Devices, systems, and methods for adjustably tensioning artificial chordae in the heart

Abstract

This invention provides an apparatus, system, and method for adjusting and setting the tension of an artificial tendon chord. The artificial tendon chord can be coupled between a leaflet clip and a tissue anchor. A locking component through which the artificial tendon chord extends can switch between a tension adjustment mode and a tension setting or locking mode. In the tension adjustment mode, the artificial tendon chord is movable to adjust the tension on the leaflet; in the tension setting or locking mode, the artificial tendon chord is inhibited, blocked, or locked so that it cannot move relative to the locking component to set or fix the tension on the leaflet.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 085,390, filed September 30, 2020, pursuant to 35 USC §119, the disclosure of which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This invention generally relates to medical devices, systems, and methods for repairing the heart. More particularly, this invention relates to medical devices, systems, and methods for delivering and implanting artificial chordae tendineae in the heart. Even more particularly, this invention relates to medical devices, systems, and methods for adjusting the tension of artificial chordae tendineae in the heart. Background Technology

[0004] Heart disease, including atrioventricular valve dysfunction, impairs a patient's cardiac output, reducing their quality of life and lifespan. Normal blood flow through the heart is regulated, particularly by the heart valves, including the atrioventricular valves. Heart valves consist of soft tissue leaflets that cyclically open and close to allow blood to flow in one direction. Healthy leaflets prevent blood flow in the opposite direction (regurgitation). Chordas extending from the leaflets to the papillary muscles support the normal function of the leaflets, such as by distributing the load to the papillary muscles during systolic closure and by preventing the leaflets from being flung into the atria. Abnormal function of the chordae tendineae impairs the leaflets' ability to form a seal at the heart valve. Various defects in the chordae tendineae, such as elongation, rupture, thickening, retraction, calcification, inelastic stretching, or other elastic changes, can lead to abnormal closure of the heart valves and / or may result in the leaflets no longer having the ability to form a seal for normal heart function.

[0005] Minimally invasive solutions are needed to repair heart valves, such as their leaflets, while maintaining options for future interventions. Furthermore, there is a need to improve the devices, systems, and methods for repositioning, repairing, and / or replacing one or more chordae tendineae in the heart to improve the treatment of heart disease. Summary of the Invention

[0006] A summary of the invention is provided to aid understanding, and those skilled in the art will understand that aspects and features of the invention may be used advantageously alone in some cases, or in combination with other aspects and features of the invention in others. The inclusion or exclusion of elements, components, etc., in this summary is not intended to limit the scope of the claimed subject matter.

[0007] In one aspect, this subject matter relates to the field of medical devices, systems, and methods for delivering artificial tendinous cords within a patient and adjusting the tension on the artificial tendinous cords.

[0008] In various embodiments described herein or elsewhere within the scope of the invention, a system for adjusting tension in an artificial chordae tendineae extending between a heart valve leaflet and a papillary muscle or heart wall includes: an artificial chordae tendineae; leaflet clips configured to engage with both the heart valve leaflet and the artificial chordae tendineae; anchors configured to engage with the papillary muscle or heart wall; and a locking assembly associated with the anchors. In various embodiments, the locking assembly is configured to selectively switch between a tension adjustment mode that allows movement of the artificial chordae tendineae relative to the locking assembly to increase or decrease tension on the leaflet and a tension setting mode that inhibits movement of the artificial chordae tendineae relative to the locking assembly to set tension on the leaflet.

[0009] In some embodiments, the locking assembly includes a housing and a movable locking element movable within a longitudinal cavity defined in the housing to transfer 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, roller, auger, or tissue engagement element axially movable within the longitudinal cavity in the housing. In some embodiments, an artificial tendon extends along a path defined by the movable locking element. In some embodiments, a longitudinal cavity in the housing defines a locking region and a tension adjustment region; when the movable locking element is in the tension adjustment region, the artificial tendon is movable relative to the movable locking element; a portion of the path extends along the exterior of the movable locking element; and when the movable locking element is in the locking region to set tension on the leaflet, a portion of the artificial tendon extending along the portion of the path extending along the exterior of the movable locking element is clamped between the movable locking element and the tension adjustment region. In some embodiments, the system further includes a probe that engages with the movable locking element to move the movable locking element to transfer the locking element between a tension adjustment configuration and a tension setting configuration. In some embodiments, the system further includes a connector configured to connect the probe and the movable locking element, wherein the artificial tendon extends axially through the probe, the connector, and the movable locking element, and laterally through the movable locking element to a portion of a path extending outward from the movable locking element, and laterally through the housing to the leaflet clip.

[0010] In some embodiments, the system further includes a probe that engages with a movable locking element to move the movable locking element so that the locking element shifts between a tension adjustment mode and a tension setting mode.

[0011] In some embodiments, the anchor includes a body portion, a tissue engagement portion extending distally from the body portion, and a locking portion extending proximally from the body portion; and the housing is part of the locking portion of the anchor.

[0012] In various embodiments described herein or elsewhere within the scope of the invention, an apparatus for adjusting tension in an artificial chordae includes: an artificial chordae; a housing, wherein a longitudinal chamber is defined therein; a locking assembly positioned within the housing and having a movable locking element movable within the longitudinal chamber of the housing between a tension adjustment mode that allows movement of the artificial chordae relative to the housing and a tension setting mode that inhibits movement of the artificial chordae relative to the housing; and a coupling extending from the movable locking element and configured to engage with an actuator for moving the movable locking element relative to the housing.

[0013] In some embodiments, the device further includes a tissue engagement element configured to engage cardiac tissue in relation to the end of a cardiac-anchored artificial tendon.

[0014] In some embodiments, the movable locking element includes one of a carriage, roller, auger, or tissue-attaching element. In some embodiments, an artificial tendon extends along a path defined by the movable locking element. In some embodiments, a portion of the path extends laterally through the movable locking element. Alternatively or additionally, in some embodiments, a portion of the path extends along the exterior of the movable locking element. In some embodiments, a longitudinal chamber in the housing defines a locking region and a tension adjustment region; when the movable locking element is in the tension adjustment region, the artificial tendon can move relative to the movable locking element; and when the movable locking element is in the locking region to set tension on the leaflet, a portion of the artificial tendon extending along a portion of the path extending along the exterior of the movable locking element is clamped between the movable locking element and the tension adjustment region.

[0015] According to various principles of the present invention, a method for adjusting the tension in an artificial chordae tendineae extending between a heart valve leaflet and a papillary muscle or heart wall is also disclosed. The method includes: extending the artificial chordae tendineae through an artificial chordae tendineae tensioning and locking device; moving the artificial chordae tendineae relative to a housing to increase or decrease tension on the leaflet while the locking assembly is in a tension adjusting configuration; and when a desired tension on the leaflet is reached, transferring the locking assembly to a tension setting configuration to set the tension on the artificial chordae tendineae and on the leaflet.

[0016] In one aspect, the artificial tendon chord that moves relative to the housing also includes a movable locking element that connects the probe and the locking assembly to move the movable locking element. In some embodiments, the locking assembly includes the movable locking element, and the method further includes associating the artificial tendon chord with the movable locking element such that movement of the artificial tendon chord relative to the housing is inhibited when the locking assembly is in a tension-setting configuration.

[0017] These and other features and advantages of the invention will become apparent from the following detailed description, in which the scope of the claimed invention is set forth in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be understood that individual aspects may be claimed individually or in combination with aspects and features of that embodiment or any other embodiment. Attached Figure Description

[0018] Non-limiting embodiments of the invention are described by way of example with reference to the illustrative and not scaled-down drawings. The drawings are provided for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the figures may vary. For example, devices may be enlarged to make details discernible, but are intended to be scaled down, for example, when fitted within the working channel of a delivery catheter or endoscope. In the drawings, identical or nearly identical or equivalent elements are generally denoted by the same reference numerals, and similar elements are generally named with similar reference numerals in increments of 100, with redundant descriptions omitted. For clarity and simplicity, not every element is labeled in every figure, and not every element of every embodiment is shown where necessary to enable those skilled in the art to understand this disclosure.

