Tissue crossing system and anchors for use therewith

Abstract

To deliver tensioning elements, such as tethers, and deployable anchors, to a desired location within the anatomy of a patient.SOLUTION: The present disclosure provides a system and method configured for delivering deployable anchors to a desired location within the anatomy and tethering the anchors together through tissue. The deployable anchors may include anchors that have a pre-deployment elongate configuration and a post-deployment planar configuration.SELECTED DRAWING: Figure 1F

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This disclosure claims priority to U.S. Provisional Patent Application No. 62 / 884,545 (filed August 8, 2019) and U.S. Provisional Patent Application No. 62 / 949,255 (filed December 17, 2019). Each of the above-referenced patent applications is hereby incorporated by reference in its entirety for all purposes.

[0002] Field of the Disclosure

[0002] The present disclosure relates to novel and advantageous systems and methods for shaping or moving organs or luminal structures. More specifically, the present disclosure relates to novel deployable anchors and methods for deploying such anchors and anchoring them across tissue, thereby shaping or relocating organs or luminal structures. [Background technology]

[0003] background

[0003] The background statement provided herein is for purposes of generally presenting the context of the present disclosure. The inventor's work is not admitted, expressly or implicitly, as prior art against the present disclosure to the extent described in this Background section, or in any manner otherwise described that does not qualify as prior art at the time of filing.

[0004]

[0004] In a variety of situations, it is necessary to traverse tissue within the body. For example, in the treatment of a structural condition requiring the reshaping or relocation of an organ or luminal structure (or a portion of the organ or luminal structure), it may be necessary to traverse the tissue of that organ or structure. For example, there are situations in which it is desirable to reshape the structure of the heart. Summary of the Invention [Problem to be solved by the invention]

[0005]

[0005] Therefore, there is a need in the art for a system and method that spans across organizations. More specifically, there is a need in the art for systems and methods for anchoring tensioning elements, such as tethers, across tissue. [Means for solving the problem]

[0006] Summary of the Disclosure The following presents a simplified summary of one or more embodiments of the present disclosure in order to provide a basic understanding of such embodiments. This summary is not an extensive overview of all possible embodiments, is intended to identify key or critical elements of all embodiments, or delineate the scope of any or all embodiments.

[0007]

[0007] The present disclosure provides a novel way to deliver a tensioning element (such as a tether) and a deployable anchor to a desired location within a patient's anatomy. More specifically, the present disclosure provides systems and methods for delivering deployable anchors to a desired location in an anatomical structure and tunneling through tissue to anchor the anchors together. The deployable anchor may include an anchor that has an elongated configuration before deployment and a planar configuration after deployment.

[0008] While the present disclosure is directed to the delivery of such anchors and tethers in structural cardiac applications, the disclosed embodiments may also be used in other applications, such as compressing the prostate or moving luminal structures. The disclosed embodiments may be used in any organ or luminal structure that needs to be reshaped or that needs to have a portion of the organ or luminal structure temporarily or permanently moved. Accordingly, the disclosed embodiments are meant to be illustrative only.

[0009] In one implementation, a tissue crossing system is disclosed that includes a wire delivery catheter, a first wire, an anchor delivery catheter, a first anchor, and a first tether. A first of the wires may be configured to be delivered through the wire delivery catheter. The first anchor may be configured to be placed adjacent to tissue and may include a deployable frame. The deployable frame may be configured such that when ejected from the anchor delivery catheter, it expands from an elongated configuration prior to deployment of the anchor delivery catheter to a planar configuration. A first said tether may be configured to be: secured to a first said anchor.

[0010] In another embodiment, an anchor is disclosed for deployment at a location within a patient's body. The anchor may have a deployable frame, a tether lumen, and a cover. The deployable frame may be configured to expand from an elongated configuration to a planar configuration having a surface area. In the elongated configuration, the deployable frame may be loaded into a catheter. In the planar configuration, the deployable frame acts to: distribute forces over a range of surfaces. The cover may be disposed over at least a portion of the deployable frame above a tissue-adjacent surface.

[0011] In yet another embodiment, a multiple anchor system for crossing tissue is provided. The multiple anchor system may include a first anchor, a first tether, a second anchor, and a locking element. The first anchor may be configured to be placed adjacent to tissue and may include a deployable frame that is configured to expand from an elongated configuration prior to deployment of the anchor delivery catheter to a planar configuration when placed adjacent to tissue. A first said tether may be configured to be: secured to a first said anchor. The second anchor may be configured to be placed adjacent to tissue and may include a deployable frame that is configured to expand from an elongated configuration prior to deployment of the anchor delivery catheter to a planar configuration when placed adjacent to tissue.

[0012] In a further embodiment, a method for delivering and deploying tensionable elements and anchors is provided. The method includes: crossing tissue with a first crossing wire; capturing the first crossing wire; and replacing the first crossing wire with a tensionable element. A first anchor is attached to the tensionable element and delivered, and upon delivery, the first anchor consumes from an elongated configuration to a planar configuration. The method further includes: crossing the tissue with a second crossing wire; capturing the second crossing wire; and replacing the second crossing wire with a tensionable element. A second anchor is attached to the tensionable element and delivered, and upon delivery, the second anchor consumes from the elongated configuration to a planar configuration.

[0013] In another embodiment, an elongate catheter is provided having a proximal end and a distal end. The elongate catheter may include an elongate tubular body and an anchor. The elongate tubular body may have a proximal end, a distal end, and at least one elongate passageway therethrough. The elongate tubular body defines a longitudinal axis along the length of the catheter. The anchor may be configured to be oriented through the elongated passageway, the anchor includes a deployable frame configured to expand from a flat elongated configuration to a planar configuration, and the anchor is coupled to a tensionable tether.

[0014] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the present invention. As will be realized, the various embodiments of the present disclosure are capable of modifications in various obvious aspects, all without departing from the spirit and scope of the disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.

[0015] A brief description of the drawings The specification concludes with claims particularly pointing out and distinctly claiming the subject matter which is regarded as forming various embodiments of the present disclosure. It is believed that the invention will be better understood from the following description taken in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0016] [Figure 1a]

[0016] Figure 1a illustrates an anchor having a tether extending therefrom, according to one embodiment; [Figure 1b]

[0017] FIG. 1b illustrates an anchor that is held proximally for controlled deployment, according to one embodiment; [Figure 1c]

[0018] FIG. 1c illustrates an anchor that is held proximally for controlled deployment, according to one embodiment; [Figure 1d]

[0019] FIG. 1d illustrates an anchor in a deployed and expanded configuration, according to one embodiment; [Figure 1e]

[0020] FIG. 1e illustrates an anchor in a deployed and expanded configuration, according to one embodiment; [Figure 1F]

[0021] Figure 1f depicts the framework of the anchor of Figure 1a in an expanded configuration. [Figure 1G]

[0022] FIG. 1g depicts a framework for a variation of the anchor according to the present disclosure. [Figure 2a]

[0023] FIG. 2a illustrates a block diagram of a method, according to one embodiment, which delivers a first anchor; [Figure 2b]

[0024] FIG. 2b illustrates a block diagram of a method for delivering a second anchor, according to one embodiment. [Figure 3]

