Multi-state anchor delivery systems, devices, and kits and methods of use thereof + multi-anchor delivery systems and methods

Abstract

A multi-anchor delivery system includes: a first anchor and a second anchor, each anchor having a suture channel extending at least partially along its outer surface; a suture slidably passing through the suture channel 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 and, after deploying the first anchor, deploy the second anchor proximal to the first tissue; wherein the suture is disposed in and slides through the suture channel of the first and second anchors, and the first tissue is configured to be shortened, wherein the distance between the second anchor located proximal to the first tissue and the first anchor deployed in the first tissue is reduced.

Description

[0001] Related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 532,394, filed August 13, 2023, and U.S. Provisional Patent Application No. 63 / 619,660, filed January 10, 2024, the contents of which are hereby incorporated herein by reference in their entirety.

[0002] This application also relates to PCT patent application No. IL2023 / 051188, filed November 16, 2023, which claims priority to U.S. Patent Application No. 63,426,024, filed November 16, 2023; U.S. Patent Application No. 63 / 443,748, filed February 7, 2023; and U.S. Provisional Application No. 63 / 532,394, filed August 13, 2023. The entire contents of the foregoing applications are incorporated herein by reference as if fully set forth herein.

[0003] Technical Field and Background Technology The present invention generally relates to soft tissue repair systems, kits, and methods for delivering implants, such as multiple soft tissue anchors.

[0004] Various surgical procedures are known to repair deformed or torn soft tissues, such as the meniscus, through suturing. There is a particular need for systems capable of delivering several anchors in a single surgical procedure.

[0005] Both U.S. Patent Nos. 8,888,798 and 9,357,994 belong to Smith & Nephew, Inc., and each discloses a tissue repair device, "in which the advancement of a knob allows an actuator to engage with a first anchor and subsequently advance the first anchor." US Patent Nos. 9,498,203 and 9,549,725, belonging to Smith & Nephew, each disclose a tissue repair device including a "spring-loaded pusher" configured "for delivering a flexible member to fix tissue".

[0006] US Patent No. 9,622,736 discloses a tissue repair device that "includes a first tubular anchor and a second tubular anchor having corresponding longitudinal channels. The tissue repair device includes corresponding first and second inserters. Each inserter has a shaft, the distal portion of which is received in the longitudinal channel of the corresponding tubular anchor. Flexible strands connect the first and second anchors" (Abstract).

[0007] Other anchor repair devices are disclosed in US patents / applications 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. Summary of the Invention

[0008] The present invention aims to provide an improved multi-anchor fastener delivery system.

[0009] Therefore, according to some embodiments of the present invention, a multi-anchor delivery system is provided, comprising: a drive unit and a hollow needle extending distally therefrom; a pusher element operatively coupled to the drive unit and extending distally therefrom within the hollow needle; a first solid anchor disposed within the hollow needle and distally relative to the pusher element; and a second tubular anchor threaded through the pusher element.

[0010] According to aspects of some embodiments of the present invention, a multi-anchor delivery system is provided, comprising: a sheath having a proximal end and a distal end, and having a sheath channel extending therethrough; a pusher element having at least one distal end located within the channel, the distal end of the pusher element being sized and shaped to shift through the passageway; a first anchor disposed within the sheath, at least a portion of the first anchor being located distally relative to the pusher element; and a second anchor disposed within the sheath, located proximally relative to the first anchor, the second anchor being disposed within the channel, and the second anchor being sized and shaped to shift along the passageway; the pusher element being sized and shaped to shift in a proximal direction to a position proximal to at least one distal portion of the second anchor; and the pusher element being sized and shaped to shift in a distal direction, the shift of the pusher element having a second shift length at least as long as the distance between the proximal end of the second anchor and the distal end of the sheath, the second shift length being sufficient to deploy the second anchor.

[0011] According to some embodiments of the invention, the system further includes a barrier that narrows the channel and prevents proximal displacement of the second anchor.

[0012] According to some embodiments of the present invention, the second anchor is mounted on the actuator element.

[0013] According to some embodiments of the present invention, the second anchor is compressible in the lateral direction.

[0014] According to some embodiments of the present invention, the first anchor includes a blind hole at the proximal end, and the distal end of the actuator element is sized and shaped to fit into the blind hole.

[0015] According to some embodiments of the invention, the distal end of the actuator element includes a retaining portion for temporarily holding the second anchor thereon.

[0016] According to some embodiments of the present invention, the retaining portion is a recess for retaining the second anchor.

[0017] According to some embodiments of the invention, the actuator element is provided with a compressible distal portion.

[0018] According to some embodiments of the invention, the sheath has a lateral opening at its distal end, and the second anchor is located proximal to the lateral opening before the second anchor is deployed.

[0019] According to some embodiments of the invention, the first anchor and the second anchor are fully contained within the sheath before deployment.

[0020] According to some embodiments of the present invention, the first anchor is configured as follows: The first anchor includes a channel extending or passing through at least a portion of the first anchor, and a stitch extends through the channel; and The first anchor slips into contact with the seam.

[0021] According to some embodiments of the present invention, the second anchor includes one of the following: Multiple loops, through which the stitches can extend; and Multiple apertures allow the suture to pass through.

[0022] According to some embodiments of the present invention, the second anchor is configured to be at least one of the following: Sufficiently thick to cushion the second soft tissue or biocompatible material, thereby preventing it from being subjected to the pressure exerted on the second soft tissue or biocompatible material by the sutures; and It is tough enough to prevent the second soft tissue or biocompatible material from being damaged by the suture.

[0023] According to some embodiments of the invention, a first anchor is configured to be inserted through a hole in a first soft tissue, and a second anchor is sized and / or shaped such that the second anchor cannot pass through the hole.

[0024] According to some embodiments, the first anchor is configured to be inserted through a first hole in a first soft tissue and a second hole in a second soft tissue or biocompatible material, and the size and / or shape of the second anchor is designed such that the second anchor cannot pass through the second hole.

[0025] According to some embodiments of the present invention, a multi-anchor delivery system is provided, comprising: a sheath having a proximal end and a distal end, and having a sheath channel extending therethrough; a first pusher element and a second pusher element disposed within the sheath, each pusher element having at least one distal end located within the channel, the distal end of each pusher element being sized and shaped to be displaced along the channel; a first anchor disposed within the sheath, at least a portion of the first anchor being distally located relative to the first pusher element; a second anchor disposed within the sheath, proximally located relative to the first anchor; the first pusher element being displaceable in a distal direction to contact the first anchor, the displacement having a displacement length sufficient to deploy the first anchor; and the second pusher element being displaceable in a distal direction to contact the second anchor, the displacement having a displacement length sufficient to deploy the second anchor.

[0026] According to some embodiments, delivery includes securing a second soft tissue or biocompatible material to a first soft tissue; wherein a plurality of anchors include a first anchor and a second anchor, wherein the first anchor is slidable relative to the suture. The second anchor can slide along the seam toward the first anchor.

[0027] According to some embodiments, the second anchor includes one of the following: Multiple loops, through which the stitches can extend; and Multiple pores allow the suture to pass through.

[0028] The present invention also aims to provide improved anchors; and apparatus, kits, systems and methods for deploying anchors, for example, for delivery through soft or bone tissue.

[0029] According to some embodiments of the present invention, a method for operating a multi-state anchor delivery system is provided, comprising: (a) Within the sheath, in a designated axially overlapping area between the anchor pusher and the second pusher, the first anchor pusher is pushed using the second pusher; (b) In the first state, the first anchor is pushed out of the sheath using the anchor pusher; (c) Retract the second pusher from the anchor pusher to reduce the specified axial overlap area between the anchor pusher and the second pusher; (d) To cause deformation of one or both of the anchor pusher and the second pusher; (e) Using a second pusher to push the anchor pusher, the deformation produced by one or both of the anchor pusher and the second pusher results in mechanical interference (interference, alteration) in a specified axial overlap region, wherein the pushing is performed on a contact area between the anchor pusher and the second pusher, which is located outside the specified axial overlap region; and (f) In the second state, the second anchor is pushed out of the sheath using the anchor pusher.

[0030] According to some embodiments of the present invention, the method further includes: using an anchor switch to switch between a first state and a second state, thereby actuating the anchor.

[0031] According to some embodiments of the present invention, the method further includes extending the second anchor from the sheath by a distance corresponding to a reduced specified axial overlap area.

[0032] According to some embodiments of the present invention, the method further includes: positioning the second anchor distally to a distance outside the sheath, the distance being greater than the distance by which the first anchor is positioned outside the sheath.

[0033] According to some embodiments of the invention, the method further includes, in a second state, that after the second pusher is retracted in the proximal direction, the designated axial overlap area between the anchor pusher and the second pusher no longer decreases.

[0034] According to some embodiments of the present invention, the anchor is an implant.

[0035] According to some embodiments of the present invention, the anchor includes a stitch.

[0036] According to some embodiments of the present invention, a multi-state anchor delivery system is provided, comprising: The sheath has a proximal end and a distal end, and has a sheath channel extending through it; At least two anchors are located at the far end of the channel; An anchor pusher, which is sized and shaped to push at least two anchors out of the far end of the channel; The second pusher is sized and shaped to push the anchor pusher to the distal side within the channel; The first axial overlap region is defined on the anchor pusher; A second axial overlap region, defined on the second actuator, wherein the specified axial overlap region may be defined as a first axial overlap region and a second axial overlap region; and An overlap switching element, located in one or both of a first axial overlap region and a second axial overlap region, has two states: a first state allows overlap at a specified axial overlap region, and a second state reduces the allowed overlap at a potential axial overlap region by mechanically interfering with the axial movement of one actuator relative to the other actuator.

[0037] According to some embodiments of the invention, the second pusher includes a rack or other pusher assembly, and the designated axial overlap region includes a recess in the rack or other pusher assembly, which can be operated to receive the proximal end of the anchor pusher.

[0038] According to some embodiments of the invention, the overlap switching member includes a movable faceplate connected to a rack, wherein in a second state, the movable faceplate covers a recess, thereby reducing the specified axial overlap area.

[0039] According to some embodiments of the invention, the overlap switching member includes a curved protrusion extending from the sheath, the curved protrusion being positioned in a second state to cause a lateral bending deformation of the proximal end of the anchor pusher, thereby preventing the recess from accommodating the anchor pusher and reducing the designated axial overlap area.

[0040] According to some embodiments of the invention, the overlap switching member includes a plate connected between the sheath and the rack, the plate having a hole not located in its center, the plate being configured to deform the proximal end of the anchor pusher or prevent the rod from being accommodated in the recess in a second state, thereby reducing the specified axial overlap area.

[0041] According to some embodiments of the invention, the overlapping switching element includes a predetermined bend in the anchor pusher that is selectively released from the rack and, once released, undergoes a lateral bend, thereby misaligning with a recess in the rack.

[0042] According to some embodiments of the invention, the overlapping switching element includes a rod extending from the second actuator.

[0043] According to some embodiments of the present invention, the designated axial overlap region is a second axial overlap region located on the distal end of the rod and a first axial overlap region located on the proximal end of the anchor pusher.

[0044] According to some embodiments of the present invention, the designated axial overlap area is a scarf-overlap-joint.

[0045] According to some embodiments of the invention, the scarf-type overlapping joint is configured such that, in a second state, one or both of the anchor pusher and the second pusher undergo elastic deformation by retracting the second pusher in a proximal direction.

[0046] According to some embodiments of the present invention, the overlapping switching element is configured to switch between a first state and a second state by elastic deformation.

[0047] According to some embodiments of the invention, the modified configuration is released by the retraction of the second pusher relative to the anchor pusher.

[0048] According to some embodiments of the present invention, at least one of the sheath, the anchor pusher, and the second pusher is disposable.

[0049] According to some embodiments of the present invention, at least one of the sheath, the anchor pusher, and the second pusher is reusable.

[0050] According to some embodiments of the invention, the sheath is flexible.

[0051] According to some embodiments of the present invention, a method for reducing axial overlap and extending an anchor pusher is provided, the method comprising: Specify the axial overlap area between the anchor pusher and the second pusher; The second pusher is retracted from the anchor pusher, thereby reducing the specified axial overlap area between the anchor pusher and the second pusher; This causes one or both of the anchor pusher and the second pusher to deform. Mechanical interference is generated in the specified axial overlap region; The lengths of the anchor pusher and the second pusher are combined using a contact area outside the specified axial overlap area. The combined new length allows for an extension of the length of both the anchor pusher and the second pusher; and In the second state, the second anchor is pushed out of the sheath using the extended length of the anchor pusher.

[0052] According to some embodiments of the present invention, a dual-anchor deployment method is provided, comprising: An anchor pusher mechanism is used to advance the first anchor to push it out of the sheath. The anchor pusher mechanism includes an anchor pusher having a first effective axial length. Modify the effective axial length of the anchor pusher; and The modified effective length is used to advance the second anchor, thereby pushing it out of the sheath.

[0053] According to some embodiments of the invention, the modification includes increasing the effective length of the anchor pusher by reducing the overlap between the anchor pusher and the pusher assembly that pushes the anchor pusher.

[0054] According to some embodiments of the invention, the modification includes retracting the pusher assembly for pushing the anchor, thereby allowing a portion of the anchor assembly and / or the anchor pusher to elastically deform or otherwise change its geometry to interfere with the axial overlap of that portion of the anchor assembly with the anchor pusher.

[0055] According to some embodiments of the invention, both advances use the same amount of manual movement, which is applied by the operator to a mechanical control element connected to the anchor push mechanism.

[0056] According to some embodiments of the present invention, an anchor deployment method is provided, comprising: Move the actuator distally along the channel that extends through the sheath; This causes the actuator to contact and deploy the first anchor bolt located within the channel. Retracting the actuator back to a position near the second anchor within the channel, the retraction including temporarily deforming the actuator so that its length changes during retraction; and The pusher is moved further to the distal side along the channel to deploy the second anchor.

[0057] According to some embodiments of the present invention, a kit for dual anchor delivery is provided, comprising: (a) Sheath; (b) An anchor pusher, at least partially disposed within the sheath; (c) At least two anchors, located inside the sheath and far from the anchor pusher; (d) A variable length anchor pusher mechanism, including an anchor pusher, wherein the mechanism is configured to support a variety of different fixed axial overlaps between the anchor pusher and the mechanism during distal movement of the anchor pusher.

[0058] According to some embodiments of the invention, the kit includes a thread configured to slidably pass through each of two anchors, the thread including a slip knot configured to be released by pulling a first end of the thread and not released by pulling a second end of the thread, wherein the thread is configured to be tightened between the two anchors by pulling the first end of the thread.

[0059] According to some embodiments of the present invention, a multi-anchor delivery system is provided, comprising: The sheath has a proximal end and a distal end, and has a sheath channel extending through it; A actuator having at least one distal end located within a channel, the distal end of the actuator being sized and shaped to displace through the channel; The first anchor, disposed within the sheath, is located distally relative to the actuator; and The second anchor is located inside the sheath and is proximal to the first anchor. The second anchor is located inside the channel and is proximal to the distal end of the pusher. The size and shape of the second anchor are designed to shift along the channel. The actuator is configured to retract proximally to a position proximally to the second anchor, wherein during the proximal retraction, at least one distal tip portion of the actuator is configured to be deformed by the second anchor; and The actuator is configured to deploy a second anchor.

[0060] According to some embodiments of the invention, the actuator is flexible enough to be deformed by the second anchor during the proximal retraction of the actuator.

[0061] According to some embodiments of the present invention, the distal end of the actuator has two configurations: The relaxed state, in which the actuator can be used to deploy the anchor; and Deformation state, wherein the pusher can be adapted between the second anchor and the sidewall of the sheath.

[0062] According to some embodiments of the invention, the distal tip portion of the actuator includes at least one curved portion.

[0063] According to some embodiments of the invention, the first anchor includes a proximal end face, and wherein the pusher includes a distal surface, the distal surface of the pusher being configured to contact the proximal end face of the first anchor during deployment.

[0064] According to some embodiments of the invention, the second anchor includes a proximal end face, and wherein the pusher includes a distal surface, the distal surface of the pusher being configured to contact the proximal end face of the second anchor during deployment.

[0065] According to some embodiments of the invention, the actuator has a non-uniform thickness along its length.

[0066] According to some embodiments, the suture includes: The first part is inserted into the first anchor of the two anchors and extends from the first anchor to the second anchor of the two anchors; The second part extends between the first anchor and the second anchor of the two anchors, and passes through the second anchor; and The third part extends from the second anchor and includes a slip knot; Pulling the first end of the suture releases the slip knot.

[0067] According to some embodiments of the present invention, a multi-anchor delivery system is provided, comprising: First anchor and second anchor, each anchor having a stitch channel extending at least partially along the outer surface of the respective anchor. A suture is slidably disposed in a suture channel in 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 The deployment device is configured to deploy a first anchor and to deploy a second anchor after deploying the first anchor. The suture is disposed within the suture channel of the first anchor and the second anchor and slidably passes through the suture channel of the first anchor and the second anchor, and the suture is configured to be effectively shortened, wherein the distance between the second anchor and the deployed first anchor is reduced.

[0068] According to some embodiments, the deployment device is configured to deploy a first anchor into a first tissue, and is configured to deploy a second anchor proximal to the first tissue after the first anchor has been deployed. The suture is disposed within the suture channel of the first anchor and the second anchor and slidably passes through the suture channel of the first anchor and the second anchor, and the suture is configured to be effectively shortened, wherein the distance between the second anchor on the proximal side of the first tissue and the first anchor deployed in the first tissue is reduced.

[0069] According to some embodiments, the deployment device is adapted to deploy at least one anchor in a first organization, wherein the first organization is a soft organization.

[0070] According to some embodiments, the deployment device is configured to deploy the second anchor at a certain distance from the proximal side of the first organization.

[0071] According to some embodiments, the deployment device is adapted to deploy at least one anchor in soft tissue, wherein the distance between the second anchor and the proximal side of the first tissue is reducible.

[0072] According to some embodiments, the deployment device is adapted to deliver a first anchor and a second anchor that are a distance from each other, and wherein the distance between the second anchor and the proximal side of the first tissue is reducible, such that the second anchor is adjacent to the proximal side of the first tissue.

[0073] According to some embodiments, the deployment device includes: The sheath has a proximal end and a distal end, and has a sheath channel extending through it; The actuator element is sized and shaped to shift distally through a sheath channel; The first anchor and the second anchor are disposed within the sheath, and the size and shape of each anchor are designed to shift along the sheath channel. Each of the first anchor and the second anchor has a proximal end and a distal end. The actuator element is sized and shaped to be displaced in a distal direction. The displacement of the actuator element has a first displacement length, which is at least as long as the distance between the proximal end of the first anchor and the distal end of the sheath, and the first displacement length is sufficient to deploy the first anchor. It also has a second displacement length, which is at least as long as the distance between the proximal end of the second anchor and the distal end of the sheath, and the second displacement length is sufficient to deploy the second anchor.

[0074] According to some embodiments, each of the first and second anchors has a proximal end and a distal end; and The sutures include: The first part is attached to the proximal end of the first anchor and extends from the proximal end of the first anchor to the distal end of the second anchor. The second part extends from the distal end of the second anchor through the channel of the second anchor to the proximal end of the second anchor. The third part extends from the proximal end of the second anchor to the distal end of the first anchor. The fourth part extends from the distal end of the first anchor through a channel to the proximal end of the first anchor; and The fifth part extends proximally from the proximal end of the first anchor.

[0075] According to some embodiments, prior to deployment, the second anchor is located proximal to the first anchor within the deployment device.

[0076] According to some embodiments, at least one of the first anchor and the second anchor is flexible and includes an elongated body having a first end and a second end and extending along a longitudinal axis of a first orientation, the body being configured to bend to a second orientation, wherein in the second orientation the first end and the second end are closer to each other than in the first orientation.

[0077] According to some embodiments, when the body of at least one of the first anchor and the second anchor is in a first orientation, one end of the suture is configured to be pulled proximally and slide through the channel, the first anchor and the second anchor and the suture are positioned such that a first length of the suture extending through the channel is effectively shortened, and the shortened length of the suture extending through the channel is configured to pull the body along the channel, thereby bending the body into a second orientation.

[0078] According to some embodiments, in the second orientation, the anchor body has a C-shaped configuration or a U-shaped configuration, with the channel located within the bend of the C-shape or U-shape.

[0079] According to some embodiments, in the second orientation, the first end and the second end of the body are at an angle to each other.

[0080] According to some embodiments, the delivery system includes: The sheath has a proximal end and a distal end, and has a sheath channel extending through it; A actuator element having at least one distal end located within a sheath channel, the distal end of the actuator element being sized and shaped to displace through the sheath channel; A first anchor, disposed within the sheath, at least a portion of the first anchor being located distally relative to the actuator element; and The second anchor is located inside the sheath and is positioned near the first anchor. The second anchor is located within the sheath channel and its size and shape are designed to shift along the sheath channel. The size and shape of the actuator element are designed to shift along the proximal direction to a proximal position relative to at least the distal portion of the second anchor; and The size and shape of the actuator element are designed to be displaced in a distal direction, and the displacement of the actuator element has a second displacement length, which is at least as long as the distance between the proximal end of the second anchor and the distal end of the sheath, and the second displacement length is sufficient to deploy the second anchor.

[0081] According to some embodiments, the second anchor overlaps axially with the pusher element.

[0082] According to some embodiments, the second anchor is tubular.

[0083] According to some embodiments, the deployment device includes a pusher element that is sized and shaped to shift in a distal direction to contact a first anchor, the shift having a first shift length sufficient to deploy the first anchor.

[0084] According to some embodiments, the multi-anchor delivery system further includes a blocking element that narrows the sheath channel, which prevents proximal displacement of the second anchor.

[0085] According to some embodiments, the second anchor is mounted on the actuator element.

[0086] According to some embodiments, the actuator element extends through the interior of the second anchor.

[0087] According to some embodiments, the second anchor is compressible in the lateral direction.

[0088] According to some embodiments, the second anchor is compressible in the lateral direction, and the pusher element can be displaced in the proximal direction to a position proximal to the second anchor.

[0089] According to some embodiments, the first anchor has a proximal end, wherein the first anchor includes a blind hole located at the proximal end, and the distal end of the actuator element is sized and shaped to fit the blind hole.

[0090] According to some embodiments, the distal end of the actuator element includes a retaining portion for temporarily holding the second anchor thereon.

[0091] According to some embodiments, the retaining portion is a recess for retaining the second anchor.

[0092] According to some embodiments, the actuator element has a compressible distal portion.

[0093] According to some embodiments, the first anchor is tubular.

[0094] According to some embodiments, the distal end of the sheath is curved.

[0095] According to some embodiments, the first and second anchors are fully contained within the sheath before deployment.

[0096] According to some embodiments, a multi-anchor delivery system is used to secure a second tissue or biocompatible material to a first tissue, wherein the second anchor is configured to secure the second tissue or biocompatible material to the first tissue.

[0097] According to some embodiments, the second tissue or biocompatible material is a second soft tissue.

[0098] According to some embodiments, at least one of the first anchor and the second anchor includes one of the following: Multiple loops, through which the stitches can extend; and Multiple pores allow the suture to pass through.

[0099] According to some embodiments, the second anchor is configured to be at least one of the following: Sufficiently thick to cushion the second tissue or biocompatible material from the pressure exerted by the suture on the second tissue or biocompatible material; and It is tough enough to prevent the second tissue or biocompatible material from being damaged by the suture.

[0100] According to some embodiments, the first anchor is configured to be inserted through a hole in the first tissue, and the size and / or shape of the second anchor is designed such that the second anchor cannot pass through the hole.

[0101] According to some embodiments, the multi-anchor delivery system includes: The sheath has a proximal end and a distal end, and has a sheath channel extending through it; A first actuator element and a second actuator element are disposed within a sheath, each actuator element having at least one distal end located within a sheath channel, the distal end of each actuator element being sized and shaped to displace through the sheath channel; The first anchor is disposed within the sheath, and at least a portion of the first anchor is located distally relative to the first pusher element. The second anchor is located inside the sheath and is positioned near the first anchor. The first pusher element can be displaced in a distal direction to contact the first anchor, and the displacement has a displacement length sufficient to deploy the first anchor. The second pusher element can be displaced in the distal direction to contact the second anchor, and the displacement has a displacement length sufficient to deploy the second anchor.

[0102] According to some embodiments, the multi-anchor delivery system includes: The sheath has a proximal end and a distal end, and has a sheath channel extending through it; A actuator element having at least one distal end located within a sheath channel, the distal end of the actuator element being sized and shaped to displace through the sheath channel; The first anchor is disposed within the sheath, and at least a portion of the first anchor is located distally relative to the actuator element; and The second anchor is located inside the sheath, near the first anchor, and is mounted on the actuator element.

[0103] According to some embodiments, the multi-anchor delivery kit includes a multi-anchor delivery system and a patch configured to be located on a first tissue. The first anchor is sized and shaped to be deployed through the patch and into the first tissue; The second anchor is configured to be deployed on the proximal side of the patch; The shortened distance is associated with the shortened distance between the patch and the first tissue.

[0104] According to some embodiments, the size and shape of the patch are designed to be adjacent to the first tissue.

[0105] According to some embodiments, the multi-anchor delivery kit includes a third anchor having a stitch channel that extends at least partially along the outer surface of the third anchor. The suture is arranged as a suture channel that can slide through the third anchor, wherein the third anchor can slide along the suture relative to at least one of the first and second anchors. The deployment device is configured to deploy the third anchor into the first organization or to the vicinity of the first organization after the first anchor is deployed; The sutures disposed within the suture channel of the third anchor and slidably passing through the suture channel of the third anchor and the first tissue are configured to be shortened, wherein the distance between the third anchor and one of the first and second anchors is shortened.

[0106] According to some embodiments, the multi-anchor delivery system includes: The actuator element has at least one distal end located within the sheath channel, and the size and shape of the distal end of the actuator element are designed to displace through the sheath channel; The first anchor is located on the far side relative to the actuator element; The second anchor is located on the proximal side of the sheath relative to the first anchor, and the second anchor is located on the proximal side relative to the distal end of the pusher element. The actuator element is configured to retract proximally to a position proximally to the second anchor, wherein during proximal retraction, at least one distal tip portion of the actuator is configured to be deformed by the second anchor; and The actuator element is configured to deploy the second anchor.

[0107] According to some embodiments, the actuator element is flexible enough to be deformed by the second anchor during the proximal retraction of the actuator.

[0108] According to some embodiments, the distal end of the actuator element has two configurations: A relaxed state, in which the actuator element can be used to deploy the anchor; and Deformed state, wherein the actuator element can be adapted between the second anchor and the sidewall of the sheath.

[0109] According to some embodiments, the distal tip portion of the actuator element includes at least one curved portion.

[0110] According to some embodiments, the first anchor includes a proximal end face, and wherein the pusher element includes a distal end face, the distal end face of the pusher element being configured to contact the proximal end face of the first anchor during deployment.

[0111] According to some embodiments, the second anchor includes a proximal end face, and wherein the pusher element includes a distal end face, the distal end face of the pusher element being configured to contact the proximal end face of the second anchor during deployment.

[0112] According to some embodiments, the actuator element has a non-uniform thickness along its length.

[0113] According to aspects of some embodiments of the present invention, a method for deploying an implant relative to a first tissue is provided, wherein the method includes: The sheath is delivered through the first tissue, such that the distal end of the sheath penetrates the first tissue; The first anchor is deployed outside the sheath and through the first tissue. The first anchor includes a first suture channel through which a suture extends and slidably passes. Withdraw the sheath from the first organization; Deploying a second anchor outside the sheath, the second anchor having a second stitch channel through which a stitch extends and slidably passes; and Tighten the sutures extending through the first suture and the second suture channel, so that the first anchor is tightened relative to the first tissue.

[0114] According to some embodiments, the first tissue is soft tissue.

[0115] According to some embodiments, deploying the second anchor includes deploying the second anchor into a second organization; Tightening includes reducing the distance between the first and second tissues.

[0116] According to some embodiments, tightening includes reducing the distance between the first anchor and the second anchor.

[0117] According to some embodiments, tightening includes reducing the distance between the second anchor and the first tissue.

[0118] According to some embodiments, tightening includes bending the first anchor.

[0119] According to some embodiments, tightening includes applying pressure to the first anchorage against the first tissue.

[0120] According to some embodiments, tightening includes bending the second anchor.

[0121] According to some embodiments, tightening includes applying pressure to the proximal side of the first tissue using the second anchor.

[0122] According to some embodiments, the method includes positioning a second tissue or biocompatible material proximal to a first tissue, wherein a first anchor is deployed through the second tissue or biocompatible material and into the first tissue, wherein tightening includes applying pressure to the second anchor against the second tissue or biocompatible material.

[0123] According to some embodiments, the distance between the second tissue or biocompatible material and the first tissue is adjustable.

[0124] According to some embodiments, bending includes bending at least one of the first anchor and the second anchor into one of a C-shape and a U-shape.

[0125] According to some embodiments, tightening the seam includes leaving a gap between the second anchor and the first tissue.

[0126] According to some embodiments, the method further includes continuing to tighten the sutures extending through the first suture channel and the second suture channel, such that the second anchor is in close contact with the first tissue.

[0127] According to some embodiments, the method includes: Positioning a second tissue or biocompatible material on the first tissue; Delivery includes delivering the sheath through a second tissue or biocompatible material; The deployment of the first anchor includes deploying the first anchor through the second tissue or biocompatible material; Withdrawal includes removing the sheath from the second tissue or biocompatible material; Tightening includes tightening the second anchor relative to the second tissue or biocompatible material.

[0128] According to some embodiments, the second tissue or biocompatible material is a second soft tissue.

[0129] According to some embodiments, the second anchor applies a reaction force to the second tissue or biocompatible material.

[0130] According to some embodiments, the first stitch channel extends along or passes through at least a portion of the first anchor.

[0131] According to some embodiments, the second anchor is at least one of flexible and compressible.

