Anchor for tissue apposition surgery

Abstract

The present disclosure describes tissue anchors and assemblies for securing sutures in tissue apposition procedures. The suture is provided with a plurality of protrusions (91) arranged along the length of the suture. The tissue anchor comprises: an anchor body (11) having an elongated shape; a passage (14) for a suture to pass through the anchor body; and a pawl (15) adjacent the outlet (141) of the passage and configured to engage with the plurality of projections (91) so as to prevent the suture from moving inwardly from the outlet into the anchor body in a first direction (92). The pawl comprises a pawl body (151) pivotally coupled to the anchor body, and the anchor body comprises a seat (111) for the pawl body such that a force exerted on the pawl body in a first direction by one of the plurality of protrusions pivots the pawl body to abut the seat.

Description

Technical Field

[0001] The present invention relates to tissue anchors for securing sutures used in endoscopic tissue approximation procedures, particularly in the gastrointestinal tract, and to assemblies comprising such tissue anchors. Background Art

[0002] Tissue anchors of the above type are known from US2004 / 0167546, US2005 / 0251208 and WO 2007 / 140309. The known tissue anchors have several drawbacks. The first drawback is that they do not have an optimal shape that allows for easy deployment through a catheter. Secondly, they require dedicated instruments for suture tensioning. Thirdly, some anchors only allow for securing the suture while additional anchors are required to press the tissue. Fourthly, some anchors may not provide the desired securing force or, alternatively, may not ensure complete suture tensioning because as the tension on the suture is increased, the force to pull the line through the anchor increases, resulting in incomplete tissue approximation. Specifically, at the beginning of tissue approximation, the distal end of the suture is relatively loose, so pulling on the proximal end relatively easily unlocks the sliding insert and tightening can begin. However, at the end of tissue approximation, due to tissue compression, the suture is significantly tensioned and thus the suture attempts to lock the sliding insert and may lock it before proper tissue approximation is achieved. Summary of the Invention

[0003] Accordingly, there is a need in the art to provide improved tissue anchors that allow overcoming at least some of the above drawbacks. Specifically, there is a need to provide a securing mechanism for the tissue anchor, wherein the force required to unlock the securing mechanism (e.g., further tighten the line) does not depend on the tightened state. There is a need in the art to provide tissue anchors that provide improved mechanical strength and / or are less prone to failure. There is a need in the art to provide tissue anchors that cause less trauma to the tissue.

[0004] According to the present disclosure, therefore, there are provided tissue anchors and assemblies comprising such anchors. The solution according to the present disclosure provides a tissue anchor having a securing mechanism for a line, wherein the force required to unlock the securing mechanism (e.g., further tighten the line) does not depend on the tightened state or tension of the line.

[0005] According to a first aspect of the present disclosure, there is provided an assembly as claimed in claim 1 for securing a suture, such as in a tissue approximation procedure, particularly in a human or animal body. The suture is provided with a plurality of protrusions arranged along the length of the suture, preferably spaced apart from each other along the length.

[0006] The tissue anchor includes an anchor body having an elongated shape that defines a longitudinal axis. The anchor body may be at least partially tubular along the longitudinal axis. The passage for the suture to pass through the anchor body includes an outlet, such as through the outer wall of the anchor body. The tissue anchor further includes a pawl adjacent to the outlet. Preferably, the pawl is disposed on the outer wall of the anchor body. The pawl is configured to engage with the plurality of protrusions to prevent the suture from moving relative to the anchor body in a first direction, preferably to prevent the suture from moving inward from the outlet into the anchor body. As a result, the pawl provides a thread locking mechanism. The pawl includes a pawl body pivotally coupled to the anchor body. The anchor body includes a seat for the pawl body such that the force applied by one of the plurality of protrusions on the pawl body in the first direction causes the pawl body to pivot and abut against the seat.

[0007] The advantage of the above tissue anchor is that the seat provides improved back support for the pawl body against the pressure of the suture. When the tissue reaction attempts to push the pawl body backward, the pawl body will not bend inward and stop. This prevents the suture from being increasingly compressed and eventually cut. Thus, stronger and reliable thread fastening can be obtained, while the anchor can be thin and of appropriate length, allowing for proper tissue anchoring and / or easy deployment through a catheter.

[0008] Advantageously, the hinge is disposed at the first end of the pawl body, and the outlet is disposed at the second end of the pawl body opposite to the first end. Preferably, the first end and the second end define a direction substantially parallel to the longitudinal axis. This solution allows for sufficient leverage during the process of tensioning the thread to pivot the pawl body outward, while actuation does not require too much force. Applying a small force on the hinge and preventing excessive deformation of the hinge if the hinge is integrally formed with the pawl body and the anchor body.

[0009] Advantageously, the seat includes a contact surface for the pawl, wherein the contact surface is inclined with respect to a plane parallel to the pivot axis of the pawl and parallel to the longitudinal axis. Advantageously, the contact surface has mirror symmetry with respect to a plane perpendicular to the pivot axis. By providing such an inclined and advantageously mirror-symmetrical seat or contact surface, automatic alignment of the pawl body relative to the anchor body is obtained in the lateral direction (crossing the longitudinal direction), and unwanted lateral movement of the pawl body that may deform the hinge is prevented, thereby improving the stability of the pawl body resting on the seat.

[0010] Advantageously, the pawl body includes side edges between the first end and the second end on both sides of the pawl body. Advantageously, these side edges extend away from the hinge to a position beyond the exit, as considered along the longitudinal axis. The seat advantageously extends along these two side edges. This solution maximizes the abutment surface area of the pawl body and improves the mechanical strength of the wire locking mechanism, and furthermore improves the alignment ability by preventing lateral movement of the pawl body.

[0011] Advantageously, the hinge is arranged at the first end of the pawl body, and the exit is arranged at the second end of the pawl body opposite the first end along the longitudinal axis. The pawl body includes an edge at the second end, which is advantageously arcuate or curved, for example in a projection in a plane parallel to the longitudinal axis. This solution further improves the self-aligning ability by preventing lateral movement of the pawl body.

[0012] Advantageously, the pawl body includes a narrower section at the first end of the pawl body and a larger section at the second end opposite the first end along the longitudinal axis, thus having, for example, a generally teardrop shape. The pawl body is pivotally coupled to the anchor body at the first end. The hinge can be integrally formed with the pawl body and the anchor body, that is, made of a single part or workpiece, such that the pawl body resembles a flap. This narrower section allows for a hinge that can be actuated with less force on the one hand, while the larger section provides an enlarged contact area with the seat. When the pawl body is additionally arcuate in shape, the mechanical resistance is further improved.

[0013] Advantageously, the tissue anchor is a T-shaped anchor, where the exit for the suture is located in the central section of the anchor body, which is located midway between the first end section and the second end section of the anchor body along the longitudinal axis. The central section and / or the end sections may include corresponding weak points that are configured to serve as pivots for the first end section and the second end section of the anchor body, thereby allowing the first end section and the second end section to flex relative to the central section. Advantageously, the cross-sectional area of the anchor body is reduced at the weak points compared to the first end section and the second end section. This allows multiple sections of the anchor body to flex at the weak points, for example, about an axis that substantially intersects the longitudinal axis. As a result, the tissue anchor better conforms to the tissue and can reduce or avoid trauma to the tissue. In some examples, the reduced thickness is obtained by a transverse incision or recess (such as located on the entry side) in the anchor body.

