Tissue anchor

ES 2 625 845 T3

DESCRIPTION

Tissue anchoring, anchoring system and procedures for its use

Technical field

The present invention relates generally to tissue anchors. Methods of using such anchors to secure an element or otherwise provide an anchor point to biological tissue and / or to secure at least two tissue portions together are also described.

Background

Many different surgical procedures require that an anchor be used either to establish a strong point of connection for other elements or fasteners in relation to a tissue location in a patient, and / or to secure two or more layers of tissue (i.e. say, portions together). In this sense, the term "anchor" as used herein is not to be limited to any particular type of tissue fixation or clamping application but rather encompasses any tissue-to-hard tissue clamping and / or fastening. or soft, tissue clamping device, or any other tissue clamping application.

One particular area that has received attention in recent years is catheter-based surgical procedures. Various tissue anchors have been developed for deployment and clamping purposes with catheter-based technology. However, there are still limitations in current technology. For example, insert size versus deployment size must be strictly controlled due to the need for catheter diameters to be kept relatively small. Many catheter-based tissue anchoring systems have highly specialized uses and are not versatile for use in many different tissue fixation or clamping operations.

US Patent Application Publication 2005/0137700 describes various tissue fixation systems. In the embodiment according to figs. 35A-35F a catheter device for implanting multiple tissue fixatives is shown. The catheter device includes three fixator implantation portions, a central portion at the distal end of the catheter device, and two additional fixator implantation portions on opposite sides of the central portion. A flexible traction member couples each fastener to each other. Once the fasteners are driven into the tissue by a fastener driver, the tension member can be pulled closely to crimp the tissue and a crimp member is applied to lock the tension member in the tensioned position.

US Patent Application Publication 2002/0019649 discloses a wound closure device having first and second anchors and a flexible member movably attached to the second anchor to position the first anchor against tissue, to pass the flexible member through the wound, to positioning the second anchor against the tissue, and to pull a free end of the flexible member to shorten a length of the flexible member between the first and second anchors, thereby closing the wound.

There is generally a need for a simpler, more versatile tissue anchor that can be deployed and firmly attached to tissue in a catheter-based operation or a non-catheter-based operation.

Resume

The invention is defined in claim 1 with preferred embodiments according to the claims dependent thereon. The present disclosure provides a tissue anchor comprising a generally flexible anchoring member capable of being inserted through tissue and movable between an elongated configuration and a shortened configuration suitable for anchoring against at least one side of the tissue. The anchoring member includes a proximal end portion, a distal end portion, and a compressible intermediate portion between the proximal end portion and the distal end portion. A tension member is operatively connected to the anchor member so that the anchor member can slide relative to the tension member. The tensioning means can be pulled to cause the anchoring member to move relative to the tensioning member from the elongated configuration to the shortened configuration. In the shortened configuration, the compressible intermediate portion of the anchoring member can be compressed or shortened and thereby conform to the thickness of the tissue between the proximal and distal end portions.

In another aspect of the disclosure there is provided a tissue anchor comprising a flat, generally flexible anchoring member capable of displacement between an elongated configuration suitable for deployment and a shortened configuration suitable for anchoring against tissue. A tension member is operatively connected to the anchor member so that the anchor member can slide relative to the tension member. The tension member can be pulled to cause the anchor member to move relative to the tension member

ES 2 625 845 T3 from elongated configuration to shortened configuration.

In a further aspect of the disclosure there is provided a tissue anchor comprising a flat anchoring member formed from a strip of textile material and capable of displacement between an elongated configuration suitable for deployment and a shortened configuration suitable for anchoring against tissue. A tension member is operatively connected to the anchor member so that the anchor member can slide relative to the tension member. The tension member can be pulled to cause the anchor member to move relative to the tension member from the elongated configuration to the shortened configuration. A locking member is provided to secure the anchor member in the shortened configuration.

In a further aspect of the disclosure there is provided a tissue anchor comprising a flat, generally flexible anchoring member capable of being inserted through tissue and movable between an elongated configuration suitable for deployment through a catheter and a suitable shortened configuration. for anchoring against the tissue. A tension member is operatively connected to the anchor member so that the anchor member can slide relative to the tension member. The tension member can be pulled to cause the anchoring member to move relative to the tension member from the elongated configuration to the shortened configuration against the tissue.

