Dynamic bone reduction and fixation system

Abstract

The invention relates to systems and methods for stabilization of diastasis of the pubic symphysis. The dynamic binder fixation system comprises dual implants that may be deployed along the bone surface of each right and left pubic bones and secured with a plurality of fixation screws at different screw trajectories through the pubic bones to increase pull out strength. Accordingly, the lacing mechanism is introduced to link the dual implants together to allow micromotion along the symphyseal joint, which may help restore vital mobility function of the pubic symphysis.

Description

DYNAMIC BONE REDUCTION AND FIXATION SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Appl. No. 63 / 644,177, filed on May 8, 2024, entitled “Dynamic Bone Reduction and Fixation System,” which is incorporated by reference in its entirety.TECHNICAL FIELD

[0002] The invention relates to methods and systems for an improved internal pelvic fixation system for symphyseal disruption. More specifically, the invention relates to methods and systems for an improved internal pelvic fixation system with dual contoured plates affixed to the left and right pubic bones for symphyseal disruption.BACKGROUND OF THE INVENTION

[0003] Disruption of the pubic symphysis is a pelvic injury in which the strong midline union (e.g., pubic symphysis) of the pubic bones tears apart, requiring surgical fixation whenever the stability of the pelvis is impaired. Currently, the preferred treatment option is open reduction and symphyseal plate (SP) fixation using a single, narrow steel plate and screws. Despite the technique being used for decades in orthopedic surgeries, SP fixation is disadvantageous because it does not adequately neutralize, adapt and / or distribute to the forces on the pubic symphysis during mobilization of the patient throughout the healing phase. This results in several complications, such as SP implant failure and recurrent gap formation through SP implant or screw loosening and breakage, leading to poor outcomes. Unfortunately, some complications are too severe, requiring surgical revision.BRIEF SUMMARY OF THE INVENTION

[0004] In one embodiment, the dynamic pelvic fixation system comprises: a plurality of fixation screws; and a first plate and a second plate, each of the first and second plates comprising a body, a first leg and a second leg, and a plurality of screw bores, the body comprises a body top surface, a body bottom surface and a body perimeter edge, the first leg comprises a first top surface, a first bottom surface, and a first longitudinal axis, the first longitudinal axis, the first leg extends from the body at a first orientation angle;the second leg comprises a second top surface, a second bottom surface, and a second longitudinal axis, the second leg extends from the body at a second orientation angle, the second leg longitudinalaxis is different than the second leg longitudinal axis; each of the plurality of screw bores comprises a plurality of screw trajectories, each of the plurality of screw bores sized and configured to receive the plurality of fixation screws. The pelvic fixation system further comprises a lacing mechanism. The first and second plates further comprise a plurality of fastening elements, the fastening elements engage with and / or are sized and configured to receive a portion of the lacing mechanism. Each of the first and second plates further comprises a plurality of anchoring openings, each of the anchoring openings are sized and configured to receive a plurality of anchoring pins. Each the plurality of screw trajectories of the plurality of screw bores on the first or second plate are different from each other. Each the plurality of longitudinal screw axis of the plurality of screw bores on the first or second plate are different from each other. Each the plurality of screw trajectories does not intersect. The lacing mechanism comprises a flexible lacing mechanism. The flexible lacing mechanism comprises a textile strand or suture or textile suture assembly. The textile strand comprises a biodegradable polymer or a non-biodegradable polymer.

[0005] In another embodiment, The method of reducing pubic symphysis separation comprises the steps of: positioning a first pelvic plate onto a first pubic bone at a first location and a second pelvic plate onto a second pubic bone at a second location; fixating the first plate onto the first location on the first pubic bone and the second plate onto the second location on the second pubic bone; engaging the lacing mechanism between the first plate and the second plate; and locking the lacing mechanism. The first pelvic plate and the second pelvic plate are mirror images of each other. The first leg of each of the first and second pelvic plates contacts a portion of the superior surface of the superior pubic ramus of the first and second pubic bones, and a second leg of each of the first and second pelvic plates contacts a portion of the posterior surface of the pubic body of the first and second pubic bones. The positioning step further comprises anchoring the first pelvic plate onto the first pubic bone at the first location and anchoring the second pelvic plate onto the second pubic bone at the second location; and reducing the separation between the first pubic bone and the second pubic bone. The anchoring step comprises the step of inserting a first anchoring pin through a first anchoring opening disposed on the first pelvic plate into the first pubic bone and a second anchoring pin through a second anchoring opening disposed on the second pelvic plate into the second pubic bone, the fixating step comprises the step of inserting a plurality of fixation screws through a plurality of screw openings disposed onto the first and second pelvic plates, the plurality of screw openings comprises a plurality of longitudinal axis, each of the plurality of longitudinal axis having a plurality of different trajectories. The reducing step comprises the steps of: extending a firstportion of a surgical tool into a first toe-hold disposed onto the first pelvic plate and a second portion of a surgical tool into a second toe-hold disposed onto a second pelvic plate; activating the surgical tool to reduce the separation between the first pubic bone and the second pubic bone.

[0006] In one embodiment, the method of making at least one pelvic plate comprises the steps of: Creating a three-dimensional (3D) model of a pubis of at least one patient; Analyzing one or more bone characteristics of a pubic bone of the pubis; Planning one or more fixation screw trajectories using the one or more bone characteristics; Inserting one or more virtual fixation screws into the 3D model to align with the one or more fixation screw trajectories; and Generating at least one virtual pelvic plate into the 3D model to substantially match the one or more bone characteristics and / or the one or more fixation screw trajectories. The step of creating a 3D model of a pubis of at least one patient comprises a virtual, patient-specific 3D model. The method of making at least one pelvic plate may further comprise providing or manufacturing the at least one pelvic plate from the virtual, patient specific 3D model. The providing or manufacturing may comprise standard manufacturing methods or 3D printing.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0007] FIG. 1 depicts a front view of a first embodiment of an internal pelvic binder fixation system;

[0008] FIG. 2 depicts a back view of a second embodiment of an internal pelvic binder fixation system;

[0009] FIG. 3 depicts a back view of a third embodiment of an internal pelvic binder fixation system;

[0010] FIGS. 4A-4B depict an anterior view and magnified anterior view illustrating diastasis of a pubic symphysis;

[0011] FIGS. 5A-5C depict various views the internal pelvic binder fixation system of FIG. 1 ;

[0012] FIG. 6 depicts a superior or top view of the internal pelvic binder fixation system of FIG. 3;

[0013] FIGS. 7A-7D depict cross-sectional views of different embodiments of screws and their longitudinal axis trajectories;

[0014] FIGS. 8A-8C depicts an anterior outlet view of one embodiment of fixation screw trajectories used to create 3D virtual plate model; and

[0015]

[0016] FIG. 9A-9B depicts a flowchart illustrating different embodiments of a method of use for the internal pelvic binder fixation system;

[0017] FIG. 10 depicts a flowchart illustrating one embodiment of a method of manufacturing the internal pelvic binder fixation plates;

[0018] FIGS. 11A-11F depicts various views of one embodiment of creating at least one 3D virtual plate model.DETAILED DESCRIPTION OF THE INVENTION

[0019] The following detailed description contains the currently contemplated modes of carrying out the invention. The description should not be limiting, but is made for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims.

[0020] Furthermore, the invention is often referred to herein as dynamic bone reduction and fixation system, or a symphyseal internal binder pelvic fixation system. It is understood that the invention is also not limited to the pubic symphysis, and the technology in this invention may be applied in numerous other medical or surgical applications that require reduction and stabilization of bones.

