Systems and methods for surgical bone repair

Abstract

System to reduce a bone fracture, including: a first specially shaped fiducial pin (SSFP) appliable to a first bone segment, the first SSFP including a first base, first stem, and first pin, the first pin insertable into the first bone segment, the first base disposable on the first bone segment, and the first stem having a material detectible with surface imaging, the first base including a male connector; and a second SSFP appliable to a second bone segment, the second SSFP including a second base, second stem, and second pin, the second pin insertable into the second bone segment, the second base disposable on the second bone segment, and the second stem having a material detectible with surface imaging, wherein the second base includes a female connector to securely receive therein the male connector, to reduce the fracture and provisionally secure the first bone segment to the second bone segment.

Description

SYSTEMS AND METHODS FOR SURGICAL BONE REPAIRBACKGROUNDField

[0001] The present application relates to orthopedic methodologies and techniques for surgical bone repair. More specifically, the present application is directed to specially shaped fiducial pins (SSFPs) capable of integration into systems and methods for surgical bone repair, including incorporation into optical bone scanning and registration processes, as well as integration with bone cutting jigs in various surgical procedures and interlocking in fracture reduction, so as to more easily and accurately track and execute one or more preoperative plans for surgical bone repair.Brief Discussion of Related Art

[0002] It is frequently the case in orthopedic surgery that the surgeon can, before the actual surgery, view a computerized image of the patient’s bone that can be displayed on a computer screen. Typically, this may be accomplished via an X-ray, a computed tomography (CT) scan, or a magnetic resonance imaging (MR1) scan. With respect to CT scan images, if a CT scan image of the patient’s bone is obtained before surgery, it is commonplace to now have a readily available three dimensional (3D) reconstruction of the bone (e.g., 3D model). Using such an image and / or model, the surgeon may, prior to surgery, outline a detailed preoperative plan on the computer screen. The surgeon’s goal at surgery is then to reproduce identically this preoperative plan.

[0003] For example, if the surgeon is performing a resection of a bone tumor, a CT scan and MRI scan may be used to image precisely and localize where the tumor stops and where the normal bone begins. Prior to surgery, on the computer screen, the surgeon may draw annotation lines to outline precisely a surgical resection plan. Similarly, prior to a knee replacement, a surgeon can look at preoperative imaging and outline exactly where and at precisely which angle the surgeon wants to cut the distal femur or the proximal tibia. Moreover, before a fracture reduction surgery, a surgeon can look at preoperative imaging and outline precisely how bone segments are to be aligned, provisionally secured, and definitively secured.

[0004] The problem then becomes that the surgeon has to reproduce the preoperative plan at the time of surgery. This problem is actually more challenging than it appears given the standard tools that are available in the operating room. Presently, a surgeon still most often uses tools such as straight rulers and identifies palpable or visible landmarks; the surgeon then measures the osteotomy from these landmarks at the time of surgery. This process is notoriously unreliable.

[0005] A custom 3D printed jig may be made when a 3D printer is used to make a jig that is the negative of a specific contour of the bone; the jig is designed to fit in a unique location on the bone and has slots built into it that allow the surgeon to insert a saw designed to reproduce the surgeon’s preoperative plan. Although custom 3D printed jigs are an enormous improvement, there are still some problems that are associated with them. First, they take considerable time and engineering expertise to manufacture. Typically, orders for the custom 3D printed jig take three to six weeks to design, print, sterilize, and ship to the surgeon. Moreover, there are still errors on the order of at least 3 mm associated with these jigs, which may come from ambiguity of placement and ergonomic errors due to the human factor. This may not seem a lot; however, if the surgeon is planning on implanting a custom metal device into a skeletal defect, errors on the order of 3 mm can be devastating and prevent successful use of a custom metal device.

[0006] Computer navigation systems present a powerful new technique to help a surgeon effect a given surgical technique, such as tumor resection, knee replacement, fracture reduction, etcetera. Typically, these systems have a preoperative CT scan. At surgery, the surgeon places a fiducial pin into the bone of interest. A camera is present at surgery and constantly marks the position of the fiducial pin, allowing for some movement of the limb at the time of surgery.

[0007] Typical registration systems involve paired point registration. The surgeon is asked to point to several (e.g., twenty) different points on the bone near an area of interest. The camera records where the pointer is pointing with respect to the fiducial pin, and it uses the foregoing points to try to define a local shape of the bone and match it to the preoperative CT scan image.

[0008] However, there are many drawbacks to this technique. First, the registration process takes time to register these points (twenty points). Second, the registration is often inadequate and / or inaccurate, and must often be repeated. Third, there needs to be a line of sight between the camera, the fiducial pin, and the registration pointer. The foregoing requires that the surgeon, instrumentation, tissue, blood, and / or any other material cannot be in the way blocking this line of sight. Fourth, the entire computer navigation system is often very expensive, sometimes on the order of one million dollars or so. Fifth, the setup is quite bulky, taking up valuable space in the operating room. Sixth, some systems have intraoperative CT scans, which can expose the patient and the entire surgical staff to significant amounts of dangerous radiation.

[0009] Optical registration systems have been developed as an alternative to the paired point registration. Currently, optical registration is being used for spinal surgery. While a powerful addition, this methodology still requires a line of sight. Bleeding, tissue blocking the line of sight, a surgeon’s hands or retractors, are some common things encountered in the operating room that can compromise the line of sight and thus affect optical registration. Therefore, because of the line of sight issues, direct optical scanning of the patient’s bone during surgical procedures for registration may not be clinically viable in many situations.

[0010] It is therefore desirable to address the foregoing as well as other problems in the orthopedic field, using specially shaped fiducial pins (SSFPs) capable of integration into various systems and methods for surgical bone repair, particularly their incorporation into automated optical bone scanning and registration processes, as well as integration with bone cutting jigs in various surgical procedures and interlocking in fracture reduction, so as to more easily and accurately track and execute preoperative plans for surgical bone repair.SUMMARY

[0011] In accordance with an embodiment, there is disclosed a system associated with reducing a fracture of a patient bone, wherein the system includes: a first specially shaped fiducial pin (SSFP) configured to be applied to a first bone segment of the patient bone in accordance with a preoperative plan, the first SSFP comprising a first base, a first stem,and a first pin, the first pin configured to be inserted into the first bone segment, the first base configured to be disposed on a surface of the first bone segment, and the first stem having a reflective material to be detectible with surface imaging, wherein the first base comprises a male connector extending from the first base; and a second SSFP configured to be applied to a second bone segment of the patient bone in accordance with the preoperative plan, the second SSFP comprising a second base, a second stem, and a second pin, the second pin configured to be inserted into the second bone segment, the second base configured to be disposed on a surface of the second bone segment, and the second stem having a reflective material to be detectible with surface imaging, wherein the second base comprises a female connector inside the second base configured to receive and secure therein the male connector of the first base, so as to reduce the fracture and provisionally secure the first bone segment to the second bone segment.

[0012] In some cases, one or more of the first stem and the second stem can facilitate maneuvering the respective first bone segment and the second bone segment associated with the reduction of the fracture.

[0013] In some cases, the male connector can be snapped into the female connector. The male connector can be is an arrowed connector that is snapped into a reciprocal arrowed female connector.

[0014] The system can further include a surface topology system configured to register a first location of the first SSFP to the first bone segment; and register a second location of the second SSFP to the second bone segment. In some cases, the surface topology system can further scan a first mold or imprint of the first SSFP and first bone segment; register the first location of the first SSFP to the first bone segment based on the first mold or imprint; scan a second mold or imprint of the second SSFP and second bone segment; and register the second location of the second SSFP to the second bone segment based on the second mold or imprint.

[0015] The system can further include a light projector and camera navigation system to project a first light pattern on the first bone segment of the patient bone to facilitate application of the first SSFP to the first bone segment in accordance with the preoperativeplan; and project a second pattern on the second bone segment of the patient bone to facilitate application of the second SSFP to the second bone segment in accordance with the preoperative plan. In some cases, the light projector and camera navigation system can track the first bone segment and the second bone segment in relation to the preoperative plan based on a first location of the first SSFP and a second location of the second SSFP.

