Biplanar adjustable bone reduction plate with wedge window

Abstract

A bone fixation system includes a biplanar adjustable damaged bone fixation plate configured to facilitate an insertion of a graft material and to enable an adjustment and manipulation of a damaged bone after a fixation of the biplanar bone fixation plate to the bone, and a wedge window access point integrated into the bone fixation plate, the access point providing a passage for graft material insertion.

Description

Attorney Docket No. 409948-507001 WOBIPLANAR ADJUSTABLE BONE REDUCTION PLATE WITH WEDGE WINDOWCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit from U.S. Provisional Patent Application Serial No. 63 / 660,400, filed June 14, 2024, which is incorporated by reference in its entirety.BACKGROUND OF THE INVENTION

[0002] The present invention relates implants in the field of orthopedic surgery, and more particularly to a biplanar adjustable bone reduction plate with a wedge window.

[0003] In general, bone fractures are a common occurrence in both humans and animals. They can occur as a result of various incidents such as, for example, accidents, falls, sports injuries, and so forth. The treatment of bone fractures often involves the use of a mono-plane bone fixation plate (e.g., a metal plate). For correcting bone fractures or malalignments, the mono-plane plate is an internal splint or fixation that is attached to the bone with fasteners such as screws, wires, pegs, or adhesives. These plates are usually made of surgical grade stainless steel or titanium. After the surgery, the plate can be removed during a surgical procedure, or it can remain in place for long-term.

[0004] What is needed are surgical bone fixation devices, in particular for correction of bones with fractures, malalignment, bone loss or fragmentary damage.SUMMARY OF THE INVENTION

[0005] The following presents a simplified summary of the innovation in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is intended to neither identify key or critical elements of the invention nor delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.

[0006] In an aspect, the invention features a bone fixation system, including a biplanar adjustable damaged bone fixation plate configured to facilitate an insertion of a graft material and to enable an adjustment and manipulation of a damaged bone after a fixation of the biplanar bone fixation plate to the bone, and a wedge window access point integrated into the bone fixation plate, the access point providing aAttorney Docket No. 409948-507001 WOpassage for graft material insertion, wherein a first fragment of the damaged bone can be moved towards the graft material and away from the graft material before and after the graft material insertion, and wherein the first fragment and a second fragment of the damaged bone can be moved towards the graft material to provide a graft material compression, wherein the plate includes a locking mechanism operative to lock the first fragment and / or the second fragment into a position and then to unlock the first fragment and / or the second fragment from the position.

[0007] In another aspect, the invention features a method for treating a subject in need of a bone adjustment, the method including the steps of (1) obtaining a biplanar adjustable damaged bone fixation plate configured to facilitate an insertion of graft material and to enable an adjustment and manipulation of a damaged bone after a fixation of the biplanar adjustable damaged bone fixation plate to the bone, and a wedge window access point integrated into the bone fixation plate, the access point providing a passage for a graft material insertion, (2) affixing the biplanar bone fixation plate to a first fragment of the damaged bone by placing a fastener through an oval compression slot in the biplanar bone fixation plate and into the bone, whereby the biplanar adjustable damaged bone fixation plate provides a normal bone trajectory that is operative to align a second fragment of the damaged bone with the first fragment, (3) affixing the biplanar bone fixation plate to the second fragment of the damaged bone, (4) opening and / or closing a graft space between the first fragment and the second fragment by loosening the fastener in the oval compression slot and moving the first fragment and / or the second fragment to widen a space in the wedge window to accept the graft material, and (5) inserting the graft material through the wedge window access point and affixing the graft material to the biplanar adjustable damaged bone fixation plate.

[0008] In still another aspect, the invention features a kit suitable for a sale, the kit including at least one biplanar adjustable damaged bone fixation plate, wherein the plate is configured to facilitate an insertion of a graft material and to enable an adjustment and manipulation of a damaged bone after a fixation of the biplanar bone fixation plate to the bone, and a wedge window access point integrated into the bone fixation plate, the access point providing a passage for graft material insertion, wherein a first fragment of the damaged bone can be moved towards the graft material and away from the graft material before and after the graft materialAttorney Docket No. 409948-507001 WOinsertion, and wherein the first fragment and a second fragment of the damaged bone can be moved towards the graft material to provide a graft material compression, wherein the plate includes a locking mechanism operative to lock the first fragment and / or the second fragment into a position and then to unlock the first fragment and / or the second fragment from the position.

[0009] These and other features and advantages will be apparent from a reading of the following detailed description and a review of the associated drawings. It is to be understood that both the foregoing general description and the following detailed description are explanatory only and are not restrictive of aspects as claimed.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 illustrates an exemplary damaged bone.

[0011] FIG. 2 illustrates an exemplary uniplanar superior plate that is used to fasten to a damaged bone 500.

[0012] FIG. 3 illustrates a front perspective view of a counter-arc biplanar wedge window plate according to some aspects of the present invention.

[0013] FIG. 4 illustrates a back perspective view of a counter-arc biplanar wedge window plate.

[0014] FIG. 5 illustrates a counter-arc biplanar wedge window plate moveably affixed to a first fragment of a damaged bone.

[0015] FIG. 6 illustrates how a second fragment has now been moved along a corrective arc to align with normal bone trajectory and the large malalignment has now been reduced to a bone gap.

[0016] FIG. 7 illustrates how the bone gap has been set to a fixed position and sliding fastener has been subsequently tightened firmly into the first sliding screw hole to hold first fragment in a fixed position, and a BB-Tak is snugly holding second fragment so that a measurement of the bone gap can now be done.

[0017] FIG. 8 illustrates a widening of the bone gap to a larger bone gap capable of accepting a bone graft during the surgery.

[0018] FIG. 9 illustrates an enlarged front view of FIG. 8 but wherein the bone graft has been inserted through the wedge window and into the larger bone gap while the sliding fastener is tightened into first sliding screw hole.

[0019] FIG. 10 illustrates a clamp is used to hold the bone graft tightly against first plane of the counter-arc biplanar wedge window plate.Attorney Docket No. 409948-507001 WO

[0020] FIG. 11 illustrates a compression that is placed upon the bone graft by moving the first fragment because the sliding fastener in the first sliding screw hole has been loosened.

[0021] FIG. 12 illustrates how the bone graft is compressed, and a sliding fastener is tightened in second sliding screw hole.

[0022] FIG. 13 illustrates the orthogonal screw placement into first plane screw holes and into second plane screw holes as the surgeon is finishing up the precision guided surgery.

[0023] FIG. 14 illustrates an example method for treating a damaged bone in a subject in need.

[0024] FIG. 15 illustrates an example method for making a biplanar adjustable damaged bone fixation plate.DETAILED DESCRIPTION

[0025] The subject innovation is now described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It may be evident, however, that the present invention may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form in order to facilitate describing the present invention.

[0026] In general, older plate implant technologies do not provide a precision guided surgery to an optimum outcome, and instead, place a huge burden on the surgeon to make critical decisions during the actual surgery. In a broad embodiment, the present invention provides an implant system that is intelligently thought out and planned to provide a precision (and predictable) surgical outcome, namely, that the bone with a fracture and / or a bone with a malalignment is precision guided by the surgery for a near perfect long-term healing outcome.

[0027] In some embodiments, the plate implants disclosed herein can include markings (or etchings) on the implants. According to some aspects, the markings guide a surgeon to the exact bone position, where to fasten an implant, where to place a graft material, where to remove a portion of bone, where to drill for a fastener or connection, or how deep to insert a fastener.Attorney Docket No. 409948-507001 WO

[0028] In accordance with embodiments, a bone treatment system is provided. The system includes an adjustable bone treatment plate that facilitates an insertion of a treatment material and enables the adjustment and manipulation of a treated bone after the plate is fixed to the bone. The system also includes a securing mechanism that secures a first and / or second bone fragment into a secured position and then can release one or both fragment(s) from the secured position during graft placement. For example, if a gap needs to be widened between the two broken bones to accept a graft, the surgeon can accomplish this after the plate has already been installed. A wedge window can then be closed compressing the fragment from both sides while maintaining the corrected bone angulation.

[0029] In other embodiments, a method of treating a bone is disclosed. The method may involve providing a bone treatment system that includes an adjustable bone treatment plate and a securing mechanism. A treatment material is inserted into a treated bone using the adjustable bone treatment plate. The treated bone is adjusted and manipulated after the plate is fixed to the bone. A first and / or second bone fragment is secured into a secured position and then released from the secured position using the securing mechanism.

[0030] In accordance with some other embodiments, a bone fixation system is provided. The system includes a biplanar adjustable damaged bone fixation plate designed to facilitate the insertion of graft material and enable the adjustment and manipulation of a damaged bone after the plate is fixed to the bone. The plate may also include a wedge window access point for graft material insertion. The system allows for movement of bone fragments towards and away from the graft material before and after its insertion and includes a locking mechanism to lock and unlock bone fragments into position.

