阅读说明：本技术 脊柱植入物系统和方法 (Spinal implant system and method ) 是由 M·T·马拉波德 J·J·普雷沃斯特 F·N·梅夫勒 S·B·斯泽雷 J·L·雷德蒙 N· 于 2019-10-18 设计创作，主要内容包括：一种脊柱植入物模板包括沿近端和远端之间的轴线延伸的轴。接合部分被配置成用于插入患者的椎骨之间。接合部分包括杆,所述杆从远端相对于纵向轴线成锐角延伸,以利于围绕患者的脊髓进入。公开了系统、外科手术器械、脊柱植入物以及方法。(A spinal implant template includes a shaft extending along an axis between a proximal end and a distal end. The engagement portion is configured for insertion between vertebrae of a patient. The engagement portion includes a stem extending from the distal end at an acute angle relative to the longitudinal axis to facilitate access around the spinal cord of the patient. Systems, surgical instruments, spinal implants, and methods are disclosed.)

1. A spinal implant template, comprising:

a shaft extending along an axis between the proximal end and the distal end; and

a joining portion configured for insertion into a surgical site of a patient, the joining portion including a stem extending from the distal end at an acute angle relative to the axis to facilitate entry of the joining portion around a spinal cord of the patient and to the surgical site.

2. A spinal implant template as recited in claim 1, wherein the acute angle is between about 1 ° and about 45 °.

3. A spinal implant template as recited in claim 1, wherein the acute angle is between about 20 ° and about 40 °.

4. A spinal implant template as recited in claim 1, wherein the engagement portion includes a head coupled to the rod, the head including a cylindrical wall configured to remove bone and intervertebral disc tissue between vertebrae at or near the surgical site of the patient.

5. A spinal implant template according to claim 4, wherein a circular opening extends through the thickness of the cylindrical wall.

6. A spinal implant template according to claim 4, wherein the head and the rod are integrally formed with the shaft.

7. A surgical system, comprising:

a spinal implant template, comprising:

a shaft extending along an axis between the proximal end and the distal end, an

An engagement portion configured for insertion into a surgical site of a patient, the engagement portion including a stem extending from the distal end at an acute angle relative to the axis to facilitate entry of the engagement portion around the spinal cord of the patient and to the surgical site; and

an image guide attachable with the shaft, the image guide positioned within a range of proximity of a sensor of a surgical navigation system such that the image guide communicates a signal representative of the template position to the sensor.

8. The surgical system of claim 7, wherein the image guide comprises an inner surface defining a cavity configured for disposal of the shaft.

9. The surgical system of claim 7, wherein the image guide includes a lock engageable with a flange of the template to secure the image guide with the template.

10. The surgical system of claim 7, wherein the image guide comprises a transmitter configured to generate a signal representative of a position of the template.

11. The surgical system of claim 10, wherein the emitter includes opposing top and bottom surfaces, the emitter including fiducial markers extending from the top surface, the engagement portion including a head coupled to the shaft, the head including a cylindrical wall with a top surface parallel to the top surface of the emitter.

12. A surgical system, comprising:

a spinal implant template, comprising:

a shaft extending along an axis between the proximal end and the distal end; and

an engagement portion configured for insertion between vertebrae of a patient, the engagement portion including a stem extending from the distal end at an acute angle relative to the axis to facilitate access around the spinal cord of the patient, the engagement portion including a head coupled to the stem, the head including a cylindrical wall configured to remove bone and disc tissue between the vertebrae; and

an implant for the spinal column is provided,

wherein the spinal implant has a maximum diameter that is less than or equal to the maximum diameter of the template.

13. The surgical system of claim 12, wherein the spinal implant is movable between a collapsed state in which the spinal implant has a first height and an expanded state in which the spinal implant has a second height, the second height being greater than the first height.

14. A surgical system, comprising:

a first template including a first shaft extending along a first axis between a first proximal end and a first distal end, the first template including a first engagement portion configured for insertion between vertebrae of a patient, the first engagement portion including a first rod extending from the first distal end at an acute angle relative to the first axis and a first head coupled to the first rod, the first head including a first cylindrical wall having a first diameter; and

a second template including a second shaft extending along a second axis between a second proximal end and a second distal end, the second template including a second engagement portion configured for insertion between the vertebrae, the second engagement portion including a second rod extending from the second distal end at an acute angle relative to the second axis and a second head coupled to the second rod, the second head including a second cylindrical wall having a second diameter,

wherein the first diameter is different from the second diameter.

15. The surgical system of claim 14, further comprising an image guide attachable with the first and second shafts, the image guide configured to be oriented relative to a sensor to transmit a signal representative of a position of the first template or a position of the second template.

16. The surgical system of claim 15, wherein the image guide comprises a transmitter configured to generate a signal representative of a position of the first template or a position of the second template.

17. The surgical system of claim 14, further comprising a third template including a third shaft extending along a third axis between a third proximal end and a third distal end, the third template including a third engagement portion configured for insertion between the vertebrae, the third engagement portion including a third rod extending from the third distal end such that the third rod is parallel to the third axis and a third head coupled to the third rod, the third head including a rectangular geometry.

18. The surgical system of claim 17, further comprising an image guide attachable with the first, second, and third axes, the image guide configured to be oriented relative to a sensor to transmit a signal representative of a position of the first template, a position of the second template, or a position of the third template.

19. The surgical system of claim 18, wherein the image guide comprises a transmitter configured to generate a signal representative of a position of the first template, a position of the second template, or a position of the third template.

20. A surgical system, comprising:

a spinal implant template, comprising:

a shaft extending along an axis between a proximal end and a distal end, the proximal end including a flange, and

a joint portion configured for insertion between vertebrae of a patient, the joint portion including a rod extending from the distal end at an acute angle relative to the axis to facilitate access around the spinal cord of the patient; and

an image guide attachable with the shaft and oriented relative to a sensor to transmit a signal indicative of a position of the template, the image guide including a collar having a main body and a pair of spaced apart tabs, each of the tabs being deflectable relative to the main body, each of the tabs including an inner surface defining a cutout having a raised portion configured to receive the flange to connect the image guide with the template.

Technical Field

The present invention relates generally to medical devices for treating musculoskeletal disorders, and more particularly to spinal implant systems and methods for treating the spine.

Background

Spinal pathologies and conditions (such as scoliosis, kyphosis, and other curvature abnormalities, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, tumors, and fractures) may be caused by factors including trauma, disease, and degenerative conditions caused by injury and aging. Spinal disorders often result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility.

Non-surgical treatments, such as drug therapy, rehabilitation, and exercise, may be effective, but may not alleviate the symptoms associated with these conditions. Surgical treatment of these spinal disorders includes fusion, immobilization, corpectomy, discectomy, laminectomy, and implantable repair. In procedures such as, for example, corpectomy and discectomy, fusion and fixation treatments may be performed, which employ implants to restore the mechanical support function of the vertebrae. The present invention describes an improvement over these prior art techniques.

Disclosure of Invention

In one embodiment, and in accordance with the principles of the present invention, a spinal implant template includes a shaft extending along an axis between a proximal end and a distal end. The engagement portion is configured for insertion between vertebrae of a patient. The engagement portion includes a stem extending from the distal end at an acute angle relative to the axis to facilitate entry around the spinal cord of the patient. Systems, surgical instruments, spinal implants, and methods are disclosed.