[0025] 3 illustrates a tissue crossing system according to one embodiment. A capture basket captures a crossing wire; [Figure 4]

[0026] Figure 4 illustrates a tissue crossing system, according to one embodiment, replacing the crossing wire with a tether; [Figure 5]

[0027] 5 illustrates a tissue crossing system, according to one embodiment, delivering a first anchor to the septal wall; [Figure 6]

[0028] FIG. 6 illustrates a tissue crossing system, illustrating achieving range access and deploying a second crossing wire; [Figure 7]

[0029] Figure 7 illustrates a tissue crossing system, according to one embodiment, replacing the crossing wire with a tether; [Figure 8]

[0030] 8 illustrates a tissue crossing system according to one embodiment, with the second anchor deployed and locked; [Figure 9]

[0031] 9 illustrates a method block diagram for delivering a second anchor according to a further embodiment; [Figure 10]

[0032] 10 illustrates a tissue crossing system according to one embodiment. A capture basket captures a crossing wire; [Figure 11]

[0033] FIG. 11 illustrates the tissue crossing system when the second anchor is introduced, according to one embodiment; [Figure 12]

[0034] FIG. 12 illustrates the tissue crossing system after delivering the lock, according to one embodiment; [Figure 13]

[0035] FIG. 13 illustrates a deployed cross-organizational system according to one embodiment; [Figure 14]

[0036] Figure 14a illustrates an anchor and lock in a substantially planar deployed position, according to one embodiment, and shows one side of the anchor, which is the side that will be placed away from tissue when deployed;

[0037] Figure 14b illustrates an anchor and lock in a substantially planar deployed position, according to one embodiment, and shows one side of the anchor, which is the side that will be placed towards tissue when deployed; [Figure 15a]

[0038] Figure 15a illustrates an anchor with a tether redirection mechanism, according to one embodiment; [Figure 15b]

[0039] Figure 15b illustrates the anchor of Figure 15a, according to one embodiment, and further illustrates a tether lock; [Figure 16a]

[0040] Figure 16a illustrates an anchor according to a further embodiment, which has a tether redirection mechanism; [Figure 16b]

[0041] Figure 16b illustrates the anchor of Figure 16a with the tether redirection mechanism in a pivoted position, according to one embodiment; [Figure 17a]

[0042] Figure 17a illustrates an anchor according to one embodiment, which has a frame with a honeycomb support pattern; [Figure 17b]

[0043] Figure 17b illustrates the anchor of Figure 17a, according to one embodiment. A material cover overlies the frame; [Figure 18a]

[0044] FIG. 18a illustrates an over-the-wire delivery catheter, according to one embodiment; [Figure 18b]

[0045] FIG. 18b illustrates an over-the-wire delivery catheter, according to one embodiment; [Figure 19]

[0046] Figure 19 illustrates a wire extending from a wire delivery catheter to a snare, according to one embodiment; [Figure 20a]

[0047] FIG. 20a illustrates a wire delivery catheter, a wire, and a protective element, according to one embodiment; [Figure 20b]

[0048] FIG. 20b illustrates a protective element according to one embodiment; [Figure 20c]

[0049] Figure 20c illustrates a protective element according to a further embodiment; [Figure 20d]

[0050] Figure 20d illustrates a protective element according to a further embodiment; [Figure 21a]

[0051] FIG. 21a illustrates an anchor delivery catheter, wire, tether, and protection element according to one embodiment; [Figure 21b]

[0052] Figure 21b illustrates an attachment mechanism according to a further embodiment; [Figure 22]

[0053] FIG. 22 illustrates deploying a retractable anchor and tether according to one embodiment; [Figure 23]

[0054] 23 illustrates aspects of a tissue crossing system, according to one embodiment, with one anchor deployed; [Figure 24]

[0055] FIG. 24 illustrates aspects of a tissue crossing system deploying one anchor, according to one embodiment. [Figure 25]

[0056] 25 illustrates a tissue crossing system deploying first and second anchors, according to one embodiment; [Figure 26a]

[0057] Figure 26a illustrates an anchor in a planar configuration according to a further embodiment; [Figure 26b]

[0058] FIG. 26b illustrates a view of the anchor of FIG. 26a. [Figure 26c]

[0059] Figure 26c illustrates the anchor of Figure 26a in an elongated configuration. [Figure 27a]

[0060] Figure 27a illustrates an anchor according to another embodiment, which is in a planar configuration; [Figure 27b]

[0061] Figure 27b illustrates the anchor of Figure 27a in a partially collapsed position; [Figure 27c]

[0062] Figure 27c illustrates the anchor of Figure 27a in an elongated configuration. DETAILED DESCRIPTION OF THE INVENTION

[0017] Detailed Description

[0063] The present disclosure provides a novel way to deliver a tensioning element (such as a tether) and a deployable anchor to a desired location within a patient's anatomy, as discussed, for example, with reference to Figures 1-13. More specifically, the present disclosure provides systems and methods for delivering deployable anchors to a desired location in an anatomical structure and tunneling through tissue to anchor the anchors together. The deployable anchors, exemplary embodiments of which are described with reference to Figures 14-27, may include anchors that have an elongated configuration before deployment and a planar configuration after deployment. In the deployed planar configuration, the anchors act as follows: Distribute forces over the surface area of ​​the tissue. In particular, the novel anchors disclosed herein are configured to be delivered using a small profile catheter and expand to a particularly large and substantial area, thereby distributing stress over a much larger area of ​​tissue than many anchors known in the art.

[0018]

[0064] While the present disclosure is directed to the delivery of such anchors and tethers in structural cardiac applications, the disclosed embodiments may also be used in other applications, such as compressing the prostate or moving luminal structures. The disclosed embodiments may be used in any organ or luminal structure that needs to be reshaped or that needs to have a portion of the organ or luminal structure temporarily or permanently moved. Accordingly, the disclosed embodiments are meant to be illustrative only.

[0019]

[0065] In various embodiments, the tissue crossing system may include a wire delivery catheter, a first wire delivered through the wire delivery catheter, an anchor delivery catheter, a first anchor placed adjacent to tissue, and a second anchor placed adjacent to tissue generally opposite where the first anchor was placed. A first tether may be provided, which secures the first of the anchors, and a locking element may be provided, which secures the first tether to the second tether. Although the term "tether" is used herein, it should be recognized that in all instances, "tether" refers to a tensionable element and does not require a particular configuration unless otherwise discussed. The anchor may have a deployable frame that is configured such that when deployed, it expands from a pre-deployed elongated configuration to a planar configuration. Such components are shown and described below.

[0020]

[0066] Figures 1a-1e illustrate an anchor 1 that may be used with a system such as that shown and described herein. 1a-1e illustrate one particular embodiment of an anchor, it should be recognized that other anchor configurations may be used that are configured to have an elongated pre-deployment configuration and a substantially planar deployed configuration. 1a-1e illustrate an anchor that is deployed from the catheter in a controlled manner with an attachment proximal to the anchor.

[0021]

[0067] Figure 1a illustrates an anchor 1 from which extends a tensionable element or tether 3. 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. In Figure 1a, the anchor is in an elongated configuration prior to deployment.

