1. The Field of the Invention
The present disclosure relates generally to anterior cruciate ligament (ACL) repair and the fixation of an ACL graft on the cortical side of the bone. The technology disclosed herein may also be used for other suspensory fixation applications such as bone/tendon or bone/ligament attachment.
2. The Relevant Technology
Currently ACL repair requires cortical fixation using some type of fixation device that can retain a graft ligament passed through a bone tunnel while maintaining fixation on the cortical side of the bone. Currently there are buttons on the market that allow for fixation without passing through the bone tunnel. Knots tied on, around or through the button are used to hold the graft and the button in place. However, knots are known for reducing the strength of the fixation.
In addition, knots do not offer the amount of tension typically desired by physicians because in tying the knot tension is often relinquished in order to achieve a completed knot. Numerous devices have been developed to eliminate the need to tie knots as a way of securing a line. The devices that accomplish the same function as a knot, which is in part to secure a line to retain tension in a portion of the line, are typically referred to as line locks. These line locks can be used as a one-way directional slide to increase tension in a line without relinquishing that tension to tie a knot.
Current ACL repair systems will engage a graft and then fix the graft using knots tied to a body on the cortical side of the bone. Physicians either have to fix the graft using cord or line prior to passage through the bone tunnel and then readjust the tension, or pass the lines and cords through the bone tunnel without tension and then adjust the tension after pass through, again, tying knots to fix the graft to the cortical fixation device.
In addition currently physicians must choose a proper suture length and bight length of a sling to hold the graft. In this case the surgeon must have multiple sutures with multiple bight lengths available in the operating room (OR) and if the improper length is chosen first then the surgeon will be required to find a different suture length and bight length leading to more guess work and longer surgery times.
As the above described techniques illustrate, the existing systems and procedures for ACL repair may not be as effective as desired.
In an aspect of the disclosed technology, a system includes a line lock, a line routed through the line lock to form a one-way slide, and a line lock stabilizer.
In an embodiment, the system may include a line lock stabilizer and a compression limiter.
In another embodiment, the system may include a line lock stabilizer, a compression limiter, and a means for adjusting the line relative to the line lock.
In yet another embodiment, the system may include a line lock stabilizer, a compression limiter, and a line cutter.
In yet another embodiment, the system may include a line lock stabilizer and a means for adjusting the line relative to the line lock.
In yet another embodiment, the system may include a line lock stabilizer, a means for adjusting the line relative to the line lock, and a line cutter.
In yet another embodiment, the system may include a line lock stabilizer and a line cutter.
In yet another embodiment, the system may include a compression limiter.
In yet another embodiment, the system may include a compression limiter and a means for adjusting the line relative to the line lock.
In yet another embodiment, the system may include a compression limiter and a line cutter.
Various embodiments of the present technology will now be discussed with reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the technology and are therefore not to be considered limiting of its scope.
The disclosed systems provide means for “locking” a line or suture at a length without using a knot, such knots being capable of reducing the strength of the line or suture. The systems allow for adjustment of the line/suture/sling length on the back table, reducing the need for multiple sizes or parts. Because of the adjustable nature the tolerance/error band on the line length is lower than competitive devices that use a fixed size and/or length line. Parts of this system may include a zip knot or “wrap” along with plate geometry and hole patterns for routing of a line. The device may also include a loop/cinch with a first loop or lead loop. Other features may include adjustability of a single free end or multiple free ends. Furthermore a first or primary filament and second or secondary filament configurations may be used to flip the plate to secure the device against a bone.
One embodiment is a rectangular piece/plate with rounded ends. One of the ends has a “dogbone” feature for lines and filaments to wrap around. The dogbone feature may comprise two cutouts toward one end of the plate on opposing sides, forming a neck, which give the structure its name as featured in the
The plate is designed to fit through a bone tunnel and can be inserted via any preferred approach (e.g., medial portal or trans-tibial approaches). A first or primary filament may have a first filament loop created along its length a specified distance from its mid-length, the loop may be stationary but may also move along the length of the first filament. The first filament may have a stationary feature, which may be a knot, at the filament's mid-length. A section of the first filament is looped through the plate body on one side. The secondary filament may pass through the body of the plate or through the first loop of the line. A second filament may be passed through one of the central holes in the body of the plate which may be the same hole that the first loop of the line is passed through. The second or secondary filament may also pass through the first filament loop. The second filament may be fixed to the plate at any specified distance from the central plate hole such as passing the second filament around the dogbone feature of the plate or around the plate in general or through any of the other plate holes. The colors and lengths of the filaments may be configured to ensure the primary filament through the plate hole will be pulled through the bone tunnel to pull up the button past the cortical wall, with the secondary filament parallel with the first loop and graft. Once the plate clears the bone tunnel, the secondary filament is pulled on either trans-tibially or from a medial portal to flip the plate so that the plate is perpendicular to the tunnel and anchors against the bone (plate contact area larger the bone tunnel area). After plate installation one end of the primary filament is pulled through the plate, simultaneously pulling the secondary filament from the bone tunnel and central hole in the body of the plate. The secondary filament is pulled from the plate.
One will appreciate that the secondary filament is not required to pass through a first filament loop and thus the secondary filament may not be removed in conjunction with removal of the primary filament. The secondary filament may pass through the bone tunnel and after installation of the plate the secondary filament may be removed through the plate similar to the primary filament.
This device may be used to hold an ACL graft and the graft may be soft or hard tissue. In addition this device is not limited to the ACL or knee and may have other applications in other parts of the body, such as the shoulder, elbow and ankle.