[0021] The current fixation methods using single plates appear to be inadequate to correct a disrupted pubic symphysis because the single plate systems are unable to endure the compression, traction, shear forces and strain under diverse physiological states. As a result, there exists a need to create an improved symphyseal fixation system that addresses the weaknesses of the current anterior pelvic fixation constructs which have a significant rate of failure due to the high strain environment at the disrupted pubic symphysis. The internal binder fixation system can correct a disrupted pubic symphysis, adapt to the forces observed under diverse physiological states, restore stability and / or biomechanical function similar to an uninjured pubic symphysis through its unique design. The symphyseal internal binder fixation system comprises a multi-planar, dual plate system that can facilitate dispersion of ferees and regional stability during the various physiological conditions. Stability is achieved by multi- planar cross-fixation of each plate with a plurality of fixation screws for increased or strengthened pull-out forces and a flexible lacing system to allow the desired motion or micromotion between the pubic bones. The flexible lacing system may allow “elastic” type motion to replace the normal function of the symphysis pubis.

[0022] Accordingly, the design of the internal pelvic binder fixation system contains further advantages. These advantages are (1) reduced complications and recovery time due tothe separate application of each plate onto the pubic bones (less muscle release compared with increased access to expose a large surface area to apply a long single spanning plate); (2) reduced plate contouring to match the patient bone anatomy because a portion of each plate would be affixed to the pubis, which the pubis contains less surface irregularity or variability; (3) reduction of surgical instruments during surgery because the internal pelvic binder fixation system can supplement reduction instruments or function as the reduction instrument (e.g., replacing screw-based clamps or other tools used for wide or difficult reductions to eliminate the potential for ‘screw traffic’ between the screw-based clamp and the definitive fixation screws); (4) increased pullout strength due to optimized, multiplanar screw trajectories of the fixation screws; and (5) improved fatigue resistance due to distribution of ferees throughout a larger surface area.

[0023] FIGS. 4A-4B depict an anterior view and magnified anterior view illustrating the pelvic girdle 32 with diastasis of a pubic symphysis 34. Disruption or separation (e.g., pubic diastasis) of the pelvic ring caused by high-energy trauma, pregnancy or degeneration can lead to prolonged recovery, persistent pain and functional disability.

[0024] Each hip bone 33 contains three bones, the ilium 31 , ischium 42 and pubis 35. The hip bones 33 are connected via the symphysis pubis (not shown). The pubis 35 can be separated into two halves or two pubic bones. Each of the pubic bones includes a body 42, a superior ramus 44 and an inferior ramus 50, where the two halves of the pubic bones are joined by the pubic symphysis (not shown). The superior pubic ramus 44 comprises a superior pubic ramus surface 46, a pubic crest 36 and / or a pubic tubercle 48. The pubic symphysis bears different types of forces under physiological conditions, including compression of the upper part and traction of the lower part when standing, shear and compression when single-leg standing, and compression when sitting. The critical function of the pubic symphysis is to maintain the stiffness and stability of the anterior pelvic ring. Therefore, the correct treatment of diastasis of the pubic symphysis is critical to the quality of life of patients. The goal of treatment should be to restore anatomical structure and function, and stabilize the pelvic ring to improve the therapeutic effect and avoid complications.

[0025] FIGS. 1-3, 5A-5C, and 6 depict various views of the first, second and third embodiment of a internal binder fixation system 2, 26, 30. The internal pelvic binder fixation system 2, 26, 30 comprises a plurality of plates 2a, 2b, 26a, 26b, 30a, 30b, a lacing mechanism 16, and a plurality of fixation screws 24a, 24b. Alternatively, the internal pelvic binder fixation system 2, 26, 30 comprises a first plate 2a, 26a, 30a, a second plate 2b, 26b, 30b, one or more lacing mechanisms 16, and a plurality of fixation screws 24a, 24b. The internal pelvic binderfixation system 2, 26, 30 may further comprise anchoring pins or wires. The anchoring pins or wires may include K-wires or pins. The internal pelvic binder fixation system 2, 26, 30 may further comprise surgical instrumentation. The surgical instrumentation includes one or more retractors, screw inserters, reduction clamps, screw drivers, plate inserters, and / or any combination thereof.

[0026] The first plate 2a, 26a, 30a and / or second plates 2b, 26b, 30b of the internal pelvic binder system 2, 26, 30 may comprise standard sizes and / or custom or patient-specific designs modeled from patient-specific 3D imaging. The plates 2a, 2b, 26a, 26b, 30a, 30b of the internal pelvic binder system 2, 26, 30 may comprise substantially custom or patient-specific designs that are considered “best-fit” for some patients. The plates 2a, 2b, 26a, 26b, 30a, 30b of the internal pelvic binder system 2, 26, 30 may comprise generic or standard designs that can accommodate the majority of patients (e.g., available in small, medium, large or x-large sizes). The plates 2a, 2b, 26a, 26b, 30a, 30b of the internal pelvic binder system 2, 26, 30 may comprise different sizes for males, females and / or pediatric patients.

[0027] The first plate 2a, 26a, 30a comprises a first plate body 4a, a first leg 6a and a second leg 8a, and the second plate 2b, 26b, 30b comprises a second plate body 4b, a first leg 6b and a second leg 8b. The first and / or second plate body 4a, 4b comprises a body top surface 5a, 5b and a body bottom surface 7a, 7b. The first leg 6a, 6b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b comprises a first leg top surface 72a, 72b, a first leg bottom surface 74a, 74b and a first longitudinal axis 10a, 10b. The second leg 8a, 8b comprises a second leg top surface 76a, 76b, a second leg bottom surface 78a, 78b and a second longitudinal axis 12a, 12b. The first plate body 4a and the second plate body 4b may comprise a shape, the shape includes triangular or substantially triangular.

[0028] In one embodiment, the body top surface of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b comprises a top surface contour and the body bottom surface comprises a bottom surface contour. The top surface contour of the body top surface comprises the same contour as the bottom surface contour of the body bottom surface. Alternatively, the top surface contour of the body top surface comprises a different contour as the bottom surface contour of the body bottom surface 7a, 7b. The bottom surface contour and / or the top surface contour may match or substantially match one or more bone surfaces. The bone surfaces may include the pubic bone surface. The body top surface contour of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b may comprise multi-planar surfaces. The body top surface contour of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b may comprise a single planar surface.

[0029] The top surface contour of the body top surface of the first plate 2a, 26a, 30a may match or substantially match the top surface contour of the body top surface of the second plate 2b, 26b, 30b. The top surface contour of the body top surface of the first plate 2a, 26a, 30a may comprise a mirror image of the top surface contour of the body top surface of the second plate 2b, 26b, 30b. The top surface contour of the body top surface of the first plate 2a, 26a, 30a may comprise a different contour than the top surface contour of the body top surface of the second plate 2b, 26b, 30b. The bottom surface contour the body bottom surface 7a, 7b of the first plate 2a, 26a, 30a may match or substantially match the bottom surface contour of the body bottom surface 7a, 7b of the second plate 2b, 26b, 30b. The bottom surface contour of the body bottom surface 7a, 7b of the first plate 2a, 26a, 30a may comprise a mirror image of the bottom surface contour of the body bottom surface 7a, 7b of the second plate 2b, 26b, 30b. The bottom surface contour of the body bottom surface 7a, 7b of the first plate 2a, 26a, 30a may comprise a different contour than the bottom surface contour of the body bottom surface 7a, 7b of the second plate 2b, 26b, 30b.

