Surgical instruments and methods

Abstract

A surgical instrument has a first member engageable with a fastener. A second member includes a deployable portion configured to capture the fastener. A third member is engageable with the deployable portion to releasably secure the fastener. An actuator is connected with the second member and the third member. The actuator includes a threaded inner surface and a threaded coupling member engageable with the threaded inner surface to facilitate axial translation of the second member relative to the third member. Systems, spinal constructs, implants, and methods are disclosed.

Description

Technical Field

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

[0002] Spinal disorders and conditions, such as scoliosis and other curvature abnormalities, kyphosis, degenerative disc disease, herniated discs, osteoporosis, anterior spinal displacement, stenosis, tumors, and fractures, can be caused by factors including trauma, disease, and degenerative conditions resulting from injury and aging. Spinal disorders typically lead to symptoms including deformities, pain, nerve damage, and partial or complete loss of mobility.

[0003] Non-surgical treatments, such as medication, rehabilitation, and exercise, may be effective; however, they may not relieve the symptoms associated with these conditions. Surgical treatments for these spinal conditions include correction, fusion, fixation, discectomy, laminectomy, and implantable prostheses. As part of these surgical treatments, spinal structures such as vertebral rods are typically used to provide stability to the treated area. During healing, the rods transfer stress from the damaged or defective area to allow for proper correction and generally provide support for the vertebral members. During surgical treatment, one or more rods and bone fasteners can be delivered to the surgical site. Rods can be attached to the exterior of two or more vertebral members via fasteners. Surgical treatment may utilize surgical instruments and implants manipulated to engage with the vertebrae to position and align one or more vertebrae. This disclosure describes improvements over these prior art techniques. Summary of the Invention

[0004] In one embodiment, a surgical instrument is provided. The surgical instrument includes a first member engageable with a fastener. A second member includes a deployable portion configured to capture the fastener. A third member engages with the deployable portion to releasably secure the fastener. An actuator is connected to the second and third members. The actuator includes a threaded inner surface and a threaded coupling member engageable with the threaded inner surface to facilitate axial translation of the second member relative to the third member. In some embodiments, systems, spinal structures, implants, and methods are disclosed.

[0005] In some embodiments, a surgical system is provided. The surgical system includes a fastener comprising a first end having a recess and a second end configured to penetrate tissue. A first member is engageable with the recess. A second member includes a clamp configured to capture the first end. A third member is engageable with the clamp to releasably secure the fastener. An actuator is connected to the second and third members. The actuator includes a knob having a threaded inner surface and a threaded coupling member engageable with the threaded inner surface to actuate axial translation of the second member relative to the third member.

[0006] In some embodiments, the surgical system includes a bone fastener comprising a spherical head including a socket and a threaded second end configured to penetrate tissue. An actuator member engages with the socket. A first sleeve includes a chuck configured to capture the fastener. A second sleeve engages with the chuck to releasably capture the head. An actuator is connected to the second and third members. The actuator includes a knob having a threaded inner surface and a connecting member having a threaded portion that engages with the threaded inner surface to actuate axial translation of the second member relative to the third member. Attached Figure Description

[0007] This disclosure will become more apparent from the specific description accompanying the following figures, in which:

[0008] Figure 1 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0009] Figure 2 yes Figure 1 A side sectional view of the components of the surgical system shown;

[0010] Figure 3 yes Figure 1 An exploded view of the components of the surgical system shown;

[0011] Figure 4 yes Figure 1 An exploded view of the components of the surgical system shown;

[0012] Figure 5 yes Figure 1 An exploded view of the components of the surgical system shown;

[0013] Figure 6 yes Figure 5 A sectional view of the component shown;

[0014] Figure 7 yes Figure 4 A sectional view of the component shown;

[0015] Figure 8 yes Figure 1 Anatomical view of the components of the surgical system shown;

[0016] Figure 9 yes Figure 1 Anatomical view of the components of the surgical system shown;

[0017] Figure 10 yes Figure 1 Anatomical view of the components of the surgical system shown;

[0018] Figure 11 yes Figure 1 Anatomical view of the components of the surgical system shown;

[0019] Figure 12 It is intercepted along line XII-XII. Figure 11 An axial sectional view of the component shown;

[0020] Figure 13 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure, wherein the components are separated;

[0021] Figure 14 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0022] Figure 15 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0023] Figure 16 yes Figure 15 Anatomical view of the components of the surgical system shown;

