US20230225770A1

Movatterモバイル変換

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Publication number: US20230225770A1
Application number: US18/124,091
Authority: US
Inventors: Daniel Paxton Wall; Christopher Good
Original assignee: Warsaw Orthopedic Inc
Current assignee: Warsaw Orthopedic Inc
Priority date: 2020-01-24
Filing date: 2023-03-21
Publication date: 2023-07-20
Also published as: US11612419B2; US20210228244A1

Abstract

A method comprises the steps of: fixing a distal end of a first member of a surgical instrument with tissue, the surgical instrument including a second member having a longitudinal passageway configured for disposal of the first member and being connected with a navigation component such that the distal end is disposable with the passageway at a selected distance from the navigation component, the navigation component being positioned relative to a sensor to communicate a signal representative of an orientation of the first member; removing the second member from the first member; and connecting a third member with the first member along the orientation such that a distal end of the third member is fixed with the tissue. Systems, spinal implants, constructs and instruments are disclosed.

Description

TECHNICAL FIELD

The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system and method for treating a spine.

BACKGROUND

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

Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics. As part of these surgical treatments, spinal constructs such as vertebral rods are often used to provide stability to a treated region. Rods redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support vertebral members. During surgical treatment, one or more rods and bone fasteners can be delivered to a surgical site. The rods may be attached via the fasteners to the exterior of two or more vertebral members. Surgical treatment may employ surgical instruments and implants that are manipulated for engagement with vertebrae to position and align one or more vertebrae. This disclosure describes an improvement over these prior technologies.

SUMMARY

In one embodiment, a method for treating a spine is provided. The method comprises the steps of: fixing a distal end of a first member of a surgical instrument with tissue, the surgical instrument including a second member having a longitudinal passageway configured for disposal of the first member and being connected with a navigation component such that the distal end is disposable with the passageway at a selected distance from the navigation component, the navigation component being positioned relative to a sensor to communicate a signal representative of an orientation of the first member; removing the second member from the first member; and connecting a third member with the first member along the orientation such that a distal end of the third member is fixed with the tissue. Systems, spinal implants, constructs and instruments are disclosed.

In one embodiment, the method comprises the steps of: fixing an anchor extending between a proximal end and a distal end with tissue; disposing the anchor with a longitudinal passageway of a dilator being connected with a navigation component such that the distal end is disposable with the passageway at a selected distance from the navigation component; positioning the navigation component relative to a sensor to communicate a signal representative of an orientation of the anchor; and mounting a drill guide with the anchor along the orientation such that a distal end of the drill guide is engageable with the tissue.

In one embodiment, the method comprises the steps of: fixing an anchor extending between a proximal end and a distal end with tissue; disposing the anchor with a longitudinal passageway of a dilator being connected with a navigation component such that the distal end is disposable with the passageway at a selected distance from the navigation component; positioning the navigation component relative to a sensor to communicate a signal representative of an orientation of the anchor; mounting a drill guide with the anchor along the orientation such that a distal end of the drill guide is engageable with the tissue; and connecting an anchor tool with the anchor to adjust a depth of the anchor relative to tissue and the navigation component.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which:

FIG.1 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

FIG.2 is a perspective view of components of the surgical system shown inFIG.1;

FIG.3 is a perspective view of components of the surgical system shown inFIG.1;

FIG.4 is a cross section view of the components shown inFIG.3;

FIG.5 is a perspective view of components of the surgical system shown inFIG.1;

FIG.6 is a perspective view of the components shown inFIG.5 with parts separated;

FIG.7 is a cross section view of the components shown inFIG.5;

FIG.8 is a cross section view of the components shown inFIG.5;

FIG.9 is a cross section view of the components shown inFIG.5;

FIG.10 is a perspective view of components of the surgical system shown inFIG.1;

FIG.11 is a cross section view of components of the surgical system shown inFIG.1;

FIG.12 is a cross section view of components of the surgical system shown inFIG.1;

FIG.13 is a perspective view of components of one embodiment of a surgical system with parts separated in accordance with the principles of the present disclosure;

FIG.14 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

FIG.15 is a perspective view of detail A shown inFIG.14;

FIG.16 is a perspective view of detail B shown inFIG.14;

FIG.17 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

FIG.18 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

FIG.19 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

FIG.20 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

FIG.21 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; and

FIG.22 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a spinal implant system and a method for treating a spine. In some embodiments, the systems and methods of the present disclosure comprise medical devices including surgical instruments and implants that are employed with a surgical treatment, as described herein, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine.

