Abstract:
The instant invention is a novel method and construct for temporary or definitive minimally invasive treatment of broken long bones such as a femur or humerus. The method includes the steps of tunneling an elongated rod subcutaneously in the subcutaneous fat layer parallel to the fractured long bone; and attaching the ends of the elongated rod to the fractured long bone. The elongated rod remains disposed in the subcutaneous fat layer and away from, but parallel to the long bone once attached to the long bone.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of and claims the priority of U.S. application Ser. No. 13/846,330 filed Mar. 18, 2013, which is a continuation of U.S. application Ser. No. 12/592,476 filed Nov. 27, 2009, now U.S. Pat. No. 8,398,686. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to methods of temporary and/or permanent fixation of long bone fracture. More specifically the invention relates to minimally invasive subcutaneous treatment of fractures of the femur and humerus. Most specifically the instant invention offers a treatment method and device that is useful for minimally invasive internal fixation of the fractured long bone with no external components and therefore reduced chance for infection. This method and device are highly suitable for battlefield injuries, use in children, and use in third world countries where more extensive treatment may not be available. 
       BACKGROUND OF THE INVENTION 
       [0003]    There are presently two basic techniques for safe transportation of a wounded soldier with a long bone fracture: 1) transportation casts and 2) temporary external fixation. Both of these methods are presently accepted for initial treatment of a patient who will be evacuated out of theater. Precise indications for external fixator use versus casting have not been established. 
         [0004]    In general, good indications for external fixator use include when the soft tissues need to be evaluated while en route, such as with a vascular injury; when other injuries make use of casting impractical, such as with a femur fracture and abdominal injury; or when the patients have extensive burns. Advantages of external fixation are that it allows for soft tissue access, can be used for polytrauma patients, and has a minimal physiologic impact on the patient. Disadvantages are the potential for pin site sepsis or colonization and less soft tissue support than casts. 
         [0005]    Advantages of transportation casts are that they preserve the maximum number of options for the receiving surgeon; the soft tissues are well supported, and the casts are relatively low tech. Disadvantages are that casts cover soft tissues, may not be suitable for polytrauma patients, and are more labor-intensive than external fixators. 
         [0006]    Though standard in civilian trauma centers, intramedullary nailing of major long bone fractures is contraindicated in combat zone hospitals because of a variety of logistical and physiologic constraints. This method may be used once a patient reaches an echelon above corps (EAC) or other site where more definitive care can be provided. 
         [0007]    Therefore, although both transportation casts and external fixators are equally acceptable methods for the initial management of long bone fractures, each has its disadvantages. Additionally, current methods of internal fixation are contraindicated, especially considering the extensive length and depth of incision required to place the fixation plate adjacent to the fractured bone. Thus, there is a need in the art for a method and apparatus for the safe transportation of a wounded soldier with a long bone fracture which allows for access to the soft tissues as needed, and yet reduces the chances of infection, sepsis or colonization. 
       SUMMARY OF THE INVENTION 
       [0008]    The present invention comprises a surgical method and device for minimally invasive treatment of long bone fractures. The method comprises the steps of: tunneling an elongated rod subcutaneously in the subcutaneous fat layer parallel to the fractured long bone; and attaching the ends of the elongated rod to the fractured long bone using attachment means. The elongated rod and the attachment means remain disposed in the subcutaneous fat layer and away from, but parallel to the long bone once attached to the long bone. 
         [0009]    The tunneling step may include creating one or more incisions in the skin through which the elongated rod can be inserted. The long bone may be a femur and the one or more incisions in the skin may be created on the lateral anterior part of the thigh. The step of attaching the ends of the elongated rod to the fractured long bone may include connecting the attachment means to attachment clamps, the clamps being attached to the elongated rod, and inserting the attachment means into the bone. The attachment clamps may include means to clamp the attachment means and the elongated rod to one another in a generally perpendicular relationship. 
         [0010]    The attachment clamps may include a body having two passageways therethrough, the passageways being generally perpendicular to one another, the passageways allowing for passage of the attachment means and the elongated rod therethrough. The attachment clamps may further include two set screw passageways therein to accommodate two set screws which lock the elongated rod and the attachment means firmly into the attachment clamp. 
         [0011]    The step of attaching the ends of the elongated rod to the fractured long bone may further include the step of inserting a threaded rod into a first end of the long bone the threaded rod being used to hold the first end steady before the step of inserting attachment screws thereinto and to the attachment clamps. The step of attaching the ends of the elongated rod to the fractured long bone may further include the steps of 1) inserting an end of the elongated rod through a first passageway in one or more of the attachment clamps; 2) inserting the attachment means through a second passageways in the attachment claps, and into the proximal end of the long bone; 3) fixing the elongated rod and the attachment means into the attachment clamps using set screws. 
