Patent Description:
The present disclosure relates to methods and devices for joint repair, including graft fixation in a surgical repair.

Native soft tissue (such as ligaments and tendons of a joint) that is damaged may generally be replaced or repaired arthroscopically. For some joint repairs, a tissue fixation system with an adjustable loop construct may be coupled to a graft (and/or also the native soft tissue) and inserted along a bone tunnel. The adjustable loop construct may then be adjusted or reduced to position the graft in a target location along the bone tunnel and fixed in place with a tissue anchor, such as a cortical button. Cortical buttons may define a thin body to lie flat on a bone external surface and limit palpability, while supporting the fixation loading on the adjustable construct. Related art cortical buttons may bend under this fixation loading. Related art adjustable loop constructs may loosen via loop slip or creep under this loading. Related art adjustable loop constructs may require extreme forces to reduce the adjustable loop construct and position the graft. Related art fixation systems may require complicated assembly and management to stage the steps of the procedure. Related art fixation systems may require high forces during coupling of the grafts to the system, potentially damaging the tissue and/or grafts, or the adjustable loop construct. There is therefore a need for an improved fixation system with associated methods that address the related art shortcomings. <CIT> discloses a cortical button in accordance with the prior art.

The cortical button in accordance with the invention is defined in claim <NUM>. Further embodiments of the invention are recited in the dependent claims.

Described herein are various improvements in methods and devices for tissue fixation using a loop construct that may be adjustable and may be formed with a flexible strand. A flexible strand may comprise suture, suture tape, cable, wire or ribbon. The suture may comprise a hollow braided suture. Such improvements may include examples of tissue anchors that are partially assembled with an adjustable loop construct, and further assembled after the adjustable loop construct has been coupled to a tissue, a graft or a second tissue anchor. The tissue anchor is preferably configured to remain sufficiently rigid to withstand the tissue fixation loads. Such improvements may include an adjustable loop construct that affords loop reduction with accessible hand tension, while also providing a knotlessly locked configuration that withstands physiological cyclic loading. Such improvements may include an assembly including a reduction handle with a tissue anchor and an adjustable loop construct housed therein, the assembly arranged in such a way as to manage the steps of releasing the adjustable loop construct and anchor from the reduction handle for coupling the adjustable loop to the tissue, graft or second tissue anchor. The handle may also be configured to re-assemble with the adjustable loop construct for reducing the adjustable loop and positioning the tissue, graft or second tissue anchor. Such improvements may include a passing construct operatively coupled to the adjustable construct in an arrangement that reduces passing forces required to thread the adjustable loop strands through a tissue or graft. Such improvements may include a method of attaching soft tissue or graft to an adjustable loop construct that concomitantly forms a low-profile end of the soft tissue or graft and provides a secure attachment.

For example, a cortical button is disclosed herein that is an oblong body, having a length greater than a width. The oblong body extending from a first end to a second end and defining a longitudinal axis. The width extends from a first sidewall to a second sidewall, the first and second sidewalls extending between the first and second ends along and either side of the longitudinal axis. The body also includes a lower surface configured to engage an external bone surface. The body further includes a pair of slotted apertures extending through an entire thickness of the body for receiving a loop of flexible strand therethrough. The button includes a rib extending from the body lower surface and disposed between the pair of slotted apertures and coextensive along the longitudinal axis with the pair of slotted apertures. The cortical button configured to be passed through a bone tunnel in an elongate orientation.

Some example button embodiments may also include a pair of enclosed apertures, adjacent the pair of slotted apertures. The rib may also be disposed between the pair of enclosed apertures and coextensive along the longitudinal axis with the pair of enclosed apertures. The cortical button may also include a first end aperture disposed between the pair of slotted apertures and first end, and a second end aperture disposed between the pair of enclosed apertures and second end. The first and second end apertures may be axially separated from the rib. The rib may be an oblong solid body and may have a longitudinal axis coincident with and parallel to the cortical button longitudinal axis. The pair of slotted apertures may each define medial surfaces that extend through the cortical button thickness and are continuous with outer lateral side surfaces of the rib. The pair of slotted apertures may each define a lateral opening through one of the first or second sidewalls, and wherein the rib is configured to compensate for a reduced structural integrity of the cortical button, the reduced structural integrity a result of the lateral openings. The rib may extend perpendicularly from the lower surface, less than <NUM> from the cortical button oblong body. The rib may extend from the lower surface defining a tib thickness that is less than the body thickness.

Another example cortical button is disclosed that is an oblong body, having a length greater than a width, the length extending from a first end to a second end with a longitudinal axis extending therebetween. The width extends from a first sidewall to a second sidewall, the first and second sidewalls extending between the first and second ends along and either side of the longitudinal axis. The body also includes a lower surface configured to engage an external bone surface. The body also includes a pair of slotted apertures extending through an entire thickness of the body for receiving a loop of a flexible strand therethrough. The button anchor includes a rib extending from the lower surface and disposed between the pair of slotted apertures and coextensive along the longitudinal axis with the pair of slotted apertures. The body width defines a minimum diameter of a bone tunnel through which the cortical button may be passed, the rib configured to increase the structural integrity of the cortical button while preserving the minimum diameter.

In some example embodiments, the pair of slotted apertures each define a lateral opening through one of the first or second sidewalls, and the rib is configured to increase the structural integrity and compensate for a loss of structural integrity due to the lateral openings. The body may also include a pair of enclosed apertures, adjacent the pair of slotted apertures, the rib disposed between the pair of enclosed apertures and coextensive along the longitudinal axis with the pair of enclosed apertures. The pair of slotted apertures may each define a lateral opening through one of the first or second sidewalls, and wherein the rib is coextensive along the longitudinal axis with the lateral openings. The button body may also include a first end aperture and a second end aperture, both axially separated from the rib. The rib may be an oblong solid body. The rib may be an oblong body having a longitudinal axis coincident with and parallel to the cortical button longitudinal axis. The pair of slotted apertures may each define medial surfaces that extend through the cortical button thickness and are continuous with outer lateral side surfaces of the rib. The rib may extend perpendicularly from the lower surface, less than <NUM> from the cortical button body. The rib may extend from the lower surface a distance that is less than a thickness of the body.

An adjustable tissue repair system is also disclosed including a tissue anchor with a plurality of apertures therethrough. The system also includes an adjustable loop construct formed from a flexible strand and coupled to the tissue anchor via the plurality of apertures. The adjustable loop construct includes a first adjustable eyesplice loop extending through a first pair of apertures of the plurality of apertures. The adjustable loop construct also includes a second adjustable eyesplice loop configured to couple to a second pair of apertures of the plurality of apertures. The adjustable loop construct also includes a saddle portion extending between the first and second adjustable eyesplice loops and disposed at an opposite end of the adjustable loop construct to the tissue anchor. The adjustable loop construct also includes a first and second limb, the first limb tensionable for shortening the first adjustable eyesplice loop and the second limb tensionable for shortening the second adjustable eyesplice loop.

In some example embodiments, the first and second eyesplice loops each include a locking passage, and wherein each locking passage includes two lengths of the flexible strand therethrough. The saddle portion may define three lengths of the flexible strand extending therealong, between locking passages. One of the three lengths of these flexible strands may be a static strand, such that while adjusting the adjustable loop construct, the static strand does not slide. Static strand defines a fixed or non-adjustable length portion of the adjustable loop construct. The fixed length may be between <NUM>-<NUM> millimeters. The fixed length during ACL repair may be about <NUM> millimeters. The tissue repair system may also include a passing construct including a threading member and a flexible loop, the flexible loop coupled to the saddle portion of the adjustable loop construct. The saddle portion may include three lengths of the flexible strand and wherein the flexible loop may be threaded between the three lengths in a complex loop, to limit sliding of the flexible loop along the adjustable loop construct. The flexible loop may be threaded between the three lengths of flexible strand of the saddle portion to stagger insertion of the three lengths through a graft. The flexible loop may be coupled to the saddle portion and form a figure-of-eight loop around the three lengths of the flexible strand. The figure-of-eight loop may include a first loop that loops around a static length of the three lengths of the flexible strand, and a second loop that loops around two dynamic lengths of the three lengths of flexible strand. The plurality of openings through the tissue anchor may include a pair of lateral slotted openings configured to selectively receive the second adjustable eyesplice loop therethrough. The saddle portion may couple directly to graft or tissue. The first and second eyesplice loops may each extend from a first and second locking passage respectively, and the first eyesplice loop and first limb both extend from a first end of the first locking passage and the second eyesplice loop and second limb both extend from a first end of the second locking passage.

Another adjustable tissue repair system embodiment is disclosed including a tissue anchor with a plurality of apertures therethrough and an adjustable loop construct formed from a flexible strand and coupled to the tissue anchor via the plurality of apertures. The adjustable loop construct may include a first adjustable eyesplice loop extending from a first locking passage, the first adjustable eyesplice loop extending through a first pair of apertures of the plurality of apertures. The adjustable loop construct may include a second adjustable eyesplice loop extending from a second locking passage, the second adjustable eyesplice loop configured to couple to a second pair of apertures of the plurality of apertures. The adjustable loop construct may include a saddle portion extending between the first and second adjustable eyesplice loops, disposed at an opposite end of the adjustable loop construct to the tissue anchor. The adjustable loop construct may include a first and second limb, the first limb tensionable for shortening the first adjustable eyesplice loop and the second limb tensionable for shortening the second adjustable eyesplice loop. The system may include a passing construct including a threading member coupled to a flexible loop, the flexible loop coupled to the saddle portion.

In some example embodiments, the saddle portion includes three lengths of the flexible strand. One of the three lengths of the flexible strand may be a static length of the adjustable loop construct extending between and continuous with the first and second locking passage. The static length may be between <NUM>-<NUM> millimeters long. The flexible loop of the passing construct may be threaded between the three lengths of flexible strand of the saddle portion to stagger insertion of the three lengths through a graft. The flexible loop may be coupled to the saddle portion and form a figure-of-eight loop around the three lengths. The figure-of eight loop may define a first loop that loops around a static length of the three lengths of flexible strand, and a second loop that loops around two dynamic lengths of the three lengths of flexible strand. The first eyesplice loop and the first limb may both extend from a first end of the first locking passage and the second eyesplice loop and the second limb may both extend from a first end of the second locking passage.

An example method of coupling an adjustable tissue repair construct to a graft is also disclosed, the method including obtaining an adjustable tissue repair construct that includes a button, an adjustable loop construct and a passing construct. The button includes a plurality of openings therethrough. The adjustable loop construct is formed with a flexible strand and coupled to the button via the plurality of openings at a first end of the adjustable loop construct. The passing construct includes a flexible strand loop and a threading member, the flexible strand loop separately formed from the adjustable loop construct and coupled to a second end of the adjustable loop construct, at the opposing end to the first end. The method includes forming a stitched region in the graft by first passing the passing construct through the graft in a first direction toward a clamped end of the graft to attach the adjustable loop construct to the graft and then passing the passing construct though the graft in an opposite direction towards a free end of the graft to attach the flexible strand loop to the graft.

In some example methods, advancing the passing construct in the first direction, further comprises drawing the adjustable loop construct through and around the graft at a location spaced away from both the clamped end and free end. The method may include passing the passing construct through the graft adjacent the adjustable loop construct that is threaded around the graft, and thereby locking the adjustable loop construct in place along the graft. Passing the passing construct in the opposite direction may wrap the flexible strand loop around the graft and also over and around the adjustable loop construct. Passing the passing construct in the opposite direction may form at least two whipstitches along and through the graft.

The method may also include passing the passing construct in the opposite direction up to a free end edge of the graft, tying a knot in the flexible strand loop at the free end edge, removing the threading member from the flexible strand loop, leaving a remaining length of flexible strand loop; and drawing the free end of the graft through and along a prepared bone tunnel via the remaining length.

