Tissue penetration system and anchors used therewith

Abstract

The present disclosure provides novel ways to deliver tensioning elements, such as tethers and deployable anchors, to a desired location within a patient's anatomy. More specifically, the present disclosure provides a system and method for delivering a deployable anchor to a desired location within an anatomy and tethering the anchor through tissue. The deployable anchor may include an anchor having an elongated configuration before deployment and a planar configuration after deployment.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This disclosure claims priority to U.S. Provisional Patent Application No. 62 / 884,545, filed on August 8, 2019, and U.S. Provisional Patent Application No. 62 / 949,255, filed on December 17, 2019. Each of the foregoing patent applications is hereby incorporated by reference in its entirety for all purposes. Technical Field

[0003] The present disclosure relates to novel and advantageous systems and methods for remodeling or mobilizing an organ or luminal structure. More particularly, the present disclosure relates to novel deployable anchors and methods for deploying these anchors and tethering them through tissue to remodel or mobilize an organ or luminal structure. Background Art

[0004] The background description provided herein is intended to generally present the context of the present disclosure. No admission is made or implied that the work of the presently named inventors, to the extent described in this background section, is prior art with respect to the present disclosure, nor are the descriptions of any aspects that may not qualify as prior art at the time of filing.

[0005] In various situations, it is necessary to penetrate tissue within the body. For example, in the treatment of a structural condition in which an organ or luminal structure, or a portion of an organ or luminal structure, requires remodeling or movement, it may be necessary to penetrate the tissue of that organ or structure. For example, in some cases, it may be necessary to remodel cardiac structure.

[0006] Therefore, there is a need in the art for systems and methods for traversing tissue. More specifically, there is a need in the art for systems and methods for anchoring a tensioning element, such as a tether, through tissue. Summary of the Invention

[0007] The following presents a simplified summary of one or more embodiments of the present disclosure in order to provide a basic understanding of these embodiments. This summary is not an extensive overview of all contemplated embodiments and is neither intended to identify key or critical elements of all embodiments nor to delineate the scope of any or all embodiments.

[0008] The present disclosure provides novel ways to deliver tensioning elements, such as tethers and deployable anchors, to a desired location within a patient's anatomy. More specifically, the present disclosure provides a system and method for delivering deployable anchors to a desired location within an anatomy and tethering the anchors through tissue. The deployable anchor may include an anchor having an elongated configuration before deployment and a planar configuration after deployment.

[0009] Although the present disclosure relates to the delivery of such anchors and tethers in structural cardiac applications, the disclosed embodiments can be used in other applications, such as compression of the prostate or movement of luminal structures. The disclosed embodiments can be used in any organ or luminal structure that requires reshaping, or where a portion of an organ or luminal structure needs to be temporarily or permanently moved. Therefore, the disclosed embodiments are illustrative only.

[0010] In one embodiment, a tissue-penetrating system is disclosed, comprising a wire delivery catheter, a first wire, an anchor delivery catheter, a first anchor, and a first tether. The first wire can be configured to be delivered through the wire delivery catheter. The first anchor can be configured for placement adjacent to tissue and can include an expandable frame. The expandable frame can be configured to expand from an elongated configuration prior to deployment in the anchor delivery catheter to a planar configuration upon ejection from the anchor delivery catheter. The first tether can be configured to be secured to the first anchor.

[0011] In another embodiment, an anchor for deployment at a location within a patient's body is disclosed. The anchor may include an expandable frame, a tether lumen, and a covering. The expandable frame may be configured to expand from an elongated configuration to a planar configuration having a surface area. In the elongated configuration, the expandable frame may be loaded into a catheter. In the planar configuration, the expandable frame may be configured to distribute forces across the surface area. The covering may be disposed over at least a portion of the expandable frame on a tissue-adjacent surface.

[0012] In yet another embodiment, a multi-anchor system for passing through tissue is provided. The multi-anchor system may include a first anchor, a first tether, a second anchor, and a locking element. The first anchor may be configured for placement adjacent to tissue and may include an expandable frame configured to expand from an elongated configuration prior to deployment of an anchor delivery catheter to a planar configuration upon placement adjacent to tissue. The first tether may be configured for attachment to the first anchor. The second anchor may be configured for placement adjacent to tissue and may include an expandable frame configured to expand from an elongated configuration prior to deployment of an anchor delivery catheter to a planar configuration upon placement adjacent to tissue.

[0013] In another embodiment, a method for delivering and deploying a tensionable element and anchor is provided. The method includes passing a first passing wire through tissue, capturing the first passing wire, and replacing the first passing wire with a tensionable element. A first anchor attached to the tensionable element is delivered, wherein the first anchor extends from an elongated configuration to a planar configuration during delivery. The method also includes passing a second passing wire through tissue, capturing the second passing wire, and replacing the second passing wire with the tensionable element. A second anchor attached to the tensionable element is delivered, wherein the second anchor extends from an elongated configuration to a planar configuration during delivery.

[0014] In another embodiment, an elongated catheter having a proximal end and a distal end is provided. The elongated catheter may include an elongated tubular body and an anchor. The elongated tubular body may have a proximal end, a distal end, and at least one elongated passageway therethrough, the elongated tubular body defining a longitudinal axis along the length of the catheter. The anchor may be configured to be guided through the elongated passageway, the anchor including an expandable frame configured to expand from a flat, elongated configuration to a planar configuration, the anchor being coupled to a tensionable tether.

[0015] Although a number of embodiments are disclosed, other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes exemplary embodiments of the present invention. As will be appreciated, the various embodiments of the present disclosure are capable of modification in various obvious respects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter that is regarded as forming the various embodiments of the disclosure, it is believed the invention will be better understood from the following description taken in conjunction with the accompanying drawings, in which:

[0017] Figure 1a An anchor having a tether extending therefrom is shown according to one embodiment;

[0018] Figure 1b An anchor secured at the proximal end for controlled deployment is shown according to one embodiment;

[0019] Figure 1c An anchor secured at the proximal end for controlled deployment is shown according to one embodiment;

[0020] Figure 1d shows an anchor in a deployed and expanded configuration according to one embodiment;

[0021] Figure 1e shows an anchor in a deployed and expanded configuration according to one embodiment;

[0022] Figure 1f Depicts the expanded structure Figure 1a The anchor frame;

[0023] Figure 1g A framework depicting variations of anchors according to the present disclosure is provided;

[0024] Figure 2a A block diagram illustrating a method for delivering a first anchor according to one embodiment is shown;

[0025] Figure 2bA block diagram illustrating a method for delivering a second anchor according to one embodiment is shown;

