Spinal implant system and method

Abstract

A surgical instrument includes a first member extending between a proximal end and a distal end, the first member configured for fixation with tissue. A second member defines a longitudinal passage and is coupled with a navigation component such that the distal end can be disposed within the passage at a selected distance from the navigation component. The navigation component is positioned relative to a sensor to convey a signal indicative of an orientation of the first member. A third member extends between a proximal end and a distal end. The third member can be mounted with the first member along the orientation such that the distal end of the third member can engage the tissue. Systems, spinal implants, constructs, and methods are disclosed.

Description

TECHNICAL FIELD

[0001] The present invention relates generally to medical devices for treating musculoskeletal conditions, and more particularly to surgical systems and methods for treating the spine. BACKGROUND

[0002] Spinal pathologies and conditions, such as scoliosis and other curvature abnormalities, kyphosis, degenerative disc disease, herniated discs, osteoporosis, spondylolisthesis, stenosis, tumors, and fractures can be caused by factors including trauma, disease, and degenerative conditions resulting from injury and aging. Spinal conditions often result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility.

[0003] Non-surgical treatments, such as medication, rehabilitation, and exercise, can be effective, but can not alleviate the symptoms associated with these conditions. Surgical treatment of these spinal conditions includes correction, fusion, fixation, discectomy, laminectomy, and implantable prosthetics. As part of these surgical treatments, spinal constructs, such as vertebral rods, are often used to provide stability to the treated region. As healing progresses, the rod redirects stress away from the damaged or defective region to restore proper alignment and overall support of the vertebral members. During the surgical treatment, one or more rods and bone fasteners can be delivered to the surgical site. The rod can be attached to the exterior of two or more vertebral members via fasteners. The surgical treatment can use surgical instruments and implants that are manipulated for engagement with the vertebrae to position and align one or more vertebrae. The present invention describes improvements to these prior art techniques. SUMMARY

[0004] In one embodiment, a surgical instrument is provided. The surgical instrument includes a first member extending between a proximal end and a distal end, the first member configured for fixation with a tissue. A second member defines a longitudinal passage and is coupled with a navigation component such that the distal end can be disposed within the passage at a selected distance from the navigation component. The navigation component is positioned relative to a sensor to convey a signal indicative of an orientation of the first member. A third member extends between a proximal end and a distal end. The third member can be mounted with the first member along the orientation such that the distal end of the third member can engage the tissue. In some embodiments, systems, spinal implants, constructs, and methods are disclosed.

[0005] In one embodiment, the surgical instrument includes an anchor extending between a proximal end and a distal end and configured for fixation with tissue. A dilator defines a longitudinal passage and is coupled with a navigation component such that the distal end can be disposed within the passage at a selected distance from the navigation component. The navigation component is positioned relative to a sensor to communicate a signal indicative of an orientation of the anchor. A drill guide can be mounted with the anchor along the orientation such that a distal end of the drill guide can engage the tissue.

[0006] In one embodiment, the surgical instrument includes an anchor configured for fixation with tissue. A dilator defines a longitudinal passage and is coupled with a navigation component such that the distal end can be disposed within the passage at a selected distance from the navigation component. The navigation component is positioned relative to a sensor to communicate a signal indicative of an orientation of the anchor. A drill guide can be mounted with the anchor along the orientation such that a distal end of the drill guide can engage the tissue. An anchoring tool can be coupled with the anchor and configured to adjust a depth of the anchor relative to the tissue and the navigation component. BRIEF DESCRIPTION OF DRAWINGS

[0007] The present application will become more fully understood from the detailed description given herein below, and the accompanying drawings which are given by way of illustration and in which:

[0008] Figure 1 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present application;

[0009] Figure 2 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present application; Figure 1 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present application;

[0010] Figure 3 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present application; Figure 1 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present application;

[0011] Figure 4 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present application; Figure 3 is a cross-sectional view of components shown;

[0012] Figure 5 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present application; Figure 1

[0013] Figure 6 is a perspective view of components shown, with components separated; Figure 5

[0014] Figure 7 is a cross-sectional view of components shown; Figure 5

[0015] Figure 8 is a cross-sectional view of components shown;​​​Figure 5 cross-sectional view of the components shown;

[0016] Figure 9 is Figure 5 cross-sectional view of the components shown;

[0017] Figure 10 is Figure 1 perspective view of components of the surgical system shown;

[0018] Figure 11 is Figure 1 cross-sectional view of the components of the surgical system shown;

[0019] Figure 12 is Figure 1 cross-sectional view of the components of the surgical system shown;

[0020] Figure 13 is a perspective view of components of one embodiment of a surgical system according to the principles of the application, with the components separated;

[0021] Figure 14 is a perspective view of components of one embodiment of a surgical system according to the principles of the application;

[0022] Figure 15 is Figure 14 perspective view of Detail A shown;

[0023] Figure 16 is Figure 14 perspective view of Detail B shown;

[0024] Figure 17 is a perspective view of components of one embodiment of a surgical system according to the principles of the application;