[0016] In accordance with another embodiment, there is disclosed a method of reducing a fracture of a patient bone, wherein the method includes: applying a first specially shaped fiducial pin (SSFP) to a first bone segment of the patient bone in accordance with a preoperative plan, the first SSFP comprising a first base, a first stem, and a first pin, the first pin configured to be inserted into the first bone segment, the first base configured to be disposed on a surface of the first bone segment, and the first stem having a reflective material to be detectible with surface imaging, wherein the first base comprises a male connector extending from the first base; and applying a second SSFP to a second bone segment of the patient bone in accordance with the preoperative plan, the second SSFP comprising a second base, a second stem, and a second pin, the second pin configured to be inserted into the second bone segment, the second base configured to be disposed on a surface of the second bone segment, and the second stem having a reflective material to be detectible with surface imaging, wherein the second base comprises a female connector inside the first base; and receiving and securing the male connector of the first base inside the female connector of the second base so as to reduce the fracture and provisionally secure the first bone segment to the second bone segment.

[0017] In some cases, the method can include maneuvering one or more of the first bone segment and the second bone segment respectively via the first stem and the second stem to facilitate the reduction of the fracture.

[0018] In some cases, the method can include snapping the male connector into the female connector. The male connector can be is an arrowed connector that is snapped into a reciprocal arrowed female connector

[0019] The method can include using a surface topology system to: register a first location of the first SSFP to the first bone segment; and register a second location of the second SSFP to the second bone segment. In some cases, the surface topology system is further used to: scan a first mold or imprint of the first SSFP and first bone segment; register the first location of the first SSFP to the first bone segment based on the first mold or imprint; scan a second mold or imprint of the second SSFP and second bone segment; and register the second location of the second SSFP to the second bone segment based on the second mold or imprint.

[0020] The method can include using a light projector and camera navigation system to: project a first light pattern on the first bone segment of the patient bone to facilitate application of the first the SSFP to the first bone segment in accordance with the preoperative plan; and project a second pattern on the second bone segment of the patient bone to facilitate application of the second SSFP to the second bone segment in accordance with the preoperative plan. In some cases, the light projector and camera navigation system can be used to track the first bone segment and the second bone segment in relation to the preoperative plan based on a first location of the first SSFP and a second location of the second SSFP.

[0021] These and other purposes, goals, and advantages of the present application will become apparent from the following detailed description of example embodiments read in connection with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Some embodiments are illustrated by way of example and not limitation in the figures of the accompanying drawings in which:

[0023] FIGS. 1A-1D illustrate an embodiment of creating an example negative mold of a patient bone;

[0024] FIG. 2 illustrates example optical scanning and registration of a negative mold of a bone obtained in accordance with FIGS. 1 A-1D;

[0025] FIG. 3 illustrates an alternate embodiment of creating an example negative mold of a patient bone;

[0026] FIG. 4 illustrates optical scanning and registration of a negative imprint of a patient bone obtained in accordance with FIG. 3;

[0027] FIGS. 5A-5F illustrate several examples of specially shaped fiducial pins (SSFPs);

[0028] FIG. 6 illustrates example details of an SSFP in accordance with FIG. 5B;

[0029] FIGS. 7A-7C illustrates incorporation of an example SSFP into an example optical registration process (top view);

[0030] FIGS. 8A-8C illustrates incorporation of an example SSFP into an example negative mold registration process (top view);

[0031] FIGS. 9A-9C illustrates incorporation of an example SSFP into the example negative mold registration process (side view);

[0032] FIGS. 10A and 10B illustrate optically scanning a negative mold (or a negative imprint) of a patient bone incorporating an example SSFP;

[0033] FIGS. 11A and 11B illustrate attaching an example bone cutting jig to an example SSFP to facilitate cutting a patient bone in accordance with a pre-operative plan (side view);

[0034] FIGS. 12A-12C illustrate attaching the example bone cutting jig to the example SSFP in accordance with the pre-operative plan (top view);

[0035] FIG. 13 illustrates an example modular jig system including elemental jig pieces that can be assembled in a custom fashion to create a surgical bone cutting jig;

[0036] FIGS. 14A and 14B illustrate a modular jig system including several assembled custom surgical bone cutting jigs;

[0037] FIGS. 15A-15C illustrate a pair of example interlocking SSFPs to facilitate fracture reduction;

[0038] FIGS. 16A-16E illustrate using example interlocking SSFPs to facilitate fracture reduction;

[0039] FIGS. 17A-17C illustrate an interlocking fracture reduction system;

[0040] FIG. 18 illustrates example preoperative planning associated with the example interlocking fracture reduction system;

[0041] FIG. 19 illustrates an interlocking fracture reduction system implemented to clinically recreate a a fracture reduction preoperative plan;

[0042] FIG. 20 illustrates a block diagram of an example surgical environment implementing a surgical system in accordance with FIGS. 1-19; and

[0043] FIG. 21 illustrates a block diagram of an example general computer system capable of performing any methods or computer-based functions in accordance with FIGS. 1-20.DETAILED DESCRIPTION

[0044] Described herein are systems and methods for surgical bone repair, and in particular, orthopedic methodologies and techniques using specially shaped fiducial pins (SSFPs) capable of integration into various systems and methods for surgical bone repair, particularly their incorporation into optical bone scanning and registration processes, as well as integration with bone cutting jigs in various surgical procedures and interlocking in fracture reduction, so as to more easily and accurately track and execute preoperative plans for surgical bone repair.

[0045] Simple optical registration systems used for surgical registration are known and incorporated herein by reference. Optical registration includes acquiring preoperative images and associated data (preoperative information) using CT, MRI, ultrasound, X-ray and / or any other clinically relevant imaging modalities and comparing such preoperativeinformation to information obtained with a surface topology imaging system during a surgical procedure (e.g., an optical or a laser surface topology system). For example, U.S. Patent Application No. 10 / 013,777, entitled “System and Method for Generating Partial Surface from Volumetric Data for Registration to Surface Topology Image Data”, discloses an optical registration system that acquires surface topology information and uses preoperative images, being an example of a type of optical registration system that may be used in the systems and methods as disclosed herein.1. Optical Registration of Negative Mold of the Bone

[0046] FIGS. 1A-1D illustrates a first embodiment of creating an example negative mold 135 of a patient bone 102. In this embodiment, a clay or cement type substance or material (molding material) 100 is applied to a selected area 103 on the bone 102 in a doughy state, and then the molding material 100 rapidly sets to form a negative mold 135. The negative mold 135 is then removed from the bone 102, and an undersurface 136 of the mold (e g., surface of the mold facing the bone) can then be scanned using an optical scanner. The negative undersurface 136 of the mold 135 represents the underlying bone, and is thus used to register the patient’s bone , as described hereinbelow with reference to FIG. 2. The main advantage of this embodiment is that the registration does not require line of sight. In particular, it completely eliminates the problem of bleeding affecting line of sight. Another advantage is a resulting less invasive surgery, where the surgeon can touch the bone but not have to have all muscles, etc. retracted for the registration process to proceed.

[0047] In particular, FIG. 1A illustrates an example molding material 100 that is used to obtain the negative impression of patient bone 102. FIG. IB illustrates an example patient bone 102 that includes example patient specific features 112a, 112b, and 112c. It should be noted that features 112a and 112b are illustrative of specific surface topology features that may be unique to the patient bone 102, such as small bumps, nodules, and / or other natural surface deformities that are present in all bone surfaces. Feature 112c represents a specific surface shape and angle of bone that is unique to the patient bone 102. Features 112a, 112b, and 112c are just examples of the types of unique features that uniquely define the patient bone 102, which can thus be used to identify location andtopology of the patient bone 102 during the registration process. It should be noted that there may be many different patient specific topology features that are unique to the patient bone 102; features 112a, 112b, and 112c are just representative examples.

[0048] Molding material 100 may be any material that can be applied to a surface of a selected area of the patient bone 102, thus molding to surface geometry of the patient bone 102, including the patient specific features of 112a, 112b, and 112c of the patient bone 102. Molding material 100 may be made of any deformable material such as bone cement, putty, or dough, which can harden within a clinically sufficient amount of time (e.g., typically two to three mins.) following the application of the molding material to the patient bone 102. Alternatively, the molding material 100 can be applied and, without hardening, retain the shape of the patient bone 102 upon removal of the molding material 100 from the patient bone 102.

[0049] FIG. 1C illustrates the molding material 100 being applied to patient bone 102 in order to obtain a negative imprint (negative mold 135) of the surface topology of the patient bone 102 (negative undersurface 136). FIG. ID illustrates the molding material 100 following shape retention of the surface topology of the patient bone 102. In this example, the patient bone 102 has patient specific topology features 112a, 112b, and 112c. Upon removal of the molding material 100 from patient bone 102, the molding material 100 includes a negative impression (negative mold 135) of the patient bone 102 (negative undersurface 136) including negative impressions 136a, 136b, and 136c of the respective patient specific topology features 112a, 112b, and 112c of the patient bone 102. There may be many different patient specific topology features that are imprinted into molding material 100; features 136a, 136b and 136c imprinted into the undersurface 136 of the negative mold 135 are just representative examples.