In another aspect of the disclosure there is provided a tissue anchor comprising an elongated flat strip formed from a generally flexible material and having proximal and distal end portions. A tension member having first and second ends is operatively connected to the elongated strap such that pulling on the first end of the tension member causes the proximal and distal end portions of the elongated strap to move toward each other to a shortened configuration suitable for anchoring against tissue.

In certain embodiments, the anchoring member is advantageously formed as a flat, generally flexible strip of material, while in other aspects it does not have to be a flat strip but may have other shapes, such as tubular, which may or may not be capable of adopting a flat shape. Various optional features may be incorporated into any or all of the various embodiments of the tissue anchor. For example, the fabric anchor can be formed of a material selected from at least one of: natural fibers, synthetic fibers, polymers, and metals. Such materials can be absorbable or nonabsorbable, and can be radiopaque or at least partially radiopaque. The tension member may further comprise a suture, or any other suitable flexible, semi-rigid or rigid tension member. The tension member can include a stop means coupled with the anchor member, such as a knot in the tension member, or a separate stop member (eg, a crimp) that can be coupled with the anchor member. The tension member can, for example, extend through the anchoring member at multiple locations between the proximal end portion and the distal end portion. Such engagement of the tension member and the anchor member can be configured in many different ways depending, for example, on the desired configuration of the anchor member after pulling the tension member and displacing the anchor member to the shortened configuration. In one embodiment, at least one fold is formed at the time of pulling the tension member. Multiple folds can be formed in a generally zigzag or accordion fashion. A locking member may be provided and engageable with the tension member to retain the anchor member in the shortened configuration. The tissue anchor may include at least one radiopaque marker on one of the anchoring member and the tension member or both. For example, a first radiopaque marker can be located near the proximal end portion when the anchoring member is in the shortened configuration and a second radiopaque marker can be located near the distal end portion when the anchoring member is in the shortened configuration. The distal end portion of the anchoring member may include a tip that is relatively stiffer compared to the anchoring member and having a reduced width compared to an adjacent portion of the anchoring member. The anchoring member itself can be designed in any of a number of ways, including designs that have a uniform width along the length thereof, and designs that have a variable width along the length. Other features such as edge portions that are slightly stiffer than a central area of ​​the anchor member may be incorporated. Entire sections of the anchoring member can be relatively rigid compared to the fold line portions thereof while still resulting in a generally flexible anchoring member. Where necessary, hinge portions, such as hinges made of the same material, may be designed within the anchor member to allow folding or other shortening action of the anchor member. Although a tension member for activation purposes (i.e., activation of the anchor member from the elongated configuration to the shortened configuration) is specifically described herein, the invention, in various combinations, may utilize other types of activation, such as activation compressive.

Each of the embodiments of the tissue anchor may be part of a catheter-based anchoring system having an implantation catheter and a suitable deployment device associated with the implantation catheter and capable of operating to extend the anchoring member from the implantation catheter. implantation catheter. The deployment device may further comprise a deployment catheter that at least partially contains

ES 2 625 845 T3 the anchoring member and at least partially contained within the implantation catheter.

The description further envisions various methods of tissue anchoring as generally described herein. For example, in one aspect there is provided a tissue anchoring method comprising inserting a generally flexible elongated anchoring member through the tissue, and pulling a first end of an engaged tensioning member for sliding motion relative to the first anchoring member to attract the proximal and distal end portions to each other and to compress the intermediate portion to the shortened configuration with at least one of the portions. of proximal and distal end engaged against the tissue.

In another aspect of the disclosure a tissue anchoring method is provided which comprises inserting the generally flexible flat elongated strip having proximal and distal end portions through the tissue, and pulling a first end of a tension member operatively connected to the strip to attract the proximal and distal end portions of the strip together into the shortened configuration engaged against the tissue.

In another aspect, a tissue anchoring method is provided comprising inserting the generally flexible flat elongated strip having proximal and distal end portions through the tissue, and pulling a first end of a tension member operatively connected to the strip to configuring at least a portion of the strip in a shortened configuration engaged against the tissue.

In each of the embodiments the engagement of the anchoring member against the tissue may be an engagement against opposite sides of at least one layer of tissue, or an engagement against only one side of at least one layer of tissue.