[0025] Figure 18 is a perspective view of components of one embodiment of a surgical system according to the principles of the application;

[0026] Figure 19 is a perspective view of components of one embodiment of a surgical system according to the principles of the application;

[0027] Figure 20 is a perspective view of components of one embodiment of a surgical system according to the principles of the application;

[0028] Figure 21 is a perspective view of components of one embodiment of a surgical system according to the principles of the application; and

[0029] Figure 22 is a perspective view of components of one embodiment of a surgical system according to the principles of the application. DETAILED DESCRIPTION

[0030] Exemplary embodiments of the disclosed surgical systems and related methods of use are discussed in the context of medical devices for treating musculoskeletal conditions, and more particularly in the context 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 surgical treatments described herein, e.g., in the cervical, thoracic, lumbar, and / or sacral regions of the spine.

[0031] In some embodiments, the surgical systems of the present invention include surgical instruments comprising an anchor and a dilator configured to engage a bone with navigation. In some embodiments, the surgical instruments are configured to guide a drill guide along the anchor to facilitate engagement of the drill guide with the bone. In some embodiments, the surgical systems include a navigation sleeve dilator, an anchor, and an anchoring tool. In some embodiments, the anchor and dilator are set together and engaged with the bone. In some embodiments, the anchor is tamped into the bone and the dilator is removed. In some embodiments, the anchor is engaged with the bone with navigation. In some embodiments, a drill guide is guided over the anchor and tamped into the bone. In some embodiments, the anchor is removable.

[0032] In some embodiments, the surgical systems of the present invention include surgical instruments comprising an anchor and a dilator configured to confirm a trajectory when tamping a drill guide. In some embodiments, the drill guide is engaged with the bone with navigation. In some embodiments, the anchor and dilator are set together and the dilator is connected with a navigation component.

[0033] In some embodiments, the surgical systems of the present invention include surgical instruments comprising a disposable anchor. In some embodiments, the anchor includes a recess disposed at a proximal end. In some embodiments, the surgical systems of the present invention include an anchoring tool having a depressible button to connect and lock the anchor with the anchoring tool. In some embodiments, the anchoring tool includes a depth setting device.

[0034] In some embodiments, the surgical system of the present invention includes surgical instruments comprising a navigation component connected to an expander, and an anchor is inserted through the expander. In some embodiments, the distal tip of the anchor extends beyond the distal end of the expander. In some embodiments, the distal tip extends a distance from the expander. In some embodiments, the distance the distal tip extends is equal to a length programmed into the navigation system and used for calculating depth navigation. In some embodiments, a depth setting device maintains the distal tip extending from the expander.

[0035] In some embodiments, the surgical system of the present invention includes a method of treating the spine, the method comprising the step of inserting a surgical instrument through a cannula into a surgical site. In some embodiments, the method includes the step of driving or hammering an anchoring tool to temporarily engage the distal tip of an anchor into the bone. In some embodiments, the method includes the step of translating a depth setting device to a retracted position to allow the anchor to be driven deeper after trajectory setting and then hammering the anchor to a selected depth. In some embodiments, the method includes the step of actuating a button to disengage the anchoring tool from the anchor and removing the expander. In some embodiments, the method includes the step of mounting a drill guide above the anchor and hammering the drill guide into the bone. In some embodiments, the method includes the step of reconnecting the anchoring tool to the anchor and removing the anchor from the bone using a percussion hammer. In some embodiments, the drill and drill guide are disposed together and used for implanting a spinal implant. See, for example, embodiments and disclosures of systems and methods for engaging one or more surgical instruments with bone using surgical navigation, filed January 24, 2020 (file number A0002407US02) and published as U.S. Patent Application Publication No. ----------- on ---- year----- month-- day, ---- year----- month-- day, which are jointly owned and assigned U.S. Patent Application Serial No. 16 / 752,565, the entire contents of which are incorporated herein by reference.

[0036] In some embodiments, the surgical system of the present invention includes a surgical instrument comprising a vertical anchor having a distal tip. In some embodiments, the anchor includes a groove at its proximal end to facilitate engagement with an anchoring tool. In some embodiments, the surgical instrument includes a cannula dilator. In some embodiments, the dilator includes a tapered distal tip. In some embodiments, the dilator includes a passage formed by slots milled along each side of the dilator.

[0037] In some embodiments, the present surgical system includes a surgical instrument that includes an anchor tool having a depth setting device, an anchor retention button, and a tap hammer. In some embodiments, the depth setting device can be set in a fully extended position to set the depth of the anchor for navigation. In some embodiments, a pin connects the depth setting device to the anchor tool in a keyed configuration. In some embodiments, the button is biased outward by a spring. In some embodiments, the button can engage with a groove on the anchor to secure the anchor tool to the anchor. In some embodiments, the tap hammer is movable to facilitate removal of the anchor from the bone.