In one embodiment, in accordance with the principles of the present invention, a surgical system is provided. The surgical system includes a first template including a first shaft extending along a first axis between a first proximal end and a first distal end. The first template includes a first engagement portion configured for insertion between vertebrae of a patient. The first engagement portion includes a first stem extending from the first distal end at an acute angle relative to the first axis and a first head coupled to the first stem. The first head includes a first cylindrical wall having a first diameter. The second template includes a second axis extending along a second axis between a second proximal end and a second distal end. The second template includes a second engagement portion configured for insertion between vertebrae. The second engagement portion includes a second stem extending from the second distal end at an acute angle relative to the second axis and a second head coupled to the second stem. The second head includes a second cylindrical wall having a second diameter. The first diameter is different from the second diameter.

In one embodiment, in accordance with the principles of the present invention, a surgical system is provided. The surgical system includes a spinal implant template including a shaft extending along an axis between a proximal end and a distal end, the proximal end including a flange. The engagement portion is configured for insertion between vertebrae of a patient. The engagement portion includes a rod extending from the distal end at an acute angle relative to the axis to facilitate entry around the spinal cord of the patient. A first image guide is attached to the shaft and is oriented relative to the sensor to transmit a signal indicative of a position of the template. The image guide includes a collar having a body and a pair of spaced apart tabs. Each of the tabs is deflectable relative to the body. Each of the tabs includes an inner surface defining a cutout having a raised portion configured to receive the flange to connect the image guide with the template.

Drawings

The invention will become more apparent from the detailed description taken in conjunction with the following drawings, in which:

FIG. 1 is a perspective view of components of a surgical system according to the principles of the present invention;

FIG. 2 is a side view of a first component and a second component of the surgical system shown in FIG. 1;

FIG. 3 is a perspective view of a first component of the surgical system shown in FIG. 1;

FIG. 4 is a side view of a first component of the surgical system shown in FIG. 1;

FIG. 5 is an enlarged view of detail A shown in FIG. 4;

FIG. 6 is a perspective view of a third component of the surgical system shown in FIG. 1;

FIG. 7 is a perspective view of a second component of the surgical system shown in FIG. 1;

FIG. 8 is a perspective view of components of one embodiment of a surgical system used by a surgeon on a patient in accordance with the principles of the invention;

FIG. 9 is a first plan view of a first component of the surgical system illustrated in FIG. 1 with vertebrae positioned therein;

FIG. 10 is a second plan view of the first component of the surgical system illustrated in FIG. 1 with vertebrae positioned;

FIG. 11 is a plan view of a fourth component of the surgical system with vertebrae positioned;

FIG. 12 is a plan view of a third component of the surgical system with vertebrae positioned;

FIG. 13 is a first graphical representation of a computer showing representations of first and second components of the surgical system shown in FIG. 1;

FIG. 14A is a perspective view of third and fifth components of the surgical system;

FIG. 14B is an isolated perspective cross-sectional view of third and fifth components of the surgical system;

FIG. 15A is an isolated first side cross-sectional view of an embodiment of third and fifth components of a surgical system;

FIG. 15B is a second side cross-sectional view of an embodiment of third and fifth components of the surgical system, separated;

FIG. 16 is a first side view of a sixth component of the surgical system, with the fifth component in a folded state;

FIG. 17 is a second side view of the sixth component of the surgical system, with the sixth component in a deployed state;

FIG. 18 is a second graphical representation of a computer showing representations of the first and sixth components of the surgical system with vertebrae positioned therein;

FIG. 19 is a third graphical representation of a computer illustrating a user interface of a surgical system;

FIG. 20 is a fourth graphical representation of a computer showing a representation of the first and sixth components of the surgical system with vertebrae positioned therein, with the sixth component in a folded state;

FIG. 21 is a fifth graphical representation of a computer showing a representation of the first and sixth components of the surgical system with vertebrae positioned therein, with the sixth component in a deployed state;

FIG. 22 is a sixth graphical representation of a computer showing a representation of the first and sixth components of the surgical system with vertebrae positioned therein, with the sixth component in a folded state;

FIG. 23 is a seventh graphical representation of a computer showing representations of the first and sixth components of the surgical system with vertebrae positioned therein, with the sixth component in a deployed state;

FIG. 24 is an eighth graphical representation of a computer showing a representation of a first component of the surgical system with vertebrae positioned therein;

FIG. 25 is a ninth graphical representation of a computer showing representations of first and sixth components of the surgical system with vertebrae positioned therein;

FIG. 26 is a tenth graphical representation of a computer showing representations of the first and sixth components of the surgical system with vertebrae positioned therein;

FIG. 27 is an eleventh graphical representation of a computer showing representations of a first component and a sixth component of the surgical system with vertebrae positioned therein;

FIG. 28 is a first plan view of sixth and seventh components of the surgical system with vertebrae positioned therein;

FIG. 29 is a first plan view of sixth and eighth components of the surgical system with vertebrae positioned therein;

FIG. 30 is a second plan view of sixth and seventh components of the surgical system with vertebrae positioned therein;

FIG. 31 is a second plan view of the fifth and eighth components of the surgical system with vertebrae positioned therein;

FIG. 32 is a first graphical representation of a computer showing representations of sixth and seventh components of the surgical system with vertebrae positioned therein, with the sixth component in a deployed state;

FIG. 33 is a second graphical representation of a computer showing representations of sixth and seventh components of the surgical system with vertebrae positioned therein, with the sixth component in a folded state;

FIG. 34 is a third graphical representation of a computer showing representations of sixth and seventh components of the surgical system with vertebrae positioned therein, with the sixth component in a folded state;

FIG. 35 is a fourth graphical representation of a computer showing representations of sixth and seventh components of the surgical system with vertebrae disposed therein;

FIG. 36 is a fifth graphical representation of a computer showing representations of sixth and seventh components of the surgical system with vertebrae disposed therein;

FIG. 37 is a sixth graphical representation of a computer showing representations of sixth and seventh components of the surgical system with vertebrae disposed therein;

FIG. 38 is a seventh graphical representation of a computer showing representations of sixth and seventh components of the surgical system with vertebrae disposed therein;

FIG. 39 is an eighth graphical representation of a computer showing representations of sixth and seventh components of a surgical system in which vertebrae are disposed; and

fig. 40 is a ninth graphical representation of a computer showing representations of sixth and seventh components of a surgical system in which vertebrae are disposed.

Detailed Description

Exemplary embodiments of the disclosed surgical systems and associated methods of use are discussed in terms of medical devices for treating musculoskeletal disorders, and more particularly, in terms of spinal implant systems and methods for treating the spine. In some embodiments, the systems and methods of the present invention include medical devices including surgical instruments and implants for use in, for example, surgical treatment of the cervical, thoracic, lumbar and/or sacral regions of the spine, as described herein.

In some embodiments, the surgical system of the present invention includes a plurality of different navigation templates, such as, for example, four navigation templates. The template includes features compatible with an image guide (such as, for example, a navigation component) to connect the navigation component with the template. In some embodiments, the template may be used for two separate approaches, such as, for example, a posterior approach and an lateral approach. In some embodiments, the template may be used for three separate approaches, such as, for example, an anterior approach, a lateral approach, and a posterior approach.