[0022]

[0068] Figures 1b and 1c illustrate the anchor 1, which is held proximally within the anchor delivery catheter for controlled deployment. The anchor 1 may have a frame 2 that may be compressed or folded to achieve the elongated configuration prior to deployment, and expanded (by itself or manually) to achieve the substantially planar configuration upon deployment. The frame 2 may support a material 4 (such as a fabric cover) on at least one side thereof. In some embodiments, the material may be biodegradable or absorbable.

[0023]

[0069] The frame or framework 2 of the anchor is preferably made from pieces of shape memory material (such as a NiTi alloy). However, it will be recognized that shape memory polymers may also 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), ABA triblock copolymers made from poly(2-methyl-2-oxazoline) and polytetrahydrofuran, etc.).

[0024]

[0070] The framework of the exemplary embodiment of FIG. 1 is shown in detail in FIG. 1F. The framework in this embodiment is made from flat strips A of NiTi alloy, which are joined at multiple points by compression bonding. The framework is heat treated so that, when unconstrained, it assumes the shape illustrated in Figure 1F. As illustrated, there are actually six (6) longitudinal straps A. The outer strap A1 forms the outer perimeter and has first and second ends, which are received into tubular couplings E at either end of the structure. Each pair of tubular couplings E is joined at a hinge point (or hinge pin) B, which allows the couplings to collapse inward when the framework is compressed laterally or transversely, thereby expanding slightly longitudinally. The coupling E also receives the ends of a pair of inner straps A2. The inner straps are clipped together at the center of the framework, approximately at the midpoint of the straps A2, and run diagonally outward from the center, forming an "X" configuration, as depicted in FIG. 1F. The ends of the inner straps A2 are received in the coupling E along with the ends of the outer straps A1. There is also an intermediate pair of straps A3. Each of the intermediate straps A3 is joined at approximately its midpoint to the corresponding outer strap A1 at approximately its midpoint by a clip or crimp C. Both ends or end regions of each intermediate strap A3 are in turn clipped to the inner strap A2 at end regions near the respective couplings E. Specifically, the inwardly facing surface of the outer strap A1 faces and contacts the outwardly facing surface of the intermediate strap A3, which are clipped together at their corresponding midpoints. The inward-facing surface (or surfaces) of each intermediate strap is clipped to the outward-facing surface of the inner strap A2, whose inward-facing surfaces face each other and are clipped together at the center of the framework. If desired, a tubular member or eyelet D may be provided in the center of the framework to route tethers or sutures therethrough. The tubular member D may be fixed in position (e.g., relative to the inner strap A2) or may rotate about a pivot point so that it faces in any desired direction. The tube or sleeve D in Figure IF is configured to allow tethers to pass through it, extending radially outward from a central region of the frame and parallel to the longitudinal axis of the framework. As will be appreciated by those skilled in the art, the framework of FIG. 1F has been heat treated so that when unconstrained, it assumes the expanded configuration depicted in FIG. 1F. However, the NiTi material can be compressed along its width, causing the straps A1, A2, and A3 to collapse into a stacked configuration, thereby allowing the structure to be retracted into the distal end of the tubular portion of the delivery catheter by pulling on a tether (not shown in FIG. 1F) that passes through the tube D and into the tubular portion of the delivery catheter. A push rod (not shown) may be releasably coupled to one end of the framework (or optionally to tubular member D) to allow the framework to be pushed out of the delivery catheter, thereby enabling deployment. It will be appreciated that the fabric, as depicted in Figures 1A-1E, will typically be sewn over the framework of Figure 1F. FIG. 1G depicts a variation of the framework of FIG. 1F. Like elements are noted with like reference marks. The operation and structure of the framework in Figure 1G is nearly identical to that of Figure 1F, except that the anchor frame is rounder in overall shape and less oval. Coupling D in FIG. 1G, however, can actually pivot and is rotationally mounted on a pin. This framework is described in more detail below with respect to FIGS.

[0025]

[0071] The tether 3 may comprise a suture, such as a braided suture, which may optionally include radiopaque material along its length. If desired, the suture material may be doped with a powdered radiopaque material. By way of further example, the tether may be made from an ultra-high molecular weight polyethylene ("UHMWPE") open-core circular braid manufactured by DSM, Dyneema, or Teleflex. In some implementations, the tether may be loaded with at least 20% bismuth by weight to enhance radiopacity. For example, the tether may be loaded with between about 20 and about 70% (or any degree therebetween in increments of about 1% by weight) bismuth or barium sulfate. Additionally or alternatively, radiopaque materials may be incorporated into portions of the devices shown herein, such as the tether, the anchors, or the delivery devices, such as tungsten, tantalum, and barium sulfate. These materials may be incorporated as drawn metal (e.g., radiopaque material such as platinum) wires that are incorporated into the braid by, for example, weaving the drawn wires or directing them along a central channel defined in the tether. While a braided material is illustrated as the tensioning tether, it will be recognized that any other suitable material may be used.

[0026]

[0072] With continued reference to Figures 1a-1e, the tether 3 may be threaded through the anchor as it is being delivered. The stitching may be through the connection point 8, which may be generally in the center of the frame 2. Figure 1b illustrates the anchor 1 in a transitional configuration, while Figure 1c illustrates the anchor 1 in a substantially planar configuration. In the planar configuration, the anchor acts to: distribute force over the surface area. As described more fully below with respect to methods of deploying the anchor, the tether may be delivered outside of the anchor delivery catheter, thereby locking it while connected to the delivery catheter.

[0027]

[0073] Figures 1d and 1e illustrate the anchor 1 fully released from the delivery catheter 5 and in an expanded configuration. In some embodiments, the anchor 1 may have a coupling, which maintains its position while the lock is deployed. Additionally, the anchor 1 may be rotated around the transverse site using the proximal coupling 6. A lock 9 may be delivered along the tether 3, thereby locking the tension on the tether 3. In the embodiment shown in FIG. 1 e, the lock is delivered along the tether 3 to a connection point 8 . In alternative embodiments, the lock may be located at other points along the tether.

[0028]

[0074] The deployable anchors expand from an elongated pre-deployed configuration to a planar deployed configuration, which may be used in a variety of procedures. Generally, these can be useful for distributing force over a surface area of ​​tissue. Additionally, such anchors used with tensionable elements and tethers extending therebetween may be used in any tissue crossing procedure. For illustrative purposes, a method for traversing cardiac tissue will be described.

[0029]

[0075] Thus, the tissue crossing system and anchors for use therewith may be used in cardiac procedures, for example, to reshape the heart. One method of using the system is the minimally invasive / hybrid approach, which is shown and described with respect to Figures 2a-2b and 3-8.

[0030]

[0076] 2a and 2b are block diagrams of the method, which threads suture material through tissue and connects anchors according to an embodiment of the minimally invasive / hybrid approach. FIG. 2a illustrates a method 100 of delivering a first anchor. FIG. 2b illustrates a method 200 for delivering a second anchor. It should be appreciated that the method illustrated in Figures 2a and 2b is specifically described with respect to traversing cardiac tissue, but may be used in any situation where tissue needs to be traversed. Crossing the tissue may include delivering a first anchor and a second anchor, said anchors tethered by a radiopaque tether across said tissue.