[0038] In some embodiments, the present surgical system includes a surgical instrument that includes a depth setting device that can be moved between a retracted position and an extended position. In some embodiments, in the retracted position, a spring tab locks the depth setting device. In some embodiments, the anchor tool includes a pin to retain the button with the body of the anchor tool. In some embodiments, the flange is welded to the anchor tool after assembly of the tap hammer. In some embodiments, the proximal end of the anchor tool is hollow to reduce the weight of the anchor tool.

[0039] In some embodiments, the present system is used in a method for use with surgical navigation (e.g., fluoroscopic or image guidance). In some embodiments, the presently disclosed system and / or method reduces the surgical time of a surgery and reduces radiation exposure due to fluoroscopic or image guidance, for example, by eliminating a surgical step and repositioning of the patient by implanting a system component in one body position.

[0040] In some embodiments, the present surgical system can be used to treat spinal conditions such as, for example, intervertebral disc degeneration, herniated discs, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures. In some embodiments, the present surgical system can be used for other bony and bone-related applications, including those associated with diagnosis and therapy. In some embodiments, the disclosed surgical system can alternatively be used in surgical treatment of patients in a prone or supine position, and / or employing various surgical approaches to the spine, including anterior, posterior, posteromedial, direct lateral, posterolateral, and / or anterolateral approaches, as well as various surgical approaches to other body regions. The present surgical system can also alternatively be used in procedures to treat the lumbar, cervical, thoracic, sacral, and pelvic regions of the spine. The present surgical system can also be used in animals, bone models, and other inanimate substrates, such as, for example, for training, testing, and demonstration.

[0041] The surgical system of the present application can be more readily understood through the following detailed description of the drawings, which is incorporated into this disclosure by reference in its entirety. It should be understood that the application is not limited to the particular devices, methods, 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 the appended claims, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. References to a particular number of values, unless expressly stated otherwise, include at least the particular value. Ranges expressed in this disclosure as "about" or "approximately" one particular value and / or to "about" or "approximately" another particular value can include the particular value and / or to the other particular value. In expressing such a range, another embodiment includes from one particular value and / or to the other particular value. Similarly, where values are expressed as approximations by the use of the antecedent "about," it will be understood that the particular value forms another embodiment. It is also to 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 can vary during use. For example, references to "upper" and "lower" are relative and are used for context only and are not necessarily "higher" and "lower."

[0042] As used in the specification and the appended claims, "treating" or "treatment" of a disease or condition refers to performing surgery, which can include administering one or more drugs to a patient (normal or non-normal human or other mammal) in need of such treatment, using implantable devices and / or using instruments to treat the disease, such as, for example, microdiscectomy instruments for removing bulging portions or herniated discs and / or bone spurs, in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur by preventing the disease or condition from developing, preventing the disease or condition from recurring, and / or relieving the signs or symptoms of the disease or condition. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing a disease from occurring in a patient that can be predisposed to the disease but has not yet been diagnosed with the disease). 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 / or inducing regrowth of new ligament, bone, and other tissues; as surgical aids; and / or any repair procedure. In some embodiments, unless specifically indicated otherwise, the term "tissue" as used in the specification and the appended claims includes soft tissue, ligaments, tendons, cartilage and / or bone.

[0043] The following discussion includes a description of a surgical system (including surgical instruments and related components) according to the principles of the invention, and a method of using said surgical system. Alternative embodiments are also disclosed. Exemplary embodiments of the invention will now be described in detail with reference to the accompanying drawings. Turn to Figures 1 to 12 The diagram shows components of a surgical system, such as, for example, a spinal implant system 10.

[0044] Components of the spinal implant system 10 may be made of bioacceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials and / or composites thereof. For example, components of the spinal implant system 10 may be made individually or collectively of materials such as stainless steel alloys, aluminum, industrially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metal alloys (e.g., Nitinol), and super-elasto-plastic metals such as GUM. ), ceramics and their composites (such as calcium phosphate (e.g., SKELITE) TM Thermoplastics (such as polyaryletherketone (PAEK), including polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 polymer rubber, polyethylene terephthalate (PET)), fabrics, silicones, polyurethanes, silicone-polyurethane copolymers, polymer rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermosetting elastomers, elastomer composites, rigid polymers (including polyphenylene oxide, polyamide, polyimide, polyetherimide, polyethylene, epoxy resins) Fat), bone materials (including autologous, allogeneic, xenograft, or transgenic cortical bone and / or cortical-spongy bone and tissue growth or differentiation factors), partially absorbable materials (such as, for example, metal-calcium-based ceramic complexes, PEEK-calcium-based ceramic complexes, PEEK-absorbable polymer complexes), 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, polyglycolic acid, polytyrosine carbonate, polycaprolactone), and combinations thereof.

[0045] The various components of the spinal implant system 10 can have material composites, including the materials described above, to achieve various desired properties, such as strength, rigidity, elasticity, compliance, biomechanical properties, durability, and radiolucency or imaging preference. The components of the spinal implant system 10 can also be made of heterogeneous materials, such as combinations of two or more of the materials described above, individually or collectively. The components of the spinal implant system 10 can be integrally formed, integrally connected, or include fastening elements and / or instruments, as described herein.

