A syndesmosis is a slightly movable articulation where the contiguous bony surfaces are united by an interosseous ligament. If the syndesmosis is separated because of bone fracture, surgeons will sometimes fix the relevant bones together with a syndesmotic screw. The screw inhibits normal movement of the bones and, thereby, the corresponding joint or joints. When the natural articulation is healed, the screw may be removed. The tightrope fixation with elastic fiberwire suture on the other hand allows physiologic motion of the ankle and may be permanent.
Syndesmosis screws have significant problems, including loosening, breakage, the need for removal, and late diastasis. The present invention has been developed to address these problems, by providing a low profile implant device intended to facilitate stabilized fixation of tissues, including bone and soft tissue to bone, for syndesmosis repair, as well as other applications.
The present inventive system, in one particular application, is designed for delivery through a pre-drilled hole through the tibia and fibula, for example, by means of a pilot needle delivery, exiting the skin opposite the initial insertion site. The system includes a flat band secured to bone by pulling a metal button through both the tibial and fibula bones, which button is then toggled into position to create tension, along the band, across the two bone segments to be fixated. Once the button is secure against the bone, suture attached to the needle can be cut and removed from the operative site. Pulling flat suture tails against the lock at the initial insertion site serves to tension the band and bone segments in place. The system band offers syndesmosis repair with a knotless closure. The system is designed to provide this stabilized fixation for bone fractures, osteotomies, and arthrodesis, plus soft tissue to bone attachment, if desired. It is designed, as discussed above, to apply a restorative fixation force across the tissue segments to stabilize them. The band's rigidity and compliant nature provides consistent and rigid fixation during the healing phase.
The present system is an assembly of four main components; a suture band, a narrow button, a lock, and a straight needle. The woven suture is made, in certain embodiments, from the same polyester (PET) as most sutures. The lock and narrow button may be manufactured, in certain embodiments, from 316 LVM stainless steel. The straight needle assembly is comprised of a PET suture tether and a guide cap. The system is designed to be a one-size-fits-all sterile implant.
The inventive system is intended for use as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the inventive band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures. However, the system may be used in treating syndesmosis disruptions with or without associated ankle fractures. Although initially developed to address ankle syndesmosis injuries and fibula and tibia fixation, additional applications may include the shoulder (CC ligament repair) and ACL/PCL repair, for example. Use of the band of the present system provides greater bone compliance and does not restrict movement, such as may occur with screw fixation.
More particularly, there is provided, in one aspect of the invention, an implant system for stabilized fixation of tissue, which comprises a button having a slot, a band threaded through the slot, and a lock comprising a frame having an intake opening, a movable member, and an exit slot. A free end of material forming the band enters the lock through the intake opening, extends around the movable member, and then through the exit slot. The movable member is movable between an open position and a locking position. The button comprises a pair of slots and the band is threaded through each of the pair of slots in sequence, so that the band is wrapped around a portion of the button separating the two slots.
The band may be formed of suture material, more particularly comprising a length of flat suture material threaded through the pair of slots of the button and through the intake opening and slots of the lock so that between the button and the lock the band comprises the length of suture doubled over itself.
The lock further comprises a plate on which the movable member is disposed, the plate having a first configuration when the movable member is in its open position and a second configuration when the movable member is in its locking position, the plate being movable from its first configuration to its second configuration responsive to applied tension exceeding a predetermined value. The movable member, which comprises a bar in illustrated embodiments, is adapted to move toward the exit slot when it is moved from its open position to its locking position to narrow an effective width of the slot and to thereby clamp the free end of the suture band extending through the slot between the movable member and an inside surface of the outer portion of the frame to lock the suture band free end in place.
Advantageously, the lock is designed to clamp the free end of the suture band in place at multiple spaced lock points. The first lock point is within the exit slot at a point where the movable member and the inside surface of the outer portion of the frame first clamp the suture band in place, and a second lock point, spaced distally from the first lock point, is created by a corner formed on the inside surface of the outer portion of the frame, so that the suture band is engaged between the corner and the movable member. A third lock point, spaced distally from the second lock point, is created by engagement of the suture band with a row of teeth, comprises a suture comb, disposed on a surface of the lock frame.
In disclosed embodiments, the frame comprises a second movable member and a second exit slot, the two exit slots being disposed on opposite sides of the intake opening adjacent to respective opposed outer portions of the frame. The construction of these two exit slots and associated movable members is substantially similar, in order to simultaneously clamp each of two free ends of the suture band extending through the lock.
Additionally, the lock comprises a second suture comb, each suture comb being disposed on the frame of the lock adjacent to respective exit points for the free ends of the suture bands from each of the two exit slots.
As noted above, the implant system further comprises a suture comb disposed on a surface of the frame. The suture comb comprises a row of teeth, and preferably multiple rows of teeth, for engaging suture passing thereover, and clamping the suture in place.
In another aspect of the invention, there is provided a lock for use in an implant system for stabilized fixation of tissue. The lock comprises a frame having an intake opening, a movable member, and an exit slot, for creating a path for a band of material to extend along, the path extending from the intake opening, around the movable member, and exiting through the exit slot, the exit slot being defined in part by an inner surface of the frame. The movable member is movable between an open position and a locking position.
