Abstract:
Disclosed are an apparatus and its associated method for minimally invasive stabilization of anterior pelvic fractures. The pelvic stabilization system consisting of two rod shaped implants that may be surgically inserted subcutaneously or along the bone surface of each hemipelvis and a means of both linking the individual rods as well as rigidly securing the construct to the pelvis.

Description:
CROSS REFERENCE TO PREVIOUSLY FILED PROVISIONAL PATENTS 
       [0001]    Continuation of previously submitted Provisional Application No. 60/856,610 filed Nov. 6, 2006 is claimed with this application. 
     
    
     CROSS REFERENCE TO RELATED APPLICATIONS 
       [0002]      
         [0000]    
       
         
               
             
               
               
               
             
           
               
                   
               
               
                 U.S. Patent Documents 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 4,292,964 
                 October, 1981 
                 Ulrich 
               
               
                 4,361,144 
                 November, 1982 
                 Slätis et al. 
               
               
                 4,454,876 
                 June, 1984 
                 Mears 
               
               
                 5,108,397 
                 April, 1992 
                 White 
               
               
                 5,350,378 
                 September, 1994 
                 Cole et al. 
               
               
                 6,162,222 
                 December, 2000 
                 Poka et al. 
               
               
                 6,340,362 
                 January, 2002 
                 Pierer et al. 
               
               
                 6,440,131 
                 August, 2002 
                 Haidukewych 
               
               
                   
               
             
          
         
       
     
       STATEMENT OF FEDERALLY SPONSORED RESEARCH/DEVELOPMENT 
       [0003]    The disclosed invention was not funded through federal sources in any manner. 
       BACKGROUND OF THE INVENTION 
       [0004]    1. Field of the Invention 
         [0005]    This invention relates to an implantable plate and/or rod system and its associated hardware used for the operation of implantation that is utilized to stabilize pelvic fractures. 
         [0006]    2. Description of the Prior Art 
         [0007]    Devices used to treat fracture of the pelvis currently fall under two general classifications; internal fixation and external fixation. Internal fixation is typically utilized when the patient exhibits unstable posterior pelvic fractures. See, for example, U.S. Pat. Nos. 4,454,876; 5,108,397; 6,340,362 and 6,440,131. This type of fracture tends to be more complex with it involving multiple bony structures. Internal fixation addresses these clinical issues through open reduction and correction of misaligned bone segments that are subsequently stabilized with a wide variety of plate and screw methods. 
         [0008]    Anterior pelvic fractures or hemodynamically unstable patients are candidates for external fixation. See, for example, U.S. Pat. Nos. 4,292,964; 4,361,144; 5,350,378 and 6,162,222. External fixation consists of stabilizing the pelvic ring with a rigid framework residing outside the patient&#39;s body that is connected to the patient&#39;s pelvis via multiple pins that penetrate through the patient&#39;s soft and hard tissues. Several frame types are currently utilized. Two of the more widely deployed devices for external pelvic stabilization are the Hoffmann 2 Inverted “A” Frame and the Ganz Pelvic C Clamp. 
         [0009]    The application of external reduction and fixation for pelvic fractures is advantageous compared to internal reduction and fixation due to its speed of deployment and lower level of technical training required for utilization. The primary disadvantages of external fixation of pelvic fractures include high risk of pin tract infections, general patient discomfort with external frame, physically blocks subsequent surgery on the abdomen and difficult to fit obese patients. The disclosed system maintains many of the advantages of external fixation while eliminating the previously associated disadvantages. 
         [0010]    It is the goal of the disclosed invention to provide a surgical hardware system that will allow for submuscular or supramuscular/subcutaneous internal fixation of anterior pelvic instability through a minimally invasive surgical approach. 
       BRIEF SUMMARY OF THE INVENTION 
       [0011]    It is herein disclosed a method for stabilization of anterior pelvic fractures consisting of an orthopedic hardware system that may be positioned between the skin and the muscle of the patient&#39;s lower torso or alternatively along the pelvic bone surface and a series of attachment devices that rigidly fix said hardware system to the bony structures of the patient&#39;s pelvis. 
         [0012]    In its preferred embodiment, the hardware system consists of two elongated members that when joined together form a framework that encompasses the anterior elements of the pelvis. 
         [0013]    The design and curvature of the two elongated members is such so as to facilitate their insertion and advancement between the skin and the muscle of the patient&#39;s lower torso or along the bony surface of the pelvis. The elongated members may also contain contours so as to ensure clearance of critical anatomical features located within the inguinal canal such as the femoral nerve, artery and vein. The location of elongated member&#39;s insertion is either over each of the patient&#39;s anterior inferior iliac spine prominences or iliac crest. The surgeon then slides the elongated member around the anterior portion of the pelvis. The depth of the elongated member during advancement is subcutaneous and supramuscular or submuscular. Elongated member advancement is complete when the distal end of the device is positioned above the patient&#39;s pubis. Elongated members are inserted from both right and left sides. The elongated members may be in the general shape of rods or plates. In one embodiment, the right and left elongated members are linked over the patient&#39;s pubis by way of interlocking ends and multiple screw or pin placement. An alternative embodiment links the two elongated members together at the pubis through application of a clamp device that accepts both device ends. Another alternative embodiment links the elongated member ends via a progressive interlocking produced by spring-loaded tabs along the male component engaging cut-out slots along the female component. A further embodiment links the two device halves through a cable driven screw advancement. A final embodiment links the two device halves through attachment of a cable linking the two medial ends of the anchored plates and external tensioning of the cable. Device stabilization to the pelvis is obtained through insertion of multiple screws or pins through the lateral device ends and into the bone of the anterior inferior iliac spine or iliac crest. Additional fixation of the device to the pelvis may be obtained through insertion of multiple screws or pins through the plate connecting means and into the underlying bone of the pubis region. Manipulation of the pelvic halves to obtain fracture reduction and plate joining may be accomplished through external loading applied via Schanz pins placed in the lateral portion of each plate half. 
     