[0019] A detailed description will be better understood in conjunction with the accompanying drawings, wherein similar reference characters denote similar elements, as described below:

[0020] Figure 1 This is a schematic cross-sectional view of a human heart with an example heart valve repair device shown as being implanted to repair the mitral valve annulus using an artificial chordae tendineae tensioning and locking device formed according to aspects of the invention.

[0021] Figure 2A This is a perspective view of an artificial chordae tendineae tensioning and locking device formed according to the principle of the present invention, wherein its housing portion is shown in dashed lines.

[0022] Figure 2B Is it like this? Figure 2A The cross-sectional view along line IIB-IIB of the artificial tendon tensioning and locking device is shown, with the housing portion shown in dashed lines and depicted in the unlocked position.

[0023] Figure 2C It is similar to Figure 2B A cross-sectional view of the artificial chordae tendineae tensioning and locking device, but shown in the locked position.

[0024] Figure 2D It is similar to Figure 2CA cross-sectional view showing an actuator formed according to the principle of the invention, detached from the artificial tendon tensioning and locking device.

[0025] Figure 3A This is a perspective view of an artificial chordae tendineae tensioning and locking device formed according to the principle of the present invention, wherein the housing portion is shown in dashed lines.

[0026] Figure 3B Is it like this? Figure 3A The cross-sectional view along line IIIB-IIIB of the artificial tendon tensioning and locking device is shown, with the housing portion shown in dashed lines and depicted in the unlocked state.

[0027] Figure 3C It is similar to Figure 3B A cross-sectional view of the artificial chordae tendineae tensioning and locking device, but shown in the locked position.

[0028] Figure 4A This is a perspective view of an artificial chordae tendineae tensioning and locking device formed according to the principle of the present invention, wherein the housing portion is shown in dashed lines.

[0029] Figure 4B Is it like this? Figure 4A The artificial tendon tensioning and locking device is shown as a cross-sectional view along line IVB-IVB, with the housing portion shown in dashed lines and depicted in the unlocked position.

[0030] Figure 4C It is similar to Figure 4B A cross-sectional view of the artificial chordae tendineae tensioning and locking device, but shown in the locked position.

[0031] Figure 5A This is a perspective view of an artificial chordae tendineae tensioning and locking device formed according to the principle of the present invention, wherein the housing portion is shown in dashed lines.

[0032] Figure 5B Is it like this? Figure 5A The artificial tendon tensioning and locking device shown is a cross-sectional view along line VB-VB, where the housing portion is shown in dashed lines and is shown in the unlocked state.

[0033] Figure 5C It is similar to Figure 5B A cross-sectional view of the artificial chordae tendineae tensioning and locking device, but shown in the locked position.

[0034] Figure 6A This is a perspective view of an artificial chordae tendineae tensioning and locking device formed according to the principle of the present invention.

[0035] Figure 6B Is it like this? Figure 6AThe cross-sectional view along line VIB-VIB of the artificial tendon tensioning and locking device is shown, with the housing portion shown in dashed lines and depicted in the unlocked state.

[0036] Figure 6C It is similar to Figure 6B A cross-sectional view of the artificial chordae tendineae tensioning and locking device, but shown in the locked position.

[0037] Figure 6D It is an alternative form of actuator, such as Figures 6A to 6C An elevation view of the artificial tendon tensioning and locking device.

[0038] Figure 6E It is an alternative form of actuator, such as Figures 6A to 6D An elevation view of the artificial tendon tensioning and locking device.

[0039] Figure 7A This is a perspective view of an artificial tendon chordae tensioning and locking device formed according to the principles of the invention, having an anchor portion in a suitable location within body tissue, wherein the elements are shown in dashed lines.

[0040] Figure 7B Is it like this? Figure 7A The cross-sectional view along line VIIB-VIIB of the artificial tendon tensioning and locking device is shown, with the housing portion shown in dashed lines and depicted in the locked position within the body tissue.

[0041] Figure 7C It is similar to Figure 7B A cross-sectional view of the artificial chordae tendineae tensioning and locking device, but shown in the unlocked position within the body tissue.

[0042] Figure 7D It can be used as Figure 7A An elevation view of an alternative embodiment of the anchor portion shown in the insertion configuration of the artificial tendon tensioning and locking device.

[0043] Figure 7E It is shown as being in an anchored state. Figure 7D An elevation view of the anchoring component.

[0044] Figure 7F It can be used as Figure 7A An elevation view of an alternative embodiment of the anchor portion shown in the insertion configuration of the artificial tendon tensioning and locking device.

[0045] Figure 7G It is shown as being in an anchored state. Figure 7F An elevation view of the anchoring component. Detailed Implementation

[0046] The following detailed description should be read with reference to the accompanying drawings, which depict illustrative embodiments. It should be understood that the invention is not limited to the specific embodiments described and therefore variations are possible. All devices, systems, and methods discussed herein are examples of devices and / or systems and / or methods implemented according to one or more principles of the invention. Each example of an embodiment is provided by way of explanation and is not the only way to implement these principles, but merely an example. Therefore, references to elements or structures or features in the drawings must be understood as references to examples of embodiments of the invention and should not be construed as limiting the invention to the specific elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will occur to those skilled in the art upon reading this invention. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made to the invention without departing from the scope or spirit of the subject matter. For example, features illustrated and described as part of one embodiment may be used with another embodiment to produce further embodiments. Therefore, this subject matter is intended to cover such modifications and variations within the scope of the appended claims and their equivalents.

[0047] It should be understood that the invention has been described in various levels of detail in this application. In some cases, details that are unnecessary for those skilled in the art to understand the invention or that make other details difficult to perceive may have been omitted. The terminology used herein is for describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, the technical terminology used herein should be understood as commonly understood by those skilled in the art to which this invention pertains. According to the invention, all the apparatuses and / or methods disclosed and claimed herein can be manufactured and performed without requiring extensive experimentation.

[0048] As used herein, “proximal” refers to the direction or location closest to the user (medical professional, clinician, technician, operator, physician, etc.; this term is used interchangeably and is not intended to limit or otherwise) such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and “distal” refers to the direction or location furthest from the user such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery). “Longitudinal” means extending along the longer or larger dimension of the element. “Center” means at least substantially bisecting the center point, and “central axis” means a line relating to an opening that at least substantially bisectes the center point of the opening, extending longitudinally along the length of the opening when the opening includes, for example, a tubular element, a strut, a channel, a chamber, or a hole.

[0049] According to various principles and aspects of the present invention, one or more leaflets of a heart valve are repositioned and / or repaired by implanting an artificial chordae tendineae extending in the heart between the leaflets and the ventricular wall and / or papillary muscles. Various embodiments of devices and systems including means for adjusting and / or setting tension in the artificial chordae tendineae are disclosed herein, and methods (such as minimally invasive methods) for using such devices and / or systems to implant and / or adjust the tension of the artificial chordae tendineae and / or to set the tension of the artificial chordae tendineae are disclosed herein for the repair of heart valves. Figure 1 The reference mitral valve illustrates an example of an artificial chordae tendineae tensioning and locking system 100. It should be understood that the artificial chordae tendineae tensioning and locking system 100 can be used in other contexts, such as for tricuspid valve repair. One end of the artificial chordae tendineae 102 is attached (e.g., via leaflet clip 104, such as a spring clip) to the free edge of the leaflet L to be repaired, and the other end of the artificial chordae tendineae 102 is connected (e.g., via anchor 110, such as a ventricular anchor) to the heart H (e.g., the ventricular wall or papillary muscle VW). The artificial chordae tendineae 102 (e.g., its length and / or tension) is adjusted to adjust the relative positions of the leaflet clip 104 and anchor 110 (e.g., to bring the leaflet clip 104 and anchor 110 closer together or further apart) to adjust / repair the valvular leaflet L, such as minimizing blood regurgitation through the valve V.

[0050] In some embodiments, a device and system for repairing a heart valve is delivered to a treatment site (e.g., the mitral or bicuspid valve) via a catheter or other suitable delivery device. The system may have one or more controls located proximally to allow a user to manipulate the disclosed device. It should be understood that the specific nature of the delivery device is not critical to the invention, as long as the delivery device is configured to allow the user to deliver, implant, and manipulate the disclosed device at a target location within the heart. It should also be understood that the delivery, engagement, and manipulation of the disclosed device can be facilitated by using known visualization techniques such as fluoroscopy, ultrasound, intracardiac echocardiography (ICE), transesophageal echocardiography, etc.