[0030] In another embodiment, at least a portion of the body bottom surface 7a, 7b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b may contact a portion of the superior pubic ramus 44 and the remaining portion of the body bottom surface may contact a portion of the inferior pubic ramus 50 and / or a portion of body of the pubic bone 42. In another embodiment, the body bottom surface 7a, 7b may comprise a first portion bottom surface and a second portion bottom surface. At least a first portion bottom surface may contact a portion of the superior pubic ramus 44 and the second portion bottom surface may contact a portion of the body of the pubic bone 42. Alternatively, at least a first portion bottom surface may contact a portion of the superior pubic ramus 44 and the second portion bottom surface may contact a portion of the body of the pubic bone 42 and a portion of the inferior pubic ramus 50. In another embodiment, the body bottom surface of the body 4a, 4b of the first and / or second plates may contact only the superior pubic ramus 44. Contacting the superior pubic ramus may further comprise contacting the superior surface 46 of the superior pubic ramus 44. Contacting a portion of the inferior pubic ramus 50 and / or a portion of body of the pubic bone 42 may comprise contacting the posterior surface of the inferior pubic ramus and / or the posterior surface 56 of the body of the pubic bone 42. Contacting a portion of the inferior pubic ramus 50 and / or a portion of body of the pubic bone 42 may comprise contacting the anterior surface of the inferior pubic ramus 50 and / or the anterior surface of the body of the pubic ramus 42.

[0031] In another embodiment, the first and / or second plate body 4a, 4b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b further comprise a body perimeter edge. Atleast a portion of the body perimeter edge may be positioned adjacent or immediately adjacent to the pubic crest 36 and / or the pubic tubercle 48. At least a portion of the body perimeter edge of the first and / or second plate body 4a, 4b may contact a portion of the pubic crest 36 and / or a portion of the pubic tubercle 48. At least a portion of the body perimeter edge of the first and / or second plate body 4a, 4b may be disposed onto, engage and / or contact the pubic crest 36 and / or the pubic tubercle 48. At least a portion of the body perimeter edge may match or substantially match the shape of the pubic crest 36 and / or the pubic tubercle 48.

[0032] The first leg 6a, 6b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b comprises a first leg top surface 72a, 72b, a first leg bottom surface 74a, 74b and a first longitudinal axis 10a, 10b. At least a portion of the first leg 6a, 6b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b contacts a portion of the superior pubic ramus 44. At least a portion of the first leg 6a, 6b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b contacts a portion of the superior surface 46 of the superior pubic ramus 44. At least a portion of the first leg 6a, 6b of the first and / or second plate 2a, 2b, 26a, 26b, 30a, 30b first longitudinal axis 10a, 10b is parallel or substantially parallel to the superior pubic ramus 44. At least a portion of the first leg 6a, 6b of the first and / or second plate 2a, 2b, 26a, 26b, 30a, 30b first longitudinal axis 10a, 10b aligns along and / or substantially aligns along a superior ramus longitudinal axis 80a, 80b.

[0033] The second leg 8a, 8b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b comprises a second leg top surface 76a, 76b, a second leg bottom surface 78a, 78b and a second longitudinal axis 12a, 12b. At least a portion of the second leg 8a, 8b contacts a portion of the body of the pubic bone 42. At least a portion of the second leg 8a, 8b contacts a posterior surface 56 of the pubic bone 42. Alternatively, at least a portion of the second leg bottom surface 78a, 78b may contact a portion of the body of the pubic bone 42. At least a portion of the second bottom surface 78a, 78b may contact a portion of the posterior surface 56 of the body of the pubic bone 42. At least a portion of the second leg 8a, 8b of the first and / or second plate 2a, 2b, 26a, 26b, 30a, 30b second longitudinal axis 12a, 12b is parallel or substantially parallel to a longitudinal axis of the body of the pubic bone 42. At least a portion of the second leg 8a, 8b of the first and / or second plate 2a, 2b, 26a, 26b, 30a, 30b second longitudinal axis 12a, 12b aligns along and / or substantially aligns along a posterior surface of the pubic bone body longitudinal axis (not shown).

[0034] Accordingly, at least a portion of the second leg 8a, 8b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b contacts a portion of the pubic body of the pubic bone 42 and a portion of the inferior pubic ramus 50. The at least a portion of the bottom surface 78a, 78bsecond leg 8a, 8b. At least a portion of the second leg longitudinal axis extends towards the inferior pubic ramus. The first leg longitudinal axis is different than the second leg longitudinal axis. The first leg longitudinal axis is transverse from the second leg longitudinal axis. The first leg longitudinal axis is non-parallel to the second leg longitudinal axis.

[0035] The first leg 6a, 6b extends from the plate body 4a, 4b at a first leg orientation and the second leg 8a, 8b extends from the plate body 4a, 4b at a second leg orientation. Between the first and second orientation comprises a total orientation angle 58, the total orientation angle 58 includes 20 degrees to 120 degrees; the total orientation angle comprises 45 degrees to 100 degrees; the total orientation angle 58 comprises 20 degrees to 60 degrees; the total orientation angle 58 comprises 30 degrees to 45 degrees; and / or the orientation angle 58 comprises at least 30 degrees or greater. Each of the first and second orientation may comprise the same orientation angles. Each of the first and second orientations may comprise different orientation angles. The first and second orientations of the first and second legs of the first plate may comprise the same or different orientation angles. The third and fourth orientations of the first and second legs of the second plate may comprise the same or different orientation angles.

[0036] In another embodiment, the first leg top surface 72a, 72b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b comprises a first leg top surface contour. The first leg top surface contour of the first plate 2a, 26a, 30a may match or substantially match the top surface contour of the second plate 2b, 26b, 30b. Accordingly, the second leg top surface 76a, 76b of the first and second plates 2a, 2b, 26a, 26b, 30a, 30b comprises a second leg top surface contour. The second leg top surface contour of the first plate 2a, 26a, 30a may match or substantially match the second leg top surface contour of the second plate 2b, 26b, 30b.

[0037] In another embodiment, the first leg bottom surface 74a, 74b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b comprises a first leg bottom surface contour. The first leg bottom surface contour may match or substantially match the superior pubic ramus 44 and / or match or substantially match the superior surface 46 of the superior pubic ramus 44. The second leg bottom surface 78a, 78b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b comprises a second leg bottom surface contour. The second leg bottom surface contour may match or substantially match the pubic bone body 42 and / or match or substantially match the posterior surface 56 of the pubic bone body 42.

[0038] The first leg top surface contour may match or substantially match the first leg bottom surface contour. The first leg top surface contour may be different than the first leg bottom surface contour. The first leg top surface and / or the first leg bottom surface comprisesmulti-planar surfaces. Alternatively, the first leg top surface and / or the first leg bottom surface may comprise a flat, planar surface or a curved surface. The curved surface may comprise an arched surface, a concave surface, or a convex surface.

[0039] The second leg top surface contour may match or substantially match the second leg bottom surface contour. The second leg top surface contour may be different than the second leg bottom surface contour. The second leg top surface and / or the second leg bottom surface comprises multi-planar surfaces. Alternatively, the second leg top surface and / or the second leg bottom surface may comprise a flat, planar surface or a curved surface. The curved surface may comprise an arched surface, a concave surface, or a convex surface.

[0040] Accordingly, the first leg top surface contour and the second leg top surface contour may comprise the same contour. The first leg top surface contour and the second leg top surface contour may comprise a different contour. The first leg bottom surface contour and the second leg bottom surface contour may comprise the same contours. The first leg bottom surface contour and the second leg bottom surface contour may comprise a different contour.

