Patent Description:
The meniscus is a piece of cartilage located within the knee joint, between the top of the tibia and the bottom of the femur. The meniscus serves to facilitate stable movement of the tibia and femur relative to one another, and to absorb shock and to spread load. The meniscus is frequently damaged (e.g., torn) as the result of injury and/or accident. A damaged meniscus can impede proper motion of the knee joint and cause pain, among other problems.

More particularly, the essential role of an intact meniscus, and its importance for proper knee function, has been well documented and accepted by the general orthopedic community. An intact and functioning meniscus is critical to optimally distribute weightbearing forces that transfer through the knee joint while maintaining knee stability. The meniscus is also vital to preserving the articular cartilage surfaces of the knee. Loss of meniscal tissue is considered to be a key precursor to the development of knee osteoarthritis.

A major challenge in repairing a torn meniscus is the fact that the tissue itself is a fibrous structure that is not uniformly vascular. The vascular zones of the meniscus comprise about one third of the meniscus tissue and are generally recognized as the "red-red" and "red-white" zones. The "red-red" zone (i.e., the most highly vascularized portion of the meniscus) is an area in which meniscal repairs are known to heal easily and is located along its outer periphery. The "red-white" zone extends from the most vascular area towards the inner portions of the meniscus where the blood supply eventually declines to nonvascular tissue (which is sometimes referred to as the "white-white" zone). It is believed that proper surgical technique is of great importance if a successful repair is to be achieved in the "red-white" zone. It is generally accepted knowledge that about <NUM>% of all meniscal tears occur in the "red-red" zone, another <NUM>% of meniscal tears occur in the "red-white" zone, and the remaining <NUM>% of meniscal tears occur in the "white-white" (or non-vascularized) zone of the meniscus.

Another significant challenge in repairing a torn meniscus is that the size and shape of the tears vary, making the reduction and apposition of the torn tissue difficult to accomplish. Without proper apposition and stability, torn meniscal tissue will not heal properly.

The art of repairing torn meniscal tissue was first developed and pioneered throughout the <NUM> by early sports medicine-focused surgeons. The earliest methods employed only suture in the repair. The techniques of "inside-out" and "outside-in" suturing became the so-called "gold standard for the repair of meniscal tissue. Both of these techniques focused on passing small diameter suture (size <NUM>-<NUM> or <NUM>-<NUM>) through the meniscus, reducing and closing the tear, and then tying a suture knot over the knee capsule so as to fixate and stabilize the tear. A feature of these early all-suture repairs was that the surface of the meniscus was kept relatively smooth since the suture knot was outside of the knee joint, and the use of a needle and suture allowed the surgeon a great deal of flexibility in adequately reducing and stabilizing the tear.

Eventually, these early surgeons began concomitant use of complementary techniques to promote a vascular response in the more non-vascular areas of the meniscus. Methods such as tear edge and meniscapsular rasping, the application of an interpositional blood clot, trephination to create a vascular channel, and fascial sheath or synovial flap coverage have been shown in several studies to be <NUM>% more effective in healing a torn meniscus when compared to repairs that do not use such concomitant techniques.

The specific issues and challenges associated with the aforementioned all-suture inside-out and outside-in repair techniques are centered primarily on issues relating to the "user interface" and to the "tethering" of the meniscus to the knee capsule. More particularly, the "user interface" issues generally relate to the technical demands required in the operating room: the skill of the surgeon and the number of assistants required to safely pass the needle and suture from the anterior portion of the meniscus through the posterior portion of the meniscus and exit out through the posterior/medial aspect of the knee joint (i.e., the so-called "inside-out" technique); or the passing of a needle and suture from the medial aspect of the exterior of the knee into the knee joint, through the meniscus, the retrieval and re-insertion back into the meniscus, and then passage back out through the capsule to the medial aspect of the knee (i.e., the so-called "outside-in" technique). The aforementioned tethering issues relate to more recent concerns about fixating suture over the knee capsule and thereby "tethering" the meniscus to the knee capsule, since evidence suggests that such tethering of the meniscus to the knee capsule may interfere with the normal biomechanics of the meniscus (e.g., load and force distribution, etc.).

