Tissue anchors that minimize migration and maximize coaptation

Abstract

A tissue anchor for securing an implantable device to tissue, such as soft tissue. The anchor includes a tissue-engaging portion having a tissue-engaging configuration that enhances, improves, increases, etc. engagement, grip, grasp, etc. of the anchor with the body tissue in which the anchor is implanted. In some embodiments, the tissue-engaging portion constricts or pinches or compresses tissue between segments of the tissue-engaging portion to grip or otherwise engage tissue. In some embodiments, segments of the tissue-engaging portion expand or otherwise extend away from other portions of the anchor to increase engagement of the anchor with the tissue. In some embodiments, segments of the tissue-engaging portion flare outward to drive further into tissue in a direction transverse to other portions of the anchor.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 083,309, filed September 25, 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 the field of implantable medical devices. More particularly, this invention relates to the field of devices implantable in body tissue. In particular, this invention relates to medical devices, systems, and methods for cardiac treatments, such as annulus repair surgery. Background Technology

[0004] Mitral regurgitation (MI) (also known as mitral regurgitation or mitral atresia) is a form of heart disease in which the mitral valve annulus is over-dilated and the valve leaflets no longer effectively close or engage during systole, the period of cardiac contraction. Blood regurgitation occurs during ventricular systole and can therefore reduce cardiac output. Surgical and endovascular annulusoplasty techniques, including transcatheter repair, have been introduced, aiming, for example, to restore the mitral valve to its natural or improved shape by implanting annulusoplasty rings or other implantable devices around the valve annulus.

[0005] One challenge in implanting devices in the heart is to anchor and secure the implant to soft materials, such as heart tissue, over a long period without the anchor migrating or being pulled out.

[0006] Devices, systems, and methods that can enhance or strengthen the positioning or connection of an implantable device at the implantation site, and / or reduce the migration (transfer or loosening) of the implantable device relative to the treatment site and / or reduce potential tissue damage at the treatment site (such as when manipulating, for example, tightening the implantable device to modify the valve annulus morphology or later after the procedure) will be welcome. Summary of the Invention

[0007] 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.

[0008] According to various principles of the present invention, a tissue anchor is disclosed having a proximal end and a distal end, the distal end being configured for insertion into body tissue. The tissue anchor includes an anchor head located at its proximal end and an anchor shaft extending distally from the anchor head to the distal end of the anchor. The anchor shaft includes a tissue engagement portion and a drive portion, the tissue engagement portion being movable relative to the drive portion to switch between an insertion configuration and a tissue engagement configuration. The insertion configuration facilitates insertion of the anchor into the tissue, and the tissue engagement configuration enhances the engagement between the anchor shaft and the tissue.

[0009] In some embodiments, the drive portion includes a lead screw configured to drive the anchor into the tissue.

[0010] In some embodiments, the tissue engagement portion includes an anchor segment that compresses to clamp tissue therebetween when the tissue engagement portion transitions from an insertion configuration to a tissue engagement configuration. In some embodiments, the anchor segment includes a helical coil that comes together when the tissue engagement portion transitions from an insertion configuration to a tissue engagement configuration to grip tissue between the coils, thereby enhancing the adhesion between the anchor and the tissue.

[0011] In various embodiments, the tissue engagement portion includes an anchor segment that extends radially outward as the tissue engagement portion transitions from an insertion mode to a tissue engagement mode. In some embodiments, the anchor segment bends outward as the tissue engagement portion transitions from an insertion mode to a tissue engagement mode. In some embodiments, the anchor segment flares radially outward as the tissue engagement portion transitions from an insertion mode to a tissue engagement mode. In some embodiments, the anchor segment includes a barb that flares outward from a storage mode as the tissue engagement portion transitions from an insertion mode to a tissue engagement mode. In some embodiments, the anchor segment includes a helical coil with an end that flares outward as the end transitions from an insertion mode to a tissue engagement mode.

[0012] In some embodiments, the drive portion is positioned within the tissue engagement portion, and the tissue engagement portion includes an external anchor segment that is movable relative to the drive portion to switch between an insertion configuration and a tissue engagement configuration.

[0013] In some embodiments, the tissue engagement portion is positioned within the drive portion and includes an anchor segment that is relative to the drive portion, moving from a storage position within the drive portion when the tissue engagement portion is in an insertion configuration to an expansion position extending outward from the drive portion when the tissue engagement portion is in a tissue engagement configuration.

[0014] In various embodiments, the proximal end of the drive portion engages with the proximal end of the tissue engagement portion to suppress relative rotational movement between the drive portion and the tissue engagement portion when the tissue engagement portion is in an insertion configuration, and the proximal ends of the drive portion and the tissue engagement portion are movable to disengage to allow relative rotational movement between the drive portion and the tissue engagement portion to transition the tissue engagement portion into a tissue engagement configuration. In some embodiments, the relative rotational movement between the drive portion and the tissue engagement portion allows at least a portion of the tissue engagement portion to move axially relative to the drive portion to allow the tissue engagement portion to transition into a tissue engagement configuration.

[0015] According to various principles of the invention, an implantable device is provided having a frame member and at least one anchor member, the at least one anchor member being coupled to the frame member and having a proximal end and a distal end, the distal end being configured for insertion into body tissue. The anchor member includes an anchor head located at the proximal end of the anchor member; an anchor shaft extending distally from the anchor head to the distal end of the anchor member; and a tissue engagement portion convertible between an insertion configuration facilitating insertion of the anchor member into tissue and a tissue engagement configuration enhancing engagement of the anchor member within the tissue in which the anchor member has been inserted.

[0016] In various embodiments, the anchor shaft includes a tissue engagement portion and a drive portion, the tissue engagement portion being movable relative to the drive portion to transition between an insertion configuration and a tissue engagement configuration. The system also includes an anchor cap configured to engage the anchor head to facilitate relative movement between the tissue engagement portion and the drive portion. In some embodiments, the anchor cap is configured to axially retain the tissue engagement portion relative to the drive portion to allow axial movement of the drive portion disengaging from the tissue engagement portion when the anchor is in the insertion configuration, thereby allowing the tissue engagement portion to move relative to the drive portion into the tissue engagement configuration. In some embodiments, the anchor cap is configured to engage a proximal end of the tissue engagement portion to suppress rotation of the proximal end of the tissue engagement portion relative to the proximal end of the drive portion, while relative rotation between the drive portion and the tissue engagement portion allows axial movement of the distal end of the tissue engagement portion to transition the tissue engagement portion into the tissue engagement configuration.

[0017] According to various principles of the present invention, a method of implanting an implantable device in soft tissue includes advancing an anchor connected to the implantable device into the soft tissue; and after the anchor has been inserted into the soft tissue, converting the anchor from an insertion mode to a tissue engagement mode, in which the anchor has increased grip on the tissue to enhance the fixation of the implantable device to the tissue.

[0018] In various embodiments, the anchor includes a driving portion and a tissue engagement portion, and the method further includes driving the driving portion into the tissue and moving the tissue engagement portion relative to the driving portion to increase the engagement between the anchor and the tissue. In some embodiments, the method further includes rotating the driving portion to move the tissue engagement portion into a tissue engagement configuration.

