Suture Clips

Abstract

The present invention describes a variety of suture clips that can be introduced to the heart via a transvascular / transseptal approach and surgically closed from a position completely within the left atrial appendage (LAA). Multiple arms of a variety of suture clips made of a superelastic alloy are expanded from a catheter delivery system, anchored in the left atrial appendage and / or the hole of the left atrial appendage, and then folded again into a suture configuration. Folding is optionally performed by a return mechanism, in which the multiple arms are constrained to fold back in a direction opposite to their original expansion direction; or by an eversion mechanism, in which the multiple arms partially move beyond their expanded position to close to each other on an opposite side of their original position. In some embodiments, multiple delivery systems include additional elements to assist in placing the clip in the left atrial appendage, for example, a spreader for spreading the left atrial appendage; and / or a plug for preventing deep invasion of the left atrial appendage.

Description

[0001] Related Applications

[0002] This application claims the benefit of priority under 35 USC §119(e) to U.S. Provisional Patent Application No. 62 / 662,266, filed on April 25, 2019; the contents of which are incorporated herein by reference in their entirety.

[0003] Field and Background of the Invention

[0004] In some embodiments of the present invention, the present invention relates to the field of closure devices for medical use, and more particularly, to closure devices for use in the left atrial appendage (LAA).

[0005] The medical community believes that the left atrial appendage is a potential cause of cardiovascular accidents because it may cause embolism.

[0006] Closure of the left atrial appendage can be performed, for example, with an open chest approach or by a minimally invasive transvascular (usually transseptal) approach. In an open chest approach, the surgeon may suture the hole (the connection between the left atrial appendage and the left atrium). In a transvascular approach, the interventional cardiologist does not open the patient's chest, but instead uses a plug and / or stent-like structure configured in the left atrial appendage to seal the left atrial appendage. The principle is that a reduction in atrial wall irregularities and / or circulatory dead zones can reduce the likelihood of thrombosis. Summary of the invention

[0007] According to some embodiments of the present disclosure, a suture clip for closing an integral cavity hole is provided, comprising: a plurality of arms, each of the arms being connected to a core of the suture clip at a bottom side of the arms; and a respective anchor at an end of each of the arms; wherein the suture clip is configured to convert between the following configurations: a folded delivery configuration; an expanded anchoring configuration having a diameter that is at least 5 times larger than a diameter of the suture clip in the folded delivery configuration, and a folded suturing configuration, formed to reposition the plurality of anchors to a position where the plurality of anchors close tissue around a hole after the tissue is attached by contact with the plurality of anchors in the expanded anchoring configuration; wherein the suture clip in the folded delivery configuration is configured to be attached to a delivery frame and to be advanced into the body cavity hole on the delivery frame by moving distally along a proximal-to-distal axis of the suture clip; and wherein the plurality of anchors of the suture clip in the folded suturing configuration are located near the core along the proximal-to-distal axis.

[0008] In some embodiments, the suture clip elastically self-expands from the collapsed delivery configuration to the expanded anchored configuration.

[0009] In some embodiments, the carrier is configured to be separated from the suture clip in the folded suturing configuration and withdrawn through tissue closed by the plurality of anchors of the suture clip to a side of the closed tissue opposite to the suture clip.

[0010] In some embodiments, the suture clip is configured to elastically self-fold from the expanded anchoring configuration to the folded suture configuration.

[0011] In some embodiments, the suture clip is configured to elastically self-fold from the expanded anchoring configuration to the folded suture configuration.

[0012] In some embodiments, the suture clip in the collapsed delivery configuration is enclosed within the sleeve cavity.

[0013] In some embodiments, the suture clip is configured to elastically self-expand from the collapsed delivery configuration to the expanded anchoring configuration after being partially unsheathed from the sheath lumen.

[0014] In some embodiments, the suture clip is configured to elastically self-fold from the expanded anchoring configuration to the folded suture configuration upon further unsheathing from the sheath cavity.

[0015] In some embodiments, the suture clip is configured to evert during transition between the collapsed delivery configuration and the expanded anchoring configuration such that a radially inward side of the plurality of anchors in the collapsed delivery configuration faces outward in the expanded anchoring configuration.

[0016] In some embodiments, the suturing clip is configured to evert during transition between the folding delivery configuration and the folding suturing configuration such that a portion of the plurality of arms initially located on a distal side of the core moves to a proximal side of the core.

[0017] In some embodiments, upon movement of the closure disc, the suture clip folds from the expanded anchoring configuration to the folded suture configuration.

[0018] In some embodiments, the closure disk moves from a position closer to the core of the suture clip to a position farther from the core to cause the suture clip to fold from the expanded anchoring configuration to the folded suture configuration as the closure disk moves.

[0019] In some embodiments, transitioning from the expanded anchoring configuration to the folded suturing configuration comprises a return movement of the plurality of arms in a direction opposite to a direction of expansion of the plurality of arms from the folded delivery configuration to the expanded anchoring configuration.

[0020] In some embodiments, the suture clip is provided with a spreader that can be manipulated separately to extend laterally from the transvascular catheter, inserted into the body cavity hole, and configured to contact tissue of the body cavity hole using a plurality of clamps to set a position for deploying the suture clip from the sheath.

[0021] In some embodiments, the suture clip is unsheathed by movement of a sheath relative to a proximal end of the suture clip, and the suture clip is oriented in the sheath along a proximal-to-distal axis, the core is on a proximal side of the suture clip, and the plurality of anchors are on a distal side of the suture clip.

[0022] In some embodiments, the suture clip is unsheathed by movement of a sheath relative to the proximal end of the suture clip, and the suture clip is oriented in the sheath along a proximal-to-distal axis, the plurality of anchors are on a proximal side of the suture clip, and the core is on a distal side of the suture clip.

[0023] In some embodiments, the plurality of anchors in the folded suture configuration define a zigzag pattern extending along a closed band of a closed tissue.

[0024] In some embodiments, the plurality of anchors in the folded suture configuration pull tissue into a surgical purse-string suture configuration.

[0025] In some embodiments, the plurality of arms extend from the core, each of the arms extending from a separate base attached to the core.

[0026] In some embodiments, a first plurality of arms extend from the core via a trunk that is common to the plurality of arms.

[0027] In some embodiments, the first plurality of arms are configured to interdigitate with the second plurality of arms in the folded and stitched configuration.

[0028] In some embodiments, a material of the plurality of arms includes nickel titanium alloy.

[0029] In some embodiments, a material of the suture clip includes a radiopaque marker that is more radiopaque than nitinol.

[0030] In some embodiments, at least one of the plurality of arms is mounted to at least one side of the torsion bar, and the torsion bar is configured to twist to move the at least one of the plurality of arms from the folded conveying configuration to the folded final configuration.

[0031] In some embodiments, at least one of the plurality of arms is configured to flex along a longitudinal extent of the arm to move at least one of the plurality of arms from the folding and delivering configuration to the folding and sewing configuration.

[0032] According to some embodiments of the present disclosure, a suture clip for closing an integral cavity hole is provided, characterized in that the suture clip comprises: a plurality of arms, each of which is connected to a core of the suture clip at a bottom side of the arm; a respective anchor at an end of each of the arms; and a closing disk; wherein the suture clip is configured to convert between the following configurations: a folded delivery configuration sized to be covered by a lumen of a transvascular catheter; an expanded anchoring configuration having a diameter that is at least 5 times larger than a covered diameter of the suture clip in the folded delivery configuration; and a folded suturing configuration, after the tissue is attached by contact with the plurality of anchors in the expanded anchoring configuration, formed to reposition the plurality of anchors to a position where the plurality of anchors close tissue around a hole; wherein the closure disk is movable along a distal-proximal axis of the suture clip to actuate the conversion between the expanded anchoring configuration and the folded suturing configuration.

[0033] According to some embodiments of the present disclosure, a suture clip for closing an integral cavity is provided, characterized in that the suture clip comprises: a plurality of arms, each of the arms being connected to a core of the suture clip at a bottom side of the arm; and a respective anchor at an end of each of the arms; and wherein the suture clip is configured to convert between the following configurations: an extended anchoring configuration, positioning at least two anchors on one side of a perimeter and at least one anchor on the other side of the perimeter; and a folded suture configuration, repositioning the plurality of anchors from the extended anchoring configuration by moving the at least one anchor to cross between the at least two anchors.

[0034] In some embodiments, the at least two anchors include at least four anchors and the at least one anchor includes at least three anchors; and the folded suture configuration repositions the plurality of anchors from the expanded anchoring configuration by moving each of the at least three anchors to cross between pairs of the at least four anchors.

[0035] According to some embodiments of the present disclosure, a suture clip for closing an integral cavity hole is provided, characterized in that the suture clip comprises: a plurality of arms, each of the arms being connected to a core of the suture clip at a bottom side of the arm; and a respective anchor at an end of each of the arms; wherein the suture clip is configured to convert between the following configurations: a folded delivery configuration, which can be expanded to attach the plurality of anchors to the tissue of the body cavity hole, and a folded suturing configuration, which is formed to reposition the plurality of anchors to a position where the plurality of anchors close the body cavity hole by movement of the attached tissue; and wherein the plurality of anchors are away from the core in the folded delivery configuration and close to the core in the folded suturing configuration, and in both configurations, the core is maintained in a same proximal-to-distal direction.

[0036] In some embodiments, the plurality of arms are configured to evert while repositioning the plurality of anchors between the folded delivery configuration and the folded suturing configuration.

[0037] In some embodiments, the anchors are positioned radially inwardly of the arms in the folded delivery configuration and move radially outwardly of the arms during movement of the arms toward the folded suturing configuration.

[0038] According to some embodiments of the present disclosure, a device for unfolding in an integral cavity is provided, characterized in that the device comprises: a plurality of arms, each arm being connected to a core of the device at a bottom side of the arm; and a respective end of each arm; wherein the device is configured to convert between the following configurations: a folded conveying configuration having a plurality of ends in a first configuration; a folded final configuration formed to reposition the plurality of ends to a second configuration; and a torsion bar; wherein at least one of the plurality of arms is mounted on at least one side of the torsion bar, and the torsion bar is configured to twist so as to move at least one of the plurality of arms from the folded conveying configuration toward the folded final configuration.

[0039] In some embodiments, the device is a suture clip comprising a respective anchor at each end; and wherein: the folding delivery configuration is expandable to attach the plurality of anchors to tissue of the body cavity hole; and the folding suturing configuration repositions the plurality of anchors to a position where the plurality of anchors close the body cavity hole by movement of the attached tissue.

[0040] In some embodiments, the torsion bar is located where at least one of the plurality of arms engages the core on a bottom side of the arm.

[0041] In some embodiments, the torsion bar is located between two sections of at least one of the plurality of arms.

[0042] According to some embodiments of the present disclosure, a method for closing a body cavity hole is provided, the method comprising: advancing a suture clip attached to a conveying frame through the body cavity hole from a first side of the body cavity hole to a second side of the body cavity hole; at least partially expanding the suture clip on the second side of the body cavity hole; anchoring tissue defining a periphery of the body cavity hole to multiple anchors of the suture clip; and folding the suture clip so that the multiple anchors close the body cavity hole, while the suture clip remains on the second side of the closed body cavity hole.

[0043] In some embodiments, the suture clip is retained entirely on the second side of the closed body cavity hole.

[0044] In some embodiments, the suture clip does not expose a plurality of contents of the body cavity on the first side of the closed body cavity hole after being folded.

[0045] In some embodiments, the method includes withdrawing the delivery scaffold through the closed body cavity hole to the first side of the body cavity hole while the suture clip is maintained on the second side of the body cavity hole and the body cavity hole is held closed by the folded suture clip.

[0046] In some embodiments, the body cavity opening is an opening of a left atrial appendage.

[0047] In some embodiments, the advancing includes advancing the delivery scaffold through a transvascular route to reach the first side of the body cavity aperture.

[0048] In some embodiments, the advancing includes advancing the delivery frame through a septal wall of the heart to reach the first side of the body cavity hole.

[0049] In some embodiments, the first side is an atrial side of an opening of a left atrial appendage, and the second side is within the left atrial appendage.

[0050] In some embodiments, the fold closes a only aperture leading to a second side of the body cavity aperture.

[0051] In some embodiments, the expanding includes unhooking at least a portion of the plurality of arms of the suture clip and allowing the plurality of arms to elastically self-expand.

[0052] In some embodiments, the folding includes unhooking a portion of the plurality of arms of the suture clip and allowing the plurality of arms to elastically fold upon themselves.

[0053] In some embodiments, the folding includes operating a closure disk to force the plurality of arms into a smaller expanded diameter.

[0054] In some embodiments, the folding comprises moving the plurality of anchors into a sawtooth configuration.

[0055] In some embodiments, the folding comprises moving the plurality of anchors toward a common radial center.

[0056] In some embodiments, the folding comprises moving at least one of the plurality of anchors radially outward while at least one of the plurality of anchors moves radially inward.

