Patent Publication Number: US-10327861-B2

Title: Surgical implant alignment device

Description:
RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application No. 62/245,015, filed Oct. 22, 2015, and entitled “Surgical Implant Alignment Guide,” which application is incorporated by reference in its entirety herein, and for all purposes 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to methods and devices for positioning and aligning orthopedic implants with bone attachment sites during surgery. 
     BACKGROUND 
     Surgeons have techniques and implants to perform stable internal fixation of the human body. Current technology has the ability to stabilize fractures or to securely attach implants to bones in the case of elective or emergent medical conditions. However, when surgery is performed, there is limited visualization of a bone in a surgical field (i.e., most of the bone is still covered by skin and other soft tissues). This is partially intentional (in the case of minimally invasive surgery) and partially due to the nature of surgical technique. Surgeons intentionally try to minimize surgical exposure to avoid iatrogenic injury to soft tissues, to avoid devascularization, and to minimize post-operative recovery for patients. Due to these reasons, the limited amount of exposed bone makes it difficult to judge the alignment of an implant on the full length of the bone. Consequently, it is difficult for a surgeon to apply an implant perfectly collinear to the bone. This becomes evident only after surgery, when x-rays are taken and it is shown that the implant is not aligned collinear with the bone. The difficulty to align a plate to a bone is equally applicable to bones of the upper extremities, lower extremities, and spine. It is also applicable to surgical technique in human beings, dogs, cats, horses, goats, sheep, cattle, pigs, and the like. 
     Consequently, a need exists for an alignment apparatus or device that facilitates the accurate alignment of an orthopedic implant to a bone attachment site that is at least partially out-of-view of the surgeon. It is toward such an alignment device that the present disclosure is directed. 
     SUMMARY 
     Briefly described, one embodiment of the present disclosure comprises an surgical implant alignment device that is securable to an orthopedic plate holder for aligning an orthopedic plate with a bone attachment site. The orthopedic plate holder generally includes a distal end that is releasably attachable to an orthopedic plate in a fixed angular position to define a plane of interest and a predetermined axis of interest of the orthopedic plate within the plane of interest, and a proximal end that is adapted for holding by a medical professional. 
     The alignment device generally includes one or more light sources that are configured to project an illuminated indication pattern onto the plane of interest of the orthopedic plate, and that is also aligned with the predetermined axis of interest of the orthopedic plate. The alignment device also includes a mounting interface that is configured to secure the light source to the orthopedic plate holder in a location spaced from the distal end, in a fixed angular position relative to the plate holder, and to maintain the angular relationship between the light source and the orthopedic plate as the distal end of the orthopedic plate holder is inserted into a patient by a medical professional and moved toward a bone attachment site that is at least partially out-of-view. In addition, the illuminated indication pattern extends a sufficient lateral distance away from the orthopedic plate holder and has a substantially constant brightness along the length thereof that allows the medical professional to align the axis of interest of the orthopedic plate with the out-of-view bone attachment site using one or more superficial anatomic landmarks on the exterior of the patient and that are remote from the bone attachment site. 
     Another embodiment of the present disclosure comprises an implant placement and alignment system for positioning and aligning an orthopedic implant to a bone attachment site. The system includes an implantation tool having a distal end that is releasably attachable to an orthopedic implant in a fixed angular position to define a plane of interest of the orthopedic implant and a predetermined axis of interest of the orthopedic implant within the plane of interest, and a proximal end that is adapted for holding by a medical professional. The system also includes an alignment device that is securable to the implantation tool for aligning the predetermined axis of interest of the orthopedic implant with the bone attachment site prior to fixation. 
     The alignment device further includes one or more light sources that are configured to project an illuminated indication pattern onto the plane of interest of the orthopedic implant and aligned with the predetermined axis of interest of the orthopedic implant, and a mounting interface that is configured to secure the light sources to the implantation tool in a location spaced from the distal end, in a fixed angular position relative to the implantation tool, and to maintain the angular relationship between the light sources and the orthopedic plate as the distal end of the implantation tool is inserted into a patient by a medical professional and moved toward a bone attachment site that is at least partially out-of-view. Moreover, the illuminated indication pattern extends a sufficient lateral distance away from the implantation tool to allow the medical professional to align the axis of interest of the orthopedic plate with the out-of-view bone attachment site using a plurality of superficial anatomic landmarks on the exterior of the patient and remote from the bone attachment site. 
     Yet another embodiment of the present disclosure comprises a method for mounting an orthopedic plate to a bone attachment site using a plate holder having a proximal end that is adapted for holding by a medical professional, a distal end, an orthopedic plate secured to the distal end in a fixed angular position to define a plane of interest of the orthopedic plate and a predetermined axis of interest of the orthopedic plate within the plane of interest, and an alignment device having a light source secured to the plate holder in a location spaced from the distal end. The method generally includes using the light source of the alignment device to project an illuminated indication pattern onto the plane of interest of the orthopedic plate and that is aligned with the predetermined axis of interest of the orthopedic plate, and then moving the plate holder to insert the orthopedic plate into a patient and adjacent to a bone attachment site that is out-of-view of the medical professional. The method also includes rotating the plate holder to align the illuminated indication pattern with one or more superficial anatomic landmarks that are visible or palpable to the medical professional on the outer surface of the patient and remote from the bone attachment site, and thereby positioning the orthopedic plate in a desired collinear orientation relative to the out-of-view bone attachment site. The method further includes attaching the orthopedic plate to the bone attachment site, generally through fixation with bone screws, and then releasing the plate holder from the orthopedic plate and removing the plate holder from the patient. 
