Intraoperative imaging and virtual modeling methods, systems, and means for fracture reduction

Abstract

A method for assessing fracture reduction includes intraoperatively imaging a fractured bone and obtaining, with a computing system, a representation of the fractured bone. The fractured bone defines at least a first bone fragment and a second bone fragment separated by a fracture. The method includes imaging a contralateral bone of the patient and obtaining, with a computing system, a representation of the contralateral bone. The method further includes intraoperatively generating, with the computing system, a virtual model of the fractured bone from data presented in the representation of the fractured bone and a virtual model of the contralateral bone from data presented in the representation of the contralateral bone. The method includes intraoperatively comparing, with the computing system, spatial dimensions measured for the virtual model of the fractured bone with corresponding spatial dimensions measured for the virtual model of the contralateral bone.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 027,567, filed May 20, 2020, entitled "IMAGE MATCHING FOR FRACTURE REDUCTION," the entire disclosure of which is incorporated herein by reference.

[0002] FIELD OF THE INVENTION The present disclosure relates to systems and methods for viewing reduced fractures. [Background technology]

[0003] Many fracture-dislocations of long bones, such as those of the lower extremities, are currently treated surgically (osteosynthesis) by supporting (e.g., fusing, fixing, or otherwise stabilizing) the bone fragments with implants such as screws, plates, nails, and / or wires, including, by way of non-limiting example, fully internal or partially external implants. Traditional osteosynthesis typically involves pre-, intra-, and post-operative medical imaging. Pre- and post-operative medical imaging are used for diagnosis, planning, and management, respectively. Intra-operative medical imaging, typically achieved using a mobile fluoroscopy device, provides optical feedback to control manipulation of the fracture fragments, proper alignment, and implant positioning. However, fluoroscopic images have limitations. For example, fluoroscopic images tend to be limited to only the fractured area and also tend to be limited to providing imaging information related to restoration of length, rotation, and angulation of the affected bone.

[0004] For fractures of the lower extremity, two primary treatment options exist: closed reduction internal fixation (CRIF) and open reduction internal fixation (ORIF), although many treatments involve a combination of CRIF and ORIF techniques. In CRIF, reduction is achieved without direct exposure and visualization of the fracture. The only visual information about the fractured bone is provided by intraoperative fluoroscopy and / or clinical signs, the latter of which can be unreliable. In contrast, in ORIF, the overlying soft tissue is dissected open to surgically expose the fracture. Once the fracture is exposed, the surgeon can reduce it under direct vision, optionally combined with fluoroscopic imaging, and then monitor the final outcome with a fluoroscopic device.

[0005] For many diaphyseal fractures of the tibia and femur, CRIF using an intramedullary nail is the treatment of choice. In other cases, for example, in facilities where closed reduction is not possible or image intensifiers are not available, ORIF and / or minimally invasive osteosynthesis (MIO) is used. Closed reduction is preferred because it is less invasive, respects soft tissues, reduces the risk of excessive blood loss, does not significantly interfere with the biology of fracture healing, and provides better cosmetic results. However, CRIF is technically more demanding for the surgeon and exposes both the patient and medical staff to higher radiation doses.

[0006] Potential complications during fixation of the femoral or tibial shaft include angular and / or rotational misalignment of the fracture fragments and inaccurate restoration of bone length. Such complications can result in incorrect positioning of the patient's joint structures, or restricted motion and / or excessive strain due to significant changes in natural anatomy and biomechanics. In many cases, the aforementioned complications can be avoided if improved intraoperative visualization modalities are available. Therefore, such improved intraoperative visualization modalities can avoid or at least reduce the need for postoperative revision surgery (e.g., weeks, months, or years after surgery) due to malreduction. Summary of the Invention [Means for solving the problem]

[0007] According to an embodiment of the present disclosure, a method includes intraoperatively imaging a fractured bone and obtaining, with a computing system, a representation of the fractured bone. The fractured bone defines at least a first bone fragment and a second bone fragment separated by a fracture. The method includes imaging a contralateral bone of the patient and obtaining, with a computing system, a representation of the contralateral bone. The method further includes intraoperatively generating, with the computing system, a 3D virtual model of the fractured bone from data presented in the representation of the fractured bone and a 3D virtual model of the contralateral bone from data presented in the representation of the contralateral bone. The method includes intraoperatively comparing, with the computing system, spatial dimensions measured in the 3D virtual model of the fractured bone with corresponding spatial dimensions measured in the 3D virtual model of the contralateral bone.

[0008] According to another embodiment of the present disclosure, a method includes intraoperatively imaging a fractured bone and obtaining, with a computing system, a representation of the fractured bone. The fractured bone defines at least a first bone fragment and a second bone fragment separated by a fracture. The representation of the fractured bone includes a composite series of images of the fractured bone taken at intervals along the length of the fractured bone. The method also includes intraoperatively measuring, with the computing system, a first spatial dimension defined with respect to at least two anatomical landmarks presented on one of the representation of the fractured bone and the representation of the contralateral bone, automatically identifying contralateral counterparts of the at least two anatomical landmarks presented on the other of the representation of the fractured bone and the representation of the contralateral bone, and measuring a second spatial dimension defined with respect to the contralateral counterparts of the at least two anatomical landmarks. [Brief explanation of the drawings]

[0009] The following description of exemplary embodiments will be better understood when read in conjunction with the accompanying drawings, in which it is understood that possible embodiments of the disclosed systems and methods are not limited to those shown. [Figure 1A] 1 is a schematic perspective view of a fractured bone with a proximal bone fragment and a distal bone fragment, with the correct orientation of the distal bone fragment shown in phantom. [Figure 1B] FIG. 1 is an anterior view of a femur showing the various anatomical parts of the femur. [Figure 1C] FIG. 1C is a bottom lateral view of the femur illustrated in FIG. 1B. [Figure 1D] FIG. 1 is a schematic diagram of the limbs of the lower torso showing the various axes of the limbs. [Figure 2A] 1 illustrates a fracture imaging system according to an exemplary embodiment for performing steps of the disclosed method. [Figure 2B]FIG. 1 illustrates an example computing system that can be used to perform various steps of the disclosed methods. [Figure 3A] 1 is a simplified flow diagram of a method for intraoperatively reducing malalignment of a patient's fractured bones, according to one example. [Figure 3B] 3B is an anterior view of a fractured femur and a contralateral unfractured femur with exemplary fluoroscopic image fields indicated by dashed circles, according to exemplary steps of the method illustrated in FIG. 3A. [Figure 3C] FIG. 1 is an example of a medical image constructed from a stitched series of images taken along each interval of a fractured bone and a contralateral bone to provide a full-length image of the bone, which image can be used to perform various steps of the disclosed method. [Figure 4] 3C illustrates an example of a masking technique for enhancing a medical image, as illustrated in FIG. 3C as a step in the exemplary method illustrated in FIG. 3A. [Figure 5A] 3B illustrates an exemplary rendering of a 3D model of a femur generated from data presented in a medical image of the present disclosure as a step of the exemplary method illustrated in FIG. 3A. [Figure 5B] 5B illustrates another example rendering of the 3D model of the femur shown in FIG. 5A as a step of the exemplary method illustrated in FIG. 3A. [Figure 6A] 5C shows an example of a subsequent rendering of a 3D model of a femur based on the 3D model shown in FIGS. 5A and 5B. FIG. [Figure 6B] 5C shows an example of a subsequent rendering of a 3D model of a femur based on the 3D model shown in FIGS. 5A and 5B. FIG. [Figure 6C] 5C shows an example of a subsequent rendering of a 3D model of a femur based on the 3D model shown in FIGS. 5A and 5B. FIG. [Figure 6D] 5C shows an example of a subsequent rendering of a 3D model of a femur based on the 3D model shown in FIGS. 5A and 5B. FIG. [Figure 6E]5C shows an example of a subsequent rendering of a 3D model of a femur based on the 3D model shown in FIGS. 5A and 5B. FIG. [Figure 7A] FIG. 6B shows an example of a rendering of a 3D model of a tibia similar to the model of the femur shown in FIGS. 6A-6E. [Figure 7B] FIG. 6B shows an example of a rendering of a 3D model of a tibia similar to the model of the femur shown in FIGS. 6A-6E. [Figure 7C] FIG. 6B shows an example of a rendering of a 3D model of a tibia similar to the model of the femur shown in FIGS. 6A-6E. [Figure 7D] FIG. 6B shows an example of a rendering of a 3D model of a tibia similar to the model of the femur shown in FIGS. 6A-6E. [Figure 7E] FIG. 6B shows an example of a rendering of a 3D model of a tibia similar to the model of the femur shown in FIGS. 6A-6E. [Figure 8] 3B shows exemplary steps for calculating a malalignment length parameter of a fractured bone by comparing it with the contralateral bone using corresponding 3D models of the fractured bone and the contralateral bone, such as during a reduction procedure, according to the exemplary method shown in FIG. [Figure 9A] FIG. 3B illustrates exemplary steps for calculating malalignment angulation parameters of a fractured bone by comparing with the contralateral bone using corresponding 3D models of the fractured bone and the contralateral bone according to the exemplary method shown in FIG. 3A. [Figure 9B] FIG. 3B illustrates exemplary steps for calculating malalignment angulation parameters of a fractured bone by comparing with the contralateral bone using corresponding 3D models of the fractured bone and the contralateral bone according to the exemplary method shown in FIG. 3A. [Figure 10A] 3B illustrates exemplary steps for calculating the misalignment torsion parameters of a fractured bone by comparing with the contralateral bone using corresponding 3D models of the fractured bone and the contralateral bone according to the exemplary method shown in FIG. 3A. [Figure 10B]3B illustrates exemplary steps for calculating the misalignment torsion parameters of a fractured bone by comparing with the contralateral bone using corresponding 3D models of the fractured bone and the contralateral bone according to the exemplary method shown in FIG. 3A. [Figure 10C] 3B illustrates exemplary steps for calculating the misalignment torsion parameters of a fractured bone by comparing with the contralateral bone using corresponding 3D models of the fractured bone and the contralateral bone according to the exemplary method shown in FIG. 3A. [Figure 10D] FIG. 10 illustrates exemplary steps for calculating misalignment torsion parameters of a fractured bone by comparing with the contralateral bone using medical images of the fractured bone and the contralateral bone, according to another exemplary method of the present disclosure. [Figure 10E] FIG. 10 illustrates exemplary steps for calculating misalignment torsion parameters of a fractured bone by comparing with the contralateral bone using medical images of the fractured bone and the contralateral bone, according to another exemplary method of the present disclosure. [Figure 11A] 11A and 11B illustrate various exemplary anatomical landmarks of the femur (FIG. 11A) and tibia (FIG. 11B) for use in calculating misalignment parameters, according to exemplary methods of the present disclosure. [Figure 11B] 11A and 11B illustrate various exemplary anatomical landmarks of the femur (FIG. 11A) and tibia (FIG. 11B) for use in calculating misalignment parameters, according to exemplary methods of the present disclosure. [Figure 12A] FIG. 11B shows exemplary steps for calculating malalignment angulation parameters of a fractured bone using anatomical landmarks selected from those shown in FIG. 11A according to an alternative step of the method shown in FIG. 3A. [Figure 12B] FIG. 11B shows exemplary steps for calculating malalignment angulation parameters of a fractured bone using anatomical landmarks selected from those shown in FIG. 11A according to an alternative step of the method shown in FIG. 3A. DETAILED DESCRIPTION OF THE INVENTION

