Patent Publication Number: US-11045241-B2

Title: Transosseous ribbon wire devices and a system and method for using the devices

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 14/866,263 filed Sep. 25, 2015, which will issue as U.S. Pat. No. 9,949,779 on Apr. 24, 2018, and which claims priority benefit under 35 U.S.C. § 119(e) of U.S. provisional application No. 62/056,173 filed Sep. 26, 2014, which is incorporated herein by reference in its entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The invention relates to the area of external fixation devices used in orthopedic surgery and, more particularly to specialized transosseous wires and assemblies for use with an external fixator. 
     Description of the Related Art 
     External fixators for correcting bone malunions, nonunions, acute fractures, deformities and defects are known. For example, external fixation has been performed since the 1950&#39;s to lengthen bones and correct deformities using an “Ilizarov” apparatus. The Ilizarov apparatus uses circular rings and semi-circular external supports centered on a patient&#39;s limb and secured to the bone by crossed, tensioned wires and half pins. 
     Such system use wires, pins and half-pins traditionally having a circular cross-section.  FIGS. 1-3  show prior art wires and  FIG. 4  shows a prior art half pin presently used in Ilizarov assemblies (as shown more particularly in  FIG. 4 ). Such prior art wires and half pins are characterized by a circular cross-section in the wire portion remaining in the bone. However, such circular wires can, in some circumstances, tear out of soft or degraded bone when tension or loads are applied. What is needed is an implant that is fixed to the ring external fixation device at two points having a surface area that will not readily tear out or cut through soft bone. 
     What is needed is a system and method utilizing an external fixator wherein transosseous wires are provided with a non-circular cross-section and mounted to external hardware having a mating cross-section. What is additionally needed is a method for installing a transosseous wire having more surface area through the use of a non-circular cross-section. 
     BRIEF SUMMARY OF THE INVENTION 
     It is accordingly an object of this invention to provide a transosseous ribbon wire and hardware, and a system and method for performing external fixation in orthopedic surgery that overcome the disadvantages of the prior art. In one particular embodiment of the invention, a specialized transosseous wire having a rectangular cross-section is provided. In another embodiment, the specialized wire is installed using a reciprocating motion. Thereafter, the specialized transosseous wires are affixed to an external fixation frame. 
     In one aspect, provided herein is a transosseous wire device, including a ribbon wire and a delivery tool. 
     In another aspect, provided herein is a method of implanting a transosseous wire, including providing a transosseous wire with a rectangular cross-section, placing the wire in a delivery tool, and advancing the wire through a bone using a reciprocating motion. 
     In yet another aspect, provided herein is a method of using a transosseous wire device, including providing a transosseous wire having a rectangular cross-section in a body portion of the transosseous wire for a length sufficient to traverse a bone, the transosseous wire including a cutting tip at a first end of the wire. The method further includes placing the wire in the sheath of a delivery tool, with the cutting tip of the wire disposed proximal to an opening in the channel at the distal end of the sheath. The delivery tool includes a sheath with a first end and a second end, a handle at the first end, an opening at the second end, a cavity extending from the second end of the sheath to the handle, a slot extending along a length of the sheath from an exterior surface of the sheath into the cavity, a driver with a hole and a tang end positioned opposite the hole in the driver and shaped to couple to a reciprocating saw, and a pin coupled to the driver through the hole and coupled to the connector hole of the ribbon wire at a first end. The method further includes engaging one end of the pin to the connector hole of the transosseous wire, the other end of the pin being engaged with the driver, connecting the tang end of the driver to a reciprocating saw, and operating the reciprocating saw to advance the transosseous wire into, and through, a bone. 
     In another aspect, provided herein is a fastener for securing a transosseous wire to an external fixator, including a threaded portion and a rectangular-shaped portion configured to receive a wire having a rectangular cross-section. 
     Although the invention is illustrated and described herein as embodied in transosseous ribbon wires, hardware and devices for performing external fixation and a system and method of using the devices, it is nevertheless not intended to be limited to the details shown, since various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims. 
