Fixation device for tissue approximation procedures

Abstract

The present disclosure describes a tissue fastener and assembly for securing a suture in a tissue approximation procedure. The suture is provided with a plurality of protrusions (91) disposed along the length of the suture. The tissue fastener includes an anchor body (11) having an elongated shape, a passageway (14) for the suture through the anchor body, and a claw (15) adjacent an exit (141) of the passageway and configured to engage the plurality of protrusions (91) to prevent migration of the suture in a first direction (92) from the exit inwardly into the anchor body. The claw includes a claw body (151) pivotally coupled to the anchor body, the anchor body including a seat (111) for the claw body such that a force exerted on the claw body in the first direction by one of the plurality of protrusions causes the claw body to pivot and abut against the seat.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to tissue fasteners for securing sutures, particularly for use in endoscopic tissue access procedures in the gastrointestinal tract, and to assemblies including such tissue fasteners. [Background technology]

[0002] Tissue fasteners of the above-mentioned type are known from U.S. Patent Application Publication No. 2004 / 0167546, U.S. Patent Application Publication No. 2005 / 0251208, and WO 2007 / 140309. Known tissue fasteners exhibit several drawbacks. First, they lack an optimal shape that allows for easy deployment through a catheter. Second, they require a dedicated tool to perform suture tensioning. Third, some fasteners only allow for suture fixation while an additional fastener is required to compress the tissue. Fourth, some fasteners may not provide the necessary fixation force or, alternatively, may not ensure complete tensioning of the suture as the force of pulling the thread through the fastener increases suture tension, resulting in incomplete tissue approximation. In particular, at the beginning of tissue approximation, the distal end of the suture is relatively loose; therefore, pulling at the proximal end can relatively easily release the sliding insertion and initiate clamping. However, at the end of tissue approximation, the suture is under too much tension due to tissue compression, and therefore the suture attempts to lock the sliding insertion and may lock it before adequate tissue approximation is achieved. Summary of the Invention [Problem to be solved by the invention]

[0003] There is a need in the art to provide improved tissue fasteners that overcome at least some of the above-mentioned drawbacks. In particular, there is a need to provide tissue fasteners with fastening mechanisms in which the force required to release the fastening mechanism, for example to further tighten the suture, is independent of the tightening status. There is a need in the art to provide tissue fasteners that have improved mechanical strength and / or are less susceptible to failure. There is a need in the art to provide tissue fasteners that cause less trauma to the tissue. [Means for solving the problem]

[0004] According to the present disclosure, therefore, there are provided tissue fasteners and assemblies including such fasteners. The solution according to the present disclosure provides a tissue fastener with a fastening mechanism for a thread, where the force required to release the fastening mechanism, for example to further tighten the thread, is not dependent on the tightening status or tension of the thread.

[0005] According to a first aspect of the present disclosure, there is provided an assembly for anchoring a suture, particularly within a human or animal body, for example in a tissue approximation procedure, as defined in claim 1. The suture is provided with a plurality of protrusions disposed along the length of the suture, preferably spaced apart from one another along the length.

[0006] The tissue fastener includes a fastener body having an elongated shape defining a longitudinal axis. The fastener body can be at least partially tubular along the longitudinal axis. A passage for the suture through the fastener body includes an outlet, for example, through an outer wall of the fastener body. The tissue fastener further includes a claw adjacent to the outlet. Preferably, the claw is disposed on the outer wall of the fastener body. The claw is configured to engage with the plurality of protrusions to prevent movement of the suture in a first direction relative to the fastener body, preferably from the outlet inward into the fastener body. As a result, the claw provides a suture locking mechanism. The claw includes a claw body pivotally coupled to the fastener body. The fastener body includes a seat for the claw body such that a force applied to the claw body in a first direction by one of the plurality of protrusions pivots the claw body into abutment against the seat.

[0007] An advantage of the tissue fastener described above is that the seat provides improved back support for the nail body to resist pressure from the suture. The nail body does not bend inward and stops when tissue reaction tries to push it backward. This prevents the suture from becoming increasingly compressed and ultimately severing. A stronger and more reliable suture fixation can thereby be obtained, while the fastener can be made slim and suitably long, allowing for proper tissue fixation and / or easy deployment through a catheter.

[0008] Advantageously, the hinge is located at a first end of the claw body and the outlet is located at a second end of the claw body opposite the first end, preferably the first and second ends defining a direction substantially parallel to the longitudinal axis. This solution makes it possible to have a sufficient lever to pivot the claw body outward while tensioning the thread without requiring much force to actuate. Less force is applied to the hinge and, if the hinge is formed integrally with the claw body and the fastener body, excessive deformation of the hinge is prevented.

[0009] Advantageously, the seat includes an abutment surface for the pawl, the abutment surface being inclined with respect to a plane parallel to the pivot axis and parallel to the longitudinal axis of the pawl. Advantageously, the abutment surface has mirror symmetry with respect to a plane perpendicular to the pivot axis. By providing such an inclined and advantageously mirror symmetric seat or abutment surface, automatic transverse (cross-longitudinal) alignment of the pawl body with the fixture body is obtained, preventing unwanted lateral movement of the pawl body which could deform the hinge and resulting in improved stability of the pawl body resting on the seat.

[0010] Advantageously, the claw body includes side edges on either side of the claw body between the first and second ends. Advantageously, the side edges extend, as considered along the longitudinal axis, away from the hinge to a position beyond the outlet. The seat advantageously extends along both of the side edges. Such a solution maximizes the contact area for the claw body and improves the mechanical strength of the thread locking mechanism, further improving alignment performance by preventing lateral movement of the claw body.

[0011] Advantageously, the hinge is located at a first end of the claw body and the outlet is located at a second end of the claw body opposite the first end along the longitudinal axis. At the second end, the claw body includes an edge, which is advantageously, for example, arcuate or curved, projecting in a plane parallel to the longitudinal axis. Such a solution further improves the self-alignment performance by preventing lateral movement of the claw body.

[0012] Advantageously, the claw body includes a narrower section at a first end of the claw body and a larger section at a second end opposite the first end along the longitudinal axis, e.g., having a substantially teardrop shape. The claw body is pivotally connected to the fastener body at the first end. The hinge can be integrally formed with the claw body and the fastener body, i.e., made from a single piece or workpiece, so that the claw body resembles a flap. Such a narrower section makes it possible to have a hinge that can be actuated with less force, while the larger section provides an expanded contact area with the sheet. When the claw body is more arcuate, mechanical resistance is even further improved.

[0013] Advantageously, the tissue fastener is a T-shaped fastener with an outlet for the suture located in a central section of the fastener body intermediate opposite first and second end sections of the fastener body along the longitudinal axis. The central section and / or end sections may include respective weaknesses configured to act as pivots for the first and second end sections of the fastener body and allow the first and second end sections to bend relative to the central section. Advantageously, the cross-sectional area of ​​the fastener body at the weaknesses is reduced relative to the first and second end sections. This allows the fastener body sections to bend at the weaknesses, for example, about an axis substantially intersecting the longitudinal axis. As a result, the tissue fastener conforms better to the tissue, and trauma to the tissue may be reduced or avoided. In some instances, the reduced thickness is achieved by transverse cuts or recesses in the fastener body, for example, from the side of the inlet.