Additional features and advantages of the description will be immediately apparent to one skilled in the art upon review of the following of the illustrative embodiments taken in conjunction with the accompanying illustrative figures.

Brief description of the drawings

Fig. 1 is a perspective view of a tissue anchor constructed in accordance with a first embodiment of the disclosure.

Fig. 2A is a side view of the tissue anchor shown in FIG. 1, with the tissue anchor unfolded through a tissue layer.

Fig. 2B is a side view similar to FIG. 2A, but illustrating the distal portion of the tissue anchor moved toward the tissue layer.

Fig. 2C is a side view similar to FIG. 2B, but showing the distal portion fully compressed and engaged against the tissue layer.

Fig. 2D is a side view similar to FIG. 2C but illustrating the proximal portion of the tissue anchor moving toward the tissue layer.

Fig. 2E illustrates the proximal and distal end portions of the tissue anchor fully compressed against opposite sides of the tissue layer.

Fig. 2F is an enlarged cross-sectional view illustrating the fully deployed and secured anchor with a layer of tissue between the proximal and distal anchor portions.

Fig. 3 is a cross-sectional view similar to FIG. 2F, but illustrating the fixation of two layers of tissue between the proximal and distal anchoring portions.

Figs. 4A-4F are perspective views illustrating successive stages in an annuloplasty procedure in the mitral valve of a patient using tissue anchors of the first embodiment

Figs. 5A-5F are perspective views illustrating a mitral valve annuloplasty procedure using tissue anchors constructed in accordance with a second embodiment of the disclosure.

Fig. 6 is a side elevation view illustrating the tissue anchor constructed in accordance with the second embodiment.

Fig. 7 is a front view of the elongated strip portion of the anchor.

ES 2 625 845 T3

Fig. 7A is a front elevation view similar to FIG. 7, but illustrating one embodiment of radiopaque markers used on the elongated strip.

Fig. 7B is a front elevational view of an alternative anchor strip that has a variable width along its length.

Fig. 7C is a side elevation view of another alternative anchor strip using stiffer fold sections separated by hinges made of the same material.

Figs. 8A-8D are respective side views illustrating a sequence of steps used to secure the anchoring of tissue of the second embodiment to a layer of tissue.

Fig. 8E is a view similar to FIG. 8D, but illustrating an alternative tip and tension member arrangement.

Figs. 9A-9C are respective side elevation views illustrating an annuloplasty procedure in which two tissue anchors of the second embodiment are connected together in a daisy chain with a single tensioning member to fold the tissue between the anchors in a more integrated procedure. .

Figs. 10A and 10B are respective side elevational views illustrating the tissue anchor of the second embodiment used to provide an anchor or clamp location on only one side of a tissue layer.

Detailed Description of Illustrative Embodiments

Referring first to FIG. 1, a tissue anchor (10) constructed in accordance with a first embodiment of the disclosure generally includes a tensioning member (12), such as a suture, that extends through separate points along an elongated strip (14 ) of flexible material, such as surgical grade cloth. It will be appreciated that the tension member 12 may take other forms than suture material, such as wire or any other small diameter member that has sufficiently high tensile strength for the intended anchor use. The elongated strip (14) can also take various forms such as woven and non-woven fabrics, polymers, metals, or other materials or combinations of materials. One or more separate pads or other fastening members (not shown) may be used in conjunction with the elongated strip (14) for added fastening and / or concealing the elongated strip (14) and, for example, thereby inhibiting blood clotting. within or adjacent to the pleats to be formed in the strip (14).

A woven or non-woven material may contain additional materials, such as threads, beads, or other elements that render at least portions of the strip (14) radiopaque. Currently, a surgical grade fabric constructed of polyester, such as Dacron®, is contemplated for use in the construction of the strip (14). One of the many possible alternative materials for use in the construction of the strip (14) is polytetrafluoroethylene (PTFE). The tissue anchor (10) may be formed partially or totally of materials that are absorbed into the patient's tissue over time, depending on the intended use. The edges and / or other portions of the strip (14) can be suitably modified to prevent fraying, such as being coated with a material that locks the fibers in place, or otherwise modified in a way that locks the fibers. at least at the edges of the strip (14) in place.