[0014] According to a second aspect of the present disclosure, there is provided a tissue anchor for securing a suture, the tissue anchor comprising: an anchor body having an elongate shape and defining a longitudinal axis; a passage for the suture to pass through the anchor body, substantially transverse to the longitudinal axis; and a lever member. The lever member has a first end pivotally coupled to the anchor body and a second end opposite the first end, at the second end, the lever member includes an engagement surface configured to engage the suture when the suture is inserted into the passage.

[0015] The passage includes a support surface for supporting the suture. The support surface is inclined relative to the longitudinal axis and faces the engagement surface such that the lever member allows the suture to pass through the passage in a first direction, in which the lever member pivots away from the support surface, and the lever member prevents the suture from moving along the passage in a second direction opposite to the first direction, in which the lever member pivots towards the support surface by the engagement action of the engagement surface and the suture.

[0016] This tissue anchor enables the engagement surface (which can 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 to pass the line in the sliding direction, regardless of the tension in the line. Additionally, the inclined support surface acts as a backing support and ultimate end stop for the lever member to provide improved securing of the line.

[0017] Advantageously, the tissue anchor further includes a spring member configured to bias the lever member towards the support surface. Advantageously, the spring member is an elastic member attached to or integral with the lever member, preferably, the spring member is configured to engage with a wall of the anchor body. Such a spring member allows the engagement surface to be preloaded on the inclined support surface. Thus, even in the rest position, the suture is compressed. This advantageously prevents minor movements that would slowly slide backward over time.

[0018] According to a third aspect of the present disclosure, there is provided a tissue anchor for securing a suture, the tissue anchor comprising an anchor body having an elongate shape and defining a longitudinal axis. A passage for the suture is provided through the anchor body. The passage includes an inlet portion and an outlet portion for the suture. The inlet portion and the outlet portion have orifices having axes oriented transverse to the longitudinal axis. These axes define the movement of the suture into and out of the anchor body.

[0019] The passage further includes a tightening portion between the inlet portion and the outlet portion, the tightening portion including a support surface for the suture, the support surface being oriented substantially parallel to the longitudinal axis. The tightening portion further includes a plurality of deflectable, resilient or pivotable leg members facing the support surface, each of the plurality of leg members being arranged to be inclined with respect to the longitudinal axis and configured to engage the suture such that the leg members allow the suture to pass along the passage in a first direction in which the leg members are pushed away from the support surface. The leg members prevent the suture from moving along the passage in a second direction opposite to the first direction, in which the leg members are pushed towards the support surface by the engagement action of the leg members and the suture.

[0020] One advantage of the tissue anchor according to the third aspect is that the orientation of the tightening portion is rotated, preferably by about 90°, compared to the direction of movement of the suture in and out of the tissue anchor. By doing so, the tightening portion can be made longer as needed, with more leg members providing a tightening force on the suture. By doing so, an elongate anchor is obtained that can be easily deployed through the instrument channel of a catheter or endoscope while having a desired shape for holding tissue in place.

[0021] According to another aspect of the present disclosure, there is provided a component for tightening a suture in a tissue approximation procedure in a human or animal body, wherein the component includes a suture, a first tissue anchor, and a second tissue anchor, advantageously, the first tissue anchor and the second tissue anchor are configured to approximate the tissue between the first tissue anchor and the second tissue anchor. The second tissue anchor is elongate and defines a second longitudinal axis, wherein the suture is tightened to the second tissue anchor in a central section of the second tissue anchor, the central section being located midway between a first end section and a second end section of the second tissue anchor along the second longitudinal axis. Advantageously, the central section includes a weak point that allows the first end section and the second end section 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 incision in the central section that forms the weak point. Advantageously, the first tissue anchor includes a wire locking mechanism that allows the first tissue anchor to be advanced along the suture towards the second tissue anchor while preventing the first tissue anchor from moving away from the second tissue anchor along the tissue. Advantageously, the first tissue anchor is a tissue anchor as described according to the first aspect, the second aspect, or the third aspect.

[0022] According to another aspect of the present disclosure, a component for securing a suture in tissue approximation surgery is provided. Such a component includes a suture and at least one tissue anchor configured to secure the suture, wherein the suture includes a frangible portion. Advantageously, the at least one tissue anchor includes an anchor body and a passage for the suture to pass through the anchor body. The tissue anchor includes a one-way securing device or system for the suture, which is configured to allow the suture to move relative to the tissue anchor in one direction while preventing the suture from moving relative to the tissue anchor in a second direction opposite to the first direction. The tissue anchor can be any of the tissue anchors described in the first, second, and third aspects of the present disclosure.

[0023] One advantage of the above-described type of component is that no additional instrument is required to cut the thread at the end of the tissue approximation surgery. In addition, it prevents excessive force from being applied to the tissue anchor, which may deform the anchor and cause failure.

[0024] A method for approximating tissue in a human or animal body is described herein. The method includes a first operation: forming a tissue fold in vivo, particularly in the lumen of the gastrointestinal tract, more particularly in the stomach, through an endoscope. In a second operation, the tissue fold is pierced by a deployment device defining an inner lumen. The component according to the present disclosure is received in the inner lumen. In a third operation, at least one of a first tissue anchor and a second tissue anchor is deployed through the inner lumen over the tissue fold. In a fourth operation, at least one additional tissue fold is formed through the endoscope, and the at least one additional tissue fold is pierced by the deployment device. In a fifth operation, the other of the first tissue anchor and the second tissue anchor is deployed through the inner lumen over the additional tissue fold. In a sixth operation, the first tissue fold and the at least one additional tissue fold are approximated by bringing the first tissue anchor and the second tissue anchor into approximation with each other, thereby securing the tissue fold between the first tissue anchor and the second tissue anchor. In an optional seventh operation, the suture is cut, for example, at the frangible portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Aspects of the present invention will now be described in more detail with reference to the drawings, in which like reference numerals indicate like features, and in which:

[0026] Figure 1 A perspective view showing an embodiment of a tissue anchor according to the present disclosure;

[0027] Figure 2 Showing Figure 1 a plan view and a sectional view along section line A-A of the tissue anchor;

[0028] Figure 3 A perspective view showing another embodiment of an organizational anchor according to the present disclosure;

[0029] Figure 4 Shows Figure 3 A plan view of the organizational anchor;

[0030] Figure 5 Shows an organizational anchor assembly according to aspects of the present disclosure;

[0031] Figure 6 Shows when the organizational anchor is deformed to conform to the tissue being approximated Figure 1 The organizational anchor;

[0032] Figure 7 A perspective view showing a fixed organizational anchor according to the present disclosure;

[0033] Figure 8 Shows Figure 7 A plan view of the fixed organizational anchor;

[0034] Figure 9A Shows when the fixed organizational anchor is deformed to conform to the tissue being approximated Figure 7 The fixed organizational anchor; Figure 9B A side view showing an alternative organizational anchor having a weak point at a longitudinal end section of the anchor body, formed as a transverse incision;

[0035] Figure 10 A view showing a tissue fold pierced by a deployment device, the deployment device including a lumen for deploying the organizational anchor and components of the present disclosure;

[0036] Figure 11 A view showing multiple tissue folds approximated by the components of the present disclosure;

[0037] Figure 12 A longitudinal cross-sectional view showing an organizational anchor according to a second aspect of the present disclosure;

[0038] Figure 13 Shows Figure 12 An exploded perspective view of the organizational anchor;

[0039] Figure 14 A longitudinal cross-sectional view showing an organizational anchor according to a third aspect of the present disclosure;

[0040] Figure 15 Shows Figure 14 An exploded perspective view of the organizational anchor. Detailed Description

[0041] Refer to Figure 1 and Figure 2, the tissue anchor 10 includes an anchor body 11 having an elongate shape and defining a longitudinal axis 100. The anchor body 11 is preferably tubular, having an internal channel 12 and a wall 13 that defines the channel 12 and also defines the outer wall 131 of the anchor body. The passage 14 for the suture 9 to pass through the anchor body includes an inlet 142 and an outlet 141 through the wall 13. The inlet 142 and the outlet 141 define a suture passage 14 that is preferably straight and is oriented transversely (perpendicular to) the longitudinal axis 100. The tissue anchor 10 further includes a pawl 15 disposed adjacent to the outlet 141 on the wall 13 of the anchor body. The pawl 15 is configured to engage a protrusion 91 of the suture 9 to prevent the suture from moving inward from the outlet 141 into the anchor body in a first direction 92, while allowing the suture to move in the opposite direction.