[0132] According to some embodiments, at least one of the first anchor and the second anchor includes one of the following: Multiple loops, through which the stitches can extend; and Multiple pores allow the suture to pass through.

[0133] According to some embodiments, the second anchor prevents damage to the second tissue or biocompatible material by at least one of the following: Sufficiently thick to cushion the second tissue or biocompatible material from the pressure exerted by the suture on the second tissue or biocompatible material; and It is tough enough to prevent the second tissue or biocompatible material from being damaged by the suture.

[0134] According to some embodiments, the first anchor is configured to be inserted through a hole in the first tissue, and the size and / or shape of the second anchor is designed such that the second anchor cannot pass through the hole.

[0135] According to some embodiments, the method includes: The third anchor is deployed outside the sheath and is located proximal to or through the first tissue. The third anchor includes a third suture channel through which a suture extends and slidably passes.

[0136] According to some embodiments, tightening includes shortening the distance between the third anchor and at least one of the first and second anchors.

[0137] According to some embodiments, tightening includes shortening the distance between the third anchor and the first tissue.

[0138] According to some embodiments, the first anchor is configured to be inserted through a first hole in a first tissue and a second hole in a second tissue or biocompatible material, and the size and / or shape of the second anchor is designed such that the second anchor cannot pass through the second hole.

[0139] According to some embodiments of the present invention, a method for attaching a biocompatible material to a tissue is provided, wherein the method includes: Deliver the sheath through the tissue so that the distal end of the sheath penetrates the tissue; The first anchor is deployed from outside the sheath and through biocompatible materials and tissues, and includes a first channel; Remove the sheath from the tissue; Deploying from outside the sheath, the second anchor has a second channel; and Tighten the sutures extending through the first and second channels so that the first anchor is tightly attached to the tissue.

[0140] According to some embodiments, tightening includes tightening the second anchor relative to the biocompatible material.

[0141] According to some embodiments, the second anchor applies a reaction force to the biocompatible material.

[0142] 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 this invention pertains. While similar or equivalent methods and materials to those described herein may 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) shall prevail. Furthermore, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting. Attached Figure Description

[0143] This specification describes some embodiments by way of example and with reference to the accompanying drawings. Please now refer specifically to the details of the drawings. It should be emphasized that the illustrations are merely examples and are intended to provide an illustrative discussion of embodiments of systems, kits, apparatuses, and methods. In this regard, the description in conjunction with the accompanying drawings will enable those skilled in the art to understand how to implement these embodiments of systems, apparatuses, kits, and methods. Furthermore, any reference to any feature or aspect of any system, apparatus, kit, or method or any combination thereof according to the invention should be understood to also refer to any system, apparatus, kit, or method discussed herein.

[0144] In the attached image: Figure 1 This is a simplified cross-sectional view and an enlarged view of the distal end of an exemplary multi-anchor delivery system according to some embodiments, showing the state of the system in its initial operational orientation; Figure 2 This is a simplified cross-sectional view and an enlarged view of the far end of a multi-anchor delivery system according to some embodiments, showing the state of the system under the first anchor deployment operation orientation; Figure 3 This is a simplified cross-sectional view and an enlarged view of the distal end of a multi-anchor delivery system according to some embodiments, showing the state of the system in the retraction operation orientation; Figure 4This is a simplified cross-sectional view and an enlarged view of the far end of a multi-anchor delivery system according to some embodiments, showing the state of the system under the second anchor deployment operation orientation; Figure 5 This is a perspective view of an exemplary multi-anchor delivery system according to some embodiments; Figure 6 According to some embodiments Figure 5 Exploded view of the apparatus shown; Figures 7A to 7E These are respectively based on some embodiments, Figure 6 Left side view, perspective view, right side view, bottom view and end view of the exemplary right half of the housing of the device shown; Figures 8A to 8E These are, respectively, perspective view, top view, side view, bottom view, and front view of an exemplary rack according to some embodiments; Figure 9A This is a perspective view of an exemplary roller according to some embodiments; Figures 9B to 9C This is a side view of an exemplary roller according to an alternative embodiment; Figures 10A to 10D These are, respectively, a perspective view, a top view, a side view, and an end view of an exemplary bobbin according to some embodiments; Figures 11A to 11D These are perspective views, front views, side views, and top views of exemplary locking elements according to some embodiments; Figures 12A to 12E These are perspective, side, top, end, and cross-sectional views of an exemplary needle length delimiter according to some embodiments; Figure 13A This is a perspective view of an exemplary sheath according to some embodiments. Figure 13D A magnified view of its far end is shown; Figures 13B to 13D These are based on some embodiments Figure 13A The cross-sectional view and top view of the sheath shown; Figure 14A This is a side view of an exemplary actuator element according to some embodiments. Figure 14B An enlarged view of its distal portion is shown; Figures 15A to 15C These are, respectively, a perspective view, a side view, and a top view of an exemplary suture retainer according to some embodiments; Figures 15D to 15E These are, respectively, a side view and a top view of an exemplary cannula according to some embodiments; Figures 16A to 16CThese are perspective, cross-sectional and top views of an exemplary first and second anchor according to some embodiments, wherein the stitching is threaded therethrough; Figures 17A to 17D These are, respectively, a side cross-sectional view (with a partial enlarged view) of an exemplary system before use according to some embodiments, an enlarged view of the distal portion of the system according to some embodiments, a top view of the system, and a side view of the system; Figures 18A to 18D These are based on some embodiments Figure 17A The diagram shows a lateral cross-sectional view of the system after it has been inserted through the tissue at its distal end, and an enlarged view of the distal portion of the system. Figure 18B The system's top view and side view; Figures 19A to 19D These are based on some embodiments Figure 18A The diagram shows a side cross-section of the system after the first anchor has been deployed through the tissue, and an enlarged view of the distal portion of the system. Figure 19B The system's top view and side view; Figures 19E to 19H These are based on some embodiments Figure 19A The diagram shows a side cross-sectional view of the system after the retracted actuator element, and an enlarged view of the distal portion of the system. Figure 19F The system's top view and side view; Figures 20A to 20D These are based on some embodiments Figure 19E The system shown is shown in a side cross-sectional view after the device has been withdrawn from the tissue, as well as an enlarged view of the distal portion of the system, a top view of the system, and a side view of the system. Figures 20E to 20G According to some embodiments Figure 19E Side cross-sectional view of the system shown. Figure 19F Enlarged view of the distal portion of the system shown and top view of the system; Figures 21A to 21D These are based on some embodiments Figure 20A The system shown is illustrated by a side cross-sectional view of the system after the second anchor has been deployed through the tissue, an enlarged view of the distal portion of the system, a top view of the system, and a side view of the system. Figures 22A to 22C These are based on some embodiments Figure 21A The diagram shows a side cross-sectional view of the system after withdrawal from the tissue at the distal end of the device, an enlarged view of the distal portion of the system, and a top view of the system. Figures 23A to 23B These are, respectively, a front view and a side view of an exemplary anchor according to some embodiments, after being attached to the tissue and before the suture material is tightened; Figures 23C to 23D These are based on some embodiments Figure 23AThe anchor shown is a side view and a front view after the small slot coil is tightened; Figures 23E to 23G These are based on some embodiments Figure 23D The anchor shown is viewed from the side, rear, and perspective after the large seam coil has been tightened. Figure 24 This is a schematic diagram of an exemplary method for delivering multiple anchors into patient tissue according to some embodiments; Figure 25 This is a schematic diagram of an exemplary method of operation of an apparatus for deploying multiple anchors according to some embodiments; Figure 26 This is a side view of a portion of a deployment device including a first anchor and a second anchor according to some embodiments. Figures 27A to 27B These are schematic diagrams of a proximal view and a distal view of a second soft tissue or biocompatible material fixed to each other and a first soft tissue, according to some embodiments. Figure 28 This is a schematic diagram of a second soft tissue or biocompatible material fixed to a first soft tissue, according to some embodiments; Figure 29A This is an exemplary abstract block diagram according to some embodiments, illustrating a designated axially overlapping area in the sheath of a multi-state anchor delivery system during the deployment of a first anchor in a first state; Figure 29B This is an exemplary abstract block diagram according to some embodiments, illustrating a reduced designated axial overlap area in the sheath of a multi-state anchor delivery system during the deployment of a second anchor in a second state; Figure 30A This is an exemplary abstract block diagram according to some embodiments, illustrating a designated axial overlap area of ​​a multi-state anchor delivery system during the deployment of a first anchor in a first state, and an axial switching element optionally located at least partially outside the sheath; Figure 30B This is an exemplary abstract block diagram according to some embodiments, illustrating a reduced designated axial overlap area of ​​a multi-state anchor delivery system during the deployment of a second anchor in a second state, and an axial switching element optionally located outside the sheath; Figure 31 This is an exemplary illustration of a multi-state anchor delivery system according to some embodiments, showing an outer housing; Figure 32 This is an exploded perspective view of a multi-state anchor delivery system according to some embodiments, showing the internal components within the housing; Figure 33This is a view showing a designated axial overlap area of ​​a mechanism having an overlapping joint during the deployment of a first anchor, according to some embodiments; Figure 34 This is a side cross-sectional view of a portion of an apparatus according to some embodiments of a system, showing a reduction in a designated axial overlap area of ​​a mechanism with an overlapping joint after the first anchor is deployed and during the retraction of the second pusher; Figure 35 This is a side cross-sectional view of a part of the apparatus of a system according to some embodiments, showing a designated axial overlap area of ​​the overlapping joint with the second pusher already deformed before the second anchor is deployed; Figure 36 This is a perspective view of a portion of an anchor delivery device according to some embodiments of a system, showing a designated axial overlap area of ​​the mechanism when the movable panel is in the open position during the first anchor deployment. Figure 37 This is a side cross-sectional view of a part of a system apparatus according to some embodiments, showing the pushing of an anchor pusher in a first state and a movable panel in an open position during the deployment of a first anchor. Figure 38 This is a side cross-sectional view of a part of a system according to some embodiments, the system including a designated axial overlap region of the mechanism when the movable panel is in the open position after the first anchor is deployed; Figure 39 This is a side cross-sectional view of an apparatus according to some embodiments of a system, the apparatus including a designated axial overlap region having a movable panel in a closed position covering a borehole (or other recess); the figure shows the reduction of the overlap region after the first anchor is deployed and the rack is retracted; Figure 40 This is a side cross-sectional view of a part of a system according to some embodiments, showing a second pusher in a second state, wherein a designated axially overlapping area with a movable panel is in a closed position and covers the borehole; Figure 41A This is a perspective view of a part of a system according to some embodiments, showing a structure as an embodiment of reducing axial overlap area, wherein the sheath is provided with a protrusion that bends the anchor pusher after the first anchor is deployed and after the rack is retracted; Figure 41B The perspective view according to some embodiments shows a sheath of the system, the proximal end of which has a protrusion for bending the anchor pusher, and the sheath is operable to deform the anchor pusher. Figure 42A The perspective view according to some embodiments shows an overlapping switching plate operable to deform an anchor pusher; Figure 42BThe perspective view, based on some embodiments, shows the assembly position of the overlapping switching plate; Figures 43A to 43B These are, respectively, side views and end views of anchors according to some embodiments; Figures 44A to 44C It is a cross-sectional view of each of the anchors comprising four rings according to some embodiments; Figure 44D According to some embodiments Figure 44A The diagram shows a pair of anchors in a state after they have been deployed and secured to the soft tissue. Figures 45A to 45B It is a cross-sectional view of an anchor comprising two rings according to some embodiments; Figure 45C According to the embodiments Figure 45A The diagram shows a pair of anchors in a state after they have been deployed and secured to the soft tissue. Figures 45D to 45G This is a side view of an additional anchor according to some embodiments; Figures 46A to 46B An alternative configuration for threading a suture through a pair of anchors, according to an embodiment, is shown, as well as the anchors secured to soft tissue. Figures 47A to 47B Further alternative configurations for threading a suture through a pair of anchors according to an embodiment are shown, as well as anchors secured to soft tissue. Figure 47C This is a simplified schematic diagram of an exemplary anchor in a first orientation according to an embodiment of the present invention, wherein a stitch passes through or extends through the anchor. Figure 47D According to some embodiments Figure 47C The diagram shows a simplified cross-section of the anchor, in which the anchor is in a second orientation and the seam is inserted into the anchor. Figure 48 This is a flowchart illustrating a method for operating a multi-state anchor delivery system according to some embodiments; Figure 49 This is a flowchart illustrating a method for reducing axial overlap and extending an anchor pusher according to some embodiments; Figure 50 This is an exploded view illustrating an anchor delivery system according to some embodiments, the anchor delivery system including a pusher element with a curved tip; Figure 51 yes Figure 50 A perspective view of the assembled anchor delivery system shown. Figure 52 According to some embodiments Figure 50A perspective view of the pusher element of the anchor delivery system shown, including an enlarged view of a portion of the pusher element; Figure 53 According to some embodiments Figures 50 to 2 Figure 3 shows a side cross-sectional view of the anchor delivery system before the anchor is deployed; Figure 54 According to some embodiments Figures 50 to 2 Figure 3 shows a side cross-sectional view of the anchor delivery system after the first anchor has been deployed, with the pusher element in the extended position. Figure 55A According to some embodiments Figures 50 to 2 The side cross-sectional view of the anchor delivery system shown in Figure 3 during the retraction of the actuator element; Figure 55B According to some embodiments Figures 50 to 2 Figure 3 shows a side cross-sectional view of the anchor delivery system after the actuator element has retracted; Figure 56 According to some embodiments Figures 50 to 2 Figure 3 shows a side cross-sectional view of the anchor delivery system after the second anchor has been deployed; Figure 57 This is an exploded view of an anchor delivery system according to some embodiments, the anchor delivery system including a pusher element having an S-shaped tip portion; Figure 58 According to some embodiments Figure 57 The figure shows a perspective view of the actuator element, which includes enlarged views of multiple parts of the actuator element; Figure 59 According to some embodiments Figure 57 The diagram shows a side cross-section of the anchor delivery system before the anchor is deployed. Figure 60 According to some embodiments Figure 57 The diagram shows a side cross-section of the anchor delivery system after the first anchor has been deployed and the pusher element is in the extended position. Figure 61A According to some embodiments Figure 57 The diagram shows a side cross-sectional view of the anchor delivery system during the retraction of the actuator element; Figure 61B According to some embodiments Figure 57 The diagram shows a side cross-section of the anchor delivery system after the actuator element has retracted. Figure 62 According to some embodiments Figure 57 The diagram shows a side cross-section of the anchor delivery system after the second anchor has been deployed. Figure 63This is a side cross-sectional view of a portion of an anchor delivery system according to some embodiments, including an anchor with a seam inserted therethrough; Figures 64A to 64H This is a side view of the stitching of the anchor delivery system after the first and second anchors have been deployed. Figure 65 This is a flowchart illustrating the steps of a method for attaching a biocompatible material to soft tissue according to some embodiments; and Figure 66 This is a schematic diagram of the needle portion of an implant delivery system according to some embodiments. Detailed Implementation

[0145] The present invention relates, in some embodiments thereto to soft tissue repair systems, and more specifically, but not exclusively, to multi-anchor delivery systems.

[0146] This document discloses a multi-anchor delivery system and method, which is particularly useful for repairing soft tissue (e.g., the meniscus), but is not limited to this specific surgical procedure. Some aspects of embodiments of the invention relate to deploying multiple anchors using a sheath. In some embodiments of the invention, two anchors are sequentially deployed from the sheath via a single pusher element, one anchor contacting the pusher element, and a second anchor loaded into the sheath and located on one side of the pusher element. Optionally, the second anchor is mounted on and / or surrounds 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 from separate pusher elements, such as those disclosed in U.S. Patent Application No. US 2008 / 0243148.

[0147] In some embodiments of the invention, retracting the pusher element after deploying the first anchor changes the position of the second anchor relative to the pusher element, such that the pusher element deploys the second anchor from the sheath as it subsequently advances distally.

[0148] In some embodiments of the invention, when the actuator element retracts in the proximal direction, the second anchor is pulled back along with the actuator element until the second anchor encounters interference geometry and is prevented from retracting further. In this way, the actuator element moves distally relative to the second anchor.

[0149] Exemplary embodiments of the present invention include systems and methods for deploying a plurality of anchors through patient tissue. These systems and methods can be used, for example, to repair torn meniscus tissue: deploying a first anchor and a second anchor through the torn tissue portion, and then optionally tightening the anchors against the tissue portion, thereby potentially pulling the separated tissue portions together to promote healing. According to some embodiments, the system includes a device having a sheath with a channel formed therein extending through it. A pusher element is located in the channel and is displaceable relative to the sheath in distal and proximal directions.

[0150] Some embodiments of the present invention relate to the deployment of a first and a second implant in the form of anchors from a sheath. The first anchor can be implanted into soft tissue (as discussed herein), and the second anchor can be deployed near the soft tissue, optionally near a biocompatible material located on the soft tissue. According to some embodiments, the first and second anchors are sized and shaped to be fully positionable within a channel of the sheath, with the first anchor distal to a pusher element and the second anchor proximal to the first anchor. Optionally, the first and second anchors are fully contained within the sheath prior to deployment.

[0151] The first and second anchors may each include a suture channel extending at least partially along the outer surface of the respective anchor. The suture is slidably disposed in the suture channel of each of the first and second anchors, such that after the first anchor is deployed into the first tissue and the second anchor is deployed, the first anchor can slide relative to the suture, and the second anchor can slide toward the first anchor. According to some embodiments, sliding the suture within the suture channels of the first and second anchors can reduce the distance between the first and second anchors. Furthermore, sliding the suture within the suture channels of the first and second anchors can reduce the distance between the second anchor and the first tissue, optionally until the second anchor is adjacent to the first tissue. Optionally, the first tissue is soft tissue, such as a tendon with a tear or partial tear.

[0152] The second anchor can be deployed at a proximal distance from the first tissue. The distance between the second anchor and the proximal side of the first tissue can be adjustable / reducible, for example, by pulling the suture, allowing the suture to subsequently slide within the channel between the first and second anchors. The distance between the second anchor and the proximal side of the first tissue can be adjustable / reducible such that the second anchor is adjacent to the proximal side of the first tissue.

[0153] A piece of suture material can extend through the first and second anchors, thereby optionally forming small and large loops extending between the anchors. The small loops can extend from near the distal end of the first anchor to near the proximal end of the second anchor, while the free end can extend proximally through the device from near the proximal end of the first anchor.

[0154] Some embodiments involve securing a second tissue or biocompatible material, such as a patch, to a first tissue. Optionally, the second tissue or biocompatible material may be a second soft tissue. The second tissue or biocompatible material may be positioned proximal to the first tissue, wherein a first anchor may be deployed through the second tissue or biocompatible material and into the first tissue. Tightening the suture may cause the second anchor to exert pressure on the second tissue or biocompatible material. The distance between the second tissue or biocompatible material and the first tissue may be adjustable, for example, by pulling the suture extending through the first and second anchors. This may cause at least one of the first and second anchors to bend 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. This gap may be reduced or eliminated by further tightening the suture extending through the first and second suture channels, causing the second anchor to be tightly against the first tissue.

[0155] According to some embodiments, deploying the second anchor includes deploying the second anchor into a second tissue, and tightening includes reducing the distance between the first and second tissues. According to some embodiments, tightening includes reducing the distance between the first and second anchors. According to some embodiments, tightening includes reducing the distance between the second anchor and the first tissue.

[0156] According to some embodiments, tightening includes bending the first anchor. According to some embodiments, tightening includes applying pressure to the first anchor against the first tissue. According to some embodiments, tightening includes bending the second anchor. According to some embodiments, tightening includes applying pressure to the proximal side of the first tissue with the second anchor.

[0157] By providing a first anchor and a second anchor with channels in which sutures are slidably disposed, and in combination with a specific configuration of these components (as discussed herein), it is possible to tighten the first and second anchors relative to the first and second tissues, or relative to the first tissue and a biocompatible material (as discussed herein). This has the potential advantage of eliminating the need for tools that might be required in other embodiments for tightening sutures extending through the first and second anchor channels.

[0158] According to some embodiments, a third anchor having a third suture channel can be deployed, for example, into the first tissue, proximal to the first tissue, or into the third tissue. After the first anchor is deployed into the first tissue, the second anchor is deployed proximal to the first tissue, and the third anchor is deployed in place, the distance between the third anchor and the first and / or second anchors can be adjusted / decreased by pulling the suture, allowing it to slide through the first, second, and third suture channels. Pulling the suture may cause the third anchor and / or the third tissue to move closer to or adjacent to the first tissue.

[0159] Some embodiments of the present invention relate to deploying multiple anchors using a sheath, the distal portion of which has a lateral opening, such as a slot, wide enough to allow passage of both small and large slotted coils. Optionally, a second anchor is positioned proximal to the lateral opening before deployment.

[0160] The device may include a tubular suture retainer for holding the suture material within a limited distance from the needle, thereby potentially preventing the suture material from tangling as the anchor moves through the channel.

[0161] According to some embodiments of the invention, the actuator element can be displaced by linear displacement of the drive mechanism. The drive mechanism can be displaced by linear displacement of a button-type actuator. Alternatively, in some embodiments, the drive mechanism can be displaced by rotation of a roller.

[0162] The actuator is movable in both distal and proximal directions and is coupled to a drive mechanism, which is coupled to a actuator element. The coupling is configured such that movement of the actuator in the distal direction causes displacement of the drive mechanism in the proximal direction; and movement of the actuator in the proximal direction causes displacement of the drive mechanism in the distal direction.

[0163] The sheath can be inserted through tissue, such as a torn meniscus. The sheath should be inserted through the tissue such that the distal end of the sheath exits the tissue before the anchor is deployed.

[0164] Once the tissue is in place, the device can be activated by moving the actuator in the proximal direction. The pusher element can be displaced along the sheath in the distal direction to contact the first anchor. The displacement of the pusher element is sufficient to deploy the first anchor from the sheath.

[0165] The blocking element is optionally positioned within the channel, proximal to the second anchor, and may optionally be in the form of a narrowing channel to interfere with proximal displacement of the second anchor. The position of the second anchor within the sheath may be affected by distal or proximal movement of the actuator, or may remain unaffected, depending on the position of the second anchor relative to the blocking element and the direction of movement of the actuator element.

[0166] After the first anchor is deployed, the pusher element can be displaced proximally within the channel to a position proximally to at least a portion of the second anchor. As the pusher element moves proximally, it may prevent the second anchor from also moving proximally once it contacts a stop in the channel.

[0167] The needle can be removed from the tissue and reinserted through the tissue at another location where the second anchor is desired to be deployed. When the device is activated by moving the actuator again in the proximal direction, the pusher element can then be displaced distally along the sheath to contact the second anchor, the displacement of the pusher element being sufficient to deploy the second anchor from the sheath.

[0168] After the second anchor is deployed, the suture loop can be tightened to ensure the anchor adheres tightly to the tissue. The in-place anchor holds the torn tissue together, promoting healing.

[0169] Some embodiments of the invention relate to deploying a first anchor and a second anchor from a sheath, wherein the first anchor may be solid, or at least not hollow, while the second anchor may be hollow. An actuator element may be displaced proximally and distally within the sheath, and the actuator element may be inserted through the second anchor. After deployment of the first anchor, proximal displacement of the actuator element effectively moves the actuator 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 actuator element, the distal end of the actuator element contacts the proximal portion of the second anchor and deploys the second anchor from the sheath. Optionally, the actuator element has a distal end wider than the proximal end of the second anchor, and the distal end of the actuator element may optionally be compressible upon insertion through the second anchor. Optionally, the second anchor has a compressible portion that is decompressed when the actuator element retracts to the position proximal to the second anchor.

[0170] Some embodiments of the invention relate to deploying a first anchor and a second anchor from a sheath, wherein the second anchor may be solid and optionally compressible. Optionally, the second anchor is laterally compressible. The second anchor may be compressed by a pusher element to position it adjacent to the pusher element. When the pusher element retracts, the pusher element may slide over the second anchor, positioning the second anchor distally relative to the pusher element. The second anchor can then be deployed by distal displacement of the pusher element. Optionally, the second anchor is compressible, and upon decompression, the outer diameter of the second anchor is 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, and this anchor is radially compressed within the sheath until deployed from the sheath by the pusher element.

[0171] Some embodiments of the present invention relate to systems and methods for deploying a first anchor and a second anchor, wherein a pusher element includes a recess for holding the second anchor. Optionally, the recess may be a notch sized and shaped to temporarily accommodate the second anchor. Optionally, the second anchor may be positioned within the recess such that at least a majority of the second anchor is surrounded by the pusher element. Optionally, the second anchor may be positioned within the recess such that at least three sides of the second anchor are surrounded by the pusher element. After the first anchor is deployed, the pusher element is retracted, which effectively positions the second anchor distally relative to the pusher element. The second anchor can then be deployed by distal displacement of the pusher element.

[0172] Some embodiments of the present invention relate to the deployment of multiple anchors, with the first and second anchors deployed by respective actuator elements that optionally operate in parallel within a single sheath.

[0173] According to some embodiments, the system may include an actuator that is proximally displaceable to deploy a first anchor. Optionally, the actuator may be a linearly displaceable trigger button. Alternatively, the actuator may be a rotatable roller. In some embodiments, this has the potential advantage that the user's finger moves in a first direction while the anchor is deployed in a second direction opposite to the first direction. For example, the user can activate the device by moving the trigger button in the proximal direction, thereby deploying the anchor in the distal direction beyond the sheath.

[0174] In one embodiment, the system may be equipped with a locking mechanism to prevent the anchors from being deployed unintentionally or prematurely.

[0175] Some embodiments of the invention relate to using a sheath to deploy multiple anchors, the distal portion of which includes an opening, such as a slot. A stitched portion disposed on or passing through the anchor may be allowed to extend from the opening, potentially preventing tangling of the stitched portion. Optionally, at least a portion of a second anchor is located proximal to the opening. Optionally, the entire length of the second anchor is located proximal to the opening.

[0176] Some embodiments relate to tissue attachment devices for securing a second soft tissue or biocompatible material (e.g., an arthroscopic patch or allogeneic graft) to a first soft tissue. The device may include a first anchor, optionally flexible, and a second anchor, with a suture passing through or engaging at least a portion of the first anchor, and the second anchor slidably mounted on the suture. The first anchor may be inserted through the first soft tissue (as discussed herein) and may be positioned distal to the first tissue, while the second anchor may be positioned proximal to the first soft tissue to secure the second soft tissue or biocompatible material to or relative to the first soft tissue. The first and second anchors, as well as the suture connecting them, may be formed of a biocompatible material.

[0177] According to some embodiments, at least a portion of the first anchor may be tubular, or may include a channel or cavity located within and / or extending along at least a portion of the first anchor. Optionally, the channel or a portion thereof may be at least partially located outside the first anchor and formed of any suitable material (e.g., a ring) attached to or integrally formed with the first anchor. Alternatively, according to some embodiments, the first anchor may not have a channel for the suture to pass through, but rather allow the first anchor to slide into the suture.

[0178] The device also includes a second anchor, which comprises at least one loop or connector to allow the second anchor to be slidably mounted on the seam. Alternatively, the second anchor may include a plurality of apertures through which the seam can pass, allowing the second anchor to be slidably mounted on the seam. The second anchor may optionally be formed of a flexible material and may optionally be formed of a compressible material.

[0179] The first anchor can be deployed by passing any system or suitable deployment device discussed herein through an opening in the first soft tissue, such that the first anchor will be positioned distal to the first soft tissue, as discussed herein. After the first anchor is deployed, a second anchor can be deployed proximal to the first soft tissue, with a portion of the suture extending between the first and second anchors.

[0180] The second soft tissue or biocompatible material attached to the first soft tissue is expected to be positioned proximally to the first soft tissue, and a portion of the suture can be pulled proximally to shorten the suture length between the first and second anchors, thereby bringing the first and second anchors closer together. As the first and second anchors move closer, the suture can slide through channels defined in the first and second anchors, as discussed herein. As the suture portion between the first and second anchors is shortened, the first anchor can thus be pressed against the distal side of the first soft tissue, while the second anchor can be pressed against the second soft tissue or biocompatible material, thereby securing the second soft tissue or biocompatible material to the first soft tissue. Thereafter, the suture can be tied or knotted, and any excess suture material can be removed.

[0181] Alternatively, according to some embodiments, the sheath or needle may optionally pass through both the second soft tissue or biocompatible material and the first soft tissue insertion simultaneously, after which a second anchor may be deployed proximal to the second soft tissue or biocompatible material. In this manner, the suture portion may extend through the first soft tissue and the second soft tissue or biocompatible material, as discussed herein.

[0182] The second anchor may be thick enough or have a large enough diameter to cushion the pressure applied to the second soft tissue or biocompatible material relative to the suture during tightening. The second anchor may also be strong enough or robust enough 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, elliptical, or rectangular cross-sectional profile, or any other suitable cross-sectional profile.

[0183] Since the first anchor is configured to be inserted through an opening in the first soft tissue, the size and / or shape of the second anchor can be designed such that the second anchor cannot pass through the opening in the first soft tissue.

[0184] It should be noted that providing a device with a first anchor and a second anchor, both of which can slide relative to the suture, essentially provides an improved device for securing a second soft tissue or biocompatible material to a first soft tissue. This can facilitate the attachment of the second soft tissue or biocompatible material to the first soft tissue. Compared to using sutures alone, this device can potentially reduce the pressure on the second soft tissue or biocompatible material, thereby enabling better tissue healing and / or preventing damage caused by excessive pressure on the second soft tissue or biocompatible material, since using sutures alone may force the second soft tissue or biocompatible material against the first soft tissue.

[0185] Furthermore, the second anchor may act as a buffer in the procedures discussed herein, thereby distributing the forces applied to the second soft tissue or biocompatible material across its entire area. This may potentially reduce the pressure and / or stress on the second soft tissue or biocompatible material compared to a first anchor that does not include a second anchor and holds the second soft tissue or biocompatible material relative to the first soft tissue by pulling the suture against it proximally. 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 the pressure and / or stress applied to the second soft tissue or biocompatible material and may potentially prevent damage to the second soft tissue or biocompatible material.