The suture (12) may extend from a proximal end portion (14a) of the fabric strip (14) to a distal end portion (14b) and then looped back through separate points of the fabric strip (14) to the proximal end portion (14a) where a knot (16) and another stop member are located for reasons described below. As will be apparent, the suture (12) extends through spaced locations along the elongated strip (14) so ​​that tension from the suture (12) or other tension member will cause the elongated strip (14) to form. folded portions (14c) when tensioning member (12) is put under tension or pulled. Thus, the elongated strip 14 is thus activated into essentially an elongated deployment orientation or configuration, as shown in FIG. 1, and a shortened configuration, such as a folded or otherwise shortened configuration having an extended width in at least one dimension compared to the elongated deployment configuration. It will be appreciated that the deployment orientation can take various forms due to the flexible nature of the strip 14, especially when using a highly flexible fabric or other material. For example, a fabric material or other equally flexible materials may be folded or otherwise deformed for purposes of transport within a catheter and / or during deployment at a tissue site and then suitably activated at the tissue site.

Referring more specifically to Figs. 2A-2E, elongated strip (14) and attached suture (12) are initially inserted through at least one layer of tissue (20) as generally shown in FIG. 2A. An end or portion (12a) of the suture (12) is then pulled and thereby placed under tension. It will be appreciated that, for catheter-based procedures, the suture portion (12a) may extend to an external location.

ES 2 625 845 T3 to the patient's body to be pulled or tensioned, or it can be grasped by a suitable mechanism within the catheter and pulled or tensioned. Pulling the suture portion (12a) may initially pull the distal portion (14b) of the elongated strip (14) toward the tissue layer (20) as shown in FIG. 2B. Once the distal portion (14b) is compressed against the tissue layer (20), the proximal portion (14a) begins to be pulled out and compressed against a proximal side of the tissue (20) as shown in FIGS. 2C-2E. This occurs because the end (12a) of the suture (12) is pulled downward (as seen for analysis purposes in Figs. 2C-2E) and, since the suture (12) loops in a reverse direction through the distal end portion (14b) of the elongated strip (14), the knot (16) at the end of the suture (12) is moved upward and the proximal portion (14a) of the elongated strip (14) is carried with it. In this manner, the proximal portion (14a) of the elongated strip (14) is being folded and drawn along the suture (12) towards the tissue layer (20) and then firmly compressed against the proximal side of the layer. of tissue (20) as shown in FIG. 2E. As further shown in FIG. 2F, a suitable locking element, such as a crimping member (22), knot, or other element, may be used to hold the suture (12) and elongated strip (14) in the positions shown in FIG. 2F firmly anchoring the proximal and distal portions (14a), (14b) of the elongated strip (14) folded against opposite sides of the tissue (20).

As further shown in FIG. 3, the same general procedure can be used to secure two distinct tissue layers (30), (32) together by initially extending the elongated strip (14) and tensioning member (12) through at least two tissue layers (30). , (32). In this way, for example, two layers of fabric 30, 32 can be firmly secured together. This may, for example, involve two totally different layers or even types of tissue or the same tissue layer that has been refolded to effectively form two layers (ie portions) of tissue.

Figs. 4A-4E schematically illustrate an annuloplasty procedure performed on a mitral valve (40) of a heart (42) using tissue anchors (10) as described above with respect to the first embodiment. The performance of the annuloplasty procedure can have many variations, but is generally illustrated by the placement of at least two tissue anchors (10) and the securing of the two anchors (10) together, such as with one or more tension members. (12) between them. For a further illustrative description of catheter-based annuloplasty procedures that may utilize any of the tissue anchors within the scope of the present disclosure, reference may be made to US Patent Application Serial No. 10 / 948,922, filed September 24, 2004, assigned to the assignee of the present invention.