[0019] 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

[0020] Non-limiting embodiments of the invention are described by way of example with reference to the illustrative drawings, which are not intended to be drawn to scale. 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 so that details are 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, wherein redundant descriptions are omitted. For clarity and simplicity, not every element is labeled in every figure, and not every element in each embodiment shown is necessary for those skilled in the art to understand the invention.

[0021] A detailed description will be better understood in conjunction with the accompanying drawings, wherein similar reference characters denote similar elements, as described below:

[0022] Figure 1 This is a schematic diagram of a human heart valve with an example of a heart valve implantation device, the example of which is shown implanted in the valve annulus using an anchor formed according to various aspects of the invention.

[0023] Figure 2 This is a perspective view of a heart valve implantation device having examples of anchors formed according to various principles of the present invention.

[0024] Figure 3 This is a perspective view of an embodiment of an anchor formed according to various aspects of the present invention.

[0025] Figure 4 According to various aspects of the invention, in tissue bonding morphology, such as Figure 3 The image shows an elevation view of the anchor.

[0026] Figure 5 Is it like this? Figure 3 The cross-sectional view of the anchor shown.

[0027] Figure 6 This is a perspective view of an example of an anchor cover that can be used with anchors formed according to various principles of the present invention.

[0028] Figure 7 Is it like this? Figure 6 The top view of the anchor cap shown.

[0029] Figure 8 This is a perspective view of another embodiment of the anchor formed according to various aspects of the present invention.

[0030] Figure 9 Is it like this? Figure 8 The cross-sectional view of the anchor shown.

[0031] Figure 10 According to various aspects of the invention, in tissue bonding morphology, such as Figure 8 The image shows an elevation view of the anchor.

[0032] Figure 11 This is a perspective view of another embodiment of the anchor formed according to various aspects of the present invention.

[0033] Figure 12 Is it like this? Figure 11 The cross-sectional view of the anchor shown.

[0034] Figure 13 According to various aspects of the invention, in tissue bonding morphology, such as Figure 11 The image shows an elevation view of the anchor.

[0035] Figure 14 This is a perspective view of another embodiment of an anchor formed according to various aspects of the present invention, and is shown in an organizational engagement morphology according to various aspects of the present invention.

[0036] Figure 15 According to various aspects of the invention, in the insertion form, such as Figure 15 The anchor shown is a three-dimensional cross-sectional view.

[0037] Figure 16 According to various aspects of the invention, in tissue bonding morphology, such as Figure 14 The cross-sectional view of the anchor shown.

[0038] Figure 17 This is a perspective view of another embodiment of an anchor formed according to various principles of the present invention, and is shown in an organizational engagement morphology according to various aspects of the present invention.

[0039] Figure 18 This is a perspective view of another embodiment of an anchor formed according to various principles of the present invention, and is shown in an organizational engagement morphology according to various aspects of the present invention.

[0040] Figure 19 This is a perspective view of another embodiment of an anchor formed according to various principles of the present invention, and is shown in an organizational engagement morphology according to various aspects of the present invention.

[0041] Figure 20 Is it like this? Figure 19 The cross-sectional view of the anchor shown. Detailed Implementation

[0042] 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.

[0043] 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.

[0044] 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, or a hole.

[0045] According to the principles of the invention, an anchor is configured to improve engagement with tissue (e.g., soft tissue) to achieve improved anchor retention and improved fixation of the implantable device at a treatment site (e.g., at a treatment site in or on a human body). According to one aspect of the invention, an anchor is configured to have at least one tissue engagement portion that moves or transitions between an insertion configuration facilitating insertion of the anchor into tissue and a tissue engagement configuration improving retention of the anchor in the implanted tissue. In some embodiments, the anchor has an anchor head and an anchor shaft, and the tissue engagement portion is part of the anchor shaft. In some embodiments, the anchor includes a drive portion coupled to the tissue engagement portion and configured to drive the anchor into the tissue. The drive portion may include a lead screw configured to be driven into and engage with the tissue. In the insertion configuration, the tissue engagement portion may be generally compact or otherwise positioned close to and / or aligned with the drive portion to facilitate insertion of the tissue engagement portion together with the drive portion into the tissue. In some embodiments, the drive portion actuates the tissue engagement portion to move between the insertion configuration and the tissue engagement configuration. For example, in some embodiments, relative movement between the tissue engagement portion and the drive portion, such as relative rotational movement, allows or enables the tissue engagement portion to move between an insertion configuration and a tissue engagement configuration. In some embodiments, the tissue engagement portion and the drive portion are selectively rotatably coupled together to rotate together, and selectively separated to allow relative rotation therebetween.

[0046] An improved tissue anchor, formed according to various principles of the present invention, includes a tissue engagement portion having a tissue engagement morphology that enhances, improves, or increases the engagement, gripping, and tightening of the anchor with body tissue in which the anchor is implanted. In some embodiments, the tissue engagement portion binds, clamps, or compresses tissue between segments of the tissue engagement portion to grip or otherwise engage the tissue. In some embodiments, segments of the tissue engagement portion expand or otherwise extend away from other portions of the anchor, such as to further embed into the tissue or increase the area or surface area of ​​the tissue engagement portion relative to the tissue, and / or increase retention in the tissue and inhibit or prevent anchor withdrawal or otherwise minimize or eliminate tissue "walking". Alternatively or additionally, segments of the tissue engagement portion may be flared outward to further drive into the tissue in a direction transverse to other portions of the anchor.

[0047] An improved anchor formed according to one or more aspects or principles of the invention may be disposed (e.g., coupled to or mounted on) an implantable device and used to secure or anchor the implantable device in tissue at a treatment site. One or more anchors may be provided. An actuator or drive shaft or drive (these terms are used interchangeably herein and are not intended to be limiting) may engage the anchor to advance or drive the anchor into tissue, and optionally, retract the anchor (if necessary). In some embodiments, the anchor includes a latch or connector configured to engage with an actuator or another latch disposed on a delivery and / or deployment device, which is set and configured to deliver and / or deploy and / or adjust and / or otherwise manipulate or control the implantable device.

[0048] According to one aspect of the invention, in embodiments where the tissue engagement portion and the actuator portion of the anchor are selectively rotated together or separated, the actuator portion may be configured to cause the tissue engagement portion to transition between an insertion configuration and a tissue engagement configuration when the tissue engagement portion is in a rotated-connected or separated position. In some embodiments, the actuator portion and the tissue engagement portion rotate together to be driven into the tissue. The actuator portion and the tissue engagement portion may then disengage or separate from each other, and the actuator portion rotates relative to the tissue engagement portion to cause or allow the tissue engagement portion to morphologically change from an insertion configuration to a tissue engagement configuration. An actuator may be used to cause the tissue engagement portion and the actuator portion to rotate together, as well as to cause the actuator portion to rotate independently (without also causing the tissue engagement portion to rotate). In some embodiments, the tissue engagement portion and the actuator portion engage, connect, interlock, etc. (these terms are used interchangeably herein and are not intended to be limiting) to rotate together, and an anchor cap may be provided to disengage, separate, detach, etc., or otherwise allow individual actuation of the actuator portion and the tissue engagement portion, such as actuation of the actuator portion separated from the tissue engagement portion, to cause or allow the tissue engagement portion to transition from an insertion configuration to a tissue engagement configuration. Anchor caps can be used, either additionally or alternatively, to maintain the desired relative position between the tissue engagement portion and the drive portion.