The flexible strand loop may form a figure-of-eight loop, a first loop of the figure-of-eight loop looped around a first strand of a plurality of strands of the adjustable loop construct at the second end, and a second loop of the figure-of-eight loop looped around a second strand of a plurality strands and wherein passing the passing construct in a first direction first passes the second loop and therefore the second strand through the graft, and then passes the first loop and therefore the first strand through the graft. Passing the passing construct in the second direction may leave the first loop of the figure-of-eight loop on a first side of the graft and passes the second loop of the figure-of-eight loop through the graft.

Another example method of coupling a suspensory fixation system to a graft is disclosed, the suspensory fixation system including an adjustable loop construct and a passing construct linked thereto. The method includes forming a first stitched region along the graft by inserting the passing construct through the graft and advancing the passing construct in a first direction toward a clamped end of the graft to stitch the adjustable loop construct through and along the graft. The method also includes forming a second stitched region by inserting the passing construct through the graft and advancing the passing construct in second direction toward a free end of the graft to stitch a flexible loop of the passing construct through and along the graft, the second stitched region overlapping the first stitched region.

In some of these example methods, advancing the passing construct in the first direction begins along a length of the graft spaced away from the free end. Forming the first stitched region may begin at a location along the graft that is about <NUM> from the free end. Inserting the passing construct through the graft and advancing the passing construct in the first direction may include inserting the passing construct a first time to stitch the adjustable loop construct through the graft followed by inserting the passing construct a second time through the graft to secure the adjustable loop construct in place along the graft. Advancing the passing construct in the second direction may include inserting the passing construct a third time and a fourth time through the graft at axially spaced locations, to form a plurality of stitches through the graft with the flexible loop. Passing the passing construct, a third time, may place the flexible loop over the adjustable loop construct. of claim <NUM> wherein inserting the passing construct through the graft a first, second, third and fourth time comprises passing the needle from a top external surface of the graft to a bottom external surface of the graft. After forming the first and second stitched region, the method may include tensioning the flexible loop to form the graft free end into a tapered cylinder. The method may also include drawing the free end into a prepared bone tunnel by drawing the flexible loop through the prepared bone tunnel first and then the graft free end.

In some example methods, the flexible loop may form a complex loop, a first loop of the complex loop looped around a first strand of a plurality of strands of the adjustable loop construct, and a second loop of the complex loop looped around a second strand of the plurality of strands and wherein forming the first stitched region may insert the second loop through the graft first, followed by the first loop, and thereby stagger the insertion of the plurality of strands to reduce a force required to form the first stitched region. Forming the second stitched region may leave the first loop of the complex loop on a top side of the graft and may pass the second loop of the complex loop through the graft. The flexible loop may include a complex loop including a first and second loop, each loop looped around different strands of the adjustable loop construct and advancing the passing construct in second direction may advance only one of the first or second loops.

A reduction bar is also disclosed herein, for managing an adjustable loop construct with a passing construct and a button attached thereto, the reduction bar including a plurality of channels, spools, recesses, and slots therethrough. The reduction bar houses the passing construct, the adjustable loop construct, and the button in a first configuration within the plurality of channels, slots, and spools, in an arrangement that stages the release of the assembled components. The passing construct may be release first, followed by the adjustable loop construct and then the button from the reduction bar to couple the adjustable loop construct to a tissue, graft, or tissue anchor. Once disassembled, the reduction bar may then assemble again to the adjustable loop construct in a second configuration that is different than the first configuration. In this second configuration the reduction bar may be used to reduce a loop of the adjustable loop construct and draw the tissue, graft, or tissue anchor towards the button upon tension being applied via the reduction bar to the adjustable loop construct.

In some example embodiments the reduction bar includes a slot of the plurality of slots that extends along a longitudinal axis of the reduction bar, the slot continuous with a recess, the slot configured to retain a threading member of the passing construct and the recess configured to allow access to an end of the threading member to remove the threading member from the reduction bar. In the second configuration, a first looped limb of the adjustable loop construct may encircle a segment of a first spool of the reduction bar, the segment defined by a notch through the first spool. In the second configuration rotating the reduction bar around a reduction bar longitudinal axis may first form a fold along the first looped limb to limit slipping of the first looped limb around the first spool. The reduction bar may house the button so as to expose two slotted apertures of the button. The reduction bar may house a first portion of the adjustable loop construct around a first spool of the plurality of spools and a second portion of the adjustable loop construct around a second spool of the plurality of spools.

Another example embodiment of a reduction handle is disclosed that houses and manages an adjustable loop construct. The adjustable loop construct includes a first end assembled to a cortical button and a second end coupled to a threading element for coupling the second end to a tissue, a graft, or a tissue anchor. The reduction handle defines a longitudinal axis and opposed lateral ends and also includes a slot at one of the lateral ends for retaining the cortical button. The slot may also orient a slotted opening of the cortical button for selectively receiving the adjustable loop second end therethrough. The reduction handle may also include a means of housing the threading element and a means directly adjacent thereto for accessing and selectively removing the threading element from the reduction handle. The reduction handle may also include a first and a second spool extending around an outer surface of the handle, a first and a second loop of the adjustable loop construct receivable in the first spool and second spool respectively.

In some example embodiments the means of housing the threading element includes a plurality of circumferential ribs defining a channel on an external surface of the reduction handle, and wherein a cavity in the handle at an end of the channel defines the means of accessing and selectively removing the threading element. The first and second spools may each define an outermost channel defining a first path, each outermost channel intersected by a corresponding notch defining a second path around a segment of the first path of each spool. The first loop of the adjustable loop construct may be receivable along the notch of the first spool so as to place the first loop along the second path around the first spool. The second loop of the adjustable loop construct may be receivable along the notch of the second spool to place the second loop along the second path around the second spool. The second path around each spool may be configured to form a fold in each loop of the first and second loop and limit spinning of the first and second loop while rotating the handle about its longitudinal axis.

A method of repairing a tissue with a reduction bar is also disclosed, the reduction bar preassembled to an adjustable loop construct, a cortical button, and a threading element. The method may include removing the adjustable loop construct and the threading element from the reduction bar and coupling the adjustable loop construct to a tissue, a graft or a tissue anchor. The method may include coupling a first and a second loop end of the adjustable loop construct to the reduction bar after it has been removed. Tension may then be applied on the first and second loop end via the reduction bar to reduce the adjustable loop construct and draw the tissue, graft, or tissue anchor towards the cortical button.

In some example methods, removing the adjustable loop construct and the threading element may include removing the threading element from a channel of the reduction bar, followed by unspooling a first portion of the adjustable loop construct from a first spool of the reduction bar. Coupling the adjustable loop construct may include inserting the adjustable loop construct through the tissue, graft, or tissue anchor with the threading member. Removing the adjustable loop construct and the threading element from the reduction bar may occur while retaining the button housed within the reduction handle. Coupling may also include coupled a free looped end of the adjustable loop construct to the cortical button after coupling the adjustable loop construct to a tissue, graft, or tissue anchor. Coupling the free looped end may include inserting the threading member through an aperture of the button while the button is housed within the reduction bar, with an aperture external to the reduction bar.

Coupling the first and a second looped ends may include inserting the first looped end along a first notch of the reduction bar to place the first looped end around a segment of a first spool on the reduction bar and inserting the second looped end along a second notch of the reduction bar to place the second looped end around a segment of a second spool of the reduction bar. The method may also include rotating the reduction bar around a longitudinal axis to wrap the first and second looped ends around an outermost surface of the first and second spool respectively and thereby reduce a length of the first and second looped end. Rotating the reduction bar and applying tension on the first and second looped ends may be performed sequentially and repeatedly. The method may include removing the button after coupling the adjustable loop construct to a tissue, graft or tissue anchor and before coupling a first and a second looped end to the reduction bar.

The disclosure will be more fully understood by reference to the detailed description, in conjunction with the following figures, wherein:.

In the description that follows, like components have been given the same reference numerals, regardless of whether they are shown in different examples. To illustrate example(s) in a clear and concise manner, the drawings may not necessarily be to scale and certain features may be shown in somewhat schematic form. Features that are described and/or illustrated with respect to one example may be used in the same way or in a similar way in one or more other examples and/or in combination with or instead of the features of the other examples.

As used in the specification and claims, for the purposes of describing and defining the invention, the terms "about" and "substantially" are used to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The terms "about" and "substantially" are also used herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. "Comprise," "include," and/or plural forms of each are open ended and include the listed parts and can include additional parts that are not listed. "And/or" is openended and includes one or more of the listed parts and combinations of the listed parts. Use of the terms "upper," "lower," "upwards," and the like is intended only to help in the clear description of the present disclosure and are not intended to limit the structure, positioning and/or operation of the disclosure in any manner.

Some of the constructs disclosed herein incorporate "locking passages". These may sometimes be referred to in the art as splices, eyesplices, cradles, suture locking regions, cinches, finger cinches, finger traps, longitudinal passages or dilated regions. They are defined by a length of a braided flexible strand with a hollow core that may receive an elongate strand therethrough. The elongate strand may be a different portion of the flexible strand, or another separate flexible strand and may extend along a path that extends from outside the braided flexible strand (and outside the locking passage) then between the braids to enter the hollow core (lumen) and then exit through the braided wall a distance along the braided flexible strand later. Multiple lengths of flexible strands may extend along and through the hollow core at spaced apart locations, thereby defining multiple locking passages. Multiple lengths of an elongate strand may extend along and through the hollow core at the same location. The braided flexible strand may be dilated first to form a dilated or laterally extended length before receiving the elongate member therein. The locking passage is configured such that tension on the braided hollow flexible strand contracts the radius thereof and thereby locks or cinches around the elongate strand extending therein, locking the elongate strand in place. This defines a "locking passage". The flexible strand may be a suture, suture tape, ribbon, or flexible tubular cable.

<FIG> illustrates a perspective view of a cortical button <NUM> (hereinafter "button <NUM>"), in accordance with example embodiments. Button <NUM> operatively couples to a flexible strand <NUM> (shown in FIGS 3A-<NUM>) via a plurality of openings forming passages through the button <NUM>. Flexible strand <NUM> may be a suture, tape, wire or cable and may be formed in an adjustable loop construct, disclosed in more detail hereinafter. Button <NUM> and flexible strand <NUM> may couple to a graft and suspend the graft along a bone tunnel, for repair of an ACL of a patient's knee for example. In other example joint repairs, button <NUM> and flexible strand <NUM> may couple to another tissue anchor such as a second button, or a soft anchor or other tissue anchors known in the art. When coupled to another tissue anchor, button <NUM> and flexible strand <NUM> may couple a first bone to a second bone, or a first bone segment to a second bone segment, wherein the segments may be parts of the same bone. For example, button <NUM> may form a portion of a repair construct for AC joint or ankle syndesmosis repair.

Button <NUM> may define a passing button; in that it is generally an oblong body with a width that is smaller in dimension than a length thereof. Passing buttons may be oriented in a passing orientation to pass through a bone tunnel, the bone tunnel approximating the anchor width, allowing the bone tunnel to be kept to a minimal opening size. Once through the bone tunnel, flipping the button <NUM> to a deployed configuration (shown in <FIG>) prevents retrograde motion of the button <NUM> into the tunnel, as the button length is greater than the bone tunnel opening size. In the deployed configuration button <NUM> engages the cortical bone outer surface. Button <NUM> may be a flat, oblong unibody with rounded edges. Button <NUM> is preferably thin to limit palpability above the cortical bone surface.

Button <NUM> may include a plurality of apertures therethrough, each aperture sized to receive a flexible strand <NUM> therethrough and couple the flexible strand <NUM> to the button. Flexible strand <NUM> may be at least partially formed in a plurality of loops, in the form of an adjustable loop construct (discussed more in FIGS. 3A-<NUM>), and the plurality of apertures may couple the adjustable loop construct to the button <NUM>. The plurality of apertures may be sized to allow the flexible strand <NUM> to slide.