[0026] Figure 3 A tissue passing system having a capture basket that captures a passing wire is shown according to one embodiment;

[0027] Figure 4 shows a tissue crossing system according to one embodiment, wherein the passing wire is replaced by a tether;

[0028] Figure 5 A tissue crossing system is shown according to one embodiment wherein a first anchor is delivered to a septal wall;

[0029] Figure 6 A tissue penetration system is shown illustrating achieving regional access and deploying a second penetration wire;

[0030] Figure 7 shows a tissue crossing system according to one embodiment, wherein the crossing wire is replaced with a tether;

[0031] Figure 8 A tissue crossing system with a deployed and locked secondary anchor is shown according to one embodiment;

[0032] Figure 9 shows a block diagram method for delivering a second anchor according to another embodiment;

[0033] Figure 10 A tissue passing system having a capture basket that captures a passing wire is shown according to one embodiment;

[0034] Figure 11 shows a tissue crossing system during introduction of a second anchor according to one embodiment;

[0035] Figure 12 shows a tissue passing system after a delivery lock according to one embodiment;

[0036] Figure 13 shows a deployed tissue crossing system according to one embodiment;

[0037] Figure 14a An anchor and lock are shown according to one embodiment, wherein the anchor is in a substantially planar deployed position and a side of the anchor is shown positioned away from tissue when deployed;

[0038] Figure 14b An anchor and lock are shown according to one embodiment, wherein the anchor is in a substantially planar deployed position and a side of the anchor is shown positioned toward tissue when deployed;

[0039] Figure 15aAn anchor with a tether redirection feature is shown according to one embodiment;

[0040] Figure 15b According to one embodiment, Figure 15a The anchor and further shows a tether lock;

[0041] Figure 16a An anchor with a tether redirection feature according to another embodiment is shown;

[0042] Figure 16b According to one embodiment, Figure 16a an anchor wherein the tether redirection feature is in a pivoted position;

[0043] Figure 17a An anchor having a frame with a honeycomb support pattern is shown according to one embodiment;

[0044] Figure 17b According to one embodiment, Figure 17a An anchor having a material covering the frame;

[0045] Figure 18a A wire delivery catheter according to one embodiment is shown;

[0046] Figure 18b A wire delivery catheter according to one embodiment is shown;

[0047] Figure 19 shows a wire extending from a wire delivery catheter to a snare according to one embodiment;

[0048] Figure 20a A wire delivery catheter, a wire, and a protective element are shown according to one embodiment;

[0049] Figure 20b shows a protection element according to one embodiment;

[0050] Figure 20c shows a protection element according to another embodiment;

[0051] Figure 20d shows a protection element according to yet another embodiment;

[0052] Figure 21a An anchor delivery catheter, wire, tether, and protective element are shown according to one embodiment;

[0053] Figure 21b shows an attachment mechanism according to another embodiment;

[0054] Figure 22 shows deployment of a retractable anchor and tether according to one embodiment;

[0055] Figure 23 illustrates aspects of a tissue crossing system having a deployment anchor according to one embodiment;

[0056] Figure 24 illustrates aspects of a tissue crossing system having a deployment anchor according to one embodiment;

[0057] Figure 25 shows a tissue crossing system with deployed first and second anchors according to one embodiment;

[0058] Figure 26a shows an anchor in a planar configuration according to another embodiment;

[0059] Figure 26b Shown Figure 26a The anchor's view;

[0060] Figure 26c Shown Figure 26a The anchor is in a slender configuration;

[0061] Figure 27a shows an anchor in a planar configuration according to another embodiment;

[0062] Figure 27b Shown Figure 27a The anchor is in a partially collapsed position; and

[0063] Figure 27c Shown Figure 27a The anchor is in an elongated configuration. DETAILED DESCRIPTION

[0064] The present disclosure provides novel ways of delivering tensioning elements such as tethers and deployable anchors to desired locations within a patient's anatomy, such as discussed with reference to Figures 1-13. More specifically, the present disclosure provides a system and method for delivering a deployable anchor to a desired location within an anatomy and tethering the anchor through tissue. The deployable anchor, illustrative embodiments of which are described with reference to Figures 14-27, may include an anchor having an elongated configuration prior to deployment and a planar configuration after deployment. In the planar configuration after deployment, the anchor is used to distribute forces over a surface area of the tissue. In particular, the novel anchors disclosed herein are configured to be delivered with a low-profile catheter and to expand to a particularly large comparative area, resulting in stress distribution over a larger area of tissue than many anchors known in the art.

[0065] Although the present disclosure relates to the delivery of such anchors and tethers in structural cardiac applications, the disclosed embodiments can be used in other applications, such as compression of the prostate or movement of luminal structures. The disclosed embodiments can be used in any organ or luminal structure that requires reshaping, or where a portion of an organ or luminal structure needs to be temporarily or permanently moved. Therefore, the disclosed embodiments are illustrative only.

[0066] In various embodiments, the tissue crossing system can include a wire delivery catheter, a first wire for delivery through the wire delivery catheter, an anchor delivery catheter, a first anchor for placement adjacent to tissue, and a second anchor for placement adjacent to tissue at a location generally opposite to where the first anchor is placed. A first tether can be provided for securing the first anchor, and a locking element can be provided for securing the first tether to the second tether. Although the term "tether" is used herein, it should be understood that in all cases, "tether" refers to a tensionable element and does not require a specific construction unless specifically discussed. The anchor can have an expandable frame that is configured to expand from a pre-deployment elongated configuration to a planar configuration when deployed. These and other components are shown and described below.

[0067] Figure 1a-Figure 1e An anchor 1 is shown that can be used with the system shown and described herein. Figure 1a-Figure 1e One particular embodiment of an anchor is shown, but it will be appreciated that other anchor configurations configured to have a pre-deployment elongated configuration and a deployed substantially planar configuration may be used. Figure 1e The anchor is shown deployed in a controlled manner with proximal attachment from the catheter to the anchor.

[0068] Figure 1a An anchor 1 is shown having a tensionable element or tether 3 extending therefrom. The tether 3 may be connected to a second anchor or another structure. The anchor 1 is positioned within an anchor delivery catheter 5 or sheath. Figure 1a , the anchor is in the elongated configuration before deployment.

[0069] Figure 1b and Figure 1c Anchor 1 is shown with its proximal end retained in an anchor delivery catheter for controlled deployment. Anchor 1 can have a frame 2 that can be compressed or folded to achieve a pre-deployment elongated configuration and expanded, either on its own or manually, to achieve a deployed, substantially planar configuration. Frame 2 can support material 4, such as a fabric covering, on at least one side. In some embodiments, the material can be biodegradable or resorbable.