As recognition of the importance of the meniscus grew in the late <NUM>, new methods of meniscus repair were developed. These new methods focused on improving execution of the procedure in order to make it easier, simpler and faster to accomplish. The new gold standard approach became the so-called "all-inside" technique. The all-inside technique is intended to not violate the knee capsule or require any incisions on the posterior/medial aspects of the knee (i.e., such as is required with the inside-out and outside-in suturing techniques discussed above). With the all-inside technique, the entire repair both approximation and fixation is performed intraarticularly.

The first all-inside repair devices were tack-like implants that were inserted through a standard arthroscopic portal and then forcefully pushed through the meniscus, crossing through the tear, thereby closing and fixing the tear without the use of suture. These tack-like implants were formed out of biomaterials such as PLA, PLLA or PGA that were expected to biodegrade over time. However, these materials are quite hard when first inserted and, in use, were found to degrade or bioabsorb much more slowly than anticipated. Clinical use and follow-up have demonstrated the inherent risks associated with the use of tack-like implants within the knee joint, as numerous published studies have reported device failure which can lead to tear reformation, loose implants within the knee joint and articular cartilage damage. Furthermore, it can be challenging for the surgeon to adequately address various tear shapes and sizes using these tack-like implants.

As a result, attention has returned to suture-based repairs, with a new focus on performing a suture-based repair using an all-inside technique. There are several recent systems that seek to accomplish this goal. An anchor system from which the pre-characterising first part of claim <NUM> starts out is disclosed in <CIT>. Related art is disclosed in <CIT>, <CIT> and <CIT>. However, none of these systems have been found to be completely satisfactory.

Thus, there is a need for a new and improved apparatus for meniscal repair.

The above object is solved by an anchor system as set forth in the appended claims. Embodiments of the present invention are directed to a system for repairing soft tissue tears such as meniscal tears. According to one aspect, the anchor system has a first implant connected to a length of suture. The length of suture is folded such that a tensioning limb extends from the first implant and a locking limb extends from the first implant. The anchor system also includes a second implant fixed to the locking limb and an adjustment mechanism in the length of a suture between the first implant and the second implant. The tensioning limb is passed through the adjustment mechanism.

Also disclosed herein is a delivery device. The delivery device includes an elongated body with a needle extending distally therefrom and a pusher assembly within the elongated body. The pusher assembly has a cannulated pusher rod extending distally from a pusher body and an actuator extending from the pusher body through the elongated body. The cannulated pusher rod is slidable within the needle. The delivery device also includes a locking mechanism on the elongated body which is movable between a locked position and unlocked position. The actuator is moveable from a first configuration to a second configuration when the locking mechanism is in the locked position and the actuator is moveable from the second configuration to a third configuration when the locking mechanism is in the unlocked position.

Also disclosed herein is a method for meniscal repair, which is not part of the invention. The method includes the steps of: (i) providing a delivery device an elongated body with a needle extending distally therefrom, a pusher assembly within the elongated body, the pusher assembly comprising a cannulated pusher rod extending distally from a pusher body and an actuator extending from the pusher body through the elongated body, wherein the cannulated pusher rod is slidable within the needle, and a locking mechanism on the elongated body, the locking mechanism movable between a locked position and unlocked position; (ii) providing an anchor system having a first implant connected to a length of suture, the length of suture folded such that a tensioning limb extends from the first implant and a locking limb extends from the first implant, a second implant fixed to the locking limb, and an adjustment mechanism in the length of suture between the first implant and the second implant, wherein the tensioning limb is passed through the adjustment mechanism; (iii) positioning the needle at a first piercing location on a first side of a tissue; (iv) piercing the needle through the first piercing location to a second side of the tissue; (v) moving the actuator distally, deploying the first implant from the delivery device; (vi) removing the needle from the first piercing location on the first side of the tissue; (vii) positioning the needle at a second piercing location on a second side of the tissue; (viii) piercing the needle through the first piercing location to a second side of the tissue; (ix) moving the locking mechanism from the locked position to the unlocked position; and (x) moving the actuator farther distally, deploying the second implant from the delivery device.

