Spinal implant system and method

Abstract

A surgical instrument includes an outer sleeve including an inner surface defining a cavity. An inner shaft is fixed with the outer sleeve and extends within the cavity. The inner shaft includes a driver engageable in a torque interface with a first mating surface of a bone fastener. An inner sleeve is disposed between the inner shaft and the outer sleeve. The inner sleeve is axially fixed and rotatable relative to the outer sleeve. The inner sleeve includes an element connectable in a connection interface with a second mating surface of the bone fastener. Systems, spinal implants, and methods are disclosed.

Description

Technical Field

[0001] This disclosure generally relates to medical devices for treating musculoskeletal disorders, and more particularly to surgical systems and methods for treating the sacroiliac joint. Background Technology

[0002] The sacroiliac joint is a movable joint that connects the sacrum to the ilium of the pelvis. Within the sacroiliac joint, hyaline cartilage on the surface of the sacrum moves against the fibrocartilage on the surface of the ilium. The spine is configured such that the weight of the upper body rests on the sacroiliac joint at the junction of the sacrum and ilium. The stress placed on the sacroiliac joint in an upright position makes the lower back susceptible to injury.

[0003] Sacroiliac joint disorders can cause lower back and radiating pain in patients with degenerative changes and laxity of the sacroiliac joint. In some cases, the sacroiliac joint may become dehydrated and unstable, similar to other cartilaginous joints, which can lead to significant pain. The sacroiliac joint is also prone to trauma and degenerative changes due to fractures and instability. It is estimated that sacroiliac joint disorders are a source of pain for millions of people suffering from back and nerve root symptoms.

[0004] Non-surgical treatments, such as medication, injections, mobilization, rehabilitation training, and exercise, may be effective; however, they may not relieve the symptoms associated with these conditions. Surgical treatment for these conditions may include the use of implants for fusion and / or fixation to provide stability to the treatment area. During surgical treatment, surgical instruments may be used to deliver the implant to the surgical site for fixation with the bone to immobilize the joint. This disclosure describes improvements to these prior art techniques. Summary of the Invention

[0005] In one embodiment, a surgical instrument is provided. The surgical instrument includes an outer cannula with an inner surface defining a cavity. An inner shaft is fixed to the outer cannula and extends within the cavity. The inner shaft includes a actuator engageable in a torque interface with a first mating surface of a bone fastener. An inner sleeve is disposed between the inner shaft and the outer cannula. The inner sleeve is axially fixed and rotatable relative to the outer cannula. The inner sleeve includes elements connectable in a connection interface with a second mating surface of the bone fastener. In some embodiments, systems, spinal implants, and methods are disclosed.

[0006] In one embodiment, the surgical instrument includes an outer cannula with an inner surface defining an axial cavity. An inner shaft is fixed to the outer cannula and extends within the cavity. The inner shaft includes an internal hexagonal drive tip engageable in a torque interface with an internal hexagonal socket of a bone fastener. The inner cannula is disposed between the inner shaft and the outer cannula in a relatively coaxial orientation. The inner cannula is axially fixed and rotatable relative to the outer cannula. The inner cannula includes a proximal end having a rotatable actuator; and a threaded tip engageable in a connection interface with an internally threaded surface of the bone fastener.

[0007] In one embodiment, a spinal implant system is provided. The spinal implant system includes a surgical instrument comprising an outer sheath, an inner shaft fixed to the outer sheath, and an inner sleeve. The inner shaft includes a driver, and the inner sleeve is rotatable relative to the outer sheath and includes an element. A sacroiliac screw has an inner surface and an external threaded surface. The inner surface includes a socket engaging with the driver in a torque interface and an internally threaded surface engaging with the element in a connection interface. A guiding member includes an inner surface defining a cavity configured to accommodate the outer sheath; and an image guide oriented relative to a sensor to transmit a signal representing the position of the guiding member. Attached Figure Description

[0008] This disclosure will become more readily apparent from the detailed description accompanying the following drawings, in which:

[0009] Figure 1 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0010] Figure 2 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure, wherein the parts are separated;

[0011] Figure 3 yes Figure 2 A perspective view of the components shown;

[0012] Figure 4 yes Figure 3 A side view of the component shown;

[0013] Figure 5 yes Figure 4 Cross-sectional view of the component shown;

[0014] Figure 6 yes Figure 5 Separate view of the components shown;

[0015] Figure 7 yes Figure 3A perspective view of the components shown, in which the parts are separated;

[0016] Figure 8 yes Figure 7 A detached perspective view of the components of the system shown;

[0017] Figure 9 yes Figure 8 A perspective view of the components shown;

[0018] Figure 10 yes Figure 7 A perspective view of the components of the system shown;

[0019] Figure 11 yes Figure 10 A perspective view of the components shown;

[0020] Figure 12 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0021] Figure 13 yes Figure 12 A perspective view of the components shown;

[0022] Figure 14 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0023] Figure 15 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0024] Figure 16 This is a side view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0025] Figure 17 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0026] Figure 18 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0027] Figure 19 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure; and

[0028] Figure 20 It is set up in conjunction with the patient's anatomical structure. Figure 18 The system components shown are depicted in a perspective view with dashed lines. Detailed Implementation

[0029] Exemplary embodiments of the disclosed surgical systems and related methods of use are discussed based on medical devices for treating musculoskeletal disorders, and more specifically, on spinal implant systems and methods for treating the spine. In some embodiments, the systems and methods of this disclosure include medical devices comprising surgical instruments and implants for surgical treatment, for example, of the cervical, thoracic, lumbar, and / or sacral regions, as described herein. In some embodiments, the disclosed surgical systems and methods provide stability and maintain structural integrity while reducing stress on the sacroiliac (SI) joint. In some embodiments, this disclosure can be used to treat musculoskeletal disorders, including SI dysfunction or syndrome, dehydration, instability, and / or laxity.

