Multi-Shield Spinal Access System

Abstract

The present invention provides an access device for accessing an intervertebral disc having an outer shroud including an access shroud having a larger diameter (approximately 16 mm to 30 mm) from the skin down to the facet joint line and an inner shroud having a second smaller diameter (approximately 5 mm to 12 mm) extending through the access shroud and down to the level of the intervertebral disc. This combines the advantages of a direct visual microsurgery / small incision approach and a percutaneous "super-MIS" technique.

Description

Background Art

[0001] Today, microsurgical spinal osteotomy and spinal decompression performed under microscopic view through micro-cannulae and retractors are becoming the standard of spinal surgical care. These access tools typically have an inner diameter between about 16 mm and 30 mm. Here, where the spinal surgeon is familiar with access and decompression techniques, and where standard equipment and instruments can be used, these known techniques should be considered as a foundation for further innovation.

[0002] However, the size of the anatomical window of the Kambin triangle through which safe disc access is performed is very limited. The access window can be enlarged by removing at least a portion of the superior articular process. However, the length of the working shield required for safely introducing the implant into the intervertebral space via this approach must be within the range of about 8mm to 12mm in diameter, thereby reaching the disc access point from the facet joint line. Summary of the invention

[0003] The inventors of the present invention contemplate introducing a second inner shield through the first outer shield mentioned above. The second inner shield extends through the first outer shield to reach a position close to the nerve tissue, thereby shielding the nerve from the instrument or device passing through the intervertebral disc space. In this step, the outer shield allows visual and safe placement of the inner shield.

[0004] In one embodiment, an outer shield (which may be, for example, a tube or blade) and an inner shield are provided, the outer shield comprising an entry shield having a larger diameter (approximately 12 mm to 30 mm) from the skin down to the bone line, and an inner shield having a second smaller diameter (approximately 5 mm to 12 mm) extending through the entry shield and down to the disc level. This combines the benefits of direct visualization of microsurgical / minimally invasive approaches with percutaneous techniques ( Figure 1A to Figure 1B and Figure 2).

[0005] The external shield has multiple features and advantages. First, the external shield enables separation and protection of surrounding soft tissue and visualization during standard microsurgical decompression / osteotomy under microscopic view, based on standard procedures that surgeons familiar with MIS technology can perform. Second, the external shield enables separation and protection of surrounding soft tissue and visualization during detection and removal of facet joints or parts of facet joints, based on standard procedures that surgeons familiar with MIS technology can perform. Third, the external shield enables identification, preparation and protection of sensitive (e.g., neural) tissue (penetrating nerve roots, descending nerve roots, dura mater) below the boundary between retraction-sensitive tissue and non-retraction-sensitive tissue (e.g., facet joint line) under direct visual control, based on standard procedures that surgeons familiar with MIS technology can perform. Fourth, the external shield enables insertion of the internal shield and possible docking of the internal shield in the intervertebral disc space or on the vertebrae under direct visual control.

[0006] Likewise, the inner shield has several features and advantages. First, it can protect the neural tissue (egressing nerve roots, descending nerve roots, dura mater) from the instruments introduced into the disc. Second, it can guide the disc instruments (discectomy instruments, visualization instruments, discectomy verification instruments, implant insertion instruments, bone graft filling instruments). Third, due to the smaller size of the outer shield, the shield can be inserted with minimal damage or trauma to the bone and soft tissue in the posterior column region of the spine, which is comparable to percutaneous access instruments.

[0007] Thus, according to the present invention, there is provided a method of accessing an intervertebral disc in a patient, the method comprising the steps of:

[0008] a) making an incision in the patient's skin,

[0009] b) percutaneously inserting through the incision an outer shield having a substantially tubular shape (such as a tube or a multi-grooved retractor) having a length adapted to extend from the incision to a boundary between sensitive and insensitive tissue in the patient's spine (e.g., the superior articular process (SAP) or lamina),

[0010] c) securing this outer shield to the pedicle anchor,

[0011] d) Insertion of an integral optical visualization device into the outer shield,

[0012] e) Resection of a portion of the superior articular process and / or microsurgical decompression,

[0013] f) inserting an inner shield through the outer shield or deploying the inner shield from the outer shield such that a distal end portion of the inner shield extends to the intervertebral disc, the inner shield having an outer surface,

[0014] g) making the outer surface of the shield contact with the nerve root to protect the nerve root,

[0015] h) Microsurgical decompression of any tissue is shown to cause nerve entrapment,

[0016] i) extraction of intervertebral disc material, including removal of cartilage material from the vertebral endplates,

[0017] j) inserting an interbody device, and

[0018] k) Deployment of stabilization mechanisms to stabilize the intervertebral segments.

[0019] In addition, according to the present invention, there is provided a method for accessing an intervertebral disc in a patient, the method comprising the following steps:

[0020] a) making an incision in the patient's skin,

[0021] b) inserting an outer shield having a substantially tubular shape percutaneously through the incision,

[0022] c) securing this outer shield to the pedicle anchor,

[0023] d) inserting the inner shield through the outer shield such that a distal end portion of the inner shield extends to the intervertebral disc, the inner shield having an outer surface,

[0024] e) making the outer surface of the shield contact with the nerve root to protect the nerve root,

[0025] f) Microsurgical decompression of any tissue has been shown to cause nerve entrapment,

[0026] g) extraction of intervertebral disc material, including removal of cartilage material from the vertebral endplates,

[0027] h) inserting an interbody device, and

[0028] i) Deployment of stabilization mechanisms to stabilize the intervertebral segments.

[0029] According to the present invention, there is also provided an access device for accessing an intervertebral disc, the access device comprising:

[0030] a) an outer shield having a substantially tubular portion, a length adapted to extend from the incision to a boundary between sensitive tissue and insensitive tissue (e.g., an articular process or a lamina), a proximal end portion, a distal end portion, an outer surface, and a longitudinal through hole defining an inner surface,

[0031] b) an inner shield having i) a first substantially tubular portion having a proximal end portion, a distal end portion, a longitudinal throughbore defining an inner surface, and an outer surface defining a diameter; and ii) a longitudinal flange extending distally from the distal end portion of the substantially tubular portion,

[0032] wherein the outer surface of the inner shield is substantially nested within the inner surface of the outer shield, such that

[0033] i) The flange extends distally past the distal end portion of the outer shield.

[0034] In one aspect, a multi-tool is provided, the multi-tool comprising a shaft component having an elongated body, the elongated body defining a central longitudinal axis extending from a proximal handle to a distal tip. The multi-tool may also include a body having an opening and one or more coupling features for receiving the shaft component therethrough, the one or more coupling features being configured to receive one or more surgical devices therein so that the surgical device engages with the shaft component when disposed within the body. There may also be an actuation feature formed on the body, the actuation feature being configured to engage the shaft component to switch the shaft component between an unlocked configuration and a locked configuration relative to the body.

[0035] The above-described multi-tool may have various modifications and / or additional features within the scope of the present disclosure. For example, in some embodiments, the surgical device of the multi-tool may be any one of a neural mapping tool and a navigation array. In some embodiments, the shaft component may form an electrical connection at an interface with the surgical device. The electrical connection may be formed by a biasing element disposed between the shaft component and the surgical device. In some embodiments, the shaft component may include a proximal handle having a conductor thereon for forming an electrical connection.

[0036] In some embodiments, the body may be configured to be removably disassembled from either the shaft component and the surgical device. For example, the actuation feature structure may also include a button that is configured to be pressed by a user to disassemble the body from the shaft component. The body may include a slider that slides in the proximal-distal direction relative to the body to lock the axial position of the shaft component to the body. The longitudinal position of the shaft component may be stationary in the locked configuration. In some embodiments, one or more of the coupling feature structures may include a modular attachment arm for coupling a surgical device thereto. The modular attachment arm may include a pin received by its axis, and one or more devices are configured to receive a pin therein for snapping the modular attachment arm to the modular attachment arm. In some embodiments, the modular attachment arm may be keyed so that the surgical device is prevented from being coupled to the modular attachment arm in all orientations except one orientation.

[0037] In another aspect, a surgical device is provided, the surgical device including a shaft component configured to be inserted into a target site in a patient's body, the shaft component having an elongated body defining a central longitudinal axis extending from a proximal handle to a distal tip. The surgical device may also include a locking handle configured to engage the shaft component with the locking handle, the locking handle including a base clamp having an opening for receiving the proximal handle of the shaft component therethrough and one or more ports configured to receive one or more surgical devices therein; and a top clamp extending proximally from the base clamp. The base clamp and the top clamp of the surgical device may also be configured to rotate relative to each other to move the multi-tool between an open position and a closed position, in which the shaft component can translate or rotate relative to the locking handle, and in which the shaft component is prevented from translating or rotating relative to the locking handle.

[0038] The above-described surgical devices may have various modifications and / or additional features within the scope of the present disclosure. For example, in some embodiments, the locking handle may include a core therein for coupling to the shaft component and one or more surgical devices. Further, in some embodiments, the shaft component may engage with a surgical device disposed through the core to establish an electrical connection therebetween. Further, in some embodiments, the core may be made of an overmolded material.

[0039] In some embodiments, the shaft component may include a locking groove configured to receive a retaining feature of the locking handle therein for securing the shaft component to the locking handle. Additionally, in some embodiments, the shaft component may include a stop configured to abut against either of the top clamp and the base clamp to prevent the shaft component from being advanced proximally relative to the locking handle.

[0040] In certain embodiments, the top clamp is disposed substantially perpendicular to the base clamp in the open position, and the top clamp is aligned with the base clamp in the closed position. The top clamp may include an opening configured to receive an axis member therethrough. Furthermore, in some embodiments, the top clamp may be received in a recess formed in the base clamp. Additionally, in some embodiments, the top clamp may further include a mating tab configured to engage an abutment surface on the base clamp to couple the top clamp to the base clamp.

[0041] In another aspect, a surgical method is provided, the surgical method comprising making an incision in a target site of a patient. The method may include inserting a shaft component into the target site to dock the shaft component therein, the shaft component being coupled to a body having an opening and one or more coupling features for receiving the shaft component therethrough, the one or more coupling features being configured to receive one or more surgical devices therein, such that the surgical devices are configured to engage with the shaft component when disposed within the body, wherein the surgical devices guide the shaft component into the target site; and advancing an access port over the shaft component into the target location.

[0042] In some embodiments, the method includes a surgical device that is either a neural mapping tool and a navigation array. In addition, the navigation array can be calibrated before the shaft component is inserted into the target site. In addition, in some embodiments, the method includes inserting a screw into the target location under the guidance of the navigation array.

[0043] In some embodiments, the shaft member can be inserted under finger pressure. In other embodiments, the shaft member can be inserted under manual force. In some embodiments, the method includes sweeping the distal end of the shaft member across the target site to dock the shaft member within the target site.

[0044] In certain embodiments, the method may further include removing the body from the shaft member. The method may further include pressing a button formed on the body to release the shaft member from the body. In some embodiments, the method may include advancing one or more dilators on the shaft member into the target site to increase the size of the target site. In addition, the method may include removing one or more dilators from the target site.

[0045] In certain embodiments, the method may include advancing one or more tools through the access port into the target site. The one or more tools may include a plug received in the access port to extend proximally from the access port. Additionally, in some embodiments, the method may include adjusting the orientation of the plug in multiple degrees of freedom to manipulate the position of the access port within the target site. In other embodiments, the method may include inserting a second shaft component through the plug to adjust the orientation of the plug.

[0046] In certain embodiments, the method may include visualizing the trajectory of the shaft member within the target site. Visualizing the trajectory may also include advancing a camera into the target site through one or more channels of the access port. The method may also include advancing the camera and the shaft member through separate channels in the access port. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1A An interbody device is shown delivered via an access device.

[0048] Figure 1B An end view of the access device is shown.

[0049] Figure 2A and Figure 2B are different views of a cannula embodiment of an access device.

[0050] FIG. 3A to FIG. 3D Different axial cross-sections of the inner shroud are shown.

[0051] Figure 4 A necked-down funnel-shaped embodiment of the inner shroud is shown.

[0052] Figures 5 and 6 Different longitudinal cross-sections of concentric and non-concentric inner shrouds are shown.

[0053] Figure 7 The access device is shown engaged.

[0054] Fig. 8A A flanged embodiment of the inner shroud is shown.

[0055] Figure 8B An inner shroud with a proximal stop is shown.

[0056] Fig. 9 An access device is shown with two ports attached to the outer shroud. One port is a connector for holding the outer tube, while the other port is an interface for the light source.

[0057] Fig.10 A cross section of an outer tube is disclosed, wherein the outer tube wall has a first channel adapted to contain a visualization unit, such as a camera, and a second channel adapted to contain a cleaning system, such as a lens cleaning device.

[0058] Fig.11 A cross section of an outer tube is disclosed, wherein the outer tube wall contains a lens cleaning device and a camera.

[0059] Fig.12 A tip chip embodiment is disclosed that includes a cross-section of an outer tube, wherein the outer tube wall has a channel containing an endoscope having a video chip near its distal end.

[0060] Fig.13 A distal end of an outer tube is disclosed, the outer tube featuring a video chip near the distal end thereof.

[0061] Fig.14 A frame for an endoscope is disclosed.

[0062] FIG. 15A to FIG. 15B An inner shroud with a proximal elbow is shown.

[0063] Fig.16 An access device is shown having a distal tip on an inner shroud within an outer shroud.

[0064] Fig.17 An entry arrangement is shown with the retaining ring between the inner and outer shrouds.

[0065] Fig.18 An access device is shown in which the depth adjustment device is formed by an inner shroud and an outer shroud.

[0066] Fig.19 An integral retractor having a flat inner surface received within a cut-out of an outer tube 245 is disclosed.

[0067] Fig. 20 A retractor having a flat inner surface received within an outer tube is disclosed.

[0068] Fig.21 An outer tube is disclosed having a retractor nested with an outer surface of the outer tube.

[0069] Figures 22 to 24B A retraction embodiment is shown.

[0070] Figures 25 to 30 An access device with an extended shroud is shown.

[0071] Fig.31 An access device having an inner shroud and an outer shroud is shown.

[0072] Figure 32 to Figure 34 The inner shroud is shown.

[0073] Fig.35 A radial soft tissue retractor is disclosed.

[0074] Fig.36 An outer tube / internal retractor assembly is disclosed wherein a first internal retractor and a second internal retractor are both angled inwardly to retract soft tissue.

[0075] Figures 37 to 46 Preferred surgical methods involving access devices are disclosed.

[0076] FIG. 47A to FIG. 47C A navigation plug is disclosed that includes a base having an array attached thereto, wherein the plug is adapted to fit within an outer tube.

[0077] Fig.48 A cookie cutter type distal end of an ultrasonic cutter extending from an end of an outer tube is disclosed, wherein the distal end has a plurality of cutting teeth.

[0078] FIG. 49A to FIG. 49BVarious cross sections of templates for guiding bone cutting devices are disclosed.

[0079] Fig.50 A cookie cutter type distal end of an ultrasonic cutter having a semicircular cutter bone cutter is disclosed.

[0080] Fig.51 A miniature flexible arm connecting an outer tube and a screw extension is disclosed.

[0081] Fig.52 An outer tube / inner retractor assembly is disclosed wherein the inner retractor is angled inwardly to retract soft tissue.

[0082] Fig.53 An outer tube / inner retractor assembly is disclosed wherein the inner retractor runs parallel to the outer tube.

[0083] Fig.54 An endoscope housed within an outer tube and an inner tube extending from the outer tube are disclosed.

[0084] Figure 55 to Figure 63 Disclosed are some of the instruments used in the preferred procedures disclosed herein.

[0085] Figures 64 to 90 Some of the instruments are disclosed in their contemplated spinal orientations for use in the preferred procedures disclosed herein.

[0086] Fig.91 is a perspective view of an embodiment of a multi-tool;

[0087] Fig.92 For Fig.91 A perspective view of a shaft assembly used with a multi-tool;

[0088] Fig.93 for Fig.92 A schematic diagram of a distal end portion of a shaft component;

[0089] Fig.94A for Fig.91 A cross-sectional view of a multi-tool;

[0090] Fig.94B for Fig.91 Another cutaway view of the multi-tool;

[0091] Fig.94C for Fig.91 Another cutaway view of the multi-tool;

[0092] Fig.95 is a perspective view of another embodiment of a multi-tool;

[0093] Fig.96 for Fig.95 A cross-sectional view of a multi-tool;

[0094] Fig.97 For connection to the navigation array Fig.91 Another cutaway view of the multi-tool;

[0095] Fig.98 is a perspective view of another embodiment of a multi-tool;

[0096] Fig.99 for Fig.98 A perspective view of a cover of a multi-tool;

[0097] Fig.100 For connection to the navigation array Fig.98 A perspective view of the multi-tool;

[0098] Fig.101 for Fig.98 a cross-sectional view of a cover of a multi-tool;

[0099] Fig.102 is a perspective view of another embodiment of a multi-tool;

[0100] Fig.103 is a perspective view of another embodiment of a multi-tool;

[0101] Fig.104 For Fig.103 A perspective view of a shaft assembly used with a multi-tool;

[0102] Fig.105 for Fig.104 A perspective view of a proximal handle of a shaft component;

[0103] Fig.106A For the open position Fig.103 Top view of the cover of the multi-tool;

[0104] Fig.106B For the closed position Fig.103 Top view of the cover of the multi-tool;

[0105] Fig.107 is a perspective view of another embodiment of a multi-tool;

[0106] Fig.108 for Fig.107 An exploded perspective view of the multi-tool;

[0107] Fig.109 for Fig.107 an exploded perspective view of a cover of a multi-tool;

[0108] Fig.110A for Fig.107 A perspective view of a knob of a multi-tool;

[0109] Fig.110B for Fig.110A A cross-sectional view of a knob;

[0110] Fig.111A For the open position Fig.107 Top view of the cover of the multi-tool;

[0111] Fig.111B For the closed position Fig.107 Top view of the cover of the multi-tool;

[0112] Fig.112 is a perspective view of another embodiment of a multi-tool;

[0113] Fig.113A for Fig.112 A perspective front view of a multi-tool fixture;

[0114] Fig.113B for Fig.113A Another perspective view of the fixture;

[0115] Fig.114 for Fig.112 A cross-sectional view of a multi-tool;

[0116] Fig.115 for Fig.112 A perspective cutaway view of the multi-tool;

[0117] Fig.116A is a perspective view of another embodiment of a multi-tool;

[0118] Fig.116B for Fig.116A A perspective view of the multi-tool;

[0119] Fig.117 is a schematic diagram of inserting a shaft component into a target site of a patient;

[0120] Fig.118 A series of expanders are provided on it. Fig.117 A perspective view of a shaft component;

[0121] Fig.119 To insert in Fig.118 A perspective view of an access port on a dilator in FIG.