As illustrated in fig. 4A, a first tissue anchor (10) is deployed through a catheter device (50) which may, for example, have an inner tubular member (52) or a deployment catheter received within an outer tubular member (54) or implantation catheter. The tissue anchor (10) and tension member (12) are carried within the inner tubular member (52) and are deployed from a distal end (52a) thereof. To ensure that the proper force is applied to penetrate the tissue, the tissue anchor (10) can be deployed or extended after the inner tubular member (52) has been inserted through the tissue at the annulus (40a) of the mitral valve (40). This is best illustrated in fig. 4B. The inner tubular member (52) is removed from the tissue of the annulus (40a) either before, during or after activation of the distal end portion (14b) of the elongated strip (14). As described above, activation (e.g., compression, folding, or otherwise shortening) of the elongated strip (14) by pulling on the suture (12) causes the distal end portion (14b) and then the proximal end (14a) are firmly compressed and folded against opposite sides of the annulus tissue (40a). This procedure is repeated at least one additional time to firmly fix an additional tissue anchor (10) at a location spaced from the initial location. For example, the initial location may be a location (P2) of the mitral valve annulus (40) while the second location may be spaced on either side of the location (P2). The catheter device (50) can be inserted into the location of the annulus 40a in various ways, but is shown being inserted down through the aortic valve (53) into the left ventricle (55), and curving upward toward the mitral valve annulus (40a).

In the illustrative example shown in fig. 4E, three tissue anchors (10) have been deployed and firmly attached to the annulus tissue (40a). As shown in fig. 4F, then a suture blocker (56) can be deployed and used to maintain the relative position and thus the tension between each of the three respective tension members or sutures (12) associated with the three tissue anchors ( 10) after the tissue anchors (10) have been pulled closer to each other, thus folding the tissue (40a) between the anchors (10). This essentially shortens the valve annulus (40a) and pulls the posterior leaflet (60) towards the anterior leaflet (62) to prevent leakage through the valve (40), that is, to achieve better coaptation of the leaflets. posterior and anterior (60), (62) during systole.

Figs. 5A-5E illustrate a similar annuloplasty procedure on a mitral valve (40) using a second embodiment of a tissue anchor (70) and a modified deployment and activation procedure. In general, the differences between anchor (70) and anchor (10) will be described later with the understanding that all other attributes, options, and features associated with anchor (70) may be as described above in relation to anchor ( 10). As shown in fig. 5A, in this embodiment a member is used again

A tensioner (72) for activating a flexible elongated flat strip (74) having proximal and distal end portions (74a), (74b). The strap (74) includes a tip (76) that is formed or otherwise secured in the distal end portion (74b). Tensioning member (72) and tip (76) are arranged so that tensioning member (72) slides relative to tip (76). More specifically, the tension member (72) can be threaded through the tip (76). The tip (76) is made to be relatively stiff compared to other flexible portions of the strip (74) and smaller in diameter than the width of the strip (74). Therefore, the tip (76) helps to penetrate the tissue of the annulus (40a) as the inner tubular member (52) and elongated strip (74) are extended through the tissue (40a). A wire (73) can be used to push the tip (76) out of the tubular member (52) at the desired time. Tip (76) protrudes slightly from inner tubular member (52) as tissue (40a) is penetrated to help pierce tissue (40a). The tip (76) may also help to force the distal portion or half (74b) of the strip (74) into a folded or otherwise shortened configuration. To help prevent the distal portion (74b) of the elongated strip from retracting through the tissue (40a) as the inner tubular member (52) is withdrawn from the annulus tissue (40a), the free end of the tension member (72) while inner tubular member (52) is still introduced through tissue (40a) and into left atrium (80) from left ventricle (55). This forms the distal portion 74b in a folded or otherwise shortened configuration as shown in FIG. 5B. The inner tubular member (52) can then be removed without also removing the elongated flexible strip (74) with it, as shown in FIG. 5C. The proximal portion (74a) of the elongated strip (74) is then unfolded by pulling the inner tubular member (52) further in a proximal direction, thereby exposing the entire length of the strip (74). Tensioning member (72) is pulled or tensioned to extract and compress proximal portion (74a) of elongated strip (74) to a shortened condition against a lower side of annulus tissue (40a) as shown in FIG. . 5 D. As with the annuloplasty procedure described above using the first embodiment of tissue anchor (10), this is repeated as many times as necessary to create the necessary number of tissue plications. Fig. 5E illustrates this by means of an exemplary view of three successive tissue anchor attachment locations with tissue anchors (70) that can be removed together and locked in place to achieve and retain the plications as described in connection with the fig. 4F. Such plications reduce or close the separation between the posterior and anterior leaflets (60), (62) during systole.

