Abstract:
The present invention is a method and device for the correction and reduction of bone deformities, such as metatarsus primus adductus, using a plate body with winged buttresses and dorsal loop. The method and device can be affixed to a bone without any drilling or violating of the bone and can use a tethering technique which does not require drilling into the second metatarsal, nor does it require the placement of a prominent suture knot/button device medially along the first metatarsal.

Description:
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS 
       [0001]    Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. 
         [0002]    This application is a divisional application of U.S. patent application Ser. No. 13/720,826, filed Dec. 19, 2012, which claims the priority benefit of U.S. Provisional Patent Application No. 61/672,297 filed on Jul. 17, 2012 and 61/713,443 filed on Oct. 12, 2012. 
     
    
     STATEMENT REGARDING COPYRIGHTED MATERIAL 
       [0003]    Portions of the disclosure of this patent document contain material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office file or records, but otherwise reserves all copyright rights whatsoever. 
       BACKGROUND 
       [0004]    1. Field of the Invention 
         [0005]    This invention relates to surgical implant devices for repairing angular bone deformities, in particular, metatarsus primus adductus. While the invention was conceived for the purposes of correcting metatarsus primus adductus, it is conceivable that the invention can be adapted to correct other bone deformities as long as there is a stable bone somewhat adjacent to an unstable bone. 
         [0006]    2. Description of the Related Art 
         [0007]    Metatarsus primus adductus is a progressive angular deformity in the foot, between the first and second metatarsals, when the unstable or hypermobile first metatarsal deviates medially, increasing the intermetatarsal angle between the first and second metatarsals Surgical procedures to correct this condition are chosen based on the severity of the angular deformity. Traditionally, surgical correction of moderate to severe angular deformities between the first and second metatarsals involves bone remodeling, osteotomies, wedge resection of bone or joint fusions, which cause irreversible alterations to bone and joint structures. A more desirable technique is to anatomically correct the deformity by reducing the abnormally wide angle between the two metatarsals by tethering them closer together using suture like material. Known are U.S. Pat. Nos. 8,221,455, 7,901,431, 7,875,058, 5,529,075, and U.S. Patent Application No. 20,110,224,729. 
         [0008]    U.S. Pat. Nos. 8,221,455, 7,901,431, 7,875,058 and U.S. Patent Application No. 20,110,224,729 are tethering techniques whereby fiberwire, a suture-like material, along with buttress plates and/or buttons are used to tether the first and second metatarsals closer together like a tightrope. These techniques require holes to be drilled through both the first and second metatarsals. The Mini Tightrope system by Arthrex is an example of the tethering technique. First, a hole is drilled through the first and second metatarsals. Next, a buttress plate is secured to the second metatarsal bone by passing the suture through holes in the plate and through holes in both bones, then reducing the angular deformity by tightening the suture using a button and suture knot located on the medial side of the first metatarsal. The Mini Tightrope FT system by Arthrex is another example of tethering technique which uses an anchor-suture-button complex, where a threaded anchor is drilled into the second metatarsal base and the suture thread is then passed through a hole in the first metatarsal and the angular deformity is reduced as the suture thread is tightened and secured with a suture knot and button located along the medial aspect of the first metatarsal. Both of these tethering techniques require drilling into both the second and first metatarsals. U.S. Pat. No. 5,529,075 is similar in that it too requires drilling through the first and second metatarsals. Instead of a flexible suture-anchor technique, this reference requires the installation of a rigid stabilizing member between the first and second metatarsal. However, each of these references suffers from one or more of the following disadvantages: a hole must be drilled into or through the second metatarsal, to secure one end of the tethering device while the other (medial) end of the tethering device is secured with a button. 