[0041] In another embodiment, the first plate 2a, 26a, 30b and / or the second plate 2b, 26b, 30b comprises a plurality of screw openings 14a, 14b, 15a, 15b, 17a, 17b. The plurality of screw openings 14a, 14b, 15a, 15b, 17a, 17b extend from a top surface 72a, 76a through the bottom surface 72b, 76b. The plurality of screw openings 14a, 14b, 15a, 15b, 17a, 17b are positioned throughout the body 4a, 4b, the first leg 6a, 6b and / or the second leg 8a, 8b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b. The plurality of screw openings 14a, 14b, 15a, 15b, 17a, 17b each of the plurality of screw openings 14a, 14b, 15a, 15b, 17a, 17b comprises a first plurality of screw opening longitudinal axis 60a, 60b with a plurality of longitudinal axis trajectories as shown in FIGS. 7A-7D and 8A-8C. Each of the plurality of screw openings 14a, 14b, 15a, 15b, 17a, 17b are sized and configured to receive a portion of a fixation screw 24a, 24b and / or at least a portion of an anchoring pin. The anchoring pins may comprise one or more K-wires pins or wires or Steinman pins. The anchoring pins may comprise standard anchoring pins known in the art. The anchoring pins may comprise a diameter of 1 mm to 5 mm and / or the diameter may comprise at least 1 mm. The anchoring pins may comprise different tips, the tips may include diamond tip, trocar tip, slotted trocar, notched trocar, Medin, hollow trocar and / or any combination thereof. The anchoring pins may further comprise threads. The anchoring pins may comprise a length, the length may include at least 100 mm.

[0042] In one embodiment, the first plate 2a, 26a, 30a and the second plate 2b, 26b, 30b comprise a first opening 14a, 14b, a second opening 15a, 15b, and a third opening 17a,17b. The first opening 14a, 14b may be sized and configured to receive a portion of an anchoring pin. The first opening 14a, 14b may comprise two or more openings. The first opening 14a, 14b may be disposed onto a portion of the first leg 6a, 6b. The second opening and third opening 14a, 14b, 17a, 17b may be sized and configured to receive a one or more fixation screws 24a, 24b.

[0043] Each of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b may comprise a second opening 15a, 15b and a third opening 17a, 17b. The third opening 17a, 17b may comprise a circular cross-sectional shape and the second opening 15a, 15b may comprise an elongated circular shape, elliptical, oval and / or a rounded rectangular shape. The second opening 15a, 15b may be positioned onto only the second leg 8a, 8b of the first and / or second plates 2a, 2b, 26a, 26b, 30a, 30b. The third opening 14a, 14b may be positioned throughout the first leg 6a, 6b, the second leg 8a, 8b, and / or the body 4a, 4b.

[0044] A portion of the plurality of screw openings 14a, 14b, 15a, 15b is positioned normal to the first leg top surface 72a, 72b, a second leg top surface 76a, 76b and / or the plate body top surface. Each of the plurality of screw openings 14a, 14b, 15a, 15b are positioned normal to the first leg top surface 72a, 72b, a second leg top surface 76a, 76b and / or the plate body top surface. A portion of the plurality of screw openings 14a, 14b, 15a, 15b is positioned non-normal to the first leg top surface 72a, 72b, a second leg top surface 76a, 76b and / or the plate body top surface. Each of the plurality of screw openings 14a, 14b, 15a, 15b are positioned non-normal to the first leg top surface 72a, 72b, a second leg top surface 76a, 76b and / or the plate body top surface.

[0045] In another embodiment, the first plate 2a, 26a, 30a comprises a first plurality of screw openings 14a, 15a, 17a having a first plurality screw trajectories, and a second plate 2b, 26b, 30b comprises a second plurality of screw openings 14b, 15b, 17b having a second plurality of screw trajectories. The first plurality of screw trajectories of the first plate 2a, 26a, 30a may comprise the same trajectories as the second plurality of screw trajectories of the second plate 2b, 26b, 30b. The first plurality of screw trajectories of the first plate 2a, 26a, 30a may comprise different trajectories than the second plurality of screw trajectories of the second plate 2b, 26b, 30b. The first plurality of screw openings 14a, 15a, 17a of the first plate 2a, 26a, 30a may comprise the same positioning (e.g., normal or non-normal) as the second plurality of screw openings 14b, 15b, 17b of the second plate 2b, 26b, 30b.

[0046] In another embodiment, each of the first plurality of screw trajectories of the first plurality screw openings 14a, 15a, 17a may be different to each other. Each of the secondplurality of screw trajectories of the of the second plurality of screw openings 14b, 15b, 17b may be different to each other.

[0047] In another embodiment, the plurality of screw openings 14a, 14b, 15a, 15b, 17a, 17b, the first plurality of screw openings 14a, 15a, 17a of the first plate 2a, 26a, 30a and / or the second plurality of screw openings 14b, 15b, 17b of the second plate 2b, 26b, 30b may comprise a counterbore as shown in FIGS. 7A-7B or a countersink (not shown). The counterbore and / or countersink allows the head of the fixation screws and / or anchoring pins to be disposed or positioned within the counterbore and / or countersink. The counterbore may comprise a hemispherical or concave shape. The counterbore may comprise a cylindrical shape.

[0048] At least a portion of the plurality of anchor openings 14a, 14b, 15a, 15b, 17a, 17b is positioned normal to the first leg top surface 72a, 72b, the second leg top surface 76a, 76b, and / or the plate body top surface. Each of the plurality of anchor openings 14a, 14b, 15a, 15b, 17a, 17b are positioned normal to the first leg top surface 72a, 72b, the second leg top surface 76a, 76b, and / or the plate body top surface. A portion of the plurality of anchor openings 14a, 14b, 15a, 15b, 17a, 17b is positioned non-normal to the first leg top surface 72a, 72b, the second leg top surface 76a, 76b, and / or the plate body top surface. Each of the plurality of anchor openings 14a, 14b, 15a, 15b, 17a, 17b are positioned non-normal to first leg top surface 72a, 72b, the second leg top surface 76a, 76b, and / or the plate body top surface.

[0049] In another embodiment, the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b may further comprise a plurality of fastening elements 18a, 18b, 20a, 20b. The plurality of fastening elements 18a, 18b, 20a, 20b may engage with the lacing mechanism. At least a portion of the lacing mechanism may extend through the plurality of fastening elements 18a, 18b, 20a, 20b. The fastening elements 18a, 18b, 20a, 20b may comprise eyelets, lacing hooks, lacing rings, and / or a combination thereof. The lacing rings may comprise “D” shaped or “U” shaped rings.

[0050] In another embodiment, the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b may further comprise a first plurality of fastening elements 18a, 18b and a second plurality of fastening elements 20a, 20b. The first plurality of fastening elements 18a, 18b may be disposed onto the plate body 4a, 4b, the first leg 6a, 6b and / or the second leg 8a, 8b. The second plurality of fastening elements 20a, 20b may be disposed onto the plate body 4a, 4b, the first leg 6a, 6b and / or the second leg 8a, 8b. In one exemplary embodiment, the first plurality of fastening elements 18a, 18b is disposed onto a portion of the first plate body 4a, 4b and a portion of the second leg 8a, 8b. The first plurality of fastening elements 18a, 18b is disposedadjacent to the perimeter edge of the first plate body 4a, 4b and the perimeter edge of the second leg 8a, 8b. At least a portion of the first plurality of fastening elements 18a, 18b is disposed parallel or substantially parallel to the longitudinal axis 12a, 12b of the second leg 8a, 8b.