More specifically, button <NUM> may include a pair of apertures 110a, 110b that may define <NUM> degree (°) bounded holes. Apertures 110a, 110b may be disposed directly opposite each other on opposing sides of the button longitudinal axis L-L. Apertures 110a, 110b may define oblong or oval shaped openings having a length along the longitudinal axis L-L greater than a corresponding width. Apertures 110a, 110b may be sized and spaced relative to each other to slidingly receive a first loop of an adjustable loop construct, formed of flexible strand <NUM>. First loop may be provided pre-assembled to the button <NUM>, and therefore may be referred to as the assembled loop. Button <NUM> may also include a pair of slotted apertures 120a, 120b that have each have a lateral opening (121a, 121b), the lateral openings 121a, 121b for receiving a second loop of the adjustable loop construct therethrough to assemble the second loop to the button <NUM> during the procedure. As such slotted apertures 120a, 120b may be provided separated from the second loop, and the second loop may be assembled to the button <NUM>, entering via lateral openings 121a, 121b during the surgical procedure. Second loop may therefore be referred to as a free loop. Slotted apertures 120a, 120b may define oblong or oval shaped openings similar to apertures 110a, 110b having a length along the longitudinal axis longer than a width. Slotted apertures 120a, 120b may be disposed directly opposite each other on opposing sides of the button longitudinal axis L-L. Slotted apertures 120a, 120b and apertures 110a, 110b may have the same opening size and shape, with the exception that slotted apertures 120a, 120b includes lateral openings 121a, 121b.

Button <NUM> defines an elongate body having opposed rounded ends 105a, 105b and lateral sides 106a, 106b. Apertures 110a, 110b, 120a, 120b may be arranged towards a central portion <NUM> of the button <NUM> spaced away from both ends 105a, 105b. Button also includes another pair of apertures 135a, 135b. Aperture 135a is disposed between the central portion <NUM> and lateral end 105a. Aperture 135b is disposed between the central portion <NUM> and lateral end 105b. Apertures 135a, 135b may be larger in opening size relative to apertures 110a, 110b, 120a, 120b and may define oblong apertures, as defined herein.

Button <NUM> also defines an upper surface <NUM> and lower surface <NUM>, that may both be smooth and planar. Upper and lower surface <NUM>, <NUM> may define planar surfaces that are parallel to each other. Button lower surface <NUM> is configured to engage an external portion of a bone. In some embodiments button lower surface <NUM> may be contoured to match an external surface of the targeted bone surface. Buttons with apertures and slotted apertures and example adjustable loop constructs are disclosed in commonly owned PCT patent application number <CIT>, titled "METHODS AND DEVICES FOR TISSUE GRAFT FIXATION".

As discussed herein, surgical fixation systems with cortical buttons may operate to couple to and suspend a graft within and along a bone tunnel of an articulating joint, and therefore experience load during use. Having a button that assembles to an adjustable loop construct during the procedure as opposed to providing the button completely preassembled, may provide improved methods for coupling the fixation system to a graft. However, the lateral openings 121a, 121b that accommodate inter-procedural assembly may reduce structural integrity of button, relative to apertures that enclosed (<NUM> degree bounded holes). This may be compensated for by increasing an overall thickness (T) of the button body, however increasing thickness may increase palpability or local tissue irritation, and therefore is less preferable. Button <NUM> therefore includes an oblong rib <NUM> extending from lower surface <NUM>, configured to increase button rigidity and compensate for a button configured to receive a free loop of a flexible strand <NUM> during the procedure. Rib <NUM> is sized to fit within and extend along a bone tunnel while surface <NUM> engages the external cortical surface of the bone surrounding the bone tunnel. Rib <NUM> is configured to increase the button structural rigidity under functional loading without increasing the thickness (T) of the button that stands proud of the bone external surface. Rib <NUM> may be configured to compensate for this reduced structural integrity, while maintaining a minimal thickness T.

Rib <NUM> may also help to center the elongate button <NUM> and hinder the button from moving relative to the bone tunnel axis. Rib <NUM> therefore has a length that extends substantially across an opening size (diameter) of a bone tunnel and also substantially axially into and along the bone tunnel, while still fitting along the limited bone tunnel diameter; the limited bone tunnel diameter defined by a width of the button body, as shown in <FIG>. Stated in another way, with reference to <FIG>, the cross section of the button including the button body and rib has an outer peripheral boundary that lies within a diameter (øD) defined by a width of the button body. For example, for a tunnel opening diameter of <NUM>, button body width may be between <NUM>, the rib length is preferably less than <NUM> and greater than <NUM>. More specifically in this example, rib length may be <NUM> in length LR and approximately <NUM> in width. Rib <NUM> may extend at least <NUM> (TR) from a button body lower surface. Rib <NUM> may be a solid cross section or hollow, as its purpose is to maintain the button location relative to the bone tunnel, more so than any structural rigidity. As such, example rib could be an annular oblong ring, or a plurality of smaller posts at spaced apart locations configured to lie within the target bone tunnel and maintain a location of the button relative to the bone tunnel axis.

Seen perhaps best in <FIG>, rib <NUM> is disposed along the longitudinal axis L-L and in-between apertures 110a, 110b, 120a, 120b. Rib <NUM> is also disposed along the central portion <NUM> of the button <NUM>. Rib <NUM> may be equally spaced from ends 105a, 105b. Rib <NUM> has a length LR that extends along the longitudinal axis L-L, with apertures 135a, 135b disposed, adjacent ends of rib <NUM>. Rib <NUM> and apertures 135a, 135b may lie along the longitudinal axis L-L. Longitudinal axis may bifurcate the rib <NUM> and apertures 135a, 135b. Rib <NUM> is axially spaced from both apertures 135a, 135b. Rib <NUM> may have a width that is narrower than a corresponding width of apertures 135a, 135b. Rib length LR may approximate a bone tunnel diameter thereby fitting within the bone tunnel and allowing surface <NUM> to engage bone outer surface. Rib length LR may axially overlap at least a portion of both apertures 110a, 110b, and 120a, 120b. Rib <NUM> may preferably axially overlap lateral openings 121a and 121b. Rib <NUM> may axially overlap entire lateral openings 121a, 121b. Stated in another way, rib <NUM> defines an elongate body having first and second ends 141a, 141b, where second end 141b is disposed axially closer to button end 105b than both of the lateral openings 121a, 121b in their entirety. Second end 141b may also be disposed axially closer to button end 105b than both of the slotted apertures 120a, 120b, in their entirety. Rib <NUM> is configured to add structural reinforcement to the button <NUM>, allowing the thickness T that protrudes above the bone surface to remain low in profile. Rib <NUM> may compensate for a reduced structural integrity, the reduced structural integrity due to the lateral openings 121a, 121b.

Best seen in <FIG> and <FIG>, rib <NUM> may define planar side surfaces 143a, 143b, that may be parallel to longitudinal axis L-L and to each other. Planar surfaces 143a, 143b may be coincident with medial edge surfaces 111a, 111b, 122a, 122b of slotted apertures 120a, 120b and apertures 110a, 110b. Planar surfaces 143a, 143b may be continuous with medial edge surfaces 111a, 111b of apertures 110a, 110b and medial edge surfaces 122a, 122b of slotted apertures 120a, 120b respectively. Medial edge surfaces 111a, 122a and planar surface 143a may all lie on a single planar vertical surface. Medial edge surfaces 111b, 122b and planar surface 143b may all lie on a single planar vertical surface.

Illustrated in <FIG> and <FIG>, rib <NUM> extends from lower surface <NUM> and may define a solid cross section, free of voids. Rib <NUM> may extend perpendicularly from button lower surface <NUM>, defining a rib thickness TR. The combined thickness of button "T" and rib "TR" may be equal to or less than a width of button <NUM>, so as to fit along bone tunnel (<FIG> illustrates an example bone tunnel having diameter "øD", relative to the button <NUM> that is in the elongate (passing) orientation. Rib <NUM> may extend <NUM>-<NUM> (TR) from lower surface <NUM>. Rib <NUM> may define a lower surface <NUM> that is planar, the lower surface <NUM> parallel with lower surface <NUM>. In other embodiments, lower surface <NUM> may be curved.

In other embodiments cortical button may include four apertures that all define <NUM> degree bounded holes, in similar locations to apertures 110a, <NUM>, 120a, 120b. These example cortical buttons may be oblong, may be passing buttons as defined herein and may also include an oblong rib, similar to rib <NUM>. While compensation for slots such as slots 121a, 121b is not required in this embodiment, inventors have found that these buttons may also benefit from the centering aspect provided by the rib <NUM>.

<FIG> illustrate another example ribbed button <NUM>, similar to embodiment <NUM> except where noted. In this embodiment, apertures 210a, 210b, 220a, 220b may define circular shaped openings. Rib <NUM> may define lateral surfaces 243a, 243b coincident with medial edge surfaces 211a, 211b, 222a, 222b of apertures 210a, 210b, 220a, 220b. Lateral surfaces 243a, 243b may be concave surfaces. Lateral surfaces 243a, 243b may be continuous with medial edge surfaces 211a, 211b, 222a, 222b of apertures 210a, 210b, 120a, 220b and each aperture 210a, 210b, 120a, 220b may define a single curved vertical surface through a thickness of the button <NUM> that includes the rib <NUM>. Stated in another way the rib <NUM> may conform to the shape of medial surface of apertures. Rib <NUM> preferably axially overlaps at least the slot lateral openings 221a, 221b. Rib <NUM> may extend further towards both button ends 205a, 205b than apertures 210a, 210b, 220a, 220b.

An example method of tissue repair with a button <NUM> is illustrated in <FIG>. Button <NUM> may alternatively be used. To prepare for the tissue repair a tunnel <NUM> (<FIG>) through at least one bone <NUM> of a joint may first be formed, and a graft <NUM> with a bone block <NUM> may be obtained. A hole 6a may be drilled through the bone block <NUM>. A suspensory fixation system <NUM> including a button <NUM> partially assembled to a flexible strand <NUM> may be obtained, the flexible strand <NUM> formed in an adjustable loop construct <NUM>. The adjustable loop construct <NUM> may include a first limb or first looped end 33a and a second limb or second looped end 33b, an assembled adjustable loop 35a and a free adjustable loop 35b. Assembled adjustable loop 35a may be provided or obtained pre-assembled to the button <NUM> via the two apertures, similar to apertures 110a, 110b. Button <NUM> may include a rib <NUM> (not shown in <FIG> for simplification of these figures). At least one locking passage <NUM> (as defined herein) may be formed by flexible strand <NUM>. Button <NUM> may be passed through bone tunnel <NUM> with the assembled adjustable loop 35a preassembled. Button <NUM> may then be flipped to engage an external cortical surface of bone <NUM> (<FIG>).

Second looped end 33b and free adjustable loop 35b may be coupled to tissue graft <NUM>. Second looped end 33b and free adjustable loop 35b may be obtained or provided coupled to a passing construct <NUM>. Passing construct <NUM> may be passed through bone block hole 6a to draw looped end 33b and free adjustable loop 35b through the bone block <NUM>. Passing construct <NUM> may be passed through bone block hole 6a to draw locking passage <NUM> through bone block hole 6a and place locking passage <NUM> within the bone block hole 6a. Bone block hole 6a may be sized to receive the locking passage <NUM>, and the locking passage <NUM> may include at least three lengths of flexible strand <NUM>. After coupling the adjustable loop construct <NUM> to the graft <NUM>, free adjustable loop 35b may be separated from passing construct <NUM> (<FIG>) and looped over the top side <NUM> of button (button <NUM> shown) and into slotted apertures 120a, 120b, as shown in <FIG>. While inserting free adjustable loop 35b into slotted apertures 120a, 120b, looped end 33b may remain coupled to passing construct <NUM>. Looped end 33b may then be inserted through aperture 135b (<FIG>) using the passing construct <NUM>, before separating passing construct <NUM> from looped end 33b. Suspension construct is now coupled to graft <NUM> and is in a closed assembly configuration, with the looped end 33b and adjustable loop end 35b assembled to button <NUM> and the passing construct <NUM> separated therefrom. Suspension construct in the closed assembled configuration may then be passed through the bone tunnel <NUM>.