[0046] The spinal implant system 10 is used, for example, with open surgical procedures, minimally invasive procedures, including percutaneous techniques, and small incision surgical techniques, to deliver and introduce instruments and / or spinal implants (e.g., bone fasteners) at a surgical site of a patient, including, for example, the spinal column. In some embodiments, the spinal implants can include one or more components of one or more spinal constructs, such as, for example, intervertebral devices, intervertebral fusion cages, bone fasteners, spinal rods, tethers, connectors, plates, and / or bone grafts, and can be used with various surgical procedures, including surgical treatment of the cervical, thoracic, lumbar, and / or sacral regions of the spinal column.

[0047] The spinal implant system 10 includes a surgical instrument 12. The surgical instrument 12 can be used with an end effector 200 as shown in Figure 1 to perform implantation with a robotic arm R( Figure 22 ). The surgical instrument 12 is guided through the end effector 200 for wireless guided insertion of a spinal implant, for example, a bone fastener 100, as described herein.

[0048] The surgical instrument 12 includes a member, for example, an anchor 14. The anchor 14 extends between a proximal end 16 and a distal end 18, as shown in Figure 2 The proximal end 16 includes a surface 20 that defines a recess 22. In some embodiments, the recess 22 is disposed circumferentially about the end 16. As described herein, the recess 22 is configured to seat a portion of a member, for example, an anchoring tool 24, to releasably secure the anchoring tool 24 with the anchor 14.

[0049] The distal end 18 includes a tip 26. In some embodiments, the tip 26 is pointed or sharp to facilitate penetration of tissue. In some embodiments, the distal end 18 can have various surface configurations, for example, smooth, rough, arcuate, undulating, porous, semi-porous, dimpled, polished, and / or textured configurations. The tip 26 is configured to secure the anchor 14 with tissue to provide an orientation, for example, for an axial trajectory of a component of the surgical instrument 12, as described herein.

[0050] The surgical instrument 12 includes a member, for example, a dilator 30, as shown inFigure 3 and Figure 4 The dilator 30 extends between a proximal end 32 and a distal end 34. The dilator 30 defines a longitudinal axis X1. In some embodiments, the dilator 30 can have various configurations, including, for example, circular, oval, polygonal, irregular, uniform, variable, uniform, and non-uniform configurations. The dilator 30 includes a surface 36 that defines a longitudinal passage 38 extending between the ends 32, 34. In some embodiments, the passage 38 is made by milling overlapping slots 40 through the surface 36 along the dilator 30, as shown in Figure 4

[0051] The end 34 includes a tapered configuration to facilitate spacing of tissue. In some embodiments, the end 34 can have various cross-sectional configurations, such as, for example, oval, elliptical, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, and / or tubular configurations.

[0052] The dilator 30 includes a mating element, for example, a hub 42. The hub 42 is configured to connect the navigation component 280 with the surgical instrument 12. The hub 42 includes a flange 44 and a flange 46 spaced apart from the flange 44. The hub 42 includes a recess 48 between the flanges 44, 46. The dilator 30 is provided with the hub 42. The dilator 30 includes a mating surface, for example, a reference surface 130. The surface 130 is provided on the shaft dilator 30 a selected distance from the distal end 34. The surface 130 can be detected by image guidance and used to determine the position of the navigation component 280 and / or the surgical instrument 12 during a surgical procedure as described herein. The surface 130 is configured to connect with a portion of the navigation component 280 to locate and / or track the navigation component 280 and / or the surgical instrument 12 during a surgical procedure. In some embodiments, the dilator 30 can include one or more mating surfaces as described herein.

[0053] The navigation component 280, as shown in Figure 1 includes a collar 282 having an inner surface 284 and an outer surface 286. The surface 284 defines a passage 288. The surface 284 is configured to releasably engage with the hub 250. The channel 288 is configured to receive the dilator 30 and a portion of the hub 42. The collar 282 includes a locking element, for example, a resilient prong or tab 290. The navigation component 280 is connected with the hub 42 by the tab 290. In some embodiments, the collar 282 can include one or more locking elements as described herein.

[0054] ​As described herein, passage 38 is configured for placement of anchor 14. Expander 30 is detachably mounted to anchor 14 such that tip 26 is positioned at a selected distance from navigation component 280. Navigation component 280 is positioned relative to a sensor to transmit a signal indicating the orientation of anchor 14 during tissue engagement. As described herein, tip 26 is configured to secure anchor 14 to tissue to provide axial trajectory for components of surgical instrument 12.

[0055] The anchoring tool 24 includes a body 50. The body 50 extends between end 52 and end 54. End 54 includes a slot 56 and a spring tab 58, as... Figure 6 As shown. The anchoring tool 24 includes components such as a depth setter 60 and a button 62, as shown. Figures 5 to 9 As shown.