[0057] Unless otherwise defined herein, all technical and / or scientific terms used herein have the same meaning as those generally understood by those of ordinary skill in the art to which the present invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In the event of a conflict, the patent specification and its definition shall prevail. In addition, materials, methods and examples are illustrative only and are not intended to be necessarily restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0058] Some embodiments of the present invention are described herein with reference to the accompanying drawings, by way of example only. With specific reference now to the accompanying drawings, it is emphasized that the details shown are by way of example and for the purpose of illustrative discussion of embodiments of the present invention. In this regard, it will be apparent to those skilled in the art from the description in conjunction with the accompanying drawings how embodiments of the present invention may be practiced.

[0059] In the diagram:

[0060] Figure 1A schematically illustrates a suture clip attached to tissue within a left atrial appendage according to some embodiments of the present disclosure;

[0061] Figure 1B Schematically illustrates a device in an expanded configuration suitable for tissue engagement according to some embodiments of the present disclosure. Figure 1A Suture clips;

[0062] Figure 1C A suture clip according to some embodiments of the present disclosure is schematically illustrated engaging tissue within a left atrial appendage and then undergoing a configurational change to close a left atrial appendage hole.

[0063] Figure 1D Schematically shows some embodiments of the present disclosure. Figure 1C suture clip in the closed configuration of the left atrial appendage;

[0064] Figure 1E Schematically illustrates a transseptal approach insertion of a suture clip using a delivery system according to some embodiments of the present disclosure;

[0065] Figure 1F is a schematic flow chart of a method for inserting a suture clip using a delivery system according to some embodiments of the present disclosure;

[0066] Figure 1G is a schematic flow chart of closing an integral cavity hole by a suture clip according to some embodiments of the present disclosure, wherein the suture clip closes the hole from a side of the closure opposite to a side to which the suture clip is introduced;

[0067] FIG. 2A to FIG. 2I schematically illustrates the deployment stage of a suture clip according to some embodiments of the present disclosure;

[0068] Figure 2J to Figure 2L Schematically illustrates the movement of the anchoring position during the transition of a suture clip between an expanded anchoring configuration and a folded suture configuration according to some embodiments of the present disclosure;

[0069] Figure 2M to Figure 2P Detail of the interaction between a delivery system and a suture clip is shown according to some embodiments of the present disclosure;

[0070] Figure 3A Schematically illustrates an expanded configuration of a recoverable core arm assembly of a suture clip according to some embodiments of the present disclosure;

[0071] Figure 3B Schematically illustrates a suture clip in an expanded configuration according to some embodiments of the present disclosure, comprising a closure disc;

[0072] Figure 3C schematically illustrates a suture clip in a refolded suture configuration according to some embodiments of the present disclosure, the suture clip being folded by movement of a closure disk;

[0073] Figure 3D Schematically illustrates a sutured closure disc according to some embodiments of the present disclosure;

[0074] Figure 3E Schematically illustrates an expanded configuration of a recoverable core arm assembly of a suture clip according to some embodiments of the present disclosure;

[0075] Figure 3F to Figure 3G Schematically illustrates a suture clip in an expanded configuration according to some embodiments of the present disclosure, comprising a closure disc;

[0076] Figure 3Hschematically illustrates a suture clip in a refolded suture configuration folded by movement of a closure disk according to some embodiments of the present disclosure;

[0077] Fig. 3I Schematically illustrates a sutured closure disc according to some embodiments of the present disclosure;

[0078] Figure 4A Schematically illustrates an expanded configuration of a core arm assembly of a suture clip according to some embodiments of the present disclosure;

[0079] Figure 4B Schematically illustrates a suture clip 400 in an expanded configuration according to some embodiments of the present disclosure, including a closure disc 420;

[0080] Figure 4C Schematically illustrates a sutured closure disc according to some embodiments of the present disclosure;

[0081] FIG. 4D to FIG. 4H shows the deployment of a suture clip under the control of a deployment system including a deployment member according to some embodiments of the present disclosure;

[0082] FIG. 5A to FIG. 5D Schematically illustrates a portion of an everted suture clip according to some embodiments of the present disclosure;

[0083] FIG. 5E to FIG. 5F schematically illustrates an assembled suture clip in an expanded configuration according to some embodiments of the present disclosure;

[0084] Figure 5G to Figure 5H schematically illustrates an assembled suture clip in an everted configuration according to some embodiments of the present disclosure;

[0085] FIG. 6A to FIG. 6D schematically illustrates the installation of a torsion bar arm according to some embodiments of the present disclosure;

[0086] 7A to 7F schematically illustrates a suture clip in three different stages of deployment, each stage from two different perspectives, according to some embodiments of the present disclosure;

[0087] Figure 7G Schematically illustrates a portion of a suture clip (only one arm is shown) according to some embodiments of the present disclosure, comprising an arm attached to a core, wherein the curvature of the arm is around one or more torsion bars, including torsion bars positioned along the longitudinal extent of the arm;

[0088] FIG. 8A to FIG. 8G Schematically illustrates an everted closed suture clip including a plurality of arm subassemblies according to some embodiments of the present disclosure;

[0089] 9A to 9F A sequence of operations is shown in accordance with some embodiments of the present disclosure, wherein a tissue spreader is used with a delivery system to assist in accessing the left atrial appendage for insertion of a suture clip;

[0090] FIG. 10A to FIG. 10C schematically illustrates design aspects of various tissue spreaders according to some embodiments of the present disclosure; and

[0091] FIG. 11A to FIG. 11G An everted closing suture clip including a plurality of arm subassemblies according to some embodiments of the present disclosure is schematically illustrated. DETAILED DESCRIPTION

[0092] In some embodiments of the present invention, the present invention relates to the field of closure devices for medical use, and more particularly, to closure devices for the left atrial appendage.

[0093] Overview

[0094] An aspect of some embodiments of the present disclosure relates to suture clips configured to close a hole from a side of the hole relative to a side into which the suture clip is introduced and methods of using the same.

[0095] In some embodiments, a suture clip is configured to close a left atrial appendage (LAA) in a heart. In order to reduce the thrombotic potential of the left atrial appendage, the left atrial appendage is closed in some patients. In some embodiments, the suture clip is used to close the left atrial appendage from a position substantially completely within the left atrial appendage. By mimicking the advantages of the left atrial appendage closure suture technology, potential advantages can be provided. As long as it closes the hole, no (or very little) artificial material remains in the atrial wall. Artificial materials may cause thrombosis, increase the risk of cerebrovascular accident (CVA), and / or produce an indication for supportive treatment with Coumadin or other anticoagulants.

[0096] The clip also offers the potential advantage of placement via a transvascular (minimally invasive) approach. Using a catheter, the suture clip is introduced (e.g., via a transseptal approach) into the left atrial appendage. The suture clip is then expanded within the left atrial appendage and connected to the left atrial appendage opening (hole). The clip is then folded into a suture configuration to close the left atrial appendage. When folded into the suture configuration, the suture clip remains within the left atrial appendage, isolated from general circulation. The left atrial appendage is thereby transformed into a closed lumen with no open passages into or out of a bag defined by the tissue of the left atrial appendage, which contains the suture clip.

[0097] In some embodiments, the flexible components of a suture clip (including the flexible arms and / or hinges of such suture clip) are comprised of a superelastic alloy such as nitinol.

[0098] Superelasticity is associated with elastic deformation up to an anomalous maximum strain (e.g., 7% to 13%); considering that the superelastic material still has a high elastic modulus (resistance to elastic deformation) typical of structural metals, such as titanium or steel; for example, an elastic modulus of 20 to 100 GPa. This gives the superelastic material the potential to store large amounts of energy through its deformation (e.g., energy that can be converted into a closing force), especially compared to similarly sized structures made of other materials.

[0099] Without specifying a particular mechanism or theory, superelasticity in metal alloys is understood to involve an elastically resilient response to applied stress associated with reversible motion during a crystal phase transition, for example, between the austenitic and martensitic phases of the crystal.

[0100] As used herein, the shape, configuration, and / or position of a component's "superelastic setting" refers to the shape that the component tends to assume when unconstrained. The shape (sometimes referred to as a "memory" shape) can be set during the manufacturing process, for example, by fixing the component in a target shape and then heating it to a temperature above a critical temperature to reset its superelastic shape.

[0101] Superelasticity is also known as "pseudoelasticity". Superelastic alloys may also have shape memory properties, thereby demonstrating superelasticity within a certain range of conditions (e.g., temperature range). Outside this range, the alloy is more easily deformed; but when returned to the superelastic range, the alloy returns to its superelastic set shape.

[0102] The common term "nitinol" refers to a family of superelastic nickel-titanium alloys (in which examples have different ratios of nickel to titanium) with good biocompatibility. Some superelastic materials may include additional elements, and / or different systems based on alloying elements. For example, superelastic alloys based on the systems Fe-Ni-Al, Cu-Zn-Al, Fe-Mn-Si, and Cu-Al-Ni (optionally in combination with other elements) have been described. Superelastic materials incorporated with polymers (e.g., polymer-coated nickel-titanium alloys) have also been described. As long as other examples and / or types of superelastic materials are available, embodiments of the present disclosure are optionally adapted to use them.

[0103] Thus, the high strain resilience of the superelastic members allows for large configuration changes. Their high elastic modulus allows those configuration changes to proceed while applying elastic forces that may be sufficient to draw attached tissues together and / or otherwise applied, such as to help obtain anchoring on the tissue. During deployment to a target orifice (e.g., an orifice of the left atrial appendage), the suture clip passes between the following configurations:

[0104] A collapsed delivery configuration that is small enough for transvascular delivery, for example, small enough to fit within a delivery tube having a diameter of 5 mm or less, a diameter of 4 mm or less, a diameter of 3 mm or less, and / or fit within another diameter, optionally within the range of approximately 3 to 5 mm.

[0105] The expanded anchoring configuration places the tissue anchoring element (anchor) in a position where it can be attached to the tissue. In some embodiments, the expanded anchoring configuration is expanded to a maximum of at least 15 mm, 20 mm, 25 mm, 30 mm, or other diameter. In some embodiments, the expanded anchoring configuration is at least 4x, 5x, 6x, 7x, 8x, 9x, 10x, or other factors larger than the diameter of the suture clip in the collapsed delivery configuration.

[0106] The folded suture configuration brings the tissue anchoring elements closer together to form a closure, such as a band-like or surgical purse-string closure.

[0107] In some embodiments, the element that undergoes a configuration change includes arms attached via a common base or "core" of the suture clip. The attachment side of the arm is also referred to herein as the "base side" of the arm. The arms themselves can be flexible, and / or they can be attached to the core by flexible elements such as torsion springs. The suture clip includes, for example, 2 to 20 arms; for example, 2, 5, 7, 10, 13, 15, or other numbers of arms.

[0108] In some embodiments, one or more transitions are configured such that they are self-actuated by elastic forces acting from within the superelastic material of the suture clip. For example, the suture clip elastically self-expands from a folded delivery configuration to an expanded anchoring configuration, and / or elastically self-folds from an expanded anchoring configuration to a folded suturing configuration. The elastic forces tend to restore the position of the arms (particularly the anchors they carry) to the superelastically set shape of the suture clip, optionally during one or more expansion and / or folding stages.

[0109] In some embodiments, one or more transitions are produced by the addition, removal, and / or movement of a restraining device. For example, elastic self-expansion and / or self-folding of a suture clip is optionally initiated by at least partial unsheathing of the suture clip from a sheath (which serves as a restraining device). In some embodiments, the expansion and / or folding is caused by movement of a control member, such as a closure disk attached to the arms in a manner that limits their expanded diameter, such as by passing each arm through a hole in the closure disk. When the closure disk is moved proximally or distally (for example), the arms are constrained to close or open.

[0110] In some embodiments, the deformation is actuated by the operation of a relatively long and narrow control member, which passes through the hole intended to be closed and is attached to the suture clip. The suture clip, once folded into its folded suture configuration, remains on the far side of the closure, opposite the side from which it was initially introduced. After the closure is complete, the control member is withdrawn to the other side. Due to the closing force applied by the folded suture clip, the small gap forced by the previous presence of the control member is closed upon withdrawal.

[0111] Although examples of the use of suture clips are provided herein with particular reference to the closure of the left atrial appendage, it should be understood that the clips are optionally used, and the clips are modified as necessary, to close other body cavities; for example, the appendix, fistulas, and / or gastric restrictions. Embodiments of suture clips can also be used, for example, in the reverse suture of wounds and / or surgical incisions and / or punctures. For example, the gastrointestinal tract can be closed by suture clips deployed via an intraperitoneal (e.g., laparoscopic) access, and optionally subsequently removed via an intraluminal (e.g., endoscopic) access. In contrast, the deployment of the suture clip is optionally performed from the outside of the lumen through the lumen, and the retrieval (if performed) is performed from the entrance outside the lumen. This may be useful, for example, as a planned and / or emergency method, using a channel from the "wrong side" of an opening to achieve closure of the opening. In another example, the skin can be reverse sutured to have the potential advantages of safety for attachment and / or later aesthetic appearance, and optionally, the reverse suture clip is then retrieved from another access port via laparoscopy. Closure can be performed from both sides of the hole and optionally from one direction of entry. In some embodiments, the suture clip is configured to form closure in a non-surgical situation, such as to perform concealed repairs to fabrics and / or membranes, and / or to position and clamp such fabrics to receive such repairs.