[0042] In an alternative configuration, it should be understood that the pawl 15 can be configured to hinge in the opposite direction to prevent the suture from moving in a direction opposite to the first direction 92, while allowing the suture to move relative to the anchor body 11 in the first direction 92. In some examples, the pawl 15 can be configured to hinge to the interior of the anchor body 11, such as into the internal channel 12.

[0043] The pawl 15 includes a pawl body 151 pivotally coupled to the anchor body 11 via a hinge 152, which can be integrally formed with the anchor body 11 and the pawl body 151. The anchor body includes a seat 111 for the pawl body 151, which seat includes or is constituted by, for example, a abutment surface, such that a force applied by one of the plurality of protrusions 91 in the first direction 92 on the pawl body causes the pawl body 151 to pivot to abut against the seat 111. The seat 111 is advantageously located between the hinge 152 and the outlet 141.

[0044] The pawl body 151 is preferably cut out from the anchor body 11, for example, by laser cutting or wire electrical discharge machining. In the case where the anchor body 11 is tubular, the pawl body 151 is formed by a portion of the wall 13 cut out from the anchor body. The pawl body 151 is advantageously still attached to the anchor body (wall 13) at the hinge portion 152 and advantageously forms a flap connected to the anchor body only via the hinge portion 152. The hinge portion 152 can be formed by one or more strips connecting the pawl body 151 to the anchor body 11. Advantageously, the hinge 152 is formed as an integral part with the anchor body 11 and the pawl body 151, such that the hinge 152 is a non-cut-out part of the (tubular) anchor body 11.

[0045] The anchor body 11 is advantageously tubular (cylindrical or prismatic), having an internal channel 12 extending along the longitudinal axis 100. The pawl body 151 advantageously has a teardrop shape, with the pawl body 151 being wider and the section adjacent to the hinge 152 being narrower (as seen in a cross-section perpendicular to the longitudinal axis). The narrower section of the hinge 152 allows the pawl body 151 (such as on a tubular or cylindrical anchor) to pivot easily. The cross-section of the pawl body 151 transverse to the axis 100 is advantageously curved or arcuate, thereby increasing the mechanical strength when the protrusion 91 presses on the pawl body 151 in the direction 92.

[0046] Advantageously, the seat 111 includes a contact surface configured to receive or engage the pawl body 151, and this contact surface is at least partially located in a plane inclined with respect to a plane parallel to the longitudinal axis 100 and the pivot axis of the hinge 152, thereby providing increased strength. As seen more clearly in the cross-section A-A of Figure 2 , the seat 111 advantageously has mirror symmetry with respect to the intermediate plane 101 of the pawl body 151, which intermediate plane is perpendicular to the pivot axis of the hinge 152 and advantageously parallel to the longitudinal axis 100, so as to align the pawl body 151 in the seat 111. This can prevent lateral movement of the pawl and contribute to the self-alignment of the pawl body relative to the seat. Additionally or alternatively, the surface of the seat 111 is advantageously oriented in a direction away from the radial direction of the anchor body, to increase the seating surface and / or improve the self-alignment ability of the pawl, that is, the surface of the seat 111 is inclined with respect to the local radial direction on the outer surface of the anchor body, or is oriented in a direction not parallel to the local radial direction. For example, the seating surface can be inclined with respect to the local normal direction on the outer surface of the anchor body.

[0047] The pawl body 151 can include further self-alignment capabilities. In some examples, the pawl body 151 has mirror symmetry with respect to an intermediate plane that is parallel to (and possibly includes) the longitudinal axis 100 and advantageously intersects (perpendicularly) the pivot axis of the hinge 152. Additionally or alternatively, the free end 153 of the pawl body opposite to the hinge section 152 can have a curved or arcuate edge, for example as seen from the direction 92, and the seat 111 can have a complementary shape to support the curved or arcuate edge of the free end 153 of the pawl body 151.

[0048] Reference Figure 3 and Figure 4, Another example of the tissue anchor 50 according to the present disclosure differs from the tissue anchor 10 described above in terms of the shape of the pawl 15. The pawl 15 includes a pawl body 551, which has a longer shape than the pawl body 151. Specifically, the pawl body 551 extends from the hinge section 552 to the free end 553, which, when considered along the longitudinal axis, extends beyond the exit 141. This allows for an extended seat 511 and thus an increased abutment surface of the pawl body 551 compared to the pawl body 151. Specifically, the pawl body 551 includes a left side edge 554 and a right side edge 555, and these two side edges advantageously extend from the hinge section 552 to the respective ends 556, 557 at the free end 553. The ends 556, 557 of the side edges are positioned away from the hinge section and along the longitudinal axis 100 beyond the position of the exit 141. The free end 553 advantageously spreads back from the ends 556, 557 at the side edges towards the central hinge section, where the free end 553 advantageously abuts the exit 141, and it advantageously spreads along a curved or arcuate edge. By doing so, the length of the abutment surface on the seat 511 can be maximized to improve mechanical strength. Additionally, this shape of the free end 553 improves the self-alignment ability of the pawl body 551 relative to the anchor body. In some examples, the free end 553 and the corresponding edge of the seat (anchor body) include abutment surfaces that are inclined (i.e., not perpendicular) relative to the longitudinal axis 100 to further improve the self-alignment ability. The pawl body 551 may additionally have the same configuration as the pawl body 151 described with respect to Figures 1 to 2 , for example, having an arcuate or curved cross-section in a plane perpendicular to the longitudinal axis 100 and / or the side edges 554, 555 and the corresponding abutment surfaces of the seat 511 are inclined relative to the local radial direction of the anchor body 11. It should be understood that the pawl body 551, like the pawl body 151, advantageously has mirror symmetry with respect to an intermediate plane that is parallel to (and may include) the longitudinal axis 100 and advantageously intersects (perpendicularly) the pivot axis of the hinge 552.

[0049] It should be understood that the seat may have serrations or teeth to allow for an increased contact area between the pawl and the anchor body. In this case, the pawl body 151 will have an edge provided with serrations or teeth to match the shape of the seat.

[0050] The width of the hinge section 152 can be increased while providing additional cuts through the hinge section to provide appropriate weakening to reduce the force required to pivot the pawl body, especially when the wall of the anchor body is curved or arcuate in a plane perpendicular to the longitudinal axis. It should be understood that the hinge section 552 of the tissue anchor 50 is the same as Figures 1 to 2is slightly wider than the hinge section 152 of the pawl body 151. The hinge section 552 includes a through-cut or through-opening 558 through the wall 13 of the anchor body 11 to reduce the force for pivoting the pawl body 551 about the hinge, and additional such (through) cuts can be provided as needed. Due to the through-cut 558, the pawl body 551 is connected to the anchor body 11 via two elongated strip members 559, which are integrally formed with the pawl body 551 and the anchor body 11 (such as by a suitable cutting operation through the anchor body).

