Patent Description:
Tissue reconstruction surgeries, such as anterior cruciate ligament (ACL) reconstructions and posterior cruciate ligament (PCL) reconstructions, typically involve drilling a tunnel through bone, positioning a substitute graft into the bone tunnel, and fixating the graft within the bone tunnel using a fixation device, such as a button, a screw, or the like. In <CIT>, an adjustable suture button construct for tissue reconstruction is disclosed. <CIT> discloses an acromioclavicular joint fixation technique. <CIT> discloses an implant having adjustable filament coils. <CIT> discloses a suspensoric graft fixation with adjustable loop length. <CIT> discloses a suspensoric graft fixation with adjustable loop length. <CIT> discloses bone-tendon-bone suture button constructs and methods of tissue fixation. <CIT> discloses adjustable suture-button constructs for ligament reconstruction. <CIT> discloses a tissue graft anchoring. <CIT> discloses an adjustable suture-button construct for ankle syndesmosis repair. <CIT> discloses an integrated adjustable button-suture-graft construct with two fixation devices.

This disclosure relates to surgical fixation systems and methods. The surgical fixation systems may include a fixation device and a loop connected to the fixation device. A graft may be carried by the loop. The surgical fixation system can be used in various tissue reconstruction procedures, including but not limited to, ACL and PCL reconstructions. The invention relates to a system as defined in the appended claims. Embodiments, examples or aspects in the following disclosure, in particular methods, which do not fall under the scope of the claims are presented for illustration purposes only and do not form part of the invention.

A surgical fixation system according to an exemplary aspect of this disclosure may include, inter alia, a fixation device and an adjustable loop connected to the fixation device. The adjustable loop includes a first adjustable eyesplice loop that passes through and interlinks with a second adjustable eyesplice loop at an interconnection that rests over a bridge of the fixation device.

A fixation device of the surgical fixation system may be a button.

A bridge is located between a first aperture and a second aperture of a fixation device.

The system may further include a third aperture of a fixation device which may carry a passing filament.

A first adjustable eyesplice loop may be received through a first aperture of the fixation device. A second adjustable eyesplice loop may be received through a second aperture of the fixation device.

An adjustable loop may include a first free braid strand for adjusting a first adjustable eyesplice loop. An adjustable loop may include a second free braid strand for adjusting a second adjustable eyesplice loop.

A first free braid strand may be passed through a second adjustable eyesplice loop and a second free braid strand may be passed through a first adjustable eyesplice loop. A first free braid strand may be passed through a first opening of a fixation device prior to passing through a second adjustable eyesplice loop. A second free braid strand may be passed through a second opening of a fixation device prior to passing through a first adjustable eyesplice loop.

A first free braid strand and/or a second free braid strand each may be spliced through an adjustable loop at least twice.

A fixation device may include a top surface and a bottom surface. A bridge may be countersunk from the top surface.

A first adjustable eyesplice loop, a second adjustable eyesplice loop, and free braid strands of an adjustable loop may co-operate to establish a knot stack at an interface between the adjustable loop and a fixation device.

A knot stack may rest over the bridge of a fixation device.

A surgical fixation system may include a knot stack at an interface between a fixation device and an adjustable loop.

A knot stack may be established by at least two adjustable eyesplice loops and free braid strands of a flexible strand that is used to form the at least two adjustable eyesplice loops.

A surgical method according to another exemplary aspect of this disclosure, not being part of the invention, includes, inter alia, fixating a graft within a bone tunnel using a surgical fixation system that includes a fixation device and an adjustable loop connected to the fixation device. An adjustable loop includes at least two adjustable eyesplice loops that are interlinked at an interconnection located at an interface between the fixation device and the adjustable loop.

A surgical fixation system according to another exemplary aspect of this disclosure may include, inter alia, a fixation device and an adjustable loop connected to the fixation device. A fixation device may include a body that extends along a central longitudinal axis and may include a top surface and a bottom surface. At least one aperture and a suture return aperture may each extend through the body. For example, a first and second aperture may each extend through the body. A bridge may extend between a first aperture and a second aperture. An adjustable loop may be connected to at least one aperture. For example, an adjustable loop may be connected to a first aperture and a second aperture. A first free braid strand may extend from a first spliced section of an adjustable loop, and a second free braid strand may extend from a second spliced section of the adjustable loop. The first free braid strand and the second free braid strand may extend through a suture return aperture and then under a loop section of an adjustable loop that rests over the bridge to establish a locking mechanism of the surgical fixation system. In a locked position of the locking mechanism, a first free braid strand and a second free braid strand may be tensioned against an outer surface of the bridge by the loop section of an adjustable loop.