Referring to
The plate 11 may also comprise grooves 36 throughout the plate. The grooves 36 may extend between passageways 14 or between a passageway 14 and a periphery 40 of the plate 11 or even grooves 36 from between the head 22 and neck 20 and the neck 20 and the body 12. The grooves 36 may also reside on the top, sides or bottom of the plate 11. The plate 11 is designed to fit through a bone tunnel and can be inserted via any preferred approach (e.g., medial portal or trans-tibial approaches). The plate may be comprised of biocompatible materials including but not limited to titanium, stainless steel, cobalt chrome, PEEK, PLLA, polymer/ceramic composites, polymers, co-polymers, or alloys or a combination of those mentions herein. In addition any material used for the plate may also be coated with bioactive or supportive materials.
The plurality of passageways 14 may be generally rounded and are capable of receiving at least one line. The plurality of passageways 14 may comprise four passageways that are configured to receive the line 24 and are shaped and patterned for the routing of the line through the passageways 14. The passageways 14 may be substantially on the body 12 of the plate 11; however in an alternate embodiment the neck 20 may also comprise a passageway 14. Of the four passageways, those disposed more laterally may comprise a more ovoid shape and those passageways disposed more medially may comprise a more triangular or tear-drop shape. The shapes of the plurality of passageways 14 are selected to enhance the routing and self-locking of the line 24 to the plate 11. The tear-drop shape of at least one of the plurality of passageways 14 may further enhance the locking of the line 24 for the adjustable loop 29. The ovoid shape of at least one of the plurality of passageways 14 may allow for multiple passes of the line 24 through the same passageway while minimizing total passageway area. The plurality of passageways 14 may also taper or enlarge from the top to the bottom of the plate 11 or the plurality of passageways 14 may taper or enlarge from the bottom to the top of the plate 11.
The neck 20 is a smaller circumference than the body 12, or is thinner than the body in at least one plane, to maintain the line 24. The smaller circumference may also provide protection of the lines as they pass through the cutouts that create the neck to prevent the lines from rubbing against the walls of a bone tunnel when passing the plate 11 through the bone tunnel.
The head 22 of the plate 11 may comprise flanges or fins 42 which extend back toward the body 12 of the plate 11. These flanges 42 may add greater security of the line 24 and the second filament 46 preventing withdrawal of the second filament 46 or the line 24 over the head 22. The flanges 42 may also provide added protection of the line 24 and second filament 46 during passage of the plate through the bone tunnel.
The line 24 of the device 10 is routed through the passageways 14 to create a self-locking slide. The line 24 may be comprised of metal, polymer, composite or suture and may be woven or braided. The line may comprise a first portion, which may be a first working portion 26, and a second portion, which may be a second working portion 30. Both of the first and second working portions 26, 30 may have free ends. Between the first working portion 26 and the second working portion 30 is an intermediate portion 28 which may comprise an adjustable loop 29. The first working portion 26 is routed along a first pathway. The first pathway may comprise routing the first working portion up through a first medially located passageway 14a, through at least one of the grooves 36, down through a first laterally located passageway 14c, around the neck 20, up through the first laterally located passageway 14c and passed underneath the portion of the line around the neck 20. The neck 20 may comprise a neck groove 32 that the line passes through underneath the portion of the line 24 that is wrapped around the neck 20. A first compression section 25 is formed with the line passing underneath the portion of the line that passes around the neck 20 wherein when the first working portion 26 is pulled tight the compression section 25 pushes a portion of the line against the neck groove 32 of the neck 20 self-locking the line 24 against the plate 11. This compression section 25 of the line creates a one-way slide allowing for the first working portion 26 to be advanced only along one direction, the one direction defined by the routing of the first working portion 26.
The second working portion 30 is routed along a second pathway. The second pathway may comprise routing the second working portion up through the first medially located passageway 14a, passed over the top of a periphery groove 38, the periphery groove 38 extending from a second medially located passageway 14b to the periphery 40 of the plate. The second working portion 30 is then passed down through the second laterally located passageway 14d, up through the second medially located passageway 14b and underneath the portion of the line 24 that passed over the periphery groove 38. A second compression section 27 is formed with the line passing underneath the portion of the line that passes over the top of the periphery groove 38 wherein when the second working portion 28 is pulled tight the compression section 27 pushes a portion of the line against the periphery groove 38 of the plate 11 self locking the line against the plate 11. This compression section 27 of the line creates a one-way slide allowing for the second working portion 30 to be advanced only along one direction, the one direction defined by the routing of the second working portion 30.
The adjustable loop 29 of the intermediate portion 28 of the line 24 is configured to hold a graft (not shown). The graft may be an ACL graft and may be a soft or hard tissue. The graft is looped around the adjustable loop 29 to retain the graft. By pulling on either the first working portion 26 or the second working portion 30, or both, the adjustable loop 29 reduces in size pulling the graft closer to the plate 11. The adjustable loop 29 is unable to increase in size after the graft is captured by the adjustable loop 29 and the line 24 is routed through the plate 11 because the routing of the line 24 forms a one-way slide so only reduction of the adjustable loop 29 occurs.
The first filament 44 passes through the second laterally positioned passageway 14d and is used to pull the plate 11 through the bone tunnel along a longitudinal axis of the plate 11. The second filament 46 may be routed around the neck 20, creating a loop around the neck 20, of the plate 11 and then passed through the second medially positioned passageway 14b. The second filament 46 is used to toggle the plate 11 after the plate 11 passes through the bone tunnel. After passing through the bone tunnel the second filament 46 may remain in the bone tunnel. The second filament 46 is pulled and the plate 11 toggles so that the longitudinal axis of the plate 11 is perpendicular to the bone tunnel. After the plate 11 is positioned on a cortical side of a bone the first and second filaments 44, 46 may be removed by pulling on one end of each filament. After positioning of the plate 11 the first working portion 26 or the second working portion 30, or both, are pulled to reduce the size of the adjustable loop 29 thereby creating greater tension in the graft and further cinching the plate 11 against the cortical side of the bone.