[0112] In some embodiments, the arm of a suture clip includes an anchor configured to engage with tissue so that a force applied to the anchor moves the tissue to a new position. Optionally, the anchor is in the shape of barbs, hooks, spikes, or other shapes. In some embodiments, the anchor operates by articulating or bending differently depending on the direction of movement (e.g., in the style of a switching harpoon). For example, the anchor can be hinged or otherwise constructed so that when receiving a force in the direction of insertion, it remains rigid, but when receiving a pulling force in the opposite direction, the hinge or flexible member activates so that a portion of the anchor rotates or expands and cannot be easily dragged out of the hole it enters. Additionally or alternatively, the anchor can be hinged and / or bent so that it becomes smaller radially as it enters the self-inflicted hole during insertion, but when a force is applied in the opposite direction, it expands and / or tends to be forced into a radially expanded state.

[0113] Compared to suturing by needle and thread, for example, a potential advantage of an actuated suturing clip is that the complexity of the configuration is reduced. Only relatively few fine control operations are required, which can make the surgeon's task easier, more reliable and / or easier to perform, while reducing the requirements for training and / or experience.

[0114] An aspect of some embodiments of the present disclosure relates to a suture clip configured to restore closure of a hole from an opposite side of the hole to the side through which the suture clip was introduced. In some embodiments, the restoration closure closes the only hole on one side of the body cavity hole, with the suture clip retained in the hole, sealing it within the closed chamber.

[0115] In some embodiments, the arms of a suture clip inserted into a body cavity are expanded from a first folded configuration to a second expanded configuration. In the expanded configuration, the suture clip is manipulated to recruit tissue of the body cavity by attaching to the body cavity. Optionally, recruitment is achieved by attaching an anchor positioned by the expanded arms to a predetermined configuration, for example, a configuration that is complementary to the shape of the anchored tissue and / or a configuration that can be manipulated by relatively simple and / or stereotyped movements to achieve reliable attachment.

[0116] From the expanded configuration, the device is actuated to achieve closure. In some embodiments, closure includes moving the attachment point to a new configuration by reversing (returning) a direction in which the arms and / or anchors moved during expansion to the expanded configuration.

[0117] In some embodiments, movement of the attachment point is actuated by manipulation of a constraining device, such as a disk, ring, or other form of clamp, which constrains the maximum radial expansion radius as it moves along a length of the device.

[0118] One aspect of some embodiments of the present disclosure relates to a suture clip configured to evert and close a hole from the opposite side of the hole from the side through which the suture clip was introduced. In some embodiments, the evert closure closes the only hole on one side of the body cavity hole, and the suture clip is retained in the hole, sealing it within the closed chamber.

[0119] In some embodiments, the arms of a suture clip inserted into a body cavity are expanded from a first folded configuration to a second expanded configuration. In the expanded configuration, the suture clip is manipulated to recruit tissue of the body cavity by attaching to the body cavity. Optionally, recruitment is achieved by attaching an anchor positioned by the expanded arms to a predetermined configuration, for example, a configuration that is complementary to the shape of the anchored tissue, and / or a configuration that can be manipulated by relatively simple and / or stereotyped movements to achieve reliable attachment.

[0120] In some embodiments, the anchor is anchored in the tissue with a success rate less than complete anchoring, for example, at least 75% anchoring, at least 80% anchoring, at least 85% anchoring, or other anchoring success rates. In the event that one or more arms fail to anchor, the remaining anchors may still be sufficient to bring the tissue of a hole opening into a suitable closed configuration.

[0121] From the expanded configuration, the device is actuated to achieve closure. In some embodiments, closure includes moving the attachment point to a new configuration by continuing a movement in a direction that moved the arm and / or anchor during expansion to the expanded configuration, thereby causing eversion of the initial folded delivery configuration. In some embodiments, eversion includes, for example, an arm portion of an anchor portion that was initially (for example) on the distal side of a core (base) of the suture clip to a position on the proximal side of the core.

[0122] In some embodiments, additionally or alternatively, eversion includes an anchoring side of the arm that is radially outward in the expanded anchored state, but radially inward in the collapsed delivery state.

[0123] An aspect of some embodiments of the present disclosure relates to a suture clip configured for closing a hole in tissue to an occlusive tape.

[0124] In some embodiments, the suture clip operates by moving a plurality of anchor locations attached to the perimeter of the hole from an open-cell configuration to a closed-cell configuration.

[0125] In some embodiments, the movement of the plurality of anchor locations includes a staggered combination of anchor locations moved from one side of the initial perimeter and anchor locations moved from another side of the initial perimeter. In some embodiments, the staggered combination includes one or more anchors (and / or support members, such as an arm supporting an anchor) from one side of the initial perimeter intersecting a geometric line extending between two anchors from another side of the initial perimeter.

[0126] In some embodiments, the closure band of the perimeter is zigzag-shaped. For example, the local lateral end of the zigzag along one side of the zigzag (the angular vertices or "points" of the zigzag) corresponds to the anchor initially connected to one side of the hole perimeter, while the local lateral end of the zigzag along the other side of the zigzag corresponds to the anchor initially connected to the other side of the hole perimeter. One side of the zigzag corresponds to the anchor initially connected to the other side of the hole perimeter. In some embodiments, the relative anchoring positions relative to a central longitudinal axis of the zigzag are swapped during closure so that anchors from one side of the perimeter are located on opposite sides of the axis when closed. In some embodiments, the zigzag includes at least two segments extending between two anchoring locations, for example, a chevron or "V" shape. In some embodiments, the zigzag includes three or more segments (optionally, N segments, where N>2) extending between four or more anchoring locations (optionally, N+1 anchoring locations, each anchoring location corresponding to an anchor successfully anchored in the tissue). In some embodiments, N+1 is the number of anchoring locations between 3 and 20. Optionally, the vertices of the zigzag shape formed about each anchoring location are rounded.

[0127] The closed pore configuration offers potential advantages for sealing and / or enhancing pore closure over time because a relatively small area of ​​new endothelial tissue needs to be generated through the closed pore, for example, compared to a plug closure.

[0128] In some embodiments, the movement of the multiple anchor locations includes at least one anchor moving radially outward from the initial perimeter, while the other anchors move radially inward. By the movement of the anchors, the perimeter is thus both stretched in one direction and folded in another direction, similar to the effect of a flexible ring stretched between pulling forces at two opposite locations.

[0129] One aspect of some embodiments of the present invention involves using torsion bars (also referred to herein as "torque beams") as springs to provide a driving force for movement of flexible suture clip elements (e.g., arms and / or anchors mounted on arms).

[0130] In some embodiments, the torsion bar is provided by cutting (e.g., laser cutting) a rod shape in the material of the core and / or arms. Connected to the middle of the rod is a member on one side of the connecting element, and connected to the end of the rod is a member on the other side of the connecting element. The torsion bar is in a relaxed state, setting the angle that the joint will tend to in the absence of external restraining forces. When the relaxed state is flat, the joint in the relaxed state will be flat (straight). When the relaxed state is twisted (e.g., because it is set to twist by superelasticity), the joint in the relaxed state will be twisted (e.g., bent outward or bent in another direction). The force that deforms the joint from the relaxed state will be resisted by the restoring force. For a given angular deformation (twisting about the longitudinal axis), the torsion bar provides the potential advantage of storing a relatively large amount of potential energy in the spring, for example, compared to the deformation of a similarly sized leaf spring through the same angle (deflection of the longitudinal axis).

[0131] In some embodiments, the torsion bar enables manipulation of tissue between an expanded anchoring configuration and a folded suture configuration by purely rotational motion. This movement may be without radial expansion. This movement may be performed along a direct and possibly shortest route. This provides the potential advantage of reducing the likelihood of tissue separation from the anchor.

[0132] In some embodiments, the torsion bars are angled at different angles to provide an arm of a suture clip with a plurality of different corresponding rotation angles. This is a potential advantage for increasing the flexibility of configuration options for moving between a pre-movement configuration and a post-movement configuration of a suture clip member (e.g., an anchor).

[0133] One aspect of some embodiments of the present disclosure relates to the formation of an aperture for receiving a suture clip. In some embodiments, an aperture expander is actuated to engage the side of an aperture (e.g., an aperture of a left atrial appendage) to prepare for advancing the suture clip toward the aperture, expanding the suture clip, and / or anchoring the suture clip into tissue of the aperture.

[0134] Before explaining at least one embodiment of the present disclosure in detail, it should be understood that the application of the present disclosure is not necessarily limited to the details of the structure and the arrangement of components and / or methods described in the following description and / or shown in the drawings or examples. The present disclosure can have other embodiments or can be practiced or implemented in various ways.

[0135] Closure of the left atrial appendage with suture clips

[0136] Closure of the left atrial appendage:

[0137] Reference now Figure 1A , which schematically illustrates a suture clip 100 attached to tissue within the left atrial appendage 1 according to some embodiments of the present disclosure. Figure 1B, which schematically illustrates an expanded configuration suitable for tissue engagement according to some embodiments of the present disclosure Figure 1A Suture clip 100. Further references Figure 1C , which schematically illustrates a suture clip 100 according to some embodiments of the present disclosure, which has engaged tissue within the left atrial appendage 1 and then undergone a configuration change to close the hole 3 of the left atrial appendage. Figure 1D , which schematically shows a method of performing a Figure 1C Suture clip 100 with a left atrial appendage closure configuration.

[0138] The suture clip 100 may optionally be constructed according to any of a variety of forms and designs, more specific examples of which include the suture clips 300, 350, 400, 500, and 800 described herein. These more specific examples differ from one another in features such as the number of arms, details of the shape of the arms, details of the shape of the anchors, details of the core design, and the type of closure. Additionally or alternatively, embodiments of the suture clip 100 include any suitable arrangement of anchoring locations. For example, in an extended anchoring configuration, the anchors may optionally be arranged in a circular, elliptical, oval, split curve (arranged along two or more perimeter portions), split line (arranged along two or more line segments), and / or an open perimeter configuration. In a folded suture configuration, for example, the anchors may optionally be arranged in a circular (e.g., folded toward a common center), linear, zigzag, or another pore-closing configuration.

[0139] It should be understood that Figures 1A to 1F The general features of suture clip 100 introduced in the description of are applicable to any of the more specific embodiments herein, mutatis mutandis, as explained in the more specific description thereof.

[0140] Figure 1A and Figure 1C It is drawn from the perspective of an atrial side of a left atrial appendage, with reference to the foramen 3 of the left atrial appendage, which is an opening in the atrial wall 5 leading to the left atrial appendage 1. Figure 1A and Figure 1C A selected stage of closure of the left atrial appendage 1 using a suture clip 100 is shown.

[0141] Figure 1A The suture clip 100 is shown expanded within the left atrial appendage 1, and Figure 1B The same expanded suture clip 100 is shown, without surrounding tissue. The arms 104 of the suture clip 100 each radially expand from their respective bases where they are connected to the core 102. Anchors 106 positioned at respective terminal ends (i.e., ends opposite to the ends attached to the core 102; also referred to herein as "free ends") of the arms 100 are configured to engage tissue within the left atrial appendage 1, such as by pricking, hooking, and / or clamping. Figure 1A In the embodiment, the core 102 of the suture clip 100 is connected to a delivery system 110. In some embodiments, the delivery system 110 includes a catheter device, such as a percutaneous catheter device, which shows a distal catheter end 112. Figure 1A Prior to being positioned in the expanded position, the suture clip 100 is delivered by a delivery system 110, for example closed within a lumen of a distal catheter end 112 in a folded delivery configuration.

[0142] Figure 1C The suture clip 100 is shown in a folded suture configuration, still engaged with tissue of the left atrial appendage 1, and Figure 1D The same folded suture configuration of the suture clip 100 is shown, without the surrounding tissue. In the folded suture configuration, the suture clip 100 is pulled from its position within the left atrial appendage to close the hole 3 of the left atrial appendage, thereby forming a closure band (optionally a zigzag closure band as shown). The hole 3 of the left atrial appendage may be closed without the suture clip 100 being exposed along any side of the atrial wall 5. For example, the suture clip 100 is completely within the left atrial appendage 1 on the hole 3 side of the closed left atrial appendage, and / or the suture clip 100 is not exposed to the contents (e.g., blood) on the atrial side of the atrial wall 5. This is a potential advantage to prevent device-induced thrombosis of blood clots that enter the circulating blood pool. Attachment at the hole 3 and / or adjacent to the hole 3 may be more advantageous than attachment at other locations within the left atrial appendage because the tissue may be thicker and / or stronger than the tissue within the inner left atrial appendage.

[0143] Device positioning in preparation for LAA closure:

[0144] Reference now Figure 1E , which schematically illustrates a transseptal approach to insertion of a suture clip 100 using a delivery system 110 according to some embodiments of the present disclosure.