An outer surface of a bridge may be flush with the top surface of a fixation device.

The surgical fixation system may further include a longitudinal axis extending through an outer surface of the bridge. The longitudinal axis may be perpendicular to a central longitudinal axis.

The first aperture and the second aperture of a fixation device may be axially aligned and may be disposed along a central longitudinal axis. A suture return aperture may be offset from a central longitudinal axis in a direction toward a side wall of the body.

The surgical fixation system may include a bump, and the bump may be disposed laterally between the suture return aperture and the bridge.

A first free braid strand and a second free braid strand of an adjustable loop may be tensioned against a bump of a fixation device.

When in a locked position of the locking mechanism, a first free braid strand and a second free braid strand may be tensioned against the bump.

The surgical fixation system may include a bump that protrudes outwardly from the top surface at a location adjacent to a suture return aperture, and a first free braid strand and a second free braid strand of an adjustable loop may extend up and over the bump.

A surgical method according to another exemplary aspect of this disclosure, not being part of the invention, may include, inter alia, fixating a graft within a bone tunnel using a surgical fixation system that includes a fixation device and an adjustable loop connected to the fixation device. The surgical method may include fixating a graft within a bone tunnel with the surgical fixation system of the previous exemplary aspects.

A surgical method according to another exemplary aspect of this disclosure, not being part of the invention, may include, inter alia, fixating a graft within a bone tunnel using a surgical fixation system that may include a fixation device and an adjustable loop connected to the fixation device as discussed herein. A fixation device may include a body that extends along a central longitudinal axis and may include a top surface and a bottom surface. At least one aperture and a suture return aperture may each extend through the body. A first and second aperture may each extend through the body. A bridge may extend between a first aperture and a second aperture. An adjustable loop may be connected to at least one aperture. For example, an adjustable loop may be connected to a first aperture and a second aperture. A first free braid strand may extend from a first spliced section of an adjustable loop, and a second free braid strand may extend from a second spliced section of the adjustable loop. The first free braid strand and the second free braid strand may extend through a suture return aperture and then under a loop section of an adjustable loop that rests over the bridge to establish a locking mechanism of the surgical fixation system. In a locked position of the locking mechanism, a first free braid strand and a second free braid strand may be tensioned against an outer surface of the bridge by the loop section of an adjustable loop.

This disclosure relates to surgical fixation systems and methods The methods disclosed herein do not form par of the invention. A surgical fixation system may include a fixation device and an adjustable loop connected to the fixation device. The loop may carry a graft. Surgical fixation systems may be used in various tissue reconstruction procedures, including but not limited to, ACL and PCL reconstructions.

<FIG>, <FIG> illustrate an exemplary surgical fixation system <NUM>. The surgical fixation system <NUM> may be used to perform a variety of tissue reconstruction procedures. The tissue reconstruction procedures could include any procedure in which it is desirable to position a replacement graft or filament within a bone tunnel to repair torn tissue. ACL and PCL reconstructions are but two non-limiting examples of reconstruction procedures which could benefit from the use of the surgical fixation system <NUM> of this disclosure. The surgical fixation system <NUM> could additionally be used in procedures related to the ankle (e.g., syndesmosis procedures) and shoulder (e.g., acromioclavicular (AC) joint procedures).

The surgical fixation system <NUM> includes, in this example, a fixation device <NUM> and a loop <NUM> connected to the fixation device <NUM>. In an embodiment, the loop <NUM> carries a graft <NUM> for fixating the graft <NUM> relative to bone. In another embodiment, the loop <NUM> carries a filament (e.g., any thread-like material such as suture, etc.) for fixating the filament relative to bone.

The fixation device <NUM> may provide cortical bone fixation of the graft <NUM> (or filament), for example, after the graft <NUM> has been positioned within a bone tunnel. In an embodiment, the fixation device <NUM> is a button. However, fixation devices having other similar configurations could also be used. The fixation device <NUM> may be oblong or round and may be made of either metallic or polymeric materials within the scope of this disclosure.