[0122] Fig.120 is configured to receive Fig.119 A perspective view of a port regulator in an access port;

[0123] Fig.121 To connect to Fig.119 The access port Fig.120 A perspective view of components of a port regulator;

[0124] Fig.122 for Fig.121 A schematic diagram of the components;

[0125] Fig.123 To set in Fig.121 A perspective view of a shaft component in an assembly of

[0126] Fig.124 To set in Fig.121 Another perspective view of the shaft component in the assembly; and

[0127] Fig.125 To set in Fig.121 A cross-sectional view of the shaft component in the assembly. DETAILED DESCRIPTION

[0128] Fluoroscopic visualization was performed to define the incision site for initial reference array placement and the incision into the disc.

[0129] Generally speaking, the shields of the present invention can be applied to any conventional method commonly used in spinal surgery. However, considering the clinical benefits of the access device and its basic principles, it is preferred to use these shields in the interlaminar approach, extraforaminal approach or transforaminal approach of the intervertebral disc.

[0130] Now refer to Figures 1 to Figure 7 , an access device for accessing an intervertebral disc is provided, the access device comprising:

[0131] a) an outer shield 1 having a substantially tubular portion, adapted to extend from the incision to a length extending to a boundary between sensitive tissue and insensitive tissue (e.g., an articular process), a proximal end portion 3, a distal end portion 5, an outer surface 7, and a longitudinal through hole 9 defining an inner surface 10,

[0132] b) an inner shield 11 having i) a first substantially tubular portion 13 having a proximal end portion 15, a distal end portion 17, a longitudinal through hole 19 defining an inner surface 21 and an outer surface 23 defining a diameter; and ii) a longitudinal flange 25 extending distally from the distal end portion of the substantially tubular portion,

[0133] wherein the outer surface of the inner shroud is substantially nested within the inner surface of the outer shroud such that the flange extends distally past a distal end portion of the outer shroud, and

[0134] A distal end portion of the substantially tubular portion of the inner shroud extends distally past the distal end of the outer shroud.

[0135] External Shield Implementation :

[0136] In the design of the outer shield, the traditional tube or split tube / retractor concept can be used. Newer concepts such as "flexible tubes" can also be used. The outer shield can be a simple cylindrical tube. The outer shield can also be a split tube, so that a conventional retractor is considered a split tube. The outer shield can be a flexible tube. The outer shield can be a tube with a narrow slot extending from the proximal end to the distal end. Various shape embodiments can be:

[0137] a) A cylindrical tube with an inner diameter D ( Figure 3A );

[0138] b) Elliptical tubes with different heights a and lengths b ( Figure 3B );

[0139] c) a "half-moon" tube of substantially circular or elliptical cross-section of diameter D, in which the section (or chord) "a" is cut ( Figure 3C );as well as

[0140] d) A rectangular tube with height a and width b ( Figure 3D ).

[0141] In some embodiments, the shape of the distal end portion 5 comprises an asymmetric shape to better retract tissue laterally to the SAP.

[0142] The outer shield can preferably be used with a variety of access window sizes (i.e., widths) ranging from 6 mm to 25 mm and lengths ranging from 40 mm to 200 mm. Typically, the outer shield includes structure that allows for attachment of a stabilizing mechanism that allows for appropriate flexibility in attachment (e.g., a ball joint). In one embodiment, the outer shield has a customization feature suitable for introducing an endoscope or camera that allows the endoscope to be introduced to a predetermined depth where the working window at the distal portion of the outer shield can be visualized.

[0143] Internal shroud implementation plan :

[0144] See now FIG. 3A to FIG. 3D , the inner shield 11 may also include various designs.

[0145] In a first embodiment, the inner shroud is a fully surrounding (ie, extending 360 degrees) rigid tube. The inner shroud has various cross-sections, such as:

[0146] e) A cylindrical tube with an inner diameter D ( Figure 3A );

[0147] f) Elliptical tubes with different height a and length b ( Figure 3B );

[0148] g) a "half-moon" tube of circular cross-section with diameter D, where the cross section (or chord)

[0149] "a" is cut ( Figure 3C );as well as

[0150] h) A rectangular tube with height a and width b ( Figure 3D ).

[0151] The inner shield may have different longitudinal shapes. For example, in the second embodiment, and now see Figures 4 to 7 The inner shield 11 is a funnel-shaped (eg, necked) tube (eg Figure 4 ). In this embodiment, the inner shield changes its cross-sectional shape / area along the shield, with a larger diameter / working area in the proximal portion and the length of this area with the larger diameter is adjusted to make it the portion of the inner shield that will nest within the outer shield, and the smaller diameter / working area where the inner shield extends the outer shield.

[0152] This design increases the range of motion of the intradiscal tool and allows for better visualization.

[0153] exist Figure 4 In the embodiment of the present invention, the flange is a second substantially tubular portion 25 having a diameter smaller than the diameter of the first substantially tubular portion 13 of the inner shroud. A necking region 27 is provided between the first substantially tubular portion and the second substantially tubular portion.

[0154] In some embodiments, the inner shield can be in the form of a retractor blade of a plurality of retractor blades.

[0155] In tubular embodiments, the smaller tube may or may not be concentric with the larger tube. Figure 5 In the embodiment of the present invention, the first substantially tubular portion and the second substantially tubular portion of the inner shroud are concentric (a=b). Figure 6 In the embodiment, the first substantially tubular portion and the second substantially tubular portion of the inner shroud are non-concentric (a>b).

[0156] In some embodiments, a spherical joint is provided between the larger and smaller tubes, thereby allowing the angle between the two tubes to be varied ( Figure 7 ).exist Figure 7In the embodiment, the outer surface 23 of the inner shield is substantially nested within the inner surface 10 of the outer shield, so that the proximal end of the substantially tubular portion of the inner shield terminates within the outer shield. Moreover, the distal end portion of the inner shield narrows distally to define a first radius R1, and the proximal end portion of the inner shield narrows distally to define a second radius, and the proximal end portion of the inner shield is nested within the distal end portion of the outer shield to achieve multi-axis pivoting of the inner shield.

[0157] In some embodiments, the inner shield is a partially enclosed tube / shield or "flange" designed only to protect the nerve. For some applications, the sole purpose of the inner tube may be to shield / protect the traversing nerve roots. In this case, the inner shield may be simplified to a cylinder with a flange 25 extending distally therefrom, so that the flange is only about one quarter of the shield of the full circle. See FIG. Fig. 8A , or if mounted on an external shroud, see Fig. 9 .

[0158] Depth Adjustment of the Nerve Protector

[0159] The aforementioned outer shield may be positioned and secured at its depth by a mechanism that relies on interference between the outer shield and the inner shield at any location along the outer shield or the inner shield.

[0160] exist Figure 8B In the embodiment of the present invention, the proximal end portion of the first substantially tubular portion 13 of the inner shield comprises a stopper 31 adapted to abut against the proximal end portion of the outer shield, the stopper being adapted to prevent excessive distal movement of the inner shield. Preferably, the stopper extends substantially radially around the proximal end portion of the substantially tubular portion of the inner shield. The stopper may further comprise a textured radial surface 33 adapted for gripping. The textured radial surface acts both as a stopper and as a handle for twisting the shield.

[0161] exist Fig. 9 In one embodiment, the outer surface of the inner shield is substantially nested within the inner surface of the outer shield such that the proximal end portion of the substantially tubular portion of the inner shield extends proximally past the proximal end of the outer shield. Fig. 9 In the embodiment, the outer surface of the outer shield further comprises a first port 41 adapted to be connected to a navigation instrument or a stabilization point, and a second port 43 adapted to be connected to a camera / light system.

[0162] Navigation of the external shroud :

[0163] The first port allows navigation of the outer shield to determine its position (depth and orientation) relative to the treatment site. In one embodiment, the outer surface of the outer shield has features that allow for direct or indirect attachment of navigation instruments. In another embodiment, the inner surface of the outer shield has features that allow for direct or indirect attachment of navigation instruments.

[0164] Endoscope in external shroud :

[0165] In some embodiments, the outer shroud has an integral endoscope that can be set in a fixed or variable (angular or circumferential) position relative to the anatomy. Such endoscopic visualization can be used for subsequent surgical steps, including bone removal, inner shroud deployment, discectomy, and implant insertion. Preferably, the endoscope has an integral lens cleaning mechanism for in-situ automatic cleaning of the lens.

[0166] Fig.10 A cross section of the outer tube is disclosed wherein the outer tube wall 138 has a first channel 238 adapted to contain a camera and a second channel 338 adapted to contain a lens cleaning device.

[0167] Fig.11 A cross section of the outer tube is disclosed, wherein the outer tube wall contains the lens cleaning device 139 and the camera 239.

[0168] Fig.12 A tip chip embodiment is disclosed that includes a cross-section of an outer tube wherein the outer tube wall has a channel 140 containing an endoscope 240 having a video chip 340 near its distal end.

[0169] Fig.13 The distal end of the outer tube is disclosed, the outer tube featuring a video chip 141 near its distal end.

[0170] Fixed endoscope :

[0171] The endoscope may be a tip chip endoscope having an outer diameter of less than 5 mm and having incremental lengths substantially matching the length of the outer shroud.Benefits of the integrated tip chip endoscope / external shroud embodiment include having relatively free space within the bore of the outer shroud, thereby enhancing visualization.

[0172] Preferably, the endoscope is angled within the port or has a built-in lens angle so that when finally positioned within the port, the circumference of the distal portion of the outer shield is visible, and the area within the circumference is also visible.

[0173] In some embodiments, the endoscope can be removed from the wall of the outer shield and independently inserted into the outer shield hole to inspect the treatment site (eg, inserted into the disc space to confirm that an appropriate discectomy was performed).

[0174] Fig.14 A scope holder 137 for an endoscope 237 is disclosed.

[0175] Still see Fig. 9 In some embodiments, the flange 25 of the inner shroud has an arcuate cross-section. In some embodiments, the arcuate cross-section of the flange defines an outer surface 47 of the flange having a curvature substantially similar to the curvature of the inner surface 10 of the outer shroud. Preferably, the flange defines a second substantially tubular portion having a diameter less than or equal to the diameter of the first substantially tubular portion of the inner shroud.

[0176] See now FIG. 15A to FIG. 15B and Fig.16 , the inner shield can be a single blade that can be mounted / hooked to the outer tube. In this case, the elbow 51 serves as a stopper and also as a connector for the outer tube. In addition, the proximal end of the inner shield can form an anchoring pin 53.

[0177] There are many ways to fix or position the inner shield to the intervertebral disc and / or the outer shield. In one embodiment, this provides security against slippage / dislocation of the inner shield, including mounting the inner shield distally (on or within the vertebral endplates or disc annulus) and / or proximally (onto the outer shield).

[0178] Distal fixation of the inner shield to the anatomical structure may include: a) fixation within the annulus of the intervertebral disc, b) fixation against the vertebrae; c) fixation against other structures; d) a Kirchner wire that extends distally through the wall of the inner shield and anchors to the anatomical structure; and e) a pin that extends the distal portion (Figure 15) to anchor to the anatomical structure.

[0179] Proximal fixation of the inner shield to the outer shield may involve a retaining ring or a depth adjustment. Fig.17 , the proximal fixation of the inner shield on the outer shield may involve a positioning ring 55. Assuming that the outer shield is fixed relative to the anatomical structure, a positioning ring having an outer tube shape on the outside and an inner tube shape on the inside may be selected. When placed on the inner shield and entering the outer shield, such a ring will stabilize the position or at least the orientation of the proximal inner shield relative to the outer shield and relative to the anatomical structure (taking into account the above assumptions).

[0180] See now Fig.18The proximal fixation of the inner shield on the outer shield may involve a depth adjustment device 57. This additionally stabilizes or anchors the distal position of the inner shield relative to the anatomical structure by anchoring or hooking the inner shield into the outer shield via a ratchet system. The ratchet system may also be positioned between the inner surface of the outer shield and the outer surface of the inner shield or within the wall of the outer shield. The ratchet system may also include a spring system to increase the friction between the inner shield and the outer shield.

[0181] Internal shroud deployment (circumferential) :

[0182] An embodiment having a separate outer shield and inner shield allows independent positioning of the inner shield relative to the outer shield. Moreover, the use of a smaller inner shield (relative to the outer shield) allows for maximum visualization at the entry point where there is no retraction sensitive tissue. This maximum visualization enables accurate placement of the inner shield. In the event that retraction sensitive tissue is present distal to the outer shield, the relatively small inner shield allows for minimal retraction while providing a passage through or past these tissues. Preferably, the inner diameter of the inner shield does not exceed 40% to 100% of the inner diameter of the outer shield.

[0183] In some embodiments, the inner shroud-outer shroud configuration is replaced with: a) a primary shroud having a substantially tubular shape with a cut-out; and b) a secondary shroud having a shape that is substantially insertable into the cut-out. Preferably, the primary shroud has a substantially annular shape and the secondary shroud has an arcuate cross-section that substantially matches the annular shape of the primary shroud. This embodiment allows the secondary shroud to be tilted relative to the primary shroud.

[0184] Internal shroud deployment (radial) :

[0185] In another nerve protection embodiment, the retraction movement of the shroud is radial rather than rotational. In these embodiments, a straight inner shroud or a bayonet-style inner shroud may be used. The inner shroud may be positioned over the area where the protected tissue is to be positioned. The flange shroud may then be angled at the distal end of the outer shroud (e.g., toward the caudal pedicle) into the center of the access window. The flange shroud may then be advanced longitudinally into the medial side of the nerve root, forming what Kambin describes as a "safety zone." The flange shroud is then angled such that the distal tip of the inner shroud is angled laterally, wherein the outer distal surface of the inner shroud gently pushes and / or shields the exiting nerve root from tools that are introduced further medially into the shroud for intradiscal surgery. This embodiment may be configured such that the inner shroud is substantially nested within: a) the wall of the outer shroud ( Fig.19 ); b) the inner surface of the outer shield ( Fig. 20); or c) the exterior of the exterior surface of the exterior shield ( Fig.21 ). In some embodiments, the inner shield is built into the wall of the outer shield or even outside the outer shield.

[0186] Fig.19 An integral retractor having a flat inner surface 145 housed within an outer tube 245 is disclosed.

[0187] Fig. 20 A retractor is disclosed having a flat inner surface 144 received within an outer tube.

[0188] Fig.21 An outer tube 150 is disclosed having a retractor 250 nested with an outer surface 350 of the outer tube.

[0189] Depth Control of Neuroprotectors :

[0190] The outer shroud may be controlled at its depth by a mechanism that relies on interference between the outer shroud and the inner shroud at any location along the outer shroud or the inner shroud.

[0191] There are a variety of ways that the devices of the present invention may be used to distract the disc space and / or provide nerve protection when installed.

[0192] In one distraction embodiment, a rotating spreader is used. This is a conventional concept involving an oval or rectangular cross-sectional rod inserted into the disc, with the smaller dimension of the rod pointing toward the vertebral endplates. After the spreader is rotated 90° under force, the larger dimension points toward the vertebral endplates, which spreads the disc apart through the difference in the two cross-sectional dimensions.

[0193] In a second distraction embodiment, as now seen in Figures 22 to 24B The inner shield may include a spreader including a frame 60 , a head blade 61 and a tail blade 63 .

[0194] A stent with cranial distraction blades 61 and caudal distraction blades 63 in cranial and caudal positions is introduced into the intervertebral disc in a collapsed / tapered configuration ( Fig. 22 The spreader blades are then spread apart using the inner core 65 (which matches the reaction geometry on the blades to prevent lateral slippage) to increase the intervertebral height from d1 to d2 ( Figure 22 to Figure 23 ). Then the side wall 67 that matches the height of the inner core is introduced inwardly / laterally ( Fig.24A ) to circumferentially close the four-walled shield. Once the core is removed, the stacked shields keep the vertebral bodies apart in a distracted state ( Fig. 24B ).

[0195] See now Figure 25 to Figure 26The inner shield may further include a rotation flange 71 that moves laterally / medially when rotated to shield the nerve roots.

[0196] In the neuroprotective embodiment, and referring now to Figures 27 to 30 , using a rotating funnel 70. Preferably, a flanged shield 71 can be cleverly introduced to protect the exiting nerve root during insertion. If this shield is introduced through the outer shield, it can be pointed at the caudal pedicle. This position is the "safe zone". Once the distal tip reaches the level of the intervertebral disc, the inner shield can be rotated approximately 90° clockwise (i.e., rotated) so that the flange gently pushes and / or shields the exiting nerve root from the tool introduced further medially into the shield for intradiscal surgery.

[0197] In a second neuroprotective embodiment, and referring now to Figure 31 to Figure 34 , using concentrically arranged multiple shields to gently move and / or shield nerves. The rotating funnel principle can also be applied to more than one rotating shield. If protection is only required for structures located on a single side, a single shield may be appropriate. However, in other cases, the shield entrance toward the intervertebral disc is constrained both medially and laterally by the outgoing and descending nerves, so the inner shield needs to shield two opposing structures. In this case, two concentrically arranged outer rotating flanges 81 and inner rotating flanges 83 are rotated 90° in respective clockwise and counterclockwise directions to achieve a final configuration, in which the opposing shields protect the nerves from further tools introduced for intradiscal surgery.

[0198] In another nerve protection embodiment, multiple radial retraction shields are used to gently mobilize and / or shield the nerve.The radial retraction principle can also be applied to more than one radial retraction shield.

[0199] Fig.35 A radial soft tissue retractor 136 is disclosed.

[0200] Fig.36 An outer tube / internal retractor assembly is disclosed wherein both the first internal retractor 153 and the second internal retractor 253 are angled inwardly to retract soft tissue.

[0201] If only structures on a single side need to be protected, a single shield may be appropriate. However, in other cases, shield access to the disc is constrained both medially and laterally by the exiting and descending nerves, such that the inner shield needs to shield two opposing structures. In this case, two opposing inner flanges are initially positioned toward the center of the outer tube access window and are subsequently retracted outwardly to shield the opposing nerves from further tools introduced to perform the intradiscal procedure.

[0202] Figures 37 to 46 Preferred surgical methods involving cannula access devices are disclosed.

[0203] In one embodiment, and referring now to Fig.37 , the surgeon places a pedicle screw-based anchor, adds a navigation reference frame 101 to the anchor, and uses a commercial navigation system for navigation. In some embodiments, the navigation array is placed on the anatomical structure with reference to anatomical features substantially symmetrically adjacent to the treatment site (e.g., the contralateral cranial or caudal pedicle).

[0204] In some embodiments, the probe is navigated to the facet joint capsule or disc space through the Kambin triangle. Preferably, after cutting the fascia and muscles, a probe with navigation visualization enabled is introduced to obtain an initial anchor point. In one embodiment, the probe is inserted into the disc space by pointing outside the lateral edge of the superior articular process and can optionally be enabled with / with the support of nerve detection and / or visualization capabilities. In another embodiment, the probe is introduced into the facet joint capsule.

