Patent Publication Number: US-2021161609-A1

Title: Surgical system and method

Description:
TECHNICAL FIELD 
     The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system and a method for treating a spine. 
     BACKGROUND 
     Spinal pathologies and disorders such as scoliosis, kyphosis and other curvature abnormalities, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, tumor and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility. 
     Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics. As part of these surgical treatments, spinal constructs such as vertebral rods are often used to provide stability to a treated region. Rods redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support vertebral members. During surgical treatment, one or more rods and bone fasteners can be delivered to a surgical site. The rods may be attached via the fasteners to the exterior of two or more vertebral members. Setscrews can be used to secure the rods with the fasteners. However, the connection force and continued integrity of the connection between the rods and the fasteners can be challenging to monitor during and after implantation. In addition, it is difficult to monitor that a proper or acceptable force is maintained between the setscrews and the rods. This disclosure describes an improvement over these prior technologies. 
     SUMMARY 
     In one embodiment, a spinal construct is provided. The spinal construct includes a first member. The first member comprises a first thread form and an implant cavity configured for disposal of a spinal implant. A second member is engageable with the spinal implant. The second member comprises a second thread form configured for engagement with the first thread form. A gauge is coupled to the second member. The gauge is configured to measure a force between the second member and the spinal implant when the second member is engaged with the first member. The second thread form is timed and/or clocked with the first thread form to position the gauge in a selected orientation relative to the spinal implant. 
     In one embodiment, a surgical method is provided that includes: coupling a first member to tissue; positioning a spinal implant in an implant cavity of the first member; and engaging a first thread form of the first member with a second thread form of a second member such that the second member applies a force to the spinal implant, wherein the second member comprises a gauge, and wherein the second thread form is timed and/or clocked with the first thread form to position the gauge in a selected orientation relative to the spinal implant. 
     In one embodiment, a spinal construct is provided. The spinal construct includes a bone screw. The bone screw comprises a pair of arms. The arms define a U-shaped implant cavity configured for disposal of a spinal rod. Inner surfaces of the arms define a first thread form. A setscrew is engageable with the spinal rod. The setscrew comprises an inner surface and an outer surface. The inner surface of the setscrew defines a socket. The outer surface defines a second thread form configured for engagement with the first thread form. A gauge is positioned within the socket. The gauge is configured to measure a force between the setscrew and the spinal rod when the setscrew is engaged with the bone screw. The second thread form is timed and/or clocked with the first thread form to position the gauge in a selected orientation relative to the spinal rod. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which: 
         FIG. 1  is a side view of components of one embodiment of a surgical system, in accordance with the principles of the present disclosure; 
         FIG. 2  is a top view of components of the system shown in  FIG. 1 ; 
         FIG. 3  is a perspective view of one embodiment of a first component of the system shown in  FIG. 1 , in accordance with the principles of the present disclosure; 
         FIG. 4  is a side view of one embodiment of a second component of the system shown in  FIG. 1 , in accordance with the principles of the present disclosure; 
         FIG. 5  is a side, cross-sectional view of the component shown in  FIG. 4  taken along lines A-A in  FIG. 4 ; 
         FIG. 6  is a top view of the second component shown in  FIG. 4  and one embodiment of a third component of the system shown in  FIG. 1 , in accordance with the principles of the present disclosure; 
         FIG. 7  is a top view of the second component shown in  FIG. 4  and one embodiment of the third component of the system shown in  FIG. 1 , in accordance with the principles of the present disclosure; 
         FIG. 8  is a top view of the second component shown in  FIG. 4  and one embodiment of the third component of the system shown in  FIG. 1 , in accordance with the principles of the present disclosure; 
         FIG. 9  is a perspective view of one embodiment of the third component of the system shown in  FIG. 1 , one embodiment of a fourth component of the system shown in  FIG. 1 , one embodiment of a fifth component of the system shown in  FIG. 1 , one embodiment of a sixth component of the system shown in  FIG. 1 , and one embodiment of a seventh component of the system shown in  FIG. 1 , in accordance with the principles of the present disclosure; 
         FIG. 10  is a side view of the second component shown in  FIG. 4 , the third component shown in  FIG. 9 , the fourth component shown in  FIG. 9 , the fifth component shown in  FIG. 9 , the sixth component shown in  FIG. 9 , and the seventh component shown in  FIG. 9 ; 
         FIG. 11  is a side view of the second component shown in  FIG. 4 , the third component shown in  FIG. 9 , one embodiment of the fourth component shown in  FIG. 9  in accordance with the principles of the present disclosure, the fifth component shown in  FIG. 9 , the sixth component shown in  FIG. 9 , and the seventh component shown in  FIG. 9 ; and 
         FIG. 12  is a top view of the second component shown in  FIG. 4 , the third component shown in  FIG. 9 , the fourth component shown in  FIG. 9 , the fifth component shown in  FIG. 9 , the sixth component shown in  FIG. 9 , and the seventh component shown in  FIG. 9 . 