[0049] According to one aspect of the invention, the implantable device is provided with at least one improved anchor. The anchor can be considered part of or independent of the implantable device. The implantable device has a body member or a frame member or a frame (these terms are used interchangeably herein and are not intended to be limiting), and one or more anchors are attached to the implantable device, such as to its body or frame, and are shaped and configured to relate to tissue attachment or anchoring of the implantable device. One or more of the anchors are formed according to various principles of the invention to enhance, improve, increase, etc., the engagement, grip, hold, etc., of the anchors with the tissue in which the anchors are implanted. The implantable device can be configured for custom remodeling of heart valves, such as the mitral valve. In some embodiments, the frame is a generally tubular frame having a proximal and a distal end, wherein at least one of the improved anchors extends distally from the distal end of the frame and can be advanced into the heart tissue. In some embodiments, the frame is formed by a plurality of struts, adjacent struts forming a proximal apex at the proximal end of the frame and a distal apex at the distal end of the frame. Anchors formed according to the principles of the invention can be positioned at one or more distal vertices to anchor the implantable device to tissue. Improved morphologies of the anchors can increase tissue engagement and / or anchor retention, and / or inhibit or prevent tissue "walking" and / or anchor disengagement, thereby increasing the effectiveness of the implantable device.

[0050] The improved tissue anchors and implantable devices with improved anchors, as well as methods of using the improved tissue anchors and methods of deploying implants with one or more improved anchors, are described in more detail below, along with other beneficial aspects. While embodiments of the invention may be specifically described with reference to the mitral valve, the principles disclosed herein can be readily applied to facilitate the reconstruction of any valvular annulus, including, for example, the tricuspid annulus, and / or may similarly benefit any other dilatation, valvular regurgitation, valvular leakage, and other similar conditions of heart failure. Furthermore, the principles disclosed herein can be applied to other implantable devices besides those implanted in the heart.

[0051] Various embodiments of improved tissue anchors and implantable devices having improved tissue anchors, and methods of use thereof, will now be described with reference to the examples illustrated in the accompanying drawings. References in this specification such as “one embodiment,” “embodiment,” “some embodiments,” “other embodiments,” etc., indicate that one or more specific features, structures, and / or characteristics may be included in conjunction with that embodiment according to the principles of the invention. However, such references do not necessarily imply that all embodiments include the specific features, structures, and / or characteristics, or that one embodiment includes all features, structures, and / or characteristics. Some embodiments may include one or more such features, structures, and / or characteristics employing various combinations thereof. Furthermore, references throughout the specification such as “one embodiment,” “embodiment,” “some embodiments,” “other embodiments,” etc., do not necessarily refer to the same embodiment, nor are they necessarily separate or alternative embodiments mutually exclusive with other embodiments. When a particular feature, structure, and / or characteristic is described in connection with an embodiment, it should be understood that, whether explicitly described or not, such feature, structure, and / or characteristic may also be used in conjunction with other embodiments, unless expressly stated otherwise. It should also be understood that such features, structures, and / or characteristics may be used or present individually, or in various combinations thereof, to create alternative embodiments shown as part of the invention, because describing all the numerous possible combinations and sub-combinations of features, structures, and / or characteristics would be overly cumbersome. Furthermore, various features, structures, and / or characteristics that may be demonstrated by some embodiments but not by others are described. Similarly, various features, structures, and / or characteristics or requirements that may be relevant to some embodiments but not to others are described. Therefore, the invention is not limited to the embodiments specifically described herein.

[0052] Turning now to the accompanying drawings, it should be understood that in the following description, similar elements or parts in the various illustrated embodiments of the anchors are generally designated by the same reference numerals incremented by 100, and redundant descriptions are omitted. Common features are identified by common reference elements, and for the sake of brevity, descriptions of common features are generally not repeated. For clarity, not all parts with the same reference numerals are numbered.

[0053] exist Figure 1 An example of an implantable device 100 that may benefit from anchors formed according to one or more aspects of the invention is shown as being implanted in a heart valve annulus using a deployment / delivery device or system 102, and... Figure 2 The details are shown in more detail below. The implantable device 100 in this example is an implantable device for annulus reconstruction, such as for customized remodeling of heart valves (e.g., the mitral or tricuspid valve as shown), and is movable between and in between collapsed and expanded morphologies to modify the shape of the annulus VA at the implantation / fixation site. The imaging catheter 104 can be used to locate the treatment site TS, where the implantable device 100 will be delivered / deployed and implanted, and / or to observe the morphology and / or position of the implantable device 100 during implantation and adjustment. Examples of manipulable delivery devices and systems with various positioning and imaging capabilities are described in U.S. Patent No. 10,335,275, entitled "Method for Deploying Heart Valve Devices Using Intravascular Ultrasound Imaging," published July 2, 2019, which is incorporated herein by reference in its entirety for all purposes. Once located at the treatment site TS, the implantable device 100, which can be held by a retaining device or by a delivery device or otherwise in a compressed or retracted or unexpanded form (such terms are used interchangeably herein and are not intended to be limiting), is allowed to expand for deployment and placement, as well as implantation, such as... Figure 1 As shown. Expansion can occur naturally, for example, if the frame is formed of a shape memory or hyperelastic material (e.g., nitinol) biased toward an expanded state. In alternative embodiments, expansion can be mechanically controlled, for example, by using forces applied to the frame using an expandable deployment device (e.g., an inflatable balloon, etc.).

[0054] refer to Figure 2The example of the implantable device 100 shown includes a frame member 110, which may be positioned around a heart valve or other cardiac feature. The frame member 110 may be generally symmetrical about a central frame axis FA, although it does not need to be symmetrical. The frame member 110 may be formed into a generally tubular shape; the term "tubular" is understood herein to include circular or other rounded or otherwise closed shapes. The frame member 110 can be configured to change shape, size, dimension, and / or morphology. For example, the frame member 110 may present various shapes, sizes, dimensions, morphologies, etc., at different stages of deployment, such as before delivery, delivery, tissue engagement, anchoring, adjustment (e.g., tightening), etc.

[0055] Frame member 110 may be formed by one or more struts 112, which may form all or part of frame member 110. Strut 112 may comprise an elongated structural member formed of a metal alloy, shape memory material, alloy of metals such as nickel-titanium or other metals, plastic, polymer, composite material, other suitable materials, or combinations thereof. In one embodiment, strut 112 may be formed from the same monolithic material (e.g., a tube blank). Therefore, reference to strut 112 may refer to different portions of the same commonly extending component. Alternatively, reference to strut 112 may refer to components formed separately and attached together (optionally, permanently, such as by welding or other methods). In some embodiments, strut 112 may be a separate component detachably coupled to form a distal vertex 116 of a proximal vertex 114. Alternatively, if formed from a monolithic material, the material may be cut or otherwise shaped to define the proximal vertex 114 and the distal vertex 116.

