Abstract:
A device for electromechanically and/or electro-pneumatically positioning a fractured bone having a first clamping unit adapted for attachment to the bone by at least one first bone fastener, a second clamping unit adapted for attachment to the bone by at least one second bone fastener, and at least one of: (i) a translation component operatively driven by a translational driver for relative translational movement of one clamping unit with respect to the other along a translational axis; (ii) an angulation component operatively driven by an angulational driver for relative angulational movement of one clamping unit with respect to the other along an articulation axis; and (iii) a rotational component operatively driven by a rotational driver for relative rotational movement of one clamping unit with respect to the other along a rotational axis.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of priority to U.S. Provisional Application Ser. No. 60/785,240, filed on Mar. 23, 2006 and fully incorporated by reference herein. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to surgical orthopedic instrumentation and to the external fixation of bone fractures. More particularly, this invention relates to electromechanical means for making automatic, multiple axis, multi-dimensional adjustments to bone fractures. 
     BACKGROUND OF THE INVENTION 
     External fixators have been in use for over a century. The first recorded use was by Wilhelm Wutzer (1789-1863) who used pins and an interconnecting rod in a clamping system to repair badly broken bones. Parkhill (1897) and Lambotte (1900) used unilateral devices with four pins and a bar/clamp system. By the 1960&#39;s, Vidal and Hoffman popularized using external fixators for open fractures and infected pseudarthroses. The problems expressed with fixation in the late 20 th  century, however, were mostly due to lack of understanding about its basic principles of application and healing. Therefore, external fixator (or “EF”) use was relegated to the most severe of injuries wherein infections, pin problems, non-unions, and mal-unions were all too common. 
     Since the 1950&#39;s, Ilizarov took developed principles and expounded on the ring and wire style of then, external fixation devices with excellent success. It was not until the late 1980&#39;s and early 1990&#39;s, when there was better communication with the Western world (after the fall of the former Soviet Union), that the methods of Ilizarov and thus, external fixation, were more easily demonstrated to the West. External fixation has now become so refined that it is now a potent tool in the management of orthopedic fractures, with or without complicated conditions. Currently, in the United States, external fixators have two widespread uses: in a damage control orthopedics (DCO) frame which is meant to be temporary, and in a treatment frame intended for a longer term, definitive treatment. 
     When external fixation is used for deformity or limb salvage, the device may require certain abilities for successful treatment. It should be able to lengthen and shorten as well as correct angular or rotational deformities. The original wire fixator design of Ilizarov utilized rings and tensioned fine wires that were connected together into an assembly with threaded rods. Use of hinges, and other accessories allowed the device to correct numerous conditions. These included all of the pre-requisites of lengthening-shortening, angular and rotational deformities. However, due to its completely manual nature, it required a significant amount of expertise and management. Subsequently, many surgeons in the United States did not employ the device routinely. 
     Some time later, the Taylor Spatial frame was developed using the science of the Stewart Platform, a device used to develop flight simulators. It allowed for a programmable multi-axis motion. The Taylor Spatial Frame utilized the hexapod mechanism of the Stewart Platform. It is placed on a limb segment with a ring above and below the deformity. The relative position of the rings to each other is readily known by the position of each of the six struts of the hexapod construct. The position of the construct to one limb segment is also known by use of radiographic measurements. Thus, by virtue of the known relationship of one limb segment to one ring, and the rings to themselves, the opposing limb segment&#39;s position is known since it is technically part of the same rigid body of the second ring. 
     Using a web based software program, the parameters can be used to create a corrective prescription that results in a relative motion between each ring, and therefore, each limb segment. A radiographic measurement of the resulting correction is performed and if needed, another iteration of the program for correction is performed, to result in a residual correction. Each corrective iteration is described by a prescription that outlines the adjustments in each hexapod strut. These maneuvers are performed manually by the surgeon or patient. Currently, the Taylor Spatial Frame is the only device available that provides a semi-manual three dimensional correction. 
     Other available fixators that can provide three-dimensional adjustments are mono-planar and utilize a series of hinges. These are not progressively adjustable like the struts of the Taylor Frame, and there is no web based software program that can be used. Some efforts at providing a uni-axial correction, e.g., axial motion such as a lengthener, have been developed. Still, these devices require experience for correct placement and are manually driven. 