         [0009]    Drilling a hole through the second metatarsal, which is significantly smaller in diameter by comparison to the first metatarsal, severely weakens the bone. To minimize weakening of the second metatarsal, the hole must be drilled through the centerline of the bone so that a maximum amount of bone remains above and below the hole. Nevertheless, drilling a hole through the centerline of the second metatarsal is especially difficult because it is done at an angle through a hole in the first metatarsal. Making the procedure more difficult, the drilling must be done with little or no visibility. A second metatarsal bone which has been drilled through is more vulnerable to stress and/or fracture from tension caused by the tethering techniques. Fracture of the second metatarsal is a common and potentially devastating complication of these tethering techniques. Additionally, the use of buttons and suture knots located along the medial aspect of the first metatarsal can cause irritation of tissue, knot loosening and skin irritation/breakdown from prominent components. 
         [0010]    Some surgeons have attempted to avoid drilling into the second metatarsal via a modification of the tethering technique, known as lasso technique. With the lasso technique, no holes are drilled through the second metatarsal, and no buttress plate or button is used. Instead, suture tape (i.e. Fibertape) is tied around the second metatarsal in the form of a cow-hitch knot and then secured to the first metatarsal. While the lasso technique avoids drilling through the second metatarsal by instead looping suture tape around the metatarsal, the suture tie itself can cause periosteal reaction and bone callus formation in some patients due to friction between the suture tape and the bone. To avoid periosteal reaction, few surgeons use absorbable suture to tether the first and second metatarsals together , but once the suture finally absorbs there is likely some loss of correction and possible recurrence of angular deformity. 
         [0011]    Because of the aforementioned problems, there is a need for method and device for reducing angular bone deformities between two bones, using a tethering technique with a suture material which not only avoids the complications associated with drilling into the second metatarsal, but also avoids the friction and tension forces (i.e. rope-burn) associated with lasso-type techniques and which also avoids the complications associated with the prominent medial button and suture knot. 
         [0012]    The present invention satisfies this need in the form of a method and device that allows for the correction and reduction of angular deformities such as metatarsus primus adductus using a tethering technique which does not require drilling into the second metatarsal, nor does it require the placement of a prominent suture knot/button device medially along the first metatarsal. 
       SUMMARY 
       [0013]    The inventive device is a Winged Looped Plate comprising a plate body with winged buttresses and dorsal loop. The Winged Looped Plate with incorporated dorsal loop can be affixed to a bone without any drilling or violating of the bone. With the plate against the bone cortex, a cerclage technique can be used to loop cerclage material, such as suture tape, fibertape, or wire, around the plate and bone. The cerclage material is passed through the dorsal loop of the plate to keep the cerclage material centered on the plate. The cerclage material is tied around the second metatarsal using a lasso-type or cowhitch-type tie, Then, upon tightening the cerclage, the plate would be affixed to the bone under tension, thereby dispensing with the need to affix the plate to the bone with screws or drilled holes. The other end of the tethering mechanism can then be fixated to the first metatarsal (with the angular deformity anatomically reduced) using knotless anchors (interference screws) thus avoiding the use of prominent buttons and suture knots that are components of all other comparative tethering methods. By using a cerclage technique to affix the Winged Looped Plate to bone under tension, the second metatarsal is protected not only from drill hole related stress fractures, but also from friction/shear forces (cortical reaction) associated with tying suture around bone and directly against the bone cortex without any shielding. 
         [0014]    This method and device addresses the aforementioned existing problem of angular bone deformities, in particular metatarsus primus adductus, the underlying cause of hallux valgus/bunion deformities, by utilizing the Winged Looped Plate of the present invention, placed directly against the second metatarsal bone. 
         [0015]    The Winged Looped Plate allows the surgeon to tie cerclage material around the plate, protecting the bone from both friction and tension forces and eliminating need for drilling through the second metatarsal. The method uses the Winged Looped Plate, cerclage material, a suture passing instrument and two tenodesis (interference) screws to achieve a true reduction of the angular deformity. The two bones are tethered together using a cerclage technique with the Winged Looped Plate protecting the second metatarsal, while knotless anchors are used in the first metatarsal. This method creates a button-less, knotless, fully adjustable and reversible angular deformity correction, while the plate protects the second metatarsal bone from harmful tension and friction. 