[0051] The first plurality of fastening elements 18a, 18b may extend upwardly from the top surface of the plate body 4a, 4b and / or the top surface 76a, 76b of the second leg 8a, 8b. The first plurality of fastening elements 18a, 18b may extend normal or perpendicular and / or substantially normal or substantially perpendicular from the top surface of the first plate body 4a, 4b, and / or the top surface 76a, 76b of the second leg 8a, 8b. The first plurality of fastening elements 18a, 18b may comprise a fastening passageway 82a, 82b. At least a portion of the lacing mechanism 16 engages with the first plurality of fastening elements 18a, 18b and extends through the fastening passageway 82a, 82b of the first plurality of fastening elements 18a, 18b. The first plurality of fastening elements 18a, 18b may comprise “D” rings or “U” rings. At least one of the first plurality of fastening elements 18a, 18b on the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b may not engage with the lacing mechanism 16 and can engage with a surgical tool.

[0052] The at least one of the first plurality of fastening elements 18a, 18b on the first plate 2a, 26a, 30a, and / or the second plate 2b, 26b, 30b may comprise a “toe-hold.” The surgical tool may comprise a clamping tool. At least a portion of the surgical tool tips may extend through the fastening passageway 82a, 82b of the at least one of the first plurality of fastening elements 18a, 18b for leverage to approximate the first pubic bone to the second pubic bone of the pelvic girdle 32 and / or move the first pubic bone relative to the second pubic bone of the pelvic girdle 32 for securement. Alternatively, the first plurality of fastening elements 18a, 18b fastening elements may extend obliquely from top surface of the first plate body 4a, 4b, the top surface 72a, 72b of the first leg 6a, 6b and / or the top surface 76a, 76b of the second leg 8a, 8b.

[0053] In another embodiment, the first plate 2a, 26a, 30a comprises at least one first toe-hold and the second plate 2b, 26b, 30b comprises at least one second toe-hold. The at least one first and second toe-holds are sized and configured to receive a portion of a clamping tool. The first and / or second toe-holds may further comprise a recess, the recess is sized and configured to receive a portion of a clamping tool. The portion of the clamping tool may comprise the clamping tool tips. The clamping tool may be used in conjunction with the first and second toe-holds to facilitate the reduction process. The clamping tool within the recess allows the clamping tool to assert a force against the toe-holds on the first and second plates to assistin partially or fully reducing the displaced symphysis. More specifically, the first tip of the clamping tool would be inserted into the first toe-hold or the recess of the first toe-hold, and the second tip of the clamping tool would be inserted into the second toe-hold or the recess of the second toe hold. The surgeon will begin compression of the handles to exert a limited amount of force and control onto each of the first and second toe-holds, to manipulate the pubic bone to move towards each other, and complete reduction of the symphysis.

[0054] The second plurality of fastening elements 20a, 20b may extend away from the top surface of the first plate body 4a, 4b, the top surface 72a, 72b of the first leg 6a, 6b and / or the top surface 76a, 76b of the second leg 8a, 8b. The second plurality of fastening elements 20a, 20b may extend transverse or substantially transverse from the top surface of the first plate body 4a, 4b, the top surface 72a, 72b of the first leg 6a, 6b and / or the top surface 76a, 76b of the second leg 8a, 8b. Alternatively, the second plurality of fastening elements 20a, 20b fastening elements may extend obliquely from top surface of the first plate body 4a, 4b, the top surface 72a, 72b of the first leg 6a, 6b and / or the top surface 76a, 76b of the second leg 8a, 8b. At least a portion of the lacing mechanism 16 engages with the second plurality of fastening elements 20a, 20b and extends through the fastening passageway 84a, 84b of the second plurality of fastening elements 20a, 20b. In one exemplary embodiment, the second plurality of fastening elements 20a, 20b may comprise lacing eyelets.

[0055] In another embodiment, the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b may comprise on or more fastening passageways 28a, 28b. The one or more fastening passageways 28a, 28b extend from a top surface of the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b through the bottom surface of the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b. Alternatively, the one or more fastening passageways 28a, 28b extend from a top surface 76a, 76b of the second leg 8a, 8b through the bottom surface 78a, 78b of the second leg 8a, 8b. At least a portion of the lacing mechanism 16 engages with the one or more fastening passageways 28a, 28b and extends through the fastening passageways 28a, 28b. The fastening passageways 28a, 28b may be disposed adjacent to the perimeter edge of the second leg 8a, 8b and be substantially parallel to the longitudinal axis 12a, 12b of the second leg 8a, 8b. In another embodiment, the fastening passageways 28a, 28b may be disposed adjacent to the perimeter edge of the second leg 8a, 8b and adjacent to the perimeter edge of the plate body 4a, 4b.

[0056] In another embodiment, the internal pelvic binder fixation system 2, 26, 30 may further comprise one or more lacing mechanisms (not shown) 16. The one or more lacing mechanisms 16 may comprise a flexible lacing system. The flexible lacing mechanism mayinclude cable or instrument ties, a textile flexible lacing mechanism or a metal, flexible lacing mechanism. The textile flexible lacing mechanism may comprise a monofilament suture, a multifilament suture, a monofilament suture assembly, a multifilament suture assembly, suture anchors, suture anchor assemblies, and / or any combination thereof. The textile flexible lacing mechanism may comprise biodegradable textile flexible lacing mechanism or non- biodegradable textile flexible lacing mechanism. The textile flexible lacing mechanism may comprise a knotted or knotless configuration. In one example, the textile flexible lacing mechanism may comprise FIBERWIRE or TIGHTROPE suture or suture assemblies (Arthrex, Inc., Naples, FL). The lacing mechanism 16 may further comprise one or more anchoring elements 86. The anchoring elements 86 may comprise anchoring screws, anchoring sleeves and / or anchoring buttons. The anchoring elements 86 may provide for anchoring fixation points or regions 22 on the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b. In one exemplary embodiment, the lacing mechanism 16 comprises a suture 88 and at least two anchoring elements 86. The suture 88 may comprise a flat suture, a round suture, and / or a flat- to round suture. The suture 88 may be cored or coreless.

[0057] The metal, flexible lacing mechanism may comprise wires or strands comprising tantalum, silver, copper, aluminum, vitallum, stainless steel, Nitinol and any combination thereof. The cable or instrument ties may comprise ties similar to “zip ties” or zip tie means, such as STERNAL ZIPFIX System (Synthes USA, LLC, Monument, CO) or ZIPSTITCH (Zipline Medical, Inc., Campbell, CA). The one or more lacing mechanisms 16 may engage fixed to each first and second plate. Alternatively, the one or more lacing mechanisms may be provided separately, and is removably connected to the first and second plate. In one embodiment, the internal binder fixation system comprises a first lacing mechanism and a second lacing mechanism.

[0058] In another embodiment, the internal pelvic binder fixation system 2a, 2b, 26a, 26b, 30a, 30b comprises a plurality of fixation screws 24a, 24b. The plurality of fixation screws 24a, 24b may comprise self-tapping fixation screws. The plurality of fixation screws 24a, 24b may comprise self-tapping cortical and / or cancellous fixation screws. The plurality of fixation screws 24a, 24b may comprise cannulated or non-cannulated fixation screws. The plurality of fixation screws 24a, 24b may comprise non-locking or locking fixation screws. For example, the locking fixation screw may comprise OSTEOCENTRIC TRAUMA SCREW FASTENERS (OsteoCentric Technologies, Logan, UT). The plurality of fixation screws 24a, 24b may comprise a plurality of lengths. Each of the plurality of lengths may be the same length. Eachof the plurality of lengths may be different. At least a portion of the plurality of lengths of the plurality of screws may be different. The length range may comprise at least 25 mm to 70 mm.

[0059] Method of Surgical Use

[0060] Injuries to the pubic symphysis include diastasis, fractures into the symphysis, and fracture-dislocations. Open reduction and internal fixation (ORIF) are usually indicated when diastasis of the pubic symphysis exceeds medically accepted gap measurement. Surgical intervention can help preserve the integrity of the pubic symphysis joint, and any other injuries. Accordingly, the internal pelvic binder fixation system may be used alone to repair the pubic symphysis joint and / or used in combination with other surgical repairs (e.g, any spinal repairs, sacroiliac repairs, posterior ring fractures or dislocations, acetabulum fractures, and / or any other injuries requiring surgery).

