WO2025229498A1

WO2025229498A1 - Surgical system and method

Info

Publication number: WO2025229498A1
Application number: PCT/IB2025/054400
Authority: WO
Inventors: Laurie BREED; Mark Dace; Jeffrey Gum; Benjamin SAMPEDRO
Original assignee: Warsaw Orthopedic Inc
Current assignee: Warsaw Orthopedic Inc
Priority date: 2024-04-29
Filing date: 2025-04-28
Publication date: 2025-11-06
Anticipated expiration: 2026-10-29

Abstract

A method for treating a spine includes registering one or more vertebra to a three dimensional surgical site of a robot including an arm; and moving a surgical needle along a selected trajectory and relative to a surgical guide to a selected location with tissue adjacent the one or more vertebra to administer a nerve block injection including at least one anesthetizing agent, the surgical guide being connectable to the arm such that a processor generates data for display of an image from a monitor, the image representing position of the surgical needle relative to the tissue. Surgical systems, instruments, constructs and implants are disclosed.

Description

SURGICAL SYSTEM AND METHOD

TECHNICAL FIELD

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/639,784, filed 29 April 2024, the entire content of which is incorporated herein by reference.

[0002] The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system, surgical instruments and methods for treating a spine.

BACKGROUND

[0003] 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.

[0004] 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 pediatric treatment, deformity procedures, correction, fusion, fixation, discectomy, laminectomy, corpectomy and implantable prosthetics. As part of these surgical treatments, spinal implants, for example, bone fasteners, spinal rods and interbody devices can be used to provide stability to a treated region. Surgical instruments are employed to prepare tissue surfaces for treatment, for example, to deliver medicaments and engage implants for disposal with vertebral members. In some cases, image guided medical and surgical navigation systems provide imaging to assist in surgical procedures and display relative positioning of various body parts and surgical instruments. This disclosure describes an improvement over these prior technologies. SUMMARY

[0005] In one embodiment, a method for treating a spine is provided. The method comprises the steps of: registering one or more vertebra to a three dimensional surgical site of a robot including an arm; and moving a surgical needle along a selected trajectory and relative to a surgical guide to a selected location with tissue adjacent the one or more vertebra to administer a nerve block injection including at least one anesthetizing agent, the surgical guide being connectable to the arm such that a processor generates data for display of an image from a monitor, the image representing position of the surgical needle relative to the tissue. In some embodiments, surgical systems, instruments, constructs and implants are disclosed.

[0006] In one embodiment, a surgical instrument is provided. The surgical instrument includes a guide being connectable with a robotic arm. The robotic arm being registrable with one or more vertebra via at least one surgical navigation component and a processor. The guide supports movement of a surgical needle along a selected trajectory and relative to the guide such that the processor generates data for display of an image from a monitor. The image represents the position of the surgical needle relative to tissue adjacent the one or more vertebra.

[0007] In one embodiment, the surgical instrument includes a member having a wall connectable with a robotic arm and a base having a receptacle. The robotic arm being registrable with one or more vertebra via at least one surgical navigation component and a processor. A guide is disposable with the receptacle for supporting movement of a surgical needle along a selected trajectory and relative to the guide such that the processor generates data for display of an image from a monitor. The image represents the position of the surgical needle relative to tissue adjacent the one or more vertebra.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which: [0009] FIG. 1 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0010] FIG. 2 is a break away view of components of the system shown in FIG. 1 ;

[0011] FIG. 3 is a break away view of components of the system shown in FIG. 1 ;

[0012] FIG. 4 is a break away view of components of the system shown in FIG. 1 ;

[0013] FIG. 5 is a break away view of components of the system shown in FIG. 1 ;

[0014] FIG. 6 is a break away view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0015] FIG. 7 is a break away view of components of the system shown in FIG. 1 ;

[0016] FIG. 8 is a break away view of components of the system shown in FIG. 1 ;

[0017] FIG. 9 is a break away view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0018] FIG. 10 is a break away view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0019] FIG. 11 is a break away view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0020] FIG. 12 is a schematic diagram of components of one embodiment of a surgical system including a representation of imaging of a surgical site in accordance with the principles of the present disclosure;

[0021] FIG. 13 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0022] FIG. 14 is a plan view of components of the system shown in FIG. 13;

[0023] FIG. 15 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; [0024] FIG. 16 is a perspective view of components of the system shown in FIG. 15;

[0025] FIG. 17 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0026] FIG. 18 is a perspective view of components of the system shown in FIG. 17;

[0027] FIG. 19 is a perspective view of components of the system shown in FIG. 17;

[0028] FIG. 20 is a perspective view of the components of the system shown in FIG. 17;

[0029] FIG. 21 is a plan view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0030] FIG. 22 is a perspective view of components of the system shown in FIG. 21 ;

[0031] FIG. 23 is an enlarged perspective view of components of the system shown in FIG. 21 ;

[0032] FIG. 24 is a perspective view of components of the system shown in FIG. 21 ;

[0033] FIG. 25 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0034] FIG. 26 is a perspective view of components of the system shown in FIG. 21 ;

[0035] FIG. 27 is a perspective view of the components of the system shown of FIG. 21 ;

[0036] FIG. 28 is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0037] FIG. 29 is a break away perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0038] FIG. 30 is a perspective view of the components shown in FIG. 29 with parts separated; [0039] FIG. 31 is a cross section view of the components shown of FIG. 29;

[0040] FIG. 32 is a break away perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure;

[0041] FIG. 33 is a perspective view of components of the system shown in FIG. 32 with parts separated; and

[0042] FIG. 34 is a cross section view of the components shown of FIG. 33.

DETAILED DESCRIPTION

[0043] The exemplary embodiments of the surgical system and related methods of use disclosed are discussed in terms of medical devices, implants and surgical instruments for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system including surgical instruments and related components for preparing tissue surfaces and/or delivering agents to a surgical site. In some embodiments, the present surgical system comprises an image guided, robot assisted surgical system for administering nerve block injections including anesthetizing agents along a selected trajectory to a surgical site in connection with computer assisted surgeries with a spine. In some embodiments, the present surgical system comprises an image guided, robot assisted spinal implant system. In some embodiments, the systems and methods of the present disclosure comprise surgical robotic guidance, surgical navigation and 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.

[0044] In some embodiments, the present surgical system includes a surgical instrument employed with an image guided, robot assisted surgical system for administering nerve block injections including anesthetizing agents along a selected trajectory to a surgical site. In some embodiments, the surgical instrument includes a modular arm guide attachment. In some embodiments, the modular arm guide attachment includes a plate that connects with an arm guide. In some embodiments, the plate attaches to the arm guide prior to placement of the arm guide in a selected orientation. In some embodiments, the surgical instrument includes an adapter connectable with the plate and a surgical needle. In some embodiments, the adapter includes a threaded connection with the plate. In some embodiments, the adapter locks with the plate. In some embodiments, the adapter accommodates a variety of surgical needle dimensions including needle diameter. In some embodiments, the adapter is needle diameter specific. In some embodiments, the adapter is disposable or nondisposable. In some embodiments, the surgical instrument is configured for use with surgical navigation. In some embodiments, the surgical navigation includes a navigation component, selected software and computer monitors. In some embodiments, a selected trajectory of the surgical needle is displayed on the computer monitor from a center of the adapter. In some embodiments, the center of the adapter mates with a center of an arm guide of a robot. In some embodiments, the selected trajectory is a saved trajectory from a navigated and/or radiographic instrument projection. In some embodiments, the surgical needle is inserted and guided through the adapter at a selected location. In some embodiments, the surgical needle is manually guided through the adapter at a preselected trajectory length. In some embodiments, the surgical needle is navigated and tracked via navigation guidance. In some embodiments, the present surgical system can be implemented with various modular attachments post sterilization of the components.

