Multi-portal surgical systems, cannulas, and related technologies

Abstract

We provide multi-portal surgical systems, cannulas, and related technologies. [Solution] A multi-portal method for treating a subject's spine includes the step of ossifying adjacent vertebrae using a ossification device positioned at a first entrance along the subject, thereby expanding the intervertebral space between adjacent vertebrae. An intervertebral fusion implant can be delivered into the expanded intervertebral space. The intervertebral fusion implant can be directly positioned between the vertebral bodies of adjacent vertebrae while endoscopically observing the intervertebral fusion implant using an endoscopic instrument. The patient's spine can be visualized using endoscopic techniques to observe, for example, the spine, tissues, instruments, and implants before, during, or after implantation. Visualization can assist the physician throughout the surgical procedure and improve patient outcomes.

Description

Technical Field

[0001] 〔Cross - Reference to Related Applications〕 This application claims priority to U.S. Patent Application No. 16 / 565,403, filed Sep. 9, 2019 and U.S. Patent Application No. 16 / 687,520, filed Nov. 18, 2019, which are hereby incorporated by reference in their entireties.

[0002] The disclosure of the present invention generally relates to medical systems, and more specifically to systems, devices, and methods for performing multi - portal surgical procedures.

Background Art

[0003] Individuals are often troubled by damaged or displaced intervertebral discs and / or vertebral bodies due to trauma, disease, degenerative defects, or long - term wear. One result of this displacement or damage to the intervertebral disc or vertebral body is thought to be chronic back pain. A common procedure for treating damage or disease of the intervertebral disc or vertebral body may involve partial or complete removal of the intervertebral disc. An implant (commonly referred to as an intervertebral spacer) can be inserted into the cavity created where the intervertebral disc has been removed to assist in maintaining the height of the spine and / or restoring stability to the spine. The intervertebral spacer can also provide anterior correction of the spinal curvature. An example of a commonly used intervertebral spacer is a fixed - dimension cage typically filled with bone and / or bone - growth - inducing material.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

[0005] Unfortunately, implanting intervertebral spacers into the intended implantation site between vertebrae can be challenging. In addition, conventional surgical techniques can cause significant trauma at or near the implantation site, which can significantly increase recovery time and cause patient discomfort. Therefore, there is a need for improved surgical systems, visualization techniques, and / or related technologies. [Brief explanation of the drawing]

[0006] [Figure 1] A side view of a multi-portal surgical system according to an embodiment of the disclosure of the present invention. [Figure 2] This is a schematic top view showing a surgical approach to the lumbar spine for performing an intervertebral fusion procedure. [Figure 3] Figure 2 is an isometric projection of the lumbar spine. [Figure 4] This is a side view of a tissue removal device positioned between adjacent vertebrae and a visualization device positioned to visualize the working area, according to an embodiment of the disclosure of the present invention. [Figure 5] This is a side view of a distraction instrument in which a collapsed expansion element is positioned in the intervertebral space and a visualization device according to an embodiment of the disclosure of the present invention. [Figure 6] This is a side view of a callus lengthening device in which an expanded expansion element is in contact with a vertebral end plate according to an embodiment of the disclosure of the present invention. [Figure 7] This is a side view of a callus lengthening device having an extension element according to an embodiment of the disclosure of the present invention. [Figure 8] This is a side view of a device positioned between two vertebrae according to an embodiment of the disclosure of the present invention. [Figure 9A] This is a frontal view of the spine of a subject in which an intervertebral spacer is positioned between the vertebrae according to an embodiment of the disclosure of the present invention. [Figure 9B] This is a frontal view of the spine of a subject in which an intervertebral spacer is positioned between the vertebrae according to an embodiment of the disclosure of the present invention. [Figure 9C] This is a frontal view of the spine of a subject in which an intervertebral spacer is positioned between the vertebrae according to an embodiment of the disclosure of the present invention. [Figure 10A] This is a side view of an intervertebral spacer in a crushed structure. [Figure 10B] This is a side view of the intervertebral spacer in the expansion configuration. [Figure 11] This flowchart illustrates a method for performing spinal surgery according to an embodiment of the disclosure of the present invention. [Figure 12] This figure shows a system for providing pre-operative, intra-operative, or post-operative support according to embodiments of the disclosure of the present invention. [Figure 13] This is a plan view of a surgical kit according to an embodiment of the disclosure of the present invention. [Figure 14] This is a perspective view of a tissue-mapping cannula according to an embodiment of the disclosure of the present invention. [Figure 14A] Figure 14 is a perspective view of the distal end of a cannula having a lumen and a tissue-mapping probe, according to an embodiment of the disclosure of the present invention. [Figure 14B] Figure 14 is a perspective view of the proximal end of the cannula. [Figure 14C] Figure 14 is a longitudinal cross-sectional view of the cannula. [Figure 15] This is an end view of the distal end of a cannula having a plurality of lumens and an array of tissue-mapping probes, according to one embodiment of the disclosure of the present invention. [Figure 16] This is a side view of a cannula having a protruding tissue-mapping probe according to an embodiment of the disclosure of the present invention. [Figure 17]A side view of a surgical system having a cannula that circulates a surgical irrigation fluid to map tissue, according to an embodiment of the disclosure of the present invention. [Figure 18] A side view of a cannula having a deployable dilator that carries a tissue-mapping probe, according to an embodiment of the disclosure of the present invention. [Figure 19] An enlarged top view of the cannula of FIG. 18 with the dilator in a deployed configuration. [Figure 20] A flowchart showing a method of performing a multi-portal spinal surgery using a circulating irrigation flow and / or tissue mapping, according to an embodiment of the disclosure of the present invention. **DETAILED DESCRIPTION**