[0030] In some embodiments, the surgical system includes a surgical instrument comprising a screwdriver capable of engaging an SI implant having a fully threaded and hollow body. In some embodiments, the SI implant includes a fenestrated body to enhance SI arthrodesis. In some embodiments, the screwdriver includes an outer sleeve and an inner shaft configured as drive and guide components. In some embodiments, the screwdriver includes an inner sleeve configured with a screw to hold a bone fastener to the screwdriver. In some embodiments, the inner shaft, inner sleeve, and outer sleeve are coaxial to facilitate axial translation of the inner sleeve. In some embodiments, the screwdriver includes a non-axially translatable inner sleeve and a knob. In some embodiments, the screwdriver includes a tapered tip to allow the SI implant to penetrate deeper into the bone.

[0031] In some embodiments, the surgical system includes a surgical instrument comprising an SI implant screwdriver that can be guided through an end effector of a robotic arm for wirelessly guided screw insertion. In some embodiments, the surgical system includes an SI implant screwdriver, a robotic arm end effector, and a SI cannulated bone screw with a fully threaded body that is windowed to enhance SI arthrodesis. In some embodiments, the SI implant screwdriver is configured to rotate within the inner diameter of the robotic arm guide without disengaging from it. In some embodiments, the SI implant screwdriver includes an inner sleeve and a knob that do not translate axially. In some embodiments, the SI implant screwdriver includes a hexagonal actuator that engages a hexagonal socket of the SI implant and is subsequently screwed onto the screwdriver. In some embodiments, the actuator engages the socket before screwing the implant in. In some embodiments, the SI implant screwdriver includes a tapered tip that allows the SI implant to sink deeper into the bone without bouncing off the screwdriver. In some embodiments, this configuration allows the SI implant screwdriver to drive the SI implant to the bone surface at extreme angles and enables sub-flat engagement of the surface.

[0032] In some embodiments, the surgical system includes a surgical instrument comprising a surgical SI wire tap that can be guided through an end effector of a robotic arm. In some embodiments, the surgical system includes a surgical instrument comprising a surgical SI cannula that can be guided through an end effector of a robotic arm. In some embodiments, the surgical SI wire tap has a larger outer diameter and a fully threaded outer body. In some embodiments, the surgical SI cannula has a larger inner diameter to accommodate the surgical SI wire tap. In some embodiments, the surgical SI cannula is configured as a tissue protector for the surgical SI wire tap.

[0033] In some embodiments, the screwdriver includes a knob that serves as a visual indicator of whether the screwdriver has been completely dislodged from the implant.

[0034] In some embodiments, the screwdriver is used for robot guidance and provides markings indicating that the screwdriver has been fully unscrewed from the implant. In some embodiments, the screwdriver provides visual markings indicating that it has been unscrewed from the implant during minimally invasive surgery. For example, the screwdriver provides visual markings indicating whether the screwdriver is engaged.

[0035] In some embodiments, the surgical system includes a screwdriver comprising an outer shaft or sleeve, the outer diameter of which is slightly larger than the screw rotation diameter of the bone screw. This configuration allows the bone screw and screwdriver to pass through the end effector.

[0036] In some embodiments, the screwdriver includes a thumbwheel that is connected to a retaining screw screwed into a bone screw.

[0037] In some embodiments, the screwdriver includes an inner shaft having a Torx tip configured to engage with a bone fastener. In some embodiments, when the Torx tip engages with the bone fastener, an actuator, such as a thumbwheel, is actuated to tighten the inner sleeve and screw and pull the bone fastener into engagement with the screwdriver. The outer sleeve is secured to the inner shaft, for example, by welding.

[0038] In some embodiments, the surgical system includes surgical instruments comprising a screwdriver that can be used with bone fasteners and one or more implant supports for spinal treatment. In some embodiments, the surgical system includes surgical instruments that can be easily attached to and disconnected from bone fasteners. In some embodiments, the surgical system includes surgical instruments that can be used with an end effector of a robotic arm for implantation with the robotic arm. In some embodiments, the surgical instruments are guided through the end effector for wirelessly guided screw insertion. In some embodiments, the surgical instruments include a robotic screwdriver for robotic and / or navigation guidance, which may include image guidance.

[0039] In some embodiments, the surgical system includes a screwdriver comprising an outer shaft or sleeve with an outer diameter slightly larger than the screw rotation diameter of the bone screw. This configuration allows the bone screw and screwdriver to pass through an end effector. In some embodiments, the screwdriver includes a thumbwheel that connects to a retaining screw screwed into the bone screw.

[0040] In some embodiments, the surgical system of this disclosure includes a hollow SI implant with a fully threaded body that is fenestrated to enhance SI arthrodesis and provide fixation of the large bones and fragments of the pelvis. In some embodiments, the system includes one or more spinal structures having one or more SI implants provided with various lengths to accommodate a patient's anatomy. In some embodiments, the SI implants are used in conjunction with SI arthrodesis surgery for conditions including SI joint rupture and degenerative sacroiliitis.

[0041] In some embodiments, the SI implant includes a fully threaded body having a threaded form extending the entire length of the body from proximal to distal tip. In some embodiments, the SI implant is cannulated and fenestrated to allow bone inward growth and bone graft material is filled inside the SI implant and on or around one or more components of the spinal structure to facilitate fusion across the SI joint. In some embodiments, the SI implant includes a recess on its proximal end to facilitate threaded engagement with surgical instruments, such as, for example, inserters. In some embodiments, the inserter is configured for manual insertion, assisted navigation, and / or equipped with a power screwdriver.

[0042] In some embodiments, the surgical system includes a tapered, fully threaded, hollow, fenestrated SI implant for stabilization and fusion of the SI joint. In some embodiments, the surgical system is used for treating lower back pain attributed to the SI joint.

[0043] In some embodiments, the surgical system includes a threaded SI implant that has been cannulated, fenestrated, and designed to enhance SI arthrodesis and provide fixation to large bones and fragments of the pelvis. In some embodiments, the SI implant includes a distal tip with a blunt profile. In some embodiments, the SI implant includes a hole with a threaded portion. In some embodiments, the threaded portion is configured to facilitate corrective surgery. In some embodiments, the hole includes a connection portion and / or a torque portion.

[0044] In some embodiments, this system is used in conjunction with methods for surgical navigation, such as fluoroscopy or image guidance.

[0045] In some embodiments, the currently disclosed systems and / or methods reduce surgical procedure time and radiation exposure due to fluorescence or image guidance, for example by eliminating surgical steps and patient repositioning through implantation of system components in a body location.

