Multi-state anchor delivery system, device, and kit, and method of use thereof + multiple anchor delivery system and method

Abstract

A multiple anchor delivery system, comprising: first and second anchors each having a suture passageway extending at least partly along an outer surface thereof; a suture slidingly disposed through the suture passageway of each anchor, wherein the first anchor is slidable relative to the suture and wherein the second anchor is slidable along the suture toward the first anchor; and a deployment device configured to deploy the first anchor into a first tissue deploy the second anchor on a proximal side of the first tissue after deployment of the first anchor; wherein the suture is disposed within and slidable through the suture passageways of the first and second anchors and the first tissue is configured to be shortened, wherein a distance between the second anchor on the proximal side of the first tissue and the first anchor deployed into the first tissue is reduced.

Description

[0001] MULTI-STATE ANCHOR DELIVERY SYSTEM, DEVICE, AND KIT, AND METHOD OF USE THEREOF + MULTIPLE ANCHOR DELIVERY SYSTEM AND METHOD

[0002] RELATED APPLICATION(S)

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 532,394 filed on 13 August 2023 and U.S. Provisional Patent Application No. 63 / 619,660 filed on 10 January 2024, the contents of which are hereby incorporated herein by reference in their entirety.

[0004] This application is also related to PCT Patent Application No. IL2023 / 051188 filed on 16 November 2023, which claims priority from U.S. Patent Application No. 63,426,024 filed 16 November 2023; U.S. Patent Application No. 63 / 443,748 filed 7 February 2023; and U.S. Provisional Application No. 63 / 532,394 filed 13 August 2023. The contents of the above application is all incorporated by reference as if fully set forth herein in its entirety.

[0005] FIELD AND BACKGROUND OF THE INVENTION

[0006] The present invention generally relates to soft tissue repair systems, kits, and methods for delivery of implants such as, for example, multiple soft tissue anchors.

[0007] It is known that various surgical procedures are performed in order to repair a deformed or tom soft tissue, such as meniscus, by means of suturing. There is a particular need for systems enabling delivery of several anchors during a single procedure.

[0008] US 8,888,798 and US 9,357,994, both to Smith & Nephew, Inc., each discloses a tissue repair device “wherein advance of the knob allows for engagement of the actuator with the first anchor and subsequent advancement of the first anchor.”

[0009] US 9,498,203 and US 9,549,725 to Smith & Nephew each disclose a tissue repair device including “a spring-loaded pusher” configured “for delivery of a flexible member to secure the tissue.”

[0010] US 9,622,736 discloses a tissue repair device that “includes first and second tubular anchors having corresponding longitudinal passages. The tissue repair device includes corresponding first and second inserters. Each inserter has a shaft with a distal portion received in the longitudinal passage of the corresponding tubular anchor. A flexible strand couples the first and second anchors” (abstract).

[0011] Additional anchor repair devices are disclosed in US 5,954,747; 6,306,156; 5,980,558; 5,993,459; 6,146,407; 6,595,911; 2003 / 0167072; US 2008 / 0167660; US 9,249,266; US 9,173,645; 5,236,445; US 4,899,743; US 4,946,468; US 4,968,315; US 5,002,550; US 5,041,129; US 5,123,914; US 5,258,016; US 5,372,604; US 5,403,348; US 5,417,712; US 5,417,691; US 5,626,614; US 5,718,717; US 5,954,747; US 6,554,852; US 6,511,498; US 5,403,348; US 7,857,830; US 7,905,903; US 7,601,165; US 8,128,658; US 7,959,650; US 8,771,314; US 8,298,262; US 8,221,454; US 2014 / 0039552; US 8,652,172; US 8,828,053; US 9,463,011; and US 9,622,738.

[0012] SUMMARY OF THE INVENTION

[0013] The present invention seeks to provide an improved multiple anchor delivery system.

[0014] There is thus provided in accordance with some embodiments of the present invention a multiple anchor delivery system, including a driving unit and a hollow needle extending distally therefrom; a pusher element operatively coupled with the driving unit and extending distally therefrom within the hollow needle; a first solid anchor disposed within the hollow needle, distally with respect to the pusher element; and a second tubular anchor being threaded onto the pusher element.

[0015] According to an aspect of some embodiments of the present invention there is provided a multiple anchor delivery system, comprising: a sheath having a proximal end and a distal end and having a passageway extending therethrough; a pusher element having at least a distal end positioned within the passageway, the pusher element distal end sized and shaped to be displaced through the passageway; a first anchor disposed within the sheath, at least a portion of the first anchor positioned distally with respect to the pusher element; and a second anchor disposed within the sheath, proximally with respect to the first anchor, the second anchor disposed within the passageway and, the second anchor sized and shaped to be displaced along the passageway; the pusher element sized and shaped to be displaced in a proximal direction to a position proximal to at least a distal portion of the second anchor; and the pusher element sized and shaped to be displaced in the distal direction, the displacement of the pusher element having a second displacement length at least as long as the distance between the proximal end of the second anchor and the sheath distal end, the second displacement length sufficient to deploy the second anchor.

[0016] According to some embodiments of the invention, the system further includes a barrier that narrows the passageway, the barrier obstructing a proximal displacement of the second anchor.

[0017] According to some embodiments of the invention, the second anchor is mounted on the pusher element. According to some embodiments of the invention, the second anchor is compressible in a lateral direction.

[0018] According to some embodiments of the invention, the first anchor includes a blind bore at its proximal end, the pusher element distal end sized and shaped to fit into the blind bore.

[0019] According to some embodiments of the invention, the pusher element distal end includes a retaining portion for temporarily retaining the second anchor thereon.

[0020] According to some embodiments of the invention, the retaining portion is a recess for retaining a second anchor.

[0021] According to some embodiments of the invention, the pusher element is provided with a compressible distal portion.

[0022] According to some embodiments of the invention, the sheath has a lateral opening at the distal end thereof, the second anchor positioned proximal to the lateral opening prior to deployment of the second anchor.

[0023] According to some embodiments of the invention, the first and second anchors are entirely housed within the sheath prior to their deployment.

[0024] According to some embodiments of the invention, one of: the first anchor includes a passageway extending alongside or through at least a portion of the first anchor, and the suture extends through the passageway; and the first anchor is slidingly engaged with the suture.

[0025] According to some embodiments of the invention, the second anchor includes one of: a plurality of loops through which the suture is extendible; and a plurality of apertures through which the suture is threadable.

[0026] According to some embodiments of the invention, the second anchor is at least one of: thick enough to cushion the second soft tissue or biocompatible material against a pressure applied by the suture to the second soft tissue or biocompatible material; and tough enough such that the second soft tissue or biocompatible material is not damaged by the suture.

[0027] According to some embodiments of the invention, the first anchor is configured to be inserted through a hole in the first soft tissue, the second anchor sized and / or shaped such that the second anchor cannot be passed through the hole.

[0028] According to some embodiments, the first anchor is configured to be inserted through a first hole in the first soft tissue and a second hole in the second soft tissue or biocompatible material, the second anchor sized and / or shaped such that the second anchor cannot be passed through the second hole. According to an aspect of some embodiments of the present invention there is provided a multiple anchor delivery system, comprising: a sheath having a proximal end and a distal end and having a passageway extending therethrough; first and second pusher elements disposed inside the sheath, each pusher element having at least a distal end positioned within the passageway, the distal end of each the pusher element sized and shaped to be displaced through the passageway; a first anchor disposed within the sheath, at least a portion of the first anchor positioned distally with respect to the first pusher element; a second anchor disposed within the sheath, proximally with respect to the first anchor; the first pusher element displaceable in a distal direction, into contact with the first anchor, the displacement having a displacement length sufficient to deploy the first anchor; the second pusher element displaceable in a distal direction, into contact with the second anchor, the displacement having a displacement length sufficient to deploy the second anchor.

[0029] According to some embodiments, the delivering includes securing a second soft tissue or biocompatible material to a first soft tissue; wherein the multiple anchors include a first anchor and a second anchor, wherein the first anchor is slidable relative to a suture; wherein the second anchor is slidable along the suture toward the first anchor.

[0030] According to some embodiments, the second anchor includes one of: a plurality of loops through which the suture is extendible; and a plurality of apertures through which the suture is threadable.

[0031] The present invention additionally seeks to provide improved anchors; and devices, kits, systems, and methods for anchor deployment, for example, for delivery through soft tissue or bone tissue.

[0032] According to an aspect of some embodiments of the present invention there is provided a method of operating a multi-state anchor delivery system, comprising:

[0033] (a) pushing a first anchor-pusher within a sheath using a second pusher on a designated axial-overlap region between the anchor-pusher and the second pusher;

[0034] (b) pushing the first anchor out of the sheath using the anchor-pusher during a first state;

[0035] (c) retracting the second pusher from the anchor-pusher thereby reducing the designated axial-overlap region between the anchor-pusher and the second pusher;

[0036] (d) deforming one or both of the anchor-pusher and the second pusher;

[0037] (e) pushing the anchor-pusher using the second pusher, one or both of the anchor-pusher and the second pusher having a deformation causing a mechanical interference over the designated axial-overlap region, wherein the pushing is on a contact-area between the anchor- pusher and the second pusher, the contact-area is outside of the designated axial-overlap region; and

[0038] (f) pushing a second anchor out of the sheath using the anchor-pusher during a second state.

[0039] According to some embodiments of the invention, the method further comprises switching between the first state and the second state to push anchors using an anchor-switch.

[0040] According to some embodiments of the invention, the method further comprises extending the positioning of the second anchor out of the sheath by a distance corresponding to the reduced designated axial-overlap region.

[0041] According to some embodiments of the invention, the method further comprises positioning the second anchor distally out of the sheath by a distance greater than the positioning of the first anchor out of the sheath.

[0042] According to some embodiments of the invention, the method further comprises stopping reduction of the designated axial-overlap region between the anchor-pusher and the second pusher during the second state after retracting the second pusher in a proximal direction.

[0043] According to some embodiments of the invention, the anchors are implants.

[0044] According to some embodiments of the invention, the anchors comprise sutures.

[0045] According to an aspect of some embodiments of the present invention there is provided a multi- state anchor delivery system, comprising: a sheath having a proximal end and a distal end and having a passageway extending therethrough; at least two anchors disposed in the distal end of the passageway; an anchor-pusher sized and shaped to push the at least two anchors out of the distal end of the passageway; a second pusher sized and shaped to push the anchor-pusher distally in the passageway; a first axial-overlap region defined on the anchor-pusher; a second axial-overlap region defined on the second pusher, wherein a designated potential axial-overlap region is defined as the first axial-overlap region and second axial- overlap region; and an overlap-switch in one or both of the first and second axial-overlap regions having two states, a first state allowing overlap at the designated axial-overlap region and a second state reducing the allowed overlap at the potential axial-overlap region by mechanically interfering with the axial movement of one pusher relative to other. According to some embodiments of the invention, the second pusher comprises a rack or other pusher assembly and the designated axial-overlap region comprises a recess in the rack or other pusher assembly operable to receive a proximal end of the anchor-pusher.

[0046] According to some embodiments of the invention, the overlap-switch comprises a movable faceplate connected to the rack, wherein the movable faceplate covers the recess during the second state, thereby reducing the designated axial-overlap region.

[0047] According to some embodiments of the invention, the overlap- switch comprises a curved protrusion extending from the sheath and positioned to deform and laterally bend a proximal end of the anchor-pusher during the second state, thereby preventing the recess from receiving the anchor-pusher and reducing the designated axial-overlap region.

[0048] According to some embodiments of the invention, the overlap- switch comprises a plate coupling between the sheath and the rack, the plate having a hole not placed centrally therein, the plate configured to deform the proximal ends of the anchor-pusher or to prevent a rod from being received in the recess during the second state and thereby reducing the designated axial-overlap region.

[0049] According to some embodiments of the invention, the overlap-switch comprises a predefined bend in the anchor-pusher which is selectively released from the rack and once released, laterally bends to be misaligned with a recess in the rack.

[0050] According to some embodiments of the invention, the overlap- switch comprises a rod extending from the second pusher.

[0051] According to some embodiments of the invention, the designated axial-overlap region is the second axial-overlap region of the rod on the distal end and the first axial-overlap axial region of the anchor-pusher on the proximal end.

[0052] According to some embodiments of the invention, the designated axial-overlap region is a scarf-overlap-joint.

[0053] According to some embodiments of the invention, the scarf-overlap-joint elastically is configured to be deformed at one or both of the anchor-pusher and the second pusher during a second state by retracting the second pusher in a proximal direction.

[0054] According to some embodiments of the invention, the overlap switch is configured to elastically deform between the first state and the second state.

[0055] According to some embodiments of the invention, the deformation is configured to be released by a retraction of the second pusher relative to the anchor-pusher.

[0056] According to some embodiments of the invention, at least one of the sheath, the anchorpusher, and the second pusher is disposable. According to some embodiments of the invention, at least one of the sheath, the anchorpusher, and the second pusher is reusable.

[0057] According to some embodiments of the invention, the sheath is bendable.

[0058] According to an aspect of some embodiments of the present invention there is provided a method for reducing axial overlap and extending an anchor-pusher, the method comprising: designating an axial-overlap region between an anchor-pusher and a second pusher; retracting the second pusher from the anchor-pusher thereby reducing the designated axial-overlap region between the anchor-pusher and the second pusher; deforming one or both the anchor-pusher and the second pusher; interfering mechanically over the designated axial-overlap region; combining the lengths of the anchor-pusher and the second pusher, using a contact-area outside of the designated axial-overlap region; extending the lengths of the anchor-pusher and the second pusher by using the new combination length; and pushing a second anchor out of the sheath using the extended length for the anchorpusher during a second state.

[0059] According to an aspect of some embodiments of the present invention there is provided a method of dual anchor deployment, comprising: advancing a first anchor out of a sheath using an anchor pushing mechanism including an anchor-pusher, the anchor-pusher having a first effective axial length; modifying the effective axial length of the anchor-pusher; and advancing a second anchor out of the sheath using the modified effective length.

[0060] According to some embodiments of the invention, the modifying includes increasing an effective length of the anchor-pusher by reducing an overlap between the anchor-pusher and a pushing assembly which pushes the anchor-pusher.

[0061] According to some embodiments of the invention, the modifying comprises retracting a pushing assembly used to push the anchor thereby allowing a portion of the anchor assembly and / or anchor-pusher to deform elastically or to otherwise geometrically move so as to interfere with axial overlap of the portion of the anchor assembly and the anchor-pusher.

[0062] According to some embodiments of the invention, the advancings both use a same amount of manual movement by an operator as applied to a mechanical control coupled to the anchor pushing mechanism

[0063] According to an aspect of some embodiments of the present invention there is provided a method of anchor deployment, comprising: displacing a pusher distally along a passageway extending through a sheath; such that the pusher contacts a first anchor disposed within the passageway and deploys the first anchor; retracting the pusher to a position proximal to a second anchor disposed within the passageway, the retracting including temporarily deforming the pusher such that a length of the pusher is changed during the retracting; and displacing the pusher distally along the passageway to deploy the second anchor.

[0064] According to an aspect of some embodiments of the present invention there is provided a kit for dual anchor delivery, comprising:

[0065] (a) a sheath;

[0066] (b) an anchor-pusher at least partially disposed in the sheath;

[0067] (c) at least two anchors lying in the sheath distal to the anchor-pusher;

[0068] (d) a variable length anchor pushing mechanism including the anchor-pusher, wherein the mechanism is configured to support different fixed axial overlap degrees between the anchorpusher and the mechanism during distal movement of the anchor-pusher.

[0069] According to some embodiments of the invention, the kit includes a suture configured to be slidingly threaded through each of the two anchors, the suture including a slip knot configured to be released by pulling on a first end of the suture, the slip knot configured to not be released by pulling on a second end of the suture, wherein the suture is configured to be tightened between the two anchors by pulling on the first end of the suture.

[0070] According to an aspect of some embodiments of the present invention there is provided a multiple anchor delivery system, comprising: a sheath having a proximal end and a distal end and having a passageway extending therethrough; a pusher having at least a distal end positioned within the passageway, the pusher distal end sized and shaped to be displaced through the passageway; a first anchor disposed within the sheath, the first anchor positioned distally with respect to the pusher; and a second anchor disposed within the sheath, proximally with respect to the first anchor, the second anchor disposed within the passageway, the second anchor disposed proximally relative to the pusher distal end, and the second anchor sized and shaped to be displaced along the passageway; wherein the pusher is configured to be retracted proximally to a position proximal to the second anchor, wherein at least a distal tip portion of the pusher is configured to be deformed by the second anchor during the proximal retraction; and wherein the pusher is configured to deploy the second anchor.

[0071] According to some embodiments of the invention, the pusher is flexible enough to be deformed by the second anchor, during the proximal retraction of the pusher.

[0072] According to some embodiments of the invention, the pusher distal end has two configurations: a relaxed state in which the pusher is usable to deploy an anchor; and a deformed state in which the pusher can be fit between the second anchor and a side wall of the sheath.

[0073] According to some embodiments of the invention, the distal tip portion of the pusher includes at least one curve.

[0074] According to some embodiments of the invention, the first anchor includes a proximally- facing end surface and wherein the pusher includes a distally-facing surface, the pusher distally- facing surface configured to contact the first anchor proximally-facing end surface during the deployment.

[0075] According to some embodiments of the invention, the second anchor includes a proximally-facing end surface and wherein the pusher includes a distally-facing surface, the pusher distally-facing surface configured to contact the second anchor proximally-facing end surface during the deployment.

[0076] According to some embodiments of the invention, the pusher has a non-uniform thickness along its length.

[0077] According to some embodiments, the suture includes: a first portion extending threaded through a first anchor of the two anchors and extending from the first anchor to a second anchor of the two anchors; a second portion extending between the first anchor and a second anchor of the two anchors and threaded through the second anchor; and a third portion extending from the second anchor, the third portion including the slip knot; wherein pulling on the first end of the suture releases the slip knot.

[0078] According to an aspect of some embodiments of the present invention there is provided a multiple anchor delivery system, comprising: first and second anchors each having a suture passageway extending at least partly along an outer surface of the respective anchor; a suture slidingly disposed through the suture passageway of each of the first and second anchors, wherein the first anchor is slidable relative to the suture and wherein the second anchor is slidable along the suture toward the first anchor; and a deployment device configured to deploy the first anchor and configured to deploy the second anchor after deployment of the first anchor; wherein the suture is disposed within and slidable through the suture passageways of the first and second anchors and the suture is configured to be effectively shortened, wherein a distance between the second anchor and the first anchor deployed is reduced.

[0079] According to some embodiments, the deployment device is configured to deploy the first anchor into a first tissue and configured to deploy the second anchor on a proximal side of the first tissue after deployment of the first anchor; wherein the suture is disposed within and slidable through the suture passageways of the first and second anchors and the suture is configured to be effectively shortened, wherein a distance between the second anchor on the proximal side of the first tissue and the first anchor deployed in the first tissue is reduced.

[0080] According to some embodiments, the deployment device is suitable for deployment of at least one anchor in a first tissue, and wherein the first tissue is soft tissue.

[0081] According to some embodiments, the deployment device is configured to deploy the second anchor at a distance from the proximal side of the first tissue.

[0082] According to some embodiments, the deployment device is suitable for deployment of at least one anchor in a soft tissue, and wherein the distance between the second anchor and the proximal side of the first tissue is reducible.

[0083] According to some embodiments, the deployment device is suitable for delivering the first and second anchors having a distance therebetween, and wherein the distance between the second anchor and the proximal side of the first tissue is reducible such that the second anchor abuts the proximal side of the first tissue.

[0084] According to some embodiments, the deployment device comprises: a sheath having a proximal end and a distal end and having a sheath passageway extending therethrough; a pusher element sized and shaped to be displaced in a distal direction through the sheath passageway; wherein the first and second anchors are disposed within the sheath and are each sized and shaped to be displaced along the sheath passageway, each of the first and second anchors having a proximal end and a distal end; wherein the pusher element is sized and shaped to be displaced in the distal direction, the displacement of the pusher element having a first displacement length at least as long as a distance between the proximal end of the first anchor and the sheath distal end, the first displacement length sufficient to deploy the first anchor, and having a second displacement length at least as long as the distance between the proximal end of the second anchor and the sheath distal end, the second displacement length sufficient to deploy the second anchor.

[0085] According to some embodiments, each of the first and second anchors has a proximal end and a distal end; and wherein the suture includes: a first portion attached to the first anchor proximal end and extending from the first anchor proximal end to the second anchor distal end; a second portion extending from the second anchor distal end, proximally through the passageway of the second anchor, toward the second anchor proximal end; a third portion extending from the second anchor proximal end, toward the first anchor distal end; a fourth portion extending from the first anchor distal end, proximally through the passageway of the first anchor toward the first anchor proximal end; and a fifth portion extending proximally from the first anchor proximal end.

[0086] According to some embodiments, prior to the deployment, the second is disposed proximally with respect to the first anchor within the deployment device.

[0087] According to some embodiments, at least one of the first anchor and the second anchor is flexible and includes an elongate body having first and second ends and extending along a longitudinal axis in a first orientation, the body configured to be bent into a second orientation wherein the first and second ends are closer to each other than in the first orientation.

[0088] According to some embodiments, when the body of the at least one of the first and second anchor is in the first orientation, an end of the suture is configured to be pulled proximally and to slide through the passageway, the first and second anchors and suture positioned such that the first length of suture extending through the passageway is effectively shortened, the shortened length of suture extending through the passageway configured to pull on the body along the passageway to thereby bend the body into the second orientation.

[0089] According to some embodiments, in the second orientation the anchor body has a c- shaped configuration or a u-shaped configuration, with the passageway positioned within a curve of the c-shape or the u-shape. According to some embodiments, in the second orientation the first and second ends of the body are at an angle relative to each other.

[0090] According to some embodiments, the delivery system comprises: a sheath having a proximal end and a distal end and having a sheath passageway extending therethrough; a pusher element having at least a distal end positioned within the sheath passageway, the pusher element distal end sized and shaped to be displaced through the sheath passageway; a first anchor disposed within the sheath, at least a portion of the first anchor positioned distally with respect to the pusher element; and a second anchor disposed within the sheath, proximally with respect to the first anchor, the second anchor disposed within the sheath passageway and, the second anchor sized and shaped to be displaced along the sheath passageway; the pusher element sized and shaped to be displaced in a proximal direction to a position proximal to at least a distal portion of the second anchor; and the pusher element sized and shaped to be displaced in the distal direction, the displacement of the pusher element having a second displacement length at least as long as the distance between the proximal end of the second anchor and the sheath distal end, the second displacement length sufficient to deploy the second anchor.

[0091] According to some embodiments, the second anchor overlaps axially with the pusher element.

[0092] According to some embodiments, the second anchor is tubular.

[0093] According to some embodiments, the deployment device includes a pusher element sized and shaped to be displaced in a distal direction, into contact with the first anchor, the displacement having a first displacement length sufficient to deploy the first anchor.

[0094] According to some embodiments, the multiple anchor delivery system further includes a barrier that narrows the sheath passageway, the barrier obstructing a proximal displacement of the second anchor.

[0095] According to some embodiments, the second anchor is mounted on the pusher element.

[0096] According to some embodiments, the pusher element extends through an interior of the second anchor.

[0097] According to some embodiments, the second anchor is compressible in a lateral direction.

[0098] According to some embodiments, the second anchor is compressible in a lateral direction, the pusher element displaceable in a proximal direction to a position proximal to the second anchor. According to some embodiments, the first anchor has a proximal end wherein the first anchor includes a blind bore at the proximal end, the pusher element distal end sized and shaped to fit into the blind bore.

[0099] According to some embodiments, the pusher element distal end includes a retaining portion for temporarily retaining the second anchor thereon.

[0100] According to some embodiments, the retaining portion is a recess for retaining a second anchor.

[0101] According to some embodiments, the pusher element is provided with a compressible distal portion.

[0102] According to some embodiments, the first anchor is tubular.

[0103] According to some embodiments, the sheath distal end is curved.

[0104] According to some embodiments, the first and second anchors are entirely housed within the sheath prior to their deployment.

[0105] According to some embodiments, the multiple anchor delivery system is for securing a second tissue or a biocompatible material to the first tissue, wherein the second anchor is configured to secure the second tissue or biocompatible material to the first tissue.

[0106] According to some embodiments, the second tissue or biocompatible material is a second soft tissue.

[0107] According to some embodiments, at least one of the first and second anchors includes one of: a plurality of loops through which the suture is extendible; and a plurality of apertures through which the suture is threadable.

[0108] According to some embodiments, the second anchor is at least one of: thick enough to cushion the second tissue or biocompatible material against a pressure applied by the suture to the second tissue or biocompatible material; and tough enough such that the second tissue or biocompatible material is not damaged by the suture.

[0109] According to some embodiments, the first anchor is configured to be inserted through a hole in the first tissue, the second anchor sized and / or shaped such that the second anchor cannot be passed through the hole.

[0110] According to some embodiments, the multiple anchor delivery system comprises: a sheath having a proximal end and a distal end and having a sheath passageway extending therethrough; first and second pusher elements disposed inside the sheath, each pusher element having at least a distal end positioned within the sheath passageway, the distal end of each the pusher element sized and shaped to be displaced through the sheath passageway; wherein the first anchor is disposed within the sheath, at least a portion of the first anchor positioned distally with respect to the first pusher element; wherein the second anchor is disposed within the sheath, proximally with respect to the first anchor; wherein the first pusher element displaceable in a distal direction, into contact with the first anchor, the displacement having a displacement length sufficient to deploy the first anchor; wherein the second pusher element displaceable in a distal direction, into contact with the second anchor, the displacement having a displacement length sufficient to deploy the second anchor.

[0111] According to some embodiments, the multiple anchor delivery system comprises: a sheath having a proximal end and a distal end and having a sheath passageway extending therethrough; a pusher element having at least a distal end positioned within the sheath passageway, the pusher element distal end sized and shaped to be displaced through the sheath passageway; wherein the first anchor is disposed within the sheath, at least a portion of the first anchor positioned distally with respect to the pusher element; and wherein the second anchor is disposed within the sheath, proximally with respect to the first anchor, the second anchor mounted on the pusher element.

[0112] According to some embodiments, a multiple anchor delivery kit includes the multiple anchor delivery system and a patch configured to be positioned on the first tissue; wherein the first anchor is sized and shaped to be deployed through the patch and into the first tissue; wherein the second anchor is configured to be deployed on a proximal side of the patch; wherein the shortened distance is associated with a shortened distance between the patch and the first tissue.

[0113] According to some embodiments, the patch is sized and shaped to abut the first tissue.

[0114] According to some embodiments, the multiple anchor delivery kit includes a third anchor having a suture passageway extending at least partly along an outer surface of the third anchor; wherein the suture is slidingly disposed through the suture passageway of the third anchor, wherein the third anchor is slidable along the suture relative to a least one of the first and second anchors; wherein the deployment device is configured to deploy the third anchor either into the first tissue or on the proximal side of the first tissue after deployment of the first anchor; wherein the suture disposed within and slidable through the suture passageway of the third anchor and the first tissue is configured to be shortened, wherein a distance between the third anchor and one of the first and second anchors is reduced.

[0115] According to some embodiments, the multiple anchor delivery system comprises: wherein the pusher element has at least a distal end positioned within the sheath passageway, the pusher element distal end sized and shaped to be displaced through the sheath passageway; wherein the first anchor is positioned distally with respect to the pusher element; wherein the second anchor is disposed proximally within the sheath, with respect to the first anchor, the second anchor disposed proximally relative to the pusher element distal end; wherein the pusher element is configured to be retracted proximally to a position proximal to the second anchor, wherein at least a distal tip portion of the pusher is configured to be deformed by the second anchor during the proximal retraction; and wherein the pusher element is configured to deploy the second anchor.

[0116] According to some embodiments, the pusher element is flexible enough to be deformed by the second anchor, during the proximal retraction of the pusher.

[0117] According to some embodiments, the pusher element distal end has two configurations: a relaxed state in which the pusher element is usable to deploy an anchor; and a deformed state in which the pusher element can be fit between the second anchor and a side wall of the sheath.

[0118] According to some embodiments, the distal tip portion of the pusher element includes at least one curve.

[0119] According to some embodiments, the first anchor includes a proximally-facing end surface and wherein the pusher element includes a distally-facing surface, the pusher element distally-facing surface configured to contact the first anchor proximally-facing end surface during the deployment.

[0120] According to some embodiments, the second anchor includes a proximally-facing end surface and wherein the pusher element includes a distally-facing surface, the pusher element distally-facing surface configured to contact the second anchor proximally-facing end surface during the deployment.

[0121] According to some embodiments, the pusher element has a non-uniform thickness along its length. According to an aspect of some embodiments of the present invention there is provided a method of deploying implants relative to a first tissue, wherein the method includes: delivering a sheath through the first tissue such that a sheath distal end penetrates the first tissue; deploying a first anchor out of the sheath and through the first tissue, the first anchor including a first suture passageway, wherein a suture extends through and is slidable through the first suture passageway; withdrawing the sheath from the first tissue; deploying a second anchor out of the sheath, the second anchor having a second suture passageway, wherein the suture extends through and is slidable through the second suture passageway; and tightening the suture extending through the first and second suture passageways, such that the first anchor is tightened relative to the first tissue.

[0122] According to some embodiments, the first tissue is a soft tissue.

[0123] According to some embodiments, the deploying the second anchor includes deploying the second anchor into a second tissue; wherein the tightening includes reducing a distance between the first tissue and the second tissue.

[0124] According to some embodiments, the tightening includes reducing a distance between the first and second anchors.

[0125] According to some embodiments, the tightening includes reducing a distance between the second anchor and the first tissue.

[0126] According to some embodiments, the tightening includes causing the first anchor to bend.

[0127] According to some embodiments, the tightening includes causing the first anchor to apply pressure to the first tissue.

[0128] According to some embodiments, the tightening includes causing the second anchor to bend.

[0129] According to some embodiments, the tightening includes causing the second anchor to apply pressure to a proximal side of the first tissue.

[0130] According to some embodiments, the method includes positioning a second tissue or biocompatible material on a proximal side of the first tissue, wherein the first anchor is deployed through the second tissue or biocompatible material and through the first tissue, wherein the tightening includes causing the second anchor to apply pressure to the second tissue or biocompatible material. According to some embodiments, a distance between the second tissue or biocompatible material and the first tissue is adjustable.

[0131] According to some embodiments, the bending includes bending at least one of the first anchor and the second anchor into one of a c-shape and a u-shape.

[0132] According to some embodiments, the tightening the suture includes leaving a gap between the second anchor and the first tissue.

[0133] According to some embodiments, the method further includes further tightening of the suture extending through the first and second suture passageways, such that the second anchor is tightened against the first tissue.

