Patent Application
20240041547
The disclosure relates to robotic assisted and/or navigational assisted spinal procedures. More specifically, the disclosure relates methods for assisting the surgeon to carryout different spinal procedures using a robotic system and/or navigational assistance to increase the increase the accuracy of vertebral preparation and/or implant positioning, thereby improving spinal alignment and range of motion.
Traditionally, surgeons use manual methods for spine surgeries. Spine surgeries often use a variety of instrumentation to prepare the vertebral surfaces to deploy implants or other fixations into the targeted vertebrae. The surgeon must develop a surgical technique and approach based on the pre-operative image scans. All access, bony preparations and deployment are judged visually during the operative procedure using fluoroscopic images and confirmed with the preoperative plan. However, such manual methods strongly rely on the surgeon's experience and can be subject to his changing predisposition, coordination, and hand stability. Furthermore, fluoroscopic images are only represented in 2D and in single views resulting in decreased accuracy for preparation and implantation. Some surgical procedures may be technically difficult because the tools are held in hand and performed manually. Due to the disadvantages described, the surgery may result in several inaccurate methods, including access, preparation and implant positioning.
There is a need to provide an improved method to improve the accuracy of one or more operative steps, including surgical access, surgical bony preparation and/or spinal implant positioning to further improve spinal alignment and range of motion by allowing surgeons to use a robotic assisted and/or navigational assisted spinal surgeries.
In one embodiment, a computer-assisted method to improve the accuracy of spinal alignment and motion restoration comprises the steps of: accessing a preoperative surgical plan from a storage device, the preoperative surgical plan including one or more preoperative virtual models, the one or more preoperative virtual models including a targeted anatomy having defined anatomical landmarks; acquiring one or more operative images of the targeted anatomy using one or more imaging techniques to create one or more operative virtual models and an operative plan; generating a first one or more spatial coordinates to create a first surgical trajectory for one or more operative methods; projecting a first one or more objects onto the display that substantially matches the first surgical trajectory to position a user to execute one or more operative methods; generating a second one or more spatial coordinates to create a second surgical trajectory and projecting a second one or more objects onto the display; comparing the first surgical trajectory relative to the second surgical trajectory; and correcting the user to return to the first surgical trajectory after a determination that the second surgical trajectory is substantially different than the first surgical trajectory by providing feedback.
In another embodiment, a computer-assisted method to improve the accuracy of spinal alignment and motion restoration comprises the steps of: accessing one or more preoperative images from a storage device comprising of a portion of a spine of a patient within a spine region collected using an imaging protocol and one or more imaging techniques; generating one or more preoperative virtual models, the at least one preoperative virtual model includes defined anatomical landmarks; creating a preoperative plan by analyzing the one or more preoperative virtual models to compute one or more desired selected surgical measurements for one or more operative methods; acquiring one or more operative images of the at least a portion of the spine of the patient within the spine region using one or more imaging techniques to create one or more operative virtual models; superimposing one or more preoperative virtual models onto the one or more operative virtual models onto a display to create one or more synchronized virtual models to confirm the preoperative surgical plan; generating a first one or more spatial coordinates to create a planned surgical trajectory for the one or more operative methods; projecting one or more objects onto the display that substantially matches the first surgical trajectory to help guide or position a user; generating a second one more spatial coordinates to create a second surgical trajectory to be projected as a second one or more objects onto the display; comparing the first surgical trajectory relative to the second surgical trajectory; and providing feedback to the user to return to the first surgical trajectory if the second surgical trajectory is substantially different than the first surgical trajectory.
In another embodiment, a computer-assisted method to improve the accuracy of spinal alignment and motion restoration comprises the steps of: accessing a preoperative plan from a storage device, the preoperative surgical plan including one or more preoperative virtual models, the one or more preoperative virtual models including a targeted anatomy having defined anatomical landmarks; acquiring one or more operative images of the targeted anatomy using one or more imaging techniques to create one or more operative virtual models and an operative plan; generating a first one or more spatial coordinates to create a first surgical trajectory for one or more operative methods; projecting one or more objects onto a display that substantially matches the first surgical trajectory to help position a user to execute the one or more operative methods; generating a second one or more spatial coordinates to create a second surgical trajectory to be projected as a second one or more objects onto the display; comparing the first surgical trajectory relative to the second surgical trajectory; and correcting the user to return to the first trajectory if the second surgical trajectory is substantially different than the first surgical trajectory. The computer-assisted method to improve the accuracy of spinal alignment and motion restoration further comprises the step of generating an outcome study report, the outcome study report including a comparison of the preoperative surgical plan relative to the operative surgical plan.
In another embodiment, a computer-assisted method to improve the accuracy of spinal alignment and motion restoration comprises the steps of: acquiring one or more operative images of the at least a portion of a targeted anatomy using one or more imaging techniques to create one or more operative virtual models; generating a first one or more spatial coordinates to create a first surgical trajectory from the one or more operative virtual models; projecting one or more objects onto the one or more operative virtual models that substantially matches the first surgical trajectory to help guide or position the user to execute the one or more operative methods; displaying a second one or more spatial coordinates that creates a second surgical trajectory onto a display; comparing the first surgical trajectory relative to the second surgical trajectory; and providing feedback to the user to return to the first trajectory after a determination that the second surgical trajectory is substantially different than the first surgical trajectory.
In another embodiment, a non-transitory computer-readable medium with instructions stored thereon, that when executed by a processor, perform the steps comprising: accessing one or more preoperative images of a target anatomy of a patient; generating a first data set, the first data set comprises one or more preoperative virtual models of the target anatomy, the one or more preoperative virtual models including identification of anatomical landmarks; calculating one or more selected surgical measurements from the one or more preoperative virtual models of the target anatomy to create a second data set; and creating a preoperative plan by analyzing the one or more preoperative virtual models and the one or more selected surgical measurements.
Traditionally, spinal surgeries are performed manually. The surgeon acquires a set of images preoperatively and uses the images to prepare a surgical plan. During the operative procedure, the surgeon relies on fluoroscopy guided free-hand surgeries and the developed preoperative plan. Long and narrow paths to the spine are difficult to navigate by free-hand leading to various complications (e.g., vascular injury, neurologic injury, improper implant positioning, etc.). However, using navigation assisted spine surgery and/or robotic assisted spine surgery may accurately identify and/or maintain bone access or bone entry position, bone access or bone entry trajectory, bone preparation trajectories, and/or implant placement or positioning. Accordingly, navigation assisted spine surgery and/or robotic assisted spine surgery may further decrease complication rates, reduce radiation exposure, reduce surgery time, reducing or eliminating surgeon individual characteristics (e.g., hand tremors, surgeon fatigue, etc.) and/or reducing incision size. Furthermore, the navigation and/or robotic systems allow the surgeon to access 2D and 3D visualizations in various planes of the patient's imaging, rather than the limited 2D single plane image of fluoroscopy.
In another embodiment, a method to improve the accuracy implant positioning may comprise the steps of: generating a preoperative surgical plan by using a preoperative planning using a software application; and completing one or more operative methods using the preoperative surgical plan. In another embodiment, the method to improve the accuracy of bony preparation of removing at least one deployed spinal implant. The preoperative planning software application will output and/or display a variety of surgical measurements or parameters and enhanced virtual models that may improve the accuracy accessing the spine, bony preparation, selecting the proper implant size and implant positioning after deployment, which will ultimately optimize spinal alignment and motion restoration of a patient.
Preoperative Protocol or Preoperative Method
The method to restore alignment and motion, to improve bony preparation accuracy and improve implant positioning will comprise a preoperative protocol and/or a pre-operative method. The ultimate goals of preoperative protocol are to reduce the patient's surgical and morbidity or mortality intraoperatively and postoperatively, and reduce the overall risk to the patient. More specifically, the detailed goals of the preoperative procedure includes the documentation of the condition(s) for which surgery is required; assessing the patient's overall health status to uncover hidden conditions that could increase perioperative and postoperative risk; development of an appropriate surgical or intraoperative plan; educate the patient about the upcoming surgery to reduce anxiety; and/or reduce costs by shortening hospital stay and increase satisfaction.
With reference to
The steps of completing a drug history and a drug management protocol 10; conducting a health behavior assessment and health behavior protocol and assessing perioperative anesthesia risk and completing perioperative anesthesia protocol for Enhanced Recovery After Surgery (ERAS) 20 may be completed to procedures known in the art for spine surgeries.
With reference to
The spinal biomechanics may be evaluated during the lordotic changes between different positions as shown in
In one embodiment, the imaging protocol 25,55 comprises the steps of: completing at least one MRI imaging scan to evaluate the soft-tissue related pathology, including disc degeneration grade, facet joint cartilage, and nerve compression; obtaining at least one or more radiographs (e.g., X-rays) at different static and dynamic positions, the positions including one or more postures 70, the postures 70 includes a lateral slump sitting views 75, at least a standing anterior/posterior 80, flexion/extension 85,90, and/or a lateral neutral to evaluate biomechanics and/or any combination thereof as shown in
In another embodiment, the imaging protocol 25 comprises the steps of acquiring at least one image using a first imaging technique 35; acquiring at least one image using a second imaging technique 40; storing at least one raw image from the first and/or second imaging techniques 45; and/or acquiring one or more projected surgical measurements (PSM) and/or processed images from the preoperative surgery planning software to create an operative plan 50. The imaging protocol 25,55 may further comprise a third imaging technique.
In another embodiment, the imaging protocol 55 comprises the steps of acquiring at least one image using a first imaging technique 35; acquiring at least one image using a second imaging technique 40; modifying at least one raw image to highlight relevant bony structures 60; storing at least one modified image from the first and/or second imaging techniques 65; and/or acquiring one or more projected surgical measurements (PSM) from the preoperative surgery planning software to create an operative plan 50. The imaging protocol 55 may further comprise a third imaging technique.
The first imaging technique may be the same as the second imaging technique. The first imaging technique may be different than the second imaging technique. Furthermore, each of the first imaging technique, the second imaging technique and/or the third imaging technique may comprise different imaging techniques. Each of the first imaging techniques, the second imaging techniques and/or the third imaging technique may comprise a same imaging technique. The imaging techniques include an MRI, a radiograph or X-ray, a CT scan, an ultrasound, and/or any combination thereof. Each of the first imaging techniques, the second imaging technique and/or the third imaging technique may comprise a single image and/or multiple images. Each of the first imaging technique, the second imaging technique and/or the third imaging technique comprises static or dynamic positions.
In one embodiment, acquiring at least one image using a CT scan technique may desirably help the surgeon by highlighting different types of structures in the body. A CT scan is an imaging tool that can provide detailed cross-sectional images of the structures, including tissues, bony structures, and organs, to understand the size, shape and position of the relevant structures. It can help identify the damaged disc(s) or disc degeneration, vertebral fractures, as well as identify other sources of pain. In another embodiment, acquiring at least one image using radiographs (e.g., X-rays) technique may desirably help the surgeon to investigate the cause of the patients' symptoms at a targeted spinal level, bone morphology, and/or identify presence of abnormal movement. The at least one image may comprise static images, dynamic images, full spine, portions of the spine and/or any combination thereof. In another embodiment, the acquiring at least one image using magnetic resonance imaging (MRI) technique may desirably help the surgeon to assess chronic low back pain by highlighting the disc and/or abnormal vertebral endplates. Such images may provide evidence for the pain being discogenic. It also provides information on the dimensions of the spinal canal and the appearance of the articular facets.
In another embodiment, the at least one radiograph image may comprise at least one static image. The at least one static image may comprise a posterior-anterior and a lateral image of the whole of the spine and pelvis under load and/or a portion of the spine and/or pelvis under load. The aim is to eliminate a non-discogenic etiology wholly or partly responsible for the patient's symptoms (non-degenerative lumbar causes: fractures, infection, neoplasia or extra-spinal causes) and to investigate the level concerned (disc degeneration, spondylolisthesis, joint abnormality, etc.). The at least one static images also provide useful information for preparing the surgical procedure, including the quality of the bone, the shape of the vertebral endplates, the orientation of the intervertebral spaces relative to the pubis to help anticipate surgical approach difficulties, on whether the disc is collapsed, identification of bony foraminal stenosis (which cannot be treated via the anterior route in isolation); on the state of adjacent discs and the lumbopelvic-femoral complex, and/or any combination thereof. The at least one static image comprises static positions, the static positions comprise standing, sitting, or lying down (in supine or prone position). Each of the static or dynamic positions comprises different postures, the postures include one or more of the following: flexion, extension, lateral flexion, lateral extension, neutral, rotating, bending, and/or any combination thereof.
In one embodiment, the at least one radiograph image may comprise at least one dynamic image. The at least one dynamic image comprises a lateral flexion, contralateral flexion, extension, flexion while lying down, sitting and/or standing. Using the at least one dynamic image may assist the surgeon to assess the mobility of the healthy discs and the presumed pathological disc (as decreased, normal or exaggerated mobility suggests intervertebral mechanical instability). The aim of dynamic images is to identify abnormal movement between two vertebrae. Each of the at least one dynamic image comprises dynamic positions, the dynamic positions comprise standing, sitting, or lying down (in supine or prone position). Each of the static or dynamic positions comprises different postures, the postures include one or more of the following: flexion, extension, lateral flexion, lateral extension, neutral, rotating, bending, and/or any combination thereof.
In another embodiment, the imaging techniques may comprise a targeted anatomy. The targeted anatomy comprises at least one full spine image or a portion of a spine image. The targeted anatomy may comprise a spine segment in a spine region. The targeted anatomy may further comprise a plurality of spine segments in a plurality of spine regions. The targeted anatomy may further comprise a first spine segment in a first spine region and a second spine segment in a second spine region. The at least on full spine image includes a full spine PA and/or a lateral static radiograph. The at least one full spine image helps the surgeon to assess the sagittal balance (e.g., lordosis), and/or scoliosis.
In another embodiment, the step of storing at least one image 45,65 comprises storing at least one raw or modified image. A raw image includes images that are minimally processed images that are directly acquired from the imaging technique. The raw image may be converted to a modified image by adjusting, annotating, highlighting, manipulating, and/or processing the raw image. The steps of modifying the at least one image 60 requires the surgeon to use at least one raw image for modification. The at least one raw image will be manipulated to highlight and predict the four corners of a vertebral body in one or more vertebral segments. The modified images may comprise annotations, the annotations include text or markers, that highlight the four corners of the one or more vertebral body for one or more targeted spine segments in a spine region. This results and/or creates at least one modified image.
The step of storing the at least one image 45,65 requires the surgeon to ensure that the one or more images collected using one or more imaging techniques are primarily stored into one or more storage devices and/or storage mediums. The one or more images may comprise CT scout images, raw images (e.g., unmodified images) and/or the modified images. The one or more storage devices may include internal (part of computer's hardware), external (installed outside of computer), virtual and/or portable. Virtual storage devices may include online or cloud-based storage. The portable computer external storage system or drive may comprise a flash storage, a USB storage, an external hard drive, external CD-ROM or DVD-ROM drives. Alternatively, the surgeon may require downloading the raw and/or modified images into a 2nd storage. The second storage may comprise a portable computer external storage system or drive.
In another embodiment, the preoperative method may further comprise the step of pre-registration, tracking or identification of the various surgical instruments with the selected or desired navigation and/or robotic system. The navigation and/or robotic systems should be able to identify and track multiple surgical instruments to meet the requirements of applying multiple surgical instruments during a surgical procedure. At least one or more of the surgical instrumentations may be configured and/or adapted to receive at least one navigation and/or robotic equipment. The at least one navigation and/or robotic equipment may comprise one or more light emitting diodes (LEDs), markers, reference arrays and/or fiducials. The identification and/or tracking of the surgical instruments would allow the navigation and/or robotic systems to identify one or more surgical instruments based on the marker's geometrical arrangement in space in relation to the body, the instruments' stability, the space distance and/or rotation of instruments, as well as understand the instruments coordinates in a 2D and/or 3D coordinate system.
The identification and/or tracking may comprise a plurality of methods. The plurality of methods may include: tracking or identification of one or more surgical instruments based on the unique geometries formed by markers coupled to the surgical instrument; tracking or identifying one or more surgical instruments based on a motion vector; and/or a stereo matching algorithm using two intersecting lines and surgical instrument codes. See Mengshi Zhang, et al., “Multiple Instruments Motion Trajectory Tracking in Optical Surgical Navigation,” Opt. Express 27, 15827-15845 (2019) and Cai K, et al. Tracking multiple surgical instruments in A Near-Infrared Optical System, Comput. Assist. Surg. (Abingdon) (December 2016), 21(1):46-55. In another embodiment, the identification and/or tracking of one or more surgical instruments may further comprise the use of matching or identifying unique 2D or 3D bar codes disposed on each of the surgical instruments. In another embodiment, the identification and/or tacking of one or more surgical instruments further comprise the use of stereotactic principles and an optical tracking system. The stereotactic optical tracking system includes at least three optical LEDs, a Bumblee2 binocular camera, and/or a near-infrared filter. The at least three optical LEDs are used as the markers that are installed or disposed on the surgical instrument in one or more different positions. The BUMBLEBEE2 binocular camera is used to capture the images of luminescence of the markers. To eliminate the interference of ambient light, the near-infrared filter is disposed in front of the binocular camera lens. To extract the pixel coordinate of a marker's center, the region growing (RG) method is used to eliminate the singular point and then the gray centroid (GC) method is adopted to obtain the pixel coordinate of the marker's center. This image processing method greatly enhances the antijamming capability and improves the accuracy of the system. Next, the algorithm matches the markers in the left and right camera images based on the sequence of its spatial positions. As a last step, it derives the coordinates of the surgical instrument tip by 3-D coordinates reconstruction of markers and realizes the tracking system. See Zhentian Zhou, et al., “Optical Surgical Instrument Tracking System Based on the Principle of Stereo Vision, J. of Biomedical Optics, Vol. 22, Issue 6 (Jun. 28, 2017).
In another embodiment, the preoperative method 5 comprises the step of acquiring, generating or computing one or more selected surgical measurements (SMM) from the preoperative surgery planning software application 50. The preoperative surgical planning software is a preoperative software used to pre-visualize a surgical intervention using computer generated surgical measurements and/or processed 2D or 3D images, in order to predefine the preoperative and/or operative steps and navigation in the context of computer-assisted surgery. More specifically, the software application allows precise planning of a surgical operation using a real anatomical image or real anatomical virtual model of the targeted anatomy that provides a precise spatial visualization enabling the surgeon or user to “practice,” “engage” or visualize the patient specific procedure before the actual procedure takes place. The preoperative plan can be prepared for surgeon or other medical user review, and can include the planning of various bone resections, sizes and types of implants, and various geometric requirements including relevant dimensions, such as height, width, orientation of particular features, etc. The preoperative surgical plan can further include a recommendation of particular implants and associated instrumentation and/or guides to be used in the surgical procedure.
The surgical planning software further integrates patients anatomic and medical information with interactive participation by a surgeon or user, various hospital and/or imaging center personnel, and a service provider or original equipment manufacturer to plan and manage a surgery from initial consultation with a surgeon through postoperative reporting and archiving. In one exemplary embodiment, the planning process includes a partially automated process utilizing a centralized user interface or web portal where the surgeon or other user and/or patient can interact. The web portal may comprise various levels of user (e.g., Surgeon, service provider and patient) access to various tools for case management, preoperative planning, communicating/sharing, manufacturing, surgical execution, and postoperative planning and data archiving.
The web portal can provide a single source of access and information sharing thereby reducing complexity and increasing efficiency for the surgeon or other user. As will be explained in more detail below, the web portal can facilitate a single source of access to an integrated workflow of tools and solutions guiding users through the preoperative planning, surgical execution and/or postoperative aspects of a surgery.
With reference to
The step of acquiring, generating or creating a preoperative plan using the preoperative surgery planning software 50 may further comprise the step of accessing the software application 95. The step of accessing the software application may comprise a number of steps that requires the surgeon and/or other user to access a web portal to log-in and/or create a new-user sign-up (see
The step of acquiring, generating or creating a preoperative plan using the preoperative surgery planning software 50 may further comprise the step of uploading the one or more operative images into the software from a storage device 100. As described herein, the storage devices may include internal (part of computer's hardware), external (installed outside of computer), virtual and/or portable storage. The one or more operative images may comprise raw or modified images.