The routing of the second filament 46 may be done in a plurality of ways. Referring to
Referring to
Referring to
After the plate 11 is secured against the cortical bone, the filaments 44, 46 are removed and the plate 11 is cinched and the adjustable loop 29 adjusted to the appropriate length and tension the free ends of the first and second working portions 26, 30 may be cut to shorter lengths.
Referring to
Referring to
The first loop 50 may be configured to receive the second filament 46. The second filament 46 is looped through the first loop 50 and is used to toggle the plate 11 after passage through the bone tunnel. The second filament 46 through the first loop 50 provides certain advantages when pulling the plate 11 through the bone tunnel including increased slidability of the second filament 46 and may provide an offset distance from the plate 11 to improve flipping of the plate 11. Furthermore the first loop 50 may allow for slidability of the second filament 46 preventing the second filament 46 from getting stuck or damaged between the plate 11 and the bone.
Referring to
First and second filaments 44, 46 (not shown in
Referring to
A method of inserting the plate 11 into the bone tunnel, passing the plate 11 through the bone tunnel, toggling the plate 11 after passage through the bone tunnel, cinching the plate 11 to the cortical side of the bone and removing the filaments 44, 46 from the plate may be accomplished in any of the ways as previously described herein.
Referring to
Alternate embodiments of the plate are depicted in
Referring to
The features in this embodiment are very similar to the previous embodiment of the plate in
Referring to
Referring to
Referring to
Referring to
Referring to
Referring to
Other characteristics which are not depicted in
Referring to
In particular, the disclosed examples may be suited to intraoperative or in situ adjustment of a line lock used to secure an ACL graft in a bone tunnel, although the technology is adaptable to many other situations inside and outside the medical field. Intraoperative adjustment may take place at any time during the surgical procedure, for example on a back table before the line lock is implanted. In situ adjustment may take place during the process of implanting the line lock, or thereafter. In situ adjustment may take place during a revision surgery some time after initial implantation of the line lock. Certain examples may disclose tools or accessories to stabilize the line lock against a bone portion, such as a lateral cortex of a distal femur so that the line lock does not lift off in response to tension on the line tending to adjust the line relative to the line lock. Other examples may provide tools or accessories to selectively decrease the self-locking action of the line in the line lock, so that it is easier to draw the line through the line lock.
Referring to
Referring to
The portion of a line that is put under tension, typically to secure some object, is commonly referred to as a standing end, or standing portion. A standing portion may be secured to, or coupled to, an object as disclosed in U.S. Pat. Nos. 7,150,757; 7,566,339; 7,594,923; 7,641,694; 7,722,644; and U.S. patent application Ser. No. 11/142,933, all of which are incorporated herein by reference. The intermediate portion 28 of the line 24 may thus be described as a standing portion 102. The standing portion 102 is shown as a loop 29 connected at both ends to the plate 11, however, the standing portion 102 may extend straight instead, and may for example terminate in a free end. The portion of a line that extends toward a line handler is commonly referred to as a working end, or working portion, such as the first working portion 26 of the line 24.
A knot in a line, or a line lock attached to a line, is the demarcation between the standing portion and the working portion. The plate 11 attached to the line 24 is the demarcation between the standing portion 102 and the first working portion 26. The portion of the line 24 that is routed along the first pathway up through the passageway 14a, down through the passageway 14c, around the neck 20, up through the passageway 14c, and underneath the portion of the line 24 across the top of the neck 20 may be described as a first locking portion 104 of the line 24. The first locking portion 104 may include the first compression section 25 and a first compressed section 106. The first compression section 25 is the portion of the line 24 that extends around the neck 20. The first compressed section 106 is the portion of the line 24 which passes underneath the first compression section 25 and rests in the neck groove 32. The first compressed section 106 may also be referred to as a first constricted section 106 to differentiate it from the first compression section 25. It is appreciated that each of the portions 28, 102, 26, 104, 25, 106 of line 24 are relative to each other in that they change as line 24 is adjusted on line lock 10.
In the example shown, line 24 also includes a second working portion 30 which extends out of passageway 14b and a second locking portion 108 that extends between standing portion 102 and second working portion 30. The second locking portion 108 is the portion of the line 24 that is routed along the second pathway up through the passageway 14a, down through the passageway 14d, up through the passageway 14b, and underneath the portion of the line 24 extending between passageways 14a and 14d. The second locking portion 108 may include the second compression section 27 and a second constricted section 110. The second compression section 27 is the portion of the line 24 that extends between passageways 14a and 14d. The second constricted section 110 is the portion of the line 24 which passes underneath the second compression section 27 and rests in the periphery groove 38. It is appreciated that each of the portions 28, 102, 30, 108, 27, 110 of line 24 are relative to each other in that they change as line 24 is adjusted on line lock 10. Any description herein relating to the first working portion 26, the first locking portion 104, the first compression section 25, and/or the first constricted section 106 may be interpreted as though it refers to the second working portion 30, the second locking portion 108, the second compression section 27, and/or the second constricted section 110.
The line lock stabilizer 100 has a shaft 112 with a distal end 114 and an opposite proximal end 116. The distal end 114 may include means to engage the plate 11. For example, the distal end 114 may be flat, as shown, to engage a flat portion of the plate 11. The distal end 114 may include a projection, boss, tab, or key which engages a complementary recess in the plate 11, for example, one of the passageways 14, the neck opening 56, or a keyhole. Conversely, the distal end 114 may include a recess which engages a complementary protrusion, boss, tab, or key on the plate 11, for example, the neck 20, head 22, dogbone feature 34, or flange(s) 42. More than one protrusion/recess pair may be provided. The plate engagement means may also be threads, quick connect, bayonet fitting, snap fit, taper fit, friction fit, collet, hook, magnetic, electromagnetic, or the like. The proximal end 116 may include a grip or handle, and may include a retaining feature, such as a cleat or a slit. The shaft 112 may include a hole 118, which may be centrally or eccentrically located relative to an exterior surface of the shaft. Another type of longitudinal passageway such as a slot or groove may be provided instead of the hole 118, or such a passageway may be absent.