[0031]

[0077] Delivery of the first or left anchor is shown and described with respect to Figure 2a. A sheath or guide is deployed 103, which receives the first transverse wire for deployment into the body. The sheath or guide may be deployed, for example, through the femoral artery or vein. The tissue is transected 105 with a first transverse wire. In cardiac embodiments, this step 105 may include transecting the cardiac tissue at the proximal anterior septum with a transverse wire. The crossing wire may be deployed through the guide or catheter deployed at 103 . A capture mechanism (such as a capture basket or snare as shown in US Pat. No. 10,433,962) may then be used to capture 110 the crossing wire. The capture basket may be deployed through a guide 12 extending from the femoral vein. Figure 3 (described more fully below) illustrates the system at approximately this point in the method.

[0032]

[0078] Returning to FIG. 2a, after capturing the first of the transverse wires, the first of the transverse wires is externalized 115. Although not required, a soft-tipped catheter may be used to protect the tissue at the point of transection. One or more of the guides or sheaths may be removed 120. In some embodiments, removing the guide or sheath may include removing the guide from the femoral artery.

[0033]

[0079] Next, the first of the cross wires is replaced 125 with a tensionable element or tether. In some embodiments, the tether may be radiopaque. Figure 4 (described more fully below) illustrates the system at this stage. The cross wire may be replaced with a tether, and the tether may then be externalized 130 . In some embodiments, the tether may be externalized out of the femoral vein.

[0034]

[0080] A first anchor delivery catheter is introduced 135 . In cardiac embodiments, this may involve introducing a first or left-sided delivery catheter through a lumen such as the femoral artery. The first anchor may then be delivered 140 to a desired location through the anchor delivery catheter. When in the anchor delivery catheter, the anchor is in a laterally collapsed, elongated configuration prior to deployment. Upon delivery, the anchor expands to a deployed planar configuration. This can occur automatically when the catheter is expelled, or it can be done manually. In the embodiment shown in Figure 5 (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 may be removed 145.

[0035]

[0081] One embodiment 200 for delivering the second or right side anchor is shown and described with respect to Figure 2b. In this embodiment, the second anchor may be delivered after the first anchor is delivered.

[0036]

[0082] A second area access is achieved 205 for delivery of the anchor. This may be done by insufflating the area and performing a mini-thoracotomy. For example, carbon dioxide insufflation may be passed through the right atrial appendage, and a mini-thoracotomy may be performed to access the subxiphoid shaft with a subxiphoid sheath.

[0037]

[0083] An over-the-wire delivery catheter is deployed at step 210 . The over-the-wire delivery catheter may be deployed 210 through the femoral vein and inferior vena cava (IVC). The wire delivery catheter may be an articulating catheter and may be positioned in the free wall facing the right ventricle. A crossing wire is deployed 215 through the wire delivery catheter. The traverse wires may be, for example, charged traverse wires. The traversing wire is captured 220 . A capture snare may be used to capture the charged crossing wire. In some embodiments, the capture snare may be deployed through a subxiphoid sheath. The position of the system at this point is shown in FIG.

[0038]

[0084] The cross wires are replaced 225 with radiopaque tethers. This may be done through the free wall. In some embodiments, the free ends of the radiopaque tether and the crossover wire are joined together (such as by crimping) prior to exchange. FIG. 7 (described more fully below) illustrates replacing the cross wire with the radiopaque tether.

[0039]

[0085] A second anchor delivery catheter is introduced 230 . A second such anchor delivery catheter may be introduced through the subxiphoid sheath and articulated toward the free wall or right ventricle. A second said anchor is delivered 235. When in the anchor delivery catheter, the anchor is in an elongated pre-deployment configuration. Upon delivery, the anchor expands to a deployed planar configuration. This can occur automatically when the catheter is expelled, or it can be done manually. In cardiac embodiments, the second anchor may be a right-sided anchor and may be delivered above the free wall. Tension may be maintained on the radiopaque tether during and after delivery. A lock may be delivered 240 to the second anchor. The locking mechanism of the lock is activated 245 to fix the tension on the radiopaque tether. Such actuation 245 may occur when the tension applied to the tether is satisfactory. 250 to cut off the excess tether. FIG. 8 (described more fully below) illustrates the system at this point in the method. Suitable examples of locks, lock delivery catheters, and suture cutting catheters can be found in US Pat. No. 10,433,962.

[0040]

[0086] It should be appreciated that the wire delivery catheter, the crossing wire, the guide, and the subxiphoid sheath are optionally removed during and after the procedure, leaving only the first anchor, the tether, the second anchor, and the lock in place.

[0041]

[0087] Turning now to the depiction of the system as shown in Figures 3-8, the cardiac tissue traversed may be the proximal anterior septum, as depicted in Figures 2a and 2b. The tissue crossing system and anchors accomplish this crossing while avoiding the anchors from impinging on the aortic valve. Figure 1 illustrates the early stages of deployment of the cross-organizational system. As shown, guides 10, 12 are deployed into the heart through the femoral artery and vein, respectively. The exact configuration of the guides may vary. In one embodiment, the guide may be a 14F guide deployed through a 16F sheath. A wire delivery catheter is deployed through the first guide 10 extending from the femoral artery. A capture basket 16 is deployed through the second guide 12 extending from the femoral vein. A first crossing wire 18 is deployed through the wire delivery catheter 14 . The catch basket 16 may be used to catch the first of the transverse wires 18 . In some embodiments, the traverse wires may be electrically energized.

[0042]

[0088] As shown in FIG. 4, exchanging the crossing wire 18 for a tether 20 may involve threading a protective catheter 22 through the guide 12 in 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 traversing wires 18, thereby achieving connection. The tether 20 and left anchor (see FIG. 5) may then be advanced.

[0043]

[0089] FIG. 5 illustrates the delivery of a first anchor, according to one embodiment. More specifically, Figure 5 illustrates an anchor 26 that is delivered to the septal wall, according to one embodiment. The anchor 26 is referred to herein as the first anchor or the left anchor, but it should be recognized that such references are intended for illustrative purposes only. Anchor delivery catheter 28 (referred to as the left anchor delivery catheter) may be threaded through the femoral artery, and the left anchor 26 is threaded through it and deployed to the septal wall by withdrawing radiopaque tether 20, to which the anchor 26 is attached, through guide 12. An anchor retaining suture 30 may be used to secure the left anchor 26 in place. The anchor delivery catheter 28 may be removed. The free end of the tether 20 that passes through the femoral vein may be anchored, thereby maintaining tension on the system.