The step of acquiring, generating or creating a preoperative plan using the preoperative surgery planning software 50 may further comprise the step of storing the data set and/or preoperative plan onto a storage device 130. As described herein, the storage devices may include internal (part of computer's hardware), external (installed outside of computer), virtual and/or portable storage. The one or more operative images may comprise raw or modified images.
The step of acquiring, generating, or creating a preoperative plan using the preoperative surgery planning software 50 may further comprise the step of displaying the data set onto a display and/or a graphical user interface (GUI) 135. The data set comprises computed one more SSM and/or one or more preoperative virtual models. The preoperative virtual models may comprise one or more 2D virtual models and/or one or more 3D virtual models. The one or more preoperative virtual models may further comprise defined anatomical landmarks. The anatomical landmarks may include vertebral body edges, borders, width, height, length, surface texture, surface changes, axes or axis, and/or any combination thereof. The anatomical landmarks may be disposed onto a plurality of spinal segments in a spine region. The anatomical landmarks may be disposed onto a plurality of spinal segments in a plurality of spine regions. Such anatomical landmarks assist the software to compute the one or more SSMs and the virtual models.
In the step of generating one or more preoperative virtual models of the target anatomy, the one or more operative images may be exhibited to a variety of processing techniques to analyze the content of the images for the production or computation of SMM or PSM. The image processing may involve numerous procedures including formatting and correcting of the data, digital enhancement to facilitate better visual interpretation, or even automated classification of targets and features entirely by computer to produce a set a set of results or data extracted from the one or more preoperative images. Image processing functions may include, but not limited to preprocessing, image enhancements, image transformations, image classification, and/or image analysis. The results or data may comprise 2D processed images, 3D processed images, and/or selected surgical measurements (SMM). The results or data will be used by the surgeon to facilitate operative surgical planning.
Preoperative Planning Software Application System Architecture
With reference to
The software system architecture for providing one or more methods of improving accuracy of bony preparation, implant positioning, spinal alignment and/or spinal motion. The software system architecture comprises a computer processing unit (CPU), a memory, a graphics adaptor, a network adapter, a storage device, a system bus and/or a transceiver. The transceiver includes a display and a keyboard. The transceiver may further include a pointing device or a mouse. In some embodiments, the display may include a touch screen display.
The memory holds instructions and data used by the processor. The graphics adapter displays images and/or other information on the display on the transceiver. The network adapter couples the transceiver to a network. The storage device comprises any device or system capable of holding data. The storage device may be fixed or portable. The portable storage may include a flash storage, a USB storage, an external hard drive, external CD-ROM or DVD-ROM drives, a memory stick, a secure digital storage (SD) card, and/or any combination thereof. The fixed storage may include a solid-state memory device or a hard-drive, cloud-storage, and/or any combination of.
The network enables communication between a client and a server coupled to a database and/or a client to a database. The network can include links using technologies such as Wi-Fi, Wi-Max, 2G, 3G, 4G, 5G, Universal Mobile Telecommunications System (UMTS), Ethernet, integrated services digital network (ISDN), digital subscriber line (DSL), asynchronous transfer mode (ATM), InfiniBand, PCI Express Advanced Switching, and/or any combination thereof.
The network may comprise network protocols. The network protocols may include transmission control protocol/Internet protocol (TCP/IP), a multi-protocol label switching (MPLS), a user datagram protocol (UDP), a multi-protocol label switching (MPLS), a user datagram protocol (UDP), a hypertext transport protocol (HTTP), a simple mail transfer protocol (SMTP), a file transfer protocol (FTP), a lightweight directory access protocol (LDAP), a code division multiple access (CDMA), wideband code division multiple access (WCDMA), global system for mobile communications (GSM), high-speed downlink packet access (HSDPA, and/or any combination thereof.
The data exchanged over the network may be represented using different formats. The formats including the hypertext markup language (HTML), the extensible markup language (XML). In addition, all or a portion of the data can be encrypted using conventional encryption technologies, such as secure sockets layer (SSL), secure HTTP, and/or virtual private networks (VPNs), Internet Protocol Security (IPsec), and/or any combination thereof.
In one embodiment, the client (e.g., a piece of computer hardware or software) or transceiver, executes a browser which may connect to a database within a cloud storage via network. The network may include the Internet. The network may further include at least one or more of a LAN, a MAN, a WAN, a mobile, wired or wireless network, a private network, a virtual network, and/or any combination thereof. While only a single client is shown, it is understood that very large numbers, from 0 to millions) of clients may be supported and can be in communication with the database at any time. The client may be a desktop computer or a portable computer. The portable computers may include a laptop, a notebook, a netbook, a tablet, a smartphone, and/or any combination thereof.
The surgeon and/or user should enter the designated website or mobile app for access to the preoperative planning software. In one embodiment, the software application may comprise a web-based software application or cloud-based software, which a user may access through a web browser such as Internet Explorer, Chrome, Firefox or Safari. The software application is housed in a server that displays the information through a native web environment as if the user was browsing a website. No additional software or hardware may be purchased or software downloaded to a user's computer. Alternatively, the software application may comprise a mobile software application, which is a software application designed to operate on a mobile device such as a phone, tablet or watch. Such mobile applications are native applications and may require software for different operating systems (e.g., Android, iOS, etc.).
The browser may be coupled to the database within a storage system. The database includes records. The records include user credentials for authentication. The user credentials may comprise first name, last name, email address, password, and/or any combination thereof. The user credentials may be placed into a folder. The folder may include other records, further including uploaded images, processed images, measurements, and/or any combination thereof.
In one embodiment, the transceiver and/or client is adapted to execute computer program modules for providing the functionality for the home, log-in and/or sign-up. The term “module” refers to a computer program utilized to provide a specified functionality. A module may be implemented in hardware, firmware, and/or software. In one embodiment, the program modules are stored on the storage device, loaded into the memory, and executed by the processor.
Accessing the Preoperative Planning Software Application (Home, Log-In & Sign-Up)
The step of acquiring, generating or creating a preoperative plan using the preoperative surgery planning software 50 may further comprise the step of accessing the software application 95. The step of accessing the software application 95 may comprise the steps of creating a new user profile using a new-user sign-up graphic user interface; and/or accessing current user profile using a current user log-in graphic user interface. The step of accessing the software application 95 may further include the step of accessing or entering the web page, web portal or website 150. The step of accessing the software application may further include the step of uploading one or more operative images from a storage device 100.
With reference to
With reference to
If the log-in credentials are not validated or authenticated, the home page 250 may display an “error” pop-up message 215 to tell the user that the log-in credentials 195 provided are invalid as shown in
With reference to
Similarly, users and/or surgeons can also select the patient specific digitized, modified images, the modified images. The modified images comprise one or more operative images that are modified by a surgeon with desired anatomical landmarks. The desired anatomical landmarks may include highlighting perimeter or borders of one or more spinal segments with markers or indicia to indicate his initial guess of vertebrae(s) of interest. The one or more operative images may further comprise static or dynamic images. The one or more operative images may comprise a portion of a patient's spine in a spine region. The spine region comprises a cervical region, a thoracic region, a lumbar region, a sacral region, and/or any combination thereof. The user and/or surgeon may press or click the second “Choose File” button 328 under the file typically stored under a “CSV” format 325 and/or any other desired format (please see
With reference to
With reference to
In one embodiment, the software application comprises a base HTML module or a base module 335 as shown in
In another embodiment, the software application comprises a home HTML module or a home module 340 as shown in
In another embodiment, the software application comprises a log-in HTML module or a log-in module 345 as shown in
In another embodiment, the software application comprises a sign-up HTML module or a sign-up module 350 as shown in
In another embodiment, the software application comprises a main.py and/or a main app module 355 as shown in
In another embodiment, the software application comprises a views.py and/or a views module 360 as shown in
In another embodiment, the software application comprises an init_.py and/or an initializer module 365 as shown in
In another embodiment, the software application comprises an auth.py and/or an authentication module 370 as shown in
Sign-up is the last function that is created in the authentication module 370. This function will be called when a new user is detected. First, the user will need to press the button ‘Sign up’ in login.html or log-in module 345 and/or signup.html or sign-up module 350 (
In another embodiment, the software application comprises a models module 375 as shown in
In another embodiment, the software application comprises a user.py and/or createuserfolder module 380 as shown in
In another embodiment, the software application comprises a store module 415, 420 as shown in
Preoperative Planning Software Application Image Processing
Once the users and/or surgeons have successfully uploaded one or more operative images to the software application, the MATLAB engine is initiated to proceed to the step of generating one or more virtual models of the target anatomy 110; and/or the calculating one or more SSM from the one or more virtual models of the target anatomy to create a data set 115 are engaged (see
With reference to
With reference to
The feasibility module 425 runs the MATLAB file that takes two inputs as an argument (at least one operative image, the at least one operative image may comprise a raw or modified image) and returns a variable P. In one embodiment, the feasibility module 425 will read and manipulate the one or more operative images and converts them into a CSV file to an array, and draws points from the dat_name to the img_name to confirm that the one or more images comprises the target anatomy. If the target anatomy is improper or invalid, a pop-up message 305 will be displayed (see
With reference to
With reference to
In another embodiment, the scaling module or scaling function may comprise the manipulation of at least one or more images using CT-scout as shown in
Scaling CT-scout images 445, 450, 475, 480 may be used as a base for scaling all subsequent one or more operative images in static or dynamic positions; allowing markers or indicia 470 that highlight anatomical landmarks 455, including vertebra corner points 460 that enable the mapping of the patient's targeted anatomy or a portion of a patient's spine; performing rigid body transformations using the markers or indicia highlighting anatomical landmarks; extrapolating and “fill-in” missing information of the targeted anatomy; and/or conducting post-operative analysis by matching post-operative images with the one or more preoperative images, including position of implant 465; and/or generate a report comparing the post-operative images from the analysis. The 2D virtual models 435 and/or 3D virtual models 440 may further comprise defined anatomical landmarks, indicia or markers, and/or annotations. The annotations may comprise numerical, alphabetical, and/or alphanumerical. The anatomical landmarks may include vertebral body or bony edges, borders, width, height, length, surface texture, surface changes, axes or axis, and/or any combination thereof. The anatomical landmarks may be disposed onto a plurality of spinal segments in a spine region. The anatomical landmarks may be disposed onto a plurality of spinal segments in a plurality of spine regions. Such anatomical landmarks assist the software to compute the one or more SSMs and the virtual models.
The indicia or markers 470 may comprise scout or reference lines, arrows, points, etc. The reference lines may be used to indicate the position of each cross-sectional image and the true size of the targeted anatomy. The markers or indicia 470 may be “burned into” the image by replacing actual image pixels, stored as a separate overlay, or, ideally, generated dynamically by a computer and/or a computer workstation software. In the last case, clinicians may be able to display specific cross-sectional images by clicking the appropriate scout or reference line in the localizer image. To dynamically generate scout lines, the workstation software must use orientation and slice location information in each cross-sectional image, as well as reference information in the localizer. The markers or indicia 470 may be added by a surgeon and/or user to create one or more modified operative images. The markers or indicia 470 may be added by the software application and/or the scaling module or function.
The scaling module or function may recognize the markers or indicia 470 as movingpoints, fixedpoints, and/or control points. The scale module or function will call upon tform, which tform will take the pairs of control points, movingpoints, and fixedpoints and uses them to infer the geometric transformation specified by the transformation type. Such function is expressed by tform=fitgeotrans*(movingpoints, fixedpoints, transformationtype). Subsequently, a forward geometric transformation will be applied to the entire targeted anatomy. Such function is expressed by [x,y]=transformpointsforward*(tform, u, v). True sizes, including width, depth, height, length, may be approximated. True sizes may also be displayed onto the scaled images, including numerical annotations.
In another embodiment, the software application and/or the image processing module may further comprise a transformation module or transformation function. A transformation is a geometric transformation of a Euclidean space that preserves the Euclidean distance between every pair of points. Any object will keep the same shape and size after a proper rigid transformation. The transformation function may comprise 2D or 3D transformations. The transformations may further comprise a rigid body transformation (e.g., preserves distance and angles), a conformal transformation (e.g., preserves angles), an affine transformation (e.g., preserves parallelism), rotation and/or scaling. In one exemplary embodiment, the transformation module or function comprises a rigid body transformation to preserve shape and size of an object. The properties preserved under a rigid-body transformation includes distance (lengths of segments remain the same), angle measures (angles remain the same), parallelism (parallel lines remain parallel), collinearity (points remain on the same lines), and/or orientation (order remains the same).
In another embodiment, the software application and/or the image processing module may further comprise an extrapolate module and/or function. The image extrapolation module or function aims to fill the surrounding region of a sub-image, e.g., completing the object appearing in the image or predicting the unseen view from the scene picture. The extrapolated missing information is used to enable mapping of the pre-operative vertebra models into subsequent post-operative spatial positions. Such a function may further improve one or more images brightness, contrast, sharpness, color, saturation, and/or any combination thereof for easier computing and evaluation.
In another embodiment, the software application and/or image processing module may further comprise an image reconstruction module and/or function. Image reconstruction is a mathematical process of forming a virtual model using the acquired raw data. A combination of multiple data sets captured at different angles or different time steps may be used. This procedure is repeated using multiple iteration steps that maps the estimated and true values or sizes, resulting in a convergence of the reconstruction process to the final image or virtual model. There is a large variety of iterative methods including maximum likelihood expectation maximization (MLEM), maximum a posteriori (MAP), algebraic reconstruction (ARC) technique, and/or any other standard methods known in the art.
In another embodiment, the software application and/or the image processing module may further comprise an enhancement module and/or function. The image enhancement module may conduct high-level image processing or low-level image enhancement of an image to improve interpretability of the contained information. Utilization of all these techniques allow for noise and inhomogeneity reduction, contrast optimization, enhancement of edges, elimination of artifacts, and improvement of other relevant properties that are crucial for the subsequent image analysis and its accurate interpretation.
In another embodiment, the software application and/or the processing module may further comprise a visualization and/or feature extraction module or function. The visualization and/or feature extraction module or function renders the image data to visually represent anatomical and physiological imaging information in a specific form over defined dimensions, resulting in optimized output or optimized images. Through direct interaction with data, the visualization can be performed both at the initial and intermediate phases of imaging analysis—for instance, to assist segmentation and registration processes, and at the final stage to display quantitative or imaging results. Other processes or functions may be available, including illumination, surface reconstruction, shading, and/or display of quantitative and/or imaging results.
In another embodiment, the software application and/or the image processing module may further comprise a beam hardening correction module and/or function as shown in
In another embodiment, the software application and/or the image processing module may further comprise an image analysis module or function. The image analysis module may interact with one or more of the modules disclosed herein. The image analysis module may be used for quantitative measurements, and interpretations of medical images. The process of quantification interprets, identifies and determines properties of various structures such as volume, diameter, composition, and other relevant anatomical or physiological information. The process or function of image measurement may facilitate the ability to display results of quantitative measurements, including surgical measurements.
Preoperative Planning Software Application Computation of Data Set Results
With reference to
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With reference to
Neutral alignment 680 is defined as the reference line 665 of the lower endplate of the upper vertebra and the reference line 670 of upper endplate of the lower vertebra resulting in a portion of the endplate reference lines 665 are parallel. Alternatively, neutral alignment 680 is defined as the reference line 665 of the lower endplate of the upper vertebra and the reference line 670 of upper endplate of the lower vertebra resulting in the entirety of the endplate reference lines 665 are parallel. The final calculation of the osteotomy sagittal angle or degree of osteotomy within the sagittal plane 685, α, is disposed onto a third virtual model 660. Furthermore, the degree of osteotomy within the coronal plane or the osteotomy coronal angle may also be calculated. The first, second, and/or third virtual model may be displayed and/or stored within the database.
With reference to
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Implant positioning may help determine implant sizing. Accordingly, a fourth virtual model 775 with one or more implants 745 may be rotated in different planes—isometric, sagittal, coronal, A/P and/or any combination thereof—to confirm implant sizing and implant position. The first 725, second 740, third 750 and/or fourth virtual model 770 may comprise the same models and/or different models. The first 725, second 740, third 750 and/or fourth virtual model 770 may comprise a 2D or 3D model. Implant positioning may further comprise (4) sagittal osteotomy angle (see
With reference to
Once the software application computes and/or manipulates the one or more images to output processed virtual models and selected surgical measurements (SSM), the software may create one or more data set files that require storage. The one or more data set files may comprise one or more virtual models (e.g., processed images) and/or quantitative data. The one or more data set files may comprise an image management module and/or a data set results module. In one embodiment, the software application may generate a CSV file after the one or more operative images are image processed via the image processing module (e.g. virtual models). The one or more virtual models may comprise annotated SSMs. The one or more virtual models may comprise 2D or 3D models.
In another embodiment, the software application may further comprise an image management module. The image management module comprises steps to manage the acquired information and encompasses various techniques for annotations, compression, storage, retrieval, and communication of image data as shown in
In another embodiment, the software application may further comprise a data results module. The data management module comprises steps to manage the acquired quantitative data and encompasses various techniques for annotations, compression, storage, retrieval, and communication of quantitative data as shown in
Intraoperative Method
The total joint replacement method to restore alignment and motion may further comprise the execution of a traditional operative protocol or intraoperative method. The traditional method may be performed manually by a surgeon. However, manual surgery may provide some disadvantages which may affect the accuracy of different steps or methods during the operative surgery. Alternatively, the surgeon may desirably select navigation assisted spine surgery and/or robotic assisted spine surgery to improve the accuracy of various operative steps by providing a greater degree of control with orientation assistance in different anatomical situations to provide highly precise positioning or trajectory data, allows precise implant positioning in a more accurate and reproducible position(s), greater visualization, and/or improve patient outcomes (e.g., shorter hospitalizations, reduced pain and discomfort, faster recovery time, reduced blood loss and transfusions, minimal scarring, etc.). Navigation assisted and/or robotic assisted spine surgery may improve the accuracy of different operative steps, including surgical access, optimal or enhanced selection of spinal implant, precise bony preparation and/or precise implant positioning as shown in
With reference to
In one embodiment, the bony preparation may include one or more coronal osteotomy angles 840, 845. The one or more coronal osteotomy angles 840, 845 is defined as the one or more implants 820,835 that are non-planar with respect to a prepared endplate surface 830 of a vertebral body and/or an endplate surface of a vertebral body. The endplate surface 830 may be generally planar or planar. Also, the coronal osteotomy angles 840, 845 is defined as the one or more implants 820,835 are non-planar with respect to a prepared endplate surface 830 of a vertebral body.
Alternatively, the bony preparation may include a vertebral body 850 with an endplate surface 830 and a vertical axis 825. The vertebral body 850 may comprise a first implant 835 with a first coronal osteotomy angle 840 and a second implant 820 with a second coronal osteotomy angle 845. The first coronal angle 840 may comprise a different angle than the second coronal osteotomy angle 845. The first coronal osteotomy angle 840 may comprise a same angle than the second coronal osteotomy angle 845. The one or more coronal osteotomy angles 840, 845, the first coronal osteotomy angle 840, and/or the second coronal osteotomy angle 845 may comprise a positive, negative or neutral angle.
With reference to
In one embodiment, implant positioning may include one or more anterior-posterior (A/P) distances 860,865 and/or one or more center of rotations (CORs) 870,875. The one or more A/P distances 860, 865 is defined as at least one implant 820 that is placed forward at a distance from the contralateral implant 835. The one or more A/P distances 860, 865 may also be defined as the one or more distances from the proposed anterior surfaces 855,860 of each of the one or more implants 820,835. The one or more center of rotations (CORs) 870,875 is defined as approximately 35-45% anterior from the posterior, caudal endplate of a cranial vertebral body or a vertebral body and/or an average of 40% from the posterior, caudal endplate of a vertebral body. The placement of the COR 870,875 of one or more implants 820,835 may affect the A/P distances 860,865 of the one or more implants 820,835. For example, if the surgeon desires to position the one or more implants 820,835 with respect to COR 870, 875 of the one or more implants 820,835, the A/P distances 860,865 may vary. However, if the surgeon desires to position the one or more implants 820,835 with respect to A/P distances 860,865 (e.g., having equal A/P distances between one or more implants 820, 835), such placement may affect the COR 870,875 of the one or more implants 820,835.