[0186] Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not necessarily limited to the construction details and arrangements and / or methods of components set forth in the following description and / or shown in the drawings and / or examples. The present invention can be implemented or practiced or carried out in various ways in other embodiments.

[0187] Potential advantages Systems and / or methods according to some embodiments of the present invention can provide one or more of a number of potential advantages not achieved in the prior art. For example, by providing a trigger button / roller (as discussed herein), easy one-handed operation of the system can be achieved through simple mechanical components. Furthermore, the force required to apply to the trigger button / roller is approximately equivalent to the force required to deploy each anchor. This allows the user to control the deployment of the anchors, a control not possible in some prior art devices, such as those employing spring-loaded mechanisms for anchor deployment.

[0188] Additionally, a system is provided in which movement of a user's finger in a first direction causes displacement of a pusher element in a second direction, and, in conjunction with the provision of a safety latch / locking mechanism as described herein, can prevent premature / unintentional deployment of the anchor.

[0189] Furthermore, the ergonomic shape of the handle makes it easier to manipulate the needle in tissue, resulting in more accurate positioning of the anchor after deployment. In addition, the ergonomic shape and operation of the handle and the drive mechanism in the form of a trigger button or roller, along with the engageable actuator drive unit, result in less pressure required to deploy the anchor compared to existing devices.

[0190] Furthermore, providing a slot on the needle through which the loop extends can make the deployment of the anchor easier, since the loop / suture may not interfere with the movement of the anchor within the channel, and providing a slot through which the loop extends can prevent the suture material from tangling when the anchor is deployed from the needle.

[0191] Furthermore, as with any device to be inserted into the human body, the internal space available for operation is limited. Inserting the actuator element through the second anchor saves internal space.

[0192] In addition, providing a bobbin for wrapping the stitching material can prevent the stitching material from tangling inside the housing.

[0193] These and other potential advantages may be obvious to those skilled in the art.

[0194] Furthermore, this disclosure generally relates to medical systems, devices, kits, and methods for delivering implants, such as multiple anchors, at least one of which is a soft tissue anchor. As described herein, the systems, devices, kits, and methods of this disclosure can also be used alternatively to deploy multiple anchors through bone.

[0195] According to certain aspects of some embodiments of the present invention, systems, apparatuses, kits, and methods are provided for deploying a first anchor and a second anchor, wherein prior to deployment of the anchor, the first anchor is positioned distally within the apparatus relative to the position of the second anchor within the apparatus. According to some embodiments, the systems, apparatuses, kits, and methods discussed herein include a pusher element that extends distally to deploy the first anchor, then retracts to a position proximal to the second anchor, and subsequently extends distally again to deploy the second anchor.

[0196] In some embodiments of the invention, a multi-state overlapping switching mechanism is provided for controlling the deployment of anchors within an anchor delivery system using an anchor pusher and a second pusher. In some embodiments, the anchor delivery system is, for example, a tissue repair system for repairing soft tissue (e.g., the meniscus), but is not limited to meniscus surgery. Alternatively, in some embodiments, the anchor delivery system is, for example, a tissue repair system for repairing bone tissue. While this application primarily discusses various anchors and deployment systems / methods for repairing soft tissue, it should be understood that such anchors and deployment systems / methods can also be alternatively applied to repairing bone tissue.

[0197] Some embodiments of the present invention relate to mechanisms for modifying the axial travel distance of an anchor pusher. Optionally, this allows the same pusher to deliver anchors to different depths. Optionally or additionally, this allows the same anchor pusher to push an anchor closer to the proximal side to the same position as an anchor closer to the distal side, or to a position further away than an anchor closer to the distal side. Such mechanisms are very useful in anchor delivery systems where an anchor pusher is used to advance an anchor out of the delivery system and into the tissue. If the proximal anchor is used as an extension of the anchor pusher to push out the distal anchor, the proximal anchor may not extend significantly beyond the distal end of the delivery system when pushing the distal anchor. However, deployment of the proximal anchor does require such withdrawal, and therefore may require the anchor pusher to have a longer axial movement. The proposed mechanism provides a variable anchor pusher movement length for different anchors. In some embodiments of the invention, a mechanism for moving the anchor pusher is provided, and this mechanism retracts after the distal anchor is deployed. This potentially allows for simpler mechanical designs for various mechanism features, such as the degree of movement of the user-operated knob and / or the location of the safety mechanism. Alternatively, the anchor pusher could be simply advanced to deploy each anchor without retracting it. However, this could also require a longer handle or other mechanism to advance the anchor pusher, and / or result in the user experiencing different operating feel or maneuver geometry each time an anchor is deployed, which may be undesirable.

[0198] In some embodiments of the invention, an overlap switching mechanism is provided, wherein the anchor pusher and the second push assembly (also referred to herein as the "second pusher") have variable axial overlap. This variable axial overlap allows the overall axial length and / or travel distance of the anchor pusher to be substantially different in different overlap states. Thus, the overall axial length and / or travel distance of the anchor pusher can be substantially different when, for example, the first anchor is deployed and the second anchor is deployed. This difference in travel amount may vary, for example, the length of the proximal anchor, which is part of the overall push structure when the distal anchor is deployed, but not when the proximal anchor is deployed. For two anchors, two different lengths (and corresponding overlap states) may be required, and additional overlap states and lengths can be provided if more anchors are deployed.

[0199] In some embodiments of the invention, the overlap switching mechanism is used to extend the distal length traveled by the anchor-pusher in a second state of deployment of the second anchor. As described below, this distal length is extended by reducing a specified axial overlap area between the proximal end of the anchor-pusher and the second pusher. The reduced specified axial overlap area is inversely proportional to the combined length of the anchor-pusher and the second pusher. This mechanism increases the distal length traveled by the anchor-pusher in the second state.

[0200] In some respects, the first and second anchors penetrate the tissue to the same depth. In other respects, the second anchor penetrates the tissue to a greater depth, longer depth, or greater depth than the first anchor.

[0201] In some embodiments of the invention, the overlap switching mechanism is activated by retracting the push assembly relative to the actuator, which deforms the push assembly and / or the anchor actuator, thereby reducing the overlap between the push assembly and the anchor actuator when the push assembly is next advanced distally. Optionally, these states are coupled by elastic deformation so that this deformation occurs elastically when the push assembly is fully retracted from the anchor actuator.

[0202] In some embodiments of the invention, the anchor pusher is deformed so that it cannot axially overlap with the push assembly (or overlaps less axially). Optionally or additionally, the push assembly is deformed to prevent axial overlap with the anchor pusher and / or to prevent the proximal portion of the anchor pusher from inserting into the orifice or recess of the pusher assembly. In some embodiments of the invention, a door or plate of the push assembly is closed to cover the orifice or recess, preventing the proximal portion of the anchor pusher from inserting into the orifice or recess of the pusher assembly. Optionally or additionally, the anchor pusher is deformed so that it cannot fit into the push assembly.

[0203] Several embodiments relate to a structure in which the anchor pusher and the second pusher have different physical configurations, thereby allowing variable anchor deployment by changing the lengths of the anchor pusher, the second pusher, or a combination of both. This can be achieved using an overlap switching mechanism having a designated axial overlap area and being located inside or outside the sheath. The lengths of the anchor pusher, the second pusher, and the axial overlap area can vary. In some embodiments of the invention, both the anchor and the anchor pusher are enclosed in a sheath for delivering the anchor to the target tissue.

[0204] The designated axial overlap area may optionally include a first axial overlap area defined on the anchor pusher and a second axial overlap area defined on the second pusher. According to some embodiments, the overlap joint between the two pushers includes this designated axial overlap area. In another embodiment discussed herein, a movable panel is used to cover the drill hole (or other recess) of the rack (preventing the anchor pusher from engaging therein), thereby extending the movement of the anchor pusher during the deployment of the second anchor. In some embodiments of the invention, a protrusion at the proximal end of the sheath deforms the anchor pusher after the first anchor is deployed. As will be discussed below, the sheath protrusion can extend the movement of the anchor pusher during the deployment of the second anchor. Another option is a cam or eccentric plate that deforms the anchor pusher to prevent it from re-entering the drill hole after retracting in the first state, thereby extending the effective length of the anchor pusher, as described below. After the first anchor is deployed a first distance, if the effective length of the anchor pusher is extended, the second anchor can be deployed a second distance, which is greater than the first distance. According to some embodiments, the anchor pusher deforms after the first state and mechanically prevents it from returning to its initial position in the drilled hole of the rack, i.e., the position in the first state.

[0205] The overlap switching mechanism can control a specified axial overlap area in one or both of the first and second axial overlap areas. In some embodiments of the invention, the overlap switching mechanism has two states. In a first state, the overlap switching mechanism allows or maintains the specified axial overlap area such that there is no interference between the connection between the anchor pusher and the second pusher. In the first state, the combined length of the distal ends of the two pushers is minimized. In a second state, the overlap switching mechanism reduces the axial overlap area by mechanically impeding the axial movement of one pusher relative to the other. The reduced axial overlap area extends the combined length of the anchor pusher and the second pusher to a degree sufficient to deploy the second anchor outside the sheath. The second anchor is used to push the first anchor out of the channel. In the second state, some compensation is required to fully deploy the second anchor outside the channel outside the sheath. As before, additional (e.g., intermediate) states may be provided.

[0206] Anchor pushers, second pushers, or both can be made of materials capable of elastic deformation and possessing a memory effect. Nickel-Titanium alloys are an example material that exhibits this property. For instance, in an overlap joint, when the second pusher retracts in the proximal direction, one or both pushers may deform, twist, or rotate, resulting in misalignment between the pushers in the second state.

[0207] Two or more anchors can be disposed within the sheath, with the anchor pusher adjacent to the proximal end of the second or third anchor. For the deployment of the first anchor, the anchor pusher pushes the second or third anchor, which in turn pushes the first anchor out of the sheath, forming a last-in-first-out (LIFO) assembly. In the first state of deployment of the first anchor, the specified axial overlap area is not altered or reduced, and the first anchor is deployed from the sheath. The anchor pusher is located at the distal end of the sheath.

[0208] The sheath can be inserted through tissue, such as a torn meniscus. In some procedures, the sheath provides the needle for penetrating the tissue. Alternatively or additionally, the sheath itself can be sharpened and used as a needle.

[0209] According to some embodiments, the device is placed at a location on the subject's body. The device is then actuated by moving the actuator in a proximal direction. An anchor pusher and a second pusher are displaced along the sheath in a distal direction to deploy the first anchor in a first state, with the displacement of the anchor pusher sufficient to deploy the first anchor from the sheath. The second pusher is engaged with the anchor pusher through a designated axial overlap area, thereby actuating the anchor pusher. For example, in the first state, it is through this engagement that the anchor pusher is able to push the anchor out of the sheath.

[0210] Next, retracting the second pusher from the anchor pusher reduces the axial overlap area between the anchor pusher and the second pusher. During retraction, the anchor pusher can disengage from the axial overlap area of ​​the second pusher.

[0211] Deformation of one or both of the anchor pusher and the second pusher causes misalignment, which interferes with the overlap between the designated overlapping portions of the two pushers and results in the combined length of the anchor pusher and the second pusher being greater in the second state than in the first state. This extension of the combined length compensates for the situation where, after the first state, the length of the second anchor is no longer part of the deployment length—while in the first state, the second anchor was used to push the first anchor out of the sheath. Now, after deformation and reduced axial overlap, the extension of the combined length allows the second anchor to be deployed from the sheath.

[0212] The second state begins with the second pusher pushing the anchor pusher, and one or both of the anchor pusher and the second pusher cause mechanical interference in a designated axial overlap area due to deformation, wherein the pushing action occurs on a contact area between the anchor pusher and the second pusher, which may optionally be located outside the designated axial overlap area.

[0213] In some embodiments of the invention, the proximal end of the anchor pusher is mounted in a rack with a drilled hole (or recess) to provide partial or complete axial overlap. The depth of the drilled hole in the rack can be non-uniform to allow for variation in the effective length of the anchor pusher in a second state of anchor deployment. In some aspects, the kit provides rack and anchor pusher assemblies in various sizes, enabling flexible drilling depths through optional assembly of components in the system to accommodate different anchor deployments.

[0214] According to aspects of some embodiments of the present invention, a multi-anchor delivery system is provided, comprising: a sheath having a proximal end and a distal end, and having a sheath channel extending therethrough; an anchor pusher and a second pusher disposed within the sheath, each pusher element having at least one distal end located within the channel, the distal end of each pusher element being sized and shaped to be displaced along the channel; a first anchor disposed within the sheath, at least a portion of the first anchor being distally located relative to the first pusher element; a second anchor disposed within the sheath, proximally located relative to the first anchor; an anchor pusher element being displaceable in a distal direction to contact 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 to contact the anchor pusher, the displacement having a displacement length sufficient to deploy the second anchor.

[0215] Some embodiments of the present invention relate to an anchor deployment system having a plurality of anchors deployed in a sheath, and a variable-length push system configured to optionally extend the anchors using the same axial actuation amount. Optionally, the push system includes a push assembly and an anchor pusher, the anchor pusher potentially having a varying axial overlap amount when extending the anchor. Optionally, the anchor includes a channel passing through the anchor and / or attached to the outside of the anchor, such that the anchor can optionally fold or bend when the seam in the channel retracts.

[0216] Some embodiments of the present invention relate to modifying the effective length of an anchor pusher. In some embodiments of the invention, the effective length is controlled by using a pusher assembly having a variable axial overlap with the anchor pusher. Optionally, for example, as the pusher assembly retracts from the anchor pusher, one or both of the pusher assembly and the anchor pusher deform, for example, elastically, to interfere with the initial axial overlap between the anchor pusher and the pusher assembly. In some embodiments, the axial overlap increases after retraction, for example by using a reverse deformation mechanism that allows for greater axial overlap (e.g., by allowing the anchor pusher to engage with a groove provided in the pusher assembly).

[0217] Some embodiments of the present invention relate to a multi-anchor delivery system comprising a pusher element having a deformable distal tip portion. After deployment of a first anchor, the pusher element can retract from a first position to a second position, in which the distal tip portion is distal to a second anchor, and in the second position, 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 along the second anchor as the pusher element retracts. 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 at least one wider and / or thicker portion prevents the second anchor from moving proximally.

[0218] The distal tip portion may be configured such that it curves upward or away from the inner wall of the sheath. Alternatively, the distal tip portion may have an S-shaped configuration. For example, according to some embodiments, providing an S-shaped distal tip portion to the actuator element may make the distal tip of the actuator more resilient or flexible, thereby potentially allowing the actuator element to deform more easily, as discussed herein. Additionally, according to some embodiments, while the S-shaped portion may make the actuator element more flexible, the upper and lower curved portions of the S-shape may limit the lateral movement of the actuator element within the sheath, as discussed herein.

[0219] Some embodiments of the present invention relate to a multi-anchor delivery system for deploying multiple anchors. The system includes a thread configured to slidably pass through each of two anchors. The thread includes a slip knot configured to be released by pulling a first end of the thread and not released by pulling a second end of the thread, wherein the thread is configured to be tightened between the two anchors by pulling the first end. The thread may include: a first portion that passes through and extends through a first anchor and from the first anchor to a second anchor; a second portion that extends between the first anchor and the second anchor and passes through the second anchor; and a third portion that extends from the second anchor and includes the slip knot. Pulling the first end of the thread releases the slip knot.

[0220] Some embodiments involve attaching a biocompatible material (e.g., a patch) to soft tissue (e.g., a torn or partially torn tendon). According to some embodiments, the patch can be positioned on the tissue to be repaired, and a needle of a deployment device can be inserted through the patch and into the tissue. According to some embodiments, a first anchor having a first channel (e.g., a channel for suture passage) can be deployed through the patch and into the tissue, after which the needle is withdrawn from the tissue and the patch. According to some embodiments, a second anchor having a second channel (e.g., a channel for suture passage) can be deployed to a location adjacent to the patch. According to some embodiments, the suture can be pulled proximally to tighten the first anchor against the tissue, and optionally, the first anchor can be bent into, for example, 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 tighten against the patch, optionally bringing the second anchor together against the patch and optionally bending the second anchor into, for example, a C-shape or a U-shape.

[0221] It should be noted that, according to some embodiments, as discussed herein, deploying first and second anchors that allow the suture to extend through them (via the suture channel) will allow the suture to extend through the tissue and patch, thereby reducing or preventing lateral movement between the tissue and the patch. According to some embodiments, placing the first anchor within the tissue and the second anchor proximal to the patch can reduce or prevent axial movement of the patch relative to the tissue because the second anchor can provide a counterforce against the patch. According to some embodiments, the amount of movement between the tissue and the patch can be controlled by adjusting the suture by a predetermined amount, thereby controlling the distance between the first and second anchors. Optionally, a certain degree of movement can be achieved by controlling the suture distance between the first and second anchors. For example, a specific amount of movement (e.g., 0.1 to 3 mm) may be advantageous. This can promote surgical site healing by preventing tension or friction between the patch and the upper surface of the tissue and avoiding tissue necrosis that may result from excessive suture tightening.

[0222] These and other aspects of some embodiments of the present invention are described herein with reference to the accompanying drawings.

[0223] Before explaining at least one embodiment of the present invention in detail, it should be understood that the invention is not necessarily limited in its application to the details set forth in the following description or illustrated in the embodiments. The invention can be implemented in other embodiments or practiced or carried out in various ways.

[0224] Now refer to Figure 1 The diagram shows a simplified cross-sectional view of the multi-anchor delivery system and an enlarged view of its far end, illustrating the initial operational orientation.

[0225] According to some embodiments, a multi-anchor delivery system, such as Figures 1 to 4As shown. The system shown includes: a sheath having a channel therethrough; a actuator element that can be displaced within the channel; and a first anchor and a second anchor that can be displaced along and deployed from the channel by the actuator element.

[0226] exist Figure 1 As can be seen, the multi-anchor delivery system according to some embodiments optionally includes a handle mechanism 102 and a delivery assembly, which in the illustrated embodiment is a needle assembly 104 connected to the handle mechanism 102. The needle assembly 104 has a distal end 106 and a proximal end 108, the proximal end of which is connected to the handle mechanism 102. The handle mechanism 102 and the needle assembly 104 are optionally arranged along a common longitudinal axis 109.

[0227] The handle mechanism 102 has a housing 110, which is optionally made of plastic by injection molding. The housing 110 defines a handle that can be gripped by a user and is configured to house the mechanism responsible for delivering the anchor through the needle assembly 104.

[0228] Especially Figure 1 As shown, according to the illustrated embodiment, a trigger button 112 is partially located within the housing 110. The trigger button 112 has a grip portion 114 for operation by a user's fingers and an elongated toothed portion 116 for interaction with a pinion 118. Optionally, a distally extending protrusion 119 may be formed at the distal end of the toothed portion 116, defining a shoulder. Alternatively, in some embodiments, a proximal extending protrusion may be formed at the distal end of the toothed portion 116, defining a shoulder.

[0229] The pinion 118 also interacts with the rack 120. The rack 120 optionally has a first wall, which optionally includes a plurality of recesses 122 for interacting with an optional leaf spring 124. The rack 120 also has a second wall configured to slidably mount a support element 126. The rack 120 optionally has a protrusion 127 configured to be fixedly connected to an actuator element 130 configured to displace an anchor within the entire needle assembly 104. It is understood that the actuator element 130 is optionally solid and optionally made of stainless steel. Alternatively, the actuator element 130 may be non-solid and may optionally be made of other materials.

[0230] As can be seen, the rack 120 is optionally positioned parallel to and spaced apart from the elongated toothed portion 116 of the trigger button 112.

[0231] exist Figure 1 As can be seen, the support element 126 is optionally slidably connected to the actuator element 130.

[0232] Optionally, a support hub 131 is formed within the housing 110 of the handle mechanism 102.

[0233] The needle depth limiter 132 is optionally connected to the support hub 131. The needle depth limiter 132 optionally includes a hub 134 and an elongated hollow sleeve 136 extending along the longitudinal axis 109, the hub 134 being rigidly connected to the housing 110.

[0234] exist Figure 1 It can also be seen that, optionally, a flexible safety latch 140 is coupled to and extends proximally to the support hub 131. It can be seen that, in this initial operating orientation, the safety latch 140 optionally abuts against a shoulder formed by the protrusion 119.

[0235] The needle assembly 104 includes a hollow needle 150 having a proximal end 152 and a pointed distal end 154. The hollow needle 150 also defines an inner surface 156 and an internal volume 158. It is understood that the hollow needle 150 may optionally be made of stainless steel.

[0236] Especially in Figure 1 As can be seen in the enlarged view, the pusher 130 is located within the internal volume 158 of the needle 150 and extends from the proximal end 152 of the needle 150 toward the distal end 154. The pusher 130 optionally defines a distal end face 159.

[0237] Anchor stop 160 is optionally located within the internal volume 158 of pin 150, on the proximal portion of pin 150, and optionally defines a distal surface 162.

[0238] A specific feature of some embodiments of the present invention is that the first anchor 170 is optionally solid and located within the internal volume 158 of the needle 150, distal to the actuator 130. The first anchor 170 has a proximal end 172 and a distal end 174, the proximal end 172 of which can abut against the distal end face 159 of the actuator 130 in this initial operational orientation. It should be noted that the first anchor is optionally flexible and made of polyethylene or polypropylene. It will be understood that, alternatively, the anchor can be rigid. Furthermore, it should be noted that the first anchor 170 can be bioabsorbable.

[0239] A further specific feature of some embodiments of the invention is that the second anchor 180 is located proximal to the first anchor 170, and the second anchor is optionally tubular and defines an inner surface 182. It should be noted that the second anchor is optionally flexible and made of polyethylene or polypropylene. It will be understood that, alternatively, the anchor can be rigid. Furthermore, it should be noted that the second anchor 180 can be bioabsorbable.

[0240] The second anchor 180 passes 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 located near or abuts against the distal surface 162 of the anchor stop 160. The distal end 186 of the second anchor 180 is located away from the proximal end 172 of the first anchor 170. Alternatively, in some embodiments, the distal end 186 of the second anchor 180 is close to the proximal end 172 of the first anchor 170, for example, as shown in the image. Figure 1 As shown.

[0241] As can be seen, the distal end of the slender hollow cannula 136 of the needle depth limiter 132 is close to the sharp distal end 154 of the hollow needle 150. Since the outer diameter of the cannula 136 is significantly larger than the outer diameter of the hollow needle 150, the penetration depth of the needle 150 into the patient's tissue is limited to the distal portion of the needle protruding from the distal end of the cannula 136.

[0242] exist Figure 1 As can be seen, in this initial operating orientation, the trigger button 112 is in the middle position. In this position, the rack 120 is also in the middle position, and the leaf spring 124 is located in a recess 122 formed on the rack 120.

[0243] A specific feature of some embodiments of the present invention is that actuation of the trigger button 112 optionally affects the displacement of the actuator 130 in the following manner: when a user places their finger on the grip portion 114 and moves the trigger button 112 proximally, the elongated toothed portion 116 of the trigger button 112 actuates the pinion 118, which in turn causes the rack 120 to displace distally through the interaction between the rack 120 and the pinion 118. Since the actuator 130 is connected to the rack 120, the actuator 130 also displaces distally accordingly.

[0244] During the shift of rack 120, leaf spring 124 is positioned in a subsequent recess 122, potentially providing the user with a tactile indication that trigger button 112 is in a different operational orientation.

[0245] Another specific feature of some embodiments of the invention is that, in this initial operating orientation, the safety latch 140 abuts against the shoulder formed by the protrusion 119 of the trigger button 112, preventing the trigger button 112 from shifting distally. This is a safety feature designed to prevent unintentional deployment of anchors from the system 100. In this initial operating orientation, the trigger button 112 can only shift in the proximal direction, which is not intuitive for the user.

[0246] exist Figure 1As can be seen, in this initial operating orientation, the first anchor 170 is optionally located near the pointed distal end 154 of the hollow needle 150, while the proximal end 172 of the first anchor 170 optionally abuts against the distal end face 159 of the pusher 130. In this initial operating orientation, the second anchor 180 is spaced proximally from the first anchor 170 and penetrates the outer surface of the pusher 130. The proximal end 184 of the second anchor 180 is optionally slightly spaced distally from the distal surface 162 of the anchor stop 160.

[0247] Now refer to Figure 2 It is a simplified cross-sectional view of the multi-anchor delivery system 100 and an enlarged view of its far end, showing the orientation of the first anchor deployment operation.

[0248] exist Figure 2 As can be seen, in this first anchor deployment operation orientation, the trigger button 112 is in the proximal position. In this position, the rack 120 is in the distal position, and the leaf spring 124 is located in another recess 122 formed on the rack 120.

[0249] The user moves the trigger button 112 proximally, thereby triggering the elongated toothed portion 116 of the button 112 to activate the pinion 118. The pinion 118, in turn, causes the rack 120 to move distally through the interaction between the rack 120 and the pinion 118. Since the actuator 130 is connected to the rack 120, the actuator 130 also moves distally accordingly.

[0250] During the shift of rack 120, leaf spring 124 is positioned in a subsequent recess 122, potentially providing the user with a tactile indication that trigger button 112 is now in the proximal position.

[0251] Another specific feature of some embodiments of the invention is that, in this first anchor deployment operation orientation, the safety latch 140 disengages from the shoulder formed by the protrusion 119 of the trigger button 112, thereby no longer preventing distal displacement of the trigger button 112. In this first anchor deployment operation orientation, the trigger button 112 can be displaced in both proximal and distal directions.

[0252] exist Figure 2As can be seen, in this first anchor deployment orientation, the first anchor 170 is optionally located distally relative to the pointed distal end 154 of the hollow needle 150, while the proximal end 172 of the first anchor 170 optionally abuts against the distally facing end face 159 of the pusher 130. The first anchor 170 is now deployed out of the internal volume 158 of the hollow needle 150 and within the patient's tissue. In this first anchor deployment orientation, the second anchor 180 is proximally spaced from the first anchor 170 and still penetrates the outer surface of the pusher 130. The proximal end 184 of the second anchor 180 is optionally spaced further from the distally facing surface 162 of the anchor stop 160 than in the initial orientation.

[0253] Now refer to Figure 3 This is a simplified cross-sectional view of the multi-anchor delivery system 100 and an enlarged view of its far end, showing the retraction operation orientation.

[0254] exist Figure 3 As can be seen, in this retraction operation orientation, the trigger button 112 is in the distal position. In this position, the rack 120 is in the proximal position, and the leaf spring 124 is located in another recess 122 formed on the rack 120.

[0255] The user moves the trigger button 112 to the distal end, thereby triggering the elongated toothed portion 116 of the trigger button 112 to activate the pinion 118. The pinion 118, in turn, causes the rack 120 to move proximally through the interaction between the rack 120 and the pinion 118. Since the actuator 130 is connected to the rack 120, the actuator 130 also retracts proximally.

[0256] During the displacement of rack 120, leaf spring 124 is positioned in a subsequent recess 122, potentially providing a tactile indication to the user that trigger button 112 is now in the distal position. Alternatively, in some embodiments, rack 120 from Figure 2 The position shown is towards Figure 3 The proximal movement at the indicated position causes the leaf spring to recede from its rightmost position by 122 ( Figure 2 Repositioned to the leftmost recess 122 ( Figure 3 )Inside.

[0257] Another specific feature of some embodiments of the invention is that, in this retraction operation orientation, the safety latch 140 remains disengaged from the shoulder formed by the protrusion 119 of the trigger button 112, thereby no longer preventing the distal displacement of the trigger button 112.

[0258] exist Figure 3 As can be seen, under this retraction operation orientation, the first anchor 170 remains deployed outside the hollow needle 150.

[0259] A particular feature of some embodiments of the present invention is that, during the proximal retraction of the pusher 130, the second anchor 180 is released from the pusher 130, i.e., no longer mounted on the pusher 130, but in this retraction operation orientation, the proximal end 184 of the second anchor 180 abuts against and is supported on the distal surface 162 of the anchor stop 160, thereby preventing proximal displacement of the second anchor 180.

[0260] exist Figure 3 As can be seen, the distal end face 159 of the pusher 130 is now proximally spaced from the proximal end 184 of the second anchor 180.

[0261] In this retraction operation orientation, the pusher 130 is prepared to deploy the second anchor 180 in a manner similar to that used for deploying the first anchor 170.

[0262] It should be noted that additional elements, such as hooks, may be formed at the distal end of the pusher 130 to ensure that the second anchor 180 is released from the outer surface of the pusher 130 and is fitted for deployment into the patient tissue.

[0263] Now refer to Figure 4 It is a simplified cross-sectional view of the multi-anchor delivery system 100 and an enlarged view of its far end, which shows the orientation of the second anchor deployment operation.

[0264] exist Figure 4 As can be seen, under this second anchor deployment operation orientation, the trigger button 112 is again in the proximal position, similar to... Figure 2 The position shown. In this position, the rack 120 is in the distal position, and the leaf spring 124 is located in another recess 122 formed on the rack 120.

[0265] The user moves the trigger button 112 proximally, thereby triggering the elongated toothed portion 116 of the button 112 to activate the pinion 118. The pinion 118, in turn, causes the rack 120 to move distally through the interaction between the rack 120 and the pinion 118. Since the actuator 130 is connected to the rack 120, the actuator 130 also moves distally accordingly.

[0266] During the shift of rack 120, leaf spring 124 is positioned in a subsequent recess 122, potentially providing the user with a tactile indication that trigger button 112 is now in the proximal position.

[0267] Alternatively, in some embodiments, the rack 120 from Figure 3 The position shown is towards Figure 4 The proximal movement at the indicated position causes the leaf spring to recede from the leftmost recess 122 ( Figure 3 Repositioned to the rightmost recess 122 ( Figure 4 )Inside.

[0268] The safety latch 140 remains disengaged from the shoulder formed by the protrusion 119 of the trigger button 112, thereby allowing the trigger button 112 to be displaced in both proximal and distal directions.

