ES2864169T3 - Anchor for implantation in a body - Google Patents

Abstract

An anchor for implantation in a body, comprising: an anchor body (64, 112, 132) adapted to be delivered through a hollow member or delivery device (18) for placement against a tissue surface (F ); and a locking mechanism (88, 118, 546) adapted to be delivered through the hollow member or delivery device (18), wherein the locking mechanism comprises a body having a proximal end and a distal end, and defining a lumen for passage of a flexible member (70, 94) therethrough; where the locking mechanism comprises at least two arms (550, 552), where a first arm of the at least two arms is arranged closer to the proximal end of the body and a second arm of the at least two arms is arranged closer to the distal end of the body, and where the at least two arms are biased to project in opposite directions into the lumen to grip the flexible member (70, 94) by creating a tortuous path so that the flexible member (70, 94) is unidirectionally moveable through the lumen with respect to the anchor body (64, 112, 132).

Description

DESCRIPTION

Anchor for implantation in a body

BACKGROUND OF THE INVENTION

Field of the invention.

[0001] The present invention relates to an anchor for implantation in a body.

[0002] Morbid obesity is a widespread serious medical condition in the United States and other countries. Its complications include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopedic problems, and lung failure with a marked decrease in life expectancy.

[0003] Various surgical techniques have been developed to treat morbid obesity, for example, by diverting an absorbent surface from the small intestine or reducing the size of the stomach. However, many conventional surgical procedures can present with numerous life-threatening postoperative complications and can cause atypical diarrhea, electrolyte imbalance, unpredictable weight loss, and reflux of nutritive chyme proximal to the site of the anastomosis.

[0004] Furthermore, the sutures or staples that are often used in these surgical procedures typically require extensive training by the physician to achieve competent use, and can concentrate significant force on a small surface area of tissue, potentially causes the suture or staple to tear through the tissue. Many of the surgical procedures require that the tissue regions within the body be approximated to each other and reliably secured. The gastrointestinal lumen includes four layers of tissue, where the mucosa layer is the innermost layer of tissue followed by the connective tissue, the muscle layer, and the serous layer.

[0005] A problem with conventional gastrointestinal reduction systems is that the anchors (or clips) must at least engage the layer of muscle tissue to provide a proper foundation. In other words, the mucosa and connective tissue layers are typically not strong enough to sustain the tensile loads imposed by the normal movement of the stomach wall during ingestion and food processing. In particular, these layers tend to stretch elastically rather than firmly holding the anchors (or staples) in position and consequently the more rigid muscle and / or serous layer should ideally engage. This problem of capturing the muscular or serous layers becomes particularly acute when it is desired to place an anchor or other transesophageal apparatus rather than intraoperatively, since care must be taken when piercing the hard wall of the stomach so as not to inadvertently puncture the tissue or organs. adjacent.

[0006] A conventional procedure for attaching anchors within a body lumen to tissue is to use stitching devices to suture the stomach wall in folds. This procedure typically involves advancing a sewing instrument through the working channel of an endoscope and into the stomach and against the tissue of the stomach wall. The tissue in contact is typically aspirated into the sewing instrument where one or more sutures or tags are implanted to hold the tissue sucked in in a folded condition known as a plication. Another procedure is to manually create sutures to hold the plication.

[0007] One of the problems associated with this type of procedure is the time and number of intubations required to perform the various endoscopic procedures. Another problem is the time required to complete a plication from the surrounding tissue with the body lumen. In the period of time that a patient is anesthetized, procedures such as for the treatment of morbid obesity or for GERD (GastroEsophageal Reflux Disease) should be performed until completion. Therefore, placement and clamping of the tissue plication should ideally be relatively quick and performed with a minimal level of confidence.

[0008] Another problem with conventional procedures is ensuring that the staple, knotted suture, or clip is firmly held against the tissue and that the newly created plication does not relax under any slack that may be created by sliding staples, knots, or clips. Other conventional tissue fixation devices such as suture anchors, twist ties, snaps, etc. they are also often used to prevent sutures from slipping through tissue. However, many of these types of devices are typically large and unsuitable for low-profile delivery through the body, eg, transesophageally.

[0009] In addition, when grasping or clamping over or over tissue layers with conventional anchors, sutures, staples, clips, etc., these devices can be configured to be placed only after the tissue has been engaged and not during implantation. royal plication procedure.

[0010] EP1013229 A2 describes a device for repairing a soft tissue defect, particularly a defect in the meniscus of a knee, comprising an external wall anchor for engagement against an external wall of the meniscus on a first side of the defect, and a medial meniscus anchor that engages an inner surface of the meniscus on a second side of the defect.

Documents US2003167062 A1, WO9620647 A1, WO0030550 A1, US6475230 B1, US2002019649 A1, US5626590 A, US2003088250 A1, EP0755656 A2, US5507754 A and GB2337934 A describe other relevant background of the art.

BRIEF SUMMARY OF THE INVENTION

The invention is defined in attached independent claim 1. Preferred embodiments of the invention are described in the dependent claims.

[0013] To secure the plications that can be created within a body lumen of a patient, various procedures and devices can be implemented. Generally, any number of conventional procedures can be used to initially create the plication. One particular procedure may involve creating a plication through which a tissue anchor can be disposed within or through it. A distal tip of a tissue plication apparatus can grasp or grasp tissue and move the coupled tissue to a proximal position relative to the tip of the device, thus providing a substantially uniform plication of predetermined size. Examples of tools and procedures that are particularly suitable for supplying anchoring and holding devices can be viewed in more detail in U.S. Patent Application Serial No. 10 / 735,030 filed December 12, 2003 ( US Patent No. 8,574,243).

[0014] To secure these plications, various tissue anchors can be used to secure the plications in their configured folds. For example, a plication (or plications) can be secured by a length or lengths of suture that extend through the plication and between a distally placed tissue anchor located on a distal side of the plication and a proximally placed tissue anchor. located on a proximal side of the plication. Examples of anchors that can be used are described in US Patent Application Serial No. 10 / 612,170, filed July 1, 2003 (US Publication No. 2004-0122456).

[0015] Generally, when grasping a tissue plication, a proximally and / or distally located tissue anchor is preferably configured to slide along the connecting suture in a unidirectional manner. For example, if the proximal anchor is to slide along the suture, it is preferably configured to translate over the suture so that the tissue plication is clamped between the anchors. In this example, the proximal anchor is preferably configured to utilize a locking mechanism that allows free unidirectional translation of the suture through it while allowing the anchor to lock into the suture if the anchor is pulled, pushed, or pushed. otherwise in the opposite direction along the suture. This one-way anchor locking mechanism facilitates clamping of the tissue plication between the anchors and can be used on one or more of the anchors to secure a fold of tissue.

Furthermore, the types of anchors used for the fixation of tissue plications are not intended to be limiting. For example, many of the anchor clamping or locking mechanisms can be used, for example, with "T" type anchors, as well as reconfigurable "basket" type anchors, which generally comprise a number of configurable struts or legs that extend between at least two collars or support members. Other variations of these or other types of anchors are also contemplated for use in an anchor lock or clamp assembly.

[0017] For example, linear anchors can also be used, ie elongated anchors that are configured to fold or compress into an arcuate or expanded configuration. Such anchors can be configured in a variety of different configurations, such as tape or flattened wire, having one or more openings along its length through which a length of suture can be routed. Generally, a linear type anchor for placement against a tissue surface may comprise an elongated member having a proximal end, a distal end, and a length between these defining a plurality of holes, a length of suture to pass through at least one of the holes, and where the elongated member is adapted to reconfigure from a straightened configuration to an expanded anchoring configuration when the elongated member is longitudinally compressed. In using such a linear type anchor, a method of positioning the anchor against the tissue surface may generally comprise positioning an elongated member in a straightened configuration against the tissue surface, the elongated member has a proximal end, a distal end and a length between these, and compressing the elongated member longitudinally so that the elongated member reconfigures to an expanded anchoring configuration against the surface of the tissue.

Furthermore, a single type of anchor may be used exclusively in an anchor lock or clamp assembly; alternatively, a combination of different anchor types can be used, each using different anchor locking or clamping mechanisms in a single assembly. In addition, the different types of Clamping or locking mechanisms are not intended to be limited to any of the particular variations shown and described below, but may be used in any combination or variable types of anchors as possible.

[0019] The suture itself can be modified or altered to integrate features or protrusions along its length or a specific portion of its length. Such characteristics can be uniformly defined at regular intervals along the length of the suture or intermittently, depending on the desired locking or clamping effects. Furthermore, the suture can be made of metals such as Nitinol, stainless steels, titanium, etc., provided they are formed suitably thin and flexible. The use of metal sutures with anchoring mechanisms can lessen any chance of suture failure and can also provide a better suture capable of withstanding the acidic and basic environment of the gastrointestinal system. In addition, it can improve the imaging of the suture and anchor assembly if it is examined under imaging systems. Sutures that incorporate the use of features or protrusions along their length, as well as sutures made from metallic materials or any other type of conventional suture, can be used with any of the locking or clamping mechanisms described below. in various combinations, if desired.

[0020] A variation to utilize a locking mechanism that allows free unidirectional translation of the suture through the anchor may include blocks or members that are adapted to slide into or over an anchor to lock the suture. These blocks or members may include sharp edges that act to cut the suture depending on the direction the anchor is translated relative to the suture. Furthermore, these blocks can be deflected or biased to restrict movement of the suture using a variety of deflection elements, such as springs, etc. In addition to blocks, one or more locking tabs can also be used that are levered to allow unidirectional displacement of the suture through an anchor.

[0021] Aside from the use of mechanical locking features integrated within or with the anchor bodies, the locking mechanisms can also utilize a variety of knotting techniques. Conventional knots, which are typically tied by the practitioner either within the body or outside the body and advanced over the length of the suture, can be used to lock the anchor in place with respect to the tissue fold and the opposite anchor; however, self-locking knots that allow unidirectional displacement of an anchor body relative to the suture and tissue are desirable. Accordingly, many different types of self-locking knots can be advanced with the anchor over the suture so that translation along a distal direction is possible, but reverse translation of the anchor is inhibited.

[0022] Various anchor clamping or locking mechanisms that use friction as the primary source for locking can also be implemented. For example, the locking pins may be driven or pushed into a frictional interference fit with portions or areas of the suture against the anchor or portions of the anchor. The use of such pins can effectively wedge the suture and thus prevent further movement of the anchor along the length of the suture. In addition to pins, collars or locking pliers can also be used to hold or lock the suture.

[0023] In addition to friction-based clamping and locking mechanisms that can be used in tissue anchors, other mechanisms that create tortuous suture paths within or through the anchors can also be used to create unidirectional locking. A variation of fastening may utilize a pulley or pin contained within the anchor over which a portion of the suture can be displaced. The looped suture can then be routed proximally and secured with a slip knot. As tension is applied to the suture, the slip knot can prevent further movement of the anchor relative to the suture.

[0024] Another variation in the use of tortuous trajectories can comprise collars that are independent of or are integrally formed with the anchors. Such clamping collars can generally be formed into tubular structures having obstructions or interference elements arranged or formed within the lumen of the collar where the obstructions may, for example, be formed from portions of the clamping collar itself. These obstructions can be adapted to form upon release of a restraining force when the anchor must be locked in position. Alternatively, the interference or obstruction elements may comprise separate elements arranged within the lumen of the collar, such as one or more balls, spheres, etc. These obstructions or elements can be used to form a tortuous path through which the suture can be routed to lock the suture within.

[0025] In addition, locking collars that form tortuous trajectories can be adapted to reconfigure from a restricted delivery configuration to a deployed locking configuration when the anchor is to be clamped or locked in position relative to tissue and suture. The locking collars can be configured to take on various configurations, such as a proximally extending "S" type configuration, or other types.

[0026] Other clamping and locking mechanisms that utilize mechanical clamping or hooking can also be used to achieve locking of the suture within or through the anchors to facilitate unidirectional locking.

For example, a simple mechanical latch can be attached to the suture proximally of the anchor to prevent reverse movement of the anchor. The latch may be a simple tubular member or it may be integrally formed in a proximal portion of the anchor body itself.

[0027] In addition to the latching mechanisms described above, additional measures may optionally be implemented to facilitate clamping or locking of an anchor. Other measures can also be taken to inhibit any damage to the suture routed through an anchor. For example, to ensure that the integrity of the suture is maintained in the presence of metal basket anchors and to ensure that the suture does not undergo cuts or incisions, the portion of the suture that passes through the basket anchor may be enclosed. in a protective sleeve made, for example, of polypropylene, PTFE, etc.

[0028] Another measure that can be optionally implemented are clamping or locking mechanisms that take advantage of any cold flow effect of an engaged portion of suture by anchoring the tissue. For example, if a portion of the suture is wedged against the collar of an anchor or clamping member to lock the anchor, the collar portion may have multiple holes defined on its surface to allow portions of the attached suture to cold flow into the anchor. less partially into or through the holes to enhance blocking effects.

[0029] Alternatively, the collar may be formed with an electrically conductive inner sleeve surrounded by an outer sleeve capable of at least partially flowing when heated. The inner sleeve may have a number of holes defined on its surface so that when the outer sleeve is heated, either by inductive heating or any other method, the material from the outer sleeve can flow through the holes and come into contact with the suture that passes through these. This contact can also enhance the locking effects of the collar.

BRIEF DESCRIPTION OF THE DRAWINGS

[0030]

Figure 1A shows a side view of a variation of a tissue plication apparatus that can be used to create tissue plications and to deliver clamping or locking anchors in tissue.

Figures 1B and 1C show detailed perspective and side views, respectively, of the tissue handling assembly of the device of Figure 1A.