The desired implant positioning may include a vertebral body 850 with an endplate surface 830, anterior vertebral body surfaces 855,860 and/or a A/P axis 880. The vertebral body 850 may comprise a first implant 835 with a first COR 875 and a first A/P distance 865 and a second implant 820 with a second COR 870 and a second A/P distance 860. The first COR 875 may comprise a same COR compared to the second COR 870. The first COR 875 may comprise a different COR compared to the second COR 870. The first A/P distance 865 may comprise a same distance compared to the second A/P distance 860. The first A/P distance 865 may comprise a different distance compared to the second A/P distance 860.
In another embodiment, implant positioning may include one or more convergence angles or transverse pedicle angles 890, 895, 900. The one or more convergence angles and/or transverse pedicle angles 890, 895, 900 may be defined as the total angle 900 between the one or more implants 820,835, which the one or more implants 820, 835 follows the mid axis of the pedicles 905, 910 and/or the total angle 900 between the mid axis of the pedicles 905,910. Alternatively, the one or more convergence angles and/or transverse pedicle angles 890, 895, 900 may be defined as an angle 890, 895 between the A/P axis 880 and the mid axis of the pedicles 905, 910 and/or an angle 890, 895 between the A/P axis 880 and the mid axis of the one or more implants 820,835 that follows or substantially follows the mid axis of the pedicles 905, 910.
The desired implant positioning comprising convergence angles 890, 895, 900 may include a vertebral body 850 with an endplate surface 830, mid axis of the pedicles 905,910 and/or a A/P axis 880. The vertebral body 850 may comprise a first implant 820 with a first convergence angle 890, a first mid-axis of a pedicle 905 and a total convergence angle 900 and/or a second implant 835 with a second convergence angle 895, a second mid-axis of a pedicle 910 and the total convergence angle 900. The first convergence angle 890 may follow, match or substantially match the first mid-axis of the pedicle 905. The second convergence angle 895 may follow, match or substantially match the second mid-axis of the pedicle 910. The first convergence angle 890 may comprise a different angle compared to the second convergence angle 895. The first convergence angle 890 may comprise a same angle compared to the second convergence angle 895.
The substantially match the first and/or second mid-axis of the pedicles 905, 910 may include an angle range 915 that is acceptable for implant positioning. The substantially match may include a 10-15% deviation from the mid-axis of the pedicles 905, 910. The convergence angles 890, 895 may further include a secondary set of angles 920 that may be acceptable for implant positioning, but may affect the overall operation and success of the restoration of motion. The convergence angles 890,895 may further include a tertiary set of angles 925 that may not likely be acceptable for implant positioning.
In another embodiment, implant positioning may include neutral alignment. Neutral alignment is defined as the lower endplate surface 945 of the upper vertebral body 935 is parallel or substantially parallel 955 to the upper endplate surface 950 of the lower vertebral body 940. Neutral alignment may also be defined as the superior element 960 of one or more implants 820, 835 is parallel or substantially parallel 955 to the inferior element 965 of the one or more implants 820, 835. Neutral alignment or neutral sagittal alignment is important for correcting spinal alignment and motion restoration via maximizing one or more implants 820, 835 range of motion. As previously discussed above, a sagittal osteotomy angles may be used to create parallel or substantially parallel 955 endplates 945, 950 for a neutral insertion of the one or more implants 820, 835. Such neutral alignment is necessary to prevent an anterior biased tilt or trajectory of the one or more implants 820, 835 as shown in
The desired implant positioning comprising neutral alignment may include a vertebral body 850 with a first endplate surface 945 of an upper vertebral body 935, a second plate surface 950 of a lower vertebral body 940, and/or one or more implants 820, 835. The one or more implants are positioned between the first endplate surface 945 and the second endplate surface 950. The first endplate surface 945 and/or the superior element 960 of the one or more implants 820, 835 is parallel or substantially parallel 955 to the second endplate surface 945 and/or the inferior element 965.
With reference to
The imaging unit 980 may to a separate imaging machine workstation 980 and/or it may communicate directly with navigational workstation 985. The navigational workstation 985 and/or the imaging unit workstation 980 includes image acquisition processing software (e.g., navigation software), a memory, a processing unit (e.g., computer), a display, and/or a transceiver to engage with the bilateral transfer of data. The imaging unit 980 is used to acquire high-resolution images of a region of interest and/or one or more targeted spinal segment(s). The images are obtained preoperatively, intraoperatively, and/or post-operatively, which the allows the surgeon to manually navigate upon these processed images to improve accuracy of access, bony preparation and implant positioning. The imaging unit 980 may comprise fluoroscopy, computerized tomography (CT), magnetic resonance imaging (MRI) and/or ultrasound machines.
Any type of navigational system may be used. The navigational system may comprise an Airo Mobile Intraoperative CT-based Spinal Navigation system (Brainlab, Munich, Germany). The Airo Mobile uses a mobile circular scanner attached to the operating table that allows for full 360 degree imaging and a scanning stereotactic camera for instrument registration. The navigational system may further comprise a Stealth Station Spine Surgery Imaging and Surgical Navigation with O-arm system (Medtronic, Minneapolis, MN). The Stealth Station Imaging and Surgical Navigation uses similar technology to the Airo, but opens at 90 degrees to allow for mobilization around the patient. The navigational system may further comprise a Ziehm Vision FD Vario 3D with NaviPort Integratiosystem (Ziehm Imaging, Orlando, FL). The Ziehm Vision FD obtains images via a 190-degree rotation with a C-arm around the patient. The navigational system may further comprise a Stryker Spinal Navigation with SpineMask Tracker and SpineMap Software system (Stryker, Kalamazoo, MI). The Stryker Navigation system uses a rectangle of trackers applied directly on the patient with an adhesive glue for referencing. The navigational system may further comprise a 7D Surgical Spine Navigation system (7D Surgical, Toronto, Ontario, Canada). The 7D Surgical Navigation System allows for radiation-free intraoperative navigation with Flash imaging, which uses high-intensity light and an overhead camera to image the surgical field and align with preoperative CT.
The referencing system 990 comprises a dynamic reference frame/array (DRA), light emitting diodes, and a tracking system. The dynamic reference array (DRA) is usually attached to fixed anatomical landmarks, such as the spinous process. One or more preoperative images may be acquired along with the fixed DRA to synchronize between the virtual navigated images and anatomical landmarks. The accuracy of the navigation depends on the stable fixation of this DRA, and, therefore, it must be left undisturbed throughout the surgery. When there is no adequate fixation point within the surgical field as in revision surgery, hypoplastic or immature bone, the iliac crest can be used by inserting a pin into it. In cervical spine surgery, where the distance from the iliac crest is more, the reference array could be fixed to the Mayfield frame.
The DRA further comprises features and/or provisions for attaching three or more spheres known as light-emitting diodes (LED). These LEDs emit light, which is tracked by an electro-optical camera and are known as active arrays. Specialized surgical instruments are used, which also have LEDs attached to them and are called passive arrays as they reflect the infrared rays emitted from the camera and gives the surgeon a real-time tracking of the exact location of these instruments over the surgical field. The 3D orientation between these active and passive LEDs, thus facilitates navigation.
Also, there are a variety of tracking systems to visualize the instrumentation. Various tracking systems are available that include optical, mechanical, acoustic or electromagnetic systems. Optical tracking systems are the most frequently used due to superiority in terms of accuracy. They use infrared camera devices to actively track the light emitted or reflected from the LEDs, which are attached to the dynamic reference frame/array DRA and surgical instruments. One such tracker includes the NavLock Tracker (Medtronic, Inc., Minneapolis, MN) that is a compatible accessory to the StealthStation System. The NavLock Tracker is available in four (4) different geometries. The trackers calculate the location and provide real-time three-dimensional (3D) positional data of the handheld surgical instruments in relation to the surgical field. This requires the “line of sight” maintenance between the LEDs and cameras at all times. Hand movements or excess operating personnel across this line of sight might hinder the navigation process. Electromagnetic systems allow an unobstructed view between transmitter and receiver. However, significant interference of the images can occur due to metal artifacts and electromagnetic fields originating from other commonly used operating room devices such as cautery and electrocardiogram monitoring equipment.
The navigation assisted spinal methods may require one or more manual operation and/or steps from the surgeon. The surgeon will continue to coordinate any methods, including access, approach, bony preparation and/or implant positioning by coordinating his own operations with the pre-processed, high-resolution images on the navigation system screen. The overall benefits include accurate access, surgical approach, bony preparation, implant positioning, minimal radiation exposure to the surgical team, and/or reduction of surgeon fatigue and surgical duration.
Alternatively, the surgeon may desirably decide to use robotic assisted spine surgery to improve the accuracy of surgical access, selection of spinal implant, bony preparation and/or implant positioning. Robotic assisted spine surgery can be used to further accurately restore spinal alignment and range of motion. Robotic assisted spine surgery requires the use of a navigational system as described herein. The robotic system mainly uses preoperative and intraoperative images for surgical planning, proving accurate positioning of surgical tools or implants through robotic arm movement and rigid guidance, assisting the surgeon to complete surgical operations. The robotic intraoperative surgical processes may comprise a plurality of broad steps, including: (1) surgical planning, with the surgeon carrying out the surgical planning and selecting the suitable implants based on the patient images using the navigational software; (2) spatial registration, obtaining the spatial coordinates of the surgical trajectories via software algorithms and tools; (3) trajectory positioning, with the robotic arm providing autonomous movement by holding the surgical instruments to the desired position according to the spatial coordinates of the planned surgical trajectory; and/or (4) assisted surgery, with the surgeon performing the surgical operation under the guidance of the robotic arm.
With reference to
The robots or robotic arms 1015 comprise different functions, the functions include supervisory-controlled robot, telesurgical robot, and/or shared control robot. Supervisory controlled robots allow the surgeon to plan the operation in its entirety pre-operatively; the robot then performs the operation under close supervision by the surgeon. Telesurgical robots allow the surgeon to directly control the robot and its instruments throughout the entire procedure from a remote location. Finally, most spinal surgery robots are shared-control robots that simultaneously allow both the surgeon and robot the ability to control instruments and motions.
Any type of robotic system may be used. The robotic systems may comprise a Mazor SpineAssist, Mazor Renaissance, and/or Mazor X (Medtronic, Inc., Minneapolis, MN). The Mazor SpineAssist is a shared-control robot that offers navigation superior to traditional intraoperative navigational systems. The Mazor Renaissance contains upgraded software and hardware improvements from the SpineAssist. The Mazor X includes a linear optic camera that allows the robot to perform a volumetric assessment of the work environment to self-detect its location and provide collision avoidance intraoperatively. The robotic systems may further comprise a ROSA Spine (Zimmer Biomet Robotics, Montpellier, France). The ROSA is a free-standing robotic arm and navigation arm. The robotic systems may further comprise a Da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA). The Da Vinci uses a telesurgical function and operates from a remote telesurgical booth equipped with 3D vision screens, allowing the robot to be an extension of the surgeon's arm. The robotic systems may further comprise an Excelsius GPS (Globus Medical, Inc., Audubon, PA). The Excelsius features real-time imaging, automatic compensation for patient movement, and constant feedback. The robotic system may further comprise a Pulse System (NuVasive, Inc., San Diego, CA). The Pulse System an open imaging platform integrated with Siemens' 3D mobile C-arm, Cios Spine; Cirq Spine System and Loop Imaging Robot (BrainLab AG, Munich, Germany). The robotic system may further comprise a Cuvis Spine System (Curexo, South Korea) and/or a Fusion Robotic System (Integrity Implants, Inc., d/b/a Accelus, Palm Beach Gardens, FL). Both the Cuvis and the Fusion are 3D imaging navigation and robotic targeting systems for spine surgery.
With reference to
With reference to
Alternatively, the surgeon may desirably decide to use navigation assisted and/or robotic assisted 1115 spine surgery to improve the accuracy of one or more operative steps 1110, 1120 as shown in as shown in
More specifically, navigation and/or robotic assisted 1115 surgery may be inserted within and/or into one or more operative steps 1125, 1200, 1205, 1210. The navigation and/or robotic assisted surgery 1115 may include additional procedures or methods than the standard or traditional operative steps 1020, 1065 to facilitate the identification of equipment within desired spatial coordinates, to confirm spatial coordinates and desired trajectory within one or more targeted vertebral segments; positioning the user to desired trajectory; and correcting the deviated trajectory back to the desired trajectory.
With reference to
The one or more navigational and/or robotic assisted operative steps 1125 comprises the steps of: transfer a preoperative plan to a workstation 1130, the preoperative plan comprises selected surgical measurements (SSM) and/or processed images obtained from the preoperative surgical planning software; selecting a surgical approach 1135; positioning the patient properly 1140; preparing the equipment for navigation and/or robotic assisted spine surgery 1145; identifying or registering a surgical instrument for at least one surgical measurement 1150; synchronizing at least one preoperative image with the at least one reconstructed operative image to confirm the at least one surgical measurement from the preoperative plan 1155; accessing at least one localized spine segment in spine region 1160; selecting proper implant size 1165; preparing intervertebral space within a localized spine segment 1170; implanting or deploying a spinal implant on at least one side; implementing navigational and/or robotic assistance 1115 in one or more of the above steps 1115.
The navigation and/or robotic assistance 1115 in one or more of the above one or more steps 1115 includes the steps of: positioning user to desired trajectory and/or object, the desired trajectory and/or object matching or substantially matching one or more SSM 1185; providing feedback to the surgeon to confirm matching or substantially matching the at least one surgical measurement from the preoperative plan and/or correcting deviated trajectory of the user to return to the desired trajectory 1190. The step of providing feedback may comprise visual feedback (using the navigation monitor), an audible feedback, a tactile feedback, and/or any combination thereof. The steps of selecting a surgical approach; positioning the patient properly; preparing the equipment for navigation; acquiring one or more operative images to create a reconstructed image of a localized spinal segment in a spinal region; and/or accessing at least one localized spine segment in spine region comprises completing the technique manually. Alternatively, the completion further comprises navigation assisted or robotic assisted.
In one embodiment, the navigational and/or robotic assisted intraoperative method may comprise the step of transferring data set and/or preoperative plan into an operative workstation 1130. The data set may include computed selected surgical measurements, 2D processed images and/or 3D processed images (see
In one embodiment, the navigational and/or robotic assisted intraoperative method may comprise the step of selecting a surgical approach 1135.
In another embodiment, the robotic assisted and/or navigation assisted intraoperative method may comprise the step of positioning the patient properly on a surgical table 1140. The step of positioning the patient properly 1140 comprises the steps of: positioning the patient onto the surgical table; and confirming alignment by acquiring one or more intraoperative images using at least one imaging technique. Patient positioning is important to ensure proper sagittal alignment, mobility and implantation of the spinal implant. The patient is initially positioned in a prone position in a neutral alignment with legs extended on an Andrews or Jackson table with bolsters. The patients' prone position on the table should match or substantially match the patient's standing sagittal position. The abdomen should remain free with no pressure on the bladder and with hip pads under the anterior superior iliac spine. This position allows the patient's spine and anatomy to move to a neutral alignment after paralytics and/or posterior bony elements are removed during the decompression step.
With reference to
The step of installing navigation and/or robotic equipment onto relevant parties and/or structures 1250 ensures that all the navigation and/or robotic systems' architecture is available. The navigation system comprises a workstation and a referencing system. The workstation includes an image acquisition/processing software and a computer (e.g., a processing unit and memory). A robotic system comprises robotic arm, a navigation system and a referencing system. The referencing system may include a DRA, LEDs and/or a tracking system or equipment. A portion of the tracking system will be attached or coupled to a portion of a patient's anatomy, table and/or the robot. A portion of the DRA may be disposed and/or coupled onto the portion of the tracking system. Such rigid coupling maintains the relationship between the patient and the DRA during the registration process and/or intraoperative surgical procedure. Furthermore, a probe or a guide may be coupled to the robot or robotic arm. The probe or a guide is a surgical tool that facilitates positioning the trajectory for the surgeon and/or robot.
The step of positioning navigation and/or robotic equipment into desired operation area 1255 may include covering the robot probe, and/or guide with sterile covers. The registrations markers should be further installed and positioned into the operation area, so the registration markers are within the fluoroscopic or image field. Any other set-up for the referencing system or robotic equipment may also be performed to standards known in the art.
The step completing navigation system registration 1260 is a process in which surgeons tell the computer where the bone, targeted anatomy, instruments and/or patient is in the space by identifying the anatomical landmarks for the computer to create proper spatial coordinates. Therefore, workstation computes a relationship between the one or more images (Xray, CT, MRI or patient's 3D bone model) with the patient's anatomy at the operative site. The step of completing navigation system registration 1260 comprises the steps of: registering of one or more navigation tools to navigation system; and/or registering of a patient's targeted anatomy to navigation system. The step of completing navigation system registration 1260 further comprises the steps of: identifying or registering one or more surgical instruments to navigation system 1150; and/or acquiring one or more images using an imaging technique to finalize registration process.
The step of registering of one or more navigation tools, robotic tools and/or robotic units to navigation system may utilize steps or methods known in the art. In one embodiment, a robotic unit has been formally positioned, the robot may proceed with automatic registration and tracking of the robot arm and/or unit. The position information obtained by the -navigation system can be directly mapped to the robotic arm, which provides great convenience for automatic registration and tracking of the robot arm.
The step of registering of a patient's targeted anatomy to a navigation system may include one or more different available anatomical registration techniques. The anatomical registration techniques include tracker pins or fiducials technique, skin surface technique, imaging technique and/or bony landmarks technique. The tracker pin or fiducial technique completes registration by placement of tracker pins or fiducial markers at the target bones during 2D/3D image acquisition. At least four fiducials are required. Registration is completed after images are acquired or the fiducial markers are identified at the surgery.
The second technique, the skin surface-matching technique, is completed by moving a registration tool, e.g., a laser pointer, probe and/or guide, over the surface of the skin. The registration tool collects a plurality of data points for registration. The third method, the imaging technique uses 2D-3D imaging registration. One or more images are obtained intraoperatively are matched automatically with preoperative CT images after manual image adjustment. The fourth technique, the bony landmarks technique, uses bone surfaces for registration. The registration tool should move between defined landmarks on the skull surface. These landmarks must be defined on the virtual patient during the presurgical planning process. These fiducials may include anatomic landmarks (i.e., suture lines or bone prominences or concavities, teeth etc.). If necessary, the registration tool is passed through the skin so it may be placed directly onto the bone surface.
The step of acquiring one or more images using an imaging technique to finalize registration process requires the collection or acquisition of one or more images to confirm proper spatial coordinates of patient's targeted anatomy. One or more images are acquired and transferred to the navigation computer or workstation. The navigation computer or workstation may reconstruct or transform acquired one or more images into sagittal, coronal and/or axial views. The navigation or workstation identifies the DRAs and/or the reference system to facilitate the registration process. The navigation computer and/or workstation correlates the one or more transformed or reconstructed images to the patient's anatomy. Then, the navigation computer and/or workstation synchronizes the one or more intraoperative images with the one or more preoperative images. Accurate registration is confirmed by the surgeon after verifying that the registration tool end correlates to a similar location on the navigation computer and/or workstation. A mismatch should prompt repetition of the step of navigation system registration 1260 process.
With reference to
The step of registering one or more surgical instruments to the navigation system 1265 comprises coupling at least one DRA onto one or more surgical instruments. The one or more surgical instruments were pre-registered, templated and/or pre-identified within the navigation system during the preoperative procedure. Alternatively, the one or more surgical instruments can be registered, templated and/or identified during the operative procedure. The one or more surgical instruments are designed and configured to receive at least one DRA, marker and/or fiducial as shown in
Accordingly, the step of positioning the one or more users and/or surgical instruments to the desired or first trajectory for the at least one intraoperative step 1270. The at least one operative step may comprise a plurality of intraoperative or operative steps. The at least one operative step may comprise the entire or all the intraoperative steps. Once all tools, surgical instruments and patient are registered, the navigation system may transmit spatial coordinates of the one or more surgical instruments relative to the patient's targeted anatomy for positioning of a first trajectory or a desired trajectory. One or more objects matching or substantially matching the first or desired trajectory may be projected onto the display. Such trajectory positioning may allow the navigation system and/or robotic system by holding one or more surgical instruments and/or a registration tool (i.e., a probe, a guide and/or any other tool) to the desired position according to the spatial coordinates of the surgical trajectory for the desired intraoperative step. The trajectory may match or substantially match one or more projected surgical measurements (PSM) and/or selected surgical measurements (SSM). The trajectory may be displayed and/or superimposed onto the workstation as one or more virtual objects. The one or more virtual objects may comprise quantitative measurements (e.g., SSMs), a virtual trajectory path, a virtual implant, and/or any combination thereof as shown in
With reference to
The step of acquiring one or more intraoperative images in a plurality of planes using an imaging technique 1280 are obtained in one or more anatomical planes of the targeted anatomy of a patient. The imaging techniques include an MRI, a radiograph, a CT scan, an ultrasound, and/or any combination thereof. The acquisition of the one or more intraoperative images may be acquired using a specialized grid, which allows for easier synchronization of the one or more preoperative images with the one or more multiplanar reconstructed (MPR) images. The one or more intraoperative images in the one or more anatomical planes are used to create one or more MPR images 1285. The one or more MPR images may include 2D and/or 3D reconstructed intraoperative images of a patient's targeted anatomy.