[0205] In some embodiments, there is expansion on the navigation probe. After the initial anchor point, expansion is performed to prepare the surgical site for the port size required for treatment. Then sequential expansion is performed until a port window of the preferred size is obtained. The port is then introduced by a related expander. In one embodiment, initial anchoring is performed in the intervertebral disc space and one or more concentric sequential expansion devices will be used to concentrically retract tissue around the initial anchor point (exposing the lateral part of the SAP on the outside and the Kambin triangle on the inside). In another embodiment, initial anchoring is performed in the facet joint capsule and one or more eccentric sequential expansion devices can be used to retract tissue laterally to focus on the lateral part of the SAP and the Kambin triangle.

[0206] In some embodiments, the outer shield is secured to an anatomical reference.The outer shield has a substantially tubular portion with points or features designed for attachment to a stabilization mechanism that in turn is secured to an anatomical feature on a vertebral body cephalad or caudal to the treatment site.

[0207] Fig.38 An outer tube is disclosed into which a plug is inserted containing a template for guiding a bone cutting device.

[0208] In some embodiments, the outer sleeve is attached to a stabilizing mechanism. In one embodiment, this stabilizing device is a device having sufficient length to reach an anatomical fixation point (e.g., a pedicle screw) on the opposite side of the treatment site. The mechanism (including its connection features to the outer shield and the anatomical anchor) allows for sufficient flexibility in the placement of the outer shield and is stable enough to hold the outer shield in place until the user releases it. The stabilizing method allows the user to determine the hardness.

[0209] In another embodiment, this device has sufficient length to reach an anatomical fixation point (e.g., a pedicle screw) on the same side of the treatment site. Likewise, the mechanism (including its connection features to the outer shield and the anatomical anchor) will allow for sufficient flexibility in the placement of the outer shield, and be stable enough to hold the outer shield in place until released by the user. The stabilization method allows the user to determine the stiffness.

[0210] In another embodiment, this device is one that is of sufficient length to reach an anatomical fixation point (e.g., a pedicle screw) in the patient's midline. Likewise, the mechanism (including its connection features to the outer shield and the anatomical anchor) will allow for sufficient flexibility in the placement of the outer shield, and be stable enough to hold the outer shield in place unless released by the user. The stabilization method allows the user to determine the stiffness.

[0211] See now FIG. 39A to FIG. 39B The surgeon then dilates the tissue beyond the pedicle-based anchor and inserts an outer shield 1 connected to the anchor with its proximal end pointing toward the superior articular process. Blunt dissection is performed on the affected disc up to the bone, followed by muscle retraction on the affected disc. This retraction involves blunt dissection of the muscle and fascia to the bone level under direct visualization.

[0212] See now Fig.40 , the surgeon then turns the outer shield 1 toward the interlaminar space, performs central bilateral decompression as required by the pathology, and then turns the shield back to its initial position.

[0213] In some embodiments, an alternative form of tilting the access channel inward from the incision site can be to use a more medial alternative entry site. In some embodiments, the initial anchor point in the disc space will be inboard of the inferior articular process. For embodiments with an initial anchor point in the facet joint capsule, expansion of an eccentric dilator will expand inward from the capsule. In addition, portions of the lamina and inferior articular process will be removed by bone removal sections.

[0214] See now Fig.41The surgeon then inserts a bone removal tool (not shown) into the outer shield tube and resects the lateral portion of the superior articular process to extend the traditional Kambin triangle inwardly.

[0215] Under direct or endoscopic visualization, a bone removal device is introduced into the outer shroud and used to remove at least the lateral portion of the SAP. Such devices are available in lengths and sizes to allow safe introduction and use through access windows ranging from 40 mm to 200 mm and window sizes ranging from 10 mm to 25 mm.

[0216] In one embodiment, the bone removal device is an ultrasonic cutting device. In another embodiment, the bone removal device is a reciprocating cutting surface. In yet another embodiment, the bone removal device is a rotary cutting tool. In another embodiment, the bone removal device is a mechanical punch with a stroke length between 10 mm and 30 mm. Bone can be removed in such a way that bone with a size smaller than the entry size is excised and removed. Bone removal can be performed using a template that is independently inserted into the outer shield and used to guide the direction of bone cutting and removal.

[0217] The negative template is a plug-type device inserted into the external access tube. It includes longitudinal incisions of different shapes, depending on the cross-sectional shape of the tissue to be removed, and the cross-sectional shape of the corresponding tissue needs to be covered and thus protected from any surgical interaction. By inserting a cutting device such as a milling cutter into the longitudinal incision, the surgeon is able to remove tissue without endangering the covered tissue / structure. In combination with a proximal stop system (at the proximal end of the external access tube and / or on the axis of the milling system), the surgeon can remove tissue layer by layer. The thickness of the layer and thus the progress of the cutting procedure can be controlled by a stop system supported by a ruler. The system allows the surgeon to perform safe tissue removal using a controlled continuous workflow: Check the anatomical situation Adjust the stop system to limit the cross-sectional thickness of the tissue that needs to be removed Insert the milling system before the stop system engages Mill / cut tissue on a plane (2D) (also blindly) Remove the milling system Check the anatomical situation Adjust the stop system.

[0218] A sequential workflow can be considered safer than a parallel workflow because the surgeon only needs to focus on one parameter at a time (here: the position of the milling cutter plane, then its depth, then the position of the milling cutter plane, ...), but a parallel workflow requires controlling two or more parameters at a time (here: the position of the milling cutter plane and its depth).

[0219] Navigation of SAP removal can be performed using the bone removal device described above, which is adapted to be navigated through its mechanical or visual connection to a navigation system.

[0220] See now Figure 42 to Figure 43The surgeon then inserts the inner shield tube into the outer shield tube, which is used to extend the outer tube forward from the facet joint line until the end of the inner shield reaches the level of the intervertebral disc. The nerve root is protected by the inner shield.

[0221] See now Fig.44 The surgeon then identifies the disc and spreads it using a wedge-shaped osteotome; checks for looseness, and removes the posterior rim, bone spurs, and annulus until the smallest annular window is opened. The surgeon then inserts the disc removal tool 201 into the access device, removes the disc, and prepares the endplates.

[0222] Fig.44 An alternative embodiment of the disc cleaning step provided in is to navigate the disc removal tool through its mechanical or visual connection to a navigation system.

[0223] See now Fig.45 , the surgeon then performs temporary disc space distraction, fills a portion of the disc space with bone graft, and inserts the fusion cage 203 into the remaining disc space.

[0224] See now Fig.46 , the surgeon then adds posterior fixation 103 .

[0225] Observation components

[0226] In some embodiments, a visualization element based on chip-on-the-tip technology and integrated into the wall of the port is used. This embodiment has many advantages over a standard rod lens endoscope mounted at the tube wall:

[0227] • Manufacturing costs. The chip-on-the-tip technology allows for very cost-effective manufacturing and can therefore be sold as a "disposable" device.

[0228] · Rigid portion only at the distal tip. While standard rod lens endoscope systems have a rigid cylindrical shape throughout the tube, a chip-on-the-tip endoscope may have a non-cylindrical configuration at the proximal outer tube end. Preferably, the shape is a flat cable shape. In some novel embodiments, the chip-on-the-tip endoscope has a relatively short "rigid" segment (approximately 20 mm) relative to a standard rod lens endoscope, where the proximal end is composed of a cable, which may be flexible. In other embodiments, the rigid portion is shorter (resulting in a smaller chip assembly) and the concept of active articulation is used to change the lens angle. Because the cable is integrated into the tube wall, the shape of the port window is maintained throughout the procedure. For example, a 5 mm chip-on-the-tip endoscope turns a 15 mm circular entry window into a kidney-shaped entry window.

[0229] · Size / weight of the camera unit. Standard rod lens endoscopes have a standard eyepiece, which is a universal interface of a certain size. Cameras connected to such systems must be built into a certain size to be compatible with the eyepiece. This requirement creates a relatively bulky camera attachment (approximately 3 mm to 6 cm in diameter and approximately 5 mm to 10 cm in length) that has many disadvantages. First, this larger camera construction can be a physical hindrance during operation, especially when the trajectory of the working port changes or interferes with the camera. Second, the size and weight of this conventional construction becomes large enough to produce certain undesirable forces on the rod lens endoscope, especially when bent. Third, the relatively fragile conventional rod lens endoscope must be embedded in a stable structure such as a metal tube, further reducing the active working window.

[0230] With the chip-on-tip embodiment disclosed herein, where the chip cable is embedded in the wall of the outer tube, the cable exiting at the proximal outer tube wall does not generate similar forces on the working port. In addition, with respect to the attachment mechanism for mounting the chip-on-tip endoscope in the tube wall, the absence of bending forces increases the possibility of using relatively thin attachment options that do not have to be very mechanically stable.

[0231] ·Working environment. Typically, a constant fluid environment (continuous flow of saline solution) is used in spinal endoscopy applications. However, in small incision and microsurgical environments, a fluid environment is not helpful because anatomical conditions vary greatly. Therefore, in the preferred novel procedures described herein, the chip-on-the-tip endoscope operates in a dry, open air environment. However, the open, dry air environment in which the chip-on-the-tip endoscope is used may produce undesirable condensation effects on the lens components of the endoscope. For example, a cooler lens may fog up in a humid body temperature environment. In addition, drill cuttings, burr fragments, or smoke from a monopolar scalpel or hemostatic tool may also affect the lens of the endoscope, thereby reducing visibility. Therefore, it is desirable to periodically clean the lens of the chip-on-the-tip endoscope.

[0232] Nerve deflection (tube in tube)

[0233] In minimally invasive spinal surgery performed through the portal vein, a set of dilators is often used to prepare the site to receive the portal vein. One such technique is shown in U.S. Patent Publication US2012-0232552 (Morgenstern). In this conventional technique (which has an eccentric dilator), the outer diameter of any one dilator is the same as the inner diameter of the next consecutive (external) dilator. This identity of diameter is necessary for fluoroscopically assisted percutaneous muscle dilation.

[0234] Since some embodiments of the present application describe procedures between the level of the spinal joint and the intervertebral disc, the surgical site is dissected under direct visualization. Therefore, the diameters of the continuous dilators used in these novel procedures do not have to match. The relaxed "precise diameter" requirements in these novel procedures allow the surgeon to be more free in many tube design areas. For example, it allows the use of tapered tubes.

[0235] It also allows the surgeon the freedom to use external and internal ports of different axes. It further allows the trajectory of the internal port relative to the external port to be changed in angle during certain treatment steps. Finally, it allows the trajectory of the internal port relative to the external port to be changed in distance during certain treatment steps.

[0236] Because percutaneous muscle dilation is performed without direct visualization due to the fluoroscopic assistance, this is a blinded procedure with limitations. These limitations include the inability to perform surgical steps that require direct visualization for safety reasons. One such treatment step that requires direct visualization is direct decompression of bone and ligamentous tissue directly adjacent to neural structures.

[0237] Because some embodiments described herein allow direct visualization of anatomical structures, these embodiments further specifically allow direct decompression of bone and ligamentous tissue directly adjacent to neural structures, and more generally allow manipulation or removal of tissue adjacent to the tube through a "tube-in-tube" access port that completely preserves the tissue.

[0238] Morgenstern also described a method in which a guidewire is introduced directly into Kambin's triangle through the intervertebral disc space under fluoroscopic guidance (ie, without direct visualization). Morgenstern also described the possibility of using an electrical-based nerve monitoring probe. In addition, Morgenstern described a method of enlarging the spinous process by subsequently rasping away bone from the SAP and pedicles.

[0239] The novel procedure described herein performs non-visualized procedures (e.g., dilation) only in the safe area above the facet joint line. In the more anatomically critical area between the facet joint level and the intervertebral disc, the novel procedure dissects the surgical site under direct visualization, thereby allowing the surgeon to leave as much bone as possible and as meaningfully as possible.

[0240] navigation

[0241] Navigation augments static X-ray, CT or MRI data with a real-time intraoperative display of the actual instruments being used in relation to the patient’s anatomy. It therefore increases the safety of these instruments by showing their shape, trajectory and positioning and even more importantly it supports the surgeon in maintaining instrument orientation during the operation.

[0242] Without wishing to be bound by theory, it is believed that one reason why minimally invasive techniques are not often used is that significantly higher X-ray exposure is required to maintain orientation compared to small incision techniques, where the surgeon still has direct visualization so that the active site can actually be seen using a microscope or a small magnifying glass. For surgeons who are often exposed to radiation, the effect of X-ray exposure is stronger. This challenge is solved by the navigation technology implemented in the novel procedures described herein, because they allow X-ray exposure to be reduced to a desired minimum of two X-rays in total for alignment purposes. Once a single lateral shot and a single front-to-back shot have been aligned, all the instruments used (e.g., Jamshidi needles, indicators, dilators, access tubes, osteotomes, extendable cages themselves, intervertebral disc removal devices ...) can be projected into these static fluorescent images in real time. Another positive effect is that a lot of time can be saved. Putting the navigation system in place also helps the surgeon understand the orientation (track and depth) of the endoscope, and therefore understands what he or she actually sees using the camera. This can be achieved indirectly by directly navigating the camera or by setting the camera in a fixed position integrated into the navigation access tube.

[0243] The Jamshidi needle, indicator, dilator, and access tube instrument can all be navigated using one instrument, the FOX Navigation Multi-Tool or "Multi-Tool". The Multi-Tool may include integrated or built-in neural monitoring, such as for detecting the presence, proximity, health, or other attributes of neural tissue. The Multi-Tool may include electrodes, transducers, or other energy delivery elements for applying energy to tissue (e.g., to ablate or cauterize tissue). The Multi-Tool may include an energy delivery element in the form of a microwave ablation element. The Multi-Tool may include an energy delivery element of the type used in the NEUWAVE system available from ETHICON, INC. (Cincinnati, Ohio). The energy delivery element may be built into the Multi-Tool, or may be supported or guided to a target location using the Multi-Tool. The energy delivery element may be mounted on a shaft or needle that is coaxially housed within or around another shaft component of the Multi-Tool. The Multi-Tool may be used to position the energy delivery element close to a target location such as a bony bone tumor. Energy may be delivered from the energy delivery element to a tumor or other target location.

[0244] FIG. 47A to FIG. 47C A navigation plug is disclosed that includes a base 147 having an array 247 connected thereto, wherein the plug is adapted to fit within an outer tube 347.

[0245] Bone cutter

[0246] In some embodiments, the novel procedure uses an ultrasonic bone cutting device for SAP removal that only cuts bone and does not cut soft tissue. An embodiment based on a conventional expandable cage device for intervertebral body fusion may require an access window at least as large as 12 mm. Such a large window can only be achieved by (partially) removing the superior articular process (SAP) to extend the Kambin triangle. The safety of this procedure is significantly increased because the ultrasonic bone cutting device will not cut the nerve when it accidentally hits the nerve. If the cutting device blade is designed to reach the shape and diameter of the inner tube / blade at the level of the intervertebral disc space distally (i.e., a cookie cutter design), SAP removal can be minimized (less trauma, less stress on the patient, faster recovery) and performed in a single step (faster than a multi-step procedure).

[0247] Fig.48 A biscuit cutter type distal end 143 of the ultrasonic cutter extending from the end of the outer tube 243 is disclosed, wherein the distal end 143 has a plurality of cutting teeth 343 .

[0248] Another way to increase the safety of bone cutting is to perform manual milling of the bone with depth control using negative guidance. The negative guidance covers those areas that will not be removed (negative template). Depth control allows to mill bone layer by layer under the continuous control of the surgeon. The reference as well as the trajectory for the depth control can be an external access tube (see also the navigation paragraph).

[0249] FIG. 49A to FIG. 49B Various cross sections of templates for guiding bone cutting devices are disclosed.

[0250] Bone cutter

[0251] In some embodiments, the bone removal device is an ultrasonic scalpel with a cookie cutter design. The scalpel has a crescent-shaped cutting surface that engages an outer tube. The scalpel is used as a single-pass instrument, removing a predetermined amount of bone in one go. In some embodiments, the scalpel also has a tube that sprays water for flushing, and the outer tube has an aspiration line for clearing slurry from the removed bone.

[0252] In some embodiments, the scalpel can be navigated and rides in a slot provided on the inner wall of the outer tube. The depth of the slot can be predetermined to provide depth-controlled milling and control the direction of the cutter. This is advantageous because it is easy to hit nerves when cutting by hand. The shape and size of the cutting surface can define a specific area of ​​bone to be removed. The specificity of the cutting is advantageous because it minimizes the amount of bone removed, which is advantageous for small joints that are extremely weak. Therefore, a faster procedure, less trauma (less pain), and a more stable structure are achieved.

[0253] Observation element (brown)

[0254] In some embodiments, the chip viewing element can be angled so that it can see around the corners of the tube.

[0255] In a conventional endoscope, the visualization is 2D (i.e., there is no depth perception), so two nerves may appear to be in close proximity when they are actually 2 cm apart. Therefore, in some embodiments, the endoscope is modified so that the chip acts as a rangefinder. Specifically, the chip identifies and evaluates a reference structure at a known distance from the chip, and then measures how far the nerve is from the chip (the end of the tube) based on that evaluation.

[0256] Nerve deflection (tube in tube)

[0257] In some embodiments, there is a pressure sensor on the outer shield to measure the pressure on the nerve. Using ultrasound technology that can measure distance, the system can measure the elongation of the nerve during retraction and define a maximum elongation limit (e.g., 20%), and then warn the surgeon when the elongation limit is exceeded. In some embodiments, the system integrates ultrasound into the port and navigates the port thereby.

[0258] In some embodiments, the surgeon navigates the camera. This allows the surgeon to understand the orientation of the camera.

[0259] In some embodiments, the visualization provides an axial view of the disc so the surgeon can understand the position of the disc removal tool.

[0260] Neuromonitoring Analysis

[0261] Currently, nerve monitoring devices are available to obtain an indication of potential nerve health or nerve damage that may be caused in a surgical setting. This indication of nerve health is achieved by measuring electrical impulses between nerves near the surgical site and the distal end of the nerve. For example, impulses may be measured between a nerve root in the spine and a point on the leg.

[0262] Nerve injury can be caused by direct manual contact with a nerve. In addition to severe injuries such as severing or crushing a nerve, other lesser forces applied to a nerve can also cause injury. For example, displacing a nerve, stretching a nerve, or compressing a nerve can cause severe injury. In some cases, applying such extended forces to a nerve can reduce blood flow through the nerve, again causing nerve injury. Typically, this exposure time depends on the amount of force applied. Therefore, there seems to be no known firm rule for how long a surgeon can load a nerve.