[0024] Figure 17 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0025] Figure 18 yes Figure 15 An exploded view of the components of the surgical system shown;

[0026] Figure 19 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0027] Figure 20 yes Figure 19 A perspective view of the components of the surgical system shown;

[0028] Figure 21 This is an exploded view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0029] Figure 22 yes Figure 21 A sectional view of the component shown;

[0030] Figure 23 This is an exploded view of components of an embodiment of a surgical system based on the principles of this disclosure;

[0031] Figure 24 yes Figure 23 A sectional view of the component shown;

[0032] Figure 25 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure; and

[0033] Figure 26 This is a perspective view of components of an embodiment of a surgical system based on the principles of this disclosure. Detailed Implementation

[0034] Exemplary embodiments of the disclosed surgical systems and related methods of use are discussed in relation to medical devices for treating musculoskeletal disorders, and more specifically in relation to spinal implant systems and methods for treating the spine. In some embodiments, the systems and methods of this disclosure include medical devices (including surgical instruments and implants) used in conjunction with surgical treatments as described herein, such as those used with the cervical, thoracic, lumbar, and / or sacral regions of the spine.

[0035] In some embodiments, this surgical system includes a surgical instrument comprising a screw driver configured for use with robotic guidance. In some embodiments, the screw driver is configured for use with a spinal implant (e.g., a bone fastener). In some embodiments, the screw driver includes an outer diameter of approximately 8.96 mm. In some embodiments, the screw driver is configured for insertion through an end effector with an inner diameter of approximately 9.0 mm. The configuration of the screw driver avoids the use of instruments with incorrectly sized arm guides, which could affect accuracy.

[0036] In some embodiments, the surgical system includes a surgical instrument comprising a screw driver having an inner shaft, an inner sleeve, and an outer sleeve. In some embodiments, the screw driver has an inner sleeve with a flexible chuck. In some embodiments, the flexible chuck is configured to snap around a spherical head of a bone fastener. In some embodiments, the inner sleeve includes an engagement surface, such as a tapered surface, configured to slidably engage with the outer sleeve to lock the chuck around the head of the bone screw. In some embodiments, the outer sleeve compresses the engagement surface and the chuck to reduce the outer diameter of the chuck. In some embodiments, this configuration allows the screw driver to maintain an outer diameter of approximately 8.96 mm.

[0037] In some embodiments, the surgical system includes a surgical instrument comprising a screw driver with an actuator. In some embodiments, the actuator includes a knob and a coupling member. In some embodiments, the coupling member includes an external thread configured to engage an internal thread on the knob. In some embodiments, the coupling member is configured to engage an inner sleeve with a pin. In some embodiments, the coupling member is threaded forward to retract an outer sleeve from the tapered inner sleeve, allowing the chuck to open. In some embodiments, the actuator is configured to slide and translate freely back and forth. In some embodiments, an inner shaft is keyed to the inner sleeve to resist and / or prevent relative rotation. In some embodiments, the surgical system includes a surgical instrument comprising a screw driver with a chuck that unfolds and latches onto the head of a bone screw. In some embodiments, the actuator translates the outer sleeve along a mating surface to latch the chuck onto the head of the bone screw.

[0038] In some embodiments, the surgical system includes a surgical instrument comprising a screw driver with an actuator having a knob and a connecting member, such that rotating the knob axially pulls the inner sleeve back to clamp onto the base of the bone screw. This clamps the outer sleeve onto the tapered shape of the chuck to secure the chuck to the head of the bone fastener. In some embodiments, the outer sleeve is bonded to the inner sleeve. In some embodiments, the inner sleeve is configured to pull the bone fastener to engage with the driver. In some embodiments, the shoulder of the hexagonal drive member resting on the inner shaft is tightened.

[0039] In some embodiments, the surgical system includes a surgical instrument comprising a screw driver having an internal shaft with a reference surface configured to engage with a navigation component and detectable via image guidance to calculate the position of the navigation component. In some embodiments, the screw driver is configured to connect the navigation component to the screw driver. In some embodiments, the surgical system includes a bushing connecting the navigation component to the screw driver. In some embodiments, the bushing is assembled from the distal end of the internal shaft to prevent damage to the reference surface.