[0044]

[0090] FIG. 6 illustrates achieving range access and deploying a second traversing wire according to one embodiment. A mini-thoracotomy may be performed to gain subxiphoid access as described with respect to Figure 2a. FIG. 6 illustrates the subxiphoid sheath 32. A snare 34 may be deployed through the subxiphoid sheath 32 . The snare 34 may be, for example, a catch basket or a gooseneck snare. A wire delivery catheter 36 threaded through the sheath 12 is used to advance a crossing wire 38 (sometimes referred to as a second crossing wire) through the femoral venous access and inferior vena cava. The traverse wire 38 may be, for example, a 0.014 inch charged traverse wire. The wire delivery catheter 36 may be in position to articulate the catheter. In the embodiment shown, the wire delivery catheter 36 is positioned in the free wall facing the right ventricle. The second transverse wire 38 is positioned so that it crosses through the free wall and passes through the subxiphoid shaft to capture it. At this stage, the radiopaque tether 20 still extends from the guide 12 to the anchor 26 . A capture snare 34 may be deployed through the subxiphoid sheath 32, which captures the charged cross wire 38. The snare 34 may be, for example, a catch basket or a gooseneck snare.

[0045]

[0091] FIG. 7 illustrates replacing the charged cross wire 38 with a radiopaque tether 20 . This may be done through the free wall. In some embodiments, the free ends of the radiopaque tether 20 and the transverse wire 38 are joined (such as by crimping) together prior to exchange. A connector 40 is shown, which connects the transverse wire 38 to the radiopaque tether 20. A corrective snare 42 or catheter may be used to substantially prevent the radiopaque tether 20 and wire 38 from tangling.

[0046]

[0092] Figure 8 illustrates the system after positioning the second anchor and locking the anchor. The first anchor 26 is positioned above the septal wall. The second anchor 50 is positioned above the free wall. A tether 20 (eg, a radiopaque tether) extends between the first anchor 26 and the second anchor 50 . A lock 52 locks the tether 20 at a desired tension. At this point, the guide 12 and the subxiphoid sheath 32 may be removed.

[0047]

[0093] Another method of using the system uses a completely percutaneous approach to deliver the anchors on the right side. This approach is shown and described with respect to Figures 9-13. It should be appreciated that this method is specifically focused on right-sided anchor delivery in cardiac embodiments. Thus, prior to commencing the method shown and described with respect to Figures 9-13, the left anchor may be delivered using the method shown and described with respect to Figures 2a and 3-5.

[0048]

[0094] 9 is a block diagram of the method of threading sutures through tissue and connecting anchors using a completely percutaneous approach to deliver anchors on the right side of the heart embodiment. Crossing the tissue may include delivering a first anchor and a second anchor, said anchor anchored by radiopacity across said tissue.

[0049]

[0095] Delivery of the first or left anchor is shown and described with respect to Figures 2a-5. The method shown and described with respect to Figure 9 may therefore begin when the system is in the configuration generally shown in Figure 5. More specifically, the method may begin when the left anchor 26 is in place at the septal wall.

[0050]

[0096] Achieve range access for delivery of the second anchor 305. This may be done by insufflating the area, but generally only to the native pericardium. The guide is then deployed 310 and the wire delivery catheter is deployed 315 therethrough. A transverse wire is delivered through the right atrial appendage and into the pericardial space 320 using the wire delivery catheter and cervical guide. The crossing wire is delivered 325 to its desired location. This may include passing the wire delivery catheter and the crossing wire through and across the pericardial space towards the apex of the heart. The wire delivery catheter may be articulated towards the right ventricle and the charged cross wire delivered through the free wall and into the right ventricle. The traversing wire is captured 330 . This may involve capturing the transverse wire within the wire delivery catheter or the guide using a wire capture basket. The crossing wires are externalized 335 . Figure 10 (described more fully below) illustrates the system at this stage in the method.

[0051]

[0097] The cross wire is replaced with a tether 340 . This may involve crimping the free ends of the tether (such as a radiopaque tether) and the transverse wire together using a crimp connector. The crossing wire may be replaced with the tether by passing it through the free wall and out the femoral venous access sheath.

[0052]

[0098] A second anchor delivery catheter is introduced 345 . This may be done through jugular venous access. A second said anchor is delivered 350 . This may involve delivering the right atrial appendage into the pericardial space and traversing it through the pericardial space until it is deployed above the free wall. Tension may be maintained in the radiopaque tether. Figure 11 (described more fully below) illustrates the system after the second (or right) anchor has been introduced, but prior to full deployment of the second anchor.

[0053]

[0099] 355 to deliver the lock. In some embodiments, this may include delivering a lock over both a first and a second radiopaque tether, the first extending from the first said anchor, and the second extending from the second said anchor. The lock may be delivered 355 using a lock delivery catheter. Figure 12 illustrates the system after the lock has been deployed. Activating the locking mechanism 360 . In some embodiments, the tether may be pulled to achieve a satisfactory tension prior to actuating the locking mechanism. The excess tether is cut 365. For example, a tether cutter is used for this purpose. FIG. 13 illustrates the system fully deployed.

[0054]

[0100] Turning now to an illustration of the system during the method shown in Figure 9, Figure 10 illustrates the system in the initial stages of delivering the right anchor, using a completely percutaneous approach. As shown, the left anchor 26 is deployed in the septal wall. A tether 20 extends from the anchor 26 and into a catheter 22 . The catheter 22 and tether 20 extend, now into the guide 12 . The guide 12 may be a femoral venous access sheath.

[0055]

[0101] A guide 60 (which may be a 14F guide, also called a jugular sheath) is deployed into the jugular vein. A wire delivery catheter 62 is inserted through the guide 60 and a crossing wire 64 is deployed through the wire delivery catheter 62 . The traverse wire 64 may be a 0.014 inch electrically charged guide wire in some embodiments. The wire delivery catheter 62 and crossing wire 64 exit the right atrial appendage and enter the pericardial space. The traversing wire traverses the free wall. A wire capture snare 66 and a capture basket 68 are delivered through the guide 12 . The capture basket 68 captures the traverse wire after it traverses the free wall.

[0056]

[0102] Figure 11 illustrates the system when the second (or right) anchor is introduced. The first (or left) anchor 26 is in place at the septal wall, from which the first tether 20 extends. A right anchor delivery catheter 72 extends through the cervical sheath 60 . A 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 cross wire 64 . The ether 74 passes through and traverses the pericardial space. A connector 76 (such as a crimp connector) connects the tether 74 to the traverse wire 64 . The crossing wire may then be exchanged for the tether across the pericardial space, thereby deploying the second anchor 70 above the free wall.

[0057]

[0103] Figure 12 illustrates the system after delivering the lock in step 355 of Figure 9. The first (or left) anchor 26 is in place at the septal wall, with the first tether 20 extending therefrom. The second (or right) anchor 70 is in place on the free wall, from which extends a second tether 74. In the embodiment shown, both the first tether 20 and the second tether 74 extend from corresponding anchors and into the femoral access sheath 12 . The lock 80 connects 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 may be slid over the first tether 20 and second tether 74 and delivered to a desired location. A lock delivery catheter 82 may be used to deliver the lock 80 . In some embodiments, the lock delivery catheter 82 may extend through the femoral venous access sheath 12 .

[0058]

[0104] FIG. 13 illustrates the system fully deployed. As shown, the first (or left) anchor 26 is in place at the septal wall, and the second (or right) anchor 70 is in place on the free wall. A first tether 20 extends from the first anchor 26. A second tether 74 extends from the second anchor 70. The first tether 20 and the second tether 74 are tensioned and locked together with a lock 80 .