[0145] In some embodiments, the delivery system 110 includes a catheter sleeve 111, a distal catheter end 112, and a delivery stent 113. Optionally, a plug 118 is provided to the delivery system 110; and is configured as, for example, an inflatable balloon, an expandable braid, and / or a nitinol structure (e.g., one or more flexible struts).

[0146] Figure 1E Also shown is a schematic diagram of the atrium 4 , including the diaphragm wall 9 , the pulmonary veins 6 , the mitral valve 7 , the left atrial appendage 1 and the atrial wall 5 surrounding the hole 3 of the left atrial appendage 1 .

[0147] The suture clip 100 is shown in an expanded anchoring configuration in which the arms 100 press the anchor 106 outwardly into contact with the tissue of the foramen 3 of the left atrial appendage, where the anchor 106 can be manipulated (e.g., by movement of the suture clip via the delivery stent 113) to anchor in the tissue.

[0148] It should be noted that in some embodiments, the plug 118 is replaced by a spreader and / or used together with a spreader, such as with respect to 9A to 10C The spreader 1000 is described.

[0149] Left atrial appendage closure method

[0150] Procedures during LAA closure:

[0151] Reference now Figure 1F , which is a schematic flowchart of a method of inserting a suture clip 100 using a delivery system 110 according to some embodiments of the present disclosure.

[0152] Figure 1F The flow chart of begins with entering the atrium after the septum, for example using a 0.35 inch guidewire. The punctured septum is expanded, and the sheath (distal catheter end 112) of the suture clip 100 is introduced into the left atrium and then placed in the left atrial appendage hole.

[0153] In some embodiments, the configuration of suture clip 100 continues by including the following operations:

[0154] At block 151 , in some embodiments, the suture clip 100 is inserted into the left atrium using the deployment system 110 .

[0155] Optionally, at box 153, in some embodiments, a plug 118 is configured and positioned against the atrial wall 5. A tip 116 of the deployment system 110 is positioned to enter the hole 3 of the left atrium 1 as it is advanced distally. Although the plug 118 is optional, it provides a potential advantage to ensure that the correct (preferably the minimum required) insertion distance of the suture clip 100 is used during deployment of the suture clip 100. The plug 118 can also help stabilize the left atrial appendage 1 and the delivery system 110 to each other during deployment.

[0156] Optionally, at block 154, in some embodiments, for example, as described with respect to 9A to 9F As described, the configuration of the spreader 1000 (about 9A to 10C described).

[0157] At box 155, in some embodiments, the suture clip 100 is deployed to an expanded anchoring position; for example, by pushing the control member of the deployment system 110 forward to move the portion of the system that holds and controls the suture clip (also referred to herein as the "inner system" and including the delivery bracket 113) forward to at least partially unhook it.

[0158] When the suture clip 100 is extended from the distal catheter end 112, its shape changes from its collapsed delivery configuration to its expanded anchoring configuration. In some embodiments, the expansion is automatic, with the arms 104 expanding to assume their superelastic setting shape.

[0159] At box 157, in some embodiments, the suture clip 100 is anchored. In some embodiments, anchoring includes pulling the suture clip 100 backward using an internal system until it is anchored into the hole wall tissue via the anchor 106 positioned on the end of the arm 104. Optionally, a position of the suture clip 100, its arm 104, and / or its anchor 106 is verified before and / or after anchoring, for example, by using imaging observation (e.g., ultrasound imaging and / or fluoroscopy). Optionally, anchoring is verified by a "tug test", including one or both of testing resistance to retraction and observing movement under imaging observation. Optionally, the suture clip 100 is provided with one or more radiopaque markers to help visualize the anchor 106, arm 104, and / or core 102 of the device. For example, the anchor 106 or another portion of the suture clip 100 includes an alloy that is more radiopaque than nickel-titanium alloy (e.g., a radiopaque marker comprising gold, tungsten, or another material). In some embodiments, the delivery system 110 includes a radiopaque marker positioned to identify, for example, a portion of the delivery stent 113 .

[0160] At box 159, in some embodiments, the suture clip is folded into its folded suture configuration. Generating sufficient closing force from the suture clip 100 is a potential challenge. For example, a typical catheter lumen diameter is approximately 3 to 5 mm, in which the suture clip's folded delivery configuration is located. The diameter of the left atrial appendage may be approximately 30 mm, which may create a mechanical disadvantage because, through the principle of leverage, the applied force tends to decrease as the distance from the fulcrum increases.

[0161] In some embodiments, the closing force is applied by using an internal system to pull back on a closing disk 120 (e.g., as described herein with respect to Figure 2N to Figure 2P 104 ). In some embodiments, a closure disk 120 is operated by sliding along the plurality of arms from a base region of the arms toward an anchoring end of the arms. The closure disk is connected to the arms (e.g., through one or more holes) so that as the closure disk moves, it changes the radial expansion of the arms 104, thereby causing the arrangement of anchors 106 to fold into their folded suture configuration, thereby leading the anchoring tissue of the hole 3 with them. The closure disk is also referred to herein as a closure "ring". Examples and additional descriptions of closure disks, their functions and their operation, for example, are also referenced herein. Figures 2M to 4H Closure discs offer potential advantages by bringing the fulcrum of the mechanical lever closer to the anchoring site that forms tissue closure.

[0162] Optionally, the superelasticity and the effects of the disc are opposite. For example, in some embodiments, the suture clip is superelastically positioned in a closed position, while the disc is initially positioned in a more proximal position. Movement of the disc pushed distally may also force the suture clip to open and assume an expanded anchoring state, for example, by approaching a distal portion of the suture clip where the arms converge at a radius smaller than the hole in the disc through which they pass. When the force on the disc is released, the arms tend to close, again pushing the disc proximally. Optionally, the disc is again pulled proximally. Note that due to differences in size constraints, the self-expanding configuration of such a disc control device may be more mobile than a corresponding self-folding configuration.

[0163] In some embodiments, another method of generating force to fold to a folded suture configuration is used. For example, an eversion closure in which the arms themselves are resiliently biased to continue toward closure after passing through a more expanded configuration. In such a configuration, the folded delivery configuration of the arms 104 accommodated by the delivery system 110 may orient them to extend from a proximal side near the core 102 to a distal side toward their free anchoring ends. It may be noted that in Figures 1A to 1D The design used as an example to illustrate certain general features of a suture clip 100 is designed to undergo eversion closure. Figure 1E The design of certain general features of the suture clip 100 and its delivery system 110 used as an example in the present invention is just subject to what is referred to herein as a resilient closure. The features of the details of these types of closures (as well as other details of specific designs) will be discussed in several more specific embodiments of the device, such as in the present invention, which will be referred to in the following. FIG. 2A to FIG. 2I for discussion. In an everted design, the folding of the arms themselves to a shorter lever distance may increase leverage in part due to the curvature along the length of the arms. Additionally, in the design of suture clip 100, a portion of the force generated for closing may be generated optionally through the use of a torsion bar feature (also referred to herein as a "torque beam"). A torsion bar is a spring design (applying rotational force through a plane transverse to a longitudinal axis of the bar or beam) that may apply a relatively high force compared to a leaf spring of the same general size and material (e.g., a flexible arm, applying rotational force through a plane passing through a longitudinal axis of the arm).

[0164] In some embodiments, closure is verified, for example, by fluoroscopy and / or ultrasonography (cardiac ultrasound). In some embodiments, closure is verified by tracking an injected dye from inside or outside the left atrial appendage.

[0165] In some embodiments, closure is followed by aspiration and / or injection of material (e.g., saline) to remove and / or displace blood remaining in the LAA. This potentially helps reduce the likelihood of a blood clot forming even within the closed-off pocket of the LAA formed by the suture clip.

[0166] At optional block 161 , in some embodiments, the plug 118 (if used) is refolded.

[0167] At block 163, in some embodiments, the delivery system 110 is detached from the suture clip 100 and removed from the body. Optionally, the detachment occurs as part of the folding of a suture configuration of the suture clip 100 and / or occurs immediately thereafter.

[0168] Optionally, during deployment, operation of the various blocks may be reversed, for example, to reposition suture clip 100, for example, based on fluoroscopy (eg, diffusion of injected dye) and / or other observations and / or feedback.

[0169] To close a hole from the side opposite to the entrance side:

[0170] Reference now Figure 1G , which is a schematic flow chart of closing an integral cavity hole by a suture clip 100 according to some embodiments of the present disclosure, wherein the suture clip 100 closes the hole from a side of the closure opposite to a side where the suture clip is introduced.

[0171] At block 171, in some embodiments, the suture clip 100 is advanced from a first side of a body cavity hole (eg, an opening 3 of a left atrial appendage 1) toward a second side of the body cavity hole.

[0172] At block 173 , in some embodiments, the suture clip 100 is expanded, wherein at least a portion of the suture clip 100 is located on the second side of the body cavity hole.

[0173] At block 175 , in some embodiments, the suture clip 100 is anchored into the body cavity hole (eg, using an anchor positioned on a portion of the suture clip 100 on a second side of the body cavity hole).

[0174] At block 177 , in some embodiments, the suture clip 100 is folded to close the body cavity hole, and the suture clip 100 remains on the first side of the body cavity hole.

[0175] Changes in clip configuration during LAA closure:

[0176] Reference now FIG. 2A to FIG. 2I, which schematically illustrates a stage of deployment of a suture clip 100 according to some embodiments of the present disclosure. Reference numeral "100" is generally used herein in the description of suture clips, with certain more specific embodiments being given their own reference numerals to identify them as species of the genus and / or to be described with reference to their specific features.

[0177] In some embodiments, Figure 2A An approach of a delivery system 110 is shown, including a distal catheter end 112 directed toward an opening 3 of a left atrial appendage 1 in an atrial wall 5 of an atrium.

[0178] In some embodiments, Figure 2B and Figure 2F 100 is partially unhooked by actuating the delivery system 110. Unhooking includes, for example, retracting the proximal end of the delivery stent 113 from the distal catheter end 112 and / or extending the delivery stent 113 from the distal end of the catheter end 112. Figure 2B In the example of FIG. 1 , the suture clip 100 is packaged with the core 102 on a distal side of the folded delivery configuration and with the anchoring ends of the arms 104 on a proximal side of the folded delivery configuration. Figure 2F For example, as in this article about FIG. 5A to FIG. 8G As described, this configuration reverses from distal to proximal. The anchoring end at the more distal end is also as Figures 1A to 1D Configuration shown.

[0179] In some embodiments, Figure 2C and Figure 2G 104 of the suture clip 100 radially away from the core 102 (relative to Figure 2B and Figure 2F and their initial engagement with a luminal side of tissue within the left atrial appendage 1 (via anchor 106, not shown). In some embodiments, the expansion of arms 104 includes a superelastic conformational change caused by the arms 100 being configured to expand as shown when unconstrained. Additionally or alternatively, an independent actuation mechanism forces the arms 104 to expand.

[0180] Compare Figure 2C and Figure 2G , it can be seen that for Figure 2GFor an everted suture clip as shown, reducing the initial insertion distance has a potential advantage. The shortened insertion distance may reduce the risk of left atrial appendage perforation. For example, this risk occurs because the interior of the left atrial appendage includes relatively thin and / or fragile tissue compared to the muscle wall of the rest of the heart, and / or it is difficult to obtain a clear view of the complex three-dimensional (3D) shape of the left atrial appendage. In contrast to inserting an entire suture clip 100 in a still folded (and therefore longitudinally maximally extended) configuration (and then expanding), an everted closed suture clip 100 can gradually expand as it advances distally, with the most expanded portion also being its most distal portion. This potentially reduces the risk of perforation of components located on the relatively rigid central shaft of the delivery system, because these components are not located at the most distal end during the important stage of initial deployment, and optionally, they themselves are not inserted into the left atrial appendage during deployment, or are inserted to a minimal extent. To the extent that the suture clip 100 itself is "self-driven", in some embodiments, it only needs to be engaged on a proximal side of the hole 3 of the left atrial appendage 1, and does not need to be actively inserted. Once the folding to the folded suture configuration is allowed to proceed, it pulls itself into the left atrial appendage to a distance limited by the previously determined anchor fixation. It should be noted that non-invasive or minimally invasive deployment also potentially reduces the chance of dislodging potential existing thrombi during the deployment process. After anchoring, there is still some protection against potential perforation events because the anchor itself controls the maximum distance the delivery system can be advanced (e.g., preventing it from advancing further).

[0181] In some embodiments, Figure 2D and Figure 2H Each represents an intermediate stage of the closure of the arm 104 toward a folded suture configuration. Different actuation mechanisms and / or shape transitions may be used to accomplish the closure of the hole 3. Figure 2D In the embodiment of the present invention, for example, the arm 104 is forced to retreat and refold in the same direction in which it was extended. This is also referred to herein as a "return" closure. Optionally, this is achieved by a closure disc 320 ( Figure 3C ) is achieved by the movement of the closure disc 320, which slides proximally along the arms 104, forcing them to close. In some embodiments, additionally or alternatively, the recoverable elastic force of the arms 104 is used to provide the force for closing.