In the back approach, three templates are used. The three templates have cylindrical geometries of different sizes, each representing a spinal implant, such as, for example, a corpectomy implant or cage (cage). In some embodiments, the template is a relatively short template. At least one of the templates includes a cylindrical dimensional feature that is angled proximally to allow insertion of the cylindrical dimensional feature into a defect space, such as, for example, a corpectomy defect, while facilitating access around the spinal cord. The template is moved against the adjacent vertebral endplates and the entire defect space to ensure that sufficient bone and/or disc material is removed so that a representative cage size can fit into the defect space at the selected cage trajectory. The navigation template can be used to identify key landmarks within the corpectomy defect, provide tactile feedback, and confirm the amount of resection.

In the outboard approach, three angled templates are used in the outboard track, or an elongated template with a rectangular geometry that represents an additional end cap option for the cradle. The elongated template is moved against the adjacent vertebral end caps and up against the lateral annulus to ensure that the bone and/or intervertebral disc is removed for the intended final placement of the representative end cap size.

In some embodiments, the template includes features that interface with an image guide, such as, for example, the NAVLOCK sold by Medtronic Navigation, Inc^TMAn interface feature oriented such that the image guide is parallel to a plane formed by the top or bottom of the instrument, allowing for proper insertion of the template into the defect space, with the top/bottom surface parallel to the vertebral end cap, and easy to view from a camera system coupled to the image guide.

In navigating the angled template, the orientation of the angle can be selected by the software menu according to the surgeon's needs to visualize the 180 degree rotation of the instrument.

The navigation template has verification features of different geometries and asymmetric cross-sections, allowing verification with navigation software. For example, in some embodiments, the navigation template may include one or more authentication features, such as, for example, a boss (boss) configured to be seated in a navigation authentication dimple (divot) of an implanted navigation feature to allow authentication of the navigation template with navigation software. In some embodiments, the authentication feature is rectangular in a manner that allows placement within the navigation authentication pocket. In some embodiments, the verification feature maintains a circular arc length with the cylindrical implant dimensional geometry.

Navigation of the template allows the template to be visually represented within the patient's anatomy. The image guide interfaces with a computer having software features including an appropriate final implant size, an estimate of the defect height size, an estimate of the implant position and trajectory in the fully collapsed and fully expanded state and/or intermediate states between the fully collapsed and fully expanded state. This software also allows the user to save a plan of implant positions and trajectories, enabling visualization of the anatomy during implant sizing.

This software allows the appropriate final implant size to be estimated by two methods. A first method includes manually estimating implant dimensions using cylindrical dimensional features of a template. The cylindrical size characteristic may represent the size of the implant selected by diameter and height, for example, by using a toggle button in either a collapsed state or an expanded state. Switching of the folded and unfolded states of the implant allows the surgeon to see if the maximum unfolded state of the implant or cage can span the corpectomy defect space. If no post-vertebrectomy image scan is performed, the defect space is represented by the vertebral body height. The virtual implant and the additional implant may be switched on or off, different sizes may be selected, and the direction of projection may be turned 180 degrees.

In a second approach, two separate projections may be saved at each of the opposite ends of the defect space. The software will then measure the resulting defect height, angulation between the coronal and sagittal planes, and the appropriate implant size for the defect. Angulation data from the software features may be used to select corresponding implant additions from the system offering at similar angles. The projection and navigation representation of the template allows easy visualization by projection with a central cavity. Saved projections representing cylindrical and rectangular implants may be used to plan the desired placement location and trajectory during actual implant insertion. Further, the implant may be combined with various types of implant additives having different geometries and sizes.

In some embodiments, the template virtual geometry may be used within software to erase the resected vertebral body by moving a physical template within the resection space and removing material from the visual representation of the patient anatomy.

In some embodiments, the implant is inserted into the defect space using a surgical instrument, such as, for example, one or more inserters. In some embodiments, the surgical system includes three different navigation inserters having different lengths, sizes, and angles. These inserters are suitable for two separate approaches and implants of different sizes. The navigation inserter has a fixed tracker geometry extending from the inserter body and perpendicular to the attachment plane of the different implants. Perpendicularity allows for proper placement of the implant or cradle while maintaining optimal visibility to the surgical system camera. On the navigation inserter, the geometry of the image guide is oriented at a 20 degree offset angle from the implant attachment plane.

One of the inserters is an angled inserter and one of the inserters is a straight inserter having a long length. These inserters share verification features at the implant interface tip. The tip geometry, which is rounded at one edge of the instrument, allows placement in the navigation verification pocket. The third inserter is a shorter navigation inserter and is a straight inserter. The tip geometry of the third inserter is not as wide and also allows the instrument to be located within the navigation verification slot. All three navigation inserters also have special markings to indicate that the correct tip geometry is used to interface with the navigation verification pits. Further, the angled inserter and implant tip geometry and software angle validation thresholds on the straight inserter allow for validation when the inserter body is parallel to the validation dimple central axis, or validation when the inserter body is offset from the validation dimple central axis.

The post-entry uses any one of three navigation inserters. Two in-line inserters allow for direct insertion of the implant into the corpectomy defect space. The navigated angled inserter, angled proximally at the implant attachment interface, allows insertion into the defect space while facilitating access around the spinal cord. The outer entry utilizes the longest navigation straight-in. It allows the insertion of an implant from a lateral trajectory directly into the corpectomy defect space.

Navigation of the inserter allows for visualization of the posterior and lateral approaches in multiple anatomical views of the inserter, implant, and projection relative to the patient anatomy. The software features include an estimate of the appropriate final implant size, an estimate of the appropriate implant placement location and trajectory, and a visualization of the implant deployment direction. It also allows easy visualization and differentiation of implants and projections while estimating the size, location, and trajectory of multiple implants and implant additions representing states.

This software allows the appropriate final implant size to be estimated by representing the implant in a folded or unfolded state. The intended deployment direction of the implant may be represented by a different colored portion than the body of the implant. The geometry of different colors and/or transparencies allows easy visualization of the anatomy while navigating. The different transparencies and colors also provide a visualization way to communicate hardware components to the surgeon that are used only for trajectory and size guidance, not for accurate navigation.

In some embodiments, the inserter, implant, and implant additive are navigated to multiple planes that are simultaneously visible in the same anatomical view. This allows the surgeon to visualize the position of the implant within the defect space. In addition to navigating the inserter and different sized implants, the projection may also display implant additions of different cylindrical and rectangular geometries and different degrees of geometric and/or mechanical detail. The navigation software also allows visualization in the lateral approach of the implant, as well as the addition of different sized implants throughout the vertebral body in order to obtain a proper placement location and ensure that the implant additions do not protrude from the lateral annulus or lateral border of the vertebral body.

In some embodiments, the surgical systems of the invention can be used to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and bone fractures. In some embodiments, the surgical systems of the present invention can be used with other bone and bone related applications, including those associated with diagnosis and therapy. In some embodiments, the disclosed surgical system may alternatively be used in surgical treatment of patients in prone or supine positions, and/or to reach the spine using various surgical approaches (including anterior, posterior midline, direct lateral, posterolateral, and/or anterolateral approaches), as well as to other body regions. The surgical system of the present invention may also alternatively be used with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of the spine. The surgical system of the invention may also be used in animals, bone models, and other non-biological substrates, such as, for example, in training, testing, and demonstration.