[0051] The delivery catheter is advanced to the treatment site in the ventricle. A leaflet clip 104 (such as a spring clip) may be manufactured on one side of the delivery catheter or otherwise provided, such as being housed in a leaflet grasping mechanism. Once the catheter has reached the treatment site, the leaflet clip 104 opens and positions itself to grasp and secure to the leaflet L (e.g., the free edge of the leaflet). Medical imaging may be used to confirm the position of the leaflet clip 104 and the quality of its grip on the leaflet L. If the grip and / or position is not ideal, the leaflet clip 104 can be returned to the open position, and the leaflet grasping steps can be repeated until the placement of the leaflet clip 104 is satisfactory, and then the leaflet clip 104 is left in the appropriate position on the leaflet L, such as... Figure 1 As shown.

[0052] An artificial chord 102, formed of any of a variety of suitable materials, including but not limited to suture materials such as polytetrafluoroethylene (PTFE) or ePTFE (expanded PTFE), extends between the leaflet clip 104 and the ventricular anchor 110, configured to anchor the artificial chord 102 to the ventricular wall VW (e.g., papillary muscle). In some embodiments, additional artificial chord threads 102a, 102b, etc., may extend between the artificial chord 102 and the leaflet clip 104 extending from the ventricular anchor 110. To deploy and secure the ventricular anchor 110 to the ventricular wall VW, the distal catheter tip is positioned above the intraatrial valve V. The working channel is pushed out of the delivery catheter, and medical imaging may be used to assist in positioning the working channel in relation to the desired location of the ventricular anchor. A rod or actuator or probe attached to the ventricular anchor (such terms are used interchangeably herein and are not intended to be limiting) may be used to deploy the ventricular anchor into the ventricular cardiac tissue by pushing the ventricular anchor out of the working channel. Medical imaging can be used to confirm the position and grip quality of the ventricular anchors on cardiac tissue. If the grip and / or position are not ideal, a probe can be used to retract the ventricular anchor into the working channel, and the ventricular anchor deployment steps can be repeated until the ventricular anchor placement is satisfactory. The ventricular anchor is then left in place, such as... Figure 1 As shown.

[0053] Final checks can be performed, such as using medical imaging to verify the placement of the ventricular anchor 110. When the placement of the ventricular anchor 110 is satisfactory, the working channel can optionally be retracted into the catheter. It should be understood that the working channel can remain connected to the ventricular anchor 110 during tensioning, if necessary. The probe remains connected to the ventricular anchor.

[0054] According to the principles of the invention, anchor 110 is associated with an artificial tendon chord tensioning and locking system 100 formed according to various aspects and principles of the invention to adjust the tension on the artificial tendon chord 102 and / or set, lock, or fix (such terms are used interchangeably herein and are not intended to be limiting) the tension on the artificial tendon chord 102. In various embodiments, anchor 110 includes a tissue engagement portion 112, a body portion 114 from which the tissue engagement portion 112 extends, and a locking portion 116. The locking portion 116 may extend from or be integrally formed with or coupled to the body portion 114 of the anchor, or otherwise associated with it (e.g., separate from and coupled to it). The tensioning and locking device (or at least a portion or component thereof) shown in the accompanying drawings and in more detail in the various embodiments described below is positioned within a housing 118, which may be associated with (e.g., part of, or separate from and coupled to) the locking portion 116 of the anchor 110, and may be coupled to the artificial tendon chord 102.

[0055] The tensioning and locking device has a tension adjustment configuration that allows the artificial chord 102 to move relative to the tensioning and locking device (e.g., to adjust the tension of the artificial chord 102 on the leaflet). Adjusting the tension on the artificial chord 102 includes slowly releasing or inserting an additional length of the artificial chord 102 (e.g., moving the artificial chord 102 distally) to reduce the tension on the artificial chord 102, the tension in the artificial chord 102, or the tension thereof, or pulling or retracting the artificial chord 102 (e.g., moving the artificial chord 102 proximally) to increase the tension on the artificial chord 102, the tension in the artificial chord 102, or the tension thereof. The tensioning and locking device also has a tension setting or locking configuration (such terms are used interchangeably herein and are not intended to be restrictive) that inhibits or prevents or locks the movement of the artificial chord 102 relative to the tensioning and locking device (e.g., to set or fix or limit the tension of the artificial chord 102 on the leaflet). The tensioning and locking device can selectively shift or move (in either direction) between a tension-adjusting mode and a locking mode. An actuator (shown and described in more detail, in conjunction with various embodiments of the tensioning and locking device shown in the accompanying drawings and described in more detail below) can be coupled to or engaged with a component of the tensioning and locking device to allow the tensioning and locking device to selectively shift or move between a tension-adjusting mode and a locking mode, thereby enabling selective movement and / or tensioning of the artificial tendon 102.

[0056] In some embodiments, the artificial tendon chord 102 travels continuously from the proximal end of the catheter, through or along the catheter, into and through a tensioning and locking device (and optionally, also through an anchor 110) and to the leaflet L, wherein the artificial tendon chord 102 is anchored to the leaflet L, such as with a leaflet clip 104. The artificial tendon chord 102 can be tensioned from the proximal end of the catheter to reduce the distance between the leaflet clip 104 and the anchor 110 to restore the function of the leaflet L. In some embodiments, the artificial tendon chord 102 can be tensioned from a location adjacent to the proximal end of the delivery system. This tensioning can be performed to reduce the distance between the leaflet clip 104 and the anchor 110. If it is desired to reduce tension, the artificial tendon chord 102 can be selectively released to increase the length of the artificial tendon chord 102 to increase the distance between the leaflet clip 104 and the anchor 110, and thereby reduce the tension therebetween. The tensioning and locking device allows the artificial tendon chord 102 to be locked and released to adjust the required tension, such as to increase or decrease the tension on or in the artificial tendon chord 102.

[0057] A locking probe or actuator (these terms are used interchangeably herein and are not intended to be limiting) may be provided, which travels from the proximal catheter handle to the ventricular anchor. A coupling feature may be provided at the distal end of the probe or actuator to engage the tensioning and locking device. Manipulating the locking probe allows the operator to manipulate (e.g., lock or unlock) the tensioning and locking device, such as to lock or unlock the artificial chordae tendineae 102, to adjust the tension on the artificial chordae tendineae 102, such as applying tension or not applying tension to the artificial chordae tendineae 102. The probe may be formed of a metallic or polymeric material, such as a relatively rigid polymer, such as PEBAX®. Optionally, a thread may be added to provide the user with additional feedback on the effect of manipulating (e.g., rotating) the probe. The effect of artificial chordae tendineae 102 tension on leaflet and valve function can be observed under medical imaging, and further tensioning or loosening by manipulating the locking probe and artificial chordae tendineae can be performed until the desired leaflet repair is achieved. If the artificial chordae tendineae is over-tensioned, as demonstrated by the visualized regurgitation characteristics of the affected heart valve, the tensioning and locking device can be released, and the distance between the artificial chordae tendineae 102 and the anchor 110 can be increased by increasing the length of the artificial chordae tendineae 102 between the leaflet clip 104 and the anchor 110 to reduce tension in the artificial chordae tendineae 102. The tension adjustment steps can be repeated as needed or as instructed. When the tension of the artificial chordae tendineae 102 and valve repair are satisfactory, the artificial chordae tendineae 102 is then dissociated from the catheter, and the catheter is removed from the heart. The procedure can then be terminated, or additional artificial chordae tendineae 102 can be implanted. In some embodiments, one or more artificial chordae tendineae 102 may be coupled to one or more leaflet clips 104. When the procedure is complete, the locking probe or actuator is dissociated from the tensioning and locking device. The action of retracting the locking probe from the tensioning and locking device can cut the artificial chordae tendineae proximal to the tensioning and locking device. Alternatively, the locking probe can be dissociated from the anchor and removed from the body along with the entire catheter. The artificial chordae tendineae can then be strung along a new catheter capable of cutting the artificial chordae tendineae. The artificial chordae tendineae cutting catheter can then be positioned to cut the artificial chordae tendineae, for example, proximal to the tensioning and locking device. Excess artificial chordae tendineae and the artificial chordae tendineae cutting catheter are then removed from the body. Alternatively, pre-cut artificial chordae tendineae (e.g., selected / pre-defined lengths) can be used, eliminating the need for post-placement cutting and allowing the proximal end of the pre-cut artificial chordae tendineae to be simply left in place after the procedure (e.g., leaving the tail). The procedure can then be terminated or additional artificial chordae tendineae can be implanted.