    
     
       BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS 
         [0014]      FIG. 1 . Female Plate Component of the Less Invasive, Multi-Holed, Variable Positioned Locked Pelvic Stabilization System. Shown is a drawing of the female plate components of the Less Invasive Pelvic Stabilization System. 
           [0015]      FIG. 2 . Male Plate Component of the Less Invasive, Multi-Holed, Variable Positioned Locked Pelvic Stabilization System. Shown is a drawing of the male plate components of the Less Invasive Pelvic Stabilization System. 
           [0016]      FIG. 3 . Male and Female Component of the Less Invasive, Multi-Holed, Variable Positioned Locked Pelvic Stabilization System. Shown is a drawing of the male and female components of the Less Invasive Pelvic Stabilization System joined together in a configuration as would be utilized clinically. 
           [0017]      FIG. 4 . Close-up of the interlocking components of the Less Invasive, Multi-Holed, Variable Positioned Locked Pelvic Stabilization System. Shown is a drawing of the male and female plate components prior to joining. 
           [0018]      FIG. 5 . Close-up of the interlocking components of the Less Invasive, Multi-Holed, Variable Positioned Locked Pelvic Stabilization System in a fully interlocked configuration. 
           [0019]      FIG. 6 . Close-up of the interlocking components of the Less Invasive, Multi-Holed, Variable Positioned Locked Pelvic Stabilization System in a slightly less than fully interlocked configuration. 
           [0020]      FIG. 7 . Close-up of the interlocking components of the Less Invasive, Multi-Holed, Variable Positioned Locked Pelvic Stabilization System in an interlocked configuration that is one-half of fully interlocked. 
           [0021]      FIG. 8 . Close-up of the interlocking components of the Less Invasive, Multi-Holed, Variable Positioned Locked Pelvic Stabilization System in a minimally interlocked configuration. 
           [0022]      FIG. 9 . Shown is the female component of the Spring Ratcheting Less Invasive Pelvic Stabilization System. 
           [0023]      FIG. 10 . Shown is the male component of the Spring Ratcheting Less Invasive Pelvic Stabilization System. 
           [0024]      FIG. 11 . Shown is the release clamp used to disengage the male and female plate components of the Spring Ratcheting Less Invasive Pelvic Stabilization System. 
           [0025]      FIG. 12 . Shown is the Cable Driven Invasive Pelvic Stabilization System. 
           [0026]      FIG. 13 . Shown is the female component of the Thread and Screw Driven Less Invasive Pelvic Stabilization system. 
           [0027]      FIG. 14 . Shown is the male component of the Thread and Screw Driven Less Invasive Pelvic Stabilization system. 
           [0028]      FIG. 15 . Shown is a clinically usable positioning of a Clamp Adjusted Less Invasive Pelvic Stabilization system on a human pelvis. 
           [0029]      FIG. 16   a . Shown is a clinically usable positioning of a Clamp/Plate Less Invasive Pelvic Stabilization system on a human pelvis. 
           [0030]      FIG. 16   b . Shown is an expanded view of the medial segment for an alternative configuration of the Clamp/Plate Less Invasive Pelvic Stabilization system. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0031]    Figure one illustrates the female plate components of the Less Invasive, Multi-Holed, Variable Positioned Locked Pelvic Stabilization System. The device is a smoothly arcing, circular rod made from typical metallic materials common to orthopedic devices such as stainless steel and titanium alloys. The medial end of the device expands ( 103 ) to a radius greater than that of the remaining rod section to allow interconnection with the male component of the plate system. At the medial end of the female plate, a circular opening ( 101 ) leading to a hollow section with the rod allows the male plate to interconnect with the female plate. Multiple screw holes run through the hollow, interlocking region of the female plate ( 102 ). The screw holes ( 102 ) may be of a standard configuration, a locking configuration or a variable angled, locking configuration. The overall length of the rod will be variable so as to better match the anatomical dimensions of a given patient ( 104 ). The distal end of the rod has multiple screw holes to allow for mechanical connection to the bony structures of the pelvic rim. Multiple screw holes are positioned at the distal rod end ( 105 ) that may be of a standard configuration, a locking configuration or a variable angled, locking configuration. A circular recess ( 106 ) is positioned at the distal rod end to allow for engagement of a Schanz pin connector for application of mechanical leverage during manipulation of the pelvic fracture. 
         [0032]    Figure two illustrates the male plate components of the Less Invasive, Multi-Holed, Variable Positioned Locked Pelvic Stabilization System. The medial end of the rod contains multiple holes ( 201 ) to allow screws to pass through the rod thus anchoring it to the female plate and to the underlying bony structures. As with the female rod, the rod length is variable to match a wide range of patient sizes ( 202 ). Identical to the female rod, screw holes ( 203 ) and Schanz pin connectors ( 204 ) are located at the distal rod end. 
         [0033]    Figure three illustrates the fully joined positions of the male and female rods. When the two components are linked they form a stable arch that spans the ventral aspect of the patient&#39;s pelvis. Linkage of this stable construct to the fractured pelvis controls both halves of the pelvis and therefore stabilizes the fracture. 