Looped end 33b may be inserted through aperture 135b, using threading member <NUM> of passing loop construct <NUM> (<FIG>). Tension on limb ends 33a, 33b may reduce the adjustable loop construct <NUM> to draw graft <NUM> towards button <NUM>. <FIG> illustrates button <NUM> engaged over a bone tunnel <NUM> formed through bone <NUM> and engaging a cortical layer of bone <NUM>. Rib <NUM> extends into bone tunnel <NUM>. For a tunnel diameter of <NUM>, the rib <NUM> may preferably have a length LR that is less than <NUM>. Rib <NUM>, <NUM> may be approximately <NUM> in length LR leaving room for limb ends 33a, 33b to route around rib <NUM>, <NUM> and extend through apertures 135a, 135b. Rib <NUM> may be between <NUM>-<NUM> wide and may more preferably be approximately <NUM> wide. Rib <NUM>, <NUM> may extend into the bone tunnel <NUM> between <NUM>-<NUM>.

In alternative methods, the adjustable loop construct <NUM> may be coupled to another tissue anchor instead of or in addition to a tissue graft <NUM>. For example, the method may include coupling the other tissue anchor to the adjustable loop construct <NUM> and then coupling the tissue anchor to a second bone. The second bone may be a different bone to bone <NUM>, or a different segment of bone <NUM>. The adjustable loop construct <NUM> may draw the other tissue anchor towards the button <NUM> to fix the second bone in place. The other tissue anchor may be a second cortical button or soft anchor.

<FIG> and <FIG> illustrate example cortical buttons <NUM> and <NUM> that may have a circular profile. These cortical buttons <NUM>, <NUM> define an outer boundary that is approximately circular, the outer boundary configured to engage an external bone surface and prevent entrance of the button <NUM> and <NUM> into the bone tunnel. Contrary to buttons <NUM> and <NUM> however, buttons <NUM> and <NUM> are non-passing buttons defined in that they are not configured to have a profile that has a small cross section profile than when deployed to provide the ability to pass it through a bone tunnel of limited diameter. While a larger bone tunnel could be formed to pass these buttons (<NUM>, <NUM>) therethrough, the tunnel diameter for a circular profile button would also remove the bone external surface that the button would engage once flipped. As such, buttons <NUM> and <NUM> are configured to remain external to the bone tunnels throughout the procedure. Buttons <NUM> and <NUM> may be similar to some embodiments disclosed in commonly owned PCT patent application number <CIT>.

Buttons <NUM> and <NUM> may be preferable for bone locations close to the patient's skin. A portion of the button <NUM>, <NUM> sits proud of the bone surface which may be easily palpable, these portions configured to have a low and tapered profile to reduce palpability. For example, in ACL repair, buttons <NUM> and <NUM> may engage the tibial side of the repair. Buttons <NUM>, <NUM> define a dome shaped top surface with a tapering outer periphery to maintain a reduce profile. Buttons <NUM>, <NUM> define a maximum dome thickness T1 that sits proud above the bone external surface that is minimized for reduced palpability. Circular buttons have improved stress distribution around the bone/button interface, which allows them to be thinner (T1) relative to oblong buttons <NUM> and <NUM>, for example.

Button <NUM> includes a post <NUM> (<FIG>) concentric with its dome portion <NUM> and extending from a lower surface <NUM> of dome portion <NUM>. Lower surface <NUM> may define a flat planar surface for engaging an external surface of the bone. Dome portion <NUM> may include an annular planar surface <NUM> that lies parallel to lower surface <NUM>. Dome portion <NUM> may also include a recess <NUM> for receiving flexible strands <NUM> therein such that the flexible strands <NUM> lie at least partially within the recess <NUM>, reducing their palpability. Recess <NUM> is disposed towards the center of dome portion <NUM> and includes a plurality of apertures 440a, 440b, 440c, 440d therethrough that provide passage for at least one flexible strand <NUM> therethrough. Button <NUM> includes four apertures 440a, 440b, 440c, 440d, each defining <NUM> degree bounded holes. Each aperture 440a, 440b, 440c, 440d may have the same diameter. The boundaries of all apertures 440a, 440b, 440c, 440d may be disposed entirely within recess <NUM>. Apertures 440a, 440b, 440c, 440d may extend through post <NUM>, having an aperture exit at a bottom surface <NUM> of post <NUM>. All four apertures 440a, 440b, 440c, 440d may be entirely enclosed within post <NUM>. apertures 440a, 440b, 440c, 440d may be equally spaced from each other. Apertures 440a, 440b, 440c, 440d may be arranged in an approximate square or rectangular arrangement, where each aperture defines an apex of the arrangement. Apertures 440a, 440b, 440c, 440d may define a first pair 440a, 440d and a second pair 440b, 440c, each pair defining ends of a strand channel 442a, 442b therebetween. Strand channel 442a, 442b extends below a bottom surface <NUM> of recess <NUM>. Strand channels 442a, 442b at least partially nests a portion of the flexible strand <NUM> therein. Strand channels 442a, 442b define pulley surfaces that the flexible strand <NUM> may slide along. This may reduce a flexible strand of an adjustable loop construct. Strand channels 442a, 442b may each define convex curved surface along their length, corresponding to the curves of the strand loops (seen best in <FIG> and <FIG>).

Recess <NUM> defines a periphery <NUM> that may be circular and concentric with dome periphery. Periphery <NUM> may be intersected by a third pair of apertures 445a, 445b. The third pair of apertures 445a, 445b extend through and along an outer circumferential surface of the post <NUM>. Apertures 445a, 445b each therefore have a first axial length portion that is fully enclosed, defining a <NUM> degree bounded hole that is formed entirely by the dome portion <NUM>. Apertures 445a, 445b also include a second axial length portion extending from and continuous with the first axial length portion, that is not fully enclosed, and defines an axial channel (446a shown) bounded by the post <NUM>, best seen in <FIG>. A first of the third pair of apertures 445a is disposed between the first pair 440a, 440d and radially spaced therefrom. A second of the third pair of apertures 445b is disposed between the second pair 440b, 440c and radially spaced therefrom. The third pair of apertures 445a, 445b may be equal to each other in diameter and both may be larger in diameter than apertures 440a, 440b, 440c, 440d. Button <NUM> is configured to be provided pre-assembled to a flexible strand construct.

5A-5F illustrate another embodiment of a button <NUM> that may have a circular or slightly oval shaped dome <NUM> and post <NUM> extending therefrom. Button <NUM> may be a non-passing button and may include radial slotted openings <NUM>/<NUM> for receiving a flexible strand therethrough and therefore coupling to a flexible strand construct during the procedure. Similar to button <NUM>, button <NUM> includes a recessed central portion <NUM> for recessing the flexible strand therein, to reduce palpability. Button <NUM> is similar to button <NUM>, except when noted. For example, button <NUM> includes four channels or pulley surfaces 542a, 542b, 542c, 542d. Channels or pulley surfaces 542a, 542b, 542c, 542d may all be orthogonal to each other, forming a square or rectangle around a central recess post <NUM>. Having four channels 542a, 542b, 542c, 542d give the user more flexibility while assembling the flexible strand construct. Recessed post <NUM> may define a top surface <NUM> that is planar and recessed below a top surface <NUM> of dome portion <NUM>.

Button <NUM> includes a plurality of openings that are slotted openings <NUM>. Slotted openings <NUM> extend radially from an end of a channel or pulley surface (542a, 542b, 542c, 542d) radially up to and including an outer periphery of dome portion <NUM>. Openings <NUM> define a dock portion <NUM> within which the flexible strand (<NUM>) nests, with a tapered opening portion <NUM> extending radially therefrom. Tapered opening portion <NUM> may be linearly ed to a larger opening at the dome periphery. Dock portion <NUM> extends vertically through a thickness of dome portion <NUM> and at least partially through a thickness of post <NUM>. Dock portion <NUM> may extend through and interrupts a circumferential outer surface of post <NUM>, as seen best in <FIG>. Post <NUM> may be configured to fit within a bone tunnel and may be a close or sliding fit with the bone tunnel. Outermost apertures <NUM> define a pair of apertures that may define <NUM>-degree bounded apertures and may be larger in diameter than dock portion <NUM>. Button <NUM> may be provided in a variety of sizes. In some larger button sizes, the post <NUM> may have a larger diameter or width and outmost apertures <NUM> may intersect with post <NUM>. In an example smaller button size, the post <NUM> may be entirely medially spaced from the outermost holes <NUM> and therefore the post <NUM> and holes <NUM> do not intersect.

<FIG> illustrate a system including a button <NUM> and flexible strand <NUM>. Flexible strand <NUM> may be provided assembled to button <NUM> and may include at least one locking passage <NUM> therealong. <FIG> shows two loop ends <NUM> extending through the two pair of apertures 440a, 440b, 440c, 440d and each aperture including a single length of strand <NUM> therethrough. Tension will nest the loops <NUM> within the corresponding channels 442a, 442b, that may be contoured, defining convex curved surfaces for engaging loops <NUM>. Limbs 625a, 625b may extend through the third pair on apertures 445a, 445b. Tension on the limbs 625a, 625b may slide the loops <NUM> through corresponding channels and reduce the overall loop lengths. Stated in another way, tension on the limbs 625a, 625b may draw the locking passage <NUM> towards the button <NUM>.

In a similar manner shown in <FIG>, button <NUM> may be provided operatively coupled to an adjustable loop formed with a flexible strand <NUM>, in a similar manner to that shown in <FIG>. For all inside techniques the surgeon may detach or disassemble at least one of the loops <NUM> from the button <NUM> via slots <NUM>. Button <NUM> may be completely removed from flexible strand <NUM>, and at least one loop <NUM> and limb 625a may be passed through the joint and then re-assembled with the button <NUM> (via pulleys) to create the fully assembled loops once again.

<FIG> illustrates an adjustable loop construct <NUM> that may include two locking passages 710a, 710b, and may be assembled or partially assembled to an anchor, such as a cortical button <NUM>. Adjustable loop construct <NUM> may be formed from a flexible strand <NUM>. Adjustable loop construct <NUM> may be preassembled to at least one side of button <NUM>, together defining an adjustable suspensory fixation system <NUM>. Adjustable loop construct <NUM> may be formed from a single length of a flexible strand <NUM>. Button <NUM> may be any button disclosed herein, or other cortical buttons known in the art such as for example, buttons disclosed in commonly owned PCT patent application number <CIT>, or commonly owned Patent <CIT>.

Adjustable loop construct <NUM> may define a portion of an adjustable suspensory fixation system <NUM> for ligament reconstruction or repair. During tissue repair, saddle end <NUM> may couple to a body, the body being at least one of, but not limited to a tissue component or a surgical component; the tissue component being for example a ligament or graft; the surgical component may be a tissue anchor, or another flexible strand. For example, the adjustable suspensory fixation system <NUM> may couple a first bone to a second bone and may have another tissue anchor operatively coupled to saddle end <NUM> (not shown here). Body may be coupled to loop saddle end <NUM> between the two locking passages 710a, 710b.