[0058] Various embodiments of artificial chord tensioning and locking devices embodying aspects of the invention and formed according to various principles of the invention are illustrated in the accompanying drawings. For simplicity, reference will be made herein simply to tensioning and locking devices rather than artificial chord tensioning and locking devices. Each of the tensioning and locking devices disclosed herein includes a locking assembly having tensioning and locking elements configured to influence the tension of the artificial chord. The locking assembly shifts or moves between a tension adjustment mode and a tension setting or locking mode, in which the artificial chord moves substantially freely with respect to other parts of the locking assembly (e.g., to adjust the tension of the artificial chord), and in the tension setting or locking mode, restricts or inhibits or prevents or locks (such terms are used interchangeably herein and are not intended to restrict) the movement of the artificial chord with respect to other parts of the locking assembly. In some embodiments, the tensioning and locking element includes a movable locking element with which the artificial chord is associated to adjust the tension of the artificial chord. The movable locking element can be selectively moved to shift the locking assembly between a locking mode and a tension adjustment mode. In some embodiments, the movable locking element moves along the longitudinal axis LA of a housing in which the tensioning and locking device is positioned. In some embodiments, the locking element is shaped and configured to engage or interact with the artificial tendon chord to affect the movement of the artificial tendon chord relative to other parts of the locking assembly.

[0059] Tensioning and locking devices may be associated with anchor 110, such as being coupled to or formed in conjunction with it (e.g., sharing a housing component therewith). In embodiments where the tensioning and locking device is associated with anchor 110, the locking portion 116 of anchor 110 may extend from or be coupled to or extend together with the body portion 114 of anchor 110 (e.g., as an extension therewith). The tensioning and locking device, or at least its components, such as its locking assembly, may be housed in a housing 118, such as the housing 118 of the locking portion 116. It should be understood that in some embodiments, the housing 118 may be separate from or extend from the locking portion 116 or otherwise associated with the locking portion 116.

[0060] The tensioning and locking devices of the disclosed embodiments are configured to allow harmonization and / or locking (e.g., setting or securing) of tension on or within the artificial chordae tendineae (such terms are used interchangeably herein and are not intended to be limiting), such as applying desired tension forces, such as between the valve leaflets and papillary muscles / heart wall. In some embodiments, the artificial chordae tendineae 102 may enter the housing 118 via a delivery conduit and via an actuator, substantially along the longitudinal axis LA of the housing 118 and exiting from one side of the housing 118. In some embodiments, other components extend through the delivery conduit, and the artificial chordae tendineae 102 instead extends along the delivery conduit (e.g., externally, optionally within an outer sheath) and enters the housing 118 through one side of the housing 118. In various embodiments of the disclosed embodiments, the tensioning and locking devices allow reversible locking and unlocking to allow setting and releasing of tension to allow for readjustment of tension when needed or desired, such as by using a control element or actuator. The tensioning and locking can be adjusted during active heartbeat. It should be understood that various features of one embodiment may be used in combination with or in lieu of features of another embodiment. Therefore, the features described herein are shown in various combinations as examples of how such features can be combined and embodied in artificial chordae tendon tensioning and locking devices to provide the various benefits disclosed herein.

[0061] Turning now to the accompanying drawings, an example of one embodiment of the tensioning and locking device 200 formed according to the principles of the present invention is shown. Figure 2A The image is shown as being associated with anchor 210 (however, other configurations are within the scope of this invention). Anchor 210 includes a tissue engagement portion 212 (configured to engage and / or anchor to tissue, such as cardiac tissue), located at the distal end 211 of anchor 210, extending distally from the body portion 214 of anchor 210. A locking portion 216 extends proximally from the body portion 214 of anchor 210. A locking assembly 230 of tensioning and locking device 200 may be housed in housing 218, which in some embodiments is associated with the locking portion 216 of anchor 210, such as... Figure 2B , Figure 2C and Figure 2D As shown and discussed in more detail below, the artificial tendon chord 202 extends into the proximal end 203 of the tensioning and locking device 200 to engage or interact with (such terms are used interchangeably herein and are not intended to be limiting) a tensioning and locking device component of the locking assembly 230 within the housing 218 (to allow adjustment and / or setting of the tension on the artificial tendon chord 202), and extends out of an outlet opening or hole or window 217 in the housing 218 to extend to the cardiac lobule, where the free end of the artificial tendon chord 202 can be anchored, for example, via a lobule clamp, as referenced above. Figure 1As described above. In the illustrated embodiment, the artificial tendon chord 202 extends substantially axially along the longitudinal axis LA of the housing 218 and enters the housing 218 via the conduit 220 and probe 222. However, as mentioned above, other entry points for the artificial tendon chord 202 are also within the scope and spirit of the invention. The probe 222 engages with a longitudinal hole or chamber 219 in the housing 218 (such terms are used interchangeably herein and are not intended to be limiting; the term hole is not limited to a circular cross-sectional shape) to actuate the locking assembly 230 of the tensioning and locking device 200, as will be referred to... Figure 2B , Figure 2C and Figure 2D The document describes various components of the tensioning and locking device 200 and the locking assembly 230, as well as their interaction with the artificial tendon chord 202.

[0062] exist Figure 2BIn the example of the probe configuration shown, probe 222 includes a threaded distal end 223 that threadedly engages within a threaded portion of a longitudinal bore or proximal portion of chamber 219 in housing 218. Probe 222 also engages a connector 232 extending from (and optionally coupled to) a movable element of locking assembly 230 of tensioning and locking device 200, such as carriage 234. Connector 232 may also be threadedly engaged within the longitudinal chamber 219 of housing 218 to be rotatably advanced distally or retracted proximally by probe 222. Thus, probe 222 and connector 232 engage to allow rotation of probe 222 to be transmitted to connector 232, causing connector 232 to rotate within longitudinal chamber 219. Examples of such engagement include, but are not limited to, locking configurations, such as a non-circular protrusion on one of the probes 222 and connector 232 engaging in a corresponding non-circular hole in the other of the probes 222 and connector 232, a slot in one of the probes 222 and connector 232 and a longitudinally extending rib in the other of the probes 222 and connector 232, and other engagements known in the art or previously known for locking relative rotational movement. Furthermore, connector 232 is coupled to carriage 234 such that carriage 234 is axially advanced or retracted as connector 232 is axially advanced or retracted, but without causing relative rotation between carriage 234 and housing 218 (which, for various reasons, will become apparent). Examples of such engagement include, but are not limited to, engaging circumferentially extending ribs (e.g., extending distally from the threaded portion of the connector 232) within a circumferentially extending groove in the carriage 234 and receiving the distally extending portion of the connector 232, as well as other engagements that lock relative rotational movement. In the illustrated embodiment, the carriage 234 is positioned within a portion of the longitudinal chamber 219 within a housing 218 located distal to the threaded portion of the longitudinal chamber 219. The longitudinal chamber 219 may include a tension 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 adjustment of tension on or in the artificial tendon chordae 202 (explained in further detail below). As used herein, the term “diameter” should generally be understood as a dimension transverse to the longitudinal dimension, such as a width dimension, and is not limited to the dimensions of a circular shape or cross-section. The locking region 219b can be formed by narrowing the diameter of the longitudinal chamber 219 relative to the tension adjustment region 219a, such as by a shoulder or other protrusion extending into the longitudinal chamber 219b and narrowing its diameter. In the illustrated embodiment, the tension adjustment region 219a is closer to the distal end 201 of the tensioning and locking device 200 than the proximal end 203 of the tensioning and locking device 200. However, the opposite configuration is also within the scope of the invention.