[0070] The anchor frame or frame 2 is preferably made of a multi-block shape memory material, such as a NiTi alloy. However, it will be appreciated that shape memory polymers may be used, such as linear block copolymers, such as certain polyurethanes, block copolymers of polyethylene terephthalate (PET) and polyethylene oxide (PEO), block copolymers containing polystyrene and poly(1,4-butadiene), and ABA triblock copolymers, such as those made of poly(2-methyl-2-oxazoline) and polytetrahydrofuran.

[0071] The framework of the illustrative embodiment of FIG. 1 is Figure 1f The frame of this embodiment is made of flat bars A of NiTi alloy, which are connected at various points by crimping. The frame is heat treated to Figure 1f The shape shown. As shown, there are actually six (6) longitudinal straps A, of which the outer strap A1 forming the outer perimeter has first and second ends which are housed in tubular couplings E at either end of the structure. Each pair of tubular couplings E is connected at a hinge point or hinge pin B. This allows the couplings to fold and collapse inwardly when the frame is compressed laterally or transversely, causing them to expand slightly in the longitudinal direction. The couplings E also house the opposite ends of a pair of inner straps A2, which are clamped together in the center of the frame at approximately the midpoint of the straps A2, and as shown Figure 1f As shown, the frame is constructed in an "X" configuration, running diagonally outward from the center, with the opposite ends of the inner strap A2 housed within the coupling E along with the opposite ends of the outer strap A1. There is also a pair of intermediate straps A3. Each intermediate strap A3 is connected to the approximate midpoint of each corresponding outer strap A1 at its approximate midpoint via a clamp or crimp C. Each end or end region of each intermediate strap A3 is, in turn, clamped to the inner strap A2 near each coupling E in the end region. Specifically, the inward-facing surface of the outer strap A1 faces the outward-facing surface of the intermediate strap A3, and they are clamped together at their respective midpoints. The inward-facing surface or face of each intermediate strap is clamped to the outward-facing surface of the inner strap A2, and the inward-facing surfaces of the straps A2 face each other and are clamped together at the center of the frame. If desired, a tubular member or eyelet D can be provided in the center of the frame for passing a tether or suture therethrough. The tubular member D can be fixed in position, for example, relative to the inner strap A2, or can be pivoted to face any desired direction. Figure 1f The tube or sleeve D in the frame is configured to allow the tether to pass therethrough radially outward from the central region of the frame and parallel to the longitudinal axis of the frame. As will be understood by those skilled in the art, Figure 1f The frame is heat treated to render it Figure 1f The expanded configuration depicted in FIG, but the NiTi material can be compressed along its width to produce a collapsed stack of ribbons A1, A2, A3 by pulling a tether ( Figure 1fA push rod (not shown) may be releasably connected to one end of the frame, or to the tubular member D, as desired, to allow the frame to be pushed out of the delivery catheter for deployment. It will be appreciated that the fabric will typically be sewn to the Figure 1f On the framework, such as Figures 1a-1e shown. Figure 1g Depicts Figure 1f Variants of the framework. Similar components are annotated with similar reference numbers. Figure 1g The operation and structure of the framework are Figure 1f are essentially the same, although the overall shape of the anchor box is rounder and slightly less elliptical. However, Figure 1g The coupling D of can actually be pivoted, and is rotatably mounted on the pin. This frame will be described in more detail below with respect to Figures 16 and 17.

[0072] As needed, the tether 3 can include a suture, such as a braided suture, which can include a radiopaque material along its length. If desired, the suture material can be doped with a radiopaque powder material in powder form. As a further example, the tether can be made of a coreless circular braid of ultra-high molecular weight polyethylene ("UHMWPE") from DSM, Dyneema, or Telefilex. In some embodiments, the tether can be loaded with at least 20% bismuth by weight to enhance radiopaqueness. For example, the tether can be loaded with about 20 to about 70% bismuth or barium sulfate, or loaded to any extent between them in increments of about 1% by weight. Additional or alternative radiopaque materials can be incorporated into other parts of the tether or anchor or in the delivery device or other instruments described herein, such as tungsten, tantalum, and barium sulfate. For example, these materials can be incorporated as drawn metal (e.g., platinum or other radiopaque materials) wires incorporated into the braid, such as by braiding, or by guiding the drawn wires along a central channel defined within the tether. While a braided material is shown for the tensioning tether, it will be appreciated that any other suitable material may be used.

[0073] Continue to refer Figure 1a-Figure 1e , the tether 3 can be threaded through the delivered anchor. The threading can be done through the connection point 8, which can usually be the center of the frame 2. Figure 1b The anchor 1 is shown in a transition configuration, while Figure 1c Anchor 1 is shown in a substantially planar configuration. In the planar configuration, the anchor serves to distribute force over a surface area. As described more fully below with respect to methods of anchor placement, a tether may be delivered to the exterior of the anchor delivery catheter to aid in locking when connected to the delivery catheter.

[0074] Figure 1d and Figure 1eThe anchor 1 is shown fully released from the delivery catheter 5 and in an expanded configuration. In some embodiments, the anchor 1 may have a coupler to maintain position when the lock is deployed. Additionally, the anchor 1 may be rotated about the insertion site using the proximal coupler 6. A lock 9 may be transmitted along the tether 3 to lock the tension in the tether 3. Figure 1e In the embodiment shown, the lock is transported along the tether 3 to the connection point 8. In alternative embodiments, the lock may be positioned at other points along the tether.

[0075] Deployable anchors expand from an elongated pre-deployment configuration to a flat deployed configuration and can be used in a variety of procedures. Typically, they can be used to distribute force over a surface area of tissue. Furthermore, such anchors, when used with a tensionable element or a tether extending therebetween, can be used in any tissue penetration procedure. For illustrative purposes, a method for penetrating cardiac tissue is described.

[0076] Thus, the tissue-penetrating system and the anchor used therewith can be used, for example, in cardiac surgery for reshaping the heart. One method of using the system is to Figure 2a-2b and Figure 3-Figure 8 Minimally invasive / hybrid approach shown and described.

[0077] Figure 2a and 2b is a block diagram of a method for passing suture through tissue and attaching anchors according to a minimally invasive / hybrid approach embodiment. Figure 2a A method 100 for delivering a first anchor is illustrated. Figure 2b A method 200 for delivering a second anchor is shown. It should be understood that Figure 2a and 2b The method shown in is specifically described with respect to passage through cardiac tissue, but can be used in any situation where passage through tissue is desired. Tissue passage can include delivery of a first anchor and a second anchor tethered by a radiopaque tether that passes through the tissue.