     The invention will be better understood upon review of the detailed description set forth below taken in conjunction with the accompanying drawing figures, which are briefly described as follows. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of an implant alignment device secured to an orthopedic plate holder, in accordance with a representative embodiment of the present disclosure. 
         FIG. 2  is a close-up view of the implant alignment device of  FIG. 1 . 
         FIG. 3  is another a perspective view of the implant alignment device of  FIG. 1  projecting an illuminated indication pattern onto the plane of interest of an orthopedic plate attached to the distal end of the plate holder. 
         FIG. 4  is a schematic diagram illustrating the application of the implant alignment device of  FIG. 1  in aligning an orthopedic plate to the anterior humerus of a patient, in accordance with another representative embodiment of the present disclosure. 
         FIG. 5  is a perspective view of another implant alignment device projecting an illuminated indication pattern onto the plane of interest of an orthopedic plate attached to the distal end of a plate holder, in accordance with another representative embodiment of the present disclosure. 
         FIG. 6  is a schematic diagram illustrating the application of the implant alignment device of  FIG. 5  in aligning an orthopedic plate to the cervical spine of a patient, in accordance with another representative embodiment of the present disclosure. 
         FIG. 7  is a schematic diagram illustrating the application of the implant alignment device of  FIG. 5  in aligning an orthopedic plate to the lateral femur of a patient, in accordance with another representative embodiment of the present disclosure. 
         FIG. 8  is a schematic diagram illustrating the application of the implant alignment device of  FIG. 5  in aligning an orthopedic plate to the distal femur of a patient, in accordance with another representative embodiment of the present disclosure. 
         FIGS. 9A-9B  are lower arm anterior surface feature and anatomic diagrams, respectively, that illustrate a combination of superficial anatomic landmarks that can be used to align an orthopedic implant to the anterior radius of a patient, in accordance with another representative embodiment of the present disclosure. 
         FIGS. 10A-10B  are lower arm posterior surface feature and anatomic diagrams, respectively, that illustrate a combination of superficial anatomic landmarks that can be used to align an orthopedic implant to the posterior ulna of a patient, in accordance with another representative embodiment of the present disclosure. 
         FIG. 11  is an anatomic diagram that illustrate a combination of superficial anatomic landmarks that can be used to align an orthopedic implant to the lateral humerus of a patient, in accordance with another representative embodiment of the present disclosure. 
         FIGS. 12A-12B  are upper leg anterior surface feature and anatomic diagrams, respectively, that illustrate a combination of superficial anatomic landmarks that can be used to align an orthopedic implant to the anterior femur of a patient, in accordance with another representative embodiment of the present disclosure. 
         FIGS. 13A-13B  are lower leg anterior surface feature and anatomic diagrams, respectively, that illustrate a combination of superficial anatomic landmarks that can be used to align an orthopedic implant to the anterior tibia of a patient, in accordance with another representative embodiment of the present disclosure. 
         FIGS. 14A-14B  are lower leg medial anatomic diagrams that illustrate a combination of superficial anatomic landmarks that can be used to align an orthopedic implant to the medial tibia of a patient, in accordance with another representative embodiment of the present disclosure. 
         FIGS. 15A-15B  are lower leg anterior surface feature and anatomic diagrams, respectively, that illustrate a combination of superficial anatomic landmarks that can be used to align an orthopedic implant to the fibula of a patient, in accordance with another representative embodiment of the present disclosure. 
     
    
    
     Those skilled in the art will appreciate and understand that, according to common practice, various features and elements of the drawings described above are not necessarily drawn to scale, and that the dimensions of the various features and elements may be expanded or reduced to more clearly illustrate the embodiments of the present disclosure described therein. 
     DETAILED DESCRIPTION 
     The following description, in conjunction with the accompanying drawings described above, is provided as an enabling teaching of exemplary embodiments of an orthopedic implant alignment device, or alignment device, and one or more methods for using the alignment device to accurately position and align an orthopedic implant with a bone attachment site that can be partially out-of-view of the surgeon. As described below, the alignment device can provide several significant advantages and benefits over other systems and devices for positioning and aligning orthopedic implants with a bone attachment site. However, the recited advantages are not meant to be limiting in any way, as one skilled in the art will appreciate that other advantages may also be realized upon practicing the present disclosure. 
     Furthermore, those skilled in the relevant art will also recognize that changes can be made to the described embodiments while still obtaining the beneficial results. It will further be apparent that some of the advantages and benefits of the described embodiments can be obtained by selecting some of the features of the embodiments without utilizing other features, and that features from one embodiment may be combined with features from other embodiments in any appropriate combination. For example, any individual or collective features of method embodiments may be applied to apparatus, product or system embodiments, and vice versa. Accordingly, those who work in the art will recognize that many modifications and adaptations to the embodiments described are possible and may even be desirable in certain circumstances, and are a part of the disclosure. Thus, the present disclosure is provided as an illustration of the principles of the embodiments and not in limitation thereof, since the scope of the invention is to be defined by the claims. 