[0269] exist Figure 4 As can be seen, under this second anchor deployment orientation, due to the distal displacement of the pusher 130 and the engagement between the distal end face 159 of the pusher 130 and the proximal end 184 of the second anchor 180, the second anchor 180 is pushed distally. At this time, the second anchor 180 is located distally relative to the sharp distal end 154 of the hollow needle 150, and is deployed out of the internal volume 158 of the hollow needle 150 and within the patient tissue.

[0270] A specific feature of some embodiments of the present invention is that the method of delivering a plurality of anchors into patient tissue optionally includes delivering the system 100 to a desired surgical location, shifting a trigger button 112 along a first direction to deploy a first anchor 170, subsequently shifting the trigger button 112 along a second direction opposite to the first direction to load a second anchor 180; and then shifting the trigger button 112 again along 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.

[0271] It should be noted that, referring to Figures 1 to 4 The described trigger button 112 is linearly shifted, but another type of trigger button can also be used, such as one that can advance or retract the pusher by rotation, thereby optionally affecting the deployment of the anchor. An exemplary rotation trigger will be referred to below. Figures 5 to 23E Further discussion.

[0272] Understandably, system 100 provides instructions to the user that the second anchor 180 has been loaded and is ready for deployment.

[0273] It is understood that, alternatively, system 100 may deploy the first anchor 100, and then, during pusher retraction, load the second anchor 180, initially located outside the internal volume 158 of the needle 150, onto the pusher 130, and prepare it for deployment. For example, the needle 250 may include a recess on its inner surface, and the second anchor 280 may be pushed into the recess before or after the pusher element 230 retracts to its nearest-side position.

[0274] Alternatively, the first anchor 170 and the second anchor 180 can be loaded together in parallel, and each anchor may optionally be covered by a resilient cap. The two anchors are loaded together into a single hollow needle 150, and the drive assembly has a first actuator for deploying the first anchor 170 and a second actuator for deploying the second anchor 180.

[0275] It should be noted that System 100 can optionally be configured for single use. After use, the device can be disposed of in a disposal container approved by the local competent authority.

[0276] It should be noted that, referring to Figures 1 to 4 The described trigger button 112 is linearly shifted. However, another type of actuator, such as roller 212, can also be used, which can advance or retract the pusher by rotation, thereby optionally affecting the deployment of the anchor. An exemplary rotation trigger will be referred to below. Figures 5 to 23E Further discussion.

[0277] Some exemplary embodiments Reference Figure 5 An exemplary multi-anchor delivery system 200 according to some embodiments of the present invention is shown. The system includes a multi-anchor delivery device 204, which includes a handle 202, a sleeve 236, and a sheath 250.

[0278] See also Figure 6 , showed Figure 5 An exploded view of system 200 is shown, which provides a clearer view of certain aspects of some components of the system. The handle 202 shown has a housing 210 with a proximal end 213 and a distal end 215. Housing 210 includes a right housing portion 210R and a left housing portion 210L. Components at least partially housed within housing 210 include a roller 212, a rack 220, a spool 300, and a locking element 242. Also shown are a sheath 250, a pusher element 230, an optional suture retainer 240, a sleeve 236, and a limiter 232, all of which will be discussed in conjunction below. Figures 17A to 22C Further discussion.

[0279] According to some embodiments, Figure 6 Some of the components shown can be omitted or replaced by other components. For example, the suture retainer 240 can be omitted, and / or the roller 212 and / or the rack 220 can be replaced by other components connected together to drive the pusher element to move distally and proximally through the sheath.

[0280] Alternatively, in some embodiments, the spool 300 can be replaced by another mechanism for storing the section of thread extending from the first anchor into the handle. Alternatively, instead of providing a mechanism for storing the section of thread, the thread can be stored inside the housing 210 or at least partially extended outside the housing.

[0281] Figures 13A to 13DAn exemplary sheath 250 according to an embodiment of the present invention is illustrated. Those skilled in the art will understand that "sheath" can be used as a general term to refer to any elongated component having a hollow lumen, such as a lumen having a circular or elliptical cross-section. The term "needle" is generally used to describe a component inserted into the human body. Therefore, a "needle" may include a "sheath" or other tubular object, and optionally include a pointed end, such as those discussed herein.

[0282] In the illustrated embodiment, the sheath 250 can be configured as a hollow needle with a circular cross-section. The needle 250 has a proximal end 252 and a distal end 254, and can be made of, for example, SS304 grade stainless steel, although other materials are also possible. The length of the needle 250 can be, for example, in the range of 176.3 to 176.7 mm; the outer diameter can be, for example, in the range of 1.8 to 2.55 mm; and the inner diameter can be, for example, in the range of 1.15 to 1.5 mm.

[0283] The distal end 254 may optionally be provided with a sharp tip 253 configured to penetrate tissue (e.g., as in a hypodermic needle). A portion of the distal end 254 adjacent to the needle 250 may be formed with a lateral opening, such as a slot 255, optionally located opposite the side having the sharp tip 253. The length of the slot may be, for example, in the range of 29 to 30 mm, and the width may be, for example, in the range of 0.8 to 0.9 mm.

[0284] The slot 255 may optionally be large enough to allow the suture loops 288a to b and the free end 288c of the suture to pass through, for example, as described below. Figures 16A to 16C Further discussion is needed. Optionally, the distal end 254 of the needle 250 may be provided with a laser mark, such as a laser mark of a type known in the art, which can be used as a reference to indicate the depth of insertion of the needle 250 into the tissue. Near the proximal end of the needle, a pair of indentations 257 may be provided. These and / or other optional features of the needle will be discussed further below.

[0285] Although the needle 250 is shown to have a straight configuration in the illustrated embodiment, it should be understood that, optionally or alternately, the distal end 254 of the needle may be curved, as is known in the art. The needle 250 may have a curvature with a radius of curvature in the range of, for example, 99 to 100 mm; a length in the range of, for example, 20 to 22 mm; and a height in the range of, for example, 2 to 3 mm.

[0286] Optionally, the needle may be flexible, for example, this can prevent damage to tissue. Optionally, the needle may have more than one bend and / or bend in more than one plane. Those skilled in the art will understand that if the needle is curved, the actuator element may optionally be thick enough and flexible enough to avoid buckling when displaced along the curved needle.

[0287] Figures 14A to 14B An exemplary actuator element 230 according to some embodiments of the present invention is shown. The actuator element 230 can generally be configured as an elongated rod 320 having a proximal end 324 and a distal end 326. The length of the actuator element 230 can range, for example, from 197 to 197.2 mm, and the outer diameter can range, for example, from 1.1 to 1.2 mm. The actuator element 230 is optionally a solid component and is optionally made of stainless steel, such as SS302 grade. However, other configurations and other materials for manufacturing the actuator element 230 are contemplated. Optionally, the actuator element 230 has a circular cross-section, although other configurations, such as elliptical, are also contemplated.

[0288] An actuator tip 322 may be provided at the proximal end 324 of the actuator, and this tip 322 may optionally be compressible. Optionally, the actuator element 230 has a widened portion 323 at the tip 322. Optionally, the widened portion 323 may be compressible. The actuator element may optionally be flexible enough to resist buckling and be able to transmit the force required to overcome the friction between each anchor 270 / 280 and the inner surface 256 of the needle 250. Optionally, the inner surface 256 of the needle is coated to reduce this friction.

[0289] According to some embodiments, the pusher element may be provided with a notch or recess for receiving a second anchor. Optionally, the distal end of the pusher element and / or the second anchor may be compressible. When the pusher element retracts, for example as described herein... Figure 20A The second anchor discussed is prevented from moving proximally by a blocking element within the channel, such as a narrowing of the channel and / or any structural component that interferes with the proximal movement of the second anchor within the channel. When the pusher element retracts, the portion of the pusher element located distal to the indentation slides over the second anchor, allowing the second anchor to be released from the indentation of the pusher element, at which point the distal end of the pusher element is proximal to the proximal end of the second anchor. The compressed distal end of the pusher element and / or the second anchor can then be decompressed, making the pusher element wide enough to push the second anchor out of the pin, for example, as follows.

[0290] According to some embodiments, the sheath may be provided with a recess or notch for the second anchor, and the pusher element may slide over the second anchor during the deployment of the first anchor. When the pusher element retracts, it may release the second anchor from the recess of the needle by no longer preventing the second anchor from decompressing and entering the lumen of the needle, thereby potentially allowing the second anchor to be positioned for subsequent deployment.

[0291] Figures 16A to 16CAn exemplary first anchor 270 is shown, having a proximal end 272 and a distal end 274, and an exemplary second anchor 280, having a proximal end 284 and a distal end 286. In the illustrated embodiment, the first anchor 270 may be substantially cylindrical and may be solid, while the second anchor 280 may be substantially cylindrical and may be hollow, for example, having an interior 281 defined by an inner surface 282 of the second anchor 280. However, those skilled in the art will understand that, optionally, the anchors may have other configurations, such as those discussed herein.

[0292] Each of the first anchor 270 and the second anchor 280 may be made of 8 to 16 strands of braided or woven USP 4-0 or 2-0 FiberWire. TM It can be made, although other materials and / or sizes may also be used, such as ultra-high molecular weight polyethylene (UHMWP), polyester polypropylene or silicone elastomer coating, and optionally dyed with D&C Blue 6, D&C Green 6 and / or Logwood Black dyes, as known in the art.

[0293] Optionally, one 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, 11 to 13 mm; and an outer diameter in the range of, for example, 1.2 to 1.4 mm. The inner diameter of the second anchor 280 may be in the range of, for example, 0.65 to 0.86 mm. A section of suture material 288 may extend through the anchor, optionally having a small section 288a forming a small loop between the proximal end 272 of the first anchor and the distal end 286 of the second anchor; a large section 288b forming a large loop between the distal end 274 of the first anchor and the proximal end 284 of the second anchor; and a free end 388c extending proximally from the proximal end of the first anchor. This section of suture material 288 may be made of, for example, 2-0 FiberWire. TM Formed, although other materials may optionally be used. Optionally, the length of the small portion 288a of the suture material is 50 mm, the length of the large portion 288b of the suture material is 220 mm, and the length of the free end 288c of the suture is 300 mm, although other lengths may also be used.

[0294] One or both of the first anchor 270 and the second anchor 280 may optionally be sufficiently flexible and / or soft to avoid damage to tissue or blood vessels near the implant. Optionally, one or both of the first anchor 270 and the second anchor 280 may be rigid. Optionally, one or both of the first anchor 270 and the second anchor 280 may be bioabsorbable, optionally maintaining the mechanical strength of the anchor before the tissue 206 heals (e.g., 1 to 3 months).

[0295] For example, as discussed herein, according to some embodiments, the first anchor may optionally be a solid anchor, optionally having a blind hole at its proximal end into which the distal end of the pusher element can be inserted prior to deployment of the first anchor. In this embodiment, the distal end of the pusher element may not contact the proximal end of the first anchor, such as... Figure 18A Instead of the embodiment shown, the distal end of the actuator element may contact the end face of the blind hole within the first anchor.

[0296] According to another alternative embodiment, the first anchor 270 may be hollow, and the pusher element may be located proximally relative to the first anchor, the pusher element being configured to contact the proximal end of the first anchor to deploy the first anchor. Optionally or additionally, the pusher element may be partially disposed inside 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 as the pusher element moves distally.

[0297] In some embodiments of the invention, the second anchor 188 may optionally be replaced with a solid anchor, which may optionally be compressible, such as those described herein. Figure 16A The discussion is up to C.

[0298] In some embodiments, the anchor has a suture portion that allows the anchor to tighten against tissue after deployment. Optionally, the suture material at least partially penetrates the interior of the second anchor 280. Optionally, the suture material may at least partially penetrate the material of the first anchor 270 and / or the material of the second anchor 280.

[0299] Optionally, each of the first anchor 270 and the second anchor 280 may have a collar or channel (not shown) extending along the outer surface of the anchor, the channel being configured to hold a portion of the suture material 288 therein. Anchors 270 and 280 may be positioned within the needle 250 such that suture portions 288a to b and the free end 288c of the suture and / or the channel extend from a slot 255 of the needle.

[0300] It should be noted that, depending on the shape of the hole through the hollow anchor 280 and the opening shape of the hole into the second anchor, the second anchor 280 may be flexible enough, and the distal end 324 of the pusher element 230 may be narrow enough to allow the pusher element to pass through the interior 281 of the second anchor 280. Furthermore, the distal end 324 of the pusher element 230 may be wide enough that, upon retraction from the second anchor 280, the pusher element will push the second anchor distally. This will be discussed further below.

[0301] Reference Figures 8A to 8EThe diagram illustrates a rack 220 according to some embodiments of the present invention. For example, as discussed further below in conjunction with the operation of system 200, rack 220 may be coupled to a roller to shift actuator element 230 via needle channel 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. Although rack 220 has two rows of teeth in the illustrated embodiment, those skilled in the art will understand that, optionally, rack 220 may have a single row of teeth extending along at least a portion of its length.

[0302] According to some embodiments, the lower surface 223 of the rack 220 may have a recess 228 with distal and proximal sides 228a to 228b near the proximal end 224 of the rack. The rack 220 may also have flexible strips 229, which are curved portions protruding from the sides of the rack. Each strip 229 has a V-shaped protrusion 229a in the middle, extending outward from the rack 220. The rack 220 may include a plurality of support portions 218a to 218d extending from the sides of the rack 220, wherein support portions 218a to 218b are located at the distal end of the rack, and support portions 218c to 218d are located near the proximal end of the rack. One or more of these elements will be described in more detail below.

[0303] Reference Figures 9A to 9C The illustration shows a plurality of exemplary rollers 212a to 212c according to some embodiments of the invention. Rollers 212 are manually movable components that can be coupled to rack 220 such that movement of the roller actuates the rack proximal or distal within the housing, for example, as further discussed below regarding the operation of the device. Each roller 212a to 212c may have a generally circular configuration with a central circular aperture 381. Each roller 212a to 212c includes an operating portion 380, optionally defined by a plurality of optionally evenly spaced teeth 382 on approximately half of its respective outer circumference 383a to 383c. Rollers 212a to 212c may also include corresponding grips 384a to 384c on approximately the remaining half of the outer circumference of the roller. In some embodiments (… Figures 9A to 9B The gripping portions 384a to 384b may include a plurality of evenly spaced teeth 386a to 386b, similar to the teeth of the operating portion 382. However, the gripping portion 384c may alternatively include fewer teeth, for example, only three teeth 386c. Figure 9C These teeth are optionally evenly spaced along the grip portion 384. It should be noted that the teeth 382 of the operating portion are optionally configured to engage with the rack 220 (…). Figure 4 The corresponding tooth 225 engages.

[0304] Roller 212c may optionally be provided with a pin 392 protruding from the surface 391 of roller 212a to 212c, which can be used to position the roller within the housing.

[0305] Rollers 212a to 212c may optionally be provided with position marks 390a to 390c for indicating the rotational position of the rollers to the user. For example, as Figure 9B As shown, roller 212b may have position markings "1", "2", and "3". Optionally, rollers 212a to 212c may be marked with markings 390D, 390N, and 390R, for example, to indicate deployed, neutral, and retracted positions, or any other markings to indicate the roller position to the user. Optionally, electronic circuitry may be provided to indicate the current position of roller 212 to the user.

[0306] Reference Figures 15D to 15E The illustration shows an exemplary sleeve 236 according to some embodiments of the present invention. The sleeve 236 may be made of PTFE and has a length in the range of, for example, 135 to 137 mm; an outer diameter in the range of, for example, 3.5 to 3.6 mm; and an inner diameter in the range of, for example, 3.3 to 3.4 mm.

[0307] The cannula 236 is fitted over the needle and suture retainer (if present). The distal end 235 of the cannula is movable relative to the distal end 254 of the needle to adjust the length of the needle extending from the cannula. This will be discussed further below in conjunction with the stopper 360. It should be noted that the inner diameter of the cannula 236 must be larger than the outer diameter of the needle 250 so that the needle 250 can be inserted into the cannula 236, optionally with the suture retainer 240 located between the inner surface of the cannula and the outer surface of the needle.

[0308] Figures 15A to 15C An exemplary suture retainer 240 according to some embodiments of the present invention is shown. The suture retainer 240 is optionally used to retain suture loops 288a to 288b near the needle 250 and optionally to prevent suture material tangling when the anchors shift within the needle 250. At anchors 270 and 280 ( Figures 16A to 16C After the needle 250 is inserted and the suture loops 288a to 288b pass through the slot 255, the suture retainer 240 can be fitted over the needle to retain the suture therein. Optionally, the suture retainer 240 may be omitted from the system 200.

[0309] The suture retainer 240 is configured as a generally cylindrical tube, having a distal end 242 and a proximal end 244. The suture retainer 240 may be made of PTFE and has a length in the range of, for example, 130 to 132 mm; an inner diameter in the range of, for example, 2.6 to 2.8 mm; an outer diameter in the range of, for example, 3.0 to 3.2 mm; and has a cut-off portion extending 5 to 6 mm from the proximal end 244 of the suture retainer.

[0310] At its proximal end 244, the suture retainer has a cut-off portion, such that the proximal end has a semi-circular arm 243 with a horizontal edge 245. Edge 245 intersects the vertical edge 241 at a right angle. The suture retainer 240 will be further discussed below in conjunction with the assembly of the system 200 components.

[0311] It should be noted that the inner diameter of the suture retainer 240 must be larger than the outer diameter of the needle 250 so that the needle 250 can be inserted into the cannula 236. Furthermore, the inner diameter of the suture retainer should be large enough to provide sufficient space between the inner surface of the suture retainer and the outer surface of the needle to accommodate the suture loops 288a to 288b. (Refer to...) Figures 11A to 11D An exemplary locking element 342 according to an embodiment of the present invention is shown, which may be provided as part of an optional locking mechanism 340. This will be discussed further below. The locking element 342 may have a generally circular body portion 343 having a generally circular opening 344 extending therethrough. A locking lever 346 and a short arm 348 configured as long arms may extend from the circular body portion 343. A pin 350 may protrude from the surface of the locking lever 346, which is formed during the manufacture of the locking element 342. The locking element 342 will be described in detail below. Figures 17A to 22C Further discussion.

[0312] Figures 12A to 12E An exemplary needle length limiter 360 according to an embodiment of the present invention is illustrated. The limiter 360 may include a hub 362 and a circular collar 364. A pair of arms 361 extend from the hub 362 away from the collar 364. A slider 366 may extend proximally along the hub 362, and the slider is provided with an indicator pin 368. The limiter 360 will be further discussed below in conjunction with the assembly of system 200. The limiter 360 may be made of any suitable material, such as polytetrafluoroethylene (PTFE). Optionally, the limiter 360 may be omitted from system 200.

[0313] Figures 10A to 10D An exemplary spool 300 according to some embodiments of the present invention is illustrated. The spool 300 optionally includes a spool 302, both sides of which are defined by flanges 304. A hole 306 may pass through the spool 302. The spool 302 is provided with a rod 308 passing through it. The rod may optionally have recesses 310 at both ends. The spool will be further discussed below in conjunction with the assembly of system 200.

[0314] Refer to Figures 7A to 7E The illustration shows further details of an exemplary right half 210R of a housing 210 according to some embodiments of the present invention. The housing 210 may be made of acrylonitrile-butadiene-styrene (ABS), although other materials are also possible.

[0315] The inner wall 290 of the right housing portion 210R may be provided with a pair of parallel flanges, an upper flange 292a and a lower flange 292b, between which protrusions 296a and 296b may be provided. Between the flanges 292a and 292b, a first recess 222a may be formed proximally to the protrusion 296a; between the flanges 292a and 292b, a second recess 222b may be formed between the protrusions 296a and 296b; and between the flanges 292a and 292b, a third recess 222c may be formed distally to the protrusion 296b. Similarly, on the inner wall 290 of the right housing portion 210R, a roller mounting pin 299, locking element stops 295a and 295c, a spool retainer 298, stops 293a to 293b, and a locking element pin 294 may be provided. It can be noted that the stop 295a is configured as a curved portion protruding from the inner wall 290 of the housing, the curved portion having a small knob 295b at its upper end. A clamping strip 297 may be provided near the distal end 215 of the housing. These components will be discussed further below in conjunction with the assembly and operation of the system 200.

[0316] Those skilled in the art will understand that, optionally, the left housing portion (not shown) may be formed as similar to housing portion 210R, but with the components in a laterally reversed configuration. The left housing portion and the right housing portions 210L and 210R may be configured to snap together or otherwise join, for example by gluing or screwing together, as is known in the art, thereby forming housing 210.

[0317] The housing 210 can be made of any suitable material, such as plastic, and optionally by injection molding. The housing 210 can be configured to partially house the mechanism responsible for delivering the anchor through the organization, for example, as discussed below in conjunction with the assembly and operation of system 200.

[0318] System component assembly According to some embodiments, the system 200 can be assembled as follows: First, the proximal end 326 of the actuator element 230 is inserted through the distal end 286 of the hollow anchor 280. Note that the inner surface 282 of the second anchor 280 may or may not contact the outer surface of the actuator element 230.

[0319] Then, the proximal end 326 of the pusher element is inserted through the distal end 254 of the needle 250 until it protrudes from the proximal end 252 of the needle, and the hollow anchor is positioned within the needle 250, optionally with the suture loops 288a and 288b located outside the needle slot 255. Next, the first anchor is inserted into the distal end 254 of the needle, optionally with the suture loops 288a and 288b located outside the needle slot 255, and the free end 288c of the suture optionally extending proximally within the needle. Optionally, the small suture loop 288a and the large suture loop 288b can be adjusted to have the desired size, for example, as described herein. Figures 16A to 16C As discussed herein. Alternatively, the free end 288c of the suture can be wrapped around the large suture loop 288b to form a knot after the 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 located distally relative to the distal end 324 of the pusher element, and the second anchor 280 may be located proximal to the proximal end 272 of the first anchor 270.

[0320] Then, the proximal end 326 of the actuator element is inserted into the hole 227 of the rack 220 and connected thereto, for example by a set screw, ensuring that the needle is positioned in a slot on the same side as the tooth 225 of the rack 220.

[0321] The proximal end 252 of the needle can be inserted into the distal end 242 of the suture retainer 240, and then the suture retainer can be passed over the needle, optionally until almost the entire needle slot 255 extends beyond the distal end 242 of the suture retainer. Optionally, approximately 2 to 3 millimeters of the needle slot 255 is covered by the suture retainer 240.

[0322] The locking element 342 is positioned relative to the rack 220 such that the locking lever 346 is located within the recess 228 of the rack 220. The rack and locking element are then positioned within a half of the housing 210, such as the right housing portion 210R, wherein the rack support portions 218b and 218d are located within the recesses 222a and 222c between the housing flanges 292a and 292b; the short arm 348 of the locking element 342 is located below the stop 295a within the housing 210, and the sleeve is located within the hub 231 of the housing.

[0323] In some embodiments, the suture retainer 240 can be adjusted such that the semicircular arm 243 is located within the right side of the housing collar 231 of the housing portion 210R, the orientation of the semicircular arm forming a complete circle together with the right side of the collar 231, and the vertical edge 241 of the suture retainer 240 abuts the edge 233 of the housing collar 231. This ensures that the free end 288c of the suture passes through the circle formed by the semicircular arm 243 and the right side of the housing collar 231, thereby potentially preventing accidental closure of the housing portions 210L and 210R at the free end 288c of the suture.

[0324] Alternatively, the free end 288c of the suture can be inserted into the hole 306 of the spool 300, and the suture can be wound around the winding tube 302 of the spool. The spool is then positioned in the housing portion 210R, with the spool rod 308 located within the retainer 398 of the right housing portion 210R. The portion of the free end 288c of the suture extending between the proximal end 237 of the sleeve and the winding tube 302 should be located within the housing hub 231. If desired, the spool can be wound more tightly, optionally by inserting a tool into the groove 310 at the end of the rod 308.

[0325] A roller (e.g., roller 212c) is positioned within the right housing portion 210R. An opening 381 on the roller fits onto a roller mounting pin 299 on the right housing portion 210R. A pin 392 is located outside the right housing portion 210R, and the pin 392 facilitates positioning the roller relative to the housing portion 210R. In this configuration, the roller's operating portion 380 is optionally located inside the right housing portion 210R, and the roller's grip portion 384c is optionally located outside the right housing portion 210R.

[0326] Next, the left housing portion 210L is snapped onto or otherwise connected to the right housing portion to form a closed housing 210, which internally includes a rack 220, a locking element 342, and a spool 300, with the roller 212a partially inside and partially outside the housing. Finally, the distal needle end 254 and the distal cannula end 235 are inserted through the collar 364 of the limiter 360, and the limiter 360 is pushed onto the cannula 236 until it sits on the housing hub 231, the limiter arm 361 is inserted into the aperture (not shown) of the housing 210, and the limiter indicator pin 368 is adjacent to the mark 232 on the housing 210. The cannula 236 is then passed over the distal needle end 254 and the suture retainer 240. Force can be applied to the cannula 236 in the proximal direction so that the proximal cannula end 237 is inserted into the collar 364 of the limiter.

[0327] Those skilled in the art will understand that, optionally, the assembly of the parts of system 200 can be performed in a different order, with the final assembly result being the same as that obtained by following the assembly procedure described above. Optionally, the assembly of some components (e.g., locking elements) can be omitted if desired.

[0328] System Operation The operation of system 200 will be described with reference to the components of the system discussed above. It can be noted that the system has three operating positions: retracted, neutral, and advanced, and in the illustrated embodiment, the transition between these operating positions is initiated by rotating roller 212, as discussed below. In the retracted position, pusher element 230 retracts to its closest position within device 204. In the advanced position, pusher element 230 advances to its furthest position within device 204, and optionally, may partially extend beyond the distal end of needle 250 of device 204. In the neutral position, pusher element 230 is located approximately midway between its retracted and advanced positions.

[0329] Now refer to Figures 17A to 17DThis illustrates an exemplary multi-anchor delivery system 200 according to some embodiments of the present invention, in an initial operational orientation, for example, before the deployment of anchors 270 and 280. As described above, system 200 may include a handle 202 having a housing 210. A rack 220 may be positioned within the housing, with its support portions 218a to 218d ( Figures 8A to 8E Supported by flanges 292a to 292b of housing 210 Figures 7A to 7E Between. In the initial operating orientation, in some embodiments, rack 220 may be in a neutral position, i.e., neither pushed distally nor retracted, such that protrusion 229a ( Figures 8A to 8D ) Located in the middle recess 222a of the housing 210 (e.g. Figure 7A )middle.

[0330] As described above, the actuator element 230 can be disposed within the needle 250, and the actuator element can extend into the housing 210 such that the proximal end 326 of the actuator element can be located and held at the distal end 226 of the rack 220. Figure 8A The needle 250 can be disposed within the sleeve 236, with the proximal end 252 of the needle passing through the clamping strip 297 of the housing 210. Figure 7B ) Indentation 257 of needle 250 ( Figures 13B to 13C The part is kept inside the housing 210.

[0331] Handle 202, actuator element 230, needle 250, and sleeve 236 are optionally all along a common longitudinal axis 209. Figure 17D )arrangement.

[0332] The limiter 360 can be positioned on the distal end 215 of the housing, such that the limiter hub 362 ( Figure 12A ) can be located in the housing hub 231 ( Figure 7A The sleeve 236 can be held within the collar 364 of the needle limiter 360. The limiter slider 366 can be positioned next to markings 232 on the housing 210, which can indicate the distance the needle 250 extends out of the sleeve 236.

[0333] Distal movement of slider 366 may optionally cause a corresponding distal movement of cannula 236 relative to needle 250, potentially allowing cannula 236 to further overtake the needle, resulting in a reduction in the portion of distal needle 254 extending beyond distal cannula 235. Similarly, proximal movement of slider 366 may optionally cause a corresponding proximal movement of cannula relative to needle 250, potentially causing partial retraction of cannula 236 from needle 250, resulting in an increase in the portion of distal needle 254 extending beyond distal cannula 235. It should be noted that the penetration depth of needle 250 into patient tissue 206 may optionally be limited to the degree to which the needle protrudes distally relative to distal cannula 236, as cannula may optionally have a blunt distal end and not enter the tissue.

[0334] Although system 200 includes a roller 212c in the illustrated embodiment, those skilled in the art will understand that any exemplary rollers 112a to 112c can be used in the apparatus discussed herein. However, for simplicity, the following description will use reference numeral 112 to refer to the roller, reference numeral 384 to refer to the grip, and reference numeral 380 to refer to the operating portion.

[0335] Roller 212 can be rotatably mounted on roller mounting pin 299 ( Figure 7B The roller 212 is partially located within the housing 210 and extends from the opening 211 of the housing 210. As described above, the roller 212 has a grip portion 384 for the user's fingers to contact and an operating portion 380 that interacts with the teeth 225 of the rack 220.

[0336] A specific feature of some embodiments of the invention is that, in the initial operating orientation, the locking element 342 can be supported against the rack 220, as discussed below, which prevents proximal displacement of the rack 220, thereby potentially preventing the roller 212 from moving counterclockwise (towards the distal end 254 of the pin). This provides a safety function to prevent unintentional or accidental deployment of the anchor 270 or anchor 280 from the system 200. In this initial operating orientation, the roller 212 may optionally only move clockwise (away from the distal end 254 of the pin), which may not be intuitive to the user, thereby potentially preventing unintentional or accidental premature deployment of the anchor 270 / 280.

[0337] The rack 220 can be supported by the flanges 292a to 292b on the inner wall 290 of the housing via the support portions 218a to 218d. Figures 7A to 7B The rack 220 is positioned such that it can slide along the lower flange 292b. A flexible strip 229 extends from the side of the rack 220, as described above. Figures 8A to 8D This allows the V-shaped protrusion 229a of the rack to be inserted into the recesses 222a to 222c of any one of the housing portions 210L to 210R. Figure 17A In the configuration shown, the rack 220 is positioned such that the protrusion 229a is inserted into the recesses 222b on both sides of the housing 220.