Figures 2A to 2D show an example of a tissue plication procedure for the delivery and placement of tissue anchors.

Figures 3A through 3G show detailed cross-sectional views of an anchor delivery assembly near a tissue plication and an example of delivery of tissue anchors on the distal and proximal sides of the plication. Figures 4A and 4B show side and end views, respectively, of an anchor variation illustrated in the form of a T-type anchor that uses locking blocks or members to hold and lock the suture. Figure 5 shows a side view of another clamp anchor variation utilizing locking blocks or members.

Figure 6 shows another side view of a clamp anchor variation utilizing locking blocks or members.

Figure 7 shows a perspective view of another variation of the locking anchor in which the anchor body defines an opening having a tapered or slotted portion.

Figures 8A and 8B show cross-sectional side and top views, respectively, of another locking anchor variation utilizing a through-hole opening or passage and one-way levers or pivots through which the suture can pass.

Figure 8C shows a cross-sectional side view of an anchor body in combination with a modified suture having features or integrated protrusions defined along its length.

Figures 9A and 9B show cross-sectional views of locking anchor variations having skewed locking members in combination with a knotted suture.

Figure 9C shows another modification of the suture that can be covered with a metal cover or slipped within a sleeve.

Figure 10 shows a cross-sectional side view of an anchor assembly that uses a choke-type loop to hold the anchors unidirectionally together.

Figure 11A shows a perspective view of another anchor assembly that uses a slip knot in the proximal anchor.

Figures 11B and 11C show top and cross-sectional side views, respectively, of an anchor that may optionally define grooves or channels extending at least partially therein to facilitate holding or engaging the sutures within the grooves.

Figures 12A through 12G show examples of anchor assemblies that utilize various slip knots and loop sections that provide unidirectional travel for anchors over sutures.

Figure 13A shows a cross-sectional side view of an anchor delivery system that delivers a basket-type anchor into or through a tissue plication.

Figure 13B shows a cross-sectional side view of multiple connectable tissue plications and basket anchors as being administrable through one or both tissue plications.

Figures 14A and 14B show cross-sectional side views of an anchor fastener assembly using a collar or collet that may be engaged in an anchor collar to fasten the suture.

Figures 15A and 15C show cross-sectional side views of another anchor fastener assembly using a pin to engage against a portion of the suture.

Figures 15B and 15D show end views of the assembly of Figures 15A and 15C, respectively. Figure 15E shows a perspective view of another clamping variation utilizing one or more sharp pins or blocks slidably disposed within a sharp channel defined in a proximal collar of the anchor.

Figure 15F shows a perspective view of the sharpened pins of Figure 15E.

Figures 15G and 15H show cross-sectional side views of an alternative clamp assembly having a retractable pin in an engaged and disengaged configuration, respectively.

Figures 16A and 16B show cross-sectional side views of another variation of a clamp assembly having a rotatable clamp collar.

Figures 17A and 17B show cross-sectional side views of another clamp assembly having a holding tube to provide a counterforce to stabilize the assembly during clamping or locking.

Figures 18A and 18B show cross-sectional side views of another clamp assembly having one or more biasing members or clamp tabs.

Figures 18C and 18D show views terminal and perspective views , respectively, of a suture release member which can be used with the assembly 18A and 18 ^b.

Figures 19A and 19B show cross-sectional side views of another variation of a clamp assembly utilizing a deformable clamp member positioned within the anchor and distally from the anchor collar.

Figure 20A shows a cross-sectional side view of another fastening assembly utilizing a rotatable fastening member configured to lock against the suture.

Figures 20B, 20C, and 20D show end and cross-sectional side views, respectively, of the rotating member positioned within the anchor collar.

Figures 20E and 20F show cross-sectional perspective and side views, respectively, of another clamp assembly having a rotatable clamp member positioned proximally of the anchor collar. Figures 21A and 21B show cross-sectional side views of another clamp assembly configured to hold or lock the suture with a sharp collar.

Figure 22A shows a cross-sectional side view of another fastening assembly that uses a looped suture and slip knot to secure the anchor over the suture.

Figures 22B and 22C show detailed cross-sectional and side views, respectively, of another fastener assembly that can be used with a suture portion wrapped or looped around a pin that allows unidirectional displacement of the anchor relative to the suture.

Figures 22D and 22E show side and detailed cross-sectional views, respectively, of another fastener assembly utilizing looped suture embedded within the anchor collar.

Figure 23 shows a cross-sectional side view of a clamp assembly variation that uses a number of pulleys to create the clamping effect.

Figure 24A shows a cross-sectional side view of another variation of the clamping assembly in which a clamping sleeve can be used to create a tortuous path for the suture.

Figures 24B and 24C show cross-sectional side views of another variation of the fastening assembly having a tubular structure, with and without retention arms, respectively, positioned within the anchoring collar through which the suture can pass unidirectionally.

Figure 24D shows a perspective view of a variation of the tubular structure of Figure 24C with retention arms.

Figures 25A and 25B show cross-sectional side views of another variation of the clamping assembly in which a clamping collar, which may be independent of the anchor or formed integrally with the anchor, respectively, can have a tortuous path formed within the collar.

Figure 25C shows a perspective view of the collar of Figure 25A in its unobstructed configuration with a restriction sleeve that can be positioned within the collar.

Figures 26A and 26B show cross-sectional side views of another variation of the clamping assembly using one or more rotary levers that allow unidirectional movement of the suture through them. Figures 26C and 26D show alternative end views of the assembly of Figure 26A in which the lever may be configured to prevent over-clamping to the suture.

Figures 26E through 26G show cross-sectional side views of alternative clamping assemblies in which the levers can be configured in various ways to create the tortuous path.

Figures 27A and 27B show side views of another variation of the clamp assembly in a supply profile and a reconfigured profile, respectively, using a self-forming latch.

Figures 28A and 28B show cross-sectional side views of another variation of the clamping assembly using two clamping collars or a single integral clamping collar, respectively.

Figure 28C shows a cross-sectional side view of the holding collar of Figure 28A in a configuration for holding the suture.

Figures 28D and 28E show perspective views of the clamping collar of Figure 28A in a supply profile and a reconfigured profile.

Figure 28F shows a cross-sectional side view of another variation for a clamping configuration of the clamping collar of Figure 28B.

Figures 28G and 28H show cross-sectional side views of another variation of the clamp assembly in a delivery profile and a reconfigured profile, respectively, in which an elongated clamping member can be reconfigured to create a tortuous path for the suture.

Figures 29A and 29B show cross-sectional side views of another variation of the clamping assembly using a mechanical latch.

Figures 30A and 30B show cross-sectional side views of another variation of the clamp assembly in which a mechanical latch can be used on the proximal collar of the anchor body.

Figure 31A shows a cross-sectional side view of a variation of a tool assembly that can be adapted to apply a mechanical engagement force on a engagement collar.

Figures 31B to 31D show side, end, and perspective views, respectively, of a variation on a latch collar that can be used as a separate latch sleeve or as part of the anchor collar.

Figures 32A and 32B show cross-sectional side and perspective views, respectively, of an alternative latch tool.

Figures 33A and 33B show perspective and end views, respectively, of a representative basket anchor having a protective sleeve overlying the suture disposed within the anchor.

Figures 34A and 34B show perspective and side cross-sectional views, respectively, of a clamp collar defining a plurality of holes through the collar surface to enhance suture locking effects.

Figure 35A shows a cross-sectional side view of a variation of the clamp assembly that may use inductive heating to partially melt a portion of an outer sleeve in contact with the suture to enhance the locking effects of the anchor.

Figures 35B and 35C show the assembly in perspective and exploded views, respectively, of an electrically conductive inner sleeve contained within the outer sleeve.

Figures 35D and 35E show perspective views of alternative internal sleeves that can be used with the assembly of Figure 35A.

Figures 36A and 36B show perspective views of variations of linear anchors generally comprising elongated tape or flattened wire and defining one or more openings along their lengths. Figures 37A and 37B show the tape anchors of Figures 36A and 36B, respectively, with lengths of suture routed through the openings.

Figure 38 shows another variation of a tape anchor having alternate portions of the tape material between the slotted or removed openings.

Figure 39 shows another variation of a tape anchor defining corrugations such that an "S" type tape pattern is formed.

Figure 40A shows the tape anchor of Figure 36A with biasing springs positioned along portions of the tape anchor with suture routed through it.

Figure 40B shows another variation of the tape anchor of Figure 40A that has skewed tape elements instead of springs.

Figure 40C shows the tape anchor of Figure 40A in a partially collapsed configuration.

Figure 40D shows the tape anchor of Figure 40B in a partially collapsed configuration.

Figure 41 shows an alternative variation of the tape anchor comprising a tubular member.

Figure 42 shows a perspective view of another alternative variation of the tape anchor comprising a tubular member having a partial cutout along its length.

Figure 43 shows a perspective view of yet another alternative variation of the tape anchor having multiple cutouts along its length.

Figure 44 shows a perspective view of yet another alternative having multiple individual lengths of elements enclosed (or at least partially enclosed) in a liner or cover.

Figure 45 shows a perspective view of yet another alternative having one or more covered or coated wire lengths.

Figure 46 shows another variation in which a length of the tape anchor can have a non-uniform thickness. Figures 47A and 47B show still other variations in which a length of wire having eyelets or defining loops can be used to fold or flatten into an expanded pattern.

Figure 48 shows another variation in which a wire or ribbon may be comprised of a shape memory alloy that is configured to form a tangled portion of the wire when unstressed. Figures 49A and 49B show partial cross-sectional views of tape anchors in a flattened linear configuration that is compressed in a collapsed and expanded configuration, respectively, against a tissue fold.

Figures 50A through 50F show top views of various arcuate or expanded configurations of a tape anchor.

Figures 51A and 51B are side views, partially in section, of a clamp assembly comprising an interference element.

Figures 52A-52C are, respectively, an isometric view, an isometric sectional view and a side sectional view of the clamp assembly of Figures 51.

Figures 53A-53D are side views, partially in section, of variations of the clamping assembly of Figures 51 and 52.

DETAILED DESCRIPTION OF THE INVENTION

[0031] In order to first create the plication within a body lumen of a patient, various procedures and devices can be implemented. Anchoring and fixation devices can be administered and placed through an endoscopic device that engages a tissue wall of the gastrointestinal lumen, creates one or more tissue folds, and disposes one or more of the anchors through the fold or folds. of tissue. The tissue anchor (s) can be placed through the muscular and / or serous layers of the gastrointestinal lumen.

[0032] Generally, when creating a plication through which a tissue anchor can be disposed within or through, a distal tip of a tissue plication apparatus can engage or grasp the tissue and move the grasped tissue to a proximal position. relative to the tip of the device, thus providing a substantially uniform plication of predetermined size.

The formation of a tissue fold can be achieved using at least two tissue contact areas that are separated by a linear or curvilinear distance, where the separation distance between the tissue contact points affects the length and / or depth of the fold. . In operation, a tissue clamp assembly engages or grips the tissue wall in its normal (ie, unfolded and substantially flat) state, thus providing a first tissue contact area. The first tissue contact area is then moved proximal to a second tissue contact area to form the tissue fold. The tissue anchor assembly can then extend through the tissue fold in the second tissue contact area. Optionally, a third tissue contact point can be established so that, after formation of the tissue fold, the second and third tissue contact areas are disposed on opposite sides of the tissue fold, thus providing stabilization of the posterior during extension of the anchor assembly through the tissue fold from the second tissue contact area.

The first tissue contact area can be used to engage and then stretch or rotate the tissue wall over the second tissue contact area to form the tissue fold. The tissue fold can then be articulated to a position where a portion of the tissue fold covers the second tissue contact area in an orientation that is substantially normal for the tissue fold. A tissue anchor can then be delivered through the tissue fold at or near the second tissue contact area. One particular apparatus that is particularly suitable for supplying the anchoring and clamping devices described in this invention can be seen in more detail in US Patent Application Serial No. 10 / 735,030 filed December 12, 2003 and entitled "Apparatus And Methods Forming And Securing Gastrointestinal Tissue Folds" (US Patent No. 8,574,243).

[0035] An illustrative side view of a tissue plication assembly 10 that can be used with the tissue anchors described in this invention is shown in Figure 1A. The plication assembly 10 generally comprises a catheter or tubular body 12 that may be configured to be flexible enough for advancement into a body lumen, eg, transoral, percutaneous, laparoscopic, etc. The tubular body 12 can be configured to be twisted through various procedures, for example, using a braided tubular construction, so that when the handle 16 is manipulated and rotated by a professional from outside the body, the torsional force is transmitted along the body 12 so that the distal end of the body 12 is rotated in a corresponding manner.

[0036] Tissue manipulation assembly 14 is located at the distal end of tubular body 12 and is generally used to contact and form the tissue plication, as mentioned above. The Figure 1B shows an illustrative detailed side view of the tissue handling assembly 14 showing the launch tube 18 extending from the distal end of the body 12 and between the arms of the upper extension member or strap 20. The launch tube 18 may define the launch tube opening 24 and may be rotatably connected near or at its distal end by hinge or pivot 22 to the distal end of the upper strap 20. The extension member or lower strap 26 may similarly extend from the end distal of the body 12 in a longitudinal direction substantially parallel to the upper strap 20. The upper strap 20 and the lower strap 26 need not be completely parallel as long as an open space between the upper strap 20 and the lower strap 26 is large enough to to accommodate the removal of multiple layers of tissue between the two limbs.