         [0012]    The step of attaching the ends of the elongated rod to the fractured long bone may further include the step of distracting and aligning the fractured long bone. The step of distracting and aligning the fractured long bone may include inserting a threaded rod into the distal end of the long bone and manually distracting and aligning the fractured long bone. The step of distracting and aligning the fractured long bone may include inserting an attachment means and attachment clamp to the distal end of the elongated rod and into the distal end of the long bone and using the attachment means and attachment clamp to manually distract and align the fractured long bone. 
         [0013]    The step of attaching the ends of the elongated rod to the fractured long bone may further include the step removing the portion of the attachment means which extends away from the long bone beyond the attachment clamp to prevent the attachment means from extending beyond the subcutaneous fat layer. 
         [0014]    The surgical device for minimally invasive fixation of long bone fractures may including: an elongated rod, the rod being of sufficient length to extend substantially between the proximal and distal ends of the fractured long bone and being designed to be placed within the subcutaneous fat layer; a plurality of attachment means designed to attach the elongate rod to the proximal and distal ends of the fractured long bone; and a plurality of attachment clamps, each designed to connect the attachment means to the elongated rod in a generally perpendicular fashion. 
         [0015]    The attachment clamps may include a body having two passageways therethrough, the passageways being generally perpendicular to one another, the passageways allowing for passage of the attachment means and the elongated rod therethrough. The attachment clamps may further include two set screw passageways therein to accommodate two set screws which lock the elongated rod and the attachment means firmly into the attachment clamp. The attachment means may be a screw, threaded pin or threaded rod. The attachment means may be a Schanz pin. The attachment means may have a shaft portion and the shaft portion may be threaded only on the portion thereof that is inserted into the long bone. The attachment means might not extend outward from the long bone beyond the attachment clamp. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  is a depiction of a thigh having a broken femur; 
           [0017]      FIG. 2  depicts a prior art external fixation technique showing how the mechanisms of the external fixator are attached by pins to the broken portions of the femur; 
           [0018]      FIG. 3  is a schematic depiction of the manner in which the elongated rod may be placed subcutaneously in the thigh; 
           [0019]      FIG. 4  is a schematic depiction of an alternative view of the manner in which the elongated rod is tunneled subcutaneously inside the thigh parallel to the broken femur between two incisions; 
           [0020]      FIG. 5 , depicts how a threaded rod  9  may be placed into one end of the bone after the rod has been placed into the thigh; 
           [0021]      FIG. 6  shows attachment means which may be used in the inventive method and with the inventive device; 
           [0022]      FIG. 7  depicts the manner in which attachment means  10 , attachment clamps  7  and rod  6  are attached through the incision into the bone  2 ; 
           [0023]      FIG. 8  depicts the results of insertion of three attachment means  10  into one part of the fractured bone  2  and an additional attachment means  10  into the other part of the bone  3 , the additional attachment means being useful to align and distract the bone; 
           [0024]      FIG. 9  shows the rod  6  attached to both ends of the bone via attachment means  10 , and clamps  6   
           [0025]      FIG. 10  depicts how the excess ends of the attachment means  10  may be removed to allow the entire fixation construct to be placed subcutaneously; and 
           [0026]      FIG. 11  is a depiction of a cross-section of a thigh  1  having the elongated rod  6  of the present invention disposed in the subcutaneous fat layer  22 , the rod  6  being held to bone  2 , 3  using attachment means  10 , which is attached to the elongated rod  6  using attachment clamp  7 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0027]    The instant invention is a novel method and construct for temporary or definitive minimally invasive treatment of broken long bones such as a femur or humerus.  FIG. 1  is a depiction of a thigh  1 , having a femur which is broken into two pieces  2  and  3 . One aspect of the present invention is an internal fixator for the femur or humerus which sits subcutaneously. The fixator is a rod and clamp system which is inserted under the skin above the fascia in the subcutaneous space. Its advantage is for transport of military wounded from the field to the definitive care facility. As noted above, currently patients/soldiers are transferred with an external fixator which has pins screwed into the bone connected to bars outside of the skin.  FIG. 2  depicts this prior art fixation technique showing how the mechanisms  4  of the external fixator are attached by pins to the broken portions of the femur  2 ,  3  via holes in the skin  5 . The external fixators are cumbersome and can lead to infection. The external fixators need to be replaced by rods or plates at the definitive care facility. If an external fixator is used on a patient for longer than 7 to 10 days there is a risk for pin site infection if it is later decided to nail the femur or humerus. Also because the pins extend from the bone to outside the skin there is always a risk for pin site infection. 
         [0028]    With the inventive device and method, definitive surgery can be performed without the risk of infection as the device is under the skin. The device is easy to apply and, because the hardware is totally subcutaneous, it is not unwieldy for the patient or for the transporting team. Medical personnel can safely wait until the soldier is safe for further surgery without the risk of infection. 