In another embodiment, the fixation device <NUM> includes one or more apertures <NUM> formed through the body of the fixation device <NUM> for receiving the loop <NUM>. The fixation device <NUM> of the embodiment of <FIG>, in accordance with the invention, includes two apertures <NUM> for connecting the loop <NUM> to the fixation device <NUM>. Although not shown, the fixation device <NUM> could include additional apertures or openings in excess of two (see, for example, the fixation device of <FIG>).

In an embodiment, the loop <NUM> is an adjustable loop made of a flexible material, and in this example, may include an adjustable length and/or perimeter. Free braid strands <NUM> of the loop <NUM>, which may also be referred to as shortening strands, may be pulled to reduce the size of the loop <NUM>. For example, the loop <NUM> may be adjusted in a first direction by pulling the free braid stands <NUM> but is prevented from loosening in the opposite direction due to applied internal tensile forces.

The loop <NUM> may include one or more adjustable eyesplice loops <NUM>, which may be formed by splicing the flexible material that is used to form the loop <NUM> through itself. The loop <NUM> may be connected to the fixation device <NUM> prior to completely forming the loop <NUM>. An exemplary method of forming the loop <NUM> and connecting it to the fixation device <NUM> is discussed in greater detail below with respect to <FIG>.

The graft <NUM> is connected to a cradle <NUM> of the loop <NUM> (see <FIG>). In an embodiment, the graft <NUM> may be looped over the cradle <NUM> of the loop <NUM>. The cradle <NUM> is the portion of the loop <NUM>, which in this example, is located opposite from the portion of the loop <NUM> that is connected to the fixation device <NUM>. The graft <NUM> could include tissue, tendon, ligament, filament (e.g., suture), synthetic material, biologic material, bone, or any combinations of such materials.

In an embodiment, the adjustable eyesplice loops <NUM> and the free braid strands <NUM> cooperate to establish a knot stack <NUM> at the loop <NUM>/fixation device <NUM> interface. The knot stack <NUM> rests over the fixation device <NUM> (e.g., just above the location where the apertures <NUM> are formed through the fixation device <NUM>) and increases the strength of the connection between the loop <NUM> and the fixation device <NUM>.

<FIG> illustrate an exemplary fixation device <NUM> for use with a surgical fixation system, such as the surgical fixation system <NUM> of <FIG>, for example. The fixation device <NUM> may include a top surface <NUM> (see <FIG>) and a bottom surface <NUM> (see <FIG>). A side wall <NUM> extends between the top surface <NUM> and the bottom surface <NUM> to establish a body of the fixation device <NUM>. In an embodiment, the body of the fixation device <NUM> is oblong shaped.

Apertures 20A, 20B, and 20C extend through both the top surface <NUM> and the bottom surface <NUM> of the fixation device <NUM>. In an embodiment, the fixation device <NUM> may include three apertures. The two apertures 20A, 20B near the middle of the fixation device <NUM> can be used to attach the loop <NUM>, whereas the peripheral aperture 20C can be used to carry a passing suture for passing and/or flipping the fixation device <NUM> relative to bone. In an embodiment, the apertures 20A and 20C are round and the aperture 20C is tear-drop shaped. Other shapes and combinations of shapes are also contemplated.

In accordance with the invention, a bridge <NUM> separates the apertures 20A, 20B from one another and provides a surface for carrying the loop <NUM> of the surgical fixation system <NUM>. The bridge <NUM> may be countersunk from the top surface <NUM> to establish a channel <NUM> at the top surface <NUM>. The knot stack <NUM> of the loop <NUM> may be at least partially received within the channel <NUM>.

The bridge <NUM> may not be countersunk at the bottom surface <NUM> (see <FIG>) since there is no need to accommodate the knot stack <NUM> on that side of the fixation device <NUM>. Thus, the bottom surface <NUM> of the fixation device <NUM> may be generally flat. Stated another way, the top surface <NUM> and the bottom surface <NUM> may be non-symmetric to one another.

<FIG> schematically illustrate an exemplary method of forming the loop <NUM> of the surgical fixation system <NUM> of <FIG>. <FIG> illustrates starting materials for constructing the loop <NUM> and attaching it to the fixation device <NUM>. The starting materials include, for example, a flexible strand <NUM>, such as a suture strand, a suture passing device <NUM>, such as a needle, and the fixation device <NUM>, such as a button.