     Referring now in more detail to the drawing figures, wherein like parts are identified with like reference numerals throughout the several views,  FIGS. 1-2  illustrate one embodiment of an surgical implant alignment device  10  that can be used to align an orthopedic plate or implant  40  with a bone attachment site (not shown). The implant alignment device  10  generally includes one or more light sources  20  that are spaced a distance from the implant  40 , and that are angularly secured and/or referenced to a predetermined or primary axis  50  of the implant  40 . The spatial and angular positioning of the implant alignment device  10  can be accomplished via an implantation tool  60  to which the implant  40  can be removably secured, as well as a mounting interface  30  that secures the light source(s) to the implantation tool  60  at a location that is remote to the implant  40 . In this way the light source(s)  20  can be activated before or after insertion of the implant  40  into the body of the patient, and are configured to project an illuminated indication pattern onto the outer surface of the patient that enables a medical professional or surgeon to align the implant  40  to the subcutaneous bone attachment site using markers or features that are visible to the surgeon on the outer surface of the patient. 
     The implant alignment device  10  of the present disclosure can allow the surgeon to effectively judge the placement of an implant, such as an orthopedic plate, relative to the full length of the bone or the anatomy in question. Instead of relying on the limited exposure of the surgical field, the surgeon can more reliably use the entire superficial anatomy to judge appropriate placement of the deep implant. In one aspect the surgeon may also choose to palpate specific superficial anatomic landmarks that predictably align with deep structures, and then mark the anatomic landmarks to create one or more visible reference markers on the exterior of the patient and remote from the bone attachment site to use as alignment reference points. Thus, the system of the present disclosure can be used to assist surgeons in placing implants (particularly plates) collinearly on bones using light beams and unique combinations of superficially palpable anatomic landmarks. 
     It will be appreciated that the present disclosure may not aid the surgeon in anatomically aligning the bones if the bones are not already in a grossly desired anatomic position. Generally, surgeons use distraction techniques, temporary fixation, and fluoroscopic visualization, among other methods, to gain anatomic alignment prior to placement of plate fixation. Plates are generally not used as a means to gain gross anatomic alignment. However, screws (with plates) are used to reduce bone fragments to the plate, to compress bone fragments, and to create buttress technique. These methods can be used by the surgeon to gain minor improvements in anatomy. The present disclosure is not intended to add to or detract from those commonly employed methods. 
     As shown in the  FIGS. 1-2 , the implantation tool to which the implant alignment device  10  is attached can be an orthopedic plate holder  60  comprising an hollow elongate rod  68  having a distal end  62  and a proximal end  72 , with the implant or orthopedic plate  40  being releasably attached to the distal end  62  of the plate holder  60  through a coupling interface  64  associated with the plate holder  60 , a coupling interface  44  associated with the plate  40 , or both. For example, in one aspect the coupling interface  64  of the plate holder  60  can be a set of actuatable pinchers that grasp around a strut or structural member that defines the coupling interface  44  of the plate  40 . The actuation of the coupling interface  64  can be accomplished through manipulation of an actuator handle  76  at the proximal end  72  of the elongate rod  60  near the handgrip  74 , and which is connected to the coupling interface via a linkage that is positioned within the hollow rod  68 . The present disclosure is not limited to any particular implant alignment device or type of coupling interface between the plate holder  60  and the orthopedic plate  40 , however, and it will be appreciated that a wide variety of plate holders and coupling interfaces  44 ,  64  associated with the plate  40  and/or the plate holder  60  can be used to releasably coupled the plate  40  to the distal end  62  of the plate holder  60 . 
     Moreover, and regardless of the type of coupling interface, the orthopedic plate or implant  40  can be releasably attached to the distal end  62  of the plate holder  60  in a fixed angular position that defines a predetermined or primary axis of interest  50 , and in some embodiments a plane of interest  52  as well. In one aspect the axis of interest  50  of the plate  40  can generally correspond to the orthopedic plate&#39;s long axis that is intended to align with the long axis of the bone. It is contemplated, however, that in some embodiments the axis of interest  50  may not correspond to the long axis of the orthopedic plate. For orthopedic plates  40  that are generally planar and flat, such as that shown in  FIG. 1 , the plane of interest  52  can correspond to either the top surface  42  of the plate  40  or the bottom surface  48  that contacts the bone of the patient, especially when the plate  40  is attached to the plate holder  60  in an orientation that is perpendicular to the longitudinal centerline axis  61  of the elongate rod  68  of the plate holder, as shown in  FIG. 1 . And in situations where the plate is curved or sculpted to match the contour of the bone at the bone attachment site, a plane of interest  52  can generally be described as the plane defined by a flat surface upon which the plate may be resting prior to attachment to the plate holder  60 , and that can also be perpendicular to the longitudinal centerline axis  61  of the elongate rod  68  after attachment to the plate holder  60 . 
     The orthopedic plate  40  can also include a secondary axis of interest  54  that is transverse to the primary axis of interest  50 . In some embodiments, such as that shown in  FIG. 1 , the secondary axis of interest  54  can be perpendicular to the primary axis of interest  50  and can intersect with the primary axis of interest  50  at the coupling point between the orthopedic plate  40  and the plate holder  60 . However, in other aspects (not shown) the secondary axis of interest  54  can intersect with the primary axis of interest  50  at a non-right angle and at a location that is laterally spaced from the distal end  62  of the plate holder  60 , so as to provide additional flexibility in aligning the orthopedic plate or implant  40  with the bone attachment site. 
     In the embodiment of the surgical implant alignment device  10  shown in  FIGS. 1-2 , the one or more light sources  20  can be a single light emission device, such as a highly-focused LED light or a laser  22 , that is capable of producing, projecting, or emitting one or more light beams  24  that can form a straight line of light or a pattern of light lines within the plane of interest  52  of the orthopedic plate  40  attached to the distal end  62  of the plate holder  60 . In addition, the projected straight line of light or a pattern of light lines can be aligned with the predetermined axis of interest  50  of the implant or orthopedic plate  40 . 