The upper strap 20 is shown in the Figure as an open loop member and the lower strap 26 is shown as a solid member; however, this is intended to be illustrative only and either or both members can be configured as looped or solid members. Tissue acquisition member 28 may be an elongated member, for example, a wire, hypotube, etc., terminating in a tissue holder 30, in this example a helically shaped member, configured to be reversibly rotatable to advance toward tissue for the purpose of grasping or acquiring a region of tissue to form a plication. Tissue acquisition member 28 may extend distally from handle 16 through body 12 and distally between upper strap 20 and lower strap 26. Acquisition member 28 may also be translatable and rotatable within body 12 so that the tissue fastener 30 is capable of longitudinal translation between the upper strap 20 and the lower strap 26. To support the longitudinal and rotational movement of the acquisition member 28, an optional guide or carriage 32 can be connected to the upper strap 20 or lower 26 to slide freely on it. Guide 32 can also be slidably connected to acquisition member 28 so that longitudinal movement of acquisition member 28 is supported by guide 32.

[0038] An example of a tissue plication procedure is seen in Figures 2A to 2D for administering and placing a tissue anchor and is described in more detail in US Patent Application Serial No. 10 / 735,030 filed December 12, 2003 (US Patent No. 8,574,243). The tissue manipulation assembly 14, as seen in Figure 2A, can be advanced into a body lumen such as the stomach and positioned adjacent a region of tissue wall 40 to receive plication. During advancement, launch tube 18 may be configured in a delivery profile such that tube 18 is disposed within or between the arms of upper strap 20 to present a relatively small profile.

[0039] Once tissue manipulation assembly 14 has been desirably positioned relative to tissue wall 40, tissue acquisition member 30 can be advanced distally so that tissue acquisition member 30 enters into contact with tissue wall 40 at the acquisition location or point 42. As the acquisition member 30 is distally advanced with respect to the body 12, the guide 32, if used, can slide distally along with the member 30 to help stabilize the bra. If a helical-shaped acquisition member 30 is used, as illustrated in Figure 2B, it can be rotated from its proximal end on handle 16 and advanced distally until tissue at point 42 has been firmly engaged by the attachment member. acquisition 30. This may require advancement of the acquisition member 30 through the mucosal layer and at least into or through the underlying muscle layer and preferably into or through the serous layer.

[0040] The grasped tissue can then be drawn proximally between the upper 20 and lower 26 straps through the acquisition member 30 so that the acquired tissue is drawn into a tissue fold 44, as seen in Figure 2C. As the acquisition member 30 is withdrawn proximally from the body 12, the guide 32 may also slide proximally to help stabilize the device, especially when the tissue fold 44 is removed.

[0041] Once tissue fold 44 has been formed, launch tube 18 can be advanced from its proximal end into handle 16 so that a portion 46 of launch tube 18, extending distally from body 12 , is forced to rotate on the hinge or pivot 22 and reconfigure itself, said portion 46 assumes a curved or arcuate shape that positions the launch tube opening 24 perpendicular to a longitudinal axis of the body 12 and / or the strap members 20, 26. The launch tube 18, or at least the portion 46 of the launch tube 18, is preferably manufactured from a highly flexible material or can be manufactured, for example, from pipe material Nitinol that is adapted to flex, for example through circumferential grooves, to allow flexing. Alternatively, assembly 14 can be configured so that launch tube 18 is reconfigured simultaneously with proximal removal of acquisition member 30 and acquired tissue 44.

[0042] As discussed above, the tissue wall of a body lumen, such as the stomach, typically comprises an inner mucosal layer, connective tissue, the muscle layer, and the serous layer. To obtain a lasting purchase, for example, when performing a stomach reduction procedure, the clips or anchors used to achieve reduction of the body lumen are preferably attached at least through or in the layer of muscle tissue, and more preferably, the serous layer. Advantageously, the stretching of the tissue fold 44 between The girth members 20, 26 allow an anchor to be expelled through the muscular and serous layers, thus allowing the durable approximation of gastrointestinal tissue.

[0043] As shown in Figure 2D, once the launch tube opening 24 has been conveniently positioned relative to the tissue fold 44, the needle assembly 48 can be advanced through the launch tube 18 by manipulation from the its proximal end on handle 16 to preferably pierce through a dual serous layer through tissue fold 44. Needle assembly 48 is preferably a hollow tubular needle through which one or more tissue and ejecting them to secure tissue fold 44, as further described below.

[0044] Because needle assembly 48 penetrates the tissue wall twice, it exits into the body lumen, thus reducing the potential for injury to surrounding organs. Shown in Figure 3A is a detailed cross-sectional view of anchor delivery assembly 50 near tissue fold F. In this example, tissue fold F may comprise a tissue plication created using apparatus 10 described in this invention. or any other tool configured to create said tissue plication. The tissue fold F can be disposed within a gastrointestinal lumen, such as the stomach, where the tissue wall W can define the outer or serous layer of the stomach. The anchor supply assembly may generally comprise launch tube 18 and needle assembly 48 slidably disposed within the lumen of launch tube 52. Needle assembly 48 generally comprises needle 54, which is preferably a hollow needle. having a sharp or pointed distal end 66 to facilitate movement towards and / or through tissue. Other parts of the assembly, such as the upper and lower strap members 20, 26, respectively, and the tissue acquisition member 28 have been omitted from these Figures for clarity only.

[0045] Once the launch tube 18 has been conveniently positioned relative to the fold of tissue F, the needle 54 can be pressed or pushed into or through the fold of tissue F through a needle push rod or member. 56 from its proximal end preferably located within handle 16. Needle 54 may define needle lumen 58 within which distal anchor 62 and / or proximal anchor 64 may be located during deployment and positioning of the assembly. A single suture or flexible element 70 (or multiple suture elements) can connect proximal anchor 64 and distal anchor 62 to each other. For example, element 70 can comprise various materials such as monofilament, multifilament, or any other conventional suture material, elastic or elastomeric materials, eg, rubber, etc.

Alternatively, metals that are biocompatible can also be used for suture materials. For example, sutures can be made of metals such as Nitinol, stainless steels, Titanium, etc., provided they are formed adequately thin and flexible. The use of metal sutures with the anchoring mechanisms described in this invention can additionally provide several benefits. For example, the use of metallic suture material can decrease any chance of suture failure due to inadvertent cutting or shearing of the suture, can provide a better suture capable of withstanding the acidic and basic environment of the gastrointestinal system, and can also improve the imaging of the suture and anchor assembly if examined under conventional imaging systems such as X-rays, fluoroscopes, MRI, etc. As used in this invention, suture 70 can encompass any of these materials or any other suitable material that is also biocompatible.

[0047] Needle 54 may optionally define needle slot 60 along its length to allow suture 70 to pass freely in and out of needle 54 when distal anchor 62 is expelled from the lumen of needle 58. Alternatively, instead of using the needle slot 60, the needle 54 may define a solid structure with the suture 70 that is passed into the needle lumen 58 through the distal opening of the needle 54.

[0048] The proximal end of suture 70 may slide through proximal anchor 64 to terminate in suture loop 74 through tie-down knot 72. Suture loop 74 may be omitted and the proximal end of suture 70 may terminate proximally of apparatus 10 within control handle 16, proximally of control handle 16, or at some point distally of control handle 16. In this variation, a suture loop 74 may be provided to allow a tool to grip or latch temporarily hold suture loop 74 to facilitate clamping of proximal 64 and distal 62 anchors together to retain a tissue fold configuration F, as described in more detail below. Tether knot 72 may also comprise a slidable knot that can be slid distally along suture 70 to lock or hold against proximal anchor 64 once tissue fold F and anchors 62, 64 have been positioned and suitably tensioned, as also described in more detail below.

[0049] After needle assembly 48 has been pushed distally outward through launch tube opening 24 and penetrated into and / or through tissue fold F, as shown in Figure 3B, the pusher or anchor member 68 may also be actuated through its proximal end to eject distal anchor 62, as shown in Figure 3C. Once the distal anchor 62 has been distally ejected from the fold of tissue F, Figure 3D shows how the needle 54 can be retracted back through the fold of tissue F by retracting the needle 54 into the lumen of the launch tube 52 or by withdrawing the whole supply set of anchor 50 proximally relative to tissue fold F.

[0050] Figure 3E shows that once needle 54 has been retracted, proximal anchor 64 can then be ejected from launch tube 18 on a proximal side of tissue fold F. With both anchors 62, 64 arranged externally of the launch tube 18 and the suture 70 connecting the two, proximal anchor 64 can be held against the distal end of launch tube 18 and urged into contact against tissue fold F, as shown in Figures 3F and 3G, respectively . As proximal anchor 64 is urged against fold of tissue F, proximal anchor 64 or a suture portion 70 may be configured to provide any number of directionally translatable locking mechanisms that provide movement of an anchor along the length of the anchor. suture 70 in a first direction and preferably blocks, inhibits, or prevents reverse movement of the anchor backward along suture 70. In other alternatives, the anchors may simply be delivered through several elongated hollow tubular members, for example, a catheter, trocars, etc.

With respect to the anchor assemblies described in this invention, the types of anchors shown and described are intended to be illustrative and are not limited to the variations shown. For example, several of the tissue anchor variations are shown as "T" type anchors, while other variations are shown as reconfigurable "basket" type anchors, which generally may comprise a number of configurable struts or legs that extend between at least two collars or support members. Other variations of these or other types of anchors are also contemplated for use in an anchor assembly. Examples of anchors that may be used are described in co-pending US Patent Application Serial No. 10 / 612,170, filed July 1, 2003 (US Publication No. 2004-0122456). Furthermore, only one type of anchor can be used exclusively in one anchor assembly; alternatively, a combination of different types of anchors can be used in one anchor assembly. Furthermore, the different types of clamping or locking mechanisms are not intended to be limited to any of the particular variations shown and described, but may be used in any of the combinations or varying types of anchors as possible.

[0052] To achieve secure placement of anchors having unidirectional anchoring motion over the suture in a self-locking manner, various devices and procedures can be used. Figures 4A and 4B show side and end views, respectively, of an anchor variation 80 that is illustrated in the form of a T-type anchor. Although a T-type anchor is shown, the procedures and devices used to secure the anchor are they can be used in other types of anchors, which will be described below. Variation 80 may generally comprise an anchor body 82 having a circular, rectangular, square, etc. cross-section defining openings 84 and 86 on opposite sides of anchor 80. Locking member or block 88 may be slidably disposed inside anchor body 82 and define a sharp face 90 on the side of block 88 that tapers to at least one of the apertures, in this case aperture 86. The apertures 84, 86 preferably align with each other, although this does not necessary.

[0053] Suture 94 can be routed through aperture 84, around locking block 88, and back through aperture 86 so that when anchor body 82 is translated in the direction of arrow 96, the anchor body 82 can slide freely over suture 94 due to the way sharp face 90 contacts suture 84 within aperture 84. However, if anchor body 82 was translated in the opposite direction, tension within suture 94 may pull locking block 88 through suture 94 positioned on contact surface 92 so that when block 88 is translated in the direction of arrow 98, suture 94 into the opening 86 is forced into slot 100 defined along the leading edge of block 88, as shown in Figure 4B. This cleavage action can effectively inhibit or prevent any further movement of anchor body 82 over suture 94. Accordingly, anchor body 82 can move unidirectionally relative to suture 94 and a distally located anchor to effectively clamp tissue between these.

[0054] Figure 5 illustrates another tether anchor in side view of anchor variation 110. In this variation, anchor body 112 similarly defines openings 114 and 116 through which the suture can be routed 96. Lock block or member 118, which may similarly also define sharp face 120, may be slidably disposed within anchor body 112. Lock block 118 may be driven through a biasing member, by For example, spring 122, to maintain a biasing force against suture 94 passing through anchor body 112. As anchor body 112 is translated over suture 94 in the direction of arrow 96, the face Sharp 120 may allow suture 94 to pass freely between openings 114, 116. However, should anchor body 112 move in the opposite direction, biasing member 122 may force locking block 118 to exert a force. za on its leading edge against suture 94, thus preventing its movement and allowing only unidirectional movement.

[0055] Still another variation of locking anchor 130 is shown in the side view in Figure 6. In this variation, anchor body 132 also defines openings 134,136 through which suture 94 can pass. anchor 132, multiple locking blocks or members 138,140 may be configured to deflect in opposite directions through deflection members or springs 142, 144, respectively. Each of the locking blocks 138, 140 can define an opening through which the suture 94 can pass. therefore, when the anchor body 132 is slowly moved over the suture 94 in a first direction, the anchor can freely translate. However, when rapidly moving in the opposite direction, the deflection members 142, 144 can drive their respective lock blocks 138, 140 in directions 146, 148 to create a tortuous path through the blocks and inhibit or impede reverse movement of anchor body 132 relative to suture 94.

[0056] Figure 7 shows a perspective view of another variation of locking anchor 150 in which anchor body 152 defines an opening 154 having a tapered or slotted portion 156. Opening 154 may be sized to allow suture 94 passes through aperture 154 so anchor body 152 can freely translate relative to suture 94. Once anchor body 152 has been conveniently positioned relative to the opposite tissue fold or anchor , suture 94 can be manipulated to slide into tapered or slotted portion 156, which preferably defines a diameter that is less than the diameter of suture 94. Sliding suture 94 into tapered or slotted portion 156 can lock a position of the body of anchoring 152 relative to suture 94 due to the cleavage effect of slotted portion 156 in suture 94.