[0051] The outlet 141 can be provided as a cavity or orifice at the edge of the pawl body 151 or 551, or at the edge of the anchor body 11 (seat 111), or a combination thereof. Advantageously, the outlet 141 is positioned between the pawl bodies 151, 551 and the wall 13 of the anchor body. Specifically, the outlet 141 is partially surrounded or delimited by the pawl bodies 151, 551 (such as at the free ends 153, 553) and partially surrounded or delimited by the inner edge of the wall 13 of the anchor body 11. In some examples, the pawl body 151 or 551 includes a recess 541 advantageously located at the edge of the pawl body (e.g., the free ends 153, 553), which forms the outlet 141. The recess 541 is configured to have a size smaller than the protrusion 91 of the suture 9 while allowing the suture 9 to pass freely through. When the suture is moved inward from the outlet 141 into the anchor body in the first direction 92, the protrusion 91 will abut against the pawl body at the periphery of the recess, causing the pawl to pivot towards the anchor body, thus stopping the further movement of the suture. Alternatively, a recess can be provided in the wall 13 of the anchor body, such as adjacent to the free ends 153, 553 of the pawl body, or partially in the pawl body and partially in the wall of the anchor body.

[0052] Thus, the tissue anchors 10, 50 are advantageously T-shaped anchors. Specifically, the inlet passage 142 and the outlet passage 141 of the suture are advantageously aligned in the transverse direction. The passage 14 is advantageously located in the central section 114 of the tissue anchor (anchor body 11), which is located between the tissue anchor end sections 112, 113 at the opposite ends of the tissue anchor (anchor body) along the longitudinal axis 100. Advantageously, the inlet 142 and the outlet 141 of the passage 14 are located at approximately the middle length of the length of the tissue anchor. Advantageously, the inlet 142 and the outlet 141 of the passage 14 are located on opposite sides of the anchor body 11.

[0053] The anchor body 11 advantageously has a reduced cross-sectional area in the region of the passage 14, particularly in the region of the outlet 141 (the region of the pawl 15) and / or the region of the inlet 142 (in a plane perpendicular to the longitudinal axis 100). Specifically, the inlet 142 may include a recess or inlet hole that is suitably larger than the size of the protrusion 91 of the suture 9 to (further) reduce the cross-sectional area of the anchor body, and / or the anchor body 11 may include a transverse incision at a position corresponding to the inlet and / or outlet of the passage (not shown). This advantageously creates a weak point in the anchor body at the position corresponding to the passage 14, thereby providing a pivot in the central section 114 that allows the end sections 112, 113 of the tissue anchor to flex relative to the central section 114 about an axis transverse to the longitudinal axis, as Figure 6 shown. When the tissue anchor is tightened against the tissue (on the inlet 142 side of the passage 14), the force exerted by the protrusion 91 on the area around the outlet 141 in the central section 114 causes deformation of the tissue anchor, where the end sections 112, 114 flex away from the tissue relative to the central section 114. This allows reduction or avoidance of trauma to the tissue due to the anchor being too rigid. The flexibility of the anchor body is further improved when the passage 14 is substantially straight and transverse to the longitudinal axis 100, particularly when the pawl body 151 is formed as a flap cut out from the anchor body (which (further) reduces the cross-section of the anchor body in the region of the outlet 141). The flexibility can be further improved by manufacturing the anchor body from a flexible or elastic material such as nitinol (nickel-titanium alloy).

[0054] The tissue anchors of the present disclosure can be easily deployed by catheter surgery because they allow easy loading into the small instrument channels of catheter devices. Referring to Figure 5 , in a typical anchor assembly 40, at least two tissue anchors are used, and the first tissue anchor 10, 50 can be pushed along the suture 9 towards the second tissue anchor 41 by any suitable device (such as a pusher) to appose the tissue between the first and second anchors. The first tissue anchor can be used to tighten the suture by a one-way locking mechanism as described in the present disclosure. An advantageous application is tissue apposition in the gastrointestinal tract, particularly gastric reduction surgery.

[0055] Referring to Figures 7 to 8, the second tissue anchor 41 is advantageously a T-shaped anchor extending along the longitudinal axis 400. The tissue anchor 41 can be tubular, having a cylindrical or prismatic base and a lumen 410. The suture 9 may be fixedly secured to the tissue anchor 41, for example, in a central section 414 of the tissue anchor located between end sections 412, 413 at its longitudinal ends. In some examples, the tissue anchor 41 includes an exit hole 441 for the suture 9 (such as located in the central section 414), and may include an inlet hole 442 opposite the exit hole 441. The exit hole 441 is advantageously smaller than the protrusion 91 to secure the suture to the tissue anchor 41. The inlet hole 442 can be larger than the protrusion 91 to facilitate assembly. The inlet hole 442 can alternatively be omitted and the wire is inserted through the lumen 410.

[0056] Like the tissue anchors 10, 50, the second tissue anchor 41 can include a weak point in the central section 414, particularly at a position corresponding to the inlet hole 442 and / or the exit hole 441. This weak point allows the end sections 412, 413 to flex and conform to the tightened or approximated tissue. In some examples, the weak point includes an incision 443 that transversely crosses the body of the tissue anchor and is particularly located at a longitudinal position corresponding to the inlet hole and / or the exit hole. This reduces the cross-sectional area of the anchor body in the central section to create a pivot as Figure 9A shown, with the pivot axis transverse to the longitudinal axis 400. When a force is applied to the suture 9 in the direction of arrow 93 due to the approximated tissue, the weak point 443 allows the end sections 412, 413 to flex in a direction opposite to the force direction 93 (i.e., flex around a transverse axis oriented perpendicular to the plane of FIG. 9). This allows the anchor to provide better compliance with the tissue and thus advantageously reduces or avoids trauma.

[0057] Alternatively, referring to Figure 9B , one or more transverse incisions 451 or notches can be provided in the anchor body of the second tissue anchor 41 at the end sections 412, 413. The transverse incisions 451 create one or more weak points such that when the suture is tightened and the tissue anchor is pressed against the tissue, the end sections can flex relative to the central section 414 to conform to the tissue. The transverse incisions 451 are advantageously provided on a side 415 of the anchor body opposite to the side 416 configured to engage the tissue (e.g., a side opposite to the side 416 of the exit hole 441). A combination of a weak point (e.g., a transverse incision 443) in the central section 414 and weak points in the end sections 412, 413 can be considered.

[0058] It should be understood that the transverse incisions 443 and / or 451 can be applied to the tissue anchors 10, 50 described above to form appropriate weak points in a similar manner.

[0059] Referring again to Figure 5 , suture 9 may include a frangible portion 42 configured to break when the stress or tension in the suture 9 exceeds a threshold. The frangible portion is advantageously a portion of the suture that locally has a reduced cross-sectional area. Such a frangible portion can be obtained in several ways, such as one or a combination of the following: – heat treating and / or mechanically deforming a section of the suture; – abutting two sections of suture with a weak joint; – in the case of a braided suture, cutting a portion of the braid at a point; – in the case of a monofilament suture, pulling the suture to have a locally smaller diameter; – laser cutting to remove a portion of the suture or increase stress concentration points. Preferably during the manufacture of the suture, such a frangible portion 42 can be provided in the suture at a convenient location along the suture. In some examples, the suture is heated and the suture can be pulled or tensioned to locally reduce the cross-section of the suture, thereby advantageously creating a frangible portion, particularly when the suture is made of a polymer or synthetic material.