[0014] According to a second aspect of the present disclosure, there is provided a tissue fastener for securing a suture, the tissue fastener including: an anchor body having an elongate shape and defining a longitudinal axis, a passageway for the suture through the anchor body substantially perpendicular to the longitudinal axis, and a lever member having a first end pivotally coupled to the anchor body and a second end opposite the first end including an engagement surface configured to engage the suture when the lever member is inserted into the passageway.

[0015] The passageway includes a support surface for supporting the suture, the support surface being angled relative to the longitudinal axis and facing the engagement surface such that the lever member allows threading of the suture along the passageway in a first direction in which the lever member is pivoted away from the support surface and prevents movement of the suture along the passageway in a second direction opposite the first direction in which the lever member is pivoted toward the support surface upon actuation of engagement of the engagement surface and the suture.

[0016] Such tissue fasteners allow for an engagement surface that may be roughened or provided with barbs, teeth, serrations, etc., to move away from the support surface for the suture to pass freely. This solution reduces the force required to lift the lever and thus thread the suture in the sliding direction, regardless of the tension on the suture. Additionally, the angled support surface acts as a back support and final end stop for the lever member to provide improved fixation of the suture.

[0017] Advantageously, the tissue fastener further includes a spring member configured to bias the lever member toward the support surface. Advantageously, the spring member is a resilient member attached to or integral with the lever member, and preferably the spring member is configured to engage a wall of the fastener body. Such a spring member allows for pre-loading of the engagement surface against the inclined support surface. The suture is thus compressed, even in its rest position. This advantageously prevents micro-movements that could allow it to slowly slide backwards over time.

[0018] According to a third aspect of the present disclosure, there is provided a tissue fastener for securing a suture, the tissue fastener including a fastener body having an elongated shape and defining a longitudinal axis. A passage for the suture is provided through the fastener body. The passage includes an entrance portion and an exit portion for the suture. The entrance and exit portions have openings with axes oriented perpendicular to the longitudinal axis. These axes define the movement of the suture into and out of the fastener body.

[0019] The passageway further includes a fixed portion between the entrance and exit portions including a support surface for the suture oriented substantially parallel to the longitudinal axis. The fixed portion further includes a plurality of deflectable, resilient, or pivoting leg members facing toward the support surface, each of the plurality of leg members disposed at an angle relative to the longitudinal axis and configured to engage the suture, thereby allowing the suture to be threaded along the passageway in a first direction in which the leg members are biased away from the support surface. The leg members, due to the action of engagement between the leg members and the suture, prevent movement of the suture along the passageway in a second direction opposite the first direction in which the leg members are biased toward the support surface.

[0020] One advantage of the tissue fastener according to the third embodiment is that it can be rotated, preferably by about 90°, relative to the direction of travel of the threads into and out of the tissue fastener. In doing so, the fastening portion can be made longer as desired, with more leg members to provide anchoring force to the threads. This results in a more elongated fastener that can be easily deployed through the instrument channel of a catheter or endoscope while still having the necessary shape to hold tissue in place.

[0021] According to a further aspect of the present disclosure, there is provided an assembly for securing a suture in a tissue approximation procedure for a human or animal body, the assembly including a suture, a first tissue anchor, and a second tissue anchor, wherein the first and second tissue anchors are advantageously configured to approximate tissue between the first and second tissue anchors. The second tissue anchor is elongate defining a second longitudinal axis, and the suture is secured to the second tissue anchor at a central section of the second tissue anchor intermediate opposite sides of the first and second end sections of the second tissue anchor along the second longitudinal axis. Advantageously, the central section includes a weakness that allows the first and second end sections of the second tissue anchor to flex relative to the central section of the second tissue anchor. Advantageously, the second tissue anchor includes a transverse notch in the central section that forms the weakness. Advantageously, the first tissue anchor includes a thread locking mechanism that allows the first tissue anchor to be advanced towards the second tissue anchor while preventing the first tissue anchor from moving along the tissue away from the second tissue anchor. Advantageously, the first tissue anchor is according to the first, second or third aspect.

[0022] According to a further aspect of the present disclosure, there is provided an assembly for securing a suture in a tissue approximation procedure. Such an assembly includes a suture and at least one tissue anchor configured to secure the suture, the suture including a frangible portion. Advantageously, the at least one tissue anchor includes an anchor body and a passage for the suture therethrough. The tissue anchor includes a unidirectional fixation means or system for the suture configured to allow movement of the suture relative to the tissue anchor in one direction while preventing movement of the suture relative to the tissue anchor in a second direction opposite the first direction. The tissue anchor may be any one of the tissue anchors according to the first, second, and third aspects of the present disclosure.

[0023] One advantage of the above-described type of assembly is that no additional instruments are required to cut the threads at the end of the tissue approximation procedure, which further prevents excessive forces from being applied to the tissue fasteners, which could deform the fasteners and cause them to fail.

[0024] Described herein are methods for approximating tissue in a human or animal body. The method includes a first act of endoscopically forming a tissue plication within the body, particularly in a gastrointestinal cavity, more particularly in the abdominal region. In a second act, the tissue plication is perforated with a deployment device defining a lumen. An assembly according to the present disclosure is housed in the lumen. In a third act, a first of at least first and second tissue fasteners is deployed along the lumen across the tissue plication. In a fourth act, at least one additional tissue plication is endoscopically formed, and the at least one additional tissue plication is perforated with the deployment device. In a fifth act, a second of the at least first and second tissue fasteners is deployed through the lumen across the additional tissue plication. In a sixth act, the first and at least one additional tissue plication are approximated by approximating the first and second tissue fasteners toward each other, thereby securing the tissue plication between the first and second tissue fasteners. In an optional seventh action, the suture is cut, for example at the frangible portion.

[0025] Aspects of the present invention will now be described in more detail with reference to the accompanying drawings, in which like reference numerals refer to like features. [Brief explanation of the drawings]

[0026] [Figure 1] 1 shows a perspective view of an embodiment of a tissue fastener according to the present disclosure. [Figure 2] 2 shows a plan view and a cross-sectional view along section line AA of the tissue fastener of FIG. 1. [Figure 3] 10 shows a perspective view of another embodiment of a tissue fastener according to the present disclosure; [Figure 4] 4 illustrates a plan view of the tissue fastener of FIG. 3. [Figure 5] 1 illustrates a tissue anchor assembly according to aspects of the present disclosure. [Figure 6] 2 illustrates the tissue fastener of FIG. 1 when deformed to conform to approximated tissue. [Figure 7]1 depicts a perspective view of a fixed tissue fastener according to the present disclosure; [Figure 8] 8 shows a top view of the secured tissue fastener of FIG. 7. [Figure 9A] 8 illustrates the secured tissue fastener of FIG. 7 as it deforms to conform to the approximated tissue. [Figure 9B] 10 depicts a side view of an alternative tissue fastener having a weakness in the longitudinal end section of the fastener body formed as a transverse notch. [Figure 10] 10 depicts a diagram of a tissue plication that has been perforated by a deployment device that includes a lumen for deploying the tissue fasteners and assemblies of the present disclosure. [Figure 11] 1 depicts a diagram of multiple tissue plications approximated by an assembly of the present disclosure. [Figure 12] 1 shows a longitudinal cross-sectional view of a tissue fastener according to a second embodiment of the present disclosure. [Figure 13] 13 shows an exploded perspective view of the tissue fastener of FIG. 12. [Figure 14] 10 shows a longitudinal cross-sectional view of a tissue fastener according to a third embodiment of the present disclosure. [Figure 15] 15 shows an exploded perspective view of the tissue fastener of FIG. 14. DETAILED DESCRIPTION OF THE INVENTION

[0027] Detailed Description 1 and 2, tissue fastener 10 includes fastener body 11 having an elongated shape defining longitudinal axis 100. Fastener body 11 is preferably tubular with interior channel 12 and wall 13 defining channel 12 and additionally defining an outer wall 131 of the fastener body. A passage 14 for suture 9 through fastener body includes an entrance 142 and an exit 141 through wall 13. Entrance 142 and exit 141 define a preferably straight suture passage 14 oriented transversely (perpendicularly) to longitudinal axis 100. Tissue fastener 10 further includes a prong 15 disposed in fastener body wall 13 adjacent exit 141. Prong 15 is configured to engage protrusion 91 of suture 9 to prevent movement of the suture from exit 141 inwardly into the fastener body in a first direction 92 while allowing movement of the suture in the opposite direction.