[0010] Conventional osteosynthesis systems and processes lack the ability to provide accurate intraoperative computerized assessment of fracture reduction, particularly during closed reduction internal fixation (CRIF). During surgery, surgeons typically assess fracture reduction through visual inspection (including with fluoroscopy), a technique commonly referred to as "eyeballing" the reduction. However, visual inspection of a reduced fracture alone rarely provides surgeons with accurate, measurable parameters to adequately assess the entire reduction, including whether the reduction restored the length, rotation, and angulation of the repaired bone or fragment. One reason for these shortcomings is that fluoroscopic imaging typically only provides visualization of short cross-sections of long bones (e.g., femur, tibia, fibula, humerus, radius, ulna). The fracture zone can further increase the difficulty of visual orientation with fluoroscopy. Visual inspection of the patient is often further hindered by the presence of surgical sterile coverings on portions of the limb. For example, a patient's uninjured contralateral side is typically not irrigated and therefore inaccessible during surgery. Ideally, the entire bone should be visible on a screen or in front of the patient, but such visualization is difficult to achieve with current medical imaging systems. The aforementioned challenges contribute to the prevalence of malalignment during bone reduction surgery. For example, one recent study found that of 154 patients treated with intramedullary (IM) nails for unilateral tibial shaft fractures and evaluated postoperatively with low-dose bilateral CT images, more than one-third of those patients (specifically, 55 patients, 36% of the observation group) had postoperative rotational malalignment of 10° or more. Megan E. Cain et al., Fractures: Can We Reliably Use the Contralateral Uninjured Side as the Reference Standard?, 102 J. of Bone and Joint Surgery 582 (2020).

[0011] The methods, systems, and features described herein employ medical imaging equipment (e.g., fluoroscopy equipment) to provide real-time intraoperative measurements that compare the length, rotation, and angulation of the repaired bone with those of an unfractured, rendered virtual two-dimensional (2D) or three-dimensional (3D) model of the bone. These comparative measurements allow the surgeon to intraoperatively assess whether further reduction and / or manipulation of the reduced bone fragments is warranted. The unfractured, rendered virtual model of the bone is created from an image of the patient's contralateral bone. As used herein, the term "contralateral" refers to the corresponding bone on the opposite side of the body along the medial-lateral direction. For example, if the fractured bone is the patient's right femur, the contralateral bone is the patient's left femur.

[0012] It should be appreciated that preoperative imaging and planning during traditional osteosynthesis does not address the aforementioned challenges associated with assessing fracture reduction. Furthermore, preoperative imaging may have several drawbacks. For example, preoperative imaging and planning consumes valuable time that may be needed for more urgent fracture reductions. Also, the time consumed by preoperative imaging and planning could otherwise be used by medical professionals to treat other patients. As another example, preoperative imaging may result in additional radiation exposure for medical professionals and patients that could be avoided if preoperative imaging were eliminated. As yet another example, the patient's anatomy may change between preoperative imaging / planning and the actual reduction procedure. For example, bone fragments may move relative to one another due to general fixation of the bone fragments or due to patient movement, for example, from the preoperative setting to the operating room or from a hospital bed to an operating table. Failure to account for such changes may result in improper fracture reduction. Alternatively, accounting for such changes may increase the time required to reduce the fracture. By providing accurate and comparable intraoperative measurements of the repaired bone, the methods and systems described below can avoid the drawbacks that arise from over-reliance on preoperative imaging and planning for osteosynthesis, and further provide intraoperative assessment of whether the surgical plan was adequately achieved.

[0013] Referring initially to FIG. 1A , an example of a fractured bone 1 is illustrated. In this particular example, bone 1 is a long bone, and the fracture is located along the diaphysis (i.e., shaft) of bone 1. The fractured bone 1 has a proximal bone fragment 3 separated from a distal bone fragment 4. In the illustrated example, bone 1 is a femur; however, it should be understood that bone 1 can include, but is not necessarily limited to, leg bones such as the femur and tibia, or arm bones such as the humerus, ulna, and radius. It should be understood that bone 1 may be a bone other than a long bone, such as a rib or clavicle, and the fracture may be located in a portion of the bone other than the shaft, such as the epiphysis or metaphysis. The outline of the distal bone fragment 4′ at the desired anatomical location is shown in dashed lines. The offset between the proximal bone fragment 3 and the distal bone fragment 4 can be defined by a coordinate system 1000. Coordinate system 1000 includes a longitudinal axis 1003 that extends generally parallel to the fractured bone when in an unfractured state, a lateral axis 1005 that extends substantially perpendicular to longitudinal axis 1003, and a transverse axis 1007 that extends substantially perpendicular to longitudinal axis 1003 and lateral axis 1005. Longitudinal axis 1003 is oriented along longitudinal direction L, lateral axis 1005 is oriented along lateral direction A, and transverse axis 1007 is oriented along lateral direction T.

[0014] Intraoperatively, reduction of the malalignment can be performed with respect to several degrees of freedom, including up to six degrees of freedom. For example, with respect to reduction with a particular degree of freedom, the distance between bone fragments 3 and 4 along the longitudinal axis 1003 can be shortened or lengthened. Deviation of angular orientation 1006 about the longitudinal axis 1003 can be adjusted via external or internal rotation of one or both of bone fragments 3 and 4. Deviation of angular orientation 1008 about the lateral axis 1005 can be adjusted via external or internal rotation of one or both of bone fragments 3 and 4. Deviation of angular orientation 1010 about the transverse axis 1007 can be adjusted via external or internal rotation of one or both of bone fragments 3 and 4. It should be understood that the degrees of freedom involved in reduction can vary based on several factors, including the type, location, and severity of the fracture, the number of bone fragments resulting from the fracture, and the number of implants and / or instruments employed to reduce and / or fixate the fracture. For example, when an IM nail is employed, lateral translation of one or more bone fragments along the lateral axis 1005 may be limited, thereby reducing the subsequent number of degrees of freedom involved in reduction.

[0015] 1B and 1C, bone 1 (i.e., a femur) in the illustrated example has anatomical proximal and distal ends 20 and 22 spaced apart along a longitudinal direction L, which is generally oriented along an anatomical axis 25 of bone 1 extending along its intramedullary canal. It should be understood that when bone 1 is a femur or a tibia, longitudinal direction L is generally oriented along the craniocaudal direction of the patient's anatomy. Proximal end 20 is spaced apart from distal end 22 in a proximal direction P, while distal end 22 is spaced apart from proximal end 20 in a distal direction D opposite proximal direction P. It should be understood that proximal direction P and distal direction D are each unidirectional components of longitudinal direction L, which is bidirectional. Bone 1 has medial and lateral sides 24 and 26 spaced apart along a lateral direction A, which are oriented along the medial-lateral direction of the patient's anatomy. Specifically, the medial side 24 is spaced from the lateral side 26 in an anatomical "medial direction," and the lateral side 26 is spaced from the medial side 24 in an anatomical "lateral direction." As used herein, the term "lateral direction A" is bidirectional and should be understood to encompass the unidirectional medial and lateral directions of a patient's anatomy. The femur 1 also has an anterior side 28 and a posterior side 30 spaced from each other along a lateral direction T, which is oriented along the anterior-posterior direction of the patient's anatomy. Specifically, the anterior side 28 is spaced from the posterior side 30 in an anatomical "anterior direction," and the posterior side 30 is spaced from the anterior side 28 in an anatomical "posterior direction." As used herein, the term "lateral direction T" is bidirectional and should be understood to encompass the unidirectional anterior and posterior directions of a patient's anatomy. The lateral direction L and the lateral direction T are each substantially perpendicular to each other and both are offset from the longitudinal direction L.