[0031] In other embodiments, a method for treating a subject in need of bone adjustment is provided. The method involves obtaining and affixing the biplanar adjustable damaged bone fixation plate to the damaged bone, opening and / or closing a graft space between bone fragments, and inserting the graft material through the wedge window access point.

[0032] In yet other embodiments, a method of making the biplanar adjustable damaged bone fixation plate is provided. The method involves receiving data representing a surgical assessment of a subject, superimposing a targeted boneAttorney Docket No. 409948-507001 WOshape over the data for the bone with a mal-alignment and / or fracture, overlaying a biplanar adjustable damaged bone fixation plate image with the superimposition, and adjusting the plate’s size, shape, and / or angles to plan a surgery for re-aligning the bone. The adjusted plate data is then outputted for manufacturing or obtaining a premanufactured plate, which is then provided for the surgery.

[0033] The present invention provides biplanar bone trauma plates that are stronger, thinner, more affordable, and better for complex fractures, osteotomies, and bone revisions than any prior art single or two-plate constructs. Prior art mono-planar plates (both single and double plates) fail in providing suitable torsion for a bone. Prior art mono-planar plates are too thick, and the hardware irritation leads to revision surgeries. Using double plates causes, in general, double the cost.

[0034] For example, FIG. 1 shows a damaged bone 500. It should be understood that the damaged bone 500 can be a bone with a fracture, a bone with a malunion, a bone with a malalignment, a bone with a defect (e.g., a genetic defect and / or an environmentally caused defect), or a bone that is in need of shortening or lengthening. The damaged bone has a first fragment 505 and a second fragment 510. The damaged bone 500 can have a bone gap 515. In some embodiments, a bone graft 520 can be used. According to some aspects, the bone graft 520 can represent a filler or a material, a metal or an alloy, a natural material, or a combination thereof.

[0035] Examining an older mono-plane plate, FIG. 2 depicts an older uniplanar superior plate 525 that is used to hold first fragment 505 and second fragment 510 together after a bone graft 520 has been positioned in bone gap 515 by a surgeon. As discussed below, the present invention can, in some embodiments, change the dynamics of such a surgery by enabling placement of a bone graft 520 after a precision alignment of a damaged bone 500.

[0036] In FIG. 3, the counter-arc biplanar wedge window plate 600 is a medical device that serves to stabilize bone fragments and to support the healing process by allowing for the placement of graft material into the site of bone damage. The graft material, which can vary in composition, acts as a scaffold to promote new bone growth. The design of the plate facilitates precise placement of this material through the wedge window access point.Attorney Docket No. 409948-507001 WO

[0037] Moreover, the plate is engineered to allow for the movement of bone fragments, enabling surgeons to align the fragments in relation to the graft material both before and after its insertion. This adjustability is key for setting the bone fragments in the desired position for healing.

[0038] In general, the plate for the surgery is selected based on the specific anatomical and pathological characteristics of the damaged bone. This selection is part of the preparatory process for the surgical procedure, ensuring that the hardware is tailored to the patient's needs. The biplanar design, adjustability, and the wedge window access point are features that facilitate the treatment of bone damage by allowing for the alignment and stabilization of bone fragments and the insertion of graft material.

[0039] The surgery can involve affixing a biplanar bone fixation plate to a first fragment of a damaged bone by placing a fastener through an oval compression slot in the plate and into the bone. The biplanar bone fixation plate is designed to be adjustable in at least two planes and in rotations to match the contours of the damaged bone. The oval compression slot allows for movement of the fastener and / or the bone, which is essential for adjusting the position of the bone fragments. The fastener, typically a screw or pin, secures the plate to the bone. A specialized surgical instrument, driver, or drill is used to drive the fastener through the slot and into the bone.

[0040] During an orthopedic surgical procedure, a surgeon aligns the plate with the first bone fragment and uses the driver, drill, or instrument to insert the fastener. This step stabilizes the bone and maintains proper alignment to facilitate healing. The plate provides a trajectory that is operative to align a second fragment of the damaged bone with the first fragment, which is necessary for the bone's proper healing and function restoration. The size and position of the fastener and the adjustments to the plate are determined by the patient's specific anatomy and the nature of the fracture or malalignment. This generally described without specific measurements or mathematical constructs, but these would be considered based on the individual surgical case.

[0041] A second fragment of the damaged bone might need rotated or moved to align with a normal bone trajectory. The next step involves the process of securing the biplanar bone fixation plate to the second fragment of a damaged bone. ThisAttorney Docket No. 409948-507001 WOstep is conducted after the plate has been attached to the first bone fragment. The procedure requires the use of a fastener, which is typically a screw, to be placed through an oval compression slot in the plate and into the bone. The oval compression slot is designed to allow for some manipulation and movement, which is necessary for adjusting the position of the bone fragments and for the insertion of graft material in subsequent steps.

[0042] The present invention can radically change the order of execution of steps in a surgery. For example, the biplanar adjustable damaged bone fixation plate can be first attached to the damaged bone, then a graft material can be inserted and compressed. In prior art surgeries, it is typical to insert a graft material before affixing a mono-plane plate. The present invention involves the adjustment of the bone fragments and the space designated for graft material after the biplanar adjustable damaged bone fixation plate has been affixed to bone. This step is conducted during orthopedic surgery to prepare for the insertion of graft material into a bone that has been damaged. The process includes loosening a fastener that has been placed through an oval compression slot in a biplanar bone fixation plate. This fastener is initially used to secure the plate to the bone fragments, providing stability and alignment. By loosening the fastener, a surgeon can modify the position of the bone fragments relative to each other, specifically to increase the space between them. This increase in space is necessary to create an adequate area to accommodate the graft material, which will assist in the healing process by providing support for new bone growth or by filling a void.

[0043] The bone fragments can be secured into a new position that maintains the increased space created for the graft material. The mechanism for this is part of the biplanar bone fixation plate and is designed to hold the bone fragments in a desired position after they have been adjusted. This mechanism must be engaged to prevent any movement that could affect the space or the alignment of the bone fragments during the healing process.

[0044] Next, the insertion of graft material through the wedge window access point integrated into the bone fixation plate is enabled after bone fixation. This step is performed after the bone fixation plate has been affixed to the bone fragments, and a space has been created to receive the graft material. The graft material is placed into this space to serve as a scaffold for bone regeneration and to aid in the healingAttorney Docket No. 409948-507001 WOprocess. The wedge window access point facilitates the passage of the graft material without additional incisions or manipulation of the bone, which is intended to minimize the risk of further injury or infection.

[0045] The next step involves the action of pushing the first and second bone fragments against the inserted graft material, resulting in the compression of the graft material between the bone fragments. This action is performed to stabilize the bone fragments and graft material, enhancing the contact and integration between the graft and the bone to support the healing process. The compression is achieved by manipulating the bone fixation plate and using its locking mechanism to maintain the desired level of compression.

[0046] The present invention provides for the adjustment of torsion for either or both the first and second bone fragments. Torsion refers to the twisting of these fragments around their longitudinal axis. During this step, a surgeon manipulates the bone fragments to correct rotational misalignments resulting from injury. The surgeon, bone fragments, and the previously affixed biplanar adjustable damaged bone fixation plate are the primary components of this step. The surgeon assesses the degree of torsional misalignment and then physically manipulates the bone fragments to achieve the desired alignment, which may involve rotating the fragments relative to each other and the rest of the bone.

[0047] The action of adjusting torsion ensures that the bone heals in an alignment that replicates its original structure, which is necessary for the restoration of function. This adjustment is typically done manually but may also involve surgical instruments designed to grip and rotate the bone fragments. The biplanar adjustable damaged bone fixation plate provides stability during this process and may have features that allow controlled movement of the attached bone fragments.

[0048] The is to achieve an alignment that closely matches the bone's original structure. The success of this step can be assessed by post-operative imaging, which confirms that the bone fragments have been correctly aligned, including rotationally. The locking mechanism of the plate may then be engaged to maintain the alignment during the healing process.

[0049] Even after affixing a biplanar adjustable damaged bone fixation plate, an initial freshening up of a fracture and debriding any dead bone can be done. This step is a surgical procedure that prepares the bone for subsequent fixation using aAttorney Docket No. 409948-507001 WObiplanar adjustable damaged bone fixation plate. The action of freshening up a fracture refers to the surgical act of removing non-viable bone tissue to create a stable surface on the bone fragments to promote healing and facilitate the integration of the fixation plate and graft material. This is typically done using specialized instruments such as curettes, rongeurs, or burrs to scrape away the damaged tissue. The goal is to stimulate the bone's natural healing response by creating a surface that can form a callus, which is the new bone tissue that will bridge the fracture.Debriding dead bone involves the surgical removal of necrotic bone tissue that cannot contribute to the healing process. This is performed to reduce the risk of infection and to ensure that only viable bone tissue remains, which can then properly integrate with the graft material and the fixation plate. The surgeon performs the debridement and freshening by manipulating the instruments to remove the unwanted tissue, while preserving healthy bone. This is done to create optimal conditions for bone healing and to prepare the site for the subsequent steps of graft material insertion and bone fixation.