Adjustable loop construct <NUM> may be formed by flexible strand <NUM> that is braided suture, braided to be hollow defining an elongate passage therealong. Adjustable loop construct <NUM> first end <NUM> may be assembled to button <NUM> and an opposite saddle end <NUM> may be coupled to a body as defined herein. Adjustable loop construct <NUM> includes two locking passages 710a, 710b spaced away from the saddle end <NUM>. Relative to the construct <NUM> shown in at least <FIG>, that includes a single locking passage <NUM>, two locking passages 710a, 710b may provide similar knotless locking strengths (withstand similar physiological cyclic loading), but two locking passages or split locking passages may offer several advantages. For example, this configuration of locking passages 710a, 710b may allow the construct <NUM> to be reduced in loop perimeter with lower forces or tensions on ends 705a, 705b relative to a construct with a single locking passage. This is a result of the locking passages 710a, 710b being approximately linear (not curved or bent) and approximately parallel to the reduction force direction (F) on ends 705a, 705b. In comparison, locking passage <NUM> is curved as it loops around the construct end. During reduction, strands <NUM> slide through the corresponding locking passage. Maintaining a linear locking passage allows the strands <NUM> to slide linearly and reduce strand cinching from a kink or curve along the locking passage. Furthermore, coupling a saddle end <NUM> free of a locking passage to a body may be easier. The inventors have found that the inherent increased outer diameter of a locking passage may add significant force and/or tissue tearing while threading through the body (as defined herein). Larger tunnel opening sizes may be required through tissue anchors for example, to fit the locking passage. In the case of soft tissue grafts, larger needles and/or higher forces may be needed to thread the locking passage through the soft tissue.

The inventors have also found that the spacing length (SL) or linear distance along the strand <NUM> between the two locking passages 710a, 710b preferably has an upper length limit. Consider that when reducing the adjustable loop construct <NUM>, the shortest the loop construct may reduce to, or a minimum reduced loop length is limited by the fixed length portions of the adjustable loop construct. These include at least the lengths of the two passages 710a, 710b and spacing length SL between the two passage 710a, 710b. Depending on the length of tissue or graft, or anatomy of the repair, significant reduction may be preferable. Depending on the length of tissue or graft, or anatomy of the repair, a short final reduction length may be preferable. Therefore, the shorter the two locking cradles 710a, 710b and spacing length SL are, the smaller the adjustable loop construct can become, with reduction. A shorter length of the locking passages 710a, 170b and spacing length SL may provide an adjustable loop construct that accommodates a wider range of graft or tissue configurations. Locking passages 710a, 710b however require a minimum length to securely cinch and knotlessly lock the adjustable loop <NUM>. The locking passages 710a, 710b therefore define a length of the adjustable loop construct <NUM> that is not adjustable and provides sufficient locking forces on the adjustable suture loop <NUM>, capable of withstanding the physiological loading. This length may depend on the flexible strand material and properties. In some example embodiments, each locking passage 710a, 710b may be between <NUM>-<NUM> millimeters long, and may more preferably be approximately <NUM> millimeters long.

The spacing SL is preferably also short to avoid adding unnecessary length to a minimum reduced loop length of the adjustable suture loop <NUM>. Spacing length SL is preferably sufficient to split the two locking passages 710a, 710b to reduce adjustable loop reduction forces F. The spacing length SL between the two locking passages as measured along the strand <NUM> linearly (see <FIG>) between the two locking passages 710a, 710b may be between <NUM>-<NUM> millimeters, and may, in some procedures be approximately <NUM> millimeters.

<FIG> demonstrate the steps to forming the construct <NUM>. Beginning with <FIG>, a length of a flexible strand <NUM> is shown. Locations of locking passages 710a, 710b are shown as enlarged or dilated portions for clarity of discussion. However, as provided, these locations may be similar in diameter and shape to the remaining length of the strand <NUM> and the act of spicing the strand <NUM> and extending the strand <NUM> through itself may dilate that portion of the strand <NUM>. A snare loop (not shown) may extend along passages 710a, 710b. A dilating means (not shown) may be first extended through passage locations.

Turning now to <FIG>, end 705b may be extend into and along the strand <NUM> at a locking passage location 710b and exit the passage 710b for a length (approximately SL) before extending into and along strand <NUM> at locking passage location 710a. This forms a first eyesplice loop 708b and limb 705b. The length SL between the two locking passages 710a, 710b may be selected, depending on the procedure or application. For example, if the saddle end <NUM> is configured to couple to a graft, the saddle length SL may be long enough the wrap around the graft width, with the locking passages 710a, 710b disposed along a side of the graft. As a second example, if the saddle end <NUM> is configured to couple to a tissue anchor, the length SL may be long enough to couple to the anchor, placing the locking passages 710a, 710b outside of the tissue anchor, and will depend on the anchor configuration. While forming this first eyesplice loop 708b, the loop may be threaded through apertures of a button, such as for example apertures 110a, 110b in <FIG>. First eyesplice loop 708b may therefore directly coupled to a button anchor <NUM>. This may assemble the construct <NUM> with a button. As shown eyesplice loop 708b is short, for simplicity of the figure, however length of loop 708b may be of any length.

<FIG> shows formation of a second eyesplice loop 708a. Limb end 705a may extend into and along the strand <NUM> at locking passage 710a first, forming the second eyesplice loop 708b. Limb end 705a may than extend for a length along saddle end <NUM> before extending into and along strand <NUM> at locking passage 710b. Second eyesplice loop 708a may also thread through apertures of a button, such as for example button <NUM>. This assembles both loops 708a, 708b to a button. In other embodiments, at least one of the loops 708a, 708b may define a free looped end, and be looped over and through slotted openings of the button during the procedure. Buttons <NUM>, <NUM> or <NUM> show slotted openings that allow for selective assembly with at least one of the eyesplice loops 708a, 708b from the button. On other examples, at least one loop and limb (708a, 708b, 705a, 705b) may be operatively coupled to a threading member such as a shaft, rod or needle (example passing construct <NUM> shown in at least <FIG>). Threading member may be configured to insert a loop and/or limb of the construct <NUM> through a body such as a tissue, a graft or a tissue anchor for example.

In this construct <NUM>, each locking passage 710a, 710b includes two lengths of strand <NUM> extending therethrough. The two lengths of strand <NUM> cross over each other to exit from opposite ends of each locking passage 710a, 701b. In other embodiments, each limb may only extend through one locking passage 710a, 710b. For example, limb 705b may extend through passage 710b only to form eyesplice loop 708a. The distance between to the two discrete locking passages 710a, 710b may be sufficient to suspend a graft thereover, or extend through a thickness of tissue, or through an anchor. Saddle end <NUM> may include three strand lengths of strand <NUM>, two of which are slideable and one single strand which is static or fixed (non slideable) and extends directly from, and is continuously braided with both locking passages 710a, 710b.

<FIG> illustrates another adjustable loop construct <NUM> that may form a plurality of adjustable loops and may include two locking passages 910a, 910b. Adjustable loop construct <NUM> may define an adjustable suspensory fixation device for ligament reconstruction or repair. In other examples, construct <NUM> may define an adjustable coupling means between a first and second bone and may have a tissue anchor operatively coupled to a portion of the construct <NUM> (not shown here).

Adjustable loop construct <NUM> may be formed by a braided suture that may be hollow to define an elongate passage therealong. The two locking passages 910a, 910b are formed by splicing the suture through itself, which under tension forms a knotless locking mechanism and prevents the loop from expanding. The adjustable loop construct defines first end <NUM> that may be assembled to a button <NUM> and an opposite saddle end <NUM>. Adjustable loop construct <NUM> may have locking forces with reduced loop reduction forces similar to construct <NUM>.

The steps of forming construct <NUM> may begin with strand <NUM>, similar to that shown in <FIG> with similar locations and philosophies for locking passages. However, compared to <FIG>, the loops are formed differently. Shown in <FIG>, forming the adjustable construct <NUM> may include extending end 905b through an aperture of a button <NUM> (shown in <FIG>) and then through the strand <NUM> at location identified as 910a first, preferably on a side adjacent end 905a and then exit the passage 910a adjacent saddle <NUM>. End 905b then extends along saddle <NUM> for a length before extending along strand <NUM> at locking passage location 910b. This forms a first loop 908b and limb 905b. While forming this loop 908b, the loop may be threaded through apertures of a button, such as for example apertures 110a, 110b in <FIG>. Another button example is disclosed in commonly owned Patent <CIT>.

Each aperture preferably provides passage for a single strand of suture therethrough. This assembles the construct <NUM> with a button. A second loop 908a may be formed in a similar manner to the first loop 908b and is shown in <FIG>. Limb end 905a extends through the strand <NUM> at locking passage 910b first then across the saddle <NUM> before extending along strand <NUM> at locking passage 710a.

<FIG> illustrates another example construct <NUM>, that may be assembled with a button <NUM> and may include four locking passages 1010a, 1010b, 1010c, 1010d.

In some embodiments, adjustable loop construct <NUM> may be provided assembled to a button <NUM> in a fully assembled configuration (also termed a closed loop configuration). Unlike the construct illustrated in 3A-3D, both loops 708a, 708b may be preassembled to button <NUM>. Button may include four <NUM> degree (°) bounded holes and therefore disassembly of a loop 708a, 708b may not be available, without deconstruction of the adjustable loop. In some embodiments, when provided in a closed loop configuration, adjustable loop construct <NUM> may include a passing construct <NUM> coupled to the saddle end <NUM>, as illustrated in <FIG>. The passing construct <NUM> is configured to draw the adjustable loop construct <NUM> through a tissue or graft.

Passing construct <NUM> may include a loop <NUM> formed of a flexible strand such as a wire or suture. Loop <NUM> may be coupled to a threading member <NUM> and loop <NUM> may having a fixed length (non-adjustable). Threading member <NUM> may be a rigid needle that pierces the tissue or graft. Threading member <NUM> may be configured to pass through apertures of another tissue anchor (not shown) or prepared tunnels through bone. Threading member <NUM> may be configured to pierce a tissue or graft and draw the loop <NUM> followed by the saddle end <NUM> of adjustable loop construct <NUM> therethrough.

Loop <NUM> may originate as a length of suture or wire, with two terminal ends that are swaged or crimped to threading member <NUM>, to form the loop <NUM>. Loop <NUM> may be formed of a flexible strand that is different or separately formed from flexible strand <NUM>. Passing construct <NUM> may be coupled to the three strand lengths of the saddle end <NUM> with a complex loop. The complex loop may be configured to sequentially draw the three strand lengths through the tissue. Sequentially drawing the strand lengths of the saddle end <NUM> may reduce tissue damage or deformation, and reduce forces required to draw the saddle end <NUM> through the tissue or graft. This passing construct <NUM> may couple the saddle end <NUM> to the tissue or graft. The complex loop may be configured to limit sliding of the passing construct <NUM> along the adjustable loop construct <NUM>. The complex loop may help to control the three length strands and maintains them in close approximation as they slide relative to each other, as explained further herein.

Loop <NUM> may form a complex loop around the saddle end, such as a figure-of-eight loop as illustrated in part in <FIG> illustrates a first locking passage 710a, with the three strand lengths extending therefrom. Strand length 730a defines a static strand, in that it is directly coupled to and extends from both locking passages 710a, 710b. While reducing the adjustable loop construct <NUM>, strand length 730a does not slide. Strand length 730a may be continuously braided with locking passages 710a, 710b and therefore does not extend through and slide through locking passages 710a, 710b. Strand lengths 730b, 730c are dynamic strands, each strand 730b, 730c continuous with a limb 705a, 705b. Drawing on limbs 705a, 705b slides dynamic strand lengths 730b, 730c through the passages 710a, 710b to reduce the adjustable loop perimeter.

