Patent Description:
Spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor, and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including pain, nerve damage, and partial or complete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics. As part of these surgical treatments, interbody devices can be employed with spinal constructs, which include implants such as bone fasteners and vertebral rods to provide stability to a treated region. These implants can redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support the vertebral members. During surgical treatment, surgical instruments are employed, for example, to facilitate surgical preparation, manipulation of tissue and delivering implants to a surgical site. From <CIT> a surgical system according to the preamble of claim <NUM> is known.

The object of this disclosure is to provide an improvement over the above- described prior technologies.

This object is solved by a surgical system according to claim <NUM>.

Further embodiments are subject of the dependent claims.

The exemplary embodiments of a surgical system are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of an inventive surgical system, wherein furthermore illustrative methods, steps and procedures for treating a spine using the inventive surgical system are described to further the understanding of the inventive surgical system. The present surgical system may be used in context of a method utilizing a saved image for navigated spine surgeries. In some embodiments, the systems of the present disclosure comprise surgical navigation and medical devices including surgical instruments and implants that can preferably be employed with a surgical treatment, as described herein, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine.

In some embodiments, the present surgical system includes images of trials and/or implants for surgical planning and performing surgical procedures. The present surgical system can preferably be employed with methods that allow a surgeon to determine a size and/or configuration of an implant by projecting an image of a spinal implant and/or a surgical trial instrument in a vertebral space from a computer display employing surgical navigation.

The present surgical system includes one or more trial instruments that preferably can be employed with methods for connection with an image guide oriented relative to a sensor to communicate a signal representative of the trial instrument relative to a patient anatomy. In some embodiments, the trial instrument includes indicia displayable from a monitor to represent orientation of the trial instrument relative to the patient anatomy. In some embodiments, the indicia includes one or more radiopaque markers disposed adjacent a distal end of the trial instrument. According to the invention, the trial instrument includes indicia displayable from the monitor to represent a size of the spinal implant. The indicia include one or more fins and/or one or more axial oriented columns. In some embodiments, the columns include a distal column, an intermediate column and a proximal column. In some embodiments, the intermediate column has a diameter different than a diameter of the distal column and a diameter of the proximal column.

The present surgical system can preferably be employed with methods for viewing a vertebral space axially and/or laterally to determine a size and/or configuration of an implant. In some embodiments, the systems of the present disclosure facilitate determining a cross section and/or height of the vertebral space to calculate a size and/or configuration of the implant.

The present surgical system can preferably be employed with methods including the step of selecting an implant strategy by selecting a size and/or configuration of an implant from a drop-down menu of a computer display that shows choices of spinal implants. The present surgical system can preferably be employed with methods including the step of delivering a trial instrument according to an implant strategy. The present surgical system can preferably be employed with methods including the step of adjusting a trial instrument and/or inserting various sizes of trial instruments to determine a size and/or configuration of a spinal implant. In some embodiments, the present surgical system includes a trial instrument that is imaged via communication of a navigation component and a CT-scan of a surgical navigation system. The present surgical system can preferably be employed with methods including the step of acquiring data points acquired by a navigation system and displaying the data points on a monitor representing an image of the trial instrument. In some embodiments, the present surgical system includes a computer that provides a graphical user interface for adjusting the size and/or configuration of the image. The method with which the inventive surgical system can preferably be employed can include the step of removing the trial instrument.

The present surgical system can preferably be employed with methods including the step of selecting spinal implants via a graphical user interface having a drop-down menu. In some embodiments, a surgeon selects an image of a sample spinal implant from the drop-down menu to overlay onto an image of a trial instrument. In some embodiments, parameters for a spinal implant to be implanted are calculated by a computer and are compared with the overlay image of the spinal implant to determine the final parameters for the spinal implant to be implanted. In some embodiments, the image of the trial instrument and the overlay image of the spinal implant is captured and saved with a database of a computer.

In some embodiments, the present surgical system preserves the image captured such that the image position, size and/or configuration continue to be displayed from a computer monitor after a trial instrument is removed from a vertebral space, and/or the image is saved in a database memory of a computer and displayed from the computer monitor upon insertion of the spinal implant with the vertebral space. The present surgical system can preferably be employed with methods including the step of inserting a spinal implant with the vertebral space and a previously captured image of the trial instrument is displayed from the computer monitor and utilized to guide and/or align a spinal implant with the image and the vertebral space, as described herein. The method with which the inventive surgical system can preferably be employed preferably includes the step of manipulating the spinal implant for alignment with the data points represented by the image. This configuration allows a surgeon to track more than one implant and/or active surgical instrument at a time.