         [0016]    While the invention was conceived for the purposes of correcting metatarsus primus adductus, it is conceivable that the invention can be adapted to correct other bone deformities as long as there is a stable bone somewhat adjacent to an unstable bone. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]      FIG. 1  is a perspective view of a device embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus. 
           [0018]      FIG. 2  is a side profile view of a device embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus. 
           [0019]      FIG. 3  is a front profile view of a device embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus. 
           [0020]      FIG. 4  is a top view of a skeleton embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus. 
           [0021]      FIG. 5  is a profile view from the second metatarsal of a skeleton embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus. 
           [0022]      FIG. 6  is a profile view from the first metatarsal of a skeleton embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus. 
           [0023]      FIG. 7  is a profile view of a medial incision made along the first metatarsal with tenodesis (interference) screws anchoring the suture tape to the first metatarsal. 
           [0024]      FIG. 8  is an illustration of the bone deformity, metatarsus primus adductus, before the device and method of the present invention is applied. 
           [0025]      FIG. 9  is an illustration of the bone deformity, metatarsus primus adductus, anatomically reduced after the device and method of the present invention is applied. 
           [0026]      FIG. 10  is an alternate embodiment of the Winged Looped Plate device embodying features of the present invention for protection of a long bone when using any cerclage technique in a series as may be necessary for longer bones. An elongated version of the Winged Looped Plate allows for multiple wings and multiple loops for applying a series of cerclage ties over a longer bone. This figure also shows a possible low-profile variation of the loops if the cerclage material is thinner (i.e. monofilament wire). 
           [0027]      FIG. 11  is a flowchart illustrating a method of using the present invention for the correction of a bone deformity. 
       
    
    
     DETAILED DESCRIPTION 
       [0028]      FIGS. 1-3  illustrate the current embodiment of the Winged Looped Plate  100  device to correct bone deformities, in particular metatarsus primus adductus, the underlying cause of hallux valgus/bunion deformities. The Winged Looped Plate  100  comprises a plate body  102  which is semi-tubular but can also be tubular, with buttress wings  104 , a dorsal loop  106 , and ingrowth holes  108 . Depending on where the plate is to be used, the number of buttress wings  104 , the number and shape of the dorsal loops  106 , and size and number of holes  108  on the plate body can be customized. For example, several sets of buttress wings  104 , dorsal loops  106 , and ingrowth holes  108  can be arranged in series along a plate body for use in longer bones when a series of cerclage ties are needed. ( FIG. 10 ). The plate body  102  is semi-tubular in shape with a convex outer surface and concave inner surface to distribute forces of the suture tape evenly and avoid the need to drill a hole through the bone. The plate body  102  comprises extension buttress wings  104  which follow the semi-tubular shape of the plate body to protect the adjacent bone cortices where suture tape wraps around the device and bone. The plate body  102  and buttress wings  104  may have ingrowth holes  108  to allow bony and soft tissue/scar tissue ingrowth for long-term fixation and stability of the plate position. The dorsal loop  106  extends from the outer convex surface of the plate body  102  to facilitate the threading of cerclage material, such as suture tape, fibertape, or wire, around the device. The dorsal loop  106  retains the cerclage material centered on the plate upon tightening to evenly secure the plate firmly against the bone under tension. 
         [0029]    The invention can be fabricated to comprise the plate body  102 , buttress wings  104 , dorsal loop  106 , and holes  108  using conventional manufacturing methods such as welding, pressing, casting, machining and/or forging. A variety of materials may be used including, metallics (i.e. titanium, stainless steel), bio absorbables (i.e. Poly-L-Lactide PLLA) or non-absorbables (i.e. PEEK polymer). Additionally, the inner surface of the Winged Looped Plate  100  could be plasma coated or otherwise roughened for enhanced grip to bone. 