[0045] In some embodiments, the present surgical instrument is employed with a method for treating a spine. In some embodiments, the method includes the step of attaching a surgical instrument to an arm guide of a modular robotic arm. In some embodiments, the robotic arm is draped. In some embodiments, the method includes the step of attaching a modular mating plate to a portion of the arm guide. In some embodiments, the method includes the step of fixing a plate with the modular mating plate. In some embodiments, the plate is fixed with the modular mating plate via a screw. In some embodiments, the method includes the step of orienting the arm guide into a selected position. In some embodiments, the method includes the step of inserting a navigation component through a centrally disposed hole in the plate saving the instrument projection as the desired trajectory at a desired angle/position. In some embodiments, the method includes the step of engaging an adapter with the plate. In some embodiments, the method includes the step of disposing a surgical needle with the adapter. [0046] In some embodiments, the present surgical instrument includes a navigation component having a first mating surface connectable with an end effector of a robotic arm and a second mating surface connectable with a surgical needle. In some embodiments, the surgical needle is guided through the second mating surface along a selected trajectory to a selected location with a surgical site. In some embodiments, the surgical instrument is configured to administer nerve block injections including anesthetizing agents with the surgical needle along a selected trajectory to a surgical site in connection with computer assisted surgeries with a spine. In some embodiments, the surgical instrument provides selective surgical needle positioning adjacent bony anatomy, for example, projecting trajectory lines with navigation software of computer assisted surgeries with a spine.

[0047] In some embodiments, the present surgical system includes a surgical instrument employed with an image guided, robot assisted surgical system such that a surgical needle trajectory is displayed from a monitor using navigation software. In some embodiments, the surgical needle trajectory may be selected based on needle length. In some embodiments, the surgical needle can be disposed at a selected trajectory employing surgical planning, as described herein. In some embodiments, movement of a surgical needle within a patient anatomy may be tracked using surgical navigation. In some embodiments, a tip and/or shaft of a surgical needle is supported by the surgical instrument to prevent axial rotation of the needle relative to the surgical instrument.

[0048] In some embodiments, the present surgical system includes a surgical instrument having a navigation component with an emitter array including a tracker. In some embodiments, the tracker includes an adapter, as described herein. In some embodiments, the tracker includes a mating surface including an opening configured for disposal of the adapter. In some embodiments, the opening is centrally disposed relative to the tracker. In some embodiments, the opening is pre-formed in the tracker or is formed within an existing navigation component. In some embodiments, the adapter is connectable with a surgical needle. In some embodiments, the surgical needle is guided through the adapter along a selected trajectory. [0049] In some embodiments, the surgical instrument of the present disclosure is employed with a method for treating a spine. In some embodiments, the method includes the step of selecting an anesthetizing agent. In some embodiments, the anesthetizing agent includes a nerve block. In some embodiments, the method includes the step of disposing an adapter within a mating surface of a navigation component, including an emitter array having a tracker. In some embodiments, the method includes the step of connecting the tracker with an end effector of a robotic arm. In some embodiments, the end effector is pre-positioned at a selected orientation. In some embodiments, the method includes the step of identifying a trajectory of a center of the adapter on a computer monitor. In some embodiments, the method includes the step of connecting the surgical needle with the adapter. In some embodiments, the method includes the step of guiding the surgical needle through the adapter to a selected depth and utilizing navigation software to track surgical needle trajectory and surgical needle depth at a surgical site.

[0050] In some embodiments, the present surgical system is configured to position the surgical needle near patient anatomy, including bony anatomy by implementing navigation guidance, including navigation software such that trajectory lines are projected on a computer monitor after positioning the robotic arm and attaching the adapter and surgical needle to the tracker. In some embodiments, a nerve block is administered near bony anatomy/spine.

[0051] In some embodiments, the present surgical system includes a surgical instrument employed with an image guided, robot assisted surgical system for administering nerve block injections including anesthetizing agents with the surgical needle along a selected trajectory to a surgical site. In some embodiments, the method includes the step of delivering a surgical needle through robotic-assisted trajectory alignment tools. In some embodiments, the present surgical system and method includes surgical robotic guidance having robotic software that performs registration of a patient anatomy to a three-dimensional working space of a robot. In some embodiments, the surgical system includes a surgical instrument having an image guide oriented relative to a sensor to communicate a signal representative of a range of movement of the surgical needle. In some embodiments, the present surgical system is employed with a method of performing robotically assisted spinal surgery including the step of generating a preoperative CT scan of a patient anatomy that is used to pre-plan location of one or more spinal implants. In some embodiments, the patient anatomy is accurately identified and located in the robot's three-dimensional coordinate system to proceed with a selected procedure.

[0052] In some embodiments, the surgical instrument includes a base member having a first mating surface connectable with an end effector of a robotic arm and a channel connectable with a surgical needle. In some embodiments, the surgical needle is guided through the channel along a selected trajectory to a selected location with a surgical site for administering nerve block injections and/or anesthetizing agents. In some embodiments, the surgical instrument is configured for administration of a trajectory focus erector spinae block. In some embodiments, the channel is centrally disposed relative to the base member and to orient the surgical needle along a target trajectory. In some embodiments, the surgical needle is supported when the needle contacts patient skin. In some embodiments, the base member is connected with a guide of a robotic arm.

[0053] In some embodiments, the surgical instrument has a first mating surface connectable with an end effector of a robotic arm and a channel is employed with an image guided, robot assisted surgical system to administer nerve block injections and/or anesthetizing agents with a surgical needle along a selected trajectory to a surgical site. In some embodiments, the method includes administering a trajectory focus erector spinae block. In some embodiments, the method includes the step of connecting the needle base with a guide of a robotic arm. In some embodiments, the method includes the step of inserting a surgical needle through a needle advancer and the channel. In some embodiments, the method includes the step of disposing the needle advancer with the needle base and the surgical needle. In some embodiments, the method includes the step of contacting the surgical needle with the needle advancer and translating the surgical needle in a downward direction through the channel to advance the surgical needle into a surgical site.

[0054] In some embodiments, the surgical instrument includes a base member having a first mating surface connectable with an end effector of a robotic arm and a channel connectable with a surgical needle including a surgical navigation component. In some embodiments, the surgical needle is guided through the channel along a selected trajectory to a selected location with a surgical site for administering nerve block injections and/or anesthetizing agents.

[0055] In some embodiments, the present surgical system includes a surgical instrument and navigated guidance for administration of an erector spinae block. In some embodiments, the surgical instrument includes a base configured for engagement with a surgical needle. In some embodiments, the base includes a channel configured for disposal of the needle. In some embodiments, the channel is centrally disposed relative to the base. In some embodiments, the surgical instrument includes a tracker attachment connected with a navigation component having a tracker. In some embodiments, the surgical instrument includes a needle lock and the surgical needle. In some embodiments, the surgical needle is guided to a surgical site via navigation guidance. In some embodiments, trajectory lines of the surgical needle are projected into anatomy of the patient and are displayed via a computer monitor. In some embodiments, the surgical needle is supported when the needle contacts patient skin. In some embodiments, the surgical needle is supported prior to contact with patient skin via a portion of the base and a sleeve engageable with the base. In some embodiments, the surgical instrument includes a robotic arm guide.

[0056] In some embodiments, the surgical instrument having a base, a tracker attachment, a needle lock and a surgical needle, is employed with a navigation guided, robot assisted surgical system to administer nerve block injections including anesthetizing agents with the surgical needle along a selected trajectory to a surgical site. In some embodiments, the surgical instrument of the present disclosure is employed with a method for administering a navigation focus erector spinae block. In some embodiments, the method includes the steps of connecting a base with a robotic arm guide. In some embodiments, the method includes the step of inserting a surgical needle through a channel of a sleeve of the base, connected to a needle lock and the channel. In some embodiments, the surgical needle and/or the base is supported when patient skin is contacted. In some embodiments, the method includes the step of engaging a tracker attachment connected to a tracker with the sleeve, needle lock and needle. In some embodiments, the method includes the step of advancing the needle tracker and translating the surgical needle via the needle tracker in a downward direction through the channel to advance the surgical needle into a surgical site.

[0057] In some embodiments, a surgical needle trajectory is identified via navigation software and displayed via a computer monitor after an instrument is selected. In some embodiments, the trajectory may vary in length based on a length of the surgical needle. In some embodiments, surgical planning may be implemented to send a guide of a robotic arm to software trajectory options, or the guide may be placed manually. In some embodiments, surgical needle progress within patient anatomy is tracked using navigation technology, for example, tracking sphere technology. In some embodiments, components of the surgical instrument are attached to a robotic system via a guide, including an arm guide, after the arm guide has been placed at a proper trajectory. In some embodiments, a tip of the surgical needle will be supported during application to prevent axial rotation of the needle.