[0056] The depth setter 60 includes a slider 64 and a sleeve 66. The sleeve 66 includes a surface 70 configured to engage with a spring tab 58 in a friction-fit configuration to hold the sleeve 66 in the extended position, such as... Figure 7 As shown, and / or the retracted position, such as Figure 8 As shown. In some embodiments, the sleeve 66 and the body 50 may be configured as an integral connection, friction fit, pressure fit, interlocking engagement, mating engagement, dovetail connection, clamp, barb, tongue in a groove, thread, magnetic and / or key / keyway. The sleeve 66 includes a surface defining a channel 72. Figure 7 As shown, channel 72 is configured to communicate with channel 74 of body 50. Channels 72 and 74 are configured to accommodate anchor 14, as described herein.

[0057] Pin 68 extends through slot 56 to connect slider 64 and sleeve 66 to body 50, as shown. Figure 7 and Figure 8 As shown, the translation of the slider 64 causes the sleeve 66 to translate relative to the body 50 between the extended position and the retracted position.

[0058] For example, slider 64 in Figure 7 The sleeve 66 is simultaneously moved in the direction indicated by the middle arrow A1, and connected to the pin 68. Figure 7 The sleeve 66 is translated to the extended position in the direction indicated by the middle arrow A1. In the extended position, the sleeve 66 is configured to engage abutment against the collar 282 of the navigation component 280, as shown in the image. Figure 13 As shown. In the extended position, the sleeve 66 positions the extension and / or depth of the tip 26 at a selected distance from the navigation component 280 beyond the end 34. The sleeve 66 prevents and / or inhibits the tip 26 from extending beyond the selected distance. As described herein, the tip 26 is temporarily fixed to the tissue under navigation via communication with the surgical navigation system 306 through the navigation component 280.

[0059] Translation of the slide 64 in the opposite direction, i.e., in the direction indicated by arrow A2, causes the sleeve 66 to simultaneously translate in the direction indicated by arrow A2 in Figure 8 Figure 8 the retracted position. In the retracted position, the sleeve 66 is spaced apart from the collar 282 by a distance, as indicated by arrow A3, to allow the anchor 14 to translate through the dilator 30 to further extend from the end 34 of the dilator 30 to facilitate driving the anchor 14 deeper into the tissue for docking. Figure 15

[0060] The button 62 is connected to the body 50 by a pin 80. The button 62 includes a protrusion 82 having a surface 84 defining an opening 86. The opening 86 is configured to seat the anchor 14 and the surface 84 is configured to engage the groove 22 to secure the anchor 14 with the anchoring tool 24. The button 62 is biased to a closed position by a spring 88 such that the protrusion 82 obstructs the passage 74. To capture the anchor 14, a force is applied to the button 62 in the direction indicated by arrow C to align the opening 86 with the passage 74 to allow the anchor 14 to translate therethrough. The button 62 is released and the bias of the spring 88 pushes the button 62 in the direction indicated by arrow D to cause the surface 84 to engage the surface 20 of the groove 22 to capture the anchor 14. To release the anchor 14, a force is applied to the button 62 in the direction indicated by arrow C to disengage the surface 84 from the surface 20 of the groove 22 to release the anchor 14. The opening 86 is aligned with the passage 74 to allow the anchor 14 to translate therethrough to disengage from the anchoring tool 24. Figure 8 Figure 8 Figure 8

[0061] In some embodiments, the anchoring tool 24 includes a handle portion 90 including a flange 92, a tapping hammer 94, and an end flange 96. The tapping hammer 94 translates between the flange 92 and the end flange 96 to facilitate removal of the anchor 14 from the surgical site. In some embodiments, the handle portion 90 is hollow to reduce the weight of the anchoring tool 24.

[0062] The surgical instrument 12 includes a member, e.g., a drill guide 100, as Figure 20 and Figure 21 ​​​​​The drill guide 100 extends between a proximal end 102 and a distal end 104. The distal end 104 is configured to engage tissue. The drill guide 100 includes a surface 106 that defines a passageway 108 configured for seating a drill. The drill guide 100 is used to help control and guide a surgical drill. The drill guide 100 is securely interfaced by mounting the drill guide 100 with the anchor 14. The anchor 14 guides the drill guide 100 along an axial trajectory to engage the distal end 104 of the drill guide 100 with a bone.

[0063] In assembly, operation, and use, the spinal implant system 10, similar to the systems and methods described herein, is used in a surgical procedure, for example, to treat an applicable condition or injury of an affected segment of a spinal column and adjacent areas in a body. In some embodiments, one or all of the components of the spinal implant system 10 can be delivered or utilized as a pre-assembled device, or can be assembled in situ. The spinal implant system 10 can be modified, removed, or replaced in whole or in part.

[0064] In some embodiments, a scalpel (not shown) is oriented to seat the end effector 200 of the robotic arm R, as described herein. An incision is made in the skin SI of the patient with the scalpel to form a surgical path for implanting components of the spinal implant system 10. A retractor (not shown) can be employed to assist in forming the surgical path. A preparation instrument (not shown) can be employed to prepare the tissue surface, as well as for suction and irrigation of the surgical area. The sleeve 150 is inserted into the end effector 200 and into the surgical path. The surgical instrument 12 is assembled. The anchor 14 is disposed within the passageway 38 of the dilator 30. The navigation component 280 is coupled with the dilator 30. The navigation component 280 is translated along the dilator 30 into mating engagement with the surface 130 and coupled with the bushing 42 by the tab 290.