Figures 8A and 8B show cross-sectional side and top views, respectively, of another variation of locking anchor 160 in which anchor body 162 may define a through-hole passage or opening 164 through which it may passing suture 94. Anchor body 162 may have one or more levered, finned, or offset locking members 166 that may be integrally formed with anchor body 162. These locking members 166 may be formed radially around opening 164 of so that when suture 94 is absent, the resting configuration of locking members 166 defines an opening 164 that is smaller in diameter than suture 94 passing through. Locking members 166 can be biased to project in only one direction, as shown in Figure 8A, so that when anchor body 162 moves in a first direction over suture 94, anchor 162 passes freely. However, when the anchor body 162 is moved in the opposite direction over the suture 94, the locking members 166 engage the suture 94 and prevent any reverse displacement, thus allowing unidirectional movement and locking of the anchor body 162 Although five locking members 166 are shown, any number of members can be used as possible and as desired to effect a desired degree of locking.

[0058] Figure 8C shows a cross-sectional side view of the anchor body 162 in combination with a modified suture 168 having features or integrated protrusions 170 defined along its length. The features or protrusions 170 may be uniformly defined at regular intervals along the length of the suture 168 or intermittently, depending on the desired effects, to enhance the locking ability of the anchor body in the suture. In addition, the features or protrusions 170 may be integrally formed protrusions or may simply comprise knotted sections of suture. Sutures that are modified or knotted can optionally be used in any of the locking anchor variations as described in this invention in place of conventional sutures, depending on the desired degree of locking and locking effects.

As shown in the cross-sectional views of Figures 9A and 9B of the locking anchor variations 180 and 188, respectively, the anchor body 182 may also comprise biased locking members 184, contained within the anchor body. anchor 182. The number and configuration of locking members 184 can vary as desired and can optionally be opposite, as shown in Figure 9A, or use a single member 184, as shown in anchor variation 188 in Figure 9B. The Figures show knotted suture 186 used with anchor variation 180; however, conventional sutures can also be used.

[0060] Figure 9C shows another modification of suture 94 that can be used with any of the anchor lock variations shown in this invention. The suture portions 94 that come into contact with the anchor lock mechanisms can be coated with a material that has a relatively higher coefficient of friction, that is, a coefficient of friction that is higher than the underlying suture material. For example, the suture portion 94 can be covered with a metal cover or slipped into the sleeve 181, which can be made of a metallic material such as titanium, nitinol, stainless steel, etc. to improve the locking force between suture 94 and the anchor. As shown in the Figure, if the sleeve 181 is used, the ends 183, 185 of the sleeve 181 can be hooked into the suture 94. One or more openings 187 can also be defined along the sleeve 181 to further enhance the capability. between the suture 94 and the locking mechanism.

[0061] Aside from the use of mechanical locking features integrated within or with the anchor bodies, the locking mechanisms can also utilize a variety of knotting techniques. Conventional knots, which are typically tied by the practitioner either within the body or outside the body and advanced over the length of the suture, can be used to lock the anchor in place with respect to the tissue fold and the opposite anchor; however, self-locking knots that allow unidirectional displacement of an anchor body relative to the suture and tissue are desirable.

[0062] Figure 10 shows the locking anchor assembly 190 with distal anchor 192, which can be positioned distally of a tissue fold, and proximal anchor 194, which can be positioned proximally of a tissue fold or folds. In this variation, suture 94 can be routed through proximal anchor 194 through apertures 196, 198 and extended to distal anchor 192. At distal anchor 192, suture 94 can be routed through aperture 200 and over the pin 202 positioned within distal anchor 192. Pin 202 can function as a pulley over which suture 94 can be displaced during anchor lock adjustments. Suture 94 can then be routed to proximal anchor 194 through aperture 204 and define loop 206 through which proximal suture portion 94 passes to thereby create a choke-type loop. The terminal end of the suture 94 can then be anchored to the fixed end 208 within the body of the proximal anchor 194.

[0063] In operation, when tension is applied to suture 94 or when proximal anchor 94 is advanced distally, proximal anchor 194 and distal anchor 192 can be freely drawn towards each other to secure any tissue creases (not shown). for clarity) arranged between them. However, if proximal anchor 194 were pulled or driven in the opposite direction away from tissue or distal anchor 192, loop 206 would "choke" suture 94 and prevent any reverse movement of proximal anchor 194.

[0064] Figure 11A shows a perspective view of the locking anchor assembly 210 having distal anchor 212 and proximal anchor 214 with suture 94 extending between the two anchors. Terminal end 230 of suture 94 may be knotted or otherwise retained by proximal anchor 214 and routed through aperture 216 and back through aperture 218 to create a looped portion 228, both apertures 216 being defined, 218 into proximal anchor 214. Suture 94 can be routed from opening 218 and through distal anchor 212 through openings 222, 224. Suture 94 can then be routed back to proximal anchor 214 through opening 220 and wrapping 226 around looped portion 228 to continue proximally. This knotted configuration facilitates advancement of proximal anchor 214 toward distal anchor 212, but constricts suture 94 when proximal anchor 214 is moved in an opposite direction.

Figures 11B and 11C show top and cross-sectional side views of an alternate variation on proximal anchor 214 (and distal anchor 212, if desired). As shown, anchor 214 may optionally define grooves or channels 232 that extend at least partially between openings 216, 218, and 220. These grooves or channels 232, as seen in Figure 11C, can be sized such that any of overlapping suture 94 is clamped or engaged in slots 232 to facilitate the clamping action of anchor 214 relative to suture 94.

Another locking anchor assembly 240 is shown in the perspective view of Figure 12A, showing distal anchor 242 and proximal anchor 244 with suture 94 extending between the two anchors. Suture 94 can be routed through opening 246 defined through proximal anchor 244 and passed through distal anchor 242 through openings 250, 252. Suture 94 can then be routed back to proximal anchor 244 and pass through opening 248 to create at least two adjacent loops (half hitch knots) 254, 256 with looped section 258. During clamping of proximal anchor 244 against tissue, the knotted suture may slide distally with the proximal anchor 244. Once proximal anchor 244 has been conveniently positioned along suture 94, the terminal end of suture 94 can be pulled, as shown by arrow 260, to alter the knot configuration, commonly referred to as shifting. of the appearance of the knot so that the knot locks into suture 94 and prevents any reverse movement of proximal anchor 244.

[0067] Figure 12B also shows a perspective view of another locking anchor variation similar to that shown in Figure 12A. In this variation, the suture 94 may be wrapped in two interlocking loops 264, 266 and further rewrapped in adjacent interlocking loops 262, 268. Distal advancement of the knotted configuration in conjunction with the proximal anchor 244 can be accomplished until the terminal end of the Suture 94 is placed under tension, as shown by arrow 260. Tension can be applied once proximal anchor 244 has been conveniently placed along suture 94 to lock the knot in position and prevent any reverse movement of proximal anchor 244 along suture 94.

[0068] Figure 12C shows a perspective view of another anchor lock assembly similar to the previous variations. The knot can be modified by wrapping suture 94 in a first set of several loops, shown as three loops 270, 272, 274, although in other variations, any number of loops can be used depending on the desired locking effects. Suture 94 may then be wrapped in a second set of several additional loops in a proximally adjacent position around suture 94, shown as loops 278, 280, 282 joined by looped section 276. Similarly, any number of loops in the second set can be used regardless of the number of loops in the first set or to mirror the first set of loops. In either situation, once the suture terminal end 284 is tightened, a knotted configuration is formed, as shown in Figure 12D, that can slide freely along the suture 94 as long as the knotted configuration itself is pushing along suture 94, for example, through a pusher tube, knot pusher, etc. However, once tension is applied along suture 94 by proximal anchor 244 pushing against the knot and by the tension created in the suture extending between anchors 242, 244, the knot locks against suture 94 and prevents reverse movement of proximal anchor 244 along suture 94.

[0069] Figure 12E shows a perspective view of another locking anchor variation similar to the variation shown in Figure 12D but having a single suture path between anchors 242, 244. In this variation, suture 94 can have terminal end 286 anchored or retained by distal anchor 242 in opening 252 and have a single suture path to proximal anchor 244. A second terminal end 288 may also be anchored or retained by proximal anchor 244 in opening 246. Suture portions 94 that extend between proximal anchor 244 and the knot may have a biasing member, for example spring 290, disposed over one or both lengths of suture to keep proximal anchor 244 and knot under constant force to ensure that the knot is held under a locking force to prevent reverse displacement of the proximal anchor 244.

[0070] Still another variation of a locking anchor variation having a single suture traversing the anchors is shown in the perspective view of Figure 12F. A terminal end 252 of suture 94 can be anchored or retained in distal anchor 242 and routed to proximal anchor 214 through opening 218. The length of suture 94 can form a loop 292 on a first side of proximal anchor 214 and a second loop 296 on the opposite side of proximal anchor 214 between openings 216, 220. Suture 94 can then be wrapped around loop 292 by loop 294 on the first side to form an interlocking suture loop. This variation is also effective in allowing proximal anchor 214 to translate over suture 94 toward tissue and distal anchor 242, but prevents reverse movement of proximal anchor 214 due to pinching action by interlocking suture loops in the Proximal Side of Proximal Anchor 214.

[0071] Figure 12G shows a perspective view of another locking anchor variation similar to that shown in Figure 12F. Here, suture 94 can be routed through aperture 220 in proximal anchor 214 to form loop 292 prior to passing through apertures 218 and 216 and entanglement loop 294 through loop 292. Similarly, this variation is also effective in allowing proximal anchor 214 to translate over suture 94 toward tissue and distal anchor 242, but prevents reverse movement of proximal anchor 214.

[0072] As mentioned above, the locking and clamping mechanisms described in this invention can be used with a variety of different anchor types. For example, the fastening mechanisms described above can be used not only with T-type anchors, but also with reconfigurable basket-type anchors. In the following, basket-type anchors configured for implantation or placement against tissue in a manner similar to that described above and examples of how clamping mechanisms can be used to secure tissue plications are described. In addition, additional clamping mechanisms that can preferably be used with basket-type anchors are also described below.

[0073] When basket-type anchors are attached or locked, the baskets can be delivered into or through the fabric in the same or similar manner as described above, particularly as shown in Figures 3A-3G. For example, Figure 13A shows anchor delivery system 300 near tissue fold F. Again, tissue fold F can be disposed within a gastrointestinal lumen, such as the stomach, where tissue wall W can define the outer or serous layer of the stomach. The delivery push tube or catheter 302 may be disposed within the delivery tube 18 proximally of the basket anchor 306, which is shown in a compressed delivery configuration with a relatively low profile when disposed within the needle lumen 58 of the needle. 54. A single basket anchor 306 is shown disposed within needle 54 for illustrative purposes only and is not intended to be limited by the number of basket anchors; rather, any number of basket anchors can be disposed within needle lumen 58 as possible depending on the desired procedure and anchoring results.

[0074] Suture 94 may be routed through or externally of the lumen of push tube 304 and further routed into and / or through proximal collar 310 of anchor 306. The terminal end of suture 94 may be routed into anchor 306 and secured to distal collar 308 in a variation. Alternatively, suture 94 may be attached or anchored within anchor 306 or proximal collar 310 depending on the effect desired and the procedure being performed. In addition, if multiple anchors are used in a tissue plication procedure, suture 94 can be routed through anchor 306 so that anchor 306 can slide freely along or over suture 94.

Basket anchors can comprise various configurations suitable for implantation within a body lumen. Basket anchors are preferably reconfigurable from a low-profile delivery configuration to a radially expanded deployment configuration in which a number of struts, arms, or mesh elements can be radially extended once released from launch tube 18 or the needle 54. Materials that have shape memory or superelastic characteristics or that are skewed to reconfigure when not forced are preferably used, for example, spring stainless steels, Ni-Ti alloys such as Nitinol, etc. Basket anchor 306 is illustrated as having a number of struts reconfigurable or arm members 312 that extend between distal collar 306 and proximal collar 310; however, this is only intended to be illustrative and suitable basket anchors are not intended to be limited to baskets that only have struts or arms. Examples of suitable anchors are further described in detail in US Patent Application Serial No. 10 / 612,170 (US Publication No. 2004-0122456).

[0076] Figure 13A shows basket anchor 306 delivered through tissue fold F through needle 54 and launch tube 18. As mentioned above, the other parts of the plication assembly, such as the members upper and lower girdle 20, 26, respectively, and tissue acquisition member 28 have been omitted from these Figures for clarity only.

[0077] Figure 13B shows a variation where a single fold F can be attached using the basket anchor 306 '. As seen, the basket anchor 306 'has been driven or ejected from the needle 54 and is shown in its radially expanded profile for placement against the surface of the tissue. In such a case, a terminal end of suture 94 may be anchored within the distal collar of anchor 306 'and routed through tissue fold F and through, or at least partially through, proximal anchor 318, where suture 94 may be secured or proximally locked to, within, or to the proximal anchor 318 through any number of fastening mechanisms 316 described in this invention. The proximal anchor 318 is also shown in a radially expanded profile that contacts the fold of tissue F along the tissue contact region 314. Locking or clamping the suture 94 proximally of the proximal anchor 318 allows adequate clamping of the tissue fold F.

[0078] If additional tissue folds are folded to hold them, the distal basket anchor 306 may be distally disposed of at least one additional tissue fold F ', as shown in Figure 13B, while the proximal anchor 318 may be disposed proximally of tissue fold F. As noted above, suture 94 can be similarly attached within distal anchor 306 and routed through proximal anchor 318, where suture 94 can be attached or locked through proximal anchor 318, as required. necessary. If the tissue folds F and F 'are to be positioned opposite each other, the distal basket anchor 306 and the proximal anchor 318 can be approximated to each other. As described above, proximal anchor 318 is preferably configured to allow suture 94 to pass freely through it during approach of the anchor. However, proximal anchor 318 is also preferably configured to prevent or inhibit reverse translation of suture 94 through proximal anchor 318 by allowing unidirectional displacement of anchor 318 over suture 94. This clamping feature thus allows automated locking of the anchors 306, 318 to each other during the approach of the anchor.