[0046] In some embodiments, the method of treating a SI joint includes identifying the posterior superior iliac spine of a patient positioned prone on an operating table. In some embodiments, the identification step includes using the posterior superior iliac spine as a landmark for creating an incision. In some embodiments, identification of the posterior superior iliac spine limits the surgical approach from damaging blood vessels and muscles. In some embodiments, the method includes establishing a trajectory path using fluoroscopy and a guidewire inserted into the posterior superior iliac spine, for example, on the iliac side of the SI joint. In some embodiments, bone graft material, such as an autologous graft and / or an allogeneic graft, is inserted into the SI joint space to create bone contact between the iliac and sacral sides. In some embodiments, the bone graft material is inserted into a cannula of a screw.

[0047] In some embodiments, the system includes an SI fixation screw attached to a surgical screwdriver. In some embodiments, the SI fixation screw is used in a method of treating an SI joint, the method including the steps of: applying a downward force and driving the screw along a path created by a drill through the ilium, through graft material, and into the sacrum until the screw is flush with the ilium and abuts into the sacrum. In some embodiments, screw placement is confirmed using fluoroscopy and / or image guidance, and the incision is closed. In some embodiments, the system is used in a method of removing a screw from an SI joint fusion. In some embodiments, the method includes the step of providing an implant inserter configured to attach to the screw. In some embodiments, the method includes the step of exposing the ilium side of the SI joint of a patient undergoing SI fusion surgery. In some embodiments, a tube may be placed above the incision site. In some embodiments, the back side of the screw is clearly identified. In some embodiments, the back side of the screw is identified using fluoroscopy and / or image guidance. In some embodiments, the implant inserter is reattached to the back end of the screw, and the screw is removed.

[0048] In some embodiments, the system includes an SI implant and a surgical inserter employing image guidance (e.g., surgical navigation). In some embodiments, the system includes an SI implant and a surgical inserter that selectively, precisely, and / or accurately connects the SI implant to the surgical inserter such that the SI implant extends a selected distance from the surgical inserter in conjunction with surgical navigation. In some embodiments, the SI implant extends a selected distance from the surgical inserter with an accuracy and / or tolerance of ±1.0 mm. In some embodiments, the SI implant extends a selected distance from the surgical inserter and is connected at a first component interface having a selected distance with an accuracy and / or tolerance of ±0.5 mm. In some embodiments, the component interface has a selected distance with an accuracy and / or tolerance of ±0.2 mm. In some embodiments, the component interface includes a threaded pouch of the SI implant. In some embodiments, the surgical inserter includes a floating, relatively rotating cannula disposed along the axis of a screwdriver. In some embodiments, the cannula includes a portion of the component interface to selectively position the SI implant at the end of the screwdriver while allowing the screwdriver to pass through the cannula and engage a second component interface of the SI implant. In some embodiments, the SI implant, combined with image guidance, extends a selected distance from and is secured to the surgical inserter to provide the SI implant with the location of the tissue to a reliable implantation strategy, which may include positioning the SI implant with the tissue and the explant of the SI implant.

[0049] In some embodiments, the surgical system of this disclosure can be used to treat spinal conditions such as, for example, intervertebral disc degeneration, intervertebral disc herniation, osteoporosis, vertebral lordosis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures. In some embodiments, the surgical system of this disclosure can be used for other skeletal and bone-related applications, including those associated with diagnosis and therapy. In some embodiments, the disclosed surgical system can be used alternatively in surgical procedures performed with the patient in a prone or supine position, and / or using various surgical approaches (including anterior, posterolateral, posterior midline, direct lateral, posterolateral, and / or anterolateral approaches) to reach the spine and other body regions. The surgical system of this disclosure can also be used alternatively for surgical procedures treating the lumbar, cervical, thoracic, sacral, and pelvic regions of the spine. The surgical system of this disclosure can also be used in animals, bone models, and other non-biological substrates, such as, for example, in training, testing, and demonstration.

[0050] The surgical system of this disclosure can be more readily understood through the following detailed description of embodiments, taken in conjunction with the accompanying drawings that form a part of this disclosure. It should be understood that this application is not limited to the specific apparatus, methods, conditions, or parameters described and / or shown herein, and 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 unless the context explicitly states otherwise, references to a particular numerical value include at least the stated particular value. Ranges may be expressed herein as from “about” or “approximately” one particular value and / or to “about” or “approximately” another particular value. In expressing this range, another embodiment includes from one particular value and / or to another particular value. Similarly, when a value is expressed as an approximation using the antecedent “about,” it should be understood that the stated particular value forms another embodiment. It should also be understood that all spatial references (e.g., horizontal, vertical, top, upper, lower, bottom, left, and right) are for illustrative purposes only and may vary within the scope of this disclosure. For example, the terms “upper” and “lower” are relative and used only in context, and do not necessarily refer to “higher” and “lower”.

[0051] As used in the specification and including the appended claims, “treatment” for a disease or condition means performing a surgical procedure that may include administering one or more medications to a patient (normal or abnormal human or other mammal), using an implantable device, and / or using instruments for treating the disease (e.g., microdissection instruments for removing protruding portions or herniated discs and / or osteophytes) to alleviate the signs or symptoms of the disease or condition. Relief may occur before or after the onset of signs or symptoms of the disease or condition. Therefore, treatment includes preventing the disease or adverse condition (e.g., preventing the disease from occurring in patients who may be susceptible to it but have not yet been diagnosed with it). Furthermore, treatment does not require complete relief of signs or symptoms, does not require a cure, and particularly includes procedures with only marginal effects on the patient. Treatment may include suppressing the disease, such as halting its progression, or alleviating the disease, such as causing relapse. For example, treatment may include reducing acute or chronic inflammation; relieving pain and reducing and inducing the regrowth of new ligaments, bone, and other tissues; as an adjunct to surgery; and / or any reparative surgery. In some embodiments, unless otherwise explicitly indicated, as used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage, and / or bone.

[0052] The following discussion includes a description of a surgical system (including surgical instruments and related components) based on the principles of this disclosure, and methods of using said surgical system. Alternative embodiments are also disclosed. Refer in detail to exemplary embodiments of this disclosure illustrated in the accompanying drawings. [Go to...] Figure 1-20 The diagram shows components of a surgical system, such as, for example, a spinal implant system 10.