[0338] The teeth 225 of rack 220 can engage with the corresponding teeth 382 of roller 212, such that clockwise rotation of roller 212 optionally affects movement of rack 220 in the distal direction. Conversely, counterclockwise rotation of roller 212 optionally affects movement of rack 220 in the proximal direction. It can be noted that in the initial operating orientation, roller 212 may be in a neutral position, such as... Figure 17D The mark 390N is visible on roller 212.

[0339] In the initial operating orientation shown, the locking lever 346 of the locking element 342 has been inserted into the recess of the rack 220. Figure 8D The main body 343 of the locking element 342 is installed in the pin 294 of the housing 210. Figure 7A On the rack 220, the locking lever 346 extends vertically upward from the main body 343 and abuts against the surface 228b of the recess 228 in the rack 220. In the initial operating orientation shown, the short arm 348 of the locking element 342 is located on the stop 295a of the housing 210. Figure 7B Below.

[0340] In the illustrated embodiment, the system 200 may include a first solid anchor 270 and a second hollow anchor 280, the first and second anchors optionally having thread material inserted therein, such as those described above. Figures 16A to 16C As discussed herein, in the initial operating orientation shown, the first anchor 270 may be positioned distal to the pusher element 230 within the needle 250, optionally adjacent to the distal end 254 of the needle, while the second anchor 280 may be mounted on the pusher element. In the illustrated embodiment, the pusher element 230 extends through the second anchor 280. However, other embodiments are also contemplated, such as C-shaped anchors, solid anchors, or other configurations, as discussed herein and as will be understood by those skilled in the art. Optionally, the first anchor 270 abuts the distal end 324 of the pusher 230.

[0341] According to the illustrated embodiment, for example in Figure 17B In this configuration, suture portions 288a to 288b can extend from anchors 270 and 280, passing through needle slot 255. It can be noted that providing slot 255 to allow suture portions 288a to 288b to extend beyond the needle prevents suture loops 288a to 288b from interfering with the movement of anchors 270 and 280 through the needle. A free end 288c of the suture can extend proximally from the proximal end 272 of the first anchor 270 along the needle 250, inside an optional suture retainer 240, and through the hub 231 of the housing 210. In embodiments omitting the suture retainer 240, the free end 288c can extend proximally along the needle, inside a sleeve 236, and through the housing hub 231. In the shown initial operating orientation, the free end 288c of the suture has already been inserted into the spool 300 (…). Figures 10A to 10D The spool 300 is then wound around the hole 306 in the winding tube 302 of the spool, and then the spool 300 is installed in the housing 210, for example, as described in this article. Figures 7A to 7B As discussed. Those skilled in the art will understand, alternatively, the free end 288c of the suture may be housed within the housing 210 without being wound around the spool 300, may be stored on another component inside or outside the housing, or may extend at least partially outside the housing.

[0342] It can be noted that, Figure 17B The distal end 242 of the suture retainer 240 is located proximal to the distal end 235 of the cannula. The suture retainer 240 can internally retain a portion of the loops 288a to b and the free end 288c of the suture near the needle 250. Optionally, in some embodiments, the length of the suture retainer 240 can be long enough that its distal end 242 is longer than... Figure 17B The configuration is closer to the distal end 235 of the bushing, or roughly flush with the distal end 235 of the bushing, thereby potentially preserving a larger portion of the annulus 288a to 288b and the free end 288c.

[0343] Before inserting the distal end 254 of the needle through the tissue 206, a probe, such as those known in the art, may be used to measure the thickness of the tissue that the needle must penetrate. The slider 366 on the limiter 360 may be advanced or retracted as needed until the indicator pin 368 indicates the length by which the distal end 254 of the needle can be inserted through the tissue 206. This causes the cannula 236 to be advanced or retracted accordingly onto the needle 250, thereby adjusting the length of the needle extending from the cannula according to the measured thickness of the tissue 206, as is known in the art.

[0344] Reference Figures 18A to 18D The distal end 254 of the needle can be inserted through the tissue 206, optionally with the aid of the sharp tip 253 of the needle 250. Figure 18C Due to the presence of the cannula 236, only the portion of the needle 250 extending beyond the distal end 235 of the cannula can be inserted into the tissue 206. The needle can penetrate the tissue 206 at most until the cannula 236 comes into contact with the tissue surface.

[0345] Optionally, the anchor 270 can close the openings at the distal tip 253 of the needle and the needle slot 255 to prevent tissue from entering the openings. Optionally, the first anchor 270 includes a distal end having an angled portion corresponding to the configuration of the distal tip 253 of the needle.

[0346] It should be noted that, in this position, although the first anchor 270 may at least partially pass through the tissue 206, the first anchor may not have been deployed from the needle 250 and may still be positioned within the needle 250.

[0347] Now refer to Figures 19A to 19D It should be noted that, according to some embodiments, the components of system 200 are designed to provide the desired characteristics discussed herein. For example, in order for the roller to rotate, the user must shift the grip 384 a sufficient distance to cause the roller to rotate in the desired direction and reach the desired angle of rotation, and to move the rack 220 a required distance in the desired direction. This latter movement also requires the protrusion 229a on the rack 220 ( Figures 8A to 8D ) at the protrusions 296a and / or 296b of the housing 210 ( Figure 7A Move on.

[0348] It can be noted that from a neutral position ( Figure 17D The force required to rotate roller 212 clockwise may optionally be the same as the force required to rotate the roller counterclockwise from the neutral position. Alternatively, if desired, the force required to rotate roller 212 clockwise (to deploy anchor 270) may be greater than the force required to rotate roller counterclockwise (to retract actuator element 230), and vice versa.

[0349] It can be seen from the mark 390N that the roller 212 may be visible on the roller 212. Figure 18D The neutral position, rotated clockwise to mark 390D, may be visible on roller 212 (as shown). Figure 19D The deployment of the first anchor 270 is initiated at the deployment location shown. This is due to the roller teeth 382 (…). Figures 9A to 9C ) and tooth 225 on rack 220 ( Figure 8A The engagement of the roller 212, this clockwise rotation, optionally affects the distal movement of the rack 220, as discussed herein. This distal movement of the rack 220 is accompanied by a corresponding distal movement of the actuator element 230 connected to the distal end 226 of the rack. As the rack 220 is advanced distally, the actuator element 230 can be advanced distally to the adjacent distal end 254 of the needle, and optionally beyond the distal end of the needle, to push the first anchor 270 out of the needle 250 and through the tissue 206, as... Figures 19A to 19D As shown.

[0350] It can be noted that during the deployment of the first anchor 270, the proximal end 272 of the first anchor is located at the distal side of the second anchor 280.

[0351] As described above, the clockwise rotation of roller 212 can optionally affect the corresponding movement of rack 220 in the distal direction. When rack 220 moves from... Figure 18A The position shown moves to the far side Figure 19A At the positions shown, support portions 218a to 218d ( Figures 8A to 8E ) along the shell flanges 292a to 292b ( Figures 7A to 7B The rack 220 slides distally. The distal movement of the rack 220 is sufficient to allow the V-shaped protrusion 229a on the rack 220 to slide from the recess 222b over the protrusion 296a into the recess 222a on the inner wall 290 of the housing portions 210L to 210R. Furthermore, the movement of the protrusion 229a over the protrusion 296a may optionally produce an audible indication, such as a clicking sound, and / or a tactile indication, informing the user that the first anchor has been deployed. Optionally and / or additionally, electronic circuitry may be provided to indicate to the user that the first anchor 270 has been deployed.

[0352] It can be noted that, although in Figures 19A to 22CIn the illustrated embodiment, both the first anchor 270 and the second anchor 280 are shown in a straight line, but this is for illustrative purposes only. Those skilled in the art will understand that, alternatively, once deployed, each anchor 270 / 280 may have a different configuration, such as a curved shape, depending on the rigidity of the anchor and the magnitude of the force applied to the suture portions 288a to 288c as they pass through the tissue 206.

[0353] As described above, when roller 212 rotates clockwise, rack 220 begins to move to the distal side, for example from... Figure 18A Move to the position shown Figure 19A The position shown. Simultaneously, the locking element 342 begins to rotate counterclockwise because as the rack moves distally, the locking lever 346 is engaged by the surface 228b of the rack 220 (…). Figure 8D ) is pushed. At the same time, the short arm 348 of the locking element 342 begins to move along the stop 295a in the housing 210 ( Figure 7B Sliding. As rack 220 continues to move distally, locking element 342 continues to rotate because locking lever 364 moves downward along surface 228a of rack 220 toward the opening of recess 228, and short arm 348 continues to slide along stop 295a. Once rack 220 has moved distally a sufficient distance such that locking lever 364 is adjacent to the opening of recess 228, short arm 348 is adjacent to knob 295b at the end of stop 295a. Further movement of rack 220 pushes locking lever 364 further out until it exits recess 228. Optionally, during this process, short arm 348 is pushed past knob 295b, optionally accompanied by a slight clicking sound. The slight clicking sound described herein should not be confused with the clicking sound produced by the movement of protrusion 229a on rack 229a on protrusion 296a of housing 210 mentioned above. Subsequently, the short arm 348 is prevented from moving further because its current position is between the knob 295b and the stop 295c. At this point, the locking element disengages from the rack 220. From then on, the locking element 342 will remain in the same position regardless of the rack 220's position.

[0354] It can be noted that once roller 212 rotates clockwise to Figure 19D At the position shown, the distal end 226 of the rack 220 abuts against the stop 293a provided on the housing 210, which may prevent the roller 21 from continuing to rotate clockwise. Because the teeth 225 of the rack 220 engage with the teeth 382 of the roller 212, the rack 220 cannot move further distally, thus preventing the roller 212 from continuing to rotate clockwise.

[0355] Specific reference Figure 19BAnchor stop 260 may be located within the internal volume 258 of pin 250, optionally on the proximal portion of pin 250. Anchor stop 260 defines a distal surface 262. Anchor stop 260 defines a stop within pin 250, causing channel 264 to narrow there, thereby potentially impeding the proximal movement of second anchor 280 within the channel. Proximal end 284 of second anchor 280 may optionally be close to or abut against the distal surface 226 of anchor stop 260. Alternatively, proximal end 284 of second anchor 280 may be slightly spaced from the distal surface 262 of anchor stop 260.

[0356] After the first anchor 270 is deployed, the distance between the proximal end 284 of the second anchor 280 and the distal surface 262 of the anchor stop 260 may optionally be greater than that in the initial operating orientation. Figure 17B The distance below ( ). This may be due to the displacement of the first anchor during deployment, caused by the pusher element pushing it to the far end.

[0357] Now refer to Figures 19E to 19H This shows that system 200 is in the retracted operation orientation. Roller 212 has been... Figure 19D Rotate counterclockwise to the position shown. Figure 19H At the indicated location, where mark 390R may be visible on roller 212. This counterclockwise rotation of roller 212 optionally affects the proximal movement of rack 220, which is achieved by the engagement of the teeth 382 of the roller with the teeth 225 on the rack, for example, as described herein. Figures 9A to 9C As discussed, this proximal movement of rack 220 may optionally be accompanied by a corresponding proximal movement of actuator element 230 connected to the distal end 226 of rack. As rack 220 moves proximally, actuator element 230 may retract within needle 250.

[0358] It should be noted that even when the actuator element 230 is in its maximum retracted position, the proximal end 326 of the actuator element remains within the housing 210. Optionally and alternatively, the actuator element 230 may extend proximally out of the housing, for example, by 5 cm or more.

[0359] As described above, the counterclockwise rotation of roller 212 can optionally affect the corresponding movement of rack 220 in the proximal direction. When rack 220 moves from... Figure 19A The indicated position moved closer to the side. Figure 19E At the positions shown, support portions 218a to 218d ( Figures 8A to 8E ) along the shell flanges 292a to 292b ( Figures 7A to 7BThe rack 220 slides proximally. Proximal movement of the rack 220 is sufficient to allow the V-shaped protrusion 229a on the rack 220 to slide from the recess 222a over the protrusions 296a and 296b into the recess 222c on the inner wall 290 of the housing portion 210L to 210R. Furthermore, the movement of the protrusion 229a over the protrusions 296a and 296b may optionally produce an audible indication, such as one or two clicks, and / or a tactile indication, informing the user that the actuator element 230 has retracted and that the second anchor 280 has been loaded and may be ready for deployment. Optionally and / or additionally, electronic circuitry may be provided to indicate to the user that the actuator element 230 has retracted.

[0360] Another specific feature of some embodiments of the invention is that, in this retraction operation orientation, the locking element 342 remains disengaged from the rack 220, thus not preventing further advance or retraction of the actuator element 230. However, further counterclockwise rotation of the roller 212 may be prevented because the proximal end 224 of the rack 220 abuts against the stop 293b provided on the housing 210. Since the teeth 225 of the rack 220 engage with the teeth 382 of the roller 212, the rack 220 cannot continue to move proximally, thereby optionally preventing further counterclockwise rotation of the roller 212.

[0361] exist Figure 19F As can be seen, under this retraction operation orientation, the first anchor 270 remains deployed outside the needle 250.

[0362] A particular feature of some embodiments of the present invention is that, when the actuator 230 is from Figure 19A and Figure 19B The position shown retracts to the proximal side. Figure 20A and Figure 20B During the retraction operation, the second anchor 280 may be released from the pusher 230 and enter the internal volume 258 of the needle 250 (optionally within the suture retainer 240), and may no longer be fitted onto the pusher 230. Instead, in this retraction operation orientation, the proximal end 284 of the second anchor 280 may abut and / or be supported against the distal surface 262 of the anchor stop 260, thereby preventing the second anchor 280 from proximally displacing past the anchor stop 260.

[0363] exist Figure 19F As can be seen, the distal end 324 of the pusher 230 may be spaced proximally from the proximal end 284 of the second anchor 280.

[0364] Reference Figures 20A to 20D System 200 remains in the retracted direction after needle 250 is withdrawn from tissue 206. Roller 212 is still present. Figure 20E The location shown is marked 390R and may be visible on roller 212.

[0365] exist Figures 20A to 20B As can be seen, since the first anchor 270 has been deployed outside the needle 250, while the second anchor 280 remains inside the needle, the suture portions 288a to 288c extend from the anchor 270 on the tissue 206 side, through the tissue, and to the anchor 280 still inside the needle 250. Figure 20B ).

[0366] It should be noted, for example, as mentioned above, that... Figures 19E to 20D The retraction of the actuator element 230 occurs after the first anchor 270 is deployed and after the needle is withdrawn from the tissue 206. Alternatively, the order of these operations can be reversed, such that the needle 250 can be withdrawn from the tissue 206 first, and then the actuator element 230 retracts.

[0367] Alternatively, an anchor configuration known in the art as a "vertical mattress" can be used, in which the second anchor 280 is implanted in the same tissue 206 location as the first anchor 270. In this case, the needle 250 can be reinserted into the tissue 206 in the same insertion position as when the first anchor 270 was deployed. Alternatively, an anchor configuration known in the art as a "horizontal mattress" can be used, in which the second anchor 280 is implanted in a different location than the first anchor 270. In this case, the needle 250 can be inserted into the tissue 206 in a different location than when the first anchor 270 was deployed. (See below for reference...) Figures 20E to 22C In the described embodiment, the first anchor 270 and the second anchor 280 are deployed in a horizontal mattress configuration.

[0368] Reference Figures 20E to 20G When it is desired to deploy the second anchor 280 via tissue 206, the needle 250 is inserted into tissue 206 again. System 200 still indicates it is in the retracted direction. Note that the roller marking 390R ( Figure 20D It may still be displayed on roller 212 to indicate that actuator element 230 has retracted.

[0369] Now refer to Figures 21A to 21D The illustration depicts a second anchor deployment operation orientation according to some embodiments. In this configuration, the second anchor 280 is deployed by moving the roller 212 from a retracted position (where marking 390R may be visible on the roller 212), Figure 20D Rotate clockwise to the deployment position (where mark 390D may be visible on roller 212, as shown). Figure 21D (As shown) to start.

[0370] The clockwise rotation of roller 212 optionally affects the distal movement of rack 220, which is achieved by the engagement of the teeth 382 of the roller with the teeth 225 on rack 220, for example, as described herein. Figures 9A to 9C The discussion focuses on this distal movement of rack 220, accompanied by a corresponding distal movement of actuator element 230 connected to the distal end 226 of rack. As rack 220 is advanced distally, actuator element 230 can be advanced distally to the adjacent distal end 254 of needle to force second anchor 280 out of needle 250. The second anchor 280, deployed through tissue 206, is visible, for example, Figures 21A to 21D .

[0371] As described above, regarding the deployment of the first anchor 270, movement of components within device 204 may optionally produce an audible indication, such as two clicks, and / or a tactile indication, informing the user that the second anchor 280 has been deployed. Optionally and / or additionally, electronic circuitry may be provided to indicate to the user that the second anchor 280 has been deployed. Another specific feature of some embodiments of the invention is that, in this second anchor deployment operation orientation, the locking element 342 remains disengaged from the rack 220. However, from Figure 21D As shown in the roller position, further clockwise rotation of roller 212 may be prevented, for example, as described herein. Figures 19A to 19D Detailed description.

[0372] exist Figure 21D As can be seen, in this second anchor deployment orientation, the second anchor 280 is optionally pushed distally due to the distal displacement of the pusher 230 and the engagement between the distal end 324 of the pusher 230 and the proximal end 284 of the second anchor 280. At this time, the second anchor 280 can be located distal to the distal end 254 of the needle 250 and can be deployed out of the internal volume 258 of the needle 250 and pass through the patient's tissue 206.

[0373] about Figures 18A to 19H and Figures 21A to 21D It should be noted that, optionally, the distal end 254 of the needle may be inserted through the tissue 206, such that it exits the tissue at a distance sufficiently large to allow the entire length of the anchors 270 and 280 to be deployed through the tissue. Optionally and alternatively, if only the tip 253 of the needle 250 penetrates the tissue 206, and a portion of the distal end 254 remains within the tissue, the anchors 270 / 280 may not completely exit the tissue.

[0374] Reference Figures 22A to 22C The system 200 according to some embodiments of the present invention is shown, in which the second anchor 280 has been deployed ( Figures 21A to 21D Afterwards, and with device 204 removed from tissue 206, needle 250 is withdrawn from the tissue, as... Figure 22B The clearest view.

[0375] It should be noted that in this configuration, the suture portions 288a to 288c attached to the first and second anchors have been released from the device and may extend proximally through tissue 206. Although the suture portions 288a to 288c are... Figure 22B The figure is shown as a single line, but those skilled in the art will understand that reference numerals 288a to 288c in this figure represent a small loop 288a, a large loop 288b, and a free end of the suture 288c. Optionally, the suture material can be tightened to secure the first anchor 270 and the second anchor 280 to the tissue, thereby potentially anchoring tissue portions together, for example, as described below. Figures 23A to 23G Detailed description.

[0376] Reference Figures 23A to 23G This shows that after the anchors are deployed from the device 204, the first anchor 270 and the second anchor 280 are tightened to abut against the organization 206. Figures 23A to 23B Anchors 270 and 280 are shown, which are loosely held in adjacent positions on one side of tissue 206, while suture material (including small loops 288a, large loops 288b, and free ends of sutures 288c) is located on the other side of tissue.

[0377] Although in the illustrated embodiment, anchors 270 and 280 are optionally presented in a generally U-shape, alternatively, each anchor may also be straight or slightly bent into a C-shape, for example, depending on the rigidity of the anchor and the degree to which the anchor is taut by the stitching material.

[0378] To secure anchors 270 and 280 tightly to tissue 206, the long suture portion 288b can be pulled. This shortens the small loops 288a, causing each anchor to take on a narrow U-shape and tighten against tissue 206, as shown. Figures 23C to 23D As shown. Then, the user can pull the free end 288c of the suture. This will shorten the large loop 288b, as... Figures 23E to 23G As shown. Since the free end 288c of the suture was previously wrapped around the large loop 288b, when the large loop 288b becomes smaller, pulling the free end will form a knot in the suture material. The excess suture length can then be cut off, optionally using a cutting device, such as the cutting device described in U.S. Patent 6,866,673.

[0379] According to an alternative embodiment, the first and second anchors can be loaded together in parallel into the sheath, and each anchor may optionally be covered by a resilient cover. The two anchors may be loaded together into a single needle, and a drive assembly may be provided having a first rack coupled to a first actuator (for deploying the first anchor 270) and a second rack coupled to a second actuator (for deploying the second anchor 280). Optionally, the second rack is in a hysteresis mode when the first rack advances distally to deploy the first anchor. Optionally, the second rack advances distally to deploy the second anchor when the first rack retracts.

[0380] Furthermore, according to another alternative embodiment, the system may include two or more anchors. For example, a solid anchor may be provided, such as the one described above. Figures 19A to 19D The deployment is as described above; and two or more tubular anchors are mounted on and deployed by the actuator element. Optionally, multiple tubular anchors may be deployed with the same distal displacement of the actuator element, depending on the retraction distance of the actuator element.

[0381] Optionally, the anchors according to any embodiment may or may not be connected to the stitching material. It is worth noting that system 200 can be configured for single use.

[0382] The method of the present invention Reference Figure 24 This illustrates a method 500 for delivering a plurality of anchors into patient tissue according to specific aspects of certain embodiments of the present invention. At 502, a sheath may be delivered through the tissue; for example, as discussed herein, the sheath may be, for example, a hollow needle, optionally having a sharpened tip. At 504, an actuator may be displaced proximally to deploy a first anchor. For example, as discussed herein, the displacement of the actuator may be, for example, a linear displacement of a trigger or a rotational movement of a roller. Subsequently, at 506, the actuator may be displaced distally to load a second anchor; then, at 508, the roller is again displaced proximally to deploy a second anchor 280.

[0383] Reference Figure 25A particular feature of certain embodiments of the present invention is that the method 600 of operating the device for delivering a plurality of anchors into patient tissue optionally includes: at 602, a proximal displacement of the actuator to displace the pusher distally through the sheath. For example, as discussed herein, the displacement of the actuator may be, for example, a linear displacement of a trigger or a rotational movement of a roller. Simultaneously, at 604, the pusher is displaced distally by a sufficient amount to deploy a first anchor outside the sheath. Thereafter, at 606, the distal displacement of the actuator causes the pusher to move proximally, thereby loading a second anchor. Thereafter, at 608, displacement of the roller in the proximal direction causes the pusher to move distally through the sheath. Simultaneously, at 610, the pusher is displaced distally by a sufficient amount to deploy a second anchor 280 outside the sheath.

[0384] It should be noted that the device can be operated outside the body, for example, by following the actions indicated above, and / or during non-medical procedures, such as during device testing.

[0385] Reference Figure 26 This image shows a portion of a deployment device 700 according to certain embodiments, used for securing a second soft tissue or biocompatible material to a first soft tissue. Some components of the deployment device 700 may be structurally and functionally similar to, for example... Figure 1 The deployment device will not be described in detail here.

[0386] According to some embodiments, the device 700 includes a sheath or needle 706 in which a first anchor 702 and a second anchor 704 are housed, the latter being a retaining anchor. The characteristics of the first and second anchors will be discussed further below. The first anchor 702 and the second anchor 704 may be structurally similar to any anchor discussed herein; similar structures, functions, and features will not be described here. While the first anchor 702 may be suitable for deployment through the first soft tissue 712, the second anchor 704 may be designed to retain a second soft tissue (e.g., a tendon or meniscus) or biocompatible material (e.g., an arthroscopic patch or graft, such as an allogeneic graft) in a position opposite the first soft tissue.

[0387] The first anchor 702 and the second anchor 704 may be connected by a stitch 710 that extends through or within a channel defined on or within the first anchor 702 and / or the second anchor 704, as discussed herein. Alternatively, the stitch 710 may be connected to the first anchor 702 and / or the second anchor 704 by any other suitable means, for example, as... Figure 16AAs discussed. Alternatively, the suture 710 may be connected by extending through a channel (e.g., an internal lumen) integrally formed or connected to one or both of the first and second anchors (702, 704). For example, one or both of the first and second anchors (702, 704) may be provided with external loops (not shown) that define the channel through which the suture 710 passes.

[0388] The first anchor 702 may include a channel 728 defined on or within the first anchor 702, through which the stitch 710 may extend. As previously stated, the channel 728 may be defined by an internal lumen, an external ring, or any other suitable component extending along at least a portion of the first anchor 702. According to some embodiments, the first anchor 702 may be slidably mounted on the stitch 710 by the stitch 710 extending through the channel 728.

[0389] Optionally, according to some embodiments, the second anchor 704 may be slidably mounted on the seam 710. The second anchor 704 may optionally be formed of a flexible material and optionally of a compressible material. While the second anchor 704 may include a pair of loops 726 through which the seam 710 may pass, alternatively, according to some embodiments, the second anchor 704 may be provided with any suitable number of loops or connectors allowing the second anchor 704 to slide along the seam 710. Alternatively, the second anchor 704 may include a plurality of apertures (not shown) through which the seam 710 may slidably pass, allowing the second anchor 704 to be slidably mounted on the seam 710.

[0390] According to some embodiments, the first anchor 702 can be deployed from the device 700 via a first organization ( Figure 28 712 in the text), the method is similar to that discussed in this article, for example, see reference. Figures 17A to 20B After the first anchor 702 is deployed through the first soft tissue 712 and the sheath or needle 706 is withdrawn from the first soft tissue 712 (as per this document regarding...) Figures 20A to 20B (As discussed), the deployment device 700 can deploy the second anchor 704.

[0391] According to some embodiments, and for example Figures 20E to 22C In contrast to the described embodiment, after the first anchor 702 is deployed, the sheath or needle 706 may not be inserted through the first tissue 712. Instead, the second anchor 704 may be deployed proximally to the first soft tissue 712. When deployed from the deployment device 700, the second anchor 704 may be connected to the first anchor 702 via a suture 710, at least a portion of which extends between the first anchor 702 and the second anchor 704.

[0392] Alternatively, according to some embodiments, the sheath or needle 706 may optionally be inserted through the second soft tissue or biocompatible material 714 (e.g., a patch) and the first soft tissue 712, after which a second anchor may be deployed proximally to the second soft tissue or biocompatible material 714. In this way, the suture portion 718 may extend through the first soft tissue 712 and the second soft tissue or biocompatible material 714, as... Figure 28 As shown.

[0393] It can be noted that a portion 708 of the suture 710 can extend proximally so as to be grasped by the surgeon operating the device 700. After the first anchor 702 is deployed through the first soft tissue and subsequently the second anchor 704 is deployed from the device 700, the first anchor 702 can be positioned distal to the first soft tissue 712, while the second anchor 704 can be positioned proximally to the first soft tissue 712, as will be discussed further below.

[0394] A second soft tissue or biocompatible material 714 (as discussed herein) that needs to be attached to the first soft tissue 712 can be placed against the first soft tissue 12 in any desired orientation. To secure the second soft tissue or biocompatible material 714 to the first soft tissue 712, the suture portion 708 can be pulled proximally, thereby shortening the length of the suture 710 between the first anchor 702 and the second anchor 704. It should be noted that the suture 710 is attached to the first anchor 702 distal to the first soft tissue 712, extends through the first soft tissue 712, and is attached to the second anchor 704 proximally to the first soft tissue 712. Therefore, by pulling the suture portion 708, as the suture length between the first anchor 702 and the second anchor 704 is shortened, the first anchor 702 and the second anchor 704 are pulled closer together, and the first soft tissue 712 and the second soft tissue or biocompatible material 714 are sandwiched between them.

[0395] Additional References Figure 28A schematic diagram of a first soft tissue 712 is shown, with a first anchor 702 deployed, for example, by a deployment device 700. During deployment of the first anchor 702, an opening 716 may be formed in the first soft tissue 712 by a needle or sheath 706 of the deployment device 700, and the first anchor 702 can be inserted through the opening 716, as discussed herein with respect to device 100. A portion 718 of a suture 710 (attached to the first anchor 702) may extend from the first anchor 702 through the opening 716 to a second anchor 704. The suture portion 708 may also be attached to the second anchor 704 and extend proximally, optionally extending to the operator of the deployment device or another person performing the fixation procedure. After placing the second soft tissue or biocompatible material 714 near the proximal surface 724 of the first soft tissue 712, pulling the suture portion 708 proximally will shorten the length of the suture portion 718 located between the first anchor 702 and the second anchor 704, thereby bringing the first anchor 702 and the second anchor 704 closer together. Further pulling the suture portion 708 will force the first anchor against the distal surface 722 of the first soft tissue 712 and force the second anchor against the proximal surface 724 of the first soft tissue 712. The shortening of the suture 710 may cause at least one of the first anchor 702 and the second anchor 704 to bend or curl, thus presenting a C-shaped or U-shaped configuration as discussed herein.

[0396] When the suture portion 708 is pulled proximally, the suture 710 can slide along the channel 728 of the first anchor 702 and the loop 726 of the second anchor 704, or along any other channel provided on or inside the first and second anchors, as discussed herein, while the suture portion 718 between the first anchor 702 and the second anchor 704 is shortened.

[0397] It can be noted that, optionally, the suture 710 may be connected to multiple locations on one or both of the first anchor 702 and the second anchor 704, such as at two or four loops or other connection locations. Depending on the number of connection locations of the suture 710 to each of the first anchor 702 and the second anchor 704, and depending on the materials of the first anchor 702 and the second anchor 704, shortening the suture portion 718 between the first anchor 702 and the second anchor 704 may result in one or both of the first anchor 702 and the second anchor 704 presenting a U-shaped, C-shaped configuration or a configuration with multiple undulations. After the second soft tissue or biocompatible material 714 is secured to the first soft tissue 712, the suture portion 708 may optionally be cut by forming a knot near the second soft tissue or biocompatible material 714.

[0398] It can be noted that the second anchor 704 may be thick enough to cushion the pressure on the second soft tissue or biocompatible material 714 when the suture 710 tightens. The second anchor 704 may also be tough or strong enough not to be cut or damaged by the suture 710.

[0399] It can also be noted that, since the first anchor 702 is configured to be inserted through the opening 716 in the first soft tissue 712, the size and / or shape of the second anchor 704 may prevent the second anchor 704 from passing through the opening 716 in the first soft tissue 712.