[0040] In some embodiments, the surgical system includes a method of assembling a screw driver component, the method including the step of attaching a bushing to an inner shaft. In some embodiments, the method includes the step of inserting a distal end of the inner shaft into an opening in the bushing and translating the bushing and selectively positioning it adjacent to at least one reference surface. In some embodiments, the surgical system includes a method of assembling a screw driver component, the method including the steps of: attaching a key to a slot in the inner shaft; attaching a knob to the inner shaft by translating a knob from the distal end of the inner shaft; and inserting a retaining ring to connect the knob to the inner shaft. In some embodiments, the method includes the steps of: inserting a distal end of the inner shaft into an outer sleeve and translating the outer sleeve along the inner shaft to engage with the knob; attaching the inner sleeve by inserting the inner sleeve into a channel in the outer sleeve and translating the inner sleeve to align with the key; attaching the connecting member by translating a connecting member along the outer sleeve to thread engagement with the knob; and inserting a pin to connect the connecting member to the inner sleeve and the outer sleeve and welding the pin. See, for example, embodiments and disclosures of systems and methods for assembling components of a screw driver, shown and described in, for example, U.S. Patent Application Serial No. 16 / 564,599 (File No. A0002403US02), filed September 9, 2019, which are jointly owned and assigned, the entire contents of which are incorporated herein by reference.

[0041] In some embodiments, the surgical system includes a surgical instrument comprising a screw driver that can be used in conjunction with a bone fastener and one or more implant supports for treating the spine. In some embodiments, the surgical system includes a surgical instrument that can be easily attached to and disconnected from the bone fastener. In some embodiments, the surgical system includes a surgical instrument that can be used with an end effector of a robotic arm for implantation using the robotic arm. In some embodiments, the surgical instrument is guided through an end effector for wirelessly guided screw insertion. In some embodiments, the surgical instrument includes a robotic screw driver that is used in conjunction with robotic and / or navigation guidance (which may include image guidance).

[0042] In some embodiments, the surgical system of this disclosure can be used to treat spinal conditions such as intervertebral disc degeneration, intervertebral disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures. In some embodiments, the surgical system of this disclosure can be used in conjunction with other bony and skeletal applications, including those related to 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 to the spine (including anterior, posterior, posterior midline, direct lateral, posterolateral, and / or anterolateral approaches) and various surgical approaches to other body regions. The surgical system of this disclosure can also be used alternatively with procedures for treating the lumbar, cervical, thoracic, sacral, and pelvic regions of the spine. The surgical system of this disclosure can also be used on animals, skeletal models, and other inanimate substrates, for example, for training, testing, and demonstration.

[0043] The surgical system of this disclosure can be more readily understood by referring to the following detailed description of embodiments in conjunction with the accompanying drawings, which 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 illustrated 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 said 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 said particular value forms another embodiment. It should also be understood that all spatial references, such as 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”.

[0044] As used in the specification and including the appended claims, “treatment” for a disease or condition means performing a surgical procedure that may involve 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 and 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 inhibiting 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.

[0045] 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. Exemplary embodiments of this disclosure are illustrated in detail in the accompanying drawings. [Turn to...] Figure 1-12 The following diagram shows the components of a spinal implantation system 10 according to the principles of this disclosure.

[0046] Components of the spinal implant system 10 may be made of biocompatible materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials and / or composites thereof. For example, components of the spinal implant system 10 may be made individually or collectively of materials such as: stainless steel alloys, aluminum, industrially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metal alloys (e.g., Nitinol), and superelastic-plastic metals (such as GUM). Ceramics and their composites (such as calcium phosphate (e.g., SKELITE™), 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 ether, polyamide) Polyimide, polyetherimide, polyethylene, epoxy resin), bone materials (including autologous grafts, allogeneic grafts, xenografts or transgenic cortical bone and / or cortical sponge bone and tissue growth or differentiation factors), partially absorbable materials (e.g., metal-calcium ceramic composites, PEEK-calcium ceramic composites, PEEK-absorbable polymer composites), fully absorbable materials (e.g., calcium 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.

[0047] The various components of the spinal implant system 10 may have material composites, including the materials described above, to achieve various desired characteristics, such as strength, rigidity, elasticity, compliance, biomechanical properties, durability, and radiopaqueness or imaging priority. The components of the spinal implant system 10 may also be made individually or collectively of heterogeneous materials, such as combinations of two or more of the materials described above. The components of the spinal implant system 10 may be integrally formed, integrally connected, or include fastening elements and / or devices, as described herein.