[0079] In addition to anchor locking or clamping mechanisms that utilize knotted and looped sutures to facilitate unidirectional locking, various mechanisms that utilize friction can also be implemented. Figures 14A and 14B show cross-sectional side views of a variation on clamp assembly 320. Proximal collar 322, proximal portions of struts 312, and distal portions of launch tube 18, and other features of the assembly and pleat are shown. of tissue F have been omitted from the Figure for clarity only.

[0080] A clamping or locking collar or clip 326 may be positioned within launch tube 18 proximally of anchoring collar 322. Clamping clamp 326 may comprise a cylindrical-shaped member defining a lumen therethrough for passage of the suture 94. A distal end of the clamp 326 may have at least one and preferably several clamping arms or teeth 328 that are configured to be clamped or clamped as the suture 94 passes. The proximal anchor collar 322 may be sized to correspondingly receiving collet 326 therein to create an interference fit with respect to an outer diameter of collet 326. A distal portion of anchor collar 322 may also define a tapered or angled portion 324 such that When the chuck 326 is advanced into the anchor collar 322, the angled portion 324 can effectively force the chuck arms or teeth 328 to s clamped radially inward over suture 94.

In operation, once proximal anchor 318 has been preferably positioned relative to tissue fold F and / or distal anchor and with proximal collar 322 positioned within launch tube 18, delivery push tube 302 can be advanced distally to drive clamp 326 toward anchor collar 322 so that clamp arms or teeth 328 grip suture 94 and clamp 326 friction fit within anchor collar 322. Anchor collar 322 can then be pushed out of launch tube 18 and the anchor left against the surface of the tissue.

[0082] Another variation of clamp assembly 330 is shown in the cross-sectional view of Figures 15A and 15C. Launch tube 18 has been omitted from these figures for clarity only. Delivery push tube 332 is shown to define suture lumen 334 and the locking member or pin lumen 336 therethrough. Although two separate lumens are shown, a single common lumen can be used in alternate variations. With proximal anchor collar 344 positioned distally of push tube 332, suture 94 can be routed through suture lumen 334 and through collar lumen 346. Locking member or pin 338 can be positioned within lumen 336 proximally of the collar lumen 326. Figure 15B shows an end view of push tube 332 with locking pin 338 and suture 94 positioned within prior to attachment of the anchor.

[0083] Once the anchor has been conveniently positioned relative to the tissue, the suture 94 can be pulled proximally so that the anchor collar 344 rests against the distal end of the push tube 332. The locking pin 338, which may define a sharp or radiused end 340 to facilitate insertion into the lumen of collar 346, it may be driven distally through push rod 342 to force locking pin 338 into anchor collar 344 so that the suture portion 94 within the anchor collar 344 effectively engages and therefore prevents further movement of the anchor along the suture 94. Figure 15C shows a cross-sectional side view of the locking pin 388 that has been driven into the collar anchor 344 into frictional engagement with suture 94. Figure 15D shows a cross-sectional end view of collar 344 with locking pin 388 and suture 94 positioned within.

[0084] Figure 15E shows a perspective view of another clamp variation 331 that is similar to the variation described above. One or more sharpened pins or blocks 339 may be slidably disposed within sharpened channel 335 defined in proximal collar 333. The Figure shows two sharpened pins 339, although a single pin may be used or more than two pins may also be used. If two or more pins 339 are used, suture 94 can pass between pins 339. Pins 339 can slide freely along internal surface 337 of channel 335 in the direction of arrows 345, depending on the direction of travel. of suture 94 through channel 335. Figure 15F shows a perspective view of only pins 339 for clarity; As seen, the pins 339 can be distally sharpened from a larger diameter to a smaller diameter and although the pins 339 are shown as semi-circular members, the contact surface 341 can be curved or arcuate for better contact suture 94. In addition , the contact surface 341, which comes into contact with the suture 94 passing through the channel 335, can define a rough surface or can alternatively define a plurality of ridges, teeth, projections, etc., to facilitate contact against the suture 94.

[0085] In use, as proximal collar 333 is translated in the direction of arrow 343, pins 339 can be forced proximally so that suture 94 can freely pass through channel 335. However, if the proximal collar 333 will translate in the opposite direction, pins 339 can be forced in the opposite direction to engage suture 94 within channel 335 and thus inhibit any further movement.

[0086] An alternative variation of the assembly is shown in the cross-sectional views of Figures 15G and 15H, which show a tether anchor having a retractable pin. Figure 15G shows the proximal collar 347 with one or more retractor arms 349 extending proximally from the collar 347. The retractor arms 349 can be configured to rotate in the curve 353 when driven through a compressive force applied to the curve. 353 in the direction of arrows 355. Application of this compressive force can push pin support collar 357 which is defined in a proximal portion of arms 349 to move in the direction of arrow 359. This in turn it can move the pin 35l, which extends from the pin support collar 357, proximally out of the proximal collar 347 to thereby release the suture 94 from its locked position. In a variation, retractor arms 349 may be angled to retain pin 351 within proximal collar 347 unless a compressive force is applied at bend 353.

[0087] Figures 16A and 16B show cross-sectional side views of another variation of clamp assembly 350. Clamp assembly 350 may generally comprise outer tubing 352 and inner tubing 358 rotatably positioned within outer tubing lumen 354. The clamping member 362 may be positioned distally of the outer tubing 352 and may generally comprise a collar base 364 and a clamping collar 374 projecting proximally from the base of the collar 364. The clamping collar 374 is preferably tapered and threaded and It may also be longitudinally slotted so that rotating collar 368 can be rotatably positioned over slotted clamping collar 374. A distal end of outer tubing 352 may define one or more coupling members 356 that accommodate mating contact retainers. or mating mating interfaces 366 located at the base of the collar 364. The inner tube 358 also may define one or more coupling members 363 that are also adapted to mating contact retainers or mating mating interfaces 372 located on rotatable clamping collar 374. Suture 94 may be routed through inner tubing lumen 360, through the clamping collar 374 and through proximal anchoring collar 310.

[0088] In operation, suture 94 can freely pass through assembly 350. Once the anchor has been properly positioned, coupling members 356 on external tubing 352 can be correspondingly engaged against interface 366 and the members. Coupling parts 363 on inner tubing 358 may engage against interface 372. With suture 94 properly tensioned, outer tubing 352 can be held stationary while inner tubing 358 is rotated to rotate twist-twist collar 368 around the collar. threaded clamp 374. As rotary collar 368 tightens over clamp collar 374, the sharp shape may urge the slotted members to grip after suture 94 passed through. Standoffs 370, which can protrude from rotating collar 368, can be adjusted in height to control up to which point the swivel collar 368 can be twisted on the base of the collar 364 so that the degree to which the swivel collar 368 is twisted around the clamping collar 374 can be conveniently adjusted. Once the clamp collar 374 has been conveniently attached to the suture 94, the proximal anchor collar 310 can be ejected from the launch tube 18 along with the clamp assembly, as shown in Figure 16B.

[0089] Another variation in clamp assembly 380 can be seen in the cross-sectional views of Figures 17A and 17B. Assembly 380 is similar to clamp assembly 330 shown previously in Figures 15A through 15D. Delivery push tube 332 and push rod 342 have been omitted from these Figures for clarity only. In this variation, when locking pin 338 is pushed distally toward proximal collar 388, a retention tube member 384 can be used to provide a counter force to stabilize proximal collar 388 during clamping. Retainer tube member 384 may generally comprise one or more collar coupling arms 386 to couple proximal anchor collar 388 to collar retainers 390 defined along anchor collar 388. During insertion of the locking pin 338 on the collar 388, the coupling arms of the collar 386 can be positioned within the launch tube 18 or within the retractable sleeve 382. After inserting the locking pin 338 into the anchor collar 388, the coupling arms 386 can be distally advanced out of launch tube 18 or retractable sleeve 382 can be removed proximally to expose coupling arms 386. Once free of any restraining force, coupling arms 386 can be spring biased or radially opened to then release proximal anchor collar 388 into a snug configuration.

[0090] Another variation on clamp assembly 400 is shown in Figures 18A through 18D, in which proximal anchor collar 406 may comprise one or more biasing members or clamp tabs 408 within collar 406. Each of the tabs 406 may be biased to project inward so that the suture 94 passing through is automatically clamped and locked in position, as shown in Figure 18A. A suture release member 404, which may generally comprise a cylindrical shaped tube or member having a sharp surface 410 and a suture lumen 412 defined therethrough, may be positioned within anchor collar 406 during anchor positioning. to allow free passage of suture 94 through the anchor, as shown in Figure 18B. Figure 18C shows an end view of release member 404 defining suture lumen 412 extending therethrough. Figure 18D shows a perspective view of release member 404 to show sharpened surface 410 and suture lumen 412 in better detail. Sharp surface 410 may be omitted, but is preferably to facilitate insertion and removal of release member 404 from anchor collar 406. When the anchor has been conveniently positioned and is ready to lock in place over suture 94, the tubular member 402 can be attached to suture release member 404 for removal from anchor collar 406. Removal of release member 404 can cause clamping tabs 408 to lock into suture 94 and prevent further movement of the anchor relative to the suture 94.

[0091] Figures 19A and 19B show another variation of clamp assembly 420 in which a deformable clamp member 424 can be positioned within the anchor distally of the anchor collar 422. The clamp member 424 can define a sharp outer surface so that when the anchor is ready to be attached to suture 94, insertion of clamping member 424 into collar 422 can compress suture member 424 around suture 94 so as to prevent any further movement of the anchor. Clamping member 424 can be pulled toward anchor collar 422 via pull wire 426, which can be manipulated at its proximal end by the surgeon or user as desired.

[0092] Figures 20A through 20D show cross-sectional views of another variation on clamp assembly 430. As shown in Figure 20A, proximal anchor collar 432 may comprise a rotatable locking member 434 contained within the clamp collar. anchor 432 or proximally of collar 432. This example illustrates locking member 434 contained within collar 432. Suture 94 can pass through locking member 434, shown in the end view of collar 432 in Figure 20B, as if it had two pivots 436. Furthermore, locking member 434 and pivots 436 may be integrally formed from proximal collar 432. Rotary locking member 434 may be inclined to rotate around pivot 436 so that a position of rest of locking member 434 is against an internal surface of collar 432. During distal anchor translation over suture 94, the tension represented by arrow 438 on suture 94 it can force pivot 434 into an open position where suture 94 can pass freely. After the anchor has been conveniently positioned against the tissue, the locking member 436 can be tilted to rotate in the direction 440 to lock the suture 94 against the internal surface of the collar 432. Opposite movement of the anchor relative to the suture 94 can act to further secure locking member 434 against suture 94 and thus further inhibit movement of the anchor in the reverse direction.

[0093] A similar variation is shown in the perspective and side cross-sectional views of Figures 20E and 20F, respectively. In this variation, locking member 434 'may extend proximally from proximal collar 432 at an angle relative to collar 432. Locking member 434' can rotate through pivot 436 'so that locking member 434' can rotate in the direction of the arrows shown depending on the direction in which the tissue anchor is translated relative to the suture 94. If the proximal collar 432 is translated distally over suture 94, it can move freely; however, if the proximal collar 432 is proximally translated in the opposite direction, the suture 94 may engage a sharp portion of the opening 442 through which the suture 94 passes. Once the suture 94 is engaged in the opening When sharpened 442, locking member 434 'can rotate toward proximal collar 432, where it is stopped from further movement, thereby locking the tissue anchor at suture 94 and preventing reverse movement.

Figures 21A and 21B show another variation of clamp assembly 450 as seen in cross-sectional side views. In this variation, the delivery push tube 452 may be disposed proximally of the locking collar 454 and the proximal tapered anchor collar 458. Once the anchor has been conveniently positioned relative to the tissue fold F, with the suture 94 under tension, locking collar 454 may be driven distally through push tube 452 so that locking collar 454 slides over proximal anchoring collar 458. An internal surface of locking collar 454 may be sharp and the collar Anchor collar 458 may also be sharpened in a corresponding opposite manner, such that when locking collar 454 is engaged with anchor collar 458, anchor collar 458 may fix locking collar 454 over suture 94 to prevent any further movement of the anchor over the suture 94. Both collars can be made of any of the same or similar materials, as described above .

[0095] In addition to friction-based clamping and locking mechanisms that can be used in tissue anchors, other mechanisms that create tortuous suture paths within or through the anchors can also be used to create unidirectional locking.

[0096] A variation of tether anchor 460 is shown in cross-sectional side view in Figure 22A. As shown, suture 94 can be routed through proximal anchor collar 462 and wound onto pulley or pin 466 contained within distal collar 464. Suture 94 can then be routed back through and looped 468 around the suture 94 and tied with slip knot 470. As tension is applied to suture 94, slip knot 470 can prevent further movement of the anchor relative to suture 94.

[0097] Figures 22B and 22C show a variation that can be used in combination with the tether anchor variation 460 or alone. Pin 474 can optionally be positioned within proximal collar 462 and suture 94 can be wrapped or wrapped around itself around pin 474 in a manner as shown in the exploded view of Figure 22C. The configuration of the loop 472 may allow uninhibited translation of the anchor in the direction of the arrow as shown; however, when the anchor is moved in the opposite direction, the loop 472 can effectively engage on itself to prevent or inhibit reverse movement of the anchor relative to the suture 94.