[0134] According to some embodiments, the method includes: positioning a second tissue or biocompatible material on the first tissue; wherein the delivering includes delivering the sheath through the second tissue or biocompatible material; wherein the deploying the first anchor includes deploying the first anchor through the second tissue or biocompatible material; wherein the withdrawing includes withdrawing the sheath from the second tissue or biocompatible material; wherein the tightening includes tightening the second anchor relative to the second tissue or biocompatible material.

[0135] According to some embodiments, the second tissue or biocompatible material is a second soft tissue.

[0136] According to some embodiments, the second anchor applies a counterforce to the second tissue or biocompatible material.

[0137] According to some embodiments, the first suture passageway extends alongside or through at least a portion of the first anchor.

[0138] According to some embodiments, the second anchor is at least one of flexible and compressible.

[0139] According to some embodiments, at least one of the first and second anchors includes one of: a plurality of loops through which the suture is extendible; and a plurality of apertures through which the suture is threadable.

[0140] According to some embodiments, the second anchor prevents damage to the second tissue or biocompatible material by at least one of: being thick enough to cushion the second tissue or biocompatible material against a pressure applied by the suture to the second tissue or biocompatible material; and being tough enough such that the second tissue or biocompatible material is not damaged by the suture.

[0141] According to some embodiments, the first anchor is configured to be inserted through a hole in the first tissue, the second anchor sized and / or shaped such that the second anchor cannot be passed through the hole.

[0142] According to some embodiments, the method includes: deploying a third anchor out of the sheath and on a proximal side of the first tissue or through the first tissue, the third anchor including a third suture passageway, wherein a suture extends through and is slidable through the third suture passageway.

[0143] According to some embodiments, the tightening includes shortening a distance between the third anchor and at least one of the first and second anchors.

[0144] According to some embodiments, the tightening includes shortening a distance between the third anchor and the first tissue.

[0145] According to some embodiments, the first anchor is configured to be inserted through a first hole in the first tissue and a second hole in the second tissue or biocompatible material, the second anchor sized and / or shaped such that the second anchor cannot be passed through the second hole.

[0146] According to an aspect of some embodiments of the present invention there is provided a method of attaching a biocompatible material to a tissue, wherein the method includes: delivering a sheath through a tissue such that a sheath distal end penetrates the tissue; deploying a first anchor out of the sheath and through the biocompatible material and tissue, the first anchor including a first passageway; withdrawing the sheath from the tissue; deploying a second anchor out of the sheath, the second anchor having a second passageway; and tightening a suture extending through the first and second passageways, such that the first anchor is tightened against the tissue.

[0147] According to some embodiments, the tightening includes tightening the second anchor relative to the biocompatible material.

[0148] According to some embodiments, the second anchor applies a counterforce to the biocompatible material. Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0149] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0150] Some embodiments are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the systems, kits, devices, and methods. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the systems, devices, kits, and methods may be practiced. Further, reference to a feature or aspect of any of the system, device, kit, and method according to the invention, or any combination thereof, may be understood as referring also to any of the system, device, kit, and method, as discussed herein.

[0151] In the drawings:

[0152] FIG. 1 is a simplified sectional view illustration of an exemplary multiple anchor delivery system and an enlargement view of a distal end thereof, shown in an initial operative orientation, in accordance with some embodiments;

[0153] FIG. 2 is a simplified sectional view illustration of the multiple anchor delivery system and an enlargement view of a distal end thereof, shown in a first anchor deployment operative orientation, in accordance with some embodiments;

[0154] FIG. 3 is a simplified sectional view illustration of the multiple anchor delivery system and an enlargement view of a distal end thereof, shown in a retraction operative orientation, in accordance with some embodiments;

[0155] FIG. 4 is a simplified sectional view illustration of the multiple anchor delivery system and an enlargement view of a distal end thereof, shown in a second anchor deployment operative orientation, in accordance with some embodiments;

[0156] FIG. 5 is a perspective view of an exemplary multiple anchor delivery system, in accordance with some embodiments;

[0157] FIG. 6 is an exploded view of the device shown in FIG. 5, in accordance with some embodiments; FIGs. 7A-E are respective left side view, perspective view from the left side, right side view, bottom view, and end view of a right half of an exemplary housing of the device shown in FIG. 6, in accordance with some embodiments;

[0158] Figs. 8A-E are respective perspective, top, side, bottom, and front views of an exemplary rack, in accordance with some embodiments;

[0159] FIG. 9A is a perspective view of an exemplary roller, in accordance with some embodiments;

[0160] FIGs. 9B-C are side views of exemplary rollers in accordance with alternative embodiments;

[0161] FIGs. 10A-D are respective perspective, top, side, and end view of an exemplary bobbin, in accordance with some embodiments;

[0162] FIGs. 11A-D are respective perspective, front, side, and top views of an exemplary locking element, in accordance with some embodiments;

[0163] FIGs. 12A-E are respective perspective, side, top, end, and cross-sectional views of an exemplary needle length delimiter, in accordance with some embodiments;

[0164] FIG. 13 A is a perspective view of an exemplary sheath, with FIG. 13D showing an enlargement of a distal end thereof, in accordance with some embodiments;

[0165] FIGs. 13B-D are respective cross-sectional and top views of the sheath shown in FIG. 13 A, in accordance with some embodiments;

[0166] FIG. 14A is a side view of an exemplary pusher element, with FIG. 14B showing an enlargement of a distal portion thereof, in accordance with some embodiments;

[0167] FIGs. 15A-C are respective perspective, side, and top views of an exemplary suture holder in accordance with some embodiments;

[0168] FIGs. 15D-E are respective side and top views of an exemplary cannula in accordance with some embodiments;

[0169] FIGs. 16A-C are respective perspective, cross-sectional, and top views of exemplary first and second anchors with suture arranged therethrough, in accordance with some embodiments;

[0170] FIGs. 17A-D are a side-sectional view of an exemplary system according to some embodiments with enlargements of portions thereof, an enlargement of a distal portion of the system, a top view of the system, and a side view of the system, respectively, prior to use, in accordance with some embodiments;

[0171] FIGs. 18A-D are a side- sectional view of the system shown in in FIG. 17A, with an enlargement of a distal portion of the system shown in FIG. 18B, a top view of the system, and a side view of the system, respectively, after insertion of a distal end thereof through a tissue, in accordance with some embodiments;

[0172] FIGs. 19A-D are a side-sectional view of the system shown in FIG. 18A with an enlargement of a distal portion of the system shown in FIG. 19B, a top view of the system, and a side view of the system, respectively, after deployment of a first anchor through the tissue, in accordance with some embodiments;

[0173] FIGs. 19E-H are a side-sectional view of the system shown in FIG. 19A with an enlargement of a distal portion of the system shown in FIG. 19F, a top view of the system, and a side view of the system, respectively, after retraction of the pusher element, in accordance with some embodiments;

[0174] FIGs. 20A-D are a side-sectional view of the system shown in FIG. 19E with an enlargement of a distal portion of the system, a top view of the system, and a side view of the system, respectively, after withdrawal of the device from the tissue, in accordance with some embodiments;

[0175] FIGs. 20E-G are a side-sectional view of the system shown in FIG. 19E, an enlargement of a distal portion of the system shown in FIG. 19F, and a top view of the system, in accordance with some embodiments;

[0176] FIGs. 21A-D are a side-sectional view of the system shown in FIG. 20A with an enlargement of a distal portion of the system, a top view of the system, and a side view of the system, respectively, after deployment of a second anchor through the tissue, in accordance with some embodiments;

[0177] FIGs. 22A-C are a side-sectional view of the system shown in FIG. 21A with an enlargement of a distal portion of the system, and a top view of the system, respectively, after withdrawal of the device distal end from the tissue, in accordance with some embodiments;

[0178] FIGs. 23A-B are respective front and side views of exemplary anchors after attachment to a tissue, before tightening of the suture material, in accordance with some embodiments;

[0179] FIGs. 23C-D are respective side and front views of the anchors shown in FIG. 23 A, after tightening of the small suture loop, in accordance with some embodiments;

[0180] FIGs. 23E-G are respective side, back, and perspective views of the anchors shown in FIG. 23D after tightening of the large suture loop, in accordance with some embodiments;

[0181] FIG. 24 is a schematic illustration of an exemplary method of delivering multiple anchors into a tissue of a patient, in accordance with some embodiments;

[0182] FIG. 25 is a schematic illustration of an exemplary method of operation of a device for deployment of multiple anchors, in accordance with some embodiments; FIG. 26 is a side view of a portion of a deployment device including a first anchor and a second anchor, in accordance with some embodiments;

[0183] FIGs. 27A-B are respective representations of proximal and distal views of a second soft tissue or biocompatible material and a first soft tissue secured to each other , in accordance with some embodiments;

[0184] Fig. 28 is a schematic illustration of a second soft tissue or a biocompatible material secured to a first soft tissue, in accordance with some embodiments;

[0185] FIG. 29A is an exemplary abstract block diagram showing a designated axial-overlap region in a sheath for a multi-state anchor delivery system during a first anchor deployment in a first state, according to some embodiments;

[0186] FIG. 29B is an exemplary abstract block diagram showing a reduced designated axial- overlap region in a sheath for a multi-state anchor delivery system during a second anchor deployment in a second state, according to some embodiments;

[0187] FIG. 30A is an exemplary abstract block diagram showing a designated axial-overlap region and an axial- switch optionally located at least partly external to a sheath for a multi- state anchor delivery system during a first anchor deployment operating in a first state, according to some embodiments;

[0188] FIG. 30B is an exemplary abstract block diagram showing a reduced designated axial- overlap region and an axial-switch optionally outside of a sheath for a multi-state anchor delivery system during a second anchor deployment operating in a second state, according to some embodiments;

[0189] FIG. 31 is an exemplary illustration of the multi-state anchor delivery system showing an external housing according to some embodiments;

[0190] FIG. 32 is an exploded perspective view of a multi-state anchor delivery system showing internal components inside of the housing, according to some embodiments;

[0191] FIG. 33 is a view showing a designated axial-overlap region for a mechanism having an overlap joint during deployment of a first anchor, according to some embodiments;

[0192] FIG. 34 is a side-sectional view of a portion of a device of the system, showing a reduction of the designated axial-overlap region for the mechanism having an overlap joint during retraction of the second pusher after the deployment of a first anchor, according to some embodiments;

[0193] FIG. 35 is a side- sectional view of a portion of the device of the system, showing a designated axial-overlap region of an overlap joint with the second pusher deformed, before deployment of a second anchor, according to some embodiments; FIG. 36 is a perspective view of a portion of an anchor delivery device of the system, showing a designated axial-overlap region for a mechanism having a movable faceplate in the open position, during deployment of a first anchor, according to some embodiments;

[0194] FIG. 37 is a side- sectional view of a portion of the device of the system, showing the pushing of an anchor-pusher in a first state and a movable faceplate in the open position, during a first anchor deployment, according to some embodiments;

[0195] FIG. 38 is a side-sectional view of a portion of the device of the system, including a designated axial-overlap region for a mechanism having a movable faceplate in the open position, after a first anchor deployment, according to some embodiments;

[0196] FIG. 39 is a side-sectional view of the device of the system, including a designated axial- overlap region having a movable faceplate in the closed position covering the borehole (or other recess), after a first anchor deployment and retraction of the rack, which shows the reduction in the overlap region, according to some embodiments;

[0197] FIG. 40 is a side- sectional view of a portion of the device of the system, showing the second pusher in the second state, where the designated axial-overlap region with the movable faceplate is in the closed position covering the borehole, according to some embodiments;

[0198] FIG. 41 A is a perspective view of a portion of the system, showing a sheath having a protrusion to bend the anchor-pusher after a first anchor deployment and after retraction of the rack as an embodiment reducing the axial-overlap region, according to some embodiments;

[0199] FIG. 4 IB is a perspective view showing a sheath of the system having a protrusion on the proximal end to bend the anchor-pusher, the sheath operable to deform the anchor-pusher, according to some embodiments;

[0200] FIG. 42A is a perspective view showing an overlap-switch plate operable to deform the anchor-pusher, according to some embodiments;

[0201] FIG. 42B is a perspective view showing the assembly location of an overlap-switch plate, according to some embodiments;

[0202] FIGs. 43A-B are respective side and end views of an anchor, according to some embodiments;

[0203] FIGs. 44A-C are cross-sectional views of anchors, each including four loops, according to some embodiments;

[0204] FIG. 44D is a plan view of a pair of anchors of Fig. 44A, the anchors shown after deployment and securing against soft tissue, according to embodiments;

[0205] FIGs. 45A-B are cross-sectional views of anchors, each including two loops, according to some embodiments; FIG. 45C is a plan view of a pair of anchors of Fig. 45A, the anchors shown after deployment and securing against soft tissue, according to embodiments;

[0206] FIGs. 45D-G are side views of additional anchors, in accordance with some embodiments;

[0207] FIGs. 46A-B illustrate an alternative configuration for threading a length of suture through a pair of anchors, and an anchor after being secured against soft tissue, in accordance with embodiments;

[0208] FIGs. 47A-B illustrate a further alternative configuration for threading a length of suture through a pair of anchors, and an anchor after being secured against soft tissue, in accordance with embodiments;

[0209] FIG. 47C is a simplified schematic illustration of an exemplary anchor with a suture threaded or extending therethrough, in a first orientation, in accordance with an embodiment of the present invention;

[0210] FIG. 47D, is a simplified sectional view illustration of the anchor having a suture threaded therethrough of Fig. 47C, the anchor in a second orientation, according to some embodiments;

[0211] FIG. 48 is a flowchart illustrating a method of operating a multi-state anchor delivery system, according to some embodiments;

[0212] FIG. 49 is a flowchart illustrating a method for reducing axial-overlap and extending an anchor-pusher, according to some embodiments;

[0213] FIG. 50 is an exploded view of an anchor delivery system including a pusher element having a curved tip, according to some embodiments;

[0214] FIG. 51 is a perspective view of the assembled anchor delivery system of Fig. 50;

[0215] FIG. 52 is a perspective view of a pusher element for the anchor delivery system of Fig. 50, according to some embodiments, including enlargements of portions of the pusher element;

[0216] FIG. 53 is a side- sectional view of the anchor delivery system of Figs. 50-23, prior to deployment of anchors, according to some embodiments;

[0217] FIG. 54 is a side- sectional view of the anchor delivery system of Figs. 50-23, after deployment of a first anchor, with the pusher element in an extended position, according to some embodiments;

[0218] FIG. 55A is a side- sectional view of the anchor delivery system of Figs. 50-23, during retraction of the pusher element, according to some embodiments;

[0219] FIG. 55B is a side-sectional view of the anchor delivery system of Figs. 50-23, after retraction of the pusher element, according to some embodiments; FIG. 56 is a side- sectional view of an anchor delivery system of Figs. 50-23, after deployment of a second anchor, according to some embodiments;

[0220] FIG. 57 is an exploded view of an anchor delivery system including a pusher element having an S- shaped tip portion, according to some embodiments;

[0221] FIG. 58 is a perspective view of a pusher element of Fig. 57, including enlargements of portions of the pusher element, according to some embodiments;

[0222] FIG. 59 is a side-sectional view of the anchor delivery system of Fig. 57, prior to deployment of anchors, according to some embodiments;

[0223] FIG. 60 is a side-sectional view of the anchor delivery system of Fig. 57, after deployment of a first anchor, with the pusher element in an extended position, according to some embodiments;

[0224] FIG. 61 A is a side-sectional view of the anchor delivery system of Fig, 57, during retraction of the pusher element, according to some embodiments;

[0225] FIG. 6 IB is a side- sectional view of the anchor delivery system of Fig. 57, after retraction of the pusher element, according to some embodiments;

[0226] FIG. 62 is a side-sectional view of the anchor delivery system of Fig. 57, after deployment of a second anchor, according to some embodiments;

[0227] FIG. 63 is a side- sectional view of a portion of an anchor delivery system, including anchors having a suture threaded therethrough, according to some embodiments;

[0228] FIGs. 64A-H are side views of a suture of the anchor delivery system, shown after deployment of the first and second anchors;

[0229] FIG. 65 is a flowchart illustrating actions of a method of attaching a biocompatible material to soft tissue, according to some embodiments; and

[0230] FIG. 66 is a schematic drawing of a needle portion of an implant delivery system, according to some embodiments.

[0231] DESCRIPTION OF SPECIFIC EMBODIMENTS

[0232] The present invention, in some embodiments thereof, relates to a soft tissue repair system, and, more particularly, but not exclusively, to a multiple anchor delivery system.

[0233] A multiple anchor delivery system and method is disclosed herein, which is particularly useful for repairing soft tissue, such as meniscus for example, but not limited to this particular surgical procedure. An aspect of some embodiments of the invention relates to deploying multiple anchors using a sheath. In some embodiments of the invention, two anchors are deployed from the sheath, sequentially, by a single pusher element, with one anchor being in contact with the pusher element and a second anchor being loaded into the sheath and located to a side of the pusher element. Optionally, the second anchor is mounted on and / or around the pusher element. In some embodiments, two anchors are deployed from the sheath, each anchor deployed by a corresponding pusher element. For example, the first and second anchors may each be deployed by a separate pusher element such as, for example, that disclosed in US 2008 / 0243148.

[0234] In some embodiments of the invention, retraction of the pusher element after deployment of the first anchor repositions the second anchor relative to the pusher element so that subsequent distal advancement of the pusher element will deploy the second anchor from the sheath.

[0235] In some embodiments of the invention, when the pusher element is retracted in a proximal direction, the second anchor is pulled back with the pusher element until the second anchor encounters an interfering geometry and is prevented from further retraction. In this way, the pusher element is moved distally relative to the second anchor.

[0236] Exemplary embodiments of the invention comprise a system and method for deploying multiple anchors through a tissue of a patient. The system and method may be utilized, for example, in the repair of torn meniscus tissue, by deploying first and second anchors through the torn tissue portions and optionally tightening the anchors against the tissue portions, thereby potentially holding the separated tissue portions together so that they may mend together. According to some embodiments, the system includes a device including a sheath having a passageway extending therethrough. A pusher element is positioned in the passageway and displaceable relative to the sheath, in a distal direction and a proximal direction.

[0237] An aspect of some embodiments of the invention relates to deploying first and second implants in the form of anchors from a sheath, the first anchor implantable into a soft tissue, as discussed herein, and the second anchor deployable adjacent the soft tissue, optionally adjacent a biocompatible material positioned on the soft tissue. According to some embodiments, the first and second anchors are sized and shaped to be positioned entirely within the passageway of a sheath, the first anchor positioned distally relative to the pusher element and the second anchor positioned proximally relative to the first anchor. Optionally, the first and second anchors are housed entirely within the sheath prior to deployment of the anchors.

[0238] The first and second anchors may each include a suture passageway extending at least partly along an outer surface of the respective anchor. A suture may be slidingly disposed through the suture passageway of each of the first and second anchors such that, after deployment of the first anchor into a first tissue and deployment of the second anchor, the first anchor is slidable relative to the suture and the second is slidable toward the first anchor. Sliding of the suture within the suture passageways of the first and second anchors may cause a distance between the first and second anchors to be reduced, according to some embodiments. Additionally, sliding of the suture within the suture passageways of the first and second anchors may cause a distance between the second anchor and the first tissue to be reduced, optionally until the second anchor abuts the first tissue. Optionally, the first tissue is soft tissue such as, for example, a tendon that may have a tear or a partial tear.

[0239] The second anchor may be deployed at a distance from the proximal side of the first tissue. The distance between the second anchor and the proximal side of the first tissue may be adjustable / reducible, for example, by pulling on the suture, which may then slide within the passageways of the first and second anchors. The distance between the second anchor and the proximal side of the first tissue may be adjustable / reducible such that the second anchor abuts the proximal side of the first tissue.

[0240] A length of suture material may extend through the first and second anchors, optionally forming a small loop and a large loop extending between the anchors. The small loop may extend from approximately the distal end of the first anchor to approximately the proximal end of the second anchor, and the free end may extend from approximately the proximal end of the first anchor, proximally through the device.

[0241] An aspect of some embodiments relates to securing a second tissue or biocompatible material such as, for example, a patch, to the first tissue. Optionally, the second tissue or biocompatible material may be a second soft tissue. A second tissue or biocompatible material may be positioned on a proximal side of the first tissue, wherein the first anchor may be deployed through the second tissue or biocompatible material and through the first tissue. Tightening the suture may cause the second anchor to apply pressure to the second tissue or biocompatible material. A distance between the second tissue or biocompatible material and the first tissue may be adjustable, for example, by pulling on the suture extending through the first and second anchors. This may cause bending of at least one of the first anchor and the second anchor into one of a c-shape and a u-shape. Optionally, according to some embodiments, a gap may be left between the second anchor and the first tissue. The gap may be reduced or eliminated by further tightening of the suture extending through the first and second suture passageways, such that the second anchor is tightened against the first tissue.

[0242] According to some embodiments, deploying the second anchor includes deploying the second anchor into a second tissue, and tightening includes reducing a distance between the first tissue and the second tissue. According to some embodiments, tightening includes reducing a distance between the first and second anchors. According to some embodiments, tightening includes reducing a distance between the second anchor and the first tissue.

[0243] According to some embodiments, tightening includes causing the first anchor to bend. According to some embodiments, tightening includes causing the first anchor to apply pressure to the first tissue. According to some embodiments, tightening includes causing the second anchor to bend. According to some embodiments, tightening includes causing the second anchor to apply pressure to a proximal side of the first tissue.

[0244] The provision of first and second anchors having a passageway via which a suture may be slidingly disposed, and the particular configuration of these components, as discussed herein, may allow tightening of the first and second anchors relative to first and second tissues or relative to a first tissue and a biocompatible material, as discussed herein. This may have a potential advantage in that it may obviate the need for a tool which may be utilized in other embodiments, to tighten the suture extending through the passageways of the first and second anchors.

[0245] According to some embodiments, a third anchor having a third suture passageway may be deployed, for example, into the first tissue, or on a proximal side of the first tissue, or into a third tissue. After deployment of the first anchor into the first tissue, deployment of the second anchor on a proximal side of the first tissue, and deployment of the third anchor, a distance between the third anchor and the first and / or second anchor may be adjusted / reduced by pulling on the suture, which is slidable through the first, second, and third suture passageways. Pulling on the suture may cause the third anchor and / or the third tissue to move closer to the first tissue proximal side or to abut the first tissue.

[0246] An aspect of some embodiments of the invention relates to deploying multiple anchors utilizing a sheath provided with a lateral opening such as, for example, a slot, at its distal end portion, the slot being wide enough for the small and large suture loops to pass therethrough. Optionally, the second anchor is positioned proximal to the lateral opening prior to deployment of the second anchor.

[0247] The device may include a tubular suture holder for retaining the suture material within a limited distance from the needle, thereby potentially preventing tangling of the suture material when the anchors are moved through the passageway.

[0248] According to some embodiments of the invention, the pusher element may be displaceable by linear displacement of a driving mechanism. The driving mechanism may be displaced by linear displacement of an actuator in the form of a trigger button. Alternatively, in some embodiments, the driving mechanism may be displaceable by rotation of a roller. The actuator is movable in a distal direction and a proximal direction, the actuator coupled to the driving mechanism which is coupled to the pusher element. The coupling is arranged so that movement of the actuator in a distal direction results in displacement of the driving mechanism in a proximal direction, and that movement of the actuator in a proximal direction results in displacement of the driving mechanism in a distal direction.

[0249] The sheath may be inserted through a tissue such as, for example, a torn meniscus. The sheath should be inserted through the tissue such that the sheath distal end exits the tissue before deployment of the anchors is performed.

[0250] Once in position through the tissue, the device may be actuated by moving the actuator in a proximal direction, the pusher element is displaceable in a distal direction through the sheath so that it contacts the first anchor, the amount of displacement of the pusher element sufficient to deploy the first anchor from the sheath.

[0251] A barrier is optionally positioned within the passageway at a location proximal to the second anchor, the barrier optionally in the form of a narrowing of the passageway so that it interferes with proximal displacement of the second anchor. The position of the second anchor within the sheath may or may not be affected by distal or proximal movement of the pusher, depending on the location of the second anchor relative to the barrier and the direction of movement of the pusher element.

[0252] After the first anchor has been deployed, the pusher element is displaceable through the passageway in a proximal direction to a position proximal to at least a portion of the second anchor. As the pusher element moves proximally, the second anchor may be prevented from also moving proximally once it contacts the barrier in the passageway.

[0253] The needle may be removed from the tissue and reinserted through the tissue at another location where it is desired to deploy the second anchor. When the device is actuated by again moving the actuator in a proximal direction, the pusher element is then displaceable distally through the sheath so that is contacts the second anchor, the amount of displacement of the pusher element sufficient to deploy the second anchor from the sheath.

[0254] After the second anchor has been deployed, the suture loops may be tightened, to tighten the anchors against the tissue. The anchors in position may hold the tom tissue portions together so that they may heal.

[0255] An aspect of some embodiments of the invention relates to deploying first and second anchors from a sheath, where the first anchor may be solid, or at least not hollow, and the second anchor may be hollow. A pusher element may be displaced proximally and distally within the sheath, the pusher element being insertable through the second anchor. After deployment of the first anchor, the proximal displacement of the pusher element is effective to move the pusher element to a position proximal to the second anchor, wherein the second anchor is effectively loaded and ready for deployment. Upon subsequent distal displacement of the pusher element, the pusher element distal end contacts a proximal portion of the second anchor and deploys the second anchor out of the sheath. Optionally, the pusher element has a distal end wider than the second anchor proximal end, the pusher element distal end optionally being compressed when the when inserted through the second anchor. Optionally, the second anchor has a compressible portion which is decompressed upon retraction of the pusher element to a location proximal to the second anchor.

[0256] An aspect of some embodiments of the invention relates to deploying first and second anchors from a sheath, where the second anchor may be solid, and is optionally compressible. Optionally, the second anchor is laterally compressible. The second anchor may be compressed by the pusher element such that it is positioned alongside the pusher element. Upon retraction of the pusher element, the pusher element may slide past the second anchor, to position the second anchor distally relative to the pusher element. The second anchor may then be deployed by distal displacement of the pusher element. Optionally, the second anchor is compressible and, when decompressed, has an external diameter equal to or greater than the inner diameter of the sheath. In some embodiments, at least one of the first and second anchors may be hollow at least along a portion of its length, the anchor radially compressed by the sheath until deployed out of the sheath by the pusher element.

[0257] An aspect of some embodiments of the invention relates to a system and method for deploying first and second anchors, where the pusher element includes a recess for retaining the second anchor. Optionally, the recess may be a notch sized and shaped to temporarily contain the second anchor. Optionally, the second anchor may be positioned within the recess such that the second anchor is at least mostly surrounded by the pusher element. Optionally, the second anchor may be positioned within the recess such that the second anchor is surrounded on at least three sides by the pusher element. After deployment of the first anchor, the pusher element is retracted, which is effective to position the second anchor distally relative to the pusher element. The second anchor may then be deployed by distal displacement of the pusher element.

[0258] An aspect of some embodiments of the invention relates to deploying multiple anchors, the first and second anchors deployed by respective pusher elements, the pusher elements optionally working in parallel within a single sheath.

[0259] In accordance with some embodiments, the system may be provided with an actuator which is displaceable proximally to deploy the first anchor. Optionally, the actuator may be a trigger button which may be linearly displaceable. Alternatively, the actuator may be a roller which may be rotatable. In some embodiments, there is the potential advantage that a finger of a user moves in a first direction and the anchor is deployed in the second direction opposite to the first direction. For example, a user may actuate a device by a movement of a trigger button in a proximal direction, which results in deployment of an anchor in a distal direction out of the sheath.

[0260] In embodiments, the system may be provided with a locking mechanism which prevents inadvertent or premature deployment of the anchors.

[0261] An aspect of some embodiments of the invention relates to deploying multiple anchors using a sheath including an opening such as, for example, a slot, at a distal portion thereof. Suture portions provided on or through the anchors may be allowed to extend out of the opening, thereby potentially preventing tangling of the suture portions. Optionally, at least a portion of the second anchor is disposed proximal to the opening. Optionally, the entire length of the second anchor is disposed proximal to the opening.

[0262] An aspect of some embodiments relates to a tissue attachment device for securing a second soft tissue or a biocompatible material such as, for example, an arthroscopic patch or an allograft, to a first soft tissue. The device may include a first anchor, which may optionally be flexible, having a suture threaded extending through at least a portion thereof or engaged therewith and a second anchor slidably mounted on the suture. The first anchor may be inserted through a first soft tissue, as discussed herein, and may be positioned on a distal side of the first tissue, and the second anchor may be positioned on a proximal side of the first soft tissue, to secure a second soft tissue or biocompatible material against or relative to the first soft tissue. The first and second anchors and a suture interconnecting the first and second anchors may be formed of biocompatible materials.

[0263] At least a portion of the first anchor may be tubular or may include a passageway or inner lumen extending within and / or along at least a portion of the first anchor, according to some embodiments. Optionally, the passageway or a portion thereof may be at least partly external to first anchor, the passageway formed of any suitable material connected to or integrally formed with first anchor such as, for example, loops. Alternatively, instead of providing the first anchor with a passageway through which the suture may pass, the first anchor may be slidingly engaged with the suture, according to some embodiments.

[0264] The device also includes a second anchor including at least one loop or connector for allowing the second anchor to be slidingly mounted on the suture. Alternatively, the second anchor may include a plurality of apertures through which the suture may be threaded, such that the second anchor is slidingly mounted on the suture. The second anchor is optionally formed of a flexible material, and is optionally formed of a compressible material.

[0265] The first anchor may be deployed, by any of the systems discussed herein or by any suitable deployment device, through an opening in a first soft tissue, such that the first anchor will be positioned on the distal side of the first soft tissue, as discussed herein. After the first anchor has been deployed, the second anchor may be deployed on a proximal side of the first soft tissue, with a portion of the suture extending between the first and second anchors.

[0266] A second soft tissue or biocompatible material which it is desired to attach to the first soft tissue may be positioned adjacent the proximal side of the first soft tissue, and a portion of the suture may be pulled proximally to shorten the length of suture between the first and second anchors, thereby urging the first and second anchors closer together. As the first and second anchors move closer together, the suture may slide through passageways defined in the first and second anchors such as, for example, discussed herein. As the suture portion between the first and second anchors is shortened, the first anchor may thereby be tightened against the distal side of first soft tissue, while the second anchor may be tightened against the second soft tissue or biocompatible material, thereby causing the second soft tissue or biocompatible material to be secured to the first soft tissue. Thereafter, the suture may be tied off or knotted and excess suture material from extension may be removed.

[0267] Alternatively, the sheath or needle may optionally be inserted through both the second soft tissue or biocompatible material and the first soft tissue, according to some embodiments, after which the second anchor may be deployed on a proximal side of the second soft tissue or biocompatible material. In this manner, suture portion may extend through both the first soft tissue and the second soft tissue or biocompatible material as discussed herein.