[0007] The following disclosure describes various embodiments of medical systems and devices and related methods of use. At least some embodiments of the surgical system provide a visualization function. A series of instruments can be delivered through portal sites to modify tissue (e.g., shape, pulverize, separate, cut, ablate, destroy, fragment, or remove tissue), prepare an implantation site, implant a device, or a combination thereof. Instrument visualization can assist the physician in preventing or limiting trauma or damage to non-target organs and tissues. In endoscopic-assisted surgery, the device can be accurately implanted using minimally invasive techniques, improving outcomes and shortening recovery time. To provide a complete understanding of such embodiments of the disclosure of the present invention, certain details are set forth in the following description and FIGS. 1-20. Other details, which describe well-known structures and systems often associated with surgical procedures, are not set forth in the following description so as not to unnecessarily obscure the description of the various embodiments of the disclosure of the present invention.

[0008] A. Overview At least some embodiments relate to a multi-portal surgical system. This surgical system can be used to treat patients with damaged or displaced intervertebral discs or vertebral bodies. The surgical system can be used to implant fixation devices or expandable intervertebral devices to separate vertebral bodies, restore spinal stability, provide lordosis correction, or a combination thereof. In spinal fusion procedures, intervertebral devices can be used alone or in combination with bone, bone growth-inducing materials, or fixation devices (e.g., pedicle screw systems, fixation rods, etc.). Endoscopic techniques can be used to visualize the patient's spine, for example, the spine (e.g., vertebral spacing, vertebral arrangement, etc.), tissues (e.g., damaged or displaced portions of intervertebral cartilage discs, tissues contributing to nerve compression, etc.), instruments, and implants before, during, or after implantation. Visualization can assist physicians throughout the surgical procedure and improve patient outcomes.

[0009] The surgical system can provide access to the surgical site. The implantation site can be prepared by performing procedures such as discectomy or intervertebral preparation. One or more devices (e.g., implants, fusion devices, etc.) can be delivered and placed in the patient's body. In some embodiments, decompression procedures can be performed to minimize or reduce the pressure on nerve tissue, and these decompression procedures may include steps to remove tissue contributing to stenosis, tissue pressing on nerve tissue, or bulging sections of intervertebral cartilage discs, etc. For example, decompression procedures can be performed to expand the epidural space and reduce spinal cord compression.