[0053] Components of the spinal implant system 10 may be manufactured from biocompatible materials suitable for medical applications, including metals, synthetic polymers, ceramics, bone materials, and / or composites thereof. For example, components of the spinal implant system 10 may be manufactured individually or collectively from materials such as: stainless steel alloys, aluminum, industrially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metal alloys (e.g., Nitinol), and super-elasto-plastic metals such as GUM. ), ceramics and their complexes (such as calcium phosphate (e.g., SKELITE) TM Thermoplastics (such as polyaryletherketone (PAEK), including polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 polymer rubber, polyethylene terephthalate (PET), fabrics, silicones, polyurethanes, silicone-polyurethane copolymers, polymer rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermosetting elastomers, elastomer composites, rigid polymers (including polyphenylene, polyamide, polyimide, polyetherimide, poly...) Ethylene, epoxy resin), bone materials (including autologous, allogeneic, xenograft or transgenic cortical bone and / or cortical-spongy bone and tissue growth or differentiation factors), partially absorbable materials (e.g., metal-calcium-based ceramic complexes, PEEK-calcium-based ceramic complexes, PEEK-absorbable polymer complexes), fully absorbable materials (e.g., calcium-based ceramics such as calcium phosphate, tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate or other absorbable polymers such as polylactide, polyglycolic acid, polytyrosine carbonate, polycaprolactone), and combinations thereof.

[0054] Various components of the spinal implant system 10 may have material composites, including the aforementioned materials, to achieve various desired characteristics, such as strength, rigidity, elasticity, compliance, biomechanical properties, durability, and radiolucency or imaging preference. Components of the spinal implant system 10 may also be manufactured individually or collectively from heterogeneous materials, for example, from a combination of two or more of the aforementioned materials. Components of the spinal implant system 10 may be monolithically formed, integrally connected, or include fastening elements and / or devices, as described herein.

[0055] Spinal implant system 10, for example, for fully open surgical procedures, minimally invasive procedures including percutaneous techniques and mini-open surgical techniques for delivering and introducing instruments and / or spinal implants at surgical sites in patients, including, for example, spinal regions including the articular surfaces of vertebrae, iliac bones, and / or SI joints. In some embodiments, components of spinal implant system 10 are used to stabilize and maintain structural integrity while reducing stress on portions of the SI joint and / or adjacent anatomical structures. In some embodiments, spinal implant system 10 is configured to treat SI joint disorders, including those caused by degenerative changes or trauma. In some embodiments, spinal implant system 10 is adapted to fix the relatively naturally separated surfaces of the SI joint. In some embodiments, the spinal implant may include one or more components of one or more spinal structures, such as, for example, intervertebral devices, interbody fusion cages, bone fasteners, spinal rods, tethers, connectors, plates, and / or bone grafts, and may be used in a variety of surgical procedures, including surgical treatment of the cervical, thoracic, lumbar, and / or sacral regions of the spine and / or the iliac bone.

[0056] The spinal implant system 10 includes surgical instruments, such as, for example, a screwdriver 12. The screwdriver 12 can be used with a robotic arm R( Figure 19 The end effector 200 ( Figure 12 The screwdriver 12 is guided through the end effector 200 for wireless guided insertion of spinal implants, such as, for example, bone fasteners 100, as described herein.

[0057] The screwdriver 12 includes, for example, an outer tubular sleeve 14. The outer sleeve 14 extends between a proximal end 16 and a distal end 18. The outer sleeve 14 defines a longitudinal axis a. In some embodiments, the outer sleeve 14 can have various shapes, including, for example, circular, elliptical, polygonal, irregular, uniform, variable, homogeneous, and non-uniform. The outer sleeve 14 includes a diameter D1. In some embodiments, the diameter D1 is slightly larger than the proximal diameter D2 of the bone fastener 100. As described herein, this shape allows the bone fastener 100 and the screwdriver 12 to pass through the end effector 200 of the robotic arm R.

[0058] The outer sleeve 14 includes a surface 20 defining an axial cavity 22. As described herein, the cavity 22 is configured to house the inner sleeve 50 and the inner shaft 72. The outer sleeve 14 includes a collar body 24 having a surface 26. The surface 26 defines a cavity 28. The body 24 includes a forked arm 30 disposed around the cavity 28 for mounting and accessing an actuator, such as a thumb wheel 32 therein. The body 24 includes an opening 34 disposed at an end 16. The opening 34 communicates with the cavity 28 and is aligned with the cavity 22 to allow the inner shaft 72 to be inserted into the end 16, through the wheel 32, and into the cavity 22 for assembly, as described herein. The wheel 32 is axially fixed and rotatable relative to the outer sleeve 14 and is configured to be integrally connected to the inner sleeve 50 such that the wheel 32 and the inner sleeve 50 do not translate axially. In some embodiments, the wheel 32 may be integrally formed with the inner sleeve 50. The wheel 32 includes a surface 36 defining a cavity 38. Cavity 38 is configured to house a correspondingly shaped portion of the inner sleeve 50, such as Figure 8 and Figure 9 As shown.

[0059] The wheel 32 includes a wall 40 having a surface 42. The surface 42 defines a plurality of openings 44 and opposing holes 46. The holes 46 are configured to engage with pins 48 to integrally connect the wheel 32 to the inner sleeve 50.

[0060] The inner sleeve 50 is configured to be disposed between the inner shaft 72 and the outer sleeve 14 and is axially fixed and rotatable relative to the outer sleeve 14. The inner sleeve 50 extends between a proximal end 52 and a distal end 54, as... Figure 7 As shown. End 52 is connected to wheel 32. Wheel 32 is integrally connected to inner sleeve 50. End 52 includes openings 56, each configured to engage with pin 48 to connect wheel 32 to inner sleeve 50. Wheel 32 drives rotation of inner sleeve 50 relative to outer sleeve 14. In some embodiments, surface 36 defines a circular cross-section of cavity 38 for mating engagement with a correspondingly shaped end 52 of inner sleeve 50. In some embodiments, cavity 38 includes various morphologies, such as, for example, circular, hexagonal, cross-shaped, square, hexagonal, polygonal, or star-shaped cross-sections, for mating engagement with a correspondingly shaped portion of inner sleeve 50. In some embodiments, wheel 32 includes a surface 58 configured to facilitate gripping of wheel 32, for example, a serrated surface.