[0063] When the tensioning and locking device 200 is conveyed (and the anchor 210 is deployed or secured to the tissue), the carriage 234 is positioned within the tension adjustment area 219a, as... Figure 2B As shown. The artificial tendon 202 extends along path 236, such as partially through and partially along the exterior of slide 234, to engage with slide 234 and subsequently exit housing 218 via outlet 217 in housing 218. For example, the artificial tendon 202 may extend through longitudinal portion 236a of path 236 (e.g., a longitudinal hole extending axially within slide 234) to engage with slide 234 (e.g., when exiting longitudinal chamber 229 via probe 222 and exiting longitudinal chamber 239 via connector 232), along peripheral portion 236b (e.g., along the exterior of slide 234), and through transverse portion 236c (e.g., extending laterally through slide 234 such that when slide 234 is axially translated along longitudinal axis LA of housing 218, the artificial tendon 202 moves axially with slide 234 along longitudinal axis LA of housing 218). When the carriage 234 is in the tension adjustment zone 219a, the artificial tendon chord 202 is substantially free to move along the path 236 and relative to the carriage 234, locking assembly 230, and anchor 210 to allow adjustment of the tension on, within, or on the artificial tendon chord 202. The tension on the artificial tendon chord 202 can be adjusted by pulling the artificial tendon chord 202 proximally (e.g., to increase tension) or by inserting or slowly releasing or otherwise releasing or inserting additional artificial tendon chords 202 distally (such terms are used interchangeably herein and are not intended to limit).

[0064] Once the desired tension has been achieved in or on the artificial tendon chord 202, the tension can be fixed, set, or locked (these terms are used interchangeably herein and are not intended to limit). An actuation (e.g., rotation) probe 222 actuates connector 232 to move proximally (towards the proximal end 203 of tensioning and locking device 200), thereby moving slide 234 proximally. Figure 2CAs shown, when the carriage 234 is advanced toward the locking region 219b in the longitudinal chamber 219 such that the portion of the artificial chord 202 traveling along the outer portion of the path 236 on the carriage 234 faces the locking region 219b, that portion of the artificial chord 202 is sandwiched or held between the carriage 234 and the locking region 219b. Thus, the tension that can be fixed on the artificial chord 202. If further adjustment of the tension is needed, the probe 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) to release the hold of the locking region 219b on the artificial chord 202 to allow adjustment of the tension on the artificial chord 202 (e.g., by slowly letting out or releasing or feeding in an additional length of the artificial chord 202 to reduce the tension thereon, or pulling proximally or retracting the artificial chord 202 to increase the tension thereon). When it is determined that the desired tension on the artificial chord 202 has been reached, the probe 222 can be disengaged from the coupler 232 (such as by continuing to rotate the probe 222 to disengage from the threaded engagement within the threaded portion of the longitudinal chamber 219 within the housing 218) and removed. Thus, a portion of the artificial chord 202 can be locked within the locking portion 216 of the housing 218, and the artificial chord 202 extending proximally from the housing 218 can be cut, and the artificial chord 202 can be held anchored in place between the heart tissue and the leaflets to act as a chord.

[0065] In Figures 2A to 2D an embodiment, the carriage 234 can have a substantially rectangular cross-section. In combination with the tensioning and locking device 300 shown in Figures 3A to 3C is shown a locking assembly 230 similar to Figures 2A to 2D but having an alternative form of a locking assembly with a carriage having a substantially circular cross-section. The carriage 334 of the locking assembly 330 functions substantially the same or similar to the carriage 234 of the locking assembly 230 shown and described hereinabove with reference thereto, but has some additional features or benefits. It should be understood that, except for some differences between the carriages 234, 334, Figures 2A to 2D the tensioning and locking devices 200 and 300 of Figures 2A to 2D and Figures 3A to 3C can be arranged and operated in substantially the same or similar manner, respectively. For example, the tensioning and locking device 300 is shown associated with an anchor 310 having a tissue engaging portion 312, a body portion 314, and a locking portion 316. For the sake of brevity and convenience, and not by way of limitation, like elements having similar functions are denoted by the same reference characters differing by 100 in value, referring to the above description of those like elements and their functions and operations.

[0066] Similar to Figures 2A to 2C the artificial chord 202 of Figures 3A to 3CThe artificial tendon chord 302 shown can extend through the probe 322 and the catheter 320 and enter the proximal end 303 of the locking device 300 and through the longitudinal chamber 339 (which, via the connector 332), to engage with the carriage 334. Also like... Figures 2A to 2D The artificial tendon chord 202 shown is the same as the slide 234. Figures 3A to 3C The artificial tendon chord 302 shown extends along path 336, which is formed partially along and partially laterally through the exterior of carriage 334, such that as carriage 334 translates axially along the longitudinal chamber 319 within housing 318, the artificial tendon chord 302 moves axially along the longitudinal axis LA of housing 318. However, compared with Figures 2A to 2D The sliding carriage 234 shown in the locking assembly 230 is the opposite of the one shown. Figures 3A to 3C The carriage 334 of the locking assembly 330 shown has a circumferential groove 335 between an exit point from the longitudinal portion 336a of the path 336 (e.g., a longitudinal hole in the carriage 334) to the outer portion 336b of the path 336 and an entry point from the outer portion 336b of the path 336 to the transverse portion 336c of the path 336 through the carriage 334. The circumferential groove 335 can provide or define two clamping points 337a, 337b, at which the artificial tendon 302 can be clamped between the locking region 319b of the longitudinal chamber 319 in the carriage 334 and the housing 318. When the carriage 334 moves from the tension adjustment region 319a (where the relatively unrestricted movement of the artificial tendon 302 within the path 336 allows adjustment of the tension of the artificial tendon 302) to the locking region 319b (e.g., toward the distal end 301 of the tensioning and locking device 300 in the example shown), the artificial tendon 302 becomes clamped between the clamping points 337a, 337b and the inner wall of the longitudinal chamber 319, thereby fixing the tension in the artificial tendon 302.

[0067] In some embodiments, a clock feature 340 may be provided to inhibit rotation of the carriage 334 within the longitudinal chamber 319, such as to guide the artificial tendon 302 through the housing 318 (e.g., by positioning the artificial tendon 302 along or around the carriage 334 with an outlet 317 in the housing 318). For example, a stop or rib or protrusion 342 (such terms are used interchangeably herein and are not intended to be limiting) may be provided in the carriage 334, engaging a corresponding recess 344 and / or window 346 in the housing 318. It should be understood that other configurations are also within the scope of the invention.

[0068] exist Figures 4A to 4C The image shows something similar to Figures 3A to 3CThe tensioning and locking device 300 has a locking component 330, but with an alternative configuration of the tensioning and locking device 400 that has a different path, with the artificial tendon chord associated with the carriage extending along that different path. The tensioning and locking device 400 may have an associated anchor 410 having a tissue engagement portion 412, a body portion 414, and a locking portion 416, similar to the anchor 410 associated with the tensioning and locking device 300. For simplicity and convenience, and not intended to be limiting, having such... Figures 3A to 3C Similar functionality in the examples of the embodiments shown in the illustrations Figures 4A to 4C Similar elements of the embodiments shown are represented by the same reference character with a numerical difference of 100, referring to the above description of those similar elements and their functions and operations.

[0069] Figures 4A to 4C Implementation examples and Figures 3A to 3C Compared to other embodiments, this may be more suitable for use with a stiffer artificial tendon chord 402. More specifically, the artificial tendon chord 402 can be inserted into the appropriate position in relation to the locking assembly 430 by inserting the first and second free ends of the artificial tendon chord 402 through the inlet 415. One end of the artificial tendon chord 402 extends through the longitudinal chamber 439 in the connector 432 and through the probe 422 and the conduit 420. The other end of the artificial tendon chord 402 extends through the carriage 434 (through the transverse path 436c therethrough) and extends to the outlet 417 in the housing 418 substantially opposite the inlet 415. The ramped path 436a can guide the artificial tendon chord 402 from the inlet 415 to the longitudinal chamber 439 in the connector 432 and / or to the transverse path 436c to exit through the outlet 417.