[0058] In some embodiments, the present surgical system includes software that determines an offset from the arm guide and the offset is incorporated for the trajectory based on an adapter and/or instrument selected. In some embodiments, the trajectory is computed via a center of the arm guide and spaced a distance from the offset trajectory. In some embodiments, the surgical system is compatible with a variety of surgical needles. In some embodiments, the anesthetizing agent administered via the surgical needle is administered prior to a surgical procedure, for example, a spinal surgery using computer navigated guidance systems to inject the anesthetizing agents.

[0059] In some embodiments, the present surgical system includes a surgical instrument employed for catheter assembly placement and/or use in connection with an image guided, robot assisted surgical system for administering anesthesia along a selected trajectory to a surgical site. In some embodiments, the surgical instrument facilitates removal of one or more components of the surgical system, for example, a surgical needle, robot components and/or the surgical instrument from the surgical site while allowing the catheter assembly to remain in position after placement and/or an injection. In some embodiments, the surgical instrument includes an adapter attached with a plate, which is fixed to a robotic arm to support movement of a surgical needle along a selected trajectory. In some embodiments, the adapter and/or the plate define one or more lateral channels. In some embodiments, the lateral channel is configured for passage of catheter assembly components to facilitate removal of components of the surgical system from the surgical site while allowing the catheter assembly to remain in position after placement and/or an injection. In some embodiments, the adapter defines a needle catheter assembly opening and one or more lateral channels. In some embodiments, a lateral channel of the plate and a lateral channel of the adapter are aligned for passage of one or more catheter assembly components. In some embodiments, the lateral channels are movable, for example, relatively rotatable into alignment. In some embodiments, the adapter includes an insert disposed with the lateral channel during placement and/or injection with a catheter assembly and a body of a patient. In some embodiments, the insert is removable from the lateral channel of the adapter to facilitate removal of components of the surgical system from the surgical site while allowing the catheter assembly to remain in position after placement and/or an injection.

[0060] In some embodiments, the surgical instrument includes a surgical guide as described herein, which may be employed with catheter assemblies or alternate needle assemblies. In some embodiments, the surgical instrument includes indicia displayed from one or more components of the surgical instrument to identify a selected surgical instrument configuration. In some embodiments, the indicia include color, symbols, numbering and/or lettering, for example, “C” for catheter. In some embodiments, one or more components of the surgical instrument are disposable. In some embodiments, the present surgical system includes a surgical instrument, which can be employed during general surgical procedures using a selected trajectory to a surgical site in connection with an image guided, robot assisted surgical system.

[0061] In some embodiments, the present surgical instrument is employed with a method for treating a spine, similar to those described herein, which includes the step of attaching a surgical guide including an adapter to a robotic arm. In some embodiments, the adapter defines a needle catheter assembly opening and one or more lateral channels. In some embodiments, the surgical guide includes a plate defining one or more lateral channels, the plate supporting the adapter such that the surgical guide supports movement of a surgical needle along a selected trajectory. In some embodiments, the method includes the step of disposing a catheter assembly with the adapter during placement and/or injection. In some embodiments, the method includes the step of removing one or more components of the surgical system from the surgical site. In some embodiments, the step of removing includes passing one or more components of the catheter assembly through the lateral channels and allowing the catheter assembly to remain disposed with a patient body after placement and/or after an injection.

[0062] In some embodiments, the surgical instrument is configured for use with navigational guidance and/or robotics, including for example, Mazor™ robotics systems and their components (Medtronic PLC, Minneapolis, Minnesota, USA).

[0063] 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. Also, 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, 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”.

[0064] 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, for example, micro discectomy 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. Also, as used in the specification and including the appended claims, the term “tissue” includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise.

[0065] The following discussion includes a description of surgical systems and related methods of employing a surgical system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to FIGS. 1 -34, there are illustrated components of a surgical system 10.

[0066] The components of surgical system 10 can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of surgical system 10, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, super elastic 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-BaSC polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, 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, for example, calcium based ceramics such as calcium phosphate such as hydroxyapatite (HA), corraline HA, biphasic calcium phosphate, tricalcium phosphate, or fluorapatite, tricalcium phosphate (TCP), HA-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations, biocompatible ceramics, mineralized collagen, bioactive glasses, porous metals, bone particles, bone fibers, morselized bone chips, bone morphogenetic proteins (BMP), such as BMP-2, BMP-4, BMP-7, rhBMP-2, or rhBMP-7, demineralized bone matrix (DBM), transforming growth factors (TGF, e.g., TGF-p), osteoblast cells, growth and differentiation factor (GDF), insulin-like growth factor 1 , platelet-derived growth factor, fibroblast growth factor, or any combination thereof.

[0067] Various components of surgical system 10 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 of surgical system 10, 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 of surgical system 10 may be monolithically formed, integrally connected, or include fastening elements and/or instruments, as described herein.

[0068] Surgical system 10 includes a surgical instrument 12, as shown for example in FIGS. 1-8. In some embodiments, surgical system 10 includes an image guided, robot assisted surgical system for administering nerve block injections including anesthetizing agents via one or more selected surgical needles, surgical needle assemblies and/or surgical instruments along a selected trajectory to a surgical site in connection with spine surgery. In some embodiments, surgical system 10 is employed with a surgical treatment, which includes, for example, erector spinae block anesthesia injection to tissue, for example, the erector spinae and/or spinal fluids. In some embodiments, the injection includes injecting an anesthetizing agent such as a local anesthesia with tissue, for example, the fascial plane. In some embodiments, the injection is employed to selectively provide analgesia to tissue adjacent the surgical site, for example, vertebral tissue, posterior, lateral, and anterior walls adjacent selected vertebrae, paravertebral tissue, intercostal tissue, one or more vertebrae, ribs and pelvis. In some embodiments, the injection includes injecting an anesthetizing agent, which may include one or more of ropivacaine, bupivacaine, neostigmine/atropine, lignocaine, prilocaine, procaine, amethocaine, saline, steroids, clonidine, and/or epinephrine. In some embodiments, surgical system 10 is 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, surgical instrument 12 is configured for administration of a trajectory focus erector spinae block.

[0069] Surgical instrument 12 includes a surgical guide, for example, an adapter 16 and a plate 18, which connects with an arm 20 of a robot R. In some embodiments, surgical instrument 12 is connected with arm 20, and a processor of a computer generates data for display of an image from a monitor to represent position of one or more selected surgical needles, surgical needle assemblies and/or surgical instruments, for example, a surgical needle 14 relative to vertebral tissue, as described herein. Adapter 16 is disposed with plate 18 to support movement of surgical needle 14 along a selected trajectory, as described herein and relative to adapter 16. In some embodiments, adapter 16 is fixed and/or locked with plate 18. In some embodiments, adapter 16 includes a post that is friction fit in a fixed engagement with plate 18. In some embodiments, adapter 16 includes a threaded post (see, for example, FIG. 13) that is fixed and/or locked with plate 18, for example, via a threaded connection. In some embodiments, adapter 16 is adhesively fixed with plate 18. In some embodiments, adapter 16 is removably attached with plate 18. In some embodiments, adapter 16 is monolithically formed with plate 18.

[0070] Adapter 16 defines a needle shaft opening 17 and includes circumferential walls 22 that define a needle assembly channel 24. In some embodiments, walls 22 are spaced apart and diametrically opposed. In some embodiments, walls 22 include an extended height to accommodate variously sized needle assemblies. In some embodiments, walls 22 include one or more lateral openings. In some embodiments, adapter 16 may include one or a plurality of walls, circumferential or planar, which define the channel. Needle shaft opening 17 is centrally disposed with adapter 16 and defines a longitudinal axis AA that extends through needle assembly channel 24. Needle shaft opening 17 supports movement of a shaft of surgical needle 14 along a selected trajectory and relative to adapter 16. In some embodiments, one or more components of surgical needle 14 are axially translatable and/or rotatable relative to adapter 16.