Fig. 6 is a side elevational view of tissue anchor (70) as shown and described with respect to the annuloplasty procedure of FIGS. 5A-5E. This embodiment differs from the first embodiment in several different ways, in addition to the use of a distal tip (76) for tissue penetration purposes. For example, the elongated strip (74) is somewhat shorter than the elongated strip (14) used in the first embodiment. For example, strip 74 may be about 40mm long by about 3mm wide. Of course, any other desired dimensions and shapes can be used depending on application needs. This may be desirable to achieve a lower profile unfolded and attached configuration with fewer folds which can lead to more versatile applications, fewer blood clotting incidents, easier use, etc. In addition, the respective proximal and distal radiopaque bands (90), (92) are secured to the suture (72) at the proximal end portion of the strip (74) and to the inside or outside of the distal tip (76). Under a fluoroscope, these bands or other markers (90), (92) will indicate to the surgeon that the anchor (70) has been fully deployed, activated and compressed and / or secured as necessary during the procedure. The tip (76) itself may alternatively be formed of a radiopaque material. In this second embodiment, the knot (94) formed in the suture (72) or other tensioning member is a slip knot through which another portion of the suture (72) slides during activation of the tissue anchor (70). It will be appreciated that this slip knot (94) may be replaced by another element which serves essentially the same purpose but takes the form, for example, of a small tubular element or other feature of function similar to a slip knot.

As further shown in Figs. 6 and 7, the tensioning member or suture (72) may advantageously extend through respective fold portions (74c) of the elongated strip (74) essentially in an hourglass configuration. Specifically, the adjacent portions of the suture (72) located near the proximal and distal end portions (74a), (74b) of the strip (74) are further apart than the adjacent portions of the suture (72) in the middle of the strip (74). As further shown in FIG. 7A, radiopaque markers, such as the various dot areas (95) can be used to allow the surgeon to visualize the folds of the elongated strip (74) during deployment and clamping of the elongated strip (74). These dots or other radiopaque markers may be printed on the strip (74). For example, dots 95 or other markers may be formed with a platinum powder ink or other suitable material that is radiopaque and biologically compatible. This radiopaque material can also add stiffness to the fold sections (74c) thereby helping to keep the fold sections (74c) flat and increasing the retention force on the tissue. Meanwhile, fold lines 74d between fold sections 74c can remain highly flexible to create narrow radius fold lines. As further shown in FIG. 7, each of the holes (96) through which the tension member or suture (72) is received may be marked by circles (98) surrounding each hole or other markers for visualization purposes during assembly of the tension member. or suture (72) with the elongated strip (74). Optionally, the holes (96) can be eliminated and the suture (72) can be threaded with a needle through the strip (74). One could also, for example, choose different sets of holes (96) along the strip (74) to receive the tension member or suture (72), thus changing the width of

ES 2 625 845 T3 the pleats and / or the number of pleats and / or the shape of the pleats depending on the application needs or the wishes of the surgeon. The tensioning member or suture (72) may be threaded or otherwise attached along the strip (74) in any number of ways including, for example, x-patterns or other cross patterns, zigzag patterns, etc. which can alter the folded or otherwise shortened or compressed space of the anchor into various beneficial shapes, such as flower shapes, circular or other rounded shapes, ball shapes, or other shapes. Modifications in the manner in which the tensioning member or suture (72) is threaded or otherwise attached along the length of the strip (74) may result in a higher or lower tensile force being required to compress the anchor and / or an upper or lower frictional holding force that can help to maintain the anchor in the compressed or shortened configuration. The width of the elongated strip (74 ') can be varied along its length, such as by tapering, staggering, or by forming an hourglass shape or shapes along the length of the strip (14). For example, as illustrated in FIG. 7B, having the proximal and distal end portions (75), (77) wider in dimension than an intermediate or middle portion (s) (79) along the length of the strip (74 ') will allow these portions to be more Wide (75), (77) can over cover more intermediate folded portions (79) and prevent unnecessary contact with adjacent tissue during use. It will be appreciated that like reference numerals are used herein to refer to like elements in all embodiments and reference numerals with prime (') or double prime (") refer to like elements that have been modified in a way. as described herein or otherwise shown in the associated figure. Strip 74 may have varying stiffness including, for example, a relatively rigid perimeter or relatively rigid edges 74e, 74f (FIG. 7) or intermittent relatively rigid sections 74c "separated by flexible sections such as hinges made of the same material (74d ") (fig. 7C) that can help to fold and secure the elongated strip (74") in a folded condition.

