Guiding off-axis surgical instruments

Abstract

A guidance system for performing alignment of an off-axis surgical instrument includes a surgical system configured to: receive first data indicating the location of a planned tunnel through a surgical site; receive second data indicating the positioning of the surgical instrument relative to the planned tunnel at the surgical site; and, based on the first and second data, cause a display to present a visual representation indicating the current positioning of a portion of the surgical instrument relative to the planned tunnel, a first rotational orientation of a aiming tool relative to the planned tunnel, and a second rotational orientation of the aiming tool relative to the planned tunnel.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 602,953, filed November 27, 2023. The entire disclosure of the above-cited applications is incorporated herein by reference. Technical Field

[0003] This disclosure relates to preoperative and intraoperative surgical analysis and processing, and more specifically, to the location and formation of tunnels for surgical procedures. Background Technology

[0004] The background description provided herein is for the purpose of presenting the overall context of this disclosure. The work described in this background section by the currently named inventors, and aspects of the description that may not qualify as prior art at the time of filing, are neither explicitly nor implicitly considered to be prior art to this disclosure.

[0005] The anterior cruciate ligament (ACL) is one of the key ligaments providing stability to the knee joint. Participation in sports involving sudden stops or changes of direction is one of the leading causes of ACL injuries, an example of which is a complete tear. Therefore, an ACL tear is a common medical condition, with over 200,000 cases annually in the United States alone. Standard treatment may include arthroscopic reconstruction. During arthroscopic reconstruction, the torn ligament is replaced with a tissue graft, which is pulled into the knee joint through tunnels opened in both the femur and tibia using a drill. Properly anatomically positioned opening of these tunnels ensures knee stability and patient satisfaction, although the current failure rate for primary ACL reconstruction ranges from 10-15%. Summary of the Invention

[0006] A guidance system for performing alignment of off-axis surgical instruments includes a surgical system configured to: receive first data indicating the location of a planned tunnel through a surgical site; receive second data indicating the positioning of a surgical instrument relative to the planned tunnel at the surgical site; and, based on the first and second data, cause a display to present a visual representation indicating the current positioning of a portion of the surgical instrument relative to the planned tunnel, a first rotational orientation of a aiming tool relative to the planned tunnel, and a second rotational orientation of the aiming tool relative to the planned tunnel.

[0007] In other respects, one or more methods may include steps corresponding to functions performed by the system described herein. In other respects, the processor may be configured to execute instructions to perform the functions of the system described herein.

[0008] Other applicable areas of this disclosure will become apparent from the detailed description, claims, and drawings. The detailed description and specific examples are intended for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

[0009] For a detailed description of the example implementation, reference will now be made to the accompanying drawings, in which:

[0010] Figure 1 This is a block diagram of exemplary configurations in which the systems and methods disclosed herein can be implemented according to some embodiments of this disclosure;

[0011] Figure 2 This is a block diagram illustrating components of an exemplary system according to some embodiments of the present disclosure;

[0012] Figures 3A to 3E The illustration shows an exemplary alignment process for an off-axis elbow aiming tool according to some embodiments of the present disclosure;

[0013] Figure 4 The illustrations depict steps of an exemplary method for aligning an off-axis bend sight tool according to some embodiments of the present disclosure; and

[0014] Figure 5 Example computer systems or computing devices configured to implement the various systems and methods disclosed herein are shown.

[0015] In the accompanying drawings, reference numerals may be used repeatedly to identify similar and / or identical elements.

[0016] definition

[0017] The various terms are used to refer to specific system components. Different companies may use different names to refer to components—this document does not intend to distinguish components that differ in name rather than function. In the following discussion and in the claims, the terms "comprising" and "including" are used in an open-ended manner and should therefore be interpreted as meaning "including, but not limited to...". Furthermore, the terms "couple" or "couples" are intended to indicate indirect or direct connections. Thus, if a first device is coupled to a second device, the connection can be either a direct connection or an indirect connection via other devices and connections.

[0018] Similarly, various terms are used to describe spatial and functional relationships between elements (e.g., between devices, modules, circuit elements, etc.), including “connection,” “joint,” “link,” “adjacent,” “closely adjacent,” “on top,” “above,” “below,” and “set.” Unless explicitly described as “direct,” when describing the relationship between a first element and a second element in the above disclosure, the relationship can be a direct relationship where no other intermediate elements exist between the first and second elements, or it can be an indirect relationship where one or more intermediate elements exist between the first and second elements (spatially or functionally). However, for electrical connections shown in the figures without any intermediate elements, this paragraph should serve as a prior basis for referencing it as a “direct connection” in the claims.

[0019] Those skilled in the art will understand that degree terms such as “substantially” or “approximately” refer to a reasonable range around a given value and include both the given value and ranges beyond it, such as general tolerances associated with the manufacture, assembly, and use of the embodiment. When referring to a structure or characteristic, the term “substantially” includes characteristics that are primarily or entirely present in the characteristic or structure. As an example, numerical values ​​described as “approximately” or “about” as used herein may refer to values ​​within + / - 5% of the stated value.

[0020] Unless the context clearly specifies otherwise, as used herein, “a,” “an,” and “the” refer to both the singular and plural indicators. As an example, “processor” programmed to perform various functions refers to one processor programmed to perform each of those functions, or more than one processor collectively programmed to perform each of those functions. It should be clear that an initial reference to “a [indicator]” followed by subsequent references to “the [indicator]” for prior grounds purposes should not preclude the fact that the listed indicators can be plural.

[0021] Generally, terms can be understood, at least in part, from their use in context. For example, terms such as “and,” “or,” or “and / or,” as used herein, can include a variety of meanings that can depend, at least in part, on the context in which such terms are used. Typically, “or” is intended to mean A, B, and C used herein in an inclusive sense, and A, B, or C used herein in an exclusive sense, when used in a list of associations such as A, B, or C. Additionally, the term “one or more,” as used herein, which depends at least in part on the context, can be used to describe any feature, structure, or characteristic in a singular sense, or can be used to describe a combination of features, structures, or characteristics in a plural sense. Similarly, terms such as “a / an” or “the” can again be understood, at least in part, on the context to express a single use or to express multiple uses. Furthermore, the term “based on” can be understood not necessarily to express a set of exclusive factors, but can allow for the presence of additional factors that are not necessarily explicitly described again, which depends at least in part on the context. As used herein, the phrases A, B, and C at least one should be interpreted as using the non-exclusive logic "or" to represent logic (A or B or C), and should not be interpreted as representing "at least one of A, at least one of B, and at least one of C".

[0022] The terms “input” and “output”, when used as nouns, refer to connections (e.g., electrical, software) and / or signals, and should not be interpreted as verbs requiring action. For example, a timer circuit may define a clock output. An exemplary timer circuit may create or drive a clock signal on the clock output. In systems implemented directly in hardware (e.g., on a semiconductor substrate), these “inputs” and “outputs” define electrical connections and / or signals transmitted or received by those connections. In software-implemented systems, these “inputs” and “outputs” respectively define parameters read or written by instructions that implement the function. In the context of user input, “input” can refer to user actions, user interaction with input devices or interfaces, etc.

[0023] "Controller", "module" or "circuit" shall, individually or in combination, mean individual circuit components configured to read inputs and drive outputs in response to inputs, application-specific integrated circuits (ASICs), microcontrollers with control software, reduced instruction set computers (RISCs) with control software, digital signal processors (DSPs), processors with control software, programmable logic devices (PLDs), field-programmable gate arrays (FPGAs) or programmable system-on-a-chip (PSOCs).

[0024] When used to describe various surgical instruments or devices (such as probes), the term "proximal" refers to the point or direction closest to the shank of the probe (e.g., the direction opposite to the probe tip). Conversely, the term "distal" refers to the point or direction closest to the probe tip (e.g., the direction opposite to the shank).

[0025] For the purposes of this disclosure, a non-transitory computer-readable medium (or computer-readable storage medium) stores computer data, which may include computer program code (or computer-executable instructions) that can be executed by a computer in a machine-readable form. By way of example and not limitation, a computer-readable medium may include a computer-readable storage medium for storing tangible or fixed data, or a communication medium for transiently interpreting coded signals. As used herein, a computer-readable storage medium refers to physical or tangible storage (as opposed to a signal) and includes, but is not limited to, volatile and non-volatile, removable and non-removable media implemented in any method or technology for tangibly storing information such as computer-readable instructions, data structures, program modules, or other data. Computer-readable storage media include, but are not limited to, RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technologies, optical storage, cloud storage, magnetic storage devices, or any other physical or material medium that can be used to tangibly store desired information or data or instructions and that can be accessed by a computer or processor.

[0026] For the purposes of this disclosure, the term "server" should be understood to refer to a point of service that provides processing, database, and communication facilities. By way of example and not limitation, the term "server" may refer to a single physical processor having associated communication, data storage, and database facilities, or it may refer to a networked or clustered complex of processors and associated network and storage devices, as well as operating software and one or more database systems and application software that support the services provided by the server. A cloud server is an example.

[0027] For the purposes of this disclosure, "network" should be understood to refer to a network that can couple devices to enable communication, such as between server and client devices or other types of devices, including between wireless devices coupled via, for example, a wireless network. For example, a network may also include mass storage devices, such as network-attached storage (NAS), storage area network (SAN), content delivery network (CDN), or other forms of computer or machine-readable media. A network may include the Internet, one or more local area networks (LANs), one or more wide area networks (WANs), wired connections, wireless connections, cellular connections, or any combination thereof. Similarly, subnetworks that may employ different architectures or be compatible with different protocols or compatible with different protocols may interoperate within a larger network.

[0028] For the purposes of this disclosure, "wireless network" should be understood as connecting client devices to a network. Wireless networks can employ standalone ad hoc networks, mesh networks, wireless LAN (WLAN) networks, cellular networks, etc. Wireless networks can also employ various network access technologies, including Wi-Fi, Long Term Evolution (LTE), WLAN, Wireless Router (WR) mesh, or 2G, 3G, 4G, or 5G (2G, 3G, 4G, or 5G) cellular technologies, Mobile Edge Computing (MEC), Bluetooth, 802.11b / g / n, etc. Network access technologies can achieve wide-area coverage for devices such as client devices with varying degrees of mobility. In short, a wireless network can include virtually any type of wireless communication mechanism through which signals can be transmitted between devices such as client devices or computing devices, between networks, or within a network.

[0029] Computing devices may be capable of transmitting or receiving signals, such as via wired or wireless networks, or may be capable of processing or storing signals in memory as a physical memory state, and thus can operate as servers. Therefore, devices capable of operating as servers may include, for example, dedicated rack servers, desktop computers, laptop computers, set-top boxes, integrated devices combining various features, such as two or more features of the aforementioned devices.

[0030] For the purposes of this disclosure, a client (or consumer or user) device, referred to as a user equipment (UE), may include a computing device capable of transmitting or receiving signals, such as via a wired or wireless network. The client device may include, for example, desktop computers or portable devices such as cellular phones, smartphones, display pagers, radio frequency (RF) devices, infrared (IR) devices, near field communication (NFC) devices, personal digital assistants (PDAs), handheld computers, tablet computers, phablets, laptop computers, set-top boxes, wearable computers, smartwatches, integrated or distributed devices combining various features (such as those of the aforementioned devices), etc.

[0031] In some implementations, as discussed below, the client device may also be, or may be communicatively coupled to, any type of known or intended medical device (e.g., any type of Class I, II, or III medical device), such as, but not limited to, MRI machines, CT scanners, electrocardiogram (ECG or EKG) devices, photoplethysmography (PPG), Doppler and emission time-flow meters, laser Doppler, endoscopic devices, neuromodulation devices, neurostimulation devices, etc., or some combination thereof. Detailed Implementation

[0032] This disclosure will now be described more fully below with reference to the accompanying drawings, which form part of this disclosure and illustrate certain exemplary embodiments by way of non-limiting illustration. However, the subject matter can be embodied in a variety of different forms, and therefore the covered or claimed subject matter is intended to be construed as not being limited to any of the exemplary embodiments set forth herein; the provision of exemplary embodiments is merely illustrative. Likewise, a reasonably broad scope is intended for the claimed or covered subject matter. For example, the subject matter can be embodied as a method, apparatus, component, or system, among other things. Thus, embodiments can take the form, for example, hardware, software, firmware, or any combination thereof (other than software itself). Therefore, the following detailed description is not intended to be construed in a limiting sense.

[0033] Throughout the specification and claims, terms may have subtle meanings that are suggested or implied in the context, going beyond their explicit statements. Similarly, the phrase "in one embodiment" as used herein does not necessarily refer to the same embodiment, and the phrase "in another embodiment" as used herein does not necessarily refer to different embodiments. For example, the subject matter intended to be claimed includes combinations of all or some of the exemplary embodiments.

[0034] The present disclosure is described below with reference to block diagrams and operational illustrations of methods and apparatus. It should be understood that each block of the block diagram or operational illustration, and combinations of blocks in the block diagram or operational illustration, can be implemented by means of analog or digital hardware and computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer to modify its functionality as detailed herein, or to a special-purpose computer, ASIC, or other programmable data processing apparatus, such that instructions executed via a processor of the computer or other programmable data processing apparatus implement the functions / actions specified in the block diagram or one or more operational blocks. In some alternative embodiments, the functions / actions indicated in the blocks may not be performed in the order indicated in the operational illustrations. For example, two blocks shown consecutively may actually be executed substantially simultaneously, or these blocks may sometimes be executed in reverse order, depending on the functions / actions involved.

[0035] The location and orientation of the femoral or tibial tunnel in surgeries such as ACL reconstruction significantly impact surgical success, thus spurring the need for preoperative planning for accurate tunnel positioning. To determine the anatomically correct location of the tunnel, some surgeons rely on specific anatomical landmarks. However, these landmarks can be unreliable and may even be absent in some patients. In computer-assisted surgeries (e.g., ACL replacement, reduction of femoral-acetabular impingement, etc.), surgical guidance can be provided within images of the surgical site (e.g., within images of the patient's anatomy) to achieve more accurate tunnel positioning and / or guide the surgeon throughout the procedure.

[0036] For the specific case of tibial tunnel drilling used for ACL reconstruction, the goal of guidance is to align a virtual line corresponding to the axis of the planned tunnel with the line of rotation of the surgical instrument (e.g., a sight) that will pass through the guidewire. Opening these tunnels is typically accomplished using a two-step process. In the first step, the tip of the sight is fixed in position to provide the desired location for the tunnel. In the second step, the sight is rotated to adjust the tunnel's orientation / orientation.

[0037] Two exemplary types of aiming tools used for ACL reconstruction are tip and bevel sights. With a tip sight, the tip is placed directly in the desired exit point of the tunnel. Therefore, the guidewire of the sight (e.g., the guidewire of the guidewire / projectile head assembly) is aligned with the tip of the sight. Conversely, with a bevel sight (“off-axis” instrument), the tip is not aligned with the projectile head through which the guidewire passes. Therefore, the tip is placed behind the desired exit point, which is difficult to precisely define / position. Thus, when using a bevel sight, once the tip is fixed to the tibial plateau, rotating the sight around the tip causes the exit point of the tunnel to change position. For this reason, opening a tunnel using a bevel sight is a more difficult task than opening a tunnel using a tip sight (for which rotation of the sight does not change the exit point position).

[0038] The elbow sight guidance system and method according to the principles of this disclosure are configured to implement surgical navigation (e.g., computer-aided surgery or CAS) techniques to provide guidance for the use of off-axis instruments such as elbow sights. As described in more detail below, the guidance image / instructions to be followed by the user / surgeon are presented on a display (e.g., an arthroscopic view covering the surgical site) to facilitate the use of the elbow sight to locate the tibial tunnel.

[0039] Figure 1An exemplary system (or framework) 100 configured to implement one or more functions of the surgical navigation (e.g., bend-point aimer guidance) system and method of this disclosure is shown. System 100 includes a user device or user equipment (UE) 106, a network 102, a cloud system 104, and a surgical engine 200. UE 106 can be any type of device, such as, but not limited to, a mobile phone, tablet, laptop, personal computer, sensor, Internet of Things (IoT) device, autonomous machine, and any other device equipped with a cellular, wireless, or wired transceiver. In some embodiments, as discussed above, UE 106 can also be a medical device, or another device communicatively coupled to a medical device, enabling it to receive readings from sensors of the medical device. For example, in some embodiments, UE 106 can be a smartphone (or, for example, an office / hospital device) connected to a peripheral nerve modulation device via, for example, WiFi, Bluetooth Low Energy (BLE), or NFC. Thus, in some embodiments, UE 106 can be configured to receive data from sensors associated with a medical device, as discussed in more detail below.

[0040] Network 102 can be any type of network, such as, but not limited to, wireless networks, cellular networks, the Internet, local area networks, or wide area networks. As discussed herein, network 102 can facilitate, Figure 1 The connection of the components of the system 100 shown in the figure.

[0041] Cloud system 104 can be any type of cloud operating platform and / or network-based system, and applications, operations, and / or other forms of network resources can reside on the cloud operating platform and / or network-based system. For example, system 104 can correspond to a service provider, network provider, and / or healthcare provider from which services and / or applications can be accessed, obtained, or performed. In some embodiments, cloud system 104 may include one or more servers and / or information databases accessible via network 102. In some embodiments, the database (not shown) of system 104 may store datasets of data and metadata associated with one or more users, patients, and UE 106, as well as local and / or network information related to services and applications provided by cloud system 104 and / or surgical engine 200.

[0042] As discussed in more detail below, the surgical engine 200 includes components configured to perform bend-point aiming guidance technology. The following section discusses in more detail how the engine 200 operates and functions, as well as its included and performed capabilities and other functional implementations.

[0043] According to some implementations, the surgical engine 200 may be a dedicated machine or processor and may be hosted by a device on network 102, within cloud system 104, and / or on UE 106. In some implementations, the engine 200 may be hosted by a peripheral device (e.g., a medical device as discussed above) connected to UE 106.

[0044] According to some implementations, the surgical engine 200 can act as an application provided by the cloud system 104. In some implementations, the engine 200 can act as an application installed on the UE 106. In some implementations, such an application can be a web-based application (e.g., as provided by...) that the UE 106 accesses from the cloud system 104 via network 102. Figure 1 (The connection between network 102 and engine 200 and / or the connection between UE 106 and engine 200 is indicated by the dashed line). In some embodiments, engine 200 may be configured and / or installed as an enhanced script, program, or application (e.g., a plugin or extension) of another application or program provided by cloud system 104 and / or executed on UE 106.

[0045] like Figure 2 As illustrated, according to some embodiments, the surgical engine 200 includes a model module 202, an instrument detection module 204, a guide generation module 206, and a display module 208. It should be understood that the engines and modules(s) discussed herein are not exhaustive, as additional or fewer engines and / or modules (or sub-modules) may be adapted to embodiments of the systems and methods discussed. The operation, configuration, and function of each module in the engine 200 and modules will be discussed in more detail below.

[0046] Figure 3A The illustration shows an example initial alignment of an off-axis bend aiming tool 300 relative to a bone (e.g., represented by a bone model 304, such as a 3D bone model of the tibia). Although represented by model 304 for illustrative purposes, during alignment as described herein, the aiming tool 300 may be positioned relative to actual patient anatomy (e.g., the end of the tibia or other bone for which tunnel placement is prepared). In some examples, a model of the tibia (such as model 304) may also be displayed (e.g., on a user device display) for the surgeon to view to facilitate alignment. A model or graphical representation of the aiming tool 300 and its positioning / orientation relative to model 304 may also be displayed for the surgeon to view. For example, the model module 202 of the surgical engine 200 may be configured to receive and / or generate model 304, receive one or more inputs / requests to generate or retrieve model 304, process digital content corresponding to model 304 for display, etc.

[0047] As shown, the aiming tool 300 includes a tip 306 identified by point 308 and defines an axis 310. The axis 310 is aligned with the bend 312 of the aiming tool 300 and can be referred to as the “center” axis of the aiming tool 300. For example, as shown, the axis 310 extends from the inner surface of the bend 312 to the end of the aiming tool 300 opposite to the bend 312. With the tip 306 of the aiming tool 300 in a fixed position, rotating the aiming tool 300 about point 308 in any direction changes the orientation of the axis 310 such that the axis 310 remains tangent to a sphere 314 centered at point 308 (i.e., the tip of the aiming tool 300) and having a radius r. In other words, the radius r of the sphere 314 corresponds to the distance (e.g., Euclidean distance) between the tip 306 of the aiming tool 300 and the point of tangency P on the axis 310. As another example, the radius r can be the orthogonal distance between the axis 310 and the center of the sphere 314.

[0048] Figure 3A Including a planned tunnel 318, in some examples, the planned tunnel may be displayed / overlaid on model 304. The planned tunnel 318 may correspond to the planned location of a tunnel as determined preoperatively. Therefore, when used to display to a surgeon, implement the systems and methods described below, etc., the planned tunnel 318 corresponds to data (e.g., stored data) indicating the location of the planned tunnel 318, as previously obtained by the surgeon and / or other personnel. As used in this context, "previously" may refer to immediately preceding the alignment of the aiming device 300 as described below. As described herein, the "location" of the planned tunnel 318 may correspond to a line or axis aligned with the center of the planned tunnel 318.

[0049] To align axis 310 with the planned tunnel 318, the tip 306 is first moved to a position of any point X on the surface of a cylinder 320 having a radius r and a rotation axis corresponding to the planned tunnel 318. Point X may correspond to various points on the surface of cylinder 320 corresponding to a distance r from the planned tunnel 318. This translational alignment of the tip 306 of the aiming tool 300 can be achieved by translating / moving the aiming tool 300 until the tip 306 is aligned with a point on the surface of cylinder 320. The system and method according to this disclosure are configured to provide visual guidance / instructions to the surgeon for moving the aiming tool 300 in the manner described above, and to complete the alignment of the aiming tool 300 in subsequent steps, as described in more detail below.

[0050] As an example, the instrument detection module 204 is configured to detect the aiming tool 300 and its positioning / orientation in 3D space within a surgical environment. For example, the surgical environment may include one or more references or other markers (e.g., skeletal references anchored to the patient's anatomy) arranged in fixed locations. The aiming tool 300 can be tracked using a camera or other imaging / sensing device based on the relative 3D positioning of the aiming tool 300 and the skeletal reference. The instrument detection module 204 is configured to determine the orientation of the aiming tool 300 relative to the patient's anatomy based on the positioning tracked in this manner. An example system and method for tracking surgical instruments relative to a skeletal reference are described in more detail in International Patent Application No. PCT / US2024 / 046069, filed September 11, 2024, the entire contents of which are incorporated herein by reference. As described generally herein, detecting the location of the aiming tool 300 or a specific portion of the aiming tool 300 (such as point 306) includes generating, receiving and / or otherwise obtaining data indicating the location of the aiming tool 300 within the surgical site, relative to the patient's anatomy, relative to the planned tunnel 318, etc.

[0051] The guidance generation module 206, based on the principles of this disclosure, is configured to generate visual guidance / instructions for the surgeon in one or more steps or stages. The visual guidance is calculated / generated based on the positioning (e.g., current positioning) of the aiming tool 300 determined by the instrument detection module 204. The visual guidance can be adjusted in real time as the aiming tool 300 moves within the surgical environment.

[0052] Display module 208 is configured to display visual guidance (e.g., visual guidance graphic element 324) (e.g., on the display of UE 106 and / or another computing device) for the surgeon to view. Graphic element 324 corresponds to a visual representation of the relative current and desired or target location of the aiming tool 300, as described in more detail below. In some examples, graphic element 324 is displayed together with visual representations of the aiming tool 300 and / or model 304, planned tunnel 318, etc. (e.g., as an overlay). In other examples, only graphic element 324 is displayed. As shown, graphic element 324 corresponds to the first guidance step.

[0053] As shown, graphic element 324 corresponds to a reference frame or plane 326. Reference plane 326 is perpendicular to the planned tunnel 318, which extends in a direction perpendicular to reference plane 326. Graphic element 324 corresponds to reference plane 326 as viewed from the direction indicated by arrow 328. The origin X of reference plane 326 (e.g., the origin of an arthroscopic view) corresponds to a point X (e.g., target location X) on the surface of cylinder 320, offset by a radius r from the axis of the planned tunnel 318, as described above. The vertical and horizontal axes of reference plane 326, as shown in graphic element 324, correspond to the coronal and sagittal directions, respectively. The current position of the tip 306 of the aiming tool 300 is shown at 330. Therefore, in the first guiding step, graphic element 324 shows the surgeon the current position 330 of tip 306, the target location X of tip 306, and the offset distance d between the current position 330 and the target location X. Alignment of the tip 306 can be achieved by translating the aiming tool 300 until the positioning of the tip 330 is aligned with the origin / target positioning X. Guidance may include graphical elements 324, additional visual instructions (e.g., arrows indicating the desired direction of movement of the aiming tool 300), numerical values ​​indicating distance d, audio instructions, or combinations thereof. Although in Figure 3A The symbol is shown as a circle and an "X", but other graphic elements can be used to represent the current position 330 of the tip 306, the target position X, etc.

[0054] Figure 3B and Figure 3C The diagram above illustrates the process. Figure 3A The aiming tool 300 is aligned after translational alignment as described in the description. For example, the surgical engine 200 can be configured to detect when the aiming tool 300 is aligned, such that the tip 306 is aligned with the target location X, and advance the application / system state to a state corresponding to the second guidance step or stage.

[0055] With the tip 306 aligned as described above, various rotations of the aiming tool 300 can be performed (e.g., by a surgeon) such that the axis 310 of the aiming tool 300 is aligned with the planned tunnel 318. In other words, one or more rotational orientations of the aiming tool 300 can be adjusted. For example, as Figure 3B As shown (and in Figure 3C middle, Figure 3B (Part of the illustration), the planned tunnel 318 is tangent to point Q on sphere 314.

[0056] In the graphic element 332 corresponding to the second guiding step, the origin of the reference plane or arthroscopic view (as shown in 334) corresponds to point Q (or, the projection of point Q onto reference frame 326). Point P' corresponds to the projection of the tangent point P onto reference frame 326. Point P' is graphically represented at 336 in graphic element 332. The aiming tool 300 rotates in a first rotational direction (e.g., a first angular deviation) indicated by arrow 338 and about an axis defined by point 308, causing the tangent point P to move in the direction indicated by arrow 340. As this rotation of the aiming tool 300 is followed, point P' (and its graphical representation 336) moves relative to the origin 334 and point Q. Therefore, as the aiming tool 300 rotates until graphic element 336 is aligned (e.g., centered) with the origin 334, graphic element 336 provides visual guidance to the surgeon. Although in Figure 3B It is displayed as a circle, but other graphic elements can be used to represent the location of point P', the origin, or the target location 334, etc. The rotation orientation of the aiming tool 300 in the first rotation direction can be referred to as the first rotation orientation.

[0057] Figure 3D Graphical element 336, corresponding to the third guiding step, is illustrated in graphic element 342, showing alignment with origin 334 after the surgeon rotates the aiming tool 300. In other words, points P and Q are also aligned. However, the aiming tool 300 (e.g., axis 310) may not be aligned with the planned tunnel 318 in another (e.g., second) rotational direction (e.g., second angular deviation). Therefore, graphic element 342 may include arrow 344 or other indicators or graphic elements that indicate the misalignment of the aiming tool 300 (e.g., axis 310) relative to the planned tunnel 318 in the second rotational direction. For example, the second angular deviation corresponds to the angle between axis 310 and the planned tunnel 318 in a plane (e.g., plane 346), the normal of which is vector 348 passing through tip 306 and point Q.

[0058] Therefore, the third guiding step or stage involves guiding the surgeon to rotate the aiming tool 300 in the direction shown at 350 (i.e., around / about the axis defined by vector 348) until the arrow 344 is aligned with an alignment feature (such as the vertical axis of graphic element 342). For example, as Figure 3DAs shown, rotating the aiming tool 300 along direction 350 causes the arrow 344 to rotate about (or away from) the vertical axis around the circular graphic element 336. During this guiding step, rotation of the aiming tool 300 in direction 338 will cause the aiming tool 300 to become misaligned with the planned tunnel 318 in the first rotational direction (i.e., causing the graphic element 336 to move away from / become misaligned with the origin 334). Therefore, during the third guiding step, visual guidance is provided to the surgeon for aligning the aiming tool 300 in the second rotational direction while maintaining alignment of the aiming tool 300 in the first rotational direction. Figure 3E Graphical element 342 is shown, wherein the aiming tool has a desired alignment in both a first rotational direction and a second rotational direction, such that graphic elements 334 and 336 are aligned (e.g., concentric), and arrow 344 is aligned with a feature of graphic element 342, such as a vertical axis. Although shown as corresponding to a vertical axis, in other examples, the alignment may be indicated by other features, such as a horizontal axis or another feature. The rotational orientation of the aiming tool 300 in the second rotational direction may be referred to as the second rotational orientation.

[0059] As described herein, an arbitrary point X on the surface of cylinder 320 is used. However, in various examples, the selected location of point X may be constrained by the specific patient anatomy. Therefore, a valid set of 3D points can be limited to the intersection point between cylinder 320 and the surface of model 304. For the specific case of the tibia, this intersection typically corresponds to a closed curve on the tibial plateau. Furthermore, since this approach can be applied to minimally invasive surgery, the aiming tool 300 will enter the joint through an inlet, which is a small incision in the patient's skin, and therefore only a subset of this set of points can be accessible. By knowing the location of the inlet relative to the bone, a subset of accessible points can be estimated and used to determine the point that will be considered the origin of the arthroscopic view. Determining such a point can involve, for example, considering the midpoint of the subset, manually selecting points from the subset, or using curvature information to select points (e.g., picking points located in regions with minimum curvature). Determining a subset of accessible points may involve (i) identifying a plane containing the entrance and the planned tunnel, (ii) intersecting the plane with all valid 3D points in the set, (iii) selecting the last point if there is more than one intersection, and (iv) considering only points whose angular deviation (relative to the point selected in (iii)) is below a predefined threshold.

[0060] When the location of the inlet is unknown, alternative methods for selecting the origin of the arthroscopic view can be considered. To guide any tunnel and considering opening the inlet at the anterior end of the tibia, the origin can be set as the last point in the set of valid 3D points. Furthermore, when using a sight to determine the tunnel, the origin of the arthroscopic view can be defined by: (i) determining a plane that best fits all sight axes and sight tips, (ii) ensuring that this plane intersects all valid 3D points in the set, and (iii) selecting the last point if more than one intersection exists.

[0061] The systems and methods of this disclosure are described for the specific case of a bend sight, but can also be used for any surgical instrument (e.g., an "off-axis" surgical instrument or tool) having an axis to be guided and a tip not aligned with the axis.

[0062] As another example, when the tip 306 is misaligned, the planned tunnel 318 may not be tangent to the sphere 314. In this case, the planned tunnel 318 may intersect the sphere 314 at two points or not. If the planned tunnel 318 intersects the sphere 314 at two points, point Q can be selected as the point on the sphere 314 closest to the centroid of the two intersection points. If the planned tunnel 318 does not intersect the sphere 314, point Q can be selected as the point on the sphere 314 closest to the planned tunnel 318. These algorithmic options allow for intuitive behavior of the circular indicator in the arthroscopic view, thereby improving the usability of the system.

[0063] In some examples, the proposed system and method can be used with CAS systems that implement any sensing modality such as vision, optics and / or electromagnetic tracking.

[0064] Although the above description is a process comprising three guiding steps, the principles of this disclosure can be implemented as a process comprising fewer or more than three guiding steps (e.g., a single guiding step having guiding graphic elements including / presenting visual indicators (e.g., multiple circular indicators, arrows, etc.) for tip positioning and two rotational directions).

[0065] Figure 4An exemplary method 400 for aligning an off-axis bend aiming tool (such as aiming tool 300) according to the principles of this disclosure is illustrated. Method 400 can be performed by one or more computing devices, processors or processing devices, surgical engines 200, surgical systems (e.g., surgical navigation systems), computer systems 500 described in more detail below, etc. At least a portion of method 400 can be performed using a user device or apparatus (such as a tablet computer or other computing devices including a user interface, display, etc.). Therefore, the portion of method 400 corresponding to providing visual and / or audio guidance can be performed / implemented by a device including a user interface. Furthermore, method 400 as described below incorporates additional steps / functions (e.g., other preoperative, intraoperative, and / or postoperative steps) that can be performed before, during, and / or after method 400.

[0066] At 404, method 400 includes detecting surgical instruments in a surgical setting, such as detecting the positioning / orientation of a curved aiming tool relative to patient anatomical structures (e.g., the tibia or other anatomical structures). Detecting surgical instruments may include using a camera to detect the positioning of the aiming tool within the view of an arthroscopy or other imaging device.

[0067] At 408, method 400 includes generating and providing (e.g., displaying) a first graphic element on a display of a computing device, the first graphic element indicating first visual guidance for movement / alignment of a aiming tool relative to a patient's anatomy. Based on the detected current location of the aiming tool, the first graphic element includes visual indicators indicating the current location and desired location of a portion of the aiming tool (such as a point of the aiming tool). In one example, the desired location is determined based on at least one of the location of a planned tunnel, the axis of the planned tunnel, and a sphere having a radius based on the tip of the aiming tool and the axis defined by the aiming tool. Generating the first graphic element may correspond to the above regarding... Figure 3A The technology described.

[0068] At 412, method 400 includes determining whether the point of the aiming tool is in the desired position (e.g., by using instrument detection techniques as described herein, in response to user input, determining whether the corresponding visual indicators of the current position and the desired position are aligned in the first graphic element, etc.). If true, method 400 proceeds to 416. If false, method 400 continues to display the first graphic element.

[0069] At 416, method 400 includes generating and providing a second graphic element that indicates second visual guidance for movement of the aiming tool relative to the patient's anatomy. The second graphic element includes visual indicators based on the detected current positioning of the aiming tool, indicating the current positioning of the aiming tool in a first rotational direction and the desired positioning of the aiming tool in the first rotational direction. In one example, the desired positioning in the first rotational direction is determined based on at least one of: the location of a planned tunnel, the axis of the planned tunnel, a sphere having a radius based on the tip of the aiming tool and the axis defined by the aiming tool, a point of tangency between the aiming tool and the sphere on the axis of the aiming tool, and a point of tangency between the aiming tool and the sphere at the location of the planned tunnel (e.g., on the axis defined by the planned tunnel). Generating the second graphic element may correspond to the above regarding... Figure 3B and Figure 3C The technology described.

[0070] At 420, method 400 includes determining whether the positioning of the aiming tool in the first rotational direction is aligned with the desired positioning in the first rotational direction. If true, method 400 proceeds to 424. If false, method 400 continues to display the second graphic element.

[0071] At 424, method 400 includes generating and providing a third graphic element that indicates second visual guidance for movement of the aiming tool relative to the patient's anatomy. The third graphic element includes visual indicators based on the detected current positioning of the aiming tool, indicating the current positioning of the aiming tool in a second rotational direction and the desired positioning of the aiming tool in the second rotational direction. In one example, the desired positioning in the second rotational direction is determined based on at least one of: the location of the planned tunnel, the axis of the planned tunnel, and the axis defined by the aiming tool. The relationship between the visual indicators of the current positioning and the desired positioning can be determined based on the angle between the axis of the planned tunnel and the axis defined by the aiming tool. Generating the third graphic element may correspond to the above regarding... Figure 3D and Figure 3E The technology described.

[0072] Figure 5Example computer systems or computing devices 500 configured to implement the various systems and methods of this disclosure are shown. In one example, computer system 500 may correspond to one or more computing devices of system 100, surgical engine 200, tablet device in a surgical operating room, or any other system implementing any or all of the various methods discussed in this specification. For example, computer system 500 may be configured to implement all or part of method 400. Computer system 500 may be connected (e.g., networked) to other computer systems in a local area network (LAN), intranet, and / or extranet, or connected (e.g., networked) to the Internet at some point (e.g., when not in use during surgery). Computer system 500 may be a server, personal computer (PC), tablet computer, or any device capable of executing a set of instructions (sequentially or otherwise) specifying the actions to be taken by the device. Furthermore, although only a single computer system is shown, the term "computer" should also be considered to include any collection of computers that individually or collectively execute a set (or more sets) of instructions to perform any or more methods discussed herein.

[0073] Computer system 500 includes processing device 502, main memory 504 (e.g., read-only memory (ROM), flash memory, dynamic random access memory (DRAM) such as synchronous DRAM (SDRAM)), static memory 506 (e.g., flash memory, static random access memory (SRAM)) and data storage device 508, which communicate with each other via bus 510.

[0074] Processing device 502 represents one or more general-purpose processing devices, such as microprocessors, central processing units, etc. More specifically, processing device 502 may be a Complex Instruction Set Computing (CISC) microprocessor, a Reduced Instruction Set Computing (RISC) microprocessor, a Very Long Instruction Word (VLIW) microprocessor, or a processor that implements other instruction sets or combinations of instruction sets. Processing device 502 may also be one or more special-purpose processing devices, such as application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), digital signal processors (DSPs), network processors, etc. Processing device 502 is configured to execute instructions for performing any of the operations and steps discussed herein. Once programmed with specific instructions, processing device 502, and thus the entire computer system 500, becomes a special-purpose device, such as a surgical engine 200.

[0075] The computer system 500 may also include a network interface device 512 for communicating with any suitable network. The computer system 500 may also include a video display 514, one or more input devices 516 (e.g., a microphone, keyboard, and / or mouse), and one or more speakers 518. In one exemplary example, the video display 514 and the input devices 516 may be combined into a single component or device (e.g., an LCD touchscreen).