[0071] In some embodiments, one or more components of adapter 16 are configured to accommodate one or more alternate selected surgical needles, surgical needle assemblies and/or surgical instruments. In some embodiments, one or more components of adapter 16 are configured to mate with a selected surgical needle 14, for example, having a selected needle shaft diameter, needle gauge, needle material and/or needle hub configuration. In some embodiments, needle assembly channel 24 and/or needle shaft opening 17 are selectively sized and/or configured to a specific needle, needle gauge, needle hub, needle assembly and/or needle shaft diameter. For example, as shown in FIG. 9, channel 24 and/or opening 17 are selectively sized and/or configured to matingly engage with a needle hub/needle assembly of surgical needle 14 having a first configuration. In another example, as shown in FIG. 10, channel 24 and/or opening 17 are selectively sized and/or configured to matingly engage with a needle hub/needle assembly of surgical needle 14 having a second configuration. In another example, as shown in FIG. 11 , channel 24 and/or opening 17 are selectively sized and/or configured to matingly engage with a needle hub/needle assembly of surgical needle 14 having a third configuration. In some embodiments, adapter 16 is disposable. In some embodiments, adapter 16 is non-disposable and/or reusable. In some embodiments, opening 17 is sized to matingly engage with a selected surgical needle 14 having a needle shaft gauge selected from a range of 15-20 gauge. In some embodiments, opening 17 is sized to matingly engage with a selected surgical needle 14 having a needle shaft gauge of 17 gauge. In some embodiments, opening 17 is sized to matingly engage with a selected surgical needle 14 having a needle shaft gauge of 18 gauge. In some embodiments, opening 17 is sized to matingly engage with a selected surgical needle 14 having a needle shaft gauge of 20 gauge. In some embodiments, opening 17 is configured to matingly engage with a selected surgical needle 14 having a straight, curved or cutting needle shaft. In some embodiments, a selected surgical needle 14 having a cutting, beveled or lancet needle tip can be employed with adapter 16. In some embodiments, surgical system 10 includes one or more alternately sized and/or configured adapters compatible and/or interchangeable with plate 18.

[0072] In some embodiments, one or more components of adapter 16 may have various cross-section configurations, for example, arcuate, cylindrical, oblong, rectangular, polygonal, undulating, irregular, uniform, non-uniform, consistent, variable, and/or U-shape. In some embodiments, one or more components of adapter 16 may have alternate surface configurations, for example, rough, undulating, corrugated, porous, semi-porous, dimpled, polished and/or textured.

[0073] Plate 18 includes a wall 26 and a wall 27 disposed transverse relative to wall 26. Wall 26 connects with arm 20 of robot R via a plate attachment 30, which is attached with arm 20. Plate attachment 30 includes an internally threaded receiver 34 and wall 26 defines an opening 32. A fastener 36 is disposed with opening 32 and threaded with receiver 34 to fix plate 18 with arm 20, for example, using a surgical tool 44, as shown in FIG. 4. In some embodiments, plate 18 is directly fixed and/or locked with arm 20. In some embodiments, wall 26 includes a post that is friction fit or threaded in a fixed engagement with arm 20. In some embodiments, wall 26 or plate attachment 30 is adhesively fixed with plate 18. In some embodiments, wall 26 is removably attached with arm 20. In some embodiments, plate 18 is monolithically formed with arm 20. [0074] Wall 27 includes a receptacle surface 28 that supports adapter 16, which supports movement of the shaft of surgical needle 14 along a selected trajectory, as described herein. Adapter 16 is removably attached, fixed and/or locked with receptacle surface 28. In some embodiments, adapter 16 includes a post that is friction fit in a fixed engagement with an opening of receptacle surface 28. In some embodiments, adapter 16 includes a threaded post (see, for example, FIG. 13) that is fixed and/or locked with a threaded opening 40 of receptacle surface 28. Opening 40 is centrally disposed with surface 28 and aligned with longitudinal axis AA. Opening 40 provides through access for the shaft of surgical needle 14 along a selected trajectory, as described herein. In some embodiments, adapter 16 is adhesively fixed with a planar surface of receptacle surface 28. In some embodiments, adapter 16 is removably attached with receptacle surface 28. In some embodiments, adapter 16 is monolithically formed with receptacle surface 28.

[0075] Surgical system 10, as shown in for example in FIG. 1 , includes image guided technologies, for example, surgical navigation components employing emitters and sensors, as described herein, which may be employed to track introduction and/or delivery of the components of surgical system 10 to a surgical site. See, for example, the surgical navigation components and their use as described in US Patent Nos. 6,021 ,343, 6,725,080, 6,796,988, and 10,751 ,127, the entire contents of each of these references being incorporated by reference herein. In some embodiments, surgical navigation components include selected pre-programmed software, interactive software and computer monitors.

[0076] In assembly, operation and use, surgical system 10, similar to the systems and methods described herein, is employed with a surgical procedure for treatment of a spinal disorder, such as those described herein, affecting a section of a spine of a patient. Surgical system 10 may also be employed with other surgical procedures. For example, surgical instrument 12 is employed with image guided, robot assisted surgical system 10 for administering one or more nerve block injections that include one or more anesthetizing agents via surgical needle 14 along a selected trajectory T1 , as shown in FIG. 12, to a surgical site including one or more vertebra V in connection with spine surgery, as described herein. Surgical instrument 12 orients surgical needle 14 along trajectory T1 in connection with the components of system 10 to administer an erector spinae block anesthesia injection to tissue, for example, the erector spinae and/or adjacent spinal fluids. In some embodiments, surgical needle 14 injects a local anesthesia, as described herein, with the tissue of the fascial plane. In some embodiments, surgical needle 14 injects the local anesthesia with tissue T adjacent one or more vertebra V to selectively provide analgesia to tissue adjacent the surgical site, for example, vertebral tissue, posterior, lateral, and anterior walls adjacent selected vertebrae, paravertebral tissue, intercostal tissue, one or more vertebrae, ribs and pelvis. In some embodiments, surgical needle 14 injects a local anesthesia in connection with a surgical treatment, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine. In some embodiments, the anesthetizing agent administered via surgical needle 14 is administered prior to the surgical procedure.

[0077] In use, to treat the selected one or more vertebra V, adjacent and/or surrounding tissue, a medical practitioner obtains access to the surgical site including the selected one or more vertebra V, adjacent and/or surrounding tissue. In some embodiments, surgical system 10 can be used in any existing surgical method or technique including open surgery, mini-open surgery or minimally invasive surgery, whereby vertebrae are accessed through a mini-incision, or a sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, the surgical procedure can be performed for treating the spine disorder.

[0078] In some embodiments, surgical system 10 includes a surgical robotic guidance system 10R having robot R, a surgical navigation system 10N and a tracking system 10T, as shown for example in FIG. 1. Robot R includes a navigation component NC oriented relative to a sensor array SA to facilitate communication between navigation component NC and sensor array SA during the surgical procedure. Navigation component NC generates a signal representative of a three-dimensional spatial position of arm 20 relative to the selected one or more vertebra V, adjacent and/or surrounding tissue. In some embodiments, a distance of an end of arm 20 that is connectable to surgical instrument 12, as described herein, relative to arm 20 and robot R is predetermined, pre-programmed with software, and/or interactively determined during the surgical procedure by a computer processor CPN of surgical navigation system 10N. The spine of the patient including the selected one or more vertebra V, adjacent and/or surrounding tissue and arm 20 are registered to a three-dimensional surgical site with surgical navigation system 10N and tracking system 10T. See, for example, similar surgical navigation and robotic systems, their components and use as described in US Patent No. 10,751 ,127, the entire contents of which being incorporated by reference herein. In some embodiments, registration includes implementing an O-arm for surgical planning and/or a C-arm for fluoroscopic registration.

[0079] Surgical instrument 12 including adapter 16 is connected with arm 20 as described herein. Sensor array SA receives signals from navigation component NC to provide three-dimensional spatial position of adapter 16 and/or a trajectory of axis AA relative to the selected one or more vertebra V, adjacent and/or surrounding tissue due to the connection of surgical instrument 12 with arm 20. The three-dimensional spatial position and/or trajectory signals are communicated to a processor of a computer CPN of navigation system 10N to generate data for display of an image on a monitor M. In some embodiments, surgical navigation system 10N provides for real-time tracking of the position of adapter 16 and/or trajectory of axis AA relative to relative to the selected one or more vertebra V, adjacent and/or surrounding tissue.

[0080] A trajectory T1 is selected pre-operatively, based on surgical planning and/or during the surgical procedure. In some embodiments, prior to connection of adapter 16 with plate 18, a navigation instrument 42 is connected with receptacle surface 28, as shown in FIG. 6. Robot R selectively orients instrument 42 to the selected one or more vertebra V, adjacent and/or surrounding tissue to determine trajectory T1 using surgical navigation system 10N. The selected trajectory T1 is saved with computer CPN of navigation system 10N. In some embodiments, selected trajectory T1 may be oriented at a selected angle relative to axis AA.