[0098] Another clamping variation is shown in Figures 22D and 22E. Suture 94 can be routed through proximal collar 462 with an additional length of holding suture 476. The distal end of holding suture 476 can form a loop 478 that is wrapped around suture 94 and free to slide over the suture. 94. After the anchor has been preferentially positioned relative to the tissue and with suture 94 preferably under tension, holding suture 476 can be pulled proximally so that loop 478 is pulled toward proximal collar 462 and engages against suture 94. The multiple lengths of suture material used for loop 478 and suture 94 preferably form a cross-sectional area that is greater than an internal diameter of proximal collar 462 so that positioning loop 478 and suture 94 within the collar 462 they ensure a friction lock that prevents further movement of the suture 94 with respect to the anchor. Suture 94 and holding suture 476 are preferably made of the same material or similar materials, although different suture materials may also be used.

[0099] Figure 23 shows a cross-sectional view of the variation of the clamp assembly 480 in which the proximal collar 482 may comprise a pulley or pin 484 around which the suture 94 may be looped one or more times 490 Distal collar 486 may also comprise a pulley or pin 488 around which suture 94 may also be looped one or more times before being wrapped or looped 492 around suture 94. The terminal end of loop 492 may be secured around suture 94 by slip knot 494. This loop configuration allows the anchor to advance unidirectionally relative to the suture and tissue, yet prevents or inhibits reverse movement of the anchor and thus effectively allows that the fabric is fastened through the anchors.

[0100] Another variation of the clamping or locking anchor 500 is shown in the cross-sectional view of Figure 24A. By creating a tortuous path for suture 94, clamping sleeve 506 can be positioned proximally of proximal collar 504 within or distally of delivery push tube 502. Holding sleeve 506 may generally comprise a tubular structure having the lumen of the sleeve 510 defined therethrough and a number of openings 508 defined along the length of the sleeve 506. The openings 508 may have a uniform pattern along the sleeve 506 or they may be randomly positioned. Also, any number of openings 508 can be used as possible. In either case, the suture 94 can be routed in various patterns through the openings 508 and through the lumen of the cuff 510 before being routed through the collar. proximal 504. Once the anchor is to be locked, the clamping sleeve 506 can be driven distally through the delivery push tube 502. When pushed or pushed distally, this can be done slowly to allow the suture 94 to pass through the tortuous path created by suture 94 passing through openings 508. However, once clamping sleeve 506 has been advanced proximally adjacent proximal collar 504, clamping sleeve 506 can be locked with the proximal collar 504 pressing against sleeve 506.

[0101] Figure 24B shows another variation of a clamping mechanism that uses a tortuous path. The holding sleeve 512 may comprise a tubular structure having an opening 514 defined along a surface of the sleeve 512 through which the suture 94 can pass. The holding sleeve 512 may be disposed within the proximal collar 504 with suture 94 routed from outside of cuff 512 and into cuff 512 through aperture 514. In operation, due to the way suture 94 is routed through cuff 512 and into the anchor, it is uninhibited distal translation of the anchor relative to the tissue and suture 94. But when the anchor is reversed in the direction relative to the suture 94, the suture 94 and holding sleeve 512 may be pulled into the anchor and locked due to interference between suture 94, clamping sleeve 512, and proximal collar 504. Accordingly, an outer diameter of clamping sleeve 512 is preferably dimensioned to be slightly less r than an internal diameter of proximal collar 504 so that when suture 94 passes through opening 514, clamping sleeve 512 snaps against collar 504. Holding sleeve 512 can be made of any of the same materials or similar materials as the anchors, as described above.

[0102] Figures 24C and 24D show another variation similar to the clamping sleeve 512 described above. The variation of the clamping sleeve 516 can be similar in size to that of the sleeve 512 and can also similarly define an opening 514; however, sleeve 516 includes one or more retention arms 518 defined at a distal end of sleeve 516. Any number of retention arms 518 can be used as long as they extend radially and reside distally of proximal collar 504 so as to prevent them from sleeve 516 slides proximally out of collar 504. Figure 24D shows a perspective view of clamping sleeve 516 with retention arms 518 extending radially from sleeve body 516. Holding sleeve 516 may also be made of the same material or of material similar to that of the anchor; for example, sleeve 516 can be made from a material that has superelastic characteristics, such as Nitinol. Accordingly, when clamping sleeve 516 is initially inserted through collar 504 and / or during delivery of anchor through launch tube 18 into or through tissue, the retention arm (s) 518 may be configured in a profile. low with the arm or arms 518 limited to a tubular shape. Upon release of the anchor or upon insertion through the collar 504, the retention arms 518 can be released to extend radially.

[0103] Still another variation 520 in the clamp assembly is shown in Figure 25A. Generally, assembly variation 520 may comprise clamp collar 522 located proximally of proximal anchor collar 524. Clamp collar 522 may be a tubular structure having superelastic material characteristics, such as those found in Nitinol. The obstruction members 526, which may be formed from portions of the clamping collar 522, can be pressed or formed to extend into a lumen of the clamping collar 522 so as to create a tortuous path for passage of the suture 94. Although Three obstruction members 526 are shown in the Figure, any number of obstructions can be created as possible depending on the desired tortuous path that is created.

[0104] Assembly 520 shows clamp collar 522 as a separate collar located proximally of anchor collar 524; however, the clamping collar can be integrated with the anchoring collar such that a singular integral structure is formed, as shown in anchor variation 530 in the cross-sectional view of Figure 25B. In either alternative during placement of the anchor with respect to the tissue fold, the retention sleeve 534 may be inserted into the clamping collar 522 to maintain the obstruction members 526 in an open position to allow the suture 94 to pass freely through the sleeve 534. Once the anchor has been properly positioned, the retention sleeve 534 can be removed, as shown in the perspective view of Figure 25C, using any number of procedures. Removal of the retaining sleeve 534 will allow the obstruction members 526 to reconfigure inwardly in the direction of arrows 532 to thereby reconfigure the clamping collar 522 in a tortuous trajectory.

[0105] Fastener assembly 540 may also utilize a single or any number of tabs or levers to help capture suture 94 and / or create a tortuous path for suture 94 to traverse. As shown in the cross-sectional view of Figure 26A, the proximal collar 542 may have a rotary lever 544 integrally formed from a side wall of the proximal collar 542. Alternatively, the lever 544 may be included in a clamping collar. separated from proximal collar 542. Lever 544 can be biased inwardly into proximal collar 542 after suture 94 passes through. During translation of the anchor in a first direction, suture 94 may be allowed to pass freely through proximal collar 542 and past lever 544 due to its pivotal movement. When the anchor is moved or urged in the reverse direction, the lever 544 may act to clamp down on the suture 54 against an internal surface of the proximal collar 542, as shown in Figure.

[0106] An embodiment 546 according to the invention is shown in the cross-sectional view of Figure 26B showing that the proximal collar 548 has at least two levers 550, 552 both biased in opposite directions to create a tortuous path for the suture 94 through. The clamping levers are configured to prevent or inhibit over-clamping or cutting of the suture 94. Figures 26C and 26D show alternate end views of Figure 26A. The one-way lever 544, as seen in Figure 26C, can be formed from the side wall of the proximal collar 542 so that when the lever 544 is clamped down over the suture 94, the corners or ends of the lever 544 will enter in contact with an internal surface of proximal collar 542 at contact points 554. The contact that occurs can ensure that an open space 556 is preserved and that lever 544 is prevented from clamping on suture 94 within space 556 and cut suture 94. Figure 26D shows an alternate one-way lever 544 'defining a curved or arcuate edge 558 that contacts suture 94. Arcuate edge 558 can prevent over-clamping on suture 94 and cutting of the suture 94.

[0107] Figures 26E, 26F and 26G show alternative variations of clamp assembly 546 in accordance with the invention with one-way levers having various configurations. Figure 26E shows a cross-sectional side view of clamp assembly 560 in which proximal collar 562 has levers 564, 566 directed and skewed in opposite directions to create a tortuous path. Each of the levers 564, 566 in this variation is curved inward toward the proximal collar 562. Figure 26F shows a cross-sectional side view of the clamp assembly 568 in which the proximal collar 570 has one-way levers 572, 574 inclined towards each other. another when they are skewed inward. And Figure 26G shows a cross-sectional side view of clamp assembly 576 in which proximal collar 578 has one-way levers 580, 582 curved outward from each other when the levers are skewed within collar 578.

[0108] Figures 27A and 27B show yet another variation of the clamp assembly 590 that uses a reconfigurable hollow member for the clamping suture 94. As shown in Figure 27A, the hollow member 594 may be constrained within the delivery member. tubular 592 to retain an elongated shape with suture 94 passing through it uninhibited. When the anchor is to be attached, the hollow member 594 can be advanced distally from the tubular member 592 and when the hollow member 594 has been ejected, it can be adapted to reconfigure into a latching configuration 594 'having a non-linear passageway. . Suture 94 passing through latch configuration 594 'can be inhibited from freely passing through by latch 596 created within the hollow member. The hollow member 594 can have a variety of cross-sectional shapes, for example, circular, rectangular, square, hexagonal, etc., and is preferably made of a material that has shape memory characteristics, for example Nitinol, so that when hollow member 594 is not forced, it can be automatically reconfigured to its latching configuration 594 '.

[0109] Another variation of clamp assembly 600 is shown in the cross-sectional views of Figures 28A through 28C that is configured to reconfigure by not being forced. In this variation shown in Figure 28A, the clamp collar 602 may comprise at least two circular members, the first collar 606 and the second collar 608, connected by an elongated bridge member 604. The clamp collar 602 may be positioned within the tube. launch tube 18 proximally adjacent to proximal collar 610 and adapted to reconfigure once released from launch tube 18 so as to create a tortuous path for suture 94. Figure 28B shows an alternative variation on the clamping collar which may be a Variation integrated with the proximal collar so that the first collar 606 is directly connected to the anchor through the attachment member 612. In either variation, once the clamping collar has been ejected from the launch tube 18, the collar can be configured such that the first collar 606 and the second collar 608 are skewed relative to each other to form, for example, a "C" shape, as shown in Figure 28C. The tortuous path that is created by the clamp collar 602 for the suture 94 to follow may be sufficient to prevent further translation of the anchor relative to the suture 94. Figures 28D and 28E, respectively, show perspective views of the clamp collar. clamp 602 in a forced supply configuration and an unforced clamp configuration.

[0110] Figure 28F shows a cross-sectional side view of another clamp assembly that is similar to the variation shown in Figure 28B. Instead of having the first collar 606 and joint member 612 reconfigure into a semi-circular shape with respect to the anchor, the first collar 606 can be reconfigured to maintain its orientation with respect to the anchor while the joint member 612 can be formed to curve accordingly. suitably or roughly in an "S" type configuration. The reconfigured clamping member may act to lock the suture 94 relative to the anchor when the anchor is moved in a reverse direction.

[0111] Another configuration for a clamp assembly is shown in the side view of Figure 28G, showing the clamping member 616 located proximally of the proximal collar 614. The clamping member 616 can be manufactured from a variety of materials, eg Nitinol, spring stainless steel, etc., exhibiting shape memory or superelastic characteristics, or aspects thereof. In use, the clamping member 616 can be configured in an elongated delivery configuration. When the tissue anchor is to be clamped or locked relative to the tissue, the clamping member 616 can be released from a restraining force so that the clamping member 616 reconfigures into an expanded or extended configuration that creates a trajectory. tortuous for suture 94 that sufficiently locks suture 94 within clamping member 616.

[0112] The clamping member 616 may generally comprise an elongated bar, tape, cylinder, etc., or any elongated member having a diameter or cross-sectional area in its delivery configuration that is small enough to be positioned and / or translate within launch tube 18. Clamping member 616 may define a plurality of openings 618 along the length of clamping member 616 so that when clamping member 616 is in its elongated delivery configuration, as shown shown in Figure 28G, suture 94 can be woven through openings 618 along a relatively straightened path. Apertures 618 can be located along the clamping member 616 at uniform locations or they can be randomly positioned along the length of the clamping member 616. When released, the clamping member 616 can be reconfigured into a suture locking configuration. expanded 616 'that is large enough to prohibit its passage into or through proximal collar 614, as shown in Figure 28H. The expanded configuration 616 'may comprise any reconfigured shape as long as the expanded shape is adapted to create the tortuous path for suture 94 and is large enough that passage through proximal collar 614 is not possible.

[0113] Other clamping and locking mechanisms that utilize mechanical clamping or hooking can also be used to achieve locking of the suture within or through the anchors to facilitate unidirectional locking.

[0114] For example, clamp assembly 620 can be seen in the cross-sectional view of Figures 29A and 29B. Figure 29A shows delivery tube member 622 having latch collar 624 disposed within it proximally of proximal anchor collar 626. Suture 94 can be passed through latch collar 624 and proximal collar 626. One time Once the anchor has been preferentially positioned, the latch collar 624 can be advanced distally adjacent to the proximal collar 624 and mechanically hooked 624 'down onto the suture 94 to create a lock and prevent reverse movement of the anchor over the suture 94, as described above. shown in Figure 29B. Engagement can be accomplished by mechanical fasteners or pliers configured to hold down the collar 624. Similarly, Figure 30A shows the clamp assembly 630 in which the latch collar 632 can be integral with the anchor rather than being a separate member. Figure 30B shows a mechanically engaged collar 632 'which eliminates the need for a separate collar.

[0115] To achieve mechanical engagement on a clamping collar, several procedures can be used. Figure 31A shows a variation of a tool assembly 640 that can be adapted to apply a mechanical engagement force on a engagement collar. As seen, launch tube 18 may have delivery push tube 642 located within it and positioned proximally of proximal collar 652 of the tissue anchor. Push tube 642 can be used to hold and / or eject proximal collar 652 from launch tube 18. Latch device 644 can be advanced into launch tube 18 through latch control member 646, which can be manipulated from its proximal end.