[0263] In addition to neuromonitoring, alternative forms of assessing potential nerve damage may bring new insights into neuroprotection during procedures. In this regard, nerve manipulation measurements can produce an indication of nerve risk. If a nerve is displaced during a procedure, it may be elongated or may be displaced laterally. These changes in the physical characteristics of the nerve can be measured and used to predict potential nerve damage. Therefore, other potential features can be measured and used to predict potential nerve damage, including arc length and the diameter of the nerve itself. These features can be measured in quantifiable terms by techniques such as ultrasound. The resulting measurements are then analyzed (by software or manually) based on absolute values, percentage changes, or some other indicators of potential nerve risk / damage that can be obtained from a database or library. In some embodiments, these metrics can be used as predictors of a safe length of time in which a nerve can have a given displacement or deformation without causing long-term damage. Calculations or algorithms can also be used to determine the maximum safe deformation, or the maximum permissible time that a nerve can have a given deformation feature.

[0264] This measurement can be obtained in many ways. It can be measured manually, optically or by other imaging modalities. This can occur with open surgery, subcutaneous injections in MIS or other types of procedures. Direct visualization can be done using a camera. The before and after images can be interpreted to calculate the absolute amount of deformation or percentage change. The measurement can be obtained by imaging (X-ray, CAT / PET scans, MRI, etc.) such as ultrasound or other forms of imaging (X-ray, CAT / PET scans, MRI, etc.) that can "see" soft tissue or identify neural tissue associated with surrounding tissue.

[0265] Other measurement methods that may be used according to this embodiment may include a) measuring density changes within the nerve due to loading, or b) changes in blood flow. Such measurements may be obtained by radar, ultrasound, and other imaging methods.

[0266] In some nerve monitoring embodiments, it is possible to measure the impedance within a nerve or pulse, where this can be done locally relative to a specific deformed area of ​​the nerve. Specifically, in some embodiments discussed herein, the nerve shield can have sensors on opposite edges of the shield that will contact the same nerve in two different nerve locations. These sensors will allow the surgeon to read electrical values ​​such as pulse or resistance before the nerve is expanded, and then measure the electrical values ​​again when expansion occurs or is achieved. The difference in these measurements can be an indicator of the degree of deformation. Any of the nerve monitoring features described above or elsewhere herein may be incorporated into or included in a multi-tool. For example, the above-mentioned sensors can be mounted to the shaft component of the multi-tool, which can be used to position the sensor close to the nerve tissue.

[0267] Fig.50 A cookie cutter type distal end 142 of an ultrasonic cutter having a semi-circular cutter cutter bone is disclosed.

[0268] Fig.51 A small flexure arm 146 connecting the outer tube 246 and the screw extension 346 is disclosed.

[0269] Fig.52 An outer tube / inner retractor assembly is disclosed wherein the inner retractor 151 is angled inwardly to retract soft tissue.

[0270] Fig.53 An outer tube / inner retractor assembly is disclosed wherein the inner retractor 152 extends parallel to the outer tube 252 .

[0271] Fig.54 An endoscope 154 housed within an outer tube and an inner tube 254 extending from the outer tube are disclosed.

[0272] In many of the embodiments disclosed above, the inner shroud is nested within the outer shroud. However, in alternative embodiments of all of these embodiments, the inner shroud is replaced by a removable blade integrated into a cutout formed in the wall of the outer shroud. In this case, the outer surface of the inner shroud is substantially nested within the outer surface of the outer shroud, such that the flange extends distally past the distal end of the outer shroud.

[0273] In many embodiments disclosed above, the proximal end of the substantially tubular portion of the inner shield includes a stop adapted to abut against the proximal end of the outer shield, the stop adapted to prevent excessive distal movement of the inner shield. In other embodiments, the abutment occurs anywhere along the outer shield.

[0274] Figures 55 to 63 Disclosed are some of the instruments used in the preferred procedures disclosed herein.

[0275] Pedicle column with reference array

[0276] See now Fig.55 , the first step of the navigation procedure is to place a pedicle screw (such as Viper 2 or ViperPrime, available from DePuy Synthes Spine, Raynham, MA) in the contralateral caudal vertebral body and then insert a central core 501, which includes a multiaxial blocking post 503 for threaded engagement with the locking cap of the pedicle screw. When tightened, the multiaxiality of the screw is completely blocked. Screw 505 locks the central core with a multiaxial blocking post. A clamp 507 with an eccentric rod securely connects a reference array 509 to the pedicle post. Two additional threaded connectors 511, 513 allow the surgeon to align the reference array set up with the camera to the navigation system, which is most often placed on the caudal side of the patient.

[0277] The reference array should be mounted directly on the blocking core (see pedicle anchors). In some embodiments, there is an adjustable orientation of the array on the post. In some embodiments, care is taken to ensure that the distance between the handle and the top of the anti-torque insert is greater than the length of the screw. In some embodiments, the navigation array is strong enough to act as an anti-torque for multi-axis blocking (which will be done before alignment).

[0278] Multi-Tool

[0279] See now Fig.56 , a multi-tool probe is provided, which includes a body 515 (including a navigation array (single piece)), a blunt-tipped stylet 517, a pointed stylet 519, and a detachable handle 521. This set of features allows the surgeon to use the device as a navigation pointer (with a blunt-tipped stylet), a navigational Jamshidi needle (pointed end), and a device for navigating the insertion of dilation tubes and access tubes (see below). This tool uses a single array, and the resulting single alignment procedure covers four functions. In some embodiments, the array is part of the detachable handle.

[0280] As described above, the multi-tool may include integrated or built-in neural monitoring, such as for detecting the presence, proximity, health, or other attributes of neural tissue. Fig.56AAs shown, one or more shaft components of the multi-tool may include a nerve monitoring sensor 522. The sensor may include one or more sensors. The sensor may be configured to detect the presence, proximity, health, or other attributes of neural tissue. For example, the sensor may be configured to use functional near infrared (fNIR) spectroscopy to assess nerve health, for example, as described in U.S. Patent Application No. 62 / 507,930 filed on May 18, 2017, which is hereby incorporated by reference herein. For another example, the sensor may be configured to measure electrical nerve impulses, EEG, EMG, evoked potentials, etc. The nerve assessment data may be transmitted to the surgeon to inform subsequent surgical steps.

[0281] As also mentioned above and as Fig.56A As shown, the multi-tool may include electrodes, transducers, or other energy delivery elements 526 for applying energy to tissue (e.g., to ablate or cauterize tissue). The multi-tool may include an energy delivery element in the form of a microwave ablation element. The multi-tool may include an energy delivery element of the type used in the NEUWAVE system available from ETHICON, INC. (Cincinnati, Ohio). The energy delivery element may be built into the multi-tool, or may be supported or guided to the target location using the multi-tool. The energy delivery element may be mounted on a shaft or needle 524. The needle may be coaxially housed within or around another shaft component of the multi-tool. The multi-tool may be used to position the energy delivery element in proximity to a target location such as a bony bone tumor. Energy may be delivered from the energy delivery element to the tumor or other target location.

[0282] Pedicle Anchors

[0283] See now Fig.57 , a pedicle anchor based on a conventional screw is provided, which includes a central core 523, which includes a multiaxial blocking column 525 that is threadedly engaged with the locking cap of the screw. When tightened, the multiaxiality of the screw is completely blocked. Screw 527 locks the central core with a multiaxial blocking column. In other embodiments that do not include the above-mentioned pedicle column with a reference array, the interface of the attachment device (miniature flexible arm) is not achieved by using a clamp but by a non-detachable structure (sphere, 529). This provides sufficient stability and is a simple add-on to existing screw systems.

[0284] Expansion tube

[0285] See now Fig.58, a dilation system is provided comprising a set of tubes 531 whose outer diameters match the inner diameters of the current access tubes (outer shield) of 12 mm, 15 mm and 18 mm. They are all circular in the cross-sectional plane and slotted on the longitudinal axis for placement on the multi-tool probe (see above) and connection to the hollow cylindrical body of the multi-tool through the navigation array. In some embodiments, the outer diameters (OD) of the set of tubes are OD1 = 12 mm, OD2 = 15 mm and OD3 = 18 mm.

[0286] Micro Flexible Arm

[0287] See now Fig.59 , a small flexure arm comprising two clamps 533, 535 is provided, which is attached to the spherical connectors on the pedicle anchor and the access tube (external shield), and thus allows multi-axial adjustment of the attached device. In the unlocked position, the segmented arm with ball and socket element 537 combines with the multi-axial clamp to allow non-restrictive three-dimensional placement of the access tube (external shield). The system can be locked using a single point handle 539 that tightens the multi-core wire 541. Potential elongation of the wire over time can be compensated on the screw 543 by adjusting the effective length of the wire, which will have a negative impact on the fixation performance of the device.

[0288] Access tube with soft tissue retractor (external shield)

[0289] See now Fig.60 , an access tube (external shield) 545 is provided as a simple cylindrical tube with a distal flange, which has a non-detachable feature (sphere 547) for connecting the access tube to the micro-flexure arm. A soft tissue retraction blade (internal shield) 549 is placed in the access tube. An attachment spring 551 allows central insertion. Once the blade is released (handle 553), the spring pushes the blade (internal shield) against the inner wall of the access tube (external shield) and thus retracts the soft tissue on its distal end. The blade (internal shield) remains free to rotate and is held together with the access tube (external shield) by pure friction. In some embodiments, it is optional to use two soft tissue retraction blades (internal shields) simultaneously, which will meet the requirements of using this embodiment for TLIF procedures because it allows retraction of descending nerves and outgoing nerves. In some embodiments, the removable handle is replaced by a simple permanent handle of about 25 mm in length.

[0290] Access tube with integrated endoscope (external shroud)

[0291] See now Fig.61, an access tube (external shield) with an integrated endoscope and a non-detachable feature (sphere, 555) is provided, which is used to connect the access tube to the micro-flexure arm. The depth-adjustable endoscope system is held in a channel 557, which has a spring feature 559 to increase friction and thus hold the endoscope in place. The endoscope system 561 consists of the endoscope itself (OD=4mm) and 2 tubes, one tube 563 for flushing and the other tube 565 for suction. In some embodiments, the endoscope is depth-adjustable. In some embodiments, the channel of the endoscope will be parallel to the lumen of the access tube (external shield).

[0292] Navigation plug

[0293] See now Fig.62 In some embodiments, there is a navigation plug 567 placed in the access tube (outer shroud) 569 that allows the multi-tool (see above) to be placed in the center of the access tube (outer shroud) flush with its distal end. This embodiment allows visualization of the central longitudinal axis of the access tube (outer shroud) and its distal end in the navigation system. Because, in some embodiments, the entry trajectory is considered more important than depth, the trajectory line can be graduated to provide depth information combined with the known port length.

[0294] Discectomy tool with handle

[0295] See now Fig.63 , provides an attachable handle 571 that attaches directly to a standard suction based discectomy tool 573 via an adapter plate 575 that is clamped to the discectomy tool container by 3 screws. In a first embodiment of this adapter plate, it holds only the attachable handle, while in a second version, it holds an attached navigation array. The navigation array is pre-calibrated: after the navigation system knows what specific discectomy tool is currently being used, it will display the correct size and tip of the device in a pre-aligned X-ray view in real time.

[0296] Figures 64 to 90 Some of the instruments are disclosed in their contemplated spinal orientations for use in the preferred procedures disclosed herein.

[0297] Step 1: Placement of reference array

[0298] Step 2 Placement of pedicle anchors

[0299] Step 3: Placement of the entry tube

[0300] Step 4SAP Removal

[0301] Step 5: Soft tissue retraction

[0302] Step 6 Disc Removal

[0303] Step 7 Insertion of expandable cage and bone substitute

[0304] Step 8: Rear stability

[0305] See now Figures 64 to 65 In one embodiment, a polyaxial screw is inserted into the spine from the contralateral side via post 576. A navigation reference array 577 is then fixedly mounted on a polyaxial blocking post 579 and engages in the distal threads of the locking cap of the pedicle screw (not visible, inner screw / tab).

[0306] Step 1: Placement of reference array

[0307] Step 2 Placement of pedicle anchors

[0308] See now Fig.66 , a pedicle anchor 581 with a connector interface 583 1s is placed on the contralateral side.

[0309] See now Fig.67 , pedicle anchor 585 is placed on the ipsilateral side.

[0310] Step 3: Placement of the entry tube

[0311] See now Fig.68 , the multi-tool 587 is inserted into the spine for use in determining the target area 589 and the trajectory of the dilator / access tube. The nerve monitoring feature of the multi-tool can be used during insertion or at any other desired time to avoid or navigate around neural tissue, safely retract neural tissue, and / or assess the health of neural tissue. The multi-tool can integrate multiple components into a single navigation tool to reduce the number of instruments that are tracked separately during surgery, for example, as part of a procedure to insert an access port into a patient during a surgical procedure. In combination with the following Figures 91 to 125 Additional embodiments of multi-tools are described.

[0312] See now Fig.69 , the K-wire and handle are removed from the multi-tool to proceed to the next step. After the multi-tool 591 is placed, the K-wire 593 needs to be removed to allow the handle 595 to be removed.

[0313] See now Fig.70 , multiple steps of dilation are performed to prepare for insertion of the access tube (outer shield). Removal of the handle (see previous steps) allows placement of the first dilator, the second dilator, and the third dilator 597 to prepare for access tube insertion.

[0314] See now Fig.71 , remove the navigation array from the multi-tool base. Since it is clinically important to keep the target point of the access tube (external shield) positioned, the access port can be placed on the body 599 of the multi-tool by removing the navigation array, leaving the navigation array interface 601 behind, which allows the reference array to be fixed in a gap-free, load-bearing and one-to-one manner.

[0315] See now Fig.72 , an access tube (external shroud) is inserted over the dilator 602 (in which the viewing element, i.e., the chip-on-the-tip endoscope, has been pre-installed). The access tube (external shroud) is retractable and adjustable in length, stabilized with a ratchet mechanism 603. The access tube includes a distal section 605 that houses a depth-adjustable chip-on-the-tip camera 607 in a channel 609 that is integrated into the wall of the distal section. The proximal portion of the access tube (external shroud) 611 slides over the distal section and holds the connector interface 613.

[0316] See now Fig.73 Once the dilator and the body of the multi-tool are removed, the access tube (outer shield) 615 provides free access to the SAP.

[0317] Fig.74 Connectors for the visualization box and cleaning box (water and suction) are disclosed. The chip-on-the-end camera consists of the actual camera 617 set in the entry tube (external shroud) and a main connector plug 619 that provides power, data cables and light to the camera. There are also two tubes 621, 623 for flushing and suction to provide a cleaning feature for the camera lens that is incorporated into a single cable 625 that connects to the camera and extends from the entry tube (external shroud).

[0318] See now Fig.75 , the access tube (external shield) is fixed to the ipsilateral or contralateral pedicle anchor. The access tube 627 is rigidly attached to the contralateral 629 or ipsilateral (not shown) pedicle anchor via connector 631. This connector allows the access tube to be locked in any 3D position. It includes a ball and socket segment 635, two interface clamps 637a, 637b and an inner wire (not visible), which is tensioned by an adjustable 639 single-point fixed handle 641, thereby blocking the single joint of the two interface clamps and segments by increasing its absolute friction. The single-point fixed connector is designed to minimize the cumulative force on the access tube and the pedicle anchor during the tightening of the structure. Another connector design (not shown) is functionally opposite because it is permanently stable unless the inner wire is released via the single-point fixed handle.

[0319] Step 4 SAP Removal

[0320] See now Fig.76, provides an axial view of the access tube, where the surgeon is ready to begin cutting the SAP. The figure discloses a single segment 643 of the microflexure arm and a connector interface 645, an outer proximal portion 647 of the telescopic access tube; an inner distal portion 649 of the telescopic access tube; a cable for an integrated chip-on-the-tip camera 651; and an unretracted nerve UN.

[0321] See now Fig.77 , which provides an integrated endoscope arrangement, the integrated endoscope comprising an outer proximal tube 653 of a telescopic entry tube; an inner distal tube 655 of the telescopic entry tube; an exit cable on an integrated chip-on-the-end camera 657; a chip-on-the-end camera in a housing 659; and a projected field of view on the chip-on-the-end camera PF

[0322] Reference now Fig.78 In some embodiments, there is optional navigation of the access tube by using a multi-tool with a navigation plug. In conjunction with the navigation plug 661, the multi-tool 663 can also be used to visualize the trajectory and distal end of the access tube 665 using navigation. The navigation plug is located on the proximal edge of the inner distal tube of the telescoping access tube, which results in accurate visualization of depth perception regardless of the position of the outer proximal tube and therefore the overall length of the access tube.

[0323] See now Fig.79 , SAP removal via the use of a MIS high speed drill or hand tools is provided. The SAP will be (partially) removed using a high speed power tool such as the Anspach system 667. The burr 669 will be partially guarded for added safety.

[0324] See now Fig.80 , showing further removal of SAP by MIS high speed drill or hand tool for different dissection planes. Removal of SAP with burr 671 occurs approximately 10mm-20mm above nerve (2) level NL.

[0325] Step 5: Soft tissue retraction

[0326] Figure 81 to Figure 82 Soft tissue retraction is disclosed, showing a clamp directly on the access tube, medial to lateral retraction. Fig.81 The soft tissue retractor 673 is shown prior to radial retraction of the nerve. In this state, the soft tissue retractor has been engaged with the access tube 675. Fig.82 A soft tissue retractor 673 is disclosed following radial retraction of the nerve.

[0327] Fig.83 Nerve shielding and positioning according to the patient's anatomy is disclosed. Fig.83The soft tissue retractor 675 is shown fully engaged with the clamp 677 holding it to the proximal outer tube 679 of the telescoping access tube. The nerve N is fully retracted and protected by the soft tissue retractor.

[0328] Step 6 Disc Removal :

[0329] See now Figure 84 to Figure 85 , disc removal is performed with a suction based discectomy tool 681 having the option to navigate. Therefore, a ring (not visible) is mounted (welded / glued) on the shaft 683 of the discectomy tool, which allows the navigation array 685 to be mounted without gaps.

[0330] Step 7: Cage Insertion

[0331] exist Fig.86 The expandable cage 687 is inserted into the intervertebral disc space. Fig.87 , retainer 687 is extended to full extension.

[0332] See now Fig.88 , a bone graft 689 is inserted around the cage via a delivery system. The expandable cage 687 is in its final position before the inserter is removed. Bone substitute 689 has been placed around the device (before and after the cage is inserted) to ensure a proper fusion process.

[0333] Step 8 Post-fix :

[0334] Fig.89 Disclose the insertion of the remaining screws 691, while Fig.90 A placement rod 693 and securing structure are disclosed.

[0335] Fig.91 Another embodiment of a multi-tool 700 that can be used for surgery (e.g., posterior lumbar surgery) is shown. For example, the multi-tool 700 can include a cover 702 having one or more coupling features 704 thereon. The coupling features 704 can couple or integrate one or more surgical devices, instruments, implants, and / or other objects into a single tool (e.g., the multi-tool 700). The instruments coupled to the multi-tool 700 can then be tracked using surgical navigation, thereby eliminating the need to track each instrument individually.