The line lock stabilizer 100 may be coupled to the plate 11 by engaging the complementary features on the distal end 114 and plate 11. The line lock stabilizer 100 may also be coupled to the plate 11 by securing a portion of the first filament 44 and/or second filament 46 to the retaining feature. For example, the filament 44 or 46 may be pulled taut and wrapped around a cleat or wedged into a slit. The filament 44 or 46 may pass alongside the shaft 112 or through the hole 118. A portion of the line 24, such as working portion 26, may pass alongside the shaft 112 or through the hole 118. Another filament 120 may be coupled to the working portion 26, as shown, and may pass alongside the shaft 112 or through the hole 118.
The line lock stabilizer 100 may be used to stabilize the line lock 10 while the length of the standing portion 102 is adjusted. The line lock stabilizer 100 resists tension in the line 24 tending to adjust the length of the standing portion 102. The line lock stabilizer 100 may be described as a counter-tension tool. The line lock stabilizer 100 may be used to push the line lock 10 against a support while the first working portion 26 is pulled to draw unwanted slack through the line lock 10.
Referring to FIGS. 21 and 22A-22B, an object such as an ACL graft 80 may be folded over the standing portion 102. The first filament 44 may be used to pull the plate 11, end 18 first, through the bone tunnel 92 so that the plate 11 exits the second segment 98 laterally, the standing portion 102 extends through the second segment 98 into the first segment 96, the folded portion of the ACL graft 80 is in the first segment 96, and the second filament 46 extends through the second segment 98 and the first segment 96. The first filament 44 extends laterally beyond the plate 11. The free ends of the ACL graft and second filament 46 extend medially beyond the mouth of the first segment 96. Once the plate 11 clears the bone tunnel 92, the second filament 46 may be pulled to flip the plate 11 to rest congruently on the bone surface around the bone tunnel 92. The line lock stabilizer 100 may be advanced over the first filament 44 to position the distal end 114 near the plate 11. The distal end 114 may be engaged with the plate 11. The first working portion 26 may pass through the hole 118, and the first filament 44 and first working portion 26 may extend from the proximal end 116 of the line lock stabilizer 100. The line lock stabilizer 100 may be used to push the plate 11 against the bone surface while the first working portion 26 is pulled to draw the line 24 through the plate 11 to adjust the length of the standing portion 102. If desired, the second working portion 30 may also pass through the hole 118 and extend from the proximal end 116 of the line lock stabilizer 100. The line lock stabilizer 100 may be used to push the plate 11 against the bone surface while the second working portion 30 is pulled to draw the line 24 through the plate 11 to adjust the length of the standing portion 102. The first and second working portions 26, 30 may be pulled independently, alternately, or simultaneously.
The compression limiter 150 may be a filament looped under the first compression section 25 before the plate 11 is pulled through the bone tunnel 92. Pulling on the compression limiter 150 may lift the first compression section 25 away from the first constricted section 106 and the plate 11 to reduce compression on the first constricted section 106. The compression limiter 150 alone may reduce compression on the first constricted section 106 enough that the line 24 is easily drawn through the plate 11 in either direction to adjust the length of the standing portion 102 shorter or longer. As soon as tension on the compression limiter 150 is released, the first compression section 25 is free to press the first constricted section 106 against the plate 11 in response to tension on the standing portion 102, so as to lock the line 24 to the plate 11. The compression limiter 150 may also be used in conjunction with the line lock stabilizer 100. In this arrangement, the compression limiter 150 may pass through the hole 118 and extend from the proximal end 116 of the line lock stabilizer 100.
The compression limiter 150 may extend between the plate 11 and the first compression section 25, between the plate 11 and the first constricted section 106, or between the first compression section 25 and the first constricted section 106. The compression limiter 150 may be coupled to the first compression section 25, the first constricted section 106, or the plate 11. The compression limiter 150 may be looped under the first compression section 25, the first constricted section 106, or both. Depending on these variables, the compression limiter 150 may separate or pull apart the plate 11 and the first compression section 25, the plate 11 and the first constricted section 106, or the first compression section 25 and the first constricted section 106.
Referring to
Referring to
Line 170 includes an outer layer 172 and an inner portion 174. The outer layer 172 may be a braided or woven sheath, which may also be called a mantle. The inner portion 174 may be monofilament, multifilament, straight, twisted, braided, woven, or the like. The inner portion 174 may be slidably received in the outer layer 172. Line 170 may include a first working portion 176 like working portion 26, a first locking portion 178 like locking portion 104, and a standing portion 180 like standing portion 102. The first locking portion 178 may include a first compression section 182 like compression section 25 and a first constricted section 184 like constricted section 106. Line 170 may also include a second working portion 186 like working portion 30 and a second locking portion 188 like locking portion 108. The second locking portion 188 may include a second compression section 192 like compression section 27 and a second constricted section 194 like constricted section 110. The outer layer 172 may cover some or all of the inner portion 174. The outer layer 172 may be present in one or more of the portions 176, 178, 180, 182, 184, 186, 188, 192, and 194.
Line 170 may be drawn through the plate 11 to adjust the length of the standing portion 180 in a manner similar to that described in the preceding embodiments. The outer layer 172 and inner portion 174 may be pulled together through the plate 11. Alternatively, only the outer layer 172 or inner portion 174 may be pulled through the plate 11. For example, the inner portion 174 may be pulled through the plate 11, causing the outer layer 172 to bunch up. The outer layer 172 may be present in the constricted section 184, as shown. In another example, the outer layer 172 may be present in the standing portion 180 and absent in the constricted section 184. In yet another example, the free end of the working portion 176 may be fixed to the plate 11 or support.