[0056] like Figure 2 As shown, in an example of an embodiment of the illustrated implantable device 100, a plurality of tightening collars 120 (alternately referred to as collars, cannulas, tightening cannulas, slides, or nuts; these terms are used interchangeably herein and are not intended to be limiting; for convenience, the collar is generally referred to as such) are carried at the proximal end 111 of the frame member 110 at its proximal vertex 114, and a plurality of tissue anchors 1000 are carried at the distal end 113 of the frame member 110, such as along the distal vertex 116 of the frame member 110. In the illustrated embodiment, the proximal end 111 of the frame member 110 is directed proximally toward or carried by the delivery / deployment system 102, and the distal end 113 of the frame member 110 extends distally from the delivery / deployment system 102 and is the end that engages with the treatment site TS. It should be understood that alternating configurations of the frame member 110, such as those depending on the manner and orientation of delivery of the implantable device 100, are within the scope and spirit of the invention.

[0057] The advance or withdrawal of the collar 120 relative to the proximal apex 114 adjusts the relative position of the struts 112 engaged at this apex, with the collar 120 positioned above the proximal apex 114. This adjustment results in an adjustment of at least one of the size, shape, morphology, dimensions, etc., of the frame members 110 (e.g., retraction / compression or expansion of the frame when bringing adjacent struts 112 closer or further apart, respectively), to affect at least one of the size, shape, morphology, dimensions, etc., of the treatment site TS (e.g., for restoring or correcting the shape of the valve annulus to achieve its proper operation or capability). The collar 120 can be adjusted in various ways, such as by engagement of a threaded collar actuator 130 with threads within the engagement collar 120, or by rotation of the collar actuator 130 causing axial movement of the collar 120 (while maintaining axial movement). A latch 132 is provided on the collar actuator 130 to engage the latch of the actuator, which is configured to actuate the collar 120 as needed (e.g., move, advance, retract, etc.).

[0058] Generally, each anchor 1000 is associated with a different distal vertex 116. In some embodiments, the anchor 1000 is translated via an anchor housing 1002 coupled to the frame member 110. The anchor 1000 is advanced distally into the annulus VA relative to the frame member 110 to insert or adjust the position of the frame member 110, and withdrawn to remove or adjust the position of the frame member 110. The anchor 1000 may generally include an anchor head 1010 at the proximal end 1001 of the anchor 1000, and an anchor shaft 1020 extending from the anchor head 1010 toward the distal end 1003 of the anchor 1000. The anchor shaft 1020 may include a helical portion or segment such that rotation of the anchor 1000 is relative to the advancement or retraction of the frame member 110. An anchor shaft 1020 (such as in the form of a helical shaft) may be coupled to and extend through a portion of the associated distal apex 116 of the frame member 110, which may or may not have an associated anchor housing 1002. A latch 1012 may be provided or formed on the anchor head 1010 and configured to engage by a corresponding latch of an actuator of the anchor 1000 that is configured to actuate (e.g., move, advance, retract, etc.).

[0059] Anchors 1000 formed according to various principles of the invention have more than one form, including insertion forms, such as compact forms facilitating insertion into tissue, and tissue-engaging forms in which the anchor 1000 is shaped to enhance engagement with tissue, such as to enhance retention of implantable devices fixed to tissue via the anchor 1000. In some embodiments, an anchor 1000 having more than one form has an anchor shaft 1020 having at least two portions movable relative to each other to allow the anchor shaft 1020 to switch between insertion and tissue-engaging forms.

[0060] In one embodiment formed according to various principles of the present invention, such as Figures 3 to 5 As shown, anchor 1100 includes an anchor head 1110 located at the proximal end 1101 of anchor 1100, and an anchor shaft 1120 extending distally from the anchor head 1110 to the distal end 1103 of anchor 1100. The anchor shaft 1120 includes a drive portion 1130 and a tissue engagement portion 1140. Actuation of the anchor head 1110 (e.g., during rotation of the latch 1112 extending proximally from the anchor head 1110) drives the drive portion 1130 into the tissue (or retracts it from the tissue when moved in the opposite direction). The drive portion 1130 and the tissue engagement portion 1140 are rotatably coupled to allow the anchor 1100 to be in a position such as... Figure 3 In the insertion configuration shown, they rotate together. As can be understood, in the insertion configuration, the tissue engagement portion 1140 extends substantially axially relative to the longitudinal axis LA of the anchor 1100 and is substantially aligned at least with the lead screw 1132 section of the drive portion 1130 of the anchor shaft 1120 for insertion into the tissue.

[0061] Once the anchor shaft 1120 has been sufficiently advanced to secure the anchor 1100 to the tissue, the anchor 1100 can be changed or transformed into a tissue engagement configuration, such as... Figure 4 As shown. In the tissue-jointing morphology, the tissue-jointing portion 1140 is reconfigured, transformed, or otherwise (such terms are used interchangeably herein and are not intended to be limiting) into a morphology having an enhanced gripping or anchoring or tissue-jointing (such terms are used interchangeably herein and are not intended to be limiting) shape or form. Figure 3 and Figure 4 In the example shown, the tissue engagement portion 1140 has an external anchor segment 1142 whose shape or form is altered or transformed to increase its grip on the tissue into which it is inserted. Figures 3 to 5 In the illustrated embodiment, the external anchor segment 1142 is in the form of a coiled external anchor segment, which is inserted from an insertion form (such as...) Figure 3As shown (where gaps may exist between each turn of the coiled outer anchor section 1142 of the tissue joint portion 1140) compressed into a tissue joint shape (such as Figure 4 (As shown in the diagram) (where at least some of the coiled sections of the turns have come together). The movement that brings together the turns of the coiled outer anchor section 1142 of the tissue engagement portion 1140 can tighten or otherwise grip the tissue in which the anchor 1100 has been inserted and, when in the inserted position, extends between the turns of the coiled outer anchor section 1142, thereby strengthening or increasing the grip or hold of the anchor 1100 on the tissue via the tissue engagement portion 1140 (such terms are used interchangeably herein and are not intended to be limiting).

[0062] As is understandable, in order to make anchor 1100 in Figures 3 to 5 In the embodiments, the transformation between forms involves the movement of the driving portion 1130 and the tissue-joining portion 1140, or at least its segments, relative to each other. Figures 3 to 5 In some embodiments, the drive portion 1130 and the tissue engagement portion 1140 selectively move axially (along the longitudinal axis LA of the anchor 1100) and rotate together with each other. Specifically, in the insertion configuration, the drive portion 1130 and the tissue engagement portion 1140 engage or connect together to rotate together during insertion of the anchor 1100 into the tissue (e.g., facilitated by rotation of the latch 1112 on the anchor head 1110 into the tissue) and are substantially not axially moved with each other. To transition to the tissue engagement configuration (e.g., ... Figure 4 In the diagram, the tissue engagement portion 1140 is movable relative to the drive portion 1130 to transition to a tissue engagement configuration.