[0268] The second anchor may be thick enough or have a large enough diameter to cushion the second soft tissue or biocompatible material relative to pressure applied by the suture to the second soft tissue or biocompatible material when tightened. The second anchor may also be tough enough or sturdy enough such that the second soft tissue or biocompatible material will not be cut or damaged by the suture. Optionally, either or both of the first and second anchors may have a circular or elliptical or rectangular cross-sectional profile, or any other suitable cross-sectional profile.

[0269] As the first anchor is configured to be inserted through an opening in the first soft tissue, the second anchor may be sized and / or shaped such that the second anchor cannot be passed through the opening in the first soft tissue. It should be noted that that provision of a device having a first anchor and second anchor, both of which are slidable relative to suture may provide an improved device for securing a second soft tissue or biocompatible material to a first soft tissue which may facilitate attaching a s second soft tissue or biocompatible material to a first soft tissue. The device may potentially reduce pressure on the second soft tissue or biocompatible material and, thereby, may allow better healing of the tissue and / or may prevent damage caused by excess pressure to the second soft tissue or biocompatible material, as compared with a suture alone which may force a second soft tissue or biocompatible material against the first soft tissue..

[0270] Additionally, the second anchor may potentially provide a cushioning component to such a procedure as discussed herein, whereby force applied to the second soft tissue or biocompatible material may be distributed across the area of the second soft tissue or biocompatible material. This may potentially reduce pressure and / or stress to the second soft tissue or biocompatible material, as compared with a first anchor which does not include a second anchor and which retains the second soft tissue or biocompatible material relative to the first soft tissue by means of the suture pulled against the second soft tissue or biocompatible material on the proximal side of the first soft tissue.. Depending on the size of the second anchor, i.e., the area of the second anchor that contacts and is forced against the second soft tissue or biocompatible material, this may potentially significantly reduce pressure and / or stress applied to the second soft tissue or biocompatible material, and may potentially prevent damage to second soft tissue or biocompatible material.

[0271] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0272] POTENTIAL ADVANTAGES

[0273] A system and / or method in accordance with some embodiments of the present invention can provide one or more of a number of potential advantages not realized by the prior art. For example, the provision of a trigger button / roller, for example, as discussed herein may provide easy, one-handed actuation of the system by simple mechanical components. In addition, the amount of force required to be exerted on the trigger button / roller is substantially the same as the amount of force with which each anchor is deployed. This can allow a user to have control over the deployment of the anchors which is not possible in some prior art devices such as, for example devices wherein deployment of the anchors is by a spring-loaded mechanism.

[0274] Additionally, the provision of a system wherein finger movement of the user in a first direction results in displacement of the pusher element in a second direction, together with the provision of a safety latch / lock for example, as described herein, may prevent premature / inadvertent deployment of anchor(s).

[0275] Further, the ergonomic shape of the handle can allow the needle to be more easily maneuverable through the tissue, which may result in more accurate positioning of the anchors after deployment. Also, the ergonomic shape and operation of the handle and actuating mechanism, in the form of a trigger button or roller, together with engageable pusher driving unit results in less pressure required to deploy the anchors as compared with prior art devices.

[0276] Yet further, the provision of a slot in the needle through which the loops extend may allow for easier deployment of the anchors, as the loops / sutures may not interfere with movement of the anchors through the passageway, and the provision of a slot through which the loops extend may prevent tangling of suture material as the anchors are deployed from the needle.

[0277] Yet further, as in any device to be inserted into the human body, there is a limited amount of space within which to work. Having a pusher element inserted through the second anchor may save space within the device.

[0278] Yet further, provision of a bobbin on which suture material is wound may prevent tangling of the suture material within the housing.

[0279] These and other potential advantages may be apparent to persons skilled in the art.

[0280] Additionally, the present disclosure generally relates to medical systems, devices, kits, and methods for delivery of implants, for example for delivery of multiple anchors, at least one being a soft tissue anchor. As discussed herein, the systems, devices, kits, and methods of the present disclosure may, alternatively, be used for the deployment of multiple anchors through bone.

[0281] According to some aspects of some embodiments of the invention there provided systems, devices, kits, and methods for deployment of first and second anchors wherein, prior to deployment of the anchors, the position of the first anchor within the device is distal relative to the position of the second anchor within the device. The systems, devices, kits, and methods discussed herein include a pusher element which is extended distally to deploy the first anchor, then is retracted to a position proximal to the second anchor, and then is extended distally to deploy the second anchor, according to some embodiments. In some embodiments of the invention, there is provided a multiple-state overlap- switch mechanism for controlling the deployment of anchors using an anchor-pusher and a second pusher within an anchor delivery system. In some embodiments, the anchor delivery system is a tissue repair system, for example, for the repairing of soft tissue, such as meniscus, for example, but not limited to only meniscus surgical procedures. Alternatively, in some embodiments, the anchor delivery system is a tissue repair system, for example, for the repairing of bone tissue. While the application may discuss various anchors and deployment systems / methods for repairing soft tissue, it is to be understood that, alternatively, such anchors and deployment systems / methods may be alternatively suitable for repairing bone tissue.

[0282] An aspect of some embodiments of the invention relates to mechanisms for modifying the axial travel distance of an anchor-pusher. Optionally, this allows a same pusher to be used to deliver anchors to different depths. Optionally or additionally, this allows a same anchor-pusher to push a more proximally located anchor to a same position as a more distally located anchor or to a further position than that of the more distally located anchor. Such mechanisms can be useful in an anchor delivery system where the anchor-pusher is used to advance an anchor out of the delivery system and into tissue. If a more proximal anchor is used as an extension of the anchor-pusher to push out the more distal anchor, during pushing of the more distal anchor, the proximal anchor might not significantly extend past the distal end of the delivery system. However, deployment of the proximal anchor does require such exit and therefore, possibly more axial movement of the anchor-pusher. Proposed mechanisms provide for variable lengths of movement of the anchor-pusher for different anchors. In some embodiments of the invention, a mechanism is provided for moving the anchor-pusher and this mechanism is retracted after the distal anchor is deployed. This potentially allows a simpler mechanical design for various mechanism features, such as degree of movement of a user manipulated knob and / or location of a safety mechanism. As an alternative, one might simply advance the anchor-pusher for each deployed anchor and not retract the anchor. However, this may also require a longer handle or other mechanism for advancing the anchor-pusher and / or may provide a different feel or manipulation geometry for the user for each anchor deployment, which may be undesirable.

[0283] In some embodiments of the invention, an overlap-switch mechanism is provided, in which the anchor-pusher and a second pushing assembly (also termed herein “second pusher”) have a variable axial overlap. Such variable axial overlap allows the overall axial length and / or travel distance of the anchor-pusher to be effectively different in different overlap states. Therefore, the overall axial length and / or travel distance of the anchor-pusher may be effectively different, for example, when deploying the first anchor and when deploying the second anchor. Such different travel amounts can differ, for example, by a length of the proximal anchor, which is part of the overall pushing structure for deploying the distal anchor but not part of this overall structure for deploying the proximal anchor. While for two anchors, two different lengths (and therefore overlap states) may be desired, if more anchors are deployed, additional overlap states and lengths may be provided.

[0284] In some embodiments of the invention, the overlap switch mechanism provides for extending the distal length travelled by the anchor-pusher during a second state for deploying a second anchor. Reducing a designated axial-overlap region between the proximal end of the anchor-pusher and a second pusher extends the distal length travelled by the anchor-pusher as explained below. A reduced designated axial-overlap region, in effect is inverse to the combined lengths of the anchor-pusher and a second pusher. This mechanism lengthens the distal length travelled by the anchor-pusher during a second state.

[0285] In some aspects, the penetration depths for deploying a first anchor and a second anchor into a tissue are equal. In some aspects, the penetration depth for deploying a second anchor into a tissue is deeper, longer or greater than the penetration depth for deploying the first anchor into a tissue.

[0286] In some embodiments of the invention, the overlap switch mechanism is activated by retraction of a pushing assembly relative to the pusher, allowing the pushing assembly and / or the anchor-pusher to deform in a way that reduces overlap between the pusher assembly and the anchor-pusher, when the pusher assembly will be next advanced distally. Optionally, the states are elastically coupled so that such deformation is elastically predisposed to occur when the pushing assembly is sufficiently retracted form the anchor-pusher.

[0287] In some embodiments of the invention, the anchor-pusher deforms so that it cannot axially overlap (over axially overlaps less) with the pushing assembly. Optionally or additionally, the pushing assembly deforms to prevent axial overlap with the anchor-pusher and / or to prevent insertion of a proximal part of the anchor-pusher into an aperture or recess in the pusher assembly. In some embodiments of the invention, a door or plate of the pushing assembly closes over the aperture or recess, preventing insertion of the anchor-pusher proximal part into the aperture or recess in the pusher assembly. Optionally or additionally, the anchor-pusher deforms so it cannot fit into the pushing assembly.

[0288] Several embodiments having different physical structures for the anchor-pusher and the second pusher to allow for a variable deployment of anchors by differing the combined lengths of either the anchor-pusher, the second pusher, or both. This may be accomplished using an overlapswitch mechanism having a designated axial-overlap region within, or external, to a sheath for the pushers. The lengths of the anchor-pusher, second pusher, and the axial-overlap region can vary. In some embodiments of the invention, the anchors and the anchor-pusher are both encased by the sheath, which is used to deliver the anchors to the target tissue.

[0289] A designated axial-overlap region optionally comprises a first axial-overlap region defined on the anchor-pusher and a second axial-overlap region defined on the second pusher. According to some embodiments, an overlap joint between the two pushers comprises the designated axial- overlap region. In another embodiment discussed herein, a moveable faceplate is used to cover the borehole (or other recess) of a rack (so the anchor-pusher cannot fit thereinto) and extend the movement of the anchor-pusher during deployment of the second anchor. In some embodiments of the invention, a protrusion on a proximal end of the sheath deforms the anchor-pusher after deployment of a first anchor. The sheath protrusion can extend the movement of the anchorpusher during deployment of the second anchor as will be described below. Another option is a cam or eccentric plate to deform the anchor-pusher from re-entering the borehole after a first state retraction and therefore extends the effective length of the anchor-pusher as described below. After a first anchor has been deployed a first distance, when the effective length of the anchor-pusher is extended, the second anchor may be deployed a second distance which is larger than the first distance. According to some embodiments, the anchor-pusher is deformed after a first state and interferes mechanically from returning to seat inside the borehole of the rack, as was the case in the first state.

[0290] An overlap- switch mechanism can control the designated axial-overlap region in one or both of the first and second axial-overlap regions. In some embodiments of the invention, the overlap-switch mechanism has two states. In a first state, the overlap- switch mechanism allows or maintains the designated axial-overlap region such that there is no interference in the coupling between the anchor-pusher and the second pusher. This first state is the minimum combined distal length of the two pushers. In the second state, the overlap- switch mechanism reduces the axial-overlap region by mechanically interfering with the axial movement of one pusher relative to other. The reduced axial-overlap region extends the combined lengths of the anchor-pusher and second pusher to a degree sufficient to deploy the second anchor out of the sheath. The second anchor was used to push the first anchor out of the passageway. In the second state, a certain compensation is required to deploy the second anchor sufficiently out of the passageway through the sheath. As noted, additional (e.g., intermediate) states may be provided.

[0291] The anchor-pusher, second pusher, or both can be fashioned from a material that elastically deforms and exhibits memory effects. Nitinol alloy metals are one example that can exhibit this property. For instance, in an overlap joint, on retraction of the second pusher in the proximal direction, one or both of the pushers can deform, or twist, or rotate and cause a misalignment between the pushers during the second state.

[0292] Two or more anchors can be disposed in a sheath, with the anchor-pusher adjacent to the proximal end of the second or third anchor. For deployment of the first anchor, the anchorpusher pushes the second or third anchor, which in turn moves the first anchor out of the sheath for a last-in-first-out (LIFO) assembly. During a first state for deploying the first anchor, the designated axial-overlap region is not altered or reduced, and the first anchor deploys out of the sheath. The anchor-pusher is in a distal position of the sheath

[0293] The sheath can be inserted through a tissue such as, for example, a tom meniscus. In some options, a needle for penetrating tissue is provided through the sheath. Alternatively or additionally, the sheath itself may be sharpened and act as a needle.

[0294] According to some embodiments, the device is placed in a position on the body of a subject. The device is then actuated by moving the actuator in a proximal direction. The anchorpusher and second pusher are displaceable in a distal direction through the sheath deploying the first anchor in a first state, the amount of displacement of the anchor-pusher being sufficient to deploy the first anchor from the sheath. Pushing the anchor-pusher is a second pusher coupling on a designated axial-overlap region between the anchor-pusher and the second pusher, e.g., a pushing of the anchor out of a sheath using an anchor-pusher occurs during the first state.

[0295] Next, a retraction of the second pusher from the anchor-pusher causes a reduction in the axial-overlap region between the anchor-pusher and the second pusher. During the retraction, the anchor-pusher can disengage from the axial-overlap region of the second pusher.

[0296] A deforming of one or both the anchor-pusher and the second pusher causes a misalignment to occur, which interferes with overlap between the designated overlap portions of the two pushers and causes the combined lengths of the anchor-pusher and second pusher to become greater during the second state than they were in the first state. This extension of the combined length can compensate for the length of the second anchor being no longer available as part of the deployment length after the first state, when the second anchor pushes the first anchor out of the sheath. Now, after the deformation and reduced axial overlap, an extension of the combined lengths allows deployment of the second anchor out of the sheath.

[0297] The second state begins by pushing the anchor-pusher using the second pusher, one or both the anchor-pusher and the second pusher having a deformation causing a mechanical interference over the designated axial-overlap region, where the pushing is on a contact-area between the anchor-pusher and the second pusher, the contact-area optionally outside of the designated axial-overlap region. In some embodiments of the invention, the anchor-pusher has a proximal end mounted in a rack with a borehole (or recess) for providing some or all of the axial-overlap region. The depth of the borehole of the rack can be non-uniform to allow for anchor-pusher changes in effective length during the second state of anchor deployment. In some aspects, a kit provides a varying number of racks, and anchor-pusher components to allow for flexible borehole depths for anchor deployments by optional assembly of components in the system.

[0298] According to an aspect of some embodiments of the present invention there is provided a multiple anchor delivery system, comprising: a sheath having a proximal end and a distal end and having a passageway extending therethrough; an anchor-pusher and a second pusher disposed inside the sheath, each pusher element having at least a distal end positioned within the passageway, the distal end of each pusher element sized and shaped to be displaced through the passageway; a first anchor disposed within the sheath, at least a portion of the first anchor positioned distally with respect to the first pusher element; a second anchor disposed within the sheath, proximally with respect to the first anchor; the anchor-pusher element displaceable in a distal direction, into contact with the second anchor, the displacement having a displacement length sufficient to deploy the first anchor; wherein the second pusher element is displaceable in a distal direction, into contact with the anchor-pusher, the displacement having a displacement length sufficient to deploy the second anchor.

[0299] An aspect of some embodiments of the invention relates to an anchor deployment system having multiple anchors deployed in a sheath and a variable length pushing system configured to push the anchors out, optionally with a same amount of axial actuation of the pushing system. Optionally, the pushing system comprises a pushing assembly and an anchor-pusher which can have a varying axial overlap amount when pushing out an anchor. Optionally, the anchor includes a passageway through the anchor and / or attached to an outside of the anchor, optionally providing for folding or bending of the anchor when a suture in the passageway is retracted.

[0300] An aspect of some embodiments of the invention relates to modifying an effective length of an anchor-pusher. In some embodiments of the invention, the effective length is controlled by using a pushing assembly with a variable amount of axial overlap with the anchor-pusher. One or both of the pushing assembly and the anchor-pusher are optionally deformed, for example, elastically deformed, for example, upon retraction of the pushing assembly from the anchorpusher, to interfere with a starting axial overlap between the anchor-pusher and the pushing assembly. In some embodiments, the amount of axial overlap increases after retraction, for example by using a reverse mechanism of deformation which allows greater axial overlap (e.g., by allowing an anchor-pusher to fit in a recess defined in a pushing assembly). An aspect of some embodiments of the invention relates to a multiple anchor delivery system including a pusher element having a deformable distal tip portion. After deployment of a first anchor, the pusher element may be retracted from a first position, in which the distal tip portion is distal to a second anchor, to a second position, in which the distal tip portion is proximal to the second anchor. During retraction of the pusher element, the distal tip portion may be deformed by the second anchor, thereby allowing the distal tip portion to slide alongside the second anchor, as the pusher element is retracted. Optionally, the pusher element includes at least one portion that is wider and / or thicker than the distal tip portion such that, during retraction of the pusher element, the second anchor is prevented from moving proximally due to the at least one wider and / or thicker portion.

[0301] The distal tip portion may have a configuration in which the distal tip portion is curved upward or away from an inner wall of the sheath. Alternatively, the distal tip portion may have an S-shaped configuration. Providing the pusher element with an S-shaped distal tip portion may allow the pusher distal tip to be more elastic or more flexible, thereby potentially allowing the pusher element to be more easily deformed, for example, as discussed herein, according to some embodiments. Additionally, while the S-shaped portion may allow the pusher element to be more flexible, the upper curved portion and the lower curved portion of the S-shape may limit lateral movement of the pusher element within the sheath, as discussed herein, according to some embodiments.

[0302] An aspect of some embodiments of the invention relates to a multiple anchor delivery system, for deployment of a plurality of anchors, the system including a suture configured to be slidingly threaded through each of two anchors, the suture including a slip knot configured to be released by pulling on a first end of the suture, the slip knot configured to not be released by pulling on a second end of the suture, wherein the suture is configured to be tightened between the two anchors by pulling on the first end of the suture. The suture may include: a first portion threaded and extending through a first anchor of the two anchors and extending from the first anchor to a second anchor of the two anchors; a second portion extending between the first anchor and a second anchor of the two anchors and threaded through the second anchor; and a third portion extending from the second anchor, the third portion including the slip knot. Pulling on the first end of the suture may release the slip knot.

[0303] An aspect of some embodiments relates to attaching a biocompatible material such as, for example, a patch, to a soft tissue such as, for example, a tom or partially tom tendon. A patch may be positioned on a tissue to be repaired, and a needle of a deployment device may be inserted through the patch and into the tissue, according to some embodiments. According to some embodiments, a first anchor, having a first passageway suitable for the passage of, for example, a suture, may be deployed through the patch and into the tissue, after which the needle may be withdrawn from the tissue and patch. A second anchor, having a second passageway suitable for the passage of, for example, a suture, may be deployed adjacent the patch, according to some embodiments. The suture may be pulled proximally, thereby tightening the first anchor against the tissue, and optionally bending the first anchor, e.g., into a c-shape or a u-shape, according to some embodiments. Further pulling of the suture in a proximal direction may cause the second anchor to be tightened against the patch, optionally tightening the second anchor against the patch and optionally causing the second anchor to be bent, e.g., into a c-shape or a u- shape, according to some embodiments.

[0304] It may be noted that the deployment of the first and second anchors having a suture extending therethrough (via suture passageways), as discussed herein, will allow a suture to extend through the tissue and the patch, thereby reducing or preventing lateral movement between the tissue and the patch, according to some embodiments. The provision of the first anchor within the tissue and the second anchor on a proximal side of the patch may reduce or prevent axial movement of the patch relative to the tissue, as the second anchor may act as a counterforce against the patch, according to some embodiments. By tightening the suture a predetermined amount, the distance between the first and second anchors and, therefore, the amount of movement between the tissue and the patch, may be controlled, according to some embodiments. Optionally, a certain degree of movement may be achievable by controlling the suture distance between the first and second anchors. For example, it may be advantageous to have movement of a certain amount such as, for example, from 0.1-3mm. This may promote healing at the surgical site, by preventing tension or abrasion between the patch and the upper surface of the tissue and avoiding possible necrosis of the tissue which may result, for example in cases where the suture is overtightened.

[0305] These and other aspects of some embodiments of the invention are described herein, with reference to the accompanying drawings.

[0306] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details set forth in the following description or exemplified by the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0307] Reference is now made to FIG. 1, which is a simplified sectional view illustration of the multiple anchor delivery system and an enlargement view of a distal end thereof, shown in an initial operative orientation. A system for delivery of multiple anchors in accordance with some embodiment is shown in Figs. 1-4. The system shown includes a sheath having a passageway therethrough, a pusher element displaceable within the passageway, and first and second anchors displaceable by the pusher element along the passage and deployable from the passageway.

[0308] It is seen in FIG. 1 that a multiple anchor delivery system in accordance with some embodiments optionally includes a handle mechanism 102 and a delivery assembly which in the shown embodiment is a needle assembly 104, which is connected to the handle mechanism 102. The needle assembly 104 has a distal end 106 and a proximal end 108, which is connected to the handle mechanism 102. The handle mechanism 102 and the needle assembly 104 are optionally arranged along a mutual longitudinal axis 109.

[0309] The handle mechanism 102 has a housing 110, which is optionally made from plastic by injection molding. The housing 110 defines a handle which may be grippable by a user and is configured to contain the mechanism responsible for delivery of anchors through the needle assembly 104.

[0310] It is particularly seen in FIG. 1 that, according to the embodiment shown, a trigger button 112 resides partially within the housing 110, whereas the trigger button 112 has a gripping portion 114 for use by the finger of the user and an elongated toothed portion 116 for interaction with a pinion 118. Optionally, a distally extending projection 119 defining a shoulder may be formed at the distal end of the toothed portion 116. Alternatively, in some embodiments, a proximally extending projection defining a shoulder may be formed at the distal end of the toothed portion 116.

[0311] The pinion 118 also interacts with a rack 120. The rack 120 optionally has a first wall, which optionally includes a plurality of indents 122, for interaction with an optional leaf spring 124. The rack 120 further has a second wall, which is configured for slidable mounting of a support element 126 thereon. The rack 120 optionally has a projection 127 that is configured for fixed connection to a pusher element 130, which is configured to displace the anchors throughout the needle assembly 104. It is appreciated that the pusher element 130 is optionally solid and optionally made of stainless steel. Optionally, the pusher element 130 is not solid and may be optionally made of other material(s).

[0312] It is seen that the rack 120 is optionally disposed in parallel and may be spaced from elongated toothed portion 116 of trigger button 112.

[0313] It is seen in FIG. 1 that the support element 126 is optionally slidably coupled with the pusher element 130.

[0314] A support hub 131 is optionally formed within housing 110 of handle mechanism 102. A needle depth limiter 132 is optionally connected to the support hub 131. The needle depth limiter 132 optionally includes a hub portion 134, which is rigidly coupled to the housing 110 and an elongated hollow cannula 136, extending along longitudinal axis 109.

[0315] It is further seen in FIG. 1 that an optionally flexible safety latch 140 is coupled to the support hub 131 and extends proximally thereof. It is seen that in this initial operative orientation the safety latch 140 is optionally supported against the shoulder formed by projection 119.

[0316] The needle assembly 104 includes a hollow needle 150, having a proximal end 152 and a distal sharpened end 154. The hollow needle 150 also defines an inner surface 156 and an interior volume 158. It is appreciated that the hollow needle 150 is optionally made of stainless steel.

[0317] It is seen particularly in the enlargement view of FIG. 1 that the pusher 130 is positioned within the interior volume 158 of needle 150 and extends distally from the proximal end 152 towards the distal end 154 of needle 150. The pusher 130 optionally defines a distally facing end surface 159.

[0318] An anchor stopper 160 is optionally located within the interior volume 158 of needle 150, at the proximal portion of the needle 150 and optionally defines a distally facing surface 162.

[0319] It is a particular feature of some embodiments of the present invention that a first anchor 170 is optionally solid and is disposed within the interior volume 158 of needle 150 distally to the pusher 130. The first anchor 170 has a proximal end 172 and a distal end 174, and it is seen that proximal end 172 may abut the distally facing end surface 159 of the pusher 130 in this initial operative orientation. It is noted that the first anchor is optionally soft, made of Polyethylene or Polypropylene. It is appreciated that alternatively, the anchor can be rigid. It is additionally noted that the first anchor 170 may be bio-absorbable.

[0320] It is a further particular feature of some embodiments of the present invention that a second anchor 180 is disposed proximally with respect to the first anchor 170 and the second anchor is optionally tubular, defining an inner surface 182. It is noted that the second anchor is optionally soft, made of Polyethylene or Polypropylene. It is appreciated that alternatively, the anchor can be rigid. It is additionally noted that the second anchor 180 may be bio-absorbable.

[0321] The second anchor 180 is threaded over the pusher 130, so that the inner surface 182 of the second anchor engages the outer surface of the pusher 130. The second anchor 180 has a proximal end 184 and a distal end 186. The proximal end 184 of the second anchor 180 is optionally disposed in the vicinity or abuts the distally facing surface 162 of the anchor stopper 160. The distal end 186 of the second anchor 180 is disposed distally to the proximal end 172 of the first anchor 170. Alternatively, in some embodiments, the distal end 186 of the second anchor 180 is disposed proximally to the proximal end 172 of the first anchor 170, for example, as shown in FIG. 1.

[0322] It is seen that the distal end of elongated hollow cannula 136 of the needle depth limiter 132 is disposed proximally of the distal sharpened end 154 of the hollow needle 150. Since the outer diameter of the cannula 136 is substantially larger than the outer diameter of the hollow needle 150, the penetration depth of the needle 150 into the tissue of the patient is limited to the extent to which the needle projects distally with respect to the distal end of cannula 136.

[0323] It is seen in FIG. 1 that in this initial operative orientation, trigger button 112 is disposed in an intermediate position. In this position, the rack 120 is also disposed in an intermediate position, in which the leaf spring 124 is seated within one of the indents 122 formed in rack 120.

[0324] It is a particular feature of some embodiments of the present invention that actuation of the trigger button 112 optionally affects displacement of the pusher 130 in the following manner: The user places his finger on gripping portion 114 and displaces the trigger button 112 proximally, thereby elongated toothed portion 116 of the trigger button 112 activates pinion 118, which in turn displaces the rack 120 distally due to the interaction between the rack 120 and the pinion 118. Since the pusher 130 is connected to rack 120, the pusher 130 is thereby also displaced distally.

[0325] During displacement of the rack 120, the leaf spring 124 is being positioned within a subsequent one of the indents 122, thereby potentially providing tactile indication to the user, indicating that the trigger button 112 is positioned in a different one of its operative orientations.

[0326] It is a further particular feature of some embodiments of the present invention that in this initial operative orientation the safety latch 140 is supported against the shoulder formed by projection 119 of the trigger button 112, which prevents distal displacement of the trigger button 112. This is a safety feature intended to prevent inadvertent deployment of anchor from the system 100. In this initial operative orientation, the trigger button 112 can only be displaced in a proximal direction, which is not intuitive for the user.

[0327] It is seen in FIG. 1 that in this initial operative orientation, the first anchor 170 is optionally disposed at the vicinity of the distal sharpened end 154 of the hollow needle 150, whereas the proximal end 172 of the first anchor 170 optionally abuts the distally facing end surface 159 of the pusher 130. The second anchor 180 is proximally spaced apart from the first anchor 170 in this initial operative orientation and is threaded over the outer surface of the pusher 130. The proximal end 184 of the second anchor 180 is optionally slightly distally spaced apart from distally facing surface 162 of the anchor stopper 160. Reference is now made to FIG. 2, which is a simplified sectional view illustration of the multiple anchor delivery system 100 and an enlargement view of a distal end thereof, shown in a first anchor deployment operative orientation.

[0328] It is seen in FIG. 2 that in this first anchor deployment operative orientation, trigger button 112 is disposed in a proximal position. In this position, the rack 120 is disposed in a distal position, in which the leaf spring 124 is seated within another one of the indents 122 formed in rack 120.

[0329] The user displaced the trigger button 112 proximally, thereby elongated toothed portion 116 of the trigger button 112 activated pinion 118, which in turn displaced the rack 120 distally due to the interaction between the rack 120 and the pinion 118. Since the pusher 130 is connected to rack 120, the pusher 130 was thereby also displaced distally.

[0330] During displacement of the rack 120, the leaf spring 124 is being positioned within a subsequent one of the indents 122, thereby potentially providing tactile indication to the user, indicating that the trigger button 112 is now positioned in the proximal position.

[0331] It is a further particular feature of some embodiments of the present invention that in this first anchor deployment operative orientation, the safety latch 140 disengaged from the shoulder formed by projection 119 of the trigger button 112, thus no longer preventing distal displacement of the trigger button 112. In this first anchor deployment operative orientation, the trigger button 112 can be displaced both in proximal and in distal directions.

[0332] It is seen in FIG. 2 that in this first anchor deployment operative orientation, the first anchor 170 is optionally disposed distally with respect to the distal sharpened end 154 of the hollow needle 150, whereas the proximal end 172 of the first anchor 170 optionally abuts the distally facing end surface 159 of the pusher 130. The first anchor 170 is now deployed out of the interior volume 158 of the hollow needle 150 and within the tissue of the patient. The second anchor 180 is proximally spaced apart from the first anchor 170 in this first anchor deployment operative orientation and is still threaded over the outer surface of the pusher 130. The proximal end 184 of the second anchor 180 is optionally more distally spaced apart from distally facing surface 162 of the anchor stopper 160 than in the initial operative orientation.

[0333] Reference is now made to FIG. 3, which is a simplified sectional view illustration of the multiple anchor delivery system 100 and an enlargement view of a distal end thereof, shown in a retraction operative orientation.

[0334] It is seen in FIG. 3 that in this retraction operative orientation, trigger button 112 is disposed in a distal position. In this position, the rack 120 is disposed in a proximal position, in which the leaf spring 124 is seated within yet another one of the indents 122 formed in rack 120. The user displaced the trigger button 112 distally, thereby elongated toothed portion 116 of the trigger button 112 activated pinion 118, which in turn displaced the rack 120 proximally due to the interaction between the rack 120 and the pinion 118. Since the pusher 130 is connected to rack 120, the pusher 130 was thereby also retracted proximally.

[0335] During displacement of the rack 120, the leaf spring 124 is being positioned within a subsequent one of the indents 122, thereby potentially providing tactile indication to the user, indicating that the trigger button 112 is now positioned in the distal position. Alternatively, in some embodiments, proximal movement of the rack 120 from the position in FIG. 2 to the position in FIG. 3 results in the leaf spring being repositioned from being within a rightmost indent 122 (FIG. 2) to being within a leftmost indent 122 (FIG. 3).

[0336] It is a further particular feature of some embodiments of the present invention that in this retraction operative orientation, the safety latch 140 remains disengaged from the shoulder formed by projection 119 of the trigger button 112, thus no longer preventing distal displacement of the trigger button 112.

[0337] It is seen in FIG. 3 that in this retraction operative orientation, the first anchor 170 remains deployed outside of the hollow needle 150.