[0182] Optionally, closure comprises a continuous configuration change of the arm 104, such as Figure 2H This type of closure is also referred to herein as an "eversion" closure, wherein the arms 104 are initially directed distally (e.g., Figure 2F oriented as shown) continue to rotate beyond their maximum expanded state, causing them to reverse relative to the proximal-to-distal direction of the core 102 to point proximally. Figures 1A to 1DThe suture clip 100 also represents an "outward-facing" suture clip. A potential advantage of an outward-facing closure is that it reduces the distance of penetration into the left atrial appendage during insertion, thereby reducing the risk of perforation and one or more of the risk of dislodging a pre-existing thrombus.

[0183] In some embodiments, Figure 2E and Fig.2I Respectively represent a final stage of closure, wherein the arms 104 have reached a fully closed folded suture configuration. The hole 3 of the left atrial appendage is now closed. The delivery system 110 is detached, and the suture clip 100 remains attached to the luminal tissue of the left atrial appendage 1 and is isolated in the left atrial appendage. Since the suture clip 100 is isolated, a center of thrombosis that could potentially enter the systemic circulation can be prevented. The suture sides of the hole 3 of the left atrial appendage 1 may gradually grow together, thereby preventing the reopening of the left atrial appendage 1.

[0184] Anchor Movement During LAA Closure:

[0185] Reference now Figure 2J to Figure 2L , which schematically illustrates the movement 203, 205, 203A, 203B, 205A, 205B of anchoring positions 201, 201A, 201B during the transition of a suture clip 100 between an expanded anchoring configuration and a folded suture configuration according to some embodiments of the present disclosure. The movement shown is seen from a direction through the hole of the hole 3 toward the left atrial appendage.

[0186] The movement shown is optionally applicable to everting and reversing one or both of the suture clips 100. Figure 2J , the anchoring locations 201 are initially arranged around the inner circumference of the hole 3. In this document, the reference numeral 201 generally refers to an anchoring location (in which a specific instance is marked), and the reference numeral of the anchoring location 201A refers to a specific marked instance of an anchoring location 201.

[0187] When a suture clip 100 is folded ( Figure 2K ), the anchoring end of each arm 104 moves in different directions within the observation plane. Arrows 203, 205 (usually marked as) point in different directions, indicating that each anchoring position 201 is Figure 2J Configuration and Figure 2K The location and then Figure 2L to move between locations.

[0188] Of particular note is that some anchor locations (e.g., anchor location 201A in direction 203A and then 205A) move radially outward, while other anchor locations (e.g., anchor location 201B in direction 203B and then 205B) move generally radially inward. However, the shared suture has a convergence point. Thus, the suture clip 100 gradually pulls the hole 3 into a new, nearly linear shape that retains a majority of the circumference of the original hole 3 (e.g., at least 50%, 70%, 80%, 90%, or 100% of the original circumference). As used herein, the term "lateral displacement folding" is used to refer to the folding movement of the anchor locations 201, arms 104, anchors 106, and / or other elements of a suture clip 100 that acts to stretch a hole in one direction (i.e., laterally) while folding it in another direction.

[0189] For example, in FIG. 5A to FIG. 8G In the embodiment of the present invention, the lateral displacement folding morphology can be seen, and in FIG. 4A to FIG. 4F Although not every embodiment of the present disclosure shows lateral displacement folding (e.g., FIG. 3A to FIG. 3D embodiments), but the laterally displaced folds help reduce stresses due to "wrinkling" or "bunching" that may occur when all anchor locations are pulled toward a common radial center.

[0190] Figure 2L Anchoring locations 201 are shown in a folded suture configuration. The actual folded suture configuration depends on the balance of forces applied to the anchoring locations 201 that urge them toward the same line, or even toward a position that passes through the same line, and forces that resist this movement. In some embodiments, the result is a wavy ("clamshell") or other irregular pattern along the lip of the hole 3. For example, tissue near the anchoring location 201 tends to press further inward, while tissue away from the anchoring location tends to give way to this pressure. To this extent, the mechanical properties of the tissue itself become part of the seal formed by the suture clip 100 at the location of the hole 3. In the folded suture configuration, for example, the anchors 106 are optionally arranged in any suitable configuration for closing, for example, a circular (e.g., folded toward a common center), a linear, a zigzag, or other hole closure configuration.

[0191] Conveying packaging and closed loop operation:

[0192] Reference now Figure 2M to Figure 2P , which shows details of the interaction between a delivery system 110 and a suture clip 100 according to some embodiments of the present invention.

[0193] Figure 2MA delivery system 110 is shown in a pre-deployed configuration. The suture clip 100 is held in a folded delivery configuration within a distal catheter end 112. Optionally, the distal catheter end 112 includes a sheath at least long enough to fit over the folded suture clip 100. It can be as long as the entire catheter, or it can include a shorter portion that is driven by a control member (e.g., a rod or wire controlled from the proximal end of the delivery system 110) to be withdrawn from the body. Optionally, the catheter distal tip 116 includes an atraumatic tip, for example, made of a suitable polymer material.

[0194] exist Figure 2N , the distal catheter end 112 is rendered transparent to show details of the suture clip 100 in its folded delivery configuration. In the example shown, the arms 104 lie flat on the delivery stent 113, constrained by being held within the distal catheter end 112. In this configuration, the anchors 106 occupy the proximal side of the arms 104, and the core 102 occupies the distal side of the arms 104. In some embodiments, the closure disc 120 is initially located near the bottom of the arms at the core 102. In this position, the closure disc 120 provides little or no control over the expansion of the arms 104 as the arms 104 are extended from the catheter distal end 120 (and / or the catheter distal end 120 is removed), e.g. Fig.2O shown.

[0195] exist Fig.2O , arms 104 are shown expanded to position anchors 106 in a radially symmetrical pattern. Optionally, arms 104 are expanded to place anchors 106 in another configuration, for example, a configuration corresponding to a portion of a perimeter of an orifice 3 of a left atrial appendage. Arms 104 are expanded sufficiently to bring anchors 106 into contact with tissue. With this contact, arms 104 may not fully expand to assume their superelastic shape, in which case forces generated by arms 104 themselves may help achieve tissue anchoring. Optionally, suture clip 100 is manipulated (e.g., pulled and / or rotated using delivery stent 113) to achieve tissue anchoring.

[0196] exist Figure 2P , suture clip 100 is shown closed again, this time in its folded suture configuration. In this case, folding includes proximal movement of closure disc 120 relative to core 102. This proximal movement can be achieved using delivery stent 113, because once anchor 106 is anchored to tissue, the rest of the device will tend to resist distal movement.

[0197] Optionally, the internal system includes a single controllable member for moving the closure disk 120 while the delivery stent 113 remains in place. This provides the potential advantage of reversibility of deployment, for example. Using such a control configuration, the suture clip 100 can optionally be completely refolded so that it can be taken out again into the distal catheter end 112.

[0198] Suture clip with radial arms and closing disc:

[0199] Reference now Figure 3A , which schematically shows an expanded configuration of a recoverable core arm assembly 301 of a suture clip 300 according to some embodiments of the present disclosure. Figure 3B , which schematically illustrates a suture clip 300 in an expanded configuration according to some embodiments of the present disclosure, including a closure disc 320. Also refer to Figure 3C , which schematically illustrates a suture clip 300 in a refolded suture configuration folded by movement of a closure disk 320 according to some embodiments of the present disclosure, and additionally references Figure 3D , which schematically shows a suture closure disc 320 according to some embodiments of the present disclosure. The suture clip 300 is an example of a recovery suture clip 100.

[0200] In some embodiments, a suture clip 300 includes a core arm assembly 301 ( Figure 3A ) and a closing disk 320 ( Figure 2C ), so that the arms 304 of the core arm assembly 301 pass through the holes 321 of the closing disk 320. Prior to delivery, the arms 304 are folded and secured in place, for example, by a surrounding lumen of a portion of the delivery system 110. When the arms 304 are released from this constraint, they move toward Figure 3B The arms are shown in the expanded position. At this stage, the restraining ring 320 is located at the base of the arms 304, near the core 302. The expansion device is manipulated within the left atrial appendage 1 so that the anchor 306 is anchored (fastened) to the tissue. The details of the anchor 306 are not shown in the schematic diagram, but any design suitable for piercing and / or clamping tissue can be used, for example, Figure 4A The thorn anchor 413, Fig. 8A The barbed anchor 806, and / or Figure 5A Barb anchor 506.

[0201] Once the anchor is attached, the closure disc 320 is moved from its initial position near the core 302 toward the anchoring ends of the arms 304. This pulls the arms 304 inward, causing their tips to converge. Thus, the tissue around the closure formed by this design of the device tends to form a radial "pucker" or surgical purse-string, as the tissue is forced into a smaller area than its natural perimeter would allow. The mechanical strength of this comes from the increased stiffness of the shortened arms, as well as the strength and mechanical advantage of the closure disc 320.

[0202] Optionally, since the anchoring force will tend to resist the force pulling the single deployment member proximally (which will be further described, for example, with respect to FIG. 4E to FIG. 4F and suture clip 400), a single deployment member serves to both secure the suture clip 300 in place and to pull the closure disc proximally.

[0203] Alternatively, movement of the closure disk 320 relative to the base 302 may be achieved by mounting the entire suture clip 300 to a first configuration member of the delivery system 110 and then using a second configuration member to pull the closure disk proximally, while the remainder of the device is held in place by the first deployment member.

[0204] In some embodiments, the closure disc 320 includes a locking aperture 322 through which the first and optionally second contoured members of the delivery system 110 extend. In some embodiments, a cutout 323 of the locking aperture 322 provides a passage into which a deployment member can be rotated to allow removal after the device has achieved closure.

[0205] Reference now Figure 3E , which schematically illustrates an expanded configuration of a recoverable core arm assembly 351 of a suture clip 350 according to some embodiments of the present disclosure. Figure 3F to Figure 3G , which schematically illustrates a suture clip 350 in an expanded configuration according to some embodiments of the present disclosure, including a closure disc 370. Also refer to Figure 3H , which schematically illustrates a suture clip 350 in a refolded suture configuration folded by movement of a closure disk 370 according to some embodiments of the present disclosure, and additionally references Fig. 3I , which schematically illustrates a suture closure disc 370 according to some embodiments of the present disclosure. The suture clip 350 is an example of a recovery suture clip 100.

[0206] In terms of its use and mechanism of action, suture clip 350 is of the same type of retractable closure design as suture clip 300, with, for example, a different number of arms, a different closure shape of the arms, and a specifically described shape (barbed) of anchor 356. It may be noted that arm 304 is located closer to the radial center along its length (e.g., at 405) than the arms of suture clip 350. Figure 3D The closure disk 320 may be folded at a pinch 331 of the closure disk 320. Although the closure disk 320 may provide the primary fulcrum once closure is complete, this more radially contracted shape provides the potential advantage of generating additional inward forces during closure. The contracted shape may also allow for a different range of selections of angles at which the anchors 106 (e.g., anchors 306, 356 are specific examples thereof) contact tissue.

[0207] Suture clamp with branched arms and closing disc:

[0208] Reference now Figure 4A , which schematically illustrates an expanded configuration of a core arm assembly 401 of a suture clip 400 according to some embodiments of the present disclosure. Figure 4B , which schematically illustrates a suture clip 400 in an expanded configuration according to some embodiments of the present disclosure, including a closure disc 420. Also refer to Figure 4C , which schematically illustrates a suture closure disc 420 according to some embodiments of the present disclosure. The suture clip 400 is an example of a recovery suture clip 100.

[0209] Similar to suture clip 300, suture clip 400 includes a core arm assembly 401 and a closure disc 420, wherein movement of closure disc 420 away from core 402 and toward the tips of arm subassemblies 408, 407 causes the arm subassemblies 407, 408 to refold, which would otherwise bend and cause the suture clip to radially expand when released from the housing during delivery.

[0210] Each of the arm subassemblies 407, 408 includes a plurality of arms 412, each of which is provided with an anchor 413 of the illustrated spike-like design and / or another anchor design. The arms 412 of each arm subassembly 407, 408 are biased to expand so that they spread their anchoring ends to define a partial perimeter. The partial perimeter may be, for example, linear or have only a slight curvature (e.g., in Figure 4G ). As such, the arm assembly trunk 411 is biased into bending when unconstrained so that the two sets of arms occupy positions on either side of the hole in the left atrial appendage.

[0211] In some embodiments, closing of suture clip 300 includes constraining arm assembly trunk 411 to return to a more straight position (e.g., by movement of closure disc 420 to slide along arm assembly trunk 411). Optionally, each arm 412 is allowed to remain expanded, thereby expanding the closed portion of the left atrial appendage into a flat configuration.

[0212] Now further reference FIG. 4D to FIG. 4H , which shows the deployment of a suture clip 400 under the control of a deployment system 410 including a deployment member 415 according to some embodiments of the present disclosure. In some embodiments, the deployment member 415 is interconnected to the device through the hole 422 of the closure disk 420. In some embodiments, a protrusion on the deployment member 415 interlocks with a portion of the core 402 (e.g., protrudes into the hole 410). If initially attached to the core 402, the release of the deployment member 415 can be achieved, for example, by rotating the deployment member 415.