     
    
    
     DETAILED DESCRIPTION 
     The exemplary embodiments of the surgical system and related methods of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system and a method for treating a spine. In some embodiments, the systems and methods of the present disclosure comprise medical devices including surgical instruments and implants that are employed with a surgical treatment, as described herein, for example, with a cervical, thoracic, lumbar and/or sacral region of a spine. 
     In some embodiments, the present surgical system comprises the ability to collect data from a fixation implant to allow surgeons to monitor the implant status and/or fusion state. In some embodiments, gauge s, such as, for example, strain gauges, are placed on the implants to collect and transmit data intra-operatively and post-operatively. The gauge s can detect loading conditions of the implanted construct. The orientation of the gauge is controlled to avoid variable loading detection. 
     In some embodiments, the implant construct contains a pedicle screw, rod, and setscrew. The setscrew contains gauge s, such as, for example, strain gauges, which detect loading. The thread on the setscrew and pedicle screw are timed and/or clocked to allow consistent orientation once the setscrew is locked. Gauges are mounted in a controlled orientation with respect to the start of the setscrew thread. This allows orientation of the gauge s to be controlled with respect to the rod. It is envisioned that the number and configuration of gauge s may vary, as discussed herein. 
     In some embodiments, the present surgical system allows loading data to be captured from an implant. The control of the orientation ensures reproducibility in the measurements. In some embodiments, gauge orientation is controlled with respect to the thread start of the setscrew. In some embodiments, the thread start of the setscrew defines a controlled dimension of the setscrew. In some embodiments, the setscrew includes an inner surface that defines a socket, the gauge being applied to the inner surface. In some embodiments, the gauge orientation is controlled such that the gauge orientation is inline with an orientation of a rod. In some embodiments, the gauge orientation is controlled such that the gauge orientation is transverse to the orientation of a rod. In some embodiments, the gauge orientation is controlled such that the gauge orientation is non-parallel (e.g., at an acute angle) relative the orientation of a rod. In some embodiments, the system includes a tulip head having threads that are timed and/or clocked to a rod slot of the tulip. 
     In some embodiments, the surgical system of the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. In some embodiments, the surgical system of the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. In some embodiments, the disclosed surgical system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The surgical system of the present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The surgical system of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration. 
     The surgical system of the present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. In some embodiments, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references “upper” and “lower” are relative and used only in the context to the other, and are not necessarily “superior” and “inferior”. 
     As used in the specification and including the appended claims, “treating” or “treatment” of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (human, normal or otherwise or other mammal), employing implantable devices, and/or employing instruments that treat the disease, such as, for example, microdiscectomy instruments used to remove portions bulging or herniated discs and/or bone spurs, in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment can include reducing acute or chronic inflammation; alleviating pain and mitigating and inducing re-growth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. In some embodiments, as used in the specification and including the appended claims, the term “tissue” includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise. 
     The following discussion includes a description of a surgical system including a surgical instrument, implants, related components and methods of employing the surgical system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to  FIGS. 1-12 , there are illustrated components of a surgical system, such as, for example, a surgical system  20 . 
     The components of surgical system  20  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  20 , individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO 4  polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations. 
     Various components of surgical system  20  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  20 , 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  20  may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein. 
     Surgical system  20  is employed, for example, with a fully open surgical procedure, a minimally invasive procedure including percutaneous techniques, and mini-open surgical techniques to deliver and introduce instrumentation and/or one or more spinal implants, such as, for example, one or more components of a bone fastener, at a surgical site of a patient, which includes, for example, a spine. In some embodiments, the spinal implant can include one or more components of one or more spinal constructs, such as, for example, interbody devices, interbody cages, bone fasteners, spinal rods, tethers, connectors, plates and/or bone graft, and can be employed with various surgical procedures including surgical treatment of a cervical, thoracic, lumbar and/or sacral region of a spine. 
     Surgical system  20  includes a first member, such as, for example, a bone screw  22  including a head, such as, for example, a tulip head  24  and a shaft  26  configured to be connected with head  36 , as discussed herein. Head  24  includes a pair of spaced-apart arms  28 ,  30 . Arm  28  includes an inner surface  32  and arm  30  includes an inner surface  34 . Surfaces  32 ,  34  define a U-shaped passageway, such as, for example, an implant cavity  36 . Cavity  36  is configured for disposal of a spinal implant, such as, for example, a spinal rod  38 . In some embodiments, all or only a portion of cavity  36  may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered. In some embodiments, arms  28 ,  30  may be disposed at alternate orientations, relative to a longitudinal axis of screw  22 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. Arm  28  includes a thread  40  and arm  30  includes a thread  42  that faces thread  40 . Threads  40 ,  42  define a first thread form  44  configured for engagement with a thread form of a second member, such as, for example, a setscrew  46  to fix rod  38  relative to head  24 , as discussed herein. In some embodiments, setscrew  46  can be made, sold, or provided with independently from one or both of screw  22  and rod  38 . 