[0338] It is a particular feature of some embodiments of the present invention that during proximal retraction of the pusher 130, the second anchor 180 is released from the pusher 130 and is not mounted over the pusher 130 anymore, rather the proximal end 184 of the second anchor 180 abuts and is supported against distally facing surface 162 of the anchor stopper 160 in this retraction operative orientation, thus preventing proximal displacement of the second anchor 180.

[0339] It is seen in FIG. 3 that the distally facing end surface 159 of the pusher 130 is now proximally spaced from the proximal end 184 of the second anchor 180.

[0340] In this retraction operative orientation, the pusher 130 is ready for deploying the second anchor 180 in a manner similar to the deployment of the first anchor 170.

[0341] It is noted that an additional element may be formed on the distal end of pusher 130, such as, for example, a hook, to ascertain release of the second anchor 180 off the outer surface of the pusher 130 and loading thereof for deployment into the tissue of the patient.

[0342] Reference is now made to FIG. 4, which is a simplified sectional view illustration of the multiple anchor delivery system 100 and an enlargement view of a distal end thereof, shown in a second anchor deployment operative orientation.

[0343] It is seen in FIG. 4 that in this second anchor deployment operative orientation, trigger button 112 is disposed in a proximal position again, similar to the position shown in FIG. 2. In this position, the rack 120 is disposed in a distal position, in which the leaf spring 124 is seated within another one of the indents 122 formed in rack 120.

[0344] The user displaced the trigger button 112 proximally, thereby elongated toothed portion 116 of the trigger button 112 activated pinion 118, which in turn displaced the rack 120 distally due to the interaction between the rack 120 and the pinion 118. Since the pusher 130 is connected to rack 120, the pusher 130 was thereby also displaced distally.

[0345] During displacement of the rack 120, the leaf spring 124 is being positioned within a subsequent one of the indents 122, thereby potentially providing tactile indication to the user, indicating that the trigger button 112 is now positioned in the proximal position.

[0346] Alternatively, in some embodiments, proximal movement of the rack 120 from the position in FIG. 3 to the position in FIG. 4 results in the leaf spring being repositioned from being within a leftmost indent 122 (FIG. 3) to being within a rightmost indent 122 (FIG. 4).

[0347] The safety latch 140 remains disengaged from the shoulder formed by projection 119 of the trigger button 112, thus permitting displacement of the trigger button 112 in both proximal and distal directions.

[0348] It is seen in FIG. 4 that in this second anchor deployment operative orientation, the second anchor 180 is pushed distally due to distal displacement of the pusher 130 and due to engagement of distally facing end surface 159 of pusher 130 and the proximal end 184 of the second anchor 180. The second anchor 180 is now disposed distally with respect to the distal sharpened end 154 of the hollow needle 150 and is now deployed out of the interior volume 158 of the hollow needle 150 and within the tissue of the patient.

[0349] It is a particular feature of some embodiments of the present invention that the method of delivering multiple anchors into the tissue of the patient optionally includes delivery of the system 100 into the desired surgical location, displacement of a trigger button 112 in a first direction to deploy the first anchor 170, thereafter displacement of the trigger button 112 in a second direction, which is opposite to the first direction, to load the second anchor 180; and thereafter another displacement of the trigger button 112 in the first direction to deploy the second anchor 180. In some embodiments, the first direction is a proximal direction and the second direction is a distal direction.

[0350] It is noted that the trigger button 112 described with reference to FIGs. 1 - 4 is displaced linearly, however another type of trigger button may be used, such that can be alternatively rotated in order to advance or retract the pusher and thereby optionally affect deployment of anchors. An exemplary rotary trigger is discussed further herein with reference to FIGs. 5-23E. It is appreciated that the system 100 provides an indication to the user that the second anchor 180 is loaded and ready to be deployed.

[0351] It is appreciated that, alternatively, the system 100 can deploy the first anchor 100 and thereafter during retraction of the pusher, the second anchor 180 that was initially disposed out of the interior volume 158 of the needle 150 is loaded onto the pusher 130 and is now ready for deployment. For example, needle 250 may include a recess on its inner surface, and second anchor 280 may be pushed into the recess before or after pusher element 230 is retracted to its most proximal position.

[0352] Further alternatively, both first anchor 170 and second anchor 180 may be loaded together in parallel, and each of the anchors is optionally covered by a resilient cover. Both anchors are loaded together into a single hollow needle 150 and a driving assembly having a first pusher that deploys the first anchor 170 and a second pusher that deploys the second anchor 180.

[0353] It is noted that the system 100 is optionally configured to be disposable. After use, the device may be disposed of in a disposal container approved by the local authority.

[0354] It is noted that the trigger button 112 described with reference to FIGs. 1 - 4 is displaced linearly. However, another type of actuator may be used, such as, for example, a roller 212, that may be rotated in order to advance or retract the pusher and thereby optionally affect deployment of anchors. An exemplary rotary trigger is discussed further herein with reference to FIGs. 5- 23E.

[0355] SOME EXEMPLARY EMBODIMENTS

[0356] With reference to FIG. 5 there is shown an exemplary multiple anchor delivery system 200, in accordance with some embodiments of the invention. The system includes a multiple anchor delivery device 204 including a handle 202, a cannula 236, and a sheath 250.

[0357] With additional reference to FIG. 6, there is shown an exploded view of system 200 shown in FIG. 5, wherein some aspects of some components of the system may be more clearly shown. The handle 202 is shown having a housing 210 with a proximal end 213 and a distal end 215, the housing 210 including a right housing portion 210R and a left housing portion 210L. Components to be at least partially housed in the housing 210 include a roller 212, a rack 220, a bobbin 300, and a locking element 242. Also shown are a sheath 250, a pusher element 230, an optional suture holder 240, a cannula 236, and a delimiter 232, all of which are discussed further herein with regard to FIGs. 17A-22C.

[0358] In accordance with some embodiments, some of the components shown in Fig. 6 may be omitted or replaced by other components. For example, suture holder 240 may be omitted, and / or roller 212 and / or the rack 220 may be replaced with other components that are coupled together to drive the pusher element distally and proximally through the sheath.

[0359] Optionally, in some embodiments, the bobbin 300 may be replaced by another mechanism for storing the length of suture that extends from the first anchor into the handle. Optionally, there is no mechanism for storing the length of suture, and the length of suture may be stored inside the housing 210 or at least partly extends outside the housing.

[0360] FIGs. 13A-D illustrate an exemplary sheath 250 in accordance with embodiments of the invention. It will be appreciated by persons skilled in the art that “sheath” may be used as a general term to indicate any elongated component having a hollow lumen, for example, a lumen with a circular or ovate cross-section. The term “needle” is generally used to describe a component that is inserted into the human body. A “needle” may, therefore include a “sheath” or other tube and optionally includes a sharpened end, for example, as discussed herein.

[0361] In the embodiment shown, sheath 250 may be configured as a hollow needle having a circular cross-section. Needle 250 has a proximal end 252 and a distal end 254 and may be fabricated of, for example stainless steel of grade SS304, although other materials are possible. Needle 250 may have a length in the range of, for example, 176.3- 176.7mm; an outer diameter in the range of, for example, 1.8-2.55mm; and an inner diameter in the range of, for example, 1.15- 1.5mm.

[0362] The distal end 254 is optionally provided with a sharpened tip 253 configured to penetrate tissue, such as, for example, a hypodermic needle. A portion of needle 250, adjacent needle distal end 254, may have a lateral opening formed therein, such as, for example, slot 155, optionally opposite the side having the sharpened tip 253. Slot may have a length in the range of, for example, 29-30mm and a width in the range of, for example, 0.8-0.9mm.

[0363] Slot 255 is optionally large enough to accommodate the passage therethrough of suture loops 288a-b and suture free end 288c, for example, as discussed further herein, for example with regard to FIGs. 16A-C. Optionally, the distal end 254 of needle 250 is provided with laser markings, for example, laser markings of a type known in the art, which may be used as a reference to indicate a depth of insertion of the needle 250 into a tissue. Near the needle proximal end, there may be provided a pair of indentations 257. These and / or other optional features of the needle will be discussed further herein.

[0364] While, in the embodiment shown, needle 250 is shown as having a straight configuration, it is to be understood that, optionally and alternately, the needle distal end 254 may be curved, as known in the art. Needle 250 may have a curvature having a radius of curvature in the range of, for example, 99- 100mm; for a length in the range of, for example, 20-22mm; and a height in the range of, for example, 2-3mm.

[0365] Optionally, the needle may be bendable, for example, which may prevent damage to tissue. Optionally, the needle may have more than one curve and / or curve in more than one plane. It will be appreciated by person skilled in the art that if the needle is curved the pusher element is optionally thick enough and flexible enough to avoid buckling as it is displaced along the curved needle.

[0366] FIGs. 14A-B show an exemplary pusher element 230 in accordance with some embodiments of the invention. Pusher element 230 may be configured generally as an elongated rod 320 having a proximal end 324 and a distal end 326. Pusher element 230 may have a length in the range of, for example, 197- 197.2mm and an outer diameter in the range of, for example, 1.1 -1.2mm. Pusher element 230 is optionally a solid component, and is optionally made of stainless steel, for example, of grade SS302 However, other configurations and other materials for fabricating pusher element 230 are conceivable. Optionally, pusher element 230 has a circular cross-section, although other configurations are conceivable, such as, for example, elliptical.

[0367] A pusher tip 322 may be provided at the pusher proximal end 324, the tip 322 optionally being compressible. Optionally, pusher element 230 has a widened portion 323 at tip 322. Optionally, widened portion 323 may be compressible. The pusher element is optionally flexible enough to be resistant to buckling and to be able to transfer a force required to overcome friction between each of the anchors 270 / 280 and an inner surface 256 of the needle 250. Optionally, the needle inner surface 256 is coated to reduce such friction.

[0368] According to some embodiments, the pusher element may be provided with an indentation or notch for retaining therein a second anchor. Optionally, the pusher element distal end and / or the second anchor may be compressible. When the pusher element is retracted, for example, as discussed herein with regard to FIG. 20A, the second anchor is prevented from moving proximally by a barrier positioned within the passageway such as, for example, a narrowing of the passageway and / or any structural component that interferes with proximal movement of the second anchor in the passageway. As the pusher element is retracted, a portion of the pusher element distal to the indentation slides over the second anchor so that the second anchor may be released from the pusher element indentation, the pusher element distal end being proximal to the second anchor proximal end. Then the compressed pusher element distal end and / or second anchor may decompress such that the pusher element is wide enough to push the second anchor out of the needle, for example, as discussed below. According to some embodiments, the sheath may be provided with a recess or notch for the second anchor, and the pusher element may slide past the second anchor when deploying the first anchor. When the pusher element is retracted, it may release the second anchor from the needle recess, by no longer blocking it from decompressing into the needle lumen, thereby potentially allowing the second anchor to be positioned for subsequent deployment.

[0369] FIGs. 16A-C show an exemplary first anchor 270, having proximal end 272 and distal 274, and an exemplary second anchor 280, having a proximal end 284 and a distal end 286. In the embodiment shown the first anchor 270 may be generally cylindrical and may be solid, while the second anchor 280 may be generally cylindrical and may be hollow, for example, having an interior 281 bounded by an inner surface 282 of second anchor 280. However, it will be appreciated by persons skilled in the art that, optionally, the anchors may have other configurations, for example, as discussed herein.

[0370] Each of first anchor 270 and second 280 may be fabricated from 8-16 braided or woven strands of USP 4-0 or 2-0 FiberWire™, although other materials and / or sizes may be usable such as, for example, ultra-high molecular weight polyethylene (UHMWP), polyester polypropylene, or silicone elastomer coating, optionally dyed using D&C Blue No. 6, D&C Green No. 6, and / or Logwood Black dyes, as known in the art.

[0371] Optionally, either or both of anchors 270 and 280 may include a silicone elastomer coating. Each of anchors 270 and 280 has a length in the range of, for example, l l-13mm; and an outer diameter in the range of, for example, 1.2- 1.4mm. Second anchor 280 may have an inner diameter in the range of, for example, 0.65-0.86mm. A length 288 of suture material may extend through the anchors, optionally having a small portion 288a forming a small loop between first anchor proximal end 272 and second anchor distal end 286, a large portion 288b forming a large loop between the first anchor distal end 274 and the second anchor proximal end 284, and a free end 388c extending proximally from the first anchor proximal end. The length 288 of suture material may be formed of, for example, 2-0 FiberWire™, although other materials may optionally be used. Optionally, the length of the small portion 288a of suture material is 50mm, the length of the large portion 288b of suture material is 220mm, and the length of the suture free end 288c is 300mm, although other lengths may be used.

[0372] One or both of first anchor 270 and second anchor 280 are optionally soft and / or flexible enough so as not to cause damage to tissue or vessels in the vicinity of the implant. Optionally, either or both of first anchor 270 and second anchor 280 may be rigid. Optionally, either or both of first anchor 270 and second anchor 280 may be bio-absorbable, optionally maintaining mechanical strength of the anchor or anchors until tissue 206 is healed such as, for example, 1-3 months.

[0373] For example, as discussed herein, in accordance with some embodiments, optionally, the first anchor may be a solid anchor optionally having a blind bore at a proximal end thereof, into which a pusher element distal end may be inserted prior to deployment of the first anchor. In this embodiment, the pusher element distal end may not contact the first anchor proximal end, as in the embodiment shown in FIG. 18 A, but instead the pusher element distal end may contact the end surface of the blind bore within the first anchor.

[0374] In accordance with a further alternative embodiment, the first anchor 270 may be hollow, and the pusher element may be disposed proximal relative to the first anchor, the pusher element configured to contact the first anchor proximal end, to deploy the firs anchor. Optionally or additionally, the pusher element may be disposed partly within the interior of the first hollow anchor, the pusher element having a distal end configured to engage the inner surface of the first anchor, thereby potentially deploying the first anchor when the pusher element is moved distally.

[0375] In some embodiments of the invention, second anchor 188 may optionally be replaced with a solid anchor which is optionally compressible, for example, as discussed herein with regard to FIGs. 16A-C.

[0376] In some embodiments, the anchors are provided with suture portions which allow tightening of the anchors against the tissue after deployment of the anchors. Optionally, suture material is threaded at least partly through the interior of second anchor 280. Optionally, suture material may be threaded at least partly through the material of first anchor 270 and / or the material of the second anchor 280.

[0377] Optionally, each of a first anchor 270 and a second anchor 280 may have a collar or channel (not shown), extending alongside an outer surface of the anchor, the channel configured for retaining therein a portion of suture material 288. The anchors 270 and 280 may be positioned within the needle 250 such that the suture portions 288a-b and suture free end 288c and / or the channels protrude out of the needle slot 255.

[0378] It should be noted that, depending on the shape of the bore through the hollow anchor 280 and the shape of an opening into the bore of the second anchor, the second anchor 280 may be flexible enough and the distal end 324 of pusher element 230 may be narrow enough so that the pusher element may pass through the interior 281 of the second anchor 280. In addition, distal end 324 of the pusher element 230 may be wide enough so that, after retraction out of the second anchor 280, the pusher element will push the second anchor distally. This is discussed further below. Referring to FIGs. 8A-E there are shown a rack 220, in accordance with some embodiments of the invention. For example, as discussed further with regard to operation of the system 200, rack 220 may be coupled to the roller for displacing the pusher element 230 through the needle passageway 264. Rack 220 has a proximal end 224 and a distal end 226. The upper surface 221 of rack 220 may be provided with a plurality of evenly spaced teeth 225 extending along the length of the rack. While, in the embodiment shown, rack 220 is provided with two rows of teeth, it will be appreciated by persons skilled in the art that, optionally, rack 220 may have a single row of teeth extending along at least a portion of the length thereof.

[0379] According to some embodiments, a lower surface 223 of rack 220 may be provided with a recess 228 having distal and proximal surfaces 228a-b, near the rack proximal end 224. The rack 220 may also be provided with flexible strips 229 which appear as curved portions protruding from the sides of the rack. The middle of each strip 229 has a v-shaped projection 229a extending away from the rack 220. The rack 220 may include a plurality of support portions 218a-d extending out of the sides of the rack 220, where support portions 218a-b are positioned at the rack distal end and support portions 218c-d are positioned near the rack proximal end. One or more of these elements may be described in more detail herein.

[0380] With reference to FIGs. 9A-C there are shown a plurality of exemplary rollers 212a-c, in accordance with some embodiments of the invention. A roller 212 is a hand-movable component may be coupled to the rack 220 so that movement of the roller actuates the rack to be displaced proximally or distally within the housing, for example, as discussed further with regard to operation of the device. Each roller 212a-c may have a generally circular configuration with a circular bore 381 disposed at the center thereof. Each roller 212a-c includes an operative portion 380 optionally on approximately half of a respective outer periphery 383a-c thereof, the operative portion 380 defined by a plurality of optionally evenly spaced teeth 382. The rollers 212a-c may also include a respective gripping portion 384a-c on approximately the remaining half of the outer periphery of the roller. In some embodiments (FIGs. 9A-B) the gripping portion 384a-b may include a plurality of evenly spaced teeth 386a-b similar to those of the operative portion 382. However, the gripping portion 384c may, alternatively, include fewer teeth such as, for example, only three teeth 386c (FIG. 9C), which are optionally evenly spaced along the gripping portion 384. It should be noted that the teeth 382 of operating portion are optionally configured so as to be engageable with corresponding teeth 225 of rack 220 (FIG. 4).

[0381] A roller 212c may optionally be provided with a peg 392 projecting out of the surface 391 of the roller 212a-c, which may be used for positioning the roller within the housing. A roller 212a-c may optionally be provided with position markings 390a-c for indicating to a user the rotational position of the roller. For example, as shown in FIG. 9B, roller 212b may have position markings “1,” “2,” and “3.” Optionally, a roller 212a-c may be provided with markings 390D-N-R, for example, to indicate respective deployment, neutral, and retracted positions, or with any other markings that indicate to the user a position of the roller. Optionally, an electronic circuit may be provided to indicate to the user the current position of the roller 212.

[0382] With reference to FIGs. 15D-E there is shown an exemplary cannula 236, in accordance with some embodiments of the invention. Cannula 236 may be fabricated from PTFE and has a length in the range of, for example, 135- 137mm; an outer diameter in the range of, for example, 3.5-3.6mm; and an inner diameter in the range of, for example, 3.3-3.4mm.

[0383] Cannula 236 is positioned over the needle and over the suture holder, if it is present. The cannula distal end 235 may be moved relative to the needle distal end 254, to adjust the length of the needle that extends out of the cannula. This is discussed further herein with regard to delimiter 360. It should be noted that the inner diameter of the cannula 236 must be larger than the outer diameter of the needle 250, such that the needle 250 may be inserted into the cannula 236, optionally with a suture holder 240 in between the cannula inner surface and the needle outer surface.

[0384] FIGs. 15A-C show an exemplary suture holder 240, in accordance with some embodiments of the invention. Suture holder 240 is optionally utilized to retain suture loops 288a-b adjacent needle 250, and optionally to prevent tangling of the suture material as the anchors are displaced within the needle 250. After anchors 270 and 280 (FIGs. 16A-C) have been inserted into the needle 250, with the suture loops 288a-b extending through slot 255, a suture holder 240 may be positioned over the needle for retaining the sutures therein. Optionally, suture holder 240 may be omitted from the system 200.

[0385] Suture holder 240 is configured as a generally cylindrical tube having a distal end 242 and a proximal end 244. Suture holder 240 may be fabricated of PTFE and has a length in the range of, for example, 130- 132mm; an inner diameter in the range of, for example, 2.6-.2.8mm; and an outer diameter in the range of, for example, 3.0-3.2mm; with a cutaway portion extending 5-6mm from the suture holder proximal end 244.

[0386] At its proximal end 244, suture holder has a cutaway portion such that the proximal end is provided with a semicircular arm 243 having a horizontal edge 245. Edge 245 intersects a vertical edge 241 at a right angle. The suture holder 240 will be discussed further herein with regard to assembly of components of the system 200. It should be noted that the inner diameter of the suture holder 240 must be larger than the outer diameter of the needle 250, such that the needle 250 may be inserted into the cannula 236. In addition, the inner diameter of the suture holder should be large enough so that there is enough room in between the inner surface of the suture holder and the outer surface of the needle for the presence of suture loops 288a-b. With reference to FIGs. 11A-D there is shown an exemplary locking element 342 which may be provided as part of an optional locking mechanism 340, in accordance with embodiments of the invention. This is discussed further herein. The locking element 342 may have a generally circular body 343 having a generally circular opening 344 therethrough. A locking bar 346 configured as a long arm and a short arm 348 may extend from the circular body 343. A peg 350 may project out of the surface of the locking bar 346, the peg having been formed during manufacture of the locking element 324. Locking element 342 will be discussed further herein with regard to FIGs. 17A-22C.

[0387] FIGs. 12A-E illustrate an exemplary needle length delimiter 360, in accordance with embodiments of the invention. Delimiter 360 may include a hub 362 and a circular collar 364. A pair of arms 361 extends from the hub 362, away from the collar 364. A slider 366 may extend proximally from the hub 362, the slider having an indicator peg 368 thereon. The delimiter 360 will be discussed further herein with regard to assembly of system 200. The delimiter 360 may be fabricated from any suitable material such as, for example, polytetrafluoroethylene (PTFE). Optionally, delimiter 360 may be omitted from system 200.

[0388] FIGs. 10A-D illustrate an exemplary bobbin 300 according to some embodiments of the invention. Bobbin 300 optionally includes a spool 302 bounded on either side by flanges 304. A bore 306 may extend through spool 302. Spool 302 is provided with a rod 308 extending through the spool. The rod is optionally provided with grooves 310 at either end thereof. The bobbin will be discussed further herein with regard to assembly of system 200.

[0389] With further reference to FIG. 7A-E, there are shown further details of an exemplary right half portion 210R of a housing 210, in accordance with some embodiments of the invention. Housing 210 may be fabricated of acrylonitrile butadiene styrene (ABS), although other materials are possible.

[0390] The inner wall 290 of right housing portion 210R may be provided with a pair of parallel flanges, an upper flange 292a and a lower flange 292b, between which there may be situated projections 296a and 296b. A first recess 222a may be formed between flanges 292a and 292b, proximal to projection 296a; a second recess 222b may be formed between flanges 292a and 292b, between projections 296a and 296b; and a third recess 222c may be formed between flanges 292a and 292b, distal to projection 296b. Also on the inner wall 290 of right housing portion 210R there may be provided a roller mounting peg 299, locking element stops 295a and 295c, a bobbin holder 298, stops 293a-b, and a locking element peg 294. It may be noted that stop 295a is configured as a curved portion projecting out of housing inner wall 290, the curved portion having a small knob 295b at its upper end. Near the housing distal end 215 there may be provided clamping bars 297. These elements will be discussed further herein with regard to assembly and operation of system 200.

[0391] It will be appreciated by persons skilled in the art that, optionally, a left housing portion (not shown) may be formed similar to housing portion 210R, but with components in a laterally reversed configuration. The left and right housing portions 210L-R may be configured to be snap fitted together, or to be otherwise joined, for example, by being glued or screwed together, as known in the art, to form a housing 210.

[0392] The housing 210 may be fabricated from any suitable material such as, for example, plastic, optionally by injection molding. The housing 210 may be configured to partly contain a mechanism responsible for delivery of anchors through a tissue, for example, as discussed herein with regard to assembly and operation of system 200.

[0393] ASSEMBLY OF COMPONENTS OF THE SYSTEM

[0394] In accordance with some embodiments, system 200 may be assembled as follows: First the proximal end 326 of pusher element 230 may be inserted through the distal end 286 of hollow anchor 280. It may be noted that the inner surface 282 of the second anchor 280 may or may not engage an outer surface of the pusher element 230.

[0395] The pusher element proximal end 326 may then be inserted through the distal end 254 of a needle 250 until it extends out of the needle proximal end 252, and the hollow anchor may be positioned within the needle 250, optionally with suture loops 288a-b positioned outside the needle slot 255. Then the first anchor may be inserted into the needle distal end 254, optionally with the suture loops 288a-b positioned outside the needle slot 255, and the suture free end 288c optionally extending proximally within the needle. Optionally, the small and large suture loops 288a-b may be adjusted such that they have the desired measurements, for example, as discussed herein with regard to FIGs. 16A-C. Optionally, the suture free end 288c may be twisted around the large suture loop 288b, so that a knot may be formed after deployment of the anchors 270 and 280, for example, as discussed herein. It should be noted that, in this configuration, the first anchor 270 may be disposed distally relative to the pusher element distal end 324, and that the second anchor 280 may be disposed proximal to the proximal end 272 of the first anchor 270. The pusher element proximal end 326 may then be inserted into bore 227 in rack 220 and attached thereto, for example, by a set screw, making sure that the needle is positioned with the slot on the same side as the teeth 225 of the rack 220.

[0396] Needle proximal end 252 may be inserted into the distal end 242 of a suture holder 240, and the suture holder may be passed over the needle, optionally until almost all of the needle slot 255 extends past the suture holder distal end 242. Optionally, approximately 2-3 mm of the needle slot 255 is covered by the suture holder 240.

[0397] A locking element 342 may be positioned relative to rack 220 such that the locking bar 346 is disposed within the recess 228 in rack 220. Then the rack and locking element are positioned within a half portion of a housing 210, e.g., right housing portion 210R, with rack support portions 218b and 218d disposed in recesses 222a and 222c, between housing flanges 292a and 292b; with small arm 348 on locking element 342 below stop 295a in housing 210, and with cannula positioned within housing hub 231.

[0398] In some embodiments, at this point the suture holder 240 may be adjusted so that the semicircular arm 243 is positioned inside the right portion of housing collar 231 in housing portion 21 OR, with the semicircular arm oriented such that it forms a complete circle together with the right portion of collar 231, and with vertical edge 241 of suture holder 240 abutting the edge 233 of housing collar 231. This ensures that the suture free end 288c passes through the circle formed by the semicircular arm 243 and the right portion of housing collar 231, thereby potentially preventing possible accidental closure of the housing portions 210L-R on the suture free end 288c.

[0399] The suture free end 288c may be optionally threaded through the bore 306 in bobbin 300 and the suture may be wound around bobbin spool 302, after which bobbin may be positioned in housing portion 210R, with bobbin rod 308 in holder 398 of right housing portion 210R. The portion of suture free end 288c that extends between the cannula proximal end 237 and the spool 302 should be positioned within the housing hub 231. The bobbin may be wound tighter, if desired, optionally by inserting a tool into groove 310 at the end of rod 308.

[0400] A roller, such as, for example, roller 212c may be positioned in the right housing portion 210R with opening 381 on the roller mounting peg 299 in right housing portion 210R, with the peg 392 outside the right housing portion 210R, the peg 392 aiding in positioning of the roller relative to the housing portion 210R. In this configuration, the roller operative portion 380 is optionally disposed inside the right housing portion 210R, and the roller gripping portion 384c is optionally disposed outside the right housing portion 210R. The left housing portion 210L may then be snap fitted onto or otherwise attached to the right housing portion, to form a closed housing 210 with the rack 220, locking element 342, and bobbin 300 inside, and with the roller 212a, partially inside and partially outside of the housing 210. Finally, the needle distal end 254 and cannula distal end 235 may be inserted through the collar 364 of delimiter 360, and delimiter 360 may be advanced over the cannula 236 until the delimiter is seated on the housing hub 231, with delimiter arms 361 inserted into apertures (not shown) in housing 210, and with delimiter indicator peg 368 adjacent markings 232 on the housing 210. Then the cannula 236 may be passed over the needle distal end 254 and over the suture holder 240. Force may be applied to the cannula 236, in a proximal direction, such that the cannula proximal end 237 is inserted into the delimiter collar 364.

[0401] It will be appreciated by persons skilled in the art that, optionally, assembly of portions of system 200 may be performed in a different order, with the final assembly being identical to that arrived at according to the assembly procedure indicated above. Optionally, assembly of some of the components such as, for example, the locking element, may be omitted, if desired.

[0402] OPERATION OF THE SYSTEM

[0403] Operation of system 200 will be described with reference to components of the system discussed hereinabove. It may be noted that the system has three operating positions, namely, retracted, neutral, and advanced, and transition between these operating positions is actuated, in the embodiment shown, by rotation of roller 212, for example, as discussed hereinbelow. In the retracted position, pusher element 230 is retracted to its most proximal position within device 204. In the advanced position, pusher element 230 is advanced to its most distal position within device 204, and may, optionally, extend partly outside the distal end of needle 250 of device 204. In the neutral position, pusher element 230 is disposed halfway between its retracted and advanced positions.

[0404] Reference is now made to FIG. 17A-D, which show an exemplary multiple anchor delivery system 200, according to some embodiments of the invention, in an initial operative orientation, e.g., prior to deployment of anchors 270 and 280. As indicated above, the system 200 may include handle 202 having housing 210. Rack 220 may be positioned within housing, with support portions 218a-d (FIGs. 8A-E) supported between flanges 292a-b (Figs. 7A-E) in housing 210. In the initial operative orientation, in some embodiments, rack 220 may be positioned in a neutral position, e.g., not advanced distally and not retracted, such that projections 229a (FIGs. 8A-D) are seated in middle recess 222a (e.g., FIG. 7A) of housing 210. As noted above, pusher element 230 may be disposed within needle 250 and pusher element may extend into housing 210 such that pusher element proximal end 326 may be disposed in and retained in bore 227 in the distal end 226 (FIG. 8A) of rack 220. Needle 250 may be disposed within cannula 236, with needle proximal end 252 retained within housing 210 by clamping bars 297 (FIG. 7B) of housing 210, at indentations 257 (FIGs. 13B-C) on needle 250.

[0405] Handle 202, pusher element 230, needle 250, and cannula 236 are optionally all arranged along a mutual longitudinal axis 209 (FIG. 17D).

[0406] Delimiter 360 may be positioned on the housing distal end 215 such that delimiter hub 362 (FIG. 12A) may be seated on housing hub 231 (FIG. 7A), and cannula 236 may be retained within collar 364 of needle delimiter 360. Delimiter slider 366 may be positioned adjacent markings 232 on housing 210 which may indicate a distance that the needle 250 protrudes out of cannula 236.

[0407] Distal movement of slider 366 optionally affects a corresponding distal movement of cannula 236 relative to needle 250, thereby potentially possibly extending cannula 236 further over the needle which can result in less of needle distal end 254 extending out of the cannula distal end 235. Similarly, proximal movement of slider 366 optionally affects a corresponding proximal movement of cannula relative to needle 250, thereby possibly partially withdrawing the cannula 236 from over the needle 250 which can result in more of the needle distal end 254 extending out of the cannula distal end 235. It should be noted that the penetration depth of needle 250 into a tissue 206 of a patient is optionally limited to the extent to which the needle projects distally with respect to the distal end 235 of cannula 236, because the cannula optionally has a blunt distal end and does not enter into the tissue.

[0408] While, in the embodiment shown, system 200 includes roller 212c, it will be understood by persons skilled in the art that any of the exemplary rollers 112a-c may be utilized in the device discussed herein. However, for the sake of simplicity, the ensuing description refers to the roller by reference no. 112, to gripping portion as 384, and to operative portion as 380.

