B and 7C, when the tissue engaging movable element 734 is engaged within tissue as shown in Figure 7B, the artificial chordae 702 can be sandwiched between the end of the passage 736 and the ends of either or both of the inlet 715 and outlet 717. By moving the shaft 722 proximally (toward the proximal end 703 of the tensioning and locking device 700) and before the tissue engaging movable element 734 is inserted into the tissue in the locking range (as shown in FIG. 7B), the artificial chordae 702 are no longer pinched (as shown in FIG. 7C), and the tension can be adjusted as desired. In the illustrated embodiment, the inlet 715, outlet 717, and passage 736 are each elongated, allowing the artificial chordae 702 to move axially as the shaft 722 is moved axially. Other configurations, such as only the inlet 715 and outlet 717 or only the passage 736 being elongated, are within the scope and spirit of the present disclosure.

[0051] While a tissue engaging movable element 734 having a spear-shaped tissue engaging distal end 750 is shown in Figures 7A-7C, other configurations are within the scope of this disclosure. For example, the tissue engaging movable element 734 can have a tissue engaging distal end that is selectively movable between an insertion configuration and a tensioning or locking configuration. For example, a tissue engaging distal end with a movable arm, as shown in Figures 7D-7G, can be provided on the tissue engaging movable element 734, such as that provided in the locking assembly 730 of the tensioning and locking device 700. In the embodiment shown in Figures 7D and 7E, the locking arm 752 can be integrally formed with (part of) the shaft portion 754. The locking arms 752 may be in an insertion configuration as shown in Figure 7D (e.g., flush with and / or conform to the peripheral contour of the shaft portion 754) when the tissue engaging movable element 734 is inserted or secured or implanted in tissue, and may extend outward from the shaft portion 754 to an anchoring configuration as shown in, for example, Figure 7E (e.g., once the tissue engaging movable element 734 is initially inserted into tissue, they may be pulled apart as the shaft portion 754 is moved proximally) to hold the tissue engaging movable element 734 in place within the tissue. Alternatively, as shown in Figures 7F and 7G, the locking arms 752' may be formed separately from the shaft portion 754' and pivotally coupled thereto, for example via a pivot 755. The locking arms 752' may be in a compact insertion configuration (e.g., extending longitudinally along the shaft portion 754) as shown in FIG. 7F when the tissue engaging movable element 734 is inserted or secured or implanted in tissue, and may extend outward from the shaft portion 754 to an anchoring configuration (e.g., moving away as the shaft portion 754 moves proximally once the tissue engaging movable element 734 is initially inserted into tissue) as shown in FIG. 7G to hold the tissue engaging movable element 734 in place within the tissue. In some embodiments, the locking arms 752, 752' may be symmetrical. In some embodiments, more than one locking arm may be provided, e.g., two or more locking arms 752, 752'.

[0052] The devices, systems, and methods of the present disclosure may be used alone or in conjunction with other devices, systems, and methods to treat heart diseases, including, but not limited to, those described in U.S. patent application Ser. No. 16 / 919,769 (entitled "DEVICES, SYSTEMS, AND METHODS FOR ADJUSTABLY TENSIONING AN ARTIFICIAL CHORDAE TENDINEAE BETWEEN A LEAFLET AND A PAPILLARY MUSCLE OR HEART WALL") and U.S. patent application Ser. No. 16 / 919,782 (entitled "DEVICES, SYSTEMS, AND METHODS FOR CLAMPING A LEAFLET OF A HEART VALVE"), both filed on July 2, 2020, respectively. No. 16 / 919,794 (entitled "DEVICES, SYSTEMS, AND METHODS FOR ANCHORING AN ARTIFICIAL CHORDAE TENDINEAE TO A PAPILLARY MUSCLE OR HEART WALL"), and U.S. Patent Application No. 16 / 919,806 (entitled "DEVICES, SYSTEMS, AND METHODS FOR ARTIFICIAL CHORDAE TENDINEAE"), each of which is incorporated herein by reference in its entirety. The example devices described therein may be modified to incorporate one or more embodiments or features of the present disclosure. All devices and methods described herein are examples of devices and / or methods implemented in accordance with one or more principles of this disclosure. These examples are not the only ways to implement these principles, but are merely examples.Therefore, references to elements or structures or features in the drawings should be recognized as references to example embodiments of the present disclosure and should not be understood to limit the present disclosure to the particular elements, structures, or features shown. Other examples of ways of implementing the principles of the disclosure will occur to those skilled in the art upon reading this disclosure.

