Spinal implant system and method
By combining surgical instruments with sleeves and knobs with porous lattice implants, the problems of implant fixation and stability in the treatment of spinal diseases have been solved, achieving flexible multi-angle insertion and stability, and making it suitable for surgical procedures of various spinal diseases.
Patent Information
- Application Number
- CN201980095753.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-04-26
- Filing Date
- 2019-10-21
- Publication Date
- 2026-02-27
- Estimated Expiration
- 2039-10-21
AI Technical Summary
Existing treatments for spinal disorders, such as medication and rehabilitation exercises, may not be effective in relieving symptoms such as deformity, pain, and nerve damage, and the need for fixation and stability of implants during surgery is not adequately met.
A surgical instrument comprising a sleeve, a knob, and a shaft is designed. The sleeve engages with the implant through its channel and joint, and the rotation of the knob achieves stable fixation of the implant. Combined with a porous lattice implant and a ratchet mechanism of the inserter, it allows for multi-angle insertion and prevents implant detachment.
It achieves stable fixation and multi-angle insertion of spinal implants, improves the operational flexibility of surgery and the stability of implants, and is suitable for the treatment of a variety of spinal diseases.
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Figure CN113747862B_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present disclosure relates generally to medical devices for treating musculoskeletal conditions, and more particularly to spinal implant systems including implants and instruments configured to deliver the implants during a surgical procedure. BACKGROUND
[0002] Spinal pathologies and conditions, such as scoliosis and other curvature abnormalities, kyphosis, degenerative disc conditions, herniated discs, osteoporosis, spondylolisthesis, stenosis, tumors, and fractures can result from factors including trauma, disease, and degenerative conditions resulting from injury and aging. Spinal conditions often result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility.
[0003] Non-surgical treatments, such as medication, rehabilitation, and exercise, can be effective, however, can fail to alleviate symptoms associated with these conditions. Surgical treatment of these spinal conditions includes correction, fusion, fixation, discectomy, laminectomy, and implantable prosthetics. As part of these surgical treatments, spinal constructs, such as bone fasteners, plates, and intervertebral devices, can be used to provide stability to a treatment area. For example, during a surgical treatment, an intervertebral implant can be delivered to a surgical site to be fixed with bone to immobilize a joint. A bone fastener extends through a plate and / or intervertebral device and into bone to secure at least a portion of the plate and / or intervertebral device to the bone. The present disclosure describes improvements to these prior art techniques. SUMMARY
[0004] In one implementation, in accordance with principles of the present disclosure, a surgical instrument includes a sleeve extending along a longitudinal axis between opposite proximal and distal ends. An inner surface of the sleeve defines a channel. The distal end defines an engagement portion. The engagement portion includes an engagement surface extending from a first end to an opposite second end. The engagement portion includes a peg extending outwardly from the first end. The engagement portion includes an opening extending through the second end. The opening is in communication with the channel. A knob is coupled to the proximal end of the sleeve. A shaft includes a proximal end and an opposite distal end. The distal end of the shaft includes a mating portion. The mating portion extends through the opening. The proximal end of the shaft is coupled to the knob. The knob is rotatable relative to the sleeve to rotate the shaft relative to the sleeve.
[0005] In one embodiment, in accordance with principles of the present disclosure, a surgical system includes a spinal implant including opposing first and second vertebral engagement surfaces. The implant includes opposing posterior and anterior surfaces each extending from the first vertebral engagement surface to the second vertebral engagement surface. The anterior surface includes spaced apart first and second cavities. A surgical instrument includes a sleeve extending along a longitudinal axis between opposing proximal and distal ends. An inner surface of the sleeve defines a channel. The distal end defines an engagement portion. The engagement portion includes an engagement surface extending from a first end to an opposing second end. The engagement portion includes a peg extending outwardly from the first end. The peg is positioned in the first cavity. The engagement portion includes an opening extending through the second end. The opening is in communication with the channel. A knob is coupled to the proximal end of the sleeve. A shaft includes a proximal end and an opposing distal end. The distal end of the shaft includes a mating portion. The proximal end of the shaft is coupled to the knob. The knob is rotatable relative to the sleeve to translate the shaft between a first orientation in which the mating portion is positioned within the channel and a second orientation in which the mating portion mates with the mating surface of the second cavity.
[0006] In one embodiment, in accordance with principles of the present disclosure, a surgical instrument includes an outer sleeve extending along a longitudinal axis between opposing proximal and distal ends. An inner surface of the sleeve defines a channel. The distal end defines an engagement portion. The engagement portion includes an engagement surface extending from a first end to an opposing second end. The first end includes a first cavity in communication with the channel. The second end includes a second cavity. An inner sleeve is rotatably positioned within the channel. The inner sleeve includes an outer surface engaged with the inner surface of the outer sleeve and an inner surface defining a female threaded form. A knob is coupled to the proximal end of the sleeve. The knob is rotatable relative to the outer sleeve to rotate the inner sleeve relative to the outer sleeve.
[0007] In one embodiment, in accordance with principles of the present disclosure, a spinal implant includes a body including opposing first and second end walls and opposing first and second side walls. The side walls each extend from the first end wall to the second end wall. A first cap is coupled to a top end of the walls. A second cap is coupled to a bottom end of the walls. The implant includes an opening extending through the caps such that the first cap defines a first ledge extending from the walls to the opening and the second cap defines a second ledge extending from the walls to the opening.
[0008] In one embodiment, in accordance with principles of the present disclosure, a spinal implant includes a body including opposing first and second end walls and opposing first and second side walls. The side walls each extend from the first end wall to the second end wall. The first side wall defines a first window. The second side wall defines a second window. Interior surfaces of the walls define a cavity. A core is positioned in the cavity such that the core is visible through the windows. A first cap is coupled to a top end of the walls. A second cap is coupled to a bottom end of the walls. The implant includes an opening extending through the caps such that the first cap defines a first ledge extending from the walls to the opening and the second cap defines a second ledge extending from the walls to the opening.
[0009] In one embodiment, in accordance with principles of the present disclosure, a spinal implant includes a body including opposing first and second end walls and opposing first and second side walls. The side walls each extend from the first end wall to the second end wall. The first side wall defines a first window. The second side wall defines a second window. Interior surfaces of the walls define a cavity. A core is positioned in the cavity such that the core is visible through the windows. The core has a lattice configuration. A first cap is coupled to a top end of the walls. A second cap is coupled to a bottom end of the walls. The implant includes an opening extending through the caps such that the first cap defines a first ledge extending from the walls to the opening and the second cap defines a second ledge extending from the walls to the opening. The ledges each extend circumferentially around the opening. A bone graft is positioned between the first and second ledges. The caps each include a plurality of apertures. The apertures have a hexagonal configuration. The core is fused together with the body and the caps. A maximum diameter of the cavity is greater than a maximum diameter of the opening. BRIEF DESCRIPTION OF DRAWINGS
[0010] The present disclosure will become more apparent from the detailed description given below, in conjunction with the accompanying drawings, wherein:
[0011] Figure 1 is a side view of a first component and a second component of a spinal system in accordance with principles of the present disclosure;
[0012] Figure 2 is a perspective view of a first component of a spinal system in accordance with principles of the present disclosure; Figure 1 is a side cross-sectional view of the first component of the spinal system shown, the first component coupled to a second component of the spinal system, one embodiment;
[0013] Figure 3 is a perspective view of a first component of a spinal system in accordance with principles of the present disclosure; Figure 1 is a perspective exploded view of the first component of the spinal system shown, with parts in phantom;
[0014] Figure 4 is a perspective exploded view of the first component of the spinal system shown, with parts separated; Figure 1
[0015] Figure 4A isFigure 1 side view of the first component of the spinal system shown, with portions in phantom;
[0016] Figure 4B is Figure 1 side view of the first component of the spinal system shown, with portions in phantom;
[0017] Figure 5 is Figure 1 side view of the first component of the spinal system shown, with portions in phantom;
[0018] Figure 6 is Figure 1 side view of the first component of the spinal system shown, with portions in phantom;
[0019] Figure 7 is Figure 1 perspective view of the first component of the spinal system shown;
[0020] Figure 8 is Figure 1 side view of the first and second components of the spinal system shown;
[0021] Figure 9 is Figure 2 side view of the first and second components of the spinal system shown;
[0022] Figure 10 is Figure 2 side view of the first and second components of the spinal system shown;
[0023] Figure 11 is a plan view showing Figure 1 plan view of the first and second components of the spinal system shown, with vertebrae disposed in different orientations; Figure 1 first and second components of the spinal system shown;
[0024] Figure 12 is an embodiment of a first component of a spinal system according to the principles of the present disclosure Figure 1 perspective view of a distal end of one embodiment of the first component of the spinal system shown;
[0025] Figure 13 is an embodiment of a first component of a spinal system according to the principles of the present disclosure Figure 1 perspective view of a distal end of one embodiment of the first component of the spinal system shown;
[0026] Figure 14 is an embodiment of a second component of a spinal system according to the principles of the present disclosure Figure 1 side view of one embodiment of the second component of the components of the spinal system shown;
[0027] Figure 15 is Figure 14a side view exploded cross-sectional view of a second assembly, the second assembly coupled to Figure 1 a first assembly of a spinal system as shown;
[0028] Figure 16 is Figure 14 a side view exploded cross-sectional view of a second assembly, the second assembly coupled to Figure 1 a first assembly of a spinal system as shown;
[0029] Figure 17 is Figure 14 a perspective exploded view of a second assembly, the second assembly coupled to Figure 1 a first assembly of a spinal system as shown;
[0030] Figure 18 is an embodiment of a second assembly of a spinal system according to the principles of the present disclosure Figure 1 a perspective view of an embodiment of a second assembly of a spinal system as shown;
[0031] Figure 19 is an embodiment of a first assembly of a spinal system according to the principles of the present disclosure Figure 1 a perspective exploded view of an embodiment of a first assembly of a spinal system as shown;
[0032] Figure 20 is Figure 19 a perspective view of a first assembly, the first assembly coupled to Figure 18 a second assembly as shown;
[0033] Figure 21 is Figure 19 a perspective view of a first assembly, the first assembly coupled to Figure 18 a second assembly as shown;
[0034] Figure 22 is an embodiment of a first assembly of a spinal system according to the principles of the present disclosure Figure 1 a perspective view of an embodiment of a first assembly of a spinal system as shown;
[0035] Figure 23 is Figure 19 a perspective view of a first assembly, the first assembly coupled to Figure 22 a second assembly as shown;
[0036] Figure 24 is Figure 19 a perspective view of a first assembly, the first assembly coupled to Figure 22 a second assembly as shown;
[0037] Figure 25 is an embodiment of a first assembly of a spinal system according to the principles of the present disclosure Figure 1 a perspective exploded view of an embodiment of a first assembly of a spinal system as shown;
[0038] Figure 26 It is based on the principles of this disclosure. Figure 1 A perspective view of one embodiment of the second component of the spinal system shown;
[0039] Figure 27 yes Figure 25 The top exploded view of the first component shown, which is connected to... Figure 26 The second component shown;
[0040] Figure 28 It is based on the principles of this disclosure. Figure 1 A perspective view of one embodiment of the second component of the spinal system shown;
[0041] Figure 29 yes Figure 28 The top exploded view of the second component shown, which is connected to... Figure 1 The first component of the spinal system shown;
[0042] Figure 30 yes Figure 28 The top exploded view of the second component shown, which is connected to... Figure 1 The first component of the spinal system shown;
[0043] Figure 31 yes Figure 28 The top exploded view of the second component shown, which is connected to... Figure 1 The first component of the spinal system shown;
[0044] Figure 32 yes Figure 28 The top exploded view of the second component shown, which is connected to... Figure 1 The first component of the spinal system shown;