[0409] Roller 212 may be rotatably mounted on roller mounting peg 299 (FIG. 7B) such that roller 212 resides partially within the housing 210, and extends out of an opening 211 in housing 210. The roller 212 has a gripping portion 384, as noted above, to be contacted by the finger of the user, and an operative portion 380 for interaction with teeth 225 of rack 220.

[0410] It is a particular feature of some embodiments of the present invention that, in the initial operative orientation, locking element 342 may be supported against the rack 220, for example, as discussed hereinbelow, which prevents proximal displacement of the rack 220 and, thereby potentially prevents movement of the roller 212 in a counterclockwise direction (toward the needle distal end 254). This may provide a safety feature which may prevent inadvertent or accidental deployment of anchor 270 or anchor 280 from the system 200. In this initial operative orientation, the roller 212 can optionally only be moved in a clockwise direction (away from the needle distal end 254), which may not be intuitive for the user, thereby potentially preventing inadvertent or accidental premature deployment of anchors 270 / 280.

[0411] The rack 220 may be supported by support portions 218a-d between flanges 292a-b of housing inner wall 290 (FIG. 7A-B), such that rack 220 may be slidable along lower flange 292b. Flexible strips 229 extend out of the sides of rack 220, as noted above with regard to FIGs. 8A-D, such that v-shaped projections 229a of the rack may project into any one of recesses 222a-c in each housing portion 210L-R. In the configuration shown in FIG. 17A, rack 220 may be positioned such that projections 229a project into recesses 222b on either side of housing 220.

[0412] Teeth 225 of rack 220 may be engaged with corresponding teeth 382 of roller 212 such that rotation of roller 212 in a clockwise direction optionally affects movement of rack 220 in a distal direction. Conversely, rotation of roller 212 in a counterclockwise direction optionally affects movement of rack 220 in a proximal direction. It may be noted that, in the initial operative orientation, roller 212 may be in a neutral position, as indicated by marking 390N being visible on roller 212, in FIG. 17D.

[0413] In the initial operative orientation shown, locking bar 346 of locking element 342 has been inserted into recess (FIG. 8D) in rack 220, and body 343 of locking element 342 has been mounted on peg 294 (FIG. 7A) of housing 210 such that locking bar 346 extends vertically upward from body 343 and abuts surface 228b of recess 228 in rack 220. In the initial operative orientation shown, small arm 348 of locking element 342 is positioned below stop 295a (FIG. 7B) of housing 210.

[0414] In the embodiment shown, system 200 may be provided with a first solid anchor 270 and a second, hollow anchor 280, the first and second anchors optionally having suture material threaded therethrough, for example, as discussed hereinabove with regard to FIGs. 16A-C. In the initial operative orientation shown, first anchor 270 may be positioned distal to pusher element 230 within needle 250, optionally adjacent the needle distal end 254, and second anchor 280 may be mounted on the pusher element. In the embodiment shown, pusher element 230 extends through second anchor 280. However, other embodiments are conceivable such as, for example, a c-shaped anchor, a solid anchor, or other configurations, for example, as discussed herein and as will be understood by persons skilled in the art. Optionally, the first anchor 270 may abut the distal end 324 of the pusher 230. According to the embodiment shown, for example, in FIGs. 17B, suture portions 288a-b may extend from anchors 270 and 280, out through needle slot 255. It may be noted that the provision of slot 255, which allows the suture portions 288a-b to extend out of the needle, may prevent loops 288a-b from interfering with movement of anchors 270 and 280 through the needle. Suture free end 288c may extend proximally from proximal end 272 of first anchor 270, alongside needle 250, inside optional suture holder 240, and through hub 231 of housing 210. In embodiments where the suture holder 240 is omitted, suture free end 288c may extend proximally alongside needle, inside cannula 236, and through housing hub 231. In the initial operative orientation shown, suture free end 288c had been threaded through bore 306 in bobbin 300 (FIGs. 10A-D) and wound around bobbin spool 302 before bobbin 300 was mounted in housing 210, for example, as discussed herein with regard to FIGs. 7A-B. It will be appreciated by persons skilled in the art that, alternatively, suture free end 288c may be housed within housing 210 without being wound around bobbin 300, may be stored on another component within or outside housing, or may extend at least partly outside of housing.

[0415] It may be noted that FIG. 17B shows distal end 242 of suture holder 240 at a location proximal to distal end 235 of cannula. Suture holder 240 may retain a portion of loops 288a-b and suture free end 288c adjacent the needle 250 within the suture holder. Optionally, in some embodiments, suture holder 240 may have a length long enough so that its distal end 242 is closer to the cannula distal end 235 than as configured in FIG. 17B, or approximately flush with cannula distal end 235, thereby potentially retaining a larger portion of loops 288a-b and free end 288c.

[0416] Prior to insertion of the needle distal end 254 through tissue 206, a probe is optionally used, for example, of a type known in the art, optionally to measure the thickness of the tissue through which the needle must penetrate. Slider 366 on the delimiter 360 may be advanced or retracted, as desired, until the indicator peg 368 indicates the length of needle distal end 254 which may be insertable through tissue 206. This causes the cannula 236 to be correspondingly advanced or retracted over the needle 250, so that the length of the needle extending out of the cannula is adjusted according to the thickness of the tissue 206 that was measured, as known in the art.

[0417] With reference to FIGs. 18A-D, the needle distal end 254 may be inserted through a tissue 206, optionally with the aid of the sharpened tip 253 (FIG. 18C) of needle 250. Due to the presence of cannula 236, only the portion of needle 250 protruding out of cannula distal end 235 may be inserted through tissue 206, the needle being inserted through the tissue 206 at most until cannula 236 abuts the surface of tissue 206. Optionally, anchor 270 may close off the opening at the needle distal tip 253 and needle slot 255, so that tissue does not collect in the openings. Optionally, first anchor 270 includes an inclined distal end having a configuration that corresponds to that of the needle distal tip 253.

[0418] It should be noted that, in this position, although the first anchor 270 may be disposed at least partly through tissue 206, the first anchor has optionally not yet been deployed from the needle 250 and may be still positioned within the needle 250.

[0419] Referring now to FIGs. 19A-D, it should be noted that, in accordance with some embodiments, the components of the system 200 are designed so as to provide the system with the desired aspects discussed herein. For example, in order for the roller to be rotated, a user must displace the gripping portion 384 by a distance sufficient to cause rotational movement of the roller in the desired direction and for the desired degree of rotation, and to move the rack 220 in the desired direction and for the desired distance. This latter movement also requires that the projections 229a (FIGs. 8A-D) on the rack 220 be moved over projections 296a and / or 296b (FIG. 7 A) in housing 210.

[0420] It may be noted that the amount of force required to rotate the roller 212 in a clockwise direction, from the neutral position (FIG. 17D) is optionally the same as the amount force required to rotate the roller in a counterclockwise direction, from the neutral position. Alternatively, if desired, the amount of force required to rotate the roller 212 in a clockwise direction (to deploy anchor 270) may be more than the amount force required to rotate the roller in a counterclockwise direction (to retract the pusher element 230), or vice versa.

[0421] Deployment of first anchor 270 may be actuated by rotation of the roller 212 in a clockwise direction, from a neutral position, in which marking 390N may be visible on roller 212 (Fig. 18D) to a deployed position in which marking 390D may be visible on roller 212, as illustrated in FIG. 19D. This clockwise rotation of the roller 212, optionally affects distal movement of the rack 220, due to the engagement of roller teeth 382 (FIGs. 9A-C) with teeth 225 (FIG. 8A) on rack 220, for example, as discussed herein. This distal movement of rack 220 is accompanied by a corresponding distal movement of the pusher element 230 which is attached to the rack distal end 226. As rack 220 advances distally, the pusher element 230 may be advanced distally to adjacent needle distal end 254, and optionally past the needle distal end, to force the first anchor 270 out of the needle 250 and through tissue 206, as shown in FIGs. 19A- D.

[0422] It may be noted that, during deployment of the first anchor 270, the proximal end 272 of the first anchor is at a location distal to the second anchor 280. As noted above, clockwise rotation of roller 212 can optionally affect a corresponding movement of the rack 220 in a distal direction. As the rack 220 moves distally, from the position shown in FIG. 18A to the position shown in FIG. 19A, support portions 218a-d (FIGs. 8A-E) slide distally along housing flanges 292a-b (FIGs. 7A-B). The distal movement of rack 220 is sufficient to move the v-shaped projections 229a on rack 220 from recesses 222b, over projections 296a, and into recesses 222a on inner walls 290 of housing portions 210L-R. Further, movement of the projections 229a over the projections 296a optionally may cause an audible indication such as, for example, a clicking sound, and / or a tactile indication, which informs a user that the first anchor has been deployed. Optionally and / or alternatively, an electronic circuit may be provided to indicate to the user that the first anchor 270 has been deployed.

[0423] It may be noted that, while in the embodiment shown in Figs. 19A-22C first and second anchors 270 / 280 are illustrated as straight elements, this is for illustrative purposes only. It will be appreciated by person skilled in the art that, optionally, once deployed, each of anchors 270 / 280 may have a different configuration such as, for example, a curve, depending on rigidity of the anchor and the amount of force exerted on it by the suture portions 288a-c extending through tissue 206.

[0424] As noted above, as the roller 212 is rotated in a clockwise direction, the rack 220 begins to move distally, e.g., from the position shown in FIG. 18A to the position shown in FIG. 19A. At the same time, the locking element 342 begins to rotate in a counterclockwise direction due to the locking bar 346 being pushed by surface 228b (FIG. 8D) of the rack 220, as the rack moves distally. At the same time, the small arm 348 of locking element 342 begins to slide along stop 295a (FIG. 7B) in housing 210. As the rack 220 continues to move distally, the locking element 342 continues to rotate as the locking bar 364 moves down the surface 228a of the rack 220, toward the opening of the recess 228, and the small arm 348 continues to slide along stop 295a. Once rack 220 has moved distally enough so that the locking bar 364 is adjacent the opening of the recess 228, the small arm 348 is adjacent knob 295b at the end of stop 295a. Further movement of the rack 220 pushes the locking bar 364 further until it has exited the recess 228. Optionally, at the same time, small arm 348 is pushed over the knob 295b, optionally producing a slight clicking noise. This slight clicking noise should not be confused with the clicking noise created by movement of projections 229a on rack over the projections 296a in housing 210, noted above. The small arm 348 is prevented from moving further, as it is now positioned between knob 295b and stop 295c. At this point the locking element is disengaged from the rack 220. From this point on, the locking element 342 will remain in this position, regardless of the position of the rack 220. It may be noted that, once the roller 212 has been rotated clockwise, to the position shown in FIG. 19D, further clockwise rotation of roller 212 may be prevented due to the distal end 226 of rack 220 abutting a stop 293a provided on housing 210. As rack 220 cannot move further distally, this prevents further rotation of roller 212 in a clockwise direction, due to the engagement of teeth 225 of the rack 220 with teeth 382 of the roller 212.

[0425] With particular reference to FIG. 19B, an anchor stopper 260 may be located within the interior volume 258 of needle 250, optionally at the proximal portion of the needle 250. The anchor stopper 260 defines a distally facing surface 262. Anchor stopper 260 defines a barrier in the needle 250 whereat the passageway 264 is narrowed, thereby potentially obstructing possible proximal movement of the second anchor 280 within the passageway. The proximal end 284 of the second anchor 280 is optionally disposed in the vicinity or abuts the distally facing surface 262 of the anchor stopper 260. Alternatively, the proximal end 284 of the second anchor 280 may be slightly distally spaced apart from distally facing surface 262 of the anchor stopper 260.

[0426] After deployment of the first anchor 270, the proximal end 284 of the second anchor 280 is optionally more distally spaced apart from distally facing surface 262 of the anchor stopper 260 than in the initial operative orientation (FIG. 17B). This may be due to its having been displaced distally by distal movement of the pusher element as the first anchor is deployed.

[0427] Reference is now made to FIGs. 19E-H, wherein the system 200 is shown in a retraction operative orientation. Roller 212 has been rotated in a counterclockwise direction, from the position shown in FIG. 19D to the position shown in FIG. 19H, in which marking 390R may be visible on roller 212. This counterclockwise rotation of roller 212 optionally affected proximal movement of rack 220, due to the engagement of roller teeth 382 with teeth 225 on rack, for example, as discussed herein with reference to FIGs. 9A-C. This proximal movement of rack 220 was optionally accompanied by a corresponding proximal movement of the pusher element 230 which is attached to the rack distal end 226. As rack 220 moves proximally, the pusher element 230 may be retracted within needle 250.

[0428] It should be noted that, even in the most retracted position of the pusher element 230, the pusher element proximal end 326 remains within the housing 210. Optionally and alternatively, pusher element 230 may extend proximally out of the housing, for example, up to 5cm or more than 5cm.

[0429] As noted above, counterclockwise rotation of roller 212 optionally affects a corresponding movement of the rack 220 in a proximal direction. As the rack 220 moves proximally, from the position shown in FIG. 19A to the position shown in FIG. 19E, support portions 218a-d (FIGs. 8A-E) slide proximally along housing flanges 292a-b (FIG. 7A-B). The proximal movement of rack 220 may be sufficient to move the v-shaped projections 229a on rack 220 from recesses 222a, over projections 296a and 296b, and into recesses 222c on inner walls 290 of housing portions 210L-R. Further, movement of the projections 229a over the projections 296a and 296b optionally may cause an audible indication such as, for example, a single or a double clicking sound, and / or a tactile indication, which informs a user that the pusher element 230 has been retracted and that the second anchor 280 has been loaded and may be ready for deployment. Optionally and / or alternatively, an electronic circuit may be provided to indicate to the user that the pusher element 230 has been retracted.

[0430] It is a further particular feature of some embodiments of the present invention that in this retraction operative orientation, the locking element 342 remains disengaged from the rack 220, and does not prevent further advancement or retraction of the pusher element 230. However, roller 212 may be prevented from rotating further in a counterclockwise direction due to the proximal end 224 of rack 220 abutting a stop 293b provided on housing 210. As rack 220 cannot move further proximally, this optionally prevents further rotation of roller 212 in a counterclockwise direction, due to the engagement of teeth 225 of the rack 220 with teeth 382 of the roller 212.

[0431] It is seen in FIG. 19F that in this retraction operative orientation, the first anchor 270 remains deployed outside of the needle 250.

[0432] It is a particular feature of some embodiments of the present invention that, during proximal retraction of the pusher 230, from the position in FIGs. 19A-B to the position in FIGs. 20A-B, the second anchor 280 may be released from the pusher 230 into the interior volume 258 of the needle 250, optionally within suture holder 240, and may not be mounted over the pusher 230 anymore. Rather the proximal end 284 of the second anchor 280 optionally abuts and / or optionally is supported against distally facing surface 262 of the anchor stopper 260 in this retraction operative orientation, thus preventing proximal displacement of the second anchor 280 past the anchor stopper 260.

[0433] It is seen in FIG. 19F that the distal end 324 of the pusher 230 may now be proximally spaced from the proximal end 284 of the second anchor 280.

[0434] With reference to FIGs. 20A-D, system 200 is shown still in the retracted orientation, after needle 250 has been withdrawn from tissue 206. Roller 212 is still in the position shown in FIG. 20E, in which marking 390R may be visible on roller 212.

[0435] It is seen in FIGs. 20A-B that, as the first anchor 270 has been deployed outside of the needle 250 and second anchor 280 remains inside the needle, suture portions 288a-c extend from anchor 270, on one side of tissue 206, through the tissue, to anchor 280 which is still inside needle 250 (FIG. 20B).

[0436] It should be noted that, for example, as described above with regard to FIGs. 19E-20D, after first anchor 270 has been deployed, retraction of pusher element 230 was followed by withdrawal of the needle from tissue 206. Alternatively, the order of these operations may be reversed, so that first needle 250 may be withdrawn from tissue 206 and then pusher element 230 may be retracted.

[0437] Optionally, it may be desired to implant second anchor 280 at the same location on tissue 206, using an anchor configuration known in the art as a “vertical mattress.” In this case, needle 250 may be reinserted into tissue 206 at the same location as that at which it was inserted for deployment of first anchor 270. Alternatively, it may be desired to implant second anchor 280 at a different location from that at which first anchor 270 was deployed, using an anchor configuration known in the art as “horizontal mattress.” In this case, needle 250 may be inserted into tissue 206 at a different location from that at which it was inserted for deployment of first anchor 270. According to the embodiment described below with reference to FIGs. 20E to 22C, first and second anchors 270 and 280 are deployed in the horizontal mattress configuration.

[0438] With reference to FIGs. 20E-G, when it is desired to deploy second anchor 280 through tissue 206, needle 250 is again inserted through tissue 206. System 200 is shown still in the retracted orientation. It may be noted that roller marking 390R (FIG. 20D) may still be shown on roller 212 to indicate that the pusher element 230 has been retracted.

[0439] Reference is now made to FIG. 21A-D, which illustrates a second anchor deployment operative orientation, in accordance with some embodiments. In this configuration, deployment of second anchor 280 has been actuated by rotation of the roller 212 in a clockwise direction, from the retracted position, in which marking 390R may be visible on roller 212 (Fig. 20D) to a deployed position in which marking 390D may be visible on roller 212, as illustrated in FIG. 21D.

[0440] Clockwise rotation of the roller 212 optionally affected distal movement of the rack 220, due to the engagement of roller teeth 382 with teeth 225 on rack 220, for example, as discussed herein with regard to FIGs. 9A-C. This distal movement of rack 220 was accompanied by a corresponding distal movement of the pusher element 230 which is attached to the rack distal end 226. As rack 220 advances distally, the pusher element 230 may be advanced distally to adjacent the needle distal end 254, to force the second anchor 280 out of the needle 250. The second anchor 280 deployed through tissue 206 may be seen, for example, in FIG. 21A-D. As noted above, with regard to deployment of first anchor 270, movement of components within device 204 may optionally cause an audible indication such as, for example, a double clicking sound, and / or a tactile indication, which informs a user that the second anchor 280 has been deployed. Optionally and / or alternatively, an electronic circuit may be provided to indicate to the user that the second anchor 280 has been deployed. It is a further particular feature of some embodiments of the present invention that in this second anchor deployment operative orientation, the locking element 342 remains disengaged from the rack 220. However, from the position of roller shown in FIG. 2 ID, further clockwise rotation of roller 212 may be prevented, for example, as described herein in detail with regard to FIG. 19A-D.

[0441] It is seen in FIG. 2 ID that in this second anchor deployment operative orientation, the second anchor 280 has been optionally pushed distally due to distal displacement of the pusher 230 and engagement of distal end 324 of pusher 230 with the proximal end 284 of the second anchor 280. The second anchor 280 may now be disposed distally with respect to the distal end 254 of the needle 250 and may now be deployed out of the interior volume 258 of the needle 250 and through tissue 206 of the patient.

[0442] With regard to FIGs. 18A-19H and 21A-D, it should be noted that, optionally, needle distal end 254 may be inserted through tissue 206 so that it exits the tissue by a distance at least large enough so that the entire length of anchors 270 and 280 is deployed through the tissue. Optionally and alternatively, if distal tip 253 only of needle 250 were to penetrate tissue 206, with a portion of needle distal end 254 still within the tissue, anchors 270 / 280 may not entirely exit the tissue.

[0443] With reference to FIG. 22A-C there is shown the system 200, in accordance with some embodiments of the invention, after second anchor 280 has been deployed (FIGs. 21A-D), and after the device 204 has been moved away from tissue 206, whereby the needle 250 has been withdrawn from the tissue, as seen most clearly in FIG. 22B.

[0444] It should be noted that, in this configuration, the suture portions 288a-c which are attached to the first and second anchors, have been released from the device and may extend through tissue 206 to its proximal side. Although suture portions 288a-c appear in FIG. 22B as a single line, it will be understood by persons skilled in the art that ref nos. 288a-c in this drawing represents small loop 288a, large loop 288b, and suture free end 288c. The suture material may optionally be tightened to secure the first and second anchors 270 / 280 to the tissue and thereby potentially anchor portions of the tissue together, for example, as described in detail below with reference to FIGs. 23A-G. With reference to FIGs. 23A-G there is shown tightening of first anchor 270 and second anchor 280 against tissue 206, after deployment of the anchors from device 204. Anchors 207 and 280 are shown in FIGs. 23A-B, where they are loosely held in position adjacent one side of the tissue 206 with the suture material including small and large loops 288a-b and suture free end 288c on the opposite side of the tissue.

[0445] While in the embodiment shown, anchors 270 and 280 optionally appear as being generally u-shaped, alternatively, the anchors may each appear as straight or slightly curved into a c-shape, depending, for example, on the rigidity of the anchors and how tightly the anchors are pulled by the suture material.

[0446] In order to tightly fasten the anchors 270 and 280 against tissue 206, the long suture portion 288b may be pulled. This shortens the small loop 288a, which causes each of the anchors to assume a narrow u-shape and to be tightened against tissue 206, as shown in FIGs. 23C-D. Then the suture free end 288c may be pulled by the user. This shortens the large loop 288b, as shown in FIGs. 23E-G. As the suture free end 288c was previously twisted around the large loop 288b, this pulling of the free end creates a knot in the suture material as the large loop 288b gets smaller. The excess suture length may then be cut off, optionally using a cutting device such as, for example, described in US 6,866,673.

[0447] In accordance with an alternative embodiment, both a first anchor and a second anchor may be loaded together in parallel into a sheath, and each of the anchors may be optionally covered by a resilient cover. Both anchors may be loaded together into a single needle and a driving assembly may be provided, having a first rack coupled to a first pusher that deploys the first anchor 270 and a second rack coupled to a second pusher that deploys the second anchor 280. Optionally, when the first rack is advanced distally to deploy the first anchor, the second rack is in a lag mode. Optionally, when the first rack is retracted, the second rack is advanced distally to deploy the second anchor.

[0448] Yet further, in accordance with another alternative embodiment, the system may include more than two anchors. For example, there may be provided a single solid anchor, deployable, for example, as described above with regard to FIGs. 19A-D, and two or more tubular anchors mounted on a pusher element and deployable by the pusher element. Optionally, depending on how far back the pusher element is retracted, more than one tubular anchor may be deployed with the same distal displacement of the pusher element.

[0449] Optionally, the anchors in accordance with any of the described embodiments may or may not be attached by suture material. It is noted that the system 200 may be configured to be disposable. METHODS OF THE INVENTION

[0450] With reference to FIG. 24, there is shown a method 500 of delivering multiple anchors into the tissue of a patient, in accordance with a particular aspect of some embodiments of the present invention. At 502, a sheath may be delivered through a tissue, for example, as discussed herein, sheath may be, for example, a hollow needle, optionally having a sharpened tip. At 504, an actuator may be displaced in a proximal direction to deploy a first anchor. For example, as discussed herein, displacement of the actuator may be, for example, linear displacement of a trigger or rotational movement of a roller. Thereafter, at 506, the actuator may be displaced in a distal direction to load a second anchor; and thereafter, at 508, another displacement of the roller in the proximal direction to deploy the second anchor 280.

[0451] With reference to FIG. 25, it is a particular feature of some embodiments of the present invention that the method 600 of operation of a device for delivering multiple anchors into the tissue of a patient optionally includes, at 602, proximal displacement of an actuator in order to displace a pusher distally through a sheath. For example, as discussed herein, displacement of the actuator may be, for example, linear displacement of a trigger or rotational movement of a roller. Simultaneously, at 604, the pusher is displaced distally by an amount sufficient to deploy the first anchor out of the sheath. Thereafter, at 606, distal displacement of the actuator causes the pusher to be moved proximally, which results in loading of a second anchor. Thereafter, at 608, displacement of the roller in the proximal direction causes the pusher to be moved distally through the sheath. Simultaneously, at 610, the pusher is displaced distally by an amount sufficient to deploy the second anchor 280 out of the sheath.

[0452] It should be noted that the device may be operated outside the body, for example, in accordance with the actions indicated above, and / or not during a medical procedure, such as, for example, during testing of the device.

[0453] With reference to Fig. 26 there is shown a portion of a deployment device 700, for securing a second soft tissue or biocompatible material to a first soft tissue, according to some embodiments. Some components of deployment device 700 may be similar in structure and function to the deployment device described herein with regard to, for example, Fig. 1, and will not be described herein again in detail.

[0454] According to some embodiments, device 700 includes a sheath or needle 706 within which there are housed a first anchor 702 and a second anchor 704, the latter of which may be a retaining anchor. Features of first and second anchors will be discussed further herein. First anchor 702 and second anchor 704 may be similar in structure to any of the anchors discussed herein, and similar structures, functions, and features will not be described again herein. While first anchor 702 may be suitable for being deployed through a first soft tissue 712, second anchor 704 may be suitable for retaining a second soft tissue such as, for example, a tendon or a meniscus, or a biocompatible material such as, for example, an arthroscopic patch or a graft such as an allograft, in position relative to the first soft tissue.

[0455] First anchor 702 and second anchor 704 may be attached by a suture 710 which may extend through a passageway defined in or on one or both of the first anchor 702 and the second anchor 704, as discussed herein. Alternatively, suture 710 may be attached to either or both of first anchor 702 and second anchor 704 by any other suitable means such as, for example, discussed with regard to Fig. 16A. Alternatively, suture 710 may be attached to either or both of first and second anchors (702, 704) by extending through a passageway such as, for example, an internal lumen, integrally formed with or attached to at least a portion of one or both of the first and second anchors. For example, one or both of first and second anchors (702, 704) may be provided with external loops (not shown) which define a passageway for suture 710.

[0456] First anchor 702 may include a passageway 728 defined on or within first anchor 702, through which suture 710 may extend. As noted here, passageway 728 may be defined by an internal lumen or external loops or any other suitable component extending along at least a portion of first anchor 702. First anchor 702 may be slidingly mounted on suture 710 by means of the suture 710 extending through passageway 728, according to some embodiments.

[0457] Optionally, second anchor 704 may be slidingly mounted on suture 710, according to some embodiments. Second anchor 704 may optionally be formed of a flexible material, and is optionally formed of a compressible material, according to some embodiments. While second anchor 704 may include a pair of loops 726 through which suture 710 may extend, alternatively, second anchor 704 may be provided with any suitable number of loops or connectors that allow second anchor 704 to slide along suture 710, according to some embodiments. Alternatively, second anchor 704 may include a plurality of apertures (not shown) through which suture 710 may slidingly be threaded, allowing second anchor 704 to be slidingly mounted on the suture 710.

[0458] According to some embodiments, first anchor 702 may be deployed from device 700 through a first tissue (712 in Fig. 28) in a manner similar to that discussed herein, for example, with regard to Figs. 17A-20B. After deployment of first anchor 702 through the first soft tissue 712 and withdrawal of sheath or needle 706 from the first soft tissue 712, as discussed herein with regard to Figs. 20A-B, deployment device 700 may deploy second anchor 704. According to some embodiments, in contrast to the embodiment described with regard to, for Example, Figs. 20E-22C, after deployment of first anchor 702, the sheath or needle 706 may not be inserted through the first tissue 712. Instead, second anchor 704 may be deployed on a proximal side of first soft tissue 712. When deployed from deployment device 700, second anchor 704 may be attached to first anchor 702 by the suture 710, at least one portion of which may extend between first anchor 702 and second anchor 704.

[0459] Alternatively, the sheath or needle 706 may optionally be inserted through both the second soft tissue or biocompatible material 714 such as, for example, a patch, and the first soft tissue 712, according to some embodiments, after which the second anchor may be deployed on a proximal side of the second soft tissue or biocompatible material 714. In this manner, suture portion 718 may extend through both the first soft tissue 712 and the second soft tissue or biocompatible material 714 as illustrated, for example, in Fig. 28.

[0460] It may be noted that a portion 708 of suture 710 may extend proximally, so that it may be held by a surgeon operating device 700. After deployment of first anchor 702 through the first soft tissue and subsequent deployment of second anchor 704 from device 700, the first anchor 702 may be positioned on a distal side of the first soft tissue 712, and the second anchor 704 may be positioned on a proximal side of the first soft tissue 712, as will be discussed further herein.

[0461] A second soft tissue or a biocompatible material 714, such as discussed herein, which it is desired to attach to the first soft tissue 712 may be positioned against the first soft tissue 12 in any orientation desired. In order to secure the second soft tissue or biocompatible material 714 against the first soft tissue 712, the suture portion 708 may be pulled proximally, thereby shortening the length of suture 710 between the first anchor 702 and the second anchor 704. It should be noted that the suture 710 may be attached to the first anchor 702 on the distal side of the first soft tissue 712, extends through the first soft tissue 712, and is attached to the second anchor 704 on the proximal side of the first soft tissue 712. Therefore, by pulling on suture portion 708, as the length of suture between the first anchor 702 and the second anchor 704 is shortened, the first anchor 702 and the second anchor 704 are urged closer together, with the first soft tissue 712 and the second soft tissue or biocompatible material 714 positioned therebetween.

[0462] With additional reference to Fig. 28, there is shown a schematic representation of first soft tissue 712 through which a first anchor 702 has been deployed, for example, by deployment device 700. During deployment of the first anchor 702, an opening 716 may be made in the first soft tissue 712 by needle or sheath 706 of deployment device 700, and first anchor 702 may be inserted through opening 716, as discussed herein with regard to device 100. A portion 718 of suture 710, which is attached to first anchor 702, may extend through opening 716, from first anchor 702 to second anchor 704. Suture portion 708 may also be attached to second anchor 704 and extend proximally therefrom, optionally to an operator of the deployment device or other person performing the securing procedure. After positioning a second soft tissue or biocompatible material 714 adjacent a proximal surface 724 of first soft tissue 712, pulling of suture portion 708 proximally will shorten the length of suture portion 718 located between first anchor 702 and second anchor 704, thereby urging first anchor 702 and second anchor 704 closer together. Further pulling of suture portion 708 will force first anchor against a distal surface 722 of first soft tissue 712, and will force second anchor against proximal surface 724 of first soft tissue 712. Shortening of suture 710 may cause at least one of first anchor 702 and second anchor 704 to become bent or crimped, thereby assuming a c-shaped or u-shaped configuration, as discussed herein.

[0463] When suture portion 708 is pulled proximately, suture 710 may slide along passageway 728 of first anchor 702 and loops 726 of second anchor 704, or along any other passageway provided in or on first and second anchors, as discussed herein, as suture portion 718 between first anchor 702 and second anchor 704 is shortened.