The surgical system of the present invention may be understood more readily by reference to the following detailed description of the embodiments taken in conjunction with the accompanying drawings, which form a part hereof. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or illustrated 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, 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. When such a range is expressed, another embodiment includes from the one particular value and/or to the other 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 should also be understood that all spatial references (such as, for example, horizontal, vertical, top, upper, lower, bottom, left, and right) are for illustrative purposes only and may vary within the scope of the present invention. For example, references to "upper" and "lower" are relative and are used only in context, and not necessarily "upper" and "lower".

As used in the specification, including the appended claims, "treating" of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (normal or abnormal human or other mammal), using an implantable device, and/or using a disease-treating device (such as, for example, a microdiscectomy device for removing a bulge or herniated disc and/or bone spurs) in an effort to alleviate signs or symptoms of the disease or condition. Remission may occur before or after the signs or symptoms of the disease or condition appear. Thus, treatment includes preventing a disease or an adverse condition (e.g., preventing the disease from occurring in a patient who may be predisposed to the disease but has not yet been diagnosed with the disease). Furthermore, treatment does not require complete relief of signs or symptoms, does not require a cure, and specifically includes surgery that has only a marginal effect on the patient. Treatment may include inhibiting the disease, e.g., arresting its development, or ameliorating the disease, e.g., causing regression. For example, treatment may include reducing acute or chronic inflammation; relief of pain and reduction and induction of regrowth of new ligaments, bone and other tissues; as an aid to surgery; and/or any revision surgery. In some embodiments, the term "tissue" as used in the specification, including the appended claims, includes soft tissue, ligaments, tendons, cartilage, and/or bone, unless other meanings are explicitly indicated.

The following discussion includes a description of a surgical system (including surgical instruments, related components, and methods of using the surgical system) in accordance with the principles of the present invention. Alternative embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Turning to fig. 1-40, components of a surgical system, such as, for example, surgical system 50, are illustrated.

The components of surgical system 50 may be made of biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials and/or composites thereof. For example, surgeryThe components of the system 50 may be made of the following materials, either individually or collectively: such as stainless steel alloys; aluminum; industrial pure titanium; a titanium alloy; grade 5 titanium; a superelastic titanium alloy; a cobalt-chromium alloy; superelastic metal alloys (e.g., Nitinol), superelastic ductile metals, such as GUM) (ii) a Ceramics and composites thereof, such as calcium phosphates (e.g., SKELITE)^TM) (ii) a Thermoplastics such as Polyaryletherketones (PAEKs), including Polyetheretherketones (PEEK), Polyetherketoneketones (PEKK), and Polyetherketones (PEK); a carbon-PEEK composite; PEEK-BaSO₄A polymeric rubber; polyethylene terephthalate (PET); a fabric; a silicone; a polyurethane; a silicone-polyurethane copolymer; a polymeric rubber; a polyolefin rubber; a hydrogel; semi-rigid and rigid materials; an elastomer; rubber; a thermoplastic elastomer; a thermoset elastomer; an elastic composite; rigid polymers including polyphenyls, polyamides, polyimides, polyetherimides, polyethylenes, epoxies; bone material including autograft, allograft, xenograft or transgenic cortical and/or pithy bone, and tissue growth or differentiation factors; partially absorbable materials such as, for example, composites of metal and calcium-based ceramics, composites of PEEK and absorbable polymers; fully absorbable materials such as, for example, calcium-based ceramics such as calcium phosphate, tricalcium phosphate (TCP), Hydroxyapatite (HA) -TCP, calcium sulfate, or other absorbable polymers such as polylactide, polyglycolide, polytyrosine carbonate, polycaprolactone (polycaro); and combinations thereof.

The various components of the surgical system 50 may have a material composite, including the above materials, to achieve various desired characteristics such as strength, stiffness, elasticity, compliance, biomechanical properties, durability and radiolucency or imaging preference. The components of the surgical system 10 may also be made of heterogeneous materials, such as a combination of two or more of the above materials, individually or collectively. The components of surgical system 50 may be integrally formed, integrally connected, or include fastening elements and/or instruments, as described herein.

The surgical system 50 is used, for example, with fully open surgery, minimally invasive surgery including percutaneous techniques, and micro-open surgical techniques to deliver and introduce instruments and/or spinal implants, such as, for example, a corpectomy cage, at a surgical site (including, for example, the spinal column) of a patient. In some embodiments, spinal implants may include one or more components of one or more spinal constructs (such as, for example, intervertebral devices, intervertebral cages, bone fasteners, spinal rods, tethers, connectors, plates, and/or bone grafts), and may be used with various surgical procedures, including surgical treatment of the cervical, thoracic, lumbar, and/or sacral regions of the spine.

System 50 includes a plurality of surgical instruments, such as, for example, a template 52 (e.g., fig. 1), a template 54 (e.g., fig. 12), and/or a template 56 (e.g., fig. 11), and an image guide, such as, for example, a navigation component 58 removably attached with templates 52, 54, 56, as discussed herein. The navigation component 58 is configured to allow visualization of the templates 52, 54, 56 within the patient anatomy. The navigation component 58 interfaces with a computer having software configured to estimate the appropriate final implant size, defect height size, and estimate implant position and trajectory in the fully and collapsed state, as discussed herein. In some embodiments, system 50 includes templates other than templates 52, 54, 56 or in addition to templates 52, 54, 56, such as, for example, templates having different sizes and/or geometries than templates 52, 54, 56.

Template 52 includes a shaft 60 extending along a longitudinal axis X1 between a proximal end 62 and an opposite distal end 64. In various embodiments, the shaft 60 is coaxial with the axis X1 along the entire length of the shaft 60. In some embodiments, shaft 60 includes a body 66 extending from end 62 to an end 68 between ends 62 and 64. The body 66 may include one or more grooves 70 along the length of the body 66 to facilitate gripping of the shaft 60. In various embodiments, the shaft 60 includes a rod 72 connected to the body 66 by a portion 74. Portion 74 extends from end 68 to end 76, and rod 72 extends from end 76 to end 64. Portion 74 may taper from end 68 to end 76, as shown in FIG. 1. In some embodiments, the portion tapers continuously from end 68 to end 76 such that the diameter of rod 72 is smaller than the diameter of body 66 to facilitate insertion of rod 72 into a surgical site, such as, for example, a corpectomy defect. For example, in some embodiments, the maximum diameter D1 of the body 66 is greater than the maximum diameter D2 of the rod 72, as shown in fig. 2. This allows body 66 to be large enough to facilitate grasping by a practitioner, while allowing rod 72 to be small enough to be inserted into a corpectomy defect. In some embodiments, the rod 72 has a uniform diameter along the entire length of the rod 72. In some embodiments, rod 72 is tapered and has a smaller diameter near end 64 than near end 76. In some embodiments, the rod 72 tapers continuously from the end 76 to the end 64. In some embodiments, the shaft 60 has a solid configuration without any cavities or openings to provide strength and/or rigidity to the shaft 60.