     The construction and method of operation of the invention, however, together with additional objects and advantages thereof will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a top plan view of a prior art wire having a circular cross-section and a bayonet shaped, eccentric tip for drilling through bone, which is used in performing external fixation in an Ilizarov procedure; 
         FIG. 2  is a side plan view of the prior art wire of  FIG. 1 ; 
         FIG. 3  is a top plan view of a prior art beaded or stopper wire having a circular cross-section, which is used in performing external fixation in an Ilizarov procedure; 
         FIG. 4  is a top plan view of a prior art half pin having a circular cross-section, which is used in performing external fixation in an Ilizarov procedure; 
         FIG. 5  is a partial perspective view of a prior art wire fixation bolt used to capture a prior art wire having a circular cross-section in an Ilizarov procedure; 
         FIG. 6  is a perspective view of a smooth transosseous ribbon wire, in accordance with an embodiment of the present disclosure; 
         FIG. 7  is a side plan view of the transosseous ribbon wire of  FIG. 6 , in accordance with an embodiment of the present disclosure; 
         FIG. 8  is a front end plan view of the smooth transosseous ribbon wire of  FIG. 6 , in accordance with an embodiment of the present disclosure; 
         FIG. 9  is a rear end plan view of the smooth transosseous ribbon wire of  FIG. 6 , in accordance with an embodiment of the present disclosure; 
         FIG. 10  is a first side perspective view of a delivery tool and ribbon wire system, in accordance with an embodiment of the present disclosure; 
         FIG. 11  is an enlarged, front plan view of the delivery tool and ribbon wire system of  FIG. 10 , in accordance with an embodiment of the present disclosure; 
         FIG. 12  is a side plan view of the delivery tool and ribbon wire system of  FIG. 10 , in accordance with an embodiment of the present disclosure; 
         FIG. 13  is a second side perspective view of the delivery tool and ribbon wire system of  FIG. 10 , taken from the side opposite the first side, in accordance with an embodiment of the present disclosure; 
         FIG. 14  is an enlarged, perspective view of a driver assembly useful with a delivery tool and ribbon wire system of an embodiment of the present disclosure; 
         FIG. 15  is a perspective view of a transosseous stopper ribbon wire, in accordance with an embodiment of the present disclosure; 
         FIG. 16  is a perspective view of a delivery tool and ribbon wire system, in accordance with another embodiment of the present disclosure; 
         FIG. 17  is a perspective view of an external fixator using transosseous ribbon wires, in accordance with an embodiment of the present disclosure; 
         FIG. 18  is a perspective view of an off center transosseous ribbon fixation bolt and set screw, in accordance with an embodiment of the present disclosure; 
         FIG. 19  is a front plan view of a transosseous ribbon implant fixation bolt and set screw, in accordance with another embodiment of the present disclosure; 
         FIG. 20  is a front plan view of a transosseous ribbon implant fixation bolt, in accordance with a further embodiment of the present disclosure; and 
         FIG. 21  is a front plan view of a bolt, in accordance with yet another embodiment of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Generally stated, disclosed herein are transosseous ribbon wire devices. Further, a system and method for using the transosseous ribbon wire devices is also discussed. 
     Referring now to  FIGS. 6-9 , there will now be described a transosseous ribbon wire  10  which may be used in performing external fixation, such as an Ilizarov fixation, in accordance with an embodiment of the present disclosure. More particularly, a transosseous wire is provided in the form of a ribbon or bar  10 , such that it has a rectangular cross-section. The terms “transosseous ribbon wire”, “ribbon wire”, “wire”, “ribbon”, “transosseous ribbon fastener”, “ribbon fastener”, “fastener”, “transosseous ribbon implant”, “ribbon implant”, “implant”, “transosseous bar”, and “bar” may be used interchangeably herein to describe the same device. In one embodiment, the transosseous ribbon wire  10  is a rectangular prism, having a height “H” that is greater than the width “W”. In another embodiment, the height “H” is, for example, about twice the width “W”. In yet another embodiment, the height “H” is, for example, three times or more the width “W”. In a further embodiment, for example, the width “W” of the ribbon wire  10  is, for example, approximately 1.5-2.5 mm, while the height “H” is selected to be in a range from, and including, approximately 3-8 mm. In one embodiment, the width “W” is, for example, 1.8 mm and the height “H” is, for example, 4 mm. In another embodiment, the width “W” is, for example, 1.8 mm and the height “H” is, for example, 6 mm. In a further embodiment, the width “W” of the ribbon wire  10  is, for example, 2.0 mm and the height “H” is, for example, 6 mm. This is not meant to be limiting, as other dimensions suitable for use in external fixation of bone can be used without departing from the scope or spirit of the invention. 