[0048] Spinal implant system 10 is used, for example, with fully open surgical procedures, minimally invasive surgical procedures (including percutaneous techniques), and mini-open surgical techniques to deliver and introduce instruments and / or spinal implants (such as bone fasteners) at a patient's surgical site (including, for example, the spine). In some embodiments, the spinal implant may include one or more components of one or more spinal structures (such as interbody devices, interbody fusion devices, bone fasteners, spinal rods, tethers, connectors, plates, and / or bone grafts) and may be used with a variety of surgical procedures (including surgical treatment of the cervical, thoracic, lumbar, and / or sacral regions of the spine).

[0049] The spinal implant system 10 includes surgical instruments, such as a surgical actuator 12. The surgical actuator 12 can be coupled with, for example, surgical instruments such as, surgical actuators 12. Figure 1 The end effector 200 shown is used together to utilize the robotic arm R ( Figure 26Implantation is performed. The surgical actuator 12 is guided through the end effector 200 for wireless guidance of insertion of a spinal implant, such as the bone fastener 100 as described herein.

[0050] The surgical actuator 12 includes components, such as an actuator shaft 14 extending along axis L between the proximal end 18 and the distal end 20, as... Figure 2 As shown. End 20 is configured for engagement with an implant (e.g., bone fastener 100), as... Figure 3 As shown. In some embodiments, end 20 may have different cross-sections, such as square, hexagonal, polygonal, triangular, star-shaped, or hexalfalcon-shaped. End 20 may have various surface textures, such as smooth, rough, arcuate, wavy, porous, semi-porous, pitted, polished, and / or textured. Shaft 14 includes a slot 114 configured to accommodate a component, such as key 116. Key 116 is configured to connect shaft 14 to a component as described herein to resist and / or prevent relative rotation.

[0051] Shaft 14 includes an outer surface 22. Surface 22 includes one or more reference surfaces 24, 24a. Surface 24 is disposed on shaft 14 at a selected distance from the distal end 20. Surface 24 can be image-guided detected and used to calculate the position of navigation component 280, surgical actuator 12, and / or bone fastener 100 as described herein during surgical procedures. Surface 24 is configured to connect to a portion of navigation component 280 to locate and / or track navigation component 280, surgical actuator 12, and / or bone fastener 100 during surgical procedures. Shaft 14 includes a diameter A1, and surface 24 includes a diameter A2. In some embodiments, diameter A2 is larger than diameter A1, such that surface 24 forms an edge 28, as... Figure 2 As shown. Edge 28 is configured to provide a stop for components (e.g., bushing 250) during assembly, as described herein. Bushing 250 is configured to connect navigation component 280 to surgical actuator 12. Bushing 250 includes flange 252 and flange 254 spaced apart from flange 252. Bushing 250 includes a recess 256 located between flanges 252 and 254. Bushing 250 includes an inner surface 258 defining an opening 260.

[0052] Surface 24a is disposed on shaft 14 at a selected distance from distal end 20. Surface 24a can be image-guided detected and used to calculate the positions of navigation component 280, surgical actuator 12, and / or bone fastener 100 as described herein during surgical procedures. Surface 24a is configured to connect to a portion of navigation component 280 to locate and / or track navigation component 280, surgical actuator 12, and / or bone fastener 100 during surgical procedures. Surface 24a includes a diameter A2a. In some embodiments, diameter A2a is larger than diameter A1, such that surface 24a forms an edge 28a, as... Figure 2 As shown.

[0053] A component, such as a sleeve 30, is configured to accommodate a shaft 14. The sleeve 30 extends along an axis L between ends 32 and 34. The sleeve 30 includes an inner surface 36 and an outer surface 38. Surface 36 defines a channel 40 coaxial with the axis L and configured to accommodate the shaft 14. Surface 36 includes an opening 37 configured to accommodate a key 116 for a keying connection between the shaft 14 and the sleeve 30, such as... Figure 12 As shown. The connection between shaft 14 and sleeve 30 allows axial translation of shaft 14 and sleeve 30, thereby preventing and / or resisting relative rotation. Surface 38 includes an opening 39 configured for alignment with a component such as sleeve 60 for relative axial translation, as described herein.

[0054] End portion 34 includes a deployable member, such as a chuck 42. The chuck 42 extends from end portion 34 and is configured for movement between a first configuration and a second configuration, as described herein. The chuck 42 includes an inner surface 44 defining a channel 46, such as... Figure 6 and 7 As shown. Channel 46 is coaxial with channel 40. Channel 46 has a cylindrical cross-sectional configuration. In some embodiments, channel 46 may have various cross-sectional configurations, such as elliptical, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and / or conical.