[0028] It will be appreciated that in alternative configurations, the claws 15 may be configured to hinge in an opposite sense to allow movement of the suture in the first direction 92 relative to the fastener body 11 while preventing movement of the suture in a direction opposite the first direction 92. In some examples, the claws 15 may be configured to hinge into the interior of the fastener body 11, for example, to hinge in the interior channel 12.

[0029] The pawl 15 includes a pawl body 151 pivotally connected to the fastener body 11 via a hinge 152, which may be integrally formed with the fastener body 11 and the pawl body 151. The fastener body includes a seat 111, e.g., including or consisting of an abutment surface, for the pawl body 151, so that a force exerted on the pawl body in the first direction 92 by one of the plurality of protrusions 91 causes the pawl body 151 to pivot and abut against the seat 111. The seat 111 is advantageously located between the hinge 152 and the outlet 141.

[0030] The claw body 151 is preferably cut out from the fixture body 11, for example through laser cutting or wire EDM. In the case where the fixture body 11 is tubular, the claw body 151 is formed by a portion of the wall 13 that has been cut out from the fixture body. The claw body 151 advantageously remains attached to the fixture body (wall 13) at a hinge portion 152, and advantageously forms a flap that is connected to the fixture body only via the hinge portion 152. The hinge portion 152 may be formed by one or more strips that connect the claw body 151 to the fixture body 11. Advantageously, the hinge 152 is formed as an integral piece with the fixture body 11, and the claw body 151, e.g. the hinge 152, is an uncut piece of the (tubular) fixture body 11.

[0031] The fastener body 11 is advantageously tubular (cylindrical or rectangular) with the internal channel 12 extending along the longitudinal axis 100. The claw body 151 advantageously has a teardrop shape, with the claw body 151 being wider and the section adjacent the hinge 152 being narrower (as seen in a cross section perpendicular to the longitudinal axis). The narrower section of the hinge 152 allows for easier pivoting of the claw body 151, for example, in a tubular or cylindrical fastener. The cross section of the claw body 151 perpendicular to the axis 100 is advantageously curved or arcuate, which increases mechanical strength when the protrusion 91 presses against the claw body 151 in the direction 92.

[0032] Advantageously, the sheet 111 includes an abutment surface configured to receive or engage the nail body 151, the abutment surface at least partially lying in a plane that is inclined relative to a plane parallel to the longitudinal axis 100 and relative to the pivot axis of the hinge 152, providing increased strength. As can be seen more clearly in cross section AA of Figure 2, the sheet 111 advantageously has mirror symmetry with respect to the median plane 101 of the nail body 151, which is perpendicular to the pivot axis of the hinge 152 and parallel to the longitudinal axis 100, to advantageously align the nail body 151 in the sheet 111. This can prevent lateral movement of the nail and assist in self-alignment of the nail body relative to the sheet. Additionally or alternatively, the surface of sheet 111 is advantageously oriented away from the radial direction of the fastener body to increase the sealing surface and / or improve the self-alignment capabilities of the jaws, i.e., the surface of sheet 111 is oblique to or oriented in a direction that is not parallel to the local radial direction of the fastener body. By way of example, the sealing surface may be inclined relative to the local normal to the exterior surface of the fastener body.

[0033] Pawl body 151 may include further self-aligning capabilities. In some examples, pawl body 151 has mirror symmetry about a median plane parallel to (and possibly including) longitudinal axis 100 and advantageously intersects (is perpendicular to) the pivot axis of hinge 152. Additionally, or alternatively, free end 153 of the pawl body opposite hinge section 152 can have a curved or arcuate edge, for example, when viewed from direction 92, and sheet 111 can have a complementary shape to support the curved or arcuate edge of free end 153 of pawl body 151.

[0034] 3 and 4 , another example of a tissue fastener 50 according to the present disclosure differs from the tissue fastener 10 described above in the shape of the claw 15. The claw 15 includes a claw body 551 that is more elongated in shape than the claw body 151. In particular, the claw body 551 extends from a hinge section 552 to a free end 553 that extends beyond the outlet 141 when considered along the longitudinal axis. This allows for an expanded seat 511, and thus an increased abutment surface, compared to the claw body 151. Specifically, the claw body 551 advantageously includes left and right edges 554, 555, respectively, that extend from the hinge section 552 to respective ends 556, 557 at the free end 553. The side edge ends 556, 557 are located away from the hinge section, beyond the location of the outlet 141, along the longitudinal axis 100. The free end 553 extends from the ends 556, 557 at side edges back toward the hinge section in the center, and the free end 553 advantageously abuts the outlet 141, and advantageously does so along a curved or arcuate edge. By doing so, the length of the abutment surface on the sheet 511 can be maximized for improved mechanical strength. Additionally, such a shape of the free end 553 improves the self-alignment ability of the claw body 551 relative to the fastener body. In some examples, the free end 553 and the corresponding edge of the sheet (fastener body) include abutment surfaces that are inclined (i.e., not perpendicular) to the longitudinal axis 100 to even further improve the self-alignment ability. 1-2, with an arcuate or curved cross-section in a plane perpendicular to the longitudinal axis 100, and / or with side edges 554, 555 and corresponding abutment surfaces of seat 511 inclined relative to the local radial direction of fastener body 11. It will be appreciated that claw body 551, like claw body 151, advantageously has mirror symmetry with respect to a median plane that is parallel to (and possibly includes) the longitudinal axis 100 and that advantageously intersects (is perpendicular to) the pivot axis of hinge 552.

[0035] It will be appreciated that the sheet may have serrations or teeth to allow for increased contact area between the pawl and the fastener body, in which case the pawl body 151 has a serrated or toothed edge to complement the shape of the sheet.

[0036] To provide adequate weakening and reduce the force required to pivot the claw body, particularly when the wall of the fastener body is curved or arcuate in a plane perpendicular to the longitudinal axis, the width of the hinge section 152 can be increased while providing additional notches through the hinge section. It will be appreciated that the hinge section 552 of the tissue fastener 50 is somewhat wider compared to the hinge section 152 of the claw body 151 in FIGS. 1-2 . The hinge section 552 includes through-notches or through-openings 558 through the wall 13 of the fastener body 11 to reduce the effort required to pivot the claw body 551 about the hinge; additional such notches can be provided as desired. Due to the through-notches 558, the claw body 551 is connected to the fastener body 11 via two more elongated strip members 559 made as a unitary piece with the claw body 551 and the fastener body 11, for example, by a suitable cutting action through the fastener body.