         [0034]    Figure four illustrates a close-up view of the medial ends of both the female ( 401 ) and male ( 402 ) rod components as they would approach each other prior to interlocking. Both the male and female rods have a series of matching screw holes along their distal end. ( 403  and  404 ) 
         [0035]    Figure five illustrates an expanded view of the female ( 501 ) and male ( 502 ) rod components fully interlocked. Two bone screws ( 503 ) are shown traveling through aligned screw holes in both the male and female rod components. The bone screws path through the linked hardware and into the underlying pelvic bone. 
         [0036]    Figure six illustrates an expanded view of the female ( 601 ) and ( 602 ) male rod components slightly retracted from a fully interlocked position. Bone screws ( 603 ) are inserted through the pair of interconnected rods in the same positions as the fully interconnected rod configuration. Alternative screw positions are available as warranted by the position of dense bone for reception of the protruding bone screw. 
         [0037]    Figure seven illustrates an expanded view of the female ( 701 ) and male ( 702 ) rod components in a position that is approximately one-half interlocked. Two full length screws ( 703 ) are utilized to attach the pelvic LISS hardware to the underlying pelvic bone while a third non-penetrating, inter-rod screw ( 704 ) is placed centrally to aid in the mechanical interlocking of the male and female rods. 
         [0038]    Figure eight illustrates an expanded view of the female ( 801 ) and male ( 802 ) rod components in a configuration of minimal interlocking. The female and male rod components are mechanically joined via two bone screws ( 803 ) and one inter-rod screw ( 804 ). 
         [0039]    Figure nine illustrates the female component of the Spring Ratcheting Less Invasive Pelvic Stabilization System. Unique features of the female component of the Spring Ratcheting Less Invasive Pelvic Stabilization System include a series of slots through the sidewall of the rod that are positioned at the male entry end of the component ( 901 ). The function of these slots ( 901 ) is to allow mechanical retention of tabbed leaf springs embedded along the received male component. Also present at the receiving end of the rod are two dorsal and pectoral flanges ( 902 ) containing locking screw holes ( 903 ). Locking screws are inserted through these holes to help mechanically secure the pelvic LISS to the patient&#39;s pubis symphysis bone. As with the alternative embodiments of the pelvic LISS, the distal, non-receiving end of the female component consists of multiple locking screw holes ( 904 ) and a Schanz pin engagement port ( 905 ). 
         [0040]    Figure ten illustrates the male component of the Spring Ratcheting Less Invasive Pelvic Stabilization System. Unique features of the male component of the Spring Ratcheting Less Invasive Pelvic Stabilization System include a series of tabbed leaf springs ( 1001 ) embedded along the surface of the lateral portion of the component. Upon insertion into the female component, the tabbed leaf springs are compressed. With further insertion, the tabbed leaf springs engage with the slots along the female component. Successive insertion is possible to facilitate further fracture reduction while disengagement will be mechanically impeded due to the interlocking of the leaf spring/slot combination. As with the alternative embodiments of the pelvic LISS, the distal end of the male component consists of multiple locking screw holes ( 1004 ) and a Schanz pin engagement port ( 1005 ). 
         [0041]    Figure eleven illustrates the novel tools for disengaging the male and female components of the Ratcheting Less Invasive Pelvic Stabilization System. Disengagement would be clinically needed during hardware removal after bone healing has generated sufficient mechanical stability. The custom clamp device ( 1101 ) would be surgically inserted to encase the medial/linked ends of the male and female plates. The insets provided along the clamp surface ( 1102 ) are designed to be of a depth sufficient to release the springs of the male plate from the slots of the female plate. Once the springs are freed, the male and female plates are free to disengage and for hardware removal to proceed. 
         [0042]    Figure twelve illustrates the Cable Driven Less Invasive Pelvic Stabilization System. The Pelvic Cable LISS could be utilized clinically as follows.
       1. LISS plates are inserted subcutaneous or submuscular. Plates are anchored via screws at the iliac crest and also possibly at the pubis synthesis. One of the two plates ( 1201 ) has a hollow tunnel with a cable running along its length. The cable has an attachment feature at its end ( 1202 ) to securely capture the end of the opposing plate ( 1203 ). The attachment feature may be a locking feature such as coarse threading or a rotational interlock.   2. Once plates are secured to each hemi-pelvis in proper anatomic relation, the surgeon manipulates the cable from the end of one plate and secures it to the end of the other plate ( 1204 ). Standard surgical instruments would be used to facilitate this maneuver.   3. Once the plates are linked through the cable, the cable is tensioned at its exit point at the lateral plate end ( 1205 ).   4. The force provided by the cable tension should close any misalignment between the pelvic halves ( 1206 ).   5. Once the fractured pelvis is brought back into anatomic alignment, plates can be linked or additional screws placed. Whether the tensioned cable is removed once the anatomy is believed stable or the cable is left inside the construct under some degree of tension is optional.       
 