[0060] Referring to Figures 10 to 11 , in order to appose tissue using the components according to the present disclosure, tissue fold 8 is formed endoscopically, particularly in a cavity of a human or animal body, such as a cavity of the gastrointestinal tract, such as the stomach. The tissue fold can be formed using known instruments (such as a grasper). A deployment device 60 (such as including a puncture needle 62 and an inner lumen 61) is advanced through the human or animal body, for example, by an endoscope or a catheter (not shown). The tissue fold 8 is pierced by the needle 62 and the deployment device 60 is advanced over the tissue fold. For example, a tissue anchor (such as a second tissue anchor 41) is deployed over the tissue fold 8 from the inner lumen 61 using a pushing device 63 (such as a pusher). Then, the deployment device 60 is retracted from the tissue fold 8. At this stage, advantageously, another tissue anchor (such as a first tissue anchor 10, 50) remains within the inner lumen 61.

[0061] Another tissue fold 81 can be formed endoscopically and the deployment device 60 pierces and is advanced over the another tissue fold 81. Another tissue anchor (such as a first tissue anchor 10, 50) is deployed over the another tissue fold 81 from the inner lumen 61. Then, the deployment device 60 is retracted from the another tissue fold to obtain Figure 11The situation shown, in which multiple tissue folds 8, 81 (which may be more than two) are inserted between a first tissue anchor and a second tissue anchor. At this stage, the first tissue anchor can be brought into alignment with the second tissue anchor 41 by advancing the first tissue anchors 10, 50 along the suture line 9. In some examples, a grasping device engages the line 9, for example at the protrusion 94, or at a loop or noose, to stretch the line 9 while a pushing device (such as a pusher) brings the first tissue anchors 10, 50 into alignment with the second tissue anchor 41. The first tissue anchor is secured to the suture line by a line locking mechanism as described above (not shown for clarity, Figures 10 to 11 in the figures). Once the tissue anchors are in place, the suture line can be cut, for example at a frangible portion. In some examples, the suture line is configured to break at the frangible portion by tensioning the line. This can be performed by pushing the most proximal tissue anchor (e.g., by the pushing device 63) and simultaneously pulling on the suture line to break the suture line at the frangible portion.

[0062] Reference Figures 12 to 13 , the tissue anchor 20 according to the second aspect of the present disclosure includes: an anchor body 21 having an elongated shape and defining a longitudinal axis 100; a passage 24 for a suture line to pass through the anchor body substantially transverse to the longitudinal axis; and a lever member 25. The lever member includes: an upper portion 251 pivotally coupled to the anchor body 11 by a pin 26; a bottom portion 253 including an engagement surface 254 configured to engage the suture line when the suture line is inserted into the passage 24; and an intermediate portion 252 connecting the upper portion 251 to the bottom portion 253. In addition to or instead of the hinge formed by the pin 26, the intermediate portion may be elastic to pivot or deflect the bottom portion 253 relative to the upper portion 251. The engagement surface 254 is thus deflectable along the direction of the passage 24, i.e., deflectable about a pivot axis 200 perpendicular to the longitudinal axis 100.

[0063] The passage 24 includes a support surface 211 for supporting the suture line. The support surface 211 is advantageously planar, or a first cross-section of the support surface 211 in a plane perpendicular to the pivot axis 200 is advantageously straight, but 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 may be curved. The support surface 211 (i.e., the first cross-section seen in the Figure 12 plane) is inclined relative to the longitudinal axis 100, and the angle α is advantageously between 30° and 85°, advantageously between 45° and 80°, advantageously between 50° and 75°.

[0064] The support surface 211 faces the engagement surface 254 such that the support surface 211 and the engagement surface 254 define opposing walls of the passage 24. Due to the inclined orientation of the support surface 211 and the pivotal mounting of the engagement surface 254 by the lever member 25, it is obtained that the suture is allowed to pass along the passage 24 in a first direction 241 in which the lever member 25 pivots away from the support surface 211. However, since the lever member 25 pivots towards the support surface 211 due to the engagement action of the engagement surface 254 and the suture, the suture is locked by the engagement surface 254 to prevent movement in a second direction 242 opposite to the first direction 241. Due to the inclined orientation of the support surface 211, the support surface acts as a seat for the lever member 25 such that the engagement surface can further engage with the suture, thereby preventing further movement of the suture along the passage in the second direction 242.

[0065] As more clearly shown in Figure 13 the anchor body 21 may have a top portion 212 which includes a slit 22 in which the lever member 25 is received. The tubular cover 23 is configured to cover the slit 22. The lever member 25 and the cover 23 are advantageously fastened relative to the anchor body 21 by a pin 26. The support surface 211 advantageously forms the end surface of the slit 22. The bottom portion 213 of the anchor body 21 extending from the support surface 211 in a direction away from the top portion 212 may be dense.

[0066] Advantageously, a spring or elastic member 255 is coupled to the upper portion 251 or the intermediate 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 with the cover 23 (or with the anchor body 21) to preload or bias the lever member 25 (engagement surface 254) on the inclined support surface 211. Thus, even in the rest position, the suture is compressed. This advantageously prevents minor movements that would slowly slide backwards over time.

[0067] Reference Figures 14 to 15, the tissue anchor 30 according to the third aspect of the present disclosure includes an anchor body 31 having an elongated shape and defining a longitudinal axis 100. The anchor body 31 is advantageously tubular, having an internal channel 32 and a channel wall 33. The passage 34 for the suture 9 to pass through the anchor body 31 includes an inlet portion 341 and an outlet portion 342 for the suture. The inlet portion and the outlet portion define through holes passing through the anchor body 31, and these through holes are arranged on opposite sides of the anchor body 31 in a direction transverse to the longitudinal axis 100. The inlet portion 341 and the outlet portion 342 are configured to guide the movement of the suture 9 in a direction substantially transverse to the longitudinal axis 100. For this purpose, the outlet portion 342 may include a suitable arcuate portion to provide proper guidance for the suture.

[0068] The passage 34 further includes a tightening portion 343 and a routing portion 344 located between the inlet portion 341 and the outlet portion 342. The suture 9 is guided through the tightening portion 343 and the routing portion 344 in substantially opposite directions, and these directions may be substantially parallel to the longitudinal axis 100. Specifically, the suture 9 is routed around a pin 361, which advantageously has a circular cross-section. This can avoid the cutting force on the edge of the inlet portion 341. The line 9 changes its direction of movement by approximately 90° around the pin 361, from being substantially transverse to the longitudinal axis 100 to being substantially parallel to the longitudinal axis, and is routed around a pin 362 to change the direction of movement by approximately 180° back to the outlet portion 342. It should be understood that the inlet portion 341 and the outlet portion 342 are advantageously arranged at corresponding positions along the longitudinal axis.

[0069] The insert 35 is disposed within the internal passage 32. The insert 35 is advantageously tubular and includes an internal cavity 352. The insert 35 includes a deflectable or pivotable member 351 configured to engage a suture 9 within the fastening portion 343. The fastening portion 343 (e.g., between the pin 362 and the outlet portion 342) includes a support surface 311 advantageously formed by the passage wall 33. The support surface 311 and the free end of the deflectable member 351 define opposing walls of the fastening portion of the passageway 34. In some examples, the deflectable member 351 includes a notched or grooved end portion 353 to allow the wire 9 to pass therethrough to form the passageway 34 (fastening portion 343). The routing portion 344 advantageously extends through the internal cavity 352, and the deflectable member 351 advantageously surrounds the routing portion 344. To this end, the deflectable member 351 can be annular. The deflectable or pivotable member 351 can be attached to the trunk of the insert 35, which extends along a longitudinal axis. The deflectable or pivotable members are thus arranged in an array along the length of the passage 32 (e.g., along the longitudinal axis). The insert 35 can be attached to the anchor body 31 by one or both of the pins 361 and 362.