[0061] like Figures 8 to 11 As shown, the assembly of the outer sleeve 14 with the inner sleeve 50 and the wheel 32 involves inserting the wheel 32 through the arm 30 and into the cavity 28. The inner sleeve 50 then translates through the cavity 22 of the outer sleeve 14. The end 52 of the inner sleeve 50 translates into the cavity 38 of the wheel 32, and each pin 48 is inserted into each hole 46 and opening 56. The pins 48 prevent and / or detach the inner sleeve 50 from the wheel 32.

[0062] The inner sleeve 50 includes an inner surface 60. Surface 60 defines an axial channel 62 configured as a movably disposed inner shaft 72, as described herein. Channel 62 extends coaxially with cavity 22. In some embodiments, channel 62 is disposed with respect to axis a in an alternative orientation, for example, laterally, vertically, and / or at other angles, such as acute or obtuse angles, and / or may be offset or staggered. End 54 of the inner sleeve 50 includes an element, such as screw 64. Screw 64 includes a threaded outer surface 66. Threaded outer surface 66 is disposed adjacent to the most distal position of the inner sleeve 50. Threaded outer surface 66 may engage or join with a mating surface, such as the internal threaded surface 102 of bone fastener 100, to retain and / or pull bone fastener 100 to engage with screwdriver 12, as described herein.

[0063] The distal end 54 of the inner sleeve 50 includes a tapered tip or portion 68 extending to the screw 64. The tapered portion 68 is configured such that the bone fastener 100 can be implanted with tissue below the outer surface of the bone, recessed into the bone and / or positioned in a sub-flush orientation and within the bone, without causing the distal end of the screwdriver 12 to bounce off the adjacent bone surface. The tapered portion 68 includes a reduced diameter D3, and the axial portion 70 has a uniform diameter D4, such as... Figure 6 As shown. Diameter D4 has a diameter that is substantially equal to the small diameter D5 of the bone fastener 100.

[0064] An inner shaft 72 extends between ends 74 and 76. The inner shaft 72 extends within the cavity 22 of the outer sleeve 14 and may be disposed together with the channel 62 of the inner sleeve 50, as described herein. The inner shaft 72 is fixed to the outer sleeve 14 such that rotation of the inner shaft 72 causes simultaneous rotation of the outer sleeve 14. In some embodiments, the inner shaft 72 is welded to the outer sleeve 14. The inner shaft 72 rotates independently of the inner sleeve 50. In some embodiments, as... Figure 14 As shown, the inner shaft 72 includes a portion 78 configured to facilitate connection of the screwdriver 12 to a surgical instrument, such as an actuator / drill 250. In some embodiments, the inner shaft 72 includes quick-connect surfaces or bonding geometries, such as, for example, triangles, hexagons, squares, or internal hexagonal flowers, for connection to the actuator 250.

[0065] like Figure 1As shown, the end 76 of the inner shaft 72 includes a distal tip, such as an actuator 80. The actuator 80 is integrally connected to or formed integrally with the inner shaft 72. This configuration facilitates tolerance control to optimize the accuracy of the connection between the inner shaft 72 and the bone fastener 100. The actuator 80 and screw 64 of the inner sleeve 50 are arranged in a tandem orientation. The actuator 80 can engage in a torque interface with a spinal implant, such as the bone fastener 100. For example, the actuator 80 mates with and can engage with a mating surface (e.g., the socket 104 of the bone fastener 100), such as... Figure 6 As shown herein, the outer sleeve 72 rotates while the actuator 80 rotates to drive, twist, insert, or otherwise connect the bone fastener 100 to the tissue. The actuator 80 includes an internal hexagonal flower geometry and an internal hexagonal flower cross-section for engaging with a correspondingly shaped socket 104. In some embodiments, the actuator 80 may alternatively include a cross-shaped, square, hexagonal, polygonal, or star-shaped cross-sectional shape for providing the socket 104.

[0066] Wheel 32 is inserted laterally through arm 30 and into cavity 28. Inner sleeve 50 then translates through cavity 22 of outer sleeve 14. End 52 of inner sleeve 50 translates into cavity 38 of wheel 32 and inserts each pin 48 into each hole 46 and opening 56. Inner shaft 72 is inserted from end 16, through opening 34, and through cavity 38 to temporarily connect wheel 32 to outer sleeve 14. Inner shaft 72 is welded to outer sleeve 14. Inner shaft 72 is provided with a channel 62 for inner sleeve 50. Inner sleeve 50 is rotatable relative to outer sleeve 14 and inner shaft 72. Inner shaft 72 and outer sleeve 14 rotate simultaneously relative to inner sleeve 50.

[0067] The bone fastener 100 includes a body 106 extending between a proximal end 108 and a distal end 110. The shaft 106 is configured to penetrate tissue, such as bone. As described herein, an inner surface 112 at the end 108 includes a socket 104 that engages with a driver 80 in a torque interface, and an internally threaded surface 102 that engages with a screw 64 in a connection interface. The bone fastener 100 includes an externally threaded surface 114 that is threaded along the entire length of the body 106.

[0068] Bone fastener 100 includes a longitudinal cavity 116 and a plurality of transverse openings, such as windows 118 communicating with the cavity 116. The bone fastener 100 is cannulated and windowed to allow bone ingrowth and to allow bone graft material to fill the interior of the bone fastener 100 to facilitate fusion across the SI joint. See, for example, similar bone fasteners and their uses, as described in U.S. Patent Publication No. 2018 / 0116814, the entire contents of which are incorporated herein by reference.

[0069] In use, the driver 80 is aligned with the end 108 of the bone fastener 100 to be set together with the socket 104, and the screw 64 is aligned with the internal thread surface 102, as shown. Figure 2 As shown. The screwdriver 12 is axially translated to connect to the bone fastener 100 in a non-locking configuration, as... Figure 6 As shown. The driver 80 engages with the socket 104 and actuates the wheel 32 to rotate such that the inner sleeve 50 rotates relative to and independently of the outer sleeve 14. The rotation of the screw 64 creates a threaded engagement between the external threaded surface 66 of the screw 64 and the internal threaded surface 102 of the bone fastener 100, to retain and / or pull the bone fastener 100 into engagement with the screwdriver 12 in a locked configuration. Figure 5 As shown.