[0070] The artificial tendon chord 402 is transitioned from its longitudinal extent through the longitudinal chamber 439 in the connector 432 along the connection path 436b via the carriage 434 to its lateral extent extending along the lateral path 436c and exiting through the outlet 417 in the housing 418. The connection path 436b may be angled relative to the axial extent of the housing 418 to provide a relatively large radius of curvature to transition the orientation of the artificial tendon chord 402 from its axial extent through the carriage 434 to its lateral extent exiting through the outlet 417.

[0071] As in Figures 4A to 4C In the example of the embodiment shown, the carriage 434 of the locking assembly 430 has a circular cross-section, similar to the carriage 334 of the locking assembly 330. Therefore, the carriage 434 can similarly benefit from the clock feature 440 to suppress rotation of the carriage 434 within the longitudinal chamber 419 of the housing 418. Also as in Figures 3A to 3C In the example of the embodiment shown, Figures 4A to 4CThe carriage 434 of the locking assembly 430 shown has a circumferential groove 435 across which the artificial tendon 402 extends (generally laterally or vertically) as the carriage 434 moves from the tension adjustment region 419a of the longitudinal chamber 419 in the housing 418 to the locking region 419b. The circumferential groove 435 can provide or define two clamping points 437a, 437b at which the artificial tendon 402 can be clamped between the carriage 434 and the locking region 419b of the longitudinal chamber 419 in the housing 418. When the carriage 434 moves from the tension adjustment region 419a (where the relatively unrestricted movement of the artificial tendon 402 within the path 436 allows adjustment of the tension of the artificial tendon 402) to the locking region 419b (e.g., toward the distal end 401 of the tensioning and locking device 400 in the example shown), the artificial tendon 402 becomes clamped between the clamping points 437a, 437b and the inner wall of the longitudinal chamber 419, thereby securing the tension in the artificial tendon 402.

[0072] In the tensioning and locking devices 200, 300, and 400, the locking components 230, 330, and 430 include movable elements in the form of a carriage. The movable element moves with respect to the housings 218, 318, 418 of the tensioning and locking devices 200, 300, 400 to allow the locking components 230, 330, 430 to shift between a tension adjustment mode and a tension setting or locking mode. In the tension adjustment mode, the artificial tendons 202, 302, 402 may selectively move with respect to the locking components 230, 330, 430 (e.g., to allow adjustment of the tension of the artificial tendons 202, 302, 402). In the tension setting or locking mode, the movement of the artificial tendons 202, 302, 402 with respect to the locking components 230, 330, 430 is inhibited or prevented (such terms are used interchangeably herein and are not intended to be limiting) to fix, set, or lock (such terms are used interchangeably herein and are not intended to be limiting) the tension of the artificial tendons 202, 302, 402. It should be understood that the movable elements of the locking assemblies 230, 330, 430 of the tensioning and locking devices formed according to the principles of the present invention may have, in addition to those related to... Figures 2A to 2D as well as Figures 3A to 3C and Figures 4A to 4C Other forms besides those described in the example shown.

[0073] exist Figures 5A to 5CIn another example of the tensioning and locking device 500 shown, the locking assembly 530 may have a movable element employing a rolling element, such as a roller 534. The rolling element rolls with the movement of the artificial chord 502 (e.g., during adjustment of the tension of the artificial chord 502) and may be substantially cylindrical or substantially spherical. Despite variations in the movable element and housing, the function of the locking assembly 530 of the tensioning and locking device 500 is substantially the same as or similar to that of the locking assemblies 230 and 330 of the tensioning and locking devices 200 and 300. Specifically, the artificial chord 502 extends into the proximal end 503 of the tensioning and locking device 500 and into the longitudinal chamber 519 of the housing 518 to interact with the locking assembly 530, and exits the housing 518 via an outlet 517 in the housing 518 to extend for fixation to the valve leaflet, in a manner similar to that described above with reference to the tensioning and locking devices 200 and 300. The movable element of the locking assembly 530 is moved by an actuator, such as a probe 522 at the end of the conduit 520, between a tension adjustment 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). Therefore, for simplicity and convenience, and not intended to be limiting, similar functions may be used in… Figures 2A to 2D and Figures 3A to 3C and Figures 4A to 4C Those similar components are represented by the same reference character with a numerical difference of 100, referring to the above description of those similar components and their functions and operations. Although Figures 5A to 5C The locking and tension adjustment functions of the tensioning and locking device 500 are respectively with Figures 2A to 2D and Figures 3A to 3C and Figures 4A to 4C The locking and tension adjustment functions of the tensioning and locking devices 200, 300, and 400 are basically the same or similar, but their functions will be described in more detail because the movable elements of the locking components 230, 330, and 430 are configured differently.

[0074] refer to Figure 5B and Figure 5CIt should be understood that the housing 518 of the tensioning and locking device 500 (which in the example embodiment is shown associated with an anchor 510 having a tissue engagement portion 512, a body portion 514, and a locking portion 516) has a tension adjustment region 519a, which has at least one dimension larger than the corresponding dimension of the locking region 519b (e.g., substantially in the same direction). When the roller 534 is positioned in the tension adjustment region 519a, the artificial tendon 502 can move substantially freely along a path 536 around the roller 534 (e.g., around the middle section of the roller 534) to allow for tension adjustment. When the roller 534 moves into the locking region 519b, such as when the actuation probe 522 is activated, the artificial tendon 502 is clamped or held between the narrowed inner walls of the longitudinal chamber 519 and is prevented from further movement, thereby setting the tension of the artificial tendon 502. Because roller 534 can rotate when adjusting the tension on artificial tendon 502, roller 534 can be engaged by probe 522 (e.g., contacted by probe 522), such as by bringing the distal end 521 of probe 522 abutting the end 538 of roller 534 (e.g., with a diameter larger than the end of the intermediate segment of artificial tendon 502 extending along path 536), and by bridging or otherwise not interfering with artificial tendon 502 as it extends around roller 534. Thus, probe 522 can hold roller 534 in a particular position against tension originating from artificial tendon 502 that tends to pull roller 534 proximally. In some embodiments, the distal end 521 extends from a connector 532 rotatably coupled to the distal end of the probe 522, such that rotation of the probe 522 for adjusting the tension on the artificial tendon 502 (to advance the probe 522 distally toward the distal end 501 of the tensioning and locking device 500 or to retract the probe 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. When the probe 532 is actuated (e.g., by proximal withdrawal) to set the tension on the artificial tendon 502, the roller 534 moves toward the locking region 519b (e.g., by tension on the artificial tendon 502 extending around the roller 534) until the artificial tendon 502 is held between the roller 534 and the longitudinal chamber 519. Figures 2A to 2D and Figures 3A to 3C and Figures 4A to 4C The tensioning and locking devices in models 200, 300, and 400 are the same. Figures 5A to 5C The tensioning and locking device 500 allows adjustment of the tension on the artificial tendon 502 until the desired tension is reached. At this point, the tensioning and locking device 500 can be switched to a tension setting or locking mode (such as moving the locking element of the locking assembly 530, such as the roller 534, into the locking region 519b), and the probe 522 can be disengaged or removed from the tensioning and locking device 500.

[0075] Figures 6A to 6C The tensioning and locking device 600 has, in addition to being respectively Figures 2A to 2D , Figures 3A to 3C , Figures 4A to 4C and Figures 5A to 5C Another configuration of the movable element of the locking assembly 630, other than those of the tensioning and locking devices 200, 300, 400, and 500. Specifically, Figures 6A to 6C The movable element of the locking assembly 630 of the tensioning and locking device 600 takes the form of a coil auger 634. For simplicity and convenience, and not intended to be limiting, devices with similar functions, such as those in… Figures 2A to 2D , Figures 3A to 3C , Figures 4A to 4C and Figures 5A to 5C Those similar components are represented by the same reference character with a numerical difference of 100, referring to the above description of those similar components and their functions and operations. Although Figures 6A to 6C The locking and tension adjustment functions of the tensioning and locking device 600 are respectively with Figures 2A to 2D , Figures 3A to 3C , Figures 4A to 4C and Figures 5A to 5C The tensioning and locking devices 200, 300, 400, and 500 have basically the same or similar locking and tension adjustment functions. However, since the movable elements of the locking components 230, 330, 430, 530, and 630 are configured differently, their functions will be described in further detail.