[0055] The chuck 42 includes a locking surface 48 defined by a plurality of radially outwardly extending cantilevered fingers 50. The fingers 50 are circumferentially arranged and equidistantly spaced. The fingers 50 are spaced apart by gaps 52. In one embodiment, the chuck 42 is flexible such that it is biased to a closed position as described herein for temporary locking between the chuck 42 and the bone fastener 100. The chuck 42 is configured to snap-fit ​​around an end, such as the head 102 of the bone fastener 100. As the chuck 42 is translated over the head 102 of the bone fastener 100, it moves from a closed position to an open position and returns to a closed position to temporarily capture the head 102.

[0056] The end 34 of the sleeve 30 includes an engagement surface 54 disposed near the collet 42. Surface 54 is configured for translating a member such as the sleeve 60, as described herein. Surface 54 includes a tapered configuration defining a ramp 56. Ramp 56 includes an inclined configuration from the end 34 to the collet 42. The sleeve 60 is configured to slidably engage the surface 54 to lock the collet 42, as described herein.

[0057] Sleeve 60 extends along axis L between proximal end 62 and distal end 64. Sleeve 60 includes an inner surface 66 and an outer surface 68. Surface 66 defines a channel 70 coaxial with axis L and configured to movably position sleeve 30. In one embodiment, inner surface 66 may have various surface configurations to enhance engagement with sleeve 30 and / or chuck 42, such as rough, arcuate, wavy, porous, semi-porous, pitted, polished, and / or textured.

[0058] End portion 62 includes a surface 72 that defines an elongated slot 74 configured for providing the pin 76, such as Figure 8 As shown. Pin 76 is provided with opening 39 and slot 74 for relative axial translation. Slot 74 extends a distance x along a portion of sleeve 60 between ends 74a and 74b.

[0059] The sleeve 60 is configured to lock the chuck 42 to the head 102 together, as discussed herein, for releasable fixation to the bone fastener 100. The end 64 slidably engages with the surface 54. The surface 54 is movably positioned within the channel 70 to move between a configuration in which the surface 54 is spaced apart from the channel 70 and a configuration in which the surface 54 is positioned within the channel 70 adjacent to the chuck 42 to lock the chuck 42. As the end 64 translates axially along the surface 54, the finger 50 is further driven inward by the force of the sleeve 60 engaging the surface 54, such that the finger 50 can move to a locked position around the head 102.

[0060] The sleeve 60 includes a diameter D1, and the chuck 42 includes a diameter D2. The diameter D1 is approximately 8.0 mm to approximately 8.99 mm for insertion through the end effector 200, whose inner diameter D4 is approximately 8.5 mm to approximately 10.0 mm. Diameters D1 and D2 are slightly larger than the proximal end diameter D3 of the bone fastener 100, such as... Figure 9 As shown, when the sleeve 60 is translated over the surface 54, the sleeve 60 compresses the chuck 42 to reduce the diameter D2 to approximately the diameter D1. This configuration allows the bone fastener 100 and the surgical actuator 12 to pass through the end effector 200, as described herein.

[0061] The surgical actuator 12 includes an actuator 80 connected to sleeves 30 and 60. The actuator 80 includes a coupling member 82 and a knob 84. The coupling member 82 includes an inner surface 86. Surface 86 includes one or more pins 76 extending therefrom to connect the actuator 80 to sleeves 30, 60, as described herein. The coupling member 82 includes a threaded portion 88. The knob 84 includes a threaded inner surface 90 configured to rotatably engage the threaded portion 88 to allow axial translation of sleeve 30 relative to sleeve 60, thereby releasably locking the chuck 42 to the bone fastener 100, as discussed herein.

[0062] Actuator 80 is engaged to cause relative translation of sleeves 30, 60. For example, to secure surgical actuator 12 with bone fastener 100, knob 84 is rotated clockwise, as... Figure 9 As indicated by arrow B. Rotation of knob 84 clockwise causes connecting member 82 to move along... Figure 9 Translation in the direction indicated by arrow E. The connection between connecting member 82 and sleeve 30 via pin 76 causes sleeve 30 to simultaneously move along... Figure 9 Translation in the direction indicated by arrow E. When pin 76 approaches end 74b, pin 76 causes sleeve 60 to move along... Figure 9 The translation in the direction indicated by arrow E in the document allows the distal end 64 to slidably engage the surface 54, and the surface 54 is positioned within the channel 70 adjacent to the chuck 42 to lock the chuck 42, as described herein.