[0070] As described herein, an inner shaft 72 with a driver 80 is connected to an outer sleeve 14. The inner shaft 72 and outer sleeve 14 rotate to drive, twist, insert, or otherwise connect the bone fastener 100 to adjacent tissue. A screw 64 remains releasably secured to an internal threaded surface 102, independent of rotation of the inner shaft 72 and outer sleeve 14 and / or engagement or friction with components of the spinal implant system 10 as described herein, to prevent and / or avoid disengagement or unscrewing of the screw 64 from the internal threaded surface 102. In some embodiments, a wheel 32 is manipulated to rotate such that the inner sleeve 50 and screw 64 rotate relative to the outer sleeve 14, and the external threaded surface 66 disengages from the internal threaded surface 102 to place the screwdriver 12 in an unlocked position, as described herein. Figure 2 As shown.

[0071] In some embodiments, such as Figure 14 and Figure 19 As shown, the screwdriver 12 includes a navigation component 300. The screwdriver 12 is configured to be positioned adjacent to the surgical site such that the navigation component 300 is oriented relative to the sensor array 302 to facilitate communication between the navigation component 300 and the sensor array 302 during surgery, as described herein. The navigation component 300 is configured to generate signals representing the position of the bone fastener 100 relative to the screwdriver 12 and / or tissue. In some embodiments, image guidance may include human-readable visual markers, human-readable tactile markers, human-readable auditory markers, one or more components having identifiers for identification under X-ray, fluoroscopy, CT, or other imaging techniques, at least one light-emitting diode, wireless components, wired components, near-field communication components, and / or one or more components generating sound signals, magnetic signals, electromagnetic signals, and / or radiation signals. The navigation component 300 is directly connected to the actuator 250, such as... Figure 14As shown. In some embodiments, the navigation component 300 is connected to a portion 78 of the inner shaft 72 or the outer sleeve 14 via an integral connection, friction fit, pressure fit, interlocking fit, mating fit, dovetail connection, clamp, barb, tenon joint, threaded connection, magnetism, key / keyway and / or drill chuck.

[0072] The navigation component 300 includes a transmitter array 304. The transmitter array 304 is configured to generate signals to the sensor array 302 of the surgical navigation system 306, such as... Figure 19 As shown and described herein. In some embodiments, the signals generated by the transmitter array 304 represent the position of the bone fastener 100 relative to the screwdriver 12 and relative to tissue (e.g., bone). In some embodiments, the signals generated by the transmitter array 304 represent the three-dimensional position of the bone fastener 100 relative to the tissue.

[0073] In some embodiments, sensor array 302 receives signals from transmitter array 304 to provide the three-dimensional spatial position and / or trajectory of bone fastener 100 relative to screwdriver 12 and / or tissue. Transmitter array 304 communicates with the processor of computer 308 of surgical navigation system 306 to generate data for displaying images on monitor 310, as described herein. In some embodiments, sensor array 302 receives signals from transmitter array 304 to provide a visual representation of the position of bone fastener 100 relative to screwdriver 12 and / or tissue. See, for example, similar surgical navigation components and their uses described in U.S. Patent Nos. 6,021,343, 6,725,080, and 6,796,988, the entire contents of each of these references are incorporated herein by reference.

[0074] Surgical navigation system 306 is configured to acquire and display medical imaging, such as X-ray images suitable for a given surgical procedure. In some embodiments, pre-acquired patient images are collected. In some embodiments, surgical navigation system 306 may include those sold by Medtronic Navigation, Inc., a company with a place of business in Louisville, Colorado, USA. Imaging device 312. Imaging device 312 may have a generally annular stage housing surrounding image capture portion 314.

[0075] In some embodiments, the image capture portion 314 may include an x-ray source or emitting portion and an x-ray receiving or image receiving portion, which are positioned generally or virtually as far as possible 180 degrees apart from each other relative to the orbit of the image capture portion 314 and mounted on a rotor (not shown). The image capture portion 314 is operable to rotate 360 ​​degrees during image acquisition. The image capture portion 314 may rotate about a central point or axis, thereby allowing image data of the patient to be acquired from multiple directions or in multiple planes. The surgical navigation system 306 may include those disclosed in U.S. Patent Nos. 8,842,893, 7,188,998, 7,108,421, 7,106,825, 7,001,045, and 6,940,941, the entire contents of each of which are incorporated herein by reference.

[0076] In some embodiments, the surgical navigation system 306 may include a C-arm fluorescein imaging system capable of generating a three-dimensional view of the patient. The position of the image capture portion 314 relative to any other part of the imaging apparatus of the navigation system 306 may be precisely known. In some embodiments, precise knowledge of the position of the image capture portion 314 may be used in conjunction with the tracking system 316 to determine the position of the image capture portion 314 and image data relative to the patient.

[0077] Tracking system 316 may include various components associated with or included in surgical navigation system 306. In some embodiments, tracking system 316 may also include various types of tracking systems, such as, for example, optical tracking systems including optical locators, such as, for example, sensor array 302, and / or EM tracking systems that may include EM locators. Tracking system 316 can be used to track various tracking devices, and surgical navigation system 306 can use the information to allow the display of the location of items, such as, for example, patient tracking devices, imaging device tracking devices 320, and instrument tracking devices, such as, for example, transmitter array 304, to allow selected portions to be tracked relative to each other using appropriate tracking systems.

[0078] In some embodiments, the EM tracking system may include those sold by Medtronic Navigation, Inc., which has a place of business in Louisville, Colorado. AXIEM TM Navigation systems. Exemplary tracking systems are also disclosed in U.S. Patent Nos. 8,057,407, 5,913,820, and 5,592,939, the entire contents of each of these references are incorporated herein by reference.

[0079] The captured fluoroscopic images are transmitted to computer 318, where they can be forwarded to computer 308. Image transmission can be performed via a standard video connection or a digital link including wired and wireless connections. Computer 308 provides the ability to display, save, digitally manipulate, or print hard copies of the received images via monitor 310. In some embodiments, the images can also be displayed to the surgeon via a heads-up display.