     The device in the present patent utilizes the characteristics of both the mono-planar fixators as well as kinematic programming to effect a three dimensional correction of two limb segments. Instead of a ring-hexapod methodology, however, this fixator utilizes a mono-planar or series of mono-planar segments that have one or more electromechanical elements that can effect motion automatically. The elements are positioned in a prescribed arrangement around the limb, and its relationship to the limb segment is established. Each electromechanical element has a known position relative to others and to the limb. Using known 3-D kinematic calculations, the corrective formula can be determined, and signals to each motorized element determine the rate and amount of correction. 
     The said elements can have the ability to communicate using standard wireless technology, and can retain a history of position, force, and rate. Such electronic and recording capability can also be used to establish the compliance of the patient and working reliability of the device. The fixator described in this report can be attached to any fixator element in each limb segment. The ability to attach to a ring, a clamp, or other pin-bar construct allows its use with a variety of other products, and it is subsequently functioning as a connecting rod. 
     Several studies have tackled the different healing patterns of fractures in various external fixators. These studies have all attempted to measure fracture callous stiffness and strain during healing for outlining “how” healing occurs. The basic principle is that of progressive load transfer. If a bone fracture is going to heal, ensuring a proper load transfer to develop callous is necessary. The first stage of external fixation attempts to achieve a rigid and still construct for allowing induction of the healing process as well as letting the adjacent soft tissues time to “recover”. Once that biologic potential is realized, the EF frame progressively “de-stiffens” to transfer more and more load to the newly developing callous. If the construct is made too flexible, too early, the resultant strain may exceed the limits of that callous. And if there is not insufficient EF load transfer, some bone resorption and disuse osteopenia may result, both of which are undesirable. EF de-stiffening can be performed by removing bars, adjusting the location of bars, or removing certain pin/wire components. 
     With ring EF designs, the load transfer is usually a repetitive stimulus that occurs with increasing functional activity. As healing progresses, wires and half pins get removed and/or support struts loosened. Finally, some of the intervening struts can be removed altogether, leaving ring/wire/pin constructs with the patient having a trial weight bearing. If there is clinical pain, the struts get reapplied with the presumption that healing is not yet complete. 
     SUMMARY OF THE INVENTION 
     The present invention provides a device for electromechanically positioning a fractured bone comprises a first clamping unit adapted for attachment to the bone by at least one first bone fastener; a second clamping unit adapted for attachment to the bone by at least one second bone fastener; and at least one of: (i) a first translation component operatively driven by a translational electromechanical driver for relative translational movement of one clamping unit with respect to the other along a first translational axis; (ii) a first angulation component operatively driven by an angulational electromechanical driver for relative angulational movement of one clamping unit with respect to the other along a first articulation axis; and (iii) a first rotational component operatively driven by a rotational electromechanical driver for relative rotational movement of one clamping unit with respect to the other along a first rotational axis. The combined utility of the device would allow an automated motion in at least one axis. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Still other advantages of the present invention will become apparent to those skilled in the art after reviewing the detailed description that follows made with reference to accompanying drawings in which: 
         FIG. 1   a  is a left side (femur) schematic showing a bone positioning device according to a first preferred embodiment of the invention; 
         FIG. 1   b  is a close up schematic for the B-B circled region of  FIG. 1   a;    
         FIG. 2  is a left side (femur) posterio-medial schematic view of a bone positioning device according to a first preferred embodiment of the invention; 
         FIG. 3  is a left side (femur) posterio-medial schematic view focusing on the upper half of the device of  FIG. 2 ; 
         FIG. 4  is a closeup left side (femur) posterio-medial schematic view of a first operatively driven component and electromechanical driver for the proximal top two-thirds of the device of  FIG. 2 ; 
         FIG. 5  is a closeup left side (femur) posterio-lateral schematic view of the first component and driver of  FIG. 4  after it has been rotated clockwise about 30 degrees; 
         FIG. 6  is a left side (femur) posterio-medial perspective schematic focusing on the middle mechanicals for the device of  FIG. 2 ; 
         FIG. 7  is an anterior-lateral, perspective schematic of the  FIG. 6  middle mechanicals; 
         FIG. 8  is a left side (femur) posterio-medial schematic view focusing on a distal, lower one third of the device of  FIG. 2 ; 