[0400] A notable feature of some embodiments is the provision of a first anchor 702 and a second anchor 704 that are slidable relative to the suture 710. This provides an improved means of securing the second soft tissue or biocompatible material 714 to the first soft tissue 712. This design may potentially reduce pressure on the second soft tissue or biocompatible material 714, thereby potentially promoting better healing of the surgical site or adjacent tissues, and / or preventing damage to the first soft tissue 712 or the second soft tissue 714 due to excessive pressure, compared to situations where using sutures alone may result in the second soft tissue or biocompatible material 714 being forced to press tightly against the first soft tissue 712.

[0401] Furthermore, according to some embodiments, the second anchor 704 may potentially provide a cushioning component for arthroscopic or other surgical procedures, thereby distributing the force applied to the proximal surface 724 of the second soft tissue or biocompatible material 714 across the area of ​​the second anchor 704. This may reduce pressure and / or stress on the second tissue compared to procedures that do not provide a second anchor 704 and simply hold the second soft tissue or biocompatible material 714 relative to the first soft tissue 712 on the proximal surface 724 of the first soft tissue using sutures. Depending on the dimensions of the second anchor 704, i.e., the area of ​​the second anchor 704 that contacts and may be pressed against the 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 the second soft tissue.

[0402] Now refer to Figures 27A to 27B These are schematic proximal and distal views of a second soft tissue or biocompatible material 714 fixed to a first soft tissue 712 according to some embodiments. It can be noted that, according to some embodiments, the first soft tissue 712 and the second soft tissue or biocompatible material 714 can be connected by sutures 710 as discussed herein. It should be noted that... Figures 27A to 28 This is for illustrative purposes only.

[0403] like Figure 27AAs shown, the second soft tissue or biocompatible material 714, as discussed herein, is connected to the first soft tissue 712 via suture 710. A first anchor 702 is adjacent to the distal surface 722 of the first soft tissue 712, and a second anchor 704 is adjacent to the proximal surface 724 of the second soft tissue or biocompatible material 714. The end 708 of the suture 710 may extend proximally.

[0404] Now refer to Figure 29A This is an exemplary abstract block diagram illustrating a designated axial overlap region of a multi-state anchor delivery system according to some embodiments of the present invention. The axial overlap region, denoted by reference numeral 6, and also referred to as axial switch 6, is represented by a dashed line in the figure. Figure 29A The image illustrates a multi-state anchor delivery system according to some embodiments of the present invention, in which the axially overlapping region is in a first state, located within a sheath 250, before the deployment of the first anchor 170. The first anchor 170 and the second anchor 180 are assembled in the sheath in a last-in-first-out (LIFO) configuration, wherein the first anchor exits the sheath first, followed by the second anchor. The distal end of the anchor pusher 3 is adjacent to the second anchor, and the proximal end is adjacent to the pusher assembly or the second pusher 4. The axial switch is located at the portion of the anchor pusher 3 adjacent to or connected to the second pusher 4. It should be noted that in some embodiments, part or all of the second pusher 4 may be located outside the sheath 250.

[0405] According to some embodiments, as shown below, the second pusher 4 may optionally include a rack 220 ( Figure 32 However, the second pusher 4 can also have a different mechanical arrangement and is not limited to a rack. Optionally, the designated axial overlap area is located inside the sheath, between the proximal end of the anchor pusher and the distal end / extension of the second pusher. The designated axial overlap area is a combination of a first axial area at the proximal end of the anchor pusher and a second axial area at the distal end of the second pusher 4. It should be noted that the axial switch can be part of the anchor pusher and / or the second pusher (pusher assembly).

[0406] Optionally, the lengths of the first and second axial regions can be adjusted during manufacturing and installation. In some embodiments, the kit provides multiple pushers and racks for mounting within the housing and for deploying variable anchors. A second pusher is operable to move the anchor pusher via an axial switch to deploy the anchor. In some embodiments, the number of anchors is three or more.

[0407] Figure 29B This is an exemplary abstract block diagram illustrating a reduced specified axial overlap area of ​​a multi-state anchor delivery system according to some embodiments of the present invention. The axial overlap area 6, indicated by dashed lines, shows the second state, in the first anchor 170 ( Figure 29A After deployment. According to some embodiments, the axial overlap region 6 is located within the sheath of the system delivery device before and during the deployment of the second anchor. The reduced axial overlap region results in a combined length of the anchor pusher and the second pusher sufficient to deploy the second anchor outside the sheath. In some embodiments of the invention, deformation of one or both of the anchor pusher and the second pusher causes misalignment and results in a combined length of the anchor pusher and the second pusher being longer in the second state than in the first state. This extension of the combined length can compensate for situations where the second anchor length is no longer part of the deployment length after the first state, as discussed herein. The second anchor pushes the first anchor as it passes through the sheath in the first state. Now, after the deformation and axial overlap are reduced, the extended combined length allows the second anchor to be deployed outside the sheath.

[0408] In some embodiments of the invention, the length and circumference of the anchor pusher are designed to be specific in size and shape such that deformation or friction will not prevent at least two anchors from being moved from the distal end of the sheath channel. A rod, or a second pusher portion that may overlap with the anchor pusher, is also designed to be specific in length and circumference such that deformation or friction will not prevent its distal and proximal movement within the sheath to push at least two anchors out of the distal end of the sheath channel. The second pusher is sized and shaped to push the anchor pusher distally within the channel. Optionally, these anchors are implants, optionally connected to one or more sutures, for example, as described herein.

[0409] Figure 30A This is an exemplary abstract block diagram illustrating a designated axial overlap region 6 (also referred to as axial switch 6) optionally partially or entirely located outside the sheath 250 in a multi-state anchor delivery system according to some embodiments of the invention. According to some embodiments of the invention, the axial overlap region 6 is shown as a first state of operation, prior to and during the deployment of the first anchor 170. Figure 30A and Figure 30B As shown, the anchor assembly within the sheath may optionally be configured in a last-in, first-out (LIFO) manner. Here, the designated axial overlap region 6 is at least partially located outside the sheath 250, between the proximal end of the anchor pusher and the distal end of the second pusher 4. In some respects, there are three or more anchors. Figure 30A The first state of the overlapping switch mechanism is shown before the specified axial overlap area decreases. A potential advantage of having the axial switch at least partially outside the sheath is that it provides lateral space for the deflection and actuation of the switch. A potential advantage of having the axial switch 6 inside the sheath 250 is that the sheath can be used to force the overlap to remain and / or prevent deformation in the first state.

[0410] Figure 30BThis is an exemplary abstract block diagram of a multi-state anchor delivery system according to some embodiments of the present invention, showing an overlap region 6 in a specified axial direction (relative to...). Figure 30A After the reduction (as shown), the system is in the second state of operation, specifying the axial overlap area 6 and the axial switch located outside the sheath, before and during the deployment of the second anchor 180.

[0411] The overlap switch mechanism is at least partially located outside the sheath, such that in the second state, the travel of the anchor pusher distally can be extended by deflecting or bending the proximal end of the anchor pusher after it exits the drill hole on the rack (as discussed further below). This is because a portion of the anchor pusher's length is located within the drill hole (or recess) in the first state (see details regarding...). Figures 41A to 41B (As discussed in the previous section) When the anchor pusher exits the borehole and deflects and is unable to return to its position within the borehole, the total length available for deploying the second anchor in the second state increases as the rack retracts.

[0412] The above overview pertains to embodiments where the anchor pusher and the second pusher have different physical structures, which allow for variable anchor deployment by shortening the length of the anchor pusher, the second pusher, or a combination of both. These will be detailed in subsequent figures. For example, this can be achieved by using an overlapping switching mechanism with a specified axial overlap area inside or outside the sheath. According to some embodiments, the length of the anchor pusher, the length of the second pusher, and the length of the axial overlap area may vary depending on the components and mechanisms used.

[0413] Figure 31 This is an example diagram of a multi-state anchor delivery system according to some embodiments, showing a housing 210 including rollers 212 (e.g., for driving distal movement, deployment, and / or retraction of the anchor push mechanism), and a sheath 250. The components are described below.

[0414] Figure 32 This is an exploded perspective view of an exemplary multi-state anchor delivery system according to some embodiments of the present invention. The system includes a handle having a right housing portion 210R and a left housing portion 210L, located on the right and left sides of the device, respectively (viewed from the distal end of the device). According to some embodiments of the present invention, components at least partially housed within the housing include manual control devices, such as a roller 212 for pushing a rack 220 (or other pushing components), and optional spools 300 (discussed herein in conjunction with the free end 288c of the suture). A sheath 250, an extended anchor pusher element 230, a first anchor 170, and a second anchor 180 are also shown, all optionally at least partially disposed within the sheath.

[0415] In some embodiments of the invention, the elongated anchor pusher element 230 can be linearly displaced in a distal direction by a second pusher serving as a drive mechanism. This second pusher can be a rack 220, linearly displaced by an actuator in the form of a trigger button. Alternatively, in some embodiments, the second pusher can be displaced by rotation of a roller 212 or a pinion. The actuator can move in both distal and proximal directions, and the actuator coupled to the drive mechanism is further coupled to the anchor pusher element. This coupling is arranged such that distal movement of the actuator causes proximal displacement of the drive mechanism, while proximal movement of the actuator causes distal displacement of the drive mechanism.

[0416] Figure 33 This is a view of the interior portion of an anchor delivery system according to some embodiments of the present invention, showing a designated axial overlap region 6 within a sheath. An axial switch moves an anchor pusher 3 distally (to the left) within the sheath; according to this embodiment, the axial switch is a lever, optionally coupled with a rack to form a second pusher 4. The anchor pusher has a first axial region 3B located between 3A and 3C. The pusher has a second axial region 4B located between 4A 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 lever are at least partially located within the sheath, which is assembled within a housing.

[0417] Figure 34 This is a side sectional view of a system device portion according to some embodiments of the present invention, showing the deployment of the first anchor 170 ( Figure 29A Following this, during the retraction of the second actuator 4, the axial overlap area 6 within the sheath 250 decreases between 4A and 3C. In some respects, the rod is secured to the rack 220 at its proximal end by screws, and the rack and rod combine to form the second actuator.

[0418] Figure 35 This is a side sectional view of a portion of the system assembly, showing a further reduction in the designated axial overlap region 6 within the sheath 250, where region 4B has been deformed and misaligned with the anchor pusher 3. Regions from 3C to 4A show the complete reduction and misalignment of the designated axial overlap region 6. In some respects, the anchor pusher and / or rod is a Nitinol alloy, which can be bent to create mechanical interference and reduce the designated axial overlap region. According to some respects, in the second state, the rod, anchor pusher, or both deform and interfere with each other, also interfering with the axial overlap region; the anchor pusher is pushed at a contact area outside the designated axial overlap region. Various deformation methods that interfere with the overlap can be used. For example, deformation or relative rotation of the anchor pusher and / or rod after the second pusher is retracted can create mechanical interference at the connection when pushed in the second state and can extend the length or depth of the second anchor deployment.

[0419] In some embodiments of the invention, the axial overlap region 6 is designated as a scarf-like overlapping joint. In some embodiments, the axial overlap region 6 is designated as a tongue and groove joint.

[0420] refer to Figure 36 A perspective view of the anchor delivery device portion of the system is shown, illustrating the specified axial overlap area 6 (e.g. Figure 30A As shown), also known as an axial switch, it is located outside the sheath 250. According to some embodiments of the invention, the axial switch 6 optionally includes a movable / foldable panel / cover 845. Figure 6 This indicates that it was in the open position during the initial anchor deployment. Figure 6 As shown, the panel / cover 845 allows contact with a notch (or hole / recess) 227 on the rack 220, into which the anchor pusher 3 is precisely inserted. As described herein, see, for example, reference... Figure 39 According to some embodiments, the panel / cover 845 can be moved, pivoted, or folded to block the entrance of the aperture 227.

[0421] The movable panel 845 assembly may include optional features. In some cases, a base 844 has mounting holes 843 for screw mounting to the rack 220. In some cases, a foldable cover 845 is provided. In some options, a plane 842 and a base 844 are provided. In some cases, the foldable cover 845 is hinged (e.g., a hinged hinge) to cover the hole 227 on the rack 220. An anchor pusher is mounted within the hole 227 and axially overlaps with the rack 220 and the panel 845 when the panel 845 is in the open position. This is discussed below. Figure 41B Hole 227 on rack 220 is shown.

[0422] refer to Figure 37 The image shows a side sectional view of a portion of a system device according to some embodiments of the present invention, including an anchor pusher in a first state, which, when pushed distally and during the deployment of a first anchor, designates an axial overlap region 6 outside a sheath 250, and a movable panel 845 is in an open position. The movable panel 845 remains in the open position as long as the proximal end of the anchor pusher is at least partially within the aperture 227. In the illustrated embodiment, the proximal end of the anchor pusher is above the foldable panel 845. Alternatively, in some embodiments, the proximal end of the anchor pusher may be below the foldable panel 845. Optionally, the anchor pusher 3 prevents the foldable cover 845 from resiliently folding (or otherwise moving) and covering the aperture (or hole / recess) 227 or preventing access to the aperture. The designated axial overlap region is defined when the proximal end of the anchor pusher is within the aperture 227.

[0423] Figure 38 This is a side sectional view of a portion of the system assembly, including a designated axial overlap area 6 located outside the sheath 250, at the deployment anchor 170 ( Figure 30A Before and during. The movable panel 845 is in the open position, and the rack 220 moves distally to push the anchor pusher 3, thereby engaging the anchor 170 ( Figure 30A Deployed from the sheath 250 to the far side.

[0424] Figure 39 This is a side sectional view of a portion of a system device according to some embodiments of the present invention, showing a reduced designated axial overlap region 6 located outside the sheath 250, and a movable panel 845 in a closed position covering the hole 227 of the rack 220. In some embodiments, this is after the deployment of the first anchor, and before and during the deployment of the second anchor. After the rack 220 retracts proximally, the anchor pusher 3 remains outside the hole 227. Note that the panel 845 covers the hole 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 can no longer enter the hole 227 when the rack 220 moves distally.

[0425] Figure 40 This is a side sectional view of a system device portion according to some embodiments, showing a second pusher in a second state, abutting against panel 845, thereby preventing the anchor pusher 3 from entering the aperture (or hole / recess) 227 of rack 220. (As mentioned above regarding...) Figure 39 By covering the hole 227, the axial overlap area 6 outside the sheath 250 is reduced to zero because the movable panel 845, while in the closed position and covering the hole 227, pushes the anchor pusher 3 to deploy the second anchor. According to some embodiments of the invention, this illustration shows the situation after the second anchor has been deployed.

[0426] Figure 41A This is a perspective view of a portion of a system according to some embodiments of the present invention, showing a deformation of a portion of the device, wherein a designated axial overlap region 6 is located outside the sheath 250. Figure 41AAs shown, the anchor pusher 3 selectively enters the rack 220 depending on whether it is straight or bent. In one embodiment, an optional resilient component allows the anchor pusher 3 to bend laterally. As long as the anchor pusher 3 is inside the rack 220, it cannot move laterally. However, once the rack 220 retracts, the anchor pusher 3 can deflect laterally. As shown, optional bent protrusions 4D (e.g., part of the sheath 250) and / or faces 4E can be resiliently preset to allow lateral deflection of the anchor pusher 3. Optionally or additionally, the anchor pusher 3 is pre-bent into an arc shape but kept straight by the rack 220 on one side and the sheath 250 on the other side. Optionally or additionally, the anchor pusher 3 is double-bent or kinked, and therefore straight overall. However, when the first bent portion enters the sheath 250, that bent portion straightens, leaving another bent or kinked portion that allows the portion of the anchor pusher 3 outside the sheath to deflect laterally. In any case, once the anchor pusher 3 bends laterally, this bending occurs after the deployment of the first anchor 170 and after the rack 220 retracts.

[0427] exist Figure 41A In some embodiments of the present invention, a reduced designated axial overlap area can be seen outside the sheath. In a first state, the anchor pusher 3 is located in the recess 227 having a first axial depth. Figure 41B When the anchor pusher 3 bends or otherwise deflects laterally, it is misaligned with the recess 227 and may instead align with a different point on the rack 220 or the recess 227G, the axial depth of which is less than the depth of the hole 227.

[0428] Figure 42A This is a perspective view of the inner sheath according to some embodiments of the present invention, showing an overlapping switch plate 1420 that can deform the anchor pusher 3 (e.g., by a pre-formed double bend that is altered by axial movement, resulting in a lateral bend of the anchor pusher 3) to prevent the anchor pusher 3 from re-entering the hole 227 of the rack 220 or other pusher components. Figure 42B An external perspective view of a system having an overlapping switch plate 1420 according to some embodiments of the present invention is shown, the plate being located on the proximal side of the sheath 250. Reference numeral 1420A indicates the approximate possible location of the overlapping switch plate 1420, rather than the plate itself. According to some aspects, the overlapping switch plate 1420 is an eccentric type of plate having a non-central hole 1410 through which an anchor pusher deforms 1430. According to some aspects, the overlapping switch plate is a cam.

[0429] Exemplary anchors Exemplary anchors that can be deployed using the anchor deployment system described herein are described herein. Other designs may also be used. In some embodiments of the invention, each anchor has a channel extending along the anchor body, the channel being at least partially non-coaxial with the anchor, and an attached seam extending along the channel. For example, the channel may be at least partially located outside the anchor. Pulling the seam can make the anchor more flexible because the torque applied to the anchor increases as the portion of the seam passing through the channel shortens.

[0430] Each anchor may have multiple loops. These loops may be defined by the stitching, portions of the anchor itself, or other elements. As discussed herein, these loops allow the stitching to be at least partially attached to the outside of the anchor.

[0431] An additional loop can be provided at the proximal end of the anchor to attach the anchor to the components of the deployment device, preventing accidental / premature deployment of the anchor.

[0432] When multiple anchors are deployed, sutures can be inserted into the channels of the anchors and between the anchors in various suture configurations. Generally, anchors and deployment methods thereof, particularly those disclosed herein, may be particularly suitable for repairing soft tissues, such as the meniscus, but are not limited to this specific type of surgery. For example, such anchors and deployment methods thereof may be particularly suitable for repairing bone tissue. One aspect of some embodiments of the invention relates to flexible anchors, each having an elongated flexible body deployed from a deployment device. In a first orientation, the elongated body has a first end, a second end, and an outer surface, extending along a longitudinal axis. The body is configured to bend into a second orientation, wherein the first end and the second end are closer to each other than in the first orientation.

[0433] When the anchor body is in the first orientation (i.e., extending along the longitudinal axis), a section of stitching can be threaded into the channel. After the anchor is deployed, by pulling a portion of the stitching, the length of the stitching slides along the channel, causing the portion of the stitching passing through the channel to shorten. As the length of the stitching passing through the channel shortens, it pulls on the anchor body and causes the anchor to bend into a second orientation. Optionally, these loops can be formed from a section of stitching, as described herein. Figure 46A and 47A The discussion.

[0434] In some embodiments, the channel may be formed from the material of the anchor itself, such that the stitch can pass through a portion of the material on the outer surface of the anchor before deployment. In some embodiments, the anchor may have an internal lumen, and the channel may partially pass through the internal lumen of the anchor. In this way, the material of the anchor itself forms the channel, allowing the material of the anchor itself to attach the stitch to the anchor body.

[0435] In some embodiments, the channel may be defined by a plurality of loops extending radially outward from the outer surface of the anchor. For example, there may be two or four loops located on the outer surface of the anchor body, between the first and second ends, with at least one loop located closer to the first end of the anchor and at least one loop located closer to the second end of the anchor. In this way, these loops define the channel, allowing the stitching to be attached to the anchor body.

[0436] Anchor bodies with channels defined by loops have a potential advantage because the stitching can more easily slide through these loops, thus facilitating the bending of the anchor body from a first orientation to a second orientation. Furthermore, since these loops can extend radially outward from the outer surface of the anchor body, this may allow the stitching to exert a greater torque on the anchor body when the length of the stitching through the channel is shortened, making it easier to bend the anchor body to the second orientation.

[0437] While this application describes in part the features of the invention with respect to embodiments having channels defined by rings, it should be understood that these features may also be relevant to embodiments discussed herein where the channels are formed of the material of the anchor body.

[0438] In some embodiments, the system, apparatus, kit, and method can be used to repair torn meniscus tissue by deploying a first anchor and a second anchor through the torn tissue portion, and then tightening the anchors against the tissue portion, thereby potentially holding the separated tissue portions together to allow healing. Optionally, any suitable number of anchors can be deployed, depending on various factors such as the extent of tissue damage, the location of the repair, and the size of the anchors. For example, a single anchor or two or more anchors can be used.

[0439] According to some embodiments, for example, when deploying the first and second anchors, an additional loop may be provided near the proximal end of the second anchor. This additional loop may be held by an optional open portion of the deployment device before the second anchor is deployed to prevent the second anchor from being accidentally or prematurely released from the deployment device. Alternatively, the deployment device may not include an optional open portion, and the anchors may be deployed by sequentially pushing the first and second anchors out of the deployment device.

[0440] A piece of stitching material can pass through the channel. Some embodiments are described as having stitches that can pass through multiple loops of the first and second anchors. However, it should be understood that, alternatively, the stitches can pass through a channel defined by the material of the anchor itself, as discussed herein.

[0441] According to some embodiments, once the first and second anchors are deployed, multiple portions of the suture pass through the soft tissue and are positioned between the first and second anchors. A loop on one of the suture portions can be pulled to position and hold the anchor distal to the soft tissue; pulling the loop tightens the suture through the channel and pulls the multiple anchor loops (or the anchor material itself defining the channel), optionally causing a slight bend in the anchor body. Once the anchor is held distal to the soft tissue, the proximal end of the suture can be pulled, further tightening the suture through the channel defined by the multiple anchor loops (or the anchor material itself).

[0442] One aspect of some embodiments of the present invention relates to deploying a first anchor and a second anchor from a deployment device, each anchor including a channel as discussed herein. A suture segment inserted into the respective channels of the first and second anchors can be deployed through soft tissue (or bone tissue) along with the deployment of the first and second anchors. A specific suture configuration of the suture segment inserted into the channel results in the anchor being positioned distal to the soft tissue (or bone tissue) by pulling on portions of the suture after the deployment of the first and second anchors, and then tightening the anchor against the distal soft tissue (or bone tissue). These suture portions include the proximal end of the suture segment and a suture segment located between the first and second anchors (which, after the deployment of the first and second anchors, are located proximal to the soft tissue).

[0443] Furthermore, providing channels defined by multiple loops extending radially outward from the outer surface of the anchor body makes it easier for sutures to pass through these loops. This may also eliminate the need to pass the suture through the interior of the anchor, potentially reducing friction as the suture moves through the channels after the anchor is deployed and when it is pulled and tightened. Because the suture can slide smoothly through the loops of the anchor, it is easier to pull and tighten the suture that has passed through the loops. This helps users to more easily position the anchor distal to the soft tissue after deployment and to more easily tighten the suture that has passed through multiple loops of the anchor. This approach is far more desirable than passing the suture through the interior of the anchor, where it may not slide smoothly.

[0444] Furthermore, according to some embodiments, a channel that is not coaxial with the longitudinal axis of the anchor can be provided, extending entirely along the outer surface of the anchor. This may allow a larger torque to be applied to the anchor body, thereby facilitating the bending of the anchor to a second orientation.

[0445] Furthermore, according to some embodiments, a channel is provided at least partially along the outer surface of the anchor to facilitate the insertion of a single thread material into both anchors, as described herein. Figures 43A to 19DAs discussed, after the first and second anchors are deployed, pulling a single loop of the suture material can position both the first and second anchors distal to the soft tissue. Subsequently, pulling a single proximal end of the suture material can tighten both the first and second anchors against the distal side of the soft tissue.

[0446] In addition, a second anchor with an additional ring is provided near the end of the anchor body to prevent the second anchor from accidentally falling off the deployment device before planned deployment, as discussed in this article.

[0447] Now for reference Figures 43A to 43B The illustration shows an anchor 10 for deployment via soft tissue according to some embodiments of the present invention. The anchor 10 has an elongated flexible body 12, with a length, for example, 1 to 5 cm and a diameter, for example, 1 to 2 cm, formed of any suitable material, such as polyester or polyethylene. It should be understood that, if desired, in some embodiments, an anchor body with other suitable lengths, other suitable diameters, and formed of other suitable materials may be used. The body 12 has a first end 14, a second end 16, and an outer surface 18. According to some embodiments, the anchor 10 is shown in a first orientation, with the body 12 extending along a longitudinal axis 20. According to some embodiments, the body 12 of the anchor 10 can be bent into a second orientation such that, after deployment via soft tissue, the anchor 10 can be secured to the soft tissue, as further described below. According to some embodiments, the cross-section of the body 12 may be circular, optionally having an opening 22 extending from the first end 14 to the second end 16 of the body 12, as shown below. Figures 43A to 43B As shown, the anchor has an inner surface 19. However, those skilled in the art will understand that, alternatively, the body may have other cross-sectional profiles, such as square or elliptical (not shown), and / or, according to some embodiments, the body may not have a through opening, or may have a blind hole that only partially passes through the body 12 along axis 20.

[0448] refer to Figure 44A An anchor 30 according to some embodiments of the present invention is shown. The anchor 30 has an elongated flexible body 32, similar to... Figures 43A to 43B The body 12 is shown. However, in some embodiments, the anchor 30 may be provided with a channel 35 defined by a plurality of rings 40, which are attached to the body 32 and extend outward from the outer surface 38 of the body 32. Similarly, according to some embodiments, and referring to Figures 44B to 44C The corresponding anchors 50 and 70 have corresponding elongated flexible bodies 52 and 72, each provided with multiple rings, 60a to 50d and 80a to 80d respectively, which define corresponding channels 65 and 85. Figures 44A to 44CIn the illustrated embodiment, each anchor 30, 50, and 70 has a channel defined by four rings. However, those skilled in the art will understand that, if desired, channels defined by any suitable number of rings can be provided, wherein these rings are attached to the anchor in any suitable manner.

[0449] Further reference Figures 44A to 44C In some embodiments, the loops 40a to 40d of anchor 30 and the loops 60a to 60d of anchor 50 are formed of, for example, any material suitable for surgical sutures, such as those discussed herein. It should be noted that each loop 40 of anchor 30 may be formed of a separate sheet of material 34, and the end 36 of loop 40 may be attached to the outer surface 38 of anchor body 32 by any known means (e.g., adhesive, welding, or by heating, etc.). Alternatively, anchor 30 may be hollow, having an opening 22 similar to that of anchor 10 (…). Figure 43B In one embodiment, 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 the 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 (e.g., knotting).

[0450] Special Reference Figure 44B The loops 60 (e.g., 60a to 60d) of the anchor 50 may be formed from a single portion of material 54, such as the stitching material discussed herein, wherein the end 56 (e.g., 56a to 56h) of each loop 60 passes through material 57 inside the outer surface 58 of the anchor 50. For example, in some embodiments, the loops 60 are shuttle-woven in material 57 on the outer surface 58 of the anchor 50 such that the end 56b of loop 60a is connected to the end 56c of the adjacent loop 60b within material 57, specifically within the outer surface material 57 or at a portion of the thickness of the outer surface material 57. In cases where the anchor 50 is hollow and the anchor body has an opening similar to the opening 22 in the anchor body 12 ( Figure 43B In some embodiments, the end 56b of ring 60a and the end 56c of adjacent ring 60b can be continuous and / or interconnected within an opening through the anchor body. Furthermore, in some embodiments, the ends 54 of rings 60a and 60d closest to their respective ends 51 and 53 of the body 52 can each have a knot 55 within the opening for retaining the ends (56a, 56h) of their respective rings 60a, 60d within the anchor body 52. ​​Alternatively, in some embodiments, ends 56a, 56h can be attached to the anchor body 52 by any other suitable means, including with respect to anchor 30 ( Figure 44A The methods discussed.

[0451] refer to Figure 44C It shows the connection with anchor 50 ( Figure 44B Similar to anchor 70. However, in anchor 70, the material 74 at the ends 76a and 76h of the respective annular ends 80a and 80d, closest to the respective ends 71 ​​and 73 of the body 72, can again extend beyond the outer surface 78 of the anchor body 72. According to some embodiments, a knot 79 may be provided at or near the ends 76a and 76h (outside the anchor 70) to retain the ends 76a and 76h outside the anchor body 72. Alternatively, according to some embodiments, the ends 76a and 76h may be provided in any other suitable manner, including those discussed with respect to anchors 30 and 50.

[0452] It can be noted that in some embodiments, the loops of anchors 30, 50, and 70 are shown to be uniformly distributed along the length of their respective anchors 30, 50, and 70. However, it should be noted that, if desired, according to some embodiments, these loops may be non-uniformly distributed along the length of the anchor, with at least one loop located closer to the first end of the anchor and at least a second loop located closer to the second end of the anchor. For example, in some embodiments, the space between two loops inside an anchor may be larger than the space between two outer loops, thereby facilitating the pulling of the two ends of the anchor closer together.

[0453] Furthermore, for example, in some embodiments, there may be more space at both ends of the anchor (i.e., the location closer to the outer ring). This may allow the two ends of the anchor to overlap when the stitching through the ring is pulled, thereby pulling the two ends of the anchor closer together.

[0454] It can be noted that at least one end of any ring in any embodiment herein may be provided with a reinforcement (as known in the art) for holding at least one end in place relative to the anchor body. Such a reinforcement can be formed into a sphere by heating a portion of the ring material at one end or by heating an additional sheet of material, thereby holding the end of the ring in place. While this can be advantageous and provides a potential benefit in some embodiments of reinforcing the connection between the ring end and the anchor body, the reinforcement may increase stress as the anchor is deployed from the delivery device and / or through soft tissue.