In some embodiments, the present surgical system comprises a surgical instrument including an anchor and a dilator configured for engagement with bone utilizing navigation. In some embodiments, the surgical instrument is configured to guide a drill guide along the anchor to facilitate engagement of the drill guide with bone. In some embodiments, the surgical system includes a navigated cannulated dilator, an anchor and an anchor tool. In some embodiments, the anchor is disposed with the dilator and engaged with bone. In some embodiments, the anchor is tamped into bone and the dilator is removed. In some embodiments, the anchor is engaged with bone utilizing navigation. In some embodiments, a drill guide is guided over the anchor and tamped into bone. In some embodiments, the anchor is removable. See, for example, the embodiments and disclosure of systems and surgical instruments for engaging bone utilizing surgical navigation, shown and described in commonly owned and assigned U.S. patent application Ser. No. ______, filed ______, 2019 (docket no. A0002407US01), and published as U.S. patent application Publication No. ______, on ______, ______, the entire contents of which being incorporated herein by reference.

In some embodiments, the present surgical system comprises a surgical instrument including the anchor and the dilator being configured to confirm a trajectory when tamping the drill guide. In some embodiments, the drill guide is engaged with bone utilizing navigation. In some embodiments, the anchor is disposed with the dilator and the dilator is connected with a navigation component.

In some embodiments, the present surgical system comprises a surgical instrument including a disposable anchor. In some embodiments, the anchor includes a groove disposed at a proximal end. In some embodiments, the present surgical system comprises an anchor tool having a depressible button to connect and lock the anchor with the anchor tool. In some embodiments, the anchor tool includes a depth setting device.

In some embodiments, the present surgical system comprises a surgical instrument including a navigation component that is connected with the dilator and the anchor is inserted through the dilator. In some embodiments, a distal tip of the anchor extends beyond a distal end of the dilator. In some embodiments, the distal tip extends a distance from the dilator. In some embodiments, the distance the distal tip extends is equal to a length programmed into the navigation system and is utilized to calculate depth navigation. In some embodiments, the depth setting device maintains extension of the distal tip from the dilator.

In some embodiments, the present surgical system includes a method of treating a spine including the step of inserting the surgical instrument through a cannula to a surgical site. In some embodiments, the method includes the step of driving or malleting the anchor tool to provisionally engage the distal tip of the anchor into bone. In some embodiments, the method includes the step of translating the depth setting device to a retracted position to allow for driving the anchor deeper once the trajectory has been set and then malleting the anchor to a selected depth. In some embodiments, the method includes the step of actuating the button to disengage the anchor tool from the anchor and removing the dilator. In some embodiments, the method includes the steps of mounting a drill guide over the anchor and malleting the drill guide into bone. In some embodiments, the method includes the step of reconnecting the anchor tool with the anchor and using a slap hammer to remove the anchor from bone. In some embodiments, a drill is disposed with the drill guide and utilized to implant spinal implants.

In some embodiments, the present surgical system comprises a surgical instrument including a straight anchor having a pointed distal tip. In some embodiments, the anchor includes a groove at the proximal end to facilitate connection with the anchor tool. In some embodiments, the surgical instrument includes a cannulated dilator. In some embodiments, the dilator includes a tapered distal tip. In some embodiments, the dilator includes a passageway formed by slots milled from each side along the dilator.