Template 52 includes an engagement portion 78 adjacent end 64. Portion 78 is configured for insertion between adjacent vertebrae of a patient, or into a corpectomy defect. Portion 78 includes a rod 80 extending from end 64 to end 82 along a longitudinal axis X2. Axis X2 extends at an angle a relative to axis X1 to facilitate insertion of portion 78 about the spinal cord of a patient, as discussed herein. In some embodiments, the angle α is greater than 0 °. In some embodiments, the angle α is an acute angle. In some embodiments, the angle α is an oblique angle. In some embodiments, the angle α is between about 1 ° and about 90 °. In some embodiments, the angle α is between about 1 ° and about 45 °. In some embodiments, the angle α is between about 20 ° and about 40 °.

Portion 78 includes a head 84 extending from end 82. Head 84 is configured to be positioned in a corpectomy defect to represent the size of an implant to be inserted into the corpectomy defect, as discussed herein. The head 84 includes a wall 86, the wall 86 having a top surface 88 and an opposite bottom surface 90, as best shown in fig. 2 and 4. The distance between surface 88 and surface 90 defines a height H1 of head 84. In some embodiments, the wall 86 has a cylindrical configuration and defines an opening 92 extending through the thickness of the head 84. That is, opening 92 extends continuously between and through surfaces 88 and 90, between and through surfaces 88 and 90. In some embodiments, height H1 is greater than diameter D2. In some embodiments, height H1 is greater than or equal to diameter D1. In some embodiments, height H1 is less than diameter D1. The size and shape of wall 86 and/or opening 92 are configured to correspond to the size and shape of an implant to be inserted into a corpectomy defect to determine whether the implant is suitable for implantation into a corpectomy defect, or whether a differently sized and shaped implant will be more suitable for implantation into a corpectomy defect, as discussed herein. In some embodiments, the wall 86 has a maximum outer diameter D3 (shown in FIG. 1) and a maximum inner diameter D4 (shown in FIG. 4). In some embodiments, the walls 86 and/or the openings 92 may have various shapes, such as, for example, circular, oval, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, wavy, arcuate, variable, and/or tapered.

In some embodiments, the head 84 is integrally and/or monolithically formed with the shaft 60 to provide increased strength and/or rigidity to the template 52. In some embodiments, the head 84 is removably coupled to the shaft 60 to allow different heads, such as, for example, heads having different sizes or shapes, to be coupled to the shaft 60. It is contemplated that allowing different heads to be coupled to the shaft 60 will reduce the number of instruments required to perform a given procedure. Indeed, rather than having multiple shafts, each with a different head coupled thereto, there may be only one shaft and multiple heads, which may be removably coupled to the shaft.

Shaft 60 includes a hub 94 located between end 62 and end 68. The hub 94 includes a flange 96 and a flange 98 spaced from the flange 96. The hub 94 includes a groove 100 between the flanges 96, 98. The groove 100 is defined by an outer surface 102 of the shaft 60, a surface 104 of the flange 96, and a surface 106 of the flange 98, as best shown in FIG. 5. In various embodiments, surface 102 extends parallel to axis X1, while surfaces 104, 106 extend perpendicular to axis X1. Flange 96 includes a surface 108 located between surface 104 and a surface 110 of hub 94. Surface 108 extends parallel to axis X1, while surface 110 extends perpendicular to axis X1. Flange 98 includes a surface 112 located between surface 106 and a surface 114 of flange 98. Surface 112 extends parallel to axis X1, while surface 114 extends perpendicular to axis X1. In some embodiments, the surface 104 is configured to act as a ramp (ramp) connecting the navigation feature 58 with the shaft 60, as discussed herein. In some embodiments, surfaces 104, 106, 108, 110, 112, and/or 114 may be disposed in alternative orientations relative to axis X1, such as, for example, parallel, transverse, perpendicular, and/or other angular orientations, such as acute or obtuse angles, coaxial, and/or may be offset or staggered.

Template 54 is similar to template 52 and includes a shaft 60 with a hub 94 located between ends 62 and 64, as shown in fig. 6. Template 54 includes an engagement portion 116 having a rod 118, rod 118 being similar to rod 80 extending from end 64. Rod 118 extends from end 64 to end 120 along longitudinal axis X3. As discussed herein, axis X3 extends at an angle β relative to axis X1 to facilitate insertion of portion 116 around the spinal cord of a patient. In some embodiments, the angle β is greater than 0 °. In some embodiments, the angle β is an acute angle. In some embodiments, the angle β is an obtuse angle. In some embodiments, the angle β is between about 1 ° and about 90 °. In some embodiments, the angle β is between about 1 ° and about 45 °. In some embodiments, the angle β is between about 20 ° and about 40 °. In some embodiments, angle β is less than or equal to angle α. In some embodiments, angle β is greater than or equal to angle α. In some embodiments, angle β is different than angle α. In some embodiments, the maximum length of rod 118 is less than the maximum length of rod 80. It is envisaged that the difference between the lengths of the rods 80 and 118 and the difference between the angles a and β provides the practitioner with a choice as to which instrument to use for a given procedure. For example, the practitioner may select either template 52 or template 54 depending on which has the greater angle, where the increased angle is needed to facilitate insertion around the patient's spinal cord.

Portion 116 includes a head 122 extending from end 120. Head 122 is similar to head 84 and is configured to be positioned in a corpectomy defect to indicate the size of an implant to be inserted into the corpectomy defect, as discussed herein. The head 122 includes a wall 124 having a cylindrical configuration and defines an opening 126 extending through the thickness of the head 122. That is, the opening 126 extends continuously between and through the opposing top and bottom surfaces of the head 122. The size and shape of wall 124 and/or opening 126 are configured to correspond to the size and shape of an implant to be inserted into a corpectomy defect to determine whether the implant is suitable for implantation into a corpectomy defect, or whether an implant of a different size and shape will be more suitable for implantation into a corpectomy defect, as discussed herein. In some embodiments, the wall 124 has a maximum outer diameter D5 and a maximum inner diameter D6. In some embodiments, diameter D3 is less than diameter D5, and diameter D4 is less than diameter D6. Thus, template 54 may be used to position proximate to larger implants, while template 52 may be used to position proximate to smaller implants. However, it is contemplated that the length of rod 80 or rod 118, the inner diameter of head 84 or head 122, and/or the outer diameter of head 84 or head 122 may be selected based on the size and configuration of the implant positioned at the corpectomy defect. In some embodiments, the walls 124 and/or openings 126 may be various shapes, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform. In some embodiments, head 122 is integrally and/or monolithically formed with shaft 60 to provide increased strength and/or rigidity to template 54. In some embodiments, the head 122 is removably coupled to the shaft 60 to allow different heads, such as, for example, the head 84 or the head 122, to be coupled to the shaft 60, depending on the preference of the practitioner.

Template 56 is similar to template 52 and template 54 and includes shaft 60 with hub 94 located between ends 62 and 64, as shown in fig. 11. Template 56 includes an engagement portion 128 having a stem 130 similar to stems 80, 118 extending from end 64. The rod 130 extends along an axis X1 from an end 64 to an end 132. In some embodiments, the maximum length of rod 130 is less than or equal to the maximum length of rod 80 and/or rod 118. In some embodiments, the maximum length of rod 130 is greater than or equal to the maximum length of rod 80 and/or rod 118. Portion 128 includes a head 134 extending from end 132. The head 134 is configured to be positioned in a corpectomy defect to represent the size of an implant to be inserted into the corpectomy defect, as discussed herein. The head 134 has a solid wall configuration with a rounded rectangular shape. That is, the head 134 is free of any grooves, holes or apertures. In some embodiments, the head 134 may be various shapes such as, for example, circular, oval, oblong, triangular, square, rectangular, polygonal, irregular, uniform. It is contemplated that the size and shape of the head 134 may be adapted to match or approximate the size and shape of an implant to be implanted in a corpectomy defect. In some embodiments, head 134 is integrally and/or monolithically formed with shaft 60 to provide increased strength and/or rigidity to template 56. In some embodiments, the head 134 is removably coupled to the shaft 60 to allow different heads, such as, for example, the head 84, the head 122, or the head 134, to be coupled to the shaft 60, depending on the preference of the practitioner.