Figs. 8A-8D illustrate a series of steps to unfold and securely attach the tissue anchor (70) of the second embodiment to a tissue layer (100). Generally, as shown in FIG. 8A, the combination of elongated strip (74) and tension member or suture (72) is deployed through tissue layer (100). An end or portion (72a) of the suture (72) is then pulled which extends through the slip knot (94). This causes the distal portion (74b) of the elongated strip (74) to fold and compress against the distal side of the tissue layer (100). As shown in fig. 8B, pulling the tension member (72) further causes the slip knot (94) to run up or distally along the suture (72) and against a proximal portion (74a) of the elongated strip (74) by folding and compressing thus the proximal portion (74a) against the proximal side of the tissue layer (100) as shown in FIG. 8C. As shown in fig. 8D, a suitable crimp or locking element (102) may be used to firmly lock the slip knot (94) in place relative to the suture or tension member segment extending therethrough. This will lock the entire anchor (70) in place with the respective proximal and distal folded strap portions (74a), (74b) firmly retaining the tissue layer (s) (100) therebetween. Fig. 8D shows tip (76) acting as a catch on top of distal end portion (74b) to help hold distal end portion (74b) in place. Fig. 8E shows an alternative in which the tension member is threaded through at least one hole (76a) located more centrally in the tip. Yet another alternative would be to thread the tension member through two centrally located holes rather than through the proximal end of the tip (76) and a centrally located hole (76a) as shown in FIG. 8E. These alternatives allow the tip (76) to act more like a "T" bar with forces acting in a more perpendicular or normal manner relative to the distal end portion (74b) of the strip (74).

Figs. 9A-9C illustrate another alternative embodiment of a plication procedure, eg, for use during an annuloplasty on a mitral valve annulus (40a). In this regard, a single tensioning member, such as a suture (103) or other member, can be used to deploy, secure, and extract together at least two separate tissue anchors (110). As shown in fig. 9A, the first and second tissue anchors (110) can be respectively deployed at spaced locations along the mitral valve angle (40a). Each tissue anchor (110) includes an elongated strip (114) of flexible material, such as cloth or other material as described above, as well as a single suture (103) or tension member that extends through each of the elongated strips (114). Upon deployment of the two tissue anchors (110) through the tissue layer (40) at separate locations, the free end of the suture (103) or tension member is pulled thereby firmly fixing the first tissue anchor (110 ) as shown in figs. 9A and 9B and subsequently firmly attaching the second tissue anchor (110) to the annulus tissue (40a). After further pulling or tightening of the suture (103), the tissue anchors (110) will be pulled together to fold the tissue (40) between them as shown in FIG. 9C. A crimp or other locking member (116) can then be used to lock in the desired amount of plication by crimping over the free end of the suture (103) adjacent the slip knot (94) of the first tissue anchor (110) as shown. in fig. 9C. The free end of suture 103 can then be cut to eliminate or reduce the length of the suture tail.

Figs. 10A and 10B illustrate a tissue anchor (70) of the second embodiment, for example, which is used to provide an anchoring or anchoring location only on one side of a tissue layer (120). In this sense, the tissue anchor (70) may extend entirely through the tissue layer (s) (120). Then it pulls

ES 2 625 845 T3 proximally of the free end of the suture or tension member (72) to compress and fold the elongated strip (74) against the distal side of the tissue layer (120) as shown in FIG. 10B. It will be appreciated that activation of the strip 74 occurs in a similar manner to the other described embodiments, except that the activated portion (i.e., the folded or otherwise shortened portion) is located entirely on one side of the layer. made of fabric (120). As illustrated, the intermediate or middle portion between the proximal and distal end portions of the anchoring member is shortened to accommodate the amount of tissue contained therebetween (if any) or shortened during the compression procedure by only a side of tissue.

Although the present invention has been illustrated by a description of various illustrative embodiments and although these embodiments have been described in some detail, it is not the intention of the applicant to restrict or limit in any way the scope of the appended claims to such detail. Additional advantages and modifications will be immediately apparent to those skilled in the art. The various features of the description can be used alone or in numerous combinations depending on the needs and preferences of the user.