The step of synchronizing one or more preoperative images with the one or more operative MPR images 1290 comprises the steps of: superimposing the one or more preoperative images onto the one or more operative MPR images. The step of synchronizing one or more preoperative images with the one or more operative MPR images 1290 may further comprise the step of: superimposing one or more selected surgical measurements (SSM) or projected surgical measurement (PSM) and/or one or more objects onto the one or more preoperative images, one or more operative images, one or more MPR images and/or one or more synchronized images.
The step of superimposing the one or more preoperative images onto the one or more operative MPR images comprises the step of acquiring the one or more preoperative images from the preoperative surgical plan as described herein. The one or more preoperative images may include original or raw one or more preoperative images, the one or more modified preoperative images and/or the one or more processed preoperative images or processed virtual models. The one or more processed preoperative images or processed virtual models are images of a targeted anatomy that are enhanced using the preoperative surgical planning software. The one or more processed preoperative images or processed preoperative virtual models are uploaded, transmitted and/or displayed to a workstation to be superimposed onto one or more operative images. The one or more operative images comprise one or more MPR images. The workstation should synchronize the one or more processed preoperative images or processed preoperative virtual models with the one or more operative MPR images to create one or more synchronized images. The synchronization process confirms that the anatomic landmarks of the targeted anatomy of the preoperative and/or operative images correlates to the one or more operative MPR images to ensure of the desired targeted anatomy is reached. The navigation workstation confirms these anatomical landmarks by matching multiple reference points on each vertebral body.
With reference to
In one embodiment, a first one or more objects are superimposed onto one or more operative images and/or MPR images and a second one or more objects are superimposed onto one or more operative images and/or MPR images. The first one or more objects may comprise a desired or first trajectory path 1310 to a targeted anatomical location. The second one or more objects may comprise a non-desired, deviated or second trajectory path 1330 to the targeted anatomical location. The second trajectory path 1330 is different than the first trajectory path 1310. The workstation provides feedback to correct the user (e.g., robot or surgeon) from the second trajectory path back to or return to the first trajectory path 1310.
In another embodiment, a first one or more objects are superimposed onto one or more operative images and/or MPR images and a second one or more objects are superimposed onto one or more operative images and/or MPR images. The first one or more objects may comprise a desired or first one or more spinal implants 1335 at a targeted anatomical location. The one or more implants 1335 provide visual support of the trajectory path. The second one or more objects may comprise a virtual tool 1320 that is deviating from the targeted anatomical location and/or does not follow or substantially follow the trajectory path of the one or more implants 1335. The trajectory path of the virtual tool 1320 is different than the trajectory path of the one or more implants 1335. The workstation provides feedback to correct the user (e.g., robot or surgeon) from the second trajectory path of the virtual tool 1320 back to or return to the first trajectory path of the one or more implants 1335.
In another embodiment, step of acquiring one or more intraoperative images to reconstruct the localized spine segment 1155 may further comprise the step of conducting real-time operative planning. The step of real-time operative planning comprises the steps of: acquiring one or more intraoperative images in a plurality of planes; and creating one or more multiplanar reconstructed (MPR) images. The step of conducting real-time operative planning may further comprise the step of superimposing one or more objects into the one or more preoperative images, one or more operative images and/or MPR images as described herein. Real-time operative planning allows the surgeon to have an option to omit the one or more preoperative images from the preoperative plan to create a new operative plan for the surgical approach and/or provide a trajectory for the surgeon and/or robot. The surgeon must perform the step of confirming an anatomical location to initiate a starting point. The confirmation of a starting point may be done by two techniques. The first technique includes direct visualization, which should confirm an adequate starting point based on the anatomical landmarks the surgeon would recognize for freehand techniques. The second technique includes confirming bony anatomy with the navigation. This can be done by using a passive planar navigation probe and placing it on an anatomical bony landmark, such as the spinous process. The navigation system should confirm that the probe position on the landmark corresponds to the probe position seen on the navigation screen. If there is a mismatch, then the surgeon needs to consider re-registration of the reference frame.
With reference to
In one embodiment, the step of completing the incision to access at least one targeted anatomical location 1345 may be performed according to standard surgical techniques (manually), navigation assisted and/or robotic assisted. The step of completing the incision to access at least one targeted spinal segment within a spinal region 1345 may include localizing the incision at, near and/or proximate to the at least one localized spinal segment in a desired spine region. The spine region may include a thoracic region, a cervical region, lumbar region, sacral region and/or any combination thereof. The at least one spine segment comprises one or more localized spinal segments that may include one or more cervical vertebral segments (C1-C8), thoracic vertebral segments (T1-T12), lumbar vertebral segments (L1-L5), and/or sacral vertebral segment (S1-S5).
The incision to access the targeted spinal segment in a spine region may comprise a standard midline incision with a subperiosteal exposure that extends laterally to include the medial edge of transverse process. Utilize intraoperative imaging with an imaging technique to confirm the proper index level and/or targeted spinal segment. The surgeon may expose the entirety of the facet joint and lamina at the targeted spinal segment within a spine region. Alternatively, the surgeon may expose the entirety of the facet joint, lamina and transverse process. The surgeon may choose to not dissect the transverse process of the L5 vertebra because it may be necessary to maintain the integrity of the iliolumbar ligament. Disruption of the iliolumbar ligament can weaken the transverse process. This is especially important for patients with spondylolisthesis at L5-S1. Furthermore, the surgeon may desirably avoid violating the cranial facet capsule of the facet joint and to avoid transverse process fracture, especially at L5. The surgeon should attempt to achieve hemostasis.
With reference to
The one or more decompression techniques 1350, 1350a, 1350b may include one or more of the following: a laminectomy, a laminotomy, a foraminotomy, a laminoplasty, a discectomy, an annulotomy and/or any combination thereof. The one or more decompression techniques may comprise a complete or partial technique. The one or more decompression techniques may be completed on least one side. The one or more decompression techniques may be completed on a first side and a second side.
In one embodiment, the step of completing at least one decompression technique 1350 may comprise a laminectomy and at least one facetectomy. The at least one facetectomy may comprise an inferior and/or superior facetectomy. The at least one facetectomy may comprise a complete/full or partial facetectomy. The laminectomy may include a standard laminectomy, a Gill laminectomy and/or a hemi-Gill laminectomy.
With reference to
With reference to
In one embodiment, the step of completing a laminectomy 1355 and completing a facetectomy 1360, 1365 may be performed to standard surgery techniques, navigation assisted techniques and/or robotic assisted techniques. In another embodiment, the step of completing a laminectomy 1355 and completing a facetectomy 1360, 1365 may be performed to standard surgery techniques with supplemental considerations. The supplemental considerations may include confirming flushness and/or the location of the nerve root. The surgeon may confirm that the medial portion of the superior articular process should be flush with the medial wall of the inferior pedicle. Also, the surgeon may remove the top portion of the superior articular process to be flush with the inferior pedicle.
The surgeon may avoid violating the cranial facet capsule of the facet joint. The supplemental considerations may further include having the surgeon confirm the visualization and/or location of the nerve root. The exiting nerve root should be exposed and visualized from the hidden zone to the far lateral zone. Any tethering tissue from the lateral pedicle to the exiting nerve root should be released to allow gentle superior-lateral retraction of the exiting nerve root. The surgeon may desirably want to avoid dissecting iliolumbar ligaments to avoid weakening of the transverse process. The surgeon should utilize gentle distraction of the nerve root. The veins near the lateral tethering ligaments may cause bleeding and may be controlled with hemostatic agents or bipolar forceps. Furthermore, the surgeon should release the intraforaminal ligaments to allow for complete decompression of the traversing and exiting nerve roots. If the surgeon identifies osteophytes, the surgeon may engage in the operation to remove any compressive osteophytes using standard instruments known in the art.
In one embodiment, the step of completing a discectomy 1370, a first discectomy 1380, and/or a second discectomy 1385 may be performed to standard surgery techniques, navigation assisted techniques and/or robotic assisted techniques. In another embodiment, the step of completing a discectomy 1370, a first discectomy 1380, and/or a second discectomy 1385 may be performed to standard surgery techniques with supplemental considerations. The supplemental considerations may include the assurance of nerve damage. The surgeon should protect the exiting nerve root and the lateral thecal sack by retracting both for protection of the neural elements prior to initiation of the discectomy. The supplemental considerations may further include a discectomy and a rectangular annulotomy on a first side and/or a second side (e.g., a bilateral annulotomy). On a first side, the surgeon may incise the disc and complete a rectangular annulotomy from paracentral to far lateral zone. The discectomy should remove endplate cartilage, nucleus pulposus, while preserving the lateral annulus and anterior longitudinal ligament (ALL). On a second side, the surgeon may incise the disc and complete a rectangular annulotomy from paracentral to far medial zone. The same procedure may be completed bilaterally (e.g., on a first side and/or second side) to allow for bilateral transforaminal approach with complete discectomy. The surgeon should ensure that the entire nucleus pulposus is removed to minimize risk for future disc herniation and to allow adequate space for implantation of the prosthesis.
The supplemental considerations may further include mobilizing the intervertebral disc space of the spinal segment. The surgeon may consider utilizing an osteotome or a thin osteotome. The osteotome may be inserted medial to the pedicle preliminarily mobilize the disc space. The surgeon may desirably want to avoid disruption of the endplates at the index level. The supplemental considerations may further include evaluation of patients with prior surgery. In the cases of patients with prior surgery at the index level, significant epidural scaring can make the decompression and/or disc preparation more challenging. The risk of incidental durotomy is increased with patients who have had prior surgery. The surgeon should pay careful attention to the location of prior laminotomy/laminectomy so the surgeon is familiar with the altered anatomy in these cases. Additionally, the principle of identifying previously unoperated anatomy and working from a virgin area to a previously operated area for the decompression should be followed.
With reference to
With reference to
In one embodiment, the step selecting a proper implant size 1165, 1165a, 1165b may comprise the step of balancing soft tissue by mobilizing the intravertebral space on at least one side 1400 and/or a first balancing of a first soft tissue by mobilizing the intervertebral space and a second balancing of a second soft tissue (not shown). The surgeon may begin intervertebral space mobilization with the smallest provided distractor to increase intervertebral height at least one side. Alternatively, the surgeon may begin intervertebral space mobilization with the smallest provided distractor on a first side and/or a second side. The surgeon should sequentially introduce other distractors with increased width and/or height into the intervertebral space to allow tensioning of the soft tissues on at least one side, a first side and/or a second side. Alternatively, the surgeon should sequentially introduce other distractors with increased width and/or height into the intervertebral space to allow a first balancing or tensioning of the soft tissues on a first side and a second tensioning or balancing a second side. The first tensioning should be the same tension and/or substantially the same as the second tensioning. The first tensioning should be a different tension than the second tensioning.
The surgeon should be aware that soft tissue responses vary depending on the severity and duration of the patient's illness so the amount of time to allow for soft tissue relaxation between insertion of larger distractors may differ. The surgeon should prevent excessive distraction of the intervertebral space and endplate fracture or compression. The proper device height will vary by patient and should primarily be estimated based on soft tissue tension.
In another embodiment, the step selecting a proper implant size 1165, 1165a, 1165b may comprise the step of determining the proper implant length using implant length trial tools 1405, 1405a, 1405b may comprise the steps of: preparing a length trial tool; introducing at least one length trial on at least one side; verifying the center of rotation (COR); and/or confirming proper implant length by acquiring at least one image using at least one imaging technique. The step of determining the proper implant length using implant length trial tools 1405, 1405a, 1405b, 1405c may further comprise superimposing one or more objects onto one or more operative images; positioning user to desired trajectory, first trajectory and/or first one or more objects; generating a second trajectory and/or a second one or more objects; correcting user to return to first trajectory and/or first one or more objects after confirming that second trajectory and/or second one or more objects is different than the first trajectory and/or first one or more objects.
With reference to
With reference to
The first length trial may be the same length as the second length trial. The first length trial may be a different length than the second length trial. Accordingly, first transverse pedicle angle may comprise the same angle as the second transverse pedicle angle. The first transverse pedicle angle may comprise a different angle than the second transverse pedicle angle. The first desired one or more objects may comprise a same object as the second desired one or more objects. The first desired one or more objects may comprise a different object as the second desired one or more objects. The first desired one or more objects may be different or the same as the third one or more objects. The second desired one or more objects may be different or the same as the fourth one or more objects.
The one or more objects, second one or more objects, third one or more objects and/or fourth one or more objects may comprise a text annotation (not shown), a trajectory path 1310, a virtual surgical instrument 1320, a spinal implant 1335 and/or any combination thereof as shown in
In one embodiment, the step of determining the proper implant length using implant length trial tools 1405, 1405a, 1405b may comprise the step of preparing a length trial tool on at least one side 1425 and/or the step of preparing a first length trial tool for a first side and/or a second length trial tool for a second side 1470. The surgeon may require the use of sequential length trials 1505 of different lengths—small (or short), medium and large (or long). The surgeon may confirm that the surgical kit 1500 may contain at least three length trials 1505. The instrumentation kit 1500 may comprise a variety of available tools for use throughout the procedure as shown in
The at least three length trials 1505 match and/or approximates of the implant as shown in
In one embodiment, the step of determining the proper implant length using implant length trial tools using trial tools 1405, 1405a, 1405b, the step preparing a length trial tool on at least one side 1425, and/or the step of preparing a first and a second length trial tool on first and/or second sides 1470 may further comprise the step of re-identifying and/or re-registering surgical instruments within the navigation system and/or robot. The surgical instruments may have been previously tracked during the preoperative procedure (e.g., a baseline registration) and during the start of the operative procedure the step of preparing equipment for navigational and/or robotic assistance 1145, and may not require further reregistration. The surgeon or staff may be able to couple a portion of a reference system and/or robotic arm to the previously identified surgical instrument and begin immediate use of the instrument. Alternatively, the surgeon or staff may couple a portion of a reference system and/or couple to a robotic arm to the previously identified instrument (e.g., the baseline registration during the preoperative method), and may require intraoperative confirmation of spatial relationship or coordinates between the patient and the pre and intraoperative images.
With reference to
Accordingly, the step of determining the proper spinal implant length 1405, 1405a, 1405b may further comprise the step of positioning the user (e.g., surgeon and/or robot) to the desired one or more objects for the at least one intraoperative step on the at least one side 1435 and/or the step of positioning the user to a first one or more objects for a first side and a second one or more objects for a second side for the at least one operative step 1480. The navigation system may transmit spatial coordinates of the one or more surgical instruments relative to the targeted anatomy for trajectory positioning. The user (e.g., surgeon and/or robotic system) may hold the one or more surgical instruments and/or a registration tool (i.e., a probe, a guide and/or any other tool) to the desired position according to the spatial coordinates of the surgical trajectory for the desired intraoperative step. The trajectory may match or substantially match one or more projected surgical measurements (PSM). The one or more objects comprise one or more PSMs, a virtual surgical instrument, a virtual spinal implant, and/or any combination thereof.
In another embodiment, the step of determining the proper implant length 1405, 1405a, 1405b may comprise the step of introducing at least one length trial on at least one side 1440 and/or the step of introducing a first length trial on the first side and/or a second length trial on a second side 1485. The step of introducing at least one length trial on at least one side, a first side and/or a second side 1440, 1485 includes the steps of: inserting a length trial into the targeted intervertebral disc space; translating the at least one length trial within the targeted intervertebral disc space until reaching the positive stop tab. Alternatively, step of determining the proper implant length on at least one side, a first side and/or a second side 1440, 1485 includes the steps of: inserting the length trial into the targeted intervertebral disc space; and translating the at least one length trial on at least one side that matches or substantially matches the transverse pedicle angle (or convergence angle) as shown in
The step of inserting a length trial into the targeted intervertebral space should follow a custom desired trajectory path. The custom desired trajectory path may be a path of least resistance and/or along and/or substantially along the transverse pedicle angle or convergence angle between a distracted disc space. Should the surgeon follow along, match or substantially match the transverse pedicle angle, such alignment, convergence and/or positioning (may also be referred to as a “toe-in angle”) would help facilitate stability and resist shear forces. The orientation of pedicles, known as the transverse pedicle angles, vary across each spine segment within a spine region as shown in
With reference to
Alternatively, the step of determining the proper spinal implant length 1405, 1405a, 1405b comprises the step of confirming or verifying the center of rotation (COR) on at least one side 1445 and/or the step of confirming a first COR on a first side and a second COR on a second side 1490 as shown in
A third technique may incorporate the navigation system and/or the preoperative virtual models from the surgical planning software by computing quantitative measurements, indicators and/or trajectory paths. The computerized quantitative measurements may be obtained during the preoperative procedure with the preoperative software application as shown in
In another embodiment, the step of determining the proper implant length 1405, 1405a, 1405b may comprise the step of providing feedback on matching or substantially matching one or more objects that were superimposed on the one or more images 1455 and/or the step of providing feedback on matching or substantially matching a first one or more objects on a first side and a second one or more objects on a second side 1455. The feedback may comprise visual feedback (using the navigation monitor or workstation display), audible feedback, tactile feedback, and/or any combination thereof. The feedback may include visual and/or audible feedback to correct or reposition the surgeon's trajectory and/or robot's trajectory to appropriately match or substantially match the one or more objects and/or projected surgical measurement. The one or more objects may include the SSM (selected surgical measurement), a virtual trajectory, a virtual tool, a virtual spinal implant, and/or any combination thereof. The SSM may include a convergence angle or transverse pedicle angle, and a COR. The virtual trajectory may match or substantially match the convergence angle or transverse pedicle angle.
In one embodiment, the step of providing feedback 1455 may further comprise the steps of: generating a non-desired trajectory path and/or non-desired one or more objects; comparing the desired trajectory path to the non-desired trajectory path 1460; correcting user to return to desired trajectory path if the non-desired trajectory path is different than the desired trajectory path 1435, 1480. In another embodiment, the step of providing feedback 1455 may further comprise the steps of: generating a second trajectory path and/or non-desired second one or more objects; comparing the first trajectory path to the second trajectory path 1460; correcting user to return to first trajectory path if the second trajectory path is different than the first trajectory path 1435, 1480. The step of providing feedback 1455 may comprise at least one side, a first side and/or a second side.
In another embodiment, the step of determining the proper implant length 1405, 1405a, 1405b may comprise the step of confirming proper or approximated spinal implant length by acquiring at least one image using at least one imaging technique for the at least one side 1450 and the step of confirming a first spinal implant length on a first side and a second spinal implant length on a second side 1495. The at least one image technique may comprise an MRI, a radiograph, a CT scan, an ultrasound, and/or any combination thereof. The at least one imaging technique may further comprise 2D or 3D images. While the one or more length trials are in position within the disc space, the surgeon may confirm one or more of the following: the proper tensioning of the soft tissues; the proper implant length; the proper center of rotation (COR) of the implant; the proper convergence angle (e.g., transverse pedicle angle or toe-in angle); the length trials do not contact a portion of the ALL or remaining annulus and/or any combination thereof. Should the proper and/or approximated spinal implant length is unable to be confirmed, the surgeon will use the subsequent length trial tool, and repeat the steps beginning from the step of assembling a length trial tool (using the new length trial).