[0050] In more detail, FIG. 3 shows a front perspective view of a counter-arc biplanar wedge window plate 600 according to some aspects of the present invention. The counter-arc biplanar wedge window plate 600 includes a first sliding screw hole 605, a second sliding screw hole 610, and a wedge window 615. The counter-arc biplanar wedge window plate 600 includes a first plane 623, a second plane 625, and a curvature 624 disposed between the planes. The curvature 624 can include an angle between the planes. The angle can be in a range from about degrees to about 150 degrees. In FIG. 3, the angle is about 90 degrees. The curvature 624 can be configured to fit a curvature of any bone. The first plane screw holes 635 and the second plane screw holes 637 can be configured to fit any type of fasteners. The angle screw holes 630 can accommodate a screw or a fastener at various angles.

[0051] FIG. 4 shows a back perspective view of a counter-arc biplanar wedge window plate 600. The wedge window 615 is depicted along a length of the second plane 625. It should be understood that the first sliding screw hole 605 and the second sliding screw hole 610 can be configured in the second plane 625.

[0052] FIG. 5 shows a damaged bone 500 with a large malalignment 516 is undergoing a surgical repair using counter-arc biplanar wedge window plate 600.Attorney Docket No. 409948-507001 WOFirst, the counter-arc biplanar wedge window plate 600 is affixed to first fragment 505 by attaching a sliding fastener 640 through the first sliding screw hole 605. The sliding fastener 640 can be tightened snugly into first sliding screw hole 605 at this time to provide a normal bone trajectory 645 along first fragment 505. This can provide a guide along normal bone trajectory 645 to place the second fragment 510 into contact with counter-arc biplanar wedge window plate 600. FIG. 6 depicts how the second fragment 510 has now been moved along a corrective arc 517 to align with normal bone trajectory 645 and the large malalignment 516 (FIG. 5) has now been reduced to a bone gap 515 (FIG. 6). Now that the counter-arc biplanar wedge window plate 600 has been used to align first fragment 505 and second fragment 510, the sliding fastener 640 in first sliding screw hole 605 can be loosened or tightened to further adjust bone gap 515, and a BB-Tak 690 can be used to temporarily affix counter-arc biplanar wedge window plate 600 to the second fragment 510. In some embodiments, a K-wire or any other fastener can be used in place of the BB-Tak 690 to hold second fragment 510.

[0053] FIG. 7 shows how, the bone gap 515 has been set to a fixed position, and sliding fastener 640 has been subsequently tightened firmly into the first sliding screw hole 605 to hold first fragment 505 in a fixed position, and BB-Tak 690 is snugly holding second fragment 510 so that a measurement 700 of the bone gap 515 can now be done. It is contemplated that the measurement 700 can be done by any means known in the art. The measurement 700 can be utilized to design a bone graft 520 or any healable filler for bone gap 515.

[0054] After the measurement 700 has been taken in FIG. 7, the sliding fastener 640 can be loosened in the first sliding screw hole 605 as is shown in FIG. 8. In the example shown in FIG. 8, the first fragment 505 has been moved to now provide a larger bone gap 518 as is shown by the larger measurement 701 in addition to the measurement 700 (from FIG. 7). The larger bone gap 518 can be used to fit in or to accommodate a bone graft 520. After the larger bone gap 518 is made, the bone graft 520 can be inserted as shown in FIG. 9.

[0055] FIG. 9 shows an enlarged front view of FIG. 8 but wherein the bone graft 520 has been inserted through the wedge window 615 and into the larger bone gap 518 while the sliding fastener 640 is tightened into first sliding screw hole 605. Now an appropriate clamp can be placed upon the bone graft 520. In FIG. 10, a clampAttorney Docket No. 409948-507001 WO710 is used to hold the bone graft 520 tightly against first plane 623 of the counterarc biplanar wedge window plate 600. While the clamp 710 is holding bone graft 520, an angle screw 715 is affixed through one of the angle screw holes 630 and into bone graft 520 to begin to hold bone graft 520 without the need for the clamp 710. Also, a sliding fastener 640 has been inserted through second sliding screw hole 610 and is firmly tightened into the second fragment 510. Subsequently, the sliding fastener 640 that is in the first sliding screw hole 605 can be loosened to provide a compression on the bone graft 520 that is shown in FIG. 11.

[0056] FIG. 11 shows a compression 519 that is placed upon the bone graft 520 by moving the first fragment 505 because the sliding fastener 640 in the first sliding screw hole 605 has been loosened. After the compression 519 is applied, the sliding fastener 640 in the first sliding screw hole 605 can be firmly tightened. In FIG. 12, the bone graft 520 is compressed, and a sliding fastener 640 is tightened in second sliding screw hole 610. The sliding fastener 640 is tightened in first sliding screw hole 605, and an additional angle screw 715 is fastened through angle screw holes 630 into the bone graft 520. An orthogonal screw 720 is shown being fastened through the first plane screw holes 635 and second plane screw holes 637. During the fixation of counter-arc biplanar wedge window plate 600, the surgeon can see the precision alignment through the wedge window 615. FIG. 13 depicts the orthogonal screw 720 placement into first plane screw holes 635 and into second plane screw holes 637 as the surgeon is finishing up the precision guided surgery. The first fragment 505 has been affixed to the bone graft 520 and to second fragment 510 by the counter-arc biplanar wedge window plate 600 while the surgeon has been able to work through the wedge window 615.

[0057] In some embodiments, the techniques described herein relate to a bone fixation system, including: a biplanar adjustable damaged bone fixation plate configured to facilitate an insertion of a graft material and to enable an adjustment and manipulation of a damaged bone after a fixation of the biplanar bone fixation plate to the bone; and a wedge window access point integrated into the bone fixation plate, the access point providing a passage for graft material insertion; wherein a first fragment of the damaged bone can be moved towards the graft material and away from the graft material before and after the graft material insertion; and wherein the first fragment and a second fragment of the damaged bone can be moved towardsAttorney Docket No. 409948-507001 WOthe graft material to provide a graft material compression; wherein the plate includes a locking mechanism operative to lock the first fragment and / or the second fragment into a position and then to unlock the first fragment and / or the second fragment from the position.

[0058] According to some aspects, the techniques described herein relate to a bone fixation system, wherein the wedge window access point provides a surgical window for a surgeon to execute at least one of a following surgical procedure: debride an end of the first fragment and / or the second fragment, remove a portion of bone, measure one or more spaces along a length of the damaged bone, perform an osteotomy, drill into a bone, align a bone, rotate a bone, manipulate a bone malalignment, fix a bone into a surgical position, and / or attach a fastener to a bone.

[0059] In some respects, the techniques described herein relate to a bone fixation system, wherein the biplanar adjustable damaged bone fixation plate includes one or more oval compression slots along a first plane and / or a second plane of the plate, each of the one or more oval compressions slots providing a locking and an unlocking mechanism for the first fragment and / or the second fragment of the damaged bone.

[0060] In some embodiments, the techniques described herein relate to a bone fixation system, wherein the biplanar adjustable damaged bone fixation plate includes a curvature disposed between the first plane and the second plane, the curvature matching a curvature of the damaged bone.

[0061] According to some aspects, the techniques described herein relate to a bone fixation system, wherein the curvature defines an angle of intersection between a length of the first plane and a length of the second plane.

[0062] In some aspects, the techniques described herein relate to a bone fixation system, wherein the angle is in a range from about degrees to about 150 degrees.

[0063] In some embodiments, the techniques described herein relate to a bone fixation system, wherein the biplanar adjustable damaged bone reduction plate allows a placement of a bone graft, a bone reduction, and a movement of a fractured bone after attachment of the biplanar adjustable damaged bone fixation plate to the damaged bone.

[0064] According to some aspects, the techniques described herein relate to a bone fixation system, wherein the damaged bone includes a bone with a fracture, aAttorney Docket No. 409948-507001 WObone with a malalignment, a bone with a genetic, an epigenetic, or a hereditary defect, a bone with a torsional defect, a bone with a length defect, a bone with a joint defect, a bone with a shape defect, a bone with an interior defect, or a combination thereof.

[0065] In some respects, the techniques described herein relate to a bone fixation system, wherein a fractured bone is reduced and moved after a fixation process.

[0066] In some embodiments, the techniques described herein relate to a bone fixation system, wherein the biplanar adjustable damaged bone fixation plate provides a normal bone trajectory after the biplanar adjustable damaged bone fixation plate is affixed to the first fragment of the damaged bone.

[0067] According to some aspects, the techniques described herein relate to a bone fixation system, wherein the second fragment of the damaged bone can be moved to a fit along the normal bone trajectory after the biplanar adjustable damaged bone fixation plate is affixed to the first fragment.