[0045] Figure 33 It is based on the principles of this disclosure. Figure 1 A top exploded view of one embodiment of the first component of the spinal system shown, the first component being coupled to Figure 1 One embodiment of the second component of the spinal system shown;
[0046] Figure 34 It is based on the principles of this disclosure. Figure 1 A top exploded view of one embodiment of the first component of the spinal system shown, the first component being coupled to Figure 1 One embodiment of the second component of the spinal system shown;
[0047] Figure 35 It is based on the principles of this disclosure. Figure 1 A top exploded view of one embodiment of the spinal system components shown, the components being coupled to Figure 1One embodiment of a second assembly of a spinal system shown;
[0048] Figure 36 is in accordance with the principles of the present disclosure Figure 1 Perspective view of one embodiment of a second assembly of a spinal system shown;
[0049] Figure 37 is in accordance with the principles of the present disclosure Figure 36 Perspective view of a second assembly shown;
[0050] Figure 38 is in accordance with the principles of the present disclosure Figure 36 Perspective cross-sectional view of a second assembly shown;
[0051] Figure 39 is in accordance with the principles of the present disclosure Figure 36 Perspective view of a second assembly shown with parts separated;
[0052] Figure 40 is in accordance with the principles of the present disclosure Figure 36 Perspective view of a second assembly shown with parts separated;
[0053] Figure 40A is in accordance with the principles of the present disclosure Figure 36 Detail view of a portion of a second assembly shown;
[0054] Figure 40B is in accordance with the principles of the present disclosure Figure 36 Graph showing structural properties of a portion of a second assembly shown;
[0055] Figure 40C is in accordance with the principles of the present disclosure Figure 36 User interface showing structural properties of a portion of a second assembly shown;
[0056] Figure 41 is in accordance with the principles of the present disclosure Figure 36 Perspective view of a second assembly shown with parts separated;
[0057] Figure 42 is in accordance with the principles of the present disclosure Figure 1 Perspective view of one embodiment of a second assembly of a spinal system shown;
[0058] Figure 43 is in accordance with the principles of the present disclosure Figure 42 Front view of a second assembly shown;
[0059] Figure 44 is in accordance with the principles of the present disclosure Figure 42 Top view of a second assembly shown;
[0060] Figure 45 is in accordance with the principles of the present disclosure Figure 42 Bottom view of a second assembly shown;
[0061] Figure 46 is in accordance with the principles of the present disclosure Figure 42a side view of the second assembly shown;
[0062] Figure 47 is Figure 42 a rear view of the second assembly shown;
[0063] Figure 48 is Figure 1 a perspective view of one embodiment of the second assembly of the spinal system shown;
[0064] Figure 49 is Figure 48 a front view of the second assembly shown;
[0065] Figure 50 is Figure 48 a top view of the second assembly shown;
[0066] Figure 51 is Figure 48 a bottom view of the second assembly shown;
[0067] Figure 52 is Figure 48 a side view of the second assembly shown;
[0068] Figure 53 is Figure 48 a rear view of the second assembly shown;
[0069] Figure 54 is Figure 1 a perspective view of one embodiment of the second assembly of the spinal system shown;
[0070] Figure 55 is Figure 54 a front view of the second assembly shown;
[0071] Figure 56 is Figure 54 a top view of the second assembly shown;
[0072] Figure 57 is Figure 54 a bottom view of the second assembly shown;
[0073] Figure 58 is Figure 54 a side view of the second assembly shown;
[0074] Figure 59 is Figure 54 a rear view of the second assembly shown;
[0075] Figure 60 is Figure 1 a perspective view of one embodiment of the second assembly of the spinal system shown;
[0076] Figure 61 yes Figure 60 The front view of the second component is shown;
[0077] Figure 62 yes Figure 60 A top view of the second component shown;
[0078] Figure 63 yes Figure 60 The bottom view of the second component shown;
[0079] Figure 64 yes Figure 60 The side view of the second component shown;
[0080] Figure 65 yes Figure 60 The rear view of the second component shown;
[0081] Figure 66 It is based on the principles of this disclosure. Figure 1 A perspective view of one embodiment of the second component of the spinal system shown;
[0082] Figure 67 yes Figure 66 The front view of the second component is shown;
[0083] Figure 68 yes Figure 66 A top view of the second component shown;
[0084] Figure 69 yes Figure 66 The bottom view of the second component shown;
[0085] Figure 70 yes Figure 66 The side view of the second component shown;
[0086] Figure 71 yes Figure 66 The rear view of the second component shown;
[0087] Figure 72 It is based on the principles of this disclosure. Figure 1 A perspective view of one embodiment of the second component of the spinal system shown;
[0088] Figure 73 yes Figure 72 The front view of the second component is shown;
[0089] Figure 74 yes Figure 72 A top view of the second component shown;
[0090] Figure 75 yes Figure 72 The bottom view of the second component shown;
[0091] Figure 76 is Figure 72 a side view of the second assembly shown in FIG. 2;
[0092] Figure 77 is Figure 72 a back view of the second assembly shown in FIG. 2;
[0093] Figure 78 is a perspective view of one embodiment of a second assembly of a spinal system in accordance with the principles of the present disclosure; Figure 1
[0094] Figure 79 is a front view of the second assembly shown in FIG. 2; Figure 78
[0095] Figure 80 is a top view of the second assembly shown in FIG. 2; Figure 78
[0096] Figure 81 is a bottom view of the second assembly shown in FIG. 2; Figure 78
[0097] is a side view of the second assembly shown in FIG. 2; and Figure 82 Figure 78
[0098] Figure 83 is a back view of the second assembly shown in FIG. 2. Figure 78 DETAILED DESCRIPTION
[0099] Exemplary embodiments of the disclosed spinal system and related methods of use are discussed in relation to medical devices for treating musculoskeletal conditions, and more particularly in relation to surgical systems and methods for treating the spine. In some embodiments, the systems and methods of the present disclosure include medical devices comprising surgical instruments and implants for use in, for example, surgically treating the cervical, thoracic, lumbar, and / or sacral regions, as described herein.
[0100] In some embodiments, the present surgical system includes a spinal implant having graft containment overhangs. The overhangs catch the graft to prevent loss of the graft during obstruction. In some embodiments, the implant includes a porous lattice optimized for strength while allowing a large graft volume to be placed between the graft containment overhangs. In some embodiments, the implant includes fully enclosed screw slots to prevent interference of the bone screws inserted into the slots with the graft, and vice versa.
[0101] In some embodiments, an implant includes a solid body having a rim, a marker, a nose, and an inserter, and a screw attachment geometry. The implant includes a core configured to be positioned within a cavity of the body. The core includes a structural lattice that reduces stiffness and opacity while maintaining strength. The implant includes a top cap and a bottom cap that are each coupled to the body when the core is positioned within the body. In some embodiments, at least one of the cap includes a trabecular structure having an interconnecting porosity optimized for ingrowth and outgrowth. In some embodiments, the cap fuses with the core and the body to prevent delamination of the implant. In some embodiments, the structural lattice of the core is a diamond lattice produced by 3D printing to provide superior buildability, superior strength, reduced internal stress, and is suitable for various spinal implant types of geometry.
[0102] A surgical system includes an inserter configured to insert an implant between vertebrae during a surgical procedure using a selected surgical approach and / or at a selected angle. For example, in some embodiments, a single inserter can be used to insert a single implant between vertebrae using four different surgical approaches (e.g., an approach for anterior lumbar interbody fusion (ALIF), an approach for oblique lateral interbody fusion at L5-S1 (OLIF 5-1), an approach for oblique lateral interbody fusion at L2-L5 (OLIF 2-5), and an approach for direct lateral interbody fusion (DLIF)), as described herein. Indeed, the inserter includes a low profile attachment geometry suitable for navigation and allows for multiple insertion angles and designs. That is, a single inserter can be used to deliver multiple different implants to a target site using different surgical approaches and / or at different angles. In some embodiments, the inserter includes a ratchet mechanism that prevents the implant from being improperly dislodged from the inserter prior to and during any obstruction.
[0103] In some embodiments, the implant includes an arcuate surface configured to engage with an arcuate surface of an inserter to couple the inserter to the implant. In some embodiments, when the arcuate surface of the inserter engages the arcuate surface of the implant, the pegs and shaft of the inserter are positioned within a cavity, such as a threaded cavity of the implant. A line intersecting an end point of the arcuate surface of the implant and an arc center of the arcuate surface of the implant can be flipped. Thus, if the implant is attached to a handle of the inserter, a given angle of attachment will change. In effect, the arcuate surface of the implant can be flipped after coupling the inserter to the implant to couple the inserter to the implant, thereby changing the insertion angle of the inserter. In some embodiments, the pegs and shaft of the inserter are configured to be positioned in the threaded cavity of the implant before and after the inserter is flipped. In some embodiments, the geometry of the implant configured for an OLIF 5-1 procedure and the geometry of the implant configured for an OLIF 2-5 procedure allow for the insertion of both implants using a single inserter, thereby allowing for further instrument integration. That is, the arcuate surface of a single inserter can match the arcuate surface of the implant configured for an OLIF 5-1 procedure and the arcuate surface of the implant configured for an OLIF 2-5 procedure. When the arcuate surface of the inserter engages the arcuate surface of the implant configured for an OLIF 5-1 procedure, the pegs and rod of the inserter are positioned in the threaded cavity of the implant configured for an OLIF 5-1, and when the arcuate surface of the inserter engages the arcuate surface of the implant configured for an OLIF 2-5 procedure, the rod and pegs of the inserter are positioned in the threaded cavity of the implant configured for an OLIF 2-5 procedure. In some embodiments, the pegs of the inserter provide a connection strength between the inserter and the implant.
[0104] In some embodiments, the inserter engages the implant such that an outer bone screw extending through the implant is accessible when the inserter engages the implant, as discussed herein. In some embodiments, the inserter includes a planar contact that engages a surface of the implant while the rod and pegs of the inserter are positioned in a threaded cavity of the implant to couple the inserter to the implant.
[0105] In some embodiments, features of the inserter are reversed from features of the implant. For example, the implant can include one or more pegs, such as threaded pegs that extend outwardly from a body of the implant. The pegs can be received within cavities of the inserter. When the pegs are received within the cavities, an arcuate surface of the inserter engages an arcuate surface of the implant to couple the inserter to the implant. In some embodiments, this allows for the use of larger threads. In some embodiments, a sleeve including a female thread form is rotatably positioned within one of the cavities of the inserter such that the female thread form mates with a male thread form of one of the pegs of the inserter to couple the inserter to the implant, as discussed herein.
[0106] In some embodiments, the arcuate surface of the inserter can be opposite the arcuate surface of the implant. For example, in some embodiments, the inserter can include a concave curved surface that engages a convex curved surface of the implant to couple the inserter to the implant. Alternatively, the inserter can include a convex curved surface that engages a concave curved surface of the implant to couple the inserter to the implant.
[0107] In some embodiments, the arcuate surface of the implant can include two or more cavities configured to house the peg of the inserter and the shaft of the inserter. For example, in one embodiment, the implant includes two cavities configured to house the peg of the inserter and the shaft of the inserter. In one embodiment, the implant includes three cavities configured to house the peg of the inserter and the shaft of the inserter such that one of the cavities is empty or unoccupied when the peg of the inserter and the shaft of the inserter are disposed in the other two cavities. This allows the implant to be disposed at three different angles relative to the inserter, as discussed herein. In some embodiments, the cavities are all located along the same arcuate path of the implant, the arcuate path of the implant coinciding with the arcuate center of the inserter. In some embodiments, at least one of the cavities is threaded.
[0108] In some embodiments, the arcuate surface of the inserter includes a central cutout configured to house a tab, such as a plate coupled to the implant, such that the inserter can be used to insert the implant by attaching to the plate of the implant, as discussed herein. In some embodiments, the arcuate surface of the inserter includes a central cutout configured to allow access to an internal thread that extends into or through the implant, such that the internal thread can be rotated relative to the implant when the internal thread extends into or through the implant and the inserter is attached to the implant.
[0109] In some embodiments, the inserter includes a ratchet knob that includes a first member or plate, such as a floating plate that engages a groove on a second plate of the inserter. In particular, a spring pushes the floating plate such that an extension of the floating plate engages the groove on the second plate to prevent the implant from coming loose undesirably when jammed. When the user rotates the ratchet knob, the floating plate rides in the groove, creating a resistance similar to a ratchet, as discussed herein.