[0053] While embodiments of the present disclosure may be described with specific reference to the mitral valve, tensioning and locking devices as disclosed herein may be used in connection with the repair or modification of any valve annulus, including, for example, the tricuspid annulus, and / or may benefit any other similar dilatation, valve insufficiency, valve leakage, and other similar heart failure conditions involving the firm fixation of components to cardiac tissue. While embodiments of the tensioning and locking device have been described with respect to a heart valve implant device, it will be further recognized that the principles of the present disclosure may be applied to tensioning and locking devices used in connection with other types of devices that are implanted within the body, for example, in areas of soft tissue and / or areas where there is regular movement in the tissue in which the implant is placed.

[0054] Although embodiments of the present disclosure may be described with specific reference to medical devices and systems for selectively accessing cardiac tissue (e.g., transluminal devices inserted through the femoral vein, etc.), it should be appreciated that such medical devices and systems may be used in a variety of medical procedures requiring tensioning of a cord-like element within the body. The disclosed medical devices and systems may also be inserted through different access points and approaches, for example, percutaneously, endoscopically, laparoscopically, or combinations thereof.

[0055] Those skilled in the art will appreciate that the discussion is merely a description of illustrative examples of embodiments and is not intended to limit the broader aspects of the present disclosure. The foregoing discussion has broad applicability and is presented for purposes of illustration and description, and is not intended to limit the present disclosure to the form or forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure may be provided in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from the concept, spirit, or scope or characteristics thereof. For example, various features of the present disclosure are grouped together in one or more aspects, embodiments, or forms for the purpose of streamlining the disclosure. However, it should be understood that various features of some aspects, embodiments, or forms of the present disclosure may be combined with alternative aspects, embodiments, or forms. Although the present disclosure is presented in terms of embodiments, it should be recognized that such individual features need not be present to achieve at least some of the desired properties and / or benefits of the present subject matter or various separate features of the present subject matter. Those skilled in the art will recognize that the present disclosure may be used with numerous modifications, or with modifications in structure, arrangement, size, materials, components, or otherwise used in practicing the present disclosure that are particularly adapted to particular environments and operating conditions, without departing from the principle, spirit, or scope of the present disclosure. For example, elements shown as integrally formed may be composed of multiple parts, or elements shown as multiple parts may be integrally formed, operations of elements may be reversed or otherwise changed, and sizes or dimensions of elements may be changed. Similarly, although operations, acts, or procedures are described in a particular order, this should not be construed as requiring such a specific order, or that all operations, acts, or procedures must be performed to achieve desired results. Furthermore, other implementations are within the scope of the following claims. In some cases, the acts recited in the claims may be performed in a different order and still achieve desired results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims and not limited to the foregoing description or the specific embodiments or arrangements described or illustrated herein. In view of the above, individual features of any embodiment may be used and claimed separately or in combination with features of that embodiment or any other embodiment, the scope of the subject matter being indicated by the appended claims and not limited to the foregoing description.

[0056] In the foregoing description and the claims that follow, it is recognized that: As used herein, the terms "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. The terms "a," "an," "the," "first," "second," etc. do not preclude a plurality. For example, as used herein, the term "a" or "an" entity refers to one or more of that entity. As such, the terms "a" (or "an"), "one or more," and "at least one" may be used interchangeably herein. All directional designations (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used for identification purposes only to aid the reader in understanding this disclosure and / or serve to distinguish regions of related elements from one another and do not limit the related elements, particularly with respect to location, orientation, or use of this disclosure. Connection designations (e.g., attached, coupled, connected, and joined) are to be interpreted broadly and may include intermediate members and relative movement of elements between groups of elements unless otherwise indicated. As such, connection designations do not necessarily imply that two elements are directly and fixedly connected to one another. Identification designations (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another. The following claims are hereby incorporated by reference into this detailed description, with each claim standing on its own as a separate embodiment of this disclosure. Reference signs in the claims are provided merely for clarifying examples and shall not be construed as limiting the scope of the claims in any way.

[0057] The following claims are hereby incorporated by reference into this detailed description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term "comprises" does not exclude the presence of other elements or steps. Furthermore, although individual features may be included in different claims, these may conceivably be combined to advantage, and inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. Furthermore, singular references do not exclude a plurality. The terms "a," "an," "the," "first," "second," etc. do not exclude a plurality. Reference signs in the claims are provided merely for the purpose of clarifying an example and are not to be construed as limiting the scope of the claims in any way.