[0078] about Figure 2a Delivery of a first or left anchor is shown and described. A sheath and / or guide is deployed 103 to receive a first passing wire for deployment within the body. For example, the sheath and / or guide can be deployed through a femoral artery or vein. Tissue is passed through the first passing wire 105. In cardiac embodiments, this step 105 can include passing the passing wire through cardiac tissue at the basilar anterior septum. The passing wire can be deployed by an introducer or catheter deployed at 103. The passing wire 110 can then be captured using a capture mechanism such as a capture basket or snare as described in U.S. Patent No. 10,433,962. The capture basket can be deployed by a guide 12 extending from the femoral vein. Figure 3 (described more fully below) describes the system at about this point in the method.

[0079] Return to Figure 2a After capturing the first passing wire, the first passing wire is externalized (externalized) 115. Optionally, a soft-tip catheter can be used to protect tissue at the point of passage. One or more guides or sheaths can be removed 120. In some embodiments, removal of the guide or sheath can include removing the guide from the femoral artery.

[0080] Next, the first passing wire is replaced with a tensionable element or tether 125. In some embodiments, the tether can be radiopaque. Figure 4 (described more fully below) illustrates the system at this stage. After replacing the passing wire with a tether, the tether can be externalized 130. In some embodiments, the tether can be externalized outside the femoral vein.

[0081] A first anchor delivery catheter is introduced 135. In cardiac embodiments, this may include introducing a first or left delivery catheter through the femoral artery or other lumen. The first anchor may then be delivered to the desired location via the anchor delivery catheter 140. While in the anchor delivery catheter, the anchor is in a pre-deployment, laterally collapsed, elongated configuration. Upon delivery, the anchor is expanded to a post-deployment, planar configuration. This may occur automatically upon discharge from the catheter or may be accomplished manually. Figure 5 In the embodiment shown (described more fully below), the left anchor is delivered to the septal wall.At this point, delivery of the first or left anchor is complete, and the first anchor delivery catheter 145 can be removed.

[0082] Reference Figure 2b One embodiment of the delivery of the second or right anchor 200 is shown and described. In this embodiment, the delivery of the second anchor may be performed after the delivery of the first anchor.

[0083] Regional access 205 is achieved for delivery of the second anchor. This can be accomplished by insufflating the area and performing a mini-thoracotomy. For example, carbon dioxide can be insufflated through the right atrial appendage and a mini-thoracotomy can be performed to gain access to the subxiphoid shaft and subxiphoid sheath.

[0084] At step 210 the wire delivery catheter is deployed. The wire delivery catheter 210 can be deployed through the femoral vein and the inferior vena cava (IVC). The wire delivery catheter can be an articulated catheter and can be positioned in the right ventricle facing the free wall. A passing wire is deployed through the wire delivery catheter 215. The passing wire can be, for example, a charged passing wire. The passing wire is captured 220. A capture snare can be used to capture the charged passing wire. In some embodiments, the capture snare can be deployed through the subxiphoid sheath. The position of the system at this point is as shown in FIG. Figure 6 shown.

[0085] The passing wire is replaced with a radiopaque tether 225. This can be accomplished through the free wall. In some embodiments, the radiopaque tether and the free end of the passing wire are coupled, for example, by a crimp, before replacement. Figure 7 (described more fully below) illustrates the passing wire being replaced with a radiopaque tether.

[0086] A second anchor delivery catheter 230 is introduced. The second anchor delivery catheter can be introduced through a subxiphoid sheath and articulated toward the free wall or right ventricle. The second anchor is delivered 235. While in the anchor delivery catheter, the anchor is in a pre-deployment elongated configuration. Upon delivery, the anchor is expanded to a post-deployment planar configuration. This can occur automatically upon expulsion from the catheter or can be done manually. In cardiac embodiments, the second anchor can be a right anchor and can be delivered on the free wall. During and after delivery, tension can be maintained on the radiopaque tether. A lock can be delivered to the second anchor 240. The locking mechanism of the lock is actuated 245 to secure the tension of the radiopaque tether. This actuation 245 can occur when the tension applied to the tether is satisfactory. Excess tether 250 is severed. Figure 8 The system at this point in the method is described more fully in

[0014] Suitable examples of locks, lock delivery catheters, and suture cutting catheters can be found in US Pat. No. 10,433,962.

[0087] It will be appreciated that the wire delivery catheter, passing wire, guide, and subxiphoid sheath are suitably removed during and / or after the procedure, leaving only the first anchor, tether, second anchor, and lock in place.

[0088] Now turn Figure 3-8 The description of the system shown in Figure 2a and Figure 2b As described in the foregoing, the passage of cardiac tissue can be accomplished at the anterior septum of the basal part. The tissue passage system and anchor achieve this passage while avoiding interference of the anchor with the aortic valve. FIG1 illustrates an early stage of deployment of the tissue passage system. As shown, guides 10, 12 are deployed to the heart through the femoral artery and vein, respectively. The exact construction of the guides may vary. In one embodiment, the guides may be 14F guides deployed through a 16F sheath. The wire delivery catheter is deployed through a first guide 10 extending from the femoral artery. The capture basket 16 is deployed through a second guide 12 extending from the femoral vein. A first passing wire 18 is deployed through the wire delivery catheter 14. The capture basket 16 can be used to encircle the first passing wire 18. In some embodiments, the passing wires can be electrically charged.

[0089] like Figure 4As shown, replacing the passing wire 18 with the tether 20 may include inserting a protective catheter 22 through the guide 12 into the femoral vein. A connector 24, such as a crimp connector, is advanced through the protective catheter 22. In one embodiment, the connector 24 is crimped onto the passing wire 18 to achieve the connection. The tether 20 and the left anchor (see FIG. 2 ) may then be advanced. Figure 5 ).

[0090] Figure 5 The delivery of the first anchor according to one embodiment is shown. More specifically, Figure 5 Anchor 26 is shown being delivered to the septal wall according to one embodiment. Anchor 26 is referred to herein as the first anchor or the left anchor, but it should be understood that such reference is for illustrative purposes only. An anchor delivery catheter 28, referred to as the left anchor delivery catheter, can be introduced through the femoral artery and, by pulling on a radiopaque tether 20 attached to anchor 26 through a guide 12, the left anchor 26 is deployed therethrough to the septal wall. An anchor retention suture 30 can be used to secure the left anchor 26 in place. Anchor delivery catheter 28 can be removed. The free end of the tether 20, passed through the femoral vein, can be secured to maintain tension on the system.