[0059]

[0105] The components of the system will now be more specifically shown and described. Generally, the anchors may be deployed through an anchor delivery catheter. The anchor delivery catheter may be an elongate catheter having a proximal end and a distal end. The elongate catheter may include an elongate tubular body and an anchor. The elongate tubular body may have a proximal end, a distal end, and at least one elongate passageway therethrough. The elongate tubular body defines a longitudinal axis along the length of the catheter. The anchor may be configured to be oriented through the elongated passageway. The anchor may include a deployable frame that is configured to expand from a flattened elongated configuration to a planar configuration, and the anchor is coupled to a tensionable tether. In a planar configuration, the deployable frame acts as follows: distributes forces over a surface area.

[0060]

[0106] As discussed in detail above with reference to Figures 1F and 1G, Figures 14a and 14b illustrate an anchor 400 and lock 402. The anchor 400 is in a substantially planar deployed configuration. Figure 14a illustrates one side of the anchor 400. This may be the side that is placed away from tissue when deployed. Figure 14b illustrates one side of the anchor 400, which may be the side that faces towards tissue when deployed. In this embodiment, the anchor 400 may be delivered attached to the lock 402 rather than delivered separately. In some embodiments, the lock 402 may be referred to as a tether lock. The anchor 400 includes a mesh or frame 404 (described in detail above) that may be compressed or folded to achieve an elongated configuration prior to deployment, and may be expanded (either by itself or manually) to achieve a substantially planar configuration upon deployment. The mesh or frame 404 may support a material 406 (such as a fabric cover).

[0061]

[0107] A tether 408 is coupled to the anchor 400 . The tether 408 may be threaded through the anchor 400 at a connection point or through a sleeve 410 . A tether lumen extension 412 (also referred to as a tether lumen) may take the form of a sleeve that is placed over the tether 408 extending between the lock 402 and the connection point 410. The tether lumen extension 412 may be flexible and may pivot about the connection point 410 (or, more generally, about the center of the anchor 400) to aid in positioning, orienting, and generally delivering the anchor. A snare 414 may be provided near the lock 402 and may be used to pull the tether 408 through the anchor 400 and lock 402 assembly.

[0062]

[0108] As described above, the anchor 400 may be delivered to a target site with a catheter configured as follows: the tether 408 is secured and the lock 402 is actuated to hold tension. The frame 404 is collapsible, as detailed in the above discussion of Figures 1F and 1G, allowing the anchor 400 to be loaded into the catheter in a collapsed, elongated configuration for delivery. The frame is relatively stiff in the direction of the tether 408 (or tension direction when deployed). The material 406 (or fabric cover) may aid in protecting the load or tissue and provide permanent fixation. However, it should be recognized that in some embodiments, no material or fabric cover may be used.

[0063]

[0109] Figures 15a, 15b, 16a, 16b, 17a and 17b illustrate further anchor variations and mechanisms. Generally, the anchor includes a deployable frame that, when ejected from the anchor delivery catheter, expands from an elongated configuration prior to deployment of the anchor delivery catheter to a planar configuration. The anchor may be self-expanding, using a shape memory material such as nitinol. Alternatively, the anchor could be manually expanded using a push-pull mechanism, allowing the user to control the shape and size.

[0064]

[0110] The pattern of construction of the frame may vary depending on the needs of the application. In some embodiments, the frame is laser cut, so any of a number of patterns of support may be achieved. The beams of the frame may be designed to bend easily in one direction to load into the catheter, but be stiffer in other directions (such as the loading or anchoring direction). In some embodiments, these directions may be perpendicular to each other. Alternatively, the directions may be at different angles relative to each other.

[0065]

[0111] Figures 15a and 15b illustrate an anchor 500, which has a tether redirection mechanism 502 or guide, see element D of Figure IF. In the embodiment shown, the tether redirection mechanism or guide 502 is located generally centrally in the frame 503 of the anchor 500 . The tether redirection mechanism may enhance the movement of the tether within the system, facilitating smooth tightening and adjustment. This can be useful when normal access to the delivery site is limited. In the embodiment shown, the tether redirection mechanism or aid may tension it at a non-straight angle, such as 90 degrees. Figure 15b illustrates a tether lock 506, which may be attached, for example, at the tether redirection mechanism 502, before or after delivery of the anchor. Thus, the tether lock 506 may be delivered in a separate step from the anchor delivery, or may be combined with the anchor prior to anchor delivery.

[0066]

[0112] 16a and 16b illustrate an anchor 520 having a tether redirection mechanism 522. In the embodiment shown, the tether redirection mechanism or guide 522 is located generally centrally in the frame 523 of the anchor 520 . The tether redirection guide may enhance the movement of the tether within the system, facilitating smooth tightening and adjustment. 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, which facilitates versatile orientation. Figure 16b illustrates the tether direction mechanism 522 in a rotated position;

[0067]

[0113] 17a and 17b illustrate an anchor 540 according to a further embodiment. As shown, the anchor 540 may include a frame 542 (described above with reference to FIG. 1G), which has a honeycomb support pattern. This pattern may be modified to provide more support or more flexibility as desired for various applications. The anchor 540 further includes a tether lumen extension 544 that extends from a generally central location on the frame 542 and terminates in a tether lock 546. The tether lumen extension may be flexible. 17b illustrates a material cover 548 that fits over the frame 542. The material cover 548 may be a fabric cover, a polymeric structure, etc., that provides the desired features of cushioning, anchoring, visibility, ingrowth control, adhesion control, etc. In some embodiments, the material covering 548 may include a biodegradable / absorbable material. In some embodiments, there may be no material covering over the frame 542 .

[0068]

[0114] Figures 18a, 18b and 19 illustrate embodiments of devices for wire traversal. 18a and 18b illustrate an over-the-wire delivery catheter 560. FIG. The wire delivery catheter 560 may include a distal catheter 562 and a proximal catheter 564 . The distal catheter 562 may be an internal catheter and may be configured to deflect, rotate, advance, or retract. The proximal catheter 564 may be an external catheter and may be configured to deflect, rotate, advance, or retract. While referred to as a single, integral wire delivery catheter 560, the catheter 560 may therefore be a combination of independent deflectable and twistable catheters that may be used to achieve a desired vector for the wire. This vector may correlate to where an anchor (eg, the first said anchor) was deployed.

[0069]

[0115] 19 illustrates a wire 566 extending from the wire delivery catheter 560 and threading through tissue 567 to a snare 568. As the wire advances through the tissue 567 and is captured on the opposite side of the tissue 567 (eg, by the snare 568). A suitable snare 568 is shown in Figure 19. However, other snare mechanisms may be used instead. In some embodiments, an energy source such as RF may be used to assist in traversing the wire. 19 illustrates a wire 566 that is captured by the snare 568.

[0070]

[0116] In some embodiments, it may be useful to provide a protective element to protect the tissue traversal site from damage resulting from the advancement of wires and sutures. Figures 20a, 20b, 20c and 20d illustrate embodiments of such a protective element. 20a illustrates a wire 566 advanced from the catheter 560 to the tissue crossing site 567. A protective element 570 is provided over the proximal side of the tissue crossing region 567 . The wire 566 extends through the protective element 570 and the tissue crossing region 567 and exits on the opposite side.