         [0030]      FIG. 11  is a flowchart illustrating the correction of a bone deformity using the method and device of the present invention. First, an unstable bone  301  and a stable bone  302  near the unstable bone  301  is located ( FIG. 4 ). Second, a hole to accommodate a tenodesis (interference type) screw  204  is drilled through the unstable bone  301  ( FIG. 5 ) so that an opening is formed on the side of the unstable bone that is furthest away from the stable bone ( FIGS. 9 ). Third, a Winged Looped Plate  100  is placed with the inner surface against the stable bone  302  and with the dorsal loop  106  furthest away from the unstable bone  301  ( FIG. 5 ). Fourth, a cerclage material  202  is passed through the dorsal loop  106  of the Winged Looped Plate  100  on the stable bone  302  and tied around the stable bone  302  and Winged Looped Plate  100  using a cerclage technique ( FIG. 5 ). Fifth, the free ends of the cerclage material  202  are passed through the hole in the unstable bone  301  and tension is applied to the suture  202  to reduce the angular bone deformity ( FIG. 6 ). Sixth, the cerclage material  202  is secured to the unstable bone  301  using a tenodesis (interference-type) screw  204  in the drill hole ( FIG. 6 ). 
         [0031]      FIGS. 4-9  illustrate a method of using a Winged Looped Plate  100  to correct the angular bone deformity, metatarsus primus adductus. First, a medial incision is made along the first metatarsal  301  (the unstable bone) head and neck as best illustrated in  FIG. 7 . Second, a small incision is made dorsally over the second metatarsal  302  (the stable bone) neck. Third, blunt dissection is used to create a tunnel through the soft tissue between the first metatarsal  301  and second metatarsal  302 , connecting the two incisions. Third, cerclage material  202  is passed through the tunnel from medial to lateral, and located through the dorsal incision where it is then threaded through the dorsal loop  106  of the Winged Looped Plate  100 , which is then placed against the lateral cortex of the second metatarsal before the cerclage material  202  is tied once around the second metatarsal  302  using a cerclage technique, as best illustrated in  FIGS. 4-5 . 
         [0032]    Fourth, the cerclage material  202  is tightened so that the Winged Looped Plate  100  is pressed firmly against the lateral aspect of the second metatarsal  302  and that buttress wings  104  of the plate cover and protect the dorsal and plantar cortices of the second metatarsal  302 . The plate would be adhered to the bone primarily via tension from tightening the suture tape cerclage however, additional forms of optional fixation may include a single setscrew through a hole  108  in the dorsal wing  104 , bone glue/paste/putty or other fixatives. Fifth, the free ends of the cerclage material  202  are then passed back through the soft tissue tunnel medially, then through a drill hole in the first metatarsal  301 , from lateral to medial as illustrated in  FIGS. 6-7 . Sixth, the cerclage material  202  is pulled tightly through the drill hole, reducing the angular deformity to a more anatomic position, as illustrated in  FIGS. 8-9 . Seventh, a tenodesis anchor screw  204 , shown in  FIGS. 6-7 , is inserted into the drill hole as an interference screw to maintain tension across the tethering mechanism between the first and second metatarsals. Finally, a second point of fixation can be achieved by passing the remaining cerclage material  202  end through a second drill hole in the first metatarsal and inserting a second tenodesis screw  204 . 
         [0033]    All features disclosed in this specification, including any accompanying claim, abstract, and drawings, may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features. 
         [0034]    Any element in a claim that does not explicitly state “means for” performing a specified function, or “step for” performing a specific function, is not to be interpreted as a “means” or “step” clause as specified in 35 U.S.C. §112, paragraph 6. In particular, the use of “step of” in the claims herein is not intended to invoke the provisions of 35 U.S.C. §112, paragraph 6. 
         [0035]    Although preferred embodiments of the present invention have been shown and described, various modifications and substitutions may be made thereto without departing from the spirit and scope of the invention. Accordingly, it is to be understood that the present invention has been described by way of illustration and not limitation.