[0063] To disengage the surgical actuator 12 from the bone fastener 100, rotate the knob 84 counterclockwise, as follows. Figure 9 As indicated by arrow C, this causes the connecting member 82 to move along... Figure 9 Translation in the direction indicated by arrow D. The connection between connecting member 82 and sleeve 30 via pin 76 causes sleeve 30 to simultaneously move along... Figure 9 Translation in the direction indicated by arrow D. When pin 76 approaches end 74a, pin 76 causes sleeve 60 to move along... Figure 9 The translation in the direction indicated by arrow D in the document allows the distal end 64 to slidably disengage from the surface 54, and the surface 54 to be spaced apart from the channel 70 to release the chuck 42, as described herein.

[0064] The bone fastener 100 includes a head 102 configured to engage with a shaft 14 and an elongated shaft 104 configured to penetrate tissue. The head 102 includes a spherical configuration. The head 102 includes an outer circumferential surface having a generally spherical configuration. The head 102 includes an inner surface 108 defining a cavity, such as a mating surface 110. The mating surface 110 is configured to accommodate instrument and / or tool extensions, such as the end 20 of the shaft 14, as discussed herein. The mating surface 110 is centrally positioned relative to the head 102. The mating surface 110 is coaxial with the axis L. In some embodiments, the mating surface 110 may have various cross-sectional configurations, such as elliptical, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular, and / or tapered. In some embodiments, the inner surface 108 may have various surface configurations (e.g., smooth) and / or surface configurations to enhance engagement with the mating surface of the shaft 14, such as rough, arcuate, wavy, porous, semi-porous, pitted, polished and / or textured.

[0065] Shaft 104 has a cylindrical cross-sectional configuration and includes an outer surface with an external thread. In some embodiments, the thread may include a single threaded loop or multiple discrete threads. In some embodiments, other engagement structures may be provided on shaft 104, such as nail constructions, barbs, unfolding elements, protrusions, and / or spikes, so that shaft 104 engages with tissues such as vertebrae.

[0066] In some embodiments, all or only a portion of the shaft 104 may have alternative cross-sectional configurations, such as elliptical, rectangular, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, wavy, arcuate, variable, and / or conical. In some embodiments, the outer surface may include one or more openings. In some embodiments, all or only a portion of the outer surface may have alternative surface configurations for enhancing fixation to tissue, such as rough, arcuate, wavy, mesh-like, porous, semi-porous, pitted, and / or textured. In some embodiments, all or only a portion of the shaft 104 may be arranged relative to the longitudinal axis of the bone fastener 100 in alternative orientations (e.g., transverse, vertical, and / or other angular orientations, such as acute or obtuse angles, coaxial), and / or may be offset or staggered. In some embodiments, all or only a portion of the shaft 104 may be cannulated.

[0067] In some embodiments, the spinal implant system 10 includes a method of assembling components of the surgical actuator 12, such as... Figure 13-24 As shown, the method includes the step of attaching the bushing 250 to the shaft 14. The distal end 20 is inserted into the opening 260 such that the bushing 250 extends along the shaft 14 from the distal end 20 along... Figure 14 Translation is indicated by arrow G. The inner diameter of opening 260 allows for relative translation of the portion of shaft 14 with diameter A1, as shown by... Figure 2 and 14 As shown. The bushing 250 is translated to engage with the edge 28, as... Figure 14 As shown. The inner diameter of the bushing 250 is smaller than the diameter A2 of the surface 24 to resist and / or prevent the bushing 250 from crossing the edge 28 and translating along the surface 24. The edge 28 prevents further translation of the bushing 250, such that the inner surface 258 does not contact the surfaces 24, 24a during assembly to resist and / or prevent damage to the surfaces 24, 24a. The bushing 250 is selectively disposed adjacent to the shaft 14 to position the navigation component 280 relative to the surface 24 for image guidance.

[0068] Insert key 116 into slot 114. Attach knob 84 by translating it from distal end 20 to position it adjacent to bushing 250, as shown. Figure 15-18 As shown. Insert retaining ring 310 to connect knob 84 to shaft 14, as shown. Figure 17 As shown. The sleeve 60 is connected by inserting the distal end 20 into the channel 70 and translating the sleeve 60 along the axis 14 to engage with the knob 84, as shown. Figure 19 As shown. The sleeve 30 is attached by inserting it into the channel 70 and translating it so that the opening 37 aligns with the key 116, as shown. Figure 20 As shown. The connecting member 82 is attached by translating it along the sleeve 60 to engage with the knob 84 in a threaded manner, as... Figure 21 and 22 As shown. Pin 76 is inserted into opening 39 and slot 74 to connect connecting member 84 to sleeves 30 and 60, as follows. Figure 23 and 24 As shown.