[0110] In some embodiments, the surgical systems of the present disclosure can be used to treat spinal conditions such as intervertebral disc degeneration, herniated discs, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures. In some embodiments, the surgical systems of the present disclosure can be used in conjunction with other bone and bone-related applications, including those associated with diagnosis and therapy. In some embodiments, the disclosed surgical systems can alternatively be used in surgical treatments where the patient is in a prone or supine position, and / or using various surgical approaches to the spine, including anterior, posterior, posteromedial, direct lateral, posterolateral, and / or anterolateral approaches, as well as to other body regions. The surgical systems of the present disclosure can also alternatively be used in conjunction with surgical procedures for treating the lumbar, cervical, thoracic, sacral, and pelvic regions of the spine. The surgical systems of the present disclosure can also be used in animals, bone models, and other non-biological matrices, such as in training, testing, and demonstration.
[0111] The surgical systems of the present disclosure can be more readily understood through the following detailed description of the embodiments taken in conjunction with the accompanying figures, which form a part of this disclosure. It is to be understood that the application is not limited to the specific devices, methods, conditions or parameters described and / or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. In some embodiments, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. References to a particular numerical value include at least that particular value unless the context clearly dictates otherwise. Ranges can be expressed herein as from "about" or "approximately" one particular value and / or to "about" or "approximately" another particular value. In expressing a range, another embodiment includes from one particular value and / or to another particular value. Similarly, where values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It is also to be understood that all spatial references (e.g., horizontal, vertical, top, upper, lower, bottom, left, and right) are for illustrative purposes only and can vary during use. For example, references to "upper" and "lower" are relative and are for context only, and are not necessarily "higher" and "lower."
[0112] As used in the specification and the appended claims, "treating" or "treatment" of a disease or condition refers to performing an operation for the purpose of the alleviation of symptoms or effects of a disease or condition, whether or not a disease or condition is actually being alleviated. As used in the specification and the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage, and / or bone, unless specifically indicated otherwise. As used in the specification and the appended claims, the term "implant" includes a device that is implanted in a patient, whether or not the device is biodegradable or bioabsorbable.
[0113] The following discussion includes a description of surgical system including implants, related components, and methods employing the surgical system in accordance with the principles of the present disclosure. Alternative embodiments are also disclosed. Reference will be made to the exemplary implementation of the surgical system 100 illustrated in the drawings.
[0114] The components of the surgical system 100 can be fabricated from biocompatible materials suitable for medical applications including metals, synthetic polymers, ceramics, and bone material and / or composites thereof. For example, the components of the surgical system 100 can be fabricated individually or collectively from materials such as stainless steel alloys; aluminum; commercially pure titanium; titanium alloys; Grade 5 titanium; super-elastic titanium alloys; cobalt-chrome alloys; superelastic metallic alloys (e.g., Nitinol, such as GUM Metal® superelastic plasticity metals); ceramics; and composites thereof such as calcium phosphate composites (e.g., SKELITE®). In some embodiments, the components of the surgical system 100 can be fabricated from a combination of materials. TM) ; thermoplastics such as polyaryletherketone (PAEK), including polyether ether ketone (PEEK), polyether ketone ketone (PEKK), and polyether ketone (PEK); carbon-PEEK composites; PEEK-BaS04polymeric rubbers; polyethylene terephthalate (PET); fabrics; silicones; polyurethanes; silicone-polyurethane copolymers; polymeric rubbers; polyolefin rubbers; hydrogels; semi-rigid and rigid materials; elastomers; rubbers; thermoplastic elastomers; thermoset elastomers; elastomer composites; rigid polymers including polyphenyl, polyamides, polyimides, polyetherimides, polyethylene, epoxy-based; skeletal materials including autograft, allograft, xenograft, or transgenic cortical and / or corticocancellous bone, and tissue growth or differentiation factors; partially absorbable materials such as composites of metals with calcium-based ceramics, PEEK with calcium-based ceramics, and PEEK with absorbable polymers; fully absorbable materials such as calcium-based ceramics such as calcium phosphate, tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other absorbable polymers such as polylactide, polyglycolide, polycaroplaetohe, and combinations thereof.
[0115] Various components of the surgical system 100 can have material composites including the above materials to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical properties, durability, and radiolucency or imaging preference. Components of the surgical system 100 can also be made of heterogeneous materials, such as combinations of two or more of the above materials, individually or collectively. Components of the surgical system 100 can be formed integrally, integrally connected, or include fastening elements and / or instruments, as described herein.
[0116] The surgical system 100 is employed in conjunction with, for example, open surgical procedures, minimally invasive procedures including percutaneous techniques, and mini-open surgical techniques to deliver and introduce instrument devices and / or one or more spinal implants (such as one or more components of a bone fastener) at a surgical site in a patient, including, for example, the spinal column. In some embodiments, the spinal implants can include one or more components of one or more spinal constructs (such as intervertebral devices, intervertebral cages, bone fasteners, spinal rods, tethers, connectors, plates, and / or bone grafts), and can be used in conjunction with various surgical procedures including surgical treatment of the cervical, thoracic, lumbar, and / or sacral regions of the spinal column.
[0117] The surgical system 100 includes an implant, such as a spinal implant 102, and an instrument, such as a surgical instrument 104 configured to insert the implant 102 into an intervertebral space defined by adjacent vertebrae, as discussed herein. In some embodiments, the instrument 104 can be used to insert the implant 102 and / or other implants similar to the implant 102 into an intervertebral space defined by adjacent vertebrae. For example, Figure 1 The instrument 104 is shown in FIG. 1A, where the instrument 104 is coupled to the implant 102 to allow the instrument 104 to insert the implant 102 into the intervertebral space. Figure 2 The instrument 104 is shown in FIG. 1B, where the instrument is coupled to an implant 106 similar to the implant 104 to allow the instrument 104 to insert the implant 106 into the intervertebral space. However, it should be understood that the instrument 104 can be used to insert implants other than the implants 102, 106 into the intervertebral space, as discussed herein.
[0118] The instrument 104 includes a sleeve 108 that extends along a longitudinal axis XI between a proximal end 110 and an opposing distal end 112. An inner surface 114 of the sleeve 108 defines a channel 116. The channel 116 is coaxial with the axis XI. The end 110 is coupled to a handle 118 of the instrument 104 such that a body 125 of the handle 118 is fixed relative to the sleeve 108. In some embodiments, a maximum diameter of the handle 118 is greater than a maximum diameter of the sleeve 108 to facilitate, for example, gripping of the handle 118 by a hand of a practitioner. In some embodiments, the handle 118 includes gripping features, such as indentations and / or protrusions configured to facilitate gripping. An inner surface 120 of the handle 118 defines a passageway 122 that is coaxial with the channel 116 and the axis XI. The passageway 122 is in communication with the channel 116 such that a shaft 124 of the instrument 104 extends through the passageway 122 and into the channel 116. As discussed herein, the shaft 124 is rotatable about the axis XI relative to the sleeve 108 and the handle 118. In some embodiments, a diameter of the channel 116 is slightly greater than a diameter of the shaft 124 such that an outer surface 126 of the shaft 124 directly engages the surface 114 of the sleeve 108 when the shaft 124 is positioned within the channel 116. It is contemplated that the engagement of the surface 126 with the surface 114 maintains an orientation of the shaft 124 relative to the sleeve 108 and / or the handle 118 such that the shaft 124 remains coaxial with the axis XI when the shaft 124 is positioned within the channel 116. That is, the engagement of the surface 126 with the surface 114 prevents the shaft 124 from extending at an acute angle relative to the axis XI when the shaft 124 is positioned within the channel 116. In some embodiments, the diameter of the channel 116 is greater than the diameter of the shaft 124 such that the surface 126 of the shaft 124 is spaced apart from the surface 114 of the sleeve 108 when the sleeve 108 is positioned within the channel 116. In some embodiments, the channel 116 has a uniform diameter along an entire length of the channel 116 and / or the passageway 122 has a uniform diameter along an entire length of the passageway 122. In some embodiments, the channel 116 and / or the passageway 122 can be various shapes, such as circular, elliptical, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable, and / or tapered.
[0119] The proximal end 128 of the shaft 124 is coupled to the knob 130, and the opposing distal end 132 of the shaft 124 includes a mating surface 132, for example, in the form of a male threading, configured to engage an implant to couple the implant to the shaft 124. In particular, as discussed herein, the male threading form of the mating surface 132 is configured to mate with a female threading form of the implant to couple the implant to the shaft 124. The proximal end 128 of the shaft 124 is fixed to the knob 130 such that rotation of the knob 130 about the axis XI also rotates the shaft 124 about the axis XI, as discussed herein. In some embodiments, the knob 130 is integrally and / or monolithically formed with the shaft 124. In some embodiments, the shaft 124 is welded to the knob 130. It is contemplated that the shaft 124 can be hollow or non-hollow, depending on the requirements of the particular application.
[0120] The distal end 112 of the sleeve 108 defines an engagement portion 136 including an engagement surface 138 extending from a first end 140 to an opposing second end 142. In some embodiments, the engagement portion 136 includes a peg 144 extending outwardly from the end 140 and an opening 146 extending through the end 136. In some embodiments, the engagement portion 136 does not include a peg or any other structure extending from the engagement surface 138, and the engagement portion 136 includes only the opening 146, where the opening 146 can be variously positioned relative to the engagement surface 138. The opening 146 is in communication with the channel 116 such that the shaft 124 is axially translatable within the channel 116 along the axis XI to move the mating surface 134 through the opening 146 to engage with the implant, as discussed herein. The peg 144 is permanently fixed relative to the surface 138. In some embodiments, the opening 146 is coaxial with the channel 116 and the axis XI, and the peg 144 extends at an acute angle relative to the axis XI. The peg 144 has a solid configuration without any gaps or openings to provide strength and rigidity to the peg 144. In some embodiments, the peg 144 has a beveled tip 148 to facilitate insertion of the peg 144 into a cavity of the implant, for example, to couple the instrument 104 to the implant, as discussed herein. In some embodiments, the beveled tip is sprung to one side. In some embodiments, the peg 144 is conical. In some embodiments, the peg 144 is cylindrical. In some embodiments, the peg 144 has a radius for a smooth transition. In some embodiments, the peg 144 is variously shaped, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, wavy, arcuate, variable, and / or tapered.
[0121] The handle 118 includes, for example, a plate 135, which is connected to the body 125 of the handle 118 such that the plate 135 is fixed relative to the body 125. The diameter of the plate 135 is larger than the diameter of the passage 122. An end face 150 of the plate 135 directly engages an end face 152 of the body 125 to attach the plate 135 to the body 125. In some embodiments, the end face 152 is integrally and / or integrally formed with the end face 150. In some embodiments, the end face 152 is welded to or otherwise coupled to the end face 150 to fix the plate 135 relative to the body 125. The plate 135 includes a hole 154 extending through the thickness of the plate 135, the thickness being defined by the distance between the end face 150 and the opposite end face 156. The hole 154 is coaxial with the shaft 124 and the axis X1. The proximal end 128 of the shaft 124 extends through the hole 154, such as... Figure 4B As best shown herein. Plate 135 includes a plurality of spaced recesses, such as openings 158 radially positioned around hole 154. That is, openings 158 extend circumferentially around hole 154. Openings 158 extend parallel to axis X1 and are each configured to handle extensions 160 of knob 130 to prevent shaft 124 from rotating about axis X1 relative to handle 118 and sleeve 108, as discussed herein.
[0122] In some embodiments, opening 158 includes a bevel 158a to facilitate insertion of extension 160 into opening 158. Specifically, the diameter of the tapered bevel 158a extending into end face 156 is larger than the diameter of the cylindrical second portion of opening 158 positioned between end face 156 and end face 150. In some embodiments, extension 160 includes a tapered tip 160a configured to facilitate insertion of extension 160 into opening 158. In some embodiments, tip 160a terminates at a cusp. In some embodiments, at least one extension in opening 158 extends through end face 156 without extending through end face 150. In some embodiments, at least one extension in opening 158 extends through both end face 156 and end face 150. In some embodiments, plate 135 has a uniform thickness. In some embodiments, the hole 154 and / or opening 158 are of various shapes, such as circular, elliptical, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, wavy, arc-shaped, variable, and / or conical.