[0455] Further reference Figure 44D According to some embodiments, a pair of anchors 30 are shown in a position after deployment and secured to soft tissue 42. Although Figure 44D It shows that it is structurally and functionally similar to anchor 30 ( Figure 44A Similar anchors 30 may be used, but those skilled in the art will understand that, according to some embodiments, alternatively, they may be depicted. Figures 30A to 30BThe anchors 30, 50 and / or 70 or any combination of any other anchors described herein.

[0456] As this article is about Figure 44A As discussed, each anchor 30 may include a channel defined by four loops 40. According to some embodiments, each anchor 30 may be held in a second orientation, wherein, after deployment via soft tissue 42, the body 32 is respectively bent into a U-shape by the stitched portions 44 / 46 of the loops 40 inserted into the anchor 30. Various stitching configurations for the stitched portions to be inserted into the anchor channels prior to anchor deployment will be discussed further below. It should be noted that, in the second orientation, according to some embodiments, the ends 31 and 33 of the anchor body 32 are more asymmetrical than in the first orientation (e.g., ...). Figure 44A When the anchor bodies 32 are positioned closer to each other, they are arranged at an angle relative to each other, according to some embodiments. Alternatively, in a second orientation, the ends 31 and 33 of the anchor body 32 are positioned relative to each other at an angle, according to some embodiments. The stitching can be formed of any suitable material, such as those discussed herein.

[0457] Further reference Figures 45A to 45B This illustrates other embodiments of the invention, specifically corresponding anchors 80 and 90. Each of anchors 80 and 90 may include a channel defined by a plurality of corresponding rings 82 and 92. Each ring 82 and 92 may be structurally and functionally similar to rings 40, 60a to 60d and 80a to 80d (…). Figures 44A to 44C However, according to some embodiments, such as Figures 45A to 45B As shown, it should be noted that each anchor 80 and 90 may consist of only two loops 82 and 92, respectively, which is different from anchors 30, 50, and 70, which have four loops. Figures 44A to 44C (This creates a contrast.)

[0458] Further reference Figure 45C According to some embodiments of the invention, a pair of anchors 80 are shown in a position after deployment and secured to soft tissue 42. Although Figure 45C It shows that it is structurally and functionally similar to anchor 80 ( Figure 45A Similar anchors 80, but those skilled in the art will understand that, as an alternative, can be depicted Figures 45A to 45B Any combination of 80 and / or 90 anchors.

[0459] As this article is about Figure 45A As discussed, each anchor 80 may include two loops 82. According to some embodiments, each anchor 80 is held in a second orientation, wherein, after deployment via the soft tissue 42, the body 84 is respectively bent into a U-shape by the corresponding stitch portion 44 / 46 of the loop 82 inserted into the anchor 80. It should be noted that in the second orientation, the ends 81 and 83 of the anchor body 84 are larger than in the first orientation (e.g., ...). Figure 45A When they are closer to each other, they are positioned closer together. Alternatively, in a second orientation, according to some embodiments, the ends 81 and 83 of each anchor body 84 are opposite each other at an angle. The stitching can be formed of any suitable material, such as those described herein. Figure 44D The materials discussed in the context of suture materials.

[0460] refer to Figures 45D to 45G This illustrates other anchors with channels defined by loops according to embodiments of the present invention. For example, according to some embodiments, anchor 91 ( Figure 45D The anchor 91 may include channels 75 defined by loops 93 formed by single-segment stitches 94 woven into the material 77 of the anchor, such that the loops 93 are connected to each other. It can be noted that the stitched portion 95 at either end of the anchor 91 extends outward from the anchor.

[0461] like Figure 45E As shown, according to some embodiments, the anchor 99 may also include channels 75 defined by loops 93 formed by single-segment stitches 96 woven through the material 77 of the anchor, such that the loops 93 are connected to each other. It can be noted that the stitch portions 97 at either end of the anchor 99 may each be provided with a knot 98. According to some embodiments, the knot 98 can prevent the stitch portion from breaking off from the anchor 99.

[0462] refer to Figures 45F to 45G The image shows anchors according to some embodiments of the present invention. Anchor 70a may be related to anchor 70 ( Figure 44C Similar to anchor 70a, the difference lies in that the end of the ring may point inwards towards the anchor 70a, which can reinforce the end of the stitching material and prevent it from detaching from the anchor. As for anchor 70b, it may be similar to anchor 70a, except that, according to some embodiments, the end of the ring is embedded in the anchor material, thereby potentially providing a stronger connection between the ring and the anchor body 72b.

[0463] Those skilled in the art will understand that, according to some embodiments of the invention, anchors with four loops can provide better soft tissue anchoring stability and may be more difficult to remove once secured to soft tissue. However, anchors with only two loops can pass through soft tissue (e.g., the meniscus) with less stress and may conform to the soft tissue more evenly.

[0464] refer to Figures 46A to 46BAccording to some embodiments, an alternative configuration of threading a suture through a pair of anchors is shown, and the state after the anchors are secured to soft tissue is illustrated. Specifically, as shown in the figures, according to some embodiments, the first anchor 401 and the second anchor 402 have corresponding bodies 431 and 432, each having a channel defined by a pair of loops. For example, anchor 401 may have a channel 405 defined by loops 404a and 404b formed by short suture portions 406 that are shuttle-woven into the material 407 of anchor 401, wherein the ends 410 and 412 of the short suture portions 406 can be attached to the body 431 by any known means, for example, by means of the loops 404a and 404b described herein. Figure 44A ), ring 60 ( Figure 45B ), Ring 82 ( Figure 45A ), Ring 92 ( Figure 45B ) or 80 rings ( Figure 44C In any of the ways discussed. According to some embodiments, anchor 402 may have a channel 405 defined by loops 408a and 408b, which are formed by a portion of a long stitch portion 416 that is shuttle-woven into the material 407 of anchor 402. According to some embodiments, the long stitch portion 416 connects anchors 401 and 402 by the following thread configuration: a. The first end 420 of the long seam portion 416 forms the end of the loop 408b, the long seam portion forms the loop 408a (as described herein), and then extends outward from the body 432 of the anchor 402.

[0465] b. Then, the long seam portion 416 extends toward the anchor 401 and passes through the channel 405 defined by the loops 404b and 404a of the anchor 401.

[0466] c. Then, the long seam portion 416 extends from the anchor 401 toward the anchor 402, where the long seam portion 416 passes through the channel 405 defined by the rings 408a and 408b.

[0467] d. The second end 422 of the long seam portion 416 extends proximally away from the anchor 402.

[0468] According to some embodiments, anchors 401 and 402 can be deployed via soft tissue, as discussed herein. According to some embodiments, after release from the deployment device, anchors 401 and 402 can be secured and tightened against the soft tissue by pulling the second end 422 of the long stitch portion 416. As discussed herein, according to some embodiments, this may cause the corresponding bodies 431 and 432 of anchors 401 and 402 to bend into U-shaped anchors as the long stitch portion 416 slides through the corresponding channels 405 of anchors 401 and 402. One such anchor 402 is in Figure 47B It is displayed as a bent state.

[0469] Now for reference Figures 47A to 47B According to some embodiments, an alternative configuration is shown in which a suture is threaded through a pair of anchors, and the state after the anchors are secured to soft tissue. Figure 47A Implementation examples and Figure 46A Similar, but the configuration of the threaded long seam 416 may differ. Specifically, the first end 420 of the long seam portion 416 may form the end of the loop 408b, and the threading configuration of the long seam portion forming the loop 408a may be as follows: a. Starting from anchor 402, the long seam portion 416 extends toward anchor 401 and passes through the channel 405 defined by rings 404b and 404a.

[0470] b. Starting from anchor 401, the long seam portion 416 extends toward anchor 402, passes through ring 408b, and then through ring 408a of channel 405. (This is consistent with...) Figure 46A The threading configurations are different. c. Starting from anchor 402, the long seam portion 416 extends proximally, passing through anchor 401.

[0471] According to some embodiments, anchors 401 and 402 can be deployed via soft tissue, as discussed herein. After release from the deployment device, according to some embodiments, anchors 401 and 402 can be secured and tightened against the soft tissue by pulling the second end 422 of the long stitch portion 416. As discussed herein, according to some embodiments, this may cause the corresponding bodies 431 and 432 of anchors 401 and 402 to bend into U-shaped anchors as the long stitch portion 416 slides through the corresponding channels 405 of anchors 401 and 402. One such anchor 402 in Figure 46B It is displayed as a bent state.

[0472] Although Figure 46A and 47AIn the embodiments, anchors 401 and 402 and anchors 501 and 502 are shown as each having a channel 405 defined by a pair of loops, but those skilled in the art will understand that any one of anchors 401, 402, 501 and 502 may, if desired, have a channel defined by more than two loops (e.g., four loops).

[0473] Now for reference Figure 47C It is a simplified schematic diagram of an exemplary anchor 1700 according to an embodiment of the present invention, wherein a stitch 1710 is inserted therein in a first orientation; and Figure 47D , it is Figure 47C A simplified cross-sectional view of the central anchor and the thread inserted therein in the second orientation.

[0474] First operational orientation ( Figure 47C In the first operating orientation, anchor 1700 is typically arranged along the longitudinal axis 1701 and defines a proximal portion 1702 and a distal portion 1704. Alternatively, anchor 1700 may have any other shape in the first operating orientation.

[0475] A specific feature of one embodiment of the present invention is that, At least one suture 1710 is configured to at least partially penetrate the distal portion 1704 of the anchor 1700 at least once, and is also configured to penetrate the proximal portion 1702 of the anchor 1700 at least once. The at least one suture 1710 is also configured to be partially disposed radially outside the anchor 1700.

[0476] Specifically, as can be seen schematically, suture 1710 can be divided into several different parts, namely, the proximal external portion 1712, the proximal internal portion 1714, the intermediate external portion 1716, the distal internal portion 1718, and the distal external portion 1720. Figure 47C Specifically, the proximal outer portion 1712 and distal outer portion 1720 of the suture 1710 are radially external relative to the outer surface 1706 of the anchor 1700, while the proximal inner portion 1714 preferably penetrates the proximal portion 1702 of the anchor 1700, and the distal inner portion 1718 preferably penetrates the distal portion 1704 of the anchor 1700. The proximal outer portion 1712, the intermediate outer portion 1716, and the distal outer portion 1720 of the suture 1710 are all preferably located outside the outer surface 1706 of the anchor 1700.

[0477] exist Figure 47DAs can be seen, the anchor 1700 is in its second tightening operation orientation. Once at least one of the proximal outer portion 1712 and / or the distal outer portion 1720 of the suture 1710 is pulled, the length of the suture extending along the anchor is shortened, causing the anchor 1700 to bend, with its proximal portion 1702 and distal portion 1704 generally close to each other.

[0478] A specific feature of one embodiment of the invention is that, because the friction between the anchor 1700 and the seam 1710 is minimized, the user can tighten the anchor 1700 to make it... Figure 47C The first operational orientation transition to Figure 47D The second tightening operation requires a relatively low force.

[0479] The minimization of friction is preferably achieved by minimizing the surface area of ​​contact between the anchor 1700 and the seam 1710. This minimization of surface area is achieved by the fact that only a portion of the seam 1710 penetrates the anchor 1700, while the remaining portion of the seam 1710 is located outside the anchor 1700.

[0480] A specific feature of one embodiment of the present invention is that, in order to tighten the anchor 1700 to make it... Figure 47C The first operational orientation transition to Figure 47D The force required for the second tightening operation is relatively lower than the force required when the seam is inserted through the entire length of the anchor.

[0481] Exemplary methods In an exemplary anchor delivery method, a pair of anchors are deployed as follows: a first anchor is deployed by advancing an anchor pusher a first distance, and then the anchor pushing mechanism (including an anchor pusher and a pushing assembly) is modified to reduce the axial overlap between the anchor pusher and the pushing assembly. The anchor pusher is then advanced again to deploy the second anchor. Optionally, the same movement (e.g., type and amount, such as sliding of a slider or rotation of a knob) is used for both deployments. Optionally, the pushing assembly retracts between the two movements. Optionally, the state of the mechanism automatically moves from a first potential overlap state to a second potential overlap state, for example, due to the elastic movement of one or more components allowed by the retraction of the pushing assembly. Then, when the pushing assembly is advanced, the anchor pusher contacts the anchor and deploys it from the sheath.

[0482] Figure 48This is a method of operating a multi-state anchor delivery device according to some embodiments of the present invention. At 2000, the method includes using a second pusher to push the anchor pusher over a designated axial overlap region between the anchor pusher and the second pusher. At 2010, the method includes using the anchor pusher to push the anchor out of the sheath in 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 of the anchor pusher and the second pusher deforms. At 2040, the second pusher pushes the anchor pusher, one or both of the anchor pusher and the second pusher having deformation, which causes mechanical disturbance in the designated axial overlap region, wherein the pushing occurs on a contact area between the anchor pusher and the second pusher, which is outside the designated axial overlap region. At 2050, in a second state, the anchor pusher pushes the next anchor out of the sheath.

[0483] Figure 49 This is a method for reducing axial overlap and extending anchor pushers according to some embodiments of the present invention. At 2100, an axial overlap region is specified between the anchor pusher and the second pusher. At 2110, the second pusher is retracted from the anchor pusher to reduce the specified axial overlap region between the anchor pusher and the second pusher. At 2120, one or both of the anchor pusher and the second pusher deform. At 2130, mechanical interference is generated in the specified axial overlap region. At 2140, the lengths of the anchor pusher and the second pusher are combined using the contact area outside the specified axial overlap region. At 2150, the lengths of the anchor pusher and the second pusher are extended using the new combined length. At 2160, in a second state, the next anchor is pushed out of the sheath using the extended anchor pusher length.

[0484] Figure 50 This is an exploded perspective view of an anchor delivery system 100 according to some embodiments of the present invention, including a pusher element with a curved tip. The components of the system may be structurally and functionally similar to those in the reference citation. Figures 31 to 34 The components of the anchor delivery system shown are similar and will not be described again here.

[0485] System 100 includes a sheath 250 having a tip 253 and an axially extending slot 255 extending along a distal portion 250a of the sheath. A suture 288 can be inserted into anchors 270 and 280, the suture including suture portions 288a and 288b extending between anchors 270 and 280 respectively, and a free end 288c extending proximally from either anchor 280 or anchor 270 along the sheath 250. The suture 288 and its function in tightening deployed anchors will be described in the reference. Figure 63 Further discussion is needed.

[0486] Further reference Figure 51 The suture portions 288a and 288b can extend outward through the needle slot 255. It can be noted that the slot 255 allows the suture portions 288a to 288b to be located outside the sheath 250, thereby potentially preventing these portions of the suture 288 from interfering with the movement of the anchors 270 and 280 within the sheath. It can also be noted that the free end 288c of the suture is not... Figure 51 As shown, it may extend proximally through the device from either the first anchor 270 or the second anchor 280 so that the user can pull it after deploying the first and second anchors. Optionally, the free end 288c of the suture may be wound around the spool 300. Figure 50 ). Thread 288 will be referenced. Figure 57 and Figure 63 This will be discussed further later. It can be noted that, for the sake of brevity, Figures 53 to 56 and Figures 59 to 34 The stitching 288 is omitted.

[0487] Figure 52 This is a perspective view of a pusher element 230 for an anchor delivery system according to some embodiments of the present invention. The pusher element 230 includes an elongated rod 320 having a tip 322 at a distal portion 232 of the pusher element, the tip having a slight upward curve. According to some embodiments, at least the distal portion 232 of the pusher element 230 is formed of a flexible / bendable material, which allows the distal portion to deform, as will be discussed further below.

[0488] The pusher element 230 includes a portion 321 having a relatively thin profile, extending between a pusher tip 322 and a portion 323 having a relatively thick profile. According to some embodiments, a beveled surface 324 may be present between portions 321 and 323. The pusher element 230 may also include a portion 325 having a relatively thin profile, extending between portions 323 and a relatively thick portion 327. Optionally, the thickness of portion 325 may be the same as that of portion 323. A beveled surface 326 may be present between portions 323 and 325. A recess 328 may be present adjacent to portion 327. Optionally, a screw can be inserted into the device 100 (… Figure 50 ) to connect the actuator element 230 to the rack 220 ( Figure 50 (or another part of the deployment device.)

[0489] It can be noted that portions of the actuator element 230 (e.g., actuator tip 322, distal portion 232, and portion 321) are shown to have a relatively thin profile, while at least portion 323 has a relatively thick profile. According to some embodiments, the relatively thin portions of the actuator element 230 allow for greater flexibility, while the relatively thick portions restrict lateral movement of the actuator element within the sheath 250.

[0490] Figure 53 This is a side sectional view of an anchor delivery system 100 according to some embodiments of the present invention, prior to the deployment of anchors 270 and 280. Figure 53 In the enlarged view, anchors 270 and 280 are shown located within the sheath 250, with anchor 270 located at the distal end of anchor 280. A pusher element 230 extends below anchor 280, with pusher tip 322 located at the distal end of anchor 280 but the proximal end of anchor 270. It can be noted that, according to some embodiments, anchor 280 may be positioned near a relatively thin portion 321 of pusher element 230.

[0491] Although the pusher element 230 is shown extending below the anchor 280, those skilled in the art will understand that, alternatively, the pusher element 230 may extend above or along the anchor 280, provided that the pusher tip 322 is located at the distal end of the anchor 280 and the proximal end of the anchor 270.

[0492] Distal movement of the pusher element 230 causes the pusher tip 322 to abut against the proximal end 272 of the anchor 270, moving the anchor 270 toward the sheath tip 253. According to some embodiments, as the pusher element 230 moves distally to deploy the anchor 270, the anchor 280 may move distally, closer to the sheath tip 253, due to contact between the inclined surface 324 and the proximal end 282 of the anchor 280. The pusher element 230 may extend toward the sheath tip 253 at least the necessary distance until the anchor 270 is deployed.

[0493] Figure 54 This is a side sectional view of the anchor delivery system, with the pusher element 230 in the extended position after the anchor 270 has been deployed. Further reference... Figures 55A to 55B The actuator element 230 can be retracted, that is, moved proximally (relative to the side). Figure 54 The position of the actuator element is to the right. When the actuator element 230 retracts, the previously upward-curved actuator tip 322 is anchored by the anchor 280. Figure 55AThe deformation causes the tip of the actuator to be coaxial with part 321 of the actuator element, and the tip of the actuator ( Figure 55A (Not shown in the image) passes under anchor 280 until it is completely located on the proximal side of the proximal end of the anchor ( Figure 55B At this point, the actuator tip 322 will return to its bent configuration.

[0494] Optionally, the second anchor 280 may be deformable, such that when the pusher element 230 retracts, the pusher tip 322 causes the second anchor to temporarily deform, while the pusher element slides past the second anchor and reaches... Figure 55B The position in the middle.

[0495] It can be noted that, according to some embodiments, an anchor ring is provided ( Figures 44A to 19B ) and / or a suture loop extending outward through the slot 255 of the sheath 250 ( Figure 50 and Figure 51 This prevents the anchor 280 from moving backward (to the far side) when the pusher element 230 retracts.

[0496] Actuator element 230 from Figure 55B Location to Figure 56 The distal movement of the position causes the pusher tip 322 to contact the proximal end 282 of the anchor 280, causing the anchor 280 to move distally within the sheath 250. For example... Figure 56 As shown, the actuator element 230 can extend at least the necessary distance toward the sheath tip 253 to deploy the anchor 280. Figure 56 ).

[0497] Figure 57 This is an exploded perspective view of an anchor delivery system 200 according to some embodiments of the present invention, including a pusher element 330 having a distal portion 332, which includes an S-shaped tip or a tip portion 342. The components of the system may be structurally and functionally similar to those in the references. Figures 31 to 34 and / or Figures 50 to 2 The components of the anchor delivery system shown in Figure 3 are similar and will not be described again here.

[0498] It can be noted that, with Figure 51 Similarly, system 200 may also include a sheath 250 having an axially extending slot 255 extending along the distal portion 250a of the sheath. A suture 288 may be arranged in a manner similar to that discussed herein (e.g., regarding...). Figures 50 to 2 3 and Figure 63 ) Inserted into anchors 270 and 280. The stitch 288 and its function in tightening deployed anchors will be discussed in the reference. Figure 63 We will discuss this in detail later.

[0499] After assembly, system 200 ( Figure 57The external appearance of ) may be similar to that of system 100 ( Figure 51 They are similar, although the actuator elements (230 or 330) within the system may differ.

[0500] Figure 58 This is a perspective view of a pusher element 330 for an anchor delivery system according to some embodiments of the present invention. The pusher element 330 includes an elongated rod 332 having an S-shaped tip portion 342 at its distal end. The S-shape of the tip portion 342 includes an upper curved portion 334, a lower curved portion 336, and a distal tip 333. According to some embodiments, at least the S-shaped tip portion 342 of the pusher element 330 is formed of a flexible / bendable material, which allows the S-shaped portion to deform, as will be discussed further below.

[0501] Although according to some embodiments, the actuator element 330 ( Figure 58 Functionally, it may be related to actuator element 320 ( Figure 52 Similar to, but it should be noted that the specific configuration of the S-shaped tip portion 342 of the actuator element 330 may make the actuator element 330 more flexible and may make the actuator element 330 more easily deformable, for example, as described herein. Figures 60 to 33 B is discussed.

[0502] It can be noted that, according to some embodiments, the S-shaped portion 342 of the actuator element 330 may make the S-shaped portion more flexible, while the upper curved portion 334 and the lower curved portion 336 may restrict the lateral movement of the actuator element within the sheath 250.

[0503] Figure 59 This is a side sectional view of an anchor delivery system 200 according to some embodiments of the present invention, prior to the deployment of anchors 270 and 280. Figure 59 In the enlarged view, anchors 270 and 280 are shown located within the sheath 250, with anchor 270 located at the distal end of anchor 280. A pusher element 330 extends below anchor 280, with an S-shaped pusher tip portion 342 located at the distal end of anchor 280 but the proximal end of anchor 270. It can be noted that anchor 280 is positioned near the rod 332 portion of pusher element 330.

[0504] Although the pusher element 330 is shown extending below the anchor 280, those skilled in the art will understand that, alternatively, the pusher element 330 may extend above or along the anchor 280, provided that the S-shaped pusher tip portion 342 is located at the distal end of the anchor 280 and the proximal end of the anchor 270.

[0505] Distal movement of the pusher element 330 causes the tip 333 of the pusher element 330 to abut against the proximal end 272 of the anchor 270, moving the anchor 270 toward the sheath tip 253. As the pusher element 330 moves distally to deploy the anchor 270, the anchor 280 may move distally, closer to the sheath tip 253, due to contact between the rod 332 and the anchor 280. Alternatively, the anchor 280 may slide relative to the rod 332 as the pusher element 330 moves distally. The pusher element 330 may extend toward the sheath tip 253 at least the necessary distance until the anchor 270 is deployed.

[0506] Figure 60 This is a side sectional view of the anchor delivery system, after the anchor 270 has been deployed, with the pusher element 330 in the extended position. Further reference... Figures 61A to 61B The actuator element 330 can be retracted, that is, moved proximally (relative to the side). Figure 60 The position of the actuator element is to the right). When the actuator element 330 retracts, the anchor 280 ( Figure 61A The S-shaped tip portion 342, which previously included the upper curved portion 334 and the lower curved portion 336, is deformed such that the tip portion 342 (previously having an S-shape) is coaxial with the rod 332 of the actuator element, and the portion of the actuator element 330 in which the S-shaped tip portion 342 was previously formed ( Figure 61A (Not shown in the image) passes under anchor 280 until it is completely located on the proximal side of the proximal end of the anchor ( Figure 61A At this point, the tip portion 342 will return to its S-shaped configuration.

[0507] Optionally, the second anchor 280 may be deformable, such that when the pusher element 330 retracts, the pusher tip portion 342 causes the second anchor to temporarily deform, while the pusher element slides past the second anchor and reaches... Figure 61B The position in the middle.

[0508] It can be noted that, according to some embodiments, an anchor ring is provided ( Figures 44A to 19B ) and / or a suture loop extending outward through the slot 255 of the sheath 250 ( Figure 58 and Figure 51 This prevents the anchor 280 from moving backward (to the far side) when the pusher element 330 retracts.

[0509] Once the actuator element 330 is retracted so that it is fully positioned proximal to the anchor 280, the S-shaped actuator tip portion 342 returns to its S-shaped configuration. Figure 61B ).

[0510] Actuator element 330 from Figure 61B Location to Figure 62The distal movement of the position causes the tip 333 of the actuator element to contact the proximal end 282 of the anchor 280, causing the anchor 280 to move distally within the sheath 250. For example... Figure 62 As shown, the actuator element 330 can extend at least the necessary distance toward the sheath tip 253 to deploy the anchor ( Figure 62 ).

[0511] Figure 63 This is a side sectional view of a portion of an anchor delivery system according to some embodiments of the present invention, including anchors 270 and 280, and a suture 288 extending or passing through them. The anchor delivery system shown may be structurally and functionally similar to any anchor delivery system discussed herein, such as system 100 (…). Figure 50 ) or System 200 ( Figure 57 Anchors 270 and 280 are shown located within the sheath 250, with anchor 270 located at the distal end of anchor 280. The system can be equipped with any suitable suture, such as FiberWire®, e.g., #2-0. The suture length can be, for example, approximately 720 mm ± 30 mm.

[0512] As discussed herein, the stitch 288 may be threaded through anchors 270 and 280, or through loops 88 as shown. Although in the illustrated embodiment anchors 270 and 280 are each equipped with a pair of loops 88, according to some embodiments, as an alternative, anchors may be equipped with more than two loops, for example, four loops each, as discussed herein.

[0513] As discussed herein, a suture 288 is loosely threaded through the loops 88 of anchors 270 and 280. Specifically, the suture 288 includes a suture portion 288a (inner loop) extending between the proximal end 272 of anchor 270 and the distal end 284 of anchor 280, where the suture portion 288a is attached to anchor 280 in a manner known in the art. According to some embodiments, the length of the suture portion 288a may be, for example, about 50 mm ± 5 mm. According to some embodiments, the suture 288 may also include a suture portion 288b (outer loop) extending between the distal end 274 of anchor 270 and the proximal end 282 of anchor 280. The length of the suture portion 288b may be, for example, about 260 mm ± 5 mm. The suture 288 may also include a free end 288c that, as shown, wraps twice around portion 288b at the wrapping portion 1298 and may extend proximally within the sheath 250 (although not shown for clarity). According to some embodiments, portion 1290 of the suture 288 may extend between portions 288a and 288b and may pass through the loop 88 of the anchor 270, while portion 1292 of the suture 288 may extend between portions 288a and 288c and may pass through the loop 88 of the anchor 280.

[0514] The portion 1294 of the stitch portion 288c, located between portion 1292 and the winding portion 1298, may, according to some embodiments, be provided with a slip knot 1299, also referred to as a "stop knot" or "slip knot," as known in the art. The slip knot 1299 may be positioned along the stitch portion 1294 at, for example, a distance of 35 mm from the anchor 280. As known in the art, the slip knot 1299 has adjacent loops, the diameter of which may be, for example, 0.5 to 2.5 cm, such as 22 mm. The slip knot 1299 may be formed such that it can be released by pulling the stitch portion 287, but the slip knot may be designed not to release when the stitch portion 289 is pulled, as known in the art. Pulling the free end 288c of the stitch can easily untie the slip knot 1299, thereby releasing the slip knot. The stitch portions 289 and 287 extend from the slip knot 1299 to portion 1292 and winding portion 1298, respectively.

[0515] As is known in the art, the slip joint 1299 may have adjacent loops 295. Furthermore, the relative dimensions of the slip joint 1299 and the loop 88 at the farthest end of the anchor 280 are chosen such that the slip joint cannot pass through the loop 88.

[0516] As discussed in this article, for example, referencing Figure 51 The suture portions 288a and 288b may extend outward through the needle slot 255. However, for clarity, in Figure 63In this embodiment, no slot is shown on the needle / shroud 250. The relative positions of the various portions of the suture 288 with respect to the anchors 270 and 280 are shown.

[0517] When anchors 270 and 280 are included within sheath 250, or after anchor 270 is deployed, the stitch 288 can freely slide past the loops 88 in anchors 270 and 280. However, if the stitch portion 289 slides past the loops 88 of anchor 280 in the direction of arrow 301, this sliding will be restricted by the slip knot 1299 when the slip knot reaches the loops 88 of anchor 280 due to the relative dimensions of the slip knot 1299 and the loops 88 (as described above).

[0518] After anchors 270 and 280 are deployed, the seam portion 288b can be pulled, as shown in the reference. Figures 64A to 64H To discuss in more detail. Specifically, the left side of suture section 288b can be pulled proximally (e.g., Figure 63 and 64A (As shown), this will cause portion 288a to shorten as the suture slips through the loop 88 of anchor 270. Proximal pulling of suture portion 288b will also cause anchors 270 and 280 to move closer to the tissue 1296 where the anchors are deployed, as portion 288a shortens and moves closer to the tissue.

[0519] Then you can pull the free end of the suture 288c proximally, for example, in the direction of arrow 302 ( Figure 63 This will cause the suture wrap 1298 to slide around the loop 288b, and the slip knot 1299 will be released due to the proximal tension of the suture portion 287. As the free end 288c is pulled further, portion 1292 will slide past the loop 88 of the anchor 280, and suture portion 288b will shorten until it abuts against the tissue. Figure 63 (Not shown in the text). Due to the winding portion 1298 configured before the deployment of anchors 270 and 280, a knot will form in the stitch 288, as referenced herein. Figure 64H As discussed, the free end 288c of the suture can then be cut close to the tissue.

[0520] Further reference Figures 64A to 64H The diagram shows a section of stitch 288, as it appears in anchors 270 and 280 ( Figure 63 This is a schematic representation of the possible appearance after the deployment of Organization 1296. It should be noted that, for clarity, Figures 64A to 64H Anchors 270 and 280, which have been deployed to the distal end of tissue 1296, are omitted. Parts of loops 288a and 288b pass through opening 271 in the tissue, and anchors 270 ( Figure 63 Inserted through this opening. Similarly, portions of rings 288a and 288b pass through opening 281 in the tissue, anchor 280 ( Figure 63 Insert through this opening.