[0071]

[0117] 20b, 20c and 20d illustrate various embodiments of suitable protective elements 570 (such as sleeves or grommets). The tissue protection device may be placed around the wire and may be advanced before or after the wire is advanced across the tissue. The protection device aids in protecting the tissue as the wire and tether lengths traverse the tissue and thereafter during tissue movement. In one embodiment, the protective element is a soft disc. In other embodiments, the protective element may be coiled, threaded, funnel-shaped, t-shaped, or collapsible. The protective element 570 helps to thread the tether through the intended path while maintaining the position of the anchor. The protective element 570 may also help protect the tissue from the anchor.

[0072]

[0118] 20b, 20c, and 20d each illustrate a protective element 570, which includes a disk 572 and an extension 574. In the embodiment of Figure 20b, the extension 574 is collapsible, thereby going from a fully extended position to a collapsed position. In the embodiment of FIG. 20c, the protective element 570 further comprises a coil 576, which is disposed around the extension 574. In the embodiment of Figure 20d, the extension has a ridge 578 around it. In some configurations, the ridges 578 may provide threads.

[0073]

[0119] 21a, 21b and 22 illustrate further embodiments of the anchor delivery system. As shown in FIG. 21 a, the wire 602 has a proximal end 612 and extends through the tissue 604 and protective element 606 . An anchor delivery catheter 608 is in place over the wire 602 . A tether 611 extends over the wire 602 and through the tissue 604 . Multiple crimps 610 may be provided along the tether 611 . Figure 21b illustrates an alternative attachment mechanism: the tether 611 is tied to a unique crimp 616, thereby connecting the wire 602 to the tether.

[0074]

[0120] The anchor delivery system facilitates secure attachment of tether 614, which follows the crossing wire 602 through protective element 606 (optional) and tissue 604. Once the traversing wire 602 is captured on the opposite side of the target tissue 604, the proximal end 612 of the wire may be attached to the leading end of a tether 614 (which may be radiopaque), which may be attached to or may be attached to another anchor. In some embodiments, the wire 602 may remain attached to the tether 614 for further tissue crossing. In other embodiments, the wire 602 may be replaced for additional tissue traversal.

[0075]

[0121] Returning to FIG. 21a, the leading end of the tether 611 has a plurality of crimps 610 arranged in series. The distal crimp may be used first and then cut from the wire 602 and tether 611 . The same or a new wire may be attached to the tether using the remaining crimp. This may be repeated for each wire to be detached. The crimp 610 may include a metal tube, which provided holding strength to the wire 602 after crimping. The crimped portion 610 may further include a polymer coating to provide good adhesion and transition with the material of the tether 611 to which it is attached.

[0076]

[0122] 21b illustrates an alternative mechanism, which attaches the tether 611 to the wire 602. As shown, the unique one-touch crimp attachment device 616 has a loop coupling that allows any tether to be tied off. This piece may be cut from the wire and tether and a new one may be attached to the same or a new wire and tether.

[0077]

[0123] FIG. 22 illustrates the deployment of retractable anchor 620 and tether 622. The retractable anchor 620 is deployed, and remaining slack may be removed as the tether is pulled through the protective element 606 (optional) and tissue 604.

[0078]

[0124] 23, 24 and 25 illustrate an embodiment of a delivery system for delivering a second anchor 720. FIG. FIG. 23 illustrates the first anchor 700 and tether 702 from a first traverse that has been externalized. To make the second wire crossing, a wire crossing system such as that previously described with respect to Figures 18a, 18b, 19 and 20a-20d is used. The wire 704 passes through and traverses the tissue 706, is captured on the opposite side of the tissue 706, and is externalized. For example, a snare 708 may be used to capture the wire.

[0079]

[0125] 24 illustrates the tether 702, which is attached to the leading wire 704. The wire / tether connection is shown at 710 . This connection may be made via a loop as shown in Figure 21b. This attachment may occur after the wire has crossed if it becomes dislodged during the crossing. 24 further illustrates an optional in-line crimp connector 705, which resides on the tether 702. A catheter 712 may be deployed to control the loop or slack as the wires and tethers are threaded through the next layer of tissue. The anchor is deployed from the catheter in a controlled manner, with the attachment proximal to the anchor, as shown, for example, in Figures 1a-1e. The anchors 700 and 720 may be pre-attached to the tether 702, or may be attached via a knot or lock. Figure 24 illustrates an anchor with an independent lock. Figure 25 illustrates an anchor with a lock 722 attached.

[0080]

[0126] 26a-26c and 27a-27c illustrate various perspective views of alternative anchor embodiments. The anchor 750 is adapted to be placed adjacent to tissue. Anchor 750 includes a deployable frame 752 that is configured such that, when ejected from an anchor delivery catheter, it expands from an elongated configuration prior to deployment of the anchor delivery catheter to a planar configuration. The frame 752 includes an outer ring or peripheral frame 754, which may be formed, for example, from a NiTi strap component, and a central member or central support 756. The pieces of frame 752 may be made of a shape memory material such as a NiTi alloy. In one embodiment, the outer ring 754 includes opposed rib members 757 . In one embodiment, the central member is a central helical spring. The central member 756 may be connected on both sides to opposing rib members 757. This is done by pivot points at either end of the framework, as shown in Figure 26b, which allow the outer two straps 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 functions as follows: moving the opposing rib members 757 apart, thereby forming the outer ring 754. A tether 758 may be attached to the central member 756 . Figure 26c illustrates the anchor 750 in a flat, elongated configuration. As shown, in this embodiment, the opposing rib members 757 and central member 756, respectively, are similar or the same length.

[0081]

[0127] The embodiment of Figures 27a-27c differs from the embodiment of Figures 26a-26c in that the central member 756 connects with the opposing rib members 757. Figure 27a illustrates the frame 752 in an expanded, planar configuration. Figure 27b illustrates the frame 752 in a partially collapsed configuration. Figure 27c illustrates the frame 752 in an elongated configuration.

[0082]

[0128] Accordingly, systems and methods are described for delivering tensioning elements (such as tethers and deployable anchors) to desired locations within a patient's anatomy. More specifically, systems and methods are disclosed for delivering deployable anchors to desired locations in anatomy and traversing tissue to anchor the anchors together. The deployable anchor may include an anchor that has an elongated configuration before deployment and a planar configuration after deployment. In the deployed planar configuration, the anchors act as follows: Distribute forces over the surface area of ​​the tissue. Such anchors and tethers may be useful in structural cardiac applications, but may also be used wherever compression, shaping, or movement of an organ or luminal structure is desired.

[0083]

[0129] While the present disclosure is directed to the delivery of such anchors and tethers in structural cardiac applications, the disclosed embodiments may also be used in other applications, such as compressing the prostate or moving luminal structures. The disclosed embodiments may be used in any organ or luminal structure that needs to be reshaped or that needs to have a portion of the organ or luminal structure temporarily or permanently moved. Accordingly, the disclosed embodiments are meant to be illustrative only.