[0010] One surgical procedure involves positioning a distraction instrument between adjacent vertebrae at a first portal site along the patient to widen the intervertebral space. A tissue removal device can be used to clear and prepare the widened intervertebral space for implantation. The intervertebral fusion implant can then be delivered into the widened intervertebral space. The expanding intervertebral fusion implant is observed endoscopically using an endoscopic instrument positioned at a second entrance along the patient. Endoscopic observation can be used to assess whether the expanded intervertebral fusion implant is in the desired location and to assist in the delivery of bone graft material or other steps that facilitate bone healing and spinal fusion. Other visualization techniques can be used in combination with endoscopic observation. For example, fluoroscopy can be used in combination with endoscopic observation.

[0011] In some embodiments, a multi-portal endoscopic-assisted method for treating a subject includes a step of performing at least a portion of a surgical procedure using a first portal site. At least a portion of the surgical procedure uses an endoscope positioned through a second portal site spaced apart from the first portal site. The spacing can be selected based on the location and accessibility of the treatment site, whether along the spine or elsewhere.

[0012] In some embodiments, a multi-portal method for treating a subject's spine includes the step of ossifying adjacent vertebrae using a ossification device positioned at a first entrance along the subject to enlarge the intervertebral space between adjacent vertebrae. An interbody fusion implant is delivered into the enlarged intervertebral space. The interbody fusion implant is directly positioned between the vertebral bodies of adjacent vertebrae while endoscopically observing using an endoscopic instrument. The endoscopic instrument may be positioned at a second entrance along the subject. The positions of the first and second entrances can be selected based on the accessibility of the implantation site.

[0013] In yet another embodiment, a multi-portal method for treating a subject's spine includes the step of positioning a first cannula at a first port along the subject. The first and second vertebral bodies are distracted using one or more ossification devices that can extend through the first cannula. An intervertebral fusion implant can be moved through the first cannula toward the intervertebral implantation site between the distracted first and second vertebral bodies. At least a portion of the intervertebral implantation site and at least a portion of the intervertebral fusion implant can be visualized using an endoscopic device positioned at a second port along the subject.

[0014] In some embodiments, the spinal implant delivery device includes an elongated body configured to be positioned on a cannula and a distractor assembly. The distractor assembly is coupled to the elongated body and can be moved from a delivery state to an expanded state to distract the first and second vertebral bodies. In certain embodiments, the distractor assembly in the delivery state is configured for insertion into the intervertebral space between the first and second vertebral bodies, and in the expanded state is configured to hold the distracted first and second vertebral bodies apart while the intervertebral fusion implant is delivered into the intervertebral space.

[0015] In yet another embodiment, the spinal implant delivery device includes an elongated body configured to be positioned on a cannula, and a ossification extender assembly coupled to the elongated body. The ossification extender assembly is movable from a delivery state to an expanded state to ossify the first and second vertebral bodies. In the delivery state, the ossification extender assembly is configured for insertion into the intervertebral space, and in the expanded state, it is configured to hold the ossified first and second vertebral bodies apart while the intervertebral fusion implant is delivered. The intervertebral fusion implant can be delivered from the ossification extender assembly into the intervertebral space. In some embodiments, a driver is detachably coupled to a rotatable connection interface of the intervertebral fusion implant. The driver can move axially to directly move the intervertebral fusion implant between the first and second vertebral bodies. The driver is configured to expand the intervertebral fusion implant from a crushed configuration to an expanded configuration. The ossification extender assembly may include a jaw that is operable to define a delivery gap through which the intervertebral fusion implant can be delivered.

[0016] In some embodiments, a multi-portal method for treating a subject's spine includes the step of inserting multiple cannulas into the subject. The cannulas can be used to identify tissues, for example, to facilitate the placement of cannulas / instruments and / or to identify tissues (e.g., target tissue, non-target tissue, etc.). The cannulas can be used to circulate a lavage fluid (e.g., saline, water, etc.) through and around the surgical site (e.g., continuously or intermittently). Tissue mapping and surgical site lavage can be performed simultaneously or sequentially. In some embodiments, fresh lavage fluid can be delivered through a first cannula by a lavage system. The lavage system may have one or more pumps that generate the desired back pressure. To remove the lavage fluid, another cannula can draw an optional vacuum to aspirate the lavage fluid and unwanted materials (e.g., blood, bone meal, loose tissue, etc.) from the subject. In addition, pressurized lavage fluid within the subject can help facilitate hemostasis. The cannulas can be used to generate the desired flow of the lavage fluid.