[0065] The anchoring tool 24 is coupled with the anchor 14. The anchor 14 is translated into the channel 72 and the channel 74. The button 62 is actuated to align the opening 86 with the channel 74 to allow the anchor 14 to be translated therethrough. The button 62 is released and the bias of the spring 88 urges the button 62 such that the surface 84 engages the surface 20 of the recess 22, thereby capturing the anchor 14.

[0066] The slider 64 is translated and, by virtue of being coupled with the pin 68, causes the sleeve 66 to be simultaneously translated to an extended position. In the extended position, the sleeve 66 is disposed in abutting engagement with the collar 282 of the navigation component 280, as shown in Figure 13 In the extended position, the sleeve 66 positions the extension and / or depth of the tip 26 at a selected distance from the navigation component 280 and the surface 130 beyond the end 34. The sleeve 66 blocks and / or prevents the tip 26 from extending beyond the selected distance.

[0067] The surgical instrument 12 is inserted into the cannula 150. The dilator 30 dilates the skin SI along the surgical path. The navigation component 280 is oriented relative to the sensor array 302, as shown, so as to communicate between the navigation component 280 and the sensor array 302 during the surgical procedure as described herein. Figure 22

[0068] The navigation component 280 is configured to generate a signal representative of the position of the anchor 14 relative to the tissue. In some embodiments, the image guide can include a human-readable visual marker, a human-readable tactile marker, a human-readable audible marker, one or more components with markers for identification under x-ray, fluoroscopy, CT, or other imaging techniques, at least one light emitting diode, a wireless component, a wired component, a near field communication component, and / or one or more components that generate acoustic, magnetic, electromagnetic, and / or radio signals.

[0069] The navigation component 280 includes an emitter array 304. The emitter array 304 is configured to generate a signal to the sensor array 302 of the surgical navigation system 306. In some embodiments, the signal generated by the emitter array 304 is representative of the position of the anchor 14 relative to the tissue (e.g., bone). In some embodiments, the signal generated by the emitter array 304 is representative of the three-dimensional position of the anchor 14 relative to the tissue.

[0070] In some embodiments, the sensor array 302 receives the signal from the emitter array 304 to provide a three-dimensional spatial position and / or trajectory of the anchor 14 relative to the tissue. The emitter array 304 is in communication with a processor of a computer 308 of the surgical navigation system 306 to generate data for display of an image on a monitor 310, as described herein. In some embodiments, the sensor array 302 receives the signal from the emitter array 304 to provide a visual representation of the position of the anchor 14 relative to the tissue. See, for example, similar surgical navigation components and their uses as described in U.S. Patent Nos. 6,021,343, 6,725,080, and 6,796,988, the entire contents of each of these references are incorporated herein by reference.

[0071] The surgical navigation system 306 is configured to acquire and display medical imaging, for example, x-ray images appropriate for a given surgical procedure. In some embodiments, pre-acquired images of the patient are collected. In some embodiments, the surgical navigation system 306 can include the StealthStation® sold by Medtronic Navigation, Inc., having a place of business in Louisville, Colorado, USA. ​Imaging device 312. Imaging device 312 can have a gantry housing that is generally annular, which surrounds image capture portion 314.

[0072] In some embodiments, image capture portion 314 can include an x-ray source or emitting portion and an x-ray receiving or image receiving portion that are positioned substantially or virtually as close to 180 degrees from each other as possible relative to the orbit of image capture portion 314 and mounted on a rotor (not shown). Image capture portion 314 can be configured to rotate 360 degrees during image acquisition. Image capture portion 314 can rotate about a center point or axis, allowing image data of a patient to be acquired from multiple directions or in multiple planes. Surgical navigation system 306 can 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 these references are incorporated herein by reference.

[0073] In some embodiments, surgical navigation system 306 can include a C-arm fluoroscopic imaging system, which can generate three-dimensional views of a patient. The position of image capture portion 314 can be known precisely relative to any other portion of the imaging device of surgical navigation system 306. In some embodiments, the precise knowledge of the position of image capture portion 314 can be used in conjunction with tracking system 316 to determine the position of image capture portion 314 and image data related to a patient.

[0074] Tracking system 316 can include various portions associated with or included in surgical navigation system 306. In some embodiments, tracking system 316 can also include multiple types of tracking systems, such as, for example, an optical tracking system including an optical localizer, such as, for example, sensor array 302 and / or an EM tracking system that can include an EM localizer. Various tracking devices can be tracked with tracking system 316, and surgical navigation system 306 can use that information to allow the display of the location of items, such as, for example, a patient tracking device, an imaging device tracking device 320, and an instrument tracking device, such as, for example, emitter array 304, to allow selected portions to be tracked relative to each other with the appropriate tracking system.