The system of the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. In some embodiments, the system of the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. In some embodiments, the disclosed system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The system of the present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The system of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration.

The system of the present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. In some embodiments, as used in the specification and including the appended claims, the singular forms "a," "an," and "the" include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" or "approximately" one particular value and/or to "about" or "approximately" another particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references "upper" and "lower" are relative and used only in the context to the other, and are not necessarily "superior" and "inferior".

As used in the specification and including the appended claims, "treating" or "treatment" of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (human, normal or otherwise or other mammal, employing implantable devices, and/or employing instruments that treat the disease, such as, for example, microdiscectomy instruments used to remove portions bulging or herniated discs and/or bone spurs, in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment can include reducing acute or chronic inflammation; alleviating pain and mitigating and inducing regrowth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. Also, as used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise.

The following discussion includes a description of an inventive surgical system including surgical navigation, surgical instruments, spinal constructs, implants and related components and also for illustrative purposed methods of employing the surgical system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to <FIG>, there are illustrated components of a surgical system <NUM>.

The components of surgical system <NUM> can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of surgical system <NUM>, individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade <NUM> titanium, super-elastic titanium alloys, cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®, ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™, thermoplastics such as polyaryletherketone (PAEK including polyetheretherketone (PEEK, polyetherketoneketone (PEKK and polyetherketone (PEK, carbon-PEEK composites, PEEK-BaSO<NUM> polymeric rubbers, polyethylene terephthalate (PET, fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP, hydroxyapatite (HA-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations.

Surgical system <NUM> can be employed, for example, with a minimally invasive procedure, including percutaneous techniques, mini-open and open surgical techniques to manipulate tissue, deliver and introduce instrumentation and/or components of spinal constructs at a surgical site within a body of a patient, for example, a section of a spine. In some embodiments, one or more of the components of surgical system <NUM> are configured for engagement with one or more components of one or more spinal constructs, which may include spinal implants, for example, interbody devices, interbody cages, bone fasteners, spinal rods, tethers, connectors, plates and/or bone graft, and can be employed with various surgical procedures including surgical treatment of a cervical, thoracic, lumbar and/or sacral region of a spine. In some embodiments, the spinal constructs can be attached with vertebrae in a revision surgery to manipulate tissue and/or correct a spinal disorder, as described herein.

Surgical system <NUM> includes a trial instrument <NUM>, which is employed with a surgical navigation system <NUM>, as described herein, and one or a plurality of surgical instruments for manipulating vertebral tissue, and for delivering and introducing components of spinal constructs for engagement with the vertebral tissue. For example, trial instrument <NUM> is utilized to determine a size, configuration and/or positioning relative to vertebral tissue of a selected spinal implant <NUM>, as described herein. Trial instrument <NUM> includes an image guide, for example, a navigation component <NUM>, as shown in <FIG>, which communicates with surgical navigation system <NUM>. Navigation component <NUM> communicates with surgical navigation system <NUM> to measure, sample, capture and/or identify sizing, configuration and/or positional data points of trial instrument <NUM> relative to vertebral tissue for generating an image of trial instrument <NUM> for display from a computer monitor, as described herein. See, for example, similar surgical navigation components, imaging and their use as described in <CIT>, <CIT>, <CIT>, <CIT>,<CIT>, <CIT>, <CIT>,<CIT>and <CIT>. Trial instrument <NUM> may be delivered along a surgical pathway, as described herein, and used to distract one or more intervertebral spaces and apply appropriate tension in the intervertebral space allowing for decompression.

Trial instrument <NUM> includes a shaft <NUM> and a body <NUM> extending from shaft <NUM>, as shown in <FIG>. Body <NUM> extends between a proximal end <NUM> and a distal end <NUM>, as shown in <FIG>. Body <NUM> includes a surface <NUM> and walls <NUM> extending about surface <NUM>, as shown in <FIG>. Body <NUM> includes fins <NUM>, <NUM>, <NUM> extending axially from surface <NUM> and laterally across body <NUM> between walls <NUM>. Fin <NUM> is disposed intermediate to fins <NUM>, <NUM>. In some embodiments, fins <NUM>, <NUM>, <NUM> may be disposed at alternate orientations, relative to body <NUM>, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, fins <NUM>, <NUM>, <NUM> are disposed at orientations relative to body <NUM> to convey information relating to size, configuration, positioning and/or trajectory, as described herein, to a surgeon. See, for example, the embodiments and disclosure of systems and methods including spinal implants having indicia, markers and/or columns, shown and described in commonly owned and assigned <CIT>.