[0076] More specifically, see reference Figures 6A to 6C And as referenced Figure 6B and Figure 6CMore clearly, the artificial tendon 602 extends laterally into the housing 618 of the tensioning and locking device 600 (which, in the example embodiment, is shown associated with an anchor 610 having a tissue engagement portion 612, a body portion 614, and a locking portion 616), for example, via an inlet 615. Instead of extending peripherally or externally around the movable element of the locking assembly 630, the artificial tendon 602 extends through the coil of the auger 634. As in the previously described tensioning and locking devices 200, 300, the probe 622 is coupled to the locking assembly 630 via a connector 632. The connector 632 may be fixed to prevent axial movement (along the longitudinal axis LA of the tensioning and locking device 600) that still allows rotation relative to the housing 618 (e.g., engagement of circumferential ribs and grooves between the connector 632 and the housing 618). The probe 622 (shown in this example as extending from the conduit 620) actuates the auger 634 to rotate, thereby conveying a portion of the artificial chord 602 proximally (towards the proximal end 603 of the tensioning and locking device 600) or distally (towards the distal end 601 of the tensioning and locking device 600). In the tension-adjusting configuration, the artificial chord 602 moves freely through the housing and across the auger 634. However, when the auger 634 rotates to move the portion of the artificial chord 602 extending therefrom away from the outlet 617, the artificial chord 602 is clamped between the auger 634 and the longitudinal chamber 619 within the housing 618 and enters a locked position in which the tension thereon is substantially fixed. In some embodiments, the inlet 615 takes the form of a slot that allows the artificial chord 602 to pass through without being clamped when the auger 634 is actuated or moved between the tension-adjusting and tension-setting or locking configurations.

[0077] To facilitate the transfer of rotational movement of probe 622 to connector 632, a trolley-style connection can be used, as shown. Specifically, probe 622 and connector 632 may have ends shaped to engage or lock with each other to lock probe 622 and connector 632 in place, preventing relative rotational movement. Figure 6B As shown, by using a locking probe 624 extending through a cavity within probe 622 and connector 632, probe 622 and connector 632 can be secured, preventing relative movement that would cause their mutually locked ends to disengage (e.g., when the ends move transversely to the longitudinal axis of probe 622 and connector 632). Alternatively, as Figure 6D As shown, a locking probe 624' extending above probe 622 and connector 632 can secure probe 622 and connector 632, preventing relative movement that would cause their mutually locked ends to disengage. Figure 6EAlternative shapes for the engagement locking ends of probe 622 and connector 632 are shown. It should be understood that the configuration shown is a non-limiting example, and other configurations are also within the scope of the invention.

[0078] exist Figures 7A to 7C Another configuration of the movable element of the locking assembly 730 is shown. For simplicity and convenience, and not intended to limit, similar functionalities are also possible. Figures 2A to 2D , Figures 3A to 3C , Figures 4A to 4C , Figures 5A to 5C and Figures 6A to 6C Those similar elements are represented by the same reference character with a numerical difference of 100, referring to the above description of those similar elements and their functions and operations.

[0079] exist Figures 7A to 7C In the tensioning and locking device 700, the movable element of the locking assembly 730 includes a tissue-engaging movable element 734, which is configured to move relative to the housing 718 of the tensioning and locking device 700 (which, in an exemplary embodiment, is shown as 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 chamber 719 in the housing 718 to move the tissue-engaging movable element 734 (which extends from the distal end 701 of the tensioning and locking device 700) between a tension-setting or locking mode and a tension-adjusting mode, in which tension is substantially fixed on the artificial chordae tendineae 702, and in the tension-adjusting mode, tension on the artificial chordae tendineae 702 can be adjusted. More specifically, the artificial tendon chord 702 extends laterally into the housing 718 of the tensioning and locking device 700, such as via an inlet 715, through a path 736 passing (in this example, laterally) through the tissue-engaging movable element 734 and exiting the housing 718 via an outlet 717 to extend to the leaflet to which the artificial tendon chord 702 is secured. (See comparison...) Figure 7B and Figure 7C Understandably, when the tissue-engaging movable element 734 is engaged in the tissue, such as Figure 7B As shown, the artificial tendon chord 702 can be clamped between the end of the path 736 and either or both of the ends of the inlet 715 and the outlet 717. This is achieved when the shaft 722 is moved proximally (towards the proximal end 703 of the tensioning and locking device 700), and when the tissue-engaging movable element 734 is used to lock the area (e.g.) Figure 7B Before being inserted into the tissue (as shown), the artificial tendineae 702 is no longer clamped (as shown). Figure 7C(As shown), and the tension therein can be adjusted as needed. In the illustrated embodiment, the inlet 715, outlet 717, and path 736 are each extended, such as to allow axial movement of the artificial tendon chord 702 therein when the shaft 722 moves axially. Other configurations are also within the scope and spirit of the invention, such as only inlet 715 and outlet 717, or only path 736, are extended.

[0080] Despite the tissue-connecting movable element 734 in Figures 7A to 7C The portion is shown as having a spear-shaped distal tissue engagement end 750, but other configurations are also within the scope of the invention. For example, the tissue engagement movable element 734 may have a distal tissue engagement end that is selectively movable between an insertion configuration and a tension-setting or locking configuration. For example, as... Figures 7D to 7G The distal end of the tissue engagement with a movable arm shown can be disposed on the tissue engagement movable element 734, such as in the locking assembly 730 of the tensioning and locking device 700. Figure 7D and Figure 7E In the illustrated embodiment, the locking arm 752 may be integrally formed with (as part of) the shaft portion 754. When the tissue-engaging movable element 734 is inserted, secured, or implanted into tissue, the locking arm 752 may be in an insertion configuration (e.g., flush with and / or matching the surrounding contour of the shaft portion 754) and may extend outward from the shaft portion 754 (e.g., pulled open as the shaft portion 754 moves proximally once the tissue-engaging movable element 734 has initially been inserted into the tissue) into an anchoring configuration, such as in… Figure 7E As shown, this is to hold the tissue-engaging movable element 734 in the proper position within the tissue. Alternatively, as... Figure 7F and Figure 7G As shown, the locking arm 752' can be formed separately from and pivotally coupled to the shaft portion 754', for example, via a pivot 755. When the tissue-engaging movable element 734 is inserted, fixed, or implanted in tissue, the locking arm 752' can be in a compact insertion configuration (e.g., extending longitudinally along the shaft portion 754), such as... Figure 7F As shown, and can extend outward from the shaft portion 754 (e.g., pulled apart as the shaft portion 754 moves proximally once the tissue-engaging movable element 734 has been initially inserted into the tissue) into an anchoring configuration, such as in Figure 7G As shown, the locking arms 752, 752' are used to hold the tissue-engaging movable element 734 in the proper position 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, such as two or more locking arms 752, 752'.

[0081] The devices, systems, and methods of the present invention can be used alone or in conjunction with other devices, systems, and methods to treat heart conditions, such as, but not limited to, those shown in U.S. Patent Application 16 / 919,769 entitled "A device, system, and method for adjustably tensioning an artificial chordae tendineae between a leaflet and a papillary muscle or a heart wall"; U.S. Patent Application 16 / 919,782 entitled "A device, system, and method for clamping a leaflet of a heart valve"; U.S. Patent Application 16 / 919,794 entitled "A device, system, and method for anchoring an artificial chordae tendineae to a papillary muscle or a heart wall"; and U.S. Patent Application 16 / 919,806 entitled "A device, system, and method for an artificial chordae tendineae," each of which was filed July 2, 2020, and is incorporated herein by reference in its entirety for all purposes. Examples of the devices described herein may be modified to incorporate embodiments or one or more features of the invention. All devices and methods discussed herein are examples of devices and / or methods implemented according to one or more principles of the invention. These examples are not the only ways to implement these principles, but are merely examples. Therefore, references to elements, structures, or features in the accompanying drawings must be understood as references to examples of embodiments of the invention and should not be construed as limiting the invention to the specific elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will occur to those skilled in the art upon reading this invention.