     Shaft  26  has a cylindrical cross-sectional configuration and includes an outer surface having an external thread form  48 . In some embodiments, thread form  48  may include a single thread or a plurality of discrete threads. In some embodiments, other engaging structures may be located on shaft  26 , such as, for example, a nail configuration, barbs, expanding elements, raised elements and/or spikes to facilitate engagement of shaft  26  with tissue. 
     In some embodiments, all or only a portion of shaft  26  may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable and/or tapered. In some embodiments, the outer surface of shaft  26  may include one or a plurality of openings. In some embodiments, all or only a portion of the outer surface of shaft  26  may have alternate surface configurations to enhance fixation with tissue, such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. In some embodiments, all or only a portion of shaft  26  may be disposed at alternate orientations, relative to its longitudinal axis, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, all or only a portion of shaft  26  may be cannulated. 
     Setscrew  46  comprises an upper portion  50  and a lower portion  52 . Portion  52  includes a second thread form  54  that extends outwardly from an outer circumferential surface of portion  52 . Thread form  54  is configured to mate with thread form  44  to fix rod  38  relative to head  24 , as discussed herein. Portion  50  has a length and width that is configured to facilitate manipulation of setscrew  46 . A bottom tip  56  is formed on a bottom end  58  of setscrew  46  and is located centrally on bottom end  58  so as to extend outward along a central longitudinal axis X of rotation of setscrew  46 . Setscrew  46  is configured to exert a compression or clamping force onto rod  38  through tip  56 . In particular, tip  56  impinges on rod  38  and may, in some embodiments, form a dimple or depression in rod  38 . In some embodiments, tip  56  is substantially dome shaped with a surface that is convex or rounded so that a small surface area is in contact with rod  38  providing a strong grip when pressed against rod  38 . Alternatively, in some embodiments, tip  56  could be of various shaped points including flat, cone, cup, dog, or knurled. In some embodiments, portion  50  has a hexagonal external cross-section and round internal cross-section. In some embodiments, the internal cross-section of portion  50  and/or the external cross-section of portion  50  can be variously shaped, such as, for example, circular, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable and/or tapered. 
     In some embodiments, an inner surface  60  of setscrew  46  defines a hollow bore, such as, for example, a socket  62  in the body of setscrew  46 . Socket  62  extends from an opening in portion  50  and, in various embodiments, into at least a section of portion  52 . The section of socket  62  extending into portion  52  comprises a driving recess  64  for assisting in the removal by internal wrenching of portion  52  after portion  50  has been broken away at a frangible portion  66 , as discussed herein. In some embodiments, recess  64  has a shape that can be a hexagon, hexalobular, clutch, fluted, frearson, slotted, star, Torx, reverse thread, Pozidriv, or Phillips. 
     Portion  66  is an area of reduced wall thickness and can have a cross-section in the form of a notch creating a weakened zone. Portion  50  can have at least one flat surface  68  for the application of torque to setscrew  46 . In some embodiments, surface  68  is on the exterior of portion  50 . Portion  66  connects portion  50  and portion  52 . Portion  66  is easily or readily ruptured, separated or broken when a pre-selected torque or force is applied. When portion  50  is removed, portion  52  remains as shown in  FIGS. 10 and 11 . An exemplary description of a setscrew having such a frangible portion is disclosed in U.S. Pat. No. 6,179,841 and U.S. patent application Ser. No. 12/609,728, which are each incorporated herein by reference, in their entireties. 
     System  20  includes one or a plurality of gauges, such as, for example, strain gauges  70  that is/are coupled to setscrew  46  to measure a force between setscrew  46  and rod  38  when setscrew  46  is engaged with head  24 , as discussed herein. That is, thread form  54  is configured to engage thread form  44  to translate setscrew  46  relative to head  24  until setscrew  46  directly engages rod  38  within cavity  36  to fix rod  38  relative to head  24 . Gauges  70  may each include one or more gauge s or gauge nodes that measure strain, force, resistance, load and or the like. References in the present specification to a gauge or sensor thereby disclose embodiments in which multiple gauges or sensors, respectively are used, and when multiple gauges/sensors are referenced in the present specification, various embodiments also include a single gauge or sensor. Gauges  70  measure the amount of force setscrew  46  exerts on rod  38 , which are indicative of loading conditions of rod  38 . For example, setscrew  46  may exert a first amount of force on rod  38  when system  20  is initially implanted within a patient. However, the amount of force setscrew  46  exerts on rod  38  may decrease over time for a variety of reasons. Such a decrease in the amount of force setscrew  46  exerts on rod  38  may indicate increased fusion of adjacent vertebrae, for example. Indeed, because the load on rod  38  is gradually transferred to bone as bone graft (e.g., autograft) heals, the load on the rod decreases over time. 