Fins <NUM>, <NUM>, <NUM> each include a cross section extending between walls <NUM>, as shown in <FIG>. The cross section of fins <NUM>, <NUM>, <NUM> is substantially circular defining columns <NUM>, <NUM>, <NUM>, respectively. Columns <NUM>, <NUM>, <NUM> facilitate determining a length of spinal implant <NUM>, for example, short, medium or long, as described herein. In some embodiments, column <NUM> includes a length L1, column <NUM> includes a length L2 and column <NUM> includes a length L3. Lengths L1, L2, L3 are varied to indicate, for example, if trial instrument <NUM> is small, medium or large prior to insertion into a vertebral space. Column <NUM> includes a diameter D1, column <NUM> includes a diameter D2 and column <NUM> includes a diameter D3. The diameter of each column <NUM>, <NUM>, <NUM> indicates a size and/or configuration of trial instrument <NUM> to facilitate determining a size and/or configuration of spinal implant <NUM>. For example, diameter D2 is larger than diameter D1 and diameter D3. Column <NUM> includes a length L1, column <NUM> includes a length L2 and column <NUM> includes a length L3. In some embodiments, length L1 is longer than lengths L2, L3. In some embodiments, length L3 is shorter than lengths L1, L2. In some embodiments, columns <NUM>, <NUM>, <NUM> may include various cross section configurations, for example, arcuate, cylindrical, oblong, rectangular, polygonal, undulating, irregular, uniform, nonuniform, consistent, variable, U-shape and/or any other configuration that facilitates communicating size, configuration, positioning and/or trajectory to the surgeon.

Body <NUM> is selectively, precisely and/or accurately connected with shaft <NUM> such that body <NUM> extends a selected distance from shaft <NUM> in connection with surgical navigation and for generating an image of trial instrument <NUM> for display from a computer monitor, as described herein. Body <NUM> extends a selected distance from and is fixed with shaft <NUM> in connection with image guidance to provide size, configuration and/or position of body <NUM> with vertebral tissue. Distal end <NUM> extends a distance measured from a proximal most end surface of shaft <NUM> in connection with image guidance, as described herein, to dispose body <NUM> relative to and/or extending from shaft <NUM>. This configuration provides indicia of the size, type and/or position of body <NUM> relative to shaft <NUM> and/or vertebral tissue.

Body <NUM> includes indicia, for example, radiopaque markers located on various points on body <NUM>. For example, the markers can include fins <NUM>, <NUM>, <NUM> and/or columns <NUM>, <NUM>, <NUM> and/or proximal end <NUM>. In some embodiments, the markers facilitate viewing and/or identification of the size, configuration, orientation and/or positioning of trial instrument <NUM> relative to vertebral tissue under x-ray, fluoroscopy, CT or other imaging techniques by surgical navigation system <NUM>, as described herein. The generated image of trial instrument <NUM> is displayed from monitor <NUM> and can include the markers within the vertebral space. In some embodiments, a processor of a computer <NUM> generates an alternate trial image having an alternate size and/or configuration relative to the image of trial instrument <NUM> for display from monitor <NUM> with the image of trial instrument <NUM>.

In some embodiments, the generated image of trial instrument <NUM> is saved to a tangible storage device of computer <NUM> having computer-readable instructions. The generated image of trial instrument <NUM> is retrievable in connection with formulating an implant strategy. The image of trial instrument <NUM> is utilized to guide and/or align a selected spinal implant <NUM> into position with the vertebral space, as described herein. During a surgical procedure, spinal implant <NUM> is tracked in real time and displayed on monitor <NUM>. Spinal implant <NUM> is tracked relative to the generated image of trial instrument <NUM>.