Referring to
The line lock stabilizer 200 may be a filament routed through one or more of the passageways 14 of the plate 11. For example, the line lock stabilizer 200 may be a single strand formed into a continuous loop by a knot 202, splice, crimp, or other securing means. A portion of the line lock stabilizer 200 may be passed through the passageway 14a and an end 16 or 18 of the plate may be passed through a remainder of the line lock stabilizer 200 so that the line lock stabilizer 200 loops over the plate 11 on opposite sides of the passageway 14a as shown in
Referring to
When the apparatus and methods of line lock stabilizer 200 are compared to those for line lock stabilizer 100, certain differences may be observed. Line lock stabilizer 200 acts through the bone tunnel 92 in the same way that tension on the graft 80 will act over the long term. The laterally-extending elements associated with line lock stabilizer 200 are all suture or filament structures, which may be much smaller in diameter than line lock stabilizer 100. Therefore, the use of line lock stabilizer 200 may result in a smaller lateral wound (i.e., scar).
In another example, a line lock stabilizer may be a single strand routed through passageway 14a of the plate 11 and beside the periphery 40 of the plate 11. In this example, the line lock stabilizer may be said to be folded over a portion of the plate 11. In this example, the free ends of the line lock stabilizer may be pulled simultaneously. Alternatively, the ends may be knotted or otherwise secured together, and an optional handle may be used to improve comfort while pulling on the line lock stabilizer.
The second filament 46 may also be used as a line lock stabilizer. As described g above, the second filament 46 may be coupled to the plate 11 or line 24 and may remain in the bone tunnel 92 after the plate has been flipped or toggled to rest against the bone surface. Therefore, the second filament 46 may be used to pull the plate 11 down against a bone surface or other support.
Referring to
The plate 222 may share some or all of the characteristics set forth for plate 11 or any of the other line locks disclosed herein. The plate 222 may include a plurality of passageways 226.
The toggle member 224 may be a generally elongated component, such as a generally rectangular or oval solid. The toggle member 224 may be another plate-like structure.
The toggle member 224 may be coupled to the plate 222. A coupling 228 may position the toggle member 224 transverse to the plate 222. The coupling 228 may permit the toggle member 224 to move relative to the plate 222 through a range of motion. The coupling 228 may be a hinge, a swivel, a joint, a pivot, a tether, a deformable element, or the like. The range of motion may include a position in which the toggle member 224 is transverse to the plate 222, and a position in which the toggle member 224 is aligned with the plate 222. The range of motion may also include a position in which the toggle member 224 is perpendicular to the plate 222, and a position in which the toggle member 224 is parallel to the plate 222.
Referring to
Referring to
Referring to
The tensioner 240 may include a pair of opposing arms 242, 244 movably coupled together. The arms 242, 244 may open and close along a linear or angular path.
The first arm 242 may couple to the first working portion 26 and the second arm 244 may couple to the first filament 44. For example, the arms 242, 244 may include locking jaws (not shown) within which the first working portion 26 and first filament 44 may be clamped. The arms 242, 244 may be close together, or closed, when initially coupled to the first working portion 26 and first filament 44. The arms 242, 244 may then be separated, or opened, to apply tension to the first working portion 26 to draw the line 24 through the plate 11, and counter tension to the first filament 44 to stabilize the plate 11. The tensioner 240 may pull the first working portion 26 and first filament 44 at oblique angles to the plate 11, or parallel to the plate 11. This arrangement may overcome at least some of the resistance provided by the tortuous pathway of the line 24 through the plate 11.
Referring to
Instrument 300 may include a handle section 302 that may include a lever arm 304 attached to a stationary beam 306. The lever arm 304 may be proximal to the stationary beam 306 and may be connected to the stationary beam 306 via a rod 308, screw or other connecting device. The rod 308 may form a pivot point, about which the lever arm 304 may rotate to change orientation relative to the stationary beam 306. The lever arm 304 may include a free end portion 310 and a working portion 312. The rod 308 may be located in the working portion 312 or at a junction between the free end portion 310 and the working portion 312.
In another example of instrument 300, the handle section 302 may resemble a trigger-like mechanism, wherein the lever arm 304 may extend below the stationary handle 306 and may be pulled toward the stationary handle like a trigger to actuate the instrument.
Instrument 300 may also include a working section 314, which may extend distally from the handle section 302 generally transverse to the stationary beam 306. The working section 314 may include a compression limiter 316, a line lock stabilizer 318 and a cord 320 that may be used as a means for adjusting a line on a line lock plate by drawing the line through the plate.
The working section 314 may also contain a spring-biased carriage 322 that may include suture tie posts 324 to connect the compression limiter 316 to the stabilizer 318. The carriage 322 may be coupled to the working section 314 and/or the working portion 312. The compression limiter 316, which may also be referred to as an unlocking suture, may include a proximal portion 326 that is connected to the suture tie posts 324 of the spring-biased carriage 322. The compression limiter 316 may extend distally from the suture tie posts 324 and may be generally aligned with the stabilizer 318. The compression limiter 316 may also include a distal portion 328 that may include a loop 330, a hook, an eyelet, a clinch, or other connecting feature to connect the compression limiter 316 to a compression section on a line lock plate. The compression section may be positioned across the loop 330 such that when the instrument 300 is actuated, the compression limiter 316 may lift the compression section to allow a line that is mounted on the line lock plate to be drawn across the plate.