Referring next to <FIG>, the flexible strand <NUM> is folded in half to create two substantially equal length and, in this example, parallel braid strands. The flexible strand <NUM> may be folded near its midpoint M to create the two substantially equal length and, in this example, parallel braid strands. A measuring device <NUM>, such as a ruler, may be used to select a desired amount of the flexible strand <NUM> for creating a loop <NUM> having a desired size.

<FIG> and <FIG> illustrate an example of the formation of a first adjustable eyesplice loop 24A of the loop <NUM>. The first adjustable eyesplice loop 24A may be created by first passing the suture passing device <NUM> through the flexible strand <NUM> (see <FIG>). The suture passing device <NUM> may be passed through the flexible strand <NUM> near the midpoint M where the flexible strand <NUM> was previously folded to mark the location where the flexible strand <NUM> will ultimately be spliced through itself. A first free end <NUM> of the flexible strand <NUM> may be next inserted through an eyelet <NUM> of the suture passing device <NUM> (see <FIG>). The suture passing device <NUM> may then be moved (e.g., pulled) in a direction of arrow <NUM> to splice the first free end <NUM> back through the flexible strand <NUM> at the location where the suture passing device <NUM> previously passed through the flexible strand <NUM>. This creates a first spliced section <NUM> in the flexible strand <NUM>.

Referring now to <FIG>, the first adjustable eyesplice loop 24A may be passed through one of the apertures <NUM> of the fixation device <NUM> to begin to connect the flexible strand <NUM> to the fixation device <NUM>. The fixation device <NUM> may be slid until, in this example, it rests just above the first spliced section <NUM>.

<FIG> illustrates the formation of a second adjustable eyesplice loop 24B of the loop <NUM>. A second free end <NUM> of the flexible strand <NUM> may be looped through the first adjustable eyesplice loop 24A and can then be inserted through the eyelet <NUM> of the suture passing device <NUM> prior to pulling the suture passing device <NUM> back through the flexible strand <NUM>. This splices the second free end <NUM> back through the flexible strand <NUM> to create a second spliced section <NUM>. In this way, the first adjustable eyesplice loop 24A and the second adjustable eyesplice loop 24B become interlinked at an interconnection <NUM> that, in this example, will ultimately rest over the bridge <NUM> of the fixation device <NUM>. This may also securely connect the loop <NUM> to the fixation device <NUM>.

Referring now to <FIG>, the first adjustable eyesplice loop 24A includes a first free braid strand 22A and the second adjustable eyesplice loop 24B includes a second free braid strand 22B. The first and second free braid strands 22A, 22B may be positioned on an opposite side of the fixation device <NUM> from the knot stack <NUM>. The first free braid strand 22A may be pulled back through the cradle <NUM> of the flexible strand <NUM>, for example, on the right side of the construct (when looking down on the construct as shown in <FIG>) to create a third spliced section <NUM>. The second free braid strand 22B may be pulled back through the cradle <NUM> of the flexible strand <NUM> on, for example, the left side of the construct to create a fourth spliced section <NUM>.

<FIG> illustrates the completed loop <NUM>, which in this embodiment, includes two adjustable eyesplice loops 24A, 24B that are interlinked to one another at the interconnection <NUM>. The fixation device <NUM> may be centered between the first adjustable eyesplice loop 24A and the second adjustable eyesplice loop 24B to complete the assembly procedure. The free braid strands 22A, 22B extending from the spliced sections <NUM>, <NUM> may be passed back through the apertures <NUM> of the fixation device <NUM>. Next, the first free braid strand 22A is passed through the first adjustable eyesplice loop 24A, and the second free braid strand 22B is passed through the second adjustable eyesplice loop 24B, thus completing the formation of the knot stack <NUM>.

The free braid strands 22A, 22B may be pulled to constrict the size of the first and second adjustable eyesplice loops 24A, 24B, respectively and thus may change the overall size of the loop <NUM>. The knot stack <NUM> may act as a first locking mechanism at the loop <NUM>/fixation device <NUM> interface. The spliced sections <NUM>, <NUM> may act as additional locking mechanisms, in this example, at the distal graft <NUM>/loop <NUM> interface.