[0068] In some embodiments, the techniques described herein relate to a bone fixation system, wherein the second fragment of the damaged bone can be affixed to the normal bone trajectory after the second fragment is moved.

[0069] In some aspects, the techniques described herein relate to a bone fixation system, wherein the first fragment of the damaged bone can be moved away from the second fragment to provide an opening of a space between the first fragment and the second fragment, said opening suitable to provide an insertion of a graft material.

[0070] According to some aspects, the techniques described herein relate to a bone fixation system, wherein the biplanar adjustable damaged bone fixation plate is operative to provide a holding of the graft material after the insertion of the material.

[0071] In some respects, the techniques described herein relate to a bone fixation system, wherein the biplanar adjustable damaged bone fixation plate includes one or more angle screw holes, each of the one or more angle screw holes operative to accept an angle screw into a graft material or into a bone material at an angle in a range from about degrees to about 90 degrees.

[0072] According to some aspects, the techniques described herein relate to a bone fixation system, wherein the graft material includes an autograft material, anAttorney Docket No. 409948-507001 WOallograft material, a synthetic material, an alloy material, a material derived from a laboratory growth, a metal material, or a combination thereof.

[0073] In some aspects, the techniques described herein relate to a bone fixation system, wherein the biplanar adjustable damaged bone fixation plate includes one or more orthogonal fastener holes, each of the one or more orthogonal fastener holes operative to accept a fastener or a screw through the biplanar adjustable damaged bone fixation plate and into a material at an angle in a range from about 80 degrees to about 90 degrees.

[0074] In some embodiments, the techniques described herein relate to a method for treating a subject in need of a bone adjustment, the method including the steps of: (1) obtaining a biplanar adjustable damaged bone fixation plate configured to facilitate an insertion of graft material and to enable an adjustment and manipulation of a damaged bone after a fixation of the biplanar adjustable damaged bone fixation plate to the bone; and a wedge window access point integrated into the bone fixation plate, the access point providing a passage for a graft material insertion; (2) affixing the biplanar bone fixation plate to a first fragment of the damaged bone by placing a fastener through an oval compression slot in the biplanar bone fixation plate and into the bone; whereby the biplanar adjustable damaged bone fixation plate provides a normal bone trajectory that is operative to align a second fragment of the damaged bone with the first fragment; (3) affixing the biplanar bone fixation plate to the second fragment of the damaged bone; (4) opening and / or closing a graft space between the first fragment and the second fragment by loosening the fastener in the oval compression slot and moving the first fragment and / or the second fragment to widen a space in the wedge window to accept the graft material; and (5) inserting the graft material through the wedge window access point and affixing the graft material to the biplanar adjustable damaged bone fixation plate.

[0075] According to some aspects, the techniques described herein relate to a method, further including the step of: (4B) locking the first fragment and / or the second fragment into a position to hold the widened space into a position to accept the graft material.

[0076] In some respects, the techniques described herein relate to a method, further including the step of: (5B) pushing the first fragment and the second fragmentAttorney Docket No. 409948-507001 WOagainst the graft material, thereby compressing the graft material between the first fragment and the second fragment.

[0077] In some embodiments, the techniques described herein relate to a method, further including the step of: (2B) adjusting a torsion of the first fragment and / or the second fragment.

[0078] According to some aspects, the techniques described herein relate to a method, further including the step of: (2A) performing an initial freshening up of a fracture and / or debriding any of a dead bone.

[0079] In some aspects, the techniques described herein relate to a method, further including the step of: (0B) selecting an appropriately sized biplanar adjustable damaged bone fixation plate.

[0080] In some embodiments, the techniques described herein relate to a method, wherein the damaged bone is a clavicle, and wherein the method includes affixing the plate to a medial fragment of the clavicle through the oval compression slot.

[0081] According to some aspects, the techniques described herein relate to a method, wherein the method further includes reducing the plate to a lateral fragment of the clavicle and affixing the plate with BB-TAK pins to the lateral fragment.

[0082] In some respects, the techniques described herein relate to a method, wherein the method includes the step of: (3B) fine tuning a reduction between the first fragment and the second fragment and / or measuring a defect size through the wedge window.

[0083] In some embodiments, the techniques described herein relate to a method, wherein the method includes the step of: (4C) debride a bone graft material and / or cutting a bone graft material to an appropriate length.

[0084] According to some aspects, the techniques described herein relate to a method, wherein the graft space can be opened or widened by loosening a screw in the oval compression slot and moving a medial fragment to create a space in the wedge window to accept the graft material.

[0085] In some aspects, the techniques described herein relate to a method, further including the step of placing a bone graft between the first fragment and the second fragment and holding the bone graft in place with a clamp pressing on a top plane of the biplanar adjustable damaged bone fixation plate and on the bone graft.Attorney Docket No. 409948-507001 WO

[0086] In some embodiments, the techniques described herein relate to a method, further including fastening an angled screw through a superior hole in an upper plane of the biplanar adjustable damaged bone fixation plate and into the bone graft; wherein the screw can be at an angle into the bone graft to stabilize the graft.

[0087] According to some aspects, the techniques described herein relate to a method, wherein the medial fragment of the clavicle and the lateral fragment of the clavicle can be pushed against the bone graft, providing a bone compression.

[0088] In some respects, the techniques described herein relate to a method, wherein the biplanar adjustable damaged bone fixation plate can be fixed by placing screws orthogonally through an anterior surface and / or a superior surface of the plate and into the bone to optimize a torsional strength and a stability.

[0089] In some embodiments, the techniques described herein relate to a method, further including the step of: (0A) obtaining a surgical assessment of the subject, whereby data from the subject's bone with a damage is acquired.

[0090] In some aspects, the techniques described herein relate to a method, wherein the damaged bone includes a bone with a fracture, a bone with a malalignment, a bone with a genetic, an epigenetic, or a hereditary defect, a bone with a torsional defect, a bone with a length defect, a bone with a joint defect, a bone with a shape defect, a bone with an interior defect, or a combination thereof.

[0091] According to some aspects, the techniques described herein relate to a method, further including one or more of a following step of surgical planning methods are executed: one or more radiographs are loaded on a surgical planning software; a biplanar adjustable damaged bone fixation plate contour is planned to match a unique bone contour of the subject; a biplanar adjustable damaged bone fixation plate is sized and / or shaped to match a unique damaged bone area of the subject; one or more positions of one or more fasteners are planned to fasten the biplanar adjustable damaged bone fixation plate to a bone of the subject; a data-driven, artificial-intelligence, and / or machine-learning process is utilized to determine a size, contour, and / or wedge window on a biplanar adjustable damaged bone fixation plate to ensure a perfect execution of the surgical plan following a data established bone contour of the subject; and a screw trajectory and / or an adhesive placement is planned using overlays of one or more prototype biplanar adjustable damaged bone fixation plates, robotic assistance, and / or ultrasound guidance.Attorney Docket No. 409948-507001 WO

[0092] In some aspects, the techniques described herein relate to the method of claim 18, further including a biplanar adjustable damaged bone fixation plate includes one or more marking one the plate.

[0093] In some embodiments, the techniques described herein relate to a kit suitable for a sale, the kit including: at least one biplanar adjustable damaged bone fixation plate; wherein the plate is configured to facilitate an insertion of a graft material and to enable an adjustment and manipulation of a damaged bone after a fixation of the biplanar bone fixation plate to the bone; and a wedge window access point integrated into the bone fixation plate, the access point providing a passage for graft material insertion; wherein a first fragment of the damaged bone can be moved towards the graft material and away from the graft material before and after the graft material insertion; and wherein the first fragment and a second fragment of the damaged bone can be moved towards the graft material to provide a graft material compression; wherein the plate includes a locking mechanism operative to lock the first fragment and / or the second fragment into a position and then to unlock the first fragment and / or the second fragment from the position.

[0094] According to some aspects, the techniques described herein relate to a kit, further including instructions for use in a media format of a video, instructions with illustrations, written instructions, or a combination thereof.

[0095] In some embodiments, the techniques described herein relate to a method of making a biplanar adjustable damaged bone fixation plate configured to facilitate an insertion of a graft material and to enable an adjustment and manipulation of a damaged bone after a fixation of the biplanar bone fixation plate to the bone; and a wedge window access point integrated into the bone fixation plate, the access point providing a passage for graft material insertion; wherein a first fragment of the damaged bone can be moved towards the graft material and away from the graft material before and after the graft material insertion; and wherein the first fragment and a second fragment of the damaged bone can be moved towards the graft material to provide a graft material compression; wherein the plate includes a locking mechanism operative to lock the first fragment and / or the second fragment into a position and then to unlock the first fragment and / or the second fragment from the position; the method including the steps of: (1) in a computer system having at least a processor, software, and memory, (A) receiving data representing a surgicalAttorney Docket No. 409948-507001 WOassessment of a subject, including data for a bone with a fracture and / or a malalignment; (B) superimposing a targeted bone shape with a normal alignment over the data for the bone with a mal-alignment and / or a fracture; (C) overlaying a biplanar adjustable damaged bone fixation plate image with a superimposition of step (2), and adjusting a biplanar adjustable damaged bone fixation plate's size, shape, and / or an angle(s) to plan a surgery for re-aligning the bone with the fracture and / or mal-alignment to the targeted bone shape; (2) outside of the computer system, outputting data for the adjusted plate and / or angle(s) suitable for either manufacturing a biplanar adjustable damaged bone fixation plate and wedge window and manufacturing such, or suitable for obtaining a pre-manufactured plate; (3) providing the plate for a surgery for the subject; whereby the surgery and the plate provide a planned surgical outcome and will correct the fracture and / or malalignment in the subject.