[0061] The internal pelvic binder fixation system 2, 26, 30 is applied to the unreduced pelvis, with the first plate 2a, 26a, 30a affixed to the first pubic bone and second plate 2b, 26b, 30b individually affixed to the second pubic bone. Once the desired positioning and fixation of the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b onto the pubic bones have been achieved, the lacing mechanism 16 is introduced to engage with the plurality of fastening elements 18a, 18b, 20a, 20b, 28a, 28b. The lacing mechanism 16 is positioned between the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b and engages with the plurality of fastening elements 18a, 18b, 20a, 20b, 28a, 28b to apply tension to reduce the gap between the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b. Once the first pubic bone is moved relative to the second pubic bone to achieve approximation, the lacing mechanism 16 is secured to one or more fixation points 22 to replace the function of the symphysis pubis joint. Centering the flexible lacing mechanism 16 can restore motion or dynamic motion of the symphysis pubis 34 and distribute the strain along the entire area of the lacing mechanism 17 and a portion of each of the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b instead of the small surface area observed during a single plate reduction method. Reduction of the symphysis is achieved either through pulling tension on the lacing mechanism to approximate the plates together and / or assisted using the strategic ‘reduction toe-holds’ placed on first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b, using standard bone reduction forceps.

[0062] FIG. 9A depicts a flowchart of one embodiment of a method of surgical use of the internal pelvic binder fixation system 2, 26, 30. The internal pelvic binder fixation system 2, 26, 30 comprises the steps of: inserting a first plate onto a first location of a first pubic bone and a second plate onto a second location of a second pubic bone; anchoring the first plate onto the first location and the second plate onto the second location; fixating the first plate onto the firstlocation on the first pubic bone and the second plate onto the second location on the second pubic bone; reducing the separation between the first pubic bone and the second pubic bone; engaging a lacing mechanism with the first plate and the second plate; and locking the lacing mechanism.

[0063] FIG. 9B depicts a flowchart of an alternate embodiment of a method of surgical use of the internal pelvic binder fixation system 2, 26, 30. The internal pelvic binder fixation system 2, 26, 30 comprises the steps of: reducing the separation between the first pubic bone and the second pubic bone, inserting a first plate onto a first location of a first pubic bone and a second plate onto a second location of a second pubic bone; anchoring the first plate onto the first location and the second plate onto the second location; fixating the first plate onto the first location on the first pubic bone and the second plate onto the second location on the second pubic bone; engaging the lacing mechanism with the first plate and the second plate; and locking the lacing mechanism.

[0064] The method of surgical use may further comprise preoperative planning (not shown). Preoperative planning may comprise the steps of obtaining one or more images from a patient. The surgeon may determine the direction and magnitude of the symphysis pubis disruption and the relative position of the pubic bones. The surgeon may obtain anterior- posterior, caudal and cephalad views. The images in the different views or planes would assist the surgeon in the determination of height differences in the height of the pubic rami and displacement in other planes. The one or more images may comprise X-ray radiographs, fluoroscopy or computed tomography (CT) images. The preoperative planning may also facilitate the creation of 3D images to create a virtual model of the first plate 2a, 26a, 30a and / or the second plate 2b, 26b, 30b. The virtual model may be used to create the implants used in surgery.

[0065] The method of surgical use may further comprise the step of preparing for surgical intervention (not shown). The step of preparing for surgical intervention comprises the steps of: positioning patient onto table; operative one or more operative images; and incising the patient. Surgery should be performed under general anesthesia. The patient is positioned supine on a radiolucent table that can accommodate the desired imaging system. The surgeon should obtain one or more operative images, including AP, cephalad, and caudal views of the pelvis. The desired incision type is selected for optimal reduction and fixation of the symphysis. The surgeon may attempt to avoid or limit transverse sectioning of the rectus abdominis because it impairs subsequent repair and healing of the abdominal wall. The surgeon mayprotect the bladder with instrumentation, and may minimally elevate the rectus from pubic body on each side of the symphysis to accommodate plate footprint.

[0066] The internal pelvic binder fixation system 2, 26, 30 comprises the step of inserting a first plate onto a first location of a first pubic bone and a second plate onto a second location of a second pubic bone. The step of inserting may comprise the steps of: determining size of first and second plates necessary; and deployment or positioning of first and second plates. Positioning and / or location of placement of the first plate onto the first pubic bone and the second plate onto the second pubic bone will be predetermined by the surgeon using one or more images from the desired imaging system. The inserting step may be performed prior to the symphyseal reduction and / or after symphyseal reduction with forceps or clamping tools.

[0067] The internal pelvic binder fixation system 2, 26, 30 comprises the step of anchoring the first plate onto the first location and the second plate onto the second location. Once the first and second plate are positioned onto the first and second pubic bones, the plates should be temporarily anchored in place onto the pubic bones. The anchoring may comprise Kirschner wires (K-wires) to secure the position of each plate. This allows the surgeon to further obtain one or more operative images to confirm ideal or desired placement.

[0068] The internal pelvic binder fixation system comprises the step of fixating the first plate onto the first location on the first pubic bone and the second plate onto the second location on the second pubic bone. The step of fixating may further comprise the steps of: identifying the fixation screw length; and / or creating one or more bone holes into first and / or second pubic bodies. The one or more bone hole trajectories may already be predetermined based on the first and second plate design of the first and second plurality of screw openings. Alternatively, the best orientation or trajectories for each of the first and second plurality of fixation screws can be determined by obtaining one or more operative images. Depth gages may be used to obtain measurements to approximate the length of the fixation screws. Once the imaging system confirms position of first and second plates and fixation screw trajectories, the first and second plurality of fixation screws are secured to the first and second plates. The appropriate size drill bit with a drill sleeve or guide may be used to create the one or more bone holes. A drill guide directs the drill trajectory for maximum screw length and density, and minimizes screw collisions for each fixation screw placed on each first and second plate. Fixation screws can also be drilled and placed independent of the drill guide. The maximum number of screws required for each first and second plate can be surgeon- and patient-dependent. Patients with compromised bone quality will benefit from maximum screw density.

[0069] The internal pelvic binder fixation system 2, 26, 30 comprises reducing the separation between the first pubic bone and the second pubic bone. In one embodiment, at least a portion jaws of the bone forceps and / or clamps may be positioned or disposed onto or into the first and second toe-holds of the first and second plates, respectively. The bone forces or clamps may comprise Farabeuf clamps, Jungbluth clamps, Weber clamps, reduction forceps, Verbrugge forceps and / or any combination thereof. Manipulation of the clamps or forceps hands allows reduction in multiple planes and compression. Reduction may be performed while using the imaging system.

[0070] In another embodiment, the reduction can be obtained using the one or more lacing mechanisms 17. The one or more lacing mechanisms 16 can engage the first plurality of fastening elements of the first plate and the second plurality of fastening elements of the second plate. The surgeon may apply tension on the one or more flexible lacing mechanism with to reduce the separation between the first and second pubic body.

[0071] In another embodiment, the reduction can be obtained by direction manipulation of the first and second pubic bone with clamps or forceps. The surgeon may apply the jaws of various large, pointed reduction clamps or forceps on each side of the symphysis - either laterally to the pubic tubercles or onto the edges of the obturator foramina. Manipulation of the clamps or forceps hands allows reduction in multiple planes and compression. Reduction may be performed while using the imaging system. This step may be performed prior to the insertion of the first and second plates to allow access to the bone(s).