[0037] The outlet 141 may be provided as a cavity or aperture in an edge of the nail body 151 or 551, or in an edge of the fastener body 11 (sheet 111), or a combination of both. Advantageously, the outlet 141 is positioned between the nail body 151, 551 and the wall 13 of the fastener body. Specifically, the outlet 141 is partially surrounded by or partially contacted by the nail body 151, 551, e.g., at the free end 153, 553, and by the interior edge of the fastener body 11 (at the wall 13). In some examples, the nail body 151 or 551 includes a recess 541, advantageously located at the edge (e.g., the free end 153, 553) of the nail body, the recess forming the outlet 141. The recess 541 is configured to have a size smaller than the protruding portion 91 of the suture 9 while allowing the suture 9 to pass freely through it. As the suture moves inwardly from the outlet 141 into the fastener body in a first direction 92, the protrusion 91 abuts the claw body around the periphery of the recess, causing the claw to pivot toward the fastener body, thus stopping further movement of the suture. Alternatively, it is possible to provide a recess in the wall 13 of the fastener body, for example adjacent the free end 153, 553 of the claw body, or partially in the claw body and partially in the wall of the fastener body.

[0038] Tissue fasteners 10, 50 are therefore advantageously T-shaped fasteners. Specifically, suture inlet and outlet passages 142, 141, respectively, are advantageously aligned transversely. Passage 14 is advantageously located in central section 114 of tissue fastener (fastener body 11) intermediate tissue fastener end sections 112, 113, which are located at opposite ends of the tissue fastener (fastener body) along longitudinal axis 100. Advantageously, inlet 142 and outlet 141 of passage 14 are located approximately midway along the length of the tissue fastener. Advantageously, inlet 142 and outlet 141 of passage 14 are located on opposite sides of fastener body 11.

[0039] The fastener body 11 advantageously has a cross-sectional area (in a plane perpendicular to the longitudinal axis 100) that decreases in the region of the passageway 14, particularly in the region of the outlet 141 and / or the inlet 142 (in the region of the claws 15). In particular, the inlet 142 may include a recess or inlet bore that is suitably larger than the size of the protrusion 91 of the suture 9 to (further) reduce the cross-sectional area of ​​the fastener body, and / or the fastener body 11 may include transverse cuts at locations corresponding to the inlets and / or outlets (not shown) of the passageway. This advantageously creates a weakness in the fastener body at the location corresponding to the passageway 14 and provides a pivot in the central section 114 that allows the end sections 112, 113 of the tissue fastener to bend relative to the central section 114 about an axis perpendicular to the longitudinal axis, as shown in FIG. 6 . When the tissue fastener is tightened against tissue (located to the side of the entrance 142 of the passage 14), the force exerted by the projections 91 on the area around the exit 141 in the central section 114 causes deformation of the tissue fastener, causing the end sections 112, 114 to bend away from the tissue relative to the central section 114. This reduces or avoids trauma to the tissue caused by an overly rigid fastener. Flexibility of the fastener body is further improved when the passage 14 is substantially straight and perpendicular to the longitudinal axis 100, and in particular when the jaw body 151 is formed as a flap cut out from the fastener body, which (further) reduces the cross-section of the fastener body in the area of ​​the exit 141. Flexibility can be further improved by fabricating the fastener body from a flexible or resilient material, such as Nitinol (a nickel-titanium alloy).

[0040] The tissue fasteners of the present disclosure can be easily deployed through catheterization procedures, allowing for easy loading into the small instrument channels of catheter devices. Referring to FIG. 5 , in a typical fastener assembly 40, at least two tissue fasteners are used, and a first tissue fastener 10, 50 can be pulled along a suture 9 toward a second tissue fastener 41 by any suitable device, such as a push rod, to approximate the tissue between the first and second fasteners. The first tissue fastener can be used to tighten the suture with the unidirectional locking mechanism described herein. An advantageous application is tissue approximation in the digestive tract, specifically gastric reduction surgery.

[0041] 7-8 , second tissue fastener 41 is advantageously a T-shaped fastener that is elongated along longitudinal axis 400. Tissue fastener 41 may be tubular with a cylindrical or rectangular base and lumen 410. Suture 9 is optionally immobilely secured to tissue fastener 41, for example, at central section 414 of the tissue fastener intermediate end sections 412, 413 located at its longitudinal ends. In some examples, tissue fastener 41 includes an exit hole 441 for suture 9, for example, at central section 414, and optionally an entrance hole 442 opposite exit hole 441. Exit hole 441 is advantageously smaller than protrusion 91 that secures the suture to tissue fastener 41. Entrance hole 442 may be larger than protrusion 91 to facilitate assembly. Entrance hole 442 may alternatively be omitted, and the thread inserted via lumen 410.

[0042] Like tissue fasteners 10, 50, second tissue fastener 41 may include weaknesses in central section 414, particularly at locations corresponding to entry hole 442 and / or exit hole 441, that allow end sections 412, 413 to flex and conform to the clamped or approximated tissue. In some examples, the weaknesses include cutouts 443 perpendicular to the body of the tissue fastener, particularly at longitudinal locations corresponding to the entry and / or exit holes. This reduces the cross-sectional area of ​​the fastener body in the central section to create a pivot axis, as shown in FIG. 9A , perpendicular to longitudinal axis 400. When a force is applied to suture 9 in the direction of arrow 93 due to the approximated tissue, weakness 443 allows end sections 412, 413 to flex in the opposite direction (i.e., about a transverse axis oriented perpendicular to the plane of FIG. 9 ) compared to the force direction 93. This can provide a better conformance to the tissue, thus advantageously reducing or avoiding trauma.

[0043] 9B, one or more transverse notches 451 or indentations can be provided in the fastener body of second tissue fastener 41 at end sections 412, 413. The transverse notches 451 create one or more weaknesses that allow the end sections to flex relative to central section 414 to conform to tissue as the suture is tightened and the tissue fastener is pressed against the tissue. The transverse notches 451 are advantageously provided from a side 415 of the fastener body opposite side 416, for example, configured to engage tissue from an opposite side 416 of exit hole 441. A combination of weaknesses in central section 414 (e.g., transverse notches 443) and end sections 412, 413 can be envisioned.

[0044] It will be appreciated that transverse cuts 443 and / or 451 may be made in the tissue fasteners 10, 50 described above to form appropriate weaknesses in a similar manner.

[0045] 5, the suture 9 may include a frangible portion 42 configured to break when a threshold stress or tension in the thread 9 is exceeded. The frangible portion is advantageously a portion of the suture having a locally reduced cross-sectional area. - heat treating and / or mechanically deforming sections of the yarn, - abutting two lengths of suture with the weak joint; - in the case of braided sutures, cutting part of the braid in one spot; In the case of monofilament sutures, pulling the suture to have a locally smaller radius, -Laser cutting to remove portions of the suture or adding stress risers; This can be achieved by several means, such as one or a combination of: Such frangible portions 42 may be provided in the suture, preferably at convenient locations along the suture when manufacturing the suture. In some instances, the suture may be heated and the thread may be pulled or tensioned to locally reduce the cross section of the suture, advantageously creating a frangible portion, particularly when the suture is a polymer or synthetic material.