The lock further comprises a plate on which the movable member is disposed, the plate having a first configuration when the movable member is in its open position and a second configuration when the movable member is in its locking position, the plate being movable from its first configuration to its second configuration responsive to applied tension exceeding a predetermined value. The movable member is adapted to move toward the exit slot when it is moved from its open position to its locking position to narrow an effective width of the slot and to thereby clamp the free end of a suture band extending through that slot between the movable member and an inside surface of the outer portion of the frame to lock the suture band free end in place.
Advantageously, the lock is designed to clamp the free end of the suture band in place at multiple spaced lock points. The first lock point is within the exit slot at a point where the movable member and the inside surface of the outer portion of the frame are first adapted to clamp the suture band in place, and a second lock point, spaced distally from the first lock point, is created by a corner formed on the inside surface of the outer portion of the frame, so that the suture band is adapted to be engaged between the corner and the movable member. A third lock point, spaced distally from the second lock point, and created by engagement of a suture band, extending along the pathway through the lock, with a row of teeth, comprises a suture comb, disposed on a surface of the lock frame.
In disclosed embodiments, the frame comprises a second movable member and a second exit slot, the two exit slots being disposed on opposite sides of the intake opening adjacent to respective opposed outer portions of the frame. The construction of these two exit slots and associated movable members is substantially similar, in order to simultaneously clamp each of two free ends of the suture band extending through the lock.
The lock comprises a second suture comb, each suture comb being disposed on the frame of the lock adjacent to respective exit points for the free ends of the suture bands from each of the two exit slots.
As noted above, the implant system further comprises a suture comb disposed on a surface of the frame. The suture comb comprises a row of teeth, and preferably multiple rows of such teeth, for engaging suture passing thereover, and clamping the suture in place.
In still another aspect of the invention, there is provided a lock for use in an implant system for stabilized fixation of tissue. The lock comprises a frame having an opening for receiving a length of material therethrough, a movable member about which the length of material may extend, and a slot through which the length of material may exit after passing about the movable member. The slot is defined in part by an inner surface of the frame. The movable member is movable between an open position and a locking position, the open position being adapted to permit free movement of the length of material through the lock and the locking position being adapted to clamp the length of material in place. The lock is constructed and designed to clamp the length of material at a plurality of locking points, spaced from one another, when the movable member is in said locking position.
In yet another aspect of the invention, there is disclosed a method for effecting repair of tissue using a tissue fixation band apparatus comprising a lock, a button, and a suture band, under tension, extending between the lock and the button. The method comprises steps of pulling the button through a hole extending through the tissue to be repaired, until it exits a distal surface of the tissue and engages the distal surface of the tissue, pulling the suture band on each end to locate the lock in position on a proximal surface of the tissue, applying tension to free ends of the suture band exiting from the lock of the fixation band apparatus to tension the suture band to a desired level, and causing a movable clamping member within the lock to move to a locking position upon application of the desired tension level to the suture band, to thereby engage the lock and clamp the suture band in place at the desired tension level.
Advantageously, the causing step creates a plurality of spaced locking points along a length of the suture band free end extending through the lock.
The invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying illustrative drawings.
Referring more particularly to the drawings, there is shown in
In the illustrated embodiment, the band 12 has an approximate three (3) inch length between the narrow button 14 and the lock 16, which is nominally set and adjustable by the physician per the anatomical requirements of the patient.
During use, when the two free ends 30, 32 of the suture 12 (see
With further consideration of
In one particular embodiment, the frame of the lock assembly 16 is generally square, with outside dimensions of 0.315 inches X 0.315 inches. Of course, these dimensions are not required, and may be varied as desired for particular applications.
Now with reference particularly to
Referring now to
After passing the narrow button 14 through the pre-drilled holes by means of the pass through needle 44, reduction of the ankle joint is achieved by applying tension to the band and the metallic button. Fixation forces are activated by pulling on the suture tails after removing the pass-through needle and pass-through suture, as discussed above. A hand-held stainless steel tensioning instrument may be utilized if higher tension levels are necessary to meet physiologic requirements.
In one particular embodiment, the straight needle 44 is made from 302 stainless steel that is used in most surgical needles. The needle may be 6 inches in length, and have a diameter of 0.0775 inches. A 5 inch (PET) suture loop 50 may be used to attach the needle and the narrow button 14, as shown. After placement of the narrow button 14, the suture loop 50 and straight needle 44 are discarded. A plastic protective cap 52 may be provided to protect the sharp end of the needle 44 before use. This cap 52 is removed at the outset of the procedure.
Though the foregoing procedure is described in connection with a Syndesmosis procedure for the repair of a fractured tibia and fibula, it is applicable, of course, to other areas of the body requiring repairs of a similar nature.
Accordingly, although exemplary embodiments of the invention have been shown and described, it is to be understood that all the terms used herein are descriptive rather than limiting, and that many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention, which is to be limited only in accordance with the following claims.
This application claims the benefit under 35 U.S.C. 119(e) of the filing date of Provisional U.S. Application Ser. No. 61/861,305, entitled Implant Device for Stabilized Fixation of Bone and Soft Tissue, filed on Aug. 1, 2013, and expressly incorporated herein by reference, in its entirety.
Number | Date | Country | |
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61861305 | Aug 2013 | US |