[0070] 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 pass through the passageway 34 (fastening portion 343) in a first direction 345, in which the deflectable member 351 is pushed away from the support surface 311. The member 351 prevents the suture from moving along the passageway in a second direction opposite the first direction 345, in which the member 351 is pushed toward the support surface 311 by the engagement action of the member 351 and the suture 9. The free end of the deflectable member 351 can be appropriately shaped to optimally engage the suture, e.g., the free end can be shaped as teeth or serrations. It should be understood that the deflectable member 351 approaches the support surface 311 at an acute angle in the first direction 345.

[0071] Thus, the tissue anchor 30 is a T-shaped anchor. Specifically, the inlet passage and the outlet passage of the suture are aligned along the transverse direction, while the deflectable member is disposed in the longitudinal direction of the anchor, and thus the engagement length with the suture can be increased while maintaining a small diameter of the anchor. By routing the suture 9 around the pins 361, 362, compression of the insert 35 at the end of tightening is avoided, and the force for moving the wire through the passageway in the direction 342 does not substantially increase with the degree of tightening.

[0072] It will be conveniently noted that the tissue anchors 20, 30 of either the second aspect or the third aspect can be used as an alternative to the tissue anchors 10, 50 described above, e.g., in Figure 5 the assemblies and / or in the surgeries described with respect to Figures 10 to 11 ​

[0073] The tissue anchor of any one of the first to third aspects can be made of any suitable material, in particular a metal such as nitinol, or a medical-grade plastic material.

[0074] It should be understood that the components according to the present disclosure may include more than two tissue anchors, in particular tissue anchors attached to the same suture. At least one of these tissue anchors may be any one of the first tissue anchors described herein, and at least one of them may be the second tissue anchor described herein.