The navigation feature 58 is configured to be coupled to the hub 94 to connect the navigation feature 58 with the template 52, the template 54, or the template 56. The navigation member 58 includes a collar 136 having an inner surface 138 and an outer surface 140, as best shown in FIG. 7. Surface 138 defines a channel 142. Surface 138 is configured to releasably engage hub 94. The channel 142 is configured to receive the shaft 60 and a portion of the hub 94. The surface 138 defines a lock, such as, for example, at least one resilient prong or tab 144. In one embodiment, collar 136 includes a plurality of tabs 144, as shown in FIG. 7. Each tab 144 includes an inner surface 146 and an outer surface 150 that define a cutout 148. Each cutout 148 includes a raised portion 152 that defines an edge of the cutout 148. The cutout 148 is configured to receive the flange 98. In its initial position, surface 150 is aligned with surface 140 of collar 136.

To connect the navigation feature 58 with template 52, 54, or 56, collar 136 is translated on shaft 60 such that flange 98 engages portion 152 and applies a force to tab 144 to move tab 144 outward in the direction indicated by arrow a shown in fig. 7 such that surface 150 is deflected from surface 140. As the flange 98 translates over the portion 152, the flange 98 moves into the cutout 148, allowing the tabs 144 to move back to their original positions. In some embodiments, navigation component 58 is configured to removably engage template 52, template 54, and template 56. In some embodiments, navigation feature 58 may be integrally formed with template 52, template 54, or template 56. In one embodiment, the flange 96 is configured to engage the collar 136 to reduce vibration caused by torque of the actuator. In some embodiments, when flange 98 is positioned in cutout 148, end face 154 of collar 136 directly engages surface 110 of hub 94 to prevent and/or reduce the amount of movement between navigation component 58 and shaft 60.

The navigation component 58 includes an array of transmitters 604, as shown in FIG. 7. The transmitter array 604 is configured to generate signals to the sensor array 602 of the surgical navigation system 606, as shown in fig. 8. In some embodiments, the signals generated by the emitter array 604 represent the position of an instrument (such as, for example, template 52, template 54, or template 56) relative to tissue (such as, for example, bone). In some embodiments, the signals generated by emitter array 604 represent the three-dimensional position of template 52, template 54, or template 56 relative to the tissue. In some implementations, the emitter array 604 includes a reflective array and/or is configured to reflect signals to the sensor array 602.

In some embodiments, sensor array 602 receives signals from emitter array 604 to provide a three-dimensional spatial position and/or trajectory of template 52, 54, or 56 relative to the tissue. The transmitter array 604 communicates with a processor of a computer 608 of the navigation system 606 to generate data for displaying an image on a monitor 610. In some embodiments, sensor array 602 receives signals from emitter array 604 to provide a visual representation of the position of template 52, template 54, or template 56 relative to the tissue. See, for example, similar surgical navigation components and uses thereof as described in U.S. patent nos. 6,021,343, 6,725,080, 6,796,988, the entire contents of each of which are incorporated herein by reference.

Surgical navigation system 606 is configured to acquire and display medical images, such as, for example, x-ray images suitable for a given surgery. In some embodiments, pre-acquired images of the patient are collected. In some embodiments, surgical Navigation system 606 may include an O-arm sold by Medtronic Navigation, IncAn imaging device 611. The imaging device 611 may have a generally annular gantry housing that encloses an image capture portion 612.

In some embodiments, navigation system 606 includes an image capture portion 614, and image capture portion 614 may include an x-ray source or emitting portion and an x-ray receiving or image receiving portion that are positioned substantially or as much as possible 180 degrees from each other and mounted on a rotor (not shown) relative to the trajectory of image capture portion 614. The image capture portion 614 is operable to rotate 360 degrees during image acquisition. The image capture portion 614 may be rotated about a center point or axis, allowing image data of the patient to be acquired from multiple directions or in multiple planes. The surgical navigation system 606 may include those disclosed in U.S. patent nos. 8,842,893, 7,188,998, 7,108,421, 7,106,825, 7,001,045, and 6,940,941, the entire contents of each of which are incorporated herein by reference.

In some embodiments, surgical navigation system 606 may include a C-arm fluoroscopic imaging system that may generate three-dimensional views of the patient. The location of the image capture portion 614 may be precisely known relative to any other portion of the imaging device of the navigation system 606. In some embodiments, accurate knowledge of the position of the image capturing portion 614 may be used in conjunction with the tracking system 616 to determine the position of the image capturing portion 614 relative to the patient and the image data of the patient.

The tracking system 616 may include various components associated with or included in the surgical navigation system 606. In some embodiments, tracking system 616 may also include various types of tracking systems, such as, for example, an optical tracking system including an optical locator, such as, for example, sensor array 602 and/or an EM tracking system that may include an EM locator. Various tracking devices may be tracked with tracking system 616, and surgical navigation system 606 may use the information to allow the location of items to be displayed, such as, for example, patient tracking devices, imaging device tracking devices 618, and instrument tracking devices, such as, for example, emitter array 604, to allow selected portions to be tracked with an appropriate tracking system.

In some embodiments, the EM tracking system may comprise that sold by Medtronic Navigation, IncAXIEM^TMA navigation system. Exemplary tracking systems are also disclosed in U.S. patent nos. 8,057,407, 5,913,820, 5,592,939, the entire contents of each of which are incorporated herein by reference.

The captured fluorescence image is sent to computer 614 and may be forwarded to computer 608. Image transmission may be performed over a standard video connection or a digital link, including wired and wireless. The computer 608 provides the ability to display and save, digitally manipulate or print a hardcopy of a received image via a monitor 610. In some embodiments, the image may also be displayed to the surgeon via a heads-up display.

In some embodiments, surgical navigation system 606 provides real-time tracking of the position of template 52, 54, or 56 relative to the tissue. As described herein, the sensor array 602 is positioned to provide a clear line of sight for the emitter array 604. In some implementations, the fiducial markers 330 of the emitter array 604 communicate with the sensor array 602 via infrared technology. The sensor array 602 is coupled to a computer 608, and the computer 608 can be programmed with a software module that analyzes the signals transmitted by the sensor array 602 to determine the location of each object in the detector space.

In some embodiments, template 52, 54, or 56 is configured for use with a guide member (such as, for example, end effector 640 of robotic arm R). End effector 640 defines a channel configured for placement of template 52, template 54, or template 56. Robotic arm R includes a position sensor (not shown) (similar to those referenced herein) that measures, samples, captures, and/or identifies position data points of end effector 640 in three-dimensional space for wireless guided insertion of template 52, template 54, or template 56. In some embodiments, the position sensors of robotic arm R are employed in conjunction with surgical navigation system 606 to measure, sample, capture, and/or identify position data points of end effector 640 associated with a surgical procedure, as described herein. The position sensor is mounted with the robotic arm R and is calibrated to measure position data points of the end effector 640 in three-dimensional space, which are transmitted to the computer 608.