Claims

1. 1. A system for adjusting tension in artificial chordae extending between a leaflet of a heart valve and a papillary muscle or a heart wall, comprising: a leaflet clip configured to engage the leaflets of the heart valve and the artificial chordae; an anchor configured to engage a papillary muscle or a cardiac wall; artificial chordae extending between the leaflet clip and the anchor; a locking assembly associated with the anchor, the artificial chordae extending through passages defined in a locking element of the locking assembly, the locking element configured to be selectively axially shiftable between a tension adjustment configuration that allows the artificial chordae to move relative to the locking assembly to increase or decrease tension on the valve leaflets, and a tension setting configuration that prevents movement of the artificial chordae relative to the locking assembly to set tension on the valve leaflets; A stylet and a coupler configured to couple the stylet and the locking element; Equipped with the locking assembly includes a housing, the locking element being axially movable but not rotatable within a longitudinal cavity defined in the housing to shift the locking assembly between the tension-adjusting configuration and the tension-setting configuration; the longitudinal cavity in the housing defines a locking region and a tension adjustment region; when the locking element is within the tension adjustment region, the artificial chordae are movable relative to the locking element; the passageway includes an exterior surface portion extending along an exterior portion of the locking element; one or more portions of the artificial chordae tendineae extending along the outer surface portion of the passage are sandwiched between the locking element and the tension adjustment region when the locking element is within the locking region of the longitudinal cavity of the housing to set tension on the valve leaflets; the artificial chordae extend axially through the stylet, the coupler, and the locking element, and extend along an outer portion of the locking element, traverse through the locking element to the outer surface portion of the passage, and extend across the housing to the leaflet clip.

2. the locking assembly includes a housing; the locking element is movable within a longitudinal cavity defined in the housing to shift the locking assembly between the tension-adjusting configuration and the tension-setting configuration; The system of claim 1 , wherein the locking assembly comprises one of a carriage or a roller axially movable within the longitudinal cavity in the housing.

3. 3. The system of claim 1 or 2, wherein the artificial chordae extend axially along the passage defined along the locking element.

4. A system described in any one of claims 1 to 3, wherein the coupler is configured to engage with the stylet and couple the stylet to the locking element so as to move the locking element to axially shift the locking assembly between the tension adjustment configuration and the tension setting configuration.

5. the anchor comprises a body portion, a tissue engaging portion extending distally from the body portion, and a locking portion extending proximally from the body portion; The system of any one of claims 1 to 4, wherein the housing is part of the locking portion of the anchor.

6. 1. A device for adjusting tension in artificial chordae extending between a cusp of a heart valve and a papillary muscle or a heart wall, comprising: a leaflet clip configured to engage the leaflets of the heart valve and the artificial chordae; the device comprises an artificial chordae; The apparatus includes a housing defining a longitudinal cavity therein; the device comprises a locking assembly disposed within the housing and having an axially movable locking element, the movable locking element having a passageway defining an inner surface portion defined therethrough to allow passage of the artificial chordae and an outer surface portion, the movable locking element being disposed within the longitudinal cavity of the housing and configured to be axially movable within the longitudinal cavity of the housing between a tension adjustment configuration that allows movement of the artificial chordae relative to the housing and a tension setting configuration that prevents movement of the artificial chordae relative to the housing; the device includes a coupler extending from the movable locking element and configured to engage a stylet to move the movable locking element relative to the housing; the device comprises a coupler configured to couple the stylet and the movable locking element; the locking assembly includes a housing, the movable locking element being axially movable but not rotatable within a longitudinal cavity defined in the housing to shift the locking assembly between the tension-adjusting configuration and the tension-setting configuration; the longitudinal cavity in the housing defines a locking region and a tension adjustment region; when the movable locking element is within the tension adjustment region, the artificial chordae are movable relative to the movable locking element; the passageway includes an outer surface portion extending along an outer portion of the movable locking element; one or more portions of the artificial chordae tendineae extending along the outer surface portion of the passage are sandwiched between the movable locking element and the tension adjustment region when the movable locking element is within the locking region of the longitudinal cavity of the housing to set tension on the valve leaflets; the artificial chordae extend axially through the stylet, the coupler, and the movable locking element, extend along an outer portion of the movable locking element, traverse through the movable locking element to the outer surface portion of the passage, and extend across the housing to the leaflet clip; Device.

7. 7. The device of claim 6, further comprising tissue engaging elements configured to engage tissue of the heart to firmly secure the ends of the artificial chordae to the heart.

8. 8. The apparatus of claim 6 or 7, wherein the locking assembly comprises one of a carriage and a roller.

9. The device of any one of claims 6 to 8, wherein the artificial chordae extend axially along a portion of the passageway.

10. The apparatus of claim 9 , wherein the inner portion of the passage extends across the movable locking element.

11. 11. The device of claim 9 or 10, wherein the movable locking element is non-rotatable within the housing.

12. the longitudinal cavity in the housing defines a locking region and a tension adjustment region; the artificial chordae are movable relative to the movable locking element when the movable locking element is within the tension adjustment region; 12. The device of claim 11, wherein one or more portions of the artificial chordae that extend along the exterior surface portion of the passage are sandwiched between the movable locking element and the tension adjustment region when the movable locking element is within the locking region to set leaflet tension.

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