[0069] Will as Figure 25 The navigation component 280 shown is assembled with the surgical actuator 12. The navigation component 280 includes a collar 282 having an inner surface 284 and an outer surface 286. Surface 284 defines a channel 288. Surface 284 is configured for releasable engagement with a bushing 250. Channel 288 is configured to receive a portion of the shaft 14 and the bushing 250. The collar 282 includes a lock, such as at least one resilient tip or tab 290. The navigation component 280 is translated from the proximal end 18 to engage with surfaces 24, 24a and connected to the bushing 250 via the tab 290.

[0070] In assembly, operation, and use, the spinal implant system 10, similar to the systems and methods described herein, is used in conjunction with surgical procedures (e.g., treatment of applicable conditions or injuries to the affected segment of the spine and adjacent areas within the body). In some embodiments, one or all of the components of the spinal implant system 10 may be delivered or utilized as a pre-assembled device, or may be assembled in situ. The spinal implant system 10 may be completely or partially modified, removed, or replaced.

[0071] Navigation component 280 is oriented relative to sensor array 302, such as Figure 26 As shown, this is to facilitate communication between the navigation component 280 and the sensor array 302 during surgical procedures as described herein. The navigation component 280 is configured to generate signals representing the position of the bone fastener 100 relative to the surgical actuator 12 and / or tissue. In some embodiments, the image guide may include human-readable visual markers, human-readable tactile markers, human-readable auditory markers, one or more components having markers 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 that generate acoustic, magnetic, electromagnetic, and / or radiographic signals.

[0072] The navigation component 280 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. In some embodiments, the signals generated by the transmitter array 304 represent the position of the bone fastener 100 relative to the surgical actuator 12 and relative to tissue, such as bone. In some embodiments, the signals generated by the transmitter array 304 represent the three-dimensional position of the bone fastener 100 relative to 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 surgical actuator 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 surgical actuator 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., which has a business location 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 substantially 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 that generates a three-dimensional view of the patient. The position of the image capture portion 314 can be precisely known relative to any other part of the imaging apparatus of the surgical navigation system 306. In some embodiments, precise knowledge of the position of the image capture portion 314 may be used in conjunction with a 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 which 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 surgical actuator 12, and / or trackable 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] The surgical actuator 12 is configured for use with a guiding member, such as an end effector 200 of a robotic arm R. The end effector 200 includes an inner surface 202 defining a cavity (e.g., channel 204). The channel 204 is configured to allow the bone fastener 100 to pass through and to position the surgical actuator 12. The robotic arm R includes position sensors (not shown, similar to those referenced herein) that measure, sample, capture, and / or identify position data points of the end effector 200 in three-dimensional space for wirelessly guiding the bone fastener 100 into tissue. In some embodiments, the position sensors of the robotic arm R are used in conjunction with a surgical navigation system 306 to combine the measurement, sampling, capture, and / or identification of position data points of the end effector 200 as described herein in surgical procedures. The position sensors are mounted on the robotic arm R and calibrated to measure position data points of the end effector 200 in three-dimensional space, which are transmitted to a computer 308.

[0082] The shaft 14 is aligned with the mating surface 110 of the bone fastener 100. The chuck 42 snaps into place around the head 102 to temporarily capture it. The actuator 80 is rotatable to cause relative translation of the sleeves 30, 60. For example, rotating the knob 84 clockwise causes translation of the connecting member 82 and the sleeve 60, as described herein. The end 64 slidably engages the surface 54 to drive the finger 50 inward to a locked position around the head 102, as described herein, to secure the surgical actuator 12 with the bone fastener 100. As the sleeve 60 translates over the surface 54, it compresses the chuck 42 to reduce the diameter D2 to approximately the diameter D1. This configuration allows the bone fastener 100 and the surgical actuator 12 to pass through the end effector 200.