One or more aspects of the present invention are particularly pointed out and distinctly claimed as examples in the claims at the conclusion of the specification. The foregoing and other objects, features, and advantages of the invention are apparent from the following description taken in conjunction with the accompanying drawings in which:.

Aspects of the present invention and certain features, advantages, and details thereof, are explained more fully below with reference to the non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the invention in detail. It should be understood, however, that the detailed description and the specific non-limiting examples, while indicating aspects of the invention, are given by way of illustration only, and are not by way of limitation. Various substitutions, modifications, additions, and/or arrangements, within the scope of the underlying inventive concepts will be apparent to those skilled in the art from this disclosure.

Referring now to the figures, wherein like reference numerals refer to like parts throughout, <FIG> shows a side perspective view schematic representation of an anchor system <NUM>, according to an embodiment. The anchor system <NUM> includes a first implant <NUM> and a second implant <NUM> interconnected by a length of suture <NUM>. The length of suture <NUM> terminates in a first end <NUM> and a second end <NUM>. The length of suture <NUM> is used to adjust the position of the first implant <NUM> relative to the second implant <NUM> (and/or vice versa) by creating an one-way adjustable loop via an adjustment mechanism <NUM> and a locking mechanism <NUM>. In some embodiments, the adjustment mechanism <NUM> is an eye splice (i.e., finger trap), while in other embodiments, the adjustment mechanism <NUM> is a sliding knot. The adjustment mechanism <NUM> can be any one-way adjustable locking construct. In an embodiment, the locking mechanism <NUM> is a pierce hitch. However, the locking mechanism <NUM> can be any fixed locking construct, such as a knot.

As shown in <FIG>, the first and second implants <NUM>, <NUM> are rectangular so they lay flat against the damaged tissue. However, the implants <NUM>, <NUM> may have any other geometric configuration. The first and second implants <NUM>, <NUM> can be composed of suture material, plastic, or any other suitable surgical material. As shown in <FIG>, each implant <NUM>, <NUM> has a pair of adjacent, spaced apertures <NUM>. In the depicted embodiment, the pair of adjacent, spaced apertures <NUM> extend through a first side <NUM> of the implant <NUM>, <NUM> to a second side <NUM> of the implant <NUM>, <NUM>. The implant <NUM>, <NUM> has a radiused saddle <NUM> between the apertures <NUM> to maintain the suture <NUM> thereacross when the anchor system <NUM> is in a deployed configuration.

Turning now to <FIG>, there are shown perspective views schematic representations of a method for creating the locking mechanism <NUM> in the length of suture <NUM>, according to an embodiment. In the embodiment shown in <FIG>, the locking mechanism <NUM> is a pierce hitch. To create a pierce hitch <NUM>, a hole <NUM> is formed in the length of suture <NUM> between the first end <NUM> and the second end <NUM>. A threader <NUM> or another similar device is placed through the hole <NUM> in the length of suture <NUM>, as shown in <FIG>. Thereafter, the first end <NUM> of the suture <NUM> is threaded or woven through the threader <NUM>, as shown in <FIG>. Then, the threader <NUM> is pulled through the hole <NUM> in the length of suture <NUM>, creating a loop <NUM> in the suture <NUM>, as can be seen in <FIG>. To minimize the loop <NUM>, thereby creating the pierce hitch <NUM> shown in <FIG>, the first end <NUM> of the suture <NUM> is tensioned.

Referring now to <FIG>, there is shown a perspective view schematic representation of the length of suture <NUM> connected to the second implant <NUM>, according to an embodiment. In the depicted embodiment, the second implant <NUM> comprises the pair of adjacent, spaced apertures <NUM>. The second end <NUM> of the length of suture <NUM> is first passed through one of the adjacent, spaced apertures <NUM> from a first side <NUM> of the implant <NUM>. Then, the second end <NUM> of the length of suture <NUM> is passed through the other of the adjacent, spaced apertures <NUM> from a second side <NUM> of the implant <NUM> such that an intermediate portion 128B of suture <NUM> extends between the adjacent, spaced apertures <NUM> on the second side <NUM> of the implant <NUM> (over the radiused saddle <NUM>). Finally, the second end <NUM> of the length of suture <NUM> is passed through the pierce hitch <NUM>, as shown in <FIG>, resulting in a "pierce hitch tail" <NUM> extending to the first end <NUM> of the suture <NUM> and a "tensioning limb" <NUM> extending to the second end <NUM> of the suture <NUM>. The pierce hitch <NUM> functions as a self-collapsing noose around the pierce hitch tail <NUM> and is stationary relative to the position of the adjustment mechanism <NUM> (<FIG>).