[0075] Aspects of the present disclosure are set forth in the following alphanumerically-ordered clauses. A1. A component for securing a suture in a tissue approximation surgery, the component comprising a suture (9) and a first tissue anchor (10), wherein the suture is provided with a plurality of protrusions (91) arranged along the length of the suture, and wherein the first tissue anchor comprises: an anchor body (11), the anchor body having an elongated shape that defines a longitudinal axis (100); a passage (14) for the suture to pass through the anchor body, the passage including an outlet (141); and a pawl (15), the pawl being adjacent to the outlet and configured to engage with the plurality of protrusions (91) to prevent the suture from moving inward from the outlet into the anchor body in a first direction (92), wherein the pawl includes a pawl body (151) pivotally coupled to the anchor body, wherein the anchor body includes a seat (111) for the pawl body such that a force applied by one of the plurality of protrusions in the first direction on the pawl body causes the pawl body to pivot and abut against the seat. A2. The component according to clause A1, wherein the pawl includes a hinge (152) coupled to the anchor body, preferably wherein the hinge is configured to pivot the pawl body about a pivot axis that substantially intersects the longitudinal axis, preferably wherein the hinge is integrally formed with the pawl body and the anchor body. A3. The component according to clause A2, wherein the hinge (152) is disposed at a first end of the pawl body (151), and the outlet (141) is disposed at a second end of the pawl body opposite the first end, preferably wherein the seat (111) is disposed between the hinge (152) and the outlet (141) when the pawl body abuts against the seat, preferably wherein the first end and the second end define a direction substantially parallel to the longitudinal axis. A4. A component as described in clause A2 or A3, wherein the seat includes an abutment surface for the pawl, and wherein the abutment surface is inclined with respect to a plane parallel to the pivot axis and parallel to the longitudinal axis. Preferably, the abutment surface has mirror symmetry with respect to a median plane of the pawl body that is perpendicular to the pivot axis. A5. A component as described in any one of clauses A1 to A4, wherein the anchor body (11) includes an outer wall that circumferentially surrounds the longitudinal axis, and wherein the pawl body (151) defines a part of the outer wall. Preferably, the outer wall has a normal vector perpendicular to the longitudinal axis. Preferably, the pawl body and the anchor body define the outer wall in a complementary manner. A6. A component as described in any one of clauses A1 to A5, wherein the pawl body (151) defines a part of the circumferential edge of the outlet (141). A7. A component as described in any one of clauses A1 to A6, wherein the anchor body includes an internal cavity (12) surrounded by the outer wall of the anchor body, wherein the pawl body defines a part of the outer wall adjacent to the internal cavity, and wherein the seat (111) is formed by an edge of the outer wall that mates with the pawl body. A8. A component as described in any one of clauses A1 to A7, preferably according to clause A7, wherein the pawl body (151) is formed by a partial cutout in the anchor body. A9. A component as described in any one of clauses A1 to A8, preferably according to clause A7 or A8, wherein the anchor body (11) is at least partially tubular at a position corresponding to the pawl (15). Preferably, the anchor body is tubular and has an inner cavity that extends along the longitudinal axis from a first end of the anchor body to a second end of the anchor body opposite the first end. A10. A component as described in any one of clauses A1 to A9, preferably according to any one of clauses A7 to A9, wherein the pawl body (15) includes a narrower section at a first end of the pawl body and a larger or wider section at a second end opposite the first end. The pawl body is pivotally coupled to the anchor body at the first end. Preferably, the pawl body has a substantially teardrop shape. Preferably, the pawl body is integrally formed with the anchor body. Preferably, the narrower section is configured to form a weakened portion so as to operate as a hinge of the pawl body. A11. A component as described in any one of clauses A1 to A10, preferably according to any one of clauses A7 to A10, wherein the anchor body (11) includes a cut edge that separates the pawl body and the anchor body except for a hinge portion where the pawl body is connected to the anchor body. A12. A component as described in any one of clauses A1 to A11, preferably as described in any one of clauses A7 to A11, wherein the cross-section of the pawl body in a plane perpendicular to the longitudinal axis has a substantially curved or arcuate shape. A13. A component as described in any one of clauses A1 to A12, wherein the passageway (14) extends substantially crosswise to the longitudinal axis (100). A14. A component as described in any one of clauses A1 to A13, wherein when the pawl body abuts against the seat, the size of the suture (9) is less than or equal to the size of the outlet (141), and wherein the size of the plurality of protrusions (91) is greater than the size of the outlet. A15. A component as described in any one of clauses A1 to A14, wherein the plurality of protrusions are knots or beads attached to the suture. A16. A component as described in any one of clauses A1 to A15, wherein the passageway includes an inlet (142) for the suture provided on the outer wall opposite to the pawl (15), and wherein the inlet is located at a position substantially corresponding to the outlet (141) along the longitudinal axis. A17. A component as described in any one of clauses A1 to A16, wherein the outer wall is substantially cylindrical or prismatic, and wherein the base is arranged in a plane perpendicular to the longitudinal axis. A18. The component (40) as described in any one of clauses A1 to A17, further comprising a second tissue anchor (41) attached to the suture, and preferably, the first tissue anchor and the second tissue anchor are configured to oppose the tissue between the first tissue anchor and the second tissue anchor. A19. A component as described in any one of clauses A1 to A18, further comprising a catheter, the catheter including a catheter body and an instrument channel, the instrument channel extending from the proximal side through the catheter body to the distal side, and wherein the instrument channel is configured to receive the first tissue anchor to deliver the first tissue anchor through the instrument channel. B1. A tissue anchor (20) for tightening a suture in a tissue opposition surgery, the tissue anchor comprising: An anchor body (21), the anchor body being elongated and defining a longitudinal axis (100); A passageway (24) for the suture to pass through the anchor body, substantially transverse to the longitudinal axis; a lever member (25) having a first end pivotally coupled to the anchor body and a second end opposite to the first end, wherein the lever member includes an engagement surface (254) at the second end, the engagement surface being configured to engage the suture when the suture is inserted into the passageway, wherein the passageway includes a support surface (211) for supporting the suture, Wherein, the support surface is inclined relative to the longitudinal axis and faces the engagement surface (254), such that the lever member allows the suture to pass through the passageway in a first direction (241), in which direction the lever member pivots away from the support surface, and the lever member prevents the suture from moving through the passageway in a second direction (242) opposite to the first direction, in which direction the lever member pivots towards the support surface by the engagement action of the engagement surface and the suture. B2. The tissue anchor as described in clause B1, wherein the second direction (242) has a direction component perpendicular to the longitudinal axis, and this direction component is oriented towards the support surface. Preferably, the first direction (241) has a direction component perpendicular to the longitudinal axis, and this direction component is oriented away from the support surface. B3. The tissue anchor as described in clause B1 or B2, wherein the engagement surface (254) extends substantially parallel to the support surface (211). B4. The tissue anchor as described in any one of clauses B1 to B3, wherein the engagement surface is roughened and / or includes suture engagement members, such as a plurality of serrations, barbs or teeth. B5. The tissue anchor as described in any one of clauses B1 to B4, wherein the lever member (25) is pivotally coupled to the anchor body (21) by a pin (26). B6. The tissue anchor as described in any one of clauses B1 to B5, wherein the support surface (211) is integral with the anchor body (211). B7. The tissue anchor as described in any one of clauses B1 to B6, wherein the support surface (211) is oriented at an angle between 30° and 85° relative to the longitudinal axis, preferably between 45° and 80°, preferably between 50° and 75°. B8. The tissue anchor as described in any one of clauses B1 to B7, further comprising a spring member (255), which is configured to bias the lever member towards the support surface. B9. The tissue anchor as described in clause B8, wherein the spring member is an elastic member attached to or integral with the lever member. Preferably, the spring member is configured to engage with the wall of the tissue anchor. B10. The tissue anchor as described in any one of clauses B1 to B9, wherein the lever member (25) includes a first portion (251) at the first end and a second portion (253) at the second end, the second portion includes the engagement surface (254), and wherein the lever member further includes an elongated intermediate portion (252) connecting the first portion to the second portion. Preferably, the intermediate portion is elastic. B11. The tissue anchor as described in any one of clauses B1 to B10, wherein the anchor body (21) includes a slit-shaped cavity (22), wherein the bottom of the cavity defines a support surface, and wherein a lever member is disposed in the cavity. Preferably, the tissue anchor includes an abutment wall exposed to the cavity, and the lever member (25) includes a spring member (255) configured to engage with the abutment wall and bias the lever member towards the support surface. B12. The tissue anchor as described in any one of clauses B1 to B11, wherein the first end and the second end of the lever member define an axis of the lever member parallel to the longitudinal axis. B13. The tissue anchor as described in any one of clauses B1 to B12, wherein the lever member, preferably at least the engaging surface, is at least partially made of a nickel-titanium alloy. B14. The tissue anchor as described in any one of clauses B1 to B13, the tissue anchor having a substantially cylindrical or prismatic outer shape, wherein the base is disposed in a plane perpendicular to the longitudinal axis. B15. The tissue anchor as described in any one of clauses B1 to B14, wherein the passage is located along the longitudinal axis between 1 / 4 and 3 / 4 of the length of the anchor body, preferably between 1 / 3 and 2 / 3 of the length. B16. A component (40) for tightening a suture in a tissue approximation surgery, the component including at least one tissue anchor as described in any one of clauses B1 to B15, a suture (9), and a second tissue anchor (41) attached to the suture. Preferably, at least one tissue anchor and the second tissue anchor are configured to approximate the tissue. B17. The component as described in clause B16, further including a catheter, the catheter including a catheter body and an instrument channel extending from the proximal side through the catheter body to the distal side, wherein the instrument channel is configured to receive the first tissue anchor to deliver the first tissue anchor through the instrument channel. C1. A tissue anchor (30) for tightening a suture in a tissue approximation surgery, the tissue anchor including: An anchor body (31), the anchor body being elongated and defining a longitudinal axis; and A passage (34) for the suture (9) to pass through the anchor body, wherein the passage includes an inlet portion (341) and an outlet portion (342) for the suture. Preferably, the inlet portion and the outlet portion define a movement axis of the suture oriented transversely to the longitudinal axis (100). Wherein, the passage further includes a tightening portion (343) located between the inlet portion and the outlet portion, and the tightening portion includes a support surface (311) for the suture, and the support surface is oriented substantially parallel to the longitudinal axis. Wherein, the tightening portion further includes a plurality of deflectable leg members (351) facing the support surface (311), and each of the plurality of leg members is arranged to be inclined relative to the longitudinal axis and configured to engage the suture, such that the leg members (351) allow the suture to pass through the passage in a first direction (345), in which the leg members are pushed away from the support surface, and the leg members prevent the suture from moving in a second direction opposite to the first direction along the passage, in the second direction, the leg members are pushed towards the support surface by the engagement action of the leg members and the suture. C2. The tissue anchor according to clause C1, wherein the passage (34) includes at least one guiding member (361, 362), and the at least one guiding member is configured to route the suture from the inlet portion to the tightening portion and / or from the tightening portion to the outlet portion. Preferably, the at least one guiding member includes a curved surface configured to route the suture from an orientation substantially perpendicular to the longitudinal axis to an orientation substantially parallel to the longitudinal axis, and vice versa. C3. The tissue anchor according to clause C1 or C2, wherein the passage further includes a routing portion (344) arranged between the inlet portion and the outlet portion, and the routing portion is substantially parallel to the tightening portion (343) and configured to route the suture from the inlet portion to the tightening portion and / or from the tightening portion to the outlet portion. C4. The tissue anchor according to clause C3, wherein the leg members (351) are substantially annular, and the routing portion (344) passes through the annular leg members. C5. The tissue anchor according to any one of clauses C1 to C4, wherein the anchor body (31) is at least partially tubular and has a channel (32) with an axis parallel to the longitudinal axis, and the support surface (311) is the wall of the channel. C6. The tissue anchor according to clause C5, wherein the leg members are formed as inserts (35) arranged in the channel. C7. The tissue anchor according to clause C6, wherein the insert (35) is attached to the anchor body by pins (361, 362). C8. The tissue anchor according to clause C7, preferably in combination with clause C4, wherein the pin (361) is a guiding member for the suture and is configured to change the direction of the suture. C9. The tissue anchor as described in any one of clauses C1 to C8, wherein the anchor body defines an outer wall circumferentially around a longitudinal axis, the outer wall having a normal vector perpendicular to the longitudinal axis, and wherein the inlet portion (341) and the outlet portion (342) are arranged to pass through the outer wall. C10. The tissue anchor as described in any one of clauses C1 to C9, wherein the inlet portion and the outlet portion are arranged on opposite sides of the anchor body in a direction transverse to the longitudinal axis. C11. A component (40) for securing a suture (9) in a tissue approximation procedure, the component comprising at least one tissue anchor as described in any one of clauses C1 to C10, a suture, and a second tissue anchor (41) attached to the suture, and preferably, the at least one tissue anchor and the second tissue anchor are configured to approximate tissue. C12. The component as described in clause C11, further comprising a catheter, the catheter comprising a catheter body and an instrument channel that extends from a proximal side through the catheter body to a distal side, wherein the instrument channel is configured to receive the first tissue anchor for delivering the first tissue anchor through the instrument channel. D1. A component (40) for securing a suture (9) in a tissue approximation procedure, the component comprising a suture (9) and at least one tissue anchor (10, 20, 30, 41) configured to secure the suture, wherein the suture includes a frangible portion (42). D2. The component as described in clause D1, wherein the at least one tissue anchor (10, 20, 30) includes an anchor body and a passage for the suture to pass through the anchor body, and wherein the tissue anchor includes a one-way securing device for the suture, the one-way securing device being configured to allow the suture to move relative to the tissue anchor in one direction while preventing the suture from moving relative to the tissue anchor in a second direction opposite to the first direction. D3. The component as described in clause D1 or D2, wherein the at least one tissue anchor is a tissue anchor as described in any one of clauses A1 to A19, B1 to B17, or C1 to C12. D4. The component as described in any one of clauses D1 to D3, wherein the frangible portion (42) is a weak point configured to break when the stress or tension in the suture exceeds a predetermined threshold.