[0063] exist Figures 3 to 5 In the illustrated embodiment, the drive portion 1130 may take the form of and / or include a lead screw 1132, which is configured to facilitate the insertion of the anchor 1100 and / or the penetration of the tissue and / or drive the anchor 1000 into the tissue. For example, the lead screw 1132 may include a pointed distal end 1133 and external threads 1135 to facilitate the penetration and / or advancement of the lead screw 1132 into the tissue. Advancement of the lead screw 1132 also advances the tissue engagement portion 114 of the anchor 1100 into the tissue, typically when the drive portion 1130 and the tissue engagement portion 1140 are rotatably coupled to rotate together. This coupling can be implemented in various ways within the scope of the invention. For example, in Figures 3 to 5 In the embodiments, as can be referred to Figure 3Most readily apparent, the drive portion 1130 and the tissue engagement portion 1140 engage at their respective proximal ends 1131, 1141 (which can be considered to form the anchor head 1110), such as with interlocking elements 1134, 1144 (e.g., keyways or latches of engaging keys or protrusions) to rotate and lock, preventing (limiting) relative rotational movement. More specifically, in the illustrated embodiment, the proximal end 1131 of the drive portion 1130 includes a keyway or latch 1134, into which the key or protrusion 1144 on the proximal end 1141 of the tissue engagement portion 1140 extends to suppress or prevent rotational movement between the drive portion 1130 and the tissue engagement portion 1140. It should be understood that the opposite arrangement (having a keyway or latch on the tissue engagement portion 1140 and a key or protrusion in the drive portion 1130) is also within the scope of the invention. Optionally, a flange 1136 may be formed on the proximal end 1131 of the drive portion 1130 (having a keyway 1134 formed therein) to suppress or prevent further distal movement of the drive portion 1130 relative to the tissue engagement portion 1140, and further proximal movement of the tissue engagement portion 1140 relative to the drive portion 1130.

[0064] Once the anchor 1100 is fully inserted into the tissue at the treatment site TS, the tissue engagement portion 1140 can be actuated to transition to the tissue engagement configuration. Figures 3 to 5 In some embodiments, the drive portion 1130 can actuate the tissue engagement portion 1140 to transition to a tissue engagement configuration. Specifically, continuous rotation of the drive portion 1130 can actuate the tissue engagement portion 1140 to transition to a tissue engagement configuration. This actuation can be achieved by allowing a portion of the tissue engagement portion 1140 to rotate relative to the drive portion 1130 and allowing the distal portion of the tissue engagement portion 1140 to move axially relative to the drive portion 1130, while suppressing axial movement of the proximal portion of the tissue engagement portion 1140 relative to the proximal portion of the drive portion 1130. (See reference...) Figure 5Understandably, the tissue engagement portion 1140 may include a drive segment 1146 having an internal thread 1145 that engages with an external thread 1135 on a lead screw 1132 segment of the drive portion 1130. In some embodiments, the internal thread 1145 is formed on an inner surface of the drive segment 1146 (e.g., on a cylindrical segment having a larger axial extent along the longitudinal axis LA of the anchor 1100 than the individual turns of the coiled outer anchor segment 1142). In other embodiments, a nut is formed in (e.g., machined into) or separately formed and disposed on the tissue engagement portion 1140, the nut having an internal thread 1145 for engaging with the external thread 1135 on the lead screw 1132. Generally, the drive portion 1146 may be disposed adjacent to the distal end 1143 of the tissue engagement portion 1140 to engage the distal end 1133 of the drive portion 1130. However, the position near the indicated location is within the scope of this invention.

[0065] To actuate the tissue engagement portion 1140, the drive portion 1130 and the tissue engagement portion 1140 can be released from rotational engagement to be allowed to rotate relative to each other. In some embodiments, the drive portion 1130 can be axially moved relative to the tissue engagement portion 1140 to disengage the interlocking elements 1134, 1144, such as by axially moving the drive portion 1130 relative to the tissue engagement portion 1140. If the flange 1136 is disposed on the proximal end 1131 of the drive portion 1130, the axial movement of the drive portion 1130 causes the flange 1136 to move proximally away from the proximal end 1141 of the tissue engagement portion 1140 to allow the drive portion 1130 to rotate relative to the tissue engagement portion 1140 (e.g., by allowing the flange 1136 to rotate over the proximal end 1144). While the drive section 1146 remains rotatably engaged with the lead screw 1132, the continued rotation of the drive section 1130 relative to the tissue engagement portion 1140 causes the drive section 1146 to move axially proximally along the lead screw 1132 of the drive section 1130. As the drive section 1146 moves proximally, the coiled outer anchor section 1142 tightens or compresses the turns of its coil, gripping or constricting the tissue therebetween, thereby increasing the grip or tightness on the tissue in which the anchor 1100 has been inserted. Once the anchor 1100 is fully secured, the drive section 1130 and the tissue engagement portion 1140 can be re-engaged, for example to suppress or prevent relative rotational movement therebetween, thereby holding the tissue engagement portion 1140 in place. Figure 5 The tissue junction morphology shown.

[0066] As will be understood, the drive portion 1130 can be axially moved via engagement and axial movement of the latch 1112 on the proximal end 1131 of the drive portion 1130. To facilitate axial movement of the drive portion 1130 relative to the tissue engagement portion 1140, a method such as... Figure 6 and Figure 7 Anchor cap 140 is shown. (See reference...) Figure 6 Understandably, the anchor cap 140 includes an anchor engagement distal end 143 configured to engage the proximal end 1101 of the anchor 1100. The anchor engagement distal end 143 of the anchor cap 140 may include a cutout 145 receiving a protrusion 1144 (which may extend proximally) on the proximal end 1141 of the tissue engagement portion 1140. A distally extending anchor engagement segment 146 of the anchor cap 140 (which may be, for example, in the form of a lug) retains the proximal end 1141 of the tissue engagement portion 1140 to prevent it from moving proximally with the drive portion 1130 when the drive portion 1130 moves proximally axially to disengage from the tissue engagement portion 1140. The anchor engagement segment 146 of the anchor cap 140 also laterally engages the protrusion 1144 on the tissue engagement portion 1140 to prevent rotation of the tissue engagement portion 1140 relative to the drive portion 1130. The distal end 143 of the anchor cover 140 has a passage 144, such as... Figure 7 As seen in the diagram, the proximal end 1131 of the drive portion 1130 can extend proximally through the passage 144 to disengage from the tissue engagement portion 1140 of the anchor shaft 1120, allowing relative rotation between the drive portion 1130 and the tissue engagement portion 1140. To re-engage the drive portion 1130 and the tissue engagement portion 1140, tension on the latch 1212 on the proximal end 1131 of the drive portion 1130 can be released.

[0067] It should be understood that various other forms of anchors having shafts with portions that transition between more than one form are within the scope of this invention. Figures 8 to 10 Another embodiment of an anchor 1200 formed according to the principle of the present invention is shown, the anchor 1200 having an anchor shaft 1220 (extending distally from the anchor head 1210) that transitions between more than one form. Figures 8 to 10 Anchor 1200 has a tissue engagement portion 1240, which in the insertion form (e.g. Figure 8 and Figure 9(As shown) (in this configuration, the tissue engagement portion 1240 extends axially substantially relative to the longitudinal axis LA of the anchor 1200 and is substantially aligned at least with the screw 1232 segment of the drive portion 1230 of the anchor shaft 1220) (such as for insertion into tissue) and the tissue engagement configuration (in this configuration, the tissue engagement portion 1240 has an outer anchor segment 1242, which undergoes changes or transformations in shape or form, such as by expansion or outward extension, to enhance the engagement between the anchor 1200 and the tissue in which the anchor 1200 is implanted) and the tissue engagement configuration. More specifically, as can be seen from Figure 10 It is understood that when the distal end 1243 of the tissue joint portion 1240 moves proximally, the external anchor segment 1242 bends or flexes outward in the tissue joint configuration.