[0050] FIG. 2 illustrates example optical scanning and registration using the negative mold 135 of patient bone 102 obtained in accordance with FIGS. 1A-1D by applying the molding material 100 to patient bone 102, allowing molding material 100 to create a negative imprint (negative undersurface 136) of patient bone 102, and then removing negative mold 135 from patient bone 102 to be scanned by a surface topology system 106.

[0051] Molding material 100 (negative mold 135), now with a negative imprint (negative undersurface 136) of patient bone 102, can be scanned by surface topology system 106 (e.g., including a probe or a scanner) to acquire surface topology information 107. Acquisition of the surface topology information 107 can include constructing an intraoperative 3D surface model of the patient bone 102 based on the negative undersurface 136 of the negative mold 135. The surface topology information 107 of the underside 136 of the mold 136 can then be processed and compared to preoperative images 105 for surgical registration. Preoperative images 105 may include CT scans, MRI scans, ultrasound scans, X-rays, etcetera. In particular, acquisition of the preoperative images can also include constructing a preoperative 3D model of the patient bone 102 based on the preoperative images 105. Upon comparison of surface topology information 107 and preoperative images 105 (e g., alignment of the intraoperative and the preoperative models), surgical registration 115 may occur by processes known in the art and incorporated herein by reference. In particular, alignment (e.g., image-to-patient registration) of preoperative images (e.g., preoperative model) with the patient's intraoperative anatomy (e.g., intraoperative model) is important for accurate navigation and guidance. A transformation matrix (e.g., including rotation and translation) can be calculated that allows alignment of the preoperative model and the intraoperative model.

[0052] FIG. 3 illustrates an alternate embodiment of creating an example negative mold of a bone. In one alternative, an apparatus 108 is illustrated in which the molding material 100 is attached to a handle 109. The handle 109 may be shaped in any reasonable way a clinician may want to grasp and apply the molding material 100 to the patient bone 102. In another alternative, an apparatus 110 includes a handle 111 attached to a deformable material 114 in preparation for application to the patient bone 102. It should be noted that the handle I l l is optional in this embodiment. The deformable material 114 may be similar in properties to so-called floral foam, a material that, when applied to the patient bone 102, immediately deforms to create and retain a negative imprint of the patient bone 102 without having to harden. In an example, FIG. 3 illustrates that the apparatus 110 is applied to and removed from the patient bone 102, wherein the deformable material 114 creates a negative imprint (undersurface) 138 of the patient bone 102, with negativeimpressions 138a, 138b, and 138c of respective patient specific topology features 1 12a, 112b, and 112c.

[0053] FIG. 4 illustrates example optical scanning and registration using the negative imprint 138 of the patient bone 102 obtained in accordance with FIG. 3 by applying the deformable material 114 (e.g., the apparatus 110 with the deformable material 114) to the patient bone 102, allowing the deformable material 114 to create a negative imprint 138 of the patient bone 102, and then removing deformable material 114 (e.g., the apparatus 110 with the deformable material 114) from patient bone 102 to be scanned by surface topology system 106, as will be illustrated in and described hereinbelow with reference to FIG. 4. The deformable material 114, now with negative imprint 138 of the patient bone 102, can be scanned by the surface topology system 106 to acquire surface topology information 107. This surface topology information 107 can then be processed and compared to preoperative images 105 for surgical registration, as described hereinbefore with reference to FIG. 2. Preoperative images 105 may include CT scans, MRI scans, ultrasound scans, X-rays, etcetera. Upon comparison of surface topology information 107 and preoperative images 105, surgical registration 115 may occur by processes known in the art and incorporated herein by reference. In particular, alignment (e.g., image-to-patient registration) of preoperative images (e.g., a preoperative model) with the patient's intraoperative anatomy (e.g., an intraoperative model) is important for accurate navigation and guidance. A transformation matrix (e.g., including rotation and translation) can be calculated that allows alignment of the preoperative model and the intraoperative model.2. Incorporating a Specially Shaped Fiducial Pin (SSFP) into the Registration Process

[0054] Standard fiducial pins used in the surgical registration process that are driven into patient bone 102 are known in the art. Herein, there are disclosed specially shaped fiducial pins (SSFPs) that themselves are used as part of the surgical registration process because they have unique features that can be identified during the optical / laser scanning process or the negative molding process. That is, rather than use a conventional spherically shaped fiducial (attached to a pin driven into the bone), a novel method involving an asymmetric fiducial is disclosed. If a prior art optical registration system is used, an optical scanner can be used to not only scan the relevant area of bone but also simultaneously scanthe fiducial. Because the fiducial is asymmetric, an exact position and orientation will be known in space of the fiducial, and the registration process will be complete. However, in an alternative embodiment, a negative moldl36 or negative imprint 138 is used as described hereinabove in FIGS. 1-4), and will incorporate the asymmetric fiducial (SSFP) into the mold 136 or imprint 138. After the mold or imprint is scanned, an exact position and orientation of the fiducial (SSFP) will be obtained, and the patient will be registered (e.g., image-to-patient registration).

[0055] FIGS. 5A-5F illustrate several representative examples of specially shaped fiducial pins (SSFPs) 116-126, wherein the example SSFPs 116-126 are illustrated with respective top views 116a-126a, and respective side views 116b-126b. As illustrated in the several examples, the SSFPs 116-126 have uniquely identifiable surface geometries, textures, angles, heights, lengths, widths, visible etchings / drawings, etcetera. The SSFPs 116-126 can be two dimensional (2D) or three dimensional (3D) and can have recognizable patterns associated with registration processes and real-time tracking of patient bones. There are many variations of SSFPs that may work in clinically acceptable ways, and thus the SSFPs are not limited by the specific examples illustrated herein, but may include a multiplicity of SSFPs having uniquely identifiable surface geometries, textures, angles, heights, lengths, widths, visible etchings / drawings, etcetera.

[0056] FIG. 6 illustrates example details of the example SSFP 118, as illustrated in FIG. 5B. Any one of the SSFPs described herein has a base 127, a stem 129, and a pin 113. Examples of unique angles and curves of the base 127 are represented by 128a (e.g., spherical shape), 128b (e.g., acute angle), and 128c (e.g., obtuse angle). These unique angles and curves, their relationships, and their accompanying 2D or 3D features, are known and correlated to the SSFP 118. Element 130a represents a first image, imprint, etching, or protrusion of a grid with known dimensions. Element 130b represents a second image, imprint, etching, or protrusion of several shapes with known dimensions. Element 130c represents a third image, imprint, etching, or protrusion of several other shapes with known dimensions. The SSFP 118 has a unique combination of angles and curves 128a, 128b, and 128c, as well as images, imprints, etchings, or protrusions represented by elements 130a, 130b, and 130c, which, along with the overall 3 -dimensional structure ofthe SSFP 1 18 give it a specific and unique set of identifying features that can be scanned and used by the surface topology system 106 during the surgical registration process.

[0057] The SSFP 118 includes a stem 129 that may be used to apply reflective material to enhance visibility and / or detectability in imaging and tracking systems, such that they can be used in aligning imaging data with the patient’s anatomy during various surgical procedures. Optionally, the stem 129 may also be used as a mechanism to attach to other surgical instrumentation, such as interlocking SSFPs and other interlocking devices used in fracture reduction and provisional fixation, as will be described in greater detail hereinbelow with reference to FIGS. 15-19. In particular, the stem 129 provides a secure male adaptor that can be used to attach to, for example, interlocking devices used in fracture reduction, in accordance with a preoperative surgical plan. Similarly, the stem 129 can be used to attach to, for example, a surgical jig that can be used to cut the patient bone 102 in bone resections, in accordance with a preoperative surgical plan. The SSFP 118 includes a pin 113 that is used to securely attach the SSFP 118 to the patient bone 102.