In some embodiments, the present surgical system comprises a surgical instrument including an anchor tool having a depth setting device, an anchor retention button and a slap hammer. In some embodiments, the depth setting device is disposable in a fully extended position to set the depth of the anchor for navigation. In some embodiments, pins connect the depth setting device with the anchor tool in a keyed configuration. In some embodiments, the button is biased outwards by a spring. In some embodiments, the button is engageable with the groove on the anchor to fix the anchor tool with the anchor. In some embodiments, the slap hammer is moveable to facilitate removing the anchor from bone.

In some embodiments, the present surgical system comprises a surgical instrument including a depth setting device being moveable 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 pins to retain the button with a body of the anchor tool. In some embodiments, a flange is welded with the anchor tool after the slap hammer is assembled. In some embodiments, a proximal end of the anchor tool is hollow to reduce a weight of the anchor tool.

In some embodiments, the present system is employed with a method used with surgical navigation, for example, fluoroscope or image guidance. In some embodiments, the presently disclosed system and/or method reduce operating time for a surgical procedure and reduce radiation exposure due to fluoroscope or image guidance, for example, by eliminating procedural steps and patient repositioning by implanting system components in one body position.

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

The surgical system of the present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, 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 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 is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references “upper” and “lower” are relative and used only in the context to the other, and are not necessarily “superior” and “inferior”.

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

The following discussion includes a description of a surgical system including a surgical instrument, related components and methods of employing the surgical system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning toFIGS.1-12, there are illustrated components of a surgical system, such as, for example, aspinal implant system10.

The components ofspinal implant system10 can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyimide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations.

Various components ofspinal implant system10 may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components ofspinal implant system10, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components ofspinal implant system10 may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.

Spinal implant system

10 is employed, for example, with a fully open surgical procedure, a minimally invasive procedure including percutaneous techniques, and mini-open surgical techniques to deliver and introduce instrumentation and/or a spinal implant, for example, a bone fastener, at a surgical site of a patient, which includes, for example, a spine. In some embodiments, the spinal implant can include one or more components of one or more spinal constructs, such as, for example, interbody devices, interbody cages, bone fasteners, spinal rods, tethers, connectors, plates and/or bone graft, and can be employed with various surgical procedures including surgical treatment of a cervical, thoracic, lumbar and/or sacral region of a spine.

Spinal implant system

10 includes asurgical instrument12.Surgical instrument12 can be employed with anend effector200, as shown inFIG.1, to facilitate implantation with a robotic arm R (FIG.22).Surgical instrument12 is guided throughend effector200 for guide-wireless insertion of a spinal implant, for example, abone fastener100, as described herein.

Surgical instrument

12 includes a member, for example, ananchor14.Anchor14 extends between aproximal end16 and adistal end18, as shown inFIG.2.Proximal end16 includes asurface20 that defines agroove22. In some embodiments,groove22 is disposed circumferentially aboutend16.Groove22 is configured for disposal of a portion of a member, for example, ananchor tool24 to releasablyfix anchor tool24 withanchor14, as described herein.

End

18 includes atip26. In some embodiments,tip26 is pointed or sharpened to facilitate penetration of tissue. In some embodiments, end18 may have various surface configurations, for example, smooth, rough, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured.Tip26 is configured to fixanchor14 with tissue to provide an orientation, for example, an axial trajectory for the components ofsurgical instrument12, as described herein.

Surgical instrument

12 includes a member, for example, adilator30, as shown inFIGS.3 and4.Dilator30 extends between aproximal end32 and adistal end34.Dilator30 defines a longitudinal axis X1. In some embodiments,dilator30 may have various configurations including, for example, round, oval, polygonal, irregular, consistent, variable, uniform and non-uniform.Dilator30 includes a surface36 that defines alongitudinal passageway38 extending between ends32,34. In some embodiments,passageway38 is manufactured by milling overlappingslots40 through surface36 alongdilator30, as shown inFIG.4.

End

34 includes a tapered configuration to facilitate spacing of tissue. In some embodiments, end34 may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tubular.