[0075] In some embodiments, an EM tracking system can include the Medtronic NavPoint® AXIEM® system sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colorado. AXIEM TM Navigation system. Exemplary tracking systems are also disclosed in U.S. Patent Nos. 8,057,407, 5,913,820, and 5,592,939, the entire contents of each of these references are incorporated herein by reference.

[0076] The captured fluoroscopic images are transmitted to the computer 318, whereby the fluoroscopic images can be relayed to the computer 308. The image transmission can be performed through standard video connections or digital links including wired and wireless. The computer 308 is capable of displaying via the monitor 310 and saving, digitally manipulating, or printing hard copies of the received images. In some embodiments, the images can also be displayed to the surgeon through a heads-up display.

[0077] In some embodiments, the surgical navigation system 306 provides real-time tracking of the position of the bone fastener 100 relative to the surgical instrument 12, and / or trackable tissue. As described herein, the sensor array 302 is positioned to provide a clear line of sight for the emitter array 304. In some embodiments, the fiducial markers 322 of the emitter array 304 communicate with the sensor array 302 via infrared technology. The sensor array 302 is coupled to the computer 308, which can be programmed with software modules that analyze the signals transmitted by the sensor array 302 to determine the position of each object in the detector space.

[0078] The surgical instrument 12 is configured for use with a guide member (e.g., the end effector 200 of the robotic arm R) to determine an axial trajectory of a surgical path and / or to facilitate positioning of one or more surgical instruments, implants, and / or components of the spinal implant system 10 in alignment with the axial trajectory of the surgical path. The end effector 200 includes an inner surface 202 that defines a cavity (e.g., a channel 204). The channel 204 is configured for seating one or more components of the surgical instrument 12 and / or implants. The robotic arm R includes position sensors (not shown, similar to those referenced herein) that measure, sample, capture, and / or identify position data points of the end effector 200 in three-dimensional space for wireless guidance of the surgical instrument 12 for insertion into tissue. In some embodiments, the position sensors of the robotic arm R are used in conjunction with the surgical navigation system 306 to measure, sample, capture, and / or identify position data points of the end effector 200 in conjunction with surgical treatment as described herein. The position sensors are mounted on the robotic arm R and calibrated to measure position data points of the end effector 200 in three-dimensional space that are communicated to the computer 308.

[0079] The tip 26 is temporarily secured with the bone B1 to define the axial trajectory AT, as shown in Figure 14 The axial trajectory AT of the anchor 14 is confirmed by communication of the navigation component 280 with the surgical navigation system 306, as described herein.

[0080] To align with anchor 14, sliding member 64 is translated to the retracted position. This translation of sliding member 64 simultaneously translates sleeve 66 to the retracted position. In the retracted position, sleeve 66 is separated from collar 282 by a distance, such as... Figure 15 As shown, this allows the anchor 14 to translate through the expander 30 to extend further from the end 34 of the expander 30, thereby driving the anchor 14 deeper into the bone B1 for docking. The anchor 14 docks with the bone B1 along an axial trajectory AT.

[0081] Anchoring tool 24 is removed from anchor 14, as follows Figure 17 As shown, to release anchor 14, button 62 is actuated to disengage surface 84 from surface 20 of groove 22, thereby releasing anchor 14. Opening 86 is aligned with channel 74 to allow anchor 14 to translate through it to disengage from anchoring tool 24. In some embodiments, hammer 94 is used to assist in releasing anchor 14 from bone B1. Figure 18 As shown, the expander 30 is removed from the anchor 14.

[0082] like Figure 19 As shown, the drill string guide 100 is mounted together with the anchor 14, such that the anchor 14 is positioned within the passage 108. The anchor 14 guides and / or directs the drill string guide 100 through the casing 150 along an axial trajectory AT. An end 104 of the drill string guide 100 extends from the distal end of the casing 150. The drill string guide 100 is compacted along the anchor 14 and the axial trajectory AT, causing the end 104 to engage the bone B1. Thus, the drill string guide 100 abuts against the bone B1 along the navigation axial trajectory AT, thereby maintaining the alignment and / or trajectory of the drill string guide 100 during abutment.

[0083] Anchor 14 is removed from bone B1 by reattaching anchoring tool 24. Anchor 14 is translated into channels 72 and 74. Button 62 is actuated, aligning opening 86 with channel 74, thereby allowing anchor 14 to translate through it. Button 62 is released, and the bias of spring 88 pushes button 62, causing surface 84 to engage surface 20 of recess 22, thereby capturing anchor 14. In some embodiments, a hammer 94 is used to assist in releasing anchor 14 from bone B1. Anchor 14 is removed from bone B1 and surgical site.

[0084] A drill (not shown) is paired with a selected drill bit and inserted into the drill guide 100. The drill guide 100 guides and / or directs the drill along an axial trajectory AT. In some embodiments, the drill includes a navigation component, similar to the navigation component 280 described herein. The navigation component is oriented relative to the sensor array 302 to confirm the trajectory through communication of the navigation component with the surgical navigation system 306, similar to that described herein. A pilot hole (not shown) is made in a selected bone region for receiving a spinal implant, such as a bone fastener for a surgical procedure.