[0091] Figure 6 The implementation of regional access and deployment of a second pass-through wire according to one embodiment is shown. Figure 2a As described, a mini-thoracotomy can be performed to gain subxiphoid access. Figure 6 A subxiphoid sheath 32 is shown. A snare 34 can be deployed through the subxiphoid sheath 32. The snare 34 can be, for example, a capture basket or gooseneck type snare. Using a wire delivery catheter 36 through the sheath 12, a passing wire 38, which can be referred to as a second passing wire, is advanced through the femoral venous access and the inferior vena cava. The passing wire 38 can be, for example, a 0.014" charged passing wire. The wire delivery catheter 36 can be a positionally articulated catheter. In the embodiment shown, the wire delivery catheter 36 is positioned in the free wall facing the right ventricle. The second passing wire 38 is positioned to traverse the free wall and through the subxiphoid shaft. At this stage, the radiopaque tether 20 still extends from the guide 12 to the anchor 26. The capture snare 34 can be deployed through the subxiphoid sheath 32 to capture the charged passing wire 38. The snare 34 can be, for example, a capture basket or gooseneck type snare.

[0092] Figure 7 The diagram shows the replacement of the live through-wire 38 with the radiopaque tether 20. This can be accomplished through the free wall. In some embodiments, the free end of the radiopaque tether 20 and the through-wire 38 are coupled, for example, by a crimp, prior to replacement. A connector 40 is shown connecting the through-wire 38 and the radiopaque tether 20. A straightening snare 42 or catheter can be used to substantially prevent the radiopaque tether 20 and wire 38 from becoming entangled.

[0093] Figure 8 The system is shown after the second anchor is positioned and locked. First anchor 26 is positioned on the septal wall. Second anchor 50 is located on the free wall. Tether 20, such as a radiopaque tether, extends between first anchor 26 and second anchor 50. Lock 52 locks tether 20 at the desired tension. At this point, guide 12 and subxiphoid sheath 32 can be removed.

[0094] Another approach using this system uses a completely percutaneous approach to deliver the correct anchor. Figures 9-13 This method is shown and described. It will be understood that this method is particularly focused on the delivery of the right anchor in cardiac embodiments. Figure 2a and Figure 3-Figure 5 The method shown and described can be used to start with Figures 9-13 The method shown and described previously delivers the left anchor.

[0095] Figure 9 is a block diagram of a method for delivering a suture and connecting anchor through tissue using a fully percutaneous approach in a cardiac embodiment to deliver a right anchor. Tissue penetration may include delivery of a first anchor and a second anchor tethered by a radiopaque tether passing through the tissue.

[0096] The delivery of the first or left anchor is relative to Figure 2a-Figure 5 Therefore, when the system is usually in Figure 5 When the structure shown is in place, you can start Figure 9 More specifically, the method may begin when the left anchor 26 is in place at the septal wall.

[0097] Access to the area for delivery of the second anchor is achieved 305. This can be done by insufflating the area and is typically only used with the native pericardium. The guide is then deployed 310 and the wire delivery catheter passing therethrough is deployed 315. The passing wire is delivered 320 through the right atrial appendage into the pericardial space using the wire delivery catheter and the jugular vein guide. The passing wire is delivered to its desired position 325. This may include passing the wire delivery catheter and the passing wire through the pericardial space toward the apex. The wire delivery catheter may be articulated toward the right ventricle and the charged passing wire delivered through the free wall into the right ventricle. The passing wire is captured 330. This may include wrapping the passing wire into the wire delivery catheter or guide using a wire capture basket. The passing wire is externalized 335. As described more fully below Figure 10 The system is shown at this stage in the method.

[0098] The passing wire is replaced with a tether 340. This may include crimping the free end of a tether, such as a radiopaque tether, and the passing wire together using a crimp connector. The passing wire may be replaced with a tether through the free wall and outside the femoral venous access sheath.

[0099] A second anchor delivery catheter is introduced 345. This can be accomplished via jugular vein access. The second anchor is delivered 350. This can involve delivering the right atrial appendage into the pericardial space and passing it through the pericardial space until it deploys onto the free wall. Tension can be maintained on the radiopaque tether. Figure 11 (described more fully below) illustrates the system after the introduction of the second or right anchor but before the second anchor is fully deployed.

[0100] Delivering lock 355. In some embodiments, this can include delivering the lock on first and second radiopaque tethers, the first extending from the first anchor and the second extending from the second anchor. Delivery of lock 355 can be accomplished using a lock delivery catheter. Figure 12 The system is shown with the lock deployed. The locking mechanism is actuated 360. In some embodiments, the tether may be pulled to achieve a desired tension before the locking mechanism is actuated. Excess tether is cut 365, for example, using a tether cutter. Figure 13 The fully deployed system is shown.

[0101] Now turn Figure 9 Illustration of the system during the illustrated method. Figure 10 The system is shown in the initial stages of delivery of the right anchor using a fully percutaneous approach. As shown, the left anchor 26 is deployed to the septal wall. The tether 20 extends from the anchor 26 into the catheter 22. The catheter 22 and tether 20 are in turn extended into the guide 12. The guide 12 can be a femoral venous access sheath.

[0102] A guide 60, optionally a 14F guide, also known as a jugular sheath, is deployed in the jugular vein. A wire delivery catheter 62 is inserted through the guide 60 and a through-wire 64 is deployed through the wire delivery catheter 62. In some embodiments, the through-wire 64 can be a 0.014" charged guidewire. The wire delivery catheter 62 and through-wire 64 exit the right atrial appendage and enter the pericardial space. The through-wire passes through the free wall. A wire capture snare 66 and capture basket 68 are delivered through the guide 12. The capture basket 68 captures the through-wire after it passes through the free wall.

[0103] Figure 11 The system is illustrated for the introduction of a second or right anchor. The first or left anchor 26 is positioned at the septal wall, with the first tether 20 extending therefrom. A right anchor delivery catheter 72 extends through the jugular vein sheath 60. The second anchor 70 is delivered through the anchor delivery catheter 72. A tether 74, such as a radiopaque tether, extends from the second anchor 70 to the pass-through wire 64. The tether 74 is passed through the pericardial space. A connector 76, such as a crimp connector, connects the tether 74 to the pass-through wire 64. Thus, the pass-through wire can be passed through the pericardial space and replaced with the tether to deploy the second anchor 70 to the free wall.