[0336] The coupling feature structure 704 may include one or more arms or connectors 706 extending or protruding from the cover 702. Each arm 706 may be integrated with one or more instruments to form a multi-tool 700. The arms 706 may be spaced apart along the surface of the cover 702 to prevent the instruments from cluttering a single location and providing access to the surgical area. The instruments that may be coupled to the cover 702 may help to navigate and insert the shaft component into the surgical site to expand the site. For example, as shown, the shaft component 707, the navigation marker or array 708, and the neural mapping tool 710 may be coupled to the arm 706 to form the multi-tool 700, but in some embodiments, one or more of these instruments may be omitted or replaced by other instruments. Some non-limiting examples of instruments that may be coupled to the multi-tool 700 may include expansion instruments (e.g., continuous expanders or tube inserters), cutting instruments (e.g., scalpels, scissors, etc.) and / or mapping instruments (e.g., ultrasound) may be added to the multi-tool.

[0337] The instruments may be shaped to be received in the openings of the arms 706, but in some embodiments, the instruments may be integrally formed with the arms 706 or fixedly attached to the arms, or snap-fit, glued, sewn, or received in a recess, opening, and / or other surface of the cover 702. In some embodiments, the arms 706 of the cover 702 may include one or more securing features adapted to retain one or more of the instruments therein. For example, the arms 706 may include through holes 711 formed therein. The through holes 711 may be formed in one or more surfaces of the cover 702 to form a passage extending through the cover 702. The through holes 711 may extend through a portion of the cover 702, such as Fig.94A As shown, or completely extending through the cover. Through hole 722 can hold one or more of the instruments therein.

[0338] The cover 702 of the multi-tool 700 can be coupled to the shaft component 707. For example, the shaft component 707 can be received in one or more coupling features of the coupling features 704 in the cover to couple thereto. The shaft component 707 can be introduced into an incision in a target site of a patient to increase or expand the target site. As shown, the shaft component 707 can be advanced proximally through the cover 702 until one or more gripping features (not shown) in the cover 702 secure the cover to the shaft component 707. In some embodiments, the gripping feature structure can include a releasable member 712 or another feature structure that adjusts the distance that the shaft component 707 can travel through the cover 702. The releasable member 712 can be actuated by the user to switch the cover 702 between multiple shaft components or between other instruments, as further described below.

[0339] The navigation marker 708 can be attached to the multi-tool 700 so that the position and orientation of the multi-tool 700 relative to the marker 708 is known. The marker 708 can be embedded in the surface of the multi-tool or can extend outward from the multi-tool. In some embodiments, the marker 708 can be rigid or integrally formed with the cover 702, as further described below, to ensure navigation accuracy and / or precision.

[0340] For example, as shown, a navigation marker 708 may be connected to one of the arms 706 protruding from the cover 702. The navigation marker 708 may be a symbol or image of a known size, shape, or other characteristic to facilitate identification of a position marker in a captured image of the multi-tool 700. Although a single navigation marker 708 is shown, the multi-tool 700 may include multiple markers, for example, one marker at each end. Using multiple markers 708 may improve tracking accuracy, field of view, or redundancy. The marker 708 may be detected by the navigation system 101, may communicate with the navigation system 101, or may be otherwise operably coupled to the navigation system 101 to allow the position and / or orientation of the multi-tool 700 and the underlying anatomical structure to be registered and tracked by the navigation system 101. Enabling the multi-tool 700 to be connected as a single functional unit allows the unit to be tracked as a whole relative to each other and the target site when the shaft components are docked in the target site, which may prevent the need to place separate markers on each instrument and perform a cumbersome and time-consuming registration process for a large number of markers. The cost and complexity of the navigation system 101 may be reduced by reducing the number of markers that the system must track. Using a single marker 708 may also provide greater access to the spine and a less cluttered surgical site.

[0341] It should be understood that the structure and operation of the marker 708 may vary depending on the type of navigation system 101 used. In the illustrated embodiment, the marker 708 includes four spherical references used with an optical navigation system. The references may be arranged in predetermined positions and orientations relative to each other. The references may be positioned within the field of view of the navigation system 101 and may be identified in images captured by the navigation system. Exemplary references include infrared reflectors, LEDs, etc. The marker 708 may be or may include an inertial measurement unit (IMU), an accelerometer, a gyroscope, a magnetometer, other sensors, or a combination thereof. The sensor may transmit position and / or orientation information to the navigation system 101, such as to a processing unit of the navigation system.

[0342] The marker 708 may be configured to be visible or detectable in patient imaging performed before, during, or after surgery. For example, the marker 708 may include a radiopaque portion to facilitate visualization of the marker in an X-ray, CT, or fluoroscopic examination. As another example, the marker 708 may include a metal, magnetic, or other material that is visible under MRI.

[0343] Any of a variety of surgical navigation systems 101 may be used, including commercially available systems such as those provided by BRAINLAB AG (Germany). The navigation system 101 may include an imaging system having a camera or image sensor that captures images of the surgical site and objects within the surgical site (such as markers 708 and similar markers attached to the instrument). The captured images may be registered to one or more patient images. A processor may be used to process the captured images and / or patient images to determine the position and / or orientation of the instrument relative to the patient's anatomy. This information may be transmitted to the user, for example, using an electronic display or a tactile, auditory, or visual feedback mechanism.

[0344] A nerve mapping tool 710 may be attached to the multi-tool 700 to provide feedback and planning of nerve locations. For example, the nerve mapping tool 710 may include a plug configured to be received in one or more of the arms 704 of the multi-tool 700 to track the distance of one or more of the instruments (e.g., the shaft component 707) from the nerve. Any of a variety of nerve mapping tools may be used, including those using various technologies such as electromyography (EMG) and electromyography (MMG), such as in commercially available systems provided by Sentio. The nerve mapping tool 710 can detect nerve locations to prevent damage during insertion of the shaft component or other instruments using the multi-tool.

[0345] For example, the neural mapping tool 710 may include an invasive stimulator capable of providing electrical stimulation, a mechanical sensor for monitoring muscle movement, and a processor that can determine whether the sensed movement is caused by the provided electrical stimulation. The neural mapping tool 710 can identify the presence of nerves during a lateral approach to the spine, but can be modified to detect nerves in multiple target sites. Some non-limiting examples of the neural mapping tool 710 may include using MMG in robotic surgical procedures, avoiding nerve injury in pelvic floor procedures such as prostate surgery, using MMG systems in a diagnostic capacity to assess changes in nerve health, etc.

[0346] Fig.92 One embodiment of a shaft component 707 for use with the multi-tool 700 is shown. The shaft component 707 can be inserted into an incision in a patient's body to expand a surgical site. The shaft component 707 can include a solid shaft, but in some embodiments, the shaft component can be hollow to allow one or more surgical devices to pass therethrough. The shaft component can be made of metal, plastic, polymer, or any other material that can be used during expansion as understood by those skilled in the art. The shaft component 707 can have a generally cylindrical shape as shown, but the shaft component can be round, triangular, conical, etc.

[0347] As shown, the shaft component 707 may include a proximal handle 714 that tapers to a distal tip 716. The handle 714 may be adapted to be received in the cap 702, as mentioned above and described in more detail below. In some embodiments, the proximal handle 714 may include a groove or annular ring 715 extending along a portion thereof to allow for enhanced gripping of the shaft component. The shaft component 707 may have a diameter D in the range of about 1 mm to about 10 mm, about 2 mm to about 9 mm, about 3 mm to about 8 mm, about 4 mm to about 7 mm, or about 5 mm to about 6 mm.

[0348] Embodiments of the distal tip 716 include Fig.93 707 is shown in more detail in the figure. The distal end 716 may be suitable for docking into the target tissue to fix the shaft component 707 in the surgical site. The distal end may include a hemispherical shape, as shown, but in some embodiments, the end may be pointed, sharp, blunt, etc. In the illustrated embodiment, the hemispherical geometry of the distal end allows the end to sweep over the target site and gently push into the target tissue, such as an intervertebral disc or a bone surface. The distal end 216 may have a length L in the range of about 1mm to about 10mm, about 1.5mm to about 9mm, about 2mm to about 8mm, about 2.5mm to about 6mm, or about 3mm to about 4mm, and a diameter of about 0.25mm to about 3mm, about 0.5mm to about 2.5mm, about 1mm to about 2mm, or about 1.5mm.

[0349] In some embodiments, the shaft member 707 may include a dielectric coating along its length to insulate the shaft member, but one or more portions thereof may not be electrically insulated in order to conduct electrical current. For example, the shaft member 707 may include one or more conductive regions adapted to be electrically connected to and / or conduct electrical current to the instruments and / or target sites of the multi-tool. As shown, the proximal handle 714 may include a first conductive region 718 on its most proximal end, and the distal tip 716 may include a second conductive region 720 on its most distal end. Each of the first conductive region 718 and the second conductive region 720 may form an electrode surface or act as an interface that may form an electrical connection with one or more instruments of the multi-tool 700. For example, the first conductive region 718 may form an electrical connection with the neural mapping tool 710, as further described below, and the second conductive region 720 may form an electrode surface through which the shaft member 707 may conduct electrical current from a source (e.g., the neural mapping tool 710) to the tissue. Although two conductive regions are shown, it should be understood that one or three or more conductive regions may be formed on the shaft member 707 to form an electrical connection therewith.

[0350] Figures 94A to 94CComponents of the cover 702 are shown in greater detail. In some embodiments, the cover 702 can include a through hole 724 formed therein. The through hole 724 can be positioned in a middle portion of the cover 702, such as Fig.94B As shown, one or more features of the multi-tool can be coupled thereto. For example, as shown, the through hole 724 can be adapted to receive a releasable member or button 712 therein. The button 712 can be positioned within the through hole, such as Fig.94A As shown, or may be fixedly attached to the cover 702. In some embodiments, the button can be a single integral component, or formed from two or more separate pieces that are configured to move relative to each other to switch the button between one or more configurations.

[0351] The button 712 may be adapted to retain a surgical device within the cover. For example, the button 712 may include one or more features for coupling to a surgical device. In some embodiments, the button 712 may include a hollow interior space to allow a surgical device to pass therethrough. For example, Fig.94A As shown, the shaft member 707 can pass through the internal hole 725 of the button 712 to attach the shaft member 707 to the cover 702. The hole 725 can extend through the diameter of the button to allow the shaft member 707 to pass therethrough. The hole 725 can be shaped in the manner of the shaft member, for example, as shown in FIG. Fig.94C The D-shape shown prevents the shaft member 707 from rotating relative to the cover 702.

[0352] The button 712 may include one or more biasing features configured to switch the button 712 between a locked configuration and an unlocked configuration. For example, the button 712 may include one or more biasing elements or springs 726 extending through the button. The biasing elements 726 may abut the inner surface of the button and the wall of the through hole 724 to apply a biasing force on the button. The button 712 may include two biasing elements 726, as shown, but it should be understood that one or three or more biasing elements may be used.

[0353] The button 712 may be adapted to switch between a locked configuration and an unlocked configuration. For example, the button 712 may be pressed or pushed into the through hole 724 to move the button from the locked configuration to the unlocked configuration. In the locked configuration, the button 712 may prevent the shaft component 707 from moving relative to the cover 702, while in the unlocked configuration, the button 712 may allow the shaft component 707 to move relative to the cover 702 within the hole 725. In the locked configuration, the biasing element 726 may be fully extended to apply an outward force on the button 712 relative to the through hole 724. The outward force may bias the button 712 to protrude from the through hole 724, which may prevent the shaft component 707 from freely traveling through the through hole.

[0354] In some embodiments, one or more features of the button 712 are configured to engage the shaft member 707 to lock the shaft member 707 within the cover 702. For example, the button 712 may include a gripper (not shown) to fix the longitudinal position of the shaft member 707 within the hole 725. The gripper may be located in an interior portion of the button 712 to cooperate with the handle 714 of the shaft member 707. For example, when the shaft member 707 is advanced proximally through the hole 725, the shaft member 707 may contact the gripper to prevent further proximal translation of the shaft member. In some embodiments, the shaft member 707 may include a recess configured to form a convex-concave interlock with the gripper. In such embodiments, the gripper may be configured to travel along the surface of the shaft member 707 until contacting the recess. At the recess, the gripper may extend into the recess to lock the longitudinal position of the shaft member 707 relative to the button 712. In some embodiments, when the button 712 is locked to the shaft member 707, the button 712 may provide tactile feedback to the user. Applying a force in a direction opposite to the outward force may cause the grasper to be detached from the shaft member 707 to switch the button 712 from a locked configuration to an unlocked configuration, thereby allowing the shaft member 707 to translate longitudinally relative to the cap 702 and causing the cap to be detached from the shaft member, for example, once the shaft member is implanted and / or docked in the target tissue. The ability to detach the cap 702 from the shaft member 707 may allow the cap 702 to be attached to other instruments, such as other shaft members, and to allow continued expansion or other instruments to be inserted over the shaft member 707 to increase the size of the target site, as further described below.

[0355] The button 712 may include one or more channels 728 therein. For example, the biasing element 726 may be disposed in a channel 728 extending through the button 712. As shown, the channel 728 may extend through the interior of the button 712 perpendicular to the shaft member 707 to allow the button to move in a direction perpendicular to the shaft member. The channel 728 may extend across the width of the button 712, or terminate in a middle portion thereof, as shown.

[0356] The cover 702 may allow communication between system components disposed therein. For example, a through hole 711 in each of the arms 706 may lead to a hollow portion of the cover to allow communication between components disposed therein. In some embodiments, the cover 702 may facilitate electrical connection between multiple components of the multi-tool 700. For example, the neural mapping tool 710 may engage with the shaft component 707 to establish an electrical connection therebetween. For example, the neural mapping tool 710 may include a conductive member 730 thereon for electrical connection. As shown, the conductive member 730 may be a spring member that can change the distance between the neural mapping tool 710 and the shaft component 707. The conductive member 730 may contact the exposed core of the shaft component 707 to complete the circuit between the shaft component 707 and the distal electrode coupled to the neural mapping tool 710. In some embodiments, the electrical connection to the neural mapping tool 710 may be used as a stimulation electrode having a muscle activity sensor thereon to detect movement of the muscle in response to stimulation applied to the spine by the shaft component. As shown, the conductive member 730 can be a spring member that can change the distance between the neural mapping tool 710 and the shaft member 707. In some embodiments, the conductive member 730 can be made of metal or another material suitable for conducting electricity.

[0357] Figures 95 to 97 An alternative embodiment of a cover 802 is shown for a multi-tool 800. Except as noted below and as will be readily appreciated by one of ordinary skill in the art, the structure and function of the multi-tool 800 is substantially the same as that of the embodiment of the multi-tool 700 described above, and thus a detailed description is omitted herein for the sake of brevity.

[0358] Instead of the above Figures 94A to 94C In addition to or in addition to the coupling features 704 discussed above (e.g., arms 706), the cover 802 may include one or more coupling features 804 thereon. For example, as shown, the coupling features 804 may include one or more modular attachment arms 806 that may be adapted to support modular coupling of one or more components thereto. Figures 94A to 94C The arm 706 discussed, or in addition thereto, may form a modular attachment arm 806 .

[0359] The use of modular attachment arms 806 can allow the multi-tool 800 to be used in procedures that do not require navigation and / or to be coupled to other surgical devices (e.g., a second axis component, a neural mapping tool 710, etc.). The cover 802 can include a single modular attachment arm 806 for modular coupling, but in some embodiments, the cover 802 can include two or more such arms. Furthermore, although the navigation array 708 is described herein as being modularly coupled to the cover, as Fig.97As shown and described, however, in some embodiments, one or more of the neural mapping tool 710 and / or the shaft component 707 can also be modularly coupled to the cover 802.

[0360] The modular attachment of the navigation array 708 to the cover 802 can be performed in a variety of ways. For example, the modular attachment arm 806 can include a chuck 808 that is configured to expand when the navigation array 708 is inserted therein. The size of the chuck 808 can be designed so that the chuck can be received within or otherwise engaged with a component of the multi-tool 800 (e.g., the navigation array 708). The design of the chuck 808 can allow the navigation array 708 to move relative to the modular attachment arm 806 to rigidly lock the array 708 to the multi-tool 800. The rigid connection between the array 708 and the multi-tool can increase and maintain navigation accuracy. In some embodiments, the navigation array 708 can be coupled to the cover 802 in a single orientation.

[0361] The modular attachment arm 806 can include a hole 810 extending therethrough. The hole 810 can extend through the entire length of the modular attachment arm 806, as shown, but in some embodiments, the hole 810 can terminate along a mid-portion of the arm 806. The hole 810 can define a central longitudinal axis A therethrough for receiving a coupling feature and / or surgical device therethrough to facilitate modular coupling.

[0362] For example, the hole 810 may include a pin 812 extending therethrough. As shown, the pin 812 may extend into the cap 802 along the central longitudinal axis A of the hole to secure the pin within the hole 810. The pin 812 may be configured to travel through the hole 810 to adjust the modular connection to attach the surgical device to the multi-tool 800.

[0363] The pin 812 may include a pin head 814 formed thereon. As shown, the pin head 814 may protrude from the hole 810 in the modular attachment arm 806. The pin head 814 may be formed of a square or rectangular element that is configured to be received in the coupling feature structure 709 of the surgical device, such as an opening in the navigation array 708, but the pin head 814 may be circular, triangular, or another shape corresponding to the coupling feature structure 816, such as Fig.97 In some embodiments, the pin head 814 can be keyed so that the opening 709 is prevented from coupling to the pin head 814 in all but one orientation, thereby ensuring a rigid connection to enhance navigation accuracy.

[0364] In some embodiments, the modular attachment arm 806 may include one or more slots 815 therein. As shown, the slot 815 may extend through a portion of the arm 806, but in some embodiments, the slot 815 may extend along the entire length of the arm 806. The slot 815 in the arm may separate the modular attachment arm into a pair of fingers 816a, 816b. The slot 815 allows the fingers 816a, 816b to move, flex and / or bend relative to each other, which limits the rigidity of the modular attachment arm 806.

[0365] In some embodiments, the pin 812 may be preloaded between the fingers 816a, 816b such that the pin head 814 protrudes from the modular attachment arm 806, as shown in FIG. Figure 96 to Figure 97 As shown. Pin 812 can travel through the hole along axis A. For example, a force applied to the pin head 814, such as by mounting a surgical device to the pin head 814, can cause pin 812 to retract longitudinally into modular attachment arm 806. When a surgical device (e.g., navigation array 708) is mounted on arm 806, the retraction of pin head 814 into hole 810 can cause fingers 816a, 816b to flex outwardly as pin head 814 advances through hole 810. As shown, pin head 814 can be larger than pin 812 to abut one or more surfaces of the inner surface of modular attachment arm 806 to resist and / or move pin 812. During the retraction of pin head 814, the size of the hole expands, thereby spacing the distance between the fingers. The retraction of pin head 814 can continue until fingers 816a, 816b abut the wall of opening 709 in the array to fix the array to modular attachment arm 806. The fingers 816a, 816b can grip one or more inner surfaces of the opening 709 to maintain a rigid connection of the array 708 for accurate navigation. In some embodiments, the fingers 816a, 816b can include graspers 818 thereon to increase the surface area of ​​contact between the modular attachment arm 806 and the opening 709 of the navigation array 708, thereby increasing the stiffness of the connection.