[0096] In some aspects, the techniques described herein relate to a method, wherein the data representing a surgical assessment of the subject includes X-ray data of the bone with the malalignment.

[0097] According to some aspects, the techniques described herein relate to a method, further including adjusting an angle of at least one plane included in the plate to define a boundary of the bone.

[0098] In some embodiments, the techniques described herein relate to a method, further including placing one or more markings on the plate, and wherein the biplanar adjustable damaged bone fixation plate includes one or more markings operative to indicate to a surgeon where a position or a movement is planned during the surgery.

[0099] In some aspects, the techniques described herein relate to a method, wherein the adjusting of the plate's size, shape, and / or wedge window is further computed using one or more artificial intelligence (Al) methods or machine learning algorithms.

[0100] In some embodiments, the techniques described herein relate to a method, further including a planning of one or more positions and / or depths of one or more fasteners or adhesions for the plate to a bone of the subject; the one or more positions and / or depths configured to fit the bone of the subject.Attorney Docket No. 409948-507001 WO

[0101] In some embodiments, the techniques described herein relate to a method, further including generating a fastener trajectory and / or an adhesion scheme using a navigation, a robotic assistance, and / or an ultrasound input.

[0102] According to some aspects, the techniques described herein relate to a method, wherein a biplanar adjustable damaged bone fixation plate is made by a method including a 3D-printing.

[0103] In some embodiments, the techniques described herein relate to a method, further including making one or more iterative adjustments of the biplanar adjustable damaged bone fixation plate.

[0104] In some aspects, the techniques described herein relate to a method, wherein the method is executed at a location remote from the subject or from the planned surgery, and wherein the plate is provided in a form of a data for manufacture at or near the subject or the planned surgery.

[0105] In some embodiments, the method of making is executed wherein one or more artificial intelligence (Al) methods or machine learning algorithms are utilized to determine fastener or adhesion positions on the spinal plate.

[0106] According to some aspects, the method of making is further including generating a fastener trajectory and / or an adhesion scheme using a navigation, a robotic assistance, and / or an ultrasound input.

[0107] In some embodiments, a bone treatment system is disclose herein, including: an adjustable bone treatment plate configured to facilitate an insertion of a treatment material and to enable an adjustment and manipulation of a treated bone after a fixation of the adjustable bone treatment plate to the bone; and a securing mechanism operative to secure a first fragment and / or a second fragment into a secured position and then to release the first fragment and / or the second fragment from the secured position.

[0108] According to some aspects, the adjustable bone treatment plate is biplanar.

[0109] In some embodiments, the plate is further including a wedge window access point integrated into the adjustable bone treatment plate, the access point providing a passage for the treatment material insertion.Attorney Docket No. 409948-507001 WO

[0110] According to some aspects, the first fragment and the second fragment of the treated bone can be moved towards the treatment material to provide a treatment material compression.

[0111] In some embodiments, a method of treating a bone is disclosed herein, including: providing a bone treatment system including an adjustable bone treatment plate and a securing mechanism; inserting a treatment material into a treated bone using the adjustable bone treatment plate; adjusting and manipulating the treated bone after a fixation of the adjustable bone treatment plate to the bone; and securing a first fragment and / or a second fragment into a secured position and then releasing the first fragment and / or the second fragment from the secured position using the securing mechanism.

[0112] The present invention is further illustrated by the following examples which in no way should be construed as being further limiting.EXAMPLES EXAMPLE 1. FRACTURED BONE FIXATIONS

[0113] Using a prior art mono-plane plate (e.g., FIG. 2), it was found that single plates and double plates both fail in torsion. The mono-plane plate was too thick: hardware irritation led to revision surgery later. There was a high cost: double plates are double the cost.

[0114] In a prophetic example, new methods are tried herein on the example of a clavicle wherein a biplanar adjustable damaged bone fixation plate is engineered. The surgeon will initially freshen up the fracture and debride any dead bone, then select an appropriately sized counter arc biplanar wedge window plate. The surgeon will affix the plate to the medial fragment of the clavicle through the oval compression slot or screw hole, oval compression slot, or sliding screw hole. The surgeon will reduce the plate to the lateral fragment of the clavicle and affix with BB-TAK pins to the lateral fragment and fine tune the reduction and measure the defect size through the wedge window.

[0115] At this point, the surgeon will debride the bone graft (e.g., from the hip) and cut the graft to the appropriate length.

[0116] The graft space can be opened or widened by loosening the screw in the oval compression slot and moving the medial fragment to create space in the wedge window to accept the bone graft.Attorney Docket No. 409948-507001 WO

[0117] The surgeon will place the bone graft between the two bone fragments and hold the graft in place with a clamp pressing on the top plane of the counter arc biplanar wedge window plate and on the graft (FIG. 10).

[0118] The surgeon will fasten an angled screw through the superior hole in the upper plane of the counter arc biplanar wedge window plate and into the bone graft; the screw can be at an angle into the bone graft to stabilize the graft.

[0119] The two clavicle fragments can then be pushed against the bone graft, providing bone compression (FIG. 11).

[0120] Once the graft is stable, the compression screw in the oval compression slot or screw hole is tightened.

[0121] The plate can then be fixed by placing screws orthogonally through the anterior and superior surfaces of the plate and into the bone to optimize torsional strength and stability.

[0122] A second angled screw can be placed into the graft through the superior plane of the counter arc biplanar plate with a wedge window.

[0123] The counter arc biplanar plate with a wedge window allows graft placement after the fracture has been reduced and stabilized. In general, the counter arc biplanar plate with a wedge window is a single plate that is stronger, thinner, more affordable, and better for complex fractures, osteotomies, and bone revisions than single or two plate constructs.

[0124] A non-union of a fracture of the clavicle can occur in up to 20% of acute clavicle fractures. The non-union is rarely asymptomatic and has disability resulting from pain at the site of the non-union, possible altered shoulder mechanics, or a compression lesion involving the underlying brachial plexus or vascular structures. Most non-unions are surgically treated using open reduction, internal fixation supplemented with either an iliac crest autograft or an allograft. The surgical technique is difficult and usually involved a uniplanar superior plate applied after the bone graft has been placed into the non-union site and held in place with a clamp.

[0125] Therefore, fractured bones are treated using a biplanar adjustable damaged bone fixation plate. FIG. 14 shows an example method 301 for treating a damaged bone in a subject in need. Step 300 involves obtaining a biplanar bone fixation plate designed for the insertion of graft material and the adjustment and manipulation of a damaged bone after fixation to the bone. The biplanar boneAttorney Docket No. 409948-507001 WOfixation plate is a medical device that serves to support bone healing and regeneration. The graft material, which can be of various types, supports bone growth and provides a scaffold for new bone formation.

[0126] The biplanar design of the plate allows for post-fixation adjustments to ensure proper alignment and positioning of bone fragments. This adjustability ensures that the bone heals in the correct anatomical position. The bone fixation plate includes a wedge window access point, an opening within the plate that provides a passage for graft material insertion. The wedge window is shaped and positioned to allow for placement of the graft between bone fragments. This design simplifies the surgical procedure by providing a clear route for graft insertion without the need to remove or reposition the plate. In this step, the biplanar bone fixation plate, the graft material, and the wedge window access point are prepared for use. This step is preparatory, selecting and readying the medical devices and materials for the surgical procedure. The goal of this step is to equip the surgical team with a device that offers structural support to the fractured bone and a means to introduce graft material, facilitating optimal healing conditions.

[0127] Step 302 entails the procedure of securing the biplanar bone fixation plate to the first fragment of a damaged bone. This is achieved by inserting a fastener through an oval compression slot located in the bone fixation plate and driving it into the bone. The biplanar bone fixation plate is designed with a wedge window access point for graft material insertion, as outlined in Step 300 and further utilized in Step 308.