         [0048]    Figure Thirteen illustrates the female component of the Thread and Screw Driven Pelvic LISS. The female rod component exhibits locking screw holes ( 1301 ) as well as Shanz pins connectors ( 1302 ) along its proximal end. The medial end of the female rod component exhibits a threaded inner surface ( 1303 ) for joining with the screw component of the male device and lateral flanges ( 1304 ) with a series of locking screw holes ( 1305 ). 
         [0049]    Figure Fourteen illustrates the male component of the Thread and Screw Driven Pelvic LISS. The male rod component contains a flexible cable ( 1401 ) that runs along the interior length of the rod. The medial end of the cable is attached to a rotating screw ( 1402 ) that is size and shape matched to engage with the female threaded medial portion ( 1303 ) of the associated female rod component. The proximal end of the cable ( 1403 ) is fitted with a mechanical means for coupling with an external, rotating drive mechanism such as threading or a mechanical interlocking configuration. The proximal end of the male rod may be capped with a threaded end cap ( 1404 ) to limit access to bodily fluids once proper clinical fixation is obtained. Proximal attachment of the device to the patient&#39;s pelvic bone may be accomplished via insertion of bone screw through locking screw holes ( 1405 ) positioned along a lateral flange. Interoperative torque may be applied to the construct as an aid in obtaining proper alignment through a Shanz pin port ( 1406 ) located toward the proximal end of the male rod component. 
         [0050]    Figure Fifteen illustrates a Clamp Adjusted Pelvic Stabilization System as it would be positioned on the pelvis. On both the right and left sides of the pelvis, rods arc around the pelvis from the iliac crest to the pubis synthesis ( 1501 ). Proximal rod ends are secured to the pelvic bone via bone screws inserted through multiple, threaded screw holes ( 1502 ). Medial rod ends are secured to the pelvic bone and to each other via a rod capturing clamp ( 1503 ) and screw fixed brackets ( 1504 ). 
         [0051]    Figure Sixteen (a) illustrates a Clamp/Plate Pelvic Stabilization System as it could be positioned on the pelvis. On both the right and left sides of the pelvis, rods arc around the pelvis from the iliac crest to the pubis synthesis ( 1601 ). Proximal rod ends are secured to the pelvic bone via bone screws inserted through multiple, threaded screw holes ( 1602 ). Across the pubis synthesis, a rigid baseplate ( 1603 ) is positioned and secured through placement of multiple bone screws ( 1604 ). Dual channels along the outer surface of the plate accept the medial ends of the right and left rods. A clamping plate ( 1605 ) compresses the rods into the baseplate via insertion of multiple locking screws ( 1606 ). 
         [0052]    Figure Sixteen (b) illustrates an expanded view of the medial segment of an alternative format for the Clamp/Plate Pelvic Stabilization System. A plate ( 1607 ) is surgically positioned over the pelvic pubis and rigidly anchored through insertion of multiple locking bone screws ( 1604 ). The medial ends of the right and left hemipelvic rods ( 1601 ) are rigidly bound together via compressive forces applied through placement of a capping plate ( 1608 ) and insertion and tightening of screws ( 1609 ) that travel through the capping plate and engage with threaded screw holes within the larger plate ( 1607 ) positioned beneath.