Claims

1. A component for securing a suture in tissue approximation surgery, the component comprising a suture (9) and a first tissue anchor (10, 50), wherein, the suture is provided with a plurality of protrusions (91) arranged along the length of the suture, wherein, the first tissue anchor comprises: an anchor body (11), the anchor body having an elongated shape that defines a longitudinal axis (100); a passage (14) for the suture to pass through the anchor body, the passage including an outlet (141); and a pawl (15), the pawl being adjacent to the outlet and configured to engage with the plurality of protrusions (91) to prevent the suture from moving relative to the anchor body in a first direction (92), wherein, the pawl comprises a pawl body (151, 551) pivotally coupled to the anchor body, wherein, the anchor body comprises a seat (111, 511) for the pawl body, such that a force applied by one of the plurality of protrusions in the first direction on the pawl body causes the pawl body to pivot and abut against the seat.

2. The component according to claim 1, wherein, the pawl comprises a hinge (152) coupled to the anchor body, wherein, the hinge (152) is arranged at a first end of the pawl body (151), and the outlet (141) is arranged at a second end (153, 553) of the pawl body opposite to the first end, wherein, the seat (111) is arranged between the hinge (152) and the outlet (141), wherein, the first end and the second end define a direction substantially parallel to the longitudinal axis (100).

3. The component according to claim 2, wherein, the pawl body (151, 551) includes a plurality of side edges (554, 555) between the first end and the second end (153, 553) on both sides of the pawl body, wherein, these side edges (554, 555) extend away from the hinge (152) to a position beyond the outlet (141), and wherein, the seat (111, 553) extends along these side edges.

4. The component according to claim 2 or 3, wherein, the hinge (152) is arranged at the first end of the pawl body (151, 551), and the outlet (141) is arranged at a second end (153, 553) of the pawl body opposite to the first end along the longitudinal axis, wherein, the pawl body includes an edge at the second end, and the projection of the edge on a plane parallel to the longitudinal axis (100) is arc-shaped or curved, preferably, the plane is also parallel to the pivot axis of the hinge (152, 552) between the pawl body and the anchor body.

5. The component according to any one of the preceding claims, wherein, The anchor body (11) includes an outer wall (13) circumferentially surrounding the longitudinal axis (100), wherein the pawl body (151, 551) defines a part of the outer wall, and wherein the cross-section of the pawl body in a plane perpendicular to the longitudinal axis is substantially curved or arcuate in shape. Preferably, the outer wall has a normal vector perpendicular to the longitudinal axis. Preferably, the pawl body and the anchor body define the outer wall in a complementary manner. Preferably, the outer wall is substantially cylindrical or prismatic, with a base disposed in a plane perpendicular to the longitudinal axis.

6. The assembly according to any one of the preceding claims, wherein, the outlet (141) includes an orifice (541) having a circumferential edge, wherein the pawl body (151, 551) defines a first part of the circumferential edge, and wherein the anchor body (11) defines a second part of the circumferential edge. Preferably, the orifice is located on the outer wall of the anchor body.

7. The assembly according to any one of the preceding claims, wherein, the pawl body (151, 551) includes a recess (541), wherein the recess forms the orifice of the outlet (141), the orifice being configured to receive the suture (9), and wherein the recess is sized such that the plurality of protrusions (91) are configured to engage the pawl body at the periphery of the recess.

8. The assembly according to any one of the preceding claims, wherein, the first direction is directed inward from the outlet into the anchor body.

9. The assembly according to any one of the preceding claims, wherein, the pawl body (151) is formed as a flap partially cut out from the anchor body. Preferably, the anchor body (11) is at least partially tubular, having a lumen extending along the longitudinal axis, and wherein the pawl body allows access to the lumen.

10. The assembly according to claim 9, wherein, the pawl body (151) is pivotally connected to the anchor body by a strip, wherein the strip includes one or more through-cutouts for weakening the strip to facilitate pivotal movement.

11. The assembly according to any one of the preceding claims, wherein, the pawl body (151) includes a narrower section at a first end of the pawl body and a larger or wider section at a second end opposite the first end along the longitudinal axis. The pawl body is pivotally coupled to the anchor body at the first end. Preferably, the pawl body is integrally formed with the anchor body. Preferably, the narrower section is configured to form a weakened portion to operate as a hinge for the pawl body.

12. The assembly according to any one of the preceding claims, wherein, the passageway (14) extends substantially transversely to the longitudinal axis (100) and is located in a central section (114) of the anchor body, the central section being intermediate a first end section and a second end section (112, 113) of the anchor body along the longitudinal axis.

13. The assembly according to any one of the preceding claims, wherein, The outlet (141) is located in a central section (114) of the anchor body, the central section being intermediate a first end section and a second end section (112, 113) of the anchor body along the longitudinal axis, wherein the central section (114) includes a weak point configured to act as a pivot to allow the first end section and the second end section to flex relative to the central section, and wherein the cross-sectional area of the anchor body at the weak point is reduced compared to the first end section and the second end section (112, 113).

14. The assembly according to the preceding claim, wherein, the passageway (14) includes an inlet (142) at an end opposite the outlet (141), and wherein the anchor body includes a transverse incision (443) at the inlet, the transverse incision being configured to form the weak point.

15. The assembly according to any one of the preceding claims, wherein, the outlet is located in a central section of the anchor body, the central section being intermediate a first end section and a second end section of the anchor body along the longitudinal axis, wherein the first end section and the second end section include respective weak points configured to flex the respective first end section and second end section relative to the central section when the anchor body is pressed against tissue, thereby providing tissue compliance.

16. The assembly according to the preceding claim, wherein, the weak points include transverse incisions through the anchor body.

17. The 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. The assembly (40) according to any one of the preceding claims, the assembly further comprising a second tissue anchor (41) attached to the suture, wherein, the first tissue anchor and the second tissue anchor are configured to appose tissue between the first tissue anchor and the second tissue anchor.

19. The assembly according to the preceding claim, wherein, the second tissue anchor (41) is elongate and defines a second longitudinal axis (400), and wherein the suture (9) is secured to the second tissue anchor in a central section (414) of the second tissue anchor, the central section being intermediate a first end section and a second end section (412, 413) of the second tissue anchor along the second longitudinal axis, and wherein the central section and / or the first end section and the second end section include respective weak points (443, 451) configured to flex the first end section and the second end section of the second tissue anchor relative to the central section (414) of the second tissue anchor when the second tissue anchor is pressed against tissue, thereby providing tissue compliance, preferably wherein the weak points include transverse incisions through the second tissue anchor.

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

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