[0081] The position of adapter 16 is tracked in real time, as described herein, and axis AA is aligned with trajectory T1 , as shown in FIG. 12. Surgical needle 14 is disposed with needle assembly channel 24 and the shaft of surgical needle 14 is disposed with needle shaft opening 17. In some embodiments, the size and/or configuration of surgical needle 14 including, for example, a length of the shaft of surgical needle 14 is predetermined, pre-programmed with software, and/or interactively determined during the surgical procedure and stored with computer processor CPN of surgical navigation system 10N.

[0082] Computer processor CPN generates data for display of three- dimensional spatial position and/or trajectory of surgical needle 14 relative to trajectory T1 , the selected one or more vertebra V, adjacent and/or surrounding tissue T from monitor M. The shaft of surgical needle 14 is moved along trajectory T1 and relative to adapter 16 to a selected location with tissue T and/or at a selected depth with tissue T such that a tip of the needle shaft penetrates tissue T to administer a nerve block injection including at least one anesthetizing agent. Surgical needle 14 injects the local anesthesia with the tissue to selectively provide analgesia to tissue adjacent the surgical site, as described herein. The three-dimensional spatial position and/or trajectory of the tip and the shaft of surgical needle 14 moving relative to adapter 16 are tracked in real time using surgical navigation system 10N and displayed from monitor M, as described herein. In some embodiments, three-dimensional spatial position and/or trajectory of the tip and the shaft of surgical needle 14 rotating and/or axially translating relative to adapter 16 are tracked in real time using surgical navigation system 10N and displayed from monitor M. In some embodiments, surgical needle 14 is manually guided through adapter 16 at a pre-selected trajectory length.

[0083] In some embodiments, a distance of one or more components of plate 18 relative to the end of arm 20 is predetermined, pre-programmed with software, and/or interactively determined during the surgical procedure and stored with computer processor CPN of surgical navigation system 10N to facilitate real time tracking of the three-dimensional spatial position and/or trajectory of surgical needle 14. In some embodiments, a distance of one or more components of adapter 16, for example, needle assembly channel 24 or needle shaft opening 17 relative to the end of arm 20 and/or plate 18 is predetermined, pre-programmed with software, and/or interactively determined during the surgical procedure and stored with computer processor CPN of surgical navigation system 10N to facilitate real time tracking of the three-dimensional spatial position and/or trajectory of surgical needle 14.

[0084] One or more of the components of surgical system 10 can be made of radiolucent materials such as polymers. Radiopaque markers may be included for identification under x-ray, fluoroscopy, CT, or other imaging techniques. In some embodiments, the use of surgical navigation, microsurgical and image guided technologies, as described herein, may be employed to access, view and repair spinal deterioration or damage, with the aid of surgical system 10. In some embodiments, surgical system 10 may include implants and/or spinal constructs, which may include one or a plurality of plates, rods, connectors and/or bone fasteners for use with a single vertebral level or a plurality of vertebral levels.

[0085] In one embodiment, as shown in FIGS. 13-16, surgical system 10, similar to the systems and methods described with regard to FIGS. 1 -12, includes a surgical instrument 112, similar to surgical instrument 12 described herein. Surgical instrument 112 includes a surgical guide, for example, adapter 16 described herein and a navigation component, which connects with arm 20 of robot R described herein. The navigation component includes an emitter array, for example, a tracker 116. T racker 116 includes a mating surface 118 that connects with an end effector 120 connected with arm 20. In some embodiments, tracker 116 is fixed and/or locked with end effector 120 via a fastener. In some embodiments, tracker 116 includes a post that is friction fit in a fixed engagement with end effector 120. In some embodiments, tracker 116 is adhesively fixed with end effector 120. In some embodiments, tracker 116 is removably attached with end effector 120. In some embodiments, tracker 116 is monolithically formed with end effector 120.

[0086] Adapter 16 is disposed with tracker 116 to support movement of surgical needle 14 described herein along a selected trajectory, as described herein and relative to adapter 16. Adapter 16 includes a threaded post that is fixed and/or locked with a centrally disposed threaded opening 123 of tracker 116 via a threaded connection. In some embodiments, opening 123 may be alternatively disposed on tracker 116, including offset or disposed on one or more arms of tracker 116. In some embodiments, adapter 16 includes a post that is friction fit in a fixed engagement with tracker 116. In some embodiments, adapter 16 is adhesively fixed with tracker 116. In some embodiments, adapter 16 is removably attached with tracker 116. In some embodiments, adapter 16 is monolithically formed with tracker 116.

[0087] In assembly, operation and use, similar to the systems and methods described herein, surgical instrument 112 is employed with image guided, robot assisted surgical system 10 for administering one or more nerve block injections that include one or more anesthetizing agents via surgical needle 14 along selected trajectory T1 to a surgical site including one or more vertebra V in connection with spine surgery, as described herein. The spine of the patient including the selected one or more vertebra V, adjacent and/or surrounding tissue and arm 20 including end effector 120 are registered to a three-dimensional surgical site with surgical navigation system 10N and tracking system 10T, similar to that described herein. A distance of one or more components of adapter 16, for example, needle assembly channel 24 or needle shaft opening 17 relative to the end of arm 20 and/or end effector 120 is predetermined, pre-programmed with software, and/or interactively determined during the surgical procedure and stored with computer processor CPN of surgical navigation system 10N to facilitate real time tracking of the three-dimensional spatial position and/or trajectory of surgical needle 14.

[0088] Tracker 116 is connected with end effector 120 and trajectory T1 is selected, similar to that described herein. Sensor array SA receives signals from tracker 116 in real time to provide three-dimensional spatial position of adapter 16 and/or a trajectory of axis AA relative to the selected one or more vertebra V, adjacent and/or surrounding tissue. The position of adapter 16 disposed with tracker 116 is tracked in real time and axis AA is aligned with trajectory T 1 . Computer processor CPN generates data for display of three-dimensional spatial position and/or trajectory of surgical needle 14 relative to trajectory T1 , the selected one or more vertebra V, adjacent and/or surrounding tissue from monitor M. The shaft of surgical needle 14 is moved along trajectory T1 and relative to adapter 16 to a selected location with the tissue and/or at a selected depth with the tissue such that a tip of the needle shaft penetrates the tissue to administer a nerve block injection including at least one anesthetizing agent. Surgical needle 14 injects the local anesthesia with the tissue to selectively provide analgesia to tissue adjacent the surgical site, as described herein. The three-dimensional spatial position and/or trajectory of the tip and the shaft of surgical needle 14 moving relative to adapter 16 disposed with tracker 116 are tracked in real time using surgical navigation system 10N and displayed from monitor M, as described herein.

[0089] In one embodiment, as shown in FIGS. 17-20, surgical system 10, similar to the systems and methods described herein, includes a surgical instrument 212, similar to surgical instrument 12 described herein. Surgical instrument 212 includes a surgical guide, for example, a base 216, which connects with end effector 120 of arm 20 of robot R described herein. End effector 120 is mounted with a post of base 216 via a set screw or similar fastener. In some embodiments, base 216 is fixed and/or locked with end effector 120 via a fastener. In some embodiments, base 216 includes a post that is friction fit in a fixed engagement with end effector 120. In some embodiments, base 216 is adhesively fixed with end effector 120. In some embodiments, base 216 is removably attached with end effector 120. In some embodiments, base 216 is monolithically formed with end effector 120.

[0090] Base 216 includes a circumferential wall 224 and a receptacle 226 defining a needle opening 228 that supports a surgical needle 214, similar to surgical needle 14 described herein. Needle opening 228 defines a longitudinal axis CC. Surgical needle 214 is guided through needle opening 228 via a needle advancer 230 along a selected trajectory, similar to that described herein. Needle advancer 230 includes a distal end that engages surgical needle 214 to move surgical needle 214 relative to base 216. In some embodiments, needle opening 228 is centered relative to one or more sides of base 216 to orient surgical needle 214 along a targeted trajectory. In some embodiments, surgical needle 214 is supported when surgical needle 214 contacts patient skin.