[0046] 10-11 , a tissue plication 8 is endoscopically formed in a cavity of a human or animal body, for example a cavity of the digestive tract, e.g., the abdomen, to approximate tissue using an assembly according to the present disclosure. The tissue plication may be formed using known instruments, for example, a grasper. A deployment device 60, e.g., including a perforation needle 62 and a lumen 61, is advanced through the human or animal body, for example, through an endoscope or catheter (not shown). The tissue plication 8 is perforated with the needle 62, and the deployment device 60 is advanced across the tissue plication. A tissue fastener, e.g., a second tissue fastener 41, is deployed from the lumen 61 across the tissue plication 8, for example, using a push device 63, e.g., a push rod. The deployment device 60 is then retracted from the tissue plication 8. At this stage, advantageously, another tissue fastener, e.g., a first tissue fastener 10, 50, is still housed in the lumen 61.

[0047] An additional tissue fold 81 may be formed endoscopically, and the deployment device 60 may be caused to pierce and advance across the additional tissue fold 81. Another tissue fastener, for example, the first tissue fastener 10, 50, is deployed from the lumen 61 across the additional tissue fold 81. The deployment device 60 is then retracted from the additional tissue fold to obtain the situation shown in FIG. 11 , where multiple tissue folds 8, 81 (which may be three or more) are inserted between the first and second tissue fasteners. At this stage, the first tissue fastener 10, 50 may be approximated toward the second tissue fastener 41 by advancing the first tissue fastener along the suture 9. In some examples, a grasping device engages the thread 9, for example, at protrusion 94 or with a loop or lasso, and a pushing device, for example, a push rod, stretches the thread 9 while approximating the first tissue fastener 10, 50 toward the second tissue fastener 41. The first tissue anchor is secured to the suture by the thread locking mechanism described above (not shown in FIGS. 10-11 for clarity). Once the tissue anchor is in place, the suture can be cut, for example, at the frangible portion. In some examples, the suture is configured to break at the frangible portion by applying tension to the thread. This can be accomplished by pushing with, for example, push device 63, on the proximal-most tissue anchor and simultaneously pulling on the suture to cause breakage of the suture at the frangible portion.

[0048] 12-13 , tissue fastener 20 according to a second aspect of the present disclosure includes fastener body 21 having an elongated shape and defining longitudinal axis 100, a passageway 24 for a suture passing through fastener body 21 substantially perpendicular to longitudinal axis 100, and lever member 25. Lever member 25 includes top portion 251 pivotally connected to fastener body 21 by pin 26, bottom portion 253 including engagement surface 254 configured to engage a suture when inserted into passageway 24, and middle portion 252 connecting top portion 251 to bottom portion 253. Middle portion 252 may be resilient to allow bottom portion 253 to pivot or deflect relative to top portion 251 in addition to or in lieu of the hinge formed by pin 26. Engagement surface 254 is thus deflectable along the direction of passageway 24, i.e., about pivot axis 200 perpendicular to longitudinal axis 100.

[0049] The passageway 24 includes a support surface 211 for supporting the suture. The support surface 211 is preferably flat, or a first cross section of the support surface 211 in a plane perpendicular to the pivot axis 200 is preferably straight, while a second cross section of the support surface 211 in a plane parallel to the pivot axis 200 and parallel to the longitudinal axis 100 is curved. The support surface 211 (i.e., the first cross section as seen in the plane of FIG. 12) is inclined relative to the longitudinal axis 100 at an angle α of preferably between 30° and 85°, preferably between 45° and 80°, preferably between 50° and 75°.

[0050] Support surface 211 faces engagement surface 254 such that support surface 211 and engagement surface 254 define opposite walls of passageway 24. Due to the angled orientation of support surface 211 and the pivotal attachment of engagement surface 254 by lever member 25, the suture is permitted to pass along passageway 24 in a first direction 241 as lever member 25 is pivoted away from support surface 211. However, due to the action of engagement surface 254 and the suture causing lever member 25 to pivot toward support surface 211, the suture is locked by engagement surface 254 to prevent movement in a second direction 242 opposite first direction 241. Due to the angled orientation of support surface 211, the support surface serves as an abutment for lever member 25 such that the engagement surface may further engage the suture and prevent further movement of the suture along the passageway in second direction 242.

[0051] 13, fastener body 21 may have a top portion 212 including a slit 22 in which lever member 25 is received. A tubular cap 23 is configured to cover slit 22. Lever member 25 and cap 23 are advantageously secured to fastener body 21 by pin 26. Support surface 211 advantageously forms an end face of slit 22. A bottom portion 213 of fastener body 21, extending from support surface 211 in a direction away from top portion 212, may be solid.

[0052] Advantageously, a spring or resilient member 255 is coupled to the upper portion 251 or middle portion 252 of the lever member 25 and is configured to bias the lever member towards the support surface 211. Advantageously, the spring member 255 is configured to engage the cap 23 (or fixator body 21) to preload or bias the lever member 25 (engagement surface 254) against the inclined support surface 211. The suture is thus compressed even in a rest position. This advantageously prevents micro-movements that could slowly allow it to slide backwards over time.

[0053] 14-15 , a tissue fastener 30 according to a third aspect of the present disclosure includes a fastener body 31 having an elongated shape and defining a longitudinal axis 100. The fastener body 31 is advantageously tubular with an interior channel 32 and a channel wall 33. A passage 34 for a suture 9 through the fastener body 31 includes an entrance portion 341 and an exit portion 342 for the suture that define a through aperture through the fastener body 31 located on opposite sides of the fastener body 31 in a direction perpendicular to the longitudinal axis 100. The entrance and exit portions 341, 342 are configured to guide movement of the suture 9 in a direction substantially perpendicular to the transverse longitudinal axis 100. To this end, the exit portion 342 may include an arcuate portion suitable for providing proper guidance of the suture.

[0054] The passageway 34 further includes a fixed portion 343 and a routing portion 344 between the inlet and outlet portions 341, 342. The suture 9 is guided through the fixed portion 343 and the routing portion 344 in substantially opposite directions, which are substantially parallel to the longitudinal axis 100. Specifically, the suture 9 is routed from the inlet 341 around a pin 361, which advantageously has a circular cross-section. This may avoid cutting forces at the edges of the inlet portion 341. The thread 9 changes direction of travel approximately 90° around pin 361, from substantially perpendicular to the longitudinal axis 100 to substantially parallel thereto, and is routed around pin 362, changing direction of travel approximately 180° back toward the outlet portion 342. It will be appreciated that the inlet portion 341 and the outlet portion 342 are advantageously disposed at corresponding positions along the longitudinal axis.

[0055] An insert 35 is disposed in the internal channel 32. The insert 35 is preferably tubular, including an internal lumen 352. The insert 35 includes a deflectable or pivotable member 351 configured to engage the suture 9 at a fixed portion 343. The fixed portion 343 includes a support surface 311, preferably formed by the channel wall 33, e.g., between the pin 362 and the outlet portion 342. The support surface 311 and the free end of the deflectable member 351 define a wall of the passageway 34 opposite the fixed portion. In some examples, the deflectable member 351 includes a notched or grooved end portion 353, allowing the thread 9 to be threaded therethrough, forming the passageway 34 (fixed portion 343). The routing portion 344 preferably extends through the internal lumen 352, and the deflectable member 351 preferably surrounds the routing portion 344. To this end, the deflectable member 351 may be annular. The deflectable or pivoting member 351 may be attached to a backbone of the insert 35 that extends along the longitudinal axis. The deflectable or pivoting members are thus positioned along the length of the channel 32, e.g., side-by-side along the longitudinal axis. The insert 35 may be attached to the fixture body 31 by either one or both pins 361 and 362.