[0123] The knob 130 includes a hub 164, which includes a cylindrical body 166. A proximal end 128 of the shaft 124 is coupled to a distal end of the hub 164, such that end 128 is fixed relative to the hub 164, as... Figure 4BThe end 128 is integrally and / or unitarily formed with the hub 164 in some embodiments. In some embodiments, the end 128 is welded to the hub 164 such that rotation of the hub 164 also rotates the shaft 124. The grip portion 172 of the knob 130 includes a disc 170 that is fixed to the hub 164. In some embodiments, the disc 170 is integrally and / or unitarily formed with the grip portion 172 such that rotation of the grip portion 172 also rotates the disc 170. In some embodiments, the disc 170 is welded to the grip portion 172. In some embodiments, the disc 170 is integrally and / or unitarily formed with the hub 164 such that rotation of the grip portion 172 also rotates the disc 170 and the hub 164. In some embodiments, the disc 170 is welded to the hub 164. The grip portion 172 also includes a member, e.g., a plate 168, that is fixed to a member of the hub 164, e.g., the disc 170 and the grip portion 172. In some embodiments, the plate 168 is integrally and / or unitarily formed with the hub 164, the disc 170, and / or the grip portion 172 such that rotation of the plate 168 also rotates the hub 164. In some embodiments, the plate 168 is welded to the hub 164.
[0124] An inner surface 174 of the grip portion 172 defines a cavity 176. A floating member or plate, e.g., a plate 178, is movably disposed in the cavity 176. The extension 160 extends outwardly from a distal end of the plate 178. The plate 168 includes a hole 188 and the plate 178 includes a hole 190. The holes 188, 190 are each coaxial with the axis X1 such that the holes 188, 190 are aligned with the hole 154 of the plate 135, and the end 128 of the shaft 124 extends through the holes 154, 188, 190 to connect with the hub 164.
[0125] The extension 160 is configured to move through the recess, e.g., the opening 180 in the plate 178 and into the opening 158 of the plate 135. In particular, the knob 130 is rotatable between a first configuration in which the extension 160 is spaced apart from the opening 158 or only the tip 160a of the extension 160 is positioned within the opening 158 and a second configuration in which the extension 160 is disposed in the opening 158. That is, when the knob 130 is in the first configuration, the extension 160 is spaced apart from the opening 158 or only partially positioned within the opening 158, and when the knob 130 is in the second configuration, the extension 160 is fully disposed in the opening 158. In some embodiments, when the extension 160 is fully disposed in the opening 158 and the knob 130 is in the second configuration, the cylindrical portion 160b of the extension 160 is positioned in the opening 158. When the knob 130 is in the first and second configurations, the cylindrical portion 160b of the extension 160 is positioned in the opening 180 and the tip 160a of the extension 160 is positioned outside of the opening 180. When the knob 130 is in the first configuration, the knob 130 is rotatable relative to the sleeve 108 and the handle 118. When the knob 130 is in the second configuration, the knob 130 is prevented from rotating relative to the sleeve 108 and the handle 118. Thus, the shaft 124 is rotatable relative to the sleeve 108 and the handle 118 when the knob 130 is in the first configuration and the shaft 124 is prevented from rotating relative to the sleeve 108 and the handle 118 when the knob 130 is in the second configuration. In effect, when only the tip 160a of the extension 160 is positioned within the opening 158, the tapered configuration of the tip 160a allows the tip 160a to move into and out of the adjacent openings 158 as the knob 130 is rotated relative to the sleeve 108 and the handle 118. When the extension 160 is further inserted into the opening 158 such that the cylindrical portion 160b of the extension is positioned within the opening 158, the knob 130 is prevented from rotating relative to the sleeve 108 and the handle 118 because the extension 160 is blocked from moving from one opening 158 to another opening 158.
[0126] In some embodiments, the knob 130 is biased to the second configuration by a biasing member, such as a spring 182 positioned about the hub 164. That is, the spring 182 has a first end 184 that directly engages the disc 170 and an opposite second end 186 that directly engages the plate 178 to move the plate 178 away from the disc 170, such that the extension 160 moves through the opening 180 and into the opening 158. In some embodiments, the force exerted by the spring 182 to the plate 178 is sufficient to move the knob 130 from the first configuration to the second configuration. In some embodiments, the force exerted by the spring 182 to the plate 178 is insufficient to move the knob 130 from the first configuration to the second configuration. For example, in one embodiment, the knob 130 will remain in the first configuration unless and until the mating surface 134 mates with a mating surface of an implant, such as the implant 104 or the implant 106. When the mating surface 134 mates with the mating surface of the implant, rotation of the knob 130 relative to the sleeve 108 and the handle 118 causes the shaft 124 to axially translate relative to the sleeve 108 and the handle 118. When the shaft 124 axially translates relative to the sleeve 108 and the handle 118, the knob 130 axially translates relative to the plate 135 to move the knob 130 toward the plate 135 such that the extension 160 is fully disposed in the opening 158 and the knob 130 is in the second configuration.
[0127] In assembly, operation, and use, the surgical system 100 similar to the systems and methods described herein are employed in surgical procedures for treating spinal conditions affecting a portion of a patient's spine, as discussed herein. Components of the surgical system 100 are employed in surgical procedures for treating conditions or injuries of affected portions of the spine, such as vertebrae.
[0128] In use, to treat a selected portion of a vertebra, a practitioner accesses the surgical site in any appropriate manner, such as through an incision and tissue retraction. In some embodiments, the surgical system 100 can be used in any existing surgical method or technique, including open surgery, mini-open surgery, minimally invasive surgery, and percutaneous surgical implantation, to access the vertebrae by providing a small incision or cannula that provides a protected passageway to the region. Once the surgical site is accessed, a particular surgical procedure can be performed to treat the spinal condition.
[0129] An incision is formed in the patient, and a cutting instrument creates a surgical path for the implanted components of the surgical system 100. A preparation instrument can be employed to prepare tissue surfaces of the vertebrae as well as to aspirate and irrigate the surgical region. The instrument 104 is coupled to an implant, such as the implant 192, which is configured to be inserted into a target site, such as the intervertebral space IS between the first vertebra VI and the second vertebra V2, as shown in FIG. 1. As shown in FIG. 2, the implant 192 is inserted into the intervertebral space IS between the first vertebra VI and the second vertebra V2. Figure 11 Figure 14-17 As shown, implant 192 includes opposing first vertebral engagement surfaces 194 and 196. Vertebral engagement surface 194 is configured to engage the endplate of vertebra V1, while vertebral engagement surface 196 is configured to engage the endplate of vertebra V2. Implant 192 includes a posterior surface 198 and an anterior surface 200 opposite to surface 198. Surfaces 198 and 200 each extend from surface 194 to surface 196. Surface 200 defines a cavity 202 and a cavity 204 spaced apart from cavity 202. Cavity 202 includes a female thread form 202a, and cavity 204 includes a female thread form 204a.
[0130] In one embodiment, implant 192 is configured for ALIF surgery. Implant 192 is connected to instrument 104 by inserting studs 144 into cavity 204 such that opening 146 is aligned with cavity 202, as... Figure 15 As shown. When the stud 144 is inserted into the cavity 204, the knob 130 is in the first configuration, allowing the knob 130 to... Figure 1 The direction indicated by the middle arrow A and / or Figure 1 The knob 130 is translated along axis X1 relative to sleeve 108 and handle 118 in the direction indicated by the middle arrow B. Figure 1 The shaft 124 is translated along axis X1 in the direction indicated by the middle arrow A to move it from a first position to a second position. In the first position, the mating surface 134 is fully positioned within the channel 116, while in the second position, the mating surface 134 extends through the opening 146 and into the cavity 202, as shown by the middle arrow A. Figure 15 As shown. When the knob 130 is relative to the sleeve 108 and the handle 118 at... Figure 1 When the knob 130 is translated along axis X1 in the direction indicated by the middle arrow A, it rotates about axis X1 in the first rotational direction, for example, clockwise, so that the male thread of mating surface 134 engages with the female thread 202a. When the male thread of mating surface 134 engages with the female thread 202a, further rotation of the knob 130 relative to sleeve 108 and handle 118 in the first rotational direction causes shaft 124 to... Figure 1 The knob 130 is axially translated relative to the sleeve 108 and handle 118 in the direction indicated by the middle arrow A. Because the knob 130 is in the first configuration, it can rotate relative to the sleeve 108 and handle 118 to axially translate the shaft 124 relative to the sleeve 108 and handle 118. When the shaft 124 is relative to the sleeve 108 and handle 118... Figure 1 When the knob 130 is axially translated in the direction indicated by the middle arrow A, the knob moves along... Figure 1 The knob 130 is axially translated relative to the plate 135 in the direction indicated by the middle arrow A, so that the extension 160 is fully disposed in the opening 158 and the knob 130 is in the second configuration.
[0131] The implant 192 is guided into the intervertebral space IS using the instrument 104. Once the implant 192 is selectively positioned within the intervertebral space IS, the knob 130 is rotated about the axis XI in a second rotational direction, e.g., a counterclockwise direction, relative to the sleeve 108 and the handle 118. The knob 130 is rotated about the axis XI in the second rotational direction relative to the sleeve 108 and the handle 118 with a force sufficient to overcome the force of the spring 182 to move the knob 130 from the second configuration to the first configuration. When the knob 130 is moved from the second configuration to the first configuration, the shaft 124 is moved from the second position to the first position, where in the second position the mating surface 134 extends through the opening 146 and into the cavity 202, and in the first position the mating surface 134 is positioned entirely within the channel 116. When the shaft 124 is in the first position, the peg 144 is removed from the cavity 204.
[0132] Upon completion of the procedure, the surgical instruments, assemblies, and non-implant components of the surgical system 100 are removed, and the incision(s) are closed, as described herein. One or more of the components of the system 100 can be made of a radiolucent material, such as a polymer. Radioactive markers can be included for identification under x-ray, fluoroscopy, CT, or other imaging techniques. In some embodiments, the surgical system 100 can include one or more spinal rods, plates, connectors, and / or bone fasteners for use in cooperation with a single vertebral level or multiple vertebral levels.
[0133] In some embodiments, one or more bone screws can be engaged with tissue through various orientations, such as, for example, tandem, parallel, offset, staggered, and / or alternating vertebral levels, as described herein. In some embodiments, one or more of the bone screws can include polyaxial screws, sagittal adjustment screws, pedicle screws, monoaxial screws, mono-plane screws, translaminar screws, fixation screws, tissue penetrating screws, conventional screws, expansion screws, wedges, anchors, buttons, clips, snaps, friction fittings, compression fittings, expansion rivets, staples, nails, adhesives, struts, fixation plates, and / or struts.
[0134] In one embodiment, the surgical system 100 includes an agent that can be disposed, packaged, coated, or layered within, on, or around the components and / or surfaces of the surgical system 100. In some embodiments, the agent can include bone growth promoting materials, such as bone grafts, to enhance the fixation of the components and / or surfaces of the surgical system 100 with the vertebrae. In some embodiments, the agent can include one or more therapeutic and / or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation, and degeneration.