[0091] In assembly, operation and use, similar to the systems and methods described herein, surgical instrument 212 is employed with image guided, robot assisted surgical system 10 for administering one or more nerve block injections that include one or more anesthetizing agents via surgical needle 214 along a selected trajectory to a surgical site including one or more vertebra in connection with spine surgery, similar to that described herein. The spine of the patient including the selected one or more vertebra, adjacent and/or surrounding tissue and arm 20 including end effector 120 connected with base 216 are registered to a three-dimensional surgical site with surgical navigation system 10N and tracking system 10T, similar to that described herein. A distance of one or more components of base 216 or needle advancer 230 relative to the end of arm 20 and/or end effector 120 is predetermined, pre-programmed with software, and/or interactively determined during the surgical procedure and stored with computer processor CPN of surgical navigation system 10N to facilitate real time tracking of the three-dimensional spatial position and/or trajectory of surgical needle 214, similar to that described herein. Needle advancer 230 engages surgical needle 214, which is moved along the selected trajectory and relative to adapter 16 to a selected location with the tissue and/or at a selected depth with the tissue such that a tip of the needle shaft penetrates the tissue to administer a nerve block injection including at least one anesthetizing agent. Surgical needle 214 injects the local anesthesia with the tissue to selectively provide analgesia to tissue adjacent to the surgical site, as described herein. The three-dimensional spatial position and/or trajectory of the tip and the shaft of surgical needle 214 moving relative to base 216 are tracked in real time using surgical navigation system 10N and displayed from monitor M, as described herein. In some embodiments, needle advancer 230 is manually guided.

[0092] In one embodiment, as shown in FIGS. 21-28, surgical system 10, similar to the systems and methods described herein, includes a surgical instrument 312, similar to surgical instrument 212 described herein. Surgical instrument 312 includes base 216, which connects with end effector 120, as described herein. Base 216 defines a needle opening 328 that supports a surgical needle 314, similar to those described herein. A tracker attachment 330 and a needle lock sleeve 332 are disposed with a channel defined by wall 224. In some embodiments, base 216 includes a receptacle 326 that supports surgical needle 314, as shown in FIG. 25.

[0093] Tracker attachment 330 includes an end 334 that connects with a navigation component, for example, an emitter array including a tracker 336, as shown in FIG. 28. In some embodiments, surgical needle 314 is navigated with trajectory lines into anatomy via the navigation software. Tracker attachment 330 includes a slot 338 configured to facilitate entry and exit of surgical tools, including tubes or wires. Needle locking sleeve 332 is configured to fix surgical needle 314 in a selected position or trajectory.

[0094] In assembly, operation and use, similar to the systems and methods described herein, surgical instrument 312 is employed with image guided, robot assisted surgical system 10 for administering one or more nerve block injections that include one or more anesthetizing agents via surgical needle 314 along a selected trajectory to a surgical site including one or more vertebra in connection with spine surgery, similar to that described herein. The spine of the patient including the selected one or more vertebra, adjacent and/or surrounding tissue and arm 20 including end effector 120 connected with base 216 are registered to a three-dimensional surgical site with surgical navigation system 10N and tracking system 10T, similar to that described herein.

[0095] Tracker 336 is connected with tracker attachment 330, which is disposed with base 216 and a trajectory is selected, similar to that described herein. Sensor array SA receives signals from tracker 336 in real time to provide a three- dimensional spatial position of adapter 16 and/or a trajectory of axis AA relative to the selected one or more vertebra, adjacent and/or surrounding tissue. The position of base 216 and tracker attachment 330 disposed with tracker 336 is tracked in real time and an axis of needle opening 328 is aligned with the selected trajectory. Computer processor CPN generates data for display of three-dimensional spatial position and/or trajectory of surgical needle 314 relative to the selected trajectory, the selected one or more vertebra, adjacent and/or surrounding tissue from monitor M. The shaft of surgical needle 314 is moved along the selected trajectory and relative to base 216 to a selected location with the tissue and/or at a selected depth with the tissue such that a tip of the needle shaft penetrates the tissue to administer a nerve block injection including at least one anesthetizing agent. Surgical needle 314 injects the local anesthesia with the tissue to selectively provide analgesia to tissue adjacent the surgical site, as described herein. The three-dimensional spatial position and/or trajectory of the tip and the shaft of surgical needle 314 moving relative to base 216 connected to tracker 336 are tracked in real time using surgical navigation system 10N and displayed from monitor M, as described herein. In some embodiments, tracker attachment 330 is manually guided.

[0096] In one embodiment, as shown in FIGS. 29-31 , surgical system 10 includes surgical instrument 12, as described with regard to FIGS. 1-12, having an adapter 416 and a plate 418, similar to adapter 16 and plate 18 described herein, which connects with arm 20 of robot R. Surgical instrument 12 includes adapter 416 and plate 418 to provide a surgical guide employed for placement of a catheter assembly 502 and/or use in connection with surgical robotic guidance system 10R, surgical navigation system 10N and tracking system 10T for administering anesthesia along a selected trajectory to a surgical site, similar to that described herein. In some embodiments, adapter 416 and plate 418 facilitate removal of one or more components of surgical system 10 from the surgical site while allowing catheter assembly 502 to remain in position after placement with a patient and/or an injection. In some embodiments, catheter assembly 502 includes or is employed with a surgical needle, as described herein.

[0097] Adapter 416 defines a needle shaft opening 417 and includes circumferential walls 422, similar to walls 22 described herein. Adapter 416 includes an inner surface that defines a cavity, for example, a catheter assembly channel 424 for disposal of one or more components of catheter assembly 502. The inner surface of channel 424 matingly engages catheter assembly 502, a surgical needle hub and/or one or more components of surgical system 10, for use of catheter assembly 502 and/or to support movement of a shaft of a surgical needle along a selected trajectory and relative to adapter 416. In some embodiments, the inner surface of channel 424 is selectively configured to accommodate one or more alternate catheter assemblies, surgical needles, surgical needle assemblies and/or surgical instruments. For example, as shown in FIG. 31 , the inner surface of channel 424 has a step configuration including a first diameter and a second decreased diameter to accommodate a selected catheter assembly 502. Needle shaft opening 417 supports movement of a shaft of a surgical needle along a selected trajectory and relative to adapter 416, similar to that described herein. Adapter 416 includes a surface that defines a lateral channel 431 configured for passage of one or more components of catheter assembly 502 to facilitate removal of components of surgical system 10 from a surgical site while allowing catheter assembly 502 to remain in position with a patient after placement and/or an injection, as described herein. In some embodiments, adapter 416 includes an outer grip surface, for example, a knurled surface. In some embodiments, catheter assembly 502 includes one or more needles, needle hub, tubing and/or body components.

[0098] Plate 418 includes a wall 426 and a wall 427, similar to wall 26 and wall 27 described herein, which are attached with arm 20. Wall 427 includes a receptacle surface 428 that supports adapter 416, which supports movement of the shaft of a surgical needle along a selected trajectory, as described herein. Adapter 416 includes a threaded post 433 that is fixed and/or locked with a threaded opening 435 of receptacle surface 428. Wall 427 includes a surface that defines a lateral channel 437 configured for passage of one or more components of catheter assembly 502 to facilitate removal of components of surgical system 10 from a surgical site while allowing catheter assembly 502 to remain in position with a patient after placement and/or an injection, as described herein.

[0099] In some embodiments, channel 431 and channel 437 are aligned for passage of one or more components of catheter assembly 502. For example, adapter 416 is rotatable relative to wall 427 such that channels 431 , 437 relatively rotate into alignment, as shown for example in FIG. 29, to allow passage of one or more components of catheter assembly 502 through channels 431 , 437. This configuration facilitates removal of components of surgical system 10 from a surgical site while allowing catheter assembly 502 to remain in position with a patient after placement and/or an injection. In some embodiments, adapter 416 includes an insert 441 disposed with channel 431 and/or channel 437 during placement and/or injection with catheter assembly 502 and a body of a patient. Insert 441 is removable from channel 431 and/or channel 437 to allow passage of one or more components of catheter assembly 502 through channels 431 , 437, as described herein. In some embodiments, one or more components of adapter 416 and/or plate 418 include indicia displayed therefrom to identify a selected surgical instrument configuration. In some embodiments, walls 426, 427, and/or one or more components of adapter 416 may include indicia having color, symbols, numbering and/or lettering, for example, “C” to identify a catheter.