Trial instrument <NUM> is configured for disposal adjacent a surgical site such that navigation component <NUM> is oriented relative to a sensor array <NUM>, as shown in <FIG>, to facilitate communication between navigation component <NUM> and sensor array <NUM> during a surgical procedure, as described herein. Navigation component <NUM> is configured to generate a signal representative of a size, configuration and/or position of trial instrument <NUM> relative to a patient anatomy for generating an image of trial instrument <NUM> for display from monitor <NUM>. In some embodiments, navigation component <NUM> is connected with trial instrument <NUM> via an integral connection, friction fit, pressure fit, interlocking engagement, mating engagement, dovetail connection, clips, barbs, tongue in groove, threaded, magnetic, key/keyslot and/or drill chuck.

Navigation component <NUM> includes an emitter array <NUM>, as shown in <FIG>. Emitter array <NUM> is configured for generating a signal to sensor array <NUM> of surgical navigation system <NUM>. The signal generated by emitter array <NUM> includes data points that represent a size, configuration and/or position of one or more components of surgical system <NUM>, for example, trial instrument <NUM> relative to a patient anatomy for generating an image of trial instrument <NUM> for display from monitor <NUM>. In some embodiments, the signal generated by emitter array <NUM> includes data points that represent a three-dimensional position of trial instrument <NUM> relative to tissue for generating an image of trial instrument <NUM> for display from monitor <NUM>. In some embodiments, emitter array <NUM> may include a reflector array configured to reflect a signal from sensor array <NUM>.

Emitter array <NUM> includes four spaced apart arms having a substantially X-shape. Emitter array <NUM> includes markers, for example, fiducials <NUM>. Fiducials <NUM> appear in the image produced by surgical navigation system <NUM> for use as a point of reference or a measure. Emitter array <NUM> generates signals representing the position of various reference points of the patient's anatomy. See, for example, similar surgical navigation components and their use as described in <CIT>, <CIT>, <CIT>. In some embodiments, fiducials <NUM> include at least one light emitting diode. In some embodiments, fiducials <NUM> may include other tracking devices capable of being tracked by sensor array <NUM>, for example, a tracking device that actively generates acoustic signals, magnetic signals, electromagnetic signals, radiologic signals. In some embodiments, fiducials <NUM> may be removably attached to emitter array <NUM>. In some embodiments, one or more of fiducials <NUM> each include a single ball-shaped marker.

In some embodiments, surgical navigation system <NUM> comprises image capturing portion <NUM> that may include an x-ray source or emission portion and an x-ray receiving or image receiving portion located generally or as practically possible <NUM> degrees from each other and mounted on a rotor (not shown relative to a track of image capturing portion <NUM>. Image capturing portion <NUM> can be operable to rotate <NUM> degrees during image acquisition. Image capturing portion <NUM> may rotate around a central point or axis, allowing image data of the patient to be acquired from multiple directions or in multiple planes. Surgical navigation system <NUM> can include those disclosed in <CIT>, <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

In some embodiments, surgical navigation system <NUM> can include medical imaging, for example, C-arm fluoroscopic imaging systems, which can generate three-dimensional views of a patient. The position of image capturing portion <NUM> can be precisely known relative to any other portion of an imaging device of navigation system <NUM>. In some embodiments, a precise knowledge of the position of image capturing portion <NUM> can be used in conjunction with a tracking system <NUM> to determine the position of image capturing portion <NUM> and the image data relative to the patient.

Tracking system <NUM> can include various portions that are associated or included with surgical navigation system <NUM>. In some embodiments, tracking system <NUM> can also include a plurality of types of tracking systems, such as, for example, an optical tracking system that includes an optical localizer, such as, for example, sensor array <NUM> and/or an EM tracking system that can include an EM localizer. Various tracking devices can be tracked with tracking system <NUM> and the information can be used by surgical navigation system <NUM> to allow for a display of a position of an item, for example, a patient tracking device, an imaging device tracking device <NUM>, and an instrument tracking device, for example, emitter array <NUM>, to allow selected portions to be tracked relative to one another with the appropriate tracking system.

In some embodiments, the EM tracking system can include the STEALTHSTATION® AXIEM™ Navigation System, sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colo. Exemplary tracking systems are also disclosed in <CIT>,<CIT>, <CIT>.

Sensor array <NUM> is located in such a manner to provide a clear line of sight with emitter array <NUM>, as described herein. In some embodiments, fiducial markers <NUM> of emitter array <NUM> communicate with sensor array <NUM> via infrared technology. Sensor array <NUM> is coupled to computer <NUM>, which may be programmed with software modules that analyze signals transmitted by sensor array <NUM> to determine the position of each object in a detector space.