[0016] For purposes of the following disclosure, reference will be made to various anatomical regions of the femur 1, including a proximal region 32, a distal region 34, and a diaphyseal region 36 extending between the proximal and distal regions 32, 34. It should be understood that the proximal region 32 is also referred to herein as the "proximal" portion of the respective bone 1 (e.g., the "proximal femur," the "proximal humerus," the "proximal tibia," etc.), the distal region 34 is also referred to herein as the "distal" portion of the bone 1 (e.g., the "distal femur," the "distal humerus," the "distal tibia," etc.), and the diaphyseal region 36 is also referred to herein as the "diaphysis" of the bone 1.

[0017] It should also be understood that the proximal and distal regions 32, 34 of the bone 1 each include multiple subregions and / or features. For example, with respect to the femur 1, its proximal portion 32 (i.e., the "proximal femur" 32) includes an intracapsular region including the femoral head 40, the femoral neck 42, a trochanteric region including the greater trochanter 44, a femoral head region including the lesser trochanter 46, and a subtrochanteric region extending 5 cm below the lesser trochanter 46 in the distal direction D. The outer surface of the femoral head 40 defines the articular surface of the proximal joint (i.e., the hip joint in this example). The distal portion 34 of the femur 1 (i.e., the "distal femur" 34) includes the medial and lateral condyles 50, 52 that define the articular surface of the joint (i.e., the knee joint in this example), as well as an intercondylar region that defines the intercondylar notch 56.

[0018] Referring now to FIG. 1D , an example of the mechanics of a limb 60 in which bone 1 resides is illustrated. In this example, the mechanics are shown for a leg. However, it will be understood that the mechanics may be applied to other limbs, such as an arm. The limb 60 may be defined by at least one axis, such as multiple axes. The at least one axis of the limb 60 may constitute a functional axis 2000 of the limb 60, extending from the center of the head of the limb, such as the femoral head 40 or the humeral head, to the center of the opposing joint, such as the ankle or wrist joint. Each long bone of the limb 60 may have a respective functional axis 2002 that generally extends from the center of one end of the bone to the center of the other end of the bone. For example, the functional axis 2002 of femur 1 extends from the center of the femoral head 40 to the intercondylar notch 56 of the distal femur 34. Each long bone of the limb 60 also defines a respective anatomical axis 25, which need not be coextensive with the bone's respective functional axis 2002. For example, the anatomical axis 25 of the femur 1 is angularly offset from its functional axis 2002 as shown. It should be understood that a bone may define one or more additional axes. For example, as shown in FIG. 1B, the head 40 and neck 42 of the femur 1 extend along a head-neck axis HN that is offset at an acute angle from the anatomical axis 25 of the femur 1.

[0019] At least one axis can be used to determine proper alignment of the limb 60's mechanics during fracture reduction. For example, the fractured bone or limb can be manipulated until the bone fragments are aligned along a particular functional axis 2002 or anatomical axis 25 of the fractured bone. As another example, one or more axes 2002, 25, 2000 of the fractured bone 1 or limb 60 can be compared to corresponding axes 2002', 25', 2000' of the contralateral bone 1' or limb 60' to assess whether the fragments of the fractured bone 1 are properly positioned and oriented during repair. As a non-limiting example, the functional axes 2002, 2002' of the fractured bone 1 and the contralateral bone 1' can be employed as primary reference features for assessing the alignment parameters of the fractured bone 1 during repair. These alignment parameters may include one or more of: (1) the length L1 of the fractured bone 1 measured along the functional axis 2002, (2) the angulation A1 of the functional axis 2002 relative to its proper orientation, and (3) the rotation A2 (i.e., angular position or twist) of the fractured bone 1 about the proper functional axis. It should be understood that one or more additional reference features, such as the sagittal plane SP of the body and / or the median longitudinal axis 2006 (i.e., the axis extending along the intersection of the sagittal and coronal planes), may be employed in the foregoing evaluation.

[0020] Referring now to FIG. 2A , an example fracture reduction system 100 is shown that can be used to perform steps of the methods described herein. The fracture reduction system 100 can include a computing system 76 and an imaging device 102 in electrical communication with the computing system 76. The imaging device 102 can be an X-ray machine, such as a “C-arm,” or any other suitable imaging device that produces, for example, X-rays, fluoroscopic images (i.e., a stream of X-ray images), CT scans, or ultrasound images. While the imaging device 102 is depicted as a C-arm with a single X-ray tube, in other embodiments, the imaging device 102 can include two X-ray tubes positioned at a fixed angle relative to each other or that are not fixed relative to each other. In other words, examples of the present disclosure are not limited to a particular configuration of a C-arm X-ray machine.

[0021] The fracture reduction system 100 may include a surgical bed or table 104 on which the patient lies during fracture reduction. Unlike some conventional fracture reduction procedures, the surgical table 104 does not need to have coordinates marked thereon to perform fracture reduction. The imaging device 102 is preferably configured to adjust its field of view (FOV) relative to the table 104 (and therefore relative to the patient thereon). For example, the C-arm 102 may include an X-ray emitter 106 that emits X-rays along a central beam 107 along a central FOV and is translatable relative to the table 104 along a longitudinal imager axis 2003 along the length of the table 104. The emitter 106 is also preferably rotatable about the longitudinal imager axis 2003, as needed, for example, to capture X-rays at selective angles relative to the patient's anatomy, such as anterior-posterior, lateral, and / or various oblique directions. The emitter 106 may also be translatable relative to the table 104 along a lateral imager axis 2005 that is substantially perpendicular to the longitudinal imager axis 2003. The fracture reduction system 100 may include a display 108 that may include one or more monitors configured to display x-ray and / or fluoroscopic images acquired by the C-arm.

[0022] Referring to FIG. 2B , a schematic diagram of a computing system 76 is shown, according to one example, that may be used to implement steps of the methods described herein. The computing system 76 may be a tablet, desktop computer, laptop, server, or any other suitable computing system. The computing system 76 is configured to transmit X-ray images to a display 108 for viewing. The computing system 76 may include at least one processor 80, memory 82, and input / output devices 84. It should be understood that the at least one processor 80, memory 82, and input / output devices 84 may be configured to execute software for processing DICOM files, particularly to read and extrapolate various data therein, including DICOM header data and image data (e.g., image acquisition parameters, image dimensions, pixel intensities, matrix size, etc.), as needed to enhance the methods and steps described below. In some examples, the computing system 76 may include a user interface (UI) 86. The at least one processor 80, memory 82, input / output devices 84, and user interface 86 may be coupled to each other to enable communication therebetween. As will be appreciated, any of the above-described components may be distributed across one or more separate devices and / or locations.

[0023] In various embodiments, the input / output device 84 includes a receiver for receiving data, such as images from an imaging machine, a transmitter for transmitting data, or a combination thereof. The input / output device 84 may be communicatively enabled, e.g., to receive and / or transmit information related to a communications network, such as the Internet or an intranet. Communications may be transmitted over wired or wireless communications channels, e.g., to communicate data with additional computing systems, remote servers, and cloud-based applications. As will be appreciated, the transmitting and receiving functionality may also be provided by one or more devices external to the computing system 76.

[0024] The at least one processor 80 may include a single processor or two or more processors. Depending on the exact configuration and type of processor, the memory 82 may be volatile (such as some types of RAM), non-volatile (such as ROM, flash memory, a hard disk drive, etc.), or a combination thereof. The computing system 76 may include additional storage (e.g., removable and / or non-removable storage), including, but not limited to, tape, flash memory, smart cards, CD-ROMs, digital versatile disks (DVDs) or other optical storage devices, magnetic cassettes, magnetic tape, magnetic disk storage devices or other magnetic storage devices, universal serial bus (USB) compatible memory, or any other medium that may be used to store information. The memory 82 may store instructions that, when executed by the at least one processor 80, cause the computing system 76 to perform various steps of the methods described herein.

[0025] User interface 86 may include inputs that provide the ability to control computing system 76 via, for example, buttons, soft keys, a mouse, voice-activated controls, a touchscreen, movements of computing system 76, visual cues (e.g., waving a hand in front of a camera on computing system 76), auditory cues, etc. User interface 86 may also include a scanner for scanning information, such as, for example, barcodes, QR codes, RFID tags, etc. User interface 86 can provide output that includes visual information (e.g., via a display, a touchscreen, or at least one light), auditory information (e.g., via a speaker), mechanically (e.g., via a vibration mechanism), or a combination thereof.