[0017] The irrigation fluid (e.g., the flow of irrigation fluid into and / or from the subject) can be monitored to provide feedback to the clinician, for example, by facilitating visualization. In some embodiments, the irrigation fluid can be circulated periodically based on endoscopic visibility. For example, if the system of the present invention detects an excess amount of bone fragments, the system can automatically circulate the irrigation fluid to the surgical site to remove the bone fragments. In some embodiments, the clinician can control the timing of the circulation of the irrigation fluid via a control pedal, hand controller, etc. Advantageously, the cannula can separate the fluid lumen from the working lumen, allowing the flow rate of the irrigation fluid to be increased or decreased without interfering with instruments positioned in the working lumen. This enables independent control of the instruments and the irrigation.

[0018] A cannula may include, but is not limited to, sensors (e.g., flow sensors), flow diffusers, flow expanders, valves (e.g., one-way valves), accessories (e.g., accessories for connecting to a hose), connectors, and other fluidic components. For example, the proximal end of a cannula may have one or more accessories for connecting to the fluid line of a lavage system. The distal end of a cannula may include a nozzle for directing the flow in a desired direction. The configuration of a cannula can be selected based on the desired circulation. For example, to reduce or minimize trauma to tissue located immediately distal to the cannula, the cannula may have an outlet or nozzle configured to direct the fluid laterally away from non-target tissue. The cannula may direct the flow of lavage fluid toward a vacuum cannula. The cannula may also have one or more expanders, including mechanical or pneumatic expanders.

[0019] In some embodiments, information obtained using the cannula can be used for guiding instruments, evaluating surgical procedures, or confirming whether a procedure is complete. In embodiments with a tissue identification probe, the cannula can be used to identify one or more types of tissue. For example, nerve detection probes can be used to identify nerve tissue, allowing the surgeon to perform the procedure while minimizing or limiting the impact on nerve tissue. In some automated detection embodiments, the system can automatically notify the user if the cannula is in contact with or adjacent to non-target tissue, allowing the surgeon to keep the cannula in a safe place. In some procedures, the cannula is used to map the route to the surgical site, the surgical site itself, or other desired locations.

[0020] A surgeon can manually rotate the cannula to map the tissue around and near the distal end of the cannula. In other embodiments, the cannula may have a distal end that rotates automatically to map a region. Such a cannula may include one or more motors or actuators, etc.

[0021] In yet another embodiment, the cannula includes an elongated body and a plurality of lumens extending through the elongated body. One of the lumens may be a working lumen through which a surgical instrument passes. Another of the lumens may be a fluid lumen configured to provide a flow of surgical irrigation fluid to and from the surgical site. In some embodiments, the cannula may have an additional fluid lumen configured to provide another flow of irrigation fluid.

[0022] In multi-portal surgical techniques, lavage fluid can be circulated using two cannulas. In some embodiments, the fluid lumen of the first cannula can be connected to a lavage fluid supply system. The lavage fluid can flow through the fluid lumen and exit from the distal end of the first cannula. The lavage fluid can flow along the surgical site. The lavage fluid can be drawn out from the surgical site through the fluid lumen of the second cannula. In some embodiments, the first and / or second cannulas may have two or more fluid lumens. Additional lumens may be connected to either a fluid supply system or a fluid return system. In this way, each cannula can be configured to supply or return lavage fluid. In yet another embodiment, the cannula can be configured to both supply and return lavage fluid.

[0023] The cleaning fluid supply system may include one or more fluid supply reservoirs, pumps, flow monitors, pressure monitoring devices, or flow control mechanisms. Similarly, the fluid return system may include one or more pumps, pressure monitoring devices, flow control mechanisms, or return fluid containers. The supply and return systems can be components of the cleaning fluid control system. The cleaning fluid control system may provide monitors such as flow monitors and pressure monitors. In some embodiments, the control system may selectively supply and return fluid through any one of the connected fluid lumens, depending on the needs of the surgical procedure.