     As discussed herein, strain data from gauges  70  can provide an in vivo assessment of the bony incorporation of an autograft, for example, and thus the fusion of the autograft and vertebrae. For example, an expected pattern of strain detected by gauges  70  will initially involve large axial forces that will decrease over time as components of system  20 , such as, for example, rod  38 , share more of the load with the vertebrae that are being fused by the autograft. If the data from gauges  70  follows or deviates from the expected patterns, conclusions can be drawn about progress of the fusion between the autograft and the vertebrae. System  20  thus provides the ability to continuously, or on-demand, monitor fusion progress and biomechanical performance during the post-operative period by assessing strain data from gauges  70 . Indeed, strain readings from gauges  70  may be used to develop an accurate, early assessment of the fracture healing rate and the potential for not uniting. An early diagnosis of delayed union is advantageous because it allows the surgeon to take remedial steps as soon as a possible non-union is suspected, thus prompting intervention. Because of this ability to continuously or on-demand monitor fusion progress and biomechanical performance, it may be possible to appropriately time, or even avoid, additional surgery. Further, information gathered from such in vivo assessments can lead to improvements in surgical techniques and spinal implant design. 
     Gauges  70  may be selectively positioned on setscrew  46  to measure a force between setscrew  46  and rod  38  when setscrew  46  is engaged with head  24 . In some embodiments, gauges  70  are positioned in socket  62 . In some embodiments, gauges  70  are positioned in recess  64 . In some embodiments, gauges  70  directly engage a surface  72  of setscrew  46  that defines a groove  74  that is distal to recess  64 , as shown in  FIG. 5 . Positioning gauges  70  in groove  74  prevents a bit of a driving tool from directly engaging gauges  70  when the bit is positioned in recess  64  so as not to deform or otherwise compromise gauges  70 . 
     In some embodiments, gauges  70  are aligned linearly on setscrew  46 . For example, in one embodiment, shown in  FIG. 6 , setscrew  46  includes a first gauge  70   a , a second gauge  70   b , a third gauge  70   c  and a fourth gauge  70   d  that are aligned along a transverse axis X 1 . It is envisioned that gauges  70  may also be positioned radially about setscrew  46 . For example, in one embodiment, shown in  FIG. 7 , setscrew  46  includes a first gauge  70   a , a second gauge  70   b , a third gauge  70   c  and a fourth gauge  70   d , wherein gauges  70   a ,  70   b ,  70   c ,  70   d  form a radial pattern, with gauges  70   a ,  70   b ,  70   c ,  70   d  each positioned 90 degrees from an adjacent one of gauges  70   a ,  70   b ,  70   c ,  70   d . In one embodiment, shown in  FIG. 8 , setscrew  46  includes a first gauge  70   a , a second gauge  70   b  and a third gauge  70   c , wherein gauges  70   a ,  70   b ,  70   c  form a radial pattern, with gauges  70   a ,  70   b ,  70   c  each positioned 120 degrees from an adjacent one of gauges  70   a ,  70   b ,  70   c . One angle indication in  FIG. 8  shows the 120 degree relationship between adjacent gauges  70  and another angle indication in  FIG. 8  shows an angle between one of gauges  70  and a vertical axis. In some embodiments, gauges  70   a ,  70   b ,  70   c ,  70   d  each include the same type of strain gauge. In some embodiments, at least one of gauges  70   a ,  70   b ,  70   c ,  70   d  is different than at least one other of gauges  70   a ,  70   b ,  70   c ,  70   d . For example, in one embodiment, gauges  70   a ,  70   d  are radial strain gauges and gauges  70   b ,  70   c  are circumferential strain gauges. In some embodiments, two of gauges  70   a ,  70   b ,  70   c ,  70   d  are positioned in a radial direction and two of gauges  70   a ,  70   b ,  70   c ,  70   d  are positioned in a tangential direction. That is, two of gauges  70   a ,  70   b ,  70   c ,  70   d  are oriented about a radius of setscrew  46  and two of gauges  70   a ,  70   b ,  70   c ,  70   d  are positioned along a tangential line of setscrew  46 . 
     Further regarding position of gauge(s)  70 , there are benefits to controlling orientation of gauges  70 . Doing so can result in more-accurate loading data. For example, in some embodiments, the orientation of gauges  70  must have a direct relationship to rod  38  when rod  38  is positioned in cavity  36 . In one embodiment, the orientation of gauges  70  must be inline with rod  38  when rod  38  is positioned in cavity  36 , as shown in  FIG. 2 . In one embodiment, the orientation of gauges  70  must be transverse to rod  38  when rod  38  is positioned in cavity  36 . In one embodiment, the orientation of gauges  70  must be at an acute angle relative to rod  38  when rod  38  is positioned in cavity  36 . 