[0128] The first bone fragment represents one piece of a fractured bone that requires stabilization. The fastener, typically a screw, is used to attach the bone fixation plate to the bone fragment. The oval compression slot within the bone fixation plate allows for adjustment of the plate's position relative to the bone, facilitating alignment and compression of the bone fragments during the healing process. During this procedure, a surgeon aligns the bone fixation plate with the first bone fragment and uses a tool to drive the fastener through the oval compression slot into the bone. This step provides initial stabilization, which is necessary for the subsequent procedures. It also permits future adjustments due to the design of the oval compression slot, which allows for movement of the plate in relation to the bone. This movement is essential for later steps, such as creating a space for the boneAttorney Docket No. 409948-507001 WOgraft in Step 306 and compressing the bone graft between the bone fragments in Step 310, leading to the final fixation with additional fasteners in Step 312. The goal of Step 302 is to ensure the bone fixation plate is properly positioned and secured to support the bone's healing process.

[0129] Step 304 involves the procedure of securing a biplanar bone fixation plate to a second fragment of a damaged bone. This step follows the attachment of the plate to a first bone fragment, as described in Step 302. The process requires a surgeon to align the second bone fragment and then fasten the plate to it using surgical fasteners, such as screws. The biplanar design of the plate allows for manipulation of the bone fragments to achieve alignment and provides a scaffold for bone healing. The components involved in Step 304 include the biplanar bone fixation plate, the second bone fragment, and the surgical fasteners. The surgeon performs the alignment of the bone fragments and the securing of the plate to ensure that the bone heals in the correct position, which is essential for the restoration of function to the affected limb or area. The design of the biplanar bone fixation plate accommodates the surgical fasteners and allows for adjustments.

[0130] The plate's design, including the wedge window access point, is integral to the method as it provides a passage for graft material insertion, which is performed in subsequent steps, specifically Steps 106 and 108. The securing of the second fragment to the bone with the biplanar bone fixation plate is a step in the overall process of bone fixation and grafting. Step 306 involves opening a space between two bone fragments to accommodate a bone graft. This is achieved by loosening a screw that has been previously placed through an oval compression slot in a bone fixation plate. The oval compression slot allows for limited movement of the screw, which in turn permits the adjustment of the position of the bone fragments. By loosening the screw, a surgeon can manipulate the position of the first and second bone fragments, thereby widening the space at the wedge window of the fixation plate.

[0131] The screw and the oval compression slot are integral to this step. The screw serves as a fastener that secures the bone fixation plate to the bone fragments. When the screw is loosened, it allows for the movement of the bone fragments within the range permitted by the oval compression slot. The first and second bone fragments are the parts of the bone that have been fractured and areAttorney Docket No. 409948-507001 WObeing realigned and stabilized by the fixation plate. The purpose of these actions is to prepare the site of the fracture for the insertion of a bone graft, which will support new bone growth and healing. The space created must be of a size that can properly receive the bone graft, ensuring that it can be inserted and positioned effectively. The precision provided by the oval compression slot and the screw mechanism is essential for the accurate adjustment of the bone fragments to create the necessary space for the bone graft. This step sets the stage for subsequent placement of the bone graft, which is a key part of the bone healing process. The understanding of the mechanism by which the screw and the oval compression slot interact to allow for the manipulation of the bone fragments is essential for the execution of step 306.

[0132] Step 308 involves the surgical procedure of inserting bone graft material into the space between two bone fragments. This step follows the creation and widening of a space in step 306, which is designed to accommodate the graft. The bone graft serves as a scaffold to promote new bone growth and stabilization of the fracture. The bone graft material can be autograft, allograft, or synthetic substitutes, and the choice depends on factors such as the size and location of the fracture, as well as patient-specific considerations. The bone fixation plate, which includes a wedge window access point, provides the passage for inserting the graft material. This feature allows for the insertion of the graft without the need to remove or significantly disturb the plate, maintaining the stability of the bone fragments. The insertion of the bone graft is performed with precision to ensure that the graft is positioned to facilitate bone healing and to provide support to the fractured bone. The graft must be sized appropriately to fill the space adequately, ensuring that it is neither too large to fit nor too small to provide the necessary support. In summary, step 308 involves the placement of a bone graft into a prepared space between bone fragments, facilitated by the design of the bone fixation plate with a wedge window. This step is essential for providing support and promoting bone healing in the treatment of fractures.

[0133] Step 310 involves the process of pushing the first and second bone fragments against a bone graft, which results in the compression of the graft. This step is part of the procedure for bone fixation using a biplanar bone fixation plate that has been previously secured to the bone fragments. During this step, a surgeon applies force to move the bone fragments toward each other, with the bone graftAttorney Docket No. 409948-507001 WOpositioned within the space provided by the wedge window of the fixation plate. The involved components are the bone fragments, the bone graft, and the fixation plate, which includes an oval compression slot for fastener placement. The purpose of this action is to stabilize the bone structure and ensure proper alignment for healing. By compressing the graft between the bone fragments, a stable environment is created, which is conducive to bone regeneration and helps maintain the position of the bone fragments during recovery. The process may utilize surgical tools or manual techniques to apply the necessary force. The design of the fixation plate, especially the wedge window, facilitates this movement and compression after attachment to the bone fragments. The graft material's characteristics are significant, as it should be compressible to allow a secure fit and robust enough to support the bone fragments and encourage bone growth. Parameters such as the size of the graft space, the force exerted, and the level of compression are measured to ensure effective bone healing. In summary, step 310 involves the compression of a bone graft by moving bone fragments towards it following the attachment of a biplanar bone fixation plate, which aids in the stabilization and recovery of a fractured bone. This step is detailed in the method for bone fixation that includes the use of a fixation plate with an integrated wedge window.

[0134] Step 312 involves the final fixation of bone fragments using additional fasteners. This step secures the position of the bone fragments after alignment and graft placement, ensuring stability for healing. In practice, step 312 entails a medical professional using surgical tools to place screws or other fasteners through the biplanar bone fixation plate and into the bone fragments. The medical professional aligns the bone fragments in the desired position relative to each other and the biplanar bone fixation plate. The fasteners are then inserted through designated holes in the plate and driven into the bone fragments to secure them in place. This action maintains the alignment and compression of the bone fragments against the bone graft, which is necessary for the healing process. The fasteners used in step 312 are made of materials such as titanium or stainless steel, chosen for their strength and compatibility with human tissue. The design of the fasteners and the biplanar bone fixation plate allows for a secure attachment that can withstand forces exerted on the bone during activities. The goal of step 312 is to ensure that the bone fragments do not move relative to each other or the bone graft, which could disruptAttorney Docket No. 409948-507001 WOthe healing process. By fastening the fragments securely, the bone can heal in the correct anatomical position, leading to better functional outcomes. The fasteners also play a role in compressing the bone graft, which can promote faster integration of the graft material into the bone. In summary, step 312 is the final step in the bone fixation process, where the medical professional uses additional fasteners to secure the bone fragments to the biplanar bone fixation plate, ensuring the stability of the construct for successful bone healing.".EXAMPLE 2. METHODS OF MAKING BIPLANAR ADJUSTABLE DAMAGED BONE FIXATION PLATES

[0135] In a prophetic example, several patients are successfully treated to align bones and joints using a biplanar adjustable damaged bone fixation plate. Patients who have no broken bones are treated to align bones and joints. After treating unbroken bones, a generalized procedure is formulated for making a biplanar adjustable damaged bone fixation plate to fit any bone. FIG. 15 shows a method 201 for making a biplanar adjustable damaged bone fixation plate.

[0136] Step 200 involves the reception of data that characterizes the surgical assessment of a subject, which includes information about a bone with a fracture or malalignment. This step is the initial phase in the process of creating a customized biplanar adjustable damaged bone fixation plate for a patient requiring orthopedic surgery.

[0137] The action in this step is the collection of patient-specific data, which is necessary for the subsequent design and manufacturing of the bone fixation plate. The components involved in this action include a computer system with a processor, software, and memory, as well as the medical data which may consist of imaging studies like X-rays, CT scans, or MRI images. The computer system is used by medical professionals who input the data representing the condition of the patient's bone.

[0138] The purpose of this action is to gather detailed information about the bone's current state, including the location and nature of the fracture or malalignment. This data serves as the foundation for planning the surgical intervention and for designing a fixation plate that will align and stabilize the bone fragments during the healing process.Attorney Docket No. 409948-507001 WO

[0139] In practice, this step would be manifested by a healthcare professional evaluating the patient's bone condition, possibly using imaging technology, and then inputting this data into a specialized software system. The software would then store and process the data, making it available for further steps in the surgical planning and plate design process.

[0140] The data received is expected to be comprehensive enough to allow for accurate superimposition of a targeted bone shape with normal alignment (Step 202) and for the precise overlaying and adjustment of the fixation plate image (Step 204). This ensures that the final plate design will be tailored to the patient's anatomy and surgical needs.

[0141] While specific measurements or mathematical constructs are not provided, in practice, the data would likely include quantitative measurements of bone length, angles of malalignment, and the size and location of fractures. These measurements would be used to create a 3D model of the bone and the fixation plate, which would then be used to manufacture the actual plate (Step 206) and eventually provide it for surgery (Step 208), aiming to correct the fracture or malalignment (Step 210).