[0026] Referring now to FIG. 3A , a method 300 for intraoperatively reducing a malalignment of a patient's fractured bone 1 is shown, according to one example. The method 300 will be described with reference to a fracture 58 of the femoral diaphysis 36, specifically the fractured femur 1 shown in FIG. 3B , which depicts the mid-diaphysis 58 of the patient's left femur 1 shown in relation to the contralateral femur 1′ (i.e., the patient's right femur in this example). However, it should be understood that the method 300 may be performed for other fractures, including the fracture shown in FIG. 1A , or any of the fractures discussed herein. The method includes a step 302 of intraoperatively imaging the fractured bone to obtain a first representation 5 of the fractured bone 1 on a computing system 76. As used herein, the terms “intraoperative,” “intraoperative,” and derivatives thereof refer to the performance of a step or procedure during the course of a surgical procedure. In one example, the terms “intraoperative,” “intraoperative,” and derivatives thereof may refer to a step or procedure performed while the patient is in the operating room where the fracture reduction is performed. In other words, "intraoperative," "intraoperative," and their derivatives exclude steps or procedures that are performed before the patient is moved to the operating room where fracture reduction occurs.

[0027] Step 302 preferably includes obtaining a full-length image of the fractured bone 1 so that the first representation 5 of the fractured bone 1 preferably includes its entire length, as shown in FIG. 3C. The length is preferably measured along the functional axis 2002 of the bone 1, although the length may alternatively be measured along the anatomical axis 25. The functional axis 2002 of the fractured bone 1 is preferably measured between corresponding landmarks used in reference to the contralateral bone 1'. In the illustrated example, the functional axis 2002 of the fractured femur 1 extends between a first or proximal landmark M1 located at the center of gravity of the femoral head 40 and a second or distal landmark M2 located at the intercondylar notch 56. As shown in FIG. 3B, the presence of a fracture 58 may cause a displacement between the proximal bone fragment 3 and the distal bone fragment 4, thereby causing the functional axis 2002 to deviate from its proper position and / or orientation, as indicated by axis 2002″, which is shown for illustrative purposes.

[0028] Step 302 may include imaging the fractured bone 1 one or more times to obtain one or more images of the fractured bone 1. The one or more images may include X-ray images, CT images or "slices," ultrasound images, and / or any other suitable medical images. The one or more images may include multiple images 62 of separate portions of the fractured bone 1, which may be combined, such as by image stitching, to create a full-length image of the bone 1. For example, the multiple images 62 may include a first series of images taken at a first image angle relative to the fractured bone 1 and spaced apart along the length of the bone, such as along the functional axis 2002. As a non-limiting example, the first series of images may be taken such that the central beam 107 is aligned along the anterior-posterior direction, thereby providing an anterior-posterior view along the length of the fractured bone 1. The multiple images 62 may also include a second series of images taken at a second image angle relative to the fractured bone 1, different from the first image angle, at intervals along the length of the bone. As a non-limiting example, the second image series can be taken with the central beam 107 aligned along the lateral-medial direction, thereby providing a lateral view along the length of the fractured bone 1. As with the previous example, the first and second image series can be taken at a substantially perpendicular angle to each other, although other relative image angles are possible. In yet another non-limiting example, the second image series can be a series of CT slices that are substantially perpendicular to the anatomical axis of the fractured bone 1.

[0029] The method 300 includes step 304 of intraoperatively imaging the contralateral bone 1′ to obtain a second representation 5′ of the contralateral bone 1′ with the computing system 76. Step 304 preferably includes obtaining a full-length image of the contralateral bone 1′, such that the second representation 5′ of the contralateral bone 1′ preferably includes its entire length. The length is preferably measured along the functional axis 2002′ of the contralateral bone 1′, although the length may alternatively be measured along the anatomical axis 25′. As described above, the functional axis 2002′ of the contralateral bone 1′ is preferably measured between a corresponding landmark used for the fractured bone 1, such as a first or proximal landmark M1 located at the center of gravity of the femoral head 40, and a second or distal landmark M2 located at the intercondylar notch 56 of the contralateral bone 1′. As with the fractured bone 1, step 304 may include imaging the contralateral bone 1′ one or more times to obtain one or more images of the contralateral bone 1′. The one or more images may include X-ray images, CT images, ultrasound images, and / or any other suitable medical images. The one or more images may include a series of images 62 of separate portions of the contralateral bone 1′, which may be combined, such as by image stitching, to create a full-length image of the contralateral bone 1′. For example, the plurality of images 62 may include a third image series taken at a third image angle relative to the contralateral bone 1′ and spaced apart along the length of the bone, such as along the functional axis 2002. As a non-limiting example, the third image series may be taken to provide an anterior-posterior view along the length of the contralateral bone 1′. The plurality of images 62 may also include a fourth image series taken at a fourth image angle relative to the contralateral bone 1′ that is different from the third angle and spaced apart along the length of the bone. As a non-limiting example, the fourth image series may be taken to provide a lateral view along the length of the contralateral bone 1′. The third and fourth image angles may be substantially perpendicular to each other, although other relative image angles are possible. For example, the fourth image series may be a series of CT slices substantially perpendicular to the anatomical axis of the contralateral bone 1'. Preferably, the third and fourth image angles correspond to the first and second image angles, respectively.

[0030] The method 300 includes a step 306 of enhancing the images of the first representation 5 of the fractured bone 1 and the second representation 5' of the contralateral bone 1'. The image enhancement in step 306 can include substeps that address issues presented in the images acquired during steps 302 and 304. One such issue can include image drift, which can be caused by radial distortion resulting from beam divergence toward the periphery of the beam. If not addressed, image drift can introduce distortion between images in a series, thereby adversely affecting the ability to stitch the series together. Image drift from radial distortion can be mitigated by employing a compensation algorithm. Another such issue can include grayscale or other contrast irregularities between images in a series. Such contrast scale can result from auto-adjust contrast modes commonly utilized by physicians. Grayscale between images can cause data noise in the images and adversely affect image stitching. Grayscale can be mitigated by employing a transition algorithm to adjust for or otherwise reduce contrast differences between images in a series. Additional challenges are presented by images along the bone shaft, which may lack distinguishable anatomical landmarks to aid in image stitching. To compensate for the lack of landmarks along the bone shaft, reference features such as X-ray tape measures (e.g., 1 mm resolution tape measures) can be placed with the limb to aid in image stitching. Yet additional challenges may be presented in regions of bone with complex anatomical structures, such as complex adjacent bone geometries and / or additional obscuration caused by adjacent soft tissue. For example, the complex anatomical structures adjacent to the proximal femur, particularly with respect to the femoral head (e.g., adjacent pelvic geometry and soft tissue attachments), can make it difficult to obtain images of the proximal femur with sufficient clarity for image stitching. To mitigate these anatomical challenges, alternative image angles (viewing angles) can be employed.For example, the inventors have demonstrated that switching from an anterior-posterior and / or lateral view and instead employing an oblique view of a bone (e.g., a femur), such as an internal oblique view or an external oblique view along the entire length of the bone, can provide that image with sufficient anatomical clarity for stitching. Step 306 can include additional enhancement substeps. For example, as shown in FIG. 4 , the stitched image series (e.g., any of the first, second, third, and / or fourth image series) can be subjected to a masking step, such as by overlaying a mask on the stitched image series to mask anatomical structures adjacent to the bone. This can further reduce image noise, such as by removing non-bone features from the image, such as implants, instruments, and other hardware.

[0031] The image enhancement of step 306 can create enhanced versions of the first representation 5 and the second representation 5′, such as stitched enhanced versions of the image series (e.g., enhanced versions of the first, second, third, and / or fourth image series). It should be understood that the stitched enhanced versions of the first and second image series can be referred to as first and second enhanced 2D images of the fractured bone 1, respectively. The stitched enhanced versions of the third and fourth image series can be referred to as third and fourth enhanced 2D images of the contralateral bone 1′, respectively. Additionally or alternatively, step 306 can include generating sets of digital data from the first, second, third, and fourth enhanced 2D images that characterize the shapes and / or other geometric features of the fractured bone 1 and the contralateral bone 1′. The image enhancement of step 306 can facilitate use of the first representation 5 of the fractured bone 1 and the second representation 5′ of the contralateral bone 1′ for the creation of 3D models of the fractured bone 1 and the contralateral bone 1′, respectively.

[0032] The method 300 includes step 308 of creating a first 3D virtual model of the fractured bone 1 based on one or both of the first and second enhanced 2D images of the fractured bone 1. The first 3D virtual model preferably accurately depicts the fractured portion of the bone 1, including the proximal bone fragment 3 and the distal bone fragment 4. Step 308 may also include creating a second 3D virtual model of the contralateral bone 1′ based on one or both of the third and fourth enhanced 2D images of the contralateral bone 1′. The creation of the first and second 3D virtual models may be performed with the assistance of one or more artificial intelligence (AI) programs that execute algorithms, such as machine learning and / or deep learning algorithms, to compare the first and second enhanced 2D images against a vast digital library of images of the target bone (e.g., femur, tibia, etc.). The library image may include a global rendering of the target bone or portion thereof. An algorithm (e.g., machine learning) can assist the AI ​​program in creating the first and second 3D virtual models based on the information depicted in the first and second enhanced 2D images (i.e., visual information and / or sets of digital data). For example, the AI ​​program can employ a deep learning algorithm that trains a neural network to reconstruct respective 3D point clouds from each of the first and second enhanced 2D images. The respective 3D point clouds can then be further constructed (e.g., with the aid of a computer-aided design (CAD) program) into respective 3D meshes that constitute the first and second 3D virtual models.

[0033] Step 308 may include rendering the first and second 3D virtual models “on top” of the respective stitched images, an example of which is shown in FIG. 5A. Additionally or alternatively, step 308 may include rendering the first and second 3D virtual models as respective overlays in the respective stitched images, an example of which is shown in FIG. 5B. These additional rendering substeps of step 308 may be employed to evaluate the geometric accuracy of the first and second 3D virtual models and may be employed as iterative steps that can be repeated with specific adjustments to enhance the accuracy of the respective 3D virtual models. Step 308 may include outputting the completed first and second 3D virtual models, which may then be employed as needed to calculate parameters to assist in repair of the fractured bone 1. FIGS. 6A-6E show various views of the 3D virtual model 10′ of the intact femur output during step 308. FIGS. 7A-7E show various views of the 3D virtual model 10′ of the intact tibia output during step 308. In other embodiments, one or both of the 3D virtual models 10, 10' of the fractured bone 1 and the contralateral bone 1' may be 3D CT constructs, such as when the second and / or fourth image series include CT slices taken along the length of the bone, as described above. In further embodiments, step 308 may include generating multiple 3D virtual models for each of the fractured bone 1 and the contralateral bone 1'. As a non-limiting example of such a further embodiment, step 308 may include generating a mesh-type 3D virtual model and a 3D CT construct-type model for each of the fractured bone 1 and the contralateral bone 1'.

[0034] It should be understood that at least a portion of step 308 (i.e., one or more substeps) may optionally be performed by second computing system 78. In such an embodiment, computing system 76 may be referred to as the “first” computing system 76 and may be in electronic communication with second computing system 78. For example, second computing system 78 may be remote or “off-site” from first computing system 76. In such an embodiment, first computing system 76 and second computing system 78 may operate on separate server systems. As a non-limiting example, second computing system 78, along with the AI ​​programs and algorithms employed thereby, may be based on those developed by Zebra Medical Vision Ltd. (Shefayim, Israel). For example, techniques for creating mesh types of first and second 3D virtual models based on the respective 2D images may be similar to those fully described in U.S. Patent No. 10,867,436(B2), issued December 15, 2020, entitled "SYSTEMS AND METHODS FOR RECONSTRUCTION OF 3D ANATOMICAL IMAGES FROM 2D ANATOMICAL IMAGES" (hereinafter "see '436"), the entire disclosure of which is incorporated herein by reference.

[0035] It should further be appreciated that the aforementioned creation of 2D bone representations (such as those shown in Figures 3C and 4) and 3D virtual models of bone is preferably completed intraoperatively in real time, thereby providing significant advantages for completing bone reduction, including for assessing potential misalignment parameters in real time, at a rate sufficient to correct, or at least significantly mitigate, one or more, and up to all, such misalignment parameters intraoperatively. In this manner, the methods and steps described herein can significantly improve patient treatment in the short and long term.

[0036] The method 300 includes a step 310 of calculating one or more misalignment parameters of the fractured bone 1. The one or more misalignment parameters can be calculated by comparing corresponding alignment parameters of the fractured bone 1 and the contralateral bone 1'. The one or more alignment parameters of the fractured bone 1 can be calculated from one or more of the first representation 5, the first and second enhanced 2D images, and the first 3D virtual model 10 of the fractured bone 1. The one or more alignment parameters of the contralateral bone 1' can be calculated from one or more of the second representation 5', the third and fourth enhanced 2D images, and the second 3D virtual model 10' of the contralateral bone 1'. The alignment parameters can include dimensional parameters, such as the length L1 of each bone 1, 1', as measured between its anatomical landmarks. The alignment parameters can also include one or more orientation parameters. One such orientation parameter can be the angulation A1 of the bone or its fragment relative to a reference axis. Another such orientation parameter may be the rotation or "twist" A2 of the bone or fragment thereof about a reference axis. Each misalignment parameter may reflect a difference between the respective alignment parameters of the fractured bone 1 and the contralateral bone 1', as represented by a first 3D virtual model 10 of the fractured bone 1 (which may also be referred to as the "fractured bone model" 10) and a second 3D virtual model 10' of the contralateral bone 1' (which may also be referred to as the "contralateral bone model" 10').

[0037] Method 300 includes step 312 of evaluating whether one or more malalignment parameters of fractured bone 1 are within acceptable limits, which may be determined by the treating physician based on many factors, including, but not limited to, the severity of the fracture, the location of the fracture (e.g., intra-articular or diaphyseal), the type and technique of implant employed to reduce the fracture, the expected impact on adjacent soft tissue, the post-operative treatment plan, the mitigation of short- and long-term side effects, and the age of the patient. If one or more malalignment parameters fall within the acceptable limits, as determined by the surgeon, the surgeon may terminate method 300 and complete the surgery as necessary. If one or more of the malalignment parameters are outside the acceptable limits, the surgeon may proceed to step 314, which includes adjusting the reduction, such as manipulating fractured bone 1 to correct such one or more malalignment parameters to fall within the acceptable limits. After step 314, the surgeon can repeat steps 302, 306, 308, 310, and 312 to determine whether the manipulated fractured bone 1' is within acceptable limits for the misalignment parameters. It should be understood that, in such a case, after step 314, the surgeon preferably does not need to repeat step 304 or portions of steps 306 and 308 on the contralateral bone 1'. By intraoperatively correcting the misalignment parameters or otherwise bringing the misalignment parameters within acceptable limits during the initial fracture reduction surgery, the method 300 and steps herein can avoid the potential need to return the patient for postoperative correction (which may itself present additional complications). In this manner, the method 300 and steps herein can significantly improve the overall fracture reduction treatment and patient experience.

[0038] Referring now to FIG. 8 , to calculate the respective lengths of each bone 1, 1′, corresponding anatomical landmarks (e.g., M1, M2) can be selected as references to assist in measurements for the fractured bone model 10 and the contralateral bone model 10′. In the illustrated example, the proximal landmark M1 is located at the center of gravity of the femoral head 40, and the distal landmark M2 is located at the intercondylar notch 56 of each of the fractured bone model 10 and the contralateral bone model 10′. In this particular example, the landmarks M1, M2 are positioned along the respective functional axes 2002, 2002′ of the bone models 10, 10′. The landmarks M1, M2 can be plotted in the virtual 3D space of the first and second 3D virtual models with respect to a three-axis coordinate system, such as an x, y, z Cartesian coordinate system, which can be aligned with the coordinate system 1000 described above with reference to FIG. 1A. The computing system 76 can autonomously plot the landmarks M1, M2 according to pre-programmed instructions. Alternatively, the surgeon can select one or more of the landmarks M1, M2. According to one such example, the system 100 can be configured to allow the surgeon to select one or both of the landmarks M1, M2 via the user interface 86 based on a list of landmark options presented on the display 108. According to another such example, the system 100 can be configured to allow the surgeon to input one or both of the landmarks M1, M2 by manual input (e.g., mouse clicks, stylus taps, etc.) within the 2D space of a selected image, such as an axial CT slice obtained during steps 302 and / or 304. After corresponding landmarks M1, M2 have been selected for the fractured bone model 10 and the contralateral bone model 10′, the computing system 76 can calculate the respective linear distances between the landmarks M1, M2 pair to calculate the length L1 of the fractured bone 1 and the length L1′ of the contralateral bone 1′. A length misalignment parameter, denoted herein as "ΔL," can then be derived by calculating the difference between the length L1 of bone model 10 and the length L1' of bone model 10' (ΔL=L1-L1').

[0039] It should be appreciated that calculating the linear distance between the landmarks M1 and M2 in the 3D space of each bone model 10, 10′ may include identifying, for each landmark M1, M2, respective values ​​along the coordinate axes (x, y, z axes in this example). Thus, the linear distance between the landmarks M1 and M2 in the 3D space of each bone model 10, 10′ may be expressed by the following equation:

[0040]

number

[0041] Furthermore, the absolute length of each bone model 10, 10' as measured between the respective landmarks M1 and M2 can be expressed by the following equation:

[0042]

number

[0043] In this way, the respective lengths L1, L1' of each bone model 10, 10' can be calculated in 3D space even if the landmarks lie in different planes along, for example, the x-axis (anterior-posterior direction).

[0044] 9A , to calculate the angulation A1 of each of the fragments 3, 4 of the fractured bone model 10 and the associated portion of the contralateral bone model 10′ in the first reference plane, corresponding anatomical landmarks (e.g., M1-M8) can be selected as reference points to assist in the measurement. The landmarks M1-M8 employed for the angulation measurement in this example are preferably located on the outer surface of the bone models 10, 10′. Accordingly, the computing system 76 can generate a contour 64 of each bone 10, 10′ in the first reference plane, in this example, in the coronal plane. The landmarks M1-M8 can then be located on the contour 64. The landmarks M1-M8 can be employed within the sets M1-M4, M5-M8 on the contour 64 of each bone model 10, 10′ such that each set M1-M4, M5-M8 approximates a respective reference shape S1, S2, S1′, S2′, which has a geometric shape similar to the geometric shape of the associated portion of the bone model 10, 10′. For example, a first set of landmarks M1-M4 can be plotted on the outline of the proximal fragment 3, and a second set of landmarks M5-M8 can be plotted on the outline of the distal fragment 4 of the fractured bone 1. The corresponding set of landmarks M1-M4, M5-M8 can be plotted at corresponding locations on the outline of the contralateral bone 1'. In this example, the reference shapes are truncated cones, and the inventors have discovered that the methods described herein are advantageous for approximating sections of the bone's diaphysis. Each truncated cone extends from base to apex along a cone axis XS. As shown, the cone axis XS can provide a substantially accurate approximation of the location and orientation of the anatomical axis of each portion of the bone model 10, 10'. The truncated cones S1, S2, S1', S2' can be circular or elliptical cones, depending on the geometry of the adjacent bone. The bases and apexes of the truncated cones S1, S2, S1', S2' can be perpendicular to the cone axis XS or oblique to the cone axis XS. In the 2D space of the first reference plane, the reference shapes S1, S2, S1', S2' are preferably represented as cross sections of a truncated cone along the cone axis XS. It should be understood that the truncated cones S1, S2, S1', S2' are also depicted as respective trapezoids in the first reference plane.

[0045] After the landmarks are plotted and the reference shapes are generated, the computing system 76 can employ the reference shapes S1, S2, S1', and S2' to calculate their respective angulations with respect to a reference axis. In this example, the reference axis can be a common reference axis, such as the central longitudinal axis 2006. In this manner, the angulation A1 of the proximal bone fragment 3 can be calculated by measuring the angle between the central longitudinal axis 2006 and the cone axis XS of shape S1 in the reference plane. Similarly, the angulation A2 of the distal bone fragment 4 can be calculated by measuring the angle between the central longitudinal axis 2006 and the cone axis XS of shape S2. The comparative angulations A1' and A2' of the contralateral bone 1' can be calculated by measuring the angle between the central longitudinal axis 2006 and the cone axes XS of shapes S1' and S2', respectively. The misalignment parameters for angulation in the first reference plane, denoted herein as "ΔA1" and "ΔA2," can then be derived for the proximal bone fragment 3 and the distal bone fragment 4 by calculating the difference between their respective angulations A1, A2 and the corresponding angulations A1', A2' of the contralateral bone 1' (ΔA1=A1-A1'; ΔA2=A2-A2').

[0046] 9B, the angulation B1 of each bone model 10, 10' in the second reference plane can be calculated in a manner similar to that described above for the first reference plane. The second reference plane is preferably substantially perpendicular to the first reference plane, although other orientations, such as oblique orientations, including internal oblique and external oblique orientations, are within the scope of this disclosure. In the illustrated example, the second reference plane is essentially a composite view showing the fractured bone 1 and the contralateral bone 1', respectively, in respective views taken in a medial-to-lateral direction from the sagittal plane. As described above, the computing system 76 can generate a contour 64 of each bone model 10, 10′ in the second reference plane and plot the sets of landmarks M1-M4, M5-M8 on the contour 64 of each bone model 10, 10′ such that each set M1-M4, M5-M8 approximates a respective reference shape S1, S2, S1′, S2′ (e.g., a truncated cone) having a similar geometry to the geometry of the associated portion of the bone model 10, 10′. As described above, the cone axis XS can provide a substantially accurate approximation of the location and orientation of the anatomical axis of each portion of the bone model 10, 10′.

[0047] The computing system 76 can employ the reference shapes S1, S2, S1', and S2' to calculate the respective angulations with respect to the reference axis. In this example, the reference axis can be a second reference axis 2007 that is parallel to the central longitudinal axis 2006 and extends along the sagittal plane at a location offset posteriorly. In this manner, the second reference axis 2007 can be spaced substantially equidistant from the fractured bone 1 and the contralateral bone 1'. In the second reference plane, the angulation B1 of the proximal bone fragment 3 can be calculated by measuring the angle between the axis 2007 and the cone axis XS of the shape S1, and the angulation B2 of the distal bone fragment 4 can be calculated by measuring the angle between the axis 2007 and the cone axis XS of the shape S2. The comparative angulations B1' and B2' of the contralateral bone 1' can be calculated by measuring the angle between the axis 2007 and the cone axis XS of the shapes S1' and S2', respectively. The misalignment parameters for angulation in the second reference plane, denoted herein as "ΔB1" and "ΔB2," can then be derived by calculating the difference between the respective angulations B1, B2 of the proximal bone fragment 3 and the distal bone fragment 4 and the corresponding angulations B1', B2' of the contralateral bone 1' (ΔB1=B1-B1'; ΔB2=B2-B2').

[0048] It should be appreciated that misalignment parameters for angulation of the fractured bone 1 can be calculated using 3D versions of reference shapes (e.g., S1, S2, S1', S2'), such as the truncated cones described above. For example, the computing system 76 can fit 3D truncated cones S1, S2 to select portions of the diaphysis of the proximal bone fragment 3 and the distal bone fragment 4 of a first 3D virtual model of the fractured bone 1. The truncated cones S1', S2' can then be fitted to corresponding portions of the diaphysis of a second 3D virtual model of the contralateral bone 1'. The fitting of the truncated cones can be performed using a shape matching algorithm, a best fit algorithm, or any suitable algorithm. The angle of the cone axis of each truncated cone S1, S2, S1', S2' can be calculated in 3D space with respect to a three-axis coordinate system, such as the Cartesian coordinate system described above. The angulation misalignment parameters in 3D space can then be derived for the proximal bone fragment 3 and the distal bone fragment 4 by calculating the difference between their respective cone axis angles and the corresponding cone axis angles of the truncated cone fitted to the contralateral bone 1′.

[0049] 10A-10E, a reference plane RPT can be selected for torsion measurements to calculate the respective torsion angles of the fractured bone 1 and the contralateral bone 1′. In the illustrated example, the transverse plane is employed for torsion measurements. In each of the fractured bone model 10 and the contralateral bone model 10′, a first or proximal set of landmarks M1, M2 can be plotted on the proximal femur at corresponding locations to define a proximal reference axis 70, and a second or distal set of landmarks M3, M4 can be plotted on the distal femur at corresponding locations to define a distal reference axis 72. The proximal and distal reference axes 70, 72 of each bone model 10, 10′ can be projected onto a torsion reference plane. Respective torsion values ​​T1, T1′ for each bone model 10, 10′ can be calculated by measuring the angle between the projections of the proximal and distal axes 70, 72 within the torsion reference plane. A torsional misalignment parameter, denoted herein as "ΔT", can then be derived by calculating the difference between the torsion angle T1 of bone model 10 and the torsion angle T1' of bone model 10' (ΔT=T1-T1').

[0050] According to one example, the proximal landmark M1 can be located at the center of mass of the femoral head, as identified in an axial image or slice 74 along a plane parallel to the lateral plane. For example, the axial image used for the proximal landmark M1 can be taken along a "head-centered" plane, as shown in FIG. 10B. The proximal landmark M2 can be located at the center of mass of the greater trochanter 44, as seen in an axial image or slice 74 in the Waidelich or Murphy plane. In the illustrated example, the distal landmarks M3 and M4 can be located on the posterior apices of the medial and lateral condyles 50 and 52, as identified in one or two axial images or slices 74 parallel to the lateral plane. Thus, the distal reference axis 72 can extend along the posterior condyle tangent. FIGS. 10D and 10E show example displays of a system showing torsion angle measurements using the techniques described above. It should be understood that other locations and axial images can be used for the proximal landmarks M1 and M2 and the distal landmarks M3 and M4.

[0051] It should be understood that one or more of the aforementioned misalignment parameters may be omitted or alternative misalignment parameters may be selected based on the particular needs of the reduction. Thus, method 300 may include the additional step of selecting misalignment parameters for assessing reduction.

[0052] It should be understood that the above-described steps for calculating a misalignment parameter may be employed in connection with a fractured tibia and its contralateral tibia. For example, method 300 may be employed to create one or more reference images, enhanced 2D image sets, and / or 3D virtual models of the fractured tibia and contralateral tibia for use in calculating the misalignment parameter of the fractured tibia. For example, landmarks may be input onto such reference images, 2D image sets, and / or 3D virtual models of the tibia to calculate the differences in length, angulation, and torsion between the fractured tibia and the contralateral tibia. According to an example of calculating a tibial length misalignment parameter, the respective lengths of each of the fractured and contralateral tibia models may be measured between a proximal landmark, which may be located on the tibial plateau, and a distal landmark, which may be located at the center of the tibial pilon. According to an example of calculating a misalignment parameter for tibial angulation, a reference shape, such as a truncated cone, may be plotted along the outer surfaces of corresponding portions of the tibial shafts of the fractured tibia model and the contralateral tibia model, and an angle may be measured between the axes of the corresponding reference shapes of the fractured tibia model and the contralateral tibia model. According to an example of calculating a tibial torsion misalignment parameter, a set of proximal landmarks can be plotted along one or more axial slices of the proximal tibia to generate a proximal reference axis, the angle of which can be measured relative to a distal reference axis that intersects a set of distal landmarks plotted along one or more axial slices of the distal tibia. It should be understood that one or more of the aforementioned tibial misalignment parameters can be omitted, or alternative tibial misalignment parameters can be selected, based on the particular needs of the reduction.

[0053] It should be understood that a variety of landmarks may be employed to calculate the maladjustment parameters of a reduced bone. For example, the computing system 76 may contain a library or database of landmarks, which may be stored in memory 82 and selectable for assessing the maladjustment parameters of the subject's bone. The landmarks in such a database may optionally have unique identifiers, such as M1 through Mn, where "n" may represent an integer identifier for the final landmark in the set of landmarks. A non-limiting example of such a database may be organized as shown in Table 1 below, with corresponding locations on the subject's bones shown in FIG. 11A (intact femur) and FIG. 11B (intact tibia).

[0054] [Table 1]

[0055] According to the database shown in Table 1, the length of each femur model 10, 10′ can be measured between any one of the proximal landmarks (M0, M1, M2, M14) and any one of the distal landmarks (M3, M4, M5). For example, in additional embodiments, the length L1 of the femur model 10, 10′ can be measured, by way of non-limiting example, between landmarks M0, M1, and M3, or between landmarks M2 and M3, or between landmarks M1 and M4, or between landmarks M1 and M5. Similarly, the length of each tibia model 10, 10′ can be measured between any one of the proximal landmarks (M15, M16, M17) and any one of the distal landmarks (M18, M19, M20).

[0056] 12A and 12B, another exemplary method for calculating misalignment parameters for the angulation of bone fragments 3, 4 of a fractured bone model 10 by comparison with associated portions of a contralateral bone model 10′ may include generating approximations of associated anatomical axes of the bone model 10, 10′ using the proximal landmarks M6-M9 and distal landmarks M10-M13 from Table 1. In this example, at each of the landmarks M6-M13, the computing system 76 may generate an axial image or slice 74 of the bone model 10, 10′. Alternatively, at each of the landmarks M6-M13, the computing system 76 may capture an axial image or slice 74 of the bone 1, 1′, particularly if the first representation 5 and / or second representation 5′ of the bone 1, 1′ includes an axial image, such as a CT or MRI image.

[0057] 12A, for each axial slice 74, the computing system 76 may generate a reference circle 75, such as by locating three reference points P1, P2, P3 on the outer surface of the bone 1 and generating the reference circle 75 to intersect with each of the reference points P1, P2, P3. Once the reference circle 75 is generated, the computing system 76 may identify its center point P4.

[0058] 12B , for axial slices corresponding to proximal landmarks M6-M9 of each of bone models 10, 10′, computing system 76 can plot a proximal reference axis XS2 in 3D space that substantially intersects center point P4 of reference circle 75, such as by calculating a linear regression line for proximal reference axis XS1 of each of bone models 10, 10′. Similarly, for axial slices 74 corresponding to distal landmarks M10-M13 of each of bone models 10, 10′, computing system 76 can plot a distal reference axis XS2 in 3D space that substantially intersects center point P4 of reference circle 75, such as along a linear regression line. To compare the angulation of the proximal bone fragment 3 with the angulation of the associated portion of the contralateral bone model 10′, computing system 76 can calculate the difference between the respective orientations of proximal reference axis XS1 in 3D space. To compare the angulation of the distal bone fragment 4 with the angulation of the relevant portion of the contralateral bone model 10', the computing system 76 can calculate the difference between the respective orientations of the distal reference axis XS2 in 3D space.

[0059] It should also be understood that the above-described method, including method 300 and its sub-steps, may be employed in connection with other bones, including other long bones (e.g., fibula, humerus, radius, and ulna), including creating one or more of reference images, enhanced 2D image sets, and / or 3D virtual models for the other bones, including comparative measurements with contralateral counterparts of the bones, and including calculating misalignment parameters between the counterparts, such as for assessing reduction of the bones.

[0060] It should be noted that the illustrations and descriptions of the examples and embodiments shown in the figures are for illustrative purposes only and should not be construed as limiting the present disclosure. Those skilled in the art will understand that the present disclosure contemplates a variety of embodiments. Additionally, it should be understood that the concepts described above, along with the above examples and embodiments, may be used alone or in combination with any of the other examples and embodiments described above. It should be further understood that the various alternative examples and embodiments described above with respect to an exemplary embodiment are applicable to all examples and embodiments described herein, unless otherwise specified.

[0061] As used herein, hypothetical language, such as "can," "could," "might," "may," "eg," and the like, among others, is intended to generally convey that certain embodiments include certain features, elements, and / or steps, and other embodiments do not, unless specifically specified otherwise or understood otherwise within the context in which it is used. Thus, such hypothetical language is not generally intended to imply that features, elements, and / or steps are required in any manner for one or more embodiments, or that one or more embodiments necessarily include logic, with or without author input or prompting, for determining whether those features, elements, and / or steps are necessarily included or performed in any particular embodiment. Terms such as "comprising," "including," and "having" are synonymous and used inclusively in a non-limiting manner and do not exclude additional elements, features, acts, operations, etc.

[0062] While certain exemplary embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of the invention(s) disclosed herein. Accordingly, nothing in the foregoing description is intended to imply that any particular feature, characteristic, step, module, or block is essential or essential. Indeed, the novel methods and systems described herein may be embodied in a wide variety of other forms. Furthermore, various omissions, substitutions, and changes can be made in the form of the methods and systems described herein without departing from the spirit of the invention(s) disclosed herein. The accompanying claims and their equivalents are intended to cover such forms or modifications as fall within the specific scope and spirit of the invention(s) disclosed herein.

[0063] It should be understood that the steps of the exemplary methods described herein do not necessarily have to be performed in the order described, and the order of steps in such methods should be understood to be merely exemplary. Similarly, additional steps may be included in such methods, and certain steps may be omitted or combined, in methods consistent with various embodiments of the present invention.

[0064] If any, elements in the following method claims will be listed in a particular order with corresponding labeling, unless the claim recitation otherwise suggests a particular order for implementing some or all of those elements, but those elements are not necessarily intended to be implemented in that particular order.

[0065] It is to be understood that the subject matter presented herein may be implemented as a computer process, computer controller, or computing system, or article of manufacture such as a computer-readable storage medium. Those skilled in the art will also appreciate that the subject matter described herein may be implemented with or in connection with other computer system configurations beyond those described herein, including multiprocessor systems, microprocessor-based or programmable consumer electronics, minicomputers, mainframe computers, handheld computers, personal digital assistants, electronic readers, cellular telephone devices, special purpose hardware devices, network appliances, and the like. The embodiments described herein can also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

[0066] Each of the processes, methods, and algorithms described in the previous sections may be embodied in code modules executed by one or more computers or computer processors and may be fully or partially automated. The code modules may be stored on any type of non-transitory computer-readable medium or computer storage device, such as a hard drive, solid-state memory, optical disk, and / or the like. The processes and algorithms may be implemented partially or entirely in application-specific circuitry. The results of the disclosed processes and process steps may be stored, persistently or otherwise, in any type of non-transitory computer storage, such as, for example, volatile or non-volatile storage.

[0067] [Embodiment] (1) A method comprising: intraoperatively imaging a fractured bone of a patient and obtaining a representation of the fractured bone with a computing system, the fractured bone defining at least a first bone fragment and a second bone fragment separated from the first bone fragment by a fracture; imaging a contralateral bone of the patient and obtaining a representation of the contralateral bone on the computing system; During the operation, the computing system a 3D virtual model of the fractured bone from the data presented in the representation of the fractured bone; and generating a 3D virtual model of the contralateral bone from the data presented in the representation of the contralateral bone; During the operation, the computing system a first spatial dimension measured within the 3D virtual model of the fractured bone by the computing system; and comparing the measured spatial dimension to a second spatial dimension measured within the 3D virtual model of the contralateral bone. (2) The method of embodiment 1, wherein the comparing step includes calculating a difference in value between the first spatial dimension and the second spatial dimension. (3) The method of embodiment 2, further comprising displaying the difference in values ​​on a display device during surgery. (4) The method of embodiment 3, further comprising manipulating at least one of the first bone fragment and the second bone fragment relative to the other of the first bone fragment and the second bone fragment, thereby reducing the difference in the values. (5) during the operation, in the computing system, and determining, at the computing system, a third spatial dimension measured within one of the 3D virtual model of the fractured bone and the representation of the fractured bone. 2. The method of claim 1, further comprising comparing a fourth spatial dimension measured within one of the 3D virtual model of the contralateral bone and the representation of the contralateral bone, wherein the third spatial dimension and the fourth spatial dimension are different from the first spatial dimension and the second spatial dimension, respectively.

[0068] (6) The method of embodiment 5, wherein the comparing step includes calculating a difference in value between the third spatial dimension and the fourth spatial dimension. (7) During the operation, the computing system and determining, at the computing system, a fifth spatial dimension measured within one of the 3D virtual model of the fractured bone and the representation of the fractured bone. 7. The method of claim 6, further comprising comparing a sixth spatial dimension measured within one of the 3D virtual model of the contralateral bone and the representation of the contralateral bone, wherein the fifth spatial dimension and the sixth spatial dimension are different from the third spatial dimension and the fourth spatial dimension, and the first spatial dimension and the second spatial dimension, respectively. (8) The method of embodiment 7, wherein the comparing step includes calculating a difference in value between the fifth spatial dimension and the sixth spatial dimension. (9) intraoperatively displaying the difference in value between the third spatial dimension and the fourth spatial dimension on the display device; and 9. The method of claim 8, further comprising intraoperatively displaying the difference in value between the fifth spatial dimension and the sixth spatial dimension on the display device. (10) The method of embodiment 9, further comprising manipulating at least one of the first bone fragment and the second bone fragment relative to the other of the first bone fragment and the second bone fragment, thereby reducing at least one of the difference in value between the third spatial dimension and the fourth spatial dimension and the difference in value between the fifth spatial dimension and the sixth spatial dimension.