[0024] In addition, the cannula may include one or more detectors, such as a tissue-mapping probe. The detectors may be configured to output and / or receive energy to acquire information, identify tissue (e.g., tissue at or near the treatment site), and / or monitor the treatment. In some embodiments, the detector is a nerve-monitoring electrode configured to identify nerves using, for example, electromyography. Mapping nerve locations is useful for guiding the position of cannulas, instruments, or other devices to reduce or avoid trauma to nerve tissue. The detector may be connected to a tissue-mapping system programmed to determine tissue locations. The tissue-mapping system may provide feedback on tissue locations, including, for example, audible sounds indicating proximity to nerves or other tissues (e.g., target tissue, non-target tissue, etc.). In other embodiments, the tissue-mapping system may provide a visual representation of tissue locations. The visual representation may be, for example, an image, or an identifier of tissue locations superimposed on image data (e.g., still images, video, etc.) provided by a visualization instrument such as an endoscope or fiber optic observation system.

[0025] In yet another embodiment, the cannula may include a deployable dilator. The dilator may be configured to enlarge the space or working volume, thereby facilitating visibility and / or facilitating the flow of irrigation fluid into or from the cannula. The dilator may have a delivery configuration to minimize its profile during insertion into a subject. The dilator may be connected to or part of the distal end of the cannula so that the body of the dilator is in contact with the cannula body. In another embodiment, the dilator is connected to the cannula by a connector mechanism and is extendably engaged with the cannula body to extend the dilator by a distance away from the cannula body, for example, before and / or during deployment. In yet another embodiment, the dilator is a separate device configured to be delivered through one of the working lumens of the cannula.

[0026] The dilator may include one or more tissue-mapping probes. These probes may replace or add to tissue-mapping probes positioned on the cannula body. The probes can be used to assist in cannula positioning, dilator deployment and / or positioning, surgical instrument insertion and use, and / or procedure evaluation (e.g., to determine whether a nerve has been damaged or severed).

[0027] Throughout several figures, similar figures represent similar elements, and with reference to the accompanying drawings illustrating exemplary embodiments, embodiments of the disclosed invention will be described more fully below. However, embodiments of the claims can be embodied in many different forms and should not be construed as being limited to the embodiments listed herein. The examples listed herein are non-limiting examples and are merely examples of other possible examples.

[0028] B. Multi-portal surgical system Figure 1 is a side view of a spinal surgery system 100 ("System 100") positioned along the spine of a human subject according to an embodiment of the disclosure of the present invention. System 100 may include an instrument assembly 130 and a visualization assembly 160. The instrument assembly 130 can be used to perform at least a portion of a surgical procedure, while the visualization assembly 160 provides visualization. The instrument assembly 130 may include an instrument 110 and a cannula 120. Ports can be used to facilitate the insertion of the instrument assembly 130 and / or the visualization assembly 160. For example, the visualization assembly 160 may be positioned at an endoscope port, and the instrument assembly 130 may be positioned at an instrument port.

[0029] A series of instruments can be delivered through a cannula 120 to perform surgical procedures. In some procedures, instruments 110 can be used to prepare the implantation site, for example, by moving organs or tissues (e.g., moving nerve tissue), removing tissues (e.g., removal of intervertebral discs 171, removal of tissue contributing to stenosis), or preparing the vertebral body (e.g., roughening or shaping the end plates). Instruments 110 can be removed, and a callus lengthening instrument can be delivered through the cannula 120. The callus lengthening instrument can lengthen the adjacent vertebrae 170, 172 by ossification, thereby expanding the intervertebral space. The intervertebral fusion implant can be delivered through the cannula 120 into the expanded intervertebral space. In expandable embodiments, the intervertebral spacer or fusion implant can be expanded to contact the end plate. During the procedure, the visualization assembly 160 can provide endoscopic observation of the delivery route, organs, tissues (e.g., nerve tissue), implantation sites, intervertebral fusion devices (e.g., pre-delivery, during delivery, and / or post-delivery), instruments, