SYSTEMS AND DEVICES FOR SETTING AND FIXING ONE OR MORE ANATOMICAL ELEMENTS
BACKGROUND
[0001] The present disclosure is generally directed to setting one or more anatomical elements, and relates more particularly to setting and fixing one or more anatomical elements using a connector capable of being in a flexible state and a rigid state.
[0002] Surgical robots may assist a surgeon or other medical provider in carrying out a surgical procedure, or may complete one or more surgical procedures autonomously. Providing controllable linked articulating members allows a surgical robot to reach areas of a patient anatomy during various medical procedures.
BRIEF SUMMARY
[0003] Example aspects of the present disclosure include:
[0004] A system for setting and fixing one or more anatomical elements according to at least one embodiment of the present disclosure comprises one or more fixation devices configured to be secured to corresponding one or more anatomical elements; a connector connecting each fixation device to an adjacent fixation device of the one or more fixation devices, the connector configured to be in a flexible state when positioning the one or more fixation devices and a rigid state to fix the one or more fixation devices, thereby fixing the one or more anatomical elements. [0005] Any of the aspects herein, wherein the one or more fixation devices comprises one or more clamps configured to clamp to the one or more anatomical elements.
[0006] Any of the aspects herein, wherein the connector comprises a polymer disposed inside of a tube, wherein the polymer is configured to harden when cured, thereby hardening the tube into the rigid state.
[0007] Any of the aspects herein, wherein the tube is transparent and the polymer is cured by an external ultraviolet (UV) light.
[0008] Any of the aspects herein, wherein the connector comprises at least one of a UV strip or an optical fiber strip disposed in the tube, and wherein the UV or light emitted from the UV strip or the optical fiber strip, respectively, are configured to cure the polymer. [0009] Any of the aspects herein, wherein the connector comprises a catalyst disposed inside of the tube, wherein the catalyst is configured to cure and harden the polymer.
[0010] Any of the aspects herein, wherein the catalyst is sealed in one or more capsules, wherein the catalyst is configured to cure and harden the polymer when the one or more capsules are ruptured.
[0011] Any of the aspects herein, wherein the connector comprises a polymer disposed inside of a tube, wherein the polymer is initially in the rigid state and configured to be in the flexible state when heated, thereby enabling the connector to be positioned when heated.
[0012] Any of the aspects herein, wherein the connector comprises a power source configured to generate an electric current, wherein the polymer is heated by the electric current.
[0013] Any of the aspects herein, wherein the connector comprises a tube and a polymer, wherein the polymer is injected into the tube and configured to harden when cured, thereby hardening the tube into the rigid state.
[0014] Any of the aspects herein, wherein the polymer is cured when a catalyst is injected into the tube.
[0015] A method for setting and fixing one or more anatomical elements according to at least one embodiment of the present disclosure comprises securing one or more fixation devices to a corresponding one or more anatomical elements; positioning the one or more anatomical elements; connecting the one or more fixation devices via a connector, the connector configured to transition between a flexible state and a rigid state; and transitioning the connector from the flexible state to the rigid state.
[0016] Any of the aspects herein, wherein the one or more fixation devices comprises one or more clamps configured to clamp to the one or more anatomical elements.
[0017] Any of the aspects herein, wherein the connector comprises a polymer disposed inside of a tube, wherein the polymer is configured to harden when cured, thereby hardening the tube into the rigid state.
[0018] Any of the aspects herein, wherein the connector comprises at least one of a UV strip or an optical fiber strip disposed in the tube, and wherein the UV or light emitted from the UV strip or the optical fiber strip, respectively, are configured to cure the polymer.
[0019] Any of the aspects herein, wherein the connector comprises a catalyst disposed inside of the tube, wherein the catalyst is configured to cure and harden the polymer. [0020] Any of the aspects herein, wherein the catalyst is sealed in one or more capsules, wherein the catalyst is configured to cure and harden the polymer when the one or more capsules are ruptured.
[0021] Any of the aspects herein, wherein the connector comprises a polymer disposed inside of a tube, wherein the polymer is initially in the rigid state and configured to be in the flexible state when heated, thereby enabling the connector to be positioned when heated.
[0022] Any of the aspects herein, wherein the connector comprises a power source configured to generate an electric current, wherein the polymer is heated by the electric current.
[0023] A system for setting and fixing a plurality of anatomical elements according to at least one embodiment of the present disclosure comprises one or more clamps configured to be secured to corresponding one or more anatomical elements, each clamp having a receptacle; a connector receivable in the receptacle of each clamp, the connector connecting each clamp to an adjacent clamp of the one or more clamps, the connector having a body with a bore extending from a first end to a second end and a polymer filling the bore, the connector configured to be in a flexible state when positioning the one or more clamps and a rigid state to fix the one or more clamps, thereby fixing the one or more anatomical elements, wherein the connector is configured to transition between the flexible state and the rigid state by at least one of curing, heating, or cooling the polymer.
[0024] Any aspect in combination with any one or more other aspects.
[0025] Any one or more of the features disclosed herein.
[0026] Any one or more of the features as substantially disclosed herein.
[0027] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.
[0028] Any one of the aspects/features/embodiments in combination with any one or more other aspects/features/embodiments .
[0029] Use of any one or more of the aspects or features as disclosed herein.
[0030] It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.
[0031] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.
[0032] The phrases “at least one”, “one or more”, and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as Xl-Xn, Yl- Ym, and Zl-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y 1 and Zo).
[0033] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.
[0034] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.
[0035] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0036] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.
[0037] Fig. 1 is a block diagram of a system according to at least one embodiment of the present disclosure;
[0038] Fig. 2A is a top, tilted view of a system for setting and fixing one or more anatomical elements according to at least one embodiment of the present disclosure;
[0039] Fig. 2B is a front, tiled view of the system of Fig. 2A according to at least one embodiment of the present disclosure;
[0040] Fig. 3A is a schematic drawing of a connector according to at least one embodiment of the present disclosure;
[0041] Fig. 3A is another schematic drawing of a connector according to at least one embodiment of the present disclosure;
[0042] Fig. 4A is a schematic illustration of a connector in a first state according to at least one embodiment of the present disclosure;
[0043] Fig. 4B is a schematic illustration of the connector of Fig. 3A in a second state according to at least one embodiment of the present disclosure;
[0044] Fig. 5 is a schematic illustration of a connector according to at least one embodiment of the present disclosure;
[0045] Fig. 6 is a schematic illustration of a connector according to at least one embodiment of the present disclosure; and
[0046] Fig. 7 is a flowchart according to at least one embodiment of the present disclosure.
DETAILED DESCRIPTION
[0047] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and/or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a computing device and/or a medical device. [0048] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions). Computer- readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).
[0049] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple Al l, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000- series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 7000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.
[0050] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.
[0051] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.
[0052] During surgical operations such as, for example, spinal operations for pediatric deformity, scoliosis, etc., a physical connection between a patient’s spine and a robotic arm of a robotic system may be relied upon to fix the patient’s spine. Such connection maintains a stiffness and position of the spine so there will be as little to no movement of the spine during the operation. This is essential to for navigation during the operation so that, for example, surgical tools can be navigated to the exact accurate position in the patient’ s spine, and to avoid patient injuries or damaging essential parts of the spine (e.g., spinal canal, spinal cord, etc.) due to spine movement during the operation.
[0053] In cases of scoliosis, for example, the spine vertebrae may be not aligned on a straight line and may be twisted and rotated such that fixing the spine in order to perform a robotic assisted or robotic surgical operation is a very complex task. Further, scoliosis operations are usually performed on a large segment of the spine, which may be time consuming to fix the spine using conventional systems involving clamps that grasp the patient’s spine vertebrae (i.e., at the spinous process parts of several vertebra of the spine) and links that connect between the clamps and to the robotic arm. In such conventional systems, a multitude of screws are tightened to reach fixation of the system, thus increasing the time needed to fix the system.
[0054] Thus, according to one embodiment of the present disclosure, a fixation system having one or more fixation devices (which may be clamps) and a connector to connect the one or more fixation devices is provided. The connector may be a flexible tube that can be inserted through each of the clamps - wherever they are located along the spine and can support a large variation of height and angle between any two clamps. Thus, the connector is easily adjusted to a variety of spine curves and to the clamps (location / height / angle). After a desired shape of the connector is achieved, a polymer may be used to harden the tube. The polymer can be located inside the tube by at least one of the two ways: (1) injection to the connector - after the connector is fixed in its flexible mode or (2) a pre-sealed connector with the polymer already inside. To harden the connector to lock the shape of the connector, the polymer can be cured and the connector becomes stiff and hard while having the desired shape.
[0055] The fixation system can reduce the time needed for fixation during preparation for the surgical operation, thereby increasing patient safety as the total operation time may be reduced. Further, the fixation system can be used in a variety of situations such as, for example, adult scoliosis and pediatric deformity surgery; large spine fixation constructs (more clamps, larger incision); and/or a non-straight spine midline because of scoliosis. Further, smaller link diameters can be used to have less coverage of the anatomy in instances such as, for example, pediatric procedures where the pediatric spine is smaller than an adult spine.
[0056] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) reducing fixation time of one or more anatomical elements, (2) reducing components for fixing one or more anatomical elements, and (3) increasing patient and surgical team safety.
[0057] Turning first to Fig. 1, a block diagram of a system 100 according to at least one embodiment of the present disclosure is shown. The system 100 may be used to set and fix one or more anatomical elements using, for example, a robot 114 and/or a system 200 for positioning and fixing the one or more anatomical elements (also referred to as a “fixation system 200”) and/or carry out one or more other aspects of one or more of the methods disclosed herein. The system 100 comprises the fixation system 200 (discussed in detail in Figs. 2A-5), a computing device 102, a robot 114, a navigation system 118, a database 130, and/or a cloud or other network 134. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 100. For example, the system 100 may not include the robot 114, the navigation system 118, one or more components of the computing device 102, the database 130, and/or the cloud 134.
[0058] The computing device 102 comprises a processor 104, a memory 106, a communication interface 108, and a user interface 110. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 102. [0059] The processor 104 of the computing device 102 may be any processor described herein or any similar processor. The processor 104 may be configured to execute instructions stored in the memory 106, which instructions may cause the processor 104 to carry out one or more computing steps utilizing or based on data received from the robot 114, the navigation system 118, the database 130, and/or the cloud 134.
[0060] The memory 106 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer-readable data and/or instructions. The memory 106 may store information or data useful for completing, for example, any step of the method 700 described herein, or of any other methods. The memory 106 may store, for example, instructions and/or machine learning models that support one or more functions of the robot 114. For instance, the memory 106 may store content (e.g., instructions and/or machine learning models) that, when executed by the processor 104, enable registration 128. Such content, if provided as in instruction, may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. Alternatively or additionally, the memory 106 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by the processor 104 to carry out the various method and features described herein. Thus, although various contents of memory 106 may be described as instructions, it should be appreciated that functionality described herein can be achieved through use of instructions, algorithms, and/or machine learning models. The data, algorithms, and/or instructions may cause the processor 104 to manipulate data stored in the memory 106 and/or received from or via the robot 114, the database 130, and/or the cloud 134. The memory 106 may also store, for example, one or more surgical plan(s) 122.
[0061] The computing device 102 may also comprise a communication interface 108. The communication interface 108 may be used for receiving image data or other information from an external source (such as the robot 114, the navigation system 118, the database 130, the cloud 134, and/or any other system or component not part of the system 100), and/or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 102, the robot 114, the navigation system 118, the database 130, the cloud 134, and/or any other system or component not part of the system 100). The communication interface 108 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and/or one or more wireless transceivers or interfaces (configured, for example, to transmit and/or receive information via one or more wireless communication protocols such as 802.11a/b/g/n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface 108 may be useful for enabling the device 102 to communicate with one or more other processors 104 or computing devices 102, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.
[0062] The computing device 102 may also comprise one or more user interfaces 110. The user interface 110 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and/or any other device for receiving information from a user and/or for providing information to a user. The user interface 110 may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system 100 (e.g., by the processor 104 or another component of the system 100) or received by the system 100 from a source external to the system 100. In some embodiments, the user interface 110 may be useful to allow a surgeon or other user to modify instructions to be executed by the processor 104 according to one or more embodiments of the present disclosure, and/or to modify or adjust a setting of other information displayed on the user interface 110 or corresponding thereto.
[0063] Although the user interface 110 is shown as part of the computing device 102, in some embodiments, the computing device 102 may utilize a user interface 110 that is housed separately from one or more remaining components of the computing device 102. In some embodiments, the user interface 110 may be located proximate one or more other components of the computing device 102, while in other embodiments, the user interface 110 may be located remotely from one or more other components of the computer device 102.
[0064] The robot 114 may be any surgical robot or surgical robotic system. The robot 114 may be or comprise, for example, the Mazor X™ Stealth Edition robotic guidance system. The robot 114 may be configured to position any component such as, for example, one or more fixation device(s) 204 and/or one or more connector(s) 208 of the fixation system 200 at one or more precise position(s) and orientation(s), and/or to return the one or more fixation device(s) 204 and/or the one or more connector(s) 208 to the same position(s) and orientation(s) at a later point in time. The robot 114 may additionally or alternatively be configured to manipulate a surgical tool (whether based on guidance from the navigation system 118 or not) to accomplish or to assist with a surgical task. In some embodiments, the robot 114 may be configured to hold and/or manipulate an anatomical element during or in connection with a surgical procedure. The robot 114 may comprise one or more robotic arms 116. In some embodiments, the robotic arm 116 may comprise a first robotic arm and a second robotic arm, though the robot 114 may comprise more than two robotic arms. In some embodiments, one or more of the robotic arms 116 may be used to hold and/or maneuver the one or more fixation device(s) 204 and/or the one or more connector(s) 208. Each robotic arm 116 may be positionable independently of the other robotic arm. The robotic arms 116 may be controlled in a single, shared coordinate space, or in separate coordinate spaces.
[0065] The robot 114, together with the robotic arm 116, may have, for example, one, two, three, four, five, six, seven, or more degrees of freedom. Further, the robotic arm 116 may be positioned or positionable in any pose, plane, and/or focal point. The pose includes a position and an orientation. As a result, the one or more fixation device(s) 204 and/or the one or more connector(s) 208, surgical tool, or other object held by the robot 114 (or, more specifically, by the robotic arm 116) may be precisely positionable in one or more needed and specific positions and orientations.
[0066] The robotic arm(s) 116 may comprise one or more sensors that enable the processor 104 (or a processor of the robot 114) to determine a precise pose in space of the robotic arm (as well as any object or element held by or secured to the robotic arm).
[0067] It will be appreciated that in some embodiments, any component of the fixation system 200 (e.g., the fixation device(s) 204 and/or the connector(s) 208) may be manually positioned by, for example, a user such as a medical provider. In other embodiments, any component of the fixation system 200 may be positioned with assistance from the robot 114 and/or the robotic 116. In other words, the user may position any component of the fixation system 200 with support or aid from the robot 114 and/or the robotic arm 116.
[0068] In some embodiments, reference markers (e.g., navigation markers) may be placed on the robot 114 (including, e.g., on the robotic arm 116), the one or more fixation device(s) 204 and/or the one or more connector(s) 208, or any other object in the surgical space. The reference markers may be tracked by the navigation system 118, and the results of the tracking may be used by the robot 114 and/or by an operator of the system 100 or any component thereof. In some embodiments, the navigation system 118 can be used to track other components of the system (e.g., the one or more fixation device(s) 204 and/or the one or more connector(s) 208) and the system can operate without the use of the robot 114 (e.g., with the surgeon manually manipulating the one or more fixation device(s) 204 and/or the one or more connector(s) 208 and/or one or more surgical tools, based on information and/or instructions generated by the navigation system 118, for example).
[0069] The navigation system 118 may provide navigation for a surgeon and/or a surgical robot during an operation. The navigation system 118 may be any now-known or future-developed navigation system, including, for example, the Medtronic StealthStation™ S8 surgical navigation system or any successor thereof. The navigation system 118 may include one or more cameras or other sensor(s) for tracking one or more reference markers, navigated trackers, or other objects within the operating room or other room in which some or all of the system 100 is located. The one or more cameras may be optical cameras, infrared cameras, or other cameras. In some embodiments, the navigation system 118 may comprise one or more electromagnetic sensors. In various embodiments, the navigation system 118 may be used to track a position and orientation (e.g., a pose) of the one or more fixation device(s) 204 and/or the one or more connector(s) 208, the robot 114 and/or robotic arm 116, and/or one or more surgical tools (or, more particularly, to track a pose of a navigated tracker attached, directly or indirectly, in fixed relation to the one or more of the foregoing). The navigation system 118 may include a display for displaying one or more images from an external source (e.g., the computing device 102, or other source) or for displaying an image and/or video stream from the one or more cameras or other sensors of the navigation system 118. In some embodiments, the system 100 can operate without the use of the navigation system 118. The navigation system 118 may be configured to provide guidance to a surgeon or other user of the system 100 or a component thereof, to the robot 114, or to any other element of the system 100 regarding, for example, a pose of one or more anatomical elements, whether or not a tool is in the proper trajectory, and/or how to move a tool into the proper trajectory to carry out a surgical task according to a preoperative or other surgical plan.
[0070] The database 130 may store information that correlates one coordinate system to another (e.g., one or more robotic coordinate systems to a patient coordinate system and/or to a navigation coordinate system). The database 130 may additionally or alternatively store, for example, one or more surgical plans (including, for example, pose information about a target and/or image information about a patient’s anatomy at and/or proximate the surgical site, for use by the robot 114, the navigation system 118, and/or a user of the computing device 102 or of the system 100); one or more images useful in connection with a surgery to be completed by or with the assistance of one or more other components of the system 100; and/or any other useful information. The database 130 may be configured to provide any such information to the computing device 102 or to any other device of the system 100 or external to the system 100, whether directly or via the cloud 134. In some embodiments, the database 130 may be or comprise part of a hospital image storage system, such as a picture archiving and communication system (PACS), a health information system (HIS), and/or another system for collecting, storing, managing, and/or transmitting electronic medical records including image data.
[0071] The cloud 134 may be or represent the Internet or any other wide area network. The computing device 102 may be connected to the cloud 134 via the communication interface 108, using a wired connection, a wireless connection, or both. In some embodiments, the computing device 102 may communicate with the database 130 and/or an external device (e.g., a computing device) via the cloud 134.
[0072] The system 100 or similar systems may be used, for example, to carry out one or more aspects of the method 700 described herein. The system 100 or similar systems may also be used for other purposes.
[0073] Turning to Figs. 2A-2B, a first view and a second view, respectively, of the fixation system 200 are shown. As previously described, the fixation system 200 includes one or more fixation devices 204 and one or more connectors 208. The one or more fixation devices 204 are configured to be secured to a corresponding one or more anatomical elements 212. In some embodiments, the one or more anatomical elements 212 are, for example, one or more vertebrae; though it will be appreciated that the one or more anatomical elements 212 may be any anatomical element.
[0074] The fixation system 200 is beneficially useful for a wide variety of anatomies between children and adults and is adaptable to various sizing needs or constraints across different patients while using less components than conventional systems. The fixation system 200 also provides for rigidity throughout the one or more anatomical elements which are fixed by the fixation system 200, which beneficially aids in registration and navigation of the patient and the robot 114. Thus, the fixation system 200 beneficially increases navigation accuracy, increases ease of registration, and is adaptable to a wide range of patients and conditions.
[0075] The one or more fixation devices 204 may be one or more clamps configured to clamp to the one or more anatomical elements. In the illustrated embodiment, the one or more fixation devices 204 include four clamps. In other instances, the one or more fixation devices 204 may be fixed to the one or more anatomical elements 212 in any way such as, for example, by screws, adhesion, or the like. Each fixation device 204 of the one or more fixation devices 204 may also include a receptacle 216 for receiving the connector 208, though in other embodiments the one or more fixation devices 204 may not include the receptacle 216. Though not shown, at least one fixation device of the one or more fixation devices 204 may be connected to the robot 114 or the robotic arm 116 via a rod so as to provide a rigid connection between the one or more fixation devices 204 and the robot 114 or the robotic arm 116.
[0076] In some embodiments, it will be appreciated that the fixation system 200 may not include the one or more fixation devices 204 and rather, the connector(s) 208 can be directly fixed, attached, or releasable secured to the one or more anatomical elements 212. In other words, the one or more fixation devices 204 provide a support for the connector 208 such that the connector 208 can be connected or attached to the one or more anatomical elements 212. In instances where the connector 208 can be directly connected to the one or more anatomical elements 212, then the fixation system 200 may not include the one or more fixation devices 204. [0077] The connector 208 is configured to connect each fixation device 204 to an adjacent fixation device 204 of the one or more fixation devices 204. The connector 208 is configured to be able to transition between a flexible state and a rigid state. The one or more fixation devices 204 are able to be moved and positioned when the connector 208 is in the flexible state to position the one or more anatomical elements 212 are a desired configuration. The connector 208 can be transitioned or hardened to the rigid state when the one or more fixation devices 204 and the one or more anatomical elements 212 are in the desired configuration to fix the one or more fixation devices 204 (and thereby fix the one or more anatomical elements 212). The connector 208 can include any number of embodiments in which the connector 208 is capable of being in a flexible state and a rigid state. For example, in at least one embodiment, the connector 208 may include a series of links having a ball joint between adjacent links and a rigid wire connecting each link. When the wire is tightened, friction is increased between each link, thereby causing the connector 208 to become rigid. When the wire is loosened, the connector 208 becomes flexible. Further embodiments of the connector 208 are described below in Figs. 3A-6.
[0078] Turning to Figs. 3A and 3B, a schematic drawing of the connector 208 with a catalyst and without a catalyst are respectively shown. The connector 208 includes a body 302 and a bore 304 extending from a first end 306 to a second end 308. In some embodiments, the connector 208 is a tube. The connector 208 also includes a polymer 310 disposed in the body 302. The polymer 310 is generally in a flexible or malleable state such that the body 302 is flexible and can be positioned in a desired configuration. In some instances, the polymer 310 may be self-curing such that the polymer 310 can be cured or hardened to the rigid state. In other instances, the connector 208 may also include a catalyst 312 that cures or hardens the polymer 310 when the catalyst 312 comes into contact with the polymer 310.
[0079] In embodiments where the connector 208 includes the polymer 310 and the catalyst 312 (such as in Fig. 3A, for example), the polymer 310 may be pre-sealed in the body 302 or injected into the body 302 during a medical procedure. The catalyst may be injected into the body 302 whether the polymer 310 is pre-sealed or injected into the body 302 during the medical procedure. In some instances, the polymer 310 and the catalyst 312 may be mixed prior to injection into the body 302. The polymer 310 and/or the catalyst 312 may be injected using, for example, a syringe or other injection device. In some embodiments, a second syringe or a vacuum device may be used on an opposite end of the body 302 into which the polymer 310 and/or the catalyst 312 are being injected into. The second syringe or vacuum device may be used to create or form a light vacuum.
[0080] In embodiments where the polymer 310 may be cured without a catalyst (such as in Fig. 3B, for example), the polymer 310 may be cured using, for example, a UV light. In such embodiments, the body 302 may be transparent and an external UV source may be used to cure the polymer 310. In other embodiments, the polymer 310 may be anaerobic such that the connector 208 is hardened when the polymer 310 is injected into the body 302 until the body 302 is full of the polymer 310. In such embodiments, the polymer 310 may be inserted into the body 302 through a filter so as to remove oxygen from polymer 310 as the polymer 310 is inserted into the body 302. In still other embodiments, the polymer 310 may be injected in a melted, thermoplastic form into the body 302 such that the melted, thermoplastic polymer 310 is malleable when injected and hardens as the thermoplastic polymer 310 cools. [0081] In further embodiments where the polymer 310 is transitioned between the rigid state and the flexible state without a catalyst, the polymer 310 and a coil submerged in the polymer 310 may be pre-sealed in the body. The coil may have two wires extending from the connector 208 such that an electric current can be applied to the two wires, which results in the coil generating heat in the polymer 310. The polymer 310 may be in the rigid state prior to applying the electric current to the coil and transitioned to the flexible state when the coil generates heat to heat up the polymer 310. The connector 208 can be moved to a desired configuration while the coil is heated, and when the connector 208 is in the desired configuration, the electric current may be stopped so that the coil stops emitting heat and the polymer 310 cools down. Once the polymer 310 is cool, it is in the rigid state. It will be appreciated that in such embodiments, the polymer 310 may be repeatedly moved between the rigid state and the flexible state.
[0082] Additional embodiments of the connector 208 are described in Figs. 4A-6 below.
[0083] Turning to Figs. 4A-4B, a schematic illustration of the connector 208 in a first state (e.g., a flexible state) and transitioning to a second state (e.g., a rigid state) are shown, respectively. In the illustrated embodiment, the polymer 310 is pre-sealed in the body 302 and the catalyst 312 are sealed in one or more capsules 314 within the polymer 310. To release the catalyst 312, the capsules 314 are broken to enable the catalyst to cure the polymer. The capsules 314 may be broken by applying force to the connector 208 to break the capsules. The force may be applied by, for example, a user such as a surgeon or a device 316 (shown in Fig. 4B) operable to crush or break the capsules.
[0084] Turning to Fig. 5, a schematic illustration of the connector 208 is shown. In the illustrated embodiment, a strip 318 and the polymer 310 are pre- sealed in the body 302, with the polymer 310 surrounding the strip 318. The strip 318 is configured to emit, for example, UV light that is capable of curing the polymer 310. It will be appreciated that in other embodiments, the strip 318 may emit any source that can cure the polymer 310. The strip 318 may have one or more wires 320 extending from the body 302 that are able to be attached to a power source. The power source may power the strip 318 to emit the UV light to cure the polymer 310 when the connector 208 is in the desired configuration. It will be appreciated that in some embodiments, the body 302 may be formed from UV blocking material so as to prevent UV exposure to the patient. [0085] Fig. 6 illustrates a schematic drawing of the connector 208. In the illustrated embodiment, an optical fiber 322 and the polymer 310 are pre-sealed in the body 302, with the polymer 310 surrounding the optical fiber 322. The optical fiber 322 is configured to emit, for example, UV light that is capable of curing the polymer 310. It will be appreciated that in other embodiments, the optical fiber 322 may emit any source that can cure the polymer 310. The optical fiber 322 may be connected to a UV source 324 that emits UV light. The UV light may travel through the optical fiber 322 and be emitted from the optical fiber 322 to cure the polymer 310 when the connector 208 is in the desired configuration. It will be appreciated that in some embodiments, the body 302 may be formed from UV blocking material so as to prevent UV exposure to the patient.
[0086] Fig. 7 depicts a method 700 that may be used, for example, for positioning and fixing one or more anatomical elements.
[0087] The method 700 (and/or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) 104 of the computing device 102 described above. The at least one processor may be part of a robot (such as a robot 114) or part of a navigation system (such as a navigation system 118). A processor other than any processor described herein may also be used to execute the method 700. The at least one processor may perform the method 700 by executing elements stored in a memory such as the memory 106. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 700. One or more portions of a method 700 may be performed by the processor executing any of the contents of memory, such as a registration 120.
[0088] The method 700 comprises securing one or more fixation devices to one or more anatomical elements (step 704). The one or more fixation devices may be the same as or similar to the one or more fixation devices 204 of a fixation system such as the fixation system 200. The one or more fixation devices are configured to be secured to a corresponding one or more anatomical elements. In some embodiments, the one or more anatomical elements are, for example, one or more vertebrae; though it will be appreciated that the one or more anatomical elements may be any anatomical element. The one or more fixation devices may be one or more clamps configured to clamp to the one or more anatomical elements. In other instances, the one or more fixation devices may be fixed to the one or more anatomical elements in any way such as, for example, by screws, adhesion, or the like. Each fixation device of the one or more fixation devices may also include a receptacle for receiving a connector such as the connector 208, though in other embodiments the one or more fixation devices may not include the receptacle.
[0089] The one or more fixation devices may be manually connected to the one or more anatomical elements by user such as, for example a surgeon or other medical provider. In other embodiments, the one or more fixation devices may be connected to the one or more anatomical elements by the user with assistance from a robotic arm such as the robotic arm 116 of a robot such as the robot 114. In still other embodiments, the one or more fixation devices may be connected to the one or more anatomical elements by the robotic arm.
[0090] It will be appreciated that in some embodiments, the method 700 may not include the step 704. For example, the connector may be fixed or secured to the anatomical elements without the one or more fixation devices.
[0091] The method 700 also comprises positioning the one or more anatomical elements (step 708). The one or more anatomical elements are moved and/or positioned until the one or more anatomical elements are in a desired configuration. In some embodiments, the desired configuration may provide relief or correct, for example, spinal deformities such as scoliosis. [0092] The one or more anatomical elements may be positioned by positioning the one or more fixation devices attached thereto. In some embodiments, the step 708 may occur after the step 712 such that the one or more anatomical elements are positioned with the connector connected to the one or more fixation devices. In other embodiments, where the fixation system does not include the one or more fixation devices, the one or more anatomical elements may be positioned directly (e.g., each anatomical element is positioned in a desired pose). In instances where the connector is directly connected to the one or more anatomical elements, the one or more anatomical elements may be positioned by adjusting a configuration of the connector.
[0093] In any embodiment, the one or more anatomical elements may be positioned by user such as, for example a surgeon or other medical provider. In other embodiments, the one or more anatomical elements may be positioned by the user with assistance from the robotic arm of the robot. In still other embodiments, the one or more anatomical elements may be positioned by the robotic arm.
[0094] It will be appreciated that in some embodiments, the one or more anatomical elements may be positioned without the one or more fixation devices. For example, the connector may be fixed or secured to the anatomical elements without the one or more fixation devices. It will also be appreciated that in other embodiments, the one or more fixation devices may be removed from the one or more anatomical elements during or after hardening of the connector. In such embodiments, the one or more fixation devices may be used to initially connect the connector to the anatomical elements, then removed once the connector is connected or secured to the one or more anatomical elements.
[0095] The method 700 also comprises connecting the one or more fixation devices via a connector while the connector is in a flexible state (step 712). Connecting the one or more fixation devices may include positioning the connector in the receptable of each fixation device. The connector is configured to connect each fixation device to an adjacent fixation device of the one or more fixation devices. The connector is configured to be able to transition between a flexible state and a rigid state. The one or more fixation devices are able to be moved and positioned when the connector is in the flexible state. The connector can be transitioned or hardened to the rigid state when the one or more anatomical elements are in the desired configuration (in some instances, via the fixation device(s)) to fix the one or more anatomical elements 212. The connector can include any number of embodiments in which the connector is capable of being in a flexible state and a rigid state as described in Figs. 2A-6.
[0096] In any embodiment, the connector may be positioned by user such as, for example a surgeon or other medical provider. In other embodiments, the connector may be positioned by the user with assistance from the robotic arm of the robot. In still other embodiments, the connector may be positioned by the robotic arm.
[0097] The method 700 also comprises hardening the connector to a rigid state (step 716). The connector may be hardened in any number of ways, including, but not limited to, the embodiments described in Figs. 2A-6. In some embodiments, the connector includes a body such as the body 302 having a bore such as the bore 304 extending from a first end such as the first end 306 to a second end such as the second end 308. The body may be filled with a polymer such as the polymer 310 that can be hardened by a catalyst such as the catalyst 312, by a source such as a UV source, or can be self-hardening or self-curing. The polymer may be pre-sealed in the connector or injected into the connector.
[0098] When the connector is hardened (whether by a catalyst, self-curing, or an external source), the connector is moved to the rigid state and fixes the one or more anatomical elements in the desired configuration. Such fixation aids in patient registration and navigation during the surgical procedure as the one or more anatomical elements are rigidly connected. Thus, movement of one anatomical element of the one or more anatomical elements will result in movement of the connected anatomical elements. Because the anatomical elements are connected, the relative position of each anatomical element relative to each other is known such that the movement of each of the connected anatomical elements can be determined from movement of one anatomical element of the connected anatomical elements. The movement can be tracked using, for example, a reference marker tracked by a navigation system such as the navigation system 118. Such information is valuable in increasing navigation accuracy and thereby, increases an accuracy of a robotic system and/or a user relying on the navigation. [0099] In other embodiments, the connector is moved to the rigid state and fixes the one or more anatomical elements in the desired configuration and the one or more anatomical elements is connected to a robotic arm via a bone fixation. In such instances, movement of the one or more anatomical elements may be sufficiently limited or constrained so as to maintain accuracy of the robotic system and/or the user relying on the navigation.
[0100] The present disclosure encompasses embodiments of the method 700 that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above. It will be appreciated that the steps of the method 700 can be performed in any order.
[0101] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Fig. 7 (and the corresponding description of the method 700), as well as methods that include additional steps beyond those identified in Fig. 7 (and the corresponding description of the method 700). The present disclosure also encompasses methods that comprise one or more steps from one method described herein, and one or more steps from another method described herein. Any correlation described herein may be or comprise a registration or any other correlation.
[0102] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and/or configurations of the disclosure may be combined in alternate aspects, embodiments, and/or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and/or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.
[0103] Moreover, though the foregoing has included description of one or more aspects, embodiments, and/or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and/or configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.
[0104] The following statements provide non-limiting examples of systems and methods for setting and fixing one or more anatomical elements of the present disclosure:
[0105] Example 1. A system for setting and fixing one or more anatomical elements comprising: one or more fixation devices configured to be secured to corresponding one or more anatomical elements; a connector connecting each fixation device to an adjacent fixation device of the one or more fixation devices, the connector configured to be in a flexible state when positioning the one or more fixation devices and a rigid state to fix the one or more fixation devices, thereby fixing the one or more anatomical elements.
[0106] Example 2. The system of example 1, wherein the one or more fixation devices comprises one or more clamps configured to clamp to the one or more anatomical elements. [0107] Example 3. The system of examples 1 or 2, wherein the connector comprises a polymer disposed inside of a tube, wherein the polymer is configured to harden when cured, thereby hardening the tube into the rigid state.
[0108] Example 4. The system of example 3, wherein the tube is transparent and the polymer is cured by an external ultraviolet (UV) light. [0109] Example 5. The system of example 3, wherein the connector comprises at least one of a UV strip or an optical fiber strip disposed in the tube, and wherein the UV or light emitted from the UV strip or the optical fiber strip, respectively, are configured to cure the polymer.
[0110] Example 6. The system of example 3, wherein the connector comprises a catalyst disposed inside of the tube, wherein the catalyst is configured to cure and harden the polymer. [0111] Example 7. The system of example 6, wherein the catalyst is sealed in one or more capsules, wherein the catalyst is configured to cure and harden the polymer when the one or more capsules are ruptured.
[0112] Example 8. The system of any one of the preceding examples, wherein the connector comprises a polymer disposed inside of a tube, wherein the polymer is initially in the rigid state and configured to be in the flexible state when heated, thereby enabling the connector to be positioned when heated.
[0113] Example 9. The system of example 8, wherein the connector comprises a power source configured to generate an electric current, wherein the polymer is heated by the electric current. [0114] Example 10. The system of any one of the preceding examples, wherein the connector comprises a tube and a polymer, wherein the polymer is injected into the tube and configured to harden when cured, thereby hardening the tube into the rigid state.
[0115] Example 11. The system of example 10, wherein the polymer is cured when a catalyst is injected into the tube.
[0116] Example 12. A method for setting and fixing one or more anatomical elements comprising: securing one or more fixation devices to a corresponding one or more anatomical elements; positioning the one or more anatomical elements; connecting the one or more fixation devices via a connector, the connector configured to transition between a flexible state and a rigid state; and transitioning the connector from the flexible state to the rigid state.
[0117] Example 13. The method of example 12, wherein the one or more fixation devices comprises one or more clamps configured to clamp to the one or more anatomical elements. [0118] Example 14. The method of examples 12 or 13, wherein the connector comprises a polymer disposed inside of a tube, wherein the polymer is configured to harden when cured, thereby hardening the tube into the rigid state. [0119] Example 15. The method of example 14, wherein the connector comprises at least one of a UV strip or an optical fiber strip disposed in the tube, and wherein the UV or light emitted from the UV strip or the optical fiber strip, respectively, are configured to cure the polymer.
[0120] Example 16. The method of example 14, wherein the connector comprises a catalyst disposed inside of the tube, wherein the catalyst is configured to cure and harden the polymer. [0121] Example 17. The method of example 16, wherein the catalyst is sealed in one or more capsules, wherein the catalyst is configured to cure and harden the polymer when the one or more capsules are ruptured.
[0122] Example 18. The method of any one of the preceding examples, wherein the connector comprises a polymer disposed inside of a tube, wherein the polymer is initially in the rigid state and configured to be in the flexible state when heated, thereby enabling the connector to be positioned when heated.
[0123] Example 19. The method of example 18, wherein the connector comprises a power source configured to generate an electric current, wherein the polymer is heated by the electric current.
[0124] Example 20. A system for setting and fixing a plurality of anatomical elements comprising: one or more clamps configured to be secured to corresponding one or more anatomical elements, each clamp having a receptacle; a connector receivable in the receptacle of each clamp, the connector connecting each clamp to an adjacent clamp of the one or more clamps, the connector having a body with a bore extending from a first end to a second end and a polymer filling the bore, the connector configured to be in a flexible state when positioning the one or more clamps and a rigid state to fix the one or more clamps, thereby fixing the one or more anatomical elements, wherein the connector is configured to transition between the flexible state and the rigid state by at least one of curing, heating, or cooling the polymer.