[0521] For example, a surgeon can pull the left side of the loop 288b proximally, causing the suture to slip across the anchor 270. Figure 63 In the ring 88, ring 288b becomes longer and ring 288a becomes shorter, from Figure 64A The respective lengths shown become Figure 64B The respective lengths shown indicate that the relaxation of loop 288a relative to tissue 1296 decreases. Further proximal pulling on the left side of loop 288b causes loop 288b to lengthen further and loop 288a to shorten further. Figure 64B The respective lengths shown become Figure 64C The respective lengths are shown, at which point the loop 288a may be substantially flat against tissue 1296.

[0522] It should be noted that if the right side of loop 288b is pulled from the proximal side, the portion 289 of the thread 288 may slip past loop 88 in anchor 280 a short distance because the thread 288 passes through loop 88 in anchor 280, until knot 1299 reaches the more distant loop 88 in anchor 280. Then, due to the relative dimensions of the slip knot 1299 and loop 88, the slip knot will prevent the thread from slipping further past loop 88, as discussed herein.

[0523] Then, the surgeon can pull the suture end 288c proximally, from its Figure 64C Location to its Figure 64D At this position, the suture wrapping portion 1298 is slightly tightened around the loop 288b. At the same time, as the suture end 288c is pulled from the proximal side, the suture portion 287 is pulled from the proximal side, causing the slip knot 1299 to begin to untie, and the loop 1295 adjacent to the slip knot 1299 becomes smaller because it slips over the slip knot, as is known in the art.

[0524] refer to Figure 64E Further pulling the seam end 288c will further tighten the wrapping portion 1298 around the loop 288b, and will cause the slip knot 1299 to completely untie. Figure 64E This is because loop 1295 slipped over the slip knot. After the slip knot is untied, further pulling on the suture end 288c will cause the suture 288 to slip over the anchor 280. Figure 63 The ring 88 in the ring causes the ring 288b to shorten, for example, from its Figure 64E Length to its Figure 64F The length.

[0525] Further pulling on the suture end 288c will cause the loop 288b to shorten further, from Figure 64F The length shown is to Figure 64G The length shown, then to Figure 64HAs shown in the diagram, at this point, both loops 288a and 288b may be substantially flat against tissue 1296. When loop 288b extends from... Figure 64G The length shown is shortened to Figure 64H When the length shown is specified, the winding portion 1298 ( Figure 64E A knot 297 will be formed, thereby securing the suture to the tissue 1296. Excess length of the suture 288c near the knot 297 can then be trimmed or otherwise removed, as is known in the art.

[0526] It should be noted that the system can be operated outside the body, for example, by the actions indicated above, and / or outside of medical procedures, such as during system testing.

[0527] refer to Figure 65 The flowchart illustrates the steps of method 2200 for attaching a biocompatible material to soft tissue according to some embodiments. At 2200, according to some embodiments, a patch may be placed on or near the soft tissue to be repaired. At 2204, according to some embodiments, a needle including a first anchor and a second anchor may be inserted through the patch and soft tissue at the surgical site, with the needle tip positioned at the location where the first anchor will be implanted. According to some embodiments, the first anchor may be deployed into the soft tissue through the patch at 2206. Then, according to some embodiments, at 2208, the needle may be withdrawn from the soft tissue and the patch. According to some embodiments, at 2210, the second anchor may be deployed on the proximal side of the patch, optionally close to the patch. According to some embodiments, at 2212, the free end of the suture may be pulled. According to some embodiments, this may cause the first anchor to tighten and optionally bend into a C-shape or U-shape, as discussed herein. According to some embodiments, at 2214, the free end of the suture can be further pulled, causing the second anchor to tighten 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 U-shape, as discussed herein.

[0528] Further details of method 2200 can be found in [reference needed]. Figure 66 (The needle portion of the implant delivery system is shown according to some embodiments) and Figure 28 (This is understood as, according to some embodiments, showing the fixation of a second tissue or biocompatible material to a first tissue.) Figure 66 As shown, anchors 270 and 280 are displayed, which have been loaded into pins 250 of the deployment device (not shown), as discussed herein. Various components of this deployment system may structurally and functionally differ from other embodiments discussed herein (e.g., Figure 63 The embodiments are the same or similar to those described herein, and will not be described in detail here.

[0529] A piece of stitching material 488 may pass through anchors 270 and 280, optionally having a short portion 488a forming a small loop between the proximal end 272 of the first anchor and the distal end 286 of the second anchor, a long portion 488b forming a large loop between the distal end 274 of the first anchor and the proximal end 284 of the second anchor, and a free end 488c extending proximally from the proximal end 272 of the first anchor. The length of stitching material 488 may be, for example, 2-0 FiberWire. TM It can be formed, but other materials can also be used. Optionally, the length of the small section 488a of the suture material is 50 mm, the length of the large section 488b is 220 mm, and the length of the free end of the suture 488c is 300 mm, but other lengths can also be used.

[0530] As discussed in this article, for example, referencing Figure 51 The suture portions 488a and 488b may extend outward through the needle slot 255. However, for clarity, in Figure 63 In this embodiment, no slot is shown on the needle / shroud 250. The relative positions of the various portions of the suture 488 with respect to the anchors 270 and 280 are shown.

[0531] It can be noted that in the illustrated embodiment, when anchors 270 and 280 are included within the sheath 250, or after anchor 270 is deployed, the stitch 488 can freely slide through the loop 88 in anchors 270 and 280.

[0532] It can be noted that the free end 488c of the suture 488 can extend proximally so as to be grasped by a surgeon operating a deployment device with a needle or shaft 250. After the first anchor 270 is deployed through the first soft tissue and subsequently the second anchor 280 is deployed from the device 700, the first anchor 270 can be positioned in the first tissue (e.g., soft tissue 712, ...). Figure 28 The second anchor 280 can be positioned on the far side of the first organization 712, while the second anchor 280 can be positioned on the proximal side of the first organization 712, as will be discussed further below.

[0533] A second tissue (e.g., a second soft tissue) or biocompatible material 714 is intended to be attached to the first tissue 712. Figure 28 As discussed herein, the second tissue or biocompatible material 714 can be placed against the first tissue 712 in any desired orientation. To secure the second tissue or biocompatible material 714 to the first tissue 712, the proximal end of the suture 488c can be pulled, thereby shortening the length of the suture 718 between the first anchor 270 and the second anchor 280. Figure 28It should be noted that the suture 488 can be attached to the first anchor 270 distal to the first tissue 712, can pass through the first tissue 712, and can be attached to the second anchor 280 proximal to the first tissue 712. Therefore, by pulling the free end 488c of the suture, as the suture length between the first anchor 270 and the second anchor 280 shortens, the first anchor 270 and the second anchor 280 are forced closer together, with the first tissue 712 and the second tissue or biocompatible material 714 located between them.

[0534] Combination Figure 28 As shown, according to some embodiments, a schematic diagram of a first soft tissue 712 is illustrated, through which a first anchor 702 has been deployed, for example, via a deployment device discussed herein. The deployment of the first anchor 702 (which may be structurally and functionally similar to...) Figure 66 During the process of inserting the first anchor 702 (which is the same as or similar to the first anchor 702), an opening 716 may be formed in the first tissue 712 by a needle or cannula 706 of the deployment device (not shown), and the first anchor 702 may be inserted through the opening 716, as discussed herein with respect to device 100 according to some embodiments. According to some embodiments, a portion 718 of a suture 710 connected to the first anchor 702 may extend from the first anchor 702 through the opening 716 to the second anchor 704. According to some embodiments, a gap may exist between the second anchor 704 and the second tissue 714 and / or between the second tissue 714 and the first tissue 712, which may be reduced or closed by pulling the suture portion 708, as described herein. According to some embodiments, the suture portion 708 may also be connected to and extend proximally from the second anchor 704, optionally extending to the operator of the deployment device or another person performing the fixation procedure.

[0535] According to some embodiments, further pulling the suture portion 708 proximally may tighten the first anchor 702 against the distal surface 722 of the first tissue 712 and may tighten the second anchor against the proximal surface 724 of the first tissue 712. According to some embodiments, shortening of the suture 710 may cause at least one of the first anchor 702 and the second anchor 704 to bend or curl, thereby presenting a C-shaped or U-shaped configuration, as described herein.

[0536] According to some embodiments, when the suture portion 708 is pulled proximally, as the suture portion 718 between the first anchor 702 and the second anchor 704 shortens, the suture 710 can travel along the channel 728 of the first anchor 702 and the loop 726 of the second anchor 704. Figure 26 Slide, or slide along any other channel provided in or on the first and second anchors, as described herein.

[0537] It is worth noting that, according to some embodiments, the suture 710 may optionally be connected to the first anchor 702 and / or the second anchor 704 at multiple locations (e.g., at two or four loops or other connection locations). According to some embodiments, depending on the number of connection points between the suture 710 and each of the first anchor 702 and the second anchor 704, and depending on the materials of the first anchor 702 and the second anchor 704, shortening the suture portion 718 between the first anchor 702 and the second anchor 704 may result in the first anchor 702 and / or the second anchor 704 having a U-shaped or C-shaped configuration or a configuration with multiple undulations. According to some embodiments, after the second tissue or biocompatible material 714 is secured to the first tissue 712 (optionally by tying a knot near the second tissue or biocompatible material 714), the suture portion 708 may optionally be cut.

[0538] It is worth noting that, according to some embodiments, the second anchor 704 may be thick enough to cushion the pressure exerted on the second tissue or biocompatible material 714 when the suture 710 is tightened. According to some embodiments, the second anchor 704 may also be tough or strong enough to prevent it from being cut or otherwise damaged by the suture 710.

[0539] It should also be noted that, according to some embodiments, since the first anchor 702 may be configured to be inserted through the opening 716 in the first tissue 712, the size and / or shape of the second anchor 704 may be set such that the second anchor 704 cannot pass through the opening 716 in the first tissue 712.

[0540] A particular feature of some embodiments is that, according to some embodiments, providing a first anchor 702 and a second anchor 704 that are slidable relative to the suture 710 can provide an improved means for securing the second tissue or biocompatible material 714 to the first tissue 712. This may reduce the pressure on the second tissue or biocompatible material 714 compared to simply pressing the second tissue or biocompatible material 714 against the first tissue 712 with the suture, thereby potentially allowing for better healing of the surgical site or surrounding tissue, and / or preventing damage to the first tissue 712 or the second tissue 714 due to excessive pressure.

[0541] Furthermore, according to some embodiments, the second anchor 704 may provide a cushioning element for arthroscopy or other surgical procedures, thereby distributing the force applied to the proximal surface 724 of the second tissue or biocompatible material 714 across the entire area of ​​the second anchor 704. According to some embodiments, this can reduce pressure and / or stress on the second tissue 714 compared to procedures that do not provide a second anchor 704 and simply secure the second soft tissue or biocompatible material 714 to the first tissue 712 by tightening sutures against the second tissue or biocompatible material 714 on the proximal surface 724. 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 tightened against the second tissue or biocompatible material 714, this can significantly reduce pressure and / or stress applied to the second tissue and may prevent damage to the second tissue.

[0542] Further reference Figure 66 After anchors 270 and 280 are deployed (e.g., deployed to...) Figure 28 (As shown in the relative positions), the free end 488c of the suture can be pulled proximally, for example, in the direction of arrow 1302. According to some embodiments, this may cause suture portion 2292 to slip past the loop 88 of anchor 270, and suture portions 488b and 488a may shorten [see...]. Figure 28 (718) of the suture portion.

[0543] It is worth noting that after the deployment of the first and second anchors (270, 280), the second organization 714 may be some distance away from the first organization 712, although this is within the acceptable range. Figure 28 (Not shown). According to some embodiments, shortening the suture portion 718 can cause any gap between the first tissue 712 and the second tissue 714 to be reduced or completely closed. Optionally, providing a gap between the second anchor 280 and the second tissue 714 allows the surgeon to verify the insertion depth of the first anchor 270 and / or verify the connection strength between the second anchor 280 and the first anchor 270, as well as the fixation strength between the second tissue 714 and the first tissue 712. After such verification, the gap can be reduced or closed depending on the extent of damage to the first tissue, the procedure performed, and the surgeon's preference.

[0544] When the free end 488c of the suture is pulled proximally, this can cause the length of the suture material passing through the loop 88 in the first anchor 270 to shorten. As described herein, this may cause the first anchor 270 to bend into a C-shape or a U-shape. As described herein, further pulling the free end 488c of the suture in the direction of arrow 1302 can cause the second anchor 280 to tighten against the patch 714 and may cause the second anchor 280 to bend into a C-shape or a U-shape. It is worth noting that, according to some embodiments, the force exerted by the second anchor 280 on the patch can provide a force opposite to that of the first anchor 270 (see...). Figure 28 ).

[0545] According to some embodiments, the final configuration of the first anchor 270 and the second anchor 280, and the first organization 712 and the second organization 714 located therebetween ( Figure 28 This allows for a certain degree of mobility between the first tissue 712 and the second tissue 714. It is worth noting that, for example, the degree of axial and / or lateral movement of the first tissue 712 and the second tissue 714 relative to each other can be adjusted by regulating the tension of the suture portion, as described herein.

[0546] It should be noted that the system can be operated externally, for example, according to the above-described procedure, and / or during non-medical procedures, such as during system testing. It is anticipated that many related anchoring systems will be developed during the term of this mature patent application, and the scope of the term "anchor" is intended to a priori include all such new technologies.

[0547] The term “about” as used in this article refers to ±10%.

[0548] The terms “comprises,” “comprising,” “includes,” “including,” “having,” and their variations, mean “including but not limited to.”

[0549] The term "composed of" means "including and limited to".

[0550] The term "consistently of..." means that the composition, method or structure may contain additional ingredients, steps and / or portions, provided that such additional ingredients, steps and / or portions do not materially alter the basic and novel features of the claimed composition, method or structure.

[0551] As used herein, the singular forms “an,” “a,” and “the” include plural references unless the context clearly specifies otherwise. For example, the terms “a compound” or “at least one compound” can include a plurality of compounds, including mixtures thereof.

[0552] Throughout this application, various embodiments of the invention may be presented in scope. It should be understood that the scope format is merely for convenience and brevity and should not be construed as a rigid limitation on the scope of the invention. Therefore, a description of a scope should be considered to specifically disclose all possible sub-scopes and the individual numerical values ​​within those scopes. For example, a description of a scope such as 1 to 6 should be considered to specifically disclose sub-scopes such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and the individual numbers within those scopes, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the scope.

[0553] Whenever a range of values ​​is indicated herein, it is intended to include any referenced numerical value (fraction or integer) within that range. The phrases “range between the first and second indicator numbers” and “range from the first indicator number to the second indicator number” are used interchangeably herein and are intended to include the first and second indicator numbers as well as all fractions and integers in between.

[0554] It should be understood that certain features of the invention are described in the context of a single embodiment for clarity, but may also be provided in combination in a single embodiment. Conversely, various features of the invention are described in the context of a single embodiment for brevity, but may also be provided individually or in any suitable sub-combination, or as a suitable part of any other described embodiment of the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiment would not function without these elements.

[0555] Although the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be readily apparent. Therefore, it is intended to cover all such alternatives, modifications, and variations falling within the spirit and broad scope of the appended claims.

[0556] The applicant intends to incorporate, in its entirety, all publications, patents, and patent applications referenced herein, as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated herein by reference. Furthermore, any reference or designation of any reference in this application should not be construed as an admission that such reference is prior art to the invention. The use of section headings should not be construed as a necessary limitation. In addition, any priority documents of this application are hereby incorporated herein by reference in their entirety.

Claims

1. A multi-anchor delivery system, comprising: First anchor and second anchor, each anchor having a stitch channel that extends at least partially along the outer surface of the respective anchor. A suture is arranged to slide through the suture channel of each of the first anchor and the second 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. as well as The deployment device is configured to deploy the first anchor and to deploy the second anchor after deploying the first anchor; The stitch is disposed in the stitch channel of the first anchor and the second anchor and is slidable through the stitch channel of the first anchor and the second anchor, and the stitch is configured to be effectively shortened, wherein the distance between the second anchor and the first anchor is reduced after deployment.

2. The multi-anchor delivery system according to claim 1, wherein, The deployment device is configured to deploy the first anchor into the first organization, and is configured to deploy the second anchor near the first organization after deploying the first anchor. The suture is disposed in the suture channel of the first anchor and the second anchor and is slidable through the suture channel of the first anchor and the second anchor, and the suture is configured to be effectively shortened, wherein the distance between the second anchor located proximal to the first tissue and the first anchor deployed in the first tissue is reduced.

3. The multi-anchor delivery system according to claim 1, wherein, The deployment device is adapted to deploy at least one anchor in the first organization, wherein the first organization is a soft organization.

4. The multi-anchor delivery system according to any one of claims 2-3, wherein, The deployment device is configured to deploy the second anchor at a distance close to the first organization.

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

6. The multi-anchor delivery system according to claim 5, wherein, The deployment device is adapted to deliver a first anchor and a second anchor that are a distance from each other, wherein the distance between the second anchor and the proximal side of the first tissue is capable of being reduced so that the second anchor abuts against the proximal side of the first tissue.

7. The multi-anchor delivery system according to any one of claims 1-3, wherein, The deployment device includes: A sheath having a proximal end and a distal end, and having a sheath channel extending through the sheath; A actuator element, the size and shape of which are designed to shift distally through the sheath channel; The first anchor and the second anchor are disposed within the sheath, and the size and shape of the first anchor and the second anchor are designed to shift along the sheath channel. The first anchor and the second anchor each have a proximal end and a distal end. The actuator element is sized and shaped to be displaced along the distal direction. The displacement of the actuator element has a first displacement length and a second displacement length. The first displacement length is at least as long as the distance between the proximal end of the first anchor and the distal end of the sheath, and the first displacement length is sufficient to deploy the first anchor. The second displacement length is at least as long as the distance between the proximal end of the second anchor and the distal end of the sheath, and the second displacement length is sufficient to deploy the second anchor.

8. The multi-anchor delivery system according to any one of claims 1-3, wherein, The first anchor and the second anchor each have a proximal end and a distal end; and The suture includes: The first part is attached to the proximal end of the first anchor and extends from the proximal end of the first anchor to the distal end of the second anchor. The second part extends from the distal end of the second anchor to the proximal end through the channel of the second anchor and toward the proximal end of the second anchor; The third part extends from the proximal end of the second anchor toward the distal end of the first anchor; The fourth part extends from the distal end of the first anchor proximally through the channel of the first anchor, toward the proximal end of the first anchor; and The fifth part extends proximally from the proximal end of the first anchor.

9. The multi-anchor delivery system according to any one of claims 1-3, wherein, Prior to deployment, the second anchor is located near the deployment device relative to the first anchor.

10. The multi-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 elongated body having a first end and a second end and extending along a longitudinal axis in a first orientation, the body being configured to bend into a second orientation, wherein the first end and the second end are closer to each other in the second orientation than in the first orientation.

11. The multi-anchor delivery system according to claim 10, wherein, When the body of at least one of the first anchor and the second anchor is in the first orientation, one end of the suture is configured to be pulled proximally and slide through the channel, the first anchor and the second anchor and the suture are positioned such that a first length of the suture extending through the channel is effectively shortened, and the shortened length of the suture extending through the channel is configured to pull the body along the channel, thereby bending the body into the second orientation.

12. The multi-anchor delivery system according to claim 10, wherein, In the second orientation, the anchor body has a C-shaped or U-shaped configuration, and the channel is located within the bend of the C-shape or U-shape.

13. The multi-anchor delivery system according to claim 10, wherein, In the second orientation, the first end and the second end of the body form an angle with each other.

14. The multi-anchor delivery system according to any one of claims 1-3, wherein, The deployment device includes: A sheath having a proximal end and a distal end, and having a sheath channel extending through the sheath; A actuator element having at least one distal end located within the sheath channel, the distal end of the actuator element being sized and shaped to displace through the sheath channel; A first anchor, disposed within the sheath, wherein at least a portion of the first anchor is located distally relative to the actuator element; and A second anchor is disposed within the sheath and located proximal to the first anchor. The second anchor is disposed within the sheath channel and is sized and shaped to shift along the sheath channel. The size and shape of the actuator element are designed to be shifted along the proximal direction to a position at least proximal to the distal portion of the second anchor; and The size and shape of the actuator element are designed to be displaced in a distal direction, the displacement of the actuator element having a second displacement length, the second displacement length being at least as long as the distance between the proximal end of the second anchor and the distal end of the sheath, the second displacement length being sufficient to deploy the second anchor.

15. The multi-anchor delivery system according to claim 14, wherein, The second anchor overlaps axially with the actuator element.

16. The multi-anchor delivery system according to claim 14, wherein, The second anchor is tubular.

17. The multi-anchor delivery system according to any one of claims 1-3, wherein, The deployment device includes a pusher element that is sized and shaped to shift in a distal direction to contact the first anchor, the shift having a first shift length sufficient to deploy the first anchor.

18. The multi-anchor delivery system of claim 7 further includes a blocking member that narrows the sheath channel, the blocking member impeding proximal displacement of the second anchor.

19. The multi-anchor delivery system according to claim 7, wherein, The second anchor is mounted on the actuator element.

20. The multi-anchor delivery system according to claim 7, wherein, The actuator element extends through the interior of the second anchor.

21. The multi-anchor delivery system according to any one of claims 1-3, wherein, The second anchor can be compressed in the lateral direction.

22. The multi-anchor delivery system according to claim 7, wherein, The second anchor can be compressed in the lateral direction, and the pusher element can be displaced in the proximal direction to a position proximal to the second anchor.

23. The multi-anchor delivery system according to claim 7, wherein, The first anchor has a proximal end, wherein the first anchor includes a blind hole located at the proximal end, and the distal end of the pusher element is sized and shaped to fit the blind hole.

24. The multi-anchor delivery system according to claim 7, wherein, The distal end of the actuator element includes a retaining portion for temporarily holding the second anchor on it.

25. The multi-anchor delivery system according to claim 24, wherein, The retaining portion is a recess for retaining the second anchor.

26. The multi-anchor delivery system according to claim 7, wherein, The actuator element has a compressible distal portion.

27. The multi-anchor delivery system according to any one of claims 1-3, wherein, The first anchor is tubular.

28. The multi-anchor delivery system according to claim 7, wherein, The distal end of the sheath is curved.

29. The multi-anchor delivery system according to claim 7, wherein, The first and second anchors are fully contained within the sheath prior to their deployment.

30. The multi-anchor delivery system according to any one of claims 2-3, the system being used to fix a second tissue or biocompatible material to the first tissue, wherein, The second anchor is configured to secure the second tissue or the biocompatible material to the first tissue.

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

32. The multi-anchor delivery system according to any one of claims 1-3, wherein, At least one of the first anchor and the second anchor includes one of the following: Multiple loops, through which the stitches can extend; as well as Multiple pores through which the suture can pass.

33. The multi-anchor delivery system according to claim 30, wherein, The second anchor meets at least one of the following conditions: Sufficiently thick to cushion the second tissue or the biocompatible material from the pressure exerted on the second tissue or the biocompatible material by the suture; and It is tough enough that the second tissue or the biocompatible material is not damaged by the suture.

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

35. The multi-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 channel extending through the sheath; A first actuator element and a second actuator element are disposed within the sheath, each actuator element having at least one distal end located within a channel of the sheath, the distal end of each actuator element being sized and shaped to be displaced through the channel of the sheath; The first anchor is disposed within the sheath, and at least a portion of the first anchor is located distally relative to the first pusher element. The second anchor is disposed within the sheath and is located on the proximal side relative to the first anchor; The first pusher element is capable of being displaced in a distal direction to contact the first anchor, and the displacement has a displacement length sufficient to deploy the first anchor. The second pusher element is capable of being displaced in a distal direction to contact the second anchor, the displacement having a displacement length sufficient to deploy the second anchor.

36. The multi-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 channel extending through the sheath; A actuator element having at least one distal end located within the sheath channel, the distal end of the actuator element being sized and shaped to displace through the sheath channel; The first anchor is disposed within the sheath, and at least a portion of the first anchor is located distally relative to the actuator element; and The second anchor is disposed within the sheath and located near the first anchor, and is mounted on the actuator element.

37. A multi-anchor delivery kit, comprising the multi-anchor delivery system of claim 36 and a patch configured to be located on a first tissue; in, The first anchor is sized and shaped to be deployed through the patch and into the first tissue; The second anchor is configured to be deployed on the proximal side of the patch; The shortened distance is related to the shortened distance between the patch and the first tissue.

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

39. The multi-anchor delivery kit of claim 37, comprising a third anchor having a stitch channel extending at least partially along the outer surface of the third anchor; in, The suture is arranged to slide through the suture channel of the third anchor, wherein the third anchor is slidable along the suture relative to at least one of the first anchor and the second anchor. The deployment device is configured to deploy the third anchor in or near the first organization after deploying the first anchor. The suture, which is disposed within the suture channel of the third anchor and the first tissue and is slidable through the suture channel of the third anchor and the first tissue, is configured to be effectively shortened, wherein the distance between the third anchor and one of the first anchor and the second anchor is reduced.

40. The multi-anchor delivery system according to claim 7, comprising: in, The actuator element has at least one distal end located within the sheath channel, the distal end of the actuator element being sized and shaped to displace through the sheath channel; Wherein, the first anchor is located on the distal side relative to the pusher element; Wherein, the second anchor is positioned proximal to the first anchor within the sheath, and the second anchor is positioned proximal to the distal end of the pusher element; The actuator element is configured to retract proximally to a position proximally to the second anchor, wherein at least one distal tip portion of the actuator is configured to deform through the second anchor during proximal retraction; and The actuator element is configured to deploy the second anchor.

41. The multi-anchor delivery system according to claim 40, wherein, The actuator element is flexible enough to deform through the second anchor during the proximal retraction of the actuator.

42. The multi-anchor delivery system according to claim 40, wherein, The distal end of the actuator element has two configurations: In a relaxed state, the actuator element can be used to deploy the anchor. as well as In the deformed state, the pusher element can be fitted between the second anchor and the sidewall of the sheath.

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

44. The system according to claim 40, wherein, The first anchor includes a proximal end face, and wherein the pusher element includes a distal end face, the distal end face of which is configured to contact the proximal end face of the first anchor during deployment.

45. The system according to claim 40, wherein, The second anchor includes a proximal end face, and wherein the pusher element includes a distal end face, the distal end face of which is configured to contact the proximal end face of the second anchor during deployment.

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

47. A method for deploying an implant relative to a first tissue, wherein, The method includes: The sheath is delivered through the first tissue, such that the distal end of the sheath penetrates the first tissue; The first anchor is deployed outside the sheath and through the first tissue, the first anchor including a first suture channel, wherein a suture extends through the first suture channel and is slidably passed through the first suture channel; Remove the sheath from the first tissue; Deploying a second anchor outside the sheath, the second anchor having a second stitch channel through which a stitch extends and is slidably pass; and Tighten the sutures extending through the first suture channel and the second suture channel, such that the first anchor is tightened relative to the first tissue.

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

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

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

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

52. The method according to any one of claims 47 and 48, wherein, The tightening includes bending the first anchor.

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

54. The method according to any one of claims 47 and 48, wherein, The tightening includes bending the second anchor.

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

56. The method of claim 54, further comprising positioning a second tissue or biocompatible material proximal to the first tissue, wherein, The first anchor is deployed through the second tissue or the biocompatible material and through the first tissue, wherein the tightening includes applying pressure to the second anchor against the second tissue or the biocompatible material.

57. The method according to claim 56, wherein, The distance between the second tissue or the 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 any one of claims 47 and 48, wherein, Tightening the suture includes leaving a gap between the second anchor and the first tissue.

60. The method of claim 59, further comprising further tightening the suture extending through the first suture channel and the second suture channel to tighten the second anchor against the first tissue.

61. The method according to any one of claims 47 and 48, wherein, The method includes: Positioning a second tissue or biocompatible material onto the first tissue; The delivery includes delivering the sheath through the second tissue or the biocompatible material; The deployment of the first anchor includes deploying the first anchor through the second tissue or the biocompatible material; The withdrawal includes removing the sheath from the second tissue or the biocompatible material; The tightening includes tightening the second anchor relative to the second tissue or the biocompatible material.

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

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

64. The method according to any one of claims 47 and 48, wherein, The first suture channel extends along at least a portion of the first anchor or through at least a portion of the first anchor.

65. The method according to any one of claims 47 and 48, wherein, The second anchor is at least one of being flexible and compressible.

66. The method according to any one of claims 47 and 48, wherein, At least one of the first anchor and the second anchor includes one of the following: Multiple loops, through which the stitches can extend; as well as Multiple pores, through which the suture can pass.

67. The method of claim 61, wherein, The second anchor prevents damage to the second tissue or the biocompatible material in at least one manner: Sufficiently thick to cushion the second tissue or the biocompatible material from the pressure exerted on the second tissue or the biocompatible material by the suture; as well as It is tough enough that the second tissue or the biocompatible material is not damaged by the suture.

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

69. The method according to any one of claims 47 and 48, comprising: A third anchor is deployed outside the sheath and proximal to or through the first tissue, the third anchor including a third suture channel through which the suture extends and is slidably pass.

70. The method according to claim 69, wherein, The tightening includes shortening the 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 the 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 through a second hole in the second tissue or the biocompatible material, and the second anchor is sized and / or shaped such that the second anchor cannot pass through the second hole.

73. A method for attaching a biocompatible material to a tissue, wherein, The method includes: The sheath is delivered through the tissue, such that the distal end of the sheath penetrates the tissue; The first anchor is deployed outside the sheath and through the biocompatible material and the tissue, the first anchor including a first channel; Remove the sheath from the tissue; Deploy a second anchor outside the sheath, the second anchor having a second channel; and Tighten the sutures extending through the first and second channels, causing the first anchor to tighten 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 any one of claims 73 and 74, wherein, The second anchor applies a reaction force to the biocompatible material.

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