[0135] As shown above, the instrument 104 is used to insert the implant 192 in connection with an ALIF procedure. To demonstrate that the instrument 104 can be used to insert the implant 192 using a different approach, the implant 192 is connected to the instrument 104 by inserting the peg 144 into the cavity 202 such that the opening 146 is aligned with the cavity 204, as shown in Figure 16 , where the implant 192 is configured for an OLIF 5-1 procedure. As shown in Figure 17 , the implant 192 includes screw holes 195a, 195b that are accessible when the peg 144 is inserted into the cavity 202 and the opening 146 is aligned with the cavity 204 such that the fastener 205a can be inserted into and / or removed from the hole 195a and the fastener 205b can be inserted into and / or removed from the hole 195b when the peg 144 is inserted into the cavity 202 and the opening 146 is aligned with the cavity 204. When the peg 144 is inserted into the cavity 202, the knob 130 is in the first configuration such that the knob 130 is able to translate the shaft 124 relative to the sleeve 108 and the handle 118 along the axis X1 in the direction indicated by arrow A in Figure 1 and / or in the direction indicated by arrow B in Figure 1 . The knob 130 translates relative to the sleeve 108 and the handle 118 along the axis X1 in the direction indicated by arrow A in Figure 1 to move the shaft 124 from a first position in which the mating surface 134 is positioned entirely within the passage 116 to a second position in which the mating surface 134 extends through the opening 146 and into the cavity 204, as shown in Figure 16 . When the knob 130 translates relative to the sleeve 108 and the handle 118 along the axis X1 in the direction indicated by arrow A in Figure 1 , the knob 130 rotates about the axis X1 in a first rotational direction, e.g., clockwise, such that the male threaded form of the mating surface 134 mates with the female threaded form 204a. When the male threaded form of the mating surface 134 mates with the female threaded form 204a, further rotation of the knob 130 relative to the sleeve 108 and the handle 118 in the first rotational direction causes the shaft 124 to axially translate relative to the sleeve 108 and the handle 118 in the direction indicated by arrow A in Figure 1 . Because the knob 130 is in the first configuration, the knob 130 is rotatable relative to the sleeve 108 and the handle 118 to axially translate the shaft 124 relative to the sleeve 108 and the handle 118. When the shaft 124 axially translates relative to the sleeve 108 and the handle 118 in the direction indicated by arrow A in Figure 1 , the knob 130 axially translates relative to the plate 135 in the direction indicated by arrow A in Figure 1 to move the knob 130 toward the plate 135 such that the extension 160 is disposed entirely in the opening 158 and the knob 130 is in the second configuration.
[0136] Implant 192 is guided into intervertebral space IS using instrument 104. Once implant 192 is selectively positioned within intervertebral space IS, knob 130 is rotated about axis XI in a second rotational direction, e.g., a counterclockwise direction, relative to sleeve 108 and handle 118. Knob 130 is rotated about axis XI in the second rotational direction relative to sleeve 108 and handle 118 with a force sufficient to overcome the force of spring 182 to move knob 130 from the second configuration to the first configuration. When knob 130 is moved from the second configuration to the first configuration, shaft 124 is moved from the second position to the first position, where in the second position mating surface 134 extends through opening 146 and into cavity 202, and in the first position mating surface 134 is positioned entirely within passage 116. When shaft 124 is in the first position, peg 144 is removed from cavity 202.
[0137] It should be appreciated that instrument 104 can be used to insert other implants, in addition to implant 192, for a variety of techniques, such as ALIF, OLIF 5-1, OLIF 2-5, and DLIF. For example, Figure 1 Instrument 104 is shown in FIG. 2A connected to implant 102 for insertion of implant 102 in connection with a DLIF procedure. Figure 8 Instrument 104 is shown in FIG. 2B connected to implant 102 for insertion of implant 102 in connection with an OLIF 2-5 procedure. Figure 9 Instrument 104 is shown in FIG. 2C connected to implant 106 for insertion of implant 106 in connection with an OLIF 5-1 procedure. Figure 10 Instrument 104 is shown in FIG. 2D connected to implant 106 for insertion of implant 106 in connection with an ALIF procedure. However, it is contemplated that instrument 104 can be connected to a variety of implants, the same as or similar to implants 102, 106, 192, for a variety of different procedures and / or approaches.
[0138] In the embodiments discussed above, instrument 104 includes shaft 124 and peg 144, which are inserted into a cavity of an implant to connect instrument 104 to the implant. In other embodiments, implants are disclosed that include a protrusion or extension that is received within a cavity of an instrument to connect the implant to the instrument. For example, in one embodiment, as shown in FIG. 3A, surgical system 100 includes implant 206, which is similar to implants 102, 106, 192, and instrument 208, which is similar to instrument 104, and is configured to be connected to implant 206 for insertion of implant 206 into a target region of a patient’s body, as discussed herein. Figure 18-21
[0139] The implant 206 includes a body 210 having opposing first vertebral engagement surfaces 212 and second vertebral engagement surfaces 214. (As...) Figure 22-24 As shown, the body 210 of the implant 206 can have various shapes and sizes. An end face 216 of the body 210 extends from the vertebral conjoint surface 212 to the vertebral conjoint surface 214. The implant 206 includes studs 218 and 220 extending from the surface 216, such that studs 220 are spaced apart from studs 218. Stud 218 includes a male thread type 218a, and stud 220 includes a male thread type 220a.
[0140] Instrument 208 includes a sleeve 108. Instead of positioning the shaft 124 in the channel 116, instrument 208 includes an inner sleeve 222 rotatably positioned within 116 such that the sleeve 222 can be axially translated relative to axis X1 in the opposite direction to the sleeve 108. In one embodiment, when the sleeve 222 is positioned in the channel 116, the outer surface of the sleeve 222 directly engages the surface 114. The proximal end of the sleeve 222 is coupled to a knob 130 to allow the knob 130 to move the sleeve 222 relative to the sleeve 108 and handle 118 in the same manner as the knob 130 moves the shaft 124 relative to the sleeve 108 and handle 118 in the embodiment of instrument 104 discussed above. The engagement portion 136 of instrument 208 is similar to the engagement portion 136 of instrument 104, except that the engagement portion 136 of instrument 208 includes a hole 224 instead of a stud 144. Sleeve 222 includes an inner surface 226 that defines a female thread form 228, which is configured to engage a male thread form 218a or a male thread form 220a to attach the implant 206 to the device 208, as discussed herein.
[0141] During assembly, operation, and use, the device 208 is coupled to an implant, such as implant 206, which is configured for insertion into a target site, such as the intervertebral space (IS). In one embodiment, implant 206 is configured for ALIF surgery. Implant 206 is coupled to the device 208 by inserting studs 218 into holes 224 such that opening 146 is aligned with studs 220. When studs 218 are inserted into holes 224, knob 130 is in a first configuration such that knob 130 can... Figure 1 The direction indicated by the middle arrow A and / or Figure 1 The sleeve 222 is translated relative to the sleeve 108 and handle 118 along axis X1 in the direction indicated by the middle arrow B. The knob 130 is positioned relative to the sleeve 108 and handle 118 in... Figure 1In the direction indicated by arrow A, sleeve 222 translates along axis X1 to move from a first position to a second position, where in the first position sleeve 222 is positioned entirely within passage 116 and in the second position sleeve 222 extends through opening 146 and engages peg 220.
[0142] When knob 130 is translated relative to sleeve 108 and handle 118 in the direction indicated by arrow A, knob 130 rotates in a first rotational direction, e.g., clockwise, about axis X1 such that threaded form 228 cooperates with female threaded form 220a. When threaded form 228 cooperates with male threaded form 220a, further rotation of knob 130 in the first rotational direction relative to sleeve 108 and handle 118 causes sleeve 222 to translate axially relative to sleeve 108 and handle 118 in the direction indicated by arrow A. Because knob 130 is in the first configuration, knob 130 can be rotated relative to sleeve 108 and handle 118 to axially translate sleeve 222 relative to sleeve 108 and handle 118. When sleeve 222 is translated axially relative to sleeve 108 and handle 118 in the direction indicated by arrow A, knob 130 translates axially relative to plate 135 in the direction indicated by arrow A to move knob 130 away from plate 135 such that extension 160 is positioned entirely within opening 158 and knob 130 is in the second configuration. Figure 1 Figure 1 When knob 130 is translated relative to sleeve 108 and handle 118 in the direction indicated by arrow A, knob 130 rotates in a first rotational direction, e.g., clockwise, about axis X1 such that threaded form 228 cooperates with female threaded form 220a. When threaded form 228 cooperates with male threaded form 220a, further rotation of knob 130 in the first rotational direction relative to sleeve 108 and handle 118 causes sleeve 222 to translate axially relative to sleeve 108 and handle 118 in the direction indicated by arrow A. Because knob 130 is in the first configuration, knob 130 can be rotated relative to sleeve 108 and handle 118 to axially translate sleeve 222 relative to sleeve 108 and handle 118. When sleeve 222 is translated axially relative to sleeve 108 and handle 118 in the direction indicated by arrow A, knob 130 translates axially relative to plate 135 in the direction indicated by arrow A to move knob 130 away from plate 135 such that extension 160 is positioned entirely within opening 158 and knob 130 is in the second configuration. Figure 1
[0143] Implant 206 is inserted into intervertebral space IS using instrument 208. Once implant 206 is selectively positioned within the intervertebral space, IS knob 130 is rotated relative to sleeve 108 and handle 118 in a second rotational direction, e.g., counterclockwise, about axis X1. Rotation of knob 130 relative to sleeve 108 and handle 118 in the second rotational direction about axis X1 is forceful enough to overcome the force of spring 182 to move knob 130 from the second configuration to the first configuration. When knob 130 moves from the second configuration to the first configuration, sleeve 222 moves from the second position to the first position, where in the second position sleeve 222 extends through opening 146 and engages peg 220 and in the first position sleeve 222 is positioned entirely within passage 116.
[0144] As shown above, instrument 208 is used to insert implant 206 in conjunction with an ALIF procedure. To demonstrate that instrument 208 can be used to insert implant 206 using a different approach, implant 206 is attached to instrument 208 by inserting peg 220 into hole 224 such that opening 146 is aligned with peg 218. When peg 220 is inserted into hole 224, knob 130 is in the first configuration such that knob 130 is able to rotate relative to sleeve 108 and handle 118 in the direction indicated by arrow A and / or Figure 1 Figure 1 When knob 130 is translated relative to sleeve 108 and handle 118 in the direction indicated by arrow A, knob 130 rotates in a first rotational direction, e.g., clockwise, about axis X1 such that threaded form 228 cooperates with female threaded form 220a. When threaded form 228 cooperates with male threaded form 220a, further rotation of knob 130 in the first rotational direction relative to sleeve 108 and handle 118 causes sleeve 222 to translate axially relative to sleeve 108 and handle 118 in the direction indicated by arrow A. Because knob 130 is in the first configuration, knob 130 can be rotated relative to sleeve 108 and handle 118 to axially translate sleeve 222 relative to sleeve 108 and handle 118. When sleeve 222 is translated axially relative to sleeve 108 and handle 118 in the direction indicated by arrow A, knob 130 translates axially relative to plate 135 in the direction indicated by arrow A to move knob 130 away from plate 135 such that extension 160 is positioned entirely within opening 158 and knob 130 is in the second configuration.Figure 1 sleeve 222 relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow B. The knob 130 is translated relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow A to move the sleeve 222 from the first position to the second position, where in the first position the sleeve 222 is positioned entirely within the channel 116 and in the second position the sleeve 22 extends through the opening 146 and engages the peg 218. Figure 1 sleeve 222 relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow B. The knob 130 is translated relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow A to move the sleeve 222 from the first position to the second position, where in the first position the sleeve 222 is positioned entirely within the channel 116 and in the second position the sleeve 22 extends through the opening 146 and engages the peg 218. Figure 1 sleeve 222 relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow B. The knob 130 is translated relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow A to move the sleeve 222 from the first position to the second position, where in the first position the sleeve 222 is positioned entirely within the channel 116 and in the second position the sleeve 22 extends through the opening 146 and engages the peg 218. Figure 1 sleeve 222 relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow B. The knob 130 is translated relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow A to move the sleeve 222 from the first position to the second position, where in the first position the sleeve 222 is positioned entirely within the channel 116 and in the second position the sleeve 22 extends through the opening 146 and engages the peg 218. Figure 1 sleeve 222 relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow B. The knob 130 is translated relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow A to move the sleeve 222 from the first position to the second position, where in the first position the sleeve 222 is positioned entirely within the channel 116 and in the second position the sleeve 22 extends through the opening 146 and engages the peg 218. Figure 1 sleeve 222 relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow B. The knob 130 is translated relative to the sleeve 108 and the handle 118 along the axis X1 in the direction of the arrow A to move the sleeve 222 from the first position to the second position, where in the first position the sleeve 222 is positioned entirely within the channel 116 and in the second position the sleeve 22 extends through the opening 146 and engages the peg 218.