Dilator

30 includes a mating element, for example, abushing42.Bushing42 is configured to connect anavigation component280 withsurgical instrument12.Bushing42 includes a flange44 and aflange46 that is spaced apart from flange44.Bushing42 includes arecess48 betweenflanges44,46.Bushing42 is disposed withdilator30.Dilator30 includes mating surfaces, for example, datum surfaces130.Surface130 is disposed onshaft dilator30 at a selected distance fromdistal end34.Surface130 is detectable by image guidance and utilized to determine a position ofnavigation component280, as described herein, and/orsurgical instrument12 during a surgical procedure.Surface130 is configured for connection with a portion ofnavigation component280 to facilitate positioning and/or tracking ofnavigation component280 and/orsurgical instrument12 during a surgical procedure. In some embodiments,dilator30 may include one or a plurality of mating surfaces, as described herein.

Navigation component

280, as shown inFIG.1, includes acollar282 having aninner surface284 and anouter surface286.Surface284 defines apassageway288.Surface284 is configured for releasable engagement with bushing250.Passageway288 is configured to receivedilator30 and a portion ofbushing42.Collar282 includes a lock, for example, a resilient prong ortab290.Navigation component280 is connected withbushing42 bytab290. In some embodiments,collar282 may include one or a plurality of locks, as described herein.

Passageway

38 is configured for disposal ofanchor14, as described herein.Dilator30 is removably mounted withanchor14 such thattip26 is positioned at a selected distance fromnavigation component280.Navigation component280 is positioned relative to a sensor to communicate a signal representative of the orientation ofanchor14 during engagement with tissue.Tip26 is configured to fixanchor14 with tissue to provide the axial trajectory for the components ofsurgical instrument12, as described herein.

Anchor tool

24 includes abody50.Body50 extends between anend52 and anend54.End54 includesslots56 andspring tabs58, as shown inFIG.6.Anchor tool24 includes a part, for example, adepth setter60 and abutton62, as shown inFIGS.5-9.

Depth setter

60 includes aslider64 and asleeve66.Sleeve66 includes asurface70 configured for engagement withspring tabs58 in a friction fit configuration to fixsleeve66 in the extended position, as shown inFIG.7 and/or the retracted position, as shown inFIG.8. In some embodiments,sleeve66 andbody50 may be disposed with an integral connection, friction fit, pressure fit, interlocking engagement, mating engagement, dovetail connection, clips, barbs, tongue in groove, threaded, magnetic and/or key/keyslot.Sleeve66 includes a surface that defines achannel72.Channel72 is disposed in communication with achannel74 ofbody50, as shown inFIG.7.

Channels

72,74 are configured for disposal ofanchor14, as described herein.

Pins

68 extend throughslots56 to connectslider64 andsleeve66 withbody50, as shown inFIGS.7 and8, such that translation ofslider64 causes translation ofsleeve66 between an extended position and a retracted position relative tobody50.

For example, translation ofslider64, in a direction shown by arrow A1 inFIG.7, causessleeve66 to simultaneously translate via connection ofpins68, in a direction shown by arrow A1 inFIG.7, to the extended position. In the extended position,sleeve66 is disposed in an abutting engagement withcollar282 ofnavigation component280, as shown inFIG.13. In the extended position,sleeve66 positions the extension and/or depth oftip26 beyond end34 a selected distance fromnavigation component280.Sleeve66 resists and/or prevents extension oftip26 further than the selected distance.Tip26 is provisionally fixed with tissue under navigation by communication ofnavigation component280 with asurgical navigation system306, as described herein.

Translation ofslider64 in the opposite direction, in a direction shown by arrow A2 inFIG.8, causessleeve66 to simultaneously translate, in the direction shown by arrow A2 inFIG.8, to the retracted position. In the retracted position,sleeve66 is spaced a distance fromcollar282, as shown inFIG.15, to allowanchor14 to translate throughdilator30 to extend further fromend34 ofdilator30 to facilitate driving anchor14 a further depth into tissue for docking.