[0083] Navigation component 280 is oriented relative to sensor array 302, such as Figure 26 As shown, this allows for communication between the navigation component 280 and the sensor array 302 during the surgical procedure. This configuration provides markings or displays of the components of the spinal implant system 10 (including the bone fastener 100 and surgical actuator 12) from the surgical navigation system 306 as described herein, and their relative positions to the surgical treatment and tissue. The surgical actuator 12 is inserted through the end effector 200 to be inserted into the surgical site.

[0084] Bone fastener 100 is inserted into the surgical site, and surgical actuator 12 is disengaged from bone fastener 100. To disengage surgical actuator 12 from bone fastener 100, actuator 80 is rotated in opposite directions to cause sleeves 30, 60 to translate relative to each other in opposite directions, thereby disengaging clamp 42 from head 102. Knob 84 is rotated counterclockwise to cause translation of connecting member 82, as described herein. Distal end 64 is slidably disengaged from surface 54, and surface 54 is spaced from channel 70 to release clamp 42 from head 102, as described herein. Surgical actuator 12 is then removed from the surgical site.

[0085] In some embodiments, the spinal implant system 10 includes an agent that may be disposed, encapsulated, coated, or layered within, over, or around components and / or surfaces of the spinal implant system 10. In some embodiments, the agent may include a bone growth promoting material, such as a bone graft, to enhance fixation of components and / or surfaces 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.

[0086] After the procedure is completed, the surgical instruments, components, and non-implanted parts of the spinal implant system 10 are removed from the surgical site, and the incision is closed. One or more components of the spinal implant system 10 may be made of a radiation-permeable 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 surgical actuator 12 is guided to the surgical site via a guidewire (e.g., a Kirschner wire, not shown) and / or without the use of an image guide as described herein.

[0087] 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. Those skilled in the art will envision other modifications within the scope and spirit of the appended claims.

Claims

1. A surgical instrument comprising: A first component, which is engageable with a fastener and includes a slot in which a key is provided; A second component, the second component including a deployable portion configured to capture the fastener; A third component, which can engage with the deployable portion to releasably secure the fastener; as well as An actuator connected to the second member and the third member, the actuator including a threaded inner surface and a threaded coupling member, the threaded coupling member being capable of engaging the threaded inner surface to facilitate axial translation of the second member relative to the third member; The second component includes a sleeve and a mating surface disposed between the sleeve and the deployable portion; The sleeve includes an inner surface with an opening, and a key for a bonding connection between the first component and the sleeve is disposed within the opening; and The first component is bonded to the second component to facilitate translation of the second component relative to the first component.

2. The surgical instrument of claim 1, wherein the deployable portion includes a deployable clamp that can engage with the fastener.

3. The surgical instrument of claim 1, wherein the deployable portion moves together with the fastener between a first closed position and a second open position.

4. The surgical instrument of claim 1, wherein the engagement surface comprises a tapered configuration.

5. The surgical instrument of claim 1, wherein the engagement surface defines a ramp.

6. The surgical instrument of claim 1, wherein the distal end of the third member is slidably engaged with the engagement surface to lock the deployable portion together with the fastener.

7. The surgical instrument of claim 1, wherein the third component includes a channel, and the engagement surface is movably positioned within the channel to move between a first configuration in which the engagement surface is spaced apart from the channel and a second configuration in which the engagement surface is positioned within the channel.

8. The surgical instrument of claim 1, further comprising a pin connecting the second member and the third member to facilitate relative axial translation.

9. The surgical instrument of claim 8, wherein the third member includes a slot configured to accommodate the pin, the slot extending along the third member to allow the pin to translate within the slot during translation of the third member relative to the second member.

10. The surgical instrument of claim 1, wherein the first component is connected to the second component to prevent the first component from rotating relative to the second component.

11. A surgical system comprising: The fastener includes a first end having a recess and a second end configured to penetrate tissue; as well as The surgical instrument as described in claim 2; The first component can be engaged with the socket; The clamp is configured to capture the first end; The third component can engage with the chuck to releasably capture the fastener; and The actuator includes a knob with a threaded inner surface and a threaded connecting member that engages with the threaded inner surface to actuate the second member relative to the third member in an axial translation.

12. A surgical system comprising: The fastener includes a first end having a recess and a second end configured to penetrate tissue; as well as The surgical instrument as described in any one of claims 1, 3 to 10; The first component can be engaged with the socket; The second component includes a clamp configured to capture the first end. The third component can engage with the chuck to releasably capture the fastener; and The actuator includes a knob with a threaded inner surface and a threaded connecting member that engages with the threaded inner surface to actuate the second member relative to the third member in an axial translation.

Images