[0058] FIGS. 7A-7C illustrate incorporation of an example SSFP 118 into an example optical registration process (top view). FIG. 7A, illustrates the example SSFP 118 to be inserted into the patient bone 102. As illustrated in FIG. 7B, pin 113 of the SSFP 118 is securely inserted into patient bone 102, thus locking the SSFP 118 in place during a surgical procedure in a certain relationship to certain patient specific features (e.g., patient specific features 112a and 112b). As a result, the location and orientation of the SSFP 118 will not move. As already described herein, the example patient bone 102 includes many specific surface topology features, represented in FIG. 7 in a non-limiting manner by patient specific features 112a and 112b. As further illustrated in FIG. 7C, the example patient bone 102 together with the example SSFP 118 can be scanned by the surface topology system 106 in similar fashion as described herein, so as to acquire surface topology information 107, as illustrated in reference to FIGS. 2 and 4 in connection with a negative mold or a negative imprint, respectively. Surface topology information 107 will thus include specific and unique identifying features of the SSFP 118 (or any SSFP, or multiple SSFPs that may be used). This surface topology information 107 can be processed and compared to preoperative images 105 and used for surgical registration 115 (e.g.,image-to-patient registration). As described hereinbefore, the images 105 may include CT scans, MRI scans, ultrasound scans, x-rays, etcetera. Upon comparison of the surface topology information 107 and the preoperative images 105, surgical registration 115 may occur by processes known in the art and incorporated herein by reference. In particular, as already described herein, the alignment (e.g., image-to-patient registration) of preoperative images (e.g., preoperative model) with the patient's intraoperative anatomy (e.g., intraoperative model) is important for accurate navigation and guidance. A transformation matrix (including rotation and translation) can be calculated that allows alignment of the preoperative model and the intraoperative model. Following optical scanning and registration, the precise location of SSFP 118 on the patient bone 102 is now precisely known.

[0059] FIGS. 8A-8C and 9A-9C illustrate a top view and a side view, respectively, of the incorporation of an example SSFP 118 into the negative mold registration process. FIGS. 8A and 9A illustrate the example SSFP 118 to be inserted into the patient bone 102, which includes patient specific features 112a and 112b. FIGS. 8B and 9B, illustrate the SSFP 118 being securely inserted into the patient bone 102 in relationship to the patient specific features 112a and 112b, and the molding material 100 (or the deformable material 114) being provided to be applied to the patient bone 102. As further illustrated in FIGS. 8C and 9C, the molding material 100 (or the deformable material 114) is thus applied to a selected area of the patient bone 102, covering at least a portion of the selected area while also covering at least a portion of the example SSFP 118.

[0060] FIGS. 10A and 10B illustrate optically scanning a negative mold 135 (or negative imprint 138) of a patient bone 102 incorporating an example SSFP 118. As described hereinabove, the molding material 100 (or the deformable material 114) is applied to a selected area of the patient bone 102 in which the example SSFP 118 has been inserted, thus covering at least a portion of the selected area of the patient bone 102, while also covering at least a portion of the example SSFP 118. As particularly illustrated in FIG. 10A, the molding material 100 (or deformable material 114) is removed from the patient bone 102, forming a negative mold 135 (or negative imprint 138) that includes negative impressions 136a, 136b, and 136c (or negative impressions 138a, 138b, and 138c)of specific surface topology features of the patient bone 102 (e.g., patient specific features 112a and 112b), represented in the negative mold 135 (or negative imprint 138) as patient specific features 134a and 134b. Moreover, the negative mold 135 (or negative imprint 138) includes a partial negative imprint of the SSFP 118, represented in the negative mold 135 (or negative imprint 138) as a fiducial specific feature 132. As further illustrated in FIG. 10B, the negative mold 135 (or negative imprint 138) with the negative impressions 134a, 134b of patient specific features 112a and 112b of the patient bone 102 and a negative impression of the example SSFP 118 may be optically scanned by the surface topology system 106, with this information then being available to be used in a surgical registration process, as is described hereinabove and known in the art.3. Using the SSFP and Registered Bone / Fiducial System as a Base to Which to Attach Adjustable Jigs

[0061] Using any of the above methods of registration, after the surgeon registers the patient bone 102 with the specially shaped fiducial (SSFP) 118, the surgeon can then attach an adaptor (connector) 145 to a bone cutting jig 140. Ultimately, the adaptor (connector) 145 is then attached to the bone cutting jig 140. The jig 140 itself (and / or the adaptor) includes small knobs 144a-144c to adjust a position and Euler angles of the jig 140 so that the cut of the patient bone 102 can be reproduced exactly based on a preoperative plan. In some cases, navigation system software (e.g., light projection and camera navigation) can be used to compute how much the surgeon must turn the various knobs 144a-144c to position the jig 142 so that a cut of the patient bone 102 can be reproduced based on a preoperative plan.

[0062] FIGS. HA and llB illustrate a side view of an attachment of an example bone cutting jig 140 to a securely attached example SSFP 118 to facilitate cutting a patient bone 102 in accordance with a preoperative plan. Prior to surgery, a preoperative plan is developed using known surgical images such as CT, MRI, X-ray, etcetera. As particularly illustrated in FIG. 11 A, the example SSFP 1 18 (or any preferred embodiment of SSFPs or a number of SSFPs) is securely inserted into the patient bone 102, and the bone cutting jig 140 is attached to a female adaptor (connector) 145, being ready for connection to the example SSFP 118. The female connector 145 includes a connection area (opening) 146that is reciprocally shaped like an external shape of SSFP 118, including its stem 129. As particularly illustrated in FIGS. 11 A and 1 IB, the preoperative plan may include a specific plan for cutting the patient bone 102 along a cutting line 148 of the patient bone 102. The patient bone 102 and the inserted SSFP 118 are optically scanned by a surface topology system 106, using for example, the process disclosed hereinabove with reference to FIG. 7, or a negative mold 135 or a negative imprint 138 are created as disclosed above with reference to FIGS. 8 and 9 and scanned by the surface topology system 106, using for example, the process disclosed hereinabove with reference to FIG. 10. As further illustrated in FIG. 1 IB, the female connector 145 snaps onto the male SSMP 118 in a snap- fit alignment, and the jig 140 is adjusted in relation to the cutting line 148, as will be described in greater detail hereinbelow.

[0063] FIGS. 12A-12C illustrate a top view of the attachment of the bone cutting jig 140 to the attached SSFP 118 in accordance with the preoperative plan. FIG. 12A illustrates a top view of the example SSFP 118, as well as the top view of the bone cutting jig 140, including the female connector 145 that snaps in a snap-fit alignment onto the male SSMP 118 inserted into the patient bone 102. FIG. 12B illustrates a top view of the SSMP 118 inserted into the patient bone 102. As described hereinabove with reference to FIGS. 11A and 1 IB, the patient bone 102 and the inserted SSFP 118 are optically scanned by a surface topology system 106, using for example, the process disclosed hereinabove with reference to FIG. 7, or a negative mold 135 or a negative imprint 138 are created as disclosed above with reference to FIGS. 8 and 9 and scanned by the surface topology system 106, using for example, the process disclosed hereinabove with reference to FIG. 10. FIG. 12C illustrates a top view of the attachment of the bone cutting jig 140 to a securely attached SSFP 118 to facilitate cutting the patient bone 102 in accordance with the preoperative plan. In particular, the female connector 145 includes a connection area (opening) 146 (not shown here) that is reciprocally shaped like an external shape of SSFP 118, including its stem 129 (not shown here). The female connector 145 snaps onto the SSMP 118 in a snap-fit alignment, and the jig 140 is adjusted in relation to the cutting line 148, as will be described in greater detail hereinbelow

[0064] As described hereinabove with reference to the side views in FIGS. 11 A, 1 IB and the top views in FIGS. 12A-12C, the patient bone 102 and the inserted SSFP 118 are optically scanned, or a mold 135 or impression 138 of the patient bone 102 and the inserted SSFP 118 are optically scanned. The patient bone 102 is registered and an exact location of all elements of the SSFP 118 are known relative to the patient bone 102. Importantly, the location of all elements of the SSFP 118 are known relative to cutting line 148. As described hereinabove, the bone cutting jig 140 includes a female connector 145 wherein connection area 146 is made to fixably connect and snap in in a snap-fit alignment onto the stem 129 of the male SSFP 118. The female connector 145 directly connects to a movement stem 141 that has alignment knobs 144a, 144b and 144c. The movement stem 141 is directly connected to a jig apparatus 142 that includes a cutting area or slot 142a that allows a surgeon to insert a saw blade and precisely cut the patient bone 102 based on the location of the jig apparatus 142, and in particular, based on the cutting slot 142a.

[0065] Following surgical registration of patient bone 102 that includes SSFP 118, the female connector 145 can attach (snap in a snap-fit alignment) to the stem 129 of the male SSFP 118. The precise location and size of the attachable jig 140 are known. Once the attachable jig 140 is securely attached to the stem 129 of the SSFP 118, precise instructions on how to move the alignment knobs 144a, 144b, and 144c are provided to the surgeon such that the knobs, upon actuation by the surgeon, will move the movement stem 141 , respectively in x-y-z dimensions, to exactly position the jig apparatus 142, in particular, aligning the slot 142a with the cutting line 148, where a cut along the cutting line 148 can be made precisely in accordance with the preoperative plan. Alternatively, an automated navigation system (e.g., light projection and camera navigation system) can be used in which actuators (not shown) associated respectively with the x-y-z dimensions of the jig 140 automatically adjust the alignment stem 141 in precisely calculated amounts so as to align the slot 142a with the cutting line 148.4. A System of Modular Jig Pieces to Effect a Wide Array of Osteotomies

[0066] For certain applications (like total knee arthroplasty), the surgeon will use almost an identical type jig for every single case. For other applications (e.g., tumor surgery, deformity correction surgery, etc.), each case is different, and the surgeon usesessentially a different type cut for each case. A relatively new advance which is powerful is the use of custom jigs created via 3D printers. In accordance therewith, the surgeon outlines his preoperative plan (i.e., where he wants to cut the bone), and sends the information to a company that makes a prefabricated custom jig, which is then sent back to the surgeon. This process, while powerful, has two large drawbacks: (1) it takes significant time (turnaround time can be two to six weeks to get such a jig), and it cannot be used for cases that need to performed very soon, (2) it is expensive due to the engineering involved, and the expensive jig is discarded as it is only for one time use.

[0067] Described herein with reference to FIGS. 13 and 14 is a modular jig system is able to keep the advantages of the precision afforded by the custom jig technology but eliminate the lead time (two to six weeks with the custom 3D printed jigs versus no real delay for the described modular jig) and minimize the expense compared to the custom jig technique. Similar to using interlocking building blocks to create complex structures, there is described herein a system of modular pieces, which when snapped together will be used to make a modular jig that can perform almost any array of bone cuts connected by straight lines. Straight cuts, triangular cuts, rectangular cuts, or any other polygonal shaped cuts can be accomplished using the modular jig disclosed herein.

[0068] In the embodiment illustrated in FIGS. 13 and 14, the surgeon will have a standard set of example modular jig pieces (elemental jig units), including one or more of each of rectangular pieces 160, comer pieces 162a-162e, straight pieces 164a- 164c (including end connectors) and straight pieces 168 (including a combination of end and side connectors), bracket pieces 166, and various other angled pieces 170a- 170c. Before surgery, the surgeon uses a computerized algorithm that facilitates building virtually any cut the surgeon desires using the elemental jig pieces of the virtual modular jig on a computer screen. In the operating room, the surgeon will be provided with a kit that has all the modular jig pieces, which can be used to quickly assemble the modular jig exactly as was done via the computerized algorithm on the computer screen. A laser or optical projection system (e.g., light projection and camera navigation system) can then be used to guide the surgeon as to where to place the assembled jig based on aligning certain specific marks on the jig construct with a projection light / laser pattern.

[0069] FIG. 13 discloses an example modular jig system that includes many elemental or modular pieces that can be assembled in a custom fashion to create a surgical bone cutting jig that can be used to create custom surgical bone cuts. The elemental pieces disclosed here are for example and are not limiting; many conformations of elemental jig units can be derived that would allow the creation of custom jigs.

[0070] FIGS. 14A and 14B disclose several assembled example jigs 172a and 172b created from the example modular jig system pieces as disclosed in FIG. 13. Example custom modular jig 172a uses modular jig pieces to create a custom cutting area 142a for certain type of surgery. A universal connector system 174 would allow, for example, the example modular jig 172a to connect to the movement stem 141 of the attachable jig 140 illustrated in FIGS 11 A-12C, for example, via a female connector 174a. In particular, the female connector 174a, similarly to the female connector 145, would include a connection area (opening) 146 that is reciprocally shaped like an external shape of the SSFP 118, including its stem 129. The example custom modular jig 172b attaches to a connector 176 that in turn connects to a universal connector system 174 including the female connector 174a (not shown). The modular jig 172b is disclosed using many different modular jig pieces to create a custom cutting area 142a that includes different angles and lengths of the patient bone 102 to be cut in accordance with the preoperative plan.5. Applications to Total Knee Arthroplasty. Total Hip Arthroplasty. Bone Tumor Resections, and Deformity Correction Surgeries

[0071] Also described herein is a system that can be readily used for total knee arthroplasty cuts (distal femur, proximal tibia cuts, and femoral 4 in 1 cuts) using the methods outlined above. Similarly, the system can be used for femoral neck cut in total hip arthroplasty. Moreover, the system can be used to help the surgeon prepare and implant acetabular cup in appropriate position.Examples and Details of Some Selected Specific Cases5(a) Total Knee Arthroplasty (TKA) Distal Femur and Proximal Tibia Cuts

[0072] Prior to surgery, the surgeon obtains a preoperative CT scan of the femur and the tibia (alternatively an x-ray of the extremity can be obtained). After obtaining an appropriate surgical exposure, the surgeon places an SSFP 118 onto an exposed area of the distal femur and another SSFP 118 onto the exposed area of the proximal tibia. It should be noted that other variations of the SSFPs, including the ones described in relation to FIG. 5, can be used herein alternatively or additionally to the SSFPs 118. The surgeon registers the patient’s bone and the fiducials (SSFPs) using any of the methods outlined above, e.g., optically scanning the exposed bone and the fiducial or molding the exposed bone and the fiducial, once for the SSFP of the distal femur and once for the SSFP of the proximal tibia. When the patient’s bones are registered using example registration 115, as described hereinabove, the registration software records the exact orientation and position in space of the SSFPs with respect to the associated bones. Using the stem 129, the SSFP 118 is configured to allow an adapter 145 to snap onto it. The adapter 145 is then connected ultimately to a cutting jig (e.g., jig 140, 172a, 172b, etcetera) that allows the surgeon to make distal femur / proximal tibia cut(s). The adapter / jig has special knobs that allow the surgeon to adjust precisely the position of the cutting jig to exactly match a preoperative planned cut(s). Based on the orientation and position of the SSFP with respect to the bone, enables a tracking system (e.g., light projection and camera navigation system) to inform the surgeon exactly how far to ‘turn’ each knob. Alternatively, the tracking system can be configured to transmit one or more signals to one or more actuators (not shown) associated respectively with the x-y-z dimensions of the adjustable jig to position the adjustable jig. In some cases, the adjustable jig and the adaptor / jig can automatically calibrate themselves so that the adjustable jig is perfectly aligned with the cut. In this way, the surgeon can make a distal femur and a proximal tibial cuts. For the femur, one can use the same system to continue the remaining femoral cuts of a TKA by then coupling the same SSFPs via more adapters to then place 4-in-l cutting jigs plus box cuts in perfect alignment.5(b) Femoral Neck Osteotomy in Primary Total Hip Arthroplasty

[0073] Prior to surgery, on either preoperative x-ray or CT scan, the surgeon defines a femoral neck osteotomy based on a preoperative templating. At surgery, the surgeon obtains exposure of the proximal femur and femoral neck area (via any approach, e.g.,direct anterior, posterior, or hardinge approach). The surgeon then places the SSFP on the bone near where a cut might be desired, but a little more proximal. The surgeon then uses an optical scanner to scan the bone and the SSFP. An adapter / jig is then attached to the SSFP, and the jig is adjusted manually or automatically as described herein (e.g., via knobs or actuators) so that the surgeon can execute a precise cut that was templated.

[0074] The main advantage of foregoing system and method compared to existing robotic / navigation systems is the lack of big bulky equipment (the robotic systems in use typically have a very large robot plus another camera plus computer screen, whereas the foregoing system only has a much smaller optical scanner plus a computer), the likely vastly cheaper construction, and the much more rapid and likely much more accurate optical registration (which obtains hundreds / thousands of points instantaneously rather than the one-by-one paired point registration system of, for example, 20 or so points).6. Unique Additional Application to Bone Fracture Reduction and Temporary StabilizationFracture Reduction and Plating

[0075] a) The surgeon can use preoperative planning software to anatomically align (i.e., reduce) the fracture on computer screen prior to a surgery. This can be done manually on a computer screen by the surgeon manipulating two main fractured pieces 158a, 158b of the patient bone 158 or with an automated algorithm that can optimize fracture alignment, or in cases where there is comminution and exact reduction of two pieces is impossible, the algorithm can optimize bone length, alignment, and rotation.