     In accordance with one embodiment, the ribbon wire  10  is rectangular along the majority of the length “L” (i.e., along the longitudinal axis of the ribbon wire  10 ). A boring tip  20  may be provided at one end of the ribbon wire  10 , for use in sawing into the bone through which the wire  10  is to be inserted. The boring tip  20  may have, for example, a pyramidal shape, with each side  22  converging on a sharpened cutting blade  20 A. The tip  20  may be, for example, ridged, and/or the edges can be sharpened, to enhance cutting into the bone. Alternately, the faces  24  of the tip  20  can be, for example, curved (preferably, concave) or fluted to assist in moving the bone out of the hole being cut. Additionally, the ribbon wire  10  can be made from a bio-compatible material, for example, titanium, stainless steel, or the like. Such material should be chosen to have sufficient strength and rigidity to permit the wire  10  to be sawed into the bone, in accordance with a method described in further detail below. 
     The ribbon wire  10  may also include a body  18  extending between the boring tip  20  and a second end  12  of the ribbon wire  10 . The second end  12  may be positioned opposite the boring tip  20 . The ribbon wire  10  may also include at least one engagement or connector hole  15  near the second end  12  of the ribbon wire  10 . The hole  15  is used to engage the ribbon wire  10  with a delivery tool, as will be described in greater detail below. In one embodiment, the hole  15  is shaped to be non-circular, for example, square, rectangular, hexagonal, octagonal, or another polygonal shape, so as to engage the tool without permitting the tool to rotate in the hole  15 . The hole  15  is hexagonal in the illustrated embodiments. 
     Referring now to  FIGS. 10-14 , there is shown an embodiment of a delivery tool  100 , for inserting the ribbon wire  10  through a bone, in accordance with one embodiment. More particularly, the delivery tool  100  can be used with the wire  10  for installing the wire  10  into and through the bone when performing an Ilizarov type or other orthopedic procedure. The delivery tool  100  may include a handle portion  105  engaged with a ribbon sheath  110 . The ribbon sheath  110  may be hollow and may include an inner channel or cavity  112 , as shown in  FIG. 11 . The cavity  112  may preferably have a rectangular cross-section complementary to that of the ribbon wire  10 . The ribbon sheath  110  may also have a roughly “C” shaped cross-section defined by opposing upper and lower walls and, by a solid side wall  113 , opposite a slotted side wall  115 , as shown in  FIG. 11 . Ribbon wire  10  is slidably received within the slot  112  of the ribbon sheath  110  through an orifice at the end  118  of the ribbon sheath  110 . The end  118  of the ribbon sheath  110  may include a rocker tip at the point of contact with the patient. 
     Referring now to  FIGS. 12-14 , the slotted side wall  115  of the ribbon sheath  110  includes a slot  115   a , through which the hole  15  of the ribbon wire  10  can be accessed. The delivery tool  100  may also include a pin  125 , which may be passed through the slot  115   a  to engage the hole  15  in order to facilitate the sliding of the ribbon wire  10  within and outside of the sheath  110 , as shown in  FIGS. 11-13 . The delivery tool  100  may also include a driver  130  with a hole  130   a  at a first end and a tang end  132  at a second end of the driver  130 . The hole  130   a  of the driver  130  may receive the pin  125 . In the embodiment shown in  FIG. 14 , the pin  125  has a non-circular cross-sectional shape, for example, a hexagonal shape, that is complementary to the cross-sectional shapes of the holes  15  and  130   a , to prevent unwanted rotation of the rod  125 . The tang end  132  of the driver  130  may be configured to be received into the blade clamp holder or shoe of a reciprocating saw (not shown). When engaged with a reciprocating saw or other power attachment, the driver  130  drives the travel of the ribbon wire  10  from inside of the sheath  110  into, and through, a bone of the patient. 