[0068] Similar to Figures 3 to 5 The anchor 1100 shown is... Figures 8 to 10 The anchor 1200's engagement portion 1240 may include a drive section 1246 having an internal thread 1245 that engages with an external thread 1235 on the lead screw 1232 section of the drive portion 1230, for example, as Figure 9 As shown. The proximal ends 1231 and 1241 of the drive portion 1230 and the tissue engagement portion 1240 can be moved into and disengaged to rotate together (and can be considered together to form the anchor head 1210 of the anchor 1200) or not rotate, as described above. Figures 3 to 5 The embodiments described herein. Therefore, for the sake of brevity, reference is made to the embodiments described herein. Figures 3 to 5 The description of the engagement and movement of the driving portion 1130 and the tissue engagement portion 1140 of the anchor 1100, the general principle of which can be applied to Figures 8 to 10 The anchor 1200 comprises a drive portion 1230 and a tissue engagement portion 1240. Once the drive portion 1230 disengages from the tissue engagement portion 1240 (e.g., by moving proximally to disengage the proximal ends 1231, 1241 of the drive portion 1230 and the tissue engagement portion 1240 from rotational locking engagement) and continues to rotate (e.g., while the latch 1212 is engaged and rotated by the drive actuator), the internal thread 1245 of the drive segment 1246 moves proximally along the external thread 1235 on the lead screw segment 1232 of the drive portion 1230. The proximal end 1241 of the tissue engagement portion 1240 is held to prevent axial movement (e.g., by the anchor cap 140, as...). Figure 7 and Figure 8 As shown, and as referenced Figures 3 to 5As described in the embodiments, the drive segment 1246 (and the distal end 1243 of the tissue engagement portion 1240) moves proximally, thereby causing the outer anchor segment 1242 to buckle outward. In some embodiments, the outer anchor segment 1242 of the tissue engagement portion 1240 is defined by a longitudinally extending slit 1247 in the tissue engagement portion 1240 between the proximal end 1241 and the distal end 1243, thereby allowing buckling or expansion or outward extension of the outer anchor segment 1242 (such terms are used interchangeably herein and are not intended to be limiting). Laser cutting can bias the walls of the outer anchor segment 1242 to buckle distally / outward in a desired shape.

[0069] Similar to Figures 3 to 5 Implementation examples, Figures 8 to 10 The internal thread 1245 of the drive segment 1246 of the anchor 1200 may be formed directly on the inner surface of the drive segment 1246, or the nut may be formed in the tissue engagement portion 1240 (e.g., machined into it) or separately formed and disposed on the tissue engagement portion 1240. Generally, the drive segment 1246 may be disposed adjacent to the distal end 1243 of the tissue engagement portion 1240 to engage the distal end 1233 of the drive portion 1230. However, the position proximal to the indicated location is within the scope of the invention. For example, the distal end 1243 of the tissue engagement portion 1240 may include a forward distal tip 1248 to assist the optionally sharpened distal end 1233 of the lead screw 1232 in penetrating the tissue.

[0070] exist Figures 11 to 13 Another embodiment of the anchor 1300 is shown, which has an anchor shaft 1320 that can be switched or moved in an insertion mode (in which the anchor shaft 1320, extending distally from the anchor head 1310, is shaped and configured to facilitate insertion into tissue) and a tissue engagement mode (in which a tissue engagement portion 1340 expands or extends outward to enhance or increase the engagement of the anchor shaft 1320 with the tissue in which the anchor shaft 1320 is inserted). Instead of a longitudinal slit facilitating the expansion of the tissue engagement portion 1340 of the anchor 1300, Figures 11 to 13The outer anchor section 1342 of the tissue engagement portion 1340 of the anchor 1300 shown is formed by a plurality of (e.g., three) helical coils. The drive section 1346 of the tissue engagement portion 1340 of the anchor shaft 1320 includes an internal thread 1345 of an external thread 1335 engaging on a lead screw 1332 section of the drive portion 1330 of the anchor 1300. When the drive section 1346 moves proximally (e.g., by rotation of the drive portion 1330 along the anchor head 1310 relative to the tissue engagement portion having proximal ends 1331, 1341, substantially restricted to prevent relative axial movement, such as by engagement with the anchor cap 140, as described above), the helical coils of the outer anchor section 1342 expand outward and may also contract or compress axially, thereby further engaging the anchor 1300 into the tissue and tightening or retaining the tissue between the coils of the tissue engagement portion 1340. If necessary, the distal ends of one or more helical coils of the external anchor segment 1342 may include sharp ends or hooks 1348 to drive the tissue engagement portion 1340 of the anchor shaft 1320 into the tissue. The distal end 1333 of the lead screw 1332 may also have sharpened ends. In some embodiments, the threaded coils may be configured to flare or open outward as the tissue engagement portion 1340 moves into the tissue engagement configuration to further increase the area occupied by the tissue engagement portion 1340 within the tissue.

[0071] It should be understood that although the drive segment 1346 of the tissue joint portion 1340 is shown adjacent to the distal end 1343 of the tissue joint portion 1340, the drive segment 1346 can be positioned more proximally if further independent movement of the distal end of the helical coil of the external anchor segment 1342 is required. Furthermore, it should be understood that the drive segment 1346 can be formed as a welded or machined part on the tissue joint portion 1340, or as a separate piece (e.g., a nut) formed from the solid part or segment of the tissue joint portion 1340 (e.g., laser-cut). Figures 11 to 13 Other features, components, and sections of the anchor 1300 can be used with Figures 3 to 5 Anchors 1100 and / or Figures 8 to 10 The corresponding features, components, and sections of the anchor 1200 are arranged and operated in a substantially the same or similar manner. Therefore, for the sake of simplicity and convenience, and not intended to be limiting, common elements with common functions are represented by the same reference character with a numerical difference of 100, referring to the above description of similar elements and operations.

[0072] exist Figures 14 to 18Another embodiment of the anchor 1400 is shown, which has an anchor shaft 1420 that can be switched or moved in an insertion mode (in which the anchor shaft 1420 is shaped and configured to facilitate insertion into tissue) and a tissue engagement mode (in which the tissue engagement portion 1440 expands or extends outward to enhance or increase the engagement of the anchor shaft 1420 with the tissue in which the anchor shaft 1420 is inserted). Compared with the embodiments of the anchors 1200 and 1300 described above, in the case where the tissue engagement portions 1240 and 1340 have external anchor segments 1242 and 1342 positioned outside or around the internal drive portions 1230 and 1330 of the anchors 1200 and 1300, Figures 14 to 18 The engagement portion 1440 of the anchor 1400 is positioned within the outer drive portion 1430 of the anchor shaft 1420. Figures 14 to 18 The external drive portion 1430 of the embodiment takes the form of a lead screw 1432, which can be driven into tissue, such as by engaging the anterior (optionally sharpened) distal tip 1438 of its distal end 1433 with tissue to penetrate tissue, and then rotating the drive portion 1430 (e.g., by rotating its proximal end 1431 along the anchor head 1410 with the anchor cap 140) to advance the anchor shaft 1420 into tissue. The tissue engagement portion 1440 has one or more resiliently biased tissue engagement barbs 1442, which can extend through an opening or window 1437 in the drive portion 1430 of the anchor shaft 1420, such as... Figure 14 and Figure 16 As shown, it extends into the tissue in which the anchor shaft 1420 has been inserted, to increase the footprint of the anchor shaft 1420 and / or improve the engagement of the anchor shaft 1420 with the tissue.