[0366] Figures 98 to 101 An alternative embodiment of a multi-tool 900 is shown. Except as noted below and as will be readily understood by one of ordinary skill in the art, the structure and function of the multi-tool 900 is substantially the same as that of the embodiments of the multi-tools 700, 800 described above, and therefore a detailed description is omitted herein for the sake of brevity.

[0367] The multi-tool 900 may include a cover 902 thereon. As shown, instead of Figures 94A to 94CIn addition to or in addition to the coupling features 704 discussed above (e.g., arms 706), the cover 902 may include one or more coupling features 904 thereon. For example, as shown, the coupling feature 904 may include one or more arms 906 that may be adapted to support coupling of one or more surgical devices thereto. Figure 95 to Figure 97 The arms 706 discussed, or in addition thereto, may form the arms 906. It should be appreciated that a combination of arms and modular attachment arms may be formed on the cover 902 to vary the manner in which a surgical device is coupled to the multi-tool 900.

[0368] For example, as shown, the arm 906 of the cover 902 may include a protrusion 907 extending proximally of the body of the cover 902. The protrusion 907 may be used in place of, or in addition to, the arm 706 or modular attachment arm 806 described above. The shape of the protrusion 907 may correspond to the shape of the surgical device coupled thereto or protruding therefrom, or the protrusion 907 may have a different shape than the surgical device, such as an oval, oblong, square, rectangular, triangular, etc. Fig.100 As shown, protrusion 907 may be received in an opening of coupling 950 that is attached to navigation array 708 , but in some embodiments, navigation array 708 may be inserted into the opening of protrusion 907 .

[0369] The projection 907 may include an outer sidewall 908 that defines a lumen 911 extending through the projection 907 into the cap 902. The lumen 911 may extend through the projection into the hollow portion of the cap 902, as described with respect to the above embodiments. The lumen may extend along an axis A1 that is parallel to the axis of the shaft member 707 that is inserted through the cap 902 from the proximal end 902p of the cap to the distal end 902d of the cap. The lumen 911 may receive an instrument or tool therethrough for performing rod reduction, derotation, drilling, set screw insertion, etc. Instruments may be inserted through the lumen 911 proximally or distally.

[0370] In this embodiment, the cover 902 can facilitate electrical connection between a number of surgical devices. For example, any surgical device (e.g., shaft member 707) that is advanced into the cover 902 can become disposed within the lumen 911. In some embodiments, the proximal handle 714 of the shaft member 707 can extend through the lumen 911 and the protrusion 907 to abut the proximal end 902 of the cover 902. In some embodiments, and as Fig.99 and Fig.100 As shown, the proximal handle 714 of the shaft component 707 can extend through the hollow portion of the cap 902 such that the proximal handle 714 protrudes from the proximal end 902p of the cap 902. When the proximal handle 714 protrudes from the proximal end 902p, the proximal handle 714 forms a contact point to which an electrical connection can be coupled, as further described below.

[0371] One or more of the arms 906 extending from the cover 902 may include an electronic component 909 therein to establish an electrical connection between the cover 902 and other surgical devices. The electronic component 909 may be in the form of a pin, a bolt, a spring, or another feature structure known to those skilled in the art that is configured to engage between two components. The electronic component 909 may be made of metal or another conductive material to enable two or more devices to send electrical signals to each other. In some embodiments, and as Figure 100 to Figure 101 As shown, the neural mapping tool 710 can be inserted into the arm 906 to engage the neural mapping tool 710 with the electronic components 909 and connect the neural mapping tool 710 to other devices coupled to the multi-tool.

[0372] Fig.101 The electrical connection established between the shaft member 707 and the neural mapping tool 710 within the cover 902 is shown in greater detail. The neural mapping tool 710 can be inserted into the arm 906 over the electronic component 909 to receive the electronic component 909 therein. The insertion of the neural mapping tool 710 over the electronic component 909 can advance the electronic component 909 further into the hollow portion of the cover 902 to abut the shaft member. The connection between the shaft member 707 and the neural mapping tool 710 at the electrical connection can allow electrical current to travel from the neural mapping tool 710, through the pin, through the shaft member 707 to the distal end 716 into the tissue in which the shaft member 707 is disposed. In some embodiments, the shaft member 707 can include a through hole therein that is configured to receive the electronic component 909. The through hole can be configured to receive a portion of the electronic component 909 therethrough, as shown, to establish an electrical connection between the two devices.

[0373] In some embodiments, the multi-tool 900 can allow for more than two devices to be electrically connected. For example, one or more devices can be attached to the protrusion 907 and to the handle of the shaft component 707 protruding proximally therefrom to establish an electrical connection between the protrusion and the handle. The first conductive region 718 of the shaft component 707 can provide another surface coupled to a surgical device configured to establish an electrical connection therebetween. An electrical signal can travel from the electronic component 909 through the shaft component 707 and into the first conductive region 718 and to the surgical device coupled thereto.

[0374] Fig.102An alternative embodiment of a multi-tool 1000 is shown. The multi-tool 1000 may include a cover 1002 having a single arm 1006 extending therefrom. The arm 1006 may be fixedly coupled to the cover or integrally formed with the cover. As shown, the cover 1002 may include an outer sidewall 1008 defining an inner cavity 1011 extending therethrough and configured to receive the shaft member 707 therein. The neural mapping tool 710 may be received in the arm 1006 to establish an electrical connection therebetween.

[0375] Fig.103 An alternative embodiment of a multi-tool 1100 is shown. Except as noted below and as will be readily understood by one of ordinary skill in the art, the structure and function of the multi-tool 1100 is substantially the same as that of the embodiments of the multi-tools 700, 800, 900, 1000 described above, and therefore a detailed description is omitted herein for the sake of brevity.

[0376] The multi-tool 1100 may include a cover or locking handle 1102 having a plurality of components that are configured to move relative to each other to couple one or more surgical devices thereto. As shown, the locking handle 1102 may include a base clamp 1120 and a top clamp 1130, each of which has one or more surgical devices coupled thereto. Those skilled in the art will appreciate that the surgical device may be coupled to either or both of the base clamp 1120 and the top clamp 1130, as further described below. In use, the base clamp 1120 and the top clamp 1130 may be rotated relative to each other to move the locking handle 1102 from an open position to a closed position, thereby locking the shaft component 707 to the locking handle 1102.

[0377] The locking handle 1102 may include one or more connection points or ports 1122, 1132 therein to which a surgical device may be coupled. For example, as shown, the locking handle 1102 may include two ports 1122, 1132, each having one of the navigation array 708 and the neural mapping tool 710 coupled thereto, but in some embodiments, the locking handle 1102 may be coupled to one or three or more surgical devices. Although the navigation array 708 is shown coupled to the base fixture 1120 and the neural mapping tool 710 is coupled to the top fixture 1130, in some embodiments, both the array 708 and the neural mapping tool 710 may be coupled to the base fixture 1120 or to the top fixture 1130.

[0378] In some embodiments, the base fixture 1120 can include a core 1124 for coupling to a surgical device (e.g., a shaft component). The core 1124 can be overmolded and / or made of a durable material such as metal, plastic, polymer, etc. that is configured to promote a more rigid connection with a surgical device received therein.

[0379] The core 1124 may include one or more holes 1126 extending therethrough adapted to receive a surgical device therein, but in some embodiments, the core 1124 may be received within the surgical device. The core 1124 may prevent the surgical device from moving or otherwise flexing relative to the locking handle 1102 to ensure that dimensional accuracy is maintained with the locking handle 1102. In some embodiments, the core may overlap one or more of the ports 1122, 1132 to further stabilize the surgical device coupled to the multi-tool 1100. For example, as shown, the core 1124 may extend along the port 1122 to receive the navigation array 708 within the base fixture 1120. Enhancing the coupling of the navigation array 708 to the core 1124 may reduce and / or eliminate movement of the array 708 relative to the base fixture 1120, thereby improving navigation accuracy.

[0380] The core 1124 may include two holes 1126a, 1126b, but in some embodiments, the core may include one or three or more holes. The holes 1126a, 1126b may be positioned substantially perpendicular to each other, as shown, but other orientations of the holes are also possible, such as parallel or at an angle. The holes 1126a, 1126b may be connected to each other so that the surgical devices disposed therein may interact with each other, such as establishing electrical connections, as discussed further below. The core 1124 may be substantially disposed in the base fixture 1120, as shown, but in some embodiments, the hole 1126a may extend through the base fixture 1120 and the top fixture 1130 to allow the surgical device to extend through two portions of the locking handle 1102, thereby ensuring greater stability of the shaft component 707 within the multi-tool 1100. In some embodiments, the holes 1126a, 1126b may be shaped so as to limit the surgical device (e.g., shaft component and / or navigation array) to a single orientation to enhance navigation accuracy and establish a defined reference frame between the devices.

[0381] The top clamp 1130 may extend proximally from the base clamp 1120. In some embodiments, the top clamp 1130 may be juxtaposed with the base clamp 1120 so that the top clamp 130 is free to move relative to the base clamp 1120. The top clamp 1130 may include one or more ports 1132 therein for coupling to a surgical device. As shown, the port 1132 may include a connection member 1134 for coupling the neural mapping tool 710 thereto, but in some embodiments, other surgical devices (e.g., a navigation array, an imaging machine, etc.) may be coupled thereto. The port 1132 may extend in the opposite direction of the hole 1126b of the base clamp 1120 so as not to confuse the surgical site with the device, as shown, but in some embodiments, the port 1132 may extend in the same direction as the hole 1126b.

[0382] Figure 104 to Figure 105 An embodiment of a shaft member 1107 that can be used with a locking handle 1102 is shown. The shaft member 1107 can be received in one or more of the base clamp 1120 and the top clamp 1130 to secure the shaft 1107 to the locking handle 1102. As discussed above, the shaft member 1107 can include an elongated body 1109 having a solid inner core, but in some embodiments, the elongated body can be hollow. The shaft member 1107 can have a generally cylindrical shape as shown, but the shaft member 1107 can be circular, triangular, conical, etc. In some embodiments, a portion of the elongated body 1109 can include a groove or annular ring 1115 thereon to facilitate a user's gripping of the body 1109. As shown, the groove 1115 can be an annular recess formed in the slender body 1109, but in some embodiments, a roughened surface or Velcro adhesive can be used to enhance the grip of the shaft member 1107 and minimize the risk of slippage, which can cause significant structural damage in the surgical site.

[0383] The elongated body 1109 may extend from the proximal handle 1114 to the distal tip 1116. The elongated body 1109 may include a dielectric coating on its outer surface adapted to insulate the elongated body 1109 from electrical current. As discussed above, the distal tip 1116 may include an uncoated material thereon so that the distal tip 1116 can conduct electrical current to tissue when docked therein. In some embodiments, the elongated body 1109 may be made of an insulating material, such as plastic, polyurethane, glass, etc., to insulate and / or inhibit electrical current passing therethrough.

[0384] Fig.105The proximal handle 1114 is shown in more detail. As shown, the proximal handle 1114 can include a locking groove 1117 thereon. The locking groove 1117 can include one or more recesses to maintain the position of the shaft component 1107 within the locking handle 1102. For example, the locking groove 1117 can extend around the perimeter of the proximal handle 1114 to form a space for receiving a retaining feature (not shown) of the locking handle 1102. The proximal handle 1114 can be advanced through the locking handle 1102 until the retaining feature engages the locking groove 1117 to prevent further advancement of the shaft component 1107. The locking groove 1117 can be located distal to the proximal-most end of the locking handle 1102, as shown, but in some embodiments, the locking groove 1117 can be provided at the proximal-most end of the locking handle 1108. In some embodiments, the locking groove 1117 can be made of an uncoated material to facilitate electrical contact. The uncoated material may be the same material as the distal tip 1116 of the shaft component 1107, but the type of uncoated material may be different.

[0385] The proximal handle 1114 may include one or more flats 1118 on its surface. The flats 1118 may provide indexing and torque transmission when the shaft component 1107 is disposed in the locking handle 1102. The flats 1118 may extend from the proximal-most end of the proximal handle to a shoulder 1119, as shown. In some embodiments, the shoulder 1119 may abut one or more components of the locking handle 1102 to prevent the shaft component 1107 from being further proximally advanced therethrough. In some embodiments, a retaining feature may abut a surface of the shoulder 1119 to set the position of the shaft component 1107 within the locking handle 1102.

[0386] FIG. 106A to FIG. 106B The locking mechanism of the locking handle 1102 is shown, which is configured to lock the shaft component 1107 to the surgical device passing through the locking handle 1102. For example, the base clamp 1120 and the top clamp 1130 can be rotated relative to each other to move the locking handle 1102 from an open position to a closed position, thereby securing the shaft component 1107 therein. Fig.106A As shown, the base clamp 1120 and the top clamp 1130 can be disposed substantially perpendicular to each other in the open position, but in some embodiments, the base clamp 1120 and the top clamp 1130 can be aligned or angled relative to each other in the open position.

[0387] In some embodiments, the top clamp 1130 may also include a channel 1136 therein. The channel 1136 may be in communication with the base clamp 1120 so that a surgical device (e.g., shaft component 1107) disposed in the locking handle 1102 may be advanced into and / or through the top clamp 1130. As shown, the channel 1136 may be substantially rectangular so that the proximal handle 1114 of the shaft component 1007 disposed therein may be flush therewith, but in some embodiments, the opening may be circular, cylindrical, triangular, conical, etc.

[0388] In use, the shaft member 1107 can be advanced or slid proximally through the channel 1136 so that the shaft member 1107 protrudes proximally through the channel 1136 in the top clamp 1130, but in some embodiments, the shaft member can be advanced or slid distally through the opening in the top clamp 1130. The shaft member 1107 can be advanced through one or more of the base clamp 1120 and the top clamp 1130 until the retaining feature of the locking handle 1102 engages the locking groove 1117 to fix the position of the shaft member 1107 relative to the locking handle 1102. In order to move the locking handle 1102 to the closed position to lock the position of the shaft member 1107 therein, the top clamp 1130 can be rotated a quarter turn (e.g., approximately 90 degrees) relative to the bottom clamp so that the bottom clamp 1120 and the top clamp 1130 are aligned, as shown. Fig.106B As shown, the top clamp 1130 can be rotated in a first direction (e.g., counterclockwise) to lock the locking handle 1102, but in some embodiments, clockwise rotation of the top clamp 1130, or clockwise or counterclockwise rotation of the base clamp 1120 can lock the locking handle 1102. During rotation of the clamp, the retaining feature structure of the locking handle travels through the locking groove 1117 until the retaining feature structure disengages from the locking groove 1117 to abut the outer wall of the shaft component 1107. When the retaining feature structure abuts the wall, the shaft component 1107 is prevented from translating or rotating relative to the clamps 1120, 1130, thereby locking the shaft component 1107 to the locking handle 1102. In some embodiments, once the multi-tool 1100 is in the locked position, a washer (not shown) disposed within the locking handle can be used to establish an electrical connection between surgical devices. The washer can include a through hole having a pin disposed therein for establishing an electrical connection between the devices.

[0389] To disengage the shaft component 1107 from the multi-tool 1100, the top clamp 1130 can be rotated in an opposite second direction relative to the base clamp 1120 to return the locking handle 1102 to the open position. Once in the open position, the shaft component 1107 can be moved relative to or removed from the locking handle 1102 to allow other surgical devices to be introduced through the locking handle 1102.

[0390] Fig.107 An alternative embodiment of a multi-tool 1200 is shown. Except as noted below and as will be readily understood by one of ordinary skill in the art, the structure and function of the multi-tool is substantially the same as that of the embodiments of the multi-tools 700, 800, 900, 1000, 1100 described above, and therefore a detailed description is omitted herein for the sake of brevity.

[0391] The multi-tool 1200 may include a cover 1202 coupled thereto. As shown, in lieu of or in addition to the top clamp described above, the cover 1202 may include a knob 1230. The knob 1230 may be positioned proximally of the base 1220, as shown, to couple the shaft component 1107 to the cover 1202. Although not shown, various configurations of these features may be used. For example, the knob 1230 may be disposed distally of the base 1220 to fix the position of the shaft component 1107 within the multi-tool 1200 and / or lock the shaft component. As another example, the shaft component 1107 may protrude proximally from the base 1220 to allow the knob 1230 to be placed along a surface of the base 1220 to engage the shaft component 1107. The knob 1230 may be secured to the base 1220 using one or more retaining pins 1240, as shown.

[0392] Figure 108 to Figure 109 The cover 1202 of the multi-tool 1200 is shown in more detail. The base 1220 may include a receiving aperture 1250 therein. The receiving aperture 1250 may be formed as a recess in the surface of the base 1220 to couple one or more components of the multi-tool 1200 to the cover. For example, the receiving aperture 1250 may be formed in the proximal surface 1220p of the base 1220 so as to form a recess in the proximal surface 1220p thereof. As shown, during assembly of the multi-tool 1200, the knob 1230 may be disposed in the recess formed by the receiving aperture 1250. In some embodiments, the receiving aperture 1250 may be shaped so that the knob 1230 may be placed flush with the wall of the aperture 1250, but in some embodiments, the shape of the recess formed by the receiving aperture 1250 may be rectangular, square, triangular, etc. to form one or more relief areas between the knob 1230 and the base 1220. In some embodiments, the receiving aperture 1250 can include one or more abutment surfaces 1252 for selectively engaging a knob, as further described below.

[0393] The base 1220 can include one or more ports 1222 extending therethrough. The ports 1222 are configured to receive a surgical device (eg, the navigation array 708, the nerve mapping tool 710, etc.) therein for coupling to the multi-tool 1200.

[0394] As shown, and as discussed with respect to the above embodiments, each port 1222 may include a core or connector 1224 for enhancing the coupling of surgical instruments to the base 1220 and the multi-tool 1200. The connector 1224 may be integrally coupled to the base 1220 so that the connector 1224 cannot be separated from the base, but in some embodiments, the connector 1224 may be removably coupled to the handle. The connector 1224 may include a generally tubular central portion defined by the sidewalls of the outer hole 1226. The hole 1226 may define a diameter D1 through which an instrument, implant, or other object may be inserted. The hole 1226 may extend from a proximal end 1224p to a distal end 1224d along a central longitudinal axis l of the connector 1224. As shown, the central longitudinal axis l may be generally perpendicular to the shaft member 707, but in some embodiments, the axes may be aligned or obliquely angled relative to each other.