[0085] As described herein, upon completion of the procedure, the surgical instruments, components, and non-implanted parts of the spinal implant system 10 are removed and the one or more incisions are closed. One or more of the components of the spinal implant system 10 can be made of a radiolucent material, such as a polymer. A radiographic marker can be included for identification under x-ray, fluoroscopy, CT, or other imaging techniques. In some embodiments, the spinal implant system 10 can include one or more of a spinal rod, plate, connector, and / or bone fastener for use with a single vertebral level or multiple vertebral levels.

[0086] In some embodiments, one or more bone fasteners can be engaged with tissue in various orientations, such as, for example, in series, in parallel, offset, staggered, and / or alternative vertebral levels, as described herein. In some embodiments, the bone fasteners can include polyaxial screws, sagittal adjustment screws, pedicle screws, monoaxial screws, mono-plane screws, facet screws, fixation screws, tissue penetrating screws, conventional screws, expansion screws, wedges, anchors, buttons, clamps, snaps, friction fittings, compression fittings, expansion rivets, staples, pins, adhesives, posts, fixation plates, and / or columns.

[0087] In one embodiment, the spinal implant system 10 includes a medicament that can be disposed, packaged, coated, or layered within, on, or around a component and / or surface of the spinal implant system 10. In some embodiments, the medicament can include a bone growth promoting material, such as, for example, a bone graft, to enhance fixation of the component and / or surface of the spinal implant system 10 with a vertebra. In some embodiments, the medicament can include one or more therapeutic and / or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation, and degeneration.

[0088] It is to be understood that various modifications can be made to the embodiments disclosed herein. Accordingly, the description is not intended to be construed as limiting, but merely as exemplification. Other modifications will occur to those skilled in the art upon reading this description.

Claims

1. A surgical instrument comprising: a first member extending between a proximal end and a distal end configured for fixation with a tissue; a second member defining a longitudinal passageway and coupled with a navigation component such that the distal end can be disposed within the passageway at a selected distance from the navigation component, the navigation component positioned relative to a sensor to convey a signal indicative of an orientation of the first member; and a third member extending between a proximal end and a distal end, the third member mountable with the first member along the orientation such that the distal end of the third member can engage the tissue; and a fourth member including a protrusion, an aperture through the protrusion, and a channel, the aperture and the channel each configured for placement of the first member, the channel defining a longitudinal axis, the protrusion movable in a direction transverse to the longitudinal axis to switch between a first position in which the aperture is offset from the channel and the protrusion obstructs the channel and a second position in which the aperture is aligned with the channel and the protrusion does not obstruct the channel. The orientation includes an axial trajectory of the first member relative to the tissue. The third member is guided by the first member along the axial trajectory to engage the tissue.

2. The surgical instrument of claim 1, wherein, The second member is removable from the first member such that the third member is mountable with the first member.

3. The surgical instrument of claim 2, wherein, The distal end of the first member includes a tip configured to penetrate the tissue.

4. The surgical instrument of claim 1, wherein, The proximal end of the first member includes a recess.

5. The surgical instrument of claim 1, wherein, The second member includes a tapered tip.

6. The surgical instrument of claim 1, wherein, The second member includes a cannula dilator.

7. The surgical instrument of claim 1, wherein, The fourth member includes a lock releasably engageable with the first member.

8. The surgical instrument of claim 1, wherein, The lock includes a spring button.

9. The surgical instrument of claim 1, wherein, The fourth member includes a zero component configured to adjust a depth of the first member relative to the tissue and the navigation component.

10. The surgical instrument of claim 9, wherein, The zero component is translatable to adjust the depth of the first member.

11. The surgical instrument of claim 1, wherein, The zero component includes a securing element configured to secure the zero component between a first position and a second position.

12. The surgical instrument of claim 11, wherein, 14. A surgical instrument comprising:

13. The surgical instrument of claim 11, wherein, an anchor extending between a proximal end and a distal end and configured for fixation with a tissue; a dilator defining a longitudinal passageway and coupled with a navigation component such that the distal end can be disposed within the passageway at a selected distance from the navigation component, the navigation component positioned relative to a sensor to convey a signal indicative of an orientation of the anchor; a drill guide mountable with the anchor along the orientation such that a distal end of the drill guide can engage the tissue; and a fourth member including a protrusion, an aperture through the protrusion, and a channel, the aperture and the channel each configured for placement of the first member, the channel defining a longitudinal axis, the protrusion movable in a direction transverse to the longitudinal axis to switch between a first position in which the aperture is offset from the channel and the protrusion obstructs the channel and a second position in which the aperture is aligned with the channel and the protrusion does not obstruct the channel. ​ ​ An anchoring tool comprising a protrusion, a hole through the protrusion, and a channel, each configured for placing an anchor, the channel defining a longitudinal axis, the protrusion being movable in a direction transverse to the longitudinal axis to switch between a first position in which the hole is offset from the channel and the protrusion blocks the channel, and a second position in which the hole is aligned with the channel and the protrusion does not block the channel.

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