<FIG> illustrates an exemplary surgical use of the surgical fixation system <NUM> of <FIG> during a tissue reconstruction procedure, such as an ACL reconstruction procedure. However, it should be understood that this disclosure is not limited to ACL reconstruction procedures, and the surgical fixation system <NUM> could be used in a variety of reconstruction procedures within the scope of this disclosure.

The surgical fixation system <NUM> may be implanted within a joint <NUM> (e.g., a knee joint) to repair a torn tissue (e.g., a torn ACL). Prior to positioning the surgical fixation system <NUM> within the joint <NUM>, a first bone tunnel <NUM> (e.g., a socket) is formed in a first bone <NUM> (e.g., a femur) and a second bone tunnel <NUM> (e.g., a passage) is formed in a second bone <NUM> (e.g., a tibia). The first bone tunnel <NUM> and the second bone tunnel <NUM> may be formed using known drilling techniques to establish voids within the first and second bones <NUM>, <NUM> for accommodating the surgical fixation system <NUM>.

In an exemplary embodiment, the surgical fixation system <NUM> is implanted by passing the fixation device <NUM> through the first bone tunnel <NUM> and the second bone tunnel <NUM>. The fixation device <NUM> may be pulled through the first and second bone tunnels <NUM>, <NUM> using a passing suture (not shown) and self-flips onto the cortex of the first bone <NUM> once tension is released on the passing suture.

After passing and flipping the fixation device <NUM>, the loop <NUM> is positioned within the first bone tunnel <NUM>. The free braid strands <NUM> may be pulled to adjust the size of the loop <NUM> and to aid the positioning of the loop <NUM> within the first bone tunnel <NUM>. The loop <NUM> suspends the graft <NUM> within portions of the first bone tunnel <NUM> and the second bone tunnel <NUM>.

Fixation of the graft <NUM> to the second bone <NUM> can be achieved in a variety of ways. For example, the graft <NUM> may be fixated within the second bone tunnel <NUM> using an interference screw, a suture anchor, or an additional surgical fixation system that includes a second fixation device and a second loop.

The surgical fixation system <NUM> of <FIG> was tested against a prior art surgical fixation system using a force controlled cyclic loading procedure. Elongation was measured over multiple load cycles for each system. The results of this testing are shown in the plots of <FIG>.

The surgical fixation system <NUM> of <FIG> was tested using a displacement controlled cyclic loading procedure. Displacement was measured over multiple load cycles. The results of this testing are shown in the plots of <FIG> (with and without retensioning).

The surgical fixation systems of this disclosure provide an adjustable fixation system for reinforcing and augmenting graft fixation within a bone tunnel. The surgical fixations systems provide the following benefits over predicate devices:.

<FIG> illustrates another exemplary surgical fixation system <NUM>. The surgical fixation system <NUM> may be used to perform a variety of tissue reconstruction procedures.

The surgical fixation system <NUM>, in this example, includes a fixation device <NUM> and a loop <NUM> connected to the fixation device <NUM>. In an embodiment, the loop <NUM> carries a graft <NUM>, for example, for fixating the graft <NUM> relative to bone.

The fixation device <NUM> may provide cortical bone fixation of the graft <NUM> (or filament), for example, after the graft <NUM> has been positioned within a bone tunnel. In an embodiment, the fixation device <NUM> is a button. However, fixation devices having other similar configurations could also be used. The fixation device <NUM> may be oblong or round and may be made of either metallic or polymeric materials within the scope of this disclosure. Two exemplary fixation device designs are further described below (see <FIG> and <FIG>, respectively).

In another embodiment, the fixation device <NUM> includes a plurality of apertures <NUM> formed through the body of the fixation device <NUM> for receiving the loop <NUM>. Some of the apertures <NUM> may additionally carry one or more filaments <NUM>, such as sutures, that can be used for passing the fixation device <NUM> through a bone tunnel and and/or for flipping the fixation device <NUM> relative to bone after exiting from the bone tunnel.

In an embodiment, the loop <NUM> is an adjustable loop made of a flexible material, and this example, includes an adjustable length and/or perimeter. Free braid strands 122A, 122B of the loop <NUM>, which may also be referred to as shortening strands, may be pulled to reduce the size of the loop <NUM>. For example, the loop <NUM> may be adjusted in a first direction by pulling the free braid stands 122A, 122B but is prevented from loosening in the opposite direction due to applied internal tensile forces.