For example, trial instrument <NUM>, with emitter array <NUM> attached thereto as described herein, is selectively disposed with vertebral tissue according to an implant strategy. Trial instrument <NUM> can be manipulated in a vertebral space. Orientation of navigation component <NUM> relative to sensor array <NUM> facilitates communication between navigation component <NUM> and sensor array <NUM> during a surgical procedure, as described herein. Sensor array <NUM> receives signals from emitter array <NUM> to provide information including the data points, as described herein, regarding the size, configuration, spatial position and/or trajectory of trial instrument <NUM> relative to a portion of the patient's anatomy, as described herein. In some embodiments, surgical navigation system <NUM> provides for real-time tracking of trial instrument <NUM>.

A processor of computer <NUM> executes one or more instructions in operation of surgical navigation system <NUM>, as described herein, for generating imaging of one or more components of surgical system <NUM>. Emitter array <NUM> generates a signal including the data points that represent size, configuration and/or a three-dimensional position of trial instrument <NUM> relative to the vertebral space. Emitter array <NUM> communicates the signal including the data points to the processor of computer <NUM>. The processor measures, calibrates, samples, captures and/or identifies the size, configuration and/or three-dimensional position of trial instrument <NUM> in a three-dimensional space and generates an image of the data points of trial instrument <NUM> that represent size, configuration and/or three-dimensional position of trial instrument <NUM> for display from monitor <NUM>, as described herein. See, for example, the surgical systems and methods described in <CIT>. The processor of computer <NUM> is programed with known parameters of trial instrument <NUM>, for example, a length of shaft <NUM> and body <NUM>, a width of body <NUM>. The processor utilizes the known parameters to calculate a position of body <NUM> relative to the vertebral space and creates an image of body <NUM> within tissue for display on monitor <NUM>.

The three-dimensional image and position of trial instrument <NUM> including body <NUM> relative to vertebral tissue is saved to a database of computer <NUM>. The three-dimensional image can be saved to the database for retrieval and/or maintained for display from monitor <NUM>. The images of trial instrument <NUM> are transmitted to computer <NUM> for display on monitor <NUM>, as well as, saved, digitally manipulated, or printed to a hard copy. In some embodiments, images may also be displayed to the surgeon through a heads-up display. Trial instrument <NUM> is removed from the vertebral space. The image of trial instrument <NUM> remains displayed on monitor <NUM>.

Spinal implant <NUM> is selected from a plurality of alternately sized and/or configured spinal implants according to the generated image of trial instrument <NUM>. Spinal implant <NUM> is connected with an inserter <NUM>, as shown in <FIG>. Inserter <NUM> includes a navigation component <NUM>, similar to navigation component <NUM>, as described herein. In some embodiments, inserter <NUM> includes an expandable surgical driver configured to expand an expandable spinal implant. Spinal implant <NUM> is introduced into the vertebral space. Navigation component <NUM> communicates a signal including data points of spinal implant <NUM> to the processor of computer <NUM> to measure, calibrate, sample, capture and/or identify the size, configuration and/or position of spinal implant <NUM> in a three-dimensional space for display and real time tracking of an image of the data points that represent a three-dimensional image including size, configuration and/or position of spinal implant <NUM> for display from monitor <NUM>, as described herein. The image of spinal implant <NUM> is generated relative to the image of trial instrument <NUM> displayed from monitor <NUM>. Spinal implant <NUM> is guided and/or aligned with the image of trial instrument <NUM> for accurate positioning of spinal implant <NUM> in accordance with an implant strategy.

In assembly, operation and use, surgical system <NUM>, similar to the systems and methods described herein, is employed with a surgical procedure, for treatment of a spine of a patient including vertebrae V. Surgical system <NUM> may also be employed with surgical procedures, such as, for example, discectomy, laminectomy, fusion, laminotomy, laminectomy, nerve root retraction, foramenotomy, facetectomy, decompression, spinal nucleus or disc replacement and bone graft and implantable prosthetics including plates, rods, and bone engaging fasteners.