[0084]

[0130] As used herein, the terms "substantially" or "largely" mean a complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, a "substantially" or "largely" enclosed object would mean that the object is either completely enclosed or nearly completely enclosed. The exact extent to which deviations from absolute perfection are permissible may depend on the particular context in each case. Generally speaking, however, near perfection will result in having roughly the same overall results as if absolute and total perfection were achieved. The use of "substantially" or "largely" is equally applicable when used in the negative sense, meaning 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 include such element, so long as there is generally no significant effect thereof.

[0085]

[0131] To assist the Patent Office and readers of any patent issued on this application in interpreting the claims appended hereto, Applicant wishes to note the following: No appended claim or claim element is intended to invoke 35 U.S.C. 112(f) unless the words "means for" or "step for" are expressly used in a particular claim.

[0086]

[0132] Additionally, 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 but not component Y; the embodiment may include component Y but not component X; or the embodiment may include both components X and Y. Similarly, when used in reference to three or more elements (e.g., "at least one of [X], [Y], and [Z]"), the phrase means that the embodiment may include any one of three or more of the elements, any combination or subcombination of some of the elements, or all of the elements.

[0087]

[0133] In the foregoing description, various embodiments of the present disclosure have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obvious modifications or variations are possible in light of the above teachings. Various embodiments have been selected and described to provide the best illustration of the principles of the present disclosure and its practical application, and so may be utilized by those skilled in the art with various modifications to adapt them to the particular use intended. All such modifications and variations are within the scope of the present disclosure as determined by the appended claims, which are to be interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.

Claims

1. An anchor to be deployed at a location within a patient's body, said anchor comprising: a deployable frame configured to expand from an elongated configuration to a planar configuration having a surface area, the deployable frame including a plurality of heat-treated straps of shape memory material bonded together, the straps being heat-treated to assume a non-linear expanded configuration when unconstrained; In the elongated configuration, the deployable frame can be loaded into a catheter; In the planar configuration, the deployable frame acts to distribute forces across the surface area; a cover disposed over at least a portion of the deployable frame above a surface adjacent to the tissue; anchor.

2. The anchor of claim 1 , wherein the deployable frame is braided.

3. 10. The anchor of claim 1, wherein the deployable frame is made from a NiTi alloy shape memory material.

4. The anchor of claim 3 , wherein the shape memory material comprises a polymeric shape memory material.

5. 3. The anchor of claim 2, wherein the cover is a fabric cover.

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

7. The anchor of claim 6 , wherein the tether lumen facilitates tether redirection.

8. The anchor of claim 1 , further comprising a tether lumen extension coupled to the tether lumen.

9. The anchor of claim 8 , wherein the tether lumen extension includes a snare configured to retract the tether.

10. The anchor of claim 1 further comprising a tether lock.

11. The anchor of claim 10, wherein the deployable frame includes a peripheral frame coupled to a central support.

12. 12. The anchor of claim 11, wherein the central support is configured to urge the peripheral frame to expand outwardly into a planar configuration.

13. In a cross-organizational system: a wire delivery catheter; a first wire delivered through said wire delivery catheter; an anchor delivery catheter; a first anchor for placement adjacent to tissue, the first anchor including a deployable frame 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; a first tether, the first tether configured to secure to the first anchor; Cross-organizational systems.

14. 14. The cross-organizational system of claim 13, further comprising: a second wire; a second anchor, positioned adjacent to tissue generally opposite the placement of the first anchor, the second anchor including a deployable frame configured to expand from a pre-deployed elongated configuration to a planar configuration when deployed; A tissue crossing system comprising a locking element that secures the first tether to the second anchor.

15. 15. The tissue crossing system of claim 14, further comprising a straightening device that reduces tangling between the first tether and the second wire.

16. 14. The cross-organizational system of claim 13, further comprising: a second wire; a second anchor positioned adjacent to tissue generally opposite the placement of the first anchor, the second anchor comprising a deployable frame configured to expand from a pre-deployed elongated configuration to a planar configuration when deployed; a second tether, the second tether configured to secure to a second of the anchors; a locking element that secures the first tether to the second tether; Cross-organizational systems.

17. 14. The tissue crossing system of claim 13, further comprising a tether lumen, which secures a first tether to a first anchor.

18. 14. The tissue crossing system of claim 13, wherein the wire is an electrically charged crossing wire.

19. 14. The tissue crossing system of claim 13, wherein the tissue protection device is positioned around a first of the wires.

20. 14. The tissue crossing system of claim 13, further comprising a capture basket, which captures the wire after delivery.

21. 14. The tissue crossing system of claim 13, wherein the wire delivery catheter is deflectable and twistable to achieve a desired vector for the first of the wires.

22. 14. The tissue crossing system of claim 13, wherein the leading end of the first tether includes a plurality of crimps, and the first wire can be secured to the first tether at one of the crimps, thereby facilitating replacement of the first wire with the first tether.

23. 14. The tissue crossing system of claim 13, further comprising a crimp connector that connects a first said wire to a first said tether.

24. 24. The tissue crossing system of claim 23, wherein the crimp connector facilitates exchange of the first wire with a first tether.

25. 1. A multiple anchor system for crossing tissue, said system comprising: a first anchor for placement adjacent to tissue, the first anchor including a deployable frame configured to expand from an elongated configuration within the anchor delivery catheter to a planar configuration when placed adjacent to tissue; a first tether, the first tether configured to secure to the first anchor; a second anchor for placement adjacent to tissue, the second anchor including a deployable frame configured to expand from an elongated configuration within the anchor delivery catheter to a planar configuration when placed adjacent to tissue; With a locking element, Multi-anchor system.

26. 26. The multiple anchor system of claim 25, wherein the locking element is configured to secure a first of the tethers to a second of the anchors.

27. 26. The multiple anchor system of claim 25, further comprising a second tether, the second tether configured to secure to a second of the anchors, and the locking element coupling the first tether to the second tether.

28. 1. A method for traversing tissue and delivering and deploying a tensionable element and an anchor, the method comprising: crossing the tissue with a first crossing wire; capturing a first said transverse wire; replacing a first of the transverse wires with a tensionable element; delivering a first anchor attached to the tensionable element, the first anchor consuming from an elongated configuration to a planar configuration upon delivery; crossing the tissue with a second crossing wire; capturing a second said transverse wire; replacing a second said transverse wire with a tensionable element; delivering a second anchor attached to the tensionable element, wherein upon delivery, the second anchor consumes from an elongated configuration to a planar configuration. method.

29. 29. The method of claim 28, wherein the tensionable element replacing a first of the traverse wires and the tensionable element replacing a second of the traverse wires are the same tensionable element.

30. An elongate catheter having a proximal end and a distal end, comprising: a) an elongate tubular body having a proximal end and a distal end and defining at least one elongate passageway therethrough, said elongate tubular body defining a longitudinal axis along its length; b) an anchor configured to be directed through the elongated passage, the anchor including a deployable frame configured to expand from a flat elongated configuration to a planar configuration, the anchor coupled to a tensionable tether; catheter.

Images