[0145] The implant 206 is guided into the intervertebral space IS using the instrument 208. Once the implant 206 is selectively positioned within the intervertebral space, the IS knob 130 is rotated relative to the sleeve 108 and the handle 118 about the axis X1 in a second rotational direction, e.g., counterclockwise direction. The knob 130 is rotated relative to the sleeve 108 and the handle 118 about the axis X1 in the second rotational direction with a force sufficient to overcome the force of the spring 182 to move the knob 130 from the second configuration to the first configuration. When the knob 130 is moved from the second configuration to the first configuration, the shaft 124 is moved from the second position to the first position, where in the second position the sleeve 222 extends through the opening 146 and in the first position the sleeve 222 is positioned entirely within the channel 116. It should be appreciated that the instrument 208 can be used to insert other implants in addition to the implant 206 for a variety of techniques, e.g., ALIF, OLIF 5-1, OLIF 2-5, and DLIF.
[0146] As described above, the engagement portion 136 can be configured differently to engage with multiple different implants. That is, the configuration of the engagement portion 136 can be adapted to match the configuration of the implants. For example, in one embodiment, such as Figure 12 As shown, the mating surface 138 is concave and curved from end 140 to end 142. In some embodiments, the mating surface 138 is continuously curved from end 140 to end 142 and / or the mating surface 138 has a continuous radius of curvature. Figure 11 The configuration of the engagement surface 138 can be used in conjunction with implants that include a convex or curved surface engaging the engagement surface 138 (e.g., the engagement surface 230 of implant 192). In another embodiment, such as Figure 13 As shown, the mating surface 138 includes a first planar portion 138a, a second planar portion 138b, and a third planar portion 138c located between portions 138a and 138b. A stud 144 extends from portion 138a and an opening 146 extends through portion 138b. Portion 138c extends at an acute angle relative to portions 138a and 138b. In one embodiment, as... Figure 25 As shown, the mating surface 138 protrudes and curves from end 140 to end 142. In some embodiments, the mating surface 138 is continuously curved from end 140 to end 142 and / or the mating surface 138 has a continuous radius of curvature. Figure 25 The configuration of the mating surface 138 in the middle can be with including Figure 26 The implant 232 is used in conjunction with the recessed curved surface 234, which is configured to engage with the engagement surface 138, such as... Figure 27 As shown.
[0147] The implants discussed above each include two threaded cavities along the engagement surface (e.g., cavities 202, 204 along surface 200) for disposing of the stud 144 and shaft 124, respectively. However, it is conceivable that the implants discussed herein may include three or more threaded cavities along the engagement surface. In some embodiments, the threaded cavities are all on an arcuate path defined by the engagement surface. For example, cavities 202, 204 of implant 192 are on the arcuate path of surface 200 and coincide with the arcuate center of surface 200. It is conceivable that providing an implant with at least three cavities would allow practitioners more options for attaching the implant to device 104. For example, three or more cavities allow device 104 to be attached to the implant at different angles or in different ways at the same angle. In one embodiment, as Figure 28 As shown, the implant 238 includes a front surface 238, said front surface including threaded cavities 240, 242, 244 spaced apart along an arcuate path along the surface 238. In one embodiment, as Figure 29As shown, peg 144 is disposed in cavity 242 and end 132 of shaft 124 is disposed in cavity 240 such that axis X2 of implant 236 is disposed at an angle a1 with respect to axis X1. In one embodiment, as shown in FIG. 2B, angle a1 is approximately 40 degrees. Figure 30 As shown, peg 144 is disposed in cavity 244 and end 132 of shaft 124 is disposed in cavity 242 such that axis X2 of implant 236 is disposed at an angle a2 with respect to axis X1. In one embodiment, as shown in FIG. 2C, angle a2 is approximately 20 degrees. Figure 31 As shown, peg 144 is disposed in cavity 240 and end 132 of shaft 124 is disposed in cavity 242 such that axis X2 of implant 236 is disposed at an angle a2 with respect to axis X1. In one embodiment, as shown in FIG. 2C, angle a2 is approximately 20 degrees. Figure 32 As shown, peg 144 is disposed in cavity 242 and end 132 of shaft 124 is disposed in cavity 244 such that axis X2 is parallel and / or coaxial with axis X1. In some embodiments, angle a1 is approximately 40 degrees and angle a2 is approximately 20 degrees.
[0148] In some embodiments, as shown in FIG. 2D, engagement surface 138 includes a gap 246 between end 140 and end 142. That is, end 142 is spaced apart from end 140 by gap 246. In one embodiment, as shown in FIG. 2E, gap 246 is configured to allow access to a screw hole 252 of implant 254 when instrument 104 is attached to implant 254. That is, while instrument 104 is attached to implant 254, a fastener can be inserted through hole 252 and into tissue, such as bone, to secure implant 254 relative to the tissue. Once the fastener is inserted through hole 252 and into the tissue, instrument 104 can be removed from implant 254. Figure 33-35 As shown, gap 246 is configured to allow access to a screw hole 252 of implant 254 when instrument 104 is attached to implant 254. That is, while instrument 104 is attached to implant 254, a fastener can be inserted through hole 252 and into tissue, such as bone, to secure implant 254 relative to the tissue. Once the fastener is inserted through hole 252 and into the tissue, instrument 104 can be removed from implant 254. Figure 33 As shown, gap 246 is configured to allow access to a screw hole 252 of implant 254 when instrument 104 is attached to implant 254. That is, while instrument 104 is attached to implant 254, a fastener can be inserted through hole 252 and into tissue, such as bone, to secure implant 254 relative to the tissue. Once the fastener is inserted through hole 252 and into the tissue, instrument 104 can be removed from implant 254. Figure 34 As shown, gap 246 is configured to allow access to a screw hole 252 of implant 254 when instrument 104 is attached to implant 254. That is, while instrument 104 is attached to implant 254, a fastener can be inserted through hole 252 and into tissue, such as bone, to secure implant 254 relative to the tissue. Once the fastener is inserted through hole 252 and into the tissue, instrument 104 can be removed from implant 254. Figure 35 As shown, gap 246 is configured to allow access to a screw hole 252 of implant 254 when instrument 104 is attached to implant 254. That is, while instrument 104 is attached to implant 254, a fastener can be inserted through hole 252 and into tissue, such as bone, to secure implant 254 relative to the tissue. Once the fastener is inserted through hole 252 and into the tissue, instrument 104 can be removed from implant 254.
[0149] As discussed herein, instrument 104 can be used to insert a number of different implants. In one embodiment, as shown in FIG. 2D, engagement surface 138 includes a gap 246 between end 140 and end 142. That is, end 142 is spaced apart from end 140 by gap 246. In one embodiment, as shown in FIG. 2E, gap 246 is configured to allow access to a screw hole 252 of implant 254 when instrument 104 is attached to implant 254. That is, while instrument 104 is attached to implant 254, a fastener can be inserted through hole 252 and into tissue, such as bone, to secure implant 254 relative to the tissue. Once the fastener is inserted through hole 252 and into the tissue, instrument 104 can be removed from implant 254.Figure 36-41 As shown, the system 100 includes an implant 260 having a solid body 262 extending between an end wall 264 and an opposing end wall 266 along a longitudinal axis X3. The body 262 includes a sidewall 268 and a sidewall 270 opposite the sidewall 268. The walls 268, 270 each extend from the wall 264 to the wall 266. In some embodiments, at least one of the walls 268, 270 is planar from the wall 264 to the wall 270. In some embodiments, at least one of the walls 268, 270 extends parallel to the axis X3. In some embodiments, at least one of the walls 264, 266 is convexly curved from the wall 268 to the wall 270. In some embodiments, at least one of the walls 264, 266 has a continuous radius of curvature from the wall 268 to the wall 270. However, it is contemplated that the walls 264, 266 can be various shapes and / or curved to match the shape and / or curvature of an engagement surface of an instrument that engages one of the walls 264, 266, such as the engagement surface 138 of the instrument 104. In some embodiments, the maximum length of each of the walls 264, 266 is less than the maximum length of the walls 268, 270. In some embodiments, the wall 264 extends perpendicular to the wall 268, the wall 268 extends perpendicular to the wall 266, the wall 266 extends perpendicular to the wall 270, and the wall 270 extends perpendicular to the wall 264.
[0150] The inner surfaces of walls 264, 266, 268, and 270 define a cavity 272. In some embodiments, the body 262 includes a support 274 positioned within the cavity 272. The support 274 includes a top wall 276 and an opposing bottom wall 278. Wall 278 is connected to wall 276 by a plurality of spaced-apart ribs 280. The support 274 is connected to wall 268 by support members 282 and to wall 270 by support members 284. The support 274 is spaced apart from walls 264 and 266 and is connected to walls 268 and 270 only by support members 282 and 284. The support 274 includes an opening 286 extending through wall 276 and an opening 288 extending through wall 278. Openings 286 and 288 extend perpendicular to axis X3. The support 274 includes a plurality of holes 290 extending through the thickness of wall 276 and a plurality of holes 292 extending through the thickness of wall 278. In some embodiments, body 262 includes a window 294 extending through wall 268 and a window 296 extending through wall 270. In some embodiments, holes 290, 292, windows 294, and / or windows 296 can be of various shapes, such as ellipse, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, wavy, arcuate, variable, and / or conical. In some embodiments, walls 268 and / or 270 can be arranged with respect to axis X3 in alternative orientations, such as lateral, vertical, and / or other angular orientations, such as acute or obtuse angles, coaxial, and / or offset or staggered. In some embodiments, holes 290 and / or 292 can be of various shapes, such as circular, elliptical, rectangular, triangular, square, hexagonal, polygonal, honeycomb, irregular, uniform, non-uniform, offset, staggered, wavy, arcuate, variable, and / or conical.
[0151] The body 262 includes a cavity 298 and a cavity 300 spaced apart from the cavity 298. Cavities 298 and 300 each extend into a wall 264. In some embodiments, the cavity 298 communicates with a channel 302 defined by a cylindrical wall 304 of the body 262 connected to the wall 264, such as... Figure 39 As best shown. Wall 304 includes a closed end 306 such that cavity 298 and channel 302 are not in communication with cavity 272. That is, an object must pass through wall 264 to be inserted into cavity 298 and channel 302. Similarly, cavity 300 communicates with channel 308 defined by cylindrical wall 310 of body 262 connected to wall 264, as shown. Figure 39The walls 310 include a closed end 312 such that the cavities 300 and passages 308 do not communicate with the cavity 272. That is, an object must be inserted through the wall 264 into the cavities 300 and passages 308. The cavities 298, 300 and passages 302, 308 are configured to engage components of an instrument, such as the peg 144 and shaft 124 of the instrument 104, as discussed herein. Accordingly, the passages 302, 308 each include a female thread form configured to mate with a male thread form of the mating surface 134 to connect the instrument with the implant 260, as discussed herein. The walls 304, 310 are permanently fixed relative to the body 262. That is, the walls 304, 310 cannot move relative to the walls 264, 266, 268, 270 such that the wall 304 does not move to allow the mating surface 134 to engage the female thread form of the passage 302 when the peg 144 is positioned in the passage 308 and / or the wall 310 does not move to allow the mating surface to engage the female thread form of the passage 308 when the peg 144 is positioned in the passage 302. In effect, permanently fixing the walls 304, 310 relative to the body 262 allows the instrument 104 to be manipulated relative to the implant 260 to couple the implant 260 to the instrument 104, as discussed herein. In contrast to systems that include an instrument configured to move the implant relative to the instrument when the implant is coupled to the instrument, the implant 260 will be fixed to the instrument 104 when the instrument 104 is connected to the implant 260. Accordingly, when the implant 260 is fixed to the instrument 104, the practitioner must manually manipulate the handle 118 to selectively position the implant 260 within the patient. In some embodiments, the cavity 298, the cavity 300, the passage 302, the passage 308, the opening 320, the opening 322, and / or the passage 324 can be disposed in alternative orientations relative to the axis X3, such as transverse, perpendicular, and / or other angular orientations, such as acute or obtuse angles, coaxial, and / or can be offset or staggered.