[0464] It may be noted that, optionally, suture 710 may be attached to either or both of first anchor 702 and second anchor 704 at a plurality of locations such as, for example, at two or four loops or other connecting locations. Depending on the number of connecting locations between suture 710 and each of first anchor 702 and second anchor 704, and depending on the materials of first anchor 702 and second anchor 704, shortening of suture portion 718 between first anchor 702 and second anchor 704 may cause one or both of the first anchor 702 and second anchor 704 to assume a u-shaped or c-shaped configuration or a configuration having a plurality of undulations. After second soft tissue or biocompatible material 714 has been secured to the first soft tissue 712, optionally by forming a knot adjacent the second soft tissue or biocompatible material 714, the suture portion 708 may optionally be severed.

[0465] It may be noted that the second anchor 704 may be thick enough to cushion the second soft tissue or biocompatible material 714 relative to pressure applied by the suture 710 when tightened. Second anchor 704 may also be tough enough or sturdy enough such that it will not be cut or otherwise damaged by the suture 710.

[0466] It may also be noted that, as the first anchor 702 is configured to be inserted through opening 716 in the first soft tissue 712, the second anchor 704 may be sized and / or shaped such that the second anchor 704 cannot be passed through the opening 716 in the first soft tissue 712.

[0467] A particular feature of some embodiments to be noted is that that provision a first anchor 702 and second anchor 704, both of which are slidable relative to suture 710 may provide an improved device for securing a second soft tissue or a biocompatible material 714 to a first soft tissue 712, which may potentially reduce pressure on the second soft tissue or a biocompatible material 714 and, thereby, may allow better healing of tissue at or near the site of the procedure, and / or may prevent damage caused by excess pressure to the first soft tissue 712 or to second soft tissue 714, as compared with a suture alone which may force second soft tissue or biocompatible material 714 against the first soft tissue 712.

[0468] Additionally, second anchor 704 may potentially provide a cushioning component for an arthroscopic or other surgical procedure, whereby force applied to the proximal surface 724 of second soft tissue or a biocompatible material 714 may be distributed across the area of the second anchor 704, according to some embodiments. This may reduce pressure and / or stress to the second tissue 714, as compared with a procedure wherein there is not provided a second anchor 704 and which retains a second soft tissue or a biocompatible material 714 relative to the first soft tissue 712 by means of the suture pulled against the second soft tissue or a biocompatible material 714 on the proximal surface 724 of the first soft tissue. Depending on the size of the second anchor 704, i.e., the area of the second anchor 704 that contacts and may be forced against second soft tissue or biocompatible material 714, this may significantly reduce pressure and / or stress applied to the second soft tissue, and may potentially prevent damage to second soft tissue, according to some embodiments.

[0469] Reference is now made to Figs. 27A-B which are representations of proximal and distal views, respectively, of a second soft tissue or biocompatible material 714 and a first soft tissue 712 secured to each other, in accordance with some embodiments. It may be noted that first soft tissue 712 and second soft tissue or a biocompatible material 714 may be connected by a suture 710 as discussed herein, in accordance with some embodiments.. It may be noted that Figs. 27 A- 28 are provided herein for illustrative purposes only.

[0470] As seen in Fig. 27A, a second soft tissue or biocompatible material 714, as discussed herein, has been attached to a first soft tissue 712 by suture 710, with first anchor 702 adjacent distal surface 722 of first soft tissue 712, and with second anchor 704 adjacent proximal surface 724 of second soft tissue or biocompatible material 714. The end portion 708 of suture 710 may be seen extending proximally.

[0471] Reference is now made to FIG. 29A, which is an exemplary abstract block diagram showing a designated axial-overlap region for a multi-state anchor delivery system, according to some embodiments of the invention. The axial-overlap region, indicated by ref. no. 6, which may also be referred to as an axial-switch 6, is illustrated with a dotted line in the drawings. In Fig. 29A, the axial-overlap region in a first state is shown positioned in a sheath 250 for a multi-state anchor delivery system, prior to deployment of a first anchor 170, according to some embodiments of the invention. First anchor 170 and a second anchor 180 are assembled in the sheath in a last-in-first-out (LIFO) configuration, where the first anchor first exits the sheath followed by the second anchor. An anchor-pusher 3 has a distal end next to the second anchor and a proximal end next to a pusher assembly or second pusher 4. The location of the axial- switch is at the portion of the anchor-pusher 3 that is adjacent to or couples with second pusher 4. It is noted that some or all of second pusher 4 may lie outside of sheath 250, in some embodiments.

[0472] According to some embodiments, as shown below, second pusher 4 optionally comprises a rack 220 (Fig. 32), but second pusher 4 may also have a different mechanical arrangement and is not limited to a rack. Optionally, the designated axial-overlap region is inside the sheath between the proximal end of the anchor-pusher and a distal end / extension of the second pusher. The designated axial-overlap region is a combination of a first axial region on the proximal end of the anchor-pusher and a second axial region on the distal end of the second pusher 4. It is noted that the axial switch may be part of the anchor-pusher and / or part of the second pusher (pusher assembly).

[0473] Optionally, first and second axial regions have lengths that are variable by manufacture and installation. In some embodiments, a kit provides a plurality of pushers and racks for installation inside the housing and for variable anchor deployment. A second pusher is operable to move the anchor-pusher using the axial-switch to deploy anchors. In some embodiments, there are three or more anchors.

[0474] FIG. 29B is an exemplary abstract block diagram showing a reduced designated axial- overlap region for a multi- state anchor delivery system, according to some embodiments of the invention. The axial-overlap region 6, illustrated with a dotted line, is shown in a second state, after the first anchor 170 (Fig. 29A) has been deployed. The axial-overlap region 6 is located in a sheath of a delivery device of the system, prior to and during deployment of a second anchor, according to some embodiments. The reduced axial-overlap region results in the combined length of the anchor-pusher and second pusher being sufficient to deploy the second anchor out of the sheath. In some embodiments of the invention, a deforming of one or both the anchorpusher and the second pusher causes a misalignment to occur and causes the combined lengths of the anchor-pusher and second pusher to become greater during the second state than the first state. This extension of the combined length can compensate for the length of the second anchor being no longer available as part of the deployment length after the first state, as discussed herein. The second anchor in a first state pushes on the first anchor when moving through the sheath. Now after the deformation and reduced axial overlap, the extended combined lengths allows deploying the second anchor out of the sheath.

[0475] In some embodiments of the invention, the anchor-pusher is sized and shaped in length and circumference, whereby a deformation, or friction, does not prevent distal movement of the at least two anchors out of the distal end of the sheath’s passageway. The rod, or portion of the second pusher which may overlap with the anchor-pusher, is sized and shaped in length and circumference, whereby a deformation, or friction, does not prevent distal and proximal movement in the sheath to push at least two anchors out of the distal end of the sheath’s passageway. A second pusher is sized and shaped to push the anchor-pusher distally in the passageway. Optionally, the anchors are implants, optionally having one or more suture threads attached, for example, as described herein

[0476] FIG. 30A is an exemplary abstract block diagram showing a designated axial-overlap region 6, also referred to as an axial-switch 6, which optionally lies in part or in whole outside of a sheath 250 in a multi-state anchor delivery system, according to some embodiments of the invention. The axial-overlap region 6 is shown in a first state of operation, prior to and during deployment of a first anchor 170, according to some embodiments of the invention. As shown in figures 30A and 30B, the anchor assembly in the sheath is optionally in a last- in-first-out (LIFO) configuration. Here, the designated axial-overlap region 6 is at least partly outside the sheath 250, between the proximal end of the anchor-pusher and the distal end of the second pusher 4. In some aspects, there are three or more anchors. Fig. 30A represents the first state of the overlap- switch mechanism before the reduction of the designated axial-overlap region. A potential advantage of the axial switch being at least partly outside the sheath is allowing lateral space for deflection and actuation of the switch. A potential advantage of the axial switch 6 lying inside the sheath 250 is that the sheath can be used to enforce overlap and / or prevent deformation during a first state.

[0477] FIG. 30B is an exemplary abstract block diagram showing a designated axial-overlap region 6 and an axial- switch partly outside of a sheath for a multi- state anchor delivery system, in a second state of operation, after the reduction of the designated axial overlap region 6 (relative to that shown in Fig. 30A), prior to and during deployment of a second anchor 180, according to some embodiments of the invention.

[0478] The overlap-switch mechanism being at least partly outside the sheath provides for extending the length travelled by the anchor-pusher in the distal direction during a second state by deflecting or bending the anchor-pusher proximal end after exiting the borehole in a rack, as discussed further herein. Since some of the length of the anchor-pusher was in a borehole (or recess) during the first state (discussed further with reference to Figs. 41A-B), when the anchor- pusher exits the borehole and is deflected and prevented from returning to its position inside the borehole, after retraction of the rack, the overall available length for the anchor-pusher to deploy the second anchor in a second state increases.

[0479] The overview above relates to embodiments having different physical structures for the anchor-pusher and the second pusher which allow for a variable deployment of anchors by shortening the combined lengths of the anchor-pusher, the second pusher, or both. These will be described below in the figures. This may be accomplished, for example, using an overlap- switch mechanism having a designated axial-overlap region within or external to a sheath. The length of the anchor-pusher, the second pusher, and the axial-overlap region may vary, depending on the components and the mechanisms employed, according to some embodiments.

[0480] FIG. 31 is an exemplary illustration of a multi-state anchor delivery system, according to some embodiments, showing an external housing 210 that includes a roller 212 (e.g., for actuating distal anchor movement and deployment and / or retracting an anchor-pushing mechanism), and a sheath 250. Descriptions for components are below.

[0481] FIG. 32 is an exploded perspective view of an exemplary multi-state anchor delivery system, according to some embodiments of the invention. The system includes a handle having a right housing portion 210R and a left housing portion 210L, on respective right and left sides of the device, as viewed from the distal end of the device. Components to be at least partially housed in the housing include a manual control, such as a roller 212 for pushing a rack 220 (or other pushing assembly), and an optional bobbin 300 (discussed herein with reference to suture free end 288c). Also shown are a sheath 250, an extended anchor-pusher element 230, first anchor 170, and second anchor 180, all of which are optionally at least partially disposed in the sheath, according to some embodiments of the invention.

[0482] In some embodiments of the invention, the extended anchor-pusher element 230 can be linearly displaced in a distal direction via a second pusher acting as a driving mechanism. The second pusher can be rack 220 displaced by linear displacement of an actuator in the form of a trigger button. Alternatively, in some embodiments, the second pusher can be displaceable by rotation of a roller 212 or pinion. The actuator is movable in a distal direction and a proximal direction, and the actuator coupled to the driving mechanism in turn is coupled to the anchorpusher element. The coupling has an arrangement so that movement of the actuator in a distal direction results in displacement of the driving mechanism in a proximal direction, and that movement of the actuator in a proximal direction results in displacement of the driving mechanism in a distal direction. FIG. 33 is a view of an internal portion of an anchor delivery system showing a designated axial-overlap region 6 in a sheath according to some embodiments of the invention. The axial-switch moves the anchor-pusher 3 distally (to the left) in the sheath, where the axial- switch is a rod that optionally combines with a rack to become the second pusher 4 according to this embodiment. The anchor-pusher has a first axial region 3B that is between 3 A and 3C. The rod has a second axial region, 4B that is between 4 A and 4C. The designated potential axial- overlap region 6 is the first axial region 3B and the second axial region 4B. The anchor-pusher and rod are at least partially disposed inside the sheath, wherein the sheath is assembled within the housing.

[0483] FIG. 34. is a side- sectional view of a portion of the device of the system, showing a reduction of the designated axial-overlap region 6 in the sheath 250 between 4A and 3C, during retraction of the second pusher 4, after the deployment of a first anchor 170 (Fig. 29A), according to some embodiments of the invention. In some aspects, the rod is fixably attached via a screw to rack 220 on the proximal end, where the rack and the rod combine to become the second pusher.

[0484] FIG. 35 is a side-sectional view of a portion of the device of the system, showing a further reduction of the designated axial-overlap region 6 in the sheath 250 where the area 4B has deformed to misalign with the anchor-pusher 3. The area from 3C to 4A shows a complete reduction of the designated axial-overlap region 6 and misalignment. In some aspects, the anchorpusher and / or the rod is a Nitinol metal alloy that bends so as to interfere mechanically and reduce the designated axial-overlap region. According to some aspects, during the second state, the rod, the anchor-pusher, or both deform and interfere with one another and with the axial- overlap region; pushing the anchor-pusher on a contact-area outside of the designated axial- overlap region. Various means of deformation which interfere with overlap can be used. For example, deforming, or relative rotating of the anchor-pusher and / or the rod after retracting the second pusher mechanically interferes with the joint when pushing in the second state and can extend the length or depth of the second anchor deployment.

[0485] In some embodiments of the invention, the designated axial-overlap region 6 is a scarf overlap joint. In some embodiments, the designated axial-overlap region 6 is a tongue and groove joint.

[0486] Referring to FIG. 36, there is shown a perspective view of a portion of an anchor delivery device of the system, showing a designated axial-overlap region 6 (as represented in Fig. 30A), also referred to as an axial switch, positioned outside of a sheath 250. The axial-switch 6 optionally comprises a movable / foldable faceplate / cover 845 that is shown in Fig. 6 in the open position, according to some embodiments of the invention, during deployment of a first anchor. In the position shown in Fig. 6, the faceplate / cover 845 allows access to an aperture (or bore or recess) 227 in rack 220 into which anchor-pusher 3 fits. As discussed herein, for example, with reference to Fig. 39, the faceplate / cover 845 may move or pivot or fold such that it blocks access to the aperture 227, according to some embodiments.

[0487] The movable faceplate 845 component can comprise optional features. In some cases, a bottom-base 844 has a mounting hole 843 for mounting to the rack 220 using a screw. In some cases there is a foldable cover 845. In some options there is a plane 842 and a bottom-base 844. In some cases, the foldable cover 845 is hingeable (e.g., a living hinge) to cover the aperture 227 in the rack 220. The anchor-pusher is mounted inside a bore 227 and is axial-overlapped by the rack 220 and the faceplate 845 in the open position. Fig. 41B, discussed below, illustrates the bore of 227 on the rack 220.

[0488] Referring to FIG. 37, there is shown a side- sectional view of a portion of the device of the system, including an anchor-pusher in a first state, while being pushed distally, wherein a designated axial-overlap region 6 is outside of sheath 250 and a movable faceplate 845 is in the open position, during deployment of a first anchor, according to some embodiments of the invention. The movable faceplate 845 is in the open position as long as the anchor-pusher proximal end is at least partially inside the bore 227. In the embodiment shown, the anchorpusher proximal end is located above the foldable faceplate 845. Alternatively, in some embodiments, the anchor-pusher proximal end may be located under the foldable faceplate 845. Optionally, anchor-pusher 3 will keep the foldable cover 845 from elastically folding (or otherwise moving) and covering the aperture (or bore or recess) 227 or preventing access thereto. The anchor-pusher proximal end when inside the bore 227 is the designated axial-overlap region.

[0489] FIG. 38. is a side-sectional view of a portion of the device of the system, including a designated axial-overlap region 6 outside of a sheath 250, prior to and during deployment of anchor 170 (Fig. 30A). A movable faceplate 845 is in the open position, and the rack 220 moves distally to push the anchor-pusher 3 to deploy an anchor 170 (Fig. 30A) distally out of the sheath 250, according to some embodiments of the invention.

[0490] FIG. 39 is a side-sectional view of a portion of the device of the system, showing a. reduced designated axial-overlap region 6 outside of a sheath 250 and a movable faceplate 845 in the closed position covering the bore 227 of the rack 220, according to some embodiments of the invention. In some embodiments, this is after deployment of a first anchor and before and during the deployment of a second anchor. The anchor-pusher 3 is left outside the bore 227 after the rack 220 retracts in the proximal direction. Note, the faceplate 845 covers the bore 227 and reduces the designated axial-overlap region to zero in this closed position. Therefore, the designated axial-overlap region 6 is reduced because the anchor-pusher cannot re-enter the bore 227 when the rack 220 moves distally.

[0491] FIG. 40 is a side- sectional view of a portion of the device of the system, showing the second pusher in the second state, abutting faceplate 845 which prevents entering of anchorpusher 3 into the aperture (or bore or recess) 227 in rack 220, according to some embodiments. As described above with regard to Fig 39, the designated axial-overlap region 6 is reduced to zero outside of a sheath 250 by covering the bore 227, because the movable faceplate 845, while in the closed position and covering the bore 227, pushed the anchor-pusher 3 to deploy the second anchor. According to some embodiments of the invention, this illustration is after deployment of a second anchor.

[0492] FIG. 41 A. is a perspective view of a portion of the system, showing deformation of a portion of the device, wherein a designated axial-overlap region 6 is outside of a sheath 250, according to some embodiments of the invention. As will be shown in Fig. 41A, anchor-pusher 3, selectively enters rack 220 depending on whether the anchor-pusher is straight or bent. In one embodiment, a component, optionally elastic, laterally bends anchor-pusher 3. So long as anchorpusher 3 is inside rack 220, it cannot be laterally moved. However, once rack 220 is retracted, anchor-pusher 3 can be laterally deflected. As shown, an optional curved protrusion 4D (e.g., part of sheath 250) and / or a face 4E can be elastically predisposed to laterally deflect anchor-pusher 3. Optionally or additionally, anchor-pusher 3 is prebent to be curved, but maintained straight by rack 220 on one side and sheath 250 on another side. Optionally or additionally, anchor-pusher 3 is double-bent or kinked, so that it overall lies straight. However, when a first part of the bend enters sheath 250, this bend straightens, leaving the other bend or part of the kink to laterally deflect anchor-pusher 3, in a portion thereof that is outside of the sheath. In any case, once anchor-pusher 3 is bent laterally, such bending bends the anchor-pusher 3 after deployment of a first anchor 170 and after retraction of the rack 220.

[0493] In FIG. 41 A a reduced designated axial-overlap region outside of a sheath can be seen, according to some embodiments of the invention. In a first state, anchor-pusher 3 lies within a recess 227 (FIG. 4 IB) with a first axial depth. When anchor-pusher 3 is bent or otherwise laterally deflected, it is misaligned with recess 227 and instead may be aligned with a different point or recess 227G on rack 220, recess 227 G having less axial depth than that of bore 227

[0494] FIG. 42A is a perspective view inside a sheath showing an overlap switch plate 1420 that may deform the anchor-pusher 3 (e.g., with a preformed double bend which is modified by axial movement to cause lateral bending of anchor-pusher 3) to prevent reentry of anchor-pusher 3 into the bore 227 of rack 220 or other pushing the assembly, according to some embodiments of the invention. FIG. 42B shows an external perspective view of a system which has overlap switch plate 1420 at a proximal side of sheath 250, according to some embodiments of the invention. Ref. no. 1420A indicates a possible general location of overlap switch plate 1420, not the plate itself. According to some aspects, overlap switch plate 1420 is an eccentric type plate having a non-centric hole 1410 through which the anchor-pusher passes to create a deformation 1430. According to some aspects, the overlap-switch plate is a cam.

[0495] EXEMPLARY ANCHORS

[0496] Herein are decsribed exemplary anchors which may be deployed using the anchor deployment systems described herein. Other designs may be used as well. In some embodiments of the invention, each anchor has a passageway extending along the body of the anchor, the passageway at least partly not coaxial with the anchor, and an attached suture extends along the passageway. For example, the passageway may be at least partly outside the anchor. Pulling on the suture allows the anchor to bend more easily, due to a greater moment applied to the anchor as the suture portion extending through the passageway is shortened.

[0497] Each anchor may be provided with a plurality of loops. These loops may be defined by a suture, by portions of the anchor itself, or by another element. The loops allow the suture to be attached at least partly to the outside of the anchor, as discussed herein.

[0498] A proximal end of the anchor may be provided with an additional loop for attaching the anchor to a component of a deployment device, to prevent inadvertent / premature deployment of the anchor.

[0499] When deploying a plurality of anchors, a suture may be threaded through the passageways of the anchors and between the anchors in a variety of threading configurations. Anchors and methods for their deployment, in general, and, in particular, anchors and methods for their deployment as disclosed herein, may be particularly useful for repairing soft tissue, such as meniscus for example, but is not limited to this particular type of surgical procedure. For example, such anchors and method for their deployment may be particularly useful for repairing bone tissue. An aspect of some embodiments of the invention relates to flexible anchors each having an elongate flexible body to be deployed from a deployment device. In a first orientation, the elongate body has first and second ends and an outer surface, the body extending along a longitudinal axis. The body is configured to be bent into a second orientation wherein the first and second ends are closer to each other than in the first orientation.

[0500] When the anchor body is in a first orientation such that it extends along a longitudinal axis, a length of suture may be threaded through the passageway. After deployment of the anchor, by pulling on a portion of the suture, the length of suture slides through the passageway such that the portion of suture extending through the passageway is shortened. While the length of suture extending through the passageway is being shortened, it pulls on the anchor body and causes the anchor to be bent into the second orientation. Optionally, the loops may be formed of a portion of the length of suture, as discussed herein with regard to Figs. 46A and 47A.

[0501] In some embodiments, the passageway may be formed through the material of the anchor itself, such that prior to deployment the length of suture may be threaded in and out of a portion of the material of the outer surface of the anchor. In some embodiments, the anchor may have an interior lumen and the passageway may extend partly through the interior lumen of the anchor. In this manner, the material of the anchor itself forms the passageway such that the material of the anchor itself attaches the suture to the anchor body.

[0502] In some embodiments, the passageway may be defined by a plurality of loops extending radially out of the outer surface of the anchor. There may be, for example, two or four loops, positioned on an outer surface of the anchor body, between the first and second ends, at least one loop positioned closer to the first end of the anchor and at least one loop positioned closer to the second end of the anchor. In this manner, the loops define the passageway such that the loops allow the suture to be attached to the anchor body.

[0503] Having an anchor body, wherein the passageway is defined by loops is potentially advantageous in that the length of suture may slide more easily through the loops, thereby facilitating bending of the anchor body from the first orientation to the second orientation. Also, as the loops may extend radially outward from the anchor body outer surface, this may allow the length of suture to apply a greater moment to the anchor body as the length of suture extending through the passageway is shortened, thereby more easily bending the anchor body to the second orientation.

[0504] While portions of the application describe features of the invention with regard to embodiments having a passageway defined by loops, it is to be understood that these features may also be relevant to embodiments wherein the passageway is formed by the material of the anchor body, as discussed herein.

[0505] The systems, devices, kits, and methods may be utilized, in some embodiments, in the repair of torn meniscus tissue, by deploying first and second anchors through the tom tissue portions and then tightening the anchors against the tissue portions, thereby potentially holding the separated tissue portions together so that they may mend together. Optionally, any suitable number of anchors may be deployed, depending on a number of factors including, for example, the extent of the tissue damage, the location of the repair, and the size of the anchors. For example, a single anchor or more than two anchors may be utilized.

[0506] According to some embodiments, for example, when first and second anchors are to be deployed, the second anchor may be provided with an additional loop at a proximal end of the second anchor. The additional loop may be retained by a selectably openable portion of a deployment device, prior to deployment of the second anchor, to prevent the second anchor from being inadvertently, prematurely discharged from the deployment device. Optionally, the deployment device does not include a selectably openable portion but, rather, deploys the anchors by pushing the first and second anchors, sequentially, out of the deployment device.

[0507] A length of suture material may extend through the passageway. The description mentions, in some embodiments, that the suture may extend through a plurality of loops of the first and second anchors. It should, however, be understood that, alternatively, the suture may extend through a passageway defined by material of the anchor itself, as discussed herein.

[0508] In accordance with some embodiments, once the first and second anchors have been deployed, a number of portions of suture extend through the soft tissue and between the first and second anchors. A loop of one of the suture portions may be pulled to position and retain the anchors on the distal side of the soft tissue, the pulling of the loop tightening the suture threaded through the passageway and pulling on the plurality of anchor loops (or on the material of the anchor itself that defines the passageway), optionally somewhat bending the anchor bodies. Once the anchors have been retained against the distal side of the soft tissue, a proximal end of the suture may be pulled, further tightening the suture extending through the passageway defined by the plurality of anchor loops (or defined by the material of the anchor itself).

[0509] An aspect of some embodiments of the invention relates to deploying first and second anchors from a deployment device, the anchors each including a passageway as discussed herein. A length of suture that has been threaded through the passageway of each of the first and second anchors may be deployed through the soft tissue (or bone tissue), together with deployment of the first and second anchors. The particular configuration of threading of the length of suture through the passageway results in, after deployment of the first and second anchors, portions of the suture length that may be pulled to position the anchors on the distal side of the soft tissue (or bone tissue) and then to tighten the anchors against the distal side of the soft tissue (or bone tissue). These portions of suture length include a proximal end of the suture length and a portion of the suture length extending between the first and second anchors, which are on a proximal side of the soft tissue, after deployment of the first and second anchors Additionally, the provision of a passageway defined by a plurality of loops extending radially outward from the outer surface of the anchor body may allow the suture to be easily threaded through the plurality of loops. Also, this may obviate the need for the suture to be passed through the interior of the anchor such that, after anchor deployment, when the suture is pulled and tightened, friction of the suture moving through the passageway may be reduced. This may allow the suture threaded through the loops to be easily pulled and tightened, as the suture may slide easily through the loops of the anchor. This can potentially allow a user to more readily position the anchors on the distal side of the soft tissue, after deployment, and to more easily tighten the suture extended through the plurality of loops of the anchor. This may be preferable to having a portion of suture threaded through the interior of the anchors, where the suture may not slide as easily through the interior of the anchors.

[0510] Further, according to some embodiments, there may be provided a passageway which is not coaxial with the anchor longitudinal axis, the passageway extending along the anchor entirely exterior to the anchor outer surface. This may allow for a greater moment to be applied to the anchor body, thereby facilitating bending of the anchor into the second orientation.

[0511] Yet further, according to some embodiments, the provision of a passageway at least partly along the outer surface of the anchors facilitates threading of a single length of suture material through two anchors, as discussed herein, for example, with reference to Figs. 43A-19D. Therefore, after deployment of the first and second anchors, pulling of a single loop of suture material may position both the first and second anchors against the distal side of the soft tissue. Thereafter, pulling of a single proximal end of suture material may tighten both the first and second anchors against the distal side of the soft tissue.

[0512] Yet further, the provision of a second anchor having an additional loop at the proximal end of the anchor body may prevent the second anchor from inadvertently falling out of the deployment device, prior to its planned deployment, as discussed herein.

[0513] Referring now to FIGs. 43A-B, there is illustrated an anchor 10 for deployment through soft tissue, according to some embodiments of the invention. The anchor 10 has an elongate flexible body 12 having a length of, for example, from l-5cm and a diameter of, for example, from l-2cm formed of any suitable material such as, for example, polyester or polyethylene. It should be understood that, if desired, an anchor body having another suitable length, having another suitable diameter, and formed of another suitable material may be employed, in some embodiments. The body 12 has first and second ends, 14 and 16, and an outer surface 18. The anchor 10 is shown in a first orientation, according to some embodiments, the body 12 extending along a longitudinal axis 20. The body 12 of anchor 10 is bendable into a second orientation, according to some embodiments, such that after deployment through soft tissue the anchor 10 may be secured against the soft tissue, as described further herein. According to some embodiments, the body 12 may be circular in cross-section, optionally having an opening 22 extending from the first end 14 to the second end 16 of body 12, as shown in Figs. 43A-B, the anchor having an inner surface 19. However, it will be appreciated by persons skilled in the art that, alternatively, the body may have another cross-sectional profile such as, for example, square or oval (not shown) and / or the body may not have an opening extending therethrough or may have a blind bore extending only partway through the body 12 along axis 20, according to some embodiments.

[0514] With reference to Fig. 44A there is shown an anchor 30 according to some embodiments of the invention. Anchor 30 has an elongate flexible body 32 similar to body 12 shown in Figs. 43A-B. However, in some embodiments, anchor 30 may be provided with a passageway 35 defined by a plurality of loops 40 attached to body 32 and extending away from an outer surface 38 of body 32. Similarly, according to some embodiments, and with reference to Figs. 44B-C, respective anchors 50 and 70 have respective elongate flexible bodies 52 and 72, each provided with a plurality of loops 60a-d and 80a-d, respectively, which define respective passageways 65 and 85. In the embodiments shown in Figs. 44A-C each of anchors 30, 50, and 70 has a passageway defined by four loops. It will, however, be appreciate by persons skilled in the art that, if desired, a passageway defined by any suitable number of loops may be provided, wherein the loops are attached in any suitable manner to an anchor.

[0515] Referring further to Figs. 44A-C, in some embodiments, loops 40a-d of anchor 30 and loops 60a-d of anchor 50 are all formed of, for example, any material suitable for surgical suture such as, for example, those discussed herein. It should be noted that each of loops 40 of anchor 30 may be formed of separate pieces of material 34, and the ends 36 of loops 40 may be attached to the outer surface 38 of anchor body 32 by any known means such as, for example, gluing, welding, or otherwise attaching by heat. Alternatively, in an embodiment where anchor 30 is hollow, having an opening similar to opening 22 of anchor 10 (Fig. 43B), then at least one end 36 of at least one loop 40 may pass through the material of the anchor 30, where it may be attached to an inner surface of the opening. Alternatively, the at least one end may pass through the material of the anchor 30 and be retained therein by any known means such as, for example a knot.

[0516] With reference to Fig. 44B in particular, loops 60 (e.g., 60a-d) of anchor 50 may be formed of a single portion of material 54, for example, suture material as discussed herein, where ends 56 (e.g., 56a-h) of each loop 60 extend through material 57 inside the outer surface 58 of anchor 50. For example, in some embodiments, loops 60 are woven in and out of material 57 on the outer surface 58 of anchor 50 such that end 56b of loop 60a and end 56c of adjacent loop 60b are connected to each other within material 57 of the outer surface or within material 57 partway through the outer surface of anchor 50. In an embodiment where anchor 50 is hollow, having an opening in the anchor body similar to opening 22 in anchor body 12 (Fig. 43B), end 56b of loop 60a and end 56c of adjacent loop 60b may be continuous and / or connected to each other within the opening through the anchor body. Additionally, the ends 54 of the loops 60a and 60d, closest to respective ends 51 and 53 of body 52, may each be provided with a knot 55 within the opening, for retaining the ends (56a, 56h) of respective loops 60a, 60d within the anchor body 52, in some embodiments. Alternatively, in some embodiments, ends 56a, 56h may be attached to the anchor body 52 by any other suitable means, including that discussed with regard to anchor 30 (Fig. 44 A).

[0517] With reference to Fig. 44C there is shown an anchor 70 similar to anchor 50 (Fig. 44B). However, in anchor 70 the ends 76a and 76h of material 74, at the ends of respective loops 80a and 80d, closest to respective ends 71 and 73 of body 72, may extend out again through the outer surface 78 of anchor body 72. A knot 79 may be provided at or near ends 76a and 76h, outside anchor 70, for retaining the ends 76a and 76h outside the anchor body 72, according to some embodiments. Alternatively, ends 76a and 76h may be provided with any other suitable means, including that discussed with regard to anchors 30 and 50, according to some embodiments.