     In order to position gauges  70  at a selected orientation relative to rod  38 , thread form  54  is timed and/or clocked with thread form  44  such that gauges  70  will be positioned at the selected orientation relative to rod  38  when thread form  54  is fully threaded with thread form  44 . In some embodiments, the timing and/or clocking of thread form  54  with thread form  44  is determined by the positioning of a start  76  of thread form  54  located at distal end  77 . As shown in  FIG. 4 , distal end  77  includes height H that is a controlled dimension used to define the position and/or orientation of start  76 . Start  76  is selectively positioned along thread form  54  such that gauges  70  will be positioned at the selected orientation relative to rod  38  when thread form  54  is fully threaded with thread form  44 . In some embodiments, setscrew  46  is prevented from being rotated relative to head  24  in a rotational direction, such as, for example, clockwise, when thread form  54  is fully threaded with thread form  44 . In some embodiments, start  76  is selectively positioned along thread form  54  such that gauges  70  will be positioned at the selected orientation relative to rod  38  when thread form  54  is fully tightened with thread form  44 . In some embodiments, start  76  is selectively positioned along thread form  54  such that gauges  70  will be positioned at the selected orientation relative to rod  38  when setscrew  46  is prevented from translating axially in one direction relative to head  24  by rod  38 . That is, gauges  70  will be positioned at the selected orientation relative to rod  38  when tip  56  first engages rod  38  such that rod  38  is fixed relative to head  24 . 
     In some embodiments, system  20  includes one or more components that allow gauges  70  to send and/or analyze the measurements from gauges  70  relating to force between setscrew  46  and rod  38 . For example, in one embodiment, shown in  FIGS. 9-12 , a load-sensing assembly  78  includes an antenna  80 , such as a radio frequency identification (RFID) coil, a near field-communication (NFC) antenna or other short-range communication transmitter and/or receiver. In some embodiments, assembly  78  includes one or more integrated circuits  82  such as, for example, an RFID chip or an NFC chip. In some embodiments, assembly  78  includes one or more electronics components  84  and gauges  70 . In some embodiments, assembly  78  is the same or similar to the load sensing assembly disclosed in U.S. Ser. No. 16/039,592, which is expressly incorporated herein by reference, in its entirety. 
     In some embodiments, electronics components  84  include a flexible electronics component, such as, for example, a flex circuit or one or more electrical circuits. In some embodiments, antenna  80  may be operably connected to electronics component  84  via a connecting member  86 . For example, as shown in  FIG. 9 , member  86  may be connected to both antenna  80  and electronics component  84 . In some embodiments, member  86  is positioned perpendicularly to both antenna  80  and electronics component  84 . In some embodiments, member  86  and antenna  80  may be constructed integrally or may be separately constructed and attached together in any suitable manner, such as for example by adhesive, chemical, mechanical or cement bonding. In some embodiments, member  86  and electronics component  84  may be constructed integrally or may be separately constructed and attached together in any suitable manner, such as for example by adhesive, chemical, mechanical or cement bonding. 
     In some embodiments, circuit  82  is operably connected to electronics component  84 . As shown in  FIG. 9 , electronics component  84  may have a top surface  88  and a bottom surface  90 . Circuit  82  may be positioned on surface  88  of electronics component  84 , and may be connected to surface  88  in any suitable manner, including, for example, adhesive, chemical, mechanical or cement bonding. Circuit  82  may include a memory  82   a  according to an embodiment. Memory  82   a  may be used to store various information. For example, one or more measurements of one or more of gauges  70  may be stored in memory  82   a . In some embodiments, a unique identifier associated with assembly  78 , a component thereof, or setscrew  46  may be stored in memory  82   a . Additional and/or alternate information or types of information may be stored according to this disclosure. 
     In some embodiments, one or more of gauges  70  may be operably connected, for example by adhesive, cement, mechanical or chemical bonding, to electronics component  84 . For example, one or more of gauges  70  may be operably connected to electronics component  84  via surface  90  of electronics component  84 . One or more of gauges  70  may be connected to surface  90  of electronics component  84  in any suitable manner including, without limitation, via an adhesive bonding agent. 
     As shown in  FIG. 9 , antenna  80  may have a generally curved shape. Antenna  80  may include a first end and a second end. Antenna  80  may include an opening that extends from the first end toward the second end, as shown in  FIG. 9 . As shown in  FIG. 10 , assembly  78  may be configured to be mounted to setscrew  46 . Antenna  80  is sized to extend around setscrew  46  such that circuit  82 , electronics component  84 , gauges  70  and member  86  are positioned within socket  62 , recess  64  and/or groove  74 . Antenna  80  may circumferentially surround at least a portion of the exterior of setscrew  46 . In one embodiment, shown in  FIG. 11 , antenna  80  may be positioned at least partially inside of socket  62 . In some embodiments, gauges  70  may be connected to setscrew  46  in any suitable manner including, without limitation via an adhesive.  FIG. 12  illustrates a top view of assembly  78  mounted to setscrew  46 . 