Turning now to <FIG>, there is shown a perspective view schematic representation of the anchor system <NUM>, according to an embodiment. From the configuration shown in <FIG>, the first implant <NUM> is connected to the length of suture <NUM>. The second end <NUM> of the length of suture <NUM> is passed through one of the pair of adjacent, spaced apertures <NUM> from the second side <NUM> of the implant <NUM>. Then, the second end <NUM> of the length of suture <NUM> (i.e., tensioning limb <NUM>) is passed through the other of the adjacent, spaced apertures <NUM> from the first side <NUM> of the implant <NUM> such that an intermediate portion 128A (<FIG>) of the suture <NUM> extends between the adjacent, spaced apertures <NUM> on the first side <NUM> of the implant <NUM> (over the radiused saddle <NUM>). Finally, the second end <NUM> of the length of suture <NUM> (i.e., tensioning limb <NUM>) is passed through the adjustment mechanism <NUM>. The tensioning limb <NUM> is slidable relative to the pierce hitch tail <NUM> (as the pierce hitch tail <NUM> does not slide).

Referring now to <FIG>, there is shown a perspective view schematic representation of the anchor system <NUM>, according to an embodiment. As shown in the depicted embodiment, the adjustment mechanism <NUM> is an eye splice. The eye splice <NUM> is formed in the length of suture <NUM> and the second end <NUM> of the length of suture <NUM> (i.e., tensioning limb <NUM>) is passed through the eye splice <NUM>, creating an adjustment loop <NUM> in the suture <NUM> between the first implant <NUM> and the eye splice <NUM>. Thus, in the pre-deployment configuration, the intermediate portion 128A extends between the apertures <NUM> on the first side <NUM> of the first implant <NUM> and the intermediate portion 128B extends between the apertures <NUM> on the second side <NUM> of the second implant <NUM> with the eye splice <NUM> and the pierce hitch <NUM> therebetween. To adjust the adjustment loop <NUM> (i.e., change its diameter), the second end <NUM> of the suture <NUM> is pulled, moving the first implant <NUM> and second implant <NUM> closer together.

Turning now to <FIG>, there are shown various views schematic representations of the anchor system <NUM>, according to alternative embodiments. <FIG> shows a side view of the anchor system <NUM> according to an alternative embodiment wherein the first and second implants <NUM>, <NUM> are cannulated anchors (or any other tubular constructs). The cannulated anchors <NUM>, <NUM> are composed of soft material, such as suture material. In the depicted embodiment, a length of suture <NUM> is folded in half, creating a sliding limb <NUM> and a non-sliding limb <NUM> (i.e., a tensioning limb <NUM> and a pierce hitch tail <NUM>).

Still referring to <FIG>, the length of suture <NUM> is passed through the first and second cannulated anchors <NUM>, <NUM>. A knot <NUM> is used to affix the second cannulated anchor <NUM> to the non-sliding limb <NUM>. An eye splice <NUM> is formed in the non-sliding limb <NUM> between the first and second cannulated anchors <NUM>, <NUM>. The first cannulated anchor <NUM> is slidably connected to the suture <NUM> (the sliding limb <NUM>). The sliding limb <NUM> is then passed through the eye splice <NUM>, creating an adjustment loop <NUM>, as shown in <FIG>.