[0518] It may be noted that the loops of anchors 30, 50, and 70 are shown, in some embodiments, as being evenly spaced along the length of respective anchors 30, 50, and 70. However, it should be noted that, if desired, the loops may be unevenly distributed along the length of the anchors, in accordance with some embodiments, with at least one loop positioned nearer a first end of the anchor and at least a second loop positioned nearer a second end of the anchor. For example, there may be more space between the inner two loops than between the outer two loops of an anchor, thereby assisting in pulling the ends of the anchor closer toward each other, in some embodiments.

[0519] Additionally, for example, there may be more space at the ends of the anchor, i.e., adjacent the outer loops, in some embodiments. This may potentially allow the anchor ends to overlap when a suture threaded through the loops is pulled, thereby pulling the ends of the anchor closer together.

[0520] It may be noted that at least one end of any of the loops of any of the herein-described embodiments may be provided with a reinforcement, as known in the art, for maintaining the at least one end in position relative to the anchor body. Such a reinforcement may be formed by heating a portion at one end of the loop material or by heating an additional piece of material, to form a ball that retains the end of the loop in position. While this may be advantageous and provide a potential advantage of reinforcing the end of the loop with the anchor body, in some embodiments, the reinforced portion may cause added stress when the anchor is deployed from a delivery device and / or through soft tissue.

[0521] With additional reference to Fig. 44D there are shown a pair of anchors 30, shown in position after deployment and secured against soft tissue 42, in accordance with some embodiments. While Fig. 44D shows anchors 30 which are each similar in structure and function to anchor 30 (Fig. 44A), it will be appreciated by persons skilled in the art that, according to some embodiments, alternatively, any combination of anchors 30, 50, and / or 70 from Figs. 30A- B or any other anchors described herein may be depicted.

[0522] Each of anchors 30 may include a passageway defined by four loops 40, as discussed herein with regard to Fig. 44A. Anchors 30 may each be retained in a second orientation wherein, after deployment through the soft tissue 42, bodies 32 have each been bent into a u-shape by a suture portion 44 / 46 that has been threaded through loops 40 in that anchor 30, in accordance with some embodiments. A number of configurations of threading a suture portion through the passageways of anchors, prior to deployment of the anchors, will be discussed further herein. It should be noted that, in the second orientation, in accordance with some embodiments, the ends 31 and 33 of the anchor body 32 are closer to each other than in the first orientation (e.g., Fig. 44A). Optionally, in the second orientation, the ends 31 and 33 of the anchor body 32 are facing each other at an angle, according to some embodiments. The suture thread may be formed of any suitable material such as, for example, those discussed herein.

[0523] With additional reference to Figs. 45A-B there are shown additional embodiments of the invention, specifically respective anchors 80 and 90. Each of anchors 80 and 90 may include a passageway defined by a plurality of respective loops 82 and 92. Each of loops 82 and 92 may be similar in structure and function to loops 40, 60a-d, and 80a-d (Figs. 44A-C). However, in accordance with some embodiments and as seen in Figs. 45A-B, it should be noted that each of anchors 80 and 90 may include only two loops 82 and 92, respectively, as opposed to the four- looped anchors 30, 50, and 70 (Figs. 44A-C).

[0524] With additional reference to Fig. 45C there are shown a pair of anchors 80, in position after deployment and securing against soft tissue 42, in accordance with some embodiments of the invention. While Fig. 45C shows anchors 80 which are each similar in structure and function to anchor 80 (Fig. 45A), it will be appreciated by persons skilled in the art that, alternatively, any combination of anchors 80 and / or 90 from Figs. 45A-B, respectively, may be depicted. Each of anchors 80 may include two loops 82, as discussed herein with regard to Fig. 45A. Anchors 80 are each retained in a second orientation wherein, after deployment through the soft tissue 42, bodies 84 have each been bent into a u-shape by a respective suture portion 44 / 46 that has been threaded through loops 82 in that anchor 80, according to some embodiments. It should be noted that, in the second orientation, the ends 81 and 83 of the anchor body 84 are closer to each other than in the first orientation (e.g., Fig. 45A). Optionally, in the second orientation, the ends 81 and 83 of each anchor body 84 are facing each other at an angle, according to some embodiments. The suture thread may be formed of any suitable material such as, for example, that discussed herein with regard to the suture material in Fig. 44D.

[0525] With reference to Figs. 45D-G there are shown additional anchors having passageways defined by loops, in accordance with embodiments of the invention. For example, anchor 91 (Fig. 45D) may include a passageway 75 defined by loops 93 which are formed by a single portion of suture 94 woven in and out of material 77 of the anchor, such that loops 93 are connected to each other, in accordance with some embodiments. It may be noted that suture portions 95, on either end of anchor 91, extend away from the anchor.

[0526] As seen in Fig. 45E, in accordance with some embodiments, anchor 99 also may include a passageway 75 defined by loops 93 formed by a single portion of suture 96 woven in and out of material 77 of the anchor, such that loops 93 are connected to each other. It may be noted that suture portions 97, on either end of anchor 99, may each be provided with a knot 98. Knot 98 may prevent the suture portion from being disconnected from the anchor 99, according to some embodiments.

[0527] With ref. to Fig. 45F-G, there are shown anchors in accordance with some embodiments of the invention. Anchor 70a may be similar to anchor 70 (Fig. 44C), except that the ends of the loops may be directed back toward the interior of the anchor 70a, which may reinforce the ends of the suture material, such that it does not become detached from the anchor. As to anchor 70b, this may be similar to anchor 70a, except that the ends of the loops are embedded in the anchor material, in accordance with some embodiments, thereby potentially providing a stronger connection between the loops and the anchor body 72b.

[0528] It will be appreciated by person skilled in the art that, according to some embodiments of the invention, an anchor having four loops may provide better anchoring stability against soft tissue and may be more difficult to remove once secured against soft tissue. However, an anchor having only two loops may pass through soft tissue, for example, a meniscus, with less stress and may lie flatter against the soft tissue. With reference to Figs. 46A-B there is shown an alternative configuration for threading a length of suture through a pair of anchors, and an anchor after being secured against soft tissue, according to some embodiments. Specifically, as shown, first and second anchors 401 and 402 have respective bodies 431 and 432, each having a passageway defined by a pair of loops, according to some embodiments. For example, anchor 401 may have passageway 405 defined by loops 404a and 404b formed of a short suture portion 406 woven in and out of material 407 anchor 401, where the ends 410 and 412 of short suture portion 406 may be attached to body 431 by any known means such as, for example, any of those discussed herein with regard to any of loops 40 (Fig. 44A), 60 (Figs. 45B), 82 (Fig. 45A), 92 (Fig. 45B), or 80 (Fig. 44C), in accordance with some embodiments. Anchor 402 may have a passageway 405 defined by loops 408a and 408b formed of a portion of long suture portion 416 which is woven in and out of material 407 of anchor 402, according to some embodiments. Anchors 401 and 402 may be attached by long suture portion 416, according to some embodiments, by following threading configuration: a. A first end 420 of long suture portion 416 may form an end of loop 408b, and long suture portion forms loop 408a, as noted herein, then extends away from body 432 of anchor 402. b. The long suture portion 416 then extends toward anchor 401 and passes through passageway 405 defined by loops 404b and 404a of anchor 401. c. Long suture portion 416 then extends away from anchor 401 toward anchor 402, whereat long suture potion 416 passes through passageway 405 defined by loops 408a and 408b. d. A second end 422 of long suture portion 416 extends proximally, away from anchor 402.

[0529] Anchors 401 and 402 may be deployed through soft tissue, as discussed herein and in accordance with some embodiments. After release from a deployment device, the anchors 401 and 402 may be secured and tightened against soft tissue by pulling on second end 422 of long suture portion 416, according to some embodiments. As discussed herein, as long suture portion 416 slides through passageway 405 of each of anchors 401 and 402, this may cause bodies 431 and 432 of respective anchors 401 and 402 to bend into u-shaped anchors, according to some embodiments. One such anchor 402 is shown in Fig. 47B in a bent configuration.

[0530] Now referring to Figs. 47A-B there is shown a further alternative configuration for threading a length of suture through a pair of anchors, and an anchor after being secured against soft tissue, according to some embodiments. The embodiment of Fig. 47A is similar to that of Fig. 46A, except that the configuration of threading the long suture 416 may differ. In particular, a first end 420 of long suture portion 416 may form an end of loop 408b, and the portion of long suture portion forming loop 408a may have a threading configuration as follows: a. From anchor 402, long suture portion 416 extends toward anchor 401 and passes through passageway 405 defined by loops 404b and 404a. b. From anchor 401, long suture portion 416 extends toward anchor 402, and passes through loop 408b and then through loop 408a of passageway 405. (This differs from the threading configuration of Fig. 46A.) c. From anchor 402, long suture portion 416 extends proximally, past anchor 401.

[0531] Anchors 401 and 402 may be deployed through soft tissue, as discussed herein, in accordance with some embodiments. After release from a deployment device, the anchors 401 and 402 may be secured and tightened against soft tissue by pulling on second end 422 of long suture portion 416, according to some embodiments. As discussed herein, as long suture portion 416 slides through passageway 405 of each of anchors 401 and 402, this may cause bodies 431 and 432 of respective anchors 401 and 402 to bend into u-shaped anchors, according to some embodiments. One such anchor 402 is shown in Fig. 46B in a bent configuration.

[0532] While in the embodiments of Figs. 46A and 47A, anchors 401 and 402 and anchors 501 and 502 are shown each having a passageway 405 defined by a pair of loops, it will be appreciated by person skilled in the art that, if desired, any of anchors 401, 402, 501, and 502 may, alternatively, have a passageway defined by more than 2 loops each such as, for example, four loops.

[0533] Reference is now made to Fig. 47C, which is a simplified schematic illustration of an exemplary anchor 1700 with a suture 1710 threaded therethrough in a first orientation, in accordance with an embodiment of the present invention and to Fig. 47D, which is a simplified sectional view illustration of the anchor of Fig. 47C and the suture threaded therethrough, in a second orientation.

[0534] When in the first operative orientation (Fig. 47C), anchor 1700 is generally arranged along a longitudinal axis 1701 and defines a proximal end portion 1702 and a distal end portion 1704. Alternatively, the anchor 1700 may have any other shape at the first operative orientation.

[0535] It is a particular feature of an embodiment of the present invention that at least one suture 1710 is configured to be partially threaded at least once through the distal end portion 1704 of anchor 1700 and also configured to be threaded at least once through the proximal end portion 1702 of anchor 1700. The at least one suture 1710 is also configured to be partially disposed radially externally of the anchor 1700.

[0536] It is specifically seen that the suture 1710 can be schematically divided into several different portions, namely a proximal external portion 1712, a proximal internal portion 1714, an intermediate external portion 1716, a distal internal portion 1718 and a distal external portion 1720. It is specifically seen in Fig. 47C that the proximal external portion 1712 and the distal external portion 1720 of the suture 1710 are disposed radially externally relative to an outer surface 1706 of the anchor 1700, whereas the proximal internal portion 1714 is preferably threaded through the proximal end portion 1702 of the anchor 1700 and the distal internal portion 1718 is preferably threaded through the distal end portion 1704 of the anchor 1700. The proximal external portion 1712, the intermediate external portion 1716 and the distal external portion 1720 of the suture 1710 are all preferably disposed externally with respect to the outer surface 1706 of the anchor 1700.

[0537] It is seen in Fig. 47D that the anchor 1700 is disposed in its second, tightened operative orientation. Once at least one of the proximal external portion 1712 and the distal external portion 1720 of the suture 1710 has been pulled, the length of suture extending along the anchor has been shortened, such that the anchor 1700 is bent, with the proximal end portion 1702 and the distal end portion 1704 thereof being generally brought into proximity with each other.

[0538] It is a particular feature of an embodiment of the present invention that the force that is required to be exerted by the user in order to tighten the anchor 1700, such that it transitions from its first operative orientation of Fig. 47C to its second, tightened operative orientation of Fig. 47D, is relatively low due to minimization of friction forces between the anchor 1700 and the suture 1710.

[0539] Minimization of friction forces is preferably achieved due to minimization of surface area where the anchor 1700 engages the suture 1710. Minimization of such surface area is in turn achieved by the fact that only a portion of the suture 1710 is threaded through the anchor 1700 and the remaining length of the suture 1710 is disposed externally of the anchor 1700.

[0540] It is a particular feature of an embodiment of the present invention that the force that is required to be exerted by the user in order to tighten the anchor 1700, such that it transitions from its first operative orientation of Fig. 47C to its second, tightened operative orientation of Fig. 47D, is relatively lower than the force that would be required if the suture were threaded through the entire length of the anchor.

[0541] EXEMPLARY METHODS

[0542] In an exemplary anchor delivery method, an anchor pair is deployed as follows. A first anchor is deployed by advancing the anchor-pusher a first amount and then the anchor pushing mechanism (which includes the anchor-pusher and a pushing assembly) is modified so that there is less axial overlap between the anchor-pusher and the pushing assembly. Then the anchor- pusher is again advanced and the second anchor is deployed. Optionally, a same movement, e.g., type and amount (for example, sliding or rotating of a knob) is used for the two deployments. Optionally, between the two movements, the pushing assembly is retracted. Optionally, the state of the mechanism automatically moves from a first state of potential overlap to a second state of potential overlap, for example, due to elastic movement of one or more components, allowed by the retraction of the pushing assembly. Then when advancing the pushing assembly the anchorpusher will contact an anchor and deploy it from the sheath.

[0543] Figure 48 is a method of operating a multi-state anchor delivery device, in accordance with some embodiments of the invention. At 2000, the method includes pushing an anchorpusher using a second pusher on a designated axial-overlap region between the anchor-pusher and the second pusher. At 2010, the method includes pushing an anchor out of a sheath using an anchor-pusher during a first state. At 2020, the method includes retracting the second pusher from the anchor-pusher, which results in a reduction of the designated axial-overlap region between the anchor-pusher and the second pusher. At 2030, one or both the anchor-pusher and the second pusher are deformed. At 2040, the anchor-pusher is pushed by the second pusher, one or both the anchor-pusher and the second pusher having a deformation which causes a mechanical interference over the designated axial-overlap region, wherein the pushing is on a contact-area between the anchor-pusher and the second pusher, the contact-area being outside of the designated axial-overlap region. At 2050, the next anchor is pushed out of the sheath usincg the anchor-pusher during a second state.

[0544] Figure 49 is a method for reducing axial-overlap and extending an anchor-pusher, in accordance with some embodiments of the invention. At 2100, an axial-overlap region is designated between an anchor-pusher and a second pusher. At 2110, the second pusher is retracted from the anchor-pusher to reduce the designated axial-overlap region between the anchor-pusher and the second pusher. At 2120, one or both the anchor-pusher and the second pusher is deformed. At 2130, mechanical interference is created over the designated axial- overlap region. At 2140, the lengths of the anchor-pusher and the second pusher are combined, using a contact-area outside of the designated axial-overlap region. At 2150, the lengths of the anchor-pusher and the second pusher are extended by using the new combination length. At 2160, the next anchor is pushed out of the sheath using the extended length for the anchor-pusher during a second state.

[0545] Figure 50 is an exploded perspective view of an anchor delivery system 100 including a pusher element having a curved tip, according to some embodiments of the invention. Components of system may be similar in structure and function to those of the anchor delivery system shown with reference to Figs. 31-4, and may not be described herein again.

[0546] System 100 includes a sheath 250 having a tip 253 and an axially-extending slot 255 extending along a distal end portion 250a of the sheath. A length of suture 288 may be threaded through anchors 270 and 280, the length of suture including suture portions 288a and 288b, each of which extends between anchors 270 and 280, and a suture free end 288c which may extend proximally from anchor 280 or anchor 270, alongside sheath 250. The suture 288 and its function in tightening the deployed anchors will be discussed further with reference to Fig. 63.

[0547] With additional reference to Fig. 51, suture portions 288a and 288b may extend out through needle slot 255. It may be noted that the provision of slot 255, allows the suture portions 288a-b to be located outside the sheath 250, thereby potentially preventing those portions of suture 288 from interfering with movement of anchors 270 and 280 through the sheath. It may also be noted that the suture free end 288c is not shown in Fig. 51, as it may extend from the first anchor 270 or from the second anchor 280, proximally through the device, so that it may be pulled by a user, after deployment of the first and second anchors. Optionally, suture free end 288c may be wrapped around bobbin 300 (Fig. 50). The suture 288 will be discussed further with reference to Figs. 57 and 63. It may be noted that, for simplicity, the suture 288 has been omitted in Figs. 53- 56 and 59-34.

[0548] FIG. 52 is a perspective view of a pusher element 230 for an anchor delivery system, according to some embodiments of the invention. Pusher element 230 includes an elongate rod

[0549] 320 having a tip 322 at a distal end portion 232 of the pusher element, the tip having a slight upward curve. At least the distal end portion 232 of pusher element 230 is formed of a flexible / bendable material, which allows the distal end portion to be deformed, as will be discussed further herein.

[0550] Pusher element 230 includes a portion 321 having a relatively thin profile which extends between pusher tip 322 and a portion 323 which has a relatively thick profile. Between portions

[0551] 321 and 323 there may be an inclined surface 324, according to some embodiments. Pusher element 230 may also include a portion 325 having a relatively thin profile which extends between portion 323 and a relatively thick portion 327. Optionally portion 325 may have the same thickness as portion 323. Between portions 323 and 325 there may be an inclined surface 326. Adjacent portion 327 there may be a recess 328. Optionally, a screw may be inserted into the device 100 (Fig. 50) to attach the pusher element 230 to rack 220 (FIG. 50) or to another portion of the deployment device. It may be noted that portions of the pusher element 230 (for example, pusher tip 322, distal end portion 232, and portion 321) are shown as having relatively thin profiles, as compared with at least portion 323, which has a relative thick profile. The relatively thin portions of the pusher element 230 allow those portions of the pusher element to be more flexible, while the relatively thick portion(s) limit lateral movement of the pusher element within the sheath 250, according to some embodiments.

[0552] FIG. 53 is a side- sectional view of an anchor delivery system 100, prior to deployment of anchors 270 and 280, according to some embodiments of the invention. In the enlargement of Fig. 53, anchors 270 and 280 are shown positioned within sheath 250, with anchor 270 being distal to anchor 280. Pusher element 230 extends beneath anchor 280, with pusher tip 322 located distal to anchor 280 but proximal to anchor 270. It may be noted that anchor 280 may be positioned adjacent relatively thin portion 321 of pusher element 230, according to some embodiments.

[0553] While pusher element 230 is shown as extending below anchor 280, it will be appreciated by person skilled in the art that, alternatively, pusher element 230 may extend above anchor 280 or alongside anchor 280, as long as pusher tip322 is located distal to anchor 280 and proximal to anchor 270.

[0554] Distal movement of pusher element 230 causes pusher tip 322 to abut a proximal end 272 of anchor 270 and to move anchor 270 toward sheath tip 253. As pusher element 230 moves distally to deploy anchor 270, anchor 280 may be moved distally, closer to sheath tip 253, due to contact of inclined surface 324 with a proximal end 282 of anchor 280, according to some embodiments. Pusher element 230 may be extended at least as far as necessary toward the sheath tip 253, until anchor 270 is deployed.

[0555] FIG. 54 is a side-sectional view of an anchor delivery system, after deployment of anchor 270, with the pusher element 230 in an extended position. With additional reference to Figs. 55A- B, pusher element 230 may be retracted, i.e., moved proximally (to the right relative to the position of the pusher element in Fig. 54). As pusher element 230 is retracted, the pusher tip 322, which was previously curved upward, is deformed by anchor 280 (Fig. 55A) such that the pusher tip is coaxial with portion 321 of the pusher element, and pusher tip (not shown in Fig. 55A) passes underneath anchor 280 until it is disposed entirely proximal to anchor proximal end (Fig. 55B), at which point the pusher tip 322 will revert to its curved configuration.

[0556] Optionally, the second anchor 280 may be deformable such that, when pusher element 230 is retracted, the pusher tip 322 causes the second anchor to become temporarily deformed, as the pusher element slides past the second anchor, to the position in Fig. 55B. It may be noted that the provision of anchor loops (Figs. 44A-19B) and / or the suture loops which extend out through slot 255 in sheath 250 (Figs. 50 and 51) may prevent the anchor 280 from moving backward (distally) when the pusher element 230 is retracted, according to some embodiments.

[0557] Distal movement of pusher element 230, from its position in Fig. 55B to its position in Fig. 56 causes pusher tip 322 to contact proximal end 282 of anchor 280, such that anchor 280 is moved distally within sheath 250. As seen in FIG. 56, pusher element 230 may be extended at least as far as necessary toward the sheath tip 253 to deploy anchor 280 (Fig. 56).

[0558] Figure 57 is an exploded perspective view of an anchor delivery system 200 including a pusher element 330 having a distal end 332 including an S-shaped tip or tip portion 342, according to some embodiments of the invention. Components of the system may be similar in structure and function to those of the anchor delivery system shown with reference to Figs. 31-4 and / or 50-23, and will not be described herein again.

[0559] It may be noted that, similar to what is shown in Fig. 51, system 200 may also include a sheath 250 having an axially-extending slot 255 extending along a distal end portion 250a of the sheath. A length of suture 288 may be threaded through anchors 270 and 280 in a manner similar to that discussed herein (for example, regarding Figs. 50-23 and 63). The suture 288 and its function in tightening the deployed anchors will be discussed further in detail with reference to Fig. 63.

[0560] When assembled, system 200 (Fig. 57) may have an outward appearance similar to that of system 100 (Fig. 51), although the pusher element (230 or 330) within the system may be different.

[0561] FIG. 58 is a perspective view of a pusher element 330 for an anchor delivery system, according to some embodiments of the invention. Pusher element 330 includes an elongate rod 332 having an S-shaped tip portion 342 at a distal end portion 332 of the pusher element. The S- shape of the tip portion 342 includes an upper curved portion 334, a lower curved portion 336, and a distalmost tip 333. At least the S-shaped tip portion 342 of pusher element 330 is formed of a flexible / bendable material, which allows the S-shaped portion to be deformed, as will be discussed further herein.

[0562] While pusher element 330 (Fig. 58) may be similar in function to pusher element 320 (Fig. 52), according to some embodiments, it should be noted that the particular configuration of the S-shaped tip portion 342 of pusher element 330 may allow pusher element 330 to be more flexible and may allow pusher element 330 to be more easily deformed, for example, as discussed herein with regard to Figs. 60-33B. It may be noted that the S- shaped portion 342 of the pusher element 330 may allow the S-shaped portion to be more flexible, while the upper curved portion 334 and the lower curved portion 336 may limit lateral movement of the pusher element within the sheath 250, according to some embodiments.

[0563] FIG. 59 is a side- sectional view of an anchor delivery system 200, prior to deployment of anchors 270 and 280, according to some embodiments of the invention. In the enlargement of Fig. 59, anchors 270 and 280 are shown positioned within sheath 250, with anchor 270 being distal to anchor 280. Pusher element 330 extends beneath anchor 280, with S-shaped pusher tip portion 342 located distal to anchor 280 but proximal to anchor 270. It may be noted that anchor 280 is positioned adjacent a portion of rod 332 of pusher element 330.

[0564] While pusher element 330 is shown as extending below anchor 280, it will be appreciated by person skilled in the art that, alternatively, pusher element 330 may extend above anchor 280 or alongside anchor 280, as long as S-shaped pusher tip portion 342 is located distal to anchor 280 and proximal to anchor 270.

[0565] Distal movement of pusher element 330 causes tip 333 of pusher element 330 to abut a proximal end 272 of anchor 270 and to move anchor 270 toward sheath tip 253. As pusher element 330 moves distally to deploy anchor 270, anchor 280 may be moved distally, closer to sheath tip 253, due to contact of rod 332 with anchor 280. Alternatively, anchor 280 may slide relative to rod 332 as pusher element 330 is moved distally. Pusher element 330 may be extended at least as far as necessary toward the sheath tip 253, until anchor 270 is deployed.

[0566] FIG. 60 is a side-sectional view of an anchor delivery system, after deployment of anchor 270, with the pusher element 330 in an extended position. With additional reference to Figs. 61A- B, pusher element 330 may be retracted, i.e., moved proximally (to the right relative to the position of the pusher element in Fig. 60). As pusher element 330 is retracted, the S-shaped tip portion 342, which previously included upper curved portion 334 and lower curved portion 336, is deformed by anchor 280 (Fig. 61A) such that the tip portion 342 (previously having the S- shape) is coaxial with rod 332 of the pusher element, and the portion of pusher element 330 that previously formed S-shape tip portion 342 (not shown in Fig. 61 A) passes underneath anchor 280 until it is disposed entirely proximal to anchor proximal end (Fig. 61 A), at which point the tip portion 342 will revert to its S-shaped configuration.

[0567] Optionally, the second anchor 280 may be deformable such that, when pusher element 330 is retracted, the pusher tip 342 portion causes the second anchor to become temporarily deformed, as the pusher element slides past the second anchor, to the position in Fig. 6 IB. It may be noted that the provision of anchor loops (Figs. 44A-19B) and / or the suture loops which extend out through slot 255 in sheath 250 (Figs. 58 and 51) may prevent the anchor 280 from moving backward (distally) when the pusher element 330 is retracted, according to some embodiments.

[0568] Once pusher element 330 has been retracted so that it is entirely proximal relative to anchor 280, S-shaped pusher tip portion 342 returns to its S-shaped configuration (Fig. 61B).

[0569] Distal movement of pusher element 330, from its position in Fig. 6 IB to its position in Fig. 62, causes tip 333 of the pusher element to contact proximal end 282 of anchor 280, such that anchor 280 is moved distally within sheath 250. As seen in FIG. 62, pusher element 330 may be extended at least as far as necessary toward the sheath tip 253 to deploy anchor (Fig. 62).

[0570] FIG. 63 is a side- sectional view of a portion of an anchor delivery system, including anchors 270 and 280 having a suture 288 extending or threaded therethrough, according to some embodiments of the invention. The anchor delivery system shown may be similar in structure and function to any of the anchor delivery systems discussed herein such as, for example, system 100 (Fig. 50) or system 200 (Fig. 57). Anchors 270 and 280 are shown positioned within sheath 250, with anchor 270 being located distal to anchor 280. The system may be provided with any suitable suture such as, for example, FiberWire®, for example #2-0. The suture length may be, for example, about 720mm ±30mm.

[0571] As discussed herein, suture 288 may be threaded through anchors 270 and 280 or, as shown, through loops 88. While in the embodiment shown anchors 270 and 280 are each provided with a pair of loops 88, the anchors may alternatively be provided with more than two loops such as, for example, four loops each, as discussed herein, according to some embodiments.

[0572] A length of suture 288 is loosely threaded through the loops 88 of anchors 270 and 280, as discussed herein. In particular, suture 288 includes a suture portion 288a (inner loop), extending between a proximal end 272 of anchor 270 and a distal end 284 of anchor 280, at which suture portion 288a is attached to anchor 280 by means known in the art. Suture portion 288a may have a length of, for example, about 50mm ±5mm, according to some embodiments. Suture 288 may also include a suture portion 288b (outer loop), which extends between a distal end 274 of anchor 270 and a proximal end 282 of anchor 280, according to some embodiments. Suture portion 288b may have a length of, for example, about 260mm ±5mm. Suture 288 may also include a suture free end 288c which is wrapped twice around portion 288b as shown at windings 1298, and may extend proximally within sheath 250 (although this is not shown in the drawing, for the sake of clarity). A portion 1290 of suture 288 may extend between portions 288a and 288b and may be threaded through the loops 88 of anchor 270, and a portion 1292 of suture 288 may extend between portions 288a and 288c and may be threaded through the loops 88 of anchor 280, according to some embodiments.

[0573] A portion 1294 of suture portion 288c, located between portion 1292 and windings 1298, may be provided with a slip knot 1299, also known as a “stopper knot” or a “running knot,” as known in the art, according to some embodiments. Slip knot 1299 may be positioned along suture portion 1294 at a location of, for example, 35mm from anchor 280. Slip knot 1299 has an adjacent loop, as known in the art, the loop having a diameter of, for example, from 0.5-2.5cm, such as, for example, 22mm. The slip knot 1299 may be formed such that it may be released by pulling on suture section 287, but slip knot may be designed such that it will not release if suture section 289 is pulled, as known in the art. Slip knot 1299 is easily undone by pulling suture free end 288c, which will release the slip knot. Suture sections 289 and 287 extend from slip knot 1299 to portion 1292 and windings 1298, respectively.

[0574] The slip knot 1299 may have an adjacent loop 295, as known in the art. Additionally, the relative dimensions of slip knot 1299 and the distalmost loop 88 of anchor 280 are selected such that slip knot may not pass through loop 88.

[0575] As discussed herein, for example, with reference to Fig. 51, suture portions 288a and 288b may extend out through needle slot 255. However, for the sake of clarity, in the embodiment of Fig. 63, there is no slot shown in needle / sheath 250. The relative positions of portions of suture 288 are shown, relative to anchors 270 and 280.

[0576] Suture 288 is free to slide through loops 88 in anchors 270 and 280, while anchors 270 and 280 are contained within sheath 250, or after anchor 270 has been deployed. However, if suture section 289 is slid through loops 88 of anchor 280, in the direction of arrow 301, this sliding will be limited by knot 1299 as it reaches loop 88 of anchor 280, due to the relative dimensions of slip knot 1299 and loop 88, as noted above.

[0577] After deployment of anchors 270 and 280, suture portion 288b may be pulled, as discussed in greater detail with reference to Figs. 64A-H. In particular, the left side of suture portion 288b (as shown in Figs. 63 and 64A) may be pulled proximally, which will result in shortening of portion 288a, as suture slides through loops 88 of anchor 270. Pulling of suture portion 288b proximally will also result in anchors 270 and 280 being moved closer to the tissue 1296 through which the anchors were deployed, as portion 288a is shortened and moved closer to the tissue.

[0578] Suture free end 288c may then be pulled proximally, for example, in the direction of arrow 302 (Fig. 63). This will cause the suture windings 1298 to slide around loop 288b and slip knot 1299 to be released due to the proximal pull on suture section 287. As free end 288c is pulled further, portion 1292 will slide through loops 88 of anchor 280 and suture portion 288b will shorten until it is positioned against the tissue (not shown in Fig. 63). Due to windings 1298, which were configured prior to deployment of the anchors 270 and 280, a knot will be formed in the suture 288, as discussed herein with reference to Fig. 64H, after which the suture free end 288c may be cut close to the tissue.

[0579] With additional reference to Figs. 64A-H, there is shown the length of suture 288 configured as it would appear schematically after deployment of anchors 270 and 280 (Fig. 63) through a tissue 1296, the length of suture seen schematically from a proximal side of the tissue. It should be noted that, for the sake of clarity, anchors 270 and 280, which have been deployed to the distal side of tissue 1296, have been omitted in Figs. 64A-H. Portions of loop 288a and 288b pass through an opening 271 in the tissue through which anchor 270 (Fig. 63) was inserted. Similarly, portions of loop 288a and 288b pass through an opening 281 in the tissue through which anchor 280 (Fig. 63) was inserted.