     In various contemplated embodiments, any activity described herein can be performed by a specially configured computer, or system or network of computers. Activities can performed by the computing device or system based on any of various input, including from one or more implanted gauges and one or more of the readers or smart tools or instruments described herein. The computing device or system can process, in performing the activities, big data or other information, such as profile or historic diagnostics data, about a subject patient and/or any number of other patients or persons. Example computing activities include but are not limited to: (i) collecting, organizing, or otherwise processing data received; (ii) monitoring gauge or patient status, (iii) transmitting alerts, notifications, or data, received or processed, to any desired destination (to, e.g., patient or hospital device) for consideration or further use; (iv) determining patterns in gauge or patient changes of state, or adherence to patterns; and (v) diagnostics. 
     In various contemplated embodiments, the specially configured computer, or system or network of computers is/are configured to provide diagnostic feedback. In some embodiments, the specially configured computer, system or network of computers communicate(s) with coils located outside a patient for powering electronic components of system  20 , such as, for example, gauges  70 . In some embodiments, the specially configured computer, system or network of computers communicate(s) with electronic components that provide remote power options using telemetry, such as, for example, NFC. In some embodiments, the electronic components include a NFC power harvesting integrated circuit. In some embodiments, the electronic components include an analog front end integrated circuit. In some embodiments, the electronic components include a microprocessor integrated circuit. In some embodiments, the electronic components are configured to provide diagnostic feedback to guide and/or determine an optimum location for an external coil for powering components of system  20 , such as, for example, gauges  70 . In some embodiments, the electronic components include resonant circuits that provide an auto tuning feature to optimize communication between components of system  20 , such as, for example, gauges  70 , and the remote power source. In some cases, various factors may contribute to detuning a resonant circuit, for example, implant depth, metal in the vicinity both inside and outside a body, and/or other factors. In some embodiments, the electronic components have an auto tuning feature and/or method that includes changing a tuning capacitor value and/or shifting operating frequency+/−over a range relative to a selected frequency. In some embodiments, the external coil and associated circuitry includes an auto tuning feature to optimize communication between the electronic components and the remote power source, and/or other components of system  20 . 
     In some embodiments, the NFC device remotely communicates with a device, such as, for example, a computer that is disposed outside or external to the patient&#39;s body to transfer, transmit and/or receive data relating to gauges  70 . Gauges  70  may include diagnostic sensor electronics connected with one or more sensors. The diagnostic sensor electronics may comprise various commercially available integrated circuit devices, see, for example, but not limited to, the AD5933 Impedance Converter Network Analyzer distributed by Analog Devices. The integrated circuit device may comprise various commercially available integrated circuit devices, see, for example, but not limited to, the RF430 microcontroller distributed by Texas Instruments RF430. 
     In some embodiments, the diagnostic sensor electronics and/or the analog device gather information from gauges  70 , such as, for example, loading information, pressure information, tension information, motion information, alignment or misalignment information and/or temperature, relating to one or more components of system  20 , as described herein. The computer remotely communicates with the NFC device, as described herein, to collect data from gauges  70  via the diagnostic sensor electronics. In some embodiments, a reader communicates with the computer. The reader emits a small electric current that creates a magnetic field to bridge the physical space between the reader and gauges  70 . The electric field is received by the NFC device and converted into electrical impulses to communicate data and diagnostics, relating to gauges  70  to the computer, as described herein. 
     The diagnostic sensor electronics provides feedback and/or measure one or more diagnostic conditions. The diagnostic sensor electronics sense and transmit to the computer various diagnostic indicia, and in some embodiments, diagnose and respond to such measurements, such as, for example, in the context of a spinal implant surgery. In some embodiments, a surgeon can monitor a patient after surgery, and make adjustments to one or more components of system  20 . In some embodiments, this configuration allows one or more components of system  20  to be corrected or modified based on changes that take place subsequent to surgery, and/or for selected and remote changes to diagnostic conditions inside the patient&#39;s body. In some embodiments, the diagnostic sensor electronics indicate a fusion rate of vertebrae. In some embodiments, one or more measurements obtained by one or more of gauges  70  may be stored by circuit  82  of assembly  78 , such as, for example, in memory  82   a  of circuit  82 . Circuit  82  may be interrogated by a reader  83 . For example, an RFID chip may be read by an RFID reader. As another example, an NFC chip of circuit  82  may be read by or may otherwise communicate with an NFC reader or other NFC-enabled device. A reader may interrogate circuit  82  when in a certain proximity to circuit  82 . In some embodiments, a reader may interrogate circuit  82  after circuit  82  has been implanted into a patient within setscrew  46 . In some embodiments, circuit  82  may communicate with a reader or other electronic device without being interrogated. 