The loop <NUM> may include one or more adjustable eyesplice loops 124A, 124B which may be formed by splicing the flexible material that may be used to form the loop <NUM> through itself. The loop <NUM> may be connected to the fixation device <NUM> prior to completely forming the loop <NUM>.

The graft <NUM> is connected to a cradle <NUM> of the loop <NUM>. In an embodiment, the graft <NUM> may be looped over the cradle <NUM> of the loop <NUM>. The cradle <NUM> in this embodiment is established by an interconnection <NUM> of the eyesplice loops 124A, 124B. The graft <NUM> could include tissue, tendon, ligament, filament (e.g., suture), synthetic material, biologic material, bone, or any combinations of such materials.

In an embodiment, the loop <NUM> and the fixation device <NUM> may cooperate to establish a locking mechanism <NUM> of the surgical fixation system <NUM>. The locking mechanism <NUM> locks the size and position of the loop <NUM> relative to the fixation device <NUM>, thereby increasing the strength at the loop <NUM>/fixation device <NUM> interface. The locking mechanism <NUM> may be a byproduct of a combination of features of the loop <NUM> and the fixation device <NUM>. The locking mechanism <NUM> is discussed in greater detail below with reference to different designs of the fixation device <NUM>.

<FIG> illustrate an exemplary fixation device 112A for use with a surgical fixation system, such as the surgical fixation system <NUM> of <FIG>, for example. The fixation device 112A includes a body <NUM> that extends along a central longitudinal axis A between opposing end portions <NUM>. In an embodiment, the body <NUM> of the fixation device 112A is oblong shaped.

The body <NUM> includes a top surface <NUM> and a bottom surface <NUM> that each extend between the opposing end portions <NUM>. A side wall <NUM> extends between the top surface <NUM> and the bottom surface <NUM>. Together, the top surface <NUM>, the bottom surface <NUM>, and the side wall <NUM> establish the body <NUM> of the fixation device 112A.

In an embodiment, the top surface <NUM> is a convex surface that curves in a direction away from the bottom surface <NUM>. In another embodiment, the bottom surface <NUM> is a flat surface.

In this example, a first aperture 120A, a second aperture 120B, a third aperture 120C, and a fourth aperture 120D are formed through the body <NUM> of the fixation device 112A and extend through both the top surface <NUM> and the bottom surface <NUM>. In an embodiment, the first aperture 120A, the second aperture 120B, and the third aperture 120C may be axially aligned and are disposed along the central longitudinal axis A, and the fourth aperture 120D may be offset from the central longitudinal axis A, for example, in a direction toward the side wall <NUM>. In an embodiment, the first aperture 120A and the second aperture 120B include irregular shapes, and the third aperture 120C and the fourth aperture 120D are oval shaped. However, the sizes and shapes of the apertures are not intended to limit this disclosure.

The first aperture 120A and the second aperture 120B may be configured and arranged to receive the loop <NUM> of the surgical fixation system <NUM>. A bridge <NUM> may separate the first and second apertures 120A, 120B from one another and may provide a surface for carrying the loop <NUM> of the surgical fixation system <NUM>. The bridge <NUM> may include an outer surface <NUM> that is flush to the top surface <NUM> of the fixation device 112A (i.e., the outer surface <NUM> is not countersunk relative to the top surface <NUM>) and, for example, a pair of angled surfaces <NUM> that extend transversely from the bridge <NUM> in a direction toward the bottom surface <NUM> of the fixation device 112A. In an embodiment, the outer surface <NUM> of the bridge <NUM> extends along a longitudinal axis A2 that is, for example, generally perpendicular to the central longitudinal axis A of the body <NUM> (see <FIG>).

The third aperture 120C may be used to carry one or more filaments <NUM> for passing the fixation device 112A through a bone tunnel and/or for flipping the fixation device 112A relative to bone after exiting from the bone tunnel. The third aperture 120C may be the aperture that is closest to one of the opposing end portions <NUM> of the fixation device 112A.

The fourth aperture 120D may be utilized as a suture return aperture for receiving the free braid strands 122A, 122B of the loop <NUM>. The fourth aperture 120D may be located adjacent to the first and second apertures 120A, 120B. In an embodiment, the longitudinal axis A2 extending through the outer surface <NUM> of the bridge <NUM> may intersect the fourth aperture 120D (see, e.g., <FIG>).