[0056] The deflectable or pivotable member 351 is disposed at an angle relative to the longitudinal axis such that the member 351 allows the suture to be threaded along the passageway 34 (fixed portion 343) in a first direction 345 in which the deflectable member 351 is biased away from the support surface 311. The member 351 prevents movement of the suture along the passageway in a second direction opposite the first direction 345 in which the engagement of the member 351 and the suture 9 biases the member 351 toward the support surface 311. The free end of the deflectable member 351 can be suitably shaped for optimal engagement with the suture; for example, the free end can be shaped as teeth or serrations. It will be appreciated that the deflectable member 351 approaches the support surface 311 in the first direction 345 at an acute angle.

[0057] Tissue fastener 30 is thus a T-type fastener. Specifically, the suture entry and exit passages are aligned transversely, while the deflectable members are disposed longitudinally of the fastener, thereby allowing the length of engagement with the suture to be increased while maintaining a small diameter of the fastener. By routing suture 9 around pins 361, 362, compression of insert 35 at the end of clamping is avoided, and the force moving the thread through the passage in direction 342 does not increase substantially with the degree of clamping.

[0058] It is convenient to note that the tissue fasteners 20, 30 of either the second or third embodiment may be used as an alternative to the tissue fasteners 10, 50 described above, for example in the assembly of FIG. 5 and / or in the procedure described in relation to FIGS. 10-11.

[0059] The tissue fastener of any of the first to third embodiments can be manufactured from any suitable material, particularly metal, such as a nickel-titanium alloy, or a medical-grade plastic material.

[0060] It will be appreciated that assemblies according to the present disclosure may include three or more tissue fasteners, particularly attached to the same suture, at least one of which may be any one of the first tissue fasteners described herein and at least one of which may be a second tissue fastener as described herein.