[0213] Once the suture clip 400 is anchored, pulling the deployment member 415 moves the closure disk 420 proximally and with it. Figure 4F (from the side) and Figure 4G As shown (from the proximal end), the arm subassemblies 407, 408 are brought together by this movement. Optionally, they are shaped so that the arm subassemblies 407, 408 interdigitate with each other in the fully actuated position. The interdigitation optionally includes movement of a portion of the arm 412 on the arm subassembly 407 from a first side of the arm 412 of the arm subassembly 408 to a second side of the arm 412 of the arm subassembly 408. The connection of the anchor 406 to the tissue may limit the degree of interdigitation. For example, the resulting closure may be similar to Figure 1C The zigzag closing band of the hole 3 in the arm assembly 408 extends alternately between the arms 412 of the arm assembly 407, for example.

[0214] Optionally, full release of the deployment member 415 is optionally performed by partial rotation, stronger pulling, actuation of an unlocking member on the deployment member 415, and / or other methods.

[0215] It should be noted that the deployment phase (for this and optionally any other embodiments of the present disclosure) is optionally fully or partially reversible. For example, for suture clip 400, this can be achieved by reconnecting the deployment member 415 and suture clip 400, restoring the closure disk 420 to its original position, and / or moving the re-expanded suture clip 400 to remove it from its anchoring position. Reversibility is a potential advantage during implantation (e.g., allowing adjustment), and / or facilitating the selection of emergency retrieval devices.

[0216] Self-folding suture clamp, radial arms:

[0217] Reference now FIG. 5A to FIG. 5D , which schematically illustrates a portion of an inside-out suture clip 500 according to some embodiments of the present disclosure. The suture clip 500 is an example of an inside-out suture clip 100.

[0218] In some embodiments, a suture clip 500 includes a plurality of arm subassemblies 501A, 501B, 501C (collectively, arm subassemblies 501A-501C), each arm subassembly independently providing a core (e.g., cores 502A, 502B, 502C, collectively cores 502A-502C, and / or equivalent to core 502 in a unit) and a portion of an arm (e.g., arms 504A, 504B, 504C, 504D, 504E, and 504F; collectively arms 504A-504F and / or arms 504). Arms 504A-504F optionally have a plurality of individual designs, with lengths, orientations, and / or bending behaviors that work together to achieve a target closed configuration. Arms 504A-504F each terminate with an anchor 506; for example, the barbed anchor type shown and / or another design and / or type. In some embodiments, the bending behavior of arms 504A to 504F is determined in part by the orientation and preset (i.e., superelastic setting) rotation of a torsion bar, whereby the torsion bar is attached to a core, for example, one of torsion bars 530, 532, 534 (also collectively referred to as torsion bars 530), which are optionally oriented for different arms 504A-504F to rotate in different planes.

[0219] In some embodiments, the arm subassemblies 501A-501C are attached to each other via the connection plate 520, for example by inserting the hook 540 of each arm subassembly 501A-501C into the hole 521 of the connection plate 520. Optionally, the connection plate 520 is fixed to the arm subassembly 501A-501C by glue and / or welding. Optionally, the connection plate 520 is made of titanium or another material (e.g., another biocompatible alloy such as stainless steel), and the various arm subassemblies 501A-501C are formed of a superelastic alloy (e.g., nickel titanium alloy).

[0220] Reference now FIG. 5E to FIG. 5F , which schematically illustrates an assembled suture clip 500 in an expanded configuration according to some embodiments of the present disclosure.

[0221] FIG. 5E to FIG. 5F The assembled suture clip 500 is shown in its expanded state (which also corresponds exactly to, for example, Figure 1A In particular, from Fig. 5F As can be seen in FIG, anchors 506 are arranged around an elliptical and / or elliptical perimeter. Alternatively, the perimeter may be selected to be any suitable shape for anchoring.

[0222] During deployment, this state is maintained by keeping the base of the arms straight using a restraining device (e.g., a surrounding lumen of the deployment system 110). The unconstrained anchoring ends of the arms are pre-positioned (e.g., superelastically configured) to assume the position shown starting from a constrained position, wherein all arms 504A to 504F are folded (e.g., by being contained in a lumen) to extend in the same longitudinal direction as shown at their bases. Thus, deployment begins with the suture clip in a first folded delivery position and continues to a second expanded anchoring position.

[0223] In the expanded state, the suture clip 500 is in a configuration suitable for establishing an anchor with the tissue, for example corresponding to Figure 2G .

[0224] Reference now Figure 5G to Figure 5H , which schematically illustrates an assembled suture clip 500 in an everted configuration according to some embodiments of the present disclosure. After the restriction on the movement of the bottom of the arms 504A to 504F is released, the arms continue to rotate (in some embodiments, primarily driven by the twisting of the torsion bars 530, 532, 534), from FIG. 5E to FIG. 5F The expansion anchor position is moved to Figure 5G to Figure 5H In this configuration, the arms are everted so that their anchors 506 end up on the side of the core component opposite to where they started. Figure 5G to Figure 5H The barbs 506 are not shown.

[0225] It can also be noted that there is also a "zigzag" suture band established by arms 104A to 104F, as described herein with respect to other embodiments. In the orientation of the suture clip 500 shown, the anchoring ends of arm 504B cross from top to bottom, as do the anchoring ends of arms 504B and 504E. They cross each other with arms 504D and 504F (crossing from bottom to top) and arms 504A on either side (also crossing upward).

[0226] Reference now FIG. 6A to FIG. 6D , which schematically illustrates the installation of a torsion bar arm according to some embodiments of the present disclosure. In some embodiments, any one of arms 504A to 504F (and optionally, any arm in any other embodiment described herein) is connected to the stitching sandwich by a torsion bar (e.g., torsion bar 530). FIG. 6A to FIG. 6D Each of the figures shows only a single arm subassembly 501A, with the two arms 504A fixed in their extended anchored configurations, in order to focus on the movement of arm 504B due to the twisting of torsion bar 530. Fig. 6A and Figure 6CIn the detailed view of FIG. 5 , the torsion bar 530 is in its constrained position. Once the constraint is released, the torsion bar 530 is free to twist the arm 504B so that it ends below the core area 502A, as shown in FIG. Figure 6B shown, and in Fig.6D The twisting may achieve a large relative position shift of the anchoring end of arm 504B even though arm 504B itself would not undergo any further configurational change if unconstrained.

[0227] As long as the torsion bar in the superelastic alloy can apply considerable force, torsion bar 530 (and other torsion bars) just have the potential advantage of realizing reliable closure.It should also be noted that different torsion bars (e.g., comparing torsion bars 530, 531) can be oriented to move the arm by the rotational motion in different planes.This provides the potential advantage of supporting three configurations to unfold a series, which starts from the first folding conveying configuration, to the second extended anchoring configuration, and finally to the third folding suture configuration.Every kind of configuration is optionally shaped to be not only relative to the core, but also relative to each other, and the anchoring end of the arm is placed in different positions.For example, the anchoring end of the arm moves from a class of circumferential configuration in the extended anchoring configuration to a forked configuration in the folding suture configuration.

[0228] Reference now 7A to 7F , which schematically illustrates a suture clip 500 in three different stages of deployment, each stage from two different viewing angles, according to some embodiments of the present disclosure.

[0229] FIG. 7A to FIG. 7B From the stereogram ( Fig. 7A ) to the view from far to near ( Figure 7B ) shows the suture clip 500 in an expanded anchoring configuration. In this configuration, each arm optionally includes a pair of bends; a base bend 505 proximal to the core 502; and an anchoring bend 507 proximal to the anchoring end of the arm. Optionally, this forms for each arm: an anchoring section 509 (carrying an anchor 506); an intermediate section 511 between the two bends 505, 507; and optionally a base section 517, located on the arm 504 relative to the base bend 505. For a given arm 504, each of the bends 505, 507 bends in a shared plane. In addition, for example, from Figure 7B As can be seen from the view of FIG. 1 , the bends 505 , 507 can be optionally positioned in multiple planes that share a common axis (as shown, an axis of the radial center of a distal end of the delivery system 110 ). This tends to orient the anchors 106 so that they face radially outward to contact the tissue of the hole 3 .

[0230] While these characteristics of the bending directions may produce convenient configurations to simplify manufacturing and / or anchoring effects, embodiments of the present disclosure are not limited to having these characteristics. For example, the bends 505, 507 of an arm 504 may optionally bend in different planes, such as due to a distortion of the shape set by superelasticity at a point along the middle section 511. Additionally, the bends 505, 507 of different arms 504 may optionally bend in multiple planes lacking a common axis.

[0231] FIG. 7C to FIG. 7D From the stereogram ( Figure 7C ) and the view from far to near ( Fig.7D ) shows the suture clip 500 in the folded suture configuration with the delivery system 110 still connected. FIG. 7E to FIG. 7F From the stereogram ( Fig. 7E ) and the view from far to near ( Figure 7F ) shows the suture clip 500 in the same folded suture configuration with the delivery system 110 separated.

[0232] It can be noted that for some of the arms 504, the bends 505, 507 can now be seen to be offset in the direction of their plane. In the embodiment shown, this is achieved by twisting the torsion bars 530, which themselves are longitudinally oriented in different directions. For example, some torsion bars 530 optionally extend longitudinally parallel to a plane of the connection disk 520. Others (e.g., as shown by torsion bars 532, 534) extend obliquely to the connection disk 520, such as extending obliquely at about 20°, 30°, 45°, or other angles.

[0233] The number of degrees of freedom available to the multi-jointed arm has the potential advantage of allowing the position of the anchor 506 in the extended anchoring configuration to be decoupled from the position of the same anchor 506 in the folded suture configuration. For each configuration and its function, an optimal anchoring position pattern can be determined, and the movement of the available degrees of freedom can be adjusted accordingly during the design and manufacture of the joints to form a suture clip that automatically switches between the determined anchoring position patterns.

[0234] After the restraint is retracted proximally, past bend 507 and then bend 505, the folding motion to achieve the suture configuration can be made similar to that to achieve the suture configuration by initially maintaining restraint only on core 502 (e.g., via distal catheter end 112). FIG. 7A to FIG. 7B Further proximal retraction then removes the constraint on motion, allowing actuation of the torsion bar 530. The motion of the bends 507 and 505 can be similarly separated in time, optionally producing three distinct deployment stages: a first bend to deploy the anchoring segment 509; a second bend to produce FIG. 7A to FIG. 7B The deployed anchoring configuration; and the third bending produces FIG. 7C to FIG. 7F Accordingly, it can be said that there are three "joints" in each arm 504, namely, the bends 505, 507 along the arm 504 and the torsion bar 530.

[0235] Furthermore, it should be noted that the motion may also be sequentially reversed by again advancing the constraint back onto the arm 104 (eg, via the distal catheter end 112).

[0236] It will be readily appreciated that in some embodiments, other numbers of joints may be provided for each arm of a suture clip 100. The joints are optionally shaped (e.g., superelastically configured) to provide any suitable combination of planar and torsional motion to adopt multiple (optionally multiple) well-defined configurations during the initial, final, and / or intermediate stages of deployment.

[0237] Reference now Figure 7G , which schematically shows a portion of a suture clip 100 (only one arm is shown), including an arm 740 attached to a core 102, wherein the bend of the arm 740 is around one or more torsion bars 741, 743, 747, including torsion bars 741, 743 located along the longitudinal extent of the arm 740. Optionally, the torsion bars 741, 743 are formed by cutting the shape of the bar from the "elbow" 742, 744 of the arm 740. For the torsion bars 530, 532, 534, the torsion bar angles can be adjusted to change the plane and / or final direction of the bend of the sections of the arm 740. An anchor cutout 745 is also shown, which shows a method of making an anchor 106, that is, the arm blank is cut (e.g., laser cut) to have a slit extending on either side of a central spike (which optionally forms the anchor 106). When unconstrained, the spike is superelastically arranged to protrude from the tip of the arm, otherwise flattened to lie within the arm 740. It should be understood that the arm 740 using the torsion bar elbow 742 may optionally be used in place of any arm 104 of another suture clip described herein, for example, in place of any arm 504 .

[0238] Self-folding suture clip, branching arms

[0239] Reference now FIG. 8A to FIG. 8G , which schematically shows an outside-outward-closed suture clip 800 according to some embodiments of the present disclosure, including arm subassemblies 807, 808. The suture clip 800 is an embodiment of the suture clip 100.

[0240] Suture clip 800 includes arm subassemblies 807 , 808 , each arm subassembly including a plurality of arms 804 connected to core 802 via an arm assembly backbone 811 .