[0080] In some embodiments, the surgical navigation system 306 provides real-time tracking of the position of the bone fastener 100 relative to the screwdriver 12 and / or tissue. As described herein, the sensor array 302 is positioned to provide a clear line of sight to the transmitter array 304. In some embodiments, a reference marker 322 of the transmitter array 304 communicates with the sensor array 302 via infrared technology. The sensor array 302 is coupled to a computer 308, which can be programmed with software modules that analyze the signals transmitted by the sensor array 302 to determine the position of each object in the detector space.

[0081] Screwdriver 12 is configured for use with a guiding member, such as, for example, an end effector 200 of robotic arm R. End effector 200 includes a defined cavity, such as the inner surface 202 of a channel 204. Channel 204 is configured to allow bone fastener 100 to pass through and position screwdriver 12. Robotic arm R includes position sensors (not shown) (similar to those referenced herein) that measure, sample, capture, and / or identify position data points of end effector 200 in three-dimensional space for wireless guided insertion of bone fastener 100 into tissue. In some embodiments, the position sensors of robotic arm R are employed in conjunction with surgical navigation system 306 to measure, sample, capture, and / or identify position data points of end effector 200 in relation to surgical procedures, as described herein. The position sensors are mounted on robotic arm R and calibrated to measure position data points of end effector 200 in three-dimensional space, which are transmitted to computer 308.

[0082] In assembly, operation, and use, the spinal implant system 10, similar to the systems and methods described herein, is used for surgical procedures, such as the treatment of applicable conditions or injuries to the affected segment of the spine and adjacent areas within the body. In some embodiments, the spinal implant system 10 is used for surgical treatment of a patient's SI joint. In some embodiments, one or all of the components of the spinal implant system 10 may be delivered or used as a pre-assembled device or may be assembled in situ. The spinal implant system 10 may be modified, removed, or replaced wholly or partially.

[0083] In use, to treat a patient's SI joint, a medical practitioner obtains access to the surgical site in any appropriate manner, such as through an incision and contracting tissue. In some embodiments, the spinal implant system 10 can be used with any existing surgical method or technique, including open surgery, micro-open surgery, minimally invasive surgery, and percutaneous implantation, thereby accessing the SI joint through a small incision or cannula providing a protected pathway to the area. Once access to the surgical site is obtained, specific surgical procedures can be performed to treat the spinal condition.

[0084] In some embodiments, the scalpel 400 is oriented to be disposed together with the end effector 200 of the robotic arm R, as described herein. An incision is made in the patient's body using the scalpel 400, as... Figure 17 and Figure 18 As shown, a surgical path is created for the implantation of components of the spinal implant system 10. A speculum (not shown) may be used to assist in creating the surgical path. Preparatory instruments (not shown) may be used to prepare the tissue surface, as well as for aspiration and irrigation of the surgical area. A cannula 402 is inserted into the end effector 200 and into the surgical path. A dilator 404 is inserted into the cannula 402 to dilate the surgical path. In some embodiments, a drill guide 406 and a drill guide anchor 408 may be inserted into the cannula 402 to aid in the control and guidance of the drill 410, such as... Figure 17 As shown. The drill bit guide 406 can be securely engaged by using a hammer (not shown) and striking it. The drill bit 410 is mated with the selected drill tip 412 and inserted into the cannula 402.

[0085] A guide hole (not shown) is created in a selected bone region using drill bit 410, such as the ilium (I), sacrum (S), and / or sacroiliac joint (J), for receiving bone fastener 100. Drill bit 410, drill guide 406, and drill guide anchor 408 are removed from cannula 402, and tap 414 is inserted into cannula 416. Cannula 416 is configured as a tissue protector for tap 414. Figure 16 and Figure 17 As shown, the cannula 416 includes a proximal end 418 and a distal end 420. The inner diameter D6 at the distal end 420 is larger than the inner diameter D7 of the cannula 402. The inner diameter D6 is larger than the inner diameter D7 to accommodate the tip 428 of the tap 414.

[0086] Tap 414 includes a proximal end 422 and a distal end 424. End 422 includes a portion 426 configured to facilitate connection of tap 414 to actuator / drill bit 250, such as... Figure 14As shown. In some embodiments, tap 414 includes a quick-connect surface or bonding geometry, such as, for example, a triangle, hexagon, square, or internal hexagonal flower, for engagement with actuator 250. End 424 includes a threaded tip, such as a tapered tip 428. Tip 428 has an outer diameter D8. End 422 includes a mark 430 configured to visually indicate the depth of tap 414 upon contact with bone. In some embodiments, the mark may include notches, slots, beads, stops, bumps, printing, labels, notches, color coding, and / or depth increments in millimeters, centimeters, or inches provided on tap 414. Tap 414 is aligned with a guide hole and tapped to a selected depth relative to the length of bone fastener 100. Tap 414 and cannula 416 are removed.

[0087] like Figure 2 As shown, the driver 80 is aligned with the end 108 of the bone fastener 100, and the screw 64 of the inner sleeve 50 is aligned with the internal thread surface 102. The screwdriver 12 is axially translated to engage with the bone fastener 100 in a non-locking configuration, as shown. Figure 6 As shown. The driver 80 engages with the socket 104 and actuates the wheel 32 to rotate such that the inner sleeve 50 rotates relative to and independently of the outer sleeve 14. The rotation of the screw 64 creates a threaded engagement between the external threaded surface 66 of the screw 64 and the internal threaded surface 102 of the bone fastener 100, to retain and / or pull the bone fastener 100 into engagement with the screwdriver 12 in a locked configuration. Figure 5 As shown.

[0088] As described herein, the screwdriver 12 is oriented to be disposed together with the end effector 200 of the robotic arm R. As described herein, the screwdriver 12 / bone fastener 100 assembly is provided with a channel 204 for implanting one or more bone fasteners 100 with the sacroiliac joint J using the robotic arm R and / or surgical navigation system 306. An actuator 250 is connected to an inner shaft 72, and a drive 80 engages the bone fastener 100, as described herein, and the inner shaft 72 and outer sleeve 14 rotate to drive, twist, insert, or otherwise connect the bone fastener 100 to adjacent tissue. A screw 64 is releasably secured to an internally threaded surface 102, independent of rotation of the inner shaft 72 and outer sleeve 14 and / or engagement or friction with, for example, the end effector 200, to prevent and / or avoid disengagement or unscrewing of the screw 64 from the internally threaded surface 102. In some embodiments, the screwdriver 12 is manipulated to deliver one or more bone fasteners 100 to a surgical site including the sacroiliac joint J.