With reference to
With reference to
The first height trial may comprise a same height as the second height trial. The first height trial may comprise a different height as the second height trial. The first soft tissue tension may comprise a same tension as the second soft tissue tension. The first soft tissue tension may comprise a different tension as the second soft tissue tension. The first custom path may comprise the same path as the second custom path. The first custom path may comprise a different custom path as the second custom path. The first transverse pedicle angle may comprise a same angle and the second transverse pedicle angle. The first transverse pedicle angle may comprise a different angle as the second transverse pedicle angle. The first one or more objects may comprise a same object as the second one or more objects. The first one or more objects may comprise a different object as the second one or more objects. The first spinal implant may comprise a same implant than the second spinal implant. The first spinal implant may comprise a different implant than the second spinal implant. The first one or more operative images may comprise a same one or more images than the second one or more operative images. The first one or more operative images may comprise a different one or more images than the second one or more operative images.
The step of selecting the proper implant height 1410, 1410a, 1410b comprises the step of preparing a height trial tool on at least one side 1610 and/or the step of preparing a first height trial tool on a first side and a second height trial tool on a second side 1640. The step of preparing a first height trial tool 1610, 1640 comprises the step of attaching the height trial 1670 to a handle or robot. The surgeon may confirm that the surgical instruments within the kit 1500 contains at least three length trials 1670 as shown in
The step of preparing a height trial tool, a first height trial tool and/or a second height trial tool 1610, 1640 may further comprise the step of re-identifying and/or re-registering surgical instruments within the navigation system and/or robot. The surgical instruments may have been previously tracked during the preoperative procedure (e.g., a baseline registration), and may not require further reregistration. The surgeon or staff may be able to couple a portion of a reference system and/or robotic arm to the previously identified surgical instrument and begin immediate use of the instrument. Alternatively, the surgeon or staff may couple a portion of a reference system and/or couple to a robotic arm to the previously identified instrument (e.g., the baseline registration during the preoperative method), and may require intraoperative confirmation of spatial relationship or coordinates between the patient and the pre and intraoperative images. As disclosed herein, each of the relevant surgical instruments may be adapted and configured to receive a portion of a reference frame, a fiducial, and/or marker.
With reference to
The step of determining the proper spinal implant height 1410, 1410a, 1410b may comprises the step of positioning the user (e.g., surgeon or robot) to the desired one or more objects for at least one intraoperative step for the at least one side 1615 and the step of positioning the user to a first one or more objects on a first side and a second one or more objects on a second side for at least one operative step 1645. The navigation system may display the one or more objects, a first one or more objects and/or a second one or more objects. The spatial coordinates may be transmitted to the robot and/or the proper referencing system to confirm the one or more surgical instruments, a first surgical instrument and/or a second surgical instrument is positioned to desired trajectory or the one or more objects relative to the targeted anatomy. The user comprising a surgeon and/or a robotic system may hold the one or more surgical instruments and/or a registration tool (i.e., a probe, a guide and/or any other tool) to the desired position according to the spatial coordinates of the surgical trajectory for the desired intraoperative step. The trajectory may match or substantially match one or more projected surgical measurements (PSM). The one or more objects comprise one or more PSMs, a virtual surgical instrument, a virtual spinal implant, and/or any combination thereof.
In another embodiment, the step of determining the proper implant height 1410, 1410a, 1410b comprises the step of introducing at least one height trial on at least one side 1625 and/or the step of introducing a first height trial on a first side and/or a second height trial on a second side 1655. The step of introducing at least one height trial on at least one side, the first side and/or second side 1625, 1655 includes the steps of: inserting at least one height trial into the targeted intervertebral disc space following or substantially following a path or custom path; translating the at least one height trial within the targeted intervertebral disc space following and/or substantially following along a custom path. The at least one height trial comprises a single height trial. The at least one height trial may comprise a first height trial and a second height trial. The custom path or path comprises matches or substantially matches the transverse pedicle angle (or convergence angle). Substantially matches may comprise at least up to a +/−10 percent deviation from the transverse pedicle angle central axis.
The step of translating the height trial 1670 along a custom desired path may comprise a custom path selected during preprocedural surgical planning, from the surgical planning software and/or real-time operative planning. The desired path and/or custom path may further comprise a path that follows along, match or substantially match the transverse pedicle angle or convergence angle located within the intervertebral space 1695. Such path alignment, convergence and/or positioning (may also be referred to as a “toe-in angle”) would help facilitate stability and resist shear forces. The orientation of pedicles, known as the transverse pedicle angles, vary across each patient and each spine segment within a spine region. As shown in
With reference to
The step of determining the proper implant height 1410, 1410a, 1410b comprises the step of verifying a tension of the soft tissues and the plane angulation on at least one side 1630 and/or the verifying a first tension of the soft tissues and a first plane angulation on first side and a second tension of the soft tissues and a second plane angulation on a second side 1660. The tension of the soft tissues includes verifying that the soft tissues are not over tensioned or excessively tensioned. The user and/or surgeon may verify using visual indicators on the one or more operative images and/or one or more MPR images. Alternatively, the user and/or surgeon may verify through a measurement, the measurement includes a force value, a resistance value and/or a compression value. An accepted resistance or force value may be set, then while translating the height trial tool 1670 one or more force values may be collected and compared to the accepted for value. If the second force value exceeds the first force value, the navigation and/or robotic system may prompt the user and/or surgeon that the intervertebral space is not properly tensioned and requires further space distraction. Thus, returning the step of introducing at least one height trial tool, a first height trial, and/or a second height trial 1625, 1655. Also, the plane angulation comprises verifying the angle of the inferior endplate of the superior vertebral body relative to the superior endplate of the inferior vertebral body. The angle comprises a coronal angle, a sagittal angle, and/or a convergence angle. The angles may be visually determined by confirming on the one or more operative images, and/or computed by the navigational software.
In another embodiment, the step of determining the proper implant length 1405, 1405a, 1405b may comprise the step of providing feedback on matching or substantially matching one or more objects that were superimposed on the one or more images 1455 and/or the step of providing feedback on matching or substantially matching a first one or more objects on a first side and a second one or more objects on a second side 1455. The feedback may comprise visual feedback (using the navigation monitor or workstation display), audible feedback, tactile feedback, and/or any combination thereof. The feedback may include visual and/or audible feedback to correct or reposition the surgeon's trajectory and/or robot's trajectory to appropriately match or substantially match the one or more objects and/or projected surgical measurement. The one or more objects may include the SSM (selected surgical measurement), a virtual trajectory, a virtual tool, a virtual spinal implant, and/or any combination thereof. The SSM may include a convergence angle or transverse pedicle angle, and a COR. The virtual trajectory may match or substantially match the convergence angle or transverse pedicle angle.
In one embodiment, the step of providing feedback 1455 may further comprise the steps of: generating a non-desired trajectory path and/or non-desired one or more objects; comparing the desired trajectory path to the non-desired trajectory path 1460; correcting user to return to desired trajectory path if the non-desired trajectory path is different than the desired trajectory path 1435, 1480. In another embodiment, the step of providing feedback 1455 may further comprise the steps of: generating a second trajectory path and/or non-desired second one or more objects; comparing the first trajectory path to the second trajectory path 1460; correcting user to return to first trajectory path if the second trajectory path is different than the first trajectory path 1435, 1480. The step of providing feedback 1455 may comprise at least one side, a first side and/or a second side.
The step of determining the proper implant height 1410, 1410a, 1410b comprises the step of confirming proper or approximate spinal implant height on the at least one side 1635 and/or the step of confirming first spinal implant height on a first side and/or a second spinal implant height on a second side 1665. The surgeon may desirably acquire at least on image using at least one imaging technique to confirm proper implant height on at least one side, a first side and/or a second side. The at least one image technique may comprise an MRI, a radiograph, a CT scan, an ultrasound, and/or any combination thereof.
While the at least one height trial, a first height trial and/or a second height trial 1670 are in position within the intervertebral disc space 1695, the surgeon may confirm one or more of the following: the proper tensioning of the soft tissues; the proper or approximate implant height; the proper plane angulation of the upper vertebral body relative to the lower vertebral body; the proper convergence angle (e.g., transverse pedicle angle or toe-in angle); and/or whether the height trials 1670 do not contact a portion of the ALL or remaining annulus and/or any combination thereof. The surgeon may mark the medial edge of the height trial 1670 for a reference line or a guideline for the step of preparing the intervertebral disc space 1695 (e.g., for marking the medial edge of the rasps for the osteotomy). Should the proper and/or approximated spinal implant height is unable to be confirmed, the surgeon will use the subsequent height trial tool, and repeat the steps beginning from the step of preparing a height trial tool (using the new height trial) 1640. In another embodiment, the step of determining the proper spinal implant length and the step of determining the proper implant height may be reversed.
With reference to
With reference to
With reference to
The first preparation on the caudal vertebral body on the first side may be the same as the second preparation on the caudal vertebral body on the second side. The first preparation on the caudal vertebral body on the first side may be different than the second preparation on the caudal vertebral body on the second side. The first preparation on the cranial vertebral body on the first side may be the same as the second preparation on the cranial vertebral body on the second side. The first preparation on the cranial vertebral body on the first side may be different than the second preparation on the cranial vertebral body on the second side. The first spinal implant may be the same size as the second spinal implant. The first spinal implant may be a different size than the second spinal implant. The first keel alignment may comprise a same keel alignment as the second keel alignment. The first keel alignment may comprise a different keel alignment as the second keel alignment.
With reference to
With reference to
The first preparation on the caudal vertebral body on the first side may be the same as the second preparation on the caudal vertebral body on the second side. The first preparation on the caudal vertebral body on the first side may be different than the second preparation on the caudal vertebral body on the second side. The first spinal implant may be the same size as the second spinal implant. The first spinal implant may be a different size than the second spinal implant. The first one or more SSM and/or first one or more objects may comprise the same object as the second one or more SSM and/or second one or more objects. The first one or more SSM or first one or more objects may comprise a different object than the second one or more SSM and/or second one or more objects. The first transverse pedicle angle may comprise a same transverse angle as the second transverse pedicle angle. The first transverse pedicle angle may comprise a different transverse angle than the second transverse pedicle angle. The first optimal alignment may be the same or different compared to the second optimal alignment.
The step of preparing the caudal vertebral body 1720, 1740, 1760, 1780 comprises the step of obtaining one or more SSM or PSM, a first one or more SSM or PSM and/or a second SSM or PSM for optimal alignment for the one or more preoperative methods or procedures or preoperative surgical plan 1800, 1830 as shown in
The sagittal osteotomy angle 1860, the coronal osteotomy angle 1875a, 1875b, the transverse pedicle angle 1880a, 1880b and/or the A/P distance 1885a, 1885b may be different in different spine segments within different spine regions. A first coronal osteotomy angle 1875a may comprise a different angle than the second coronal osteotomy angle 1875b. A first coronal osteotomy angle 1875a may comprise a same angle than the second coronal osteotomy angle 1875b. A first sagittal osteotomy angle 1860 may comprise a different angle than the second sagittal osteotomy angle 1860. A first sagittal osteotomy angle 1860 may comprise a same angle than the second sagittal osteotomy angle 1860. A first A/P distance 1885a may comprise the same distance as the second A/P distance 1885b. The first A/P distance 1885a may comprise a different distance as the second A/P distance 1885b. The one or more SSM or PSM may be transformed into one or more objects that are superimposed onto the one or more preoperative images, one or more operative images, one or more synchronized image, one or more MPR images.
With reference to
In another embodiment, the step of preparing the caudal vertebral body 1720, 1740, 1760, 1780 comprises the step of positioning the user, surgeon and/or robot to the desired one or more objects on the at least one side 1810 and/or the step of positioning the user to a first one or more objects or trajectory on a first side and the second one or more objects or trajectory on a second side 1840. The navigation system may display the one or more objects, a first one or more objects and/or a second one or more objects. The spatial coordinates may be transmitted to the robot and/or the proper referencing system to confirm the one or more surgical instruments, a first surgical instrument and/or a second surgical instrument is positioned to desired trajectory or the one or more objects relative to the targeted anatomy. The user comprising a surgeon and/or a robotic system may hold the one or more surgical instruments and/or a registration tool (i.e., a probe, a guide and/or any other tool) to the desired position according to the spatial coordinates of the surgical trajectory for the desired intraoperative step. The trajectory may match or substantially match one or more projected surgical measurements (PSM). The one or more objects comprise one or more PSMs, a virtual surgical instrument, a virtual spinal implant, and/or any combination thereof.
In another embodiment, the step of preparing the caudal vertebral body 1720, 1740, 1760, 1780 comprises the step of introducing a preparation tool on at least one side 1815 and/or the step of introducing a first preparation tool on a first side and a second preparation tool on a second side 1845. The step of introducing a preparation tool on at least one side, a first side and/or a second side 1815, 1845 comprises the steps of: assembling the preparation tool, a first preparation tool and/or a second preparation tool; distracting the intervertebral disc space of a localized spine segment within a spine region; and inserting the preparation tool, the first preparation tool and/or a second preparation tool into the localized intervertebral space. The step of introducing a preparation tool on at least one side, a first side and/or a second side may further comprise the step of re-registering and/or re-identifying the preparation tool.
In another embodiment, the step of introducing a preparation tool, a first preparation tool and/or a second preparation tool on at least one side, a first side and/or a second side 1815, 1845 comprises the step of assembling the preparation tool, a first preparation tool and/or a second preparation tool. The step of assembling or preparing the preparation tool, a first preparation tool and/or a second preparation tool comprises attaching the preparation tool to a handle system or a robot. The preparation tool comprises a rasp, the rasp includes a long, short and/or flat rasp. The handle system comprises a manual handle, and/or a powered handle system. The surgeon may prepare the endplates and/or pedicles manually using manual handle and/or using a powered system under navigational and/or robotic assistance.
In one embodiment, the surgeon may use a powered handle system 1980. The powered handle system 1980 comprises a powered reciprocating control box 1985, a powered handle or handpiece 1995, a footswitch pedal 2000, one or more cable connectors 1990a, 1990b as shown in
In another embodiment, the step of introducing a preparation tool, a first preparation tool and/or a second preparation tool on at least one side, a first side and/or a second side 1815, 1845 comprises the step of re-identifying and/or re-registering surgical instruments within the navigation system and/or robot. The surgical instruments may have been previously tracked during the preoperative procedure (e.g., a baseline registration), and may not require further reregistration. The surgeon or staff may be able to couple a portion of a reference system and/or robotic arm to the previously identified surgical instrument, and begin immediate use of the instrument. Alternatively, the surgeon or staff may couple a portion of a reference system and/or couple to a robotic arm to the previously identified instrument (e.g., the baseline registration during the preoperative method), and may require intraoperative confirmation of spatial relationship or coordinates between the patient and the pre and intraoperative images. As disclosed herein, each of the surgical instruments, including the powered handpiece of the powered system may be adapted and configured to receive a portion of a reference system including at least one tracker, at least one probe, one or more fiducials and/or one or more LEDs. The handpiece may comprise an indentation or channel along the length of the handpiece, between the first end and/or second end of the handpiece. The portion of the reference system may align with the indentation and/or channel.
In another embodiment, the step of introducing a preparation tool, a first preparation tool and/or a second preparation tool on at least one side, a first side and/or a second side 1815, 1845 comprises the step of distracting the intervertebral disc space of a localized spine segment within a spine region. This step requires the surgeon to distract the interverbal disc space on at least one side, a first side and/or a second side. The surgeon should over distract the at least one side, a first side and/or a second side by using a height trial. The height trial should comprise at least 1 mm larger or taller than the height trial determined at the step of determining the proper implant height. Maintaining the at least one side, a first side and/or a second side using a height trial that is at least 1 mm greater than determined implant height from the previous step will provide extra tension on the tissues and increase the intervertebral disc space for easier endplate preparation and the completion of the osteotomy of the pedicles.
In another embodiment, the step of introducing a preparation tool, a first preparation tool and/or a second preparation tool on at least one side, a first side and/or a second side 1815, 1845 comprises the step of inserting the preparation tool into the localized intervertebral space of at least one side and/or inserting a first preparation tool into the localized intervertebral space of a first side and a second preparation tool into the localized intervertebral space on a second side that follows or substantially follows a custom path. This step may require the surgeon to introduce or insert the inactivated powered rasp into the distracted intervertebral disc space on the native caudal vertebral body into the at least one side, a first side and/or a second side along a desired path and/or desired one or more objects, a first one or more objects and/or a second one or more objects. The desired path may be a custom path chosen by the surgeon. The desired path, one or more objects, a first one or more objects and/or a second one or more objects may comprise a path that follows along, match or substantially match the pedicle transverse angle (or pedicle axis) on the at least one side, a first side and/or a second side within a distracted intervertebral disc space. The rasp comprises a long, flat rasp and/or a short, flat rasp. The surgeon should confirm placement and/or positioning of the preparation tools by acquiring at least one image with at least one imaging technique on the native caudal endplate surface and/or pedicle surface. The surgeon may refer or obtain the pre-operative measurements, the preoperative measurements include the optimal sagittal and/or coronal angle of correction.
In another embodiment, the step of preparing the caudal vertebral body 1720, 1740, 1760, 1780 comprises the step of completing at least one preparation along a custom path on at the least one side to create at least one resected surface 1820 and/or the step of completing a first preparation along the first custom path on the first side to create a first resected surface and a second preparation along a second custom path on the second side to create a second resected surface 1850. The preparation comprises the step of completing a resection of the endplate and osteotomy of a pedicle within the disc space of a localized spine segment and/or the vertebral bodies. The step of completing an osteotomy and/or resection within a disc space and/or vertebral body of a localized spine segment is a corrective osteotomy to restore sagittal and/or coronal balance, along with maximizing implant range of motion or motion restoration. The osteotomy and/or resection will result in the creation of one or more parallel resected surfaces or endplates for neutral insertion of the spinal implant. The degree of osteotomy, the osteotomy sagittal angle (e.g., the sagittal angle of correction (AOC) and the osteotomy coronal angle (e.g., the coronal angle of correction) that is necessary is generally the angle to create parallel cranial and caudal prepared endplates at the index vertebral segment level and as determined in preoperative (or intraoperative if using navigation) planning and confirmed intraoperatively. The custom path, first custom path and/or a second custom path comprises matching or substantially matching the convergence angle and/or transverse pedicle angle.
With reference to
The sagittal osteotomy angle 1860, the coronal osteotomy angle 1875a, 1875b, the transverse pedicle angle 1880a, 1880b and/or the A/P distance 1885a, 1885b may be different in different spine segments within different spine regions. A first coronal osteotomy angle 1875a may comprise a different angle than the second coronal osteotomy angle 1875b. A first coronal osteotomy angle 1875a may comprise a same angle than the second coronal osteotomy angle 1875b. A first sagittal osteotomy angle 1860 may comprise a different angle than the second sagittal osteotomy angle 1860. A first sagittal osteotomy angle 1860 may comprise a same angle than the second sagittal osteotomy angle 1860. A first A/P distance 1885a may comprise the same distance as the second A/P distance 1885b. The first A/P distance 1885a may comprise a different distance as the second A/P distance 1885b. The one or more SSM or PSM may be transformed into one or more objects that are superimposed onto the one or more preoperative images, one or more operative images, one or more synchronized image, one or more MPR images.
The surgeon may activate the powered rasp (see
The at least one resected surface, a first resected surface and/or a second resected surface 1870, 1870a, 1870b may comprise a flat, planar plane or surface and/or be parallel to the native endplate surface. The at least one resected surface, a first resected surface and/or a second resected surface 1870, 1870a, 1870b may comprise an osteotomy angle, the angles may comprise 0 degrees to 40 degrees. The angles may comprise a sagittal angle, a coronal angle, a transverse pedicle angle (e.g., a convergence angle), and/or any combination thereof. The angles of the at least one resected surface, a first resected surface and/or a second resected surface 1870, 1870a, 1870b may be angled relative to the native endplate plane 1865. The at least one resected surface, a first resected surface and/or a second resected surface 1870, 1870a, 1870b may be below and parallel relative to the native endplate plane 1865. The at least one resected surface, a first resected surface and/or a second resected surface 1870, 1870a, 1870b may be below and angled relative to the native endplate plane 1865. The first resected surface may comprise a flat and angled surface.