     The delivery tool  100  may additionally include a Luer lock connector  120  on the side  113  of the sheath  110 , as shown in  FIG. 10 . The lock connector  120  may be in fluid communication with the cavity  112  of the ribbon shaft  110 , so as to provide saline or water into the cavity  112  during the procedure, to cool the ribbon wire  10  during insertion and prevent heat induced osteonecrosis. In one embodiment, the Luer lock connector  120  is placed one (1) inch from the distal end  118  of the ribbon sheath  110 . 
     Referring now to  FIGS. 6-14 , there will be described a method for assembling a delivery system with a ribbon wire, in accordance with one embodiment. More particularly, the method may include loading a ribbon wire  10  into the sheath  110  of the delivery tool  100 . The ribbon wire  10  may have a rectangular cross-section through the length “L” of its body  18 , as described in greater detail above. Next, the pin  125  of the driver  130  may optionally be attached to the ribbon wire  10  before loading into the tool  100 , to assist in loading the ribbon wire  10 . The pin  125  may be attached to the ribbon wire  10  by inserting the pin  125  into the hole  15  in the second end  12  of the ribbon wire  10 . The pin  125  may optionally be coupled to the driver  130  prior to or after insertion of the pin  125  into the hole  15  of the ribbon wire  10 . Once the pin  125  is coupled to the ribbon wire  10 , the ribbon wire  10  may be inserted into the slot  115   a  at the end  118  of the delivery tool  100 . The ribbon wire  10  may be slid through the slot  115   a  until the ribbon wire  10  is seated in the cavity  112 . The ribbon wire  10  may be seated in the cavity  112  with the end  12  of the ribbon wire  10  at the handle  105  or at a desired position along the cavity  112 . After the ribbon wire  10  is fully inserted into the delivery tool  100  and the pin  125  and driver  130  assembled, the tang end  132  of the driver may be coupled to a reciprocating saw, as indicated by the arrows in  FIGS. 10 and 14 . 
     In an alternative method of assembly, the ribbon wire  10  may be inserted into the sheath  110  of the delivery tool  100  prior to coupling the pin  125 . The ribbon wire  10  may be seated in a position with the end  12  of the ribbon wire  10  at the handle  105  or at a desired position along the cavity  112 . In this embodiment, after the ribbon wire  10  is seated in the cavity  112 , the pin  125  may be inserted into the hole  15  of the ribbon wire  10 . The pin  125  may be coupled to the driver  130  prior to or after insertion of the pin  125  into the hole  15  of the ribbon wire  10 . After the ribbon wire  10  is fully inserted into the delivery tool  100  and the pin  125  and driver  130  assembled, the tang end  132  of the driver may be coupled to a reciprocating saw, as indicated by the arrows in  FIGS. 10 and 14 . 
     Referring now to  FIGS. 6-21 , there will be described a method for using a ribbon wire and delivery system in accordance with one embodiment. The method may include, for example, a surgeon positioning and attaching a frame  200  around the patient&#39;s bone needing fixation. Next, a trajectory guide, for example, a guide  212  as shown in  FIG. 20 , may optionally be attached to the frame  200  in a desired position to assist with insertion of a ribbon wire  10 . Once the surgeon has determined the insertion position for the ribbon wire  10  to enter the patient&#39;s body, a stab incision may be made using a small surgical scalpel blade. The stab incision will allow the sheath  110  to enter the patient&#39;s body and serve as a soft tissue protector as well as a guide for the implant. Next, the surgeon may obtain the delivery tool  100  and ribbon wire  10  for insertion into the patient. In one embodiment, the delivery tool  100  will be provided to a physician pre-assembled, as shown in  FIG. 10 . In an alternative embodiment, the delivery tool  100  and ribbon wire  10  may be provided un-assembled and would need to be assembled during the surgery. 