Loop <NUM> may form a first loop 1455a of the figure-of-eight loop around the static strand 730a, and second loop 1455b of the figure-of-eight loop may wrap around both dynamic strands 730b, 730c. The figure-of-eight configuration may limit sliding of the passing construct <NUM> along and around the adjustable loop construct <NUM>. Sliding off-center may need correction by the user during stitching. The first loop 1455a of the figure-of-eight is limited to sliding only along the static strand 730a, and the extent of sliding is bounded by the locking passage 710a, 710b. Limiting sliding may avoid asymmetry as the adjustable loop construct <NUM> is threaded through a tissue or graft. The figure-of-eight loop configuration is configured to maintain the passing construct <NUM> between the two locking passages 710a, 710b. Without the figure-of-eight loop formation, loop <NUM> may slide over one of the locking passages 710a, 710b and draw that locking passage first into and through a graft or tissue. As explained earlier, this may increase the forces required to couple the adjustable loop construct <NUM> to the graft of tissue. In addition, if the loop <NUM> was not a figure-of-eight loop and wrapped around just the static strand length 730a, the dynamic strand lengths 730b, 730c may trail too far behind when passing through tissue/graft, creating confusion during stitching and uneven adjustment of the construct <NUM>. The figure-of-eight loop may first pass the dynamic strand lengths 730b, 730c through a graft, followed by the static strand length 730a, followed by the two locking passages 710a, 710b. The second loop 1455b is configured to contain the two dynamic strand lengths in close apposition while passing the saddle end <NUM> through the tissue/graft, which may reduce confusion during stitching through tissue or graft. Loop <NUM> is coupled to the adjustable loop construct <NUM> such that it maintains a substantially central location of the passing construct <NUM> along the adjustable suture loop <NUM> (limits sliding of the passing construct <NUM> along the saddle portion <NUM>), while allowing the dynamic strand lengths 730b, 730c to slide without inhibiting reduction of the adjustable loop construct <NUM>. The passing suture loop <NUM> is coupled to the adjustable loop construct <NUM> to manage effective passing of the three strand lengths 730a, 730b, 730c through tissue, keeping them aligned relative to each other.

In another configuration, loop <NUM> may form a complex loop in the form of a luggage tag loop, around all three strands 730a, 730b, 730c. However, this may cinch around the moving (dynamic) strands 730b, 730c and consequently increases the loop reduction force. A further embodiment is shown in <FIG> wherein loop <NUM> forms a complex loop in the form of a split luggage tag loop including a first loop 1455aa around the static strand 730a. The second loop 1455bb splits to loop around both sides of the dynamic strands 730b, 730c (seen best in <FIG>). This loop however requires a more complicated assembly.

A method of attaching an adjustable loop construct <NUM> to a graft <NUM> is illustrated in <FIG>. Adjustable loop construct <NUM> may be similar to adjustable loop constructs (<NUM>, <NUM>, <NUM>, <NUM>) disclosed herein and may be linked to a passing construct <NUM> at a linking end <NUM> of the adjustable loop construct <NUM>. Passing construct may be coupled to a linking end <NUM> with a complex loop, as disclosed herein. For example, adjustable loop construct may be construct <NUM> linked to passing construct <NUM> at a saddle end <NUM> with a figure-of-eight loop. However, this method is not limited to construct <NUM> and construct <NUM>. The method disclosed couples an adjustable loop construct <NUM> to a graft <NUM>, such that the final stitched graft includes both an adjustable loop construct <NUM> and a flexible loop <NUM> of a passing construct <NUM> stitched therethrough, the flexible loop <NUM> linked to, but separately formed from adjustable loop construct <NUM>. In the final stitched graft, the flexible loop <NUM> may define stitches that axially overlap the adjustable loop construct stitches. <FIG> shows a simplified form of an adjustable loop construct <NUM>, omitting elements such as but not limited to locking passages (such as but not limited to locking passages 710a, 710b) and the individual adjustable loops (such as but not limited to loops 708a, 708b) and a linking end <NUM> (such as but not limited to saddle end <NUM>). These details are omitted from the figures to simplify understanding of the figures and thereby method. In addition, this method may couple any of the adjustable loop constructs disclosed herein, or others known in the art, with differing locking passages and adjustable loop configurations to a graft in this manner.

Starting with <FIG>, the method may include obtaining and/or obtaining a graft <NUM>. Graft <NUM> may be an elongate body, defining a top side <NUM>, bottom side <NUM>, and two opposing ends <NUM>, <NUM>. One of the two opposing ends (<NUM>) may be clamped to stabilize the graft <NUM> during stitching, and therefore may be defined as a clamped end <NUM>. The other of the two opposing ends may be the free end <NUM>. Free end <NUM> may be inserted first into a prepared tissue tunnel and may be directly coupled to both the adjustable loop construct and passing construct loop. Free end <NUM> may be tapered or bulletized using a scalpel or scissors for easier threading through a prepared bone tunnel. Graft <NUM> may be a single solid body, typically harvested from the Quad Tendon. Graft <NUM> may include wispy ends. Graft <NUM> may be provided as a plurality of elongate strands, typical when harvesting from the hamstring for example. Graft <NUM> may be folded over itself to form a target thickness of graft <NUM>.

Now turning to <FIG> showing a side view of the graft <NUM>, the method of attaching may include forming and/or obtaining an adjustable loop construct <NUM> that may be assembled to a cortical button <NUM> at one end and assembled to a flexible loop <NUM> of a passing construct at the other end (hereinafter linked end <NUM>). The flexible loop <NUM> may be operatively coupled to a threading member <NUM> such as a needle defining, together, the passing construct <NUM>. Threading member <NUM> may pierce the graft top surface <NUM> and draw the flexible loop <NUM> from the graft top surface <NUM> through the thickness of graft <NUM> to the lower external surface <NUM>, at a first location (<NUM>), defining a first pass through the graft <NUM>. First location (<NUM>) may be about <NUM>-<NUM> from terminal edge of free end <NUM>. In some example methods, flexible loop <NUM> may form a complex loop and couple to a plurality of strands (730a, 730b, 730c) along the linked end <NUM> that may be similar to saddle end <NUM>. Complex loop is not shown in <FIG> but may be seen in at least <FIG> and may be configured to stagger entrance of the plurality of strands (730a, 730b, 730c) through the graft <NUM> during this first pass. Complex loop may also maintain a location of the flexible loop within a target zone along the adjustable loop construct <NUM>. The first pass may be complete when passing construct <NUM> is drawn completely through graft <NUM>, until the entire passing construct <NUM> is external to the graft <NUM> and the adjustable loop construct <NUM> extends through graft <NUM> and from both the top surface <NUM> and bottom surface <NUM> (<FIG>). The conclusion of the first pass places the cortical button <NUM> adjacent the free end <NUM> and top surface <NUM> and the linked end <NUM> adjacent the bottom surface <NUM> (<FIG>). This may also preferably place any locking passages external to the graft <NUM> adjacent the bottom side <NUM>. Adjustable loop construct <NUM> may include two limbs 1705a, 1705b wrapped around a carrying card or tool <NUM> for management thereof. First pass may extend through the graft <NUM> at an angle that is neither inclined relative to the longitudinal axis (Y-Y), and therefore neither parallel to nor orthogonal to longitudinal axis (Y-Y) of the graft <NUM>. Angle may be between <NUM>-<NUM> degrees relative to the longitudinal axis. First pass may extend along and intersect the longitudinal axis. First pass, and all subsequent passes may extend through a midline of the graft <NUM>, as best possible, given the nature of soft tissue grafts.

The adjustable loop construct linked end <NUM> may then be spread to wrap around both external side surfaces of graft <NUM> and flip over the free end <NUM>, the button <NUM> and card or tool <NUM> to the top surface <NUM> (<FIG>). This may place the linked end <NUM> between the clamped end <NUM> and the first location (<NUM>). The adjustable loop construct <NUM> may then be reduced via tension on the limbs 1705a, 1705b (which may be coupled to a card or tool <NUM>). Adjustable loop construct <NUM> may be reduced such that the linked end <NUM> is circumferentially wrapped around the external surfaces of graft <NUM> (<FIG>) and button <NUM> is adjacent free end <NUM>. While flipping the linked end <NUM>, the flexible loop <NUM> of passing construct <NUM> may be maintained between any locking passages, via the complex loop such as the figure-of-eight loop through the linked end <NUM>. Adjustable loop construct <NUM> may be reduced by drawing the flexible strand through any locking passages of the adjustable loop construct <NUM>, such that the locking passages circumferentially wrapped around the external surfaces of graft <NUM> (<FIG>). Reducing the construct <NUM> may place the locking passages substantially external to the graft and not within the graft, which may cinch the locking passages and frustrate loop reduction.

Turning now to <FIG>, threading member <NUM> may be passed again (second pass) from the graft top surface <NUM> to the bottom surface <NUM>, at a second location (<NUM>), directly adjacent to linked end <NUM> (<FIG>). This locks the location of linked end <NUM> along the graft <NUM> and prevents the linked end <NUM> from sliding along the graft <NUM>. Second location (<NUM>) may be approximately coincident with linked end <NUM>, and between the clamped end <NUM> and first location (<NUM>). The adjustable loop construct <NUM> in now fixedly attached to the graft <NUM>. The second pass may be orthogonal to the graft longitudinal axis (Y-Y) and may define the furthest-most pass from the free end <NUM>. At the end of the second pass a portion of flexible loop <NUM> may extend through the graft <NUM>. At the end of the second pass (<FIG>) a first loop 1755a of a complex loop of flexible loop <NUM> may be retained on top surface <NUM> while second loop 1755b may extend through graft <NUM>.

The flexible loop <NUM> may now form a running whipstitch along graft <NUM>, progressively moving towards the free end <NUM>, the running whipstitch preferably including at least two whipstitch passes (a third and a fourth pass of the attachment method) through the graft <NUM>. This running whipstitch forms a plurality of axially spaced circumferential wraps around the graft free end <NUM>. Tensioning these plurality of axially spaced circumferential wraps forms the graft free end <NUM> into a more cylindrical shape, for easier passing through the prepared bone tunnel. Tensioning on these whipstitches may further taper the graft free end <NUM>, for easier passing through the prepared bone tunnel. This running whipstitch may include at least two passes, and acts to mitigate attachment rip-stopping (adjustable loop construct <NUM> and flexible loop <NUM> from cheese-wiring out of graft). Whipstitches run progressively towards the free end <NUM>. Whipstitches may be formed by looping the flexible loop <NUM> (which may be second loop 1755b) around from the bottom surface <NUM> and end <NUM> to place the threading member <NUM> on the top surface (<FIG> and <FIG>). Threading member <NUM> may then passe from the top surface <NUM> to the bottom surface <NUM> again. This may be at a location (<NUM>) between free end <NUM> and location (<NUM>). This may circumferentially wrap the flexible loop <NUM> (1755b) around the graft <NUM>, over and across the adjustable loop <NUM> that is wrapped around the graft external side surfaces and the linked end <NUM>.

The steps shown in <FIG> may be repeated to form a second whipstitch of the running whipstitch, shown in <FIG>. Flexible loop <NUM> may be wrapped around the graft <NUM> and over the free end <NUM> to place the threading member <NUM> on the top surface <NUM>. Threading member <NUM> may then pierce the graft and pass through from the top surface <NUM> to the bottom surface <NUM> at a location between location (<NUM>) and free end <NUM>. This may be repeated until the whipstitch passes reach the terminal edge <NUM> of the free end <NUM>. Loop <NUM> may then be tied in a knot and cinched tightly to further taper tapered free end <NUM>. The threading member <NUM> may then be removed, leaving a trimmed loop <NUM>' available (<FIG>).

Graft <NUM> coupled to adjustable loop construct <NUM> and trimmed loop <NUM>' (trimmed from threading member <NUM>) may then be threaded through a prepared bone tunnel (not shown). Trimmed loop <NUM>' (<FIG>) may be sufficiently long to couple to a tool to draw graft <NUM> into and along prepared bone tunnel. Trimmed loop <NUM>' therefore has a length, as provided or obtained sufficient to form at least two whipstitch passes through a graft, leaving sufficient length to be drawn along prepared bone tunnel. Drawing on the trimmed loop <NUM>' is preferable over drawing with the adjustable construct <NUM> to avoid the graft free end <NUM> from folding over itself while sliding through prepared bone tunnel. Drawing on the adjustable construct <NUM> only may form a fold adjacent second location (<NUM>).