[0076] b) At the time of surgery, the surgeon uses standard exposure. The surgeon can then use any of above registration techniques to register both segments 158a, 158b of the fractured patient bone 158. It should be noted that, in alternative embodiments, the surgeon can potentially use the negative mold 135 or negative imprint 138 techniques as described hereinbefore. Specifically, the surgeon can expose the fractured edges of each of the (two) main bony segments 158a, 158b. Thereafter, the surgeon can place the molding material or deformable material onto the exposed fractured edge of each bone, and subsequently optically scan the negative mold or the negative imprint. There should be enoughasymmetry and unique fracture edges that each bone segment 158a, 158b can be sufficiency registered.

[0077] c) The surgeon can then use the laser / optical projection system (or an adaptor placed onto the SSFP to connect a special jig on one bone that has some ‘male’ extensions on it in a very precise position and orientation. The jig is placed precisely according to a preoperative plan. Similarly, another female jig is placed on the other bone fragment in the precise plan. The two jigs are mated male to female, which based on appropriate planning (and intraoperative registration) can automatically align (e.g., reduce) the two bone fragments and provide provisional fixation so that the surgeon can then readily apply definitive internal fixation (e.g., a rod, a plate, or a screw, etc.).

[0078] FIGS. 15A-15C illustrate a pair of example interlocking SSFPs 150 and 152 that can be used to facilitate fracture reduction. In particular, FIG. 15A illustrates side and top views of a male SSFP 150 that includes a male SSFP connector 154. Moreover, FIG. 15B illustrates top and side views of a female SSFP 152 that includes a female connector (or receiver) 156. The male connector 154 of the SSFP 150 is configured to be received (snapped-in) and secured in the female connector 156 of the SSFP 152, with the female receiver 156 including resilient legs for facilitating snapping-in of the male connector 154. In one embodiment, the male SSFP 150 can have an arrowhead connector 154 and the female SSFP 152 can have arrowhead receiver 156, such that the arrowhead connector 154 can be snapped-in and fixedly attached to the arrowhead receiver 156. Other male / female connector embodiments having different connectors geometries are of course possible. As illustrated in FIG. 15C, the male SSFP 150 is fixedly inserted and attached (snapped-in) to the female SSFP 152. The fixed attachment of the SSFP 150, 152 can provide provisional fixation of bone segments in fracture reduction of a patient bone.

[0079] As further illustrated, the male SSFP 150 and female SSFP 152 have pins 113, bases 127, and stems 129, as described hereinbefore. The pins 113 can be used to securely attach the SSFPs 150,152 to the patient bone. The bases 127 can have unique angles and curves as described herein. The stem 129 can be covered with reflective material to enhance visibility and / or detectability in imaging and tracking systems, such that they canbe used in aligning imaging data with patient’s anatomy during fracture reduction. Further, one or more of the stems 129 of the SSFPS 150, 152 may also be used to assist with positioning the SSFPs 150, 152 in relationship to one another and their snapping-in into a fixedly attached connection. Lastly, the stems 129 may be used to attach other surgical instrumentation, such as other interlocking devices to be used in fracture reduction and provisional fixation, as will be described in greater detail hereinbelow with reference to FIGS. 17 and 19.

[0080] FIGS. 16A-16E illustrate the use of interlocking SSFPs 150, 152 to facilitate fracture reduction. FIG. 16A illustrates a patient bone 158. As illustrated in FIG. 16B, the patient bone 158 may be fractured into two main pieces - fracture piece 158a and fracture piece 158b - which may be displaced and rotated one with respect to the other. As further illustrated in FIG. 16E, a preoperative plan is developed wherein the fracture piece 158a and the fracture piece 158b will be reduced (aligned) according to the preoperative plan illustrated in a reduced fracture 180. In accordance with the preoperative plan, the SSFPs 150,152 are positioned and affixed to the respective fracture pieces 158a, 158b of the patient bone 158, as illustrated in FIG. 16C. In particular, the male SSFP 150 is fixedly inserted into the fracture piece 158a, and female SSFP 152 is fixedly inserted into the fracture piece 158b. As illustrated in FIGS. 16C and 6D, the stems 129 of the respective SSFPs 150,152 can be used to reduce (align) the respective facture pieces 158a, 158b according to the preoperative plan, and further to snap-in the male connector 154 of the SSFP 150 into the female receiver 156 of the SSFP 152 to provide provisional fixation of the fracture piece 158a, 158b, with the definite (e.g., a rod, a plate, a screw, etc.) fixation to follow.

[0081] FIGS. 17A-17C illustrate an interlocking fracture reduction system. The system includes a female interlock component (or simply interlock) 190, a male interlock component (or simply interlock) 192, and several respectively associated SSFPs 118, 118. As particularly illustrated in FIG. 17A, the female interlock 190 includes a female connector 145 with a connection area (receiver) 146 to fixedly connect and snap-in onto the stem 129 of the associated SSFP 118. Moreover, the female connector 145 directly connects to a movement stem 141 that has alignment knobs 144a, 144b and 144c (not allknobs are illustrated in the side view), similar to the stem 141 ofthejig 140 described with reference to FIG 11A. The movement stem 141 is directly connected to a female interlock cone 196, which includes a female connection area (receiver) 198. The cone 196 is configured to receive, direct, and connect the male interlock connector 194 into a female connection area (receiver) 198 of the cone 198. As particularly illustrated in FIG. 17B, the male interlock 192 includes a female connector 145 with connection area (connector) 146 to fixedly connect and snap-in onto the stem 129 of the associated SSFP 118. Similarly, the female connector 145 directly connects to a movement stem 141 that has alignment knobs 144a, 144b and 144c (not all knobs are illustrated in the side view). The movement stem 141 is directly connected to a male interlock connector 194.

[0082] As further illustrated in FIG. 17C, when the male interlock connector 194 is received into the female interlock cone 196, the male interlock connector 194 snaps-in to the female receiver 198 to thus fixedly connect the female interlock 190 and male interlock 192, such that the interlocks 190, 192 cannot rotate or move with respect to one another. Moreover, distance and orientation 199 among the interlocks 190, 192 is known and can be adjusted by moving the alignment knobs 144a, 144b and 144c on one or more of the movement stems 141 based upon the clinical need. Alternatively, a tracking system can be used and configured to transmit one or more signals to one or more actuators (not shown) associated with the one or both of the adjustable alignment stems 141 to make adjustments among the interlocks 190, 192 in the precisely calculated amounts, so as to recreate a preoperative plan for the fracture reduction.

[0083] FIG. 18 illustrates example preoperative planning associated with the example interlocking fracture reduction system (e.g., using medical imaging such as CT scan, an MRI scan, or an X-ray). A fracture reduction preoperative plan 200c represents a surgeon’s final desired positioning of the fractured patient bone piece 158a and the fractured patient bone piece 158b of the fractured bone 158, represented as the reduced fracture 180. An exact distance and orientation 202 between patient specific features 112c and 112d are precisely known in the preoperative plan based on the medical imaging and associated fracture reduction of the bone pieces 158a, 158b, as particularly illustrated in the reduced fracture 180. The distance and orientation 202 are used as a representative example.However, different distances and orientations may be used. Replicating the distance and orientation 202 in the operating room would clinically implement the preoperative plan on the patient.

[0084] FIG. 19 illustrates an interlocking fracture reduction system implemented to clinically recreate a fracture reduction preoperative plan 200c illustrated in FIG. 18. A location of a first SSFP 118 in the fracture piece 158a is registered using optical scanning or negative molding, as disclosed herein and in the art. The precise location of patient specific features, for example, patient specific feature 112d, is known both in the medical images in the fracture reduction preoperative plan 200c as well as in the fracture piece 158a, and can thus be used to help register the first SSFP 118. A first relationship distance 204 is an example that represents a known distance and orientation between the patient specific feature 112d and the first SSFP 118. Therefore, the precise location of the first SSFP 118 in the fracture piece 158a is precisely known.

[0085] Similarly, the location of a second SSFP 118 in the fracture piece 158b is registered using optical scanning or negative molding, as disclosed herein and in the art. The precise location of patient specific features, for example, patient specific feature 112c, is known both in the medical images in the fracture reduction preoperative plan 200c as well as in the fracture piece 158b, and can thus be used to help register the second SSFP 118. A second relationship distance 206 is an example that represents a known distance and orientation between the patient specific feature 112c and the second SSFP 118. Therefore, the precise location of SSFP 118 in the fracture piece 158b is precisely known.