Button

62 is connected withbody50 bypins80.Button62 includes aprotrusion82 having asurface84 that defines anopening86.Opening86 is configured for disposal ofanchor14 andsurface84 is configured to engagegroove22 to fixanchor14 withanchor tool24.Button62 is biased to a closed position bysprings88 such thatprotrusion82

blocks channel

74. To captureanchor14, a force is applied tobutton62, in a direction shown by arrow C inFIG.8, causingopening86 to align withchannel74 to allowanchor14 to translate therethrough.Button62 is released and the bias ofsprings88

pushes button

62, in a direction shown by arrow D inFIG.8, causingsurface84 to engagesurface20 ofgroove22 to captureanchor14. To releaseanchor14, a force is applied tobutton62, in the direction shown by arrow C inFIG.8, causingsurface84 to disengagesurface20 ofgroove22 to releaseanchor14.Opening86 aligns withchannel74 to allowanchor14 to translate therethrough for disengagement fromanchor tool24.

In some embodiments,anchor tool24 includes ahandle portion90 that includes aflange92, aslap hammer94 and an end flange96.Slap hammer94 translates betweenflange92 and end flange96 to facilitate removinganchor14 from the surgical site. In some embodiments, handleportion90 is hollow to reduce the weight ofanchor tool24.

Surgical instrument

12 includes a member, for example, adrill guide100, as shown inFIGS.20 and21.Drill guide100 extends between aproximal end102 and adistal end104.Distal end104 is configured to engage tissue.Drill guide100 includes asurface106 that defines apassageway108 configured for disposal of a drill.Drill guide100 is utilized to assist in control and guidance of a surgical drill.Drill guide100 is securely docked by mountingdrill guide100 withanchor14.Anchor14

guides drill guide

100 along the axial trajectory to engagedistal end104 ofdrill guide100 with bone.

In assembly, operation and use, as shown inFIGS.13-22,spinal implant system10, similar to the systems and methods described herein, is employed with a surgical procedure, for example, a treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body. In some embodiments, one or all of the components ofspinal implant system10 can be delivered or utilized as a pre-assembled device or can be assembled in situ.Spinal implant system10 may be completely or partially revised, removed or replaced.

In some embodiments, a scalpel (not shown) is oriented for disposal withend effector200 of robotic arm R, as described herein. An incision is made in the skin S1 of a patient with the scalpel, which creates a surgical pathway for implantation of components ofspinal implant system10. A speculum (not shown) can be employed to assist in creating the surgical pathway. A preparation instrument (not shown) can be employed to prepare tissue surfaces as well as for aspiration and irrigation of a surgical region. Acannula150 is inserted intoend effector200 and is inserted into the surgical pathway.Surgical instrument12 is assembled.Anchor14 is disposed withpassageway38 ofdilator30.Navigation component280 is connected withdilator30.Navigation component280 is translated alongdilator30 into a mating engagement withsurface130 and connected withbushing42 bytab290.

Anchor tool

24 is connected withanchor14.Anchor14 is translated intochannel72 andchannel74.Button62 is actuated causingopening86 to align withchannel74 to allowanchor14 to translate therethrough.Button62 is released and the bias ofsprings88

pushes button

62 causingsurface84 to engagesurface20 ofgroove22 to captureanchor14.

Slider

64 is translated and causessleeve66 to simultaneously translate via connection ofpins68 into the extended position. In the extended position,sleeve66 is disposed in an abutting engagement withcollar282 ofnavigation component280, as shown inFIG.13. In the extended position,sleeve66 positions the extension and/or depth oftip26 beyond end34 a selected distance fromnavigation component280 andsurface130.Sleeve66 resists and/or prevents extension oftip26 further than the selected distance.

Surgical instrument

12 is inserted intocannula150.Dilator30 expands skin S1 along the surgical pathway.Navigation component280 is oriented relative to asensor array302, as shown inFIG.22, to facilitate communication betweennavigation component280 andsensor array302 during a surgical procedure, as described herein.