The stabilizer 318 may include a rigid, cylindrical body 332 and a cannula 334. Alternatively, the body 332 of the stabilizer 318 may be polygonal, curved, or another shape. The stabilizer 318 may also include a proximal portion 336 that connects to the stationary beam 306 of the handle section 302. The stabilizer 318 may be connected to the stationary beam 306 via a weld or other connecting methods known in the art to provide secure fixation. The stabilizer 318 may also include a distal portion 338, which may have a distal face 340 that may be flat to contact a line lock plate and to press the line lock plate against a bone face or other surface to prevent the plate from slipping, flipping or moving during in-situ adjustment of the line on the plate. Alternatively, the distal face 340 may be rounded to match the contour of a desired line lock shape or bone surface. The distal face 340 may include any previously described means to engage the plate.
The cord 320, which may be a suture that is doubled back on itself, may be a means for adjusting a line on a plate, and may be received in the cannulated portion 334 of the stabilizer 318. The cord 320 may have a proximal portion 342, which may be connected to the working portion 312 of the lever arm 304. The cord 320 may also have a distal portion 344 that may extend from the distal face 340 of the stabilizer 318, and may include a loop 346, hook, eyelet, crimp, or other connecting method for attaching to a line that is mounted on a line lock plate. In operation, the line may be draped through the distal loop 346 such that when the instrument is actuated, the cord 320 retracts distally to pull the line along the line lock plate. In another example, the distal loop 346 may pass through an eyelet formed in the line.
In operation, the instrument 300 may be positioned such that the distal face 340 of the stabilizer 318 is placed against the line lock. The line that is mounted on the line lock may be placed through the loop 346 at the distal portion 338 of the cord 320. The compression limiter may be connected to a compression section of the line by attaching the loop 330 of the distal portion 328 to the compression section. The instrument 300 may then be actuated by compressing the free end 310 of lever arm 304 towards the stationary beam 306. The lever arm 304 rotates around the rod 308 such that as the free end 310 moves towards the stationary beam 306, the working portion 312 is lifted proximally, as indicated by movement arrows 348 and 350. The proximal motion of the working portion 312 pulls the cord 320 proximally through the cannula 334 of the stabilizer 318. Additionally, as the handle section 302 is compressed 348, the spring-biased carriage 322 may be lifted proximally to lift the compression limiter 316, which may then lift the compression section of the line. As the compression section is lifted, the line may be easily pulled along the plate and adjusted. The force applied onto the line lock plate against a bone surface by the stabilizer 318 may help to prevent the plate from slipping or moving during the adjustment.
When the line has been sufficiently adjusted, the compressed handle section 302 may be released. As the lever arm 304 is returned to its original position, the spring-bias may urge the carriage 322 to move distally. The distal movement of the spring-biased carriage 322 and the attached compression limiter 316 may cause the compression section to press another portion of the line against the plate to fix the line to the plate and prevent further adjustment.
Alternatively, the instrument 300 may be used to flip the line lock plate in-situ by attaching the cord 320 to the line on the line lock and actuating the instrument by compressing the handle section 302. In this application, the stabilizer 318 is not placed against the plate, so the plate is free to move in response to tension applied to the line by instrument 300. In another example, the distal portion 328 and the distal portion 344 may be coupled to the first filament 44 and second filament 46, and the instrument 300 may be actuated to flip the line lock plate.
The distal working section 366 may extend distally generally transverse to the handle section 362. The distal working section 366 may include a line lock stabilizer 372, a compression limiter 374 and a cord 376. The stabilizer 372, which may also be referred to as a tension instrument tube, may include a rigid, cylindrical body 378 and a cannula 380. The stabilizer 372 may also include a distal face 382 that may contact a line lock plate in use to keep the plate from slipping during adjustment. Plate 11 is illustrated in
The cord 376 may also be received by the cannula 380 of the stabilizer 372. A proximal portion 392 of the cord 376 may connect to an outer wheel 390 in wheel section 364. The cord may include a distal hook 392, loop, eyelet or other connection feature to engage a line mounted on a line lock plate.
The wheel section 364 may be positioned at the intersection between the handle section 362 and the working section 366. The wheel section 364 may include the inner wheel 388 and the outer wheel 390, wherein the diameter of the inner wheel 388 may be smaller than the diameter of the outer wheel 390. The outer wheel 390 may include at least one feature 396 that connects the cord 376 to the outer wheel 390. In one example, the connection feature 396 holds the cord 376 away from the surface of the wheel 390. The outer wheel 390 may also be fixed to the lever arm 368. The inner wheel 388 may include at least one feature 398 to connect the compression limiter 374 to the inner wheel 388. The inner wheel 388 may be integrally formed or separately formed from the outer wheel 390, and may be situated in the center of the outer wheel 390.
The wheel section 364 may be encapsulated in a frame 400 that is continuous with the stationary beam 370, wherein the lever arm may extend outward from a slit or channel 402 on the distal side of the frame.
In operation, instrument 360 may be positioned such that the distal face 382 of stabilizer 372 may contact a line lock plate and secure the plate to a bone surface. The cord 376 may be attached to a line that is mounted on a line lock plate by looping the line through the hook on the distal portion 392 of the cord 376. The compression limiter 374 may be connected to a compression section of the line by looping the compression section through the distal loop of the compression limiter 374.
The lever arm 368 may then be compressed such that it may slide along the channel 402 in the frame 400 towards the stationary beam 370. As the lever arm 368 is compressed, it may cause the outer wheel 390, which is fixed to the lever arm 368, to rotate clockwise. As the outer wheel 390 rotates, the inner wheel 388, which may be fixed to the outer wheel 390 also rotates clockwise. In another example, the inner and outer wheels 388, 390 may rotate counterclockwise when the lever arm 368 is compressed. As the inner wheel 390 rotates, attached compression limiter 374 is drawn proximally such that the distal loop and the attached compression section is drawn upward, releasing the compression section. As the outer wheel rotates 388, the attached cord 376 is also drawn proximally such that the distal hook is pulled at least partially into the cannulated shaft 380 of the stabilizer 372. As the distal hook is pulled proximally, the attached line may be drawn along the plate.