Turning now to a more specific example, a method of attaching may include forming or obtaining adjustable loop construct <NUM> assembled with a cortical button <NUM> at one end and coupled to a passing construct <NUM> at saddle end <NUM>. Needle <NUM> may pierce the graft top surface <NUM> and draw the loop <NUM> of passing construct <NUM> from the graft top surface <NUM> through the thickness of graft <NUM> to the lower external surface <NUM>, at a first location (<NUM>), defining a first pass. First location may be about <NUM>-<NUM> from terminal edge <NUM> of free end <NUM>. In some example methods, flexible loop <NUM> may form a complex loop and couple to a plurality of strands (730a, 730b, 730c) along the saddle end <NUM>. Complex loop may be configured to stagger entrance of the plurality of strands (730a, 730b, 730c) through the graft <NUM> during this first pass. Complex loop may be a figure-of eight loop, with a first loop 1455a looped about static strand 730a, and a second loop 1455b looped around strands 730b, 730c. The first pass may be complete when passing construct <NUM> is drawn completely through graft <NUM>, until the entire passing construct <NUM> is external to the graft <NUM> and the adjustable loop construct <NUM> extends through graft <NUM> and from both the top surface <NUM> and bottom surface <NUM>. The conclusion of the first pass places the cortical button <NUM> adjacent the top surface <NUM> and the saddle end <NUM> adjacent the bottom surface <NUM>. Adjustable loop construct <NUM> may include two limbs (705a, 705b) wrapped around a carrying card or tool <NUM> for management thereof. First pass may extend through the graft <NUM> at an angle that is inclined relative to a longitudinal axis (L-L) of the graft <NUM>. Angle may be between <NUM>-<NUM> degrees relative to the longitudinal axis. First pass may extend along and intersect the longitudinal axis. First pass may be oriented substantially along a midline of the graft <NUM>, as best possible, given the nature of soft tissue grafts.

Saddle end <NUM> may then be spread to wrap around both sides of graft <NUM> and flip over the free end <NUM>, the button <NUM> and card or tool <NUM> to the top surface <NUM>. This may place the saddle end <NUM> between the clamped end and the first location (<NUM>) on the top side <NUM>. The adjustable loop construct <NUM> may then be reduced via tension on the limbs 705a, 705b (which may be coupled to a card or tool <NUM>. Adjustable loop construct <NUM> may be reduced such that the saddle end <NUM> is circumferentially wrapped around the graft <NUM> and button <NUM> is adjacent free end <NUM>. While flipping the saddle end <NUM>, the passing construct <NUM> may be maintained between locking passages (710a, 710b), via the complex loop such as the figure-of-eight loop through the saddle end <NUM>.

Needle <NUM> may be passed again (second pass) from the graft top surface <NUM> to the bottom surface <NUM>, at a second location (<NUM>), directly adjacent to saddle end <NUM>. This locks the location of saddle end <NUM> along the graft <NUM> and prevents the saddle end <NUM> from sliding along the graft <NUM>. Second location (<NUM>) may be approximately coincident with saddle end <NUM>, and between the clamped end <NUM> and first insertion location (<NUM>). The adjustable loop construct <NUM> in now fixedly attached to the graft <NUM>. The second pass may be approximately orthogonal to the graft longitudinal axis and may define the furthest-most pass from the free end <NUM>. At the end of the second pass a portion of flexible loop <NUM> may extend through the graft <NUM>. At the end of the second pass a first loop 1455a of the complex loop of flexible loop <NUM> may be retained on top surface <NUM> while second loop 1455b may extend through graft <NUM>.

The flexible loop <NUM> may now form a running whipstitch that progressively stitches towards the free end <NUM>, the running whipstitch preferably including at least two whipstitch passes (a third and a fourth pass of the attachment method) through the graft <NUM>. This running whipstitch forms a plurality of axially spaced circumferential wraps around the graft free end <NUM>. Tensioning these plurality of axially spaced circumferential wraps forms the graft free end <NUM> into a more cylindrical shape, for easier passing through the prepared bone tunnel. Tensioning on these whipstitches may further taper the graft free end <NUM>, for easier passing through the prepared bone tunnel. This running whipstitch may include at least two passes, and acts to mitigate attachment rip-stopping (adjustable loop construct <NUM> and flexible loop <NUM> from cheese-wiring out of graft). Whipstitches run progressively towards the free end <NUM>. Whipstitches may be formed by looping the second loop 1455b around from the bottom surface <NUM> and graft end <NUM> to place the needle <NUM> on the top surface. Needle <NUM> then passes through from the top surface <NUM> to the bottom surface <NUM>. This may be at a location (<NUM>) between free end <NUM> and insertion location (<NUM>). This may circumferentially wrap the second loop 1455b around the graft <NUM>, over and across the adjustable loop saddle end <NUM>. This may circumferentially wrap the second loop 1455b around the graft <NUM>, over and across the locking passages 710a, 710b such that upon tensioning this, the locking passages 710a, 710b may no longer be adjustable.

A second whipstitch may be formed by looping the second loop 1455b again around from the bottom surface <NUM> and end <NUM> to place the needle <NUM> on the top surface. Needle <NUM> then passes again through from the top surface <NUM> to the bottom surface <NUM>. This may be at a location between free end <NUM> and insertion location (<NUM>). This may be repeated until the whipstitch passes reach the terminal edge of the free end <NUM>. Second loop 1455b may then be tied in a knot <NUM> and cinched tightly to further taper tapered free end <NUM>. The needle <NUM> may then be removed, leaving a length of second loop 1455b available (that may no longer be a loop. ) Graft <NUM> coupled to adjustable loop construct <NUM> and second loop 1455b' (trimmed from needle <NUM>) may then be threaded through a prepared bone tunnel (not shown).

<FIG> illustrates a top down view of the adjustable loop construct <NUM> stitched through graft <NUM>, after the first pass and before the second pass, similar to arrangement shown in <FIG>. <FIG> illustrates a top down view of the adjustable loop construct <NUM> and flexible loop <NUM> stitched through graft <NUM>, in the final stitched configuration. <FIG> also shows the circumferential wraps and tapering of the free end <NUM>. Knot <NUM> is shown in second loop 1455b with trimmed second loop 1455b' extending therefrom.

<FIG> illustrate various features of a reduction bar <NUM> and an associated method of use. Reduction bar <NUM> may provide a plurality of functions during a tissue repair. Reduction bar <NUM> may be assembled to an adjustable suspensory fixation system and used as a handle or tool that applies tension to adjustable loops of the fixation system to place the graft in the target location. Reduction bar <NUM> may also be provided or obtained with the suspensory fixation system preassembled thereto and therefore could equally be called a fixation system storage tool.

Suspensory fixation systems, such as system <NUM> shown in <FIG> include multiple loops of a flexible strand <NUM>, which if provided in loose form may be difficult to keep track of and prone to strand entanglement or errors while coupling to the graft. Reduction bar <NUM> may include retaining and storing means including cavities, slots, cleats, channels and spools arranged along the reduction bar <NUM>, for housing or retaining portions of the suspensory fixation system. Other example fixation systems that may be assembled to this reduction bar <NUM>, are disclosed herein, as well as in commonly owned PCT patent application number <CIT>, titled "METHODS AND DEVICES FOR TISSUE GRAFT FIXATION".

These storing means may retain and manage components of the suspensory fixation system such that they are on an external surface of bar <NUM> and selectively removeable from the bar <NUM> in stages, according to the stages of operation of the tissue repair. Reduction Bar <NUM> may therefore not only store a suspensory fixation system but also arrange the suspensory fixation system to guide the staged release thereof, according to the preferred stages of the procedure.

More specifically, these storing means may arrange components of a suspension fixation system that may include an adjustable loop construct (<NUM>), passing construct (<NUM>) and tissue anchor (<NUM>, <NUM>) around the reduction bar <NUM> such that release of these components is staged to improve management of the suspensory fixation system during the tissue repair and limit entanglements and confusion. With reference to <FIG>, these storing means may arrange the adjustable loop construct <NUM>, passing construct <NUM> and tissue anchor <NUM>, <NUM> around the reduction bar <NUM> such that the passing construct <NUM> may be released first, the passing construct <NUM> preassembled to the free limb 33b and free adjustable loop 35b. The free limb 33b and free adjustable loop 35b may then be removed from the bar <NUM>. The remains of the suspensory fixation system <NUM> may be left retained by the bar <NUM>, while the passing construct <NUM>, free limb 33b and free adjustable loop 35b are coupled to the graft (<FIG>).

Additionally, the reduction bar <NUM> may operate as a tool that guides closing of an open adjustable loop construct such as suspensory fixation system <NUM>. For example, the anchor (<NUM>, <NUM>) may be provided stored within the bar <NUM> in an orientation that exposes the slotted apertures 120a, 120b (<FIG>). The slotted apertures 120a, 120b may align with a guide surface of the reduction bar <NUM>,to align and guide the free adjustable loop 35b into the slotted apertures 120a, 120b.

Additionally, the reduction bar <NUM> may operate as a handle while reducing the adjustable loop construct <NUM>, and thereby alleviate forces on the surgeon's hand. Reduction bar <NUM> may include a means of operatively coupling to looped limb ends 33a, 33b of the adjustable loop construct <NUM> for example, placing the suspensory fixation system <NUM> in a reducing configuration. The bar <NUM> may then be rocked and rotated while applying tension to the ends 33a, 33b, to reduce the adjustable loop construct size and thereby draw the tissue, graft, or tissue anchor towards the tissue anchor (<NUM>, <NUM>).

As such, reduction bar <NUM> is a multi-functional handle body, configured to store a suspensory fixation system that may include at least one of an adjustable loop construct, a tissue anchor, and a passing construct. Reduction bar <NUM> may also provide a means of guiding assembly of an open loop adjustable construct to the tissue anchor. Reduction bar <NUM> may be provided assembled with the suspensory fixation system, to stage the release of components of the system in accordance with the tissue repair. Reduction bar <NUM> may also reassemble with the adjustable loop construct, in a different arrangement to the preassembled arrangement to reduce/adjust the adjustable loop construct.

<FIG> illustrate various features of reduction bar <NUM>, with a suspension fixation system removed. Starting with <FIG>, reduction bar <NUM> may generally be a unibody, sized to fit within a surgeon's hand and be comfortable while tensioning and reducing the adjustable loop construct. Reduction bar <NUM> may define an elongate body, defining a longitudinal axis X-X and an oval or oblong cross section. Bar <NUM> may have a more bulbous, larger cross section along a lower side <NUM>, configured to sit within a user's curled fingers. Bar lower side <NUM> may also define an arced or convex curved surface <NUM>, curved along the longitudinal axis X-X such that the handle <NUM> has thickest cross section close to a midline M-M of handle <NUM>. Elongate convex curved surface <NUM> and bulbous lower side <NUM> together are shaped to rests within a surgeon's fingers while applying tension on the adjustable loop construct.

Bar <NUM> has a medial length portion <NUM>, with circumferential spools 1113a, 1113b at either end thereof. Bar <NUM> includes a first lateral end <NUM> extending from spool 1113a that has a first lateral end surface <NUM> that may be planar. A second opposing lateral end <NUM> extends from spool 1113b. Each spool may be intersected (one each) by a notch 1123a, 1123b. Each notch 1123a, 1123b may be curved and may be an "L" shape, or reverse "L" shape. Each notch 1123a, 1123b extends through a thickness of the bar <NUM>, best shown in <FIG>. Bar End <NUM> may be different to bar end <NUM>. Bar end <NUM> may extend further along the longitudinal axis X-X from the medial portion <NUM>. Therefore bar <NUM> may be an asymmetrical body about a plane through the midline M-M. Bar end <NUM> is sized to include a slot <NUM> for housing a portion of a tissue anchor. Bar end <NUM> includes channel <NUM> extending from slot <NUM> for housing a portion a flexible strand coupled to the anchor.

Bar <NUM> may define a plurality of circumferentially extending ribs <NUM> that may add structural integrity to the bar <NUM> while accommodating manufacturing processes and reducing material use. At least some of the ribs <NUM> may be non-continuous, defining gaps along the medial length portion <NUM>, such as relief <NUM>, channel <NUM> and retention channel <NUM>. These gaps may provide at least some of the storing means for portions of the suspensory fixation system including the adjustable loop construct and passing construct, disclosed in more detail hereafter.