[0116] A collar retention channel 650 may be defined at a distal end of latch 644 and adapted to receive and securely hold proximal collar 652 within during a clamping or latching procedure. Latching members or arms 648 can be positioned within latching device 644 on either side of retention channel 650. When proximal collar 652 or latching sleeve is to be clamped or engaged, latching members or arms 648 can be brought into contact. with proximal collar 652 to engage the collar. In addition, the latch arms 648 can be actuated through a variety of procedures, eg, hydraulically, pneumatically, by mechanical leverage, and the like.

[0117] An alternative hitch assembly 660 is shown in the cross-sectional view of Figure 32A. The latch 662 can be seen within the release tube 18 extending from the latch control member 664. The collar retention channel 672 can also be defined within the latch 662 to retain the proximal collar 670 during a hitching procedure. This variation may utilize a separate elongated latch member 666 having operable latch arms 668 positioned at a distal end of elongated member 666. In use, with proximal anchor collar 670 positioned within retention channel 672, the elongated member 666 can be advanced distally until latching arms 668 position over proximal collar 670 and latch downward. Figure 32B shows an exploded perspective view of the latch assembly.

[0118] Figures 31B to 31D show side, end and perspective views, respectively, of a variation of a proximal anchor collar 652 that is adapted to engage over a suture passing through it. To facilitate engagement of collar 652, a circumferential slot 656 may be defined through collar 652 partially around its circumference. Another longitudinal groove 658 may be defined through collar 652 extending longitudinally from a proximal edge of collar 652 to circumferential groove 656. These grooves 656, 658 may define at least two latching arms 654 that can engage downwardly over a length suture passing through collar 652.

[0119] In addition to the latching mechanisms described above, you can implement optionally additional measures to facilitate the holding or locking of an anchor. Other measures can also be taken to inhibit any damage to the suture routed through an anchor.

[0120] To ensure that the integrity of suture 94 is maintained in the presence of metal basket anchors 682 and to ensure that suture 94 is not cut or incised, the portion of suture 94 that passes through the basket anchor 682 may be encased in a protective sleeve 690, as shown in the perspective view of Figure 33A of the anchor sleeve assembly 680. The basket anchor 682 is shown in this variation as having anchor struts or arms 688 in a partially deployed configuration. Sleeve 690 may extend between distal collar 684 and proximal collar 686 to avoid excessive contact between suture 94 and basket anchor elements 682. Figure 33B shows an end view of anchor sleeve assembly 680 showing the relative positioning of sleeve 690 with respect to suture 94 and anchor collar 686. Sleeve 690 can be made from a variety of polymeric materials, eg, polypropylene, PTFE, etc., provided the material is suitably soft.

[0121] Figure 34A shows a cross-sectional view of clamp assembly 700 that can be implemented with any of the clamping and locking mechanisms described above. This particular variation utilizes the partial cold flow of the attached suture 94 to enhance the locking or clamping effect of the tissue anchor. The clamp collar, or in this variation proximal collar 702, against which suture 94 is nested may have multiple through holes 704 defined on the surface of collar 702. The cross-sectional side view shows suture 94 nested within collar 702 against it. locking pin 338. The portion of suture 94 that is adjacent to through holes 704 may have regions that partially cold flow into through holes 704, as shown by cold flow suture material 706. These portions of the suture material 706 can enhance the locking aspects of suture 94 against collar 702. Figure 34B shows a perspective view of collar 702 with multiple through holes 704 defined on the body of collar 702. Through holes 704 can be defined in a uniform pattern; alternatively, they may be defined randomly on collar 702 or only on portions of collar 702.

[0122] Figures 35A to 35E show an alternative variation 710 for locking a tissue anchor relative to suture 94. An outer sleeve 720 preferably comprising a polymeric material capable of at least partially flowable when heated, eg, PTFE , may be disposed circumferentially around an electrically conductive inner sleeve 722. As shown in the perspective views of Figures 35B and 35C, the inner sleeve 722 can be disposed within the lumen 726 of the outer sleeve 720. The inner sleeve 722 can define randomly or uniformly a plurality of openings or through holes 724 on the surface of the inner sleeve 722.

[0123] In operation, outer and inner sleeves 720, 722, respectively, may be positioned within delivery push tube 716 proximally of proximal collar 718 with suture 94 passing through. When the tissue anchor has been preferentially positioned and the suture 94 has also preferably been tensioned, an induction unit 712 having one or more induction coils 714 within it can be positioned circumferentially (or at least partially circumferentially) around the outer sleeves. and internals 720, 722. Induction unit 712 may be configured to be positioned within launch tube 18 or it may be configured to advance or position after launch tube 18. Thermal energy or electrical energy in various forms, for example , RF, microwave, etc., can be supplied to induction coils 714 so that the energy heats the inner sleeve 722, which can be placed inside the induction coils 714, as shown in Figure 35A. As the inner sleeve 722 is heated by induction, the inner surface of the outer sleeve 720 may be partially fused or deformed so that the material flows at least partially through or into the through hole 724 and comes into contact with the suture 94 located within inner sleeve 722. Flowable material can cool and act to lock outer and inner sleeves 720, 722 at suture 94. Induction unit 712 can then be removed from the area leaving outer and inner sleeves 720, 722 locked with respect to tissue anchoring.

[0124] Although the inner sleeve 722 exhibits through holes 724 as circularly defined openings, other shapes can be used. For example, Figure 35D shows a perspective view of an inner sleeve variation 728 having longitudinally defined grooves 730. Alternatively, Figure 35E shows a perspective view of another inner sleeve variation 732 having circumferentially defined grooves 734. You can use any variety of aperture shapes as long as the aperture or apertures allow the material of the outer sleeve 720 to flow through contact with the suture placed within.

[0125] Other configurations for anchoring itself may also be used in conjunction with any of the fastening apparatus described in this invention. For example, the linear clamp member 616 shown in Figures 28G and 28H can also be used to function as an anchor itself. Such a linear anchor can be made from a metal, eg Nitinol, spring stainless steel, etc., exhibiting shape memory or superelastic characteristics, as described above.

[0126] Alternatively, an elongated linear anchor may comprise a flexible polymeric material so that the anchor remains in a linear configuration when placed within a supply tube for deployment. Examples of potential polymeric materials can include, for example, polyethylene, polyester, polystyrene, polycarbonate, nylon, Teflon, elastomers, etc. However, once the elongated anchor is ejected or deployed from the supply tube, the anchor can be configured to compress longitudinally, that is, along the length of the anchor, upon application of a force in a longitudinal direction with relative to the anchor so that portions of the anchor arc are linear or expanded in a radial direction. The anchors can be configured to bow or expand through a number of techniques such as thermal configuration of the material. Additional procedures and variations are described in more detail below.

[0127] Figure 36A shows a perspective view of a variation 740 of a linear anchor. In this variation, linear anchor 740 may generally comprise an elongated tape or flattened wire 742 having at least one or more openings 744 defined through anchor 740 along its length. Linear anchor 740 generally can range anywhere in length from, for example, 8.99 to 18.415 cm (3.50 to 7.25 inches) or more. The thickness of the linear anchor 740 can also range from, for example, 0.0254 to 0.0508 cm (0.010 to 0.020 inches), and is preferably 0.03302 cm (0.013 inches), while the width can vary from, by example, 0.0762 to 0.1651 cm (0.030 to 0.065 inches), and is preferably 0.127 cm (0.050 inches).

[0128] Tape 742 illustrates apertures 744 in a pattern optionally offset from one another along the length to enhance the twisting or bowing effect of tape 740 when linearly compressed. Alternatively, the apertures 744 may be linearly aligned along the length, if desired. Furthermore, this variation illustrates openings 744 evenly spaced from one another anywhere from, for example, 0.9525 to 1.905 cm (0.375 to 0.750 inches), in the length of the anchor 740. Alternatively, the openings 744 may vary in diameter, by For example, 0.0381 cm (0.015 inches), as long as the length of the suture that is routed or weaved through the openings 744 is capable of sliding freely through the openings 744.

[0129] One or both ends 748 of tape 742 may optionally be configured to be atraumatic by having a blunt end or a sharp end to reduce or inhibit damage to surrounding tissue. Regions 746 of tape 742 located between openings 744 can be configured to flex in a predetermined orientation when anchor 740 is linearly compressed so that expanded and compressed tape 742 expands in a predetermined orientation, as described below.

[0130] Figure 36B shows a perspective view of another variation 750 of tape 752 that is similar to variation 740 of Figure 36A. Variation 750 defines a plurality of openings 754 that can be defined in a varied displacement pattern, eg, pairs of openings 754 can move relative to each other, as shown.

[0131] In order to ensure collapse of the tape into an arcuate or expanded pattern, the suture can be routed through each, or at least several, of the openings. Figure 37A shows the tape 742 of Figure 36A with the suture 94 routed through each opening 744 in an alternating or interwoven pattern. Similarly, Figure 37B shows tape 752 of Figure 36B with suture 94 routed through apertures 754 in a similar manner in an alternating or interwoven pattern. In either case, a terminal end of suture 94 may be formed in a knot 760 distally of the tape to prevent passage of suture 94 proximally. This can be done to facilitate collapse of the tape simply by pulling or tensioning the suture 94 to collapse the tape on itself. Instead of forming a knot 760, the suture 94 may be attached to the tape through any variety of procedures, for example, the suture 94 may be tied or welded to the tape, or it may simply be attached via an adhesive. , etc. Accordingly, when the tape is compressed in a longitudinal direction relative to the suture 94 by tensioning the suture 94, the tape is compressed in an expanded pattern while folding or folding along the regions between the openings.

[0132] Various procedures can be used to facilitate bending or folding of the tape anchor into desired expanded patterns. A variation may include an elongated tape 770 having alternate portions 772 of the tape material between the slotted or stripped openings 744, as shown in the variation of Figure 38. Alternatively, Figure 39 shows another variation in which it can form tape 780 to define corrugations 782 so that an "S" type tape pattern is made.

[0133] Once the web anchor is biased into its folded and deployed configuration, the web anchor can be further configured to provide some degree of spring force that allows the anchor to absorb a range of deflections that can be imparted on the anchor. The ability of the tape anchor to absorb a range of deflections may allow the tape anchor to absorb some force that would otherwise be imparted to the underlying tissue surface.

[0134] Such spring force can be imparted to the tape anchor in a variation as shown in Figure 40A, which shows a perspective view of the tape anchor 790 with the suture 94 routed through the openings. Biasing elements, such as springs 792, may be positioned along portions of tape anchor 790 with suture 94 routed therethrough. The variation shows two springs 792 positioned near either end of tape 790; however, a single spring or multiple springs can be used depending on the desired elastic spring effects of the strap anchor 790. In addition, the spring (s) 792 may be positioned at any position along the length of the strap anchor 790; alternatively, one or more springs 792 may even be positioned proximally or distally of one or both ends of tape anchor 790 rather than between the folds of tape anchor 790.

[0135] Figure 40B shows a variation on tape anchor 790 that is similar to the assembly of Figure 40A. This variation utilizes skewed elements 794, which can be manufactured from one of a variety of metallic or polymeric materials similar to or the same as the material of tape anchor 790. Tapered elements 794 generally may comprise angled members having suture 94 routed through of these and that are skewed to rotate around a hinge and retain their angled configuration.

[0136] In use, when suture 94 is tensioned or pulled relative to tape anchor 790, tape anchor 790 can be reconfigured to its compressed configuration. Figure 40C shows a perspective view of the tape 790 of Figure 40A that has been partially contracted. As shown, springs 792 can be compressed between the tape anchor portions 790 and function to provide a deflection force that allows the anchor assembly to absorb a range of deflections while isolating the force from the underlying tissue. Figure 40D shows the partially compressed anchor strap 790 with the skewed elements 794 of Figure 40B. This variation of the anchor assembly can function in a similar manner to the assembly of Figure 40C.

[0137] An alternative variation of the tape anchor is shown in the perspective view of Figure 41. Rather than using a tape or flattened wire, this variation uses a tubular member 800 with suture 94 routed through a plurality of openings defined along its length. Tubular member 800 can be manufactured from any of the materials described above, and due to its circular cross section, it can provide some spring force as tubular member 800 contracts on itself. Other alternatives can also use elongated members that have elliptical, rectangular, triangular cross sections, etc.

[0138] Figure 42 shows a perspective view of tubular member 810 having a partial cut 812 along the length of tubular member 810. A single cut may be used to provide a flex portion. Alternatively, multiple cutouts 822 can be formed on a tubular member 820, as shown in Figure 43. Multiple cutouts 822 can be formed along a single side of the tubular member 820, or they can alternate on opposite sides, as shown in the figure. In either case, suture 94 may be routed in an alternating pattern along the lengths of the tubular members to facilitate flexing or folding of the members, as described above.

[0139] Another alternative anchor tape 830 is shown in Figure 44, which illustrates multiple individual lengths of elements 832 encased (or at least partially encased) in a liner or cover 836. All or more of the elements 832 can be manufactured from of a variety of materials, eg, metals such as titanium, stainless steel, nitinol, etc., or plastics, etc., and the coating or liner 836 can be made of a variety of flexible polymeric or elastomeric materials. The length of the covering 836 that extends between each of the elements 832 can function as live hinges 834 while the suture 94 can be routed through each or more of the elements 832. When the tape anchor 830 is compressed, it can be folded along live hinges 834 as described above.