As shown in <FIG>, surgical system <NUM>, similar to the systems described herein, is employed in connection with one or more surgical procedures. During a surgery <NUM>, an implant strategy is determined, in a step <NUM>. For example, a surgeon reviews three-dimensional scans of the patient and formulates and selects an implant strategy for the components of a spinal construct with the patient anatomy according to the three-dimensional scan. In some embodiments, the implant strategy includes preparing a pre-operative surgical plan based on the three-dimensional scan. In some embodiments, the implant strategy includes selecting a surgical pathway P, for example, for insertion of the components of surgical system <NUM> into a lateral portion of vertebral tissue, as shown in <FIG>. In some embodiments, the implant strategy employs pre-operative analytics software including anatomy recognition and vertebral segmentation algorithms for surgical visualization based on a patient's images, which facilitates formulating the implant strategy including implant and trajectory placement planning. In some embodiments, the implant strategy may be created pre-operatively or intraoperatively.

Trial instrument <NUM>, as described herein, is selected according to the implant strategy. In a step <NUM>, trial instrument <NUM> is delivered along surgical pathway P through dilator D for disposal with a lateral portion of vertebrae V, as shown in <FIG>. Trial instrument <NUM> distracts one or more intervertebral spaces and applies appropriate tension in the intervertebral space allowing for indirect decompression. Trial instrument <NUM> is adjusted and/or various sizes of trial instruments <NUM> may be inserted.

In a step <NUM>, an image of trial instrument <NUM> is generated by measuring, sampling, capturing and/or identifying size, configuration and/or positional data points of trial instrument <NUM> relative to vertebrae V for display from computer monitor <NUM>, as described herein. The generated image of trial instrument <NUM> including markers <NUM> is graphically displayed on monitor <NUM>, as shown in <FIG>.

In some embodiments, in an optional step <NUM>, the processor of computer <NUM> calculates parameters for the shape, height and length of spinal implant <NUM> to be implanted. In some embodiments, in an optional step <NUM>, the processor provides model spinal implants, for example, spinal implants 100a, 100b, on a graphical user interface including a drop-down menu, as shown in <FIG>. Spinal implants 100a, 100b can vary by material, length, width, height, configuration and/or the procedure to be utilized. For example, the configuration of spinal implants 100a, 100b may be straight, curved, bullet nose, dolphin nose, and/or hockey stick shaped.

In some embodiments, an image of spinal implants 100a, 100b selected from the dropdown menu can be overlaid on the generated image of trial instrument <NUM> to compare the configuration, size, height and/or length of the overlay image to the generated image of trial instrument <NUM>. In an optional step <NUM>, a surgeon enters a selection of one of spinal implants 100a, 100b from the drop-down menu, for example, spinal implant 100a. The image of spinal implant 100a is oriented for overlay relative to the generated image of trial instrument <NUM>, as shown in <FIG>.

In some embodiments, the surgeon can toggle between spinal implants 100a, 100b provided on the drop-down menu to determine which spinal implant 100a, 100b is optimal based on the comparison with the generated image of trial instrument <NUM>. In some embodiments, the graphical user interface allows for adjusting the configuration, size and/or length of the overlay image of spinal implant 100a relative to the generated image of trial instrument <NUM> and/or patient anatomy. In some embodiments, the generated image of trial instrument <NUM> and the overlay image of spinal implant 100a is generated and saved on computer <NUM>. The generated image of trial instrument <NUM> with overlay of spinal implant 100a is utilized to guide and/or align insertion of a selected spinal implant <NUM>, as described herein.

Trial instrument <NUM> is removed. In a step <NUM>, a spinal implant <NUM> is selected according to the implant strategy. Spinal implant <NUM> is connected with an inserter <NUM>, as described herein. In a step <NUM>, the generated image of trial instrument <NUM> is retrieved and displayed on monitor <NUM>. In some embodiments, the generated image of trial instrument <NUM> remains on monitor <NUM> from step <NUM>. In a step <NUM>, spinal implant <NUM> is inserted along surgical pathway P, as shown in <FIG>. An image of spinal implant <NUM> is generated by measuring, sampling, capturing and/or identifying size, configuration and/or positional data points of spinal implant <NUM> relative to vertebral tissue for display from computer monitor <NUM>, as described herein. The image of spinal implant <NUM> is generated relative to the image of trial instrument <NUM> displayed from monitor <NUM>. The generated image of trial instrument <NUM> is utilized to guide and/or properly align spinal implant <NUM> within vertebral space S, as shown in <FIG>. In some embodiments, monitor <NUM> may indicate when spinal implant <NUM> is properly aligned with the generated image of trial instrument <NUM> to alert the surgeon. For example, the generated image of trial instrument <NUM> may illuminate, change color, red, blue or green, and/or a border around the display window illuminates or changes color or indicates a home position, when spinal implant <NUM> is aligned and/or sufficiently overlapped with the generated image of trial instrument <NUM>. In a step <NUM>, once spinal implant <NUM> is aligned, inserter <NUM> is disengaged from spinal implant <NUM> and removed, as shown in <FIG>. One or more steps or portions of a surgical procedure may be performed without the use of pre-operative analytics software, a generated image of a trial instrument and/or a generated image of a spinal implant.