The rotation of the inner wheel 390, which has a relatively small diameter, causes a small vertical displacement of the compression limiter 374 compared to the displacement distance of the cord 376, which is connected to the larger, outer wheel 388. Therefore, the compression section on the plate may be pulled upwards a small distance to release the compression section, while the cord 320 and attached line may have a greater length of displacement for adjustment.
Other examples of instrument 360 may employ different mechanisms to displace the cord 376 more than the compression limiter 374 when the lever arm 368 is actuated. In one example, the cord 376 and compression limiter 374 may be connected directly to an extension of the lever arm 368, with the cord 376 far from the pivot point and the compression limiter close to the pivot point. In another example, the lever arm 368 may drive one or more gears which cause translation of carriages (not shown) proximally along the working section 366.
The proximal handle 422 may have a substantially rectangular body 430, and may include at least one flange or beam 432 that extends beyond the rectangular body. The handle 422 may include a cannulated portion 433.
The stabilizer 424 may include a rigid, hollow body 434, which may be cylindrical, or may be a variety of other shapes. The stabilizer may include a cannula 436, which may be continuous with the cannulated portion 433 of the handle 422. The stabilizer 424 may include a distal working end 438. The working end 438 may include a window portion 440. The window portion 440 may be surrounded by at least one wall 442 that extends distally and may contain a distal face 444 that intersects the wall 442. The distal face may have a semicircular shape and, in use, may contact the line lock plate to prevent the plate from slipping during adjustment. The distal face 444 may include any previously described means to engage the plate.
The working end 438 may also include a snare or the suture shuttle 450. The suture shuttle 450 is illustrated with a plate 11 and a line 24 in
In operation, a user may grip the handle 422 to position the distal face 444 against the line lock plate and apply force against the line lock device. As pressure is applied, the suture shuttle 450 may pass outward from the window portion 440 of the working end 438. A portion of the line 24 may be secured to the suture shuttle 450, for example by passing a free end of the line 24 through a looped distal portion of the suture shuttle. The suture shuttle 450 may be drawn proximally out of the instrument 420, thus drawing the line 24 through the cannulae 436 and 433. The suture shuttle 450 may be used to draw the line 24 through the plate 11 to adjust the length of a standing portion of the line, or the line 24 may be pulled directly if it is long enough to extend from the proximal end of the handle 422.
The method may include positioning a line lock 652 such that it lies against a bone surface, for example on the lateral side of the femur, such that a standing portion of a line 24 or cord and an attached graft are at least partially contained in a bone tunnel and such that there is some slack in the cord, as described previously. A free end of the line 24 may be positioned outside of the tunnel such that it extends outside of the body.
Referring to
The working portion 664 may extend from the cannulated portion 670 of the handle portion 662 and may include a neck portion 675 and an elongated shaft or rod 674, which may also be cannulated. The neck portion 675 may be rotatable and may be used as a cutting tool to remove excess cord. The working portion may also contain a line lock-engaging tip portion 676, which may include a window portion 678 and a line lock-engaging feature. The line lock-engaging feature may be any of the previously described means to engage the plate.
In an example of use, the line lock 652 may be positioned against the lateral side of the femur with the graft positioned at least partially in the tunnel 92 and a free end of the cord positioned outside of the body. The tensioner instrument 660 may be positioned over the cord such that the free end may be received in the cannulated portion of the elongated rod and further through the cannulated portion of the handle portion. The trigger arm may then be compressed and released repeatedly, as seen best in
The cannula 552 may include an elongated, fixed arm 554 and a tip portion 556. The fixed arm 554 may be cylindrical or may be shaped to match the contour of the bone tunnel. The arm 554 may be slotted along its length. The tip portion may have a bone-tunnel facing surface 562. The surface 562 may be obliquely angled relative to the length of the arm 554.
The line lock 550 may have features similar or identical to the line locks previously described, including a body 564. The body 564 may include a first surface 558 and a second surface 560 opposite the first surface 558. A line 24 may be routed through one or more passageways in the body 564 as described previously.
In operation, the line lock 550 may be mounted on the tip portion 556 of the cannula 552 such that the first surface 558 contacts the tip portion 556 of the cannula 552 and lies along the bone-tunnel facing surface 562 of the cannula 552. The length of the body 564 may be greater than the outside diameter or width of the cannula 552, however, the surface 562 may be obliquely angled so that the length of the surface 562 is similar to the length of the body 564. In this arrangement, the cannula 552 holds the line lock 550 in an orientation that reduces the effective length of the line lock 550 to fit through a tunnel. The line lock 550 may be reversibly attached to the bone-tunnel facing surface 562 of the cannula 552 such that once the line lock 550 has been positioned along a desired bone surface, the cannula 552 can be retracted to detach from the line lock. The second surface 560 of the line lock may be positioned such that it faces away from the cannula 552 and towards the bone tunnel. Free ends and standing portions of the mounted line 24 may extend from the first surface 558 into the cannula. The cannula 552 may then be used to insert the line lock 550 into the bone tunnel by pushing the body 564 and line into the bone tunnel until the line lock 550 emerges on the opposite side of the bone tunnel. The cannula 552 may then be rotated axially such that shear forces due to the rotation cause the line lock 550 to become detatched from the tip portion 556. The line lock 550 may re-orient itself to rest against the bone surface after detaching from the tip portion 556. In the new orientation, the length of the line lock 550 may be transverse or perpendicular to the bone tunnel. In this arrangement, the effective length of the line lock 550 may be greater than the diameter of the bone tunnel, so that the line lock 550 resists being pulled back through the tunnel. The cannula 552 can then be retracted through the bone tunnel, leaving the free ends and standing loop portions of the line to hang through the tunnel where they are available for adjustment.