With reference now to <FIG>, the fixation device 112A and the loop <NUM> may be configured to establish the locking mechanism <NUM> of the surgical fixation system <NUM>. In an embodiment, a first free braid strand 122A extends from a first spliced section <NUM> of the loop <NUM>, and a second free braid strand 122B extends from a second spliced section <NUM> of the loop <NUM>. The first free braid strand 122A and the second free braid strand 122B may be passed upwardly through, in this example, the fourth aperture 120D (i.e., in a direction that extends from the bottom surface <NUM> toward the top surface <NUM> of the fixation device 112A) and may then be passed beneath a loop section <NUM> of the loop <NUM> that may, for example, rest over the bridge <NUM> (i.e., between the loop section <NUM> and the bridge <NUM>) to establish the locking mechanism <NUM>.

<FIG> illustrate a locked position L1 of the locking mechanism <NUM> that is established by the loop <NUM> and the fixation device 112A. In the locked position L1, the free braid strands 122A and 122B are held in tension directly against the outer surface <NUM> of the bridge <NUM> by the loop section <NUM> of the loop <NUM>. This tension may be created, for example, by tensioning an opposite section of the loop <NUM> (i.e., for example, the cradle <NUM> that carries the graft <NUM>). The free braid strands 122A, 122B may therefore be held against the type of movement that is necessary for constricting the size of the first and second adjustable eyesplice loops 124A, 124B of the loop <NUM>.

<FIG> illustrate an unlocked position L2 of the locking mechanism <NUM> that is established by the loop <NUM> and the fixation device 112A. In the unlocked position L2, the tension that holds the loop section <NUM> against the free braid strands 122A and 122B is released, such as by releasing the tension on the graft <NUM>, thereby permitting the free braid strands 122A, 122B to move relative to the bridge <NUM> and the loop section <NUM>. Once the tension being applied by the loop section <NUM> has been removed, the free braid strands 122A, 122B can be tensioned in, for example, a direction D1 to constrict the size of the first and/or second adjustable eyesplice loops 124A, 124B of the loop <NUM>.

<FIG> illustrate another exemplary fixation device 112B for use with a surgical fixation system, such as the surgical fixation system <NUM> of <FIG>, for example. The fixation device 112B includes a body <NUM> that extends along a central longitudinal axis A between opposing end portions <NUM>. In an embodiment, the body <NUM> of the fixation device 112B is oblong shaped.

The body <NUM> includes a top surface <NUM> and a bottom surface <NUM> that each extend between the opposing end portions <NUM>. A side wall <NUM> extends between the top surface <NUM> and the bottom surface <NUM>. Together, the top surface <NUM>, the bottom surface <NUM>, and the side wall <NUM> establish the body <NUM> of the fixation device 112B.

For example, a first aperture 120A, a second aperture 120B, a third aperture 120C, and a fourth aperture 120D may be formed through the body <NUM> of the fixation device 112B and extend through both the top surface <NUM> and the bottom surface <NUM>. In an embodiment, the first aperture 120A, the second aperture 120B, and the third aperture 120C are axially aligned and, for example, may be disposed along the central longitudinal axis A, and the fourth aperture 120D may be offset from the central longitudinal axis A, for example, in a direction toward the side wall <NUM>. In an embodiment, the first aperture 120A and the second aperture 120B include irregular shapes, and the third aperture 120C and the fourth aperture 120D are oval shaped. However, the sizes and shapes of the apertures are not intended to limit this disclosure.

The first aperture 120A and the second aperture 120B may be arranged to receive the loop <NUM> of the surgical fixation system <NUM>. A bridge <NUM> separates the first and second apertures 120A, 120B from one another and provides a surface for carrying the loop <NUM> of the surgical fixation system <NUM>. The bridge <NUM> may include an outer surface <NUM> that is flush with the top surface <NUM> of the fixation device 112B (i.e., the outer surface <NUM> is not countersunk relative to the top surface <NUM>) and, for example, a pair of angled surfaces <NUM> that extend transversely from the bridge <NUM> in a direction toward the bottom surface <NUM> of the fixation device <NUM>. In an embodiment, the outer surface <NUM> of the bridge <NUM> extends along a longitudinal axis A2 that may be generally perpendicular to the central longitudinal axis A of the body <NUM> (see <FIG>).