Navigation component

280 is configured to generate a signal representative of a position ofanchor14 relative to tissue. In some embodiments, the image guide may include human readable visual indicia, human readable tactile indicia, human readable audible indicia, one or more components having 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 signals, magnetic signals, electromagnetic signals and/or radiologic signals.

Navigation component

280 includes an emitter array304. Emitter array304 is configured for generating a signal tosensor array302 of asurgical navigation system306. In some embodiments, the signal generated by emitter array304 represents a position ofanchor14 relative to tissue, for example, bone. In some embodiments, the signal generated by emitter array304 represents a three-dimensional position ofanchor14 relative to tissue.

In some embodiments,sensor array302 receives signals from emitter array304 to provide a three-dimensional spatial position and/or a trajectory ofanchor14 relative to tissue. Emitter array304 communicates with a processor of acomputer308 ofsurgical navigation system306 to generate data for display of an image on amonitor310, as described herein. In some embodiments,sensor array302 receives signals from emitter array304 to provide a visual representation of a position ofanchor14 relative to tissue. See, for example, similar surgical navigation components and their use as described in U.S. Pat. Nos. 6,021,343, 6,725,080, and 6,796,988, the entire contents of each of these references being incorporated by reference herein.

Surgical navigation system

306 is configured for acquiring and displaying medical imaging, for example, x-ray images appropriate for a given surgical procedure. In some embodiments, pre-acquired images of a patient are collected. In some embodiments,surgical navigation system306 can include an O-Arm® imaging device312 sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colo., USA.Imaging device312 may have a generally annular gantry housing that encloses animage capturing portion314.

In some embodiments,image capturing portion314 may include an x-ray source or emission portion and an x-ray receiving or image receiving portion located generally or as practically possible 180 degrees from each other and mounted on a rotor (not shown) relative to a track ofimage capturing portion314.Image capturing portion314 can be operable to rotate 360 degrees during image acquisition.Image capturing portion314 may rotate around a central point or axis, allowing image data of the patient to be acquired from multiple directions or in multiple planes.Surgical navigation system306 can include those disclosed in U.S. Pat. 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 being incorporated by reference herein.

In some embodiments,surgical navigation system306 can include C-arm fluoroscopic imaging systems, which can generate three-dimensional views of a patient. The position ofimage capturing portion314 can be precisely known relative to any other portion of an imaging device ofsurgical navigation system306. In some embodiments, a precise knowledge of the position ofimage capturing portion314 can be used in conjunction with atracking system316 to determine the position ofimage capturing portion314 and the image data relative to the patient.

Tracking system

316 can include various portions that are associated or included withsurgical navigation system306. In some embodiments,tracking system316 can also include a plurality of types of tracking systems, such as, for example, an optical tracking system that includes an optical localizer, such as, for example,sensor array302 and/or an EM tracking system that can include an EM localizer. Various tracking devices can be tracked withtracking system316 and the information can be used bysurgical navigation system306 to allow for a display of a position of an item, such as, for example, a patient tracking device, an imagingdevice tracking device320, and an instrument tracking device, such as, for example, emitter array304, to allow selected portions to be tracked relative to one another with the appropriate tracking system.

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

Fluoroscopic images taken are transmitted to acomputer318 where they may be forwarded tocomputer308. Image transfer may be performed over a standard video connection or a digital link including wired and wireless.Computer308 provides the ability to display, viamonitor310, as well as save, digitally manipulate, or print a hard copy of the received images. In some embodiments, images may also be displayed to the surgeon through a heads-up display.

In some embodiments,surgical navigation system306 provides for real-time tracking of the position ofbone fastener100 relative tosurgical instrument12 and/or tissue can be tracked.Sensor array302 is located in such a manner to provide a clear line of sight with emitter array304, as described herein. In some embodiments, fiducial markers322 of emitter array304 communicate withsensor array302 via infrared technology.Sensor array302 is coupled tocomputer308, which may be programmed with software modules that analyze signals transmitted bysensor array302 to determine the position of each object in a detector space.