[0089] Sensor array 302 receives signals from navigation component 300 to provide the three-dimensional spatial position and / or trajectory of the screwdriver 12 / bone fastener 100 assembly (which may be configured with end effector 200) relative to the sacroiliac joint J and / or the spinal implant system 10, for display on monitor 310. Actuation wheel 32 rotates such that inner sleeve 50 and screw 64 rotate relative to outer sleeve 14, and external thread surface 66 disengages from internal thread surface 102. Screwdriver 12 is translated away from implant 100 to unscrew screwdriver 12 from internal thread surface 102, and screwdriver 12 is considered to be in an unlocked configuration relative to bone fastener 100, as... Figure 2 As shown.

[0090] As described herein, upon completion of the procedure, surgical instruments, components, and non-implanted parts of the spinal implant system 10 are removed, and one or more incisions are closed. One or more components of the spinal implant system 10 may be made of a radiolucent material, such as a polymer. Radioactive markers may be included for identification under X-ray, fluoroscopy, CT, or other imaging techniques. In some embodiments, the spinal implant system 10 may include one or more of a spinal rod, plate, connector, and / or bone fasteners for use on a single vertebral segment or multiple vertebral segments.

[0091] In some embodiments, as described herein, one or more bone fasteners may engage with tissue in various orientations (e.g., tandem, parallel, offset, staggered, and / or alternative vertebral segments). In some embodiments, bone fasteners may include multiaxial screws, sagittal adjustment screws, pedicle screws, uniaxial screws, single-plane screws, small-plane screws, fixation screws, tissue-penetrating screws, conventional screws, expansion screws, wedges, anchors, buttons, clamps, snaps, friction fittings, compression fittings, expansion rivets, U-shaped pins, nails, adhesives, posts, fixation plates, and / or posts.

[0092] In one embodiment, the spinal implant system 10 includes an agent that may be disposed, packaged, coated, or layered within, on, or around a component and / or surface of the spinal implant system 10. In some embodiments, the agent may include bone-growth-enhancing materials, such as bone grafts, to enhance fixation of the component and / or surface of the spinal implant system 10 to the vertebrae. In some embodiments, the agent may include one or more therapeutic and / or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation, and degeneration.

[0093] It should be understood that various modifications can be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as examples of various embodiments. Other modifications can be conceived by those skilled in the art within the scope and spirit of the appended claims.

Claims

1. A surgical instrument comprising: an outer sleeve including an inner surface defining a lumen; an inner shaft fixed with the outer sleeve and extending within the lumen, the inner shaft including a driver engageable in a torque interface with a first mating surface of a bone fastener, wherein the fixation of the inner shaft with the outer sleeve is such that rotation of the inner shaft causes simultaneous rotation of the outer sleeve; and an inner sleeve disposed between the inner shaft and the outer sleeve, the inner sleeve being axially fixed and rotatable relative to the outer sleeve, the inner sleeve including an element connectable in a connection interface with a second mating surface of the bone fastener.

2. The surgical instrument of claim 1, wherein the element includes a threaded outer surface.

3. The surgical instrument of claim 1, wherein the element includes a threaded outer surface disposed proximate a distal-most position of the inner sleeve.

4. The surgical instrument of claim 1, wherein the driver defines a hexalobular cross-section of the inner shaft.

5. The surgical instrument of claim 1, wherein the first mating surface includes a hexalobular socket and the torque interface includes a hexalobular driver of the inner shaft engageable with the socket.

6. The surgical instrument of claim 1, wherein the second mating surface includes an internally threaded surface of the bone fastener and the connection interface includes a threaded outer surface of the element engageable with the internally threaded surface.

7. The surgical instrument of claim 1, wherein the element and the driver are disposed in a series orientation.

8. The surgical instrument of claim 1, wherein the inner sleeve includes a proximal end including an actuator and a distal end including the element.

9. The surgical instrument of claim 8, wherein the actuator is axially fixed and rotatable relative to the outer sleeve.

10. The surgical instrument of claim 8, wherein the actuator is integrally connected with the inner sleeve.

11. The surgical instrument of claim 8, wherein the distal end includes a tapered tip extending to the element.

12. The surgical instrument of claim 1, wherein the inner sleeve includes a tip extending to the element, the tip including a tapered portion having a decreasing diameter and an axial portion having a uniform diameter.

13. The surgical instrument of claim 12, wherein the axial portion has a diameter substantially equal to a minor diameter of the bone fastener.

14. A surgical instrument comprising: an outer sleeve including an inner surface defining an axial lumen; an inner shaft fixed with the outer sleeve and extending within the lumen, the inner shaft including a hexalobular driver tip engageable in a torque interface with a hexalobular socket of a bone fastener, wherein the fixation of the inner shaft with the outer sleeve is such that rotation of the inner shaft causes simultaneous rotation of the outer sleeve; and an inner sleeve disposed between the inner shaft and the outer sleeve in a relatively coaxial orientation, the inner sleeve being axially fixed and rotatable relative to the outer sleeve, The inner sleeve includes a proximal end having a rotatable actuator and a threaded tip connectable in a connection interface with an internal threaded surface of the bone fastener.

15. A spinal implant system comprising: a surgical instrument including an outer sleeve, an inner shaft fixed with the outer sleeve, and an inner sleeve including a driver and rotatable relative to the outer sleeve and including an element, wherein the fixation of the inner shaft with the outer sleeve is such that rotation of the inner shaft causes simultaneous rotation of the outer sleeve; a sacral-iliac screw having an internal surface including a socket engageable with the driver in a torque interface and an internal threaded surface connectable with the element in a connection interface; and a guide member including an internal surface defining a cavity configured to dispose the outer sleeve and an image guide oriented relative to a sensor to convey a signal representative of a position of the guide member.

Images