The third aperture 120C may be used to carry one or more filaments <NUM> for passing the fixation device 112B through a bone tunnel and/or for flipping the fixation device <NUM> relative to bone after exiting from the bone tunnel. The third aperture 120C may be, for example, the aperture that is closest to one of the opposing end portions <NUM> of the fixation device 112B.

A bump <NUM> may be positioned laterally between the bridge <NUM> and the fourth aperture 120D of the fixation device 112B. The bump <NUM> may protrude outwardly from the top surface <NUM> of the fixation device 112B and the outer surface <NUM> of the bridge <NUM>. Unlike the outer surface <NUM> of the bridge <NUM> in this example, the bump <NUM> is therefore not flush relative to the top surface <NUM>.

With reference to <FIG> and <FIG>, the fixation device 112B and the loop <NUM> may be configured to establish the locking mechanism <NUM> of the surgical fixation system <NUM>. In an embodiment, a first free braid strand 122A extends from a first spliced section <NUM> of the loop <NUM>, and a second free braid strand 122B extends from a second spliced section <NUM> of the loop <NUM>. The first free braid strand 122A and the second free braid strand 122B may be passed upwardly through, as in this example, the fourth aperture 120D (i.e., for example, in a direction that extends from the bottom surface <NUM> toward the top surface <NUM> of the fixation device 112A), may then be passed along a tortuous path up and over the bump <NUM>, and may then be passed beneath a loop section <NUM> of the loop <NUM> that may, for example, rest over the bridge <NUM> to establish the locking mechanism <NUM>.

<FIG> illustrate a locked position L1 of the locking mechanism <NUM> that may be established by the loop <NUM> and the fixation device 112B. In the locked position L1, the free braid strands 122A and 122B are held in tension directly against the outer surface <NUM> of the bridge <NUM> by the loop section <NUM> of the loop <NUM>. This tension may be created, for example, by tensioning an opposite section of the loop <NUM> (i.e., for example, the section that carries the graft <NUM>). The bump <NUM> of the fixation device 112B may augment the amount of tension that can be exerted against the free braid strands 122A, 122B in the locked position L1. The free braid strands 122A, 122B are therefore held against the type of movement that is necessary for constricting the size of the first and second adjustable eyesplice loops 124A, 124B of the loop <NUM>.

<FIG> illustrate an unlocked position L2 of the locking mechanism <NUM> that is established by the loop <NUM> and the fixation device 112B. In the unlocked position L2, the tension that holds the loop section <NUM> against the free braid strands 122A and 122B is released, such as by releasing the tension on the graft <NUM>, thereby permitting the free braid strands 122A, 122B to move relative to the bridge <NUM>, the loop section <NUM>, and the bump <NUM>. Once the tension being applied by the loop section <NUM> has been removed, the free braid strands 122A, 122B can be tensioned in a direction D1 to constrict the size of the first and/or second adjustable eyesplice loops 124A, 124B of the loop <NUM>.

Although the different non-limiting embodiments are illustrated as having specific components or steps, the embodiments of this disclosure are not limited to those particular combinations. It is possible to use some of the components or features from any of the non-limiting embodiments in combination with features or components from any of the other non-limiting embodiments.

It should further be understood that although a particular component arrangement is disclosed and illustrated in these exemplary embodiments, other arrangements could also benefit from the teachings of this disclosure.

Claim 1:
A surgical fixation system (<NUM>), comprising:
a fixation device (<NUM>) including a top surface and a bottom surface; and
an adjustable loop (<NUM>) connected to the fixation device (<NUM>)
wherein
the adjustable loop (<NUM>) includes a first adjustable eyesplice loop (24A) that passes through and interlinks with a second adjustable eyesplice loop (24B) at an interconnection (<NUM>) that rests over a bridge (<NUM>) of the fixation device (<NUM>), wherein the bridge (<NUM>) is located between a first aperture (20A) and a second aperture (20B) of the fixation device (<NUM>)
characterized in that
the bridge (<NUM>) is countersunk from the top surface to establish a channel (<NUM>) at the top surface,
wherein the first adjustable eyesplice loop (24A), the second adjustable eyesplice loop (24B), and free braid strands of the adjustable loop (<NUM>) cooperate to establish a knot stack (<NUM>) that rests over the bridge (<NUM>) of the fixation device (<NUM>) and is at least partially received within the channel (<NUM>).