Alternatively, the angle of the at least one resected surface, a first resected surface and/or a second resected surface 1870, 1870a, 1870b may match or substantially match the sagittal and/or coronal osteotomy angle. The angle of the at least one resected surface, a first resected surface and/or a second resected surface 1870, 1870a, 1870b on at least one side, a first side and/or a second side may match or substantially match the transverse pedicle angle. The at least one resected surface, a first resected surface and/or a second resected surface 1870, 1870a, 1870b may comprise a resected shape, first resected length and first resected width may match or substantially match the shape, length and width of the spinal implant.
The at least one resected surface, a first resected surface and/or a second resected surface 1870, 1870a, 1870b on at least one side, a first side and/or a second side may extend from a portion of the superior endplate to a portion of the pedicle on the caudal vertebral body. The at least one resected surface, a first resected surface and/or a second resected surface 1870, 1870a, 1870b on at least one side, a first side and/or a second side may comprise resected shape, a resected length, a resected width and a resected depth. The resected surface length and/or the resected width may match at least a portion of the spinal implant length and/or width. The resected surface may be positioned or created at an angle. The angle of the resected surface may match or substantially match the pre-determined SSM or PSM, one or more objects, and/or an AOC from pre-procedure step. The angle may comprise an osteotomy sagittal angle, an osteotomy coronal angle, a transverse pedicle angle (e.g., convergence angle), and/or any combination thereof.
In another embodiment, the step of preparing the caudal vertebral body on at least one side, a first side and/or a second side 1720, 1740, 1760, 1780 may comprise the step of providing feedback on matching or substantially matching one or more objects that were superimposed on the one or more images 1455 and/or the step of providing feedback on matching or substantially matching a first one or more objects on a first side and a second one or more objects on a second side 1455. The feedback may comprise visual feedback (using the navigation monitor or workstation display), audible feedback, tactile feedback, and/or any combination thereof. The feedback may include visual and/or audible feedback to correct or reposition the surgeon's trajectory and/or robot's trajectory to appropriately match or substantially match the one or more objects and/or projected surgical measurement. The one or more objects may include the SSM (selected surgical measurement), a virtual trajectory, a virtual tool, a virtual spinal implant, and/or any combination thereof. The SSM may include a convergence angle or transverse pedicle angle, and a COR. The virtual trajectory may match or substantially match the convergence angle or transverse pedicle angle.
In one embodiment, the step of providing feedback 1455 may further comprise the steps of: generating a non-desired trajectory path and/or non-desired one or more objects; comparing the desired trajectory path to the non-desired trajectory path 1460; correcting user to return to desired trajectory path if the non-desired trajectory path is different than the desired trajectory path 1435, 1480. In another embodiment, the step of providing feedback 1455 may further comprise the steps of: generating a second trajectory path and/or non-desired second one or more objects; comparing the first trajectory path to the second trajectory path 1460; correcting user to return to first trajectory path if the second trajectory path is different than the first trajectory path 1435, 1480. The step of providing feedback 1455 may comprise at least one side, a first side and/or a second side.
Furthermore, step of preparing the caudal vertebral body on the at least one side, first side and/or second side 1720, 1740, 1760, 1780 may include the step of acquiring at least image using an imaging technique on at least one side, a first side and/or a second side 1825, 1855 to confirm the one or more objects, a first one or more objects and/or a second one or more objects of the resected surface, the first resected surface and/or the second resected surface on at least one side, a first side and/or a second side 1870, 1870a, 1870b by acquiring at least one image using at least one imaging technique. The surgeon may verify that the angles of the resected surface, the first resected surface and/or second resected surface by comparing it to the preoperative surgical plan and/or the at least one or more objects, a first one or more objects and/or second one or more objects displayed or superimposed onto the workstation. The at least one image may be performed by using at least one imaging technique. The imaging techniques may comprise 2D or 3D images. The imaging techniques may comprise an MRI, a radiograph, a CT scan, an ultrasound, and/or any combination thereof. The preparation of the endplate surface and pedicle surface of caudal vertebral body on the contralateral side may be performed by repeating the above steps.
With reference to
With reference to
The step of preparing a cranial vertebral body on a first side and/or a second side 1745 may further comprise the steps of obtaining one or more SSM or PSM from the preoperative method and/or software application for optimal alignment. The one or more objects may match or substantially match the SSM/PSM, the SSM comprises sagittal angle, a resection depth, a transverse pedicle angle or convergence angle. The custom path or trajectory path matches or substantially matches the transverse pedicle angle or convergence angle.
The first preparation on the cranial vertebral body on the first side may be the same as the second preparation on the cranial vertebral body on the second side. The first preparation on the cranial vertebral body on the first side may be different than the second preparation on the cranial vertebral body on the second side. The first angle of correction may comprise the same angle as the second angle of correction. The first angle of correction may comprise a different angle than the second angle of correction. The first transverse pedicle angle may comprise a same transverse angle as the second transverse pedicle angle. The first transverse pedicle angle may comprise a different transverse angle than the second transverse pedicle angle. The first and/or second transverse pedicle angle may comprise an angle of 0 to 45 degrees. The first one or more objects may comprise a same object as the second one or more objects. The first one or more objects may comprise a different one or more objects than the second one or more objects. The first one or more SSM or PSM may comprise a same or different measurement than the second one or more SSM or PSM. The first custom path or trajectory may be the same or different compared to the second custom path or trajectory.
In one embodiment, the step of preparing the cranial vertebral body on at least one side, a first side and/or a second side 1725, 17451765, 1785 comprises the step of obtaining one or more SSM or PSM, a first one or more SSM or PSM and/or a second SSM or PSM for optimal alignment (e.g., sagittal and/or coronal alignment) from the preoperative method or procedure or software application. The one or more SSM or PSM, the first one or more SSM or PSM, and/or a second one or more SSM or PSM may comprise a resection depth, a sagittal osteotomy angle or trajectory (e.g., sagittal angle of correction), a coronal osteotomy angle or trajectory (e.g., coronal angle of correction), a transverse pedicle angle or convergence angle, an A/P distance, and/or neutral alignment. The sagittal osteotomy angle or trajectory comprises an angle of 0 degrees to 40 degrees. The coronal osteotomy angle or trajectory comprises an angle of 0 degrees to 40 degrees. The transverse pedicle angle may comprise 0 degrees to 45 degrees. The sagittal osteotomy angle, the coronal osteotomy angle, the transverse pedicle angle and/or the A/P distance may be different in different spine segments within different spine regions. A first coronal osteotomy angle may comprise a different angle than the second coronal osteotomy angle. A first coronal osteotomy angle may comprise a same angle than the second coronal osteotomy angle. A first sagittal osteotomy angle may comprise a different angle than the second sagittal osteotomy angle. A first sagittal osteotomy angle may comprise a same angle than the second sagittal osteotomy angle. The resection depth may comprise 0 to 10 mm.
With reference to
In another embodiment, the step of preparing the cranial vertebral body 1725, 1745, 1765, 1785 comprises the step of positioning the user, surgeon and/or robot to the desired one or more objects on the at least one side 1895 and/or the step of positioning the user to a first one or more objects or trajectory on a first side and the second one or more objects or trajectory on a second side 1920. The navigation system may display the one or more objects, a first one or more objects and/or a second one or more objects. The spatial coordinates may be transmitted to the robot and/or the proper referencing system to confirm the one or more surgical instruments, a first surgical instrument and/or a second surgical instrument is positioned to desired trajectory or the one or more objects relative to the targeted anatomy. The user comprising a surgeon and/or a robotic system may hold the one or more surgical instruments and/or a registration tool (i.e., a probe, a guide and/or any other tool) to the desired position according to the spatial coordinates of the surgical trajectory for the desired intraoperative step. The trajectory may match or substantially match one or more projected surgical measurements (PSM). The one or more objects comprise one or more PSMs, a virtual surgical instrument, a virtual spinal implant, and/or any combination thereof. In one exemplary embodiment, the one or more objects, the first one or more objects and/or the second one or more objects comprises a one or more text annotations and one or more trajectory paths. The text annotations include PSM or SSM, the SSM includes a resection depth, an osteotomy sagittal angle (e.g., a sagittal angle of correction), an osteotomy coronal angle (e.g., a coronal angle of correction), a transverse pedicle angle or convergence angle, A/P distance and/or neutral alignment.
In another embodiment, the step of preparing the cranial vertebral body 1725, 1745, 1765, 1785 comprises the step of introducing a preparation tool along a path or trajectory on at least one side 1900 and/or the step of introducing a first preparation tool along a first custom path or trajectory on a first side and a second preparation tool along a second custom path or trajectory on a second side 1925. The step of introducing a preparation tool on at least one side, a first side and/or a second side 1900, 1925 comprises the steps of assembling one or more preparation tools on at least one side, a first side and/or a second side; distracting the intervertebral disc space of a localized spine segment within a spine region; and inserting the one or more preparation tools into the localized intervertebral space on at least one side, a first side and/or a second side.
In another embodiment, the step of introducing a preparation tool, a first preparation tool and/or a second preparation tool on at least one side, a first side and/or a second side 1900, 1925 comprises the step of re-identifying and/or re-registering surgical instruments within the navigation system and/or robot. The surgical instruments may have been previously tracked during the preoperative procedure (e.g., a baseline registration), and may not require further reregistration. The surgeon or staff may be able to couple a portion of a reference system and/or robotic arm to the previously identified surgical instrument and begin immediate use of the instrument. Alternatively, the surgeon or staff may couple a portion of a reference system and/or couple to a robotic arm to the previously identified instrument (e.g., the baseline registration during the preoperative method), and may require intraoperative confirmation of spatial relationship or coordinates between the patient and the pre and intraoperative images. As disclosed herein, each of the surgical instruments, including the powered handpiece of the powered system may be adapted and configured to receive a portion of a reference system including at least one tracker, at least one probe, one or more fiducials and/or one or more LEDs. The handpiece may comprise an indentation or channel along the length of the handpiece, between the first end and/or second end of the handpiece. The portion of the reference system may align with the indentation and/or channel.
In another embodiment, the step of introducing a preparation tool on at least one side, a first side and/or a second side 1900, 1925 comprises the step of assembling the preparation tool, a first preparation tool and/or a second preparation tool. The preparation tool comprises a rasp, a manual handle, a powered handle system and/or any combination thereof. The surgeon may prepare the endplates and/or pedicles manually and/or using a powered system. In one embodiment, the surgeon may use a powered system. The surgeon may use a powered handle system 1980. The powered handle system 1980 comprises a powered reciprocating control box 1985, a powered handle or handpiece 1995, a footswitch pedal 2000, one or more cable connectors 1990a, 1990b as shown in
In another embodiment, the step of introducing a preparation tool, a first preparation tool and/or a second preparation tool on at least one side, a first side and/or a second side 1815, 1845 comprises the step of distracting the intervertebral disc space of a localized spine segment within a spine region. This step requires the surgeon to distract the interverbal disc space on at least one side, a first side and/or a second side. The surgeon and/or the robot should over distract the at least one side, a first side and/or a second side by using a height trial. The height trial should comprise at least 1 mm larger or taller than the height trial determined at the step of determining the proper implant height. Maintaining the at least one side, a first side and/or a second side using a height trial that is at least 1 mm greater than determined implant height from the previous step will provide extra tension on the tissues and increase the intervertebral disc space for easier endplate preparation and the completion of the osteotomy of the pedicles. This distraction should be maintained when transitioning from the step of preparing the caudal vertebral body to the step of preparing the cranial vertebral body.
In another embodiment, the step of introducing a preparation tool on at least one side, a first side and/or a second side 1815, 1845 comprises the step of inserting the preparation tool into the localized intervertebral space on at least one side, a first side and/or a second side. This step may require the surgeon and/or robot to introduce or insert the inactivated powered rasp into the distracted intervertebral disc space on the native cranial vertebral body into the at least one side, a first side and/or a second side along a desired path, the one or more objects and/or the one or more SSMs or PSMs. The desired path and/or the one or more objects may be a custom path or virtual trajectory. Alternatively, the desired path and/or one or more objects may comprise a path or trajectory that follows along, match or substantially match the pedicle transverse angle (or pedicle axis) on the at least one side, a first side and/or a second side within a distracted intervertebral disc space. The rasp comprises a long, flat rasp and/or a short, flat rasp. The surgeon should confirm placement and/or positioning of the preparation tool by acquiring at least one image with at least one imaging technique on the native cranial endplate surface.
Alternatively, the surgeon may prepare at least a portion of the native inferior endplate surface 1955 on the cranial vertebral body 1945 following along, matching or substantially matching the one or more objects, the one or more SSM or PSM, and/or a custom path. The custom path, one or more objects, and/or one or more SSMs comprises a pedicle transverse angle (e.g., the pedicle mid axis or convergence angle). The transverse pedicle angle may include 0 degrees to 45 degrees. Accordingly, the surgeon may prepare at least a portion of the native inferior endplate surface 1955 of the cranial vertebral body to comprise a portion of at least one resected surface, a first resected surface, and/or a second resected surface 1965a, 1965b. Alternatively, the surgeon may prepare the entirety of the native cranial surface 1955 to create an entire at least one resected surface, a first rested surface and/or a second resected surface. The resected surface comprises a resected or prepared shape, a first resected or prepared length, a first resected or prepared width and a first resected or prepared depth.
The step of preparing the cranial vertebral body on the at least one side, first side and/or second side 1725, 1745, 1765, 1785 may include the step of acquiring at least image using an imaging technique to confirm the one or more SSMs on at least one side, a first side and/or a second side 1910, 1935. The SSMs comprises a coronal osteotomy angle, a sagittal osteotomy angle, transverse pedicle angle or convergence angle, resection depth, A/P distance and/or neutral alignment. The surgeon may acquire at least one image using at least one imaging technique on at least one side, a first side and/or a second side. The surgeon may further verify SSMs by comparing it to the SSMs measured during the pre-operative planning procedures for restoration or substantial restoration of a patient's coronal and/or sagittal alignment. The at least one image may be performed by using at least one imaging technique. The imaging techniques may comprise 2D or 3D images. The imaging techniques may comprise an MRI, a radiograph, a CT scan, an ultrasound, and/or any combination thereof. The preparation of the endplate surface of the cranial vertebral body on the contralateral side may be performed by repeating the above steps.
In another embodiment, the step of preparing the cranial vertebral body on the at least one side, first side and/or second side 1725, 1745, 1765, 1785 may comprise the step of providing feedback on matching or substantially matching one or more objects that were superimposed on the one or more images 1455 and/or the step of providing feedback on matching or substantially matching a first one or more objects on a first side and a second one or more objects on a second side 1455. The feedback may comprise visual feedback (using the navigation monitor or workstation display), audible feedback, tactile feedback, and/or any combination thereof. The feedback may include visual and/or audible feedback to correct or reposition the surgeon's trajectory and/or robot's trajectory to appropriately match or substantially match the one or more objects and/or projected surgical measurement. The one or more objects may include the SSM (selected surgical measurement), a virtual trajectory, a virtual tool, a virtual spinal implant, and/or any combination thereof. The SSM may include a convergence angle or transverse pedicle angle, A/P distance, neutral alignment, coronal osteotomy angle and/or sagittal osteotomy angle.
With reference to
With reference to
With reference to
The first keel channel may comprise the same dimensions as the second keel channel. The first keel channel may comprise different dimension as the second keel channel. The first transverse pedicle angle of the first keel channel may comprise the same angle as the second transverse pedicle angle of the second keel channel. The first spinal implant may comprise the same selected size as the second spinal implant. The first spinal implant may comprise a different selected size as the second spinal implant. The selected sizes may include different lengths or heights. The first one or more objects may comprise a same object as the second one or more objects. The first one or more objects may comprise a different object as the second on or more objects. The first trajectory may comprise a same and/or different trajectory than the second trajectory. The first SSM or PSM may comprise a different measurement than the second PSM or SSM. The first SSM or PSM may comprise a same measurement than the second PSM or SSM.
In one embodiment, the step of completing at least one caudal keel channel on the caudal vertebral body on at least one side, a first side and/or a second side 1730, 1750, 1770, 1790 comprises the step of obtaining one or more SSM or PSM, a first one or more SSM or PSM and/or a second SSM or PSM for optimal alignment (e.g., sagittal and/or coronal alignment) from the preoperative method or procedure or software application. The one or more SSM or PSM, the first one or more SSM or PSM, and/or a second one or more SSM or PSM may comprise a sagittal osteotomy angle or trajectory (e.g., sagittal angle of correction), a coronal osteotomy angle or trajectory (e.g., coronal angle of correction), a transverse pedicle angle or convergence angle, an A/P distance, keel alignment, and/or neutral alignment. The sagittal osteotomy angle or trajectory comprises an angle of 0 degrees to 40 degrees. The coronal osteotomy angle or trajectory comprises an angle of 0 degrees to 40 degrees. The transverse pedicle angle may comprise 0 degrees to 45 degrees. The sagittal osteotomy angle, the coronal osteotomy angle, the transverse pedicle angle and/or the A/P distance may be different in different spine segments within different spine regions. A first coronal osteotomy angle may comprise a different angle than the second coronal osteotomy angle. A first coronal osteotomy angle may comprise a same angle than the second coronal osteotomy angle. A first sagittal osteotomy angle may comprise a different angle than the second sagittal osteotomy angle. A first sagittal osteotomy angle may comprise a same angle than the second sagittal osteotomy angle.
In one embodiment, the step of completing at least one caudal keel channel, a first caudal keel channel and/or a second caudal keel channel on the caudal vertebral body on at least one side, a first side and/or a second side 1730, 1750, 1770, 1790 comprises the step of superimposing one or more objects, a first one or more objects and/or a second one or more objects onto one or more operative images 2005, 2030. Alternatively, the step of superimposing one or more objects onto one or more operative images further comprises the step of transforming the preoperative SSM or PSM into one or more objects, a first one or more objects and/or a second one or more objects onto one or more operative images. The operative images may comprise a one or more preoperative images, one or more operative images, one or more synchronized operative images and/or one or more MPR images.
The one or more objects, the first one or more objects, and/or a second one or more objects may comprise a surgical measurement or projected surgical measurement (PSM), a trajectory path, a virtual surgical instrument, a virtual spinal implant and/or any combination thereof. The trajectory path may comprise the trajectory of a surgical instrument, surgical approach and/or one or more spinal implants. The trajectory path, surgical instrument and/or spinal implant may include a first end and a second end. The trajectory path may match or substantially match one or more SSM or PSM, a first one or more SSM and/or a second one or more SSM or PSM. In one exemplary embodiment, the one or more objects, the first one or more objects and/or the second one or more objects comprises a PSM or SSM. The PSM or SSM includes an osteotomy sagittal angle (e.g., a sagittal angle of correction), an osteotomy coronal angle (e.g., a coronal angle of correction), a transverse pedicle angle or convergence angle, A/P distance, keel alignment and/or neutral alignment.
In one embodiment, the step of completing at least one caudal keel channel, a first caudal keel channel and/or a second caudal keel channel on the caudal vertebral body on at least one side, a first side and/or a second side 1730, 1750, 1770, 1790 comprises the step of positioning the user, surgeon and/or robot to the desired one or more objects, a first one or more objects and/or a second one or more objects for the selected intraoperative step and/or the entire intraoperative steps 2010, 2035. The navigation system may display one or more objects, the first one or more objects and/or the second one or more objects. The navigation system may further transmit spatial coordinates for the targeted anatomy to create a surgical trajectory, a first surgical trajectory, a second surgical trajectory and projecting one or more objects, the first one or more objects and the second one or more objects that matches the surgical trajectory.
The surgeon and/or robotic system may hold the one or more surgical instruments and/or a registration tool (i.e., a probe, a guide and/or any other tool) to the desired position and/or one or more objects according to the spatial coordinates of the surgical trajectory for the desired intraoperative step. The one or more objects, the first one or more objects and/or a second one or more objects may match or substantially match one or more projected surgical measurements (PSM). The one or more objects comprise one or more PSMs, a virtual surgical instrument, a virtual spinal implant, and/or any combination thereof. In one exemplary embodiment, the one or more objects, the first one or more objects and/or the second one or more objects comprises a PSM or SSM. The PSM or SSM includes an osteotomy sagittal angle (e.g., a sagittal angle of correction), an osteotomy coronal angle (e.g., a coronal angle of correction), a transverse pedicle angle or convergence angle, A/P distance, keel alignment, and/or neutral alignment.