[0076] Data storage device 508 may include computer-readable storage medium 520 storing instructions 522 embodying any one or more methods or functions described herein (e.g., implementing any method and any function performed by any means and / or component described herein). Instructions 522 may also reside wholly or at least partially within main memory 504 and / or processing device 502 during execution by computer system 500. Thus, main memory 504 and processing device 502 also constitute computer-readable media. In some cases, instructions 522 may also be transmitted or received over a network via network interface device 512.

[0077] Although computer-readable storage medium 520 is shown as a single medium in the illustrative example, the term "computer-readable storage medium" should be considered to include a single medium or multiple media (e.g., a centralized or distributed database and / or associated caches and servers) that store one or more sets of instructions. The term "computer-readable storage medium" should also be considered to include any medium capable of storing, encoding, or carrying a set of instructions for machine execution and causing the machine to perform any one or more of the methods of this disclosure. Therefore, the term "computer-readable storage medium" should be understood to include, but is not limited to, solid-state memory, optical media, and magnetic media.

[0078] The foregoing description is merely illustrative in nature and is by no means intended to limit this disclosure, its application, or use. The broad teachings of this disclosure can be implemented in various forms. Therefore, while this disclosure includes specific examples, its true scope should not be so limited, as other modifications will become apparent upon examination of the drawings, specification, and appended claims. It should be understood that one or more steps in the method may be performed in different orders (or simultaneously) without altering the principles of this disclosure. Furthermore, although each embodiment of the embodiments is described above as having certain features, any one or more of those features described with respect to any embodiment of this disclosure may be implemented in the features of any embodiment of other embodiments and / or combined with the features of any embodiment of other embodiments, even if such combination is not explicitly described. In other words, the described embodiments are not mutually exclusive, and the arrangement of one or more embodiments with respect to each other remains within the scope of this disclosure.

Claims

1. A guiding system for performing alignment of off-axis surgical instruments, the guiding system comprising: Surgical system, the surgical system being configured to Receive first data, which indicates the planned location of the tunnel through the surgical site. Receive second data, the second data indicating the positioning of the surgical instrument relative to the planned tunnel at the surgical site, and Based on the first data and the second data, the display presents a visual representation indicating (i) the current positioning of a portion of the surgical instrument relative to the planned tunnel, (ii) a first rotational orientation of the aiming tool relative to the planned tunnel, and (iii) a second rotational orientation of the aiming tool relative to the planned tunnel.

2. The guidance system of claim 1, wherein the surgical instrument is a curved aiming tool.

3. The guiding system of claim 2, wherein the tip of the curved aiming tool and the corresponding trajectory of the guide wire of the curved aiming tool do not intersect.

4. The guidance system of claim 2, wherein the visual representation includes a first graphic element indicating a first target location of the portion of the bend aiming tool and the current location of the portion of the bend aiming tool.

5. The guiding system of claim 4, wherein the portion of the curved aiming tool is the tip of the curved aiming tool.

6. The guidance system of claim 5, wherein the first target location corresponds to a location offset by a predetermined distance from the planned tunnel location.

7. The guiding system of claim 6, wherein the predetermined distance corresponds to the radius of a sphere centered on the tip of the bend aiming tool, wherein the radius corresponds to the distance between the tip of the bend aiming tool and the guide wire.

8. The guidance system of claim 7, wherein the visual representation includes a second graphic indicating a second target location of the bend aiming tool in a first rotational direction corresponding to the first rotational orientation and the current location of the bend aiming tool in the first rotational direction.

9. The guidance system of claim 8, wherein the second target positioning corresponds to the point of tangency of the sphere on the axis of the planned tunnel.

10. The guidance system of claim 8, wherein the visual representation includes a third graphic indicating the third target location of the bend aiming tool in a second rotational direction corresponding to the second rotational orientation and the current location of the bend aiming tool in the second rotational direction.

11. The guidance system of claim 10, wherein the third target location corresponds to the axis of the planned tunnel.

12. A method for aligning an off-axis surgical instrument, the method comprising: Receive first data, which indicates the planned location of a tunnel through the surgical site; Receive second data, the second data indicating the positioning of the surgical instrument relative to the planned tunnel at the surgical site; as well as Based on the first data and the second data, the display presents a visual representation indicating (i) the current positioning of a portion of the surgical instrument relative to the planned tunnel, (ii) a first rotational orientation of the aiming tool relative to the planned tunnel, and (iii) a second rotational orientation of the aiming tool relative to the planned tunnel.

13. The method of claim 12, wherein the surgical instrument is a curved sight tool, and wherein the portion of the curved sight tool is the tip of the curved sight tool.

14. The method of claim 13, wherein the visual representation includes a first graphic element indicating a first target location of the tip of the bevel sight tool and the current location of the tip of the bevel sight tool.

15. The method of claim 14, wherein the first target location corresponds to a location offset by a predetermined distance from the location of the planned tunnel.

16. The method of claim 15, wherein the predetermined distance corresponds to the radius of a sphere centered on the tip of the bend aiming tool, wherein the radius corresponds to the distance between the tip of the bend aiming tool and the guide wire.

17. The method of claim 16, wherein the visual representation includes a second graphic indicating a second target location of the bend aiming tool in a first rotational direction corresponding to the first rotational orientation and the current location of the bend aiming tool in the first rotational direction.

18. The method of claim 17, wherein the second target location corresponds to the point of tangency of the sphere on the axis of the planned tunnel.

19. The method of claim 17, wherein the visual representation includes a third graphic indicating a third target location of the bend aiming tool in a second rotational direction corresponding to the second rotational orientation and the current location of the bend aiming tool in the second rotational direction.

20. The method of claim 19, wherein the third target location corresponds to the axis of the planned tunnel.

Images