[00100] In assembly, operation and use, similar to the systems and methods described herein, surgical instrument 12 including adapter 416 and plate 418 is employed with image guided, robot assisted surgical system 10 for administering anesthetizing agents via a surgical needle along a selected trajectory to a surgical site including one or more vertebra in connection with spine surgery, and includes disposing catheter assembly 502 with adapter 416 and plate 418 for placement and/or injection at the surgical site. In some embodiments, during use, after placement of catheter assembly 502 at the surgical site and/or after an injection, adapter 416 is rotatable relative to plate 418 such that channels 431 , 437 relatively rotate into alignment, as shown for example in FIG. 29, to allow passage of one or more components of catheter assembly 502 through channels 431 , 437. Insert 441 is removable from channel 431 and/or channel 437 to allow passage of one or more components of catheter assembly 502 through channels 431 , 437. With channels 431 , 437 aligned, one or more components of the catheter assembly 502 are passed through channels 431 , 437 such that one or more components of surgical system 10 are removed from the surgical site allowing catheter assembly 502 to remain at the surgical site and disposed with a patient body during use, after placement and/or after an injection.

[00101] In one embodiment, as shown in FIGS. 32-34, surgical system 10 includes surgical instrument 12 having an adapter 616 and a plate 618, similar to that described with regard to FIGS. 29-31 , which connects with arm 20 of robot R and provide placement of a catheter assembly 702 and/or use for administering anesthesia along a selected trajectory to a surgical site. Adapter 616 and plate 618 facilitate removal of one or more components of surgical system 10 from the surgical site while allowing catheter assembly 702 to remain in position after placement with a patient and/or an injection.

[00102] Adapter 616 defines a needle shaft opening 617 and includes circumferential walls 622. Adapter 616 includes an inner surface that defines a catheter assembly channel 624 for disposal of one or more components of catheter assembly 702. The inner surface of channel 624 matingly engages catheter assembly 702, a surgical needle hub and/or one or more components of surgical system 10, for use of catheter assembly 702 and/or to support movement of a shaft of a surgical needle along a selected trajectory and relative to adapter 616. As shown in FIG. 34, the inner surface of channel 624 has a step configuration including a first diameter defined by walls 622 and a second decreased diameter to accommodate a selected catheter assembly 702. Needle shaft opening 617 supports movement of a shaft of a surgical needle along a selected trajectory and relative to adapter 616. Adapter 616 includes a surface that defines a lateral channel 631 configured for passage of one or more components of catheter assembly 702 to facilitate removal of components of surgical system 10 from a surgical site while allowing catheter assembly 702 to remain in position with a patient after placement and/or an injection, as described herein. Adapter 616 includes an outer knurled grip surface.

[00103] Plate 618 includes a wall 626 and a wall 627, which are attached with arm 20. Wall 627 includes a receptacle surface 628 that supports adapter 616, which supports movement of the shaft of a surgical needle along a selected trajectory. Adapter 616 includes a threaded post 633 that is fixed and/or locked with a threaded opening (not shown) of receptacle surface 628. Wall 627 includes a surface that defines a lateral channel 637 configured for passage of one or more components of catheter assembly 702 to facilitate removal of components of surgical system 10 from a surgical site while allowing catheter assembly 702 to remain in position with a patient after placement and/or an injection, as described herein.

[00104] Adapter616 is rotatable relative to plate 618 such that channels 631 , 637 relatively rotate into alignment, as shown for example in FIG. 32, to allow passage of one or more components of catheter assembly 702 through channels 631 , 637. Adapter 616 includes an insert 641 disposed with channel 631 and/or channel 637 during placement and/or injection with catheter assembly 702 and a body of a patient. Insert 641 is removable from channel 631 and/or channel 637 to allow passage of one or more components of catheter assembly 702 through channels 631 , 637. In some embodiments, one or more components of adapter 616 and/or plate 618 include indicia displayed therefrom to identify a selected surgical instrument configuration. In some embodiments, walls 626, 627, and/or one or more components of adapter 616 may include indicia having color, symbols, numbering and/or lettering, for example, “C” for catheter.

[00105] In assembly, operation and use, similar to the systems and methods described herein, surgical instrument 12 including adapter 616 and plate 618 is employed with image guided, robot assisted surgical system 10 for administering anesthetizing agents via a surgical needle along a selected trajectory to a surgical site including one or more vertebra in connection with spine surgery, and includes disposing catheter assembly 702 with adapter 616 and plate 618 for placement and/or injection at the surgical site. In some embodiments, during use, after placement of catheter assembly 702 at the surgical site and/or after an injection, adapter 616 is rotatable relative to plate 618 such that channels 631 , 637 relatively rotate into alignment, as shown for example in FIG. 32, to allow passage of one or more components of catheter assembly 702 through channels 631 , 637. Insert 641 is removable from channel 631 and/or channel 637 to allow passage of one or more components of catheter assembly 702 through channels 631 , 637. With channels 631 , 637 aligned, one or more components of the catheter assembly 702, for example, needle, needle hub, tubing and/or body components, can be passed through channels 631 , 637 such that one or more components of surgical system 10 are removed from the surgical site allowing catheter assembly 702 to remain at the surgical site and disposed with a patient body during use, after placement and/or after an injection.

[00106] In some embodiments, the surgical system of the present disclosure and related methods of use may be described by reference to the following numbered paragraphs:

[00107] A method for treating a spine, the method comprising the steps of: registering one or more vertebra to a three-dimensional surgical site of a robot including an arm; and moving a surgical needle along a selected trajectory and relative to a surgical guide to a selected location with tissue adjacent the one or more vertebra to administer a nerve block injection including at least one anesthetizing agent, the surgical guide being connectable to the arm such that a processor generates data for display of an image from a monitor, the image representing position of the surgical needle relative to the tissue.

[00108] The method of paragraph [00106], wherein the step of registering includes registering the arm via at least one surgical navigation component and the processor.

[00109] The method of paragraph [00106], wherein the step of moving includes guiding the surgical needle to a selected depth within the selected location.

[00110] The method of paragraph [00106], further comprising a surgical instrument including the surgical guide and a member connectable with the arm.

[00111] The method of paragraph [00109], wherein the member includes a wall and a receptacle being disposed transverse relative to the wall, the receptacle being configured to receive the surgical guide.

[00112] The method of paragraph [00109], wherein the member includes a receptacle and the surgical guide includes a threaded adapter fixable with the receptacle.

[00113] The method of paragraph [00109], wherein the member includes a receptacle and the surgical guide includes one or more alternate adapters disposable with the receptacle.

[00114] The method of paragraph [00109], wherein the surgical instrument includes a navigation component and the surgical guide includes a needle support disposed a selected distance from the arm and centrally disposed with the navigation component.

[00115] The method of paragraph [00106], wherein the surgical guide includes at least one circumferential wall that defines a needle channel.

[00116] The method of paragraph [00106], wherein the surgical guide includes an adapter defining a cavity for disposal of one or more components of a catheter assembly and further comprising the step of removing the surgical guide from the surgical site such that the catheter assembly remains at the surgical site.

[00117] The method of paragraph [00115], wherein the adapter defines a lateral channel configured for passage of the catheter assembly therethrough.

[00118] A surgical instrument comprising: a guide being connectable with a robotic arm, the robotic arm being registrable with one or more vertebra via at least one surgical navigation component and a processor, and the guide supporting movement of a surgical needle along a selected trajectory and relative to the guide such that the processor generates data for display of an image from a monitor, the image representing position of the surgical needle relative to tissue adjacent the one or more vertebra.

[00119] The surgical instrument of paragraph [00117], further comprising a member being connectable with the arm and including a receptacle, the receptacle being configured to receive the surgical guide.

[00120] The surgical instrument in any of paragraphs [00117 or 00118], wherein the surgical guide includes an adapter defining a cavity for disposal of one or more components of a catheter assembly and a lateral channel configured for passage of the catheter assembly therethrough.

[00121] The surgical instrument in any of paragraphs [00117, 00118 or 00119], wherein the at least one surgical navigation component includes an emitter array including a tracker.

[00122] The surgical instrument in any of paragraphs [00117, 00118, 00119 or 00120], wherein the guide is disposed a selected distance from the arm and centrally disposed with the at least one surgical navigation component.

[00123] The surgical instrument in any of paragraphs [00117, 00118, 00119, 00120 or 00121], wherein the guide includes at least one circumferential wall that defines a needle channel.

[00124] A surgical instrument comprising: a member including a wall connectable with a robotic arm and a base having a receptacle, the robotic arm being registrable with one or more vertebra via at least one surgical navigation component and a processor, and a guide disposable with the receptacle for supporting movement of a surgical needle along a selected trajectory and relative to the guide such that the processor generates data for display of an image from a monitor, the image representing position of the surgical needle relative to tissue adjacent the one or more vertebra.