[0073] In order to Figures 14 to 16 The tissue engagement portion 1440 of the anchor 1400 transitions from an insertion mode to a tissue engagement mode, allowing the tissue engagement portion 1440 to move relative to the drive portion 1430. In the insertion mode, as... Figure 15 As shown, one or more outwardly extending flanges 1436 on the proximal end 1441 of the tissue engagement portion 1440 are held by a shoulder or flange 1444 on the proximal end 1431 of the drive portion 1430, thereby inhibiting relative axial movement between the tissue engagement portion 1440 and the drive portion 1430. Rotation of the tissue engagement portion 1440 relative to the drive portion 1430 releases the flanges 1436, and a biasing element 1450 (e.g., a spring) biases the tissue engagement portion 1440 proximally relative to the drive portion 1430, as... Figure 14 and Figure 16 As shown in the reference. Figure 16Understandably, the biasing element 1450 can be positioned between the distal end 1443 of the tissue engagement portion 1440 and the crossbar 1439 within the drive portion 1430; however, other arrangements are also within the scope of the invention. Thus, the tissue engagement barb 1442 can be positioned from its position within the drive portion 1430 (e.g., Figure 15 (as shown) is confined or limited to a location where the tissue-engaging barb 1442 can extend outward from the anchor shaft 1420 (such as... Figure 14 and Figure 16 (As shown in the diagram) The tissue engagement barb 1442 can be resiliently biased to extend outward once positioned next to the window 1437 in the drive portion 1430, such as when the tissue engagement portion 1440 moves axially proximally relative to the drive portion 1430. In some embodiments, the tissue engagement barb 1442 can be shaped to prevent misalignment with the window 1437 when the respective proximal ends 1431, 1441 of the drive portion 1430 and the tissue engagement portion 1440 are unlocked from the anchor shaft 1420.

[0074] The tissue engagement barb 1442 can be separately shaped and engaged with other segments of the tissue engagement portion 1440. For example, the tissue engagement barb 1442 can extend from a ring or collar or base 1449 (such terms are used interchangeably herein and are not intended to be limiting) having segments that engage within one or more grooves 1447 in the exterior of the tissue engagement portion 1440. The tissue engagement barb 1442 extends through a window 1437 in the drive portion 1430 and can therefore be restricted once it extends through it to prevent rotational movement with respect to the tissue engagement portion 1440. Therefore, the tissue engagement barb 1442 does not need to be restricted to prevent rotational movement with respect to the tissue engagement portion 1440. Preferably, when the tissue engagement portion 1440 is in the insertion configuration, at least a portion of the tissue engagement barb 1442 extends through the window 1437 to maintain alignment of the tissue engagement barb 1442 with the window 1437, such that when the tissue engagement portion 1440 moves into the tissue engagement configuration, the tissue engagement barb 1442 is positioned to extend radially outward through the window 1437 into the expansion configuration. Once in the expansion configuration, the tissue engagement barb 1442 increases the tissue engagement of the anchor 1400 with the tissue and / or prevents the anchor from disengaging and / or prevents the tissue from "walking".

[0075] It should be understood that, for example Figures 14 to 16 Various modifications to the tissue engagement portion 1440 in the anchor 1400 are within the scope of this invention. For example, the anchor 1400' with an external drive portion 1430' is shown in dashed lines. Figure 17 As shown, the interlocking barb 1442' can be formed into more than one component. Specifically, although... Figures 14 to 16In the illustrated embodiment, each barb 1442 extends from a common ring or collar or base 1449, but Figure 17 The barb 1442' in the embodiment can also extend from a separate base 1449' (e.g., more than one semi-circular base instead of a circular base). Furthermore, Figures 14 to 18 The bases 1449, 1449', 1449" of the embodiments may be in the form of a ring that extends to varying degrees around the circumference or periphery of the tissue engagement portion 1440. An anchor 1400" with an external drive portion 1430" is shown in dashed lines. Figure 18 As shown in the embodiments, the base 1449” may extend only partially around the circumference or periphery of the tissue engagement portion 1440”, thereby leaving a visible gap between the open-loop ends of the base 1449”. See also... Figures 14 to 18 The various tissue-jointing barbs 1442, 1442', 1442" shown are understood to be provided with different numbers of barbs.

[0076] Replacement Figures 14 to 18 In the embodiment, the inner tissue joining portion 1440 extends through the barb of the window in the outer driving portion 1430, as... Figure 19 and Figure 20 The anchor 1500 shown includes a tissue-engaging barb 1542 extending from the distal end 1543 of the tissue-engaging portion 1540. During insertion of the anchor 1500, the drive portion 1530 (in) Figure 19 (Shown in dashed lines) and the tissue engagement portion 1540 can be rotatably engaged to rotate together. For example, the anchor head 1510 can be configured to be engaged by the anchor cap 140, such that the anchor cap 140 inhibits relative rotation between the drive portion 1530 and the tissue engagement portion 1540. Once the anchor shaft 1520 has been advanced to the desired position within the tissue, the tissue engagement portion 1540 can be allowed to rotate relative to the drive portion 1530 (e.g., by releasing the engagement of the anchor cap 140 from the anchor head 1510) to allow relative rotational movement therebetween. See reference Figure 20 It is understood that the tissue engagement portion 1540 and the drive portion 1530 can be threadedly engaged (e.g., to axially hold the tissue engagement portion 1540 and the drive portion 1530 together), and the continuous rotation of the tissue engagement portion 1540 relative to the drive portion 1530 allows the tissue engagement portion 1540 to be advanced distally relative to the drive portion 1530 until the tissue engagement barb 1542 located at the distal end 1543 of the tissue engagement portion 1540 extends outward beyond the outer drive portion 1530 to engage within the tissue in which the anchor 1500 has been inserted. It should be understood that... Figures 14 to 16 , Figure 17 or Figure 18Any of the anchors can use a similar threaded engagement of the tissue engagement portion and the drive portion of the anchor 1500, instead of a biasing element, to advance the tissue engagement barb into the tissue.