The line lock 565 may also include a line 590 that is mounted on the plate 568, wherein the line 590 may include a standing loop portion 594 that extends from at least one surface 580, 586 of the plate 568. The line 590 may be routed through one or more passageways in the plate 568 as described previously. The line 590 may include a compression section 596, where a portion of the line crosses itself to fix the line 590 to the body 565 to the plate.
The compression limiter 570 may contain at least one passageway. Referring to
In operation, the tubular sleeve 570 may be placed on the line 590 under the compression section 596. The tube 570 may be dimensioned so that there is little or no resistance to the movement of the line 590 through the tube 570. The line 590 may then be drawn along the plate 568 in either direction to adjust the line in situ. After adjustment, the tube 570 may be removed by applying a force on the tensioning suture 576 to pull the tube 570 off of the line 590. As force is applied to the tensioning suture 576, the knot 577 in the trailing suture 574 may move to contact the tube 570, and the tube 570 may be pulled from the line 590. As the tube 570 is removed, the compression section 596 may fix an underlying portion of the line 590 to the plate 568 to prevent further adjustment of the line 590.
The system illustrated in
The line lock 620 may be passed at an angle to the bone tunnel as described in
All of the embodiments illustrated and described herein may have features mixed and matched to create a plate of physician's choice. The plurality of passageways 14 may be spaced apart at greater or lesser distance from one another. Similarly the plurality of passageways 14 may reside nearer or further from the periphery 40 of the plate 11. Each of the plurality of passageways 14 may be smaller or larger so long as they are capable of receiving at least one line and/or filament.
The technology disclosed herein may be embodied in other specific forms without departing from its spirit or essential characteristics. For example, above are described various alternative examples of plates and securing of lines as well as routing of the line and the routing of filaments. It is appreciated that various features of the above-described examples can be mixed and matched to form a variety of other combinations and alternatives. It is also appreciated that this system is not limited to simply ACL repair and fixation. This system may also be used to secure other ligaments, tendons or soft or hard tissue. As such, the described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
This application is a continuation-in-part of: U.S. patent application Ser. No. 13/243,715 filed 23 Sep. 2011, which carries Applicants' docket no. MLI-77 CIP 2, and is entitled SYSTEMS AND METHODS FOR INTRA-OPERATIVE TENSION AND FIXATION OF ZIPKNOT ACL FIXATION, which is a continuation-in-part of: U.S. patent application Ser. No. 12/828,856 filed 1 Jul. 2010, which carries Applicants' docket no. MLI-77, and is entitled SYSTEMS AND METHODS FOR ZIP KNOT ACL FIXATION, which claims the benefit of the following: U.S. Provisional Patent Application No. 61/222,574 filed 2 Jul. 2009, which carries Applicants' docket no. MLI-77 PROV, and is entitled ZIP KNOT ACL FIXATION BUTTON; U.S. Provisional Patent Application No. 61/333,363 filed 11 May 2010, which carries Applicants' docket no. MLI-84 PROV, and is entitled ZIP KNOT ACL FIXATION BUTTON; and U.S. Provisional Patent Application No. 61/333,548 filed 11 May 2010, which carries Applicants' docket no. MLI-85 PROV, and is entitled ZIP KNOT ACL FIXATION BUTTON. U.S. patent application Ser. No. 13/243,715 also claims the benefit of: U.S. Provisional Patent Application No. 61/386,396 filed 24 Sep. 2010, which carries Applicants' docket no. MLI-87 PROV, and is entitled INTRA-OPERATIVE TENSION AND FIXATION OF AN ACL GRAFT. This application also claims the benefit of: U.S. Provisional Patent Application No. 61/389,524 filed 4 Oct. 2010, which carries Applicants' docket no. MLI-88 PROV, and is entitled INTRA-OPERATIVE ACL GRAFT INSTRUMENTATION. The above documents are hereby incorporated by reference in their entirety. The following documents are also hereby incorporated by reference in their entirety: U.S. patent application Ser. No. 11/001,866 filed 1 Dec. 2004, now U.S. Pat. No. 7,594,923, which carries Applicants' docket no. MLI-17, and is entitled LINE LOCK SUTURE ATTACHMENT SYSTEMS AND METHODS; U.S. patent application Ser. No. 10/936,376 filed 7 Sep. 2004, now U.S. Pat. No. 7,566,339, which carries Applicants' docket no. MLI-15, and is entitled ADJUSTABLE LINE LOCKS AND METHODS; U.S. patent application Ser. No. 10/459,375 filed 11 Jun. 2003, now U.S. Pat. No. 7,150,757, which carries Applicants' docket no. 13447.35, and is entitled ADJUSTABLE LINE LOCKS AND METHODS; U.S. patent application Ser. No. 11/112,814 filed 21 Apr. 2005, now U.S. Pat. No. 7,641,694, which carries Applicants' docket no. MLI-23, and is entitled LINE LOCK GRAFT RETENTION SYSTEM AND METHOD; U.S. patent application Ser. No. 11/125,885 filed 8 May 2005, now U.S. Pat. No. 7,722,644, which carries Applicants' docket no. MLI-32, and is entitled COMPACT LINE LOCKS AND METHODS; and U.S. patent application Ser. No. 11/142,933 filed 2 Jun. 2005, now abandoned, which carries Applicants' docket no. MLI-33, and is entitled BONE IMPLANTS WITH INTEGRATED LINE LOCKS.
Number | Date | Country | |
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61389524 | Oct 2010 | US | |
61222574 | Jul 2009 | US | |
61333363 | May 2010 | US | |
61333548 | May 2010 | US | |
61386396 | Sep 2010 | US |
Number | Date | Country | |
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Parent | 13243715 | Sep 2011 | US |
Child | 13252951 | US | |
Parent | 12828856 | Jul 2010 | US |
Child | 13243715 | US |