[0580] A surgeon, for example, may pull proximally on the left side of loop 288b, thereby causing the suture to slide through loops 88 in anchor 270 (Fig. 63), lengthening loop 288b, and shortening loop 288a, from the respective lengths shown in Fig. 64A to the respective lengths shown in Fig. 64B, at which loop 288a has less slack relative to tissue 1296. Further pulling proximally on the left side of loop 288b causes further lengthening of loop 288b and further shortening of loop 288a, from the respective lengths shown in Fig. 64B to the respective lengths shown in Fig. 64C, at which point loop 288a may lie substantially flat against tissue 1296.

[0581] It should be noted that, if the right side of loop 288b were to be pulled proximally, due to the threading of suture 288 through loops 88 in anchor 280, suture portion 289 may slide a small distance through loops 88 in anchor 280, until knot 1299 reaches the more distal loop 88 in anchor 280. Then, due to the relative dimensions of slip knot 1299 and loop 88, the slip knot will prevent the suture from sliding further through loop 88, as discussed herein.

[0582] The surgeon may then pull proximally on suture end 288c, from its position in Fig. 64C to its position in Fig. 64D, at which point the suture windings 1298 tighten somewhat around loop 288b. Also, due to the suture end 288c being pulled proximally, suture portion 287 is pulled proximally, such that the slip knot 1299 starts to become undone, with loop 1295 adjacent slip knot 1299 becoming smaller as it slides through the slip knot, as known in the art.

[0583] With reference to Fig. 64E, further pulling on suture end 288c will further tighten windings 1298 around loop 288b, and will cause slip knot 1299 to become entirely undone (Fig. 64E), as loop 1295 slides through the slip knot. After the slip knot is undone, further pulling on suture end 288c will cause the suture 288 to slide through loops 88 on anchor 280 (Fig. 63), resulting in a shortening of loop 288b, for example, from its length in Fig. 64E to its length in Fig. 64F.

[0584] Yet further pulling on suture end 288c will cause loop 288b to shorten further, from the length shown in Fig. 64F to the length shown in Fig. 64G, and then to the length shown in Fig. 64H, at which point both loops 288a and 288b may lie substantially flat against tissue 1296. As loop 288b is shortened from the length shown in Fig. 64G to the length shown in Fig. 64H, windings 1298 (Fig. 64E) will form a knot 297, thereby securing the suture against the tissue 1296. Excess length of suture 288c may then be cut off near knot 297 or otherwise removed, as known in the art.

[0585] It should be noted that the system may be operated outside the body, for example, according to the actions indicated above, and / or not during a medical procedure, such as, for example, during testing of the system.

[0586] With reference to Fig. 65 there is shown a flowchart illustrating actions of a method 2200 of attaching a biocompatible material to soft tissue, according to some embodiments. At 2200, a patch may be positioned on or adjacent soft tissue to be repaired, according to some embodiments. A 2204, according to some embodiments, a needle containing first and second anchors may be inserted through the patch and soft tissue at the surgical site, the needle tip positioned at a location at which the first anchor is to be implanted. The first anchor may be deployed, at 2206, through the patch, into the soft tissue, according to some embodiments. The needle may then be withdrawn from the soft tissue and patch, at 2208, according to some embodiments. At 2210, the second anchor may be deployed on a proximal side of the patch, optionally adjacent the patch, according to some embodiments. At 2212, a free end of the suture may be pulled, according to some embodiments. This may cause the first anchor to tighten, according to some embodiments, and, optionally, to bend into a c-shape or a u-shape, as discussed herein. According to some embodiments, at 2214, the suture free end may be pulled further, causing the second anchor to be tightened relative to the patch, optionally causing the second anchor to be tightened against the patch and / or optionally causing the second anchor to bend into a c-shape or a u-shape, as discussed herein.

[0587] Further details of method 2200 may be understood with reference to Figs. 66, which illustrates a needle portion of an implant delivery system, according to some embodiments, and to Fig. 28, which illustrates a second tissue or a biocompatible material secured to a first tissue, according to some embodiments. As seen in Fig. 66, anchors 270 and 280 are shown, having been loaded into a needle 250 of a deployment device (not shown), as discussed herein. Various components of the deployment system may be identical or similar in structure and function to those of other embodiments discussed herein such as, for example, the embodiment of Fig. 63, and will not be described here again in detail.

[0588] A length 488 of suture material may extend through anchors 270 and 280, optionally having a small portion 488a forming a small loop between first anchor proximal end 272 and second anchor distal end 286, a large portion 488b forming a large loop between the first anchor distal end 274 and the second anchor proximal end 284, and a free end 488c extending proximally from the first anchor proximal end 272. The length 488 of suture material may be formed of, for example, 2-0 FiberWire™, although other materials may optionally be used. Optionally, the length of the small portion 488a of suture material is 50mm, the length of the large portion 488b of suture material is 220mm, and the length of the suture free end 488c is 300mm, although other lengths may be used.

[0589] As discussed herein, for example, with reference to Fig. 51, suture portions 488a and 488b may extend out through needle slot 255. However, for the sake of clarity, in the embodiment of Fig. 63, there is no slot shown in needle / sheath 250. The relative positions of portions of suture 488 are shown, relative to anchors 270 and 280.

[0590] It may be noted that, in the embodiment shown, suture 488 is free to slide through loops 88 in anchors 270 and 280, while anchors 270 and 280 are contained within sheath 250, or after anchor 270 has been deployed.

[0591] It may be noted that a free end 488c of suture 488 may extend proximally, so that it may be held by a surgeon operating the deployment device having a needle or shaft 250. After deployment of first anchor 270 through the first soft tissue and subsequent deployment of second anchor 280 from device 700, the first anchor 270 may be positioned on a distal side of a first tissue such as, for example, soft tissue 712 (Fig. 28), and the second anchor 280 may be positioned on a proximal side of the first tissue 712, as will be discussed further herein.

[0592] A second tissue such as, for example, a second soft tissue, or a biocompatible material 714 (Fig. 28), such as discussed herein, which it is desired to attach to the first tissue 712 may be positioned against the first tissue 712 in any orientation desired. In order to secure the second tissue or biocompatible material 714 against the first tissue 712, the suture free end 488c may be pulled proximally, thereby shortening the length of suture 718 (Fig. 28) between the first anchor 270 and the second anchor 280. It should be noted that the suture 488 may be attached to the first anchor 270 on the distal side of the first tissue 712, may extend through the first tissue 712, and may be attached to the second anchor 280 on the proximal side of the first tissue 712. Therefore, by pulling on suture free end 488c, as the length of suture between the first anchor 270 and the second anchor 280 is shortened, the first anchor 270 and the second anchor 280 are urged closer together, with the first tissue 712 and the second tissue or biocompatible material 714 positioned therebetween.

[0593] With additional reference to Fig. 28, there is shown a schematic representation of first soft tissue 712 through which a first anchor 702 has been deployed, according to some embodiments, for example, by a deployment device as discussed herein. During deployment of the first anchor 702 (which may be identical or similar in structure and function to first anchor 702 in Fig. 66), an opening 716 may be made in the first tissue 712 by needle or sheath 706 of deployment device (not shown), and first anchor 702 may be inserted through opening 716, as discussed herein with regard to device 100, according to some embodiments. A portion 718 of suture 710, which is attached to first anchor 702, may extend through opening 716, from first anchor 702 to second anchor 704, according to some embodiments. There may be a gap between second anchor 704 and second tissue 714 and / or between second tissue 714 and first tissue 712, which may be narrowed or closed, according to some embodiments, by pulling on suture portion 708, as discussed herein. Suture portion 708 may also be attached to second anchor 704 and extend proximally therefrom, optionally to an operator of the deployment device or other person performing the securing procedure, according to some embodiments. After positioning a second tissue or biocompatible material 714 adjacent a proximal surface 724 of first tissue 712, pulling of suture portion 708 proximally may shorten the length of suture portion 718 located between first anchor 702 and second anchor 704, thereby urging first anchor 702 and second anchor 704 closer together, according to some embodiments.

[0594] Further pulling of suture portion 708 may force first anchor 702 against a distal surface 722 of first tissue 712, and may force second anchor against proximal surface 724 of first tissue 712, according to some embodiments. Shortening of suture 710 may cause at least one of first anchor 702 and second anchor 704 to become bent or crimped, thereby assuming a c-shaped or u-shaped configuration, as discussed herein, according to some embodiments.

[0595] When suture portion 708 is pulled proximately, according to some embodiments, suture 710 may slide along passageway 728 of first anchor 702 and loops 726 (Fig. 26) of second anchor 704, or along any other passageway provided in or on first and second anchors, as discussed herein, as suture portion 718 between first anchor 702 and second anchor 704 is shortened.

[0596] It may be noted that, optionally, according to some embodiments, suture 710 may be attached to either or both of first anchor 702 and second anchor 704 at a plurality of locations such as, for example, at two or four loops or other connecting locations. Depending on the number of connecting locations between suture 710 and each of first anchor 702 and second anchor 704, and depending on the materials of first anchor 702 and second anchor 704, shortening of suture portion 718 between first anchor 702 and second anchor 704 may cause one or both of the first anchor 702 and second anchor 704 to assume a u-shaped or c-shaped configuration or a configuration having a plurality of undulations, according to some embodiments. After second tissue or biocompatible material 714 has been secured to the first tissue 712, optionally by forming a knot adjacent the second t tissue or biocompatible material 714, the suture portion 708 may optionally be severed, according to some embodiments.

[0597] It may be noted that the second anchor 704 may be thick enough to cushion the second tissue or biocompatible material 714 relative to pressure applied by the suture 710 when tightened, according to some embodiments. Second anchor 704 may also be tough enough or sturdy enough such that it will not be cut or otherwise damaged by the suture 710, according to some embodiments.

[0598] It may also be noted that, as the first anchor 7020 may be configured to be inserted through opening 716 in the first tissue 712, the second anchor 704 may be sized and / or shaped such that the second anchor 704 cannot be passed through the opening 716 in the first tissue 712, according to some embodiments.

[0599] A particular feature of some embodiments to be noted is that, according to some embodiments, provision a first anchor 702 and second anchor 704, both of which may be slidable relative to suture 710 may provide an improved device for securing a second tissue or a biocompatible material 714 to a first tissue 712, which may potentially reduce pressure on the second tissue or a biocompatible material 714 and, thereby, may allow better healing of tissue at or near the site of the procedure, and / or may prevent damage caused by excess pressure to the first tissue 712 or to second tissue 714, as compared with a suture alone which may force second tissue or biocompatible material 714 against the first tissue 712, according to some embodiments.

[0600] Additionally, second anchor 704 may potentially provide a cushioning component for an arthroscopic or other surgical procedure, whereby force applied to the proximal surface 724 of second tissue or a biocompatible material 714 may be distributed across the area of the second anchor 704, according to some embodiments. This may reduce pressure and / or stress to the second tissue 714, as compared with a procedure wherein there is not provided a second anchor 704 and which retains a second soft tissue or a biocompatible material 714 relative to the first tissue 712 by means of the suture pulled against the second tissue or biocompatible material 714 on the proximal surface 724 of the first tissue, according to some embodiments. Depending on the size of the second anchor 704, i.e., the area of the second anchor 704 that contacts and may be forced against second tissue or biocompatible material 714, this may significantly reduce pressure and / or stress applied to the second tissue, and may potentially prevent damage to second tissue, according to some embodiments.

[0601] With further reference to Fig. 66, after deployment of anchors 270 and 280 such as, for example, to their relative positions shown in Fig. 28, a suture free end 488c may be pulled proximally, for example, in the direction of arrow 1302. This may cause a suture portion 2292 to slide through loops 88 of anchor 270 and suture portions 488b and 488a may shorten [see suture portion(s) 718 in Fig. 28], according to some embodiments.

[0602] It may be noted that, after deployment of first and second anchors (270, 280), second tissue 714 may be disposed at a distance from first tissue 712, although this is not shown in Fig. 28. Shortening of suture portion(s) 718 may cause any gap between first tissue 712 and second tissue 714 to narrow or close completely, according to some embodiments. Optionally, the provision of a gap between second anchor 280 and second tissue 714 may allow the surgeon to verify the depth of insertion of the first anchor 270 and / or to verify the strength of the attachment of the second anchor 280 to the first anchor 270 and / or of the second tissue 714 to the first tissue 712. After such verification, the gap may be narrowed or closed, depending on the injury to the first tissue, the procedure being performed, and the surgeon’s preference.

[0603] As the suture free end 488c is pulled proximally, this may cause shortening of the length of suture material extending through loops 88 in the first anchor 270. This may cause the first anchor 270 to bend into a c-shape or a u-shape, as discussed herein. Further pulling on the suture free end 488c in the direction of arrow 1302 may cause the second anchor 280 to be forced again the patch 714, and may bend the second anchor 280 into a c-shape or a u-shape, as discussed herein. It may be noted that the force of the second anchor 280 on the patch may provide a counter-force to that of the first anchor 270 (see Fig. 28), according to some embodiments.

[0604] The resulting configuration of the first anchor 270 and second anchor 280, with first tissue 712 and second tissue 714 therebetween (Fig. 28), may allow some movement between the first tissue 712 and second tissue 714, according to some embodiments. It may be noted that, for example, the degree of axial movement and / or lateral movement of the first tissue 712 and second tissue 714 relative to each other may be adjusted, by adjusting tension in the suture portions, as discussed herein.

[0605] It should be noted that the system may be operated outside the body, for example, according to the actions indicated above, and / or not during a medical procedure, such as, for example, during testing of the system. It is expected that during the life of a patent maturing from this application many relevant anchoring systems will be developed and the scope of the term anchor is intended to include all such new technologies a priori.

[0606] As used herein the term “about” refers to ± 10 %.

[0607] The terms "comprises", "comprising", "includes", "including", “having” and their conjugates mean "including but not limited to".

[0608] The term “consisting of’ means “including and limited to”.

[0609] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0610] As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0611] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0612] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0613] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements. Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A multiple anchor delivery system, comprising: first and second anchors each having a suture passageway extending at least partly along an outer surface of the respective anchor; a suture slidingly disposed through the suture passageway of each of the first and second anchors, wherein the first anchor is slidable relative to the suture and wherein the second anchor is slidable along the suture toward the first anchor; and a deployment device configured to deploy the first anchor and configured to deploy the second anchor after deployment of the first anchor; wherein the suture is disposed within and slidable through the suture passageways of the first and second anchors and the suture is configured to be effectively shortened, wherein a distance between the second anchor and the first anchor deployed is reduced.

2. The multiple anchor delivery system according to claim 1, wherein said deployment device is configured to deploy said first anchor into a first tissue and configured to deploy said second anchor on a proximal side of the first tissue after deployment of said first anchor; wherein said suture is disposed within and slidable through said suture passageways of said first and second anchors and said suture is configured to be effectively shortened, wherein a distance between said second anchor on the proximal side of the first tissue and said first anchor deployed in the first tissue is reduced.

3. The multiple anchor delivery system according to claim 1, wherein the deployment device is suitable for deployment of at least one anchor in a first tissue, and wherein the first tissue is soft tissue.

4. The multiple anchor delivery system according to either one of claims 2-3 wherein the deployment device is configured to deploy the second anchor at a distance from the proximal side of the first tissue.

5. The multiple anchor delivery system according to claim 4, wherein the deployment device is suitable for deployment of at least one anchor in a soft tissue, and wherein the distance between the second anchor and the proximal side of the first tissue is reducible.

6. The multiple anchor delivery system according to claim 5, wherein the deployment device is suitable for delivering the first and second anchors having a distance therebetween, and wherein the distance between the second anchor and the proximal side of the first tissue is reducible such that the second anchor abuts the proximal side of the first tissue.

7. A multiple anchor delivery system according to any one of claims 1-3, wherein said deployment device comprises: a sheath having a proximal end and a distal end and having a sheath passageway extending therethrough; a pusher element sized and shaped to be displaced in a distal direction through the sheath passageway; wherein the first and second anchors are disposed within the sheath and are each sized and shaped to be displaced along the sheath passageway, each of the first and second anchors having a proximal end and a distal end; wherein the pusher element is sized and shaped to be displaced in the distal direction, the displacement of the pusher element having a first displacement length at least as long as a distance between the proximal end of the first anchor and the sheath distal end, the first displacement length sufficient to deploy the first anchor, and having a second displacement length at least as long as the distance between the proximal end of the second anchor and the sheath distal end, the second displacement length sufficient to deploy the second anchor.

8. A multiple anchor delivery system according to any one of claims 1-3, wherein each of the first and second anchors has a proximal end and a distal end; and wherein the suture includes: a first portion attached to the first anchor proximal end and extending from the first anchor proximal end to the second anchor distal end; a second portion extending from the second anchor distal end, proximally through the passageway of the second anchor, toward the second anchor proximal end; a third portion extending from the second anchor proximal end, toward the first anchor distal end; a fourth portion extending from the first anchor distal end, proximally through the passageway of the first anchor toward the first anchor proximal end; and a fifth portion extending proximally from the first anchor proximal end.

9. A multiple anchor delivery system according to any one of claims 1-3, wherein, prior to the deployment, the second is disposed proximally with respect to the first anchor within the deployment device.

10. A multiple anchor delivery system according to any one of claims 1-3, wherein at least one of the first anchor and the second anchor is flexible and includes an elongate body having first and second ends and extending along a longitudinal axis in a first orientation, thebody configured to be bent into a second orientation wherein the first and second ends are closer to each other than in the first orientation.

11. A multiple anchor delivery system according to claim 10, wherein, when the body of the at least one of the first and second anchor is in the first orientation, an end of the suture is configured to be pulled proximally and to slide through the passageway, the first and second anchors and suture positioned such that the first length of suture extending through the passageway is effectively shortened, the shortened length of suture extending through the passageway configured to pull on the body along the passageway to thereby bend the body into the second orientation.

12. A multiple anchor delivery system according to claim 10, wherein in the second orientation the anchor body has a c-shaped configuration or a u-shaped configuration, with the passageway positioned within a curve of the c-shape or the u-shape.

13. A multiple anchor delivery system according to claim 10, wherein in the second orientation the first and second ends of the body are at an angle relative to each other.

14. A multiple anchor delivery system according to any one of claims 1-3, wherein the deployment device comprises: a sheath having a proximal end and a distal end and having a sheath passageway extending therethrough; a pusher element having at least a distal end positioned within the sheath passageway, the pusher element distal end sized and shaped to be displaced through the sheath passageway; a first anchor disposed within the sheath, at least a portion of the first anchor positioned distally with respect to the pusher element; and a second anchor disposed within the sheath, proximally with respect to the first anchor, the second anchor disposed within the sheath passageway and, the second anchor sized and shaped to be displaced along the sheath passageway; the pusher element sized and shaped to be displaced in a proximal direction to a position proximal to at least a distal portion of the second anchor; and the pusher element sized and shaped to be displaced in the distal direction, the displacement of the pusher element having a second displacement length at least as long as the distance between the proximal end of the second anchor and the sheath distal end, the second displacement length sufficient to deploy the second anchor.

15. A multiple anchor delivery system according to claim 14, wherein the second anchor overlaps axially with the pusher element.

16. A multiple anchor delivery system according to claim 14, wherein the second anchor is tubular.

17. A multiple anchor delivery system according to any one of claims 1-3, wherein the deployment device includes a pusher element sized and shaped to be displaced in a distal direction, into contact with the first anchor, the displacement having a first displacement length sufficient to deploy the first anchor.

18. A multiple anchor delivery system according to claim 7, further including a barrier that narrows the sheath passageway, the barrier obstructing a proximal displacement of the second anchor.

19. A multiple anchor delivery system according to claim 7, wherein the second anchor is mounted on the pusher element.

20. A multiple anchor delivery system according to claim 7, wherein the pusher element extends through an interior of the second anchor.

21. A multiple anchor delivery system according to any one of claims 1-3, wherein the second anchor is compressible in a lateral direction.

22. A multiple anchor delivery system according to claim 7, wherein the second anchor is compressible in a lateral direction, the pusher element displaceable in a proximal direction to a position proximal to the second anchor.

23. A multiple anchor delivery system according to claim 7, wherein the first anchor has a proximal end wherein the first anchor includes a blind bore at the proximal end, the pusher element distal end sized and shaped to fit into the blind bore.

24. A multiple anchor delivery system according to claim 7, wherein the pusher element distal end includes a retaining portion for temporarily retaining the second anchor thereon.

25. A multiple anchor delivery system according to claim 24, wherein the retaining portion is a recess for retaining a second anchor.

26. A multiple anchor delivery system according to claim 7, wherein the pusher element is provided with a compressible distal portion.

27. A multiple anchor delivery system according to any one of claims 1-3, wherein the first anchor is tubular.

28. A multiple anchor delivery system according to claim 7, wherein the sheath distal end is curved.

29. A multiple anchor delivery system according to claim 7, wherein the first and second anchors are entirely housed within the sheath prior to their deployment.

30. A multiple anchor delivery system according to either one of claims 2-3, the system for securing a second tissue or a biocompatible material to the first tissue, wherein the second anchor is configured to secure the second tissue or biocompatible material to the first tissue.

31. The multiple anchor delivery system according to claim 30, wherein the second tissue or biocompatible material is a second soft tissue.

32. A multiple anchor delivery system according to any one of claims 1-3, wherein at least one of the first and second anchors includes one of: a plurality of loops through which the suture is extendible; and a plurality of apertures through which the suture is threadable.

33. A multiple anchor delivery system according to claim 30, wherein the second anchor is at least one of: thick enough to cushion the second tissue or biocompatible material against a pressure applied by the suture to the second tissue or biocompatible material; and tough enough such that the second tissue or biocompatible material is not damaged by the suture.

34. A multiple anchor delivery system according to either one of claims 2-3, wherein the first anchor is configured to be inserted through a hole in the first tissue, the second anchor sized and / or shaped such that the second anchor cannot be passed through the hole.

35. A multiple anchor delivery system according to any one of claims 1-3, comprising: a sheath having a proximal end and a distal end and having a sheath passageway extending therethrough; first and second pusher elements disposed inside the sheath, each pusher element having at least a distal end positioned within the sheath passageway, the distal end of each the pusher element sized and shaped to be displaced through the sheath passageway; wherein the first anchor is disposed within the sheath, at least a portion of the first anchor positioned distally with respect to the first pusher element; wherein the second anchor is disposed within the sheath, proximally with respect to the first anchor; wherein the first pusher element displaceable in a distal direction, into contact with the first anchor, the displacement having a displacement length sufficient to deploy the first anchor;wherein the second pusher element displaceable in a distal direction, into contact with the second anchor, the displacement having a displacement length sufficient to deploy the second anchor.

36. A multiple anchor delivery system according to any one of claims 1-3, comprising: a sheath having a proximal end and a distal end and having a sheath passageway extending therethrough; a pusher element having at least a distal end positioned within the sheath passageway, the pusher element distal end sized and shaped to be displaced through the sheath passageway; wherein the first anchor is disposed within the sheath, at least a portion of the first anchor positioned distally with respect to the pusher element; and wherein the second anchor is disposed within the sheath, proximally with respect to the first anchor, the second anchor mounted on the pusher element.

37. A multiple anchor delivery kit including the multiple anchor delivery system according to claim 36 and a patch configured to be positioned on a first tissue; wherein the first anchor is sized and shaped to be deployed through the patch and into the first tissue; wherein the second anchor is configured to be deployed on a proximal side of the patch; wherein the shortened distance is associated with a shortened distance between the patch and the first tissue.

38. The multiple anchor delivery kit according to claim 37, wherein the patch is sized and shaped to abut the first tissue.

39. The multiple anchor delivery kit according to claim 37, including a third anchor having a suture passageway extending at least partly along an outer surface of the third anchor; wherein the suture is slidingly disposed through the suture passageway of the third anchor, wherein the third anchor is slidable along the suture relative to a least one of the first and second anchors; wherein the deployment device is configured to deploy the third anchor either into a first tissue or on the proximal side of the first tissue after deployment of the first anchor; wherein the suture disposed within and slidable through the suture passageway of the third anchor and the first tissue is configured to be effectively shortened, wherein a distance between the third anchor and one of the first and second anchors is reduced.

40. A multiple anchor delivery system according to claim 7, comprising:wherein the pusher element has at least a distal end positioned within the sheath passageway, the pusher element distal end sized and shaped to be displaced through the sheath passageway; wherein the first anchor is positioned distally with respect to the pusher element; wherein the second anchor is disposed proximally within the sheath, with respect to the first anchor, the second anchor disposed proximally relative to the pusher element distal end; wherein the pusher element is configured to be retracted proximally to a position proximal to the second anchor, wherein at least a distal tip portion of the pusher is configured to be deformed by the second anchor during the proximal retraction; and wherein the pusher element is configured to deploy the second anchor.

41. The multiple anchor delivery system according to claim 40, wherein the pusher element is flexible enough to be deformed by the second anchor, during the proximal retraction of the pusher.

42. The multiple anchor delivery system according to claim 40, wherein the pusher element distal end has two configurations: a relaxed state in which the pusher element is usable to deploy an anchor; and a deformed state in which the pusher element can be fit between the second anchor and a side wall of the sheath.

43. The system according to claim 40, wherein the distal tip portion of the pusher element includes at least one curve.

44. The system according to claim 40, wherein the first anchor includes a proximally- facing end surface and wherein the pusher element includes a distally-facing surface, the pusher element distally-facing surface configured to contact the first anchor proximally-facing end surface during the deployment.

45. The system according to claim 40, wherein the second anchor includes a proximally-facing end surface and wherein the pusher element includes a distally-facing surface, the pusher element distally-facing surface configured to contact the second anchor proximally- facing end surface during the deployment.

46. The system according to claim 40, wherein the pusher element has a non-uniform thickness along its length.

47. A method of deploying implants relative to a first tissue, wherein the method includes: delivering a sheath through the first tissue such that a sheath distal end penetrates the first tissue;deploying a first anchor out of the sheath and through the first tissue, the first anchor including a first suture passageway, wherein a suture extends through and is slidable through the first suture passageway; withdrawing the sheath from the first tissue; deploying a second anchor out of the sheath, the second anchor having a second suture passageway, wherein the suture extends through and is slidable through the second suture passageway; and tightening the suture extending through the first and second suture passageways, such that the first anchor is tightened relative to the first tissue.

48. The method according to claim 47, wherein the first tissue is a soft tissue.

49. The method according to either one of claims 47 and 48, wherein the deploying the second anchor includes deploying the second anchor into a second tissue; wherein the tightening includes reducing a distance between the first tissue and the second tissue.

50. The method according to either one of claims 47 and 48, wherein the tightening includes reducing a distance between the first and second anchors.

51. The method according to either one of claims 47 and 48, wherein the tightening includes reducing a distance between the second anchor and the first tissue.

52. The method according to either one of claims 47 and 48, wherein the tightening includes causing the first anchor to bend.

53. The method according to claim 52, wherein the tightening includes causing the first anchor to apply pressure to the first tissue.

54. The method according to either one of claims 47 and 48, wherein the tightening includes causing the second anchor to bend.

55. The method according to claim 54, wherein the tightening includes causing the second anchor to apply pressure to a proximal side of the first tissue.

56. The method according to claim 54, including positioning a second tissue or biocompatible material on a proximal side of the first tissue, wherein the first anchor is deployed through the second tissue or biocompatible material and through the first tissue, wherein the tightening includes causing the second anchor to apply pressure to the second tissue or biocompatible material.

57. The method according to claim 56, wherein a distance between the second tissue or biocompatible material and the first tissue is adjustable.

58. The method according to claim 52, wherein the bending includes bending at least one of the first anchor and the second anchor into one of a c-shape and a u-shape.

59. The method according to either one of claims 47 and 48, wherein the tightening the suture includes leaving a gap between the second anchor and the first tissue.

60. The method according to claim 59, further including further tightening of the suture extending through the first and second suture passageways, such that the second anchor is tightened against the first tissue.

61. The method according to either one of claims 47 and 48, wherein the method includes: positioning a second tissue or biocompatible material on the first tissue; wherein the delivering includes delivering the sheath through the second tissue or biocompatible material; wherein the deploying the first anchor includes deploying the first anchor through the second tissue or biocompatible material; wherein the withdrawing includes withdrawing the sheath from the second tissue or biocompatible material; wherein the tightening includes tightening the second anchor relative to the second tissue or biocompatible material.

62. The method according to claim 61, wherein the second tissue or biocompatible material is a second soft tissue.

63. The method according to claim 61, wherein the second anchor applies a counterforce to the second tissue or biocompatible material.

64. A method according to either one of claims 47 and 48, wherein the first suture passageway extends alongside or through at least a portion of the first anchor.

65. A method according to either one of claims 47 and 48, wherein the second anchor is at least one of flexible and compressible.

66. A method according to either one of claims 47 and 48, wherein at least one of the first and second anchors includes one of: a plurality of loops through which the suture is extendible; and a plurality of apertures through which the suture is threadable.

67. A method according to claim 61, wherein the second anchor prevents damage to the second tissue or biocompatible material by at least one of: being thick enough to cushion the second tissue or biocompatible material against a pressure applied by the suture to the second tissue or biocompatible material; andbeing tough enough such that the second tissue or biocompatible material is not damaged by the suture.

68. The method according to either one of claims 47 and 48, wherein the first anchor is configured to be inserted through a hole in the first tissue, the second anchor sized and / or shaped such that the second anchor cannot be passed through the hole.

69. The method according to either one of claims 47 and 48, including: deploying a third anchor out of the sheath and on a proximal side of the first tissue or through the first tissue, the third anchor including a third suture passageway, wherein a suture extends through and is slidable through the third suture passageway.

70. The method according to claim 69, wherein the tightening includes shortening a distance between the third anchor and at least one of the first and second anchors.

71. The method according to claim 69, wherein the tightening includes shortening a distance between the third anchor and the first tissue.

72. The method according to claim 61, wherein the first anchor is configured to be inserted through a first hole in the first tissue and a second hole in the second tissue or biocompatible material, the second anchor sized and / or shaped such that the second anchor cannot be passed through the second hole.

73. A method of attaching a biocompatible material to a tissue, wherein the method includes: delivering a sheath through a tissue such that a sheath distal end penetrates the tissue; deploying a first anchor out of the sheath and through the biocompatible material and tissue, the first anchor including a first passageway; withdrawing the sheath from the tissue; deploying a second anchor out of the sheath, the second anchor having a second passageway; and tightening a suture extending through the first and second passageways, such that the first anchor is tightened against the tissue.

74. The method according to claim 73, wherein the tightening includes tightening the second anchor relative to the biocompatible material.

75. The method according to either one of claims 73 and 74, wherein the second anchor applies a counterforce to the biocompatible material.

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