     It will be appreciated that the light source  20  can be any of a variety of light sources, such as a laser, metal halide light, fluorescent light, high-pressure sodium light, incandescent light or LEDs (light emitting diode), or a device to focus visible light, is operably coupled or attached to the plate holder  60  with the mounting inter face  30 . In addition, the housing of the light source  20  could be composed of plastic, metal, or any like material and would be sterilized by a manufacturer prior to use in the operating room. In one aspect the emission of laser or light from the light emitting device can be triggered by the surgeon when he or she is ready to use the laser during surgery. Moreover, the source of energy to power the laser can be a battery (energy storage) or wire (energy delivery) from a power source. 
     The light source  20  can further include one or more light-directing or optical devices  23 , such as lenses, mirrors and the like, at an output end for shaping the beam of light  24  into a flattened and expanding triangular shape that forms a single straight light line  26  upon contact with any physical object in its path ( FIG. 3 ). If desired, a single light source  20  can be configured to project a single light line  26 , as shown in the drawing, or multiple light lines, with the light line or lines projecting from the light source defining an illuminated indication pattern  28 . Moreover, the illuminated indication pattern  28  can be any form of pattern useful for aligning the implant or orthopedic plate  40  with one or more reference markers exterior to the patient and remote from the bone attachment site, including but not limited to a straight line, a cross hair pattern, and a grid pattern. 
     As discussed in more detail below, in one aspect these reference markers can be superficial anatomic structures on a body that may act as landmarks for the alignment of an orthopedic plate with bone structures deeper within the body, as well as visible marks made with a skin marker on the skin directly above the underlying anatomic landmark. In other aspects the reference markers could be any marked location on the body of the patient, with or without an underlying anatomic structure, or any location in the surrounding environment (e.g. a table, a wall, or target device in the operating room), that can serve as a remote marking site for aligning the illuminated indication pattern  28  with the bone attachment site. 
     In addition, while using an ink-based skin marker may be a preferred technique for creating a reference marker on the skin or protective covering, other forms of marking and types of markers are also possible and considered to fall within the scope of the present disclosure. For instance, reflective or fluorescent tapes, adhesive stickers, liquid inks and the like can be used to create reference markers that interact with the beam of light  24  from the light source  20  to create a stronger visible indication when alignment has been achieved. Various types of targets, both non-active and electronic, can be also attached to straps or brackets or otherwise coupled to the patient&#39;s body at the anatomic location to establish the reference markers aligning the illuminated indication pattern  28 . 
     The light source  20  is operably coupled to the orthopedic plate holder  60  with a mounting interface  30 , and at a location sufficiently spaced from the distal end  62  of the plate holder  60  so as to remain external to the patient after the distal end  62  and attached orthopedic plate  40  have been inserted into the patient. In the embodiment of the surgical implant alignment device  10  shown in  FIGS. 1-2 , the mounting interface  30  can comprise a light mounting bracket  32  having a base portion  34 , a light mounting element  36 , and a plate holder mounting element  38 . The light mounting element  36  can provide the structure for holding or attaching the light source  20  to the light mounting bracket  32 , while the plate holder mounting element  38  can provide the structure for operably attaching the light mounting bracket  32  to a plate holder  32 . In addition, a variety of configurations and materials may be used for making different portions of the light mounting bracket  32 . For example, the base  34  may be made of one or more metals such as titanium, aluminum or steel, as well as various forms of plastics, depending upon the specific type of applications for the implant alignment device  10  as well as the specific type of plate holder  60  to which the light mounting bracket  32  will be attached. 
     In one aspect one or both of the light mounting element  36  and the plate holder mounting element  38  can provide for angular or rotational adjustment of the attached element (i.e. light source  20  or plate holder  60 ) relative to the base portion  34  of the light mounting bracket  32 . For example, the light mounting element  36  can provide for rotation of the light source relative  20  to the base portion  34  so as to bring a projected light line into contact with the distal end  62  of the plate holder  60 . In a similar fashion, the plate holder mounting element  38  can provide for angular or rotational adjustment of the entire implant alignment device  10  relative to the longitudinal centerline axis  61  of the elongate rod  68  of the plate holder  60 , so as to bring the projected illuminated indication pattern  28  of line  26  into alignment with the predetermined axis of interest  50  of the orthopedic plate  40  that is releasably attached or coupled to the distal end  62  of the plate holder  60 . 
     Although shown in  FIGS. 1-2  as being separable from both light source  20  and plate holder  60 , the mounting interface  30  can also be formed integral with the plate holder  60  or implantation tool. For instance, the light mounting bracket  32  may be cast together with the elongate rod  68  of the plate holder  60 , so as to form a single integral supporting structure into which the other components, such as an actuator  76  for the plate holder  60  or the light source  20 , can be mounted. 
     With reference to  FIGS. 1 and 3 , the implant alignment device  10  and the implantation tool or orthopedic plate holder  60  can together form an implantation system  14  for inserting, positioning, and aligning an orthopedic plate or implant  40  to a bone attachment site. In the illustrated embodiment the light source  20 , such as LED  22 , can project a thin, triangularly-shape (i.e. expanding) beam of light  24  that forms a straight light line  26  upon contact with a physical object in its path, and which light line  26  can intersect with the distal end  62  of the plate holder  60  in one direction and extend laterally or radially away from the plate holder  60  in the opposite direction to defined an illuminated indication pattern  28  comprised of the single light line  26 . In addition, the implant alignment device  10  and the orthopedic plate holder  60  can be coupled or arranged together so that the illuminated indication pattern  28  aligns with the primary axis of interest  50  of the orthopedic plate  40  prior to insertion of the orthopedic plate into the body. 