[0152] In some embodiments, the body 262 includes a tunnel 314 having an end 316 fixed to the wall 264 and an opposite end 318. The tunnel 314 extends at an oblique angle relative to the axis X3 and is positioned between the cavity 298 and the cavity 300 and includes an opening 320 extending through the end 316 and the wall 264 and an opening 322 extending through the end 318. The tunnel 314 extends continuously from the opening 320 to the opening 322 such that there is no gap or opening between the opening 320 and the opening 322 of the tunnel 314 and the bore of a passage 324 defined, for example, by the inner surface of the tunnel 314 does not communicate with the cavity 272, the cavity 298, the cavity 300, the passage 304, or the passage 308. The passage 324 is configured for disposal of a fastener, such as a bone screw, such that the bone screw extends through the openings 320, 322 to engage a tissue, such as a bone, as discussed herein. It is contemplated that the body 262 can include one or more tunnels in addition to the tunnel 314, where each of the additional tunnels is configured for disposal of an additional bone screw such that more than one bone screw can be used to attach the implant 260 to a bone. In some embodiments, the tunnel 314 can be disposed at alternative orientations relative to the axis X3, such as parallel, transverse, perpendicular, and / or other angular orientations, such as acute or obtuse, coaxial, and / or can be offset or staggered.
[0153] The core 326 is positioned in the cavity 272 such that the core 326 is visible around the stent 274 and through the windows 294, 296. The core 326 includes a body 328 having a lattice configuration that reduces rigidity and opacity while maintaining strength. The body 328 extends from the inner surface of the wall 264 to the stent 274, from the inner surface of the wall 266 to the stent 274, from the inner surface of the wall 268 to the stent 274, and from the inner surface of the wall 270 to the stent 274. In some embodiments, when the core 326 is positioned within the cavity 272, the uppermost surface of the body 328 is flush with the uppermost surface of the body 262 and the lowermost surface of the body 328 is flush with the lowermost surface of the body 262. The core 326 extends a central passageway 330 that extends through the thickness of the body 328 defined by the distance between the uppermost surface and the lowermost surface of the body 328. When the core 326 is positioned within the cavity 272, the passageway 330 is aligned with the openings 286, 288. In some embodiments, the core 326 is fused to the body 262. In some embodiments, the core 326 is welded to the body 262. In some embodiments, the core 326 is integrally and / or monolithically formed with the body 262.
[0154] In some embodiments, the lattice configuration of the body 328 is a diamond lattice that provides superior buildability, strength, reduced internal stress, and is suitable for the geometry of various spinal implant types. That is, the lattice configuration of the body 328 is formed from a plurality of rhombuses 332 that are coupled together to form the body 328. The parameters of the rhombuses 332 are shown in Figure 40B . However, it is contemplated that the parameters of the rhombuses 332 can be changed by changing the x, y, and z values of the rhombuses 332 in the user interface, as shown in Figure 40C . In some embodiments, the lattice configuration of the body 328 is formed using 3D printing.
[0155] The implant 26 includes a cap 334 coupled to the top end of the walls 264, 266, 268, 270 and the brace 274 and a cap 336 coupled to the opposite bottom end of the walls 264, 266, 268, 270 and the brace 274. The cap 334 includes an opening 338 that is aligned with the opening 286 and the passage 330 when the cap 334 is coupled to the body 262, 328 and the cap 336 includes an opening 340 that is aligned with the opening 288 and the passage when the cap 336 is coupled to the body 262, 328. The opening 338 is surrounded by a plurality of holes 342 and the opening 340 is surrounded by a plurality of holes 344. The holes 342 are aligned with the holes 290 when the cap 334 is connected to the body 262, 328 and the holes 344 are aligned with the holes 292 when the cap 336 is connected to the body 262, 328. In some embodiments, the holes 342 have the same size and shape as the holes 290 and / or the holes 344 have the same size and shape as the holes 292. In some embodiments, the caps 334, 336 are fused to the body 262 and / or the body 328. In some embodiments, the caps 334, 336 are welded to the body 262 and / or the body 328. In some embodiments, the caps 334, 336 are integrally and / or monolithically formed with the body 262 and / or the body 328.
[0156] The wall 276 and the cap 334 define a ledge 346 that extends from the rib 280 of the brace 274 to the opening 286, 338 and the wall 279 and the cap 336 define a ledge 348 that extends from the rib 280 to the opening 288, 340. The ledge 346 extends circumferentially around the opening 286, 338 such that the ledge 246 surrounds the opening 286, 338. Likewise, the ledge 348 extends circumferentially around the opening 288, 340 such that the ledge 246 surrounds the opening 288, 340. The implant 260 includes a cavity 350 defined by the inner surface of the rib 280. As Figure 38As shown, the maximum diameter D1 of each of the openings 286, 288, 338, and 340 is smaller than the maximum diameter D2 of the cavity 350. The cavity 350 defines the graft receiving area. Specifically, it is conceivable that material such as a bone graft BG can be inserted through openings 286 and 338 into the cavity 350, or through openings 388 and 340 into the cavity 350 to position the bone graft BG between the ledges 346 and 348, as... Figure 36 As shown.
[0157] In one implementation, such as Figure 42-47 As shown, system 100 includes an implant 352 similar to implant 260. The wall 264 of implant 352 includes a recess 354 configured to dispose of at least a portion of the engagement portion 136 of device 104. Implant 352 also includes a threaded hole 356 located between the wall 268 of implant 352 and the cavity 298 of implant 352, and a threaded hole 358 located between the wall 270 of implant 352 and the cavity 300 of implant 352. Holes 356 and 358 are each configured to dispose of fasteners, such as bone screws. Holes 356 and 358 each extend at an angle relative to axis X3 such that holes 356 and 358 each extend through the patina 346 and 348 of implant 352. In some embodiments, hole 356 includes an opening 356a extending through cap 334 of implant 352 and an opening 356b extending through cap 336 of implant 352 and wall 264 of implant 352. Hole 356 has no gaps or openings such that hole 356 does not communicate with cavity 350 of implant 352. In some embodiments, hole 358 includes an opening 358a extending through cap 334 of implant 352 and an opening 358b extending through cap 336 of implant 352 and wall 264 of implant 352. Hole 358 has no gaps or openings such that hole 358 does not communicate with cavity 350 of implant 352. In some embodiments, the maximum length of each of walls 264, 266 of implant 352 is greater than the maximum length of walls 268, 270 of implant 352. In some embodiments, the implant 352 is circular at the interface between the wall 264 and the wall 268 of the implant 352, at the interface between the wall 268 and the wall 266 of the implant 352, at the interface between the wall 266 and the wall 270 of the implant 352, and at the interface between the wall 270 and the wall 264 of the implant 352.
[0158] In one implementation, such as Figure 48-53As shown, system 100 includes an implant 360 similar to implants 260 and 352. The height of the wall 268 of implant 360 is greater than the height of the sidewall 270 of implant 360, such that the cap 334 of implant 360 is positioned relative to the cap 336 of implant 360 at an angle α3, as shown. Figure 49 As shown. Angle α3 provides a wedge shape for implant 360. In some embodiments, angle α3 is between 0 and 90 degrees. In some embodiments, angle α3 is between 1 and 89 degrees. In some embodiments, angle α3 is between 1 and 45 degrees. In some embodiments, angle Ω3 is between 10 and 45 degrees. In some embodiments, angle Ω3 is between 10 and 30 degrees. In some embodiments, angle Ω3 is between 15 and 25 degrees. However, it is contemplated that angle α3 can be selected at any angle to achieve proper lordosis when implant 360 is positioned between adjacent vertebrae. In some embodiments, the maximum length of each of walls 264 and 266 of implant 360 is less than the maximum length of walls 268 and 270 of implant 360. In some embodiments, the wall 264 of the implant 360 extends at an acute angle relative to the wall 268 of the implant 360, the wall 268 of the implant 360 extends at an acute angle relative to the wall 266 of the implant 360, the wall 266 of the implant 360 extends at an acute angle relative to the wall 270 of the implant 360, and the wall 270 of the implant 360 extends at an acute angle relative to the wall 264 of the implant 360.
[0159] In one implementation, such as Figure 54-59 As shown, system 100 includes an implant 362 similar to implants 260, 352, and 360. The height of the wall 268 of implant 362 is greater than the height of the sidewall 270 of implant 362, such that the cap 334 of implant 362 is positioned relative to the cap 336 of implant 362 at an angle α4, as shown. Figure 55As shown. Angle α4 is less than angle α3. In some embodiments, angle α4 is between 0 degrees and 15 degrees. In some embodiments, angle α4 is between 1 degree and 15 degrees. In some embodiments, angle α4 is between 1 degree and 10 degrees. In some embodiments, angle α4 is between 1 degree and 5 degrees. However, it is conceivable that when the implant 362 is positioned between adjacent vertebrae, angle α4 can be selected at any angle to achieve proper lordosis. In some embodiments, the maximum length of each of the walls 264 and 266 of the implant 362 is less than the maximum length of the walls 268 and 270 of the implant 362. In some embodiments, the wall 264 of the implant 362 extends at an acute angle relative to the wall 268 of the implant 362, the wall 268 of the implant 362 extends at an acute angle relative to the wall 266 of the implant 362, the wall 266 of the implant 362 extends at an acute angle relative to the wall 270 of the implant 362, and the wall 270 of the implant 362 extends at an acute angle relative to the wall 264 of the implant 362.
[0160] In one implementation, such as Figure 60-65 As shown, system 100 includes an implant 364 similar to implants 260, 352, 360, and 362. The wall 264 of implant 364 includes a recess 366 configured to dispose of at least a portion of the engagement portion 136 of device 104. Implant 364 also includes a threaded hole 356 located between the wall 268 of implant 364 and the cavity 298 of implant 364, and a threaded hole 358 located between the wall 270 of implant 364 and the cavity 300 of implant 364. Holes 356 and 358 are each configured to dispose of fasteners, such as bone screws. Holes 356 and 358 each extend at an angle relative to axis X3 such that holes 356 and 358 each extend through the pilaster 346 and 348 of implant 364. In some embodiments, hole 356 includes an opening 356a extending through the cap 334 of implant 364 and an opening 356b extending through the wall 264 of implant 364. Hole 356 has no gaps or openings such that hole 356 does not communicate with cavity 350. In some embodiments, hole 358 includes an opening 358a extending through the cap 334 of implant 364 and an opening 358b extending through the wall 264 of implant 364. Hole 358 has no gaps or openings such that hole 358 does not communicate with cavity 350. In some embodiments, neither hole 356 nor hole 358 extends through the cap 336 of implant 364, such as... Figure 63As shown. In some embodiments, the maximum length of each of the walls 264 and 266 of the implant 364 is greater than the maximum length of the walls 268 and 270 of the implant 364. In some embodiments, the implant 364 is circular at the interface between the walls 264 and 268 of the implant 364, at the interface between the walls 268 and 266 of the implant 364, at the interface between the walls 266 and 270 of the implant 364, and at the interface between the walls 270 and 264 of the implant 364. In some embodiments, the walls 264, 266, 268, 270 of the implant 364 each have a height from the cap 334 of the implant 364 to the cap 336 of the implant 364, said height being greater than the height of the walls 264, 266, 268, 270 of the implant 352 from the cap 334 of the implant 352 to the cap 336 of the implant 352.