<FIG> and <FIG> show perspective views schematic representations of the anchor system <NUM> of <FIG>. In <FIG>, the first cannulated anchor <NUM> is slidably attached to the suture <NUM> by passing the adjustment loop <NUM> through a slit <NUM> (or another type of segment) in the first cannulated anchor <NUM>. Specifically, as shown in <FIG>, the adjustable loop segment <NUM> is passed through the slit <NUM> in the first cannulated anchor <NUM> and exited out of a side <NUM> of the anchor <NUM>. Then, the adjustable loop segment <NUM> is passed over a distal end <NUM> of the first cannulated anchor <NUM>, thereby lassoing it, as shown in <FIG>.

<FIG> shows a perspective view schematic representation of an anchor system <NUM>, according to another alternative embodiment. The implants <NUM>, <NUM> in <FIG> are also cannulated anchors (or any other tubular constructs). In the depicted embodiment, the cannulated anchors <NUM>, <NUM> are composed of braided material. A length of suture <NUM> adjustably connects the first cannulated anchor <NUM> and the second cannulated anchor <NUM>. In an embodiment, the length of suture <NUM> is a <NUM>-<NUM> suture, although other types of suture can be used. The length of suture <NUM> is folded in half so that both ends <NUM>, <NUM> terminate on the same side and the other end forms a "U" shape (as also shown in <FIG>). The second cannulated anchor <NUM> is secured to the suture <NUM> via a knot <NUM> in the length of suture <NUM>. As with the previous embodiments of the anchor system <NUM>, an eye splice <NUM> is formed in a locking limb <NUM> (also referred to herein as a non-sliding limb or pierce hitch tail) of the length of suture <NUM>. The other limb, a tensioning limb <NUM>, is passed through the eye splice <NUM>, forming an adjustment loop <NUM>. Similar to the anchor system <NUM> shown in <FIG> and <FIG>, the adjustment loop <NUM> extends around the distal end <NUM> of the first cannulated anchor <NUM>.

Referring now to <FIG>, there are shown various views schematic representations of a delivery device <NUM>, according to an example. The delivery device <NUM> is configured to store one or more anchor systems <NUM> therein for deployment. <FIG> shows a perspective view of the delivery device <NUM>. The delivery device <NUM> comprises an elongated body <NUM> having a proximal end <NUM> and a distal end <NUM>. The delivery device <NUM> comprises an adjustable introducer sleeve <NUM> and a stop (not shown) with a positive locking mechanism (not shown) extending from the distal end <NUM> of the elongated body <NUM>. A needle <NUM> extends distally from within the introducer sleeve <NUM>. The anchor system <NUM> (<FIG>) is disposed completely within the needle <NUM> of the delivery device <NUM>. A cannulated pusher rod <NUM> extends within a lumen <NUM> of the needle <NUM> of the delivery device <NUM>. The purpose of the cannulated pusher rod <NUM> is to push the anchor system <NUM> from the delivery device <NUM>, as described in detail below. The elongated body <NUM> additionally comprises an actuator <NUM> and a locking mechanism <NUM>.

Turning now to <FIG>, there is shown a perspective view schematic representation of a pusher assembly <NUM> of the delivery device <NUM>, according to an example. The pusher assembly <NUM> comprises a pusher body <NUM> with the cannulated pusher rod <NUM> extending distally therefrom. The pusher body <NUM> comprises the actuator <NUM>. In the depicted example, the actuator <NUM> is a thumb slide. The cannulated pusher rod <NUM> comprises a relieved area <NUM> between a distal end <NUM> of the pusher assembly <NUM> and the pusher body <NUM>. The relieved area <NUM> is where a portion of the cannulated pusher rod <NUM> has been removed. The relieved area <NUM> allows for ease of rounding a corner or bend formed in the needle <NUM>.

Still referring to <FIG>, the cannulated pusher rod <NUM> also comprises a slit <NUM> at the distal end <NUM> of the pusher assembly <NUM>. As shown, the slit <NUM> extends into the distal end <NUM> of the cannulated pusher rod <NUM> from the relieved area <NUM>. This allows an end <NUM>, <NUM> of suture <NUM> to be positioned within the slit <NUM>. The cannulated pusher rod <NUM> can then be drawn proximally toward an opening <NUM> (<FIG>) of the needle <NUM>, creating a pinch point <NUM> between the cannulated pusher rod <NUM> and the lumen <NUM> of the needle <NUM> and severing an end <NUM>, <NUM> of the suture <NUM>.