         [0029]    While the inventive device and method can be used for battlefield trauma of long bones, the treatment can also be used for children between 3 to 12 years of age. The inventive internal fixator can be definitive treatment but should be removed after 8 weeks to 3 months. In this context, the present invention would replace the use of flexible ender nails. The inventive device is much stiffer than flexible ender nails and would not need any other immobilization. 
         [0030]    Further, in civilian treatment the present method and device may be used to temporize polytrauma patients as a damage control measure and may later be replaced by conventional internal fixation. The present method and device may be used as definitive care in certain situations when further surgery is not possible. The present method and device would be exceptionally useful in peripheral centers when used to transfer patients after early treatment to a definitive care facility. 
         [0031]    Also the inventor notes that the present method and device could be used as definitive fixation in third-world areas where a C-arm is not available as it is easy to apply. Of course, it would still need to be removed after 3 months in adults. 
         [0032]    Turning now to a detailed description of the present method and device,  FIG. 3  is a schematic depiction of the manner in which the elongated rod  6  may be placed subcutaneously in the thigh  1 . The rod  6  may be placed into the subcutaneous fat layer through two incisions  8  in the skin. One incision is near the proximal end of the bone and one is near the distal end of the bone. The incisions  8  may be approximately 2 inches or less on each end and may preferably be placed in the lateral anterior area of the thigh  1  when the bone being fixated  2 , 3  is a femur. Of course, the rod  6  may come in many different sizes to accommodate different bone sizes. This placement of the elongated rod  6  just under the skin prevents disruption of the muscle tissue and since there is no dissection, there is little chance for infection.  FIG. 4  is a schematic depiction of an alternative view of the manner in which the elongated rod  6  is tunneled subcutaneously inside the thigh  1  parallel to the broken femur  2 , 3  between the two incisions  8 . 
         [0033]    As shown in  FIG. 7 , once the rod  6  has been placed into the thigh, a threaded rod  9  may be placed into one end of the bone  2 . Preferably the rod  9  is placed into the proximal end of the bone. This threaded rod may be used to hold the bone in place as the rod  6  is attached to the bone. 
         [0034]      FIG. 6  shows attachment means which may be used in the inventive method and device. Threaded rods  9  may be used to hold the broken bone sections steady as screws  10  are used to attach the device to the bone. Attachment screw  10  may have a threaded shaft  12 , preferably threaded only on the end thereof that will be inserted into the bone. Attachment screws  10  may be cortical screws, such as uni-cortical or bi-cortical screws, Schanz pins, or other threaded rod type devices. The attachment means  10  are attached to the elongated rod by attachment clamps  7 . The clamps  7  allow the attachment means  10  and the elongated rod  6  to be attached to each other in a generally perpendicular fashion. An example of such an attachment clamp  7  is depicted in  FIG. 6 . The attachment clamp has two perpendicular passageways ( 11   a  and  11   b ) therein through which elongated rod  6  and attachment means  10  separately pass. The attachment clamp  7  also has two set screw passageways ( 11   a ′ and  11   b ′) to accommodate set screws which lock the elongated rod  6  and attachment means  10  firmly into the attachment clamp. 
         [0035]    Next, as shown in  FIG. 7 , attachment means  10  are inserted through the attachment clamp  7 , which is attached to the elongated rod  6  and into the bone  2 . Preferably each end of the elongate rod is attached to the bone by three or more sets of attachments  10  and attachment clamps  7 .  FIG. 7  depicts the results of placement of three attachment screws  10  and three attachment clamps  7 . 
         [0036]      FIG. 8  depicts the manner in which the attachment means  10  may be inserted into the other end of the bone  3  and attached to elongated rod  6  via attachment clamp  7 . The attachment means  10  and clamp  7  may be used to align and distract the bone  3 , or at a minimum, hold it in place as additional attachment means  10  are inserted into the bone  3 . 
         [0037]      FIG. 9  depicts three sets of attachment means  10  and attachment clamps  7  attached to the other (proximal) end of the bone  3 , which align and fixate the bone to allow for healing/regrowth thereof. 
         [0038]      FIG. 10  shows how the excess ends of the attachment means  10  may be removed to allow the entire fixation construct to be placed subcutaneously. 
         [0039]    Finally,  FIG. 11  is a depiction of a cross-section of a thigh  1  having the elongated rod  6  of the present invention disposed in the subcutaneous fat layer  22 . The rod  6  is held to bone  2 , 3  using attachment means  10 , which is attached to the elongated rod  6  using attachment clamp  7 . 
         [0040]    It is to be expected that considerable variations may be made in the embodiments disclosed herein without departing from the spirit and scope of this invention. Accordingly, the significant improvements offered by this invention are to be limited only by the scope of the following claims.