[0395] The base 1220 may include a channel 1227 therein. The channel 1227 may be configured to allow a surgical device (e.g., shaft member 1107) to be inserted therethrough. As shown, the port 1222 and / or the core 1224 may be in communication with the channel to allow a surgical device inserted through the port to engage with the shaft member 707. The channel 1227 may be defined by a sidewall 1228 of the circumscribed channel 1227. The channel 1227 may extend from the proximal surface 1220 to the distal surface 1220d along the central longitudinal axis A2 of the base 1220. In some embodiments, and as shown, the channel 1227 may terminate in a receiving aperture 1250. The channel 1227 may define a diameter D through which an instrument, implant, or other object may be inserted. The channel 1227 may be configured to allow either proximal loading or distal loading of an instrument therethrough. The inner surface of the channel 1227 may be threaded or may include other mating features for mating with an instrument (e.g., shaft member 1107) inserted therethrough to advance the instrument longitudinally relative to the base 1220. In some embodiments, the base 1220 may include two or more channels to allow multiple instruments to be inserted therethrough.

[0396] In some embodiments, the channel 1227 may include a stabilizing member 1229. The stabilizing member may be disposed in the base 1220 to provide a rigid interface between surgical instruments inserted therethrough. For example, the stabilizing member 1229 may be aligned with the central longitudinal axis A2 of the channel 1227 to allow the shaft member 1107 to pass through the stabilizing member 1229. In some embodiments, the stabilizing member may be fixedly coupled to the base 1220 or integrally formed therewith, but in some embodiments, the stabilizing member 1220 may be an insert that may be removably connected to the interior of the base 1220.

[0397] As shown, the connector 1224 can protrude from the stabilizing member 1229 to allow the shaft member 1107 disposed within the stabilizing member 1229 to engage with a surgical instrument received within the connector 1224. For example, the channel 1227 and the hole 1226 can communicate with each other so that an instrument inserted through the hole 1226 can engage with a surgical device disposed in the channel 1227, for example, to establish an electrical connection. For example, as described above, Fig.109 The two connectors 1224 shown can receive the navigation array 708 and the neural mapping tool 710 to allow one or more of the navigation array 708, the neural mapping tool 710, and / or the shaft component 1107 to communicate electrically. In some embodiments, the base 1220 can include one or three or more connectors 1224 extending therethrough.

[0398] like Fig.109 As shown, the base 1220 can receive a retaining pin or cross pin 1240 for coupling the knob thereto. For example, the base 1220 can include one or more openings 1242 in a surface thereof that are configured to receive the retaining pin 1240 therethrough. The retaining pin 1240 can couple the knob 1130 to the base 1120 while allowing the knob 1130 to rotate relative to the base. The retaining pin 1240 can travel within a pin slot or path formed in the knob, as further described below.

[0399] FIG. 110A to FIG. 110B The knob 1230 is shown in more detail. The knob 1230 may include a generally circular or annular body 1232 defined by a sidewall 1234 having a channel 1237. The channel 1237 may extend along axis A3 from a proximal end 1230p of the knob 1230 to a distal end 1230d of the knob 1230. In some embodiments, the channel 1237 may correspond to the shape of an instrument inserted therethrough. In some embodiments, the shape of the channel 1237 may vary throughout the length of the channel. For example, as Fig.110A As shown, the channel 1237 at the distal end 1230d may include a rectangular shape, and as shown in FIG. Fig.110B As shown, the channel 1237 at the proximal end 1230p may include a circular shape. The shape of the channel 1237 at the distal end 1230d may allow for distal loading and proximal advancement of the shaft component 1107, while the shape of the channel 1237 at the proximal end 1230p may allow for proximal loading and distal advancement of the shaft component 1107. In some embodiments, the shape of the channel 1237 may be independent of the loading direction and advancement direction of the shaft component 1107.

[0400] The knob 1230 can have a circular shape, as shown, or can have various other shapes, such as oval, oblong, square, rectangular, triangular, etc. In some embodiments, as discussed above, the knob 1230 can correspond to the shape of the receiving aperture 1250 in which it is disposed.

[0401] The knob 1230 may include one or more handles or gripping surfaces 1238 positioned along its sidewall 1234. The gripping surfaces 1238 may be in the form of recesses or grooves formed in the exterior of the knob 1230 such that a force applied to the gripping surfaces 1238 may cause the knob 1230 to move between an open position and a closed position, as discussed further below. While the gripping surfaces 1238 are shown as being evenly distributed along the circumference of the knob 1230, in some embodiments, the gripping surfaces 1238 may extend from the knob 1230 such that a force applied to the gripping surfaces 1238 may cause the gripping surfaces 1238 and the knob 1230 to move between an open position and a closed position.

[0402] The knob 1230 may include a mating projection 1236 extending therefrom. The mating projection 1239 may be a separate component mounted to the knob 1230, or, as shown, may be integrally or monolithically formed with the knob to be fixedly coupled to the knob 1230 such that a force applied to the knob 1230 may cause the mating projection 1236 and the knob to move as a single unit. The mating projection 1236 may be configured to engage an abutment surface 1252 on the receiving aperture 1250 to maintain the rotational position of the knob 1230 relative to the base 1220, as further described below.

[0403] The knob 1230 may include a wing projection or protrusion 1239 extending therefrom. The wing projection 1239 may be a separate component mounted to the knob 1230, or as shown, may be integrally or integrally formed with the knob 1230 to be fixedly coupled to the knob so that a force applied to the knob 1230 may cause the wing projection 1239 and the knob to move as a single unit. In other arrangements, the knob 1230 may include fewer or additional springs and mating projections. The wing projection 1239 may be configured to bend or bend relative to the knob 1230 to allow the knob to move into engagement and disengagement with the receiving aperture 1250 when switching between an open position and a closed position, as discussed further below. In some embodiments, the wing projection 1239 may be connected to the knob by a spring (not shown) such as a leaf spring, a coil spring, a wave spring, a non-cantilever projection, or other biasing elements that may cause the wing projection 1239 to move between an open configuration and a closed configuration.

[0404] The knob 1230 may include one or more pin paths 1241 therein. The pin path may be defined as a port formed in the knob 1230 that may receive the retaining pin 1240 therethrough. In some embodiments, the pin path 1241 may be a circumferential cutout in the knob 1230 that may receive the retaining pin 1240 therethrough. The retaining pin 1240 may travel through the pin path 1241 when the knob 1230 is rotated relative to the base 1230 to move the multi-tool 1200 between the open position and the closed position. In some embodiments, the knob 1230 may have two or more pin paths 1241 therein.

[0405] Fig.111A The cover 1202 of the multi-tool 1200 is shown in an open position, and Fig.111B The cover 1202 of the multi-tool 1200 is shown in a closed position. The knob 1230 can be rotated to move the multi-tool 1200 between (i) an open position, in which the shaft member 1107 is free to translate and rotate relative to the cover 1202, and (ii) a closed position, in which the shaft member 1107 is blocked from translating and rotating relative to the cover 1202 to limit or prevent relative movement of the shaft member 1107.

[0406] The base 1220 and the knob 1230 may include one or more indicators showing whether the multi-tool 1200 is in an open position or a closed position. Fig.111A As shown, the base 1220 and / or the knob 1230 may include labels or images thereon to indicate the position of the multi-tool 1200. The base 1220 may include a first image 1260 of a padlock in a closed position, which may be aligned with a second image of an arrow 1230 on the knob 1230. Although a set of arrows 1262 are shown, a circle or another marking may be used that may be aligned with or point to the padlock image on the base 1220. When the arrow 1262 points away from the padlock image 1260, the multi-tool 1200 is not in a closed position, for example, in an open position. The multi-tool 1200 may include additional indicators for communicating the position of the multi-tool 1200. In some embodiments, the base 1220 may include an image of a padlock in an unlocked or open position, which may be aligned with the arrow on the lid 1230 to indicate that the multi-tool is in an open position. It should be understood that other imagery, such as text labels reading "open" and "closed," or "unlocked" and "locked," respectively, other drawings, etc., may alternatively or additionally be used.

[0407] Additional features of the relative arrangement of the base 1220 and the knob 1230 may indicate that the multi-tool 1200 is in an open position. Fig.111AAs shown, the wing tab 1239 may protrude at an angle from the knob 1230, which may indicate that the knob 1230 is in the open position. The arrow 1262 on the knob 1230 does not point to the indicator 1260 on the base 1260, which may also indicate that the multi-tool is in the open position. In some embodiments, the mating tab 1236 may be disposed outside of any release area in the receiving aperture 1250, which may also indicate that the multi-tool 1200 is in the open position.

[0408] Knob 1230 is rotatable about axis A3 to move between an open position and a closed position. Fig.111B As shown, when viewed from a proximal angle, the knob 1230 can be rotated in a counterclockwise direction to move the knob 1230 to the closed position, but in other embodiments, the direction of rotation can be reversed. When a rotational force is applied to the knob 1230, one or more retaining pins 1240 can travel from the first end of the pin path 1241 toward the second end of the pin path 1241. When the retaining pin 1240 approaches the second end of the pin path 1241, the retaining pin 1240 can engage the flat portion 1118 of the shaft component 1107, thereby preventing the knob 1230 from rotating further. During the rotation of the knob 1230, the wing projection 1239 can enter the release area in the receiving aperture 1250 and abut the abutment surface 1252 in the receiving aperture 1250. As the knob 1230 is further rotated, the abutment surface 1252 may move or snap the wing tab 1239 toward the knob 1230, causing the wing tab 1239 to move to a position flush with the knob 1230 to prevent further rotation of the knob. Further rotation of the knob 1230 may also be prevented by the pin path 1241, which may limit further travel of the retaining pin 1240 therein.

[0409] Fig.111BThe multi-tool 1200 is shown with the knob 1230 in the closed position. As shown, the wing tabs 1239 and the mating tabs 1236 may be disposed in a release area of ​​the receiving aperture 1250 to prevent the knob 1230 from rotating relative to the base 1220. The indicator 1262 on the knob 1230 may be aligned with the indicator 1262 on the knob 1230. That is, the arrow 1262 on the knob 1230 may point to the first image 1260 to suggest that the multi-tool 1200 is in the closed position. To switch the multi-tool 1200 to the open position, the knob 1230 may be rotated in an opposite second direction (e.g., clockwise) to release the wing tabs 1239 from the receiving aperture 1250. When a rotational force is applied to the knob 1230 in the second direction, the retaining pin 1240 may disengage from the flat portion 1118 of the shaft member 1107 and travel from the second end of the pin path 1241 toward the first end of the pin path 1241. As the knob 1230 continues to rotate, the wing tabs 1239 are present in the release region to allow the wing tabs 1239 to pivot away from the knob 1230, thereby returning the multi-tool 1200 to the open position. Once in the open position, the shaft member 1107 is free to translate and / or rotate within the multi-tool 1200.

[0410] Figures 112 to 115 An alternative embodiment of a multi-tool 1300 is shown. Except as noted below and as will be readily understood by one of ordinary skill in the art, the structure and function of the multi-tool is substantially the same as that of the embodiments of the multi-tools 700, 800, 900, 1000, 1100, 1200 described above, and therefore a detailed description is omitted herein for the sake of brevity.

[0411] The multi-tool 1300 may include a quick-connect feature that allows easy switching between components of the tool (e.g., shaft components and covers). As shown, instead of or in addition to the covers described in the above embodiments, the multi-tool 1300 may include a fixture 1302. The fixture 1302 may be defined by a sidewall 1304 of a channel 1305 extending therethrough. The channel 1305 may be configured to receive at least a portion of another tool or instrument therein. The channel 1305 may extend along a central longitudinal axis A4 aligned with the central longitudinal axis A1 of the shaft component 707. The channel 1305 may define a diameter D2 through which an instrument (e.g., shaft component 707) may be inserted. The fixture 1302 may also include one or more arms 1306 protruding from the sidewall 1304 for coupling the navigation array 708 and the neural mapping tool 710 thereto.

[0412] The fixture 1302 is shown in more detail at FIG. 113A to FIG. 113BThe clamp 1302 may include a slider 1312 that translates along a surface thereof. The slider 1312 may be configured to operate as a one-way clamp to lock the axial position of the shaft component 707 to the clamp 1302. For example, the slider 1312 may translate between a first position in which the clamp 1302 is in an open position to allow the shaft component 1302 to freely rotate and / or translate relative to the multi-tool 1300, and a second position in which the clamp 1302 is in a closed position to prevent the shaft component 707 from rotating and / or translating relative to the multi-tool 1300.

[0413] The clamp 1302 may include one or more tracks or slots 1314 on its surface. The tracks 1314 may be formed as recesses or through holes in the sidewalls 1304 of the clamp. Fig.115 As shown, the clamp may include a first track 1314a and a second track 1314b formed therein. The first track 1314a may be positioned substantially parallel to the length of the clamp 1302, and the second track 1314b may be angled relative to the axis of the clamp 1302 and / or an axis member inserted therethrough, as further shown and described below. The tracks 1314a, 1314b may extend substantially across the entire width of the clamp, for example, from arm to arm, as shown, but in some embodiments, the tracks may encompass narrower sections of the sidewalls.

[0414] The slider 1312 can be disposed in the tracks 1314a, 1314b and move relative thereto to lock and unlock the shaft member 707 relative to the clamp 1302. As shown, the length of the slider 1312 can be less than the length of the tracks 1314a, 1314b, so that the slider 1312 can move proximally and distally within the tracks 1314a, 1314b. The slider 1312 can extend through the tracks 1214a, 1314b to protrude from the opposite sidewall 1304 of the clamp 1302, but in some embodiments, the slider 1312 can terminate within the tracks 1314a, 1314b so that the slider 1312 protrudes from only one side of the clamp 1302.

[0415] The slider 1312 may include one or more gripping surfaces 1316 on its surface. The gripping surfaces 1316 may include grooves or ridges in their surface to provide friction when held by a user. As shown, the gripping surfaces 1316 may be located on opposite sides of the slider 1312, but in some embodiments, the gripping surfaces may be located on a single side of the slider 1312. When a force is applied to the gripping surfaces 1316, the gripping surfaces 1316 and the slider may move as a single unit.

[0416] The slider 1312 may include one or more apertures or retainers 1318 formed therein. The retainers 1318 may be defined in the inner surface of the slider 1312 to receive one or more clamping pins 1320 therein, as further described below. The retainers 1318 may have a cylindrical shape, as shown, or may have a variety of other shapes, such as oval, oblong, square, rectangular, triangular, etc. As shown, the slider 1312 may include one or more sets of retainers 1318 positioned along the length of the slider. As shown, two sets of retainers 1318 may be distributed on opposite sides of the slider 1312 such that the shaft member 707 is disposed between the retainers 1318. The retainers 1318 may be positioned along a common axis, but as shown Fig.114 As shown, one or more retainers 1318 in each set can be offset relative to the remaining retainers to facilitate engagement with a surgical device disposed within the fixture, as further described below.

[0417] The clamping pin 320 can extend internally from the retainer 1318. The clamping pin 1320 can extend along an axis A5 that is substantially perpendicular to the axis A1 of the shaft member 707. Although each retainer 1318 can include a clamping pin 1320 therein, in some embodiments, such as Fig.115 As shown, one or more of the retainers 1318 may be devoid of the pin 1320. The clamping pin 1320 may be fixedly coupled to the retainer 1318 such that a force applied to the clamping pin 1320 may move the clamping pin 1320 and the slider 1312 as a single unit. In some embodiments, the clamping pin 1320 may be integrally or unitarily formed with the retainer, but in some embodiments, the clamping pin 1320 may be removably received within the retainer 1318. As shown, the clamping pin 1320 may have a cylindrical shape as shown, or may have various other shapes corresponding to the shape of the retainer 1318 in which the pin is disposed, such as an oval, oblong, square, rectangular, triangular, etc.

[0418] The clamp 1302 may include one or more biasing elements or springs 1322 coupled thereto. The spring 1322 may extend distally from the proximal end 1302p of the clamp 1302 to the retainer 1318 and / or the clamp pin 1320 disposed in the slider 1312 to create a separation between the slider 1312 and the proximal end 1302p of the clamp 1302. The force applied by the spring 1322 may bias the slider 1312 distally so that the slider 1312 is spaced apart from the proximal end 1302p of the clamp 1302 by the length of the spring 1322. The spring 1322 may bias the clamp pins 1320 toward each other so that the distance between the biased clamp pins is less than the distance between the non-biased clamp pins. Although two biased clamp pins 1320 are shown, in some embodiments, one or three or more clamp pins 1320 may be biased by the spring 1322. The clamping pins 1320 can be configured to engage with instruments, implants, or other objects (eg, shaft member 707 ) received therebetween to secure their positions within the clamp 1302 .

[0419] In use, the clamp pin 1320 can ride within tracks 1314a, 1314b formed in the side wall 1304 of the clamp 1302 to allow proximal-distal translation of the pin 1320 and the slider 1312 associated therewith. For example, as shown, the clamp pin 1320 can ride in the first track 1314a, and the offset clamp pin can ride in the second track 1314b. When assembling the multi-tool, the shaft member 707 can be inserted distally and advanced proximally through the clamp 1302. Continued proximal advancement of the shaft member 707 can apply a force to the offset clamp pin 1320 to counteract the biasing force applied by the spring 1322 to move the clamp pin 1320 proximally. The proximal movement of the clamp pin 1320 may contract the length of the spring 1322 to move the clamp pin 1320 proximally at an angle to the axis of the shaft member 707 in the second track 1314b, thereby separating the clamp pin 1320. The proximal movement of the clamp pin 1320 may also move the slider 1312 proximally.

[0420] The clamping pins 1320 and the slider 1312 can continue to travel proximally in the second track 1314b until the distance between the clamping pins 1320 is substantially equal to the diameter D3 of the shaft component, as shown in FIG. Fig.114 In this configuration, the clamp pin 1320 stops moving proximally and the pin 1320 is biased distally by the spring 1322. The biasing force allows the clamp pin 1320 to engage the shaft component 707 to exert a clamping force thereon, thereby preventing further translation and / or rotation of the shaft component 707 relative to the clamp 1302. Any attempt to pull the proximal handle 714 of the shaft component 707 out of the clamp increases the clamping force exerted on the shaft component 707 by the clamp pin 1320.

[0421] Once secured, electrical connections may be established between the shaft assembly 707 and one or more of the navigation array 708 and the neural mapping tool 710. For example, in Fig.115 In the illustrated multi-tool 1300 , electrical current may pass through the contact between the clamp pin 1320 and the shaft member 707 , through the spring 1322 , and into the proximal end 1302 p of the clamp 1302 attached to the neural mapping tool 710 .

[0422] To change the position and / or disengage the shaft component 707 from the clamp 1302, a proximal force may be applied, such as by a user's hand, to the slider 1312. Applying a proximal force on the slider 1312 to counteract the distal biasing force of the biasing element 1322 may push the slider 1312 proximally to release the clamp pin 1320 from the shaft component 707. Once the clamp pin 1320 is released, the position of the shaft component 707 may be changed and the shaft component 707 may be disengaged from the clamp 1302. The clamp 1302 may then be coupled to another instrument, for example, a second shaft component.