Turning now to <FIG>, there are shown side views schematic representations of the delivery device <NUM> in numerous configurations, according to an example. In the first configuration, the actuator <NUM> is a first distance from the distal end <NUM> of the elongated body <NUM>, as shown in <FIG>. In the first configuration, delivery device <NUM> is prepared to deploy the anchor system <NUM>. In the second configuration, the actuator <NUM> is a second distance from the distal end <NUM> of the elongated body <NUM>, as shown in <FIG>. In an example, the first distance is greater than the second distance. When moving from the first configuration to the second configuration, the first implant <NUM> is deployed. Thus, by moving the actuator <NUM> (e.g., thumb slide) distally along the elongated body <NUM>, the first implant <NUM> is deployed.

In both the first and second configurations, in <FIG> and <FIG>, the locking mechanism <NUM> is in the locked position. In the depicted example, the locking mechanism <NUM> is a lockout switch. The lockout switch <NUM> is slidable or otherwise movable between a locked position and an unlocked position. In the locked position, as shown in <FIG> and <FIG>, the actuator <NUM> cannot advance distally from the second configuration in <FIG>. The actuator <NUM> cannot advance distally along the elongated body <NUM> past the lockout switch <NUM>. The lockout switch <NUM> can be depressed and moved to the unlocked position, as shown in <FIG>.

When the lockout switch <NUM> is in the unlocked position, as shown in <FIG>, the actuator <NUM> can move distally to a third distance from the distal end <NUM> of the elongated body <NUM> to achieve the third configuration shown in <FIG>. When moving from the second configuration to the third configuration, the pusher rod <NUM> is extended out of the needle <NUM>, deploying the second implant <NUM>. In the third configuration, the relieved area <NUM> is exposed between the pusher rod <NUM> and the needle <NUM>, as shown.

In the third configuration, suture <NUM> can be moved into the relieved area <NUM> between the pusher rod <NUM> and the needle <NUM>. With the end(s) <NUM>, <NUM> of suture <NUM> extending through the relieved area <NUM>, the delivery device <NUM> can be moved from the third configuration to a fourth configuration. To move the delivery device <NUM> from the third configuration to the fourth configuration, the actuator <NUM> is pulled in the proximal direction. When the delivery device <NUM> moves from the third configuration to the fourth configuration (<FIG>), the cannulated pusher rod <NUM> is drawn back into the needle <NUM>, allowing the end(s) <NUM>, <NUM> of suture <NUM> to be cut against needle <NUM>.

Referring now to <FIG>, there are shown various views schematic representations of a delivery device <NUM>, according to an alternative example. <FIG> and <FIG> show an optional latching slide <NUM> and a tensioning wheel <NUM> of the elongated body <NUM> of the delivery device <NUM>. The delivery device <NUM> also includes the actuator <NUM> on an opposing side of the elongated body <NUM> relative to the latching slide <NUM>. As shown in <FIG>, a rack <NUM> within the elongated body <NUM> connects to the cannulated pusher rod <NUM> and moves the cannulated pusher rod <NUM> in and out from the needle <NUM>.

Still referring to <FIG>, the actuator <NUM> comprises a ratchet mechanism for selectively advancing the cannulated pusher rod <NUM>. When the actuator <NUM> is pulled in the proximal direction, the rack <NUM> is moved distally, driving the cannulated pusher rod <NUM> in the distal direction. The actuator <NUM> may have a spring return such that the actuator <NUM> returns back to its first (or starting) configuration when released. The tensioning wheel <NUM> extends partially through the elongated body <NUM> such that suture <NUM> extending within the needle <NUM> can wrap around the tensioning wheel <NUM>. The tensioning wheel <NUM> provides traction on the suture <NUM> when the implants <NUM>, <NUM> are deployed. In the depicted example, the tensioning wheel <NUM> comprises teeth <NUM> for gripping the suture <NUM>. The latching slide <NUM> is optional and can be used to selectively lock the tensioning wheel <NUM> against rotation.