     Once the delivery tool  100  and ribbon wire  10  are assembled, the ribbon wire  10  will be fully received into the cavity  112  and the tang end  132  of the driver  130  will be locked into the shoe of a reciprocating saw. The surgeon may then hold the handle  105  of the sheath  110  in one hand, and the reciprocating saw body in the other hand. In the embodiment illustrated, the handle  105  has a flattened face  105   a  that will be near, or in contact with, the body of the reciprocating saw. Holding the handle in one hand, the tool  100  is disposed adjacent to the entry position for the ribbon wire. The distal end  118  of the delivery tool  100  may be, for example, placed on the patient&#39;s skin at the point of the stab incision or, if a trajectory guide is being used, the distal end  118  may be placed with the ribbon wire  10  adjacent to the opening in the trajectory guide  212 . Next, with the reciprocating saw turned on, the surgeon may advance the saw and the ribbon wire  10  (via the driver  130  and pin  125 ), such that the cutting tip of the ribbon wire  10  emerges from the distal end  118  of the sheath  110 . The reciprocating motion of the ribbon wire (imparted by the saw via the driver  130  and pin  125 ) causes the blade tip  20   a  of the ribbon wire  10  to cut into the soft tissue and bone of the patient. The surgeon continues to advance the saw, while holding the handle  105  steady in the original position, until the ribbon wire  10  traverses the soft tissue and bone of the patient and emerges from the other side. The tool  100  and pin  125  can then be disconnected from the ribbon wire  10 , with the ribbon wire  10  still traversing the bone. 
     The ribbon wire  10  can then be attached at a first end to an external fixator ring  200  using a bolt or other attachment mechanism, for example, bolt  210 ,  212 ,  214 ,  218 . If a trajectory guide was used, then the trajectory guide may be removed and replaced by a bolt  210 ,  212 ,  214 ,  218  or other attachment mechanism on the first end. Next, another bolt  210 ,  212 ,  214 ,  218  or attachment mechanism may be used to secure the ribbon wire  10  on a second end. Optionally, a tensioner (not shown) may be used to apply tension to the ribbon wire  10  before securing the ribbon wire  10  to the frame  200  with a second bolt  210 ,  212 ,  214 ,  218 , as described in greater detail below. Use of the tensioner (not shown) enables the surgeon to secure the ribbon wire  10  in tension. Once the ribbon wire  10  is secured to the frame  200  on each end, the excess ribbon wire  10  may be removed from each end. 
     The method may further include pre-drilling an opening into the patient&#39;s bone prior to inserting the ribbon wire  10 . The pre-drilling may be used when the ribbon wire  10  is being inserted through a long, dense cortical bone. The opening that is drilled in the patient&#39;s bone may be, for example, smaller than the size of the ribbon wire  10 . The opening may be, for example, smaller than 2 mm, such as 1.5 to 1.8 mm. 
     It should be understood that other forms of ribbon wires can be used without departing from the scope and spirit of the present invention. For example, referring now to  FIGS. 15 and 16 , the principles of the present disclosure can be applied to other types of transosseous wire, such as stopper wire  150 . As with the embodiment of  FIG. 10 , the stopper wire  150  has a body portion  152  having a rectangular cross-section, sized and dimensioned as described in connection with ribbon wire  10  which will not be described again here for brevity sake, and an engagement hole  154  for connection to a drive rod. However, the ribbon wire  150  also includes a stopper portion  156  to provide a stop at the bone interface. 
     A delivery tool  160 , similar in all respects to delivery tool  100 , as described in greater detail above and which will not be described again here for brevity sake. The delivery tool  160  may include a cavity  165  of the sheath  162  that has been sized or otherwise configured to receive the ribbon wire  150 , including its larger stopper  156 . Additionally, the orifice at the distal end  168  of the sheath  160  would be sized and configured to permit the stopper  156  to exit therefrom. 