[0086] To recreate the fracture reduction preoperative plan 200c, the exact distance and orientation 202 between the patient specific features 112c and 112d is precisely known in the preoperative plan, and can thus be recreated clinically by calculating a relationship between the first and the second SSFPs 118, a relationship between the female and the male interlocks 190 and 192, and specifically controlling a distance and location 199 among the alignment stems 141 of the interlocks 190, 192, in a manner such that when the male connector 194 is fixedly connected to the female receiver 198 of the cone 196, the distance and orientation 202 are clinically recreated, the fracture pieces 158a and 158b arepositioned and reduced to recreate the preoperative plan 200c, and fracture pieces 158a and 158b are provisionally fixated so that the surgeon can apply definitive fixation (e.g., a rod, a plate, a screw, etc.) as might be appropriate clinically for the fracture reduction.

[0087] FIG. 20 is a block diagram illustrating an example surgical environment 208 in which a surgical system 210 may be implemented in accordance with FIGS. 1-19. As illustrated in FIG. 20, the surgical system 210 can include a controller 220 (e.g., computer and software to perform operations and / or functionality as described herein), a 3D surface topology scanner system 106 (e.g., EinScan-SP) and a light projector and camera navigation system 214 communicatively coupled with and operated by the controller 220. The surgical system 210 may be utilized during surgery on a patient 212. The patient 212 is illustrated with an exposed bone 102, 158 as the patient 212 is undergoing bone surgery, such as a total knee arthroplasty, total hip arthroplasty (e.g., including femoral neck osteotomy), a tumor resection (e.g., including custom patient-specific cuts to bone for removal of tumor), fracture reduction procedures (e.g., requiring precise alignment of bone segments and provisional fixation), other procedures where specific placement of a screw, a pin, and / or a needle might be required, skeletal deformity correction surgery, as well as a host of other surgical procedures that can benefit from the surgical system 210.

[0088] The 3D surface scanner system 106 is operable to optically scan an object, for example, a patient bone and / or bone fractured pieces (e.g., 102, 158, and / or 158a, 158b), a fiducial marker SSFP 118 (e.g., including any of the SSFPs described herein), a negative mold 135 or a negative imprint 138, another object or surface, or one or more combinations thereof (e.g., optical scan of the patient bone 102 with the SSFP 118, or an optical scan of a negative mold / negative imprint of the bone with the SSFP 118). The 3D surface scanner 212 transmits a surface scan of the object (bone, bone fragment, or negative mold / negative imprint) to the controller 220, which is configured to then process and compare the scanned surface of the object against preoperative scans (e.g., CT scan, MRI scan, X-ray, etc.) of the patient bone 102, 158, or bone fragments 158a, 158b of the patient bone 158, and to generate a preoperative plan, e.g., preoperative plan 200c.

[0089] The light projector and camera navigation system 214 can include a camera 216 (e.g., Varifocal Lens USB Camera with a Sony IMX179 sensor) and a projector 218 (e.g., BenQ TK800). The camera 216 is operable to capture images and / or video, while the projector 218 is capable of projecting an array of desired patterns and / or colors onto one or more surfaces, such as bones 102, 158, or bone fragments 158a, 158b. The camera 216 and the projector 218 have a predetermined relative position to each other. The light projector and camera navigation system 214 can be calibrated prior to a surgical procedure, or can be continuously calibrated, so that relative positions between the camera 216 and the projector 218 are consistent and stable.

[0090] In at least one example embodiment as described herein, during a surgical procedure, the light projector and camera navigation system 214, driven by the controller 220, can project one or more structured light patterns onto the target of the object, such as the bone 102, 158, or the bone pieces 158a, 158b so that various articles as described herein in accordance with FIGS. 1-19 can be appropriately positioned, aligned, and secured in respect to the bones 102, 158 or the bone segments 158a, 158b, for real-time tracking during the surgical procedure in relation to the preoperative plan (e.g., preoperative plan 200c). The various articles can include one or more SSFPs (e.g., the SSFP 118), bone cutting jigs (e.g., the bone cutting jig 140), modular jigs (e.g., the modular jig 172a and 172b), interlocking SSFPs (e g., the interlocking SSFPs 150, 152), as well as various interlocking jigs and associated components (e.g., the interlocks 190, 192). As such, for example, alignment jigs featuring unique snap-fit designs such as interlocks 190,192 can facilitate surgeon manipulation to more closely replicate and maintain to the preoperative planned fracture reduction 200c.

[0091] FIG. 21 is a block diagram of an illustrative embodiment of a general computer system 300. The computer system 300 can include a set of instructions that can be executed to cause the computer system 300 to perform any one or more of the methods or computer based functions disclosed herein in FIGS. 1-20. The computer system 300, or any portion thereof, may operate as a standalone device or may be connected, e.g., using a network or other connection, to other computer systems or peripheral devices, such as the 3D surface topology scanner system 106 and the light projector and camera navigation system 214,and / or other systems or devices providing preoperative images 105, intraoperative topology information 107, and registration 107. For example, the computer system 300 may be the controller 220 as illustrated in FIG. 20.

[0092] The computer system 300 may also be implemented as or incorporated into various devices, such as a personal computer (PC), a tablet PC, a personal digital assistant (PDA), a computing device or mobile device (e.g., smartphone), a palmtop computer, a laptop computer, a desktop computer, a communications device, a control system, a web appliance, or any other machine capable of executing a set of instructions (sequentially or otherwise) that specify actions to be taken by that machine. Further, while a single computer system 300 is illustrated, the term “system” shall also be taken to include any collection of systems or sub-systems that individually or jointly execute a set, or multiple sets, of instructions to perform one or more computer functions.

[0093] As illustrated in FIG. 21, the computer system 300 may include a processor 302, e.g., a central processing unit (CPU), a graphics-processing unit (GPU), or both. Moreover, the computer system 300 may include a main memory 304 and a static memory 306 that can communicate with each other via a bus 326. As shown, the computer system 300 may further include a video display unit 310, such as a liquid crystal display (LCD), an organic light emitting diode (OLED), a flat panel display, a solid state display, a cathode ray tube (CRT), or another video display unit. Additionally, the computer system 300 may include an input device 312, such as a keyboard, and a cursor control device 314, such as a mouse. The computer system 300 can also include a disk drive (or solid state) unit 316, a signal generation device 322, such as a speaker or remote control, and a network interface device 308.

[0094] In a particular embodiment or aspect, as depicted in FIG. 21, the disk drive (or solid state) unit 316 may include a computer-readable medium 318 in which one or more sets of instructions 320, e.g., software, can be embedded. Further, the instructions 320 may embody one or more of the methods or logic as described herein. In a particular embodiment or aspect, the instructions 320 may reside completely, or at least partially, within the main memory 304, the static memory 306, and / or within the processor 302during execution by the computer system 300. The main memory 304 and the processor 1002 also may include computer-readable media.

[0095] In an alternative embodiment or aspect, dedicated hardware implementations, such as application specific integrated circuits, programmable logic arrays and other hardware devices, can be constructed to implement one or more of the methods described herein. Applications that may include the apparatus and systems of various embodiments or aspects can broadly include a variety of electronic and computer systems. One or more embodiments or aspects described herein may implement functions using two or more specific interconnected hardware modules or devices with related control and data signals that can be communicated between and through the modules, or as portions of an application-specific integrated circuit. Accordingly, the present system encompasses software, firmware, and hardware implementations.

[0096] In accordance with various embodiments or aspects, the methods described herein may be implemented by software programs tangibly embodied in a processor- readable medium and may be executed by a processor. Further, in an example, non-limited embodiment or aspect, implementations can include distributed processing, component / object distributed processing, and parallel processing. Alternatively, virtual computer system processing can be constructed to implement one or more of the methods or functionality as described herein.

[0097] It is also contemplated that a computer-readable medium includes instructions 320 or receives and executes instructions 320 responsive to a propagated signal, so that a device connected to a network 324 can communicate voice, video or data over the network 324. Further, the instructions 320 may be transmitted or received over the network 324 via the network interface device 308.

[0098] While the computer-readable medium is shown to be a single medium, the term “computer-readable medium” includes a single medium or multiple media, such as a centralized or distributed database, and / or associated caches and servers that store one or more sets of instructions. The term “computer-readable medium” shall also include any medium that is capable of storing, encoding or carrying a set of instructions for executionby a processor or that cause a computer system to perform any one or more of the methods or operations disclosed herein.