[0077] It should be understood that tissue anchors as described herein can be used for, for example Figure 1 and Figure 2 The implantable device shown, as well as its use with related delivery systems and methods of use and mechanisms for positioning anchors for ring reconstruction, and in conjunction with other implantable devices as described in the following patents and patent applications, each of which is incorporated herein by reference in its entirety for all purposes. U.S. Patent Application Publication No. 2010 / 0249920, entitled "Device for Transluminal Mitral Valve Annulus Remodeling," published September 30, 2010; U.S. Patent No. 9,180,005, entitled "Adjustable Transluminal Mitral Valve Annulus," published November 10, 2015; U.S. Patent No. 9,192,471, entitled "Device for Transluminal Mitral Valve Annulus Remodeling," published November 24, 2015; U.S. Patent No. 9,610,156, entitled "Inverted Mitral Valve Prosthesis," published April 4, 2017; U.S. Patent No. 9,795,480, entitled "Reconfiguration of Tissue Features of Cardiac Valve Annulus," published October 24, 2017; and U.S. Patent No. 2010 / 0249920, entitled "Device for Transluminal Mitral Valve Annulus Remodeling," published December 26, 2017. U.S. Patent No. 9,848,983 entitled "Valve Replacement Using Rotating Anchors"; U.S. Patent No. 10,321,999 entitled "System and Method for Cardiac Valve Remodeling" published June 18, 2019; U.S. Patent No. 10,335,275 entitled "Method for Delivering Cardiac Valve Devices Using Intravascular Ultrasound Imaging" published July 2, 2019; U.S. Patent No. 10,548,731 entitled "Implantable Device and Delivery System for Remodeling Cardiac Valve Annuities" published February 4, 2020; and / or U.S. Patent No. 10,555,813 entitled "Implantable Device and Delivery System for Remodeling Cardiac Valve Annuities" published February 11, 2020.

[0078] Various embodiments of tissue anchors configured to secure implantable devices to body tissues have been shown and described. While embodiments of the invention may be described specifically with reference to medical devices and systems for implantation in cardiac tissue (e.g., transcavitary devices inserted via the femoral vein, etc.), it should be understood that the disclosed anchors and related systems and methods may also be used in conjunction with other implantable devices, such as those implanted in soft tissue and / or tissues with regular movement and which may benefit from enhanced tissue retention capabilities.

[0079] Most of the anchors disclosed herein can be manufactured via CNC (Computer Numerical Control) milling machines and / or lathes. Some features, such as coils, slits, and interlocking elements, can be made using laser cutting and EDM (Electrical Discharge Machining). Most components can be made from polymers (such as polyetheretherketone (PEEK)) or metals (e.g., nitinol, stainless steel, such as 316L stainless steel, etc.). The barb concept disclosed herein can be made of nitinol to handle the required deflection.

[0080] The foregoing discussion is of broad applicability and has been set forth for illustrative and descriptive purposes, 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, various features of the invention are combined in one or more aspects, embodiments, or forms to simplify the invention. 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 invention can be used with many 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 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.

[0081] The following will be understood in 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 into the detailed description, 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.

[0082] 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 tissue anchor for an implantable device, the tissue anchor having a proximal end and a distal end, the distal end being configured for insertion into body tissue, the tissue anchor comprising: The anchor head located at the proximal end of the anchor; as well as An anchor shaft extending distally from the head of the anchor to the distal end of the anchor; in: The anchor shaft includes a tissue-joining portion and a driving portion; and The tissue-engaging portion is movable relative to the driving portion to switch between an insertion configuration and a tissue-engaging configuration. The proximal end of the driving portion engages with the proximal end of the tissue engagement portion to suppress relative rotational movement between the driving portion and the tissue engagement portion when the tissue engagement portion is in the insertion mode, and the proximal end of the driving portion and the proximal end of the tissue engagement portion can move out of engagement to allow relative rotational movement between the driving portion and the tissue engagement portion to convert the tissue engagement portion into the tissue engagement mode. The insertion configuration facilitates the insertion of the anchor into the tissue, and the tissue engagement configuration enhances the engagement between the anchor shaft and the tissue.

2. The tissue anchor of claim 1, wherein the driving portion includes a lead screw configured to drive the anchor into the tissue.

3. The tissue anchor according to any one of claims 1 to 2, wherein the tissue engagement portion includes an anchor segment that compresses to clamp tissue therebetween when the tissue engagement portion transitions from the insertion configuration to the tissue engagement configuration.

4. The tissue anchor according to any one of claims 1 to 2, wherein the anchor segment includes a helical coil that, when the tissue engagement portion transitions from the insertion mode to the tissue engagement mode, brings the helical coil together to grip tissue between the coils to enhance the engagement between the anchor and the tissue.

5. The tissue anchor according to any one of claims 1 to 2, wherein the tissue engagement portion includes an anchor segment that extends radially outward as the tissue engagement portion transitions from the insertion configuration to the tissue engagement configuration.

6. The tissue anchor according to any one of claims 1 to 2, wherein the anchor segment buckles outward when the tissue engagement portion transitions from the insertion configuration to the tissue engagement configuration.

7. The tissue anchor according to any one of claims 1 to 2, wherein when the tissue engagement portion changes from the insertion mode to the tissue engagement mode, the anchor segment is radially flared outward.

8. The tissue anchor according to any one of claims 1 to 2, wherein the anchor segment includes a barb that flares outward from the storage form when the tissue engagement portion transitions from the insertion form to the tissue engagement form.

9. The tissue anchor according to any one of claims 1 to 2, wherein the anchor segment includes a helical coil having an end that flares outward when the tissue engagement portion changes from the insertion mode to the tissue engagement mode.

10. The tissue anchor according to any one of claims 1 to 2, wherein the drive portion is positioned within the tissue engagement portion, and the tissue engagement portion includes an external anchor segment movable relative to the drive portion to switch between the insertion configuration and the tissue engagement configuration.

11. The tissue anchor according to any one of claims 1 to 2, wherein the tissue engagement portion is positioned within the drive portion and includes an anchor segment that is movable relative to the drive portion from a storage position within the drive portion when the tissue engagement portion is in the insertion configuration to an extension position extending outward from the drive portion when the tissue engagement portion is in the tissue engagement configuration.

12. An implantable device comprising: Frame components; as well as At least one anchor connected to the frame member, the anchor having a proximal end and a distal end, the distal end being configured to be inserted into body tissue; The anchoring components include: The anchor head located at the proximal end of the anchor; An anchor shaft extending distally from the head of the anchor to the distal end of the anchor; The anchor shaft includes a tissue engagement portion and a drive portion; and The tissue joining portion is capable of switching between an insertion configuration that facilitates the insertion of the anchor into the tissue and a tissue joining configuration that enhances the engagement of the anchor within the tissue in which the anchor has been inserted; The proximal end of the driving portion engages with the proximal end of the tissue engagement portion to suppress relative rotational movement between the driving portion and the tissue engagement portion when the tissue engagement portion is in the insertion mode, and the proximal end of the driving portion and the proximal end of the tissue engagement portion can move out of engagement to allow relative rotational movement between the driving portion and the tissue engagement portion to convert the tissue engagement portion into the tissue engagement mode.

13. The implantable device of claim 12, wherein the implantable device further comprises an anchor cap configured to engage the anchor head to facilitate relative movement between the tissue engagement portion and the drive portion.

14. The implantable device according to any one of claims 12 to 13, wherein the anchor cap is configured to axially retain the tissue engagement portion relative to the drive portion to allow the drive portion to be axially moved out of engagement with the tissue engagement portion when the anchor is in the insertion configuration, thereby allowing the tissue engagement portion to move relative to the drive portion into the tissue engagement configuration.

15. The implantable device according to any one of claims 12 to 13, wherein the anchor cap is configured to engage the proximal end of the tissue engagement portion to suppress rotation of the proximal end of the tissue engagement portion relative to the proximal end of the drive portion, while relative rotation between the drive portion and the tissue engagement portion allows axial movement of the distal end of the tissue engagement portion to convert the tissue engagement portion into the tissue engagement configuration.

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