Surgical instrument

12 is configured for use with a guide member, for example, anend effector200 of robotic arm R to determine axial trajectory of a surgical pathway and/or facilitate positioning of one or more surgical instruments, implants and/or components ofspinal implant system10 in alignment with the axial trajectory of a surgical pathway.End effector200 includes aninner surface202 that defines a cavity, for example, achannel204.Channel204 is configured for disposal of one or more components ofsurgical instrument12 and/or implants. Robotic arm R includes position sensors (not shown), similar to those referenced herein, which measure, sample, capture and/or identify positional data points ofend effector200 in three-dimensional space for a guide-wireless insertion ofsurgical instrument12 with tissue. In some embodiments, the position sensors of robotic arm R are employed in connection withsurgical navigation system306 to measure, sample, capture and/or identify positional data points ofend effector200 in connection with surgical treatment, as described herein. The position sensors are mounted with robotic arm R and calibrated to measure positional data points ofend effector200 in three-dimensional space, which are communicated tocomputer308.

Tip

26 is provisionally fixed with bone B1 to define an axial trajectory AT, as shown inFIG.14. Axial trajectory AT ofanchor14 is confirmed by communication ofnavigation component280 withsurgical navigation system306, as described herein.

To dockanchor14,slider64 is translated into the retracted position. Translation ofslider64 causessleeve66 to simultaneously translate into the retracted position. In the retracted position,sleeve66 is spaced a distance fromcollar282, as shown inFIG.15, to allowanchor14 to translate throughdilator30 to extend further fromend34 ofdilator30 to drive anchor14 a greater depth into bone B1 for docking.Anchor14 is docked with bone B1 along axial trajectory AT.

Anchor tool

24 is removed fromanchor14, as shown inFIG.17. To releaseanchor14,button62 is actuated to causesurface84 to disengagesurface20 ofgroove22 to releaseanchor14.Opening86 aligns withchannel74 to allowanchor14 to translate therethrough for disengagement fromanchor tool24. In some embodiments,slap hammer94 is utilized to facilitate releasinganchor14 from bone B1.Dilator30 is removed fromanchor14, as shown inFIG.18.

Drill guide

100 is mounted withanchor14, as shown inFIG.19, such thatanchor14 is disposed withpassageway108.Anchor14 directs and/or guidesdrill guide100 along axial trajectory AT throughcannula150.End104 ofdrill guide100 extends from a distal end ofcannula150.Drill guide100 is tamped alonganchor14 and axial trajectory AT causingend104 to engage bone B1. As such,drill guide100 is docked with bone B1 along navigated axial trajectory AT thereby maintaining the alignment and/or trajectory ofdrill guide100 during docking.

Anchor

14 is removed from bone B1 by reattachinganchor tool24.Anchor14 is translated intochannel72 andchannel74.Button62 is actuated causingopening86 to align withchannel74 to allowanchor14 to translate therethrough.Button62 is released and the bias ofsprings88

pushes button

62 causingsurface84 to engagesurface20 ofgroove22 to captureanchor14. In some embodiments,slap hammer94 is utilized to facilitate releasinganchor14 from bone B1.Anchor14 is removed from bone B1 and the surgical site.

A drill (not shown) is paired with a selected drill bit and inserted intodrill guide100.Drill guide100 directs and/or guides the drill along the axial trajectory AT. In some embodiments, the drill includes a navigation component, similar tonavigation component280 as described herein. The navigation component is oriented relative tosensor array302 to confirm trajectory by communication of the navigation component withsurgical navigation system306, similar to that described herein. Pilot holes (not shown) are made with the selected areas of bone for receiving spinal implants such as bone fasteners for the surgical procedure.

Upon completion of a procedure, as described herein, the surgical instruments, assemblies and non-implanted components ofspinal implant system10 are removed and the incision(s) are closed. One or more of the components ofspinal implant system10 can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments,spinal implant system10 may include one or a plurality of spinal rods, plates, connectors and/or bone fasteners for use with a single vertebral level or a plurality of vertebral levels.