<FIG> illustrates various views of bar <NUM> with an example button assembled thereto. <FIG> illustrates the back side of bar <NUM>, that may be free of any retaining slots or channels along the median portion <NUM>. Slot <NUM> is configured to house a portion of button, such as button <NUM>, <NUM>. <FIG> illustrates button <NUM>, <NUM> housed within slot <NUM>. The channel <NUM> is continuous with and extends from the slot <NUM> and is also continuous with spool 1113a, such that a portion of the adjustable loop construct (shown in later figures) coupled to the button may extend from within the slot <NUM>, along channel <NUM> and into and around spool 1113a (<FIG>).

Slot <NUM> may house button <NUM> to expose a portion thereof including lateral openings 121a, 121b, seen best in <FIG>. Planar surface <NUM> may be orientated at a non-orthogonal angle to longitudinal axis X-X and may provide a guiding surface when assembling a free adjustable loop end 35b of an open adjustable loop construct to cortical button (a small portion of free adjustable loop end 35b is shown adjacent surface <NUM>) As such sliding free adjustable loop end 35b along surface <NUM> (see arrow) may thread the adjustable loop end 35b through the lateral slots 121a, 121b and into the slotted apertures 120a, 120b to close the open adjustable loop construct <NUM> (<FIG>). This preferably occurs after threading the free loop end 35b through a graft, as disclosed herein.

<FIG> illustrates the suspension fixation system <NUM>. This includes a button <NUM> (illustrated in simpler form), and adjustable loop construct <NUM>. For understanding of assembly of the suspension fixation system <NUM> to the reduction bar <NUM>, <FIG> illustrates an imaginary split of the suspension fixation system <NUM> into portions 1200a and 1200b. Portion 1200a, as indicated on the figure may include the passing construct <NUM>, (threading element <NUM> and passing loop <NUM>) the free adjustable loop end 35b, the free looped end 33b, the locking passage <NUM>. Portion 1200a may also include some of the flexible strand <NUM> that forms the portion of the assembled loop end 35a that extends directly between the locking passage <NUM> and anchor <NUM>. Portion 1200a may also include all strands <NUM> that extend directly between anchor <NUM> and passage <NUM>. As such is may include strand length portions of first looped end 33a and limb 35b that are directly between the button <NUM> and locking passage <NUM>. Portion 1200b as indicated on the figure may include the anchor <NUM>, assembled to the assembled loop end 35a and the looped end 33a.

<FIG> illustrate (in combination) how the bar <NUM> and a suspensory fixation system may be provided or obtained in a preassembled configuration. In the example, suspensory fixation system <NUM> is assembled to the bar <NUM>, and reference made to <FIG> and <FIG>. Other suspensory fixation systems may assemble using similar philosophies, however. Both <FIG> are to be viewed in combination. Stated another way, as provided both portions 1200a and 1200b may be assembled to the reduction bar <NUM>. <FIG> illustrates assembly of portion 1200b only with the remainder of the system <NUM> (portion 1200a) shown assembled in <FIG>. Portion 1200a is not shown in <FIG> for clarity of understanding. Similarly, only portion 1200a is shown in <FIG>, with portion 1200b removed from the figure for simplification of explanation only. As packaged the bar <NUM> is pre-assembled to both portions 1200a and 1200b, and both <FIG> should be viewed in combination to view the preassembled configuration.

Starting with <FIG>, a front side of bar <NUM> is shown, with a portion of the front half of end <NUM> removed for improved understanding of the strand routing. Suspensory fixation construct <NUM> may be provided in the pre-assembled configuration, with a tissue anchor, such as button <NUM> nested within slot <NUM>. This is also shown in at least <FIG>. Portion 1200b including looped end 33a may extend recessed within end <NUM>, along channel <NUM>, across spool 1113a and into and along channel <NUM> towards spool 1113b. Looped end 33a may then wrap around an outermost circumferential surface of spool 1113b for a plurality of wraps and then through cleat 1133b, to secure it in place and prevent uncoiling of looped end 33a. Channel <NUM> may be defined by an interruption in the circumferential ribs <NUM> around bar <NUM>. Channel <NUM> may extend parallel to longitudinal axis X-X. Channel <NUM> may have openings at both spool 1113a and spool 1113b, such that looped end 33a is assembled substantially recessed within channel <NUM> and channel <NUM> in the assembled configuration. Spools 1113a and 1113b may extend from and be continuous with ends of channel <NUM>.

<FIG> illustrates the routing of portion 1200a. Again, <FIG> is illustrated with a portion of the front half of end <NUM> removed for improved understanding of the strand routing. The multiple lengths of flexible strand <NUM> may extend from anchor <NUM>, along channel <NUM> and wraps around spool 1113a. Locking passage <NUM>, adjustable looped end 35b and looped end 35b may all wrap around an outermost circumference of spool 1113a (represented in the figure in simplified form to simplify the figure). In addition, flexible loop <NUM> may also wrap around spool 1113a. Threading member <NUM> may extend along retention channel <NUM>. Retention channel <NUM> is defined by an interruption in the circumferential ribs <NUM>, the interruption defining a retention channel width. Retention channel may loosely house threading member <NUM>, except for a central most end of retention channel <NUM>, defined by end of circumferential ribs that form a narrowed width <NUM>, spaced to pinch a threading member tip 305a. Retention channel <NUM> may be continuous with spool 1113a. Threading member <NUM> may be oriented parallel to longitudinal axis X-X and may be positively retained at end <NUM>. Threading member may be a tube, needle or thick portion of a flexible material. Channel <NUM> may be continuous with relief or cavity <NUM>. Threading member tip 305a may extend into relief <NUM>. Relief <NUM> may be deeper than channel <NUM> (best seen in <FIG>), allowing a user to place a finger or tool within relief <NUM> and grasp threading element tip 305a. Threading member tip 305a may be accessible from or extend into relief <NUM>, relief <NUM> defining a cavity within the reduction bar <NUM> that allows a surgeon to access and remove the threading member <NUM> from the reduction bar <NUM>.

A method of tissue repair may therefore start with the obtaining bar <NUM>, pre-assembled with the fixation system <NUM>, including both portions 1200a and 1200b, as shown in <FIG> in combination. A surgeon may first remove portion 1200a. This includes first removing the threading member <NUM> from the channel <NUM> by placing a finger or tool in the relief <NUM> and engaging a tip 305a of threading member <NUM>. Once removed, a portion of the adjustable loop construct <NUM> may then be uncoiled from spool 1113a. This may include uncoiling a flexible loop <NUM>, an adjustable free looped end 35b, a looped end 33b and at least one locking passage <NUM> from the spool 1113a. With portion 1200b still assembled to bar <NUM>, threading member <NUM> may be then inserted through a body (tissue/graft or tissue anchor) to couple the suspensory fixation system <NUM> thereto. While inserting the threading member <NUM> through the body, the cortical button (<NUM>, <NUM>) may remain within slot <NUM>. While inserting the threading member <NUM> through the body, a looped end 33a may remain coiled around spool 1113b. Inserting the threading member <NUM> may include inserting the threading member <NUM> through a bone hole 6a which first draws looped end 33b through the hole 6a, and then draws the adjustable loop 35b through the bone hole 6a.

Once coupled to the body, bar <NUM> may also serves as a tool to ease coupling the free adjustable loop end 33b and free looped end 35b to button <NUM>. After the suspensory fixation system <NUM> is coupled to the body, the threading member <NUM> may be inserted through an aperture (135b) of the button <NUM> disposed adjacent surface <NUM> of bar <NUM>, to draw looped end 33b therethrough, while button <NUM> is held within bar slot <NUM>. As shown in at least <FIG>, button <NUM> is orientated by slot <NUM> to expose lateral slots 121a, 121b and aperture 135b. Lateral slots 121a, 121b may align with planar surface <NUM>. End <NUM> and slot <NUM> is therefore deep enough to house the button <NUM> in this orientation while aligning the lateral slots 121a, 121b with the planar surface <NUM>. Free looped end 35b may slidingly engage with surface <NUM> and be drawn towards the slotted apertures 121a, 121b, to thread the adjustable loop 35b over the top side <NUM> of button <NUM> and into slotted apertures 121a, 121b, illustrated in <FIG>. Surface <NUM> may be coincident with a portion of lateral slots 121a, 121b.

Continuing with the example method, the entire suspensory fixation construct <NUM> may now be removed from the reduction bar <NUM>, including now removing portion 1200b, before being reassembled into a reducing configuration. In this reducing configuration, reduction bar <NUM> may be a tool to impart tension on the system <NUM> and reduce the adjustable loop construct <NUM>. This tension may also knotlessly lock any locking passages of the system <NUM>.

To assemble in the reducing configuration, looped ends 33a and 33b may slide, one each, into and along notches 1123a, 1123b to lie around a segment of their corresponding spools 1113a, 1113b. Notches 1123a, 1123b define a reduced perimeter relative to the outermost spools 1113a, 1113b, having a secondary surface or cut-through that looped ends 33a, 33b may lie in, illustrated best in <FIG>. Looped ends 33a, 33b may extend quite a long distance from button <NUM>, this long distance being cumbersome. The act of reducing the system <NUM> may increase this distance further. Bar <NUM> may preferably be first rotated (indicated as step <NUM> in <FIG>) around its longitudinal axis, to shorten the length of ends 33a, 33b before and as the adjustable loop construct reduces. Reducing the adjustable loop construct <NUM> and rotating the bar <NUM> may be performed sequentially and repeatedly. For example, the bar <NUM> may first be rotated to wrap a portion of the ends 33a, 33b around spool 1113a, 1113b, then tension (indicated by arrow step <NUM>) may be applied to reduce the adjustable loop size (which lengthens ends 33a, 33b). Then the bar <NUM> may be rotated again to further wrap ends 33a, 33b around the corresponding spool 1113a, 1113b), to reduce the distance between the bar <NUM> and button <NUM>.

Illustrated in <FIG>, is a cross section of spool 1113a, illustrating the outermost circumferential surface 1313a and a second surface 1323a defined by notch 1123a (only one spool shown, spools may be similar). Spool 1113b may have the same cross section. Second surface 1323a may define a planar surface 1313a that traverses the reduction bar <NUM>. Second surface 1323a may define a "short cut" that is configured to inhibit the looped ends 33a, 33b from slipping around the spool 1113a as the bar is rotated (step <NUM>). Each looped ends 33a, 33b may be formed with a spice or knot at point "P". Second surface 1323a may define a corner or discontinuity sufficient to limit the looped end from spinning around the spool out circumference 1313a, such that the looped end 33a may preferentially fold over itself (as illustrated in <FIG>) and wrap, without slipping as the bar <NUM> is rotated (step <NUM>). Each notch 1123a, 1123b is configured to place a looped end (33a, 33b) within a segment of its respective spool to inhibit slipping or sliding of the looped end 33a, 33b as they are wrap around the corresponding spool 1113a, 1113b. Notch (1123a, 1123b) is configured to form a folded portion of the looped end as the bar <NUM> is rotated about the longitudinal axis X-X.

Claim 1:
A cortical button (<NUM>, <NUM>, <NUM>, <NUM>) configured to be passed through a bone tunnel (<NUM>) in an elongate orientation before being flipped to a deployed configuration, the cortical button comprising:
an oblong body, having a length greater than a width, and a longitudinal axis (L-L);
the width extending from a first sidewall to a second sidewall of the body, the first and second sidewalls along the longitudinal axis between a first and a second end, the body also having a lower surface (<NUM>) configured to engage an external bone surface when the cortical button is in the deployed configuration; and
a pair of slotted apertures (120a, 120b) extending through an entire thickness of the body for receiving a loop of a flexible strand (<NUM>) therethrough;
characterized by a rib (<NUM>, <NUM>) extending from the oblong body lower surface and disposed between the pair of slotted apertures, coextensive along the longitudinal axis with the pair of slotted apertures.