[0142] Step 202 involves superimposing a targeted bone shape with normal alignment over data for a bone with mal-alignment or a fracture. This process is conducted using medical imaging software, which overlays a digital representation of the desired bone shape onto the actual image of the patient's damaged bone. The computer system, which includes a processor, software, and memory, processes the imaging data and the targeted bone shape to create a visual overlay. This overlay shows the differences between the damaged bone and the desired alignment.

[0143] The purpose of this step is to provide a visual guide to understand the extent and nature of the mal-alignment or fracture and to plan the surgical intervention. This planning may include determining the size, shape, and angles for a biplanar adjustable bone fixation plate that will be used to correct the bone's alignment.

[0144] The targeted bone shape represents the anatomical configuration that the surgery aims to achieve. The normal alignment is based on anatomical standards or may be derived from the patient's own undamaged bone, considering bilateral symmetry, such as with legs or arms.Attorney Docket No. 409948-507001 WO

[0145] The superimposition assists in identifying the areas where adjustments are needed, which is essential for customizing the bone fixation plate to the patient's specific anatomy. It also aids in planning the approach, such as where to make incisions and how to manipulate the bone fragments during the procedure.

[0146] While Step 202 does not involve specific measurements or mathematical constructs, it would likely involve the use of coordinates, geometric transformations, and algorithms to accurately align the images and to calculate the necessary adjustments to the bone fixation plate. This step is a visualization process that allows for the accurate planning of surgical interventions to correct bone mal-alignments or fractures by overlaying a digital model of the desired bone shape onto the patient's actual bone condition, guiding the customization of the bone fixation plate and the surgical strategy.

[0147] Step 204 involves overlaying a biplanar adjustable damaged bone fixation plate image with a superimposition of the targeted bone shape, followed by adjusting the plate's size, shape, and angles to plan a surgery for re-aligning a bone with a fracture and / or malalignment to a targeted bone shape. This step is conducted using computer-aided design software, where the surgical team manipulates a digital representation of the bone fixation plate over the image of the damaged bone to achieve a precise fit for the surgical procedure.

[0148] The process includes receiving and processing data that represents the condition of the bone, superimposing the digital images, and making necessary adjustments to the parameters of the bone fixation plate. The adjustments are based on the unique contours and alignment of the patient's bone, which are determined from the data provided. The software allows for manipulation of the digital representation of the plate in relation to the bone, ensuring that the plate will be able to support the bone effectively during healing.

[0149] The adjustments to the plate may require several iterations to ensure that the final design is suitable for the patient's anatomy. Once the design is finalized, the data for the adjusted plate can be used to either manufacture a custom plate or to select a pre-manufactured plate that matches the specifications derived from the planning process.

[0150] Step 204 does not specify the exact measurements or the mathematical constructs used in the adjustment process, as these would vary based on theAttorney Docket No. 409948-507001 WOindividual case and the software utilized. The focus of this step is on the planning and customization of the bone fixation plate to match the patient's bone structure for optimal alignment and fixation.

[0151] Step 206 involves the generation and provision of data for the adjusted bone fixation plate and / or angles, which is suitable for manufacturing the plate and wedge window or for obtaining a pre-manufactured plate. This step is part of the method for making the bone fixation system.

[0152] In this step, a computer system equipped with software processes medical imaging data and design software to create specifications for the bone fixation plate. The output from this step includes dimensions, shape, curvature, and other geometrical parameters that have been determined in previous steps (200, 202, and 204) to match the anatomical features of the subject's damaged bone. The computer system uses the processed data to create a digital model or a set of instructions that can be used to fabricate the plate or to identify a suitable pre-manufactured plate from an inventory.

[0153] The purpose of generating this data is to ensure that the bone fixation plate produced or selected will fit the subject's bone anatomy, thereby facilitating treatment of the bone fracture or malalignment. The output data may be in the form of computer-aided design (CAD) files, which can be directly used by manufacturing machines, such as 3D printers or CNC milling machines, to create the physical bone fixation plate. The data could also be used to select an existing plate that closely matches the required specifications.

[0154] The output data must be precise and detailed, as it directly influences the fit and effectiveness of the bone fixation plate in the surgical procedure. The data must include all necessary details to allow for the plate to be manufactured or selected without the need for further adjustments, ensuring that the surgical plan can be executed and the intended surgical outcome can be achieved, which is the correction of the fracture and / or malalignment as described in Step 210.

[0155] Step 208 involves the delivery of a biplanar adjustable damaged bone fixation plate for surgical use. This step follows the design and manufacturing processes, where the plate has been tailored to match the specific anatomical requirements based on prior assessment and planning steps (Steps 200, 202, 204).Attorney Docket No. 409948-507001 WOThe delivery of the plate ensures that the surgical team has the necessary equipment to proceed with the bone adjustment procedure.

[0156] The action in Step 208 is the transfer of the bone fixation plate from the production or storage facility to the medical staff who will use it in the operating room. This includes the manufacturing team that produces the plate, the logistics personnel responsible for its delivery, and the medical staff who receive and prepare the plate for surgery. The plate is designed to be adjustable, allowing for manipulation of the damaged bone after it is affixed to the bone. It includes a wedge window for graft material insertion and a mechanism to secure bone fragments in place.

[0157] The delivery of the plate must ensure that it arrives in a condition suitable for surgical use, which typically means sterile and ready for immediate application. While Step 208 does not detail the precise dimensions or specifications of the plate, these aspects are determined in the earlier steps of the process. The delivery is a logistical step that facilitates the subsequent surgical procedure aimed at correcting bone fractures or mal-alignments. The success of the surgery is dependent on the availability and condition of the plate provided in Step 208.

[0158] Step 210 involves the surgical procedure of correcting a fracture or malalignment in a bone. During this step, a surgeon manipulates bone fragments using a biplanar adjustable damaged bone fixation plate that has been designed to match the contours of the patient's bone. The plate includes a wedge window access point and locking mechanisms, which allow the surgeon to adjust the position of the bone fragments relative to each other and to the graft material.

[0159] The locking mechanism enables the surgeon to secure the bone fragments in the corrected position after alignment is achieved. This function ensures that the bone fragments remain stationary during the healing process, maintaining the alignment.

[0160] The graft material, inserted through the wedge window access point in previous steps, plays a role in this step as well. The surgeon may apply pressure to the bone fragments to compress the graft material, which aids in the stability of the bone structure and promotes healing.

[0161] In summary, step 210 encompasses the surgeon's use of the biplanar adjustable damaged bone fixation plate to adjust and secure the position of boneAttorney Docket No. 409948-507001 WOfragments, ensuring the graft material is appropriately positioned to support the healing process. This step represents the application of the bone fixation system's design features to achieve bone repair and stabilization.

[0162] Various methods are used for making the biplanar adjustable bone reduction plate with wedge window, fasteners to go with the plate, and instruments to surgically implant the fasteners and the plate. Machining is found to be useful for prototypes. Molding is also found to be useful. With molding, it is found that various materials can be easily compared. Bending of materials is utilized for some prototypes. Rapid waterjet cutting is utilized along with CAD (computer aided drafting) as different prototypes are transitioned from a computer design to metals, alloys, and polymers.

[0163] Locking screws are made with locking threads on the underside of the screw head. These locking screws are mated with threads in holes in the biplanar adjustable bone reduction plate. In another example, cortical screws are machined with fine threads along the shaft. These are used in cortical bone. Cancellous screws are machined with coarser threads and a smooth, unthreaded portion, between the threads nearer the tip and the head. This allows it act as a lag screw. Coarser threads are found to anchor in a softer medullary bone.

[0164] The unique screws and fasteners require new instruments for fastener and screw insertion. Design of these instruments is carried from initial drawing to CAD and then to milling and cutting. After a prototype is made, various scale up methods are tried and tested for speed, cost, and quality optimization.EXAMPLE 3. SCREW / BIPLANAR ADJUSTABLE BONE REDUCTION PLATE WITH WEDGE WINDOW INTERFACE

[0165] Through use it is found that the biplanar adjustable bone reduction plate with wedge window can be manufactured with less thickness than any known prior art plates, while still providing greater strength, greater bend resistance, and better fastening to bone. Considering the lower thickness, a unique screw / biplanar adjustable bone reduction plate interface is adapted, in some embodiments, to provide a countersunk screw into the low-thickness plate, thus eliminating any skin irritation and screw protrusion from the plate after the screw is passed through the plate and into bone. The distance between skin surface and bone in the clavicle area can be less than about mm to about mm, so having a low profile is even more criticalAttorney Docket No. 409948-507001 WOin the clavicle areas. It is found that this low-profile design overall will lessen discomfort and will prevent the need for correction surgeries as is often required with the mono-planar thick plates.