[0082] While embodiments of the invention may be specifically described with reference to the mitral valve, tensioning and locking devices such as those disclosed herein can be used in conjunction with any valve annulus, including, for example, repairs or modifications of the tricuspid valve annulus, and / or may similarly benefit any other dilatation, valvular regurgitation, valvular leakage, and other similar heart failure conditions involving anchoring components to cardiac tissue. It should also be understood that although embodiments of tensioning and locking devices have been described with respect to cardiac valve implantation devices, the principles of the invention are also applicable to tensioning and locking devices used in conjunction with other types of devices for use within the body, such as those implanted within the body, particularly in areas with soft tissue and / or where the implant is located, where there is regular movement.

[0083] While embodiments of the present invention may be specifically referenced to medical devices and systems for selective access to cardiac tissue (e.g., transcavitary devices inserted via the femoral vein, etc.), it should be understood that such medical devices and systems can be used for a variety of medical procedures requiring tension of a cord-like element within the body. The disclosed medical devices and systems can also be inserted via different entry points and methods, such as percutaneous, endoscopic, laparoscopic, or combinations thereof.

[0084] Those skilled in the art will understand that this discussion is merely a description of illustrative examples of embodiments and is not intended to limit the broader aspects of the invention. The foregoing discussion is of broad applicability and has been set forth for purposes of illustration and description, and is not intended to limit the invention to the forms disclosed herein. It should be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the invention. In particular, it will be apparent to those skilled in the art that the principles of the invention can be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from its concept, spirit, scope, or characteristics. For example, to simplify the invention, various features of the invention are combined in one or more aspects, embodiments, or forms. However, it should be understood that various features of certain aspects, embodiments, or forms of the invention can be combined in alternative aspects, embodiments, or forms. Although the invention has been presented in the form of embodiments, it should be understood that not all of the various individual features of the subject matter need to be present in order to achieve at least some of the desired characteristics and / or benefits of the subject matter or such individual features. Those skilled in the art will understand that the present invention can be used with numerous modifications or alterations to the structures, arrangements, proportions, materials, components, and others used in the practice of the invention, which are particularly suited to specific environments and operational requirements without departing from the principles, spirit, or scope of the invention. For example, an element shown as integrally formed may be composed of multiple parts or elements shown as being integrally formed, the operation of the element may be reversed or otherwise varied, and the size or dimensions of the element may vary. Similarly, although the operations or actions or procedures are described in a particular order, this should not be construed as requiring such a particular order, or that all operations or actions or procedures must be performed to achieve the desired result. Additionally, other embodiments are also within the scope of the following claims. In some cases, the actions recited in the claims may be performed in a different order and still achieve the desired result. Therefore, the embodiments disclosed herein should be shown in all respects as illustrative rather than restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or specific embodiments or arrangements described or shown herein. In view of the foregoing, individual features of any embodiment may be used and may be claimed individually or in combination with features of that embodiment or any other embodiment, the scope of which is indicated by the appended claims and is not limited to the foregoing description.

[0085] The following will be understood from the description above and the claims below. The phrases “at least one,” “one or more,” and “and / or” as used herein are open-ended expressions that are operationally both conjunctions and non-conjunctions. The terms “a,” “an,” “the,” “first,” “second,” etc., do not exclude multiple entities. For example, the term “a” or “an” as used herein refers to one or more of that entity. Therefore, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or similar) are used only for identification purposes to aid the reader’s understanding of the invention and / or to distinguish areas of associated elements from one another, and do not limit the associated elements, in particular not limiting the location, orientation, or use of the invention. Unless otherwise indicated, connection references (e.g., attachment, link, connection, and combination) are to be interpreted broadly and may include intermediate components between sets of elements as well as relative movement between elements. In this respect, a connection reference does not necessarily imply that two elements are directly connected and have a fixed relationship with each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to signify importance or priority, but are used to distinguish one feature from another. The following claims are incorporated herein by reference in this way, wherein each claim exists independently as a separate embodiment of the invention. Reference numerals in the claims are provided only as clarifying examples and should not be construed as limiting the scope of the claims in any way.

[0086] The following claims are incorporated herein by reference into the detailed description, wherein each claim exists independently as a separate embodiment of the invention. In the claims, the term "comprising / including" does not exclude the presence of other elements or steps. Furthermore, although individual features may be included in different claims, these features may be advantageously combined, and inclusion in different claims does not imply that such combinations of features are impractical and / or advantageous. Additionally, singular reference does not exclude plural. The terms "an," "a," "the," "first," "second," etc., do not exclude a plurality. Reference numerals in the claims are provided only as clarifying examples and should not be construed as limiting the scope of the claims in any way.

Claims

1. A system for adjusting tension in an artificial chordae tendineae extending between a heart valve leaflet and papillary muscle or heart wall, the system comprising: Leaflet clip, the leaflet clip being configured to engage with the heart valve leaflet and the artificial chordae tendineae; An anchor, which is configured to engage with the papillary muscle or the heart wall; An artificial tendon cord extending between the leaflet clip and the anchor; as well as A locking component, associated with the anchor and configured to selectively switch between a tension adjustment mode and a tension setting mode, wherein the tension adjustment mode allows the artificial tendon chord to move relative to the locking component to increase or decrease the tension on the leaflet, and the tension setting mode inhibits the movement of the artificial tendon chord relative to the locking component to set the tension on the leaflet; The locking assembly includes a housing and a movable locking element, the movable locking element being axially movable but not rotatable within a longitudinal cavity defined in the housing, so as to allow the locking assembly to transfer between the tension adjustment mode and the tension setting mode; The artificial tendon extends along a path defined by the movable locking element; The longitudinal chamber within the housing defines a locking region and a tension adjustment region; When the movable locking element is in the tension adjustment area, the artificial tendon chord can move relative to the movable locking element; A portion of the path extends along the outside of the movable locking element; as well as When the movable locking element is in the locking region, one or more portions of the artificial tendon extending along the path and the portion extending outward from the movable locking element are clamped between the movable locking element and the locking region to set tension on the leaflet.

2. The system of claim 1, wherein the movable locking element comprises one of a carriage, roller, auger, or tissue bonding element that is axially movable within the longitudinal cavity of the housing.

3. The system of claim 1, further comprising a connector configured to connect the probe and the movable locking element, wherein the artificial tendon extends axially through the probe, the connector and the movable locking element, and laterally through the movable locking element to a portion of the path extending outward along the movable locking element, and laterally through the housing to the leaflet clip.

4. The system of claim 1, further comprising a probe engageable with the movable locking element to move the movable locking element so that the locking assembly shifts between the tension adjustment mode and the tension setting mode.

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

6. A device for adjusting the tension of an artificial chordae tendineae extending between a heart valve leaflet and papillary muscle or heart wall, the device comprising: Artificial tendineae; A housing, wherein a longitudinal chamber is defined therein; A locking assembly, positioned within the housing and having a movable locking element, the movable locking element being movable but not rotatable within the longitudinal cavity of the housing between a tension adjustment mode and a tension setting mode, the tension adjustment mode allowing movement of the artificial tendon relative to the housing, and the tension setting mode inhibiting movement of the artificial tendon relative to the housing; as well as A connector extending from the movable locking element and configured to engage with an actuator for moving the movable locking element relative to the housing, wherein... The artificial tendon extends along a path defined by the movable locking element; The longitudinal chamber within the housing defines a locking region and a tension adjustment region; When the movable locking element is in the tension adjustment area, the artificial tendon chord can move relative to the movable locking element; A portion of the path extends along the exterior of the movable locking element; and When the movable locking element is in the locking region, one or more portions of the artificial tendon extending along the path and the portion extending outward from the movable locking element are clamped between the movable locking element and the locking region to set tension on the leaflet.

7. The device of claim 6, further comprising a tissue engagement element configured to engage cardiac tissue to anchor the end of the artificial chordae tendineae relative to the heart.

8. The apparatus of claim 6, wherein the movable locking element comprises one of a carriage, a roller, an auger, or a tissue bonding element.

9. The apparatus of claim 6, wherein a portion of the path extends laterally through the movable locking element.

10. The device according to any one of claims 6-9, wherein a portion of the path extends along the outside of the movable locking element.

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