In one embodiment, the step of completing at least one caudal keel channel, a first caudal keel channel and/or a second caudal keel channel on the caudal vertebral body on at least one side, a first side and/or a second side 1730, 1750, 1770, 1790 may comprise the step introducing a preparation tool, a first preparation tool and/or a second preparation tool on at least one side, a first side and/or a second side 2015, 2040. The step of introducing a preparation tool, a first preparation tool and/or a second preparation tool on at least one side, a first side and/or a second side 2015, 2040 comprises the steps of: assembling the keel tools; and inserting the keel tool into the prepared interverbal disc space.
The step of introducing a preparation tool, a first preparation tool and/or a second preparation tool on at least one side, a first side and/or a second side 2015, 2040 comprises the steps of registering or re-identification of one or more surgical instruments for the navigation system and/or robotic system. The surgical instruments may have been previously tracked during the preoperative procedure (e.g., a baseline registration), and may not require further reregistration. The surgeon or staff may be able to couple a portion of a reference system and/or robotic arm to the previously identified surgical instrument and begin immediate use of the instrument. Alternatively, the surgeon or staff may couple a portion of a reference system and/or couple to a robotic arm to the previously identified instrument (e.g., the baseline registration during the preoperative method), and may require intraoperative confirmation of spatial relationship or coordinates between the patient and the pre and intraoperative images. As disclosed herein, each of the surgical instruments, including the powered handpiece of the powered system may be adapted and configured to receive a portion of a reference system including at least one tracker, at least one probe, one or more fiducials and/or one or more LEDs. The handpiece may comprise an indentation or channel along the length of the handpiece, between the first end and/or second end of the handpiece. The portion of the reference system may align with the indentation and/or channel.
In another embodiment, the step introducing a preparation tool, a first preparation tool and/or a second preparation tool on at least one side, a first side and/or a second side 2015, 2040 comprises the step of assemble the at least one preparation tool, a first preparation tool and/or a second preparation tools. The tools may comprise a rasp, a manual handle, and/or a powered system. The surgeon may create the caudal keel channels using a manual and/or a powered system. In one embodiment, the surgeon may use a powered system as shown in
In one embodiment, the step of completing at least one caudal keel channel, a first caudal keel channel and/or a second caudal keel channel on the caudal vertebral body on at least one side, a first side and/or a second side 1730, 1750, 1770, 1790 may comprise the steps of inserting the at least one keel tool, a first keel tool and/or a second keel tool onto at least one resected caudal surface, a first resected caudal surface, and/or a second caudal keel surface within the prepared interverbal disc space. The user, surgeon and/or robot may align the keel rasp onto the resected surface, the first resected surface and/or the second resected surface of the caudal vertebral body. The surgeon may continue to translate, slide or introduce the inactivated powered rasp to the at least one side, a first side and/or a second side along the desired resected surface, a custom path, one or more objects and/or one or more SSM or PSM to ensure that the proper path or trajectory is followed. Alternatively, the surgeon and/or robot may introduce the inactivated powered rasp following along the pedicle transverse angle (or pedicle mid axis or convergence angle) on the at least one side within an intervertebral disc space. The rasp comprises a long or short keel rasp. Furthermore, the surgeon and/or robot may desirably retract the exiting nerve root and lateral thecal sack to protect the neural elements during the use of the rasp.
In one embodiment, the step of completing at least one caudal keel channel on the caudal vertebral body on at least one side, a first side and/or a second side 1730, 1750, 1770, 1790 comprises the step of creating at least one keel channel on at least one side 2020 and/or the step of creating a first keel channel on a first side and/or a second keel channel on a second side 2045. The surgeon should realign the keel rasp to the posterior end of the caudal vertebral body and activate the powered rasp by pressing on the footswitch—a light pressure equals a slow reciprocating speed, and a hard pressure equals a faster reciprocating speed. The surgeon prepares and/or creates a keel channel on a least a portion of the resected surface on the caudal vertebral at a desired speed on at least one side, a first side and/or a second side. Alternatively, the surgeon may create the keel channel on the caudal vertebral body following along, matching or substantially matching the pedicle transverse angle (e.g., the pedicle axis) to create a keel channel on at least one side, a first side and/or a second side.
The keel rasp comprises a long or short keel rasp. The keel channel comprises a keel channel depth, a width and a length. The keel channel depth on the caudal vertebral body extends from a top surface of the caudal resected surface downwards towards the inferior direction. The keel channel length of the caudal vertebral body further extends from the posterior end of the caudal vertebral body towards the anterior surface of the caudal vertebral body. The keel channel may be positioned centrally on the caudal resected surface and/or following along the transverse mid axis of the caudal resected surface. The keel channel depth, width and length matches or substantially matches a portion of the spinal implant keel length, width and/or depth. The keel channel width matches or substantially matches the widest portion of the spinal implant keel width.
In another embodiment, the surgeon prepares and/or creates a first keel channel on a least a portion of the first resected surface on the caudal vertebral body on a first side following a first custom path or trajectory and a second keel channel on the second resected surface on the caudal vertebral body on a second side following a second custom path or trajectory as shown in
In another embodiment, the step of completing at least one caudal keel channel on the caudal vertebral body on at least one side, a first side and/or a second side 1730, 1750 comprises the step of confirming at least one keel channel on a first side 2025 and/or the step of confirming a first caudal keel channel on a first side of a caudal vertebral body and a second caudal keel channel on the second side on the caudal vertebral body by acquiring at least one or more images. The surgeon may confirm the at least one caudal keel channel, a first caudal keel channel and/or a second caudal keel channel dimensions, the alignment and/or the trajectory or custom path. The at least one caudal keel channel, a first caudal keel channel and/or a second caudal keel channel dimensions comprises a length, a width and/or a depth. The alignment comprises confirmation that the keel channel follows or substantially is positioned along the transverse mid axis of the caudal resected surface and/or centrally located between the width of the resected surface. The custom path or trajectory path comprises confirmation of the at least one caudal keel channel, the first caudal keel channel and/or the second caudal keel channel follows, matches or substantially matches the convergence angle (or transverse pedicle angle). One or more operative images are acquired using at least one imaging technique. The imaging techniques may comprise 2D or 3D images. The imaging techniques may comprise an MRI, a radiograph, a CT scan, an ultrasound, and/or any combination thereof.
In another embodiment, the step of completing at least one caudal keel channel, a first caudal keel channel and/or a second caudal keel channel on the caudal vertebral body on at least one side, a first side and/or a second side 1730, 1750, 1770, 1790 may comprise the step of providing feedback on matching or substantially matching one or more objects that were superimposed on the one or more images 1455 and/or the step of providing feedback on matching or substantially matching a first one or more objects on a first side and a second one or more objects on a second side 1455. The feedback may comprise visual feedback (using the navigation monitor or workstation display), audible feedback, tactile feedback, and/or any combination thereof. The feedback may include visual and/or audible feedback to correct or reposition the surgeon's trajectory and/or robot's trajectory to properly match or substantially match the one or more objects and/or projected surgical measurement. The one or more objects may include the SSM (selected surgical measurement), a virtual trajectory, a virtual tool, a virtual spinal implant, and/or any combination thereof. The SSM may include a keel alignment, keel dimensions, convergence angle or transverse pedicle angle, A/P distance, neutral alignment, coronal osteotomy angle and/or sagittal osteotomy angle.
In one embodiment, the step of providing feedback 1455 may further comprise the steps of: generating a non-desired trajectory path and/or non-desired one or more objects; comparing the desired trajectory path to the non-desired trajectory path 1460; correcting user to return to desired trajectory path if the non-desired trajectory path is different than the desired trajectory path 2010, 2035, 2040, 2045. In another embodiment, the step of providing feedback 1455 may further comprise the steps of: generating a second trajectory path and/or non-desired second one or more objects; comparing the first trajectory path to the second trajectory path 1460; correcting user to return to first trajectory path if the second trajectory path is different than the first trajectory path 2010, 2035, 2040, 2045. The step of providing feedback 1455 may comprise at least one side, a first side and/or a second side.
With reference to
With reference to
In another embodiment, the step of preparing an intervertebral space within a localized spinal segment for alignment and motion restoration 1170, 1170a, 1170b, 1170c comprises the step of completing a first cranial keel channel on the cranial vertebral body on a first side. The step of completing a first cranial keel channel on the cranial vertebral body on the first side comprises the steps of: superimposing a first one or more objects onto a first one or more operative images on a first side; positioning robot and/or surgeon to the first one or more objects on a first side; introducing the first preparation tool into the prepared intervertebral disc space that aligns with the first caudal keel channel on a first side; creating a first cranial keel channel above the first prepared or resected surface on the cranial vertebral body; confirming the at least one cranial keel channel placement or positioning by acquiring at least one image using at least one imaging technique; providing feedback on matching or substantially matching the first one or more objects on a second side.
The first keel channel comprises following along, matching or substantially matching the transverse pedicle angle. The transverse pedicle angle comprises an angle of 0 degrees to 45 degrees. With this embodiment, the surgeon should proceed with all the remaining steps of preparing the intervertebral space within a localized spinal segment for alignment and motion restoration for a first side prior to completing the steps for a second side. The remaining steps include step of preparing an intervertebral space within a localized spinal segment for alignment and motion restoration for a first side; implanting a first spinal implant on a first side; preparing an intervertebral space within a localized spinal segment for alignment and motion restoration for a second side; and implanting a second spinal implant on a second side. In one embodiment, the step of preparing a first cranial keel channel on the cranial vertebral body on a first side comprises the step of repeating all the above steps for a second cranial keel channel on the cranial vertebral body on a second side.
The first cranial keel channel may comprise the same dimensions as the second cranial keel channel. The first cranial keel channel may comprise different dimensions as the second cranial keel channel. The first transverse pedicle angle of the first cranial keel channel may comprise the same angle as the second transverse pedicle angle of the second cranial keel channel. The first spinal implant may comprise the same selected size as the second spinal implant. The first spinal implant may comprise a different selected size as the second spinal implant. The selected sizes may include different lengths or heights.
In one embodiment, the step of completing at least one cranial keel channel, a first cranial keel channel and/or a second cranial keel channel on the cranial vertebral body on at least one side, a first side and/or a second side 1735, 1755, 1775, 1795 comprises the step of superimposing one or more objects, a first one or more objects and/or a second one or more objects onto one or more operative images 2050, 2075. Alternatively, the step of superimposing one or more objects onto one or more operative images further comprises the step of transforming the preoperative SSM or PSM into one or more objects, a first one or more objects and/or a second one or more objects onto one or more operative images. The operative images may comprise a one or more preoperative images, one or more operative images, one or more synchronized operative images and/or one or more MPR images.
The one or more objects, the first one or more objects, and/or a second one or more objects may comprise a surgical measurement or projected surgical measurement (PSM), a trajectory path, a virtual surgical instrument, a virtual spinal implant and/or any combination thereof. The trajectory path may comprise the trajectory of a surgical instrument, surgical approach and/or one or more spinal implants. The trajectory path may match or substantially match one or more SSM or PSM, a first one or more SSM and/or a second one or more SSM or PSM. In one exemplary embodiment, the one or more objects, the first one or more objects and/or the second one or more objects comprises a PSM or SSM. The PSM or SSM includes an osteotomy sagittal angle (e.g., a sagittal angle of correction), an osteotomy coronal angle (e.g., a coronal angle of correction), a transverse pedicle angle or convergence angle, A/P distance, keel alignment and/or neutral alignment.
In one embodiment, the step of completing at least one cranial keel channel, a first cranial keel channel and/or a second cranial keel channel on the cranial vertebral body on at least one side, a first side and/or a second side 1735, 1755, 1775, 1795 comprises the step of positioning the user, surgeon and/or robot to the desired one or more objects, a first one or more objects and/or a second one or more objects onto one or more images for the selected intraoperative step and/or the entire intraoperative steps 2055, 2080. The navigation system may display one or more objects, the first one or more objects and/or the second one or more objects. The navigation system may further transmit spatial coordinates for the targeted anatomy for one or more objects, the first one or more objects and the second one or more objects. The surgeon and/or robotic system may hold the one or more surgical instruments and/or a registration tool (i.e., a probe, a guide and/or any other tool) to the desired position and/or one or more objects according to the spatial coordinates of the surgical trajectory for the desired intraoperative step. The one or more objects, the first one or more objects and/or a second one or more objects may match or substantially match one or more projected surgical measurements (PSM). The one or more objects comprise one or more PSMs, a virtual surgical instrument, a virtual spinal implant, and/or any combination thereof. In one exemplary embodiment, the one or more objects, the first one or more objects and/or the second one or more objects comprises a PSM or SSM. The PSM or SSM includes an osteotomy sagittal angle (e.g., a sagittal angle of correction), an osteotomy coronal angle (e.g., a coronal angle of correction), a transverse pedicle angle or convergence angle, A/P distance, keel alignment, and/or neutral alignment.
In another embodiment, the step of completing at least one cranial keel channel, a first cranial keel channel and/or a second cranial keel channel on the cranial vertebral body on at least one side, a first side and/or a second side 1735, 1755, 1775, 1795 comprises the step of introducing the at least one preparation tool, a first preparation tool, and/or a second preparation tool into the prepared intervertebral disc space that aligns with the at least one caudal keel channel on at least one side, a first side and/or a second side 2060, 2085. The step of introducing the at least one preparation tool, a first preparation tool, and/or a second preparation tool into the prepared intervertebral disc space that aligns with the at least one caudal keel channel on at least one side, a first side and/or a second side 2060, 2085 comprises the steps of: assembling the at least one preparation tool, a first preparation tool and/or a second preparation tool; and inserting a portion of the at least one preparation tool, a first preparation tool and/or a second preparation tool into the at least one caudal keel channel, a first caudal keel channel and/or second caudal keel channel to align the at least one cranial keel channel, a first cranial keel channel and/or a second cranial keel channel.
In one embodiment, the surgeon may subsequently prepare and/or assemble the proper preparation tools. The tools may comprise a keel rasp, a manual handle, and/or a powered system. The tools may further comprise an AO modular connector and/or a keel alignment guide 3030. In one embodiment, the surgeon may use a powered system, a keel alignment guide and a keel rasp. The powered system comprises a powered reciprocating system 1980 as shown in
The surgeon may also assemble the alignment guide, if necessary, as shown in
In another embodiment, the step of introducing the at least one preparation tool, a first preparation tool, and/or a second preparation tool into the prepared intervertebral disc space that aligns with the at least one caudal keel channel on at least one side, a first caudal keel channel on a first side and/or a caudal keel channel on a second side comprises the step of inserting a portion of the at least one preparation tool, a first preparation tool and/or a second preparation tool into the at least one caudal keel channel, a first caudal keel channel and/or second caudal keel channel to align the at least one cranial keel channel, a first cranial keel channel and/or a second cranial keel channel.
The step of inserting a portion of the at least one preparation tool, a first preparation tool and/or a second preparation tool into the at least one caudal keel channel, a first caudal keel channel and/or second caudal keel channel to align the at least one cranial keel channel, a first cranial keel channel and/or a second cranial keel channel comprises the step of retracting the exiting nerve root and the thecal sac using retractors to protect the neural elements. This step may further comprise aligning the keel member 3035 to the posterior end of the caudal keel channel 3005a. The surgeon and/or user may insert or introduce a portion of the preparation tool assembly into a portion of the caudal keel channel 3005 on the one the at least one side, a first side and/or a second side without pressing, squeezing or compressing 3100 the handle 3050 of the alignment guide 3030 relative to the powered handpiece 1995 and/or toward the powered handle piece 1995 as shown in
Alternatively, surgeon may align and insert or introduce a portion of the alignment guide 3030 rasp into the at least one caudal keel channel, the first caudal keel channel and/or a second caudal keel channel 3005a within the prepared intravertebral disc space that follows, matches and/or substantially matches the pedicle transverse angle (or pedicle axis) on the at least one side without pressing, squeezing or compressing 3100 the handle 3050 of the alignment guide 3030 relative to the powered handpiece 1995 as shown in
The step of completing at least one cranial keel channel, a first cranial keel channel and/or a second cranial keel channel on the cranial vertebral body on at least one side, a first side and/or a second side 1735, 1755, 1775, 1795 comprises the step of creating at least one cranial keel channel along a custom path or trajectory path on at least one side 2065 and/or the step of creating first cranial keel channel along a first custom path or trajectory path on a first side and a second cranial keel channel along a second custom path or trajectory path on a second side 2090. The surgeon and/or user may activate the powered rasp by pressing on the footswitch—a light pressure equals a slow reciprocating speed, and a hard pressure equals a faster reciprocating speed. The surgeon and/or user may compress 3100 the handle 3050 of the alignment guide 3030 toward the powered handpiece 1995 to lift the keel member 3035 and/or the keel base 3040 of the alignment guide 3030 superiorly towards at least a portion of the cranial resected or prepared surface 1965a until it contacts at least a portion of the at least one resected or prepared surface, a first resected or prepared surface and/or a second resected or prepared surface 1965a of the cranial vertebral body 1940 on at least one side, a first side and/or a second side as shown in
The compression 3100 and the contact with at least a portion of the cranial resected surface 1965a will prepare and/or create at least one cranial keel channel, a first cranial keel channel and/or a second cranial keel channel 3105a, 3105b on a least a portion of the cranial resected surface 1965a on the cranial vertebral body 1940. The keel rasp 3085 may stamp or inscribe as shown in
The at least one cranial keel channel, a first cranial keel channel and/or a second cranial keel channel 3105a, 3105b on the cranial vertebral body 1940 extends from the cranial resected surface 1965a towards the superior direction. The at least one cranial keel channel, a first cranial keel channel and/or a second cranial keel channel 3105a, 3105b comprises a cranial keel channel depth 3145, a width 3140 and a length 3135. The cranial keel channel depth 3145, width 3140 and length 3135 matches or substantially matches a portion of the spinal implant keel length, width and/or depth. The cranial keel channel width 3145 matches or substantially matches the widest portion of the spinal implant keel width. The cranial keel channel length 3135 may match or substantially match the cranial resected surface length. The cranial keel channel length 3135 may be less than the cranial resected surface length. Once the keel channel has been created, the surgeon may remove the alignment guide and/or the keel rasp from the prepared intervertebral space.
The step of completing at least one cranial keel channel, a first cranial keel channel and/or a second cranial keel channel on the cranial vertebral body on at least one side, a first side and/or a second side 1735, 1755, 1775, 1795 comprises the step of confirming cranial keel channel placement, alignment and/or positioning on the at least one side 2070 and/or the step of confirming a first cranial keel channel placement and alignment on a first side and a second cranial keel channel placement and alignment on a second side by acquiring at least one image with at least one imaging technique 2095. The placement, alignment and/or positioning of the at least one cranial keel channel includes longitudinal alignment along 3130, 3155 and/or vertical alignment 3125, 3150 of the at least one caudal keel channel 3005a on the at least one caudal vertebral body 1945 relative to the at least one cranial keel channel 3105a on the at least one cranial vertebral body 1940. Alternatively, the placement, alignment and/or positioning includes longitudinal alignment along 3130, 3155 and/or vertical alignment 3125, 3150 of the first caudal keel channel 3005a on the at least one caudal vertebral body 1945 relative to the first cranial keel channel 3105a on the at least one cranial vertebral body 1940 and the second caudal keel channel 3005b on the at least one caudal vertebral body 1945 relative to the second cranial keel channel 3105b on the at least one cranial vertebral body.
In one embodiment, the at least one side comprises at least one caudal keel channel 3005a and at least one cranial keel channel 3105a. The at least one caudal keel channel 3005a comprises a caudal longitudinal axis 3150 and the at least one cranial keel channel 3105a comprises a cranial longitudinal axis 3130. The cranial longitudinal axis 3130 and the caudal longitudinal axis 3155 are parallel and/or substantially parallel. In another embodiment, the at least one caudal keel channel 3005a comprises a caudal vertical axis 3150 and the at least one cranial keel channel 3105a comprises a cranial vertical axis 3125. The cranial vertical axis 3125 and the caudal vertical axis 3150 are co-axial and/or substantially co-axial. In another embodiment, the at least a portion of the cranial longitudinal axis 3130 and at least a portion of the caudal longitudinal axis 3155 are parallel and/or substantially parallel, and/or a least a portion of the cranial vertical axis 3125 and the caudal vertical axis 3150 are co-axial and/or substantially co-axial.