In assembly, operation and use, as discussed herein, the navigation component 58 is connected with the template 52 and the template 52 is inserted into the corpectomy defect space S of the vertebra V using a posterior approach such that the engagement portion 78 moves around the spinal cord SC for positioning in the space S and the rod 72 is positioned between the spinous process SP of the vertebra V and the transverse process TP of the vertebra V, as shown in fig. 9. The navigation feature 58 has been omitted from fig. 9 for clarity. The shaft 60 is manipulated to move the head 84 so that the surface 90 moves against the end plate EP of the vertebra V. In some embodiments, the shaft 60 is manipulated to move the head 84 such that the surface 88 moves against an endplate of a vertebra higher than the vertebra V and defines a portion of the space S. The head 84 is moved against the endplates and/or the lateral annulus of the vertebrae and the entire space S to remove bone and/or disc material within the space S. In some embodiments, the head 84 is moved within the space S to remove sufficient bone and/or intervertebral disc material within the space S to fit an implant (such as, for example, implant I at a desired location and a desired trajectory within the space S). For example, in some embodiments, the implant I is movable between a collapsed state (as shown in fig. 16) and an expanded state (as shown in fig. 17). When implant I is in the collapsed state, the implant has a height H2, and when implant I is in the expanded state, the implant has an increased height H3. Thus, when implant I is in a collapsed state, an expanded state, or a state between the collapsed state and the expanded state (where implant I has a height between height H2 and height H3), head 84 moves within space S to remove sufficient bone and/or disc material within space S to fit implant I in space S. In some embodiments, head 84 includes a blade or other sharp surface to facilitate cutting and/or scraping tissue, such as, for example, bone and/or intervertebral disc material. In some embodiments, template 52 is used to identify key landmarks within space S, provide tactile feedback, and confirm the amount of resection by navigation component 58 and surgical navigation system 606, as discussed herein. In some embodiments, implant I is the same as or similar to one or more of the implants disclosed in U.S. patent application No. 14/510,895 filed on 9/10/2014, which is expressly incorporated herein by reference in its entirety.

In some embodiments, as discussed herein, the navigation component 58 is connected with the template 52 and the template 52 is inserted into the space S of the vertebra V using a lateral approach such that the engagement portion 78 is positioned in the space S, as shown in fig. 10. The navigation feature 58 has been omitted from fig. 10 for clarity. The shaft 60 is manipulated to move the head 84 so that the surface 90 moves against the end plate EP of the vertebra V. In some embodiments, the shaft 60 is manipulated to move the head 84 such that the surface 88 moves against an endplate of a vertebra higher than the vertebra V and defines a portion of the space S. The head 84 is moved against the endplates and/or the lateral annulus of the vertebrae and the entire space S to remove bone and/or disc material within the space S. In some embodiments, the head 84 is moved within the space S to remove sufficient bone and/or intervertebral disc material within the space S to fit an implant (such as, for example, implant I at a desired location and a desired trajectory within the space S).

In some embodiments, as discussed herein, navigation component 58 is connected with template 56 and template 56 is inserted into space S of vertebra V using a lateral approach such that engagement portion 128 is positioned in space S, as shown in fig. 11. The navigation feature 58 has been omitted from fig. 11 for clarity. The shaft 60 is manipulated to move the head 134 such that the head 134 moves against the endplate EP of the vertebra V. In some embodiments, the shaft 60 is manipulated to move the head 134 against the endplates and the lateral annulus of the vertebrae and the entire space S to remove bone and/or disc material within the space S. In some embodiments, the head 134 is moved within the space S to remove sufficient bone and/or intervertebral disc material within the space S to fit an implant (such as, for example, implant I at a desired location and a desired trajectory within the space S). The head 134 has a rectangular geometry representing an endplate option for the implant I. For example, one or more endplates may be used in conjunction with the implant I. The endplates of the implant I may have different geometries such as, for example, rectangular, oval, circular, square, etc. Thus, the head 134 may be adapted to have a geometry that matches the geometry of the end plate of the implant I to approximate the position of the end plate within the space S.

In some embodiments, as discussed herein, the navigation component 58 is connected with the template 54 and the template 54 is inserted into the space S of the vertebra V using a lateral approach such that the engagement portion 116 is positioned in the space S, as shown in fig. 12. The navigation feature 58 has been omitted from fig. 12 for clarity. The shaft 60 is manipulated to move the head 122 so that the head 122 moves against the end plate EP of the vertebra V. In some embodiments, the shaft 60 is manipulated to move the head 122 such that the head 122 moves against an endplate of a vertebra higher than the vertebra V and defines a portion of the space S. The head 122 is moved against the endplates and the lateral annulus of the vertebrae and the entire space S to remove bone and/or disc material within the space S. In some embodiments, the head 122 is moved within the space S to remove sufficient bone and/or intervertebral disc material within the space S to fit an implant (such as, for example, implant I at a desired location and a desired trajectory within the space S).

Navigation assembly 58 is coupled to template 52, template 54, and/or template 56 such that axis X4 defined by emitter array 604 is parallel to axis X1, as shown in fig. 2, for example. This allows template 52, template 54, and/or template 56 to be properly inserted into space S with the top and bottom surfaces of heads 84, 122, 134 parallel to the end caps of the vertebrae. It is contemplated that having axis X4 parallel to axis X1 facilitates viewing from a camera system of surgical navigation system 606.

In some embodiments, the orientation of the angle α of the template 52 and/or the orientation of the angle β of the template 54 may be selected using a software menu of the surgical navigation system 606 (such as, for example, the software menu 156 of the computer 608), as shown in fig. 13. In some embodiments, menu 156 is displayed on monitor 610. In some embodiments, the menu 156 provides instructions 158 to the practitioner on how he or she should hold the template 52 and/or the template 54. The practitioner may then select the first window 160 to orient the shaft 80 and/or the shaft 118 in a first orientation, or the second window 162 to orient the shaft 80 and/or the shaft 118 in a second orientation. This allows template 52 and/or template 54 to be rotated 180 degrees.

In some embodiments, template 52, template 54, and/or template 56 may include one or more verification features, such as, for example, one or more bosses 190 configured to seat in verification recesses 192 of an implanted navigation feature 194 to allow verification with navigation software, as shown in fig. 14A-15B. Bosses 190 of template 54 extend outwardly from wall 124 of head 122, as shown in fig. 14B-15B. It is contemplated that bosses 190 of templates 52, 56 may be similarly positioned on head 84 of template 52 and head 134 of template 56. For example, bosses 190 of template 52 may extend outwardly from wall 86, and bosses 190 of template 52 may extend outwardly from an outer surface of head 134 of template 56. Prior to inserting head 84 of template 52, head 122 of template 54, or head 134 of template 56 into the disc space, member 194 is implanted in or near the disc space. After the component 194 is implanted in or near the disc space, the head 84 of the template 52, the head 122 of the template 54, or the head 134 of the template 56 are guided into the disc space such that the bosses 190 are seated within the recesses 192 to allow verification with navigation software. The bosses 190 may have different geometries and/or non-concentric cross-sections. In one embodiment, the boss 190 is rectangular to allow placement within the pocket 192 in a manner that prevents the boss 190 from moving within the pocket 192, as shown in FIG. 15A. In one embodiment, boss 190 is arcuate to allow placement within pocket 192 in a manner that allows boss 190 to move within pocket 192, as shown in FIG. 15A.