         FIG. 9  is a closeup right side schematic view of a first operatively driven component and electromechanical driver for the lower half of the device of  FIG. 2 ; 
         FIG. 10  is an anterio-medial, perspective schematic of the  FIG. 9  lower device component and driver; and 
         FIG. 11  is a closeup reverse angle schematic view of the distal, lower one third of the  FIG. 9  device component and driver after it has been rotated clockwise about 180 degrees. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     As described herein below, the term “positioning” is also meant to expressly address the need for subsequent bone “re-positioning” as well. And, while repeated references are made to uses to repair fractured bone by the methods and apparatus of this invention, it should be equally understood to address beyond “broken bone” repairs, the possibilities for both mal-union and non-union, or as a slow bone correcting device. (i.e. the purposeful correction of misaligned or non-healed bones). The deformity of the bone would be an independent variable, and its correction would be such to place it in an anatomic or mechanical axis. The gradual correction would occur in multiple planes and be driven by the coordinated movements of each electromechanical component. In addition, using the same electromechanical elements, the external fixator can be used for intentional compression to stimulate partially healed bone. Furthermore, in the event of missing sections of bone, the device can be used to perform bone transport. In this configuration, one or more of the bone fixation units would be powered to move relative to others, so as to result in a relative transport of one bone segment with another. It would do so in a prescribed fashion so as to result in “bone regeneration”. The use of modular segments give the fixator attached thereto greater options for application. It can easily be assembled to specific, sometimes even awkward configurations, positioning its various hinges on where the patient most needs that degree of movement. 
     In some embodiments depicted, the hinges of one part of the fixator are knowingly passive. Nevertheless, they can be made to accept motorized drives like those schematically depicted in accompanying  FIGS. 1   a  and  1   b . With such a configuration, the EF device may get calibrated for an initial positioning thereby generating an initial, or “start up” position. The initial position will serve as a baseline after which CPU programming, either full time on-board, or off-board, can be used for calculating the patient&#39;s next corrective steps and ex-fix movements relative to same. Finally, with a series of force gauges or other monitoring means, the stiffness of intervening bone can be calculated using standard mechanical and physics formulas. By knowing the distance of the force transducer from the bone segment in question, and knowing the material and mechanical properties of the fixator and pin device, the amount of force generated with load can be used to calculate the stiffness or modulus of the intervening bone segment. This modulus or stiffness of the “callus” can provide knowledge of the consolidation of the intervening bone segment. This information can be used to determine bone healing, since as the bone heals and the callus matures, it will stiffen and accept more load, and thus share with load transfer. When this occurs, the force sensed by the transduction elements will decrease. Other methods using displacement have been used and described by Burny and others. This use of force is a simple substitution where in stiffness is substituted for displacement during the determination of healing. 
     The changes in such “fracture stiffness” or modulus can be periodically detected . . . and reported out, for assessing when the proper degree of bone healing has transpired. The measurements can be recorded and even transmitted to a device in a wireless fashion and can be transmitted to office of the surgeon for monitoring. With “smart” chips, USB&#39;s and other computer-based interfaces, the load cells for this invention can conceivably take healing “information” in while also delivering information out for subsequent medical interpretation. These same devices can further be programmed to automatically correct based on a prescription determined by the deformity and surgeon. 
     Since the external fixator device is primarily functioning as a connecting device between different fixator components, it could potentially be used on any number of different commercially available devices. Thus, it is not restricted to use with only one external fixator design. And while there are numerous references to various motor drive mechanisms herein, it is understood that such components, or sub-components, can be driven by commercially available micro-motors with gear assemblies, or with known or subsequently developed, electro-pneumatic drive devices, i.e., the type used to drive pneumatic cylinders and the like. 
     Referring now to the FIGS., especially the schematic representation of one preferred embodiment at  FIG. 1   a  (and its close up view  FIG. 1   b  taken from an enlargement of area B-B in  FIG. 1   a ), there is generally shown the device  10  for electromechanically positioning a fractured bone. To better illustrate a fractured bone, in some of the accompanying photographs of this preferred embodiment, the bone connected to same is divided as a top bone TB, middle bone MB, and lower bone LB. Adjacent top bone TB, there is situated a first clamping unit  20  that is meant to attach to bone TB with a plurality of known fixator fasteners, in this case bone screws  25 . 