     Depending the distance between the implant alignment device  10  and the distal end  62  of the plate holder  60 , as well as the angle of expansion provided of the beam of light  24  by the optical device  23  at the output end of the light source  20 , the light line  26  projected by the light source  20  can be configured to extend a substantial lateral (i.e. radial) distance away from the plate holder  60  to facilitate alignment with reference markers or anatomical features that are some distance away from the bone attachment site for the implant  40 . For instance, the light line  26  can be configured to project laterally (i.e. radially) away from the plate holder  60  at least two, three and even four times the length of the elongate rod  68  of the orthopedic plate holder  60 , which can generally be 10 to 12 inches in length. In other aspects the light line  26  can be configured to project laterally up to 3 feet, or 36 inches, or more away from the plate holder. In addition, the light line  26  can have a substantially constant brightness along its entire length, and its brightness can be sufficient to be readily visible in the highly illuminated operating room setting. 
     The lateral projection distance of the light line  26  away from the bone attachment site can allow the operator, (in most cases the surgeon) to accurately judge the alignment of the implant in the longitudinal plane of the body. If the implant or plate is positioned inaccurately, then the extreme end of the light beam will be positioned far from the expected surface anatomy or reference marker and easily judged by the operator to be off target, since a small angular misalignment of the implant  40  at the bone attachment will be amplified into a large angular displacement from the anatomical or reference marker at the extreme end of the light line  26 . If the extreme end of the light line  26  is on target with the surface anatomy of the bone(s) in question, then the surgeon can confidently judge the implant to also be collinear to the bone that is deep within the soft tissue. 
     For example, in the tibia, the tibial tubercle is commonly considered the center of the proximal end of the anterior tibia while the mid-point of the ankle joint is considered the center of the distal end of the anterior tibia. If one end of a continuous light line is on the tibial tubercle and the other end in on the mid-point of the ankle, then the surgeon can be confident that the plate is collinear to the tibia. Another example; in the cervical spine, after stabilizing rotation of the neck in a neutral position, if one end of the continuous light line is at the center of the patient&#39;s forehead, while the other end is at the center of the sternal notch, then the surgeon can feel confident that they are collinear to the cervical spine. 
     The following examples are provided to illustrate further the various applications and are not intended to limit the invention beyond the limitations set forth in the appended claims. 
     Example 1 
       FIG. 4  illustrates an embodiment of the implant alignment device  10  and implantation system  14  of the present disclosure as may be applied to align an orthopedic plate  40  to the humerus  90  of a patient. As shown in the drawing, a limited exposure of the typical anterior humerus  92  is provided through a typical anterior incision  94  on the upper arm  80 . The surgeon may palpitate and/or mark anatomic structures  96 ,  98  using a skin marker to create superficial anatomic landmarks or reference markers  82  on the exterior of the patient and remote from the bone attachment site. 
     The surgeon or an assisting medical professional can also attach the orthopedic plate  40  to the distal end of the plate holder  60  and activate the light source  20  of the implant alignment device  10  to verify that the illuminated indication pattern  28  is aligned with the primary axis of interest  50  of the orthopedic plate. In situations where the illuminated indication pattern  28  is not aligned with the primary axis of interest  50  and angular or rotational adjustment of the implant alignment device  10  relative to the bone holder  60  is possible, the angular position of the implant alignment device  10  can be adjusted to bring the illuminated indication pattern  28  into alignment with the primary axis of interest  50 . 
     During surgery the distal end of the implantation system  14  can then be used to insert the plate  40  into the incision  94  and adjacent the desired bone attachment site, and the light source  20  can be activated to project an illuminated indication pattern  28  that extends from the distal end of the plate holder to one or both of the reference markers  82  on the exterior of the patient. The surgeon can then align the illuminated indication pattern  28  emitted by the light source  20  of the implant alignment device  10  with these marked superficial anatomic structures  96 ,  98  to aid in maintaining position. In embodiments where the implant alignment device  10  includes a single light source  20  that projects an illuminated indication pattern  28  comprising a single light line  26  aligned with the primary axis of interest  50  of the orthopedic plate  40 , the light line  26  may be aligned with either of the reference markers  82 . 
     In another aspects where the implant alignment device  10  projects a single radially-extending light line  26  from the plate holder, the surgeon could also palpitate and/or mark two superficial anatomic landmarks that are located on the same side of the bone attachment site. In this scenario one of the superficial anatomic landmarks or reference markers can be closer to the bone attachment site while the other is more remote, and which together can be used to accurately align the illuminated indication pattern  28  with the bone attachment site to facilitate collinear alignment of the primary axis of interest  50  of the orthopedic plate  40  with the deep bone structure. 
     As discussed in more detail below, however, in other embodiments the implant alignment device can include multiple light sources that together project an illuminated indication pattern comprising multiple light lines that can be simultaneously aligned with multiple markers  82  for more accurate placement and alignment of the orthopedic plate  40 . For example, the center of the acromion  96  and the tendon of the biceps brachii  98  are superficial structures that are centered at the ends of the humerus  90 . If the surgeon palpates these structures, marks them with a skin marker to create reference markers  82 , and aligns the primary axis of interest  50  of an anterior humeral orthopedic plate  41  to both of these marked points  82  using the implantation system of the present disclosure, the doctor may be confident that the plate  41  is aligned collinearly to the typical anterior humerus  92 . 