     Circuit  82  may transmit one or more measurements to the reader. This transmission may occur in response to being interrogated by the reader, or the transmission may be initiated by circuit  82 . The reader may receive the transmitted measurements, and may cause at least a portion of the measurements to be displayed to a user. For example, a physician may use a reader to interrogate an RFID chip of a patient&#39;s implant, such as, for example bone screw  22 , rod  38  or setscrew  46 . The reader may include a display, or may be in communication with a display device, which may display at least a portion of the measurements received from the RFID chip. 
     In some embodiments, circuit  82  is passive such that the chip has no internal power source and is powered by the energy transmitted from a reader. In such embodiments, circuit  82  may not transmit information until interrogated by a reader. In some embodiments, circuit  82  may be active such that the chip is battery-powered and capable of broadcasting its own signal. Active circuit  82  may transmit information in response to be interrogated by a reader, but also on its own without being interrogated. For example, active circuit  82  may broadcast a signal that contains certain information such as, for example, one or more measurements gathered by one or more of gauges  70 . Active circuit  82  may continuously broadcast a signal, or it may periodically broadcast a signal. Power may come from any number of sources, including, for example, thin film batteries with or without encapsulation or piezo electronics. 
     In some embodiments, one or more sensors of gauges  70  may transmit information by directly modulating a reflected signal, such as an RF signal. The sensors of gauges  70  may form a Wireless Passive Sensor Network (WPSN), which may utilize modulated backscattering (MB) as a communication technique. External power sources, such as, for example, an RF reader or other reader, may supply a WPSN with energy. The sensor(s) of the WPSN may transmit data by modulating the incident signal from a power source by switching its antenna impedance. 
     One or more measurements received from assembly  78  may be used to make determinations of the condition of a spinal implant and/or treatment of a spinal disorder. For instance, proper placement of rod  38  and/or setscrew  46  may result in an acceptable range of force measurements collected by gauges  70 . Measurements outside of this range may indicate a problem with the placement or positioning of rod  38  and/or setscrew  46 , such as, for example, loosening of setscrew  46 , failure or rod  38 , yield or fracture/breakage, improper torque, breakage of the bone segment or portion, the occurrence of fusion or amount of fusion, and/or the like. 
     One or more tools or instruments may include a reader which may be used to gather information from circuit  82  during or in connection with a procedure. For instance, a torque tool may be used to loosen or tighten setscrew  46 . A torque tool may include a reader, or may be in communication with a reader, such that a user of the torque tool is able to obtain, in substantially real time, one or more measurements relating to setscrew  46  and rod  38  placement that are measured by gauges  70  via the tool. For example, as a user is applying torque to setscrew  46 , the user may see one or more force measurements between setscrew  46  and rod  38  in order to determine that the positioning of setscrew  46  and/or rod  38  is correct and that the proper force is being maintained. In some embodiments, a tool or instrument may include a display device on which one or more measurements may be displayed. In some embodiments, a tool or instrument may be in communication with a display device, and may transmit one or more measurements for display on the display device via a communications network. 
     In some embodiments, an electronic device, such as a reader or an electronic device in communication with a reader, may compare one or more measurements obtained from circuit  82  to one or more acceptable value ranges. If one or more of the measurements are outside of an applicable value range, the electronic device may cause a notification to be made. For example, an electronic device may generate an alert for a user, and cause the alert to be displayed to the user via a display device. Alternatively, an electronic device may send an alert to a user such as via an email message, a text message or otherwise. 
     In some embodiments, circuit  82  may store a unique identifier associated with setscrew  46 . Circuit  82  may transmit the unique identifier to an electronic device. For example, when a reader interrogates circuit  82 , circuit  82  may transmit a unique identifier for setscrew  46  that is stored by circuit  82  to the reader. Having access to a unique identifier for setscrew  46  may help a user ascertain whether the measurements that are being obtained are associated with setscrew  46 . Also, having access to a unique identifier for setscrew  46  may help a user take inventory of one or more components. For instance, after spinal surgery, a physician or other health care professional may use a reader to confirm that all of the setscrews allocated for the procedure have been used and are positioned in a patient. 
     In assembly, operation and use, surgical system  20 , similar to the systems and methods described herein, is employed with a surgical procedure for treatment of a spinal disorder affecting a section of a spine of a patient, as discussed herein. The components of surgical system  20  are employed with a surgical procedure for treatment of a condition or injury of an affected section of the spine, such as, for example, vertebrae. 
     In use, to treat a selected section of vertebrae, a medical practitioner obtains access to a surgical site in any appropriate manner, such as through incision and retraction of tissues. In some embodiments, surgical system  20  can be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby vertebrae are accessed through a mini-incision, or sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, the particular surgical procedure can be performed for treating the spine disorder. 