[0104] Figure 12 Shown in Figure 9 The system is then delivered in step 355 after the lock is delivered. The first or left anchor 26 is in place at the septal wall, and the first tether 20 extends from it. The second or right anchor 70 is in place on the free wall, and the second tether 74 extends from it. In the embodiment shown, the first tether 20 and the second tether 74 both extend from their respective anchors into the femoral venous access sheath 12. A lock 80 couples the first tether 20 and the second tether 74. The lock 80 is associated with the first tether 20 and the second tether 74. For example, the lock 80 can be slid over the first tether 20 and the second tether 74 and delivered to the desired location. The delivery of the lock 80 can be accomplished using a lock delivery catheter 82. In some embodiments, the lock delivery catheter 82 can extend through the femoral venous access sheath 12.

[0105] Figure 13 The fully deployed system is shown. As shown, the first or left anchor 26 is in place at the septal wall, while the second or right anchor 70 is in place on the free wall. The first tether 20 extends from the first anchor 26 and the second tether 74 extends from the second anchor 70. The first tether 20 and the second tether 74 are tensioned and locked together by a lock 80.

[0106] The components of the system will now be shown and described in more detail. Generally, the anchor can be deployed by an anchor delivery catheter. The anchor delivery catheter can be an elongated catheter having a proximal end and a distal end. The elongated catheter can include an elongated tubular body and an anchor. The elongated tubular body can have a proximal end, a distal end, and at least one elongated passageway therethrough, the elongated tubular body defining a longitudinal axis along the length of the catheter. The anchor can be configured to be guided through the elongated passageway. The anchor can include an deployable frame configured to expand from a flat, elongated configuration to a planar configuration, the anchor being connected to a tensionable tether. In the planar configuration, the deployable frame is used to distribute force over a surface area.

[0107] As referenced above Figure 1f and 1g Discussed in detail, Figure 14a and 14b Anchor 400 and lock 402 are shown with anchor 400 in a substantially planar, deployed configuration. Figure 14a A side of the anchor 400 is shown that may be positioned away from tissue when deployed. Figure 14b The side of the anchor 400 is shown, which can be positioned toward the tissue during deployment. In this embodiment, the anchor 400 can be delivered with an attached lock 402, rather than separately. In some embodiments, the lock 402 can be referred to as a tether lock. The anchor 400 has a webbing or frame 404, which, as described in detail above, can be compressed or folded to achieve a pre-deployment elongated configuration and can be expanded by itself or manually to achieve a substantially planar deployed configuration. The webbing or frame 404 can support a material 406, such as a fabric covering.

[0108] A tether 408 is coupled to the anchor 400. The tether 408 can be threaded through the anchor 400 via a connection point or sleeve 410. A tether lumen extension 412, also referred to as a tether lumen, can take the form of a sleeve with the tether 408 disposed on the tether 408 extending between the lock 402 and the connection point 410. The tether lumen extension 412 can be flexible and can be rotated about the connection point 410, or more generally about the center of the anchor 400, to help position and orient the anchor and generally facilitate delivery of the anchor. A snare 414 is disposed near the lock 402 and can be used to pull the tether 408 through the anchor 400 and lock 402 assembly.

[0109] As described above, anchor 400 can be delivered to the target site via a catheter configured to tighten tether 408 and activate lock 402 to maintain tension. Frame 404 is collapsible, as in Figure 1f and 1g The anchor 400 is configured to allow for loading of the anchor 400 into a catheter in a collapsed, elongated configuration for delivery. The frame is relatively rigid in the direction of the tether 408 or in the direction of tension when deployed. The material 406 or fabric covering can help cushion loads or tissue and provide permanent fixation. However, it should be understood that in some embodiments, no material or fabric covering may be used.

[0110] Figure 15a 、 15b , 16a, 16b, 17a and 17b illustrate further anchor variations and / or features. Typically, the anchor comprises an expandable frame that is configured to expand from an elongated configuration within the anchor delivery catheter prior to deployment to a planar configuration upon ejection from the anchor delivery catheter. The anchor can be self-expanding, using a shape memory material such as Nitinol. Alternatively, the anchor can be manually expanded using a push or pull mechanism that allows the user to control the shape and size.

[0111] The pattern of the frame structure may vary depending on the needs of the application. In some embodiments, the frame is laser cut, allowing for any of a variety of support patterns. The beams of the frame can be designed to bend easily in one direction to allow loading into a catheter, but may be more rigid in other directions, such as in the direction of the load or tether. In some embodiments, these directions can be perpendicular to each other. Alternatively, the directions can be provided at some other angle relative to each other.

[0112] Figure 15a and 15b refer to Figure 1fElement D of FIG. 5 shows an anchor 500 having a tether redirection feature 502 or guide. In the embodiment shown, the tether redirection feature or guide 502 is generally positioned in the center of the frame 503 of the anchor 500. The tether redirection feature can enhance tether movement within the system to facilitate smooth tightening and adjustment. This can be useful when normal access to the delivery site is limited. In the embodiment shown, the tether redirection feature can also facilitate tensioning at indirect angles, such as 90 degrees. Figure 15b A tether lock 506 is shown which may be attached, for example, at the tether redirecting feature 502, before or after delivery of the anchor. Thus, the tether lock 506 may be delivered in a separate step from anchor delivery, or may be combined with the anchor prior to anchor delivery.

[0113] Figure 16a and 16b An anchor 520 is shown with a tether redirection feature 522. In the illustrated embodiment, the tether redirection feature or guide 522 is generally disposed in the center of the frame 523 of the anchor 520. The tether redirection guide can enhance tether movement to facilitate smooth tightening and adjustment within the system. This can be useful when normal access to the delivery site is limited. In the illustrated embodiment, the tether redirection guide is a tilt / pivot tether guide that facilitates universal orientation. Figure 16b Tether orientation feature 522 is shown in a pivoted position.

[0114] Figure 17a and 17b An anchor 540 according to another embodiment is shown. As shown, the anchor 540 may include a frame having a honeycomb support pattern (see above with reference to FIG. Figure 1g 542. This pattern can be varied to provide more support or flexibility as needed in various applications. Anchor 540 also includes a tether lumen extension 544 extending from a generally central location on frame 542 to a tether lock 546. The tether lumen extension can be flexible. Figure 17b A material covering 548 is shown on the frame 542. The material covering 548 can be a fabric covering, a polymer structure, or other material that provides cushioning, fixation, visibility, ingrowth control, attachment control, or other desired features. In some embodiments, the material covering 548 can include a biodegradable / resorbable material. In some embodiments, no material covering can be provided on the frame 542.