In another embodiment, the first side comprises first caudal keel channel 3005a and a first cranial keel channel 3105a, and the second side comprises a second caudal keel channel 3005b and a second cranial keel channel 3105b. The first caudal keel channel 3005a comprises a first caudal longitudinal axis 3150 and the second caudal keel channel 3005b comprises a second caudal longitudinal axis. The first cranial keel channel 3105a comprises a first cranial longitudinal axis 3130 and the second cranial keel channel 3105b comprises a second cranial longitudinal axis. The first cranial longitudinal axis 3130 and the first caudal longitudinal axis 3155 are parallel and/or substantially parallel on the first side and the second cranial longitudinal axis and the second caudal longitudinal axis are parallel and/or substantially parallel on the second side. In another embodiment, the first caudal keel channel 3005a comprises a first caudal vertical axis 3150 and the first cranial keel channel 3105a comprises a first cranial vertical axis 3125, and the second caudal keel channel 3005b comprises a second caudal vertical axis and the second cranial keel channel 3105b comprises a second cranial vertical axis. The first cranial vertical axis 3125 and the first caudal vertical axis 3150 are co-axial and/or substantially co-axial on a first side and the second cranial vertical axis and the second caudal vertical axis are co-axial and/or substantially co-axial on a second side.
In another embodiment, the first side includes a first caudal keel channel and a first cranial keel channel as shown in
Surgical Deployment Technique—Implanting a Spinal Implant
With reference to
With reference to
The first spinal implant may comprise the same selected size as the second spinal implant. The first spinal implant may comprise a different selected size as the second spinal implant. The first prepared intervertebral space may comprise the same vertebral localized segment as the second prepared intervertebral space. The first intervertebral space may comprise a different localized segment as the second prepared intervertebral space. The at least one spinal implant, the first spinal implant and/or a second spinal implant characteristics may comprise confirmation of aligned cranial and caudal keel channels, the angle of convergence or transverse pedicle angle, the implant positioning, the proper intervertebral space preparation, the proper implant sizing, and/or any combination thereof. The first one or more objects are the same objects as the second one or more objects. The first one or more objects are different than the second one or more objects. The first trajectory path is the same trajectory as the second trajectory path. The first trajectory path is a different trajectory as the second trajectory path.
The step of implanting at least one spinal implant, a first implant and/or a second implant within a prepared intervertebral space on at least one side, a first side and/or a second side 1175, 1175a, 1175b comprises the step of superimposing one or more objects, a first one or more objects and/or a second one or more objects onto one or more operative images 3160, 3195. Alternatively, the step of superimposing one or more objects, a first one or more objects and/or a second one or more objects onto one or more operative images 3160, 3195 further comprises the step of transforming the preoperative SSM or PSM into one or more objects, a first one or more objects and/or a second one or more objects onto one or more operative images. The operative images may comprise a one or more preoperative images, one or more operative images, one or more synchronized operative images and/or one or more MPR images.
The one or more objects, the first one or more objects, and/or a second one or more objects may comprise a surgical measurement or projected surgical measurement (PSM), a trajectory path, a virtual surgical instrument, a virtual spinal implant and/or any combination thereof. The trajectory path may comprise the trajectory of a surgical instrument, surgical approach and/or one or more spinal implants. The trajectory path may match or substantially match one or more SSM or PSM, a first one or more SSM and/or a second one or more SSM or PSM. In one exemplary embodiment, the one or more objects, the first one or more objects and/or the second one or more objects comprises a PSM or SSM. The PSM or SSM includes an osteotomy sagittal angle (e.g., a sagittal angle of correction), an osteotomy coronal angle (e.g., a coronal angle of correction), a transverse pedicle angle or convergence angle, A/P distance, keel alignment and/or neutral alignment.
The step of implanting at least one spinal implant, a first implant and/or a second implant within a prepared intervertebral space on at least one side, a first side and/or a second side 1175, 1175a, 1175b comprises the step of positioning the user, surgeon and/or robot to the desired one or more objects, a first one or more objects and/or a second one or more objects on at least one side, a first side and/or a second side 3165, 3200 onto one or more images for the selected intraoperative step and/or the entire intraoperative steps. The navigation system may display one or more objects, the first one or more objects and/or the second one or more objects. The navigation system may further transmit spatial coordinates for the targeted anatomy for one or more objects, the first one or more objects and the second one or more objects.
The surgeon and/or robotic system may position the one or more surgical instruments and/or a registration tool (i.e., a probe, a guide and/or any other tool) to the one or more objects, first one or more objects and/or second one or more objects, trajectory path or custom path according to the spatial coordinates of the surgical trajectory for the desired intraoperative step. The one or more objects, the first one or more objects and/or a second one or more objects may match or substantially match one or more projected surgical measurements (PSM). The one or more objects comprise one or more PSMs, a virtual surgical instrument, a virtual spinal implant, and/or any combination thereof. In one exemplary embodiment, the one or more objects, the first one or more objects and/or the second one or more objects comprises a PSM or SSM. The PSM or SSM includes an osteotomy sagittal angle (e.g., a sagittal angle of correction), an osteotomy coronal angle (e.g., a coronal angle of correction), a transverse pedicle angle or convergence angle, A/P distance, keel alignment, and/or neutral alignment.
The step of implanting at least one spinal implant, a first implant and/or a second implant within a prepared intervertebral space on at least one side, a first side and/or a second side 1175, 1175a, 1175b comprises the steps of: preparing at least a portion of at least one deployment tool for the at least one side 3170 and/or the steps of preparing at least a portion of a first deployment tool for a first side and at least a portion of a second deployment tool for the second side 3205. The step of preparing at least a portion of the at least one deployment tool, a first deployment tool and/or a second deployment tool for the at least one side, first side and/or second side 3170, 3205 comprises the steps of: acquiring a portion of the at least one deployment tool, a first deployment tool and/or a second deployment tool parts; and assembling at least a portion of the at least one deployment tool, a first deployment tool and/or a second deployment tool.
The step of acquiring a portion of the at least one deployment tool, a first deployment tool and/or a second deployment tool parts includes confirming one or more of the deployment tool parts are available to assemble into a deployment tool assembly. With reference to
The user and/or surgeon may dispose and/or couple the draw bar 3270 onto the shaft subassembly 3250. The draw bar 3270 comprises a first end, a second end and an opening 3275. The shaft subassembly 3250 comprises a first end, a second end. The first end of the shaft subassembly 3250 comprises a grasping tip 3265, the grasping tip 3265 includes a hook. The user and/or surgeon may align the opening 3275 on the draw bar 3270 to the dowel pin 3255 that extends from the shaft subassembly 3250. The first end of the draw bar 3270 may flush or below the first end of the shaft subassembly 3250. The locking knob 3245 may be secured onto the shaft subassembly 3250 and the draw bar 3270 by turning clockwise. The surgeon and/or user should ensure that the second end of the draw bar 3270 may be disposed within the locking knob 3245 to secure the draw bar 3270 and prevent premature or unwarranted translation. The locking knob 3245 that is secured over the draw bar 3270 and the shaft subassembly 3250 should be coupled and/or secured to the handle subassembly 3230.
The step of implanting at least one spinal implant, a first implant and/or a second implant within a prepared intervertebral space on at least one side, a first side and/or a second side 1175, 1175a, 1175b comprises the step of preparing the at least one spinal implant for deployment on the at least one side 3175 and the step of preparing a first spinal implant for deployment on a first side and a second spinal implant for deployment on a second side 3210. The step of preparing at least one spinal implant, a first spinal implant and/or a second spinal implant on at least one side, a first side and/or a second side 3175, 3210 comprises the steps of: selecting at least one pre-determined and/or proper sized at least one spinal implant, a first implant and/or a second implant; and assembling the at least one spinal implant, a first implant and/or a second implant; and securing the at least one spinal implant, a first implant and/or a second implant to the at least one deployment tool, a first deployment tool and/or a second deployment tool.
The step of selecting at least one predetermined spinal implant includes a selection of the implant that was pre-determined during the step of selecting a proper spinal implant size on at least one side. Alternatively, the selection of the proper spinal implant may further comprise a first spinal implant and a second implant that was predetermined during the step of selecting a proper first spinal implant on a first side and a second spinal implant on a second side. As discussed herein, the surgeon engaged in tissue balancing, length trialing and height trialing on at least one side a spinal region to determine the proper size (e.g., length and height) of the spinal implant, a first spinal implant and/or a second spinal implant that should be deployed into the prepared intervertebral space. The surgeon may acquire the proper size from 15 different available sizes.
With reference to
The inferior component 3300 comprises an inferior articulation component 3315, an inferior keel 3335 and a bridge 3320. The inferior articulation component 3315 comprises a ball surface 3325. The ball surface 3325 comprising a convex or hemi-spherical shape. The socket surface 3310 of the superior component 3295 contacts and engages the ball surface 3325 of the inferior component 3300 to create a polyaxial articulation joint. The polyaxial articulation joint is movable in different orientations, including flexion, extension, rotation, lateral flexion; contralateral flexion; and/or any combination thereof. The fixation screw is disposed through the posterior end of the bridge 3320 to be secured to inferior or caudal vertebral body. The fixation screw is disposed at an angle. The angle may match or substantially match the sagittal pedicle angle. The bridge 3320 further comprises a channel 3340, the channel 3340 is sized and configured to receive a retainer ring.
The superior component 3295 further comprises a superior base and a superior keel 3330. The superior articulation component 3305 is disposed onto the superior base and/or the superior articulation component 3305 is coupled to the superior base. The superior base comprises a first material and the superior articulation component 3305 comprises a second material. The first material may comprise the same material as the second material. The first material may comprise a different material than the second material. The materials may comprise a polymer, a metal and/or a ceramic. The polymer may comprise thermoplastics or thermosets. The polymer may further comprise cross-linked polymers. The polymer may comprise polyethylene (PE), high density polyethylene (HDPE), ultra-high molecular weight polyethylene (UHMWPE), and/or any combination thereof. The polymers may further comprise being cross-linked one or more times. The polymers may further comprise antioxidant doped or impregnated polymers. The antioxidants may include Vitamin E or Vitamin C. The metals may comprise stainless steel, titanium, titanium alloys, cobalt chrome, cobalt chrome alloys, and/or any combination thereof.
The inferior component 3300 further comprises an inferior base and an inferior keel 3335. The inferior articulation component 3315 is disposed onto the inferior base and/or the inferior articulation component 3315 is coupled to the inferior base. The bridge 3320 is coupled to the posterior end of the inferior base and extends posteriorly and/or extends in the posterior direction. The inferior base comprises a third material. Each of the first material, second material and/or third material may comprise the same material. Each of the first material, second material and/or the third material may comprise a different material. The materials may comprise a polymer, a metal and/or a ceramic. The polymer may comprise thermoplastics or thermosets. The polymer may further comprise cross-linked polymers. The polymer may comprise polyethylene (PE), high density polyethylene (HDPE), ultra-high molecular weight polyethylene (UHMWPE), and/or any combination thereof. The polymers may further comprise being cross-linked one or more times. The polymers may further comprise antioxidant doped or impregnated polymers. The antioxidants may include Vitamin E or Vitamin C. The metals may comprise stainless steel, titanium, titanium alloys, cobalt chrome, cobalt chrome alloys, and/or any combination thereof.
At least a portion of the bridge 3320, the inferior base and/or the superior base may comprise a coating. Alternatively, the entirety of the bridge 3320, inferior base and/or superior base may comprise a coating. The coatings may include inorganic coatings or organic coatings. The coatings may further include a metal coating, a polymer coating, a composite coating (ceramic-ceramic, polymer-ceramic, metal-ceramic, metal-metal, polymer-metal, etc.), a ceramic coating, an anti-microbial coating, a growth factor coating, a protein coating, a peptide coating, an anti-coagulant coating, an antioxidant coating and/or any combination thereof. The antioxidant coatings may comprise naturally occurring or synthetic compounds. The natural occurring compounds comprises Vitamin E and Vitamin C (tocotrienols and tocopherols, in general), phenolic compounds and carotenoids. Synthetic antioxidant compounds include a-lipoic acid, N-acetyl cysteine, melatonin, gallic acid, captopril, taurine, catechin, and quercetin, and/or any combination thereof. The coatings can be impregnated, applied and/or deposited using a variety of coating techniques. These techniques include sintered coating, electrophoretic coating, electrochemical, plasma spray, laser deposition, flame spray, biomimetic deposition and wet methods such as sol-gel-based spin- and -dip or spray-coating deposition have been used most often for coating implants.
The metal coatings may comprise titanium, titanium alloys, cobalt-chrome alloys, platinum and stainless steel, and/or any combination thereof. More specifically, the metal coating includes titanium and/or cobalt-chrome molybdenum (CoCrMo). The polymer coatings may include thermoplastic or thermoset polymers. The polymers may further include carbon fiber, polyether ether ketone (PEEK), polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE), polycarbonate (PC), polypropylene (PP) and/or any combination thereof. The ceramic coatings may include alumina ceramics, Zirconia (ZrO2) ceramics, Calcium phosphate or hydroxyapatite (Ca10(PO46(OH)2) ceramics, titanium dioxide (TiO2), silica (SiO2), Zinc Oxide (ZnO) and/or any combination thereof.
With reference
The step of implanting at least one spinal implant, a first implant and/or a second implant within a prepared intervertebral space on at least one side, a first side and/or a second side 1175, 1175a, 1175b comprises the steps of: deploying at least one spinal implant into at least one side 3180 and/or deploying a first spinal implant into a first side and a second spinal implant into a second side 3215. With reference to
With reference to
With reference to 58B-58D, the surgeon and/or user may complete the step of securing the fixation screw 3385 to the caudal or inferior vertebral body. The surgeon and/or user may desirably attach a screw guide 3375 near and/or proximate to the first end of the deployment tool 3225. The screw guide 3375 will be positioned and/or disposed onto a portion of the grasping tip 3265, the draw bar 3270 and/or a portion to the shaft subassembly 3250 and secured. Alternatively, the screw guide 3375 may be attached prior to the step of aligning each of the superior keel 3330 and/or inferior keel 3335 to each of the caudal keel channel 3005a, 3005b and/or cranial keel channels 3105a, 3105b. The guide barrel or the guide tube 3395 of the screw guide 3375 is positioned obliquely and/or at an angle 3380 relative the longitudinal axis 3400 of the body of the screw guide 3375. Accordingly, the longitudinal axis 3400 of the guide barrel or the guide tube 3395 is at an angle relative to the longitudinal axis 3400 of the body of the screw guide 3375.
The surgeon and/or user may desirably insert the fixation screw 3385 into the bore (e.g., inner diameter) 3405 of the guide barrel or guide tube 3395 of the screw guide 3375. A deployment screwdriver 3390 may be utilized to secure the fixation screw 3385 into the caudal vertebral body. The deployment screwdriver 3390 may be powered and/or manual. The deployment screwdriver 3390 is coupled to a handle (e.g., Hudson handle not shown) for manual installation. The surgeon and/or user will insert the drive tip or tip 3410 into a portion of the drive recess of the fixation screw 3385. The surgeon and/or user may begin to rotate the deployment screwdriver 3390 clockwise to perforate the cortex using the fixation screw tip until the surgeon receives feedback and/or torque feedback (e.g., tightening). The fixation screw 3385 comprises a self-tapping tip. The surgeon should not over-rotate, over-tighten or over-torque the fixation screw 3385 into the caudal vertebral body—it may cause changes to positioning, alignment, and/or prepared bone interface.
With reference to
The step of implanting at least one spinal implant, a first implant and/or a second implant within a prepared intervertebral space on at least one side, a first side and/or a second side 1175, 1175a, 1175b comprises the step of confirming at least spinal implant characteristics on the at least one side 3185 and/or the step of confirming a first spinal implant characteristics on the first side and a second spinal implant characteristics on a second side 3220. With reference to
The one or more spinal implant characteristics, a first one or more spinal implant characteristics and/or a second one or more spinal implant characteristics as shown in
The one or more spinal implant characteristics may further comprise the toe-in angle or convergence angle or transverse pedicle angle (see
Surgical Removal Technique
With reference to
The step of removing at least one spinal implant, a first spinal implant and/or a second spinal implant the at least one side, a first side and/or a second side comprises the steps of: removing the at least one fixation screw from the at least one spinal implant 3425; removing the at least one spinal implant using at least one removal tool 3430; selecting at least one action needed to successfully deploy at least one spinal implant 3435; and implanting a new or subsequent at least one spinal implant 1175. The selection of at least one action 3535 comprises the actions: does a different sized spinal implant required 3440; if yes, the reselecting a new proper spinal implant size is required 3445; and re-preparing the intervertebral (IV) space is required 3450 and/or is the spinal implant not aligned 3455—if yes, then re-preparing the intervertebral space is required 3450. However, if the selection to actions is “no,” the surgeon and/or user may proceed with completing the step of implanting a spinal implant 1175, 1175a, 1175b, 1175c and closing the surgical access to the localized spine segment 1180. “Not aligned” comprises improper neutral alignment, improper keel alignment, improper sagittal osteotomy angle, and/or improper coronal osteotomy angle.
With reference to
With reference to
The surgeon and/or user may insert the first end of the removal tool 3470 into the prepared intervertebral space. The surgeon and/or user should locate the fixation screw bore disposed on the bridge 3320 of the inferior component 3300 of the spinal implant 3290. The hook 3480 disposed in the first end of the removal tool 3470 grasps is inserted into the screw bore of the bridge 3320 of the inferior component 3300 of the spinal implant 3290. The removal tool 3470 should translate posteriorly until at least a portion of the hook 3480 on the first end of the removal tool 3470 contacts or engages with a portion of an inner diameter of the screw bore. Once the removal tool 3470 is secured, the surgeon and/or user may begin translating or pulling the at least one spinal implant, a first spinal implant and/or a second spinal implant 3290 on the at least one side, the first side and/or the second side to remove the superior component 3295 and inferior component 3300 of the spinal implant 3290. After spinal implant 3290 is retracted from the prepared interverbal space, the spinal implant 3290 may be discarded. Ensure both pieces, superior component 3295 and/or inferior components 3300 of the spinal implant 3290 were removed.
In another embodiment, the surgeon may complete the step of selecting at least one action needed to successfully deploy at least one spinal implant on the at least one side. The selecting of one action may comprise re-selecting a different sized spinal implant or re-preparing the Intervertebral space within a localized spine segment for alignment restoration on at least one side. The action of re-selecting of a different sized spinal implant may be necessary if excessive friction during or excessive tension was noted during deployment of the at least one spinal implant. The surgeon should repeat one or more steps disclosed herein, described as implanting at least a spinal implant on the at least one side. For example, if too much tension and/or too much friction was observed, it may be necessary to decrease the height of the implant.
The entire disclosure of each of the publications, patent documents, and other references referred to herein is incorporated herein by reference in its entirety for all purposes to the same extent as if each individual source were individually denoted as being incorporated by reference.
The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. Scope of the invention is thus intended to include all changes that come within the meaning and range of equivalency of the descriptions provided herein.
Many of the aspects and advantages of the present invention may be more clearly understood and appreciated by reference to the accompanying drawings. The accompanying drawings are incorporated herein and form a part of the specification, illustrating embodiments of the present invention and together with the description, disclose the principles of the invention.
Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the disclosure herein. What have been described above are examples of the present invention. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the present invention, but one of ordinary skill in the art will recognize that many further combinations and permutations of the present invention are possible. Accordingly, the present invention is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims.
This application is a continuation application of Patent Cooperation Treaty Application No. PCT/US22/74635 entitled “ROBOTIC & NAVIGATION ASSISTED TOTAL SPINAL JOINT METHODS” filed Aug. 5, 2022, which claims the benefit of U.S. Provisional Application No. 63/229,989 entitled “Spine System Improvements” filed Aug. 5, 2021; U.S. Provisional Application No. 63/351,568 entitled “Robotic & Navigation Assisted Total Spinal Joint Replacement Methods” filed Jun. 13, 2022 and U.S. Provisional Application No. 63/345,560 entitled “Total Spinal Joint Replacement Methods & Instrumentation” filed May 25, 2022, the disclosures of which are each incorporated by reference herein in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 63229989 | Aug 2021 | US | |
| 63351568 | Jun 2022 | US | |
| 63345560 | May 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US22/74635 | Aug 2022 | US |
| Child | 18226979 | US |