     An incision is made in the body of a patient and a cutting instrument creates a surgical pathway for implantation of components of surgical system  20 . A preparation instrument can be employed to prepare tissue surfaces of vertebrae as well as for aspiration and irrigation of a surgical region. A pilot hole is made in a vertebra for receiving shaft  26 . Shaft  26  is positioned in the pilot hole and is rotated relative to the vertebra using a driver, for example, such that thread form  48  directly engages tissue to drive shaft  26  into to the vertebra. Shaft  26  may be driven into the vertebrae a selected amount to fix shaft  26  relative to the vertebra. Once shaft  26  is sufficiently fixed relative to the vertebra, head  24  is connected with shaft  26 . In some embodiments, head  24  is configured to snap onto shaft  26  to prevent head  24  from unintentionally being removed from shaft  26 . A spinal construct, such as, for example, rod  38  is inserted into cavity  36 . Once rod  38  is positioned in cavity  36 , thread form  54  is aligned with thread form  44  and setscrew  46  is rotated relative to head  24  in a rotational direction, such as, for example, clockwise such that thread form  54  engages thread form  44 . Further rotation of setscrew  46  relative to head  24  causes setscrew  46  to translate relative to head  24  such that tip  56  moves toward rod  38 . Setscrew  46  is rotated relative to head  24  until tip  56  directly engages rod  38  and/or thread form  54  is fully threaded with thread form  44 . Because thread form  54  is timed and/or clocked with thread form  44  to position gauges  70  at a selected orientation relative to rod  38  when rod  38  is positioned in cavity  36 , gauges  70  will be positioned at the selected orientation relative to rod  38  when tip  56  directly engages rod  38  and/or thread form  54  is fully threaded with thread form  44 . 
     One or more measurements obtained by gauges  70  are stored by circuit  82  of assembly  78 , such as, for example, in memory  82   a  of circuit  82 . In some embodiments, circuit  82  is interrogated by a reader to transmit the measurements obtained by gauges  70  to the reader. For example, an RFID chip of circuit  82  may be read by an external RFID reader. Alternatively, an NFC chip of circuit  82  may be read or otherwise communicate with an external NFC reader or other NFC-enabled device. In some embodiments, the reader interrogates circuit  82  when the reader is within a certain distance of circuit  82  to transmit the measurements obtained by gauges  70  to the reader. In some embodiments, circuit  82  may to transmit the measurements obtained by gauges  70  to the reader without the reader being interrogated. The reader can cause one or more of the measurements obtained by gauges  70  to be displayed on the reader itself or a separate display, such as, for example, a computer monitor. 
     The measurements obtained by gauges  70  are displayed to provide an in vivo assessment of the bony incorporation of an autograft, for example, and thus the fusion of the autograft and vertebrae. In some embodiments, the measurements obtained by gauges  70  are compared with an expected pattern of strain. If the data from gauges  70  follows or deviates from the expected patterns, conclusions can be drawn about progress of the fusion between the autograft and the vertebrae. In some embodiments, a surgeon may perform one or more procedures to improve the fusion between the autograft and the vertebrae, based on the in vivo assessment. In that gauges  70  may be configured to continuously provide measurements that can be read and displayed, system  20  thus provides the ability to continuously, or on-demand, monitor fusion progress and biomechanical performance during the post-operative period by assessing strain data from gauges  70 . Indeed, strain readings from gauges  70  may be used to develop an accurate, early assessment of the fracture healing rate and the potential for not uniting. An early diagnosis of delayed union is advantageous because it allows the surgeon to take remedial steps as soon as a possible non-union is suspected, thus prompting intervention. Because of this ability to continuously or on-demand monitor fusion progress and biomechanical performance, it may be possible to appropriately time, or even avoid, additional surgery. 
     Upon completion of a procedure, as described herein, the surgical instruments, assemblies and non-implanted components of surgical system  20  are removed and the incision(s) are closed. One or more of the components of surgical system  20  can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, surgical system  20  may include one or a plurality of spinal rods, plates, connectors and/or bone fasteners for use with a single vertebral level or a plurality of vertebral levels. 
     In some embodiments, one or more bone screws, as described herein, may be engaged with tissue in various orientations, such as, for example, series, parallel, offset, staggered and/or alternate vertebral levels. In some embodiments, one or more of the bone screws may comprise multi-axial screws, sagittal adjusting screws, pedicle screws, mono-axial screws, uni-planar screws, facet screws, fixed screws, tissue penetrating screws, conventional screws, expanding screws, wedges, anchors, buttons, clips, snaps, friction fittings, compressive fittings, expanding rivets, staples, nails, adhesives, posts, fixation plates and/or posts. 
     In one embodiment, surgical system  20  includes an agent, which may be disposed, packed, coated or layered within, on or about the components and/or surfaces of surgical system  20 . In some embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the components and/or surfaces of surgical system  20  with vertebrae. In some embodiments, the agent may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration. 
     It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.