[0423] FIG. 116A to FIG. 116B An alternative embodiment of a quick connect feature structure of a multi-tool 1400 is shown. Except as noted below and as will be readily understood by one of ordinary skill in the art, the structure and function of the multi-tool is substantially the same as that of the embodiments of the multi-tools 700, 800, 900, 1000, 1100, 1200, 1300 described above, and therefore a detailed description is omitted herein for the sake of brevity.

[0424] As shown, the multi-tool 1400 may include a cover 1402 configured to receive the shaft component 707 therein. A stop 1404 may extend distally from the cover 1402 and may be used in place of or in addition to the slider 1312 having the retaining pin 1320 to secure the shaft component 707 to the cover 1402. For example, the stop 1404 may include a sidewall 1406 defining an opening 1408 therein that is configured to receive the shaft component 707 therethrough.

[0425] The proximal handle 714 of the shaft component 707 can be received through the opening 1408 in the stopper 1404 and advanced proximally therethrough. The stopper 1404 can include a retaining mechanism (not shown) that can engage the groove 715 in the shaft component 707 to prevent further translation and / or rotation of the shaft component 707 relative to the cap 1402. To deploy the retaining mechanism, the stopper 1404 can be advanced distally so that the retaining mechanism snaps into the groove 715. To change position and / or disengage the shaft component 707 from the stopper 1404, the stopper 1404 can be advanced proximally, such as by the hand of a user, to disengage the stopper 1404 from the groove of the shaft component 707 to release the shaft component 707 therefrom.

[0426] Figure 117 to Figure 118 A method of docking an axis component in a target tissue to insert an access port for performing a procedure (e.g., posterior lumbar surgery) using an embodiment of a multi-tool disclosed herein is shown. Except as noted below and as will be readily understood by one of ordinary skill in the art, the steps of the described method may be performed in various orders, and one or more steps may be omitted or added. For the sake of brevity, a detailed description of each sequence of steps and each embodiment is omitted here. Although the method is discussed with respect to a given set of embodiments, it should be understood that any of the embodiments discussed herein may be used to perform the following steps.

[0427] In use, the bone anchor or contralateral screw may be implanted in the patient, for example, in the pedicle or lumbar spine of the patient. In some embodiments, the bone anchor may be inserted with the navigation array to calibrate the array to the system and pre- and post-operative images of the patient. Calibration may include analyzing the position and / or orientation of the bone anchor within the patient's dimensions. Using the positioning of the array and its position within the patient, a target site for inserting an access port may be determined.

[0428] In order to insert the access port, an incision can be made at the target site 1. Once the size of the incision is large enough, the shaft component 707 of the multi-tool 700 can be inserted into the target site 1. The shaft component 707 can be inserted under the guidance of one or more of the navigation array 708 and the neural mapping tool 710 to ensure the accuracy of the placement of the shaft component 707 and that the surrounding tissue, nerves and / or bones are not damaged during insertion. The distal end 716 of the shaft component 707 can be configured to slide along the bone while also being sharp so that the distal end 716 can dock with the bone when impacted with sufficient force. The force sufficient to dock the shaft component 707 to the target site 1 may include finger pressure or manual force via a user, but in some embodiments, the shaft component 707 may be knocked into the bone using a mallet, hammer, etc. As shown in FIG. Fig.117 As shown, in some embodiments, the distal tip 716 can be swept across the bone surface until the tip 716 reaches the target site 1, at which time the tip 716 can be advanced into the target site 1 while avoiding the exiting nerve root.

[0429] Once the shaft member 707 is docked, the cap 702 of the multi-tool 700 can be removed from the shaft member in the various ways described above while the shaft member 707 is docked in the target site 1. The target site 1 can then be enlarged by continuous expansion to allow for receiving an access port therein. In continuous expansion, one or more hollow dilators can be sequentially inserted into the target site 1 over the shaft member 707 to increase the opening in the target site 1. For example, a series of hollow dilators 2, 4, 6, each having a diameter greater than the shaft member 707, and each previous dilator can be slid into the target site 1 over the shaft member 707 and the previously inserted dilator.

[0430] The hollow dilators 2, 4, 6 may include a generally tubular shape having sidewalls circumscribing a channel 3, 5, 7 extending therethrough. The channels 3, 5, 7 may extend parallel to the central longitudinal axis A1 of the shaft member 707 to receive the shaft member 707 and the smaller diameter hollow dilators therethrough. As shown, the first dilator 2 may be inserted onto the shaft member 707 such that the shaft member passes through the channel 3, the second dilator 4 may be inserted onto the shaft member 707 and the first dilator 2, the third dilator 6 may be inserted onto the shaft member 707 and the first dilator 2 and the second dilator 4, and so on.

[0431] In some embodiments, each of the hollow dilators 2, 4, 6 in a series of dilators for sequential dilation may have a different length. For example, as shown, the length L2 of the first dilator 2 may be greater than the length L4 of the second dilator 4, which may be greater than the length L6 of the third dilator 6, and so on. The greater length of the previously inserted dilator allows the dilator to protrude distally from the subsequently inserted dilator to allow the previously inserted dilator to be removed from the target site. That is, as shown in FIG. Fig.118 As shown, the first dilator 2 and the second dilator 4 protrude distally from the third dilator 6, thereby allowing the first dilator 2 and the second dilator 4 to be removed from the target site 1 before the fourth dilator and / or the access port are introduced.

[0432] Continuous expansion can be performed by continuing to add hollow dilators of increasing diameter to the target site 1 until the size of the opening at the target site is designed to receive the access port therein. As shown, three dilators 2, 4, 6 are inserted into the target site, but in some embodiments, two or less, or four or more dilators may be used until the target site is sufficiently expanded to receive the port therein. In some embodiments, the access port may have a length less than the previously inserted dilator (e.g., the third dilator 6) to allow the previously inserted dilator to be removed from the target site 1.

[0433] Fig.119An embodiment of an access port 100 that can be inserted into a target site 1 is shown. For example, the access port 100 can be used to form an access path for an object (e.g., a device such as a bone anchor, an instrument) and / or a surgical material (e.g., a suture) to be introduced into a surgical site. The access port 100 may include a generally tubular or cylindrical body defined by a sidewall 102 having a central opening 104. The opening 104 may extend from a proximal end 100p of the access port 100 to a distal end 100d of the access port along an axis A6. In some embodiments, the opening 104 may be shaped to correspond to the shape of an object or instrument inserted therethrough. It should be understood that the access port 100 may be another example of an access device known to those of ordinary skill in the art for forming an access path into a patient's surgical site. The opening 104 of the access port 100 may have a uniform diameter, but in some embodiments, the access port 100 may have two or more diameters, as discussed further below.

[0434] In some embodiments, the central opening 104 of the access port 100 may include multiple channels therein. As shown, the central opening 104 may include a working channel 106 and a camera channel 108. The working channel 106 may be configured to receive objects and / or instruments therethrough, while the camera channel 108 may support a camera inserted therein to allow a user to observe the distal end of the access port 100 and the target site 1. The working channel 106 and the camera channel 108 may be separated from each other by a wall 110 that passes through an interior portion of the access port 100, but in some embodiments, the channels may be connected to each other to allow objects to pass between the channels. In some embodiments, the working channel 106 and the camera channel 108 may be recessed portions formed in the proximal end 100p of the access port 100, as shown, but as shown in the figure, Fig.122 As shown, one or more of the camera channel 108 and the working channel 106 can protrude proximally from the access port 100 to receive devices, instruments, and / or objects therethrough.

[0435] The access port 100 disclosed herein can be made of rigid or flexible materials. Some non-limiting examples of rigid materials can include stainless steel, titanium, nickel, cobalt chromium or alloys and combinations thereof, polymers such as PEEK, ceramics, carbon fiber, etc. Some non-limiting examples of flexible materials can include rubber, any of a variety of flexible polymers, etc. The material can be selected based on the surgical site, the type of surgery, and / or the objects used during the procedure. Rigid materials can provide additional support for objects introduced into the surgical site, while flexible materials can be more easily manipulated by the surgeon to increase the amount of space at the surgical site. It should be understood that a sufficiently deformable flexible material can allow the access port to be removed when desired without damaging surrounding tissue.

[0436] The sidewalls 102 of the illustrated access port 100 may be smooth to facilitate insertion of the access port with minimal friction. Having smooth sidewalls 102, while minimizing impact on surrounding tissue, may make the access port 100 susceptible to accidental withdrawal from the patient's body. In some embodiments, surface structures may be added to the access port 100 to retain the access port within the surgical site and prevent ejection. The surface structures may include screws, pins, serrations, or other features known in the art to increase friction, thereby preventing the structure from withdrawing from the target site 1.

[0437] In some embodiments, the access port 100 can be coupled to an instrument and / or device to manipulate the orientation of the access port in situ, for example, to adjust the position of the access port. For example, the central opening 104 can include one or more mating features 112 thereon for receiving corresponding mating features of an instrument and / or device. As shown, the mating features 112 can include a recess formed in the proximal end 102p of the access port 100. In some embodiments, the mating features 112 can be protrusions received in corresponding mating features of an instrument and / or device coupled to the access port.

[0438] Figure 120 to Figure 122 An embodiment of a plug or port adjuster 120 is shown that can be coupled to the access port 100 to adjust the orientation of the port. For example, the port adjuster 120 can be coupled to the proximal end 100p of the access port 100 to facilitate single-handed operation and adjustment of the orientation and / or angle of the port.

[0439] The port regulator 200 can be defined by a sidewall 202 having a central lumen 204 extending therethrough. The central lumen 204 can extend from a proximal end 200p of the port regulator 200 to a distal portion 200d along a central longitudinal axis A7 of the port regulator 200. The central lumen 204 can define a space through which an instrument, implant, or other object can be inserted. For example, the central lumen 204 can define an inner diameter D4 extending through the port regulator 200. The inner diameter D4 can be smaller than the diameter of the working channel 106 and / or the camera channel 108 of the access port, such that an instrument received through the central lumen 204 of the port regulator 200 can be advanced through the access port 100. An instrument can be inserted through the central lumen 204 proximally or distally.

[0440] The distal portion 200d of the port regulator 200 can be configured to be received in the proximal end 100p of the access port 100. For example, the distal portion 200d can include a generally cylindrical shaft through which the central lumen 204 passes. The distal portion 200d can be sized so that it can be inserted through the central opening 104 in the access port 100. Fig.121As shown, the distal portion 200d can be received in either the working channel 106 or the camera channel 108 to couple the port regulator 200 to the access port 100 without blocking one of the working channel 106 or the camera channel 108 .

[0441] The proximal end 200p of the port regulator 200 may include a handle 206 or another feature structure that facilitates the user to grasp the instrument. The handle 206 may be configured to adjust the angle and / or orientation of the access port 100 before or after insertion into the target site 1. For example, the handle 206 may include a ball or a joystick extending proximally from the distal portion 200d. The handle 206 can be used similar to a gear lever in a car to manipulate the position of the port. In some embodiments, the port regulator 200 can position the port to a desired position under the guidance of the navigation array 708 and the neural mapping tool 710. The handle 206 may include a handle lumen (not shown) therein, which is communicated with the central lumen 204 of the distal portion 200d, so that a tool inserted through the central lumen 204 can pass through the handle lumen, and a tool inserted through the handle lumen can pass through the central lumen 204.

[0442] The handle 206 and the distal portion 200d can be separated by an abutment surface or shoulder 300 defined by a platform that can abut the proximal end 100p of the access port 100, such as Fig.121 The abutment surface 300 can prevent the adjustment port 200 from being advanced too far distally into the central opening 104 of the access port 100. The abutment surface 300 can wrap around the circumference of the port adjuster 200, but in some embodiments, the abutment surface 300 can include a cutout therein so as not to block access to the camera channel 108, such as Figure 121 to Figure 122 The abutment surface 300 may also include one or more mating features 302 thereon that are configured to be received in mating features of the access port 100 to couple the port regulator 200 to the access port.

[0443] like Fig.122As shown, the port regulator 200 can be received in the working channel 106 so that the central axis A7 of the port regulator 200 is aligned or coincident with the axis A6 of the access port 100 to allow instruments, devices and / or other objects to be advanced therethrough. In some embodiments, the handle 206 can be flexed and / or bent to change the position of the access port 100 to increase the ease of inserting a tool through the access port 100 and / or change the position of a camera set in the target site 1 through the working channel 106. For example, in some embodiments, the handle 206 can be configured to move in all six degrees of freedom (surge, heave, roll, yaw, pitch, and roll) to adjust the angle of the access port 100 and / or rotate the port to change the camera position. Adjustments to the access port 100 can be made before the tool passes through the central opening 104 of the access port and the port regulator 200, or once the tool is set therein to reposition the port. In some embodiments, a port regulator 200 can be coupled to the access port 100 prior to inserting the access port 100 into the target site 1 to provide better control during insertion of the access port through the hollow dilator into the target site.

[0444] Figure 123 to Figure 125 1 shows an embodiment in which a multi-tool 700 can be used to navigate an access port 100. For example, the multi-tool 700 can be inserted through the port regulator 200 and the access port 100 to position the access port 100 in the target site 1. Fig.123 As shown, the shaft component 707 of the multi-tool 700 can be received through the overlapping inner lumens of the port regulator 200 and the working channel 106 of the access port 100 to access the target site 1. In such a configuration, the shaft component 707 can be advanced distally through the access port 100 so that the distal tip 716 extends distally from the access port 100, as shown in FIG. Figure 124 to Figure 125 As shown. The shaft component 707 can then contact tissue at the target site 1 distal to the access port 100. In this configuration, the shaft component 707 can be docked to the target site 1. Inserting the shaft component 707 through the working channel 106 can allow indirect navigation of the access port 100 without the need to couple a permanently fixed navigation array thereto, which can be cumbersome and interfere with the procedure. A camera or another visualization device can be inserted through the camera channel 108 and advanced into the target site 1 to visualize the distal end 716 of the shaft component 707 and assess the trajectory and / or path of the shaft component 707 into the target site 1.

[0445] In some embodiments, in addition to the camera in the camera channel 108, a navigation array 708 and a neural mapping tool 710 may be attached to the shaft member 707, as described in the above embodiments, to ensure the accuracy of the placement of the shaft member 707 in the target site 1.

[0446] It should be noted that any order of method steps expressed or implied in the above description or in the accompanying drawings should not be understood as limiting the disclosed method to perform the steps in that order. On the contrary, the various steps of each method disclosed herein can be performed in any number of orders. In addition, since the described methods are only exemplary embodiments, various other methods including more steps or including fewer steps are also included in the scope of the present disclosure.

[0447] The instruments disclosed herein may be constructed of any of a variety of known materials. Exemplary materials include materials suitable for use in surgical applications, including metals (such as stainless steel, titanium, nickel, cobalt-chromium, or alloys and combinations thereof), polymers (such as PEEK, ceramics, carbon fiber), etc. The various components of the instruments disclosed herein may be rigid or flexible. One or more components or portions of the instruments may be formed of radiopaque materials to facilitate visualization under fluoroscopy and other imaging techniques, or may be formed of radiolucent materials so as not to interfere with visualization of other structures. Exemplary radiolucent materials include carbon fibers and high-strength polymers.

[0448] The apparatus and methods disclosed herein can be used in minimally invasive surgery and / or open surgery. Although the apparatus and methods disclosed herein are generally described in the context of spinal surgery on human patients, it should be understood that the methods and apparatus disclosed herein can be used in any type of surgery on human or animal subjects, on inanimate objects (in non-surgical applications), etc.

[0449] While specific embodiments are described above, it will be appreciated that numerous changes could be made within the spirit and scope of the concepts described.

Claims

1. A multi-tool comprising: a shaft member having an elongated body defining a central longitudinal axis extending from a proximal handle to a distal tip; a body having a first opening for receiving the shaft member therethrough and a second opening therein, the first opening being angularly offset from the first opening and communicating with the first opening, one or more modular attachment arms extending from the body and having the second opening formed therein, the one or more modular attachment arms being configured to receive one or more surgical devices therein such that the surgical devices engage the shaft member when disposed within the body; as well as A button is disposed in the body, the button having an internal opening formed therein to receive the shaft member and to switch the shaft member between an unlocked configuration and a locked configuration relative to the body.

2. The multi-tool of claim 1, wherein the surgical device is any one of a neural mapping tool and a navigation array.

3. The multi-tool of claim 1, wherein the shaft component forms an electrical connection at an interface with the surgical device.

4. The multi-tool of claim 3, wherein the electrical connection is formed by a biasing element disposed between the shaft member and the surgical device.

5. The multi-tool of claim 3, wherein the proximal handle further comprises a conductor for making the electrical connection.

6. The multi-tool of claim 1, wherein the body is configured to be removably detachable from either the shaft member and the surgical device.

7. The multi-tool of claim 6, wherein the button is configured to be pressed by a user to detach the body from the shaft member.

8. The multi-tool of claim 1, wherein the body further comprises a slider that slides in a proximal-distal direction relative to the body to lock the axial position of the shaft member to the body.

9. The multi-tool of claim 1, wherein a longitudinal position of said shaft member is stationary in said locked configuration.

10. The multi-tool of claim 1, wherein the one or more modular attachment arms include a pin received through an axis thereof, the one or more devices being configured to receive the pin therein for snapping one or more devices to the modular attachment arms.

11. The multi-tool of claim 1 , wherein the one or more modular attachment arms are keyed such that the surgical device is prevented from being coupled to the modular attachment arms in all orientations except one.

12. The multi-tool of claim 1, wherein the one or more modular attachment arms protrude from the body at a location between the proximal handle and the button.

13. The multi-tool of claim 1, wherein the second opening is positioned substantially transverse to the first opening.

14. A multi-tool comprising: a shaft member configured to be inserted into a target site within a patient, the shaft member having an elongated body defining a central longitudinal axis extending from a proximal handle to a distal tip; a body having a first opening for receiving the shaft member therethrough and a second opening therein, the first opening being angularly offset from the first opening and in communication with the first opening; one or more transverse modular attachment arms extending from the body and in which the second opening is formed, the one or more transverse modular attachment arms being configured to receive one or more surgical devices therein such that the surgical devices engage the shaft member when disposed within the body; as well as a knob disposed in the body, the knob configured to engage the shaft member, the knob configured to switch relative to the shaft member to move the multi-tool between an open position in which the shaft member can translate or rotate relative to the body and a closed position in which the shaft member is prevented from translating or rotating relative to the body.

15. The multi-tool of claim 14, wherein the knob includes an internal opening formed therein for coupling to the shaft member.

16. The multi-tool of claim 15, wherein the shaft member engages the one or more surgical devices received within the one or more transverse modular attachment arms to establish an electrical connection therebetween.

17. The multi-tool of claim 15, wherein the knob includes one or more biasing features for switching the knob between the open position and the closed position.

18. The multi-tool of claim 14, wherein the one or more lateral modular attachment arms are positioned substantially perpendicular to the first opening.

19. The multi-tool of claim 14, wherein the one or more lateral modular attachment arms protrude from the body at a location between the proximal handle and the knob.

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