[0061] Aspects of the present disclosure are presented in the following alphabetical appendix. A1. An assembly for securing a suture in a tissue approximation procedure, the assembly comprising: a suture (9) and a first tissue fastener (10); The suture is provided with a plurality of protrusions (91) disposed along the length of the suture; A first tissue fixation device a fastener body (11) having an elongated shape defining a longitudinal axis (100); a passageway (14) for the suture through the fastener body, the passageway (14) including an outlet (141); a pawl (15) adjacent the outlet and configured to engage the plurality of protrusions (91) to prevent movement of the suture in a first direction (92) inwardly from the outlet into the fastener body; Including, The pawl includes a pawl body (151) pivotally connected to the fixture body; An assembly, wherein the fixture body includes a seat (111) for the claw body such that a force applied to the claw body in a first direction by one of the plurality of protrusions causes the claw body to pivot and abut against the seat. A2. The assembly of clause A1, wherein the pawl includes a hinge (152) coupled to the fastener body, preferably the hinge configured to pivot the pawl body about a pivot axis that substantially intersects the longitudinal axis, preferably the hinge being integrally formed with the pawl body and the fastener body. A3. The assembly of appended paragraph A2, wherein the hinge (152) is disposed at a first end of the bawl body (151) and the outlet (141) is disposed at a second end of the bawl body opposite the first end, and preferably the seat (111) is disposed between the hinge (152) and the outlet (141) when the bawl body abuts the seat, and preferably the first end and the second end define a direction substantially parallel to the longitudinal axis. A4. An assembly according to claim A2 or A3, wherein the sheet includes an abutment surface for the pawl, the abutment surface being inclined relative to a plane parallel to the pivot axis and parallel to the longitudinal axis, and preferably the abutment surface having mirror symmetry with respect to the median plane of the pawl body perpendicular to the pivot axis. A5. The assembly of any one of clauses A1-A4, wherein the fastener body (11) includes an outer wall circumferentially oriented about a longitudinal axis, and the claw body (151) defines a portion of the outer wall, preferably the outer wall having a normal vector perpendicular to the longitudinal axis, and preferably the claw body and fastener body define the outer wall in a complementary manner. A6. The assembly of any one of clauses A1-A5, wherein the pawl body (151) defines a portion of a circumferential edge of the outlet (141). A7. The assembly of any one of clauses A1-A6, wherein the fixture body includes an internal cavity (12) surrounded by an outer wall of the fixture body, the claw body defines a portion of the outer wall adjacent to the internal cavity, and the seat (111) is formed by an edge of the outer wall interfacing with the claw body. A8. An assembly according to any one of appendix A1 to A7, preferably appendix A7, wherein the claw body (151) is formed by partially cutting out the fastener body. A9. An assembly according to any one of clauses A1-A8, preferably clause A7 or A8, wherein the fastener body (11) is at least partially tubular at a location coincident with the claw (15), preferably the fastener body being tubular with a lumen extending from a first end of the fastener body to a second end of the fastener body opposite the first end along the longitudinal axis. A10. An assembly according to any one of clauses A1-A9, preferably any one of clauses A7-A9, wherein the claw body (15) comprises a narrower section at a first end of the claw body and a larger or wider section at a second end opposite the first end, the claw body being pivotally connected to the fixture body at the first end, preferably the claw body having a substantially teardrop shape, preferably the claw body being integrally formed with the fixture body, and preferably the narrower section being configured to form a weakened portion to act as a hinge for the claw body. A11. An assembly according to any one of appendices A1 to A10, preferably any one of appendices A7 to A10, wherein the fastener body (11) includes a cutting edge separating the claw body and the fastener body except for the hinge portion, and the claw body is attached to the fastener body. A12. Any one of the assemblies according to clauses A1 to A11, preferably any one of clauses A7 to A11, wherein the cross section of the claw body in a plane perpendicular to the longitudinal axis has a substantially curved or arcuate shape. A13. The assembly of any one of clauses A1-A12, wherein the passageway (14) extends substantially transverse to the longitudinal axis (100). A14. An assembly according to any one of appended items A1 to A13, wherein when the nail body abuts against the sheet, the suture (9) has a size equal to or smaller than the size of the outlet (141), and the plurality of protrusions (91) have a size larger than the size of the outlet. A15. The assembly of any one of clauses A1-A14, wherein the plurality of protrusions are knots or beads attached to the suture. A16. The assembly of any one of clauses A1 to A15, wherein the passage includes an inlet (142) for the suture provided on the opposite outer side of the claw (15), the inlet being located at a longitudinal position substantially coincident with the outlet (141). A17. The assembly of any one of clauses A1-A16, wherein the outer wall is essentially cylindrical or rectangular and the base is disposed in a plane perpendicular to the longitudinal axis. A18. The assembly (40) of any one of appended clauses A1 to A17, wherein the assembly (40) further includes a second tissue fastener (41) attached to the suture, preferably the first and second tissue fasteners being configured to approximate the tissue between the first and second tissue fasteners. A19. The assembly of any one of clauses A1-A18, wherein the assembly further includes a catheter, the catheter including a catheter body and an instrument channel extending through the catheter body from a proximal end to a distal end, the instrument channel configured to receive a first tissue fastener for delivering the first tissue fastener through the instrument channel. B1. A tissue fastener (20) for securing a suture in a tissue approximation procedure, the tissue fastener comprising: a fastener body (21) that is elongate and defines a longitudinal axis (100); a passageway (24) for the suture through the fastener body substantially perpendicular to the longitudinal axis; a lever member (25) having a first end pivotally coupled to the fixture body and a second end opposite the first end, the lever member (25) including an engagement surface (254) at the second end configured to engage the suture when the lever member is inserted into the passage; Including, the passageway includes a support surface (211) for supporting the suture; A tissue fastener (20), wherein the support surface is inclined relative to the longitudinal axis and faces the engagement surface (254) so ​​as to allow the lever member to pass the suture along the passage in a first direction (241) in which the lever member is pivoted away from the support surface, and the lever member prevents movement of the suture along the passage in a second direction (242) opposite the first direction in which the lever member is pivoted toward the support surface upon operation of engagement of the engagement surface and the suture. B2. The tissue fixation device of clause B1, wherein the second direction (242) has a directional component perpendicular to the longitudinal axis, the directional component being directed towards the support surface, and preferably the first direction (241) has a directional component perpendicular to the longitudinal axis directed away from the support surface. B3. The tissue fastener of paragraph B1 or B2, wherein the engagement surface (254) extends substantially parallel to the support surface (211). B4. The tissue fastener of any one of clauses B1-B3, wherein the engaging surface is roughened and / or includes suture engaging members, such as a plurality of serrations, barbs, or teeth. B5. The tissue fixation device of any one of appended paragraphs B1 to B4, wherein the lever member (25) is pivotally connected to the fixation device body (21) through a pin (26). B6. The tissue fixation device of any one of appended paragraphs B1 to B5, wherein the support surface (211) is integral with the fixation device body (211). B7. The tissue fastener of any one of clauses B1-B6, wherein the support surface (211) is oriented at an angle of 30° to 85°, preferably an angle of 45° to 80°, preferably an angle of 50° to 75° relative to the longitudinal axis. B8. The tissue fastener of any one of clauses B1-B7, wherein the tissue fastener further includes a spring member (255) configured to bias the lever member toward the support surface. B9. The tissue fastener of paragraph B8, wherein the spring member is a resilient member attached to or integral with the lever member, preferably configured so that the spring member engages a wall of the tissue fastener. B10. A tissue fixation device according to any one of appended clauses B1 to B9, wherein the lever member (25) comprises a first portion (251) at a first end and a second portion (253) at a second end, the second portion comprising an engagement surface (254), and the lever member further comprises an elongated intermediate portion (252) connecting the first portion to the second portion, preferably the intermediate portion being resilient. B11. The tissue fastener of any one of appended clauses B1 to B10, wherein the fastener body (21) includes a slit-shaped cavity (22), the bottom of the cavity defining a support surface, and a lever member is disposed in the cavity, preferably the tissue fastener includes an abutment wall exposed to the cavity, and the lever member (25) includes a spring member (255) configured to engage the abutment wall and to bias the lever member toward the support surface. B12. The tissue fastener of any one of clauses B1-B11, wherein the first and second ends of the lever member define an axis of the lever member that is parallel to the longitudinal axis. B13. The tissue fastener of any one of clauses B1-B12, wherein the lever member, preferably at least the engagement surface, is made at least in part of a nickel-titanium alloy. B14. The tissue fastener of any one of paragraphs B1-B13, having an essentially cylindrical or angular outer shape with the base disposed in a plane perpendicular to the longitudinal axis. B15. The tissue fastener of any one of clauses B1-B14, wherein the passageway is located 1 / 4 to 3 / 4 of the length of the fastener body along the longitudinal axis, preferably 1 / 3 to 2 / 3 of the length. B16. An assembly (40) for securing a suture in a tissue approximation procedure, the assembly including at least one tissue fastener of any one of claims B1 to B15, a suture (9), and a second tissue fastener (41) attached to the suture, preferably wherein the at least one tissue fastener and the second tissue fastener are configured to approximate tissue. B17. The assembly of clause B16, wherein the assembly further includes a catheter, the catheter including a catheter body and an instrument channel extending through the catheter body from a proximal end to a distal end, the instrument channel configured to receive a first tissue fastener for delivering the first tissue fastener through the instrument channel. C1. A tissue fastener (30) for securing a suture in a tissue approximation procedure, the tissue fastener comprising: a fastener body (31) that is elongate and defines a longitudinal axis; a passageway (34) for the suture (9) through the fixture body; Including, the passageway includes an entrance portion (341) and an exit portion (342) for the suture, the entrance and exit portions preferably defining an axis of travel for the suture oriented perpendicular to the longitudinal axis (100); the passage further includes a fixed portion (343) between the inlet and outlet portions, the fixed portion including a support surface (311) for the suture oriented substantially parallel to the longitudinal axis; A tissue fastener (30), wherein the fixing portion further includes a plurality of deflectable leg members (351) facing toward the support surface (311), each of the plurality of leg members being arranged so as to be inclined relative to the longitudinal axis, and the leg members (351) being configured to engage with the suture so as to allow threading of the suture along the passage in a first direction (345) in which the leg members are biased away from the support surface, and to prevent movement of the suture along the passage in a second direction opposite to the first direction in which the leg members are biased toward the support surface due to the engagement of the leg members and the suture. C2. The tissue fixation device of appended paragraph C1, wherein the passage (34) includes at least one guide member (361, 362) configured to direct the suture from the entrance portion to the fixation portion and / or from the fixation portion to the exit portion, and preferably at least one guide member includes a curved surface configured to direct the suture from an orientation substantially perpendicular to the longitudinal axis to an orientation substantially parallel to the longitudinal axis or vice versa. C3. The tissue fastener of clause C1 or C2, wherein the passage further includes a routing portion (344) disposed between the entrance portion and the exit portion, the routing portion being substantially parallel to the anchoring portion (343) and configured to route the suture from the entrance portion to the anchoring portion and / or from the anchoring portion to the exit portion. C4. The tissue fastener of clause C3, wherein the leg member (351) is substantially annular and the routing portion (344) passes through the annular leg member. C5. The tissue fastener of any one of C1-C4, wherein the fastener body (31) is at least partially tubular with a channel (32) having an axis parallel to the longitudinal axis, and the support surface (311) is a wall of the channel. C6. The tissue fastener of clause C5, wherein the leg members are formed as inserts (35) disposed in the channels. C7. The tissue fixation device of clause C6, wherein the insert (35) is attached to the fixation device body via pins (361, 362). C8. The tissue fastener of clause C7, preferably in conjunction with clause C4, wherein the pin (361) is configured to guide and redirect the suture. C9. The tissue fixation device of any one of clauses C1 to C8, wherein the fixation device body defines a circumferential outer wall about a longitudinal axis, the outer wall having a normal vector perpendicular to the longitudinal axis, and the inlet portion (341) and the outlet portion (342) disposed through the outer wall. C10. The tissue fastener of any one of clauses C1-C9, wherein the inlet portion and outlet portion are disposed on opposite sides of the fastener body in a direction perpendicular to the longitudinal axis. C11. An assembly (40) for securing a suture (9) in a tissue approximation procedure, the assembly including at least one tissue fastener of any one of claims C1 to C10, the suture, and a second tissue fastener (41) attached to the suture, preferably wherein the at least one tissue fastener and the second tissue fastener are configured to approximate tissue. C12. The assembly of clause C11, wherein the assembly further includes a catheter, the catheter including a catheter body and an instrument channel extending through the catheter body from a proximal end to a distal end, the instrument channel configured to receive a first tissue fastener for delivering the first tissue fastener through the instrument channel. D1. An assembly (40) for securing a suture in a tissue approximation procedure, the assembly (40) comprising a suture (9) and at least one tissue fastener (10, 20, 30, 41) configured to secure the suture, the suture including a frangible portion (42). D2. The assembly of clause D1, wherein at least one tissue fastener (10, 20, 30) includes a fastener body and a passageway for a suture therethrough, and wherein the tissue fastener includes unidirectional fixation means for the suture configured to allow movement of the suture relative to the tissue fastener in one direction while preventing movement of the suture relative to the tissue fastener in a second direction opposite the first direction. D3. The assembly of clause D1 or D2, wherein at least one tissue fastener is as in any one of clauses A1-A19, B1-B17, or C1-C12. D4. The assembly of any one of clauses D1-D3, wherein the frangible portion (42) is a weak point configured to break when stress or tension in the suture exceeds a predetermined threshold.