In a first configuration, as shown in <FIG> and <FIG>, the cannulated pusher rod <NUM> extends within the needle <NUM>. The delivery device <NUM> can then be moved from the first configuration to a second configuration, shown in <FIG>. To move the delivery device <NUM> from the first configuration to the second configuration, the actuator <NUM> is squeezed or pulled in the proximal direction. Moving the actuator <NUM> proximally, drives the rack <NUM> distally and as a result, pushes the cannulated pusher rod <NUM> distally out from the needle <NUM>, expelling the first implant <NUM> from the needle <NUM>. The actuator <NUM> can be released and then pulled proximally again when it is time to expel and deploy the second implant <NUM>. The actuator <NUM> can also be maintained in the second configuration (<FIG>) by holding the actuator <NUM> proximally, exposing the relieved area <NUM>. With the relieved area <NUM> exposed, the ends <NUM>, <NUM> of suture <NUM> can be extended into the relived area <NUM>. When the actuator <NUM> is then released (<FIG>), the end(s) <NUM>, <NUM> of suture <NUM> are cut against the needle <NUM>.

Referring now to <FIG>, there are shown various views schematic representations of the anchor system <NUM> in various stages between the pre-deployment configuration and deployed configuration, according to an alternative embodiment. As stated above, the anchor system <NUM> (<FIG>) is disposed completely within the needle <NUM> of the delivery device <NUM>. For example, the first implant <NUM> is loaded distally in the needle <NUM> relative to the second implant <NUM> with the pierce hitch tail <NUM> and the tensioning limb <NUM> extending proximally therefrom within the delivery device <NUM>. (Note, it is contemplated that multiple anchor systems <NUM> can be loaded into the delivery device <NUM> with the first implant <NUM> of an additional anchor system <NUM> behind the second implant <NUM> of the primary anchor system <NUM>).

In an embodiment, the pierce hitch tail <NUM> is releasably connected to the delivery device <NUM> and functions as a tether used to control the delivery of the second implant <NUM> and apply traction to the first implant <NUM>. To deploy the anchor system <NUM>, the delivery device <NUM> is placed on a first side <NUM> of a tissue <NUM> or other object. As shown in <FIG>, the tissue <NUM> comprises a tear <NUM> (or cut or other tissue injury). The delivery device <NUM>, in the first configuration, is placed on the first side <NUM> of the tissue <NUM> and the tear <NUM>. The needle <NUM> is advanced through the tissue <NUM> and the tear <NUM>, at a first piercing location <NUM>, and out of a second, opposing side <NUM> of the tissue <NUM> (<FIG>).

With the needle <NUM> on the second side <NUM> of the tissue <NUM>, the actuator <NUM> is engaged, e.g., the thumb slide <NUM> is advanced in the distal direction along the elongated body <NUM>, driving the cannulated pusher rod <NUM> distally to achieve the second configuration. In the second configuration, the cannulated pusher rod <NUM> pushes the first implant <NUM> from the delivery device <NUM> and it is deployed on the second side <NUM> of the tissue <NUM>, as shown in <FIG>. The needle <NUM> is then withdrawn from the first piercing location <NUM> on the first side <NUM> of the tissue <NUM> (<FIG> and <FIG>). In the embodiment of the delivery device <NUM> shown in <FIG>, the suture <NUM> can be tractioned by the tensioning wheel <NUM> as the needle <NUM> is withdrawn. The needle <NUM> is then moved to a second piercing location <NUM> (adjacent to the first piercing location <NUM>) on the first side <NUM> of the tissue <NUM> and tear <NUM> (<FIG>).

The needle <NUM> is then advanced through the first side <NUM>, the tear <NUM>, and the second side <NUM> of the tissue <NUM> at the second piercing location <NUM> (<FIG>). With the needle <NUM> on the second side <NUM> of the tissue <NUM>, the delivery device <NUM> is moved to the third and fourth configurations. From the second configuration, the lockout switch <NUM> is depressed or otherwise engaged to allow for additional distal movement of the actuator <NUM>. With the lockout switch <NUM> in the unlocked position, the actuator <NUM> is moved distally to the third configuration, driving the cannulated pusher rod <NUM> distally again. In the third configuration, the cannulated pusher rod <NUM> pushes the second implant <NUM> from the delivery device <NUM> and it is deployed, as also shown in <FIG>.