In some embodiments, navigation component 58 communicates with surgical navigation system 606 to provide a visual representation of template 52, template 54, and/or template 56 within the patient's anatomy. In some embodiments, computer 608 includes software that provides an estimate of the appropriate full implant size, an estimate of the defect height size, and an estimate of the implant position and trajectory in either the fully collapsed or fully expanded state. In some embodiments, the software may be configured to determine the size of a region (such as, for example, space S), as well as the size of an implant (such as, for example, implant I). For example, the software may determine height H2 and/or height H3. In some embodiments, the software may create an image of space S and a representation of implant I within space S, so the practitioner may make whether there is sufficient space within space S for implant I to be visualized. In some embodiments, the image created by the software may display the trajectory of the implant I within the space S. In some embodiments, the software may adjust the trajectory of the implant I within the space S and provide an image representing this trajectory so that the practitioner may determine the optimal trajectory of the implant I within the space S. In some embodiments, the software may allow visualization of the anatomy during implant sizing by allowing the user to save a plan of implant positions and trajectories.

In some embodiments, computer 608 includes software that estimates the final implant system using head 84 and/or head 122. For example, the head 84 and/or the head 122 may be used to generate a cylindrical representation 164, the cylindrical representation 164 representing the size of the implant I, as shown in fig. 18. In some embodiments, the software is configured to generate toggle button 166 viewable on monitor 610. The toggle button 166 toggles the representation 164 between a view with the implant I in a folded state and a view with the implant I in an unfolded state. This allows the practitioner to quickly visualize the implant I within the space S through the representation 164, with the implant I in a collapsed state (fig. 20) and an expanded state (fig. 21). That is, the toggling of representation 164 allows the practitioner to see if the maximum expanded state of implant I can span the space between adjacent vertebrae.

In some implementations, the software is configured to flip the orientation of the representation 164 by 180 degrees. In some embodiments, the software is configured to turn on and off the representation 164. That is, this software may be configured to provide an image of the template 52 in space without the need for the representation 164. If the practitioner wishes to visualize how an implant (such as, for example, implant I) will fit within the space S, he or she may use the toggle button 166 to provide an image of the template 52 within the space via the representation 164.

In some embodiments, the computer 608 includes software that uses the projections 168 and 170 to estimate the final implant system, the projections 168 and 170 may be stored at each of the opposite ends of the space S, as shown in fig. 22 and 23. The projections 168, 170 represent the cylindrical geometry of an implant (such as, for example, implant I). In some embodiments, projection 168 represents the cylindrical geometry of implant I, with implant I in a folded state, and projection 170 represents the cylindrical geometry of implant I, with implant I in an unfolded state. The software will then measure the resulting defect height, angulation between the coronal and sagittal planes, and the appropriate implant size to be used in space S. Angulation data from the software may be used to select a corresponding implant additive, such as, for example, one or more endplates of an implant (such as, for example, implant I). The visual representation of the template 52 allows for easy visualization through the opening 92, as shown in fig. 24.

In some embodiments, the software may generate one or more projections 172 that correspond to polygonal or rectangular geometries of implant additives, such as, for example, one or more endplates of an implant (such as, for example, implant I), as shown in fig. 25 and 26. Projections 168, 170, 172 are saved, representing the cylindrical and rectangular geometry of the implant I. The projections 168, 170, 172 are used to plan the optimal placement position and trajectory of the implant I during the actual implant insertion. It is contemplated that the projection 172 may be used to provide representations of implant additions of various shapes and sizes. In some embodiments, this software is configured to erase the resected vertebral body by moving the template 52 within the space S and removing material from the visual representation of the patient' S anatomy, as shown in fig. 27. Although the above disclosed method discusses the use of template 52 to estimate implant size, position, and trajectory, it is contemplated that template 54 and/or template 56 may be used in place of template 52 or in addition to template 52.

After determining the optimal implant size, location, and trajectory, an implant is selected from a plurality of implants having different sizes and/or geometries, such as, for example, implant I. In some embodiments, implant I is inserted into space S using a posterior approach. In some embodiments, an image guide (such as, for example, the navigation component 58) is coupled to a surgical instrument, such as, for example, an in-line inserter 174, as shown in fig. 28. Implant I is coupled to inserter 174, and inserter 174 is manipulated using a posterior approach to position implant I within space S. In some embodiments, the image guide (such as, for example, the navigation component 58) is coupled to a surgical instrument, such as, for example, an angled inserter 176, as shown in fig. 29. The implant I is coupled to the inserter 176 and the inserter 176 is manipulated using a posterior approach to position the implant I within the space S while facilitating access around the spinal cord SC.

In some embodiments, implant I is inserted into space S using a lateral approach. For example, in some embodiments, an image guide (such as, for example, the navigation component 58) is coupled to the inserter 174 and the inserter 174 is manipulated using a lateral approach to position the implant I within the space S, as shown in fig. 30.

In some embodiments, the implant I is inserted into the space S using an anterior approach. For example, in some embodiments, an image guide (such as, for example, the navigation component 58) is coupled to the inserter 174 and the inserter 174 is manipulated using an anterior approach to position the implant I within the space S, as shown in fig. 31.

The navigation component 58 allows for the visual representation of the inserters 174, 176 for posterior, lateral and anterior approaches in multiple anatomical views of the inserters 174, 176, the implant and the projection relative to the patient anatomy. In some embodiments, computer 608 includes software configured to estimate a suitable final implant size, estimate a suitable implant placement location and trajectory, and provide visualization of implant deployment. In some embodiments, this software provides visualization and differentiation of implants and projections while estimating the size, location, and trajectory of multiple implants and/or multiple implant additions in multiple presentation states. For example, in some embodiments, the software provides an estimate of the appropriate implant size through a representation of the implant, such as, for example, implant I in an expanded state (fig. 32) and a collapsed state (fig. 33). In some embodiments, the intended deployment direction of the implant I is represented by a colored portion 178 of a different color than the body portion 180 of the implant I. The implant additive, such as, for example, the end plate 182, may be represented in a different color than the color representing the portion 178 or the portion 180, as shown in fig. 32-37. The geometry of different colors and/or transparencies allows easy visualization of the anatomy while navigating. The different transparencies and colors also provide a way to visualize and communicate hardware components to the surgeon, which are only represented, but not navigated. In some embodiments, this software provides visualization of the inserter 174, inserter 176, implant I, and/or endplate 182, with multiple planes in similar anatomical views being visible at the same time, as shown in fig. 35-37. This allows the surgeon to visualize the position of the implant I within the space S. As shown in fig. 38, implant I is shown without any implant additives, such as, for example, end plate 182. Implant I is shown attached to end plate 182 in fig. 39. In some embodiments, this software is configured to allow visualization of the implant I in a lateral approach, as shown in fig. 40, to ensure that the end plates do not protrude beyond, for example, the lateral annulus or lateral border of the vertebra V.

It should be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.