[0099] In a particular non-limiting, example embodiment or aspect, the computer-readable medium can include a solid-state memory, such as a memory card or other package, which houses one or more non-volatile read-only memories. Further, the computer-readable medium can be a random access memory or other volatile re-writable memory. Additionally, the computer-readable medium can include a magneto-optical or optical medium, such as a disk or tapes or other storage device to capture carrier wave signals, such as a signal communicated over a transmission medium. A digital fde attachment to an e-mail or other self-contained information archive or set of archives may be considered a distribution medium that is equivalent to a tangible storage medium. Accordingly, any one or more of a computer-readable medium or a distribution medium and other equivalents and successor media, in which data or instructions may be stored, are included herein.

[0100] In accordance with various embodiments or aspects, the methods described herein may be implemented as one or more software programs running on a computer processor. Dedicated hardware implementations including, but not limited to, application specific integrated circuits, programmable logic arrays, and other hardware devices can likewise be constructed to implement the methods described herein. Furthermore, alternative software implementations including, but not limited to, distributed processing or component / object distributed processing, parallel processing, or virtual machine processing can also be constructed to implement the methods described herein.

[0101] It should also be noted that software that implements the disclosed methods may optionally be stored on a tangible storage medium, such as: a magnetic medium, such as a disk or tape; a magneto-optical or optical medium, such as a disk; or a solid state medium, such as a memory card or other package that houses one or more read-only (nonvolatile) memories, random access memories, or other re-writable (volatile) memories. The software may also utilize a signal containing computer instructions. A digital file attachment to e-mail or other self-contained information archive or set of archives is considered a distribution medium equivalent to a tangible storage medium. Accordingly,a tangible storage medium or distribution medium as listed herein, and other equivalents and successor media, in which the software implementations herein may be stored, are included herein.

[0102] There have thus been described systems and methods for surgical bone repair, and in particular orthopedic methodologies and techniques using specially shaped fiducial pins (SSFPs) capable of integration into various systems and methods for surgical bone repair, particularly their incorporation into optical bone scanning and registration processes, as well as integration with bone cutting jigs in various surgical procedures and interlocking in fracture reduction, so as to more easily and accurately track and execute preoperative plans for surgical bone repair.

[0103] Although specific example embodiments or aspects have been described, it will be evident that various modifications and changes may be made to these embodiments or aspects without departing from the broader scope of the invention. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. The accompanying drawings that form a part hereof, show by way of illustration, and not of limitation, specific embodiments or aspects in which the subject matter may be practiced. The embodiments or aspects illustrated are described in sufficient detail to enable those skilled in the art to practice the teachings disclosed herein. Other embodiments or aspects may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. This Detailed Description, therefore, is not to be taken in a limiting sense, and the scope of various embodiments or aspects is defined only by the appended claims, along with the full range of equivalents to which such claims are entitled.

[0104] Such embodiments or aspects of the inventive subject matter may be referred to herein, individually and / or collectively, by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept if more than one is in fact disclosed. Thus, although specific embodiments or aspects have been illustrated and described herein, it should be appreciated that any arrangement calculated to achieve the same purpose may be substituted for thespecific embodiments or aspects shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments or aspects. Combinations of the above embodiments or aspects, and other embodiments or aspects not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

[0105] The Abstract is provided to allow the reader to quickly ascertain the nature and gist of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.

[0106] In the foregoing description of the embodiments or aspects, various features are grouped together in a single embodiment for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting that the claimed embodiments or aspects have more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment or aspect. Thus each claim can stand on its own as a separate example embodiment or aspect. It is contemplated that various embodiments or aspects described herein can be combined or grouped in different combinations that are not expressly noted in the Detailed Description. Moreover, it is further contemplated that claims covering such different combinations can similarly stand on their own as separate example embodiments or aspects.

Claims

Claims:

1. A system associated with reducing a fracture of a patient bone, the system comprising: a first specially shaped fiducial pin (SSFP) configured to be applied to a first bone segment of the patient bone in accordance with a preoperative plan, the first SSFP comprising a first base, a first stem, and a first pin, the first pin configured to be inserted into the first bone segment, the first base configured to be disposed on a surface of the first bone segment, and the first stem having a reflective material to be detectible with surface imaging, wherein the first base comprises a male connector extending from the first base; and a second SSFP configured to be applied to a second bone segment of the patient bone in accordance with the preoperative plan, the second SSFP comprising a second base, a second stem, and a second pin, the second pin configured to be inserted into the second bone segment, the second base configured to be disposed on a surface of the second bone segment, and the second stem having a reflective material to be detectible with surface imaging, wherein the second base comprises a female connector inside the second base configured to receive and secure therein the male connector of the first base, so as to reduce the fracture and provisionally secure the first bone segment to the second bone segment.

2. The system according to claim 1, wherein one or more of the first stem and the second stem are configured to facilitate maneuvering the respective first bone segment and the second bone segment associated with the reduction of the fracture.

3. The system according to claim 1, wherein the male connector is snapped into the female connector.

4. The system according to claim 3, wherein the male connector is an arrowed connector that is snapped into a reciprocal arrowed female connector.

5. The system according to claim 1, further comprising a surface topology system configured to: register a first location of the first SSFP to the first bone segment; and register a second location of the second SSFP to the second bone segment.

6. The system according to claim 5, wherein the surface topology system is further configured to: scan a first mold or imprint of the first SSFP and first bone segment; register the first location of the first SSFP to the first bone segment based on the first mold or imprint; scan a second mold or imprint of the second SSFP and second bone segment; and register the second location of the second SSFP to the second bone segment based on the second mold or imprint.

7. The system according to claim 1, further comprising a light projector and camera navigation system configured to: project a first light pattern on the first bone segment of the patient bone to facilitate application of the first SSFP to the first bone segment in accordance with the preoperative plan; and project a second pattern on the second bone segment of the patient bone to facilitate application of the second S SFP to the second bone segment in accordance with the preoperative plan.

8. The system according to claim 7, wherein the light proj ector and camera navigation system is further configured to track the first bone segment and the second bone segment in relation to the preoperative plan based on a first location of the first SSFP and a second location of the second SSFP.

9. A method of reducing a fracture of a patient bone, the method comprising: applying a first specially shaped fiducial pin (SSFP) to a first bone segment of the patient bone in accordance with a preoperative plan, the first SSFP comprising a first base, a first stem, and a first pin, the first pin configured to be inserted into the first bone segment, the first base configured to be disposed on a surface of the first bone segment, and the first stem having a reflective material to be detectible with surface imaging, wherein the first base comprises a male connector extending from the first base; andapplying a second SSFP to a second bone segment of the patient bone in accordance with the preoperative plan, the second SSFP comprising a second base, a second stem, and a second pin, the second pin configured to be inserted into the second bone segment, the second base configured to be disposed on a surface of the second bone segment, and the second stem having a reflective material to be detectible with surface imaging, wherein the second base comprises a female connector inside the first base; and receiving and securing the male connector of the first base inside the female connector of the second base so as to reduce the fracture and provisionally secure the first bone segment to the second bone segment.

10. The method according to claim 9, further comprising maneuvering one or more of the first bone segment and the second bone segment respectively via the first stem and the second stem to facilitate the reduction of the fracture.

11. The method according to claim 9, further comprising snapping the male connector into the female connector.

12. The method according to claim 11, wherein the male connector is an arrowed connector that is snapped into a reciprocal arrowed female connector.

13. The method according to claim 9, further comprising using a surface topology system to: register a first location of the first SSFP to the first bone segment; and register a second location of the second SSFP to the second bone segment.

14. The method according to claim 13, wherein the surface topology system is further used to: scan a first mold or imprint of the first SSFP and first bone segment; register the first location of the first SSFP to the first bone segment based on the first mold or imprint; scan a second mold or imprint of the second SSFP and second bone segment; and register the second location of the second SSFP to the second bone segment based on the second mold or imprint.

15. The method according to claim 9, further comprising using a light projector and camera navigation system to: project a first light pattern on the first bone segment of the patient bone to facilitate application of the first the SSFP to the first bone segment in accordance with the preoperative plan; and project a second pattern on the second bone segment of the patient bone to facilitate application of the second S SFP to the second bone segment in accordance with the preoperative plan.

16. The method according to claim 15, wherein light projector and camera navigation system is further used to track the first bone segment and the second bone segment in relation to the preoperative plan based on a first location of the first SSFP and a second location of the second SSFP.

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