[0241] The curvature of the arms 805, 809 is exposed by releasing the restraint from the distal catheter end 112 of the delivery system 810, thereby allowing the suture clip 800 to expand to an expanded anchoring configuration. FIG. 8A to FIG. 8C The expanded anchoring configurations are angles from distal to proximal, lateral and lateral oblique, respectively. The expansion produces a deployment of the anchor 806 in which each arm assembly 807, 808 spreads its anchoring end to define a local perimeter, such as described with respect to the suture clip 400. In the expanded configuration, the anchor 806 is maintained in a position in the tissue that allows it to be inserted into the hole 3 of the left atrial appendage 1 by manipulating the delivery system 110.

[0242] Closure of suture clip 800 (e.g., after anchoring) is eversion, such as FIG. 8D to FIG. 8G The eversion of the suture clip 800 is achieved by further releasing the constraint, such as by the distal catheter end 112, to expose the trunk 811. When the constraint is released, the trunk 811 bends (e.g., is super-elastically configured to bend) through an everted turn (which may be 180° or greater).

[0243] FIG. 8D to FIG. 8G The suture clip 800 is shown in its folded suture configuration from a side view, a side oblique view, a distal to proximal view, and a side oblique view, respectively. FIG. 8D to FIG. 8E In FIG. 1 , suture clip 800 is attached to delivery system 110 via delivery bracket 113, and in FIG. FIG. 8F to FIG. 8G In the embodiment of the present invention, the suture clip 800 is separated.

[0244] As also described for suture clip 400, the arms 804 of the arm subassemblies 807, 808 are positioned to intersect each other into a folded suture configuration when folded. When attached to tissue, the bodies of the two peripheral portions of the hole 3 that meet each other may prevent complete folding to the configuration shown. Therefore, the arms 804 continue to apply a closing force, potentially helping to ensure a more complete and / or more stable closure. The resulting closure line can be a zigzag band that alternates between the positions of the interdigitated arms 804 of the two arm subassemblies 807, 808.

[0245] Reference now FIG. 11A to FIG. 11G , which schematically shows an outside-out closing suture clip 1100 according to some embodiments of the present disclosure, including arm subassemblies 1107 and 1108. Suture clip 1100 is an embodiment of suture clip 100.

[0246] Suture clip 1100 includes arm subassemblies 1107, 1108, each arm subassembly including a plurality of arms 1104 connected to core 1102 via an arm assembly backbone 1105. Fig.11A ) to a folded suture configuration ( FIG. 11F to FIG. 11G) may optionally include one or both of a bending movement of the arm 1104 (e.g., at the bend 1109 and / or along the trunk 1105), and a twisting movement of the torsion bar 1110.

[0247] exist Fig.11A , a folded delivery configuration is shown. The arm subassemblies 1107, 1108 are connected at the core 1102 by connecting discs 1101. Optionally, each subassembly 1107, 1108 comprises a separate part, which can be manufactured by cutting (e.g., laser cutting) from a thin sheet of a superelastic material such as nickel titanium alloy.

[0248] The suture clip 1100 is allowed to expand to the expanded anchoring configuration by releasing the restraint from the distal catheter end 112 of the delivery system 110, thereby exposing the bend in the assembly trunk 1105 and the bends along the arms 1104 (e.g., bend 1109) (not shown in these figures).

[0249] In some embodiments, in the expanded anchoring configuration ( FIG. 11D to FIG. 11E ) is a part of the extended positioning configuration. FIG. 11B to FIG. 11C This configuration is shown from a sideways and from a far-to-near perspective.

[0250] In the partially extended positioning configuration, the constraints are partially removed, such as retracted to a position where each trunk 1105 engages the respective segments of the arm subassemblies 1107, 1108. The plurality of arms 1104 extend along a lateral axis over a majority of their full horizontal range (e.g., at least 70%, 80%, 90% or their full horizontal range. The arms 1104 extend along a vertical axis to a lesser portion of their ultimate full vertical range, such as half or less of their fully extended vertical range, such as about 30%, 40% or 50%.

[0251] A potential advantage is provided by expanding sufficiently to force the suture clip 1100 to be centered within the LAA, while still remaining unexpanded enough so as not to cause anchoring. An outer sleeve 111 can be pushed forward again to re-constrain the suture clip 1100 and since it has been embedded in the tissue (e.g., the hole 3 of the LAA 1), it can be refolded with a low risk of tearing. This helps in the process of repeatedly expanding and folding to ensure that the device is properly positioned before fully expanding and establishing device anchoring.

[0252] exist FIG. 11D to FIG. 11E A later stage representing an extended anchoring configuration is shown in FIG. 1 from a lateral oblique and distal to proximal perspectives. FIG. 11B to FIG. 11C as well as FIG. 11D to FIG. 11EDuring an expansion phase between the first and second expansion phases, anchors 1106 may come into contact with tissue; thus, multiple anchors 1106 may come into contact with tissue. Then, as expansion continues, multiple anchors 1106 "flip over," not only dragging the tissue along with them, but also potentially gaining further grip and / or insertion as they change the angle of pull to an angle that the tissue resists.

[0253] The expansion produces a deployment of the anchor 1106 wherein each arm assembly 1107, 1108 deploys its anchoring end to define a local perimeter, such as described with respect to the suture clip 400. In the expanded configuration, the anchor 1106 is maintained in a position in the tissue that permits its insertion into the orifice 3 of the left atrial appendage 1 by manipulating the delivery system 110.

[0254] FIG. 11F to FIG. 11G The suture clip 1100 is shown in its folded suture configuration from a lateral oblique and distal-to-proximal perspective, respectively. Closure of the suture clip 1100 (e.g., after anchoring) is everted. Everting of the suture clip 1100 is achieved by further unconstraining, e.g., by the distal catheter end 112, exposing the trunk 1105. Upon unconstraining, the trunk 1105 bends (e.g., is superelastically configured to bend) by an everted turn (which may be 180° or greater).

[0255] In some embodiments, this motion includes motion caused by twisting of torsion bar 1110. For example, Fig.11A and Fig.11F A comparison of 1110 shows a torsion bar 1110 which twists about 90° during deployment. The use of a torsion bar 1110 can result in the storage of significant force by concentrating the strain motion into a relatively small area.

[0256] As also described for suture clip 400, the arms 1104 of the arm subassemblies 1107, 1108 are positioned to interlace with each other into a folded suture configuration when folded. The interlacement can be excessive (to form a distinct zigzag shape), or as shown, toward a more linear configuration. When attached to tissue, the body of the two peripheral portions of the hole 3 that meet each other may prevent complete folding to the configuration shown. Therefore, the arms 1104 continue to apply a closing force, potentially helping to ensure a more complete and / or stable closure. The anchoring along the closed closure line alternates between the positions of the interlace arms 1104 of the two arm subassemblies 1107, 1108.

[0257] Spreader used with suture clips:

[0258] Reference now 9A to 9F, which illustrates a series of operations according to some embodiments of the present disclosure, wherein a tissue spreader 1000 is used with a delivery system 910 to assist in accessing the left atrial appendage 1 for insertion of a suture clip 100. Delivery system 910 is an example of a delivery system 110. Suture clip 100 is shown as having a retractable closure similar to suture clip 300. However, it should be understood that the delivery system 910 including the tissue spreader 1000 is characterized by being optionally provided with any suture clip design, such as any of the retractable closure suture clips 300, 350, 400, and / or the eversion closure suture clips 500, 800, 1100 described herein.

[0259] Fig.9A A catheter outer sleeve 911 is shown. Fig. 9B In the embodiment, the distal end 912 of the catheter is advanced distally from the outer sleeve 911 of the catheter and has the suture clip 100 inside. The arm of the spreader 1000 is also advanced distally, and its components and operation will be combined with FIG. 10A to FIG. 10C Further discussion. Fig. 9C In the embodiment, after the distal catheter end 912 is removed, the suture clip 100 is exposed outside the expander 1000 on the delivery stent 913 .

[0260] In general, the expander 1000 engages tissue within or adjacent to an orifice 3 of the left atrial appendage 1 to perform one or more of the following: (1) opening the orifice (in the expansion direction) to allow insertion of a suture clip 100; (2) shaping the orifice into a shape suitable for engagement with the expanded anchoring configuration of the suture clip 100; (3) centering and / or orienting the device within the orifice 3 of the left atrial appendage 1; and (4) closing the orifice 3 in another direction (which may be folded along an axis orthogonal to the expansion direction), potentially increasing the contact force with the anchor 106 of the suture clip 100. The folding is due to the circumference of the orifice 3 being stretched in the expansion direction.

[0261] Once the suture clip 100 is in place (optionally also after anchoring), the spreader 1000 is removed again, e.g. Fig.9D Closure of the suture clip 100 continues through the stages already described, such as the proximal movement of the closure disc 120 ( Fig.9E ), and separation of the delivery stent 913 ( Fig.9F ). In some embodiments, this closing sequence can optionally be replaced by a stepwise eversion of a suture clip 100, for example with an eversion closure.

[0262] Reference now FIG. 10A to FIG. 10C , which schematically illustrates design aspects of various tissue spreaders 1000 , 1000A, 1000B, 1000C according to some embodiments of the present disclosure.

[0263] Fig. 10A Elements of a tissue spreader 1000 are shown, including a plurality of spreader arms 1004 attached to a spreader core 1002. Each arm 1004 includes a handle 1006 at its free end. Each arm 1004 also includes a base bend 1003 located near where the arm 1004 is attached to the core 1002, and a distal bend 1005 that repositions a tip of the arm 1004 so that when the spreader 1000 is expanded, the handle 1006 is oriented radially outward to contact the cavity tissue.

[0264] In some embodiments, the spreader 1000 is formed of a superelastic alloy, such as Nitinol, allowing it to be packaged for delivery, for example, within a catheter overtube 911. When the constraints on its expansion are removed, it is superelastically configured to exhibit, for example, Fig. 10A configuration.

[0265] Fig. 10B Other arm designs 1004A, 1004B, 1004C for a tissue spreader 1000A, 1000B, 1000C are shown. The arm designs differ in the amount of curvature at their ends (where handles 1006 may be placed) and / or the angle at which their expanded form is bent relative to a longitudinal axis of a distal portion of the delivery system 110.

[0266] The greater the curvature of the tip, the more likely it is that the rounded tip surface will encounter tissue rather than the tip, while reducing the chance of accidental perforation. Designs with greater curvature than perpendicular to the longitudinal axis of the distal portion of the delivery system 110 may exhibit lower stiffness in tension, but may also reduce the chance of perforation.

[0267] Fig. 10C A design of a handle 1006 is shown that includes one or more roughened (e.g., ridged and / or toothed) plates 1008. The plates 1008 are optionally disposed in a hole 1009 in the arm 1004 and secured by crimping and / or welding. Optionally, the ridges and / or teeth 1007 are offset from one another on adjacent different plates. In some embodiments, the surface of the handle is roughened by another method, such as machining a thickened end of the arm 1004. Preferably, the handle 1006 is rough enough to engage the surface of the tissue, but not so sharp, penetrating, and / or abrasive as to cause damage thereto.

[0268] generally:

[0269] Reference now Figure 1A , which schematically illustrates a suture clip 100 joined to tissue within a left atrial appendage 1 according to some embodiments of the present disclosure.

[0270] Also refer to Figure 1B , which schematically illustrates an expanded configuration suitable for tissue engagement according to some embodiments of the present disclosure Figure 1A Suture clip 100.

[0271] refer to Figure 1C , which schematically illustrates a suture clip 100 according to some embodiments of the present disclosure, wherein the suture clip 100 engages tissue within a left atrial appendage 1 and then undergoes a configuration change to close a left atrial appendage hole 3.

[0272] Also refer to Figure 1D , which schematically shows a method of performing a Figure 1C Suture clip 100 in a left atrial appendage closed configuration.

[0273] Reference now Figure 1E , which schematically illustrates the transseptal insertion of a suture clip 100 using a delivery system 110 according to some embodiments of the present disclosure.

[0274] Reference now Figure 1F , which is a schematic flowchart of a method of inserting a suture clip 100 using a delivery system 110 according to some embodiments of the present disclosure.

[0275] Reference now FIG. 2A to FIG. 2I , which schematically illustrates the deployment stage of a suture clip 100 according to some embodiments of the present disclosure.

[0276] Reference now Figure 2J to Figure 2L , which schematically illustrates the movement 203, 205, 203A, 203B, 205A, 205B of anchoring positions 201, 201A, 201B during the transition of a suture clip 100 between an extended anchoring configuration and a folded suture configuration according to some embodiments of the present disclosure.

[0277] Reference now Figure 2M to Figure 2P , which shows details of the interaction between a delivery system 110 and a suture clip 100 according to some embodiments of the present disclosure.

[0278] Reference now Figure 3A , which schematically illustrates an expanded configuration of a recoverable core arm assembly 301 of a suture clip 300 according to some embodiments of the present disclosure.

[0279] Also refer to Figure 3B , which schematically illustrates a suture clip 300 in an expanded configuration, including a closure disc 320, according to some embodiments of the present disclosure.

[0280] Reference now Figure 3C , which schematically illustrates a suture clip 300 in a refolded suture configuration according to some embodiments of the present disclosure, the suture clip 300 being folded by movement of a closure disk 320; and

[0281] refer to Figure 3D , which schematically illustrates a suture closure disc 320 according to some embodiments of the present disclosure.