[0069] (11) The method described in embodiment 7, wherein the first spatial dimension and the second spatial dimension are the lengths of the fractured bone and the contralateral bone, respectively. (12) The method described in embodiment 11, wherein the third spatial dimension is the angulation of one of the first bone fragment and the second bone fragment relative to the functional axis of the fractured bone, and the fourth spatial dimension is the angulation of a portion of the contralateral bone relative to the functional axis of the contralateral bone, and the portion of the contralateral bone corresponds to the one of the first bone fragment and the second bone fragment. (13) The method described in embodiment 12, wherein the fifth spatial dimension is the torsion of the proximal portion of the fractured bone relative to the distal portion of the fractured bone about the functional axis of the fractured bone, and the sixth spatial dimension is the torsion of the proximal portion of the contralateral bone relative to the distal torsion of the contralateral bone, and the proximal and distal portions of the contralateral bone correspond to the proximal and distal portions of the fractured bone, respectively. (14) plotting a first set of landmarks within the 3D virtual model of the fractured bone, wherein the first spatial dimension is measured autonomously with respect to the first set of landmarks; 2. The method of claim 1, further comprising plotting a second set of landmarks within the 3D virtual model of the contralateral bone, wherein the second spatial dimension is measured autonomously with respect to the second set of landmarks. (15) The method of embodiment 14, wherein the first set of landmarks includes a first subset of landmarks plotted on the first bone fragment and a second subset of landmarks plotted on the second bone fragment.

[0070] (16) The second set of landmarks a third subset of landmarks autonomously plotted on the first portion of the contralateral bone corresponding to the first bone fragment by the computing system; and a fourth subset of landmarks autonomously plotted by the computing system on a second portion of the contralateral bone corresponding to the second bone fragment. (17) The method of embodiment 15, wherein the fractured bone is a femur or a tibia, and the fracture is located along the diaphysis of the fractured bone, whereby the first bone fragment and the second bone fragment and the first portion and the second portion of the contralateral bone each comprise a portion of the diaphysis, and the first subset, the second subset, the third subset, and the fourth subset of landmarks each define a respective frustum defining a respective frustum axis that substantially approximates an anatomical axis of the respective portion of the diaphysis. (18) The method of embodiment 17, wherein the computing system calculates the respective angulations between each frustum axis and a central longitudinal axis of the patient's anatomy. (19) A method comprising: imaging a fractured bone of a patient intraoperatively and obtaining a representation of the fractured bone with a computing system, the fractured bone defining at least a first bone fragment and a second bone fragment separated from the first bone fragment by a fracture, the representation of the fractured bone including a composite series of images of the fractured bone taken at intervals along a length of the fractured bone; intraoperatively imaging a contralateral bone of the patient and obtaining a representation of the contralateral bone on the computing system, the representation comprising a composite series of images of the contralateral bone taken at intervals along a length of the contralateral bone; Intraoperatively, measuring with the computing system a first spatial dimension defined with respect to at least two anatomical landmarks presented on one of the representation of the fractured bone and the representation of the contralateral bone; automatically identifying, intraoperatively, with the computing system, contralateral counterparts of the at least two anatomical landmarks presented on the other of the representation of the fractured bone and the representation of the contralateral bone; and intraoperatively measuring, with the computing system, a second spatial dimension defined relative to the contralateral counterparts of the at least two anatomical landmarks. (20) The method of embodiment 19, wherein the composite series of images of the fractured bone and the contralateral bone each includes a respective plurality of X-ray images stitched together to depict the entire length of the respective fractured bone and the contralateral bone.

Claims

1. 1. A method of operating a computing system, comprising: a processor of the computing system imaging a fractured bone of a patient to obtain a representation of the fractured bone, the fractured bone defining at least a first bone fragment and a second bone fragment separated from the first bone fragment by a fracture; the processor imaging a contralateral bone of the patient to obtain a representation of the contralateral bone; the processor generates a 3D virtual model of the fractured bone by combining the representation of the first bone fragment and the representation of the second bone fragment from the data presented in the representation of the fractured bone together by image stitching to depict the entire length of the fractured bone along a functional axis of the fractured bone, and a 3D virtual model of the contralateral bone from the data presented in the representation of the contralateral bone to depict the entire length of the contralateral bone along the functional axis of the contralateral bone; the processor calculating a difference in value between a first spatial dimension, the length of the fractured bone measured along the functional axis of the fractured bone in the 3D virtual model of the fractured bone, and a second spatial dimension, the length of the contralateral bone measured along the functional axis of the contralateral bone in the 3D virtual model of the contralateral bone, wherein the difference in value can be reduced by manipulating at least one of the first bone fragment and the second bone fragment relative to the other of the first bone fragment and the second bone fragment in the 3D virtual model; the processor outputting the difference in values ​​to an output device of the computing system; A method of operation comprising:

2. The method of claim 1 further comprising the processor displaying the difference in values ​​on a display device.

3. calculating a second value, the second value being the difference between a first angular parameter measured in a reference plane in one of the 3D virtual model of the fractured bone and the representation of the fractured bone as an angle between the functional axis of the fractured bone and a cone axis of a shape of the first bone fragment, and a second angular parameter measured in a reference plane in one of the 3D virtual model of the contralateral bone and the representation of the contralateral bone as an angle between the functional axis of the fractured bone and a cone axis of a shape of a portion of the contralateral bone corresponding to the first bone fragment, wherein the second value can be reduced by manipulating at least one of the first bone fragment and the second bone fragment relative to the other of the first bone fragment and the second bone fragment in the 3D virtual model; the processor outputting the second value to an output device of the computing system; The method of claim 1 further comprising:

4. calculating a third value, the third value being the difference between a third angular parameter measured in a reference plane in one of the 3D virtual model of the fractured bone and the representation of the fractured bone as an angle between the functional axis of the fractured bone and a cone axis of a shape of the second bone fragment, and a fourth angular parameter measured in a reference plane in one of the 3D virtual model of the contralateral bone and the representation of the contralateral bone as an angle between the functional axis of the fractured bone and a cone axis of a shape of the portion of the contralateral bone corresponding to the second bone fragment, wherein the third value can be reduced by manipulating at least one of the first bone fragment and the second bone fragment relative to the other of the first bone fragment and the second bone fragment in the 3D virtual model; the processor outputting the third value to an output device of the computing system; The method of claim 3 further comprising:

5. the processor displaying the second value on a display device; and The method of claim 4 , further comprising the processor displaying the third value on the display device.

6. the processor calculating a fourth value difference between a seventh spatial dimension, the seventh spatial dimension being a twist of a proximal portion of the fractured bone relative to a distal portion of the fractured bone about the functional axis of the fractured bone, at a reference plane in one of the 3D virtual model of the fractured bone and the representation of the fractured bone, and an eighth spatial dimension, the eighth spatial dimension being a twist of a proximal portion of the contralateral bone relative to the distal portion of the contralateral bone about the functional axis of the contralateral bone, at a reference plane in one of the 3D virtual model of the contralateral bone and the representation of the contralateral bone, wherein the fourth value difference can be reduced by manipulating at least one of the first bone fragment and the second bone fragment relative to the other of the first bone fragment and the second bone fragment in the 3D virtual model; the processor outputting the fourth value difference to an output device of the computing system; and The method of claim 4 further comprising:

7. the processor autonomously plotting a first set of landmarks within the 3D virtual model of the fractured bone, the first spatial dimension being measured as a linear distance of the first set of landmarks; 2. The method of claim 1, further comprising: the processor autonomously plotting a second set of landmarks within the 3D virtual model of the contralateral bone, wherein the second spatial dimension is measured as a linear distance of the second set of landmarks.

8. 8. The method of claim 7, wherein the first set of landmarks includes a first subset of landmarks established on the first bone fragment and a second subset of landmarks established on the second bone fragment.

9. 1. A method of operating a computing system, comprising: a processor of the computing system images a fractured bone of a patient to obtain a representation of the fractured bone, the fractured bone defining at least a first bone fragment and a second bone fragment separated from the first bone fragment by a fracture, the representation of the fractured bone including a composite series of images of the fractured bone taken at intervals along a length of the fractured bone; the processor images a contralateral bone of the patient to obtain a representation of the contralateral bone, the representation of the contralateral bone comprising a composite series of images of the contralateral bone taken at intervals along a length of the contralateral bone; measuring a first spatial dimension as a linear distance between two anatomical landmarks presented on a 3D virtual model of the fractured bone, the representation of the first bone fragment and the representation of the second bone fragment being combined together by image stitching to depict a full length of the fractured bone along a functional axis of the fractured bone; the processor identifying contralateral counterparts of two anatomical landmarks in a 3D virtual model of the representation of the contralateral bone, the 3D virtual model having been generated to depict the entire length of the contralateral bone along a functional axis of the contralateral bone; the processor measuring a second spatial dimension as the linear distance between the contralateral counterparts of the two identified anatomical landmarks; the processor outputting the first spatial dimension and the second spatial dimension to an output device of the computing system. A method of operation comprising:

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