[0115] Figure 18a 、 18b and 19 show aspects for wire threading equipment. Figure 18a and 18bWire delivery catheter 560 is shown. Wire delivery catheter 560 can include a distal catheter 562 and a proximal catheter 564. Distal catheter 562 can be an inner catheter and can be configured to deflect, rotate, advance, or retract. Proximal catheter 564 can be an outer catheter and can be configured to deflect, rotate, advance, or retract. Although referred to as a single, integral wire delivery catheter 560, catheter 560 can therefore be a combination of deflectable, torsionally movable, independent catheters that can be used to achieve the desired vector of the wire. The vector can be related to the deployed position of an anchor, for example, a first anchor.

[0116] Figure 19 Wire 566 is shown extending from wire delivery catheter 560 through tissue 567 and to snare 568. As the wire is advanced through tissue 567 and captured by, for example, snare 568 on the opposite side of tissue 567, a suitable snare 568 may be provided. Figure 19 As shown, other snare mechanisms may also be used. In some embodiments, RF or other energy sources may be used to assist in threading the wire. Figure 19 Wire 566 is shown captured by snare 568.

[0117] In some embodiments, it may be useful to provide a protective element to protect the tissue passage site from advancing wires and sutures. Figure 20a 、 20b , 20c and 20d show embodiments of such protection elements. Figure 20a Wire 566 is shown advanced from catheter 560 to tissue passing site 567. Protective element 570 is disposed proximal to tissue passing site 567. Wire 566 extends through protective element 570 and tissue passing site 567 to exit out the other side.

[0118] Figure 20b 、 Figure 20c and Figure 20d Various embodiments of suitable protective elements 570 are shown, such as sleeves or grommets. The tissue protection device can be placed around the wire and can be advanced before or after the wire is advanced through the tissue. The protection device helps protect the tissue as the wire and the length of tether pass through the tissue and during subsequent movement of the tissue. In one embodiment, the protective element is a floppy disk. In other embodiments, the protective element can be coiled, threaded, funnel-shaped, T-shaped, and / or can be collapsible. The protective element 570 can help maintain the position of the anchor while the tether is passed through the intended path. The protective element 570 can also help cushion the tissue from the anchor.

[0119] Figure 20b 、 Figure 20c and Figure 20d Each of the Figures shows a protective element 570 comprising a disc 572 and an extension 574. Figure 20b In the embodiment of the present invention, the extension portion 574 can be collapsed from the fully extended position to the collapsed position. Figure 20c In the embodiment of FIG. 5 , the protection element 570 further includes a coil 576 disposed around the extension 574. Figure 20d In the embodiment of the present invention, the extension has a ridge 578 disposed therearound. In some configurations, the ridge 578 can provide threads.

[0120] Figure 21a 、 Figure 21b and Figure 22 Other aspects of the anchor delivery system are shown. Figure 21a As shown, a wire 602 having a proximal end 612 extends through tissue 604 and a protective element 606. An anchor delivery catheter 608 is positioned over the wire 602. A tether 611 extends over the wire 602 and through the tissue 604. A plurality of crimps 610 may be provided along the tether 611. Figure 21b An alternative attachment mechanism is shown in which the tether 611 is tied to a separate crimp 616 to connect the wire 602 to the tether.

[0121] The anchor delivery system facilitates secure attachment of a tether 614 to follow the threading wire 602 through the protective element 606 (optional) and tissue 604. Once the threading wire 602 is captured on the opposite side of the target tissue 604, its proximal end 612 can be connected to the front end of a tether 614 (optionally radiopaque), which is or can be connected to another anchor. In some embodiments, the wire 602 can remain attached to the tether 614 for further tissue crossing. In other embodiments, the wire 602 can be replaced for further tissue crossing.

[0122] Return to Figure 21a The front end of the tether 611 has multiple crimps 610 in series. The distal crimp can be used first and then cut from the wire 602 and tether 611. The remaining crimps can be used to connect the same or new wire to the tether. This can be repeated for each wire that is connected or disconnected. The crimp 610 can include a metal tube that provides holding strength for the wire 602 after the crimp. The crimp 610 can also have a polymer coating to provide a good connection and transition with the adjacent material of the tether 611.

[0123] Figure 21b An alternative attachment mechanism for a tether 611 to a wire 602 is shown. As shown, a separate crimp attachment device 616 has a loop coupler that allows any tether to be tied. This piece can be cut from the wire and tether and a new one attached to the same or a new wire and tether.

[0124] Figure 22Shown is the deployment of retractable anchor 620 and tether 622. Retractable anchor 620 is deployed, and as the tether is pulled through protective element 606 (optional) and tissue 604, any remaining slack can be removed.

[0125] Figure 23 、 Figure 4 and Figure 25 Aspects of a delivery system are shown that delivers a second anchor 720 . Figure 23 A first anchor 700 and a tether 702 from an externalized first pass-through point are shown. Figure 18a 、 Figure 18b 、 Figure 19 and Figure 20a-20d The wire passing system described performs a second wire passing. Wire 704 passes through tissue 706 and is captured on the opposite side of tissue 706 and externalized. For example, a snare 708 can be used to capture the wire.

[0126] Figure 24 Tether 702 is shown attached to wire 704. The wire / tether connection is shown at 710. This connection can be via a Figure 21b If the wires separate while threading, you can make this connection after the wires are threaded through. Figure 24 An optional in-line crimp connector 705 on the tether 702 is further shown. The catheter 712 can be deployed to control the loop or slack as the wire and tether pass through the next layer of tissue. The anchor is deployed in a controlled manner, with the proximal end of the catheter attached to the anchor, such as Figure 1a-Figure 1e Anchors 700 and 720 may be pre-attached to tether 702 or may be attached via a knot or lock. Figure 24 An anchor with a separate lock is shown. Figure 25 An anchor is shown with a lock 722 attached.

[0127] Figure 26a-26c and Figure 27a-Figure 27c Various perspective views of alternative anchor embodiments are shown. Anchor 750 is suitable for placement adjacent tissue. Anchor 750 includes an expandable frame 752 that is configured to expand from an elongated configuration prior to deployment of the anchor delivery catheter to a planar configuration upon ejection from the anchor delivery catheter. Frame 752 includes an outer ring or peripheral frame 754 formed, for example, from a NiTi band component and a central member or central support 756. The components of frame 752 can be formed from a memory shape material such as a NiTi alloy. In one embodiment, outer ring 754 includes opposing rib members 757. In one embodiment, the central member is a central coil spring. The central member 756 can be connected on each side to opposing rib members 757, such as Figure 26bAs shown, at pivot points at either end of the frame, this allows the two outer bands 752, 754 to rotate and slide relative to each other about an axis or hinge pin that defines the longitudinal axis of the device. This achieves the connection and also serves to drive the opposing rib members 757 apart to form the outer ring 754. A tether 758 can be attached to the central member 756. Figure 26c The anchor 750 is shown in a flat, elongated configuration. As shown, in this embodiment, each of the opposing rib members 757 and the central member 756 are of similar or identical lengths.