[00125] The surgical instrument of paragraph [00123], wherein the at least one surgical navigation component includes an emitter array including a tracker.

[00126] The surgical instrument in any of paragraphs [00123 or 00124], wherein the receptacle is configured to receive one or more alternate adapters.

[00127] It will be understood that various modifications and/or combinations 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.

[00128] The techniques of this disclosure may also be described in the following examples.

[00129] Example 1. A method for treating a spine, the method comprising the steps of: registering one or more vertebra to a three-dimensional surgical site of a robot including an arm; and moving a surgical needle along a selected trajectory and relative to a surgical guide to a selected location with tissue adjacent the one or more vertebra to administer a nerve block injection including at least one anesthetizing agent, the surgical guide being connectable to the arm such that a processor generates data for display of an image from a monitor, the image representing position of the surgical needle relative to the tissue.

[00130] Example 2. A method as recited in Example 1 , wherein the step of registering includes registering the arm via at least one surgical navigation component and the processor.

[00131] Example 3. A method as recited in Example 1 , wherein the step of moving includes guiding the surgical needle to a selected depth within the selected location.

[00132] Example 4. A method as recited in Example 1 , further comprising a surgical instrument including the surgical guide and a member connectable with the arm. [00133] Example s. A method as recited in Example 4, wherein the member includes a wall and a receptacle being disposed transverse relative to the wall, the receptacle being configured to receive the surgical guide.

[00134] Example 6. A method as recited in Example 4, wherein the member includes a receptacle and the surgical guide includes a threaded adapter fixable with the receptacle.

[00135] Example 7. A method as recited in Example 4, wherein the member includes a receptacle and the surgical guide includes one or more alternate adapters disposable with the receptacle.

[00136] Example s. A method as recited in Example 4, wherein the surgical instrument includes a navigation component and the surgical guide includes a needle support disposed a selected distance from the arm and centrally disposed with the navigation component.

[00137] Example 9. A method as recited in Example 1 , wherein the surgical guide includes at least one circumferential wall that defines a needle channel.

[00138] Example 10. A method as recited in Example 1 , wherein the surgical guide includes an adapter defining a cavity for disposal of one or more components of a catheter assembly and further comprising the step of removing the surgical guide from the surgical site such that the catheter assembly remains at the surgical site.

[00139] Example 11. A method as recited in Example 10, wherein the adapter defines a lateral channel configured for passage of the catheter assembly therethrough.

[00140] Example 12. A surgical instrument comprising: a guide being connectable with a robotic arm, the robotic arm being registrable with one or more vertebra via at least one surgical navigation component and a processor, and the guide supporting movement of a surgical needle along a selected trajectory and relative to the guide such that the processor generates data for display of an image from a monitor, the image representing position of the surgical needle relative to tissue adjacent the one or more vertebra.

[00141] Example 13. A surgical instrument as recited in Example 12, further comprising a member being connectable with the arm and including a receptacle, the receptacle being configured to receive the surgical guide.

[00142] Example 14. A surgical instrument as recited in Example 12, wherein the surgical guide includes an adapter defining a cavity for disposal of one or more components of a catheter assembly and a lateral channel configured for passage of the catheter assembly therethrough.

[00143] Example 15. A surgical instrument as recited in Example 12, wherein the at least one surgical navigation component includes an emitter array including a tracker.

[00144] Example 16. A surgical instrument as recited in Example 12, wherein the guide is disposed a selected distance from the arm and centrally disposed with the at least one surgical navigation component.

[00145] Example 17. A surgical instrument as recited in Example 12, wherein the guide includes at least one circumferential wall that defines a needle channel.

[00146] Example a guide disposable with the receptacle for supporting movement of a surgical needle along a selected trajectory and relative to the guide such that the processor generates data for display of an image from a monitor, the image representing position of the surgical needle relative to tissue adjacent the one or more vertebra.

[00147] Example 19. A surgical instrument as recited in Example 18, wherein the at least one surgical navigation component includes an emitter array including a tracker.

[00148] Example 20. A surgical instrument as recited in Example 18, wherein the receptacle is configured to receive one or more alternate adapters.

[00149] Example 21. A surgical instrument (12) comprising: a guide (16) being connectable with a robotic arm (20), the robotic arm being registrable with one or more vertebra via at least one surgical navigation component (NC) and a processor (CPN), and the guide supporting movement of a surgical needle (14) along a selected trajectory and relative to the guide such that the processor generates data for display of an image from a monitor (M), the image representing position of the surgical needle relative to tissue adjacent the one or more vertebra.

[00150] Example 22. A surgical instrument as recited in Example 21 , further comprising a member (18) being connectable with the arm and including a receptacle (28), the receptacle being configured to receive the surgical guide.

[00151] Example 23. A surgical instrument as recited in any of Example 21 or 22, wherein the surgical guide includes an adapter defining a cavity for disposal of one or more components of a catheter assembly (502, 702) and a lateral channel (431 , 631 ) configured for passage of the catheter assembly therethrough.

[00152] Example 24. A surgical instrument as recited in any of Examples 21 , 22 or 23, wherein the at least one surgical navigation component includes an emitter array including a tracker (116).

[00153] Example 25. A surgical instrument as recited in any of Examples 21 , 22, 23 or 24, wherein the guide is disposed a selected distance from the arm and centrally disposed with the at least one surgical navigation component.

[00154] Example 26. A surgical instrument as recited in any of Examples 21 , 22, 23, 24 or 25, wherein the guide includes at least one circumferential wall (22) that defines a needle channel (24).

[00155] Example 27. A surgical instrument (12) comprising: a member (18) including a wall (26) connectable with a robotic arm (20) and a base (27) having a receptacle (28), the robotic arm being registrable with one or more vertebra via at least one surgical navigation component (NC) and a processor (CPN), and a guide (16) disposable with the receptacle for supporting movement of a surgical needle (14) along a selected trajectory and relative to the guide such that the processor generates data for display of an image from a monitor (M), the image representing position of the surgical needle relative to tissue adjacent the one or more vertebra.

[00156] Example 28. A surgical instrument as recited in Example 27, wherein the at least one surgical navigation component includes an emitter array including a tracker (116).

[00157] Example 29. A surgical instrument as recited in any of Example 27 or 28, wherein the receptacle is configured to receive one or more alternate adapters.

Claims

WHAT IS CLAIMED IS:

1. A surgical instrument (12) comprising: a guide (16) being connectable with a robotic arm (20), the robotic arm being registrable with one or more vertebra via at least one surgical navigation component (NC) and a processor (CPN), and the guide supporting movement of a surgical needle (14) along a selected trajectory and relative to the guide such that the processor generates data for display of an image from a monitor (M), the image representing position of the surgical needle relative to tissue adjacent the one or more vertebra.

2. A surgical instrument as recited in Claim 1 , further comprising a member (18) being connectable with the arm and including a receptacle (28), the receptacle being configured to receive the surgical guide.

3. A surgical instrument as recited in any of Claims 1 or 2, wherein the surgical guide includes an adapter defining a cavity for disposal of one or more components of a catheter assembly (502, 702) and a lateral channel (431 , 631) configured for passage of the catheter assembly therethrough.

4. A surgical instrument as recited in any of Claims 1 , 2 or 3, wherein the at least one surgical navigation component includes an emitter array including a tracker (116).

5. A surgical instrument as recited in any of Claims 1 , 2, 3 or 4, wherein the guide is disposed a selected distance from the arm and centrally disposed with the at least one surgical navigation component.

6. A surgical instrument as recited in any of Claims 1 , 2, 3, 4 or 5, wherein the guide includes at least one circumferential wall (22) that defines a needle channel (24).

7. A surgical instrument (12) comprising: a member (18) including a wall (26) connectable with a robotic arm (20) and a base (27) having a receptacle (28), the robotic arm being registrable with one or more vertebra via at least one surgical navigation component (NC) and a processor (CPN), and a guide (16) disposable with the receptacle for supporting movement of a surgical needle (14) along a selected trajectory and relative to the guide such that the processor generates data for display of an image from a monitor (M), the image representing position of the surgical needle relative to tissue adjacent the one or more vertebra.

8. A surgical instrument as recited in Claim 7, wherein the at least one surgical navigation component includes an emitter array including a tracker (116).

9. A surgical instrument as recited in any of Claims 7 or 8, wherein the receptacle is configured to receive one or more alternate adapters.