[0282] Reference now Figure 3E , which schematically illustrates an expanded configuration of a recoverable core arm assembly 351 of a suture clip 350 according to some embodiments of the present disclosure.

[0283] Also refer to Figure 3F to Figure 3G , which schematically illustrates a suture clip 350 in an expanded configuration, including a closure disc 370, according to some embodiments of the present disclosure.

[0284] refer to Figure 3H , which schematically illustrates a suture clip 350 in a refolded suture configuration folded by movement of a closure disk 370 according to some embodiments of the present disclosure.

[0285] Reference now Fig. 3I , which schematically illustrates a suture closure disc 370 according to some embodiments of the present disclosure.

[0286] Reference now Figure 4A , which schematically illustrates an expanded configuration of a core arm assembly 401 of a suture clip 400 according to some embodiments of the present disclosure.

[0287] Also refer to Figure 4B , which schematically illustrates a suture clip 400 in an expanded configuration, including a closure disc 420, according to some embodiments of the present disclosure.

[0288] refer to Figure 4C , which schematically illustrates a suture closure disc 420 according to some embodiments of the present disclosure.

[0289] Reference now FIG. 4D to FIG. 4H , which illustrates the deployment of a suture clip 400 under the control of a deployment system 410 including a deployment member 415 according to some embodiments of the present disclosure.

[0290] Reference now FIG. 5A to FIG. 5D , which schematically illustrates a portion of an everted suture clip 500 according to some embodiments of the present disclosure.

[0291] Reference now FIG. 5E to FIG. 5F , which schematically illustrates an assembled suture clip 500 in an expanded configuration, according to some embodiments of the present disclosure.

[0292] Reference now Figure 5G to Figure 5H , which schematically illustrates an assembled suture clip 500 in an everted configuration according to some embodiments of the present disclosure.

[0293] Reference now FIG. 6A to FIG. 6D , which schematically illustrates the installation of a torsion bar arm according to some embodiments of the present disclosure.

[0294] Reference now 7A to 7F , which schematically illustrates a suture clip 500 in three different stages of deployment, each stage from two different viewing angles, according to some embodiments of the present disclosure.

[0295] Reference now Figure 7G , which schematically illustrates a portion of a suture clip 100 (only one arm is shown), comprising an arm 740 attached to a core 102, wherein the arm 740 is bent around one or more torsion bars 741, 743, 747, including torsion bars 741, 743 positioned along the longitudinal extent of the arm 740.

[0296] Reference now FIG. 8A to FIG. 8G , which schematically illustrates an outside-out closing suture clip 800 including a plurality of arm subassemblies 807 , 808 according to some embodiments of the present disclosure.

[0297] Reference now 9A to 9F , which illustrates a series of operations according to some embodiments of the present invention, in which a tissue spreader 1000 is used with a delivery system 910 to assist in accessing the left atrial appendage 1 for insertion of a suture clip 100.

[0298] Reference now FIG. 10A to FIG. 10C , which schematically illustrates design aspects of various tissue spreaders 1000 , 1000A, 1000B, 1000C according to some embodiments of the present disclosure.

[0299] As used herein with respect to quantities or values, the term "about" means "within ± 10%."

[0300] The terms "comprises," "comprising," "includes," "including," "having" and variations thereof mean: "including but not limited to."

[0301] The term "consisting of" means: "including and limited to".

[0302] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or parts, but only if the additional ingredients, steps, and / or parts do not substantially change the basic and novel characteristics of the claimed composition, method, or structure.

[0303] Unless the context clearly indicates otherwise, as used herein, the singular forms "a", "an" and "the" include plural references. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0304] As used herein, the terms "example" and "exemplary" are used herein to mean "serving as an example, instance, or illustration." Any implementation described as "example" or "exemplary" is not necessarily to be construed as preferred or advantageous over other implementations and / or to exclude the incorporation of features from other implementations.

[0305] As used herein, the term “optionally” is used herein to mean “provided in some embodiments and not provided in other embodiments.” Any particular embodiment of the present disclosure may include multiple “optional” features, unless such features conflict with each other.

[0306] As used herein, the term "method" refers to means, methods, techniques and steps for completing a given task, including but not limited to those known means, methods, techniques and steps, or means, methods, techniques and steps that are readily developed from known means, methods, techniques and steps by practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine.

[0307] As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating the clinical or aesthetic symptoms of a condition, or substantially preventing the appearance of clinical or aesthetic symptoms of a condition.

[0308] Throughout this application, embodiments may be presented with reference to range format. It should be understood that the description of range format is only for convenience and brevity, and should not be interpreted as an inflexible limitation on the scope of the present disclosure. Therefore, the description of the range should be deemed to have specifically disclosed all possible sub-ranges and each numerical value within the range. For example, the description of a range such as from 1 to 6 should be deemed to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, and each number within the range, such as 1, 2, 3, 4, 5 and 6. This applies regardless of the width of the range.

[0309] Whenever a numerical range is indicated herein (e.g., "10-15," "10 to 15," or any pair of numbers connected by these other such range indications), it is intended to include any number (fractional or integer) within the indicated range limits, including range limits, unless the context clearly dictates otherwise. The phrases "range / ranging / ranges between" a first indicating number and a second indicating number, and "range / ranging / ranges from" a first indicating number "to," "up to," "until," or through (or other similar range indicating terms) a second indicating number, are used interchangeably herein and are intended to include the first indicating number and the second indicating number and all fractions and integers therebetween.

[0310] Although the present invention has been described in conjunction with the specific embodiments of the present invention, it is obvious that many substitutions, modifications and variations will be apparent to those skilled in the art. Therefore, it is intended to cover all such substitutions, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0311] All publications, patents and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, the citation or identification of any reference in this application should not be construed as an admission that the reference can be used as prior art for the present disclosure. To the extent that section headings are used, they should not be construed as necessarily limiting.

[0312] It should be understood that certain features described in the context of separate embodiments in this disclosure for clarity may also be provided in combination in a single embodiment. Conversely, various features described in the context of a single embodiment for brevity may also be provided separately; in any suitable subcombination; or as appropriate in any other described embodiment of this disclosure. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiment cannot function without those elements.

[0313] In addition, any priority documents of the present application are hereby incorporated by reference in their entirety.

Claims

1. A suture clip for closing a hole in a body cavity, the hole in the body cavity defining a passage into a portion of the body cavity, the passage extending from a first side of the hole to a second side of the hole, characterized in that The suture clip comprises: a plurality of arms, each of the arms being connected to a core of the suture clip at a bottom side of the arm; and a respective anchor at a distal end of each of said arms; The suture clip is configured to convert between the following configurations: a collapsed delivery configuration expandable to attach the plurality of anchors to tissue within the portion of the body lumen and on the second side of the aperture; as well as a folding suture configuration configured to reposition the plurality of anchors in a direction of entry into and exit from the portion of the body cavity to a position where the plurality of anchors close the aperture and the passageway; wherein the plurality of anchors close the passageway by movement of the attached tissue to a position isolating the suture clip from the first side of the aperture of the body cavity; wherein the suture clip in the folded delivery configuration is configured to be attached to a delivery frame and to be advanced on the delivery frame from the first side of the aperture of the body cavity by distal movement along a proximal to distal axis of the suture clip; wherein said plurality of arms of said suturing clip in said folded delivery configuration extend in a proximal-distal configuration relative to said core along said proximal-distal axis; wherein, during a transition between the folding delivery configuration and the folding suturing configuration, the plurality of arms of the suturing clip are configured to transition from a proximal-to-distal configuration to a distal-to-proximal configuration relative to the core; and Wherein the plurality of anchors of the suture clip in the folded suture configuration are located proximal to distal to the core along the proximal to distal axis, the core and the plurality of arms are isolated on the first side of the aperture.

2. The suture clip according to claim 1, characterized in that: The suture clip is together with the transport frame attached to the suture clip, and wherein the transport frame is configured to be separated from the suture clip in the folded suture configuration and withdrawn through the tissue closed by the plurality of anchors of the suture clip to the first side of the closed tissue relative to the suture clip isolated on the second side.

3. The suture clip according to claim 1, characterized in that: The suture clip elastically self-expands from the folded delivery configuration to an expanded anchored configuration and has a maximum diameter that is at least 5 times greater than a maximum diameter of the suture clip in the folded delivery configuration.

4. The suture clip according to claim 3, characterized in that: The suture clip is configured to elastically self-fold from the expanded anchoring configuration to the folded suture configuration.

5. The suture clip according to claim 3, characterized in that: The suture clip is sized to be contained by a lumen of a transvascular catheter and is provided with the lumen and the transvascular catheter, wherein the suture clip in the collapsed delivery configuration is contained within the lumen.

6. The suture clip according to claim 5, characterized in that: The suture clip is configured to elastically self-expand from the collapsed delivery configuration to the expanded anchoring configuration after being partially unsheathed from the sheath lumen.

7. The suture clip according to claim 6, characterized in that: The suture clip is configured to elastically self-fold from the expanded anchoring configuration to the folded suture configuration upon further unsheathing from the sheath cavity.

8. The suture clip according to claim 7, characterized in that: The suture clip is configured to evert during transition between the collapsed delivery configuration and the expanded anchoring configuration such that a radially inward side of the plurality of anchors in the collapsed delivery configuration faces outward in the expanded anchoring configuration.

9. The suture clip according to claim 7, characterized in that: The suture clip has a proximal-distal axis, wherein the suture clip is configured to evert during transition between the folding delivery configuration and the folding suturing configuration such that a portion of the plurality of arms initially located on a distal side of the core moves to a proximal side of the core.

10. The suture clip according to claim 6, characterized in that: The suture clip includes a closure disk attached to the plurality of arms, and wherein upon movement of the closure disk, the suture clip folds from the expanded anchoring configuration to the folded suture configuration.

11. The suture clip according to claim 10, characterized in that: The closure disk moves from a position closer to the core of the suture clip to a position farther from the core to cause the suture clip to fold from the expanded anchoring configuration to the folded suture configuration as the closure disk moves.

12. The suture clip according to claim 6, wherein: Transitioning from the expanded anchoring configuration to the folded suturing configuration includes a return movement of the arms in a direction opposite to a direction of expansion of the arms from the folded delivery configuration to the expanded anchoring configuration.

13. The suture clip according to claim 1, wherein: The arms are sized to attach the anchors to tissue of an aperture of a left atrial appendage and are configured to fold into a shape closing the aperture of the left atrial appendage.

14. The suture clip according to claim 5, characterized in that: The suture clip is unsheathed by movement of a sheath relative to the proximal end of the suture clip, and the suture clip is oriented in the sheath along a proximal-distal axis, the core is on a proximal side of the suture clip, and the plurality of anchors are on a distal side of the suture clip.

15. The suture clip according to claim 5, characterized in that: The suture clip is unsheathed by movement of a sheath relative to the proximal end of the suture clip, and the suture clip is oriented along a proximal-distal axis in the sheath, the plurality of anchors are on a proximal side of the suture clip, and the core is on a distal side of the suture clip.

16. The suture clip according to any one of claims 5 to 10, characterized in that: The suture clip is individually manipulable together with a spreader to extend laterally from the transvascular catheter, inserted into the hole of the body cavity, and configured to contact tissue of the hole of the body cavity with a plurality of clamps to set a position for deploying the suture clip from the sheath.

17. The suture clip according to any one of claims 1 to 15, characterized in that: The plurality of anchors in the folded suture configuration define a zigzag pattern extending along a closed band of a closed tissue.

18. The suture clip according to any one of claims 1 to 15, characterized in that: The plurality of anchors in the folded suture configuration draws tissue into a surgical purse-string suture configuration.

19. The suture clip according to any one of claims 1 to 15, characterized in that: The plurality of arms extend from the core, each of the arms extending from a separate base attached to the core.

20. The suture clip according to any one of claims 1 to 15, characterized in that: A first plurality of arms extend from the core via a trunk common to the plurality of arms.

21. The suture clip of claim 20, wherein: The suturing clip includes a second plurality of arms, and wherein the first plurality of arms are configured to interdigitate with the second plurality of arms in the folded suturing configuration.

22. The suture clip according to any one of claims 1 to 12, characterized in that: A material of the plurality of arms includes nickel-titanium alloy.

23. The suture clip of claim 22, wherein: A material of the suture clip includes a radiopaque marker that is more radiopaque than Nitinol.

24. The suture clip according to any one of claims 1 to 15, characterized in that: The suturing clamp includes a torsion bar, wherein at least one of the plurality of arms is mounted to at least one side of the torsion bar, and the torsion bar is configured to be twisted to move at least one of the plurality of arms from the folding delivery configuration to the folding suturing configuration.

25. The suture clip according to any one of claims 1 to 15, characterized in that: At least one of the plurality of arms is configured to flex along a longitudinal extent of the arm to move at least one of the plurality of arms from the folding and delivering configuration to the folding and sewing configuration.

Images