[0128] Figure 27a-Figure 27c Examples and Figure 26a-26c The embodiment of FIG. 7 differs in the connection of the central member 756 to the opposing rib members 757 . Figure 27a The frame 752 is shown in an expanded planar configuration. Figure 27b Frame 752 is shown in a partially collapsed configuration. Figure 27c The frame 752 is shown in an elongated configuration.

[0129] Thus, systems and methods for delivering tensioning elements, such as tethers and deployable anchors, to a desired location within a patient's anatomy are described. More specifically, a system and method for delivering a deployable anchor to a desired location within an anatomy and tethering the anchor through tissue are disclosed. The deployable anchor may include an anchor having a pre-deployment elongated configuration and a post-deployment planar configuration. In the post-deployment planar configuration, the anchor is configured to distribute force over a surface area of the tissue. Such anchors and tethers may be used in structural cardiac applications, but may also be used in areas where compression, reshaping, or movement of an organ or luminal structure is desired.

[0130] Although the present disclosure relates to delivering such anchors and tethers in structural cardiac applications, the disclosed embodiments can be used in other applications, such as compression of the prostate or movement of luminal structures. The disclosed embodiments can be used in any organ or luminal structure that requires reshaping, or where a portion of an organ or luminal structure needs to be temporarily or permanently moved. Therefore, the disclosed embodiments are illustrative only.

[0131] As used herein, the terms "substantially" or "generally" refer to the complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, an object that is "substantially" or "generally" enclosed means that the object is completely enclosed or nearly completely enclosed. In some cases, the exact degree of deviation from absolute completeness that is permitted may depend on the specific circumstances. However, in general, a degree of near completeness will have approximately the same overall result as if absolute completeness and complete completeness were obtained. The use of "substantially" or "generally" also applies to a negative meaning, referring to the complete or nearly complete absence of an action, characteristic, property, state, structure, item, or result. For example, an element, combination, embodiment, or composition that is "substantially free" or "generally free" of an element may still actually contain the element, as long as it does not generally have a significant effect.

[0132] To assist the Patent Office and any reader of any patent issuing based on this application in interpreting the appended claims, applicants wish to note that they do not intend for any of the appended claims or claim elements to invoke 35 U.S.C. §112(f) unless the term "means" or "step" is expressly used in a particular claim.

[0133] Furthermore, as used herein, the phrase “at least one of [X] and [Y],” where X and Y are different components that may be included in an embodiment of the present disclosure, means that the embodiment may include component X without component Y, the embodiment may include component Y without component X, or the embodiment may include components X and Y. Similarly, when used with respect to three or more components, such as “at least one of [X], [Y], and [Z],” the phrase means that the embodiment may include any one of the three or more components, any component, or any combination or subcombination of all of the components.

[0134] In the foregoing description, various embodiments of the present disclosure have been presented for the purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed. In light of the above teachings, obvious modifications or variations are possible. The various embodiments were chosen and described to provide the best illustration of the principles of the present disclosure and its practical application, and to enable those skilled in the art to utilize the various embodiments and make various modifications to suit the intended particular use. All such modifications and variations are within the scope of the present disclosure when interpreted in accordance with the scope of the appended claims to which they are fairly, legally, and equitably entitled.

Claims

1. An anchor for deployment at a location within a patient's body, the anchor comprising: A frame that is deployable and configured to automatically expand laterally from an elongated configuration in which the frame is constrained to an expanded, substantially planar configuration having a surface area, wherein in the elongated configuration the frame is configured to be loaded into an anchor delivery catheter; the frame comprising a proximal end and a distal end, wherein when the frame is in the elongated configuration the proximal end and the distal end are located at longitudinally opposite ends of the elongated configuration of the frame; a longitudinal axis is defined by the proximal end and the distal end when the frame is in the elongated configuration; the frame comprising bands extending longitudinally and comprising a pair of outer bands, a pair of inner bands and a pair of intermediate bands, wherein the pair of outer bands form the periphery of the frame, the pair of inner bands are connected together at the center of the frame, and each of the pair of intermediate bands is connected at its approximate midpoint to the approximate midpoint of each corresponding outer band in the pair of outer bands, whereby the frame is configured to expand in a lateral direction that is substantially orthogonal to the longitudinal axis, characterized in that the surface area of the frame when expanded is substantially parallel to the longitudinal axis.

2. An anchor according to claim 1, wherein The frame also includes a pair of tubular connectors at either longitudinal end, wherein the longitudinally opposite ends of each of the pair of outer straps are received in the corresponding tubular connectors, and wherein the pair of tubular connectors at each longitudinal end are connected at a hinge point to allow the frame to fold and collapse inward when compressed laterally.

3. The anchor according to claim 1, wherein The frame is made of a shape memory material, and wherein the frame is heat treated to be configured to unfold into an expanded planar configuration when unconstrained.

4. Anchor according to claim 3, wherein: The shape memory material includes NiTi alloy or polymer shape memory material.

5. The anchor of any one of claims 1 to 4, further comprising a covering provided on at least a portion of the frame.

6. Anchor according to claim 5, wherein The covering is a fabric covering.

7. The anchor of claim 1, further comprising a tensionable tether received by a tether lumen defined in the anchor.

8. Anchor according to claim 7, wherein The tether lumen facilitates tether redirection.

9. The anchor of claim 7, further comprising a tether lumen extension coupled to the tether lumen.

10. Anchor according to claim 9, wherein The tether lumen extension includes a snare configured to pull in the tether.

11. The anchor of claim 1 , further comprising a tether lock.

12. Anchor according to claim 11, wherein The center of the frame includes a central support.

13. Anchor according to claim 12, wherein The central support is configured to cause the peripheral frame to expand outwardly into a planar configuration.

14. An anchor delivery catheter having a proximal end and a distal end, comprising: an elongated tubular body having a proximal end, a distal end, and defining at least one elongated passageway therethrough, the elongated tubular body defining a longitudinal axis along its length; and the anchor of any one of claims 1-13, disposed in an elongated channel in an elongated configuration, wherein the anchor is configured to be advanced distally outwardly through a distal opening of the elongated channel.

15. The anchor delivery catheter of claim 14, wherein: The surface area of the expanded framework of the anchor is substantially parallel to the longitudinal axis of the anchor delivery catheter.

16. An anchor delivery catheter according to any one of claims 14-15, wherein: The anchor is coupled to a tensionable tether.

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