     The foregoing disclosure provides an improved transosseous wire, system and method for use in external fixation surgery. By providing a transosseous wire having a greater surface area, the present disclosure provides an increased pullout resistance for the wire and greater load bearing properties. An insertion tool is provided for installing the inventive ribbon wire through the bone. Additionally, the present disclosure provides improved hardware for securing the ribbon wire to an external fixator, such as a ring fixator or other type of external frame. More particularly, referring now to  FIG. 17 , there is shown one embodiment of external fixator hardware  200  for performing external fixation surgery using the ribbon wires  10 ,  150 , described herein. More particularly, the hardware  200  is used to maintain tensioned ribbon wires  10  using fasteners  210 ,  212 ,  214  to secure the wires  10  to the frame or hardware  200 . 
     More particularly, external fixation can be performed using ribbon wires  10 ,  150 , as described herein, wherein the ribbon wires  10 ,  150  are secured to the hardware  200  using traditional fasteners. However, in one embodiment, specialized fasteners  210 ,  212 ,  214  having portions adapted to fit the rectangular cross-sections of the wires  10 ,  150  are provided. Referring now to  FIGS. 18-20 , there are shown fasteners  210 ,  212 ,  214 , that can be used with the wires  10 ,  150  having a rectangular cross-section. As shown, each of the fasteners  210 ,  212 ,  214  includes a rectangular cavity  210   a ,  212   a ,  214   a , for receiving and tightly holding the rectangular bodies of the wires  10 ,  150 . Additionally, the off-center bolt  214  includes a set screw  214   b , which can be used to tighten the wire  10 ,  150  firmly against the hardware  200 , using a hex wrench. Similarly, the fastener  210  includes a protrusion  210   b  that can be used to firmly trap the wire in the rectangular cavity  210   a . The fastener  212  includes a mechanism wherein the cap  212   b  is tightened down on the body of the wire  10 ,  150  to hold it in place. Other fasteners can be used to engage a wire having a rectangular cross-section without departing from the scope and spirit of the present disclosure. For example,  FIG. 21  shows another type of fastener  218  including a rectangular cavity  218   a  and a biased cap  218   b  which is biased to move the cap downwards, for example, toward the threaded shank of the bolt, to entrap and retain the ribbon wire  10 ,  150  tightly in the cavity  218   a  through friction. 
     It is also contemplated that the ribbon wire  10 ,  150  may be tensioned in accordance with the requirements of an Ilizarov procedure. Tensioning of the ribbon wire  10 ,  150  involves drawing the wire against its fixed end. Wire tensioners are known, such as the TRUELOK™ wire tensioner, in which the tensioner is slid over the wire to be tensioned, while the head captures the wire fixation bolt and is firmly against the external support. The TRUELOK™ wire tensioner operates by squeezing the handles of that tool together until the desired amount of tension is generated in the wire. Note that such a wire tensioner can be adapted specifically to work with (i.e., fit over and accept) ribbon wires  10 ,  150  of various diameters, as described herein. Additionally, in one embodiment, the wire tensioner includes a set device or temporary, resettable locking device that allows for the wire tensioner to be reset on the same wire for additional tension, if required, without losing the tension gained from the last use. In one particular embodiment, the temporary locking device is a collet that is set when tensioning the transosseous wire or ribbon wire  10 ,  150 , and, after releasing the grip, can be reset to add additional tension to the same wire. 
     Although described herein with an external fixator such as the Ilizarov fixator, it should be understood that the transosseous ribbon wire of the present disclosure could also be used as a standalone bone fixation and stabilization implant due to its shape and method of insertion, without departing from the scope and spirit of the present disclosure. 
     Accordingly, while a preferred embodiment of the present disclosure is shown and described herein, it will be understood that the invention may be embodied otherwise than as herein specifically illustrated or described, and that within the embodiments certain changes in the detail and construction, as well as the arrangement of the parts, may be made without departing from the principles of the present disclosure. 
     The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has”, and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.