[0161] In one implementation, such as Figure 66-71 As shown, system 100 includes an implant 368 similar to implants 260, 352, 360, 362, and 364. The height of the wall 268 of implant 368 is greater than the height of the sidewall 270 of implant 368, such that the cap 334 of implant 368 is positioned relative to the cap 336 of implant 368 at an angle α5. Figure 67As shown. Angle α5 provides a wedge shape for implant 368. In some embodiments, angle α5 is between 0 degrees and 90 degrees. In some embodiments, angle α5 is between 1 degree and 89 degrees. In some embodiments, angle α5 is between 1 degree and 45 degrees. In some embodiments, angle Ω5 is between 10 degrees and 45 degrees. In some embodiments, angle Ω5 is between 10 degrees and 30 degrees. In some embodiments, angle Ω5 is between 15 degrees and 25 degrees. However, it is contemplated that angle α5 can be selected at any angle to achieve proper lordosis when implant 368 is positioned between adjacent vertebrae. In some embodiments, the maximum length of each of walls 264, 266 of implant 368 is less than the maximum length of walls 268, 270 of implant 368. In some embodiments, the wall 264 of the implant 368 extends at an acute angle relative to the wall 268 of the implant 368, the wall 268 of the implant 368 extends at an acute angle relative to the wall 266 of the implant 368, the wall 266 of the implant 368 extends at an acute angle relative to the wall 270 of the implant 368, and the wall 270 of the implant 368 extends at an acute angle relative to the wall 264 of the implant 368. In some embodiments, the wall 264 of the implant 368 includes a planar portion 264a, a planar portion 264b, and a planar portion 264c located between the planar portions 264a and 264b. The planar portion 264b extends at an acute angle relative to the planar portion 264a, and the planar portion 264c extends at an acute angle relative to the planar portion 264b. In some embodiments, the planar portions 264a, 264b, and 264c are configured to... Figure 13 The planar portions 138a, 138b, and 138c of the device 104 shown are joined.
[0162] In one implementation, such as Figure 72-77 As shown, system 100 includes an implant 370 similar to implants 260, 352, 360, 362, 364, and 368. The height of the sidewall 268 of implant 370 is greater than the height of the sidewall 270 of implant 370, such that the cap 334 of implant 370 is positioned relative to the cap 336 of implant 370 at an angle α6. Figure 73angle a6 is less than angle a5. In some embodiments, angle a6 is between 0 degrees and 15 degrees. In some embodiments, angle a6 is between 1 degree and 15 degrees. In some embodiments, angle a6 is between 1 degree and 10 degrees. In some embodiments, angle a6 is between 1 degree and 5 degrees. However, it is contemplated that angle a6 can be selected to achieve any angle that results in an appropriate lordosis when implant 370 is positioned between adjacent vertebrae. In some embodiments, the maximum length of each of walls 264, 266 of implant 370 is less than the maximum length of walls 268, 270 of implant 370. In some embodiments, wall 264 of implant 370 extends at an acute angle relative to wall 268 of implant 370, wall 268 of implant 370 extends at an acute angle relative to wall 266 of implant 370, wall 266 of implant 370 extends at an acute angle relative to wall 270 of implant 370, and wall 270 of implant 370 extends at an acute angle relative to wall 264 of implant 370. In some embodiments, wall 264 of implant 370 includes a planar portion 264a, a planar portion 264b, and a planar portion 264c located between planar portion 264a and planar portion 264b. Planar portion 264b extends at an acute angle relative to planar portion 264a and planar portion 264c extends at an acute angle relative to planar portion 264b. In some embodiments, planar portions 264a, 264b, 264c are configured to engage planar portions 138a, 138b, 138c, respectively, of instrument 104 as shown. Figure 13
[0163] In one embodiment, as shown in FIG. 6, instrument 104 includes a first arm 106a and a second arm 106b. First arm 106a includes a first end 106a1 and a second end 106a2. Second arm 106b includes a first end 106b1 and a second end 106b2. First end 106a1 of first arm 106a is coupled to first end 106b1 of second arm 106b. In some embodiments, first end 106a1 of first arm 106a is coupled to first end 106b1 of second arm 106b by a hinge 108. In some embodiments, first end 106a1 of first arm 106a is coupled to first end 106b1 of second arm 106b by a hinge 108 that is configured to allow first arm 106a to rotate relative to second arm 106b. In some embodiments, first end 106a1 of first arm 106a is coupled to first end 106b1 of second arm 106b by a hinge 108 that is configured to allow first arm 106a to rotate relative to second arm 106b in a first direction and a second direction. In some embodiments, first end 106a1 of first arm 106a is coupled to first end 106b1 of second arm 106b by a hinge 108 that is configured to allow first arm 106a to rotate relative to second arm 106b in a first direction and a second direction, and wherein the first direction is opposite the second direction. Figure 78-83 As shown, the system 100 includes an implant 372 similar to the implants 260, 352, 360, 362, 364, 368, 370. The wall 264 of the implant 372 includes a recessed portion 354 configured for engagement of at least a portion of the engagement portion 136 of the instrument 104. The implant 372 also includes a threaded hole 356 between the wall 268 of the implant 372 and the cavity 298 of the implant 372 and a threaded hole 358 between the wall 270 of the implant 372 and the cavity 300 of the implant 372. The holes 356, 358 are each configured for disposal of a fastener, such as a bone screw. The holes 356, 358 each extend at an oblique angle relative to the axis X3 such that the holes 356, 358 each extend through the ledge 346, 348 of the implant 372. In some embodiments, the hole 356 includes an opening 356a that extends through the cap 334 of the implant 372 and an opening 356b that extends through the cap 336 of the implant 372 and the wall 264 of the implant 372. The hole 356 is free of any gaps or openings such that the hole 356 does not communicate with the cavity 350 of the implant 372. In some embodiments, the hole 358 includes an opening 358a that extends through the cap 334 of the implant 372 and an opening 358b that extends through the cap 336 of the implant 372 and the wall 264 of the implant 372. The hole 358 is free of any gaps or openings such that the hole 358 does not communicate with the cavity 350 of the implant 372. In some embodiments, the maximum length of each of the walls 264, 266 of the implant 372 is greater than the maximum length of the walls 268, 270 of the implant 372. In some embodiments, the implant 372 is rounded at the interface between the wall 264 of the implant 372 and the wall 268 of the implant 372, at the interface between the wall 268 of the implant 372 and the wall 266 of the implant 372, at the interface between the wall 266 of the implant 372 and the wall 270 of the implant 372, and at the interface between the wall 270 of the implant 372 and the wall 264 of the implant 372.
[0164] It should be understood that various modifications can be made to the embodiments disclosed in this disclosure. Therefore, the description should not be interpreted as limiting, but merely as an exemplification of various embodiments. Other modifications can be made by those skilled in the art within the scope and spirit of the claims below.
Claims
1. A surgical instrument, comprising: A sleeve extending along a longitudinal axis between opposing proximal and distal ends, an inner surface of the sleeve defining a channel, the distal end defining an engagement portion including an engagement surface extending from a first end to an opposing second end, the engagement portion including a stud extending outwardly from the first end, and the engagement portion including an opening extending through the second end communicating with the channel. A knob, the knob being connected to the proximal end of the sleeve; and A shaft including a proximal end and a relatively distal end, the distal end of the shaft including a mating portion extending through the opening, the proximal end of the shaft being coupled to a knob rotatable relative to the sleeve to rotate the shaft relative to the sleeve; The surgical instrument includes a first component positioned between the sleeve and the knob, the first component being fixed relative to the sleeve, and the first component including a plurality of first openings; The knob includes a second component and a third component, the second component including a plurality of second openings and the third component including a plurality of extensions aligned with the second openings, the shaft being fixed relative to the second component; and The knob is rotatable between a first configuration and a second configuration. In the first configuration, the extension is spaced apart from the first opening, and in the second configuration, the extension is disposed in the first opening. When the knob is in the first configuration, the knob is rotatable relative to the sleeve, and when the knob is in the second configuration, the knob resists rotation relative to the sleeve.
2. The surgical instrument of claim 1, wherein the engagement surface is continuously curved from the first end to the second end.
3. The surgical instrument of claim 1, wherein the engagement surface is concave and curved from the first end to the second end.
4. The surgical instrument of claim 1, wherein the engagement surface is convex and curved from the first end to the second end.
5. The surgical instrument of claim 1, wherein the engagement surface comprises a plurality of planar surfaces, the stud extends outward from one of the planar surfaces, and the opening extends through another planar surface among the planar surfaces.
6. The surgical instrument of claim 5, wherein the axis defined by the stud intersects the axis defined by the opening.
7. The surgical instrument of claim 6, wherein the stud extends perpendicular to a first planar surface in the planar surface and the opening extends perpendicular to a second planar surface in the planar surface, the stud extending from the first planar surface in the planar surface and the opening extending through the second planar surface in the planar surface.
8. The surgical instrument according to claim 1, wherein the first end and the second end are spaced apart by a gap.
9. The surgical instrument of claim 1, wherein the stud has an angled tip.
10. The surgical instrument of claim 1, wherein the mating portion comprises a male thread and the stud comprises a non-threaded outer surface.
11. The surgical instrument of claim 1, wherein the mating portion comprises a non-threaded outer surface, and the stud comprises a male thread.
12. The surgical instrument of claim 1, wherein the knob is configured to translate axially relative to the sleeve to move the shaft from a first orientation in which the mating portion is disposed in the channel to a second orientation in which the mating portion is positioned outside the channel.
13. The surgical instrument of claim 1, wherein the shaft is rotatable relative to the sleeve when the knob is in the first configuration, and the shaft resists rotation relative to the sleeve when the knob is in the second configuration.
14. The surgical instrument of claim 1, wherein the knob is spring-loaded toward the second configuration.
15. A surgical system comprising: A spinal implant, the spinal implant including opposing first vertebral engagement surfaces and second vertebral engagement surfaces, the implant including opposing posterior and anterior surfaces, the posterior and anterior surfaces each extending from the first vertebral engagement surface and the second vertebral engagement surface, the anterior surface including a spaced-apart first cavity and a second cavity. and Surgical instruments, the surgical instruments comprising: A sleeve extending along a longitudinal axis between opposing proximal and distal ends, an inner surface of the sleeve defining a channel, the distal end defining an engagement portion including an engagement surface extending from a first end to an opposing second end, the engagement portion including a stud extending outwardly from the first end, the stud being positioned within a first cavity, and the engagement portion including an opening extending through the second end communicating with the channel. A knob, the knob being connected to the proximal end of the sleeve, and A shaft, comprising a proximal end and an opposing distal end, the distal end of the shaft including a mating portion, the proximal end of the shaft being coupled to the knob. The knob is rotatable relative to the sleeve to translate the axis relative to the sleeve between a first orientation in which the mating portion is positioned within the channel and a second orientation in which the mating portion mates with the mating surface of the second cavity; The surgical instrument includes a first component positioned between the sleeve and the knob, the first component being fixed relative to the sleeve, and the first component including a plurality of first openings; The knob includes a second component and a third component, the second component including a plurality of second openings and the third component including a plurality of third extensions aligned with the second openings, the shaft being fixed relative to the second component; and The knob is rotatable between a first configuration and a second configuration. In the first configuration, the extension is spaced apart from the first opening, and in the second configuration, the extension is disposed in the first opening. When the knob is in the first configuration, the knob is rotatable relative to the sleeve, and when the knob is in the second configuration, the knob resists rotation relative to the sleeve.
16. The surgical system of claim 15, wherein the engagement surface is concave and curved and configured to engage a protruding portion of the front surface.
17. The surgical system of claim 15, wherein the engagement surface is convexly curved and configured to engage a recessed portion of the front surface.
18. A surgical instrument comprising: A sleeve extending along a longitudinal axis between opposing proximal and distal ends, the inner surface of the sleeve defining a channel, the distal end defining an engagement portion including an opening communicating with the channel; A knob, the knob being connected to the proximal end of the sleeve, A shaft including a proximal end and a relatively distal end, the distal end of the shaft including a mating portion extending through the opening, the proximal end of the shaft being coupled to a knob rotatable relative to the sleeve to rotate the shaft relative to the sleeve; and A first component is positioned between the sleeve and the knob, the first component is fixed relative to the sleeve, and the first component includes a plurality of first openings; The knob includes a second component and a third component, the second component including a plurality of second openings and the third component including a plurality of extensions aligned with the second openings, the shaft being fixed relative to the second component; and The knob is rotatable between a first configuration and a second configuration. In the first configuration, the extension is spaced apart from the first opening, and in the second configuration, the extension is disposed in the first opening. When the knob is in the first configuration, the knob is rotatable relative to the sleeve, and when the knob is in the second configuration, the knob resists rotation relative to the sleeve.
19. The surgical instrument of claim 18, wherein the knob is spring-loaded toward the second configuration.
Citation Information
Patent Citations
Implant Instrument Interconnection
US20140277493A1