[0140] Figure 45 shows yet another alternative in which the tape anchor 840 may comprise one or more lengths of wire 842 covered or coated with the same or similar material as the previous coating or coating 836. The wires 842 can be made from the same or similar material as the elements 832 above. Similarly, suture 94 can be routed through a plurality of openings defined along the length of tape anchor 840.

[0141] Figure 46 shows yet another variation of the tape anchor 850 that is similar to the tape anchors described above, however, this variation may have a length that has a non-uniform thickness. For example, the tape anchor 850 may have one or more regions 852 that are slotted or tapered relative to the remainder of the length of the tape anchor 850. The thicknesses of the slotted or tapered regions 852 can vary to alter flex characteristics. or folding the tape anchor 850, as desired.

[0142] Figure 47A shows yet another variation in which a length of wire 860 can simply be used to fold or flatten into an expanded pattern. The 860 wire can be extruded from various materials, for example, stainless steel, Nitinol, Titanium, plastic, etc., and can be further configured to have shape memory characteristics such that, when contracted, the 860 wire will fold or collapse into a predetermined pattern. Wire 860 may also comprise one or more grommets 862 along its length through which suture 94 may be routed. Grommets 862 may be welded or bonded to wire 860 through any number of fastening procedures. Another alternative is shown in Figure 47B, which is similar to the variation in Figure 47A. In this variation, a single wire 860 ', similar to the above, can be configured to define a plurality of loops 862' instead of having separate grommets attached to it. Suture 94 can be routed through these loops formed 862 '.

[0143] Alternatively, a length of 870 wire can be used without suture. Figure 48 shows an example where wire or tape 870 may be comprised of a shape memory alloy, such as Nitinol, that is configured to form a tangled portion 872 of wire 870 when unstressed, similar to a " bird's Nest". This entangled portion 872 can simply be expanded into an interlocking mass of wire that prevents it from passing through a fold of tissue F.

[0144] In operation for any of the tape anchors described above, one or more tape anchors can be used. For example, a first anchor can be positioned distally of a fold of tissue F and a second anchor can be positioned proximally of the same fold of tissue F, as shown in Figure 49A. The distal portion of suture 94, which extends between the two anchors, can be anchored to the first anchor by, for example, a fastener or knot 760. As suture 94 is tensioned or pulled, each of the tape anchors 742 can be compressed and folded into an expanded configuration against the fold of tissue F. A locking mechanism 880, which may comprise any of the locking mechanisms described above, can be positioned proximally over suture 94 and clamped against tape anchor 742 to thereby locking each of the tape anchors 742 in its folded and expanded configurations, as shown in Figure 49B. Although this example illustrates the use of 742 tape anchors, any of the linear anchors described above can be used alone or in combination with any other linear anchor or other anchor described above.

[0145] As mentioned above, the tape anchor can be folded into an expanded configuration against the surface of the fabric. Accordingly, the tape anchor can be configured to collapse into a variety of arcuate or expanded configurations so that the contact area of the anchor against the tissue surface is increased, if desired. Figure 50A shows a top view of a variation of a strap anchor 890 that is simply configured to fold linearly on itself to form arms 892.

[0146] Figure 50B shows a top view of another variation 894 in which the tape anchor can be configured to form a crossover pattern with at least four arms 896. And Figure 50C shows a top view of yet another tape anchor 898 where multiple arms 900 can be formed in a radial pattern to facilitate distribution of the anchor against the tissue surface.

[0147] Alternatively, the tape anchor may be configured to form a number of secondary support arms 904, as shown in the bow tie-like configuration of variation 902 in Figure 50D. Figure 50E shows another variation 906 where a square configuration can be formed through multiple support arms 908 formed by the collapsible anchor. Figure 50F shows yet another variation 910 where a single support arm 912 can be formed by the collapsible anchor structure. Any number of folded arms and patterns can be formed depending on the desired configuration and aspects of the folded tape anchor.

[0148] With reference now to Figures 51 and 52, a clamp assembly comprising an interference element is described. Clamp assembly 1000 comprises a hollow or tubular body member 1002 having a distal opening 1004 and a proximal opening 1006. If body member 1002 is tubular or cylindrical in shape, the passageway defined through body member 1002 preferably has a sharp or tapered shape. Optionally, body member 1002 can be shaped in a tapered or tapered configuration. Distal opening 1004 is sized for passage of suture 1008 therethrough, while proximal aperture 1006 is sized for passage of both suture and interference element 1010, illustratively a ball or sphere.

[0149] The assembly 1000 further comprises a proximal plug or cap 1012 that is coupled to the proximal end of the body member 1002 and that fills the proximal opening 1006 of the body member. Plug or cap 1012 can be fitted or maintained within body member 1002 through a variety of procedures. For example, plug or cap 1012 may friction fit within proximal opening 1006. Alternatively, plug or cap 1012 may be mounted through a circumferential retainer configured to snap into place within proximal aperture 1006; and in yet another example, plug or cap 1012 may simply be held within or adjacent to proximal opening 1006 through an adhesive. As best seen in Figures 52, plug 1012 comprises a through hole 1014 configured for passage of suture 1008 (for purposes of illustration, suture 1008 is not shown in Figures 52).

[0150] Ball 1010 can, for example, have a diameter between about 0.020 "and 0.040", although any other diameter can be provided as desired. Additionally, the ball can be manufactured from any of a variety of materials, such as aluminum, titanium, or steel; Alternative materials will be apparent. Suture 1008 may, for example, have a nominal diameter of about 0.016 ", although other diameters may be provided. Distal opening 1004 of body member 1002 and through hole 1014 of proximal plug 1012 may, for example, have a diameter about 0.018 ", although other diameters can be provided.

[0151] As illustrated by arrows in Figures 51A, driving the body member 1002 distally, that is, in the direction of the arrows shown, relative to the suture 1008 drives the ball 1010 toward the proximal end of the body member. body 1002 and against plug or cap 1012. In this example, since the proximal end of the tapered body member may have a larger cross-section than its tapered distal end, the suture 1008 can freely pass through the clamp assembly 1000, thus allowing the suture to close. As illustrated by arrows in Figure 51B, moving body member 1002 proximally relative to suture 1008 drives ball 1010 toward the sharp distal end of body member 1002. This interference or friction blocks suture 1008 between the ball. 1010 and the interior wall of body member 1002, thus allowing unidirectional clamping of assembly 1000 with respect to suture 1008 by locking clamp assembly 1000 and preventing any reverse movement of the suture clamp.

[0152] Referring now to Figures 53, variations of the clamp assembly 1000 are described. In the variation of Figure 53A, the tapered body 1002 has been replaced with the tubular body 1020 having a tapered or profiled inner lumen 1021, which facilitates friction locking of suture 1008 between ball 1010 and the profiled wall of the lumen. Body 1020 may, for example, be machined, cast, or molded to achieve the profile of lumen 1021. Proximal plug 1012 illustratively comprises a hypotube disposed concentrically within body 1020. Through-hole or lumen 1014 of plug or hypotube 1012 is dimensioned to the passage of the suture 1008 through this, but is smaller than the diameter of the ball 1010 to prevent the ball 1010 from exiting or falling out of the body 1020.

[0153] Figure 53B provides a similar variation of assembly 1000 having body 1020 'with profiled inner lumen 1021'. In contrast to the variation of Figure 53A, the body 1020 'can, for example, comprise a standard hypotube, while the profile of the lumen 1021' can be formed through the secondary insert 1022 disposed within the hypotube. The insert 1022 may, for example, comprise epoxy injected into the hypotube, or it may comprise a separate piece that frictionally fits or otherwise fits within the hypotube.

[0154] In the variation of Figure 53C, the assembly 1000 comprises a tubular body 1030 having lumen 1031, as well as an end cap 1032 with proximal opening 1034 for passage of the suture 1008. The end cap may, for For example, comprising an epoxy bead, while the tubular body can comprise a hypotube. Engaged hypotube 1040 is disposed concentrically on or within tubular body 1030 and is coupled to body 1030 at junction 1042. Coupling 1042 may, for example, comprise a weld formed between the tubular body and the hypotube, or it may comprise a coupling glue, such as a cyanoacrylate coupling, etc. Hypotube 1040 further comprises central latch 1044. The reduced diameter of lumen 1041 through hydraulic tube 1040 in the vicinity of latch 1044 facilitates frictional locking of ball 1010 with suture 1008 to prevent reversal of suture latch.

[0155] In the variation of Figure 53D, the clamp assembly 1000 is formed from three tubes, eg, hypotubes. The proximal hypotube 1060 is disposed concentrically within a proximal end of the body hypotube 1050, while the distal hypotube 1070 is disposed within a distal end of the body hypotube. Body hypotube 1050 comprises lumen 1051 configured for passage of ball 1010 and suture 1008 therethrough; while the proximal hypotube 1060 comprises lumen 1061, and the distal hypotube 1070 comprises lumen 1071, both are configured for the passage of the suture 1008 through these, but not for the passage of the ball 1010. The body hypotube 1050 and the Distal hypotube 1070 comprises latch 1080 that locally reduces lumens 1051 and 1071. As seen in Figure 53D, the ball and suture are disposed within lumen 1051 in a manner that allows free proximal movement of suture 1008 with respect to the clamp assembly 1000, but that friction locks suture 1008 between ball 1010 and latch 880 during distal movement of the suture relative to the assembly.

[0156] Variations of the clamp assembly of Figures 51-53 depend on an interference and / or friction fit between a suture, thread, or other flexible element; an interference element, such as a ball or sphere; and an inner surface of a body member element through which the flexible element and the interference element pass. The material characteristics and / or the surface texture or roughness of these three elements can be specified to achieve, for example, desired frictional characteristics and interactions, ease of clamping, locking forces, etc. Examples of materials and surface characteristics for any or all fastener assembly elements include, but are not limited to, metals, polymers, elastomers, sandblasted metals, smooth metals, sapphire, glass, etc. Additional materials and surface characteristics will be apparent to those of skill in the art.

[0157] Although various illustrative variations are described above, it will be apparent to those skilled in the art that various changes and modifications can be made thereto without departing from the scope of the invention as defined in the appended claims. Furthermore, although specific locking or clamping configurations may be shown with various types of anchors, it is intended that the various locking or clamping configurations be used with the various types of anchors in various combinations as possible.

Claims (22)

1. An anchor for implantation in a body, comprising: an anchor body (64, 112, 132) adapted to be delivered through a hollow member or delivery device (18) for placement against a tissue surface (F); and a locking mechanism (88, 118, 546) adapted to be delivered through the hollow member or delivery device (18), wherein the locking mechanism comprises a body having a proximal end and a distal end, and defining a lumen for passage of a flexible member (70, 94) therethrough; where the locking mechanism comprises at least two arms (550, 552), where a first arm of the at least two arms is arranged closer to the proximal end of the body and a second arm of the at least two arms is arranged closer to the distal end of the body, and where the at least two arms are biased to project in opposite directions into the lumen to grip the flexible member (70, 94) by creating a tortuous path so that the flexible member (70, 94) is unidirectionally moveable through the lumen with respect to the anchor body (64, 112, 132). 2. The anchor of claim 1, wherein the anchor body comprises a basket anchor (306). The anchor of claim 2, wherein the basket anchor (306) is reconfigured from a delivery configuration within the hollow member or delivery device to an expanded configuration outside the hollow member. 4. The anchor of any preceding claim, wherein the hollow member or delivery device is selected from the group consisting of endoscopes, hollow members, tubular members, catheters, needles, and trocars. 5. The anchor of any of the preceding claims, wherein the flexible member (70, 94) comprises a length of suture. The anchor of claim 5, wherein the suture comprises a plurality of knots or protrusions (170) along the length of the suture. The anchor of claim 6, wherein the knots or protrusions (170) are formed at regular intervals along the length. 8. The anchor of claim 6, wherein the knots or protrusions (170) are formed intermittently along the length. 9. The anchor of any of claims 5 to 8, wherein the length of the suture comprises a monofilament, multifilament, elastic or elastomeric material. The anchor of any of claims 5 to 8, wherein the suture length comprises a metallic material, preferably where the metallic material is selected from the group consisting of Nitinol, stainless steel and titanium. The anchor of any of claims 5 to 10, wherein at least a portion of the length of the suture is surrounded by a material having a higher coefficient of friction than the suture. 12. The anchor of claim 11, wherein the material comprises a metallic liner or sleeve (181). The anchor of any preceding claim, wherein the anchor body (64, 112, 132) defines a sharp opening for the flexible member to pass through. The anchor of any of the preceding claims, wherein the locking mechanism (64, 88, 118) is contained within the anchor body (64, 112, 132). 15. The anchor of any preceding claim, wherein the locking mechanism (64, 88, 118) is in line with the flexible member (70, 94). The anchor of any of the preceding claims, wherein the locking mechanism (64, 88, 118) is adapted to automatically impart a locking force on the flexible member (70, 94). 17. The anchor of any preceding claim, wherein the arms (118, 138, 140) are biased to hold the flexible member (70, 94) against a surface of the lumen. 18. The anchor of claim 17, wherein the arms (118, 138, 140) are further adapted to release the flexible member (70, 94) when the anchor body is advanced distally. 19. The anchor of any preceding claim, wherein the arms (118, 138, 140) deflect to project at a proximal angle from the anchor body. The anchor of claim 19, wherein the arms (118, 138, 140) define a sharp opening through which the flexible member (70, 94) passes. 21. The anchor of claim 19, wherein the arms (118, 138, 140) are integral with the anchor body (64, 112, 132). 22. The anchor of any of the preceding claims, wherein the locking mechanism is positioned proximally of the anchor body.