In some embodiments, one or more bone fasteners, as described herein, may be engaged with tissue in various orientations, such as, for example, series, parallel, offset, staggered and/or alternate vertebral levels. In some embodiments, the bone fasteners may comprise multi-axial screws, sagittal adjusting screws, pedicle screws, mono-axial screws, uni-planar screws, facet screws, fixed screws, tissue penetrating screws, conventional screws, expanding screws, wedges, anchors, buttons, clips, snaps, friction fittings, compressive fittings, expanding rivets, staples, nails, adhesives, posts, fixation plates and/or posts.

In one embodiment,spinal implant system10 includes an agent, which may be disposed, packed, coated or layered within, on or about the components and/or surfaces ofspinal implant system10. In some embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the components and/or surfaces ofspinal implant system10 with vertebrae. In some embodiments, the agent may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration.

It will 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 exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims

1-20. (canceled)

21. A method for treating a spine, the method comprising the steps of:

connecting an end effector to a first member;

connecting a second member to the first member; and

positioning a third member through the first member and the second member to adjust a depth of the third member relative to tissue and the end effector.

22. A method as recited inclaim 21, further comprising connecting the end effector with a robot arm.

23. A method as recited inclaim 22, wherein the robot arm includes position sensors which measure and identify positional data points of the end effector in three-dimensional space for a guide-wireless insertion of the members with tissue.

24. A method as recited inclaim 21, wherein connecting the end effector to the first member comprises inserting the first member through a channel of the end effector.

25. A method as recited inclaim 21, wherein connecting the end effector to the first member comprises releasably engaging a lock of the end effector with the first member.

26. A method as recited inclaim 25, wherein the lock includes a spring button.

27. A method as recited inclaim 21, wherein the end effector comprises opposite proximal and distal end surfaces, the distal end of the second member extending through the distal end surface, the second member comprising an opposite proximal end that directly engages the proximal end surface.

28. A method as recited inclaim 21, further comprising connecting a navigation component with the third member such that the navigation component is positioned relative to a sensor to communicate a signal representative of an orientation of the third member.

29. A method as recited inclaim 21, wherein the distal end of the second member comprises a plurality of teeth extending radially about the distal end of the second member.

30. A method as recited inclaim 21, wherein the third member extends through the end effector when the third member is positioned through the first member and the second member.

31. A method as recited inclaim 21, wherein the third member extends through opposite proximal and distal end surfaces of the end effector when the third member is positioned through the first member and the second member.

32. A method as recited inclaim 21, wherein the distal end of the second member extends through a distal end surface of the first member.

33. A method as recited inclaim 32, wherein the distal end of the third member extends through the distal end of the second member.

34. A method as recited inclaim 21, wherein the distal end of the third member includes a pointed tip configured to penetrate tissue.

35. A method as recited inclaim 21, further comprising removing the third member from the first member and the second member.

36. A method as recited inclaim 21, wherein the first member includes a cannulated dilator.

37. A method as recited inclaim 21, wherein the second member includes a part configured to adjust the depth of the third member relative to tissue and the end effector.

38. A method as recited inclaim 37, wherein the part is translatable to adjust the depth of the third member.

39. A method for treating a spine, the method comprising the steps of:

connecting an end effector to a dilator;

connecting a drill guide to the dilator; and

positioning an anchor through the dilator and the drill guide to adjust a depth of the anchor relative to tissue and the end effector.

40. A method for treating a spine, the method comprising the steps of:

connecting an end effector to a first member;

connecting a second member to the first member;

positioning a third member through the first member and the second member to adjust a depth of the third member relative to tissue and the end effector;

connecting a navigation component with the third member such that the navigation component is positioned relative to a sensor to communicate a signal representative of an orientation of the third member; and connecting the end effector with a robot arm,

wherein the robot arm includes position sensors which measure and identify positional data points of the end effector in three-dimensional space for a guide-wireless insertion of the members with tissue.