Claims

1. 1. An assembly for securing a suture in a tissue approximation procedure, said assembly comprising a suture (9) and a first tissue fastener (10, 50); The suture is provided with a plurality of protrusions (91) disposed along the length of the suture; The first tissue fastener is a fastener body (11) having an elongated shape defining a longitudinal axis (100); a passageway (14) for the suture through the fastener body, the passageway (14) including an outlet (141); a pawl (15) adjacent the outlet and configured to engage a plurality of protrusions (91) to prevent movement of the suture in a first direction (92) relative to the fastener body; Including, the pawl includes a pawl body (151, 551) pivotally coupled to the fastener body; an assembly wherein the fastener body includes a seat (111, 511) for the claw body, whereby a force exerted on the claw body in the first direction by one of a plurality of protrusions causes the claw body to pivot against the seat.

2. 2. The assembly of claim 1, wherein the claw includes a hinge (152) coupled to the fastener body, the hinge (152) disposed at a first end of the claw body (151), the outlet (141) disposed at a second end (153, 553) of the claw body opposite the first end, the seat (111) disposed between the hinge (152) and the outlet (141), and the first end and the second end defining a direction substantially parallel to the longitudinal axis (100).

3. 3. The assembly of claim 2, wherein the claw body (151, 551) includes side edges (554, 555) on either side of the claw body between the first end and the second end (153, 553), the side edges (554, 555) extending away from the hinge (152) to a position beyond the outlet (141), and the seat (111, 553) extending along the side edges.

4. 4. An assembly according to claim 2 or 3, wherein the hinge (152) is located at a first end of the claw body (151, 551), the outlet (141) is located at a second end (153 553) of the claw body opposite the first end along the longitudinal axis, and the claw body includes at the second end a protruding arcuate or curved edge in a plane parallel to the longitudinal axis (100), preferably the plane being additionally parallel to a pivot axis of the hinge (152, 552) between the claw body and the fastener body.

5. 5. An assembly according to any one of claims 1 to 4, wherein the fastener body (11) comprises an outer wall (13) circumferentially centered about the longitudinal axis (100), the claw body (151, 551) defining a portion of the outer wall, a cross section of the claw body in a plane perpendicular to the longitudinal axis having a substantially curved or arcuate shape, preferably the outer wall having a normal vector perpendicular to the longitudinal axis, preferably the claw body and the fastener body defining the outer wall in a complementary manner, preferably the outer wall being essentially cylindrical or angular, and a base disposed in a plane perpendicular to the longitudinal axis.

6. 6. An assembly according to any one of claims 1 to 5, wherein the outlet (141) includes an aperture (541) having a circumferential edge, the pawl body (151, 551) defining a first portion of the circumferential edge and the fastener body (11) defining a second portion of the circumferential edge, preferably the aperture being located in an outer wall of the fastener body.

7. 7. The assembly of claim 1, wherein the claw body (151, 551) includes a recess (541), the recess forming an aperture of the outlet (141) configured to receive the suture (9), the recess being sized such that the plurality of protrusions (91) are configured to engage the claw body around the recess.

8. The assembly of any preceding claim, wherein the first direction is directed inwardly from the outlet into the fastener body.

9. 9. An assembly according to any one of claims 1 to 8, wherein the claw body (151) is formed as a flap partially cut out from the fastener body, preferably the fastener body (11) being at least partially tubular with a lumen extending along the longitudinal axis, the claw body providing access to the lumen.

10. 10. The assembly of claim 9, wherein the pawl body (151) is pivotally connected to the fastener body by a strip, the strip including one or more through notches for weakening the strip to facilitate pivotal movement.

11. 11. An assembly according to any one of claims 1 to 10, wherein the claw body (151) includes a narrower section at a first end of the claw body and a larger or wider section at a second end opposite the first end along the longitudinal axis, the claw body being pivotally connected to the fastener body at the first end, preferably the claw body being integrally formed with the fastener body, preferably the narrower section being configured to form a weakened portion to act as a hinge for the claw body.

12. 12. The assembly of claim 1, wherein the passage (14) extends substantially transverse to the longitudinal axis (100) and is located in a central section (114) of the fastener body intermediate opposite first and second end sections (112, 113) of the fastener body along the longitudinal axis.

13. 13. The assembly of any one of claims 1 to 12, wherein the outlet (141) is located in a central section (114) of the fastener body intermediate first and second opposite end sections (112, 113) of the fastener body along the longitudinal axis, the central section (114) including a weakness configured to act as a pivot allowing the first and second end sections to flex relative to the central section, and wherein a cross-sectional area of ​​the fastener body at the weakness is reduced compared to the first and second end sections (112, 113).

14. 14. The assembly of claim 13, wherein the passage (14) includes an inlet (142) at an end opposite the outlet (141), and the fastener body includes a transverse cut (443) at the inlet configured to form the weak point.

15. 15. The assembly of any one of claims 1-14, wherein the outlet is located in a central section of the fastener body intermediate first and second opposite end sections of the fastener body along the longitudinal axis, the first and second end sections including respective weaknesses configured to cause the respective first and second end sections to flex relative to the central section when the fastener body is pressed against tissue, thereby providing tissue conformance.

16. The assembly of claim 15 , wherein the weakened point comprises a transverse cut through the fastener body.

17. An assembly according to any one of the preceding claims, wherein the plurality of protrusions (91) are knots or beads attached to the suture (9).

18. 18. The assembly of any one of claims 1 to 17, wherein the assembly (40) further includes a second tissue anchor (41) attached to the suture, the first and second tissue anchors configured to approximate tissue between the first and second tissue anchors.

19. 19. The assembly of claim 18, wherein the second tissue anchor (41) is elongate defining a second longitudinal axis (400), the suture (9) is secured to the second tissue anchor at a central section (414) of the second tissue anchor intermediate first and second end sections (412, 413) of the second tissue anchor that are opposite each other along the second longitudinal axis, the central section and / or the first and second end sections including respective weaknesses (443, 451) configured to cause the first and second end sections of the second tissue anchor to bend relative to the central section (414) of the second tissue anchor when the second tissue anchor is pressed against tissue, thereby providing tissue conformance, and preferably the weaknesses include transverse cuts through the second tissue anchor.

20. 20. The assembly (40) of any one of claims 1 to 19, wherein the suture includes a frangible portion (42), the frangible portion (42) being a weak point configured to break when stress in the suture exceeds a predetermined threshold.

Images