[0072] The internal pelvic binder fixation system 2, 26, 30 comprises the step of engaging the lacing mechanism 16 with the first plate 2a, 26a, 30a and the second plate 2b, 26b, 30b. The one or more flexible lacing mechanisms 16 can engage the first plurality of fastening elements 18a, 18b, 20a, 20b, 28a, 28b of the first plate 2a, 26a, 30a and the second plate 2b, 26b, 30b. More specifically, the one or more flexible lacing mechanisms 16 can extend through the fastening passageways 28a, 28b, 82a, 82b, 84a, 84b of the plurality of fastening elements 18a, 18b, 20a, 20b, 28a, 28b. If the lacing system 16 becomes compromised, or intentionally removed and replaced during revision surgery, the plating construct can be relaced using a new flexible lacing mechanism 16.

[0073] The internal pelvic binder fixation system 2, 26, 30 comprises the step of locking the lacing mechanism. Final securing or locking of the lacing system is done by applying several surgeon's knots to hand tie the laces. Knotless constructs may also be used. Alternatively, locking the lacing mechanism 16 may comprise the use of anchoring elements 86.

[0074] The internal pelvic binder fixation system 2, 26, 30 comprises the step of finalizing the patient. After fixation and locking step, the imaging system is used to verify the final reduction and final position of the first and second plates by AP, inlet and outlet views. Routine closure of the rectus abdominis and deep / superficial layers is completed.

[0075] In another embodiment, the method of reducing pubic symphysis separation comprises the steps of: inserting a first plate onto a first location of a first pubic bone and a second plate onto a second location of a second pubic bone; anchoring the first plate onto the first location and the second plate onto the second location; fixating the first plate onto the first location on the first pubic bone and the second plate onto the second location on the second pubic bone; reducing the separation between the first pubic bone and the second pubic bone; engaging the lacing mechanism with the first plate and the second plate; and locking the lacing mechanism.

[0076] The first plate and the second plate are mirror images of each other. Each of the first plate and the second plate comprises a body, a first leg and a second leg. The first leg of each of the first and second plates comprises a first leg bottom surface, the first leg bottom surface contacts a portion of the superior surface of the superior pubic ramus. The second leg of each of the first and second plates comprises a second leg bottom surface, at least a portion the second leg bottom surface contacts a portion of the body of the first and second pubic bones. The portion of the body of the first and second pubic bones comprises the body posterior surface.

[0077] The anchoring step comprises the steps of: inserting anchoring pins through a plurality of anchoring openings disposed on the first and second plates into the first and second pub bones; and confirming first plate on the first location and the second plate on the second location using imaging, the fixating step comprises the steps: creating or generating or planning a plurality of fixation screw trajectories or screw orientations using a plurality of screw openings disposed onto the first and second plates; inserting the plurality of fixation screws into the plurality of screw openings on the first and second plates using the generated or planned plurality of fixation screw trajectories, the reducing step comprises the steps of: extending a portion of a surgical tool into a portion of at least one toe-hold disposed onto a portion of the first and second plates; and activating the surgical tool to reduce the separation between the first pubic bone and the second pubic bone. The engaging step comprises the step of weaving the flexible lacing mechanism through a plurality of fastening elements disposed onto the first and second plates.

[0078] The plurality of screw openings comprises a plurality of longitudinal axis, each of the longitudinal axis having a different trajectory or orientation. The lacing mechanism comprises a flexible lacing mechanism, the flexible lacing mechanism comprises a textile strand or suture or textile suture assembly. The textile suture or textile suture assembly comprises a biodegradable polymer or a non-biodegradable polymer. The flexible lacing mechanism comprises a metallic strand or suture. The metallic strand or suture comprises tantalum, silver, copper, aluminum, vitallum, stainless steel, Nitinol and any combination thereof. The locking of the flexible lacing mechanism comprises a knotted or knotless locking.

[0079] Method of Making or Manufacturing a Pelvic Fixation Plate

[0080] FIGS. 10 and 11 A-11 F depicts a flowchart of one embodiment of a method of making the pelvic plates. The method of making at least one pelvic plate comprises the steps of: creating a 3D model of the pubis (first and second pubic bones) of a patient; analyzing one or more bone characteristics of the first and / or second pubic bones; generating one or more fixation screw trajectories using the one or more bone characteristics; inserting one or more virtual fixation screws into the 3D model to substantially match or match the one or more screw trajectories; and generating at least one plate virtual profile or model that matches or substantially aligns with the one or more fixation screw trajectories.

[0081] The method of making at least one pelvic plate comprises the step of creating a 3D model of the pubis (first and second pubic bones) of a patient. Preoperative images may be used to be able to create a 3D patient-specific model of a patient. Alternatively, several historical preoperative images from a database may be used to create a “generic” or “best fit” 3D model of the pubis for a patient. The patient may comprise a male, female or pediatric patients.

[0082] The method of making at least one pelvic plate comprises the step of analyzing the one or more bone characteristics of the first and second pubic bones. The 3D model generated from the one or more preoperative images may be used to analyze the bone density, bone planes 66b, bone irregularities (not shown), and / or fractures (not shown). Fixation screw trajectories may be predetermined based on the optimal bone surfaces, density, and / or thickness.

[0083] The method of making at least one pelvic plate comprises the step of generating one or more screw trajectories 64 using the one or more bone characteristics, one or more bone planes 66b, and inserting one or more virtual fixation screws 24b into the 3D model to match or substantially match the one or more bone trajectories 64b. Once the optimal screw trajectories are identified, a plurality of virtual screw openings or holes and its respective plurality of virtualtrajectories are introduced into the 3D model. In one example, a 3.5 mm cancellous fixation screw was preferred. The virtual screw openings and its virtual trajectories were modeled to accommodate the 3.5 cancellous fixation screw as shown in FIGS. 8A-8C. The lengths of each screw can be adjusted in the 3D model to obtain an optimal screw placement without collision to the adjacent fixation screw.

[0084] The method of making at least one pelvic plate comprises the step of generating at least one plate virtual profile and model that aligns or substantially matches the one or more fixation screw trajectories as shown in FIGS. 8A-8C and 11A-11 B. As shown in FIG. 11A-11C, a path, referred to as the guide or screw trajectory 64b, was drawn into the 3D model that intersected the head of each fixation screw. For the screws nearest the symphysis, the guide trajectory passed exactly between two screws 24b. Planes 66b were then created along this path at points coincident with the screw centers, and a side profile of the plate was sketched. The plate profile features dimensions with a hole inner diameter, plate thickness, and a minimum width from hole to plate edge, all globally parameterized. Each fixation screw virtual model may feature an additional width from hole to edge for a smooth plate shape. The 3D model also has an angular dimension from screw head to plate. All plate profiles or geometries are angled, curved, or oriented to accommodate the cross-sectional geometry of the pubic bones in that plane.

[0085] A loft feature may be added to facilitate intersection of each of the sketch planes. An iterative optimization process should be executed with the one or more fixation screws. The iterative process into the 3D model allows the one or more fixation screws to rotated or angled to optimize fixation screw trajectories into the most desirable locations of each of the pubic bones. Once the optimized fixation screw trajectories were selected, the 3D virtual plate model was generated to obtain a smooth plate contour with maximal contouring to match or substantially match the pubic bones.