Any time after the second implant <NUM> is deployed, the pierce hitch tail <NUM> can be released (i.e., releasing the tether and traction), allowing for the delivery device <NUM> to be removed, i.e., the needle <NUM> is pulled back through the second piercing location <NUM> to the first side <NUM> of the tissue <NUM>. With the anchor system <NUM> deployed, the anchor system <NUM> can be used to move the first side <NUM> of the tissue <NUM> and the second side <NUM> of the tissue <NUM> together in order to close the tear <NUM>. To do this, the adjustable loop <NUM> is tightened (i.e., a diameter of the adjustable loop <NUM> decreases) or is otherwise collapsed by pulling/tensioning the second end <NUM> (or the tensioning limb <NUM>) of the suture <NUM> (<FIG>). Tensioning the second end <NUM> pulls both implants <NUM>, <NUM> toward the second side <NUM> of the tissue <NUM>, decreasing the length of suture <NUM> between them. In <FIG>, there are shown two anchor systems <NUM>, each with a different adjustment mechanism <NUM>. The anchor system <NUM> on the left comprises a sliding knot 108A and the anchor system <NUM> on the right comprises an eye splice 108B. The eye splice 108B (and the sliding knot 108A) locks the first implant <NUM> in relative position to the second implant <NUM>. The pierce hitch <NUM> maintains the position of the second implant <NUM> along the suture <NUM>.

After the desired compression is achieved (between the first implant <NUM> and the second implant <NUM>) and with the delivery device <NUM> still in the third configuration, the relieved area <NUM> is exposed between cannulated pusher rod <NUM> and the needle <NUM>. The delivery device <NUM> can be rotated or otherwise maneuvered to receive the excess tensioning limb <NUM> in the relived area <NUM>. The actuator <NUM> can then be engaged again, e.g., by sliding the thumb slide <NUM> back in the proximal direction (toward the proximal end <NUM> of the elongated body <NUM>). Moving the actuator <NUM> proximally, pulls the cannulated pusher rod <NUM> proximally into the needle <NUM>, allowing the excess tensioning limb <NUM> to be cut against the needle <NUM> and removed. The same process can be repeated (or occur simultaneously) with any excess pierce hitch tail <NUM> remaining. The resulting deployed configuration of the anchor system <NUM> is shown in <FIG>. <FIG> and <FIG> show alternative embodiments wherein the implants <NUM>, <NUM> are cannulated anchors.

It will be further understood that the terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as, "has" and "having"), "include" (and any form of include, such as "includes" and "including"), and "contain" (any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a method or device that "comprises", "has", "includes" or "contains" one or more steps or elements. Likewise, a step of method or an element of a device that "comprises", "has", "includes" or "contains" one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

Claim 1:
An anchor system, comprising:
a first implant (<NUM>) connected to a length of suture (<NUM>), the length of suture folded such that a tensioning limb (<NUM>) extends from the first implant to a second end (<NUM>) and a locking limb (<NUM>) extends from the first implant to a first end (<NUM>);
a second implant (<NUM>); and
an adjustment mechanism (<NUM>) in the length of suture between the first implant (<NUM>) and the second implant (<NUM>),
wherein the tensioning limb (<NUM>) is passed through the adjustment mechanism (<NUM>), and
the second implant (<NUM>) is fixed to the locking limb (<NUM>) via a pierce hitch (<NUM>) in the locking limb,
characterized in that
the pierce hitch (<NUM>) is formed by inserting the end (<NUM>) of the locking limb (<NUM>) through a hole in the locking limb,
both the first and second implants (<NUM>, <NUM>) are configured to lie flat against damaged tissue, and
the length of suture (<NUM>) is connected to the second implant (<NUM>) by its second end (<NUM>) passing through one of a pair of apertures (<NUM>) in the second implant (<NUM>), then through the other of the pair of apertures (<NUM>) in the second implant (<NUM>) and then through the pierce hitch (<NUM>).