     The plate holder  60  can be firmly attached to the plate  41  using the plate manufacturer&#39;s attachment mechanism, and the light source  20  included in implant alignment device  10  can project the illuminated indication pattern  28  onto the skin overlying the hidden humerus  90 . Now the surgeon can confidently attach the plate to the surface of the anterior humerus  92  with consistently good radiographic results. 
     Another embodiment of the implant alignment device  110  and implantation system  114  of the present disclosure is shown in  FIG. 5 , in which the implant alignment device  110  includes multiple light sources  120  that together project an illuminated indication pattern  128  comprising multiple light lines  126 ,  127  that are arranged in the form a crosshair. In this embodiment the mounting interface  130  can comprise a block-shaped body  132  that encircles the elongate rod  168  of the plate holder  160  at a location spaced from the distal end  162 , but below the handgrip  174  and the actuator handle  176  located at the proximal end of the plate holder  160 . The body  132  can serve as an enclosure that supports four light sources  120 , such as lasers or highly-focused LED&#39;s, that are equally spaced into each of the four quadrants surrounding the elongate rod  168 , with each of the light sources  120  projecting a shaped beam of light  124  downward onto the plane  152  of the orthopedic plate  140  to create primary light lines  126  and secondary light lines  127  on the body of the patient, with the primary light lines being aligned with the primary axis of interest  150  of the orthopedic plate  140 , and the secondary light lines  127  being aligned with the secondary axis of interest  154  that is perpendicular to the primary axis of interest  150 . Both the primary light lines  126  and secondary light lines  127  can intersect with the distal end  162  of the plate holder  160 . 
     In one embodiment the body  132  of the mounting interface  130  can also include an adjustment member  134 , such as a blunt-tipped screw mounted within a threaded hole that intersects with the central aperture. The fastening member  134  can be used to secure the mounting interface  130  to the elongate rod  168  when tight while permitting rotation around the rod when loose, thereby allowing the angular position of the implant alignment device  110  to be adjusted to align the illuminated indication pattern  128  with the axes of interest  150 ,  154  of the orthopedic plate  140 . 
     In addition, in one aspect the laser or light for the secondary light lines  127  can be projected a shorter lateral distance from the plate holder  160  than the primary light lines  126 , but still ranging from three inches to two feet or more in length. The length of the secondary light lines  127  could be, however, as long as desired. The secondary light lines  127  can provide the surgeon with a second check on the collinearity to the bone/body in the transverse plane. For example, a skilled surgeon would expect the secondary light lines  127  to be orthogonal to the limb or body edge. If the secondary light lines  127  intersect the edge of the limb or body at an angle that is not orthogonal, then the surgeon should question collinearity to the bone. Of course, each bone has a unique relationship to its respective surface anatomy, but surgeons can become experienced with the variations in surface anatomy from one location to another. They can then make accommodation based on experience as to whether the secondary light lines  127  is expected to be orthogonal to the edge of the limb or body when the primary light lines  126  are aligned with their designated reference markers. 
     Example 2 
       FIG. 6  provides a diagram of an example of the use of the implant alignment device  110  and implantation system  114  of the present disclosure to align a cervical plate to the cervical spine  190 . As shown in the drawing, during an anterior cervical discectomy and fusion (ACDF), the surgeon is visualizing a limited region of the cervical spine  190  through a small incision  194  in the neck  180 . The cervical spine anatomy  192  is significantly deeper in the neck  180  and it is difficult to judge alignment based solely on the limited exposure. In this scenario, after stabilizing the head in an appropriate position to avoid bending and rotation, the surgeon could palpate and mark the chin  196  or the center of the forehead as the cranial center position, thereby establishing a first superficial anatomic landmark or reference marker  182 . Next, the surgeon could palpate and mark the sternal notch  198  or the xiphoid as the caudal center position, thereby establishing a second superficial anatomic landmark or reference marker  184 . 
     The surgeon or an assisting medical professional can also attach the orthopedic plate  140  to the distal end of the plate holder  160  and activate the light sources  120  of the implant alignment device  110  to verify that the illuminated indication pattern  128  is aligned with the primary axis of interest  150  of the orthopedic plate  140 . In situations where the illuminated indication pattern  128  is not aligned with the primary axis of interest  150  and angular adjustment of the implant alignment device  110  relative to the bone holder  160  is possible, the angular position of the implant alignment device  110  can be adjusted to bring the illuminated indication pattern  128  into alignment with the primary axis of interest  150 . 
     During surgery the distal end of the implantation system  114  can then be used to insert the plate  140  into the incision  194  and adjacent the desired bone attachment site, and the light sources  120  can be activated to project the illuminated indication pattern  128  with primary light lines  126  that extend from the distal end of the plate holder  160  in opposite directions to both of the reference markers  182 ,  184  that have been marked on the exterior of the patient. The surgeon can then align the primary light lines  126  emitted from the implant alignment device  110  to these marked anatomic structures  196  and  198 , after which he or she can insert two temporary stabilizing pins into the cervical plate  140  while closely observing that the primary light lines  126  do not deviate from the strategically placed marks  182 ,  184 . At the same time the surgeon can observe the relationship between the secondary light lines  127  and the visible edges of the neck  180  to verify the collinearity of the cervical plate  140  to the spine  190  in the transverse direction. 