[0086] The plurality of fixation screw openings or holes were created within the virtual plate model as shown in FIG. 11 D. Using the screw heads, the orientations of the plurality of holes were confirmed, and the plurality of holes / openings were created in the plate. If desired, elongated holes or openings can be created to accommodate difficult areas of the anatomy that may change for each patient. In one embodiment, at least one of the plurality of fixation screw openings may comprise an elongated opening or a slot. The elongated opening or slot allows the surgeon translate at least one fixation screw from a range of 0.5 mm to 2 mm in length (e.g., the length of the slot) to avoid intersection with the patient’s bladder. The at least one fixation screw may comprise an oblique trajectory to avoid the patient’s bladder. Also, the elongatedopening may be sized and configured to accommodate a portion of the at least one fixation screw head and threaded shank because the at least one threaded screw may be fixated at an oblique trajectory. The elongated opening may allow 1-5 mm of travel for the fixation screw. The at least one elongated opening or slot may further include a boss or extrusion from the plate to create a more appropriate point of contact for the at least one fixation screw. The plurality of opening or holes may be filleted and / or counterbored to hide the fixation screw head. The counterbore may comprise a concave shape to accommodate different screw trajectories.

[0087] Lastly, the plurality of fastening elements 18a, 18b, 20a, 20b, 28a, 28b was introduced into the 3D virtual plate model. A fastener path was drawn along at least a portion of the perimeter edge of the plate as shown in FIG. 11 E. More specifically, the fastener path was drawn onto the 3D virtual plate model along at least a portion of the perimeter of the plate body and the second leg. A plurality of fastening elements was generated to follow or align with the fastener path as shown in FIG. 11 E. The plurality of fastening elements 18a, 18b, 20a, 20b, 28a, 28b may comprise passageways, rings, grommets or eyelets. The plurality of fastening elements is sized and configured to receive a portion of the lacing mechanism 16. The lacing mechanism may comprise a suture assembly similar to the ARTHREX TIGHTROPE system (Arthrex, Inc., Naples, FL). The rings may include a “U” shaped ring or a “D” shaped ring. At least a portion of the lacing mechanism and / or the fastening elements may be fixed to the plate.

[0088] The first 3D virtual plate model and the plurality of fixation screws (“plate system”) were mirrored about the pubic symphysis to create a second 3D virtual plate model with fixation screws (plate system) as shown in FIG. 11 F. The first 3D virtual plate system was positioned onto the first pubic bone and the second 3D virtual plate system was positioned onto the second pubic bone. The second 3D virtual plate system was slightly adjusted onto the second pubic bone to adjust to asymmetries in the second pubic bone anatomy. Once the desired positioning onto the second pubic body was achieved, the first and second 3D virtual plate system can be reviewed to ensure that there are no fixation screw or plate interference between the first and second plates. Alternatively, a second 3D virtual plate model may be created to accommodate the second pubic bone rather than mirroring the first 3D virtual plate model.

Claims

CLAIMS l / we claim:

1. A dynamic pelvic fixation system comprising: a plurality of fixation screws; and a first pelvic plate and a second pelvic plate; each of the first pelvic plate and the second pelvic plate comprises a first leg, a second leg, a plurality of fixation screw openings, and a plurality of fastening elements, the first leg having a first longitudinal axis and the second leg having a second longitudinal axis, the first longitudinal axis of the first leg is nonparallel to the second longitudinal axis of the second leg, the plurality of fixation screw openings disposed onto the first pelvic plate and a second pelvic plate, the plurality of fixation screw openings having a plurality of screw opening longitudinal axis, at least a portion of the plurality of fastening elements including a fastening passageway, the at least a portion of the fastening elements disposed onto the second leg, a lacing mechanism, the lacing mechanism is disposed between the first pelvic plate and the second pelvic plate and engages with the at least a portion of the plurality of fastening elements on the first pelvic plate and the second pelvic plate.

2. The dynamic pelvic fixation system of claim 2, wherein the lacing mechanism engages with the at least a portion of the plurality of fastening elements on the first pelvic plate and the second pelvic plate comprises at least a portion of the lacing mechanism extending through the fastening passageway.

3. The dynamic pelvic fixation system of claim 1 , wherein each of the first and second pelvic plates further comprises a plurality of anchoring openings, each of the anchoring openings are sized and configured to receive a plurality of anchoring pins.

4. The dynamic pelvic fixation system of claim 1, wherein the plurality of screw opening longitudinal axis comprises a plurality of longitudinal axis trajectories, each of the plurality of longitudinal axis trajectories are different.

5. The dynamic pelvic fixation system of claim 4, wherein each the plurality of longitudinal axis trajectories does not intersect.

6. The dynamic pelvic fixation system of claim 1 , wherein the lacing mechanism comprises a flexible lacing mechanism, the flexible lacing mechanism comprises a suture assembly.

7. The dynamic pelvic fixation system of claim 6, wherein the suture assembly comprises anchoring elements.

8. The dynamic pelvic fixation system of claim 6, wherein the flexible lacing mechanism allows motion of the first pelvic plate relative to the second pelvic plate.

9. The method of reducing pubic symphysis separation comprises the steps of:Positioning a first pelvic plate onto a first pubic bone at a first location and a second pelvic plate onto a second pubic bone at a second location;Fixating the first plate onto the first location on the first pubic bone and the second plate onto the second location on the second pubic bone;Engaging the lacing mechanism between the first plate and the second plate; andLocking the lacing mechanism.

10. The method of claim 9, wherein the first pelvic plate and the second pelvic plate are mirror images of each other.

11. The method of claim 9, wherein each of the first plate and the second plate comprises a first leg and a second leg.

12. The method of claim 11, wherein the first leg of each of the first and second pelvic plates contacts a portion of the superior surface of the superior pubic ramus of the first and second pubic bones, and a second leg of each of the first and second pelvic plates contacts a portion of the posterior surface of the pubic body of the first and second pubic bones.

13. The method of claim 9, wherein the positioning step further comprises: anchoring the first pelvic plate onto the first pubic bone at the first location and anchoring the second pelvic plate onto the second pubic bone at the second location; and reducing the separation between the first pubic bone and the second pubic bone.

14. The method of claim 13, wherein the anchoring step comprises the step of inserting a first anchoring pin through a first anchoring opening disposed on the first pelvic plate into the first pubic bone and a second anchoring pin through a second anchoring opening disposed on the second pelvic plate into the second pubic bone.

15. The method of claim 9, wherein the fixating step comprises the step of inserting a plurality of fixation screws through a plurality of screw openings disposed onto the first and second pelvic plates.

16. The method of claim 15, wherein the plurality of screw openings comprises a plurality of longitudinal axis, each of the plurality of longitudinal axis having a plurality of different trajectories.

17. The method of claim 13, wherein the reducing step comprises the steps of:Extending a first portion of a surgical tool into a first toe-hold disposed onto the first pelvic plate and a second portion of a surgical tool into a second toe-hold disposed onto a second pelvic plate;Activating the surgical tool to reduce the separation between the first pubic bone and the second pubic bone.

18. The method of claim 9, wherein the lacing mechanism comprises a flexible lacing mechanism, the flexible lacing mechanism comprises suture assembly.

19. The method of claim 18, wherein the suture assembly comprises anchoring elements.

20. The method of claim 18, wherein the engaging step comprises weaving the flexible lacing mechanism through a first plurality of fastening passageways of a first plurality of fastening elements disposed onto the first pelvic plate and a second plurality of fastening passageways of a second plurality of fastening elements disposed onto the second pelvic plates.

21. The method of claim 9, wherein the locking of the flexible lacing mechanism comprises a knotted or knotless locking.

22. The method of claim 18, wherein the locking of the flexible lacing mechanism allows motion of the first pelvic plate relative to the second pelvic plate.

23. The method of claim 11, wherein the first leg comprises a first longitudinal axis and the second leg comprises a second longitudinal axis, the first longitudinal axis is non-parallel to the second longitudinal axis.

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