     Device  10  further includes a second clamping unit  30  adapted for attaching to a lower bone LB by its own set of bone screws  35 . More preferably, and for better illustrating use of this device for joining multiple bone fragments together, there is shown yet a third, more intermediate clamping unit  40  that attaches to middle bone MB via its own set of bone screws  45 . 
     The three main clamping units of device  10  all interconnect along mainframe  50 . As shown, however, mainframe  50  includes an upper portion  54  and lower portion  58 . Internal to that mainframe, as best seen in partial cutaway at  FIGS. 1   a  and  1   b , there is a series of lead screws  56 . By the relative, in this case electromechanical, positioning of lead screws  56 , the overall relative length of mainframe  50  can increase or decrease, as needed for external fixation purposes. 
     At each end to mainframe  50  of device  10 , there are positioned elbow articulations. At the top of upper portion  54 , upper elbow articulation  64  can be found for rotating on a first axis shown by articulation arrow A 64 . Similarly, towards the base of mainframe  50 , there is a corresponding lower elbow articulation  68  whose direction of rotation is generally shown by articulation arrow A 68 . The movement of these elbows provides a certain “hinge-like” quality to the relative movement of device  10  with the various bone parts to which they are connected. They account for the relative angulational movement of device  10 . 
     Because of the manner in which elbow articulations  64  and  68  pivotally mount to the upper and lowermost tips of mainframe  50 , these same elbows may be further rotated (left to right, or vice versa) about an axis that runs substantially parallel to the overall length/direction of mainframe  50 . Those directions of rotational movement are marked by axial arrows A 50  (both upper and lower). 
     For assisting with the electromechanical translation, angulation and/or rotation of device  10  about upper bone, middle bone and lower bone, there are shown an upper transport drive  74  and a more intermediate, longitudinal or lengthening drive  76 . As better seen by the closeup view at  FIG. 1   b , the general connection means for such drives include a turning gear  82 , a disengagement pin  83  to a friction plate  84  behind which a spring brake  85  is pushing away from an interior wall of device  10 . Though not shown, one or more of these drives can be supplemented with and/or superseded by wormgears and/or other temporary lockout mechanisms. 
     In one embodiment of the invention, device  10  remains affixed to the patient&#39;s bone and can be connected, disconnected and reconnected to drives  74  and  76  for making periodic adjustments. Depending on the materials selected for mainframe  50  and the various bone connectors, as well as whether the drive units remain “on board” for near full time healing management, the device itself has the potential to be rendered MRI compatible. 
     To better serve the preferred functions of monitoring the healing of bone with an electromechanically driven device  10 , there are a series of force gauges positioned about the mainframe  50 . Preferably, an upper force gauge  94 , intermediate gauge  96  and lower force gauge  98  are commonly wired for providing a feedback signal for when measurable stress and/or strain reductions have occurred, such changes from a preset norm being indicative of the degree of bone callous formed and from which subsequent movements of the fixator can be precisely planned. One such force gauge sensor is a Flexiforce pressure sensor as made and sold by Parallax, though it to be understood that any one or more known, or subsequently conceived, force sensors can be substituted for same. 
     With the aforementioned device and its preferred combinations of motors, breaks, gears, and/or lockouts, it is conceivable to automatically move one or more connection points to a patient&#39;s anatomy slowly and smoothly between in a plurality of axes. In other words, this device allows for a better transition from starting points ABC to end points XYZ without having to go in just one direction, i.e., all along a vertical, from A to X, then along the horizontal, from B to Y, etc. But instead, through a more “flowing” synchronicity of axial movements, this device can transfer the patient gradually, and less painfully, from beginning A to desired end point Z. 
     The foregoing discussion discloses and describes merely exemplary embodiments of the present invention. One skilled in the art will readily recognize from such discussion, and from the accompanying drawings and claims, that various changes, modifications and variations can be made therein without departing from the spirit and scope of the invention.