     Once the surgeon has confidently positioned the implant  140  on the bone (that has limited visualization) with the primary light lines  126  collinear to the surface anatomy, then the surgeon can permanently fixate the implant  140  to the bone. He or she would place permanent screws through the plate  140  to stably fix the plate in the desired collinear position. Since the primary light lines  126  are long, small deviations of the plate will be easily noticed by an exaggerated deviation of the light lines at their extremes near the reference markers  182 ,  184 . Therefore, anatomic points that are farther from the bone attachment site under the incision  194  will provide better accuracy. 
     It will be appreciated that during the fixation process (e.g., when screws are being placed through the holes of a plate to attach the plate to the bone), the implant  140  can shift. The present disclosure will also assist the surgeon in assessing whether an implant has shifted during the fixation process. If the cross-hair lines (primary light lines  126  or secondary light lines  127 ) shift from the intended surface anatomy during the fixation process, then the surgeon would know that they would need to re-adjust the implant  140  to the desired position and then re-apply fixation screws. Once the implant  140  has been confidently attached collinear to the bone, then the implantation system  114  can be detached from the implant  140  and removed from the patient. This feature allows the surgeon to collinearly attach the plate to the bone in “real time.” 
     Example 3 
       FIG. 7  illustrates another embodiment of the implant alignment device  110  and implantation system  114  of the present disclosure, as may be applied in the alignment of an orthopedic plate, such as lateral femoral fixation plate  210 , to the lateral femur  220  of a patient. Since the desired anatomic landmarks for this surgery are generally palpable through the ski, the surgeon could palpate and mark the anterior distal femoral condyle  226 , thereby establishing a first superficial anatomic landmark or reference marker  216 . Next, the surgeon could palpate and mark the anterior one-third of the greater trochanter  228 , thereby establishing a second superficial anatomic landmark or reference marker  218 . In this scenario the alignment between the reference markers can appear off-center due to the bow-shape of the femur  220 . 
     Prior to inserting the orthopedic plate  210  into the patient, the surgeon or an assisting medical professional can first attach the orthopedic plate  210  to the distal end of the plate holder  160  and activate the light sources  120  of the implant alignment device  110  to verify that the primary light lines  126  of the illuminated indication pattern  128  are aligned with the primary axis of interest  212  of the orthopedic plate  210 . In situations where the illuminated indication pattern  128  is not aligned with the primary axis of interest  212  and angular adjustment of the implant alignment device  110  relative to the bone holder  160  is possible, the angular position of the implant alignment device  110  can be adjusted to bring the primary light lines  126  into alignment with the primary axis of interest  212  prior to inserting the plate  210  into the incision  222  and moving it toward the bone attachment site. 
     As shown in the drawing, a limited exposure of the lateral femur  220  can be provided through a standard direct lateral incision  222  into the thigh  206 , allowing the plate  210  to be placed onto the lateral femur  220 . The light sources  120  can be activated to project the illuminated indication pattern  128  with primary light lines  126  that extend from the distal end of the plate holder  160  in opposite directions to both of the reference markers  216 ,  218  that have been marked on the exterior of the leg of the patient. Once the primary light lines  126  are aligned according the desired superficial anatomic landmarks or reference marker  216 ,  218  and the secondary light lines  127  are aligned perpendicular to the long axis of the leg, the surgeon places temporary fixation (k-wires) and then permanent screw fixation. As long as the illuminated indication pattern  128  does not deviate from the reference markers  216 ,  218 , the surgeon can be confident that the lateral femoral plate  210  was applied collinear to the lateral femur  220 . 
     Example 4 
       FIG. 8  illustrates another embodiment of the implant alignment device  110  and implantation system  114  of the present disclosure, as may be applied in the alignment of a plate to the proximal femur  240  using a minimally invasive technique known to one skilled in the art. This minimally invasive approach is what differentiates this example from Example 3. As shown in  FIG. 8 , a small incision  242  is made over the lateral aspect of the distal femur  240 . Then, the plate  230 , such as a lateral femoral plate, is slid along a sub-muscular plane along the lateral thigh over the femur  240 . The minimally invasive plate  230  used in this technique has a screw guide that is used to place locking screws through stab wounds in the skin into the plate; fixing the plate to the femur. Current application of the plate  230  along the lateral femur  240  can be tenuous as the surgeon does this solely by tactical sensation. During the sliding process, there is risk to neurovascular structures anterior and posterior to the femur  240  if the plate  230  slides off course. The method and system of the present disclosure, as provided in  FIG. 8 , may be used to guide the surgeon in sliding the minimally invasive plate  230  along the correct trajectory. For instance, the primary light lines  126  that extend from the distal end of the plate holder  160  in opposite directions can be aligned with the superficial anatomic landmarks or reference markers  236 ,  238  that have been established on the anterior distal femoral condyle  246  and the anterior one-third of the greater trochanter  248 , respectively, while the secondary light lines  127  can be maintained orthogonal to long axis of the leg. This method can help guide the orthopedic plate  230  along a safe trajectory in the submuscular plane to the bone attachment site. 
     It will be further appreciated that the surgical implant alignment device of the present disclosure can provide additional features and benefits beyond the initial alignment of the implant. For instance, when the first screw is placed into position within an aligned orthopedic fixation plate, it will many times shift the position of the plate. This will be seen as a change in the angle and/or position of the projected laser or light lines. The length of the light lines amplifies the movement of the plate imparted by positioning the screw, thus making potential misalignment detectable. Once a deviation from true alignment or collinearity has detected with the first screw in position, the handle of the plate holder may be rotated to the correct orientation and the second screw inserted. With two screws, proper alignment can be confirmed and the position of the orthopedic plate will remain stable for the insertion of the final two screws. 