[0166] Unique screws and fasteners are designed to provide a low-profile fastener head, but these also require new instruments for fastener and screw insertion through the plate and into bone. In some designs, the underside of the fastener head is etched with ridges that match similar ridges in a countersunk screw hole in the biplanar adjustable bone reduction plate with wedge window. Thus, when the underside of the fastener head contacts the countersunk screw hole, there is a locking mechanism between the ridges on the underside of the screw head and the ridges in the countersunk hole. In another prototype, a small protrusion is machined in a countersunk hole in the biplanar adjustable bone reduction plate, and the protrusion acts as a lock washer when the underside of the fastener head contacts the countersunk hole during tightening. In another prototype, a locking mechanism is placed next to the countersunk fastener hole.

[0167] During prototype testing, it is found that biplanar adjustable bone reduction plate with wedge window uniquely provides orthogonal screw penetration into bone. For example, the screws can be placed orthogonal to the surface of the bone due to the close fit of the biplanar adjustable bone reduction plate with the planar bone surface(s). Thus, in some prototypes, the screw holes are offset on one plane of the biplanar adjustable bone reduction plate compared to the other plane to avoid screw overlap from the screws entering from one bone surface and the screws entering from another bone surface.

[0168] Importantly, through use of the offset screw holes on one plane of the biplanar adjustable bone reduction plate compared to the other plane (to avoid screw overlap), it is found that less screws or fasteners can be used (compared to any previous technologies). Thus, in some embodiments, the number of screws and screw holes on one plane can be less than prior art mono-planar devices. For example, if a prior art mono-planar device requires fasteners to span a cm length of a bone, each plane of the biplanar adjustable bone reduction plate can include less than fasteners, or less than about half of the number of fasteners of the prior art devices. This is because orthogonal fastener insertions are provided by the biplanar adjustable bone reduction plate and the fastener holes on one plane are offset fromAttorney Docket No. 409948-507001 WOthe fastener holes on another plane to prevent screws contacting each other (or screw overlap) when the screws are inserted into bone.

[0169] In another example, it is found that the biplanar adjustable bone reduction plate with wedge window prevents plate slip during a temporary orthogonal fixation (even if with non-threaded BB-Tak fasteners). For example, the surgeon temporarily fixes the biplanar adjustable bone reduction plate with wedge window to a fractured bone using (non-threaded) BB-Tak fasteners. Then, the surgeon steps away to take an X-ray. It is found that the biplanar adjustable bone reduction plate prevents plate movement on the bone and slippage when the surgeon steps away. This is found to provide a convenient alternative to the slippage experienced with mono-planar plates. In another example, mildly threated BB-Tak fasteners (temporary fasteners) are used and the biplanar adjustable bone reduction plate has zero slippage. It is found that the orthogonal fastener placements hold bone more securely. In particular, when any portion of the biplanar adjustable bone reduction plate with wedge window is contoured to a bone (or near a bone end), having orthogonal screw insertion into the end (or near an epiphysis) provides less bone fracturing, provides stronger fastener placement, means less fasteners are used, and provides long term patient comfort. The thinner design, bend resistance, and better grip are tested further. Various prototypes are manufacture and tested for bend resistance (i.e. , strength).

[0170] It would be appreciated by those skilled in the art that various changes and modifications can be made to the illustrated embodiments without departing from the spirit of the present invention. All such modifications and changes are intended to be within the scope of the present invention except as limited by the scope of the appended claims.

Claims

Attorney Docket No. 409948-507001 WOWHAT IS CLAIMED IS:

1. A bone fixation system, comprising:a biplanar adjustable damaged bone fixation plate configured to facilitate an insertion of a graft material and to enable an adjustment and manipulation of a damaged bone after a fixation of the biplanar bone fixation plate to the bone; and a wedge window access point integrated into the bone fixation plate, the access point providing a passage for graft material insertion;wherein a first fragment of the damaged bone can be moved towards the graft material and away from the graft material before and after the graft material insertion; andwherein the first fragment and a second fragment of the damaged bone can be moved towards the graft material to provide a graft material compression;wherein the plate includes a locking mechanism operative to lock the first fragment and / or the second fragment into a position and then to unlock the first fragment and / or the second fragment from the position.

2. The bone fixation system of claim 1 , wherein the biplanar adjustable damaged bone fixation plate includes one or more oval compression slots along a first plane and / or a second plane of the plate, each of the one or more oval compressions slots providing a locking and an unlocking mechanism for the first fragment and / or the second fragment of the damaged bone.

3. The bone fixation system of claim 2, wherein the biplanar adjustable damaged bone fixation plate includes a curvature disposed between the first plane and the second plane, the curvature matching a curvature of the damaged bone.

4. The bone fixation system of claim 3, wherein the biplanar adjustable damaged bone fixation plate is operative to provide a holding of the graft material after the insertion of the material.

5. The bone fixation system of claim 1 , wherein the biplanar adjustable damaged bone fixation plate includes one or more angle screw holes, each of the one or moreAttorney Docket No. 409948-507001 WOangle screw holes operative to accept an angle screw into a graft material or into a bone material at an angle in a range from about degrees to about 90 degrees.

6. The bone fixation system of claim 1 , wherein the biplanar adjustable damaged bone fixation plate comprises one or more orthogonal fastener holes, each of the one or more orthogonal fastener holes operative to accept a fastener or a screw through the biplanar adjustable damaged bone fixation plate and into a material at an angle in a range from about 80 degrees to about 90 degrees.

7. A method for treating a subject in need of a bone adjustment, the method comprising the steps of:(1) obtaining a biplanar adjustable damaged bone fixation plate configured to facilitate an insertion of graft material and to enable an adjustment and manipulation of a damaged bone after a fixation of the biplanar adjustable damaged bone fixation plate to the bone; anda wedge window access point integrated into the bone fixation plate, the access point providing a passage for a graft material insertion;(2) affixing the biplanar bone fixation plate to a first fragment of the damaged bone by placing a fastener through an oval compression slot in the biplanar bone fixation plate and into the bone; whereby the biplanar adjustable damaged bone fixation plate provides a normal bone trajectory that is operative to align a second fragment of the damaged bone with the first fragment;(3) affixing the biplanar bone fixation plate to the second fragment of the damaged bone;(4) opening and / or closing a graft space between the first fragment and the second fragment by loosening the fastener in the oval compression slot and moving the first fragment and / or the second fragment to widen a space in the wedge window to accept the graft material; and(5) inserting the graft material through the wedge window access point and affixing the graft material to the biplanar adjustable damaged bone fixation plate.

8. The method of claim 7, further comprising the step of:Attorney Docket No. 409948-507001 WO(4B) locking the first fragment and / or the second fragment into a position to hold the widened space into a position to accept the graft material.

9. The method of claim 7, further comprising the step of:(5B) pushing the first fragment and the second fragment against the graft material, thereby compressing the graft material between the first fragment and the second fragment.

10. The method of claim 7, further comprising the step of:(2B) adjusting a torsion of the first fragment and / or the second fragment.

11. The method of claim 7, further comprising the step of:(2A) performing an initial freshening up of a fracture and / or debriding any of a dead bone.

12. The method of claim 7, further comprising the step of:(OB) selecting an appropriately sized biplanar adjustable damaged bone fixation plate.

13. The method of claim 12, wherein the method further comprises reducing the plate to a lateral fragment of a clavicle and affixing the plate with BB-TAK pins to the lateral fragment.

14. The method of claim 7, wherein the method comprises the step of:(3B) fine tuning a reduction between the first fragment and the second fragment and / or measuring a defect size through the wedge window.

15. The method of claim 7, wherein the method comprises the step of:(4C) debride a bone graft material and / or cutting a bone graft material to an appropriate length.

16. The method of claim 7, further comprising the step of placing a bone graft between the first fragment and the second fragment and holding the bone graft inAttorney Docket No. 409948-507001 WOplace with a clamp pressing on a top plane of the biplanar adjustable damaged bone fixation plate and on the bone graft.

17. The method of claim 16, further comprising fastening an angled screw through a superior hole in an upper plane of the biplanar adjustable damaged bone fixation plate and into the bone graft; wherein the screw can be at an angle into the bone graft to stabilize the graft.

18. The method of claim 7, further comprising the step of:(OA) obtaining a surgical assessment of the subject, whereby data from the subject’s bone with a damage is acquired.

19. A kit suitable for a sale, the kit comprising:at least one biplanar adjustable damaged bone fixation plate; wherein the plate is configured to facilitate an insertion of a graft material and to enable an adjustment and manipulation of a damaged bone after a fixation of the biplanar bone fixation plate to the bone; anda wedge window access point integrated into the bone fixation plate, the access point providing a passage for graft material insertion;wherein a first fragment of the damaged bone can be moved towards the graft material and away from the graft material before and after the graft material insertion; andwherein the first fragment and a second fragment of the damaged bone can be moved towards the graft material to provide a graft material compression;wherein the plate includes a locking mechanism operative to lock the first fragment and / or the second fragment into a position and then to unlock the first fragment and / or the second fragment from the position.

20. The kit of claim 19, further comprising instructions for use in a media format of a video, instructions with illustrations, written instructions, or a combination thereof.

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