A surgical procedure, similar to that described herein, includes insertion of spinal implant <NUM> with a lateral portion of vertebrae V, as described herein, and a spinal implant <NUM> inserted with a contra-lateral portion of vertebrae V, as shown in <FIG>. In some embodiments, the implant strategy includes selecting one or more surgical pathways P for positioning a plurality of spinal implants <NUM>, <NUM> with vertebrae V. Trial instrument <NUM> and spinal implant <NUM> are inserted, as described herein. A trial instrument <NUM> is inserted with vertebrae
V and an image of trial instrument <NUM> relative to vertebrae V is generated, as described herein. The generated image of trial instrument <NUM> is stored in computer <NUM> for display on monitor <NUM>, as described herein. Trial instrument <NUM> is removed.

A selected spinal implant <NUM> is connected with an inserter, as described herein, and is disposed with vertebrae V. Real time tracking of spinal implant <NUM> is captured and displayed on monitor <NUM> relative to the image of trial instrument <NUM>, an image of spinal implant <NUM> as described herein, and/or an image of trial instrument <NUM> as described herein, to simultaneously track one or more components of surgical system <NUM>, for example, instruments and/or implants. The image of spinal implant <NUM> is generated relative to the images and vertebrae V displayed from monitor <NUM>. The generated images of trial instrument <NUM>, spinal implant <NUM> and/or trial instrument <NUM>, are utilized to guide and/or align spinal implant <NUM> within vertebral space S. Once spinal implant <NUM> is selectively aligned with vertebrae V, the inserter is disengaged from spinal implant <NUM> and removed. Spinal implants <NUM>, <NUM> remain with vertebrae V, as shown in <FIG>.

The surgical procedure requires that trial instruments <NUM>, <NUM> remain within vertebral space S to maintain distraction of vertebrae during insertion of spinal implants <NUM>, <NUM>. For example, navigation components <NUM>, <NUM> may be removed from trial instruments <NUM>, <NUM> and trial instruments <NUM>, <NUM> remain within vertebral space S. As such, trial instruments <NUM>, <NUM> are no longer viewable on monitor <NUM>. The surgeon can retrieve the saved generated images of trial instruments <NUM>, <NUM> to facilitate insertion, guidance and positioning of spinal implants <NUM>, <NUM> with the vertebral tissue, as described herein.

Upon completion of one or more surgical procedures, the surgical instruments and non-implanted components of surgical system <NUM> are removed and the incision (s are closed. One or more of the components of surgical system <NUM> can be made of radiolucent materials such as polymers. In some embodiments, surgical system <NUM> includes an agent, which may be disposed, packed, coated or layered within, on or about the components and/or surfaces of surgical system <NUM>. In some embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the fixation elements with vertebrae. In some embodiments, the agent may be HA coating. In some embodiments, the agent may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration.

Claim 1:
A surgical system (<NUM>) comprising:
a trial (<NUM>) connected with a first image guide oriented relative to a sensor to communicate a signal representative of the trial relative to a patient anatomy;
a tracking device (<NUM>) including the sensor and communicating with a processor (<NUM>) to generate a storable image of the trial relative to the patient anatomy for display from a monitor; and
a spinal implant (<NUM>) connected with a second image guide oriented relative to the sensor to communicate a signal representative of the spinal implant relative to the patient anatomy, the sensor receiving the signal of the second image guide and communicating with the processor to generate an image of the spinal implant in real time for display from the monitor in a configuration to align the spinal implant in real time with the stored image of the trial,
wherein the trial includes indicia displayable from the monitor, characterised in that the indicia represent a size of the spinal implant; wherein the indicia include one or more fins (<NUM>, <NUM>, <NUM>) and/or one or more axial oriented columns (<NUM>, <NUM>, <NUM>).