     Other benefits of the implant alignment device of the present disclosure include the reduction in a patient&#39;s exposure to radiation, since common fixation procedures require the use of X-rays are used to confirm the position of the implant fixation plate, sometimes multiple times during the procedure. The use of the implant alignment device to properly orient the implant during initial positioning, as well as to correct any shifts caused by screw insertions, can substantially reduce the need for as many X-rays as would otherwise be required, thus reducing the patient&#39;s radiation exposure. 
     Superficial Anatomic Landmark Combinations 
     In addition to the detailed examples illustrated and described above, the inventor has also discovered several new superficial anatomic landmark combinations that can be established and referenced in different orthopedic plate-setting surgeries. For example, as illustrated in  FIGS. 9A-9B , when setting a plate on the anterior radius  300  of a patient, the flexor carpii radialis tendon  302  can be designated as the location for a first reference marker  304 , and a 1 cm radial offset  307  from the insertion of the biceps brachii muscle  306  can be designated as the marking site for a second reference marker  308 . During surgery, the primary axis of interest of an orthopedic plate can then be aligned with the imaginary reference line  310  drawn between the two reference markers  304 ,  308  using the implant alignment device and/or and implantation system of the present disclosure, as described above, to establish accurate collinearity between the implant and the longitudinal axis of the radius. 
     In another embodiment of the present disclosure illustrated in  FIGS. 10A-10B , when setting a plate on the posterior ulna  320  of a patient, the olecranon  322  can be designated as the location for a first reference marker  324 , and the styloid process of the ulna  326  can be designated as the marking site for a second reference marker  328 . During surgery, the primary axis of interest of an orthopedic plate can then be aligned with the imaginary reference line  330  drawn between the two reference markers  324 ,  328  using the implant alignment device and/or and implantation system of the present disclosure, as described above, to establish accurate collinearity between the implant and the longitudinal axis of the ulna. 
     In another embodiment of the present disclosure illustrated in  FIG. 11 , when setting a plate on the lateral humerus  340  of a patient, the center of the lateral acromion  342  can be designated as the location for a first reference marker  344 , and the lateral humeral condyle  346  can be designated as the marking site for a second reference marker  348 . During surgery, the primary axis of interest of an orthopedic plate can then be aligned with the imaginary reference line  350  drawn between the two reference markers  344 ,  348  using the implant alignment device and/or and implantation system of the present disclosure, as described above, to establish accurate collinearity between the implant and the longitudinal axis of the humerus. 
     In another embodiment of the present disclosure illustrated in  FIGS. 12A-12B , when setting a plate on the anterior femur  360  of a patient, the center of the superior pole of the patella  362  can be designated as the location for a first reference marker  364 , and a 2 cm lateral offset  367  from the deep femoral artery pulse  366  can be designated as the marking site for a second reference marker  368 . During surgery, the primary axis of interest of an orthopedic plate can then be aligned with the imaginary reference line  370  drawn between the two reference markers  364 ,  368  using the implant alignment device and/or and implantation system of the present disclosure, as described above, to establish accurate collinearity between the implant and the longitudinal axis of the femur. 
     In another embodiment of the present disclosure illustrated in  FIGS. 13A-13B , when setting a plate on the anterior tibia  380  of a patient, the tuberosity of the tibia  382  can be designated as the location for a first reference marker  384 , and the extensor digitorum tendon  386  can be designated as the marking site for a second reference marker  388 . During surgery, the primary axis of interest of an orthopedic plate can then be aligned with the imaginary reference line  390  drawn between the two reference markers  384 ,  388  using the implant alignment device and/or and implantation system of the present disclosure, as described above, to establish accurate collinearity between the implant and the longitudinal axis of the tibia. 
     In another embodiment of the present disclosure illustrated in  FIGS. 14A-14B , when setting a plate on the medial tibia  400  of a patient, the medial femoral condyle of the tibia  402  can be designated as the location for a first reference marker  404 , and the medial malleolus of the tibia  406  can be designated as the marking site for a second reference marker  408 . During surgery, the primary axis of interest of an orthopedic plate can then be aligned with the imaginary reference line  410  drawn between the two reference markers  404 ,  408  using the implant alignment device and/or and implantation system of the present disclosure, as described above, to establish accurate collinearity between the implant and the longitudinal axis of the tibia. 
     In another embodiment of the present disclosure illustrated in  FIGS. 15A-15B , when setting a plate on the lateral fibula  420  of a patient, the head of the fibula  422  can be designated as the location for a first reference marker  424 , and the lateral malleolus of the fibula  426  can be designated as the marking site for a second reference marker  428 . During surgery, the primary axis of interest of an orthopedic plate can then be aligned with the imaginary reference line  430  drawn between the two reference markers  424 ,  428  using the implant alignment device and/or and implantation system of the present disclosure, as described above, to establish accurate collinearity between the implant and the longitudinal axis of the fibula. 
     As indicated above, the invention has been described herein in terms of preferred embodiments and methodologies considered by the inventor to represent the best mode of carrying out the invention. It will be understood by the skilled artisan, however, that a wide range of additions, deletions, and modifications, both subtle and gross, may be made to the illustrated and exemplary embodiments of the implant alignment device without departing from the spirit and scope of the invention. For example, while a principle use of the surgical implant alignment device of the present disclosure is the application in surgery on human patients, the alignment device is also suitable for application during surgery on any animal, including but not limited to dogs, cats, horses, cattle, goats, sheep, cattle, pigs, as well as other animals such as birds and lizards. These and other revisions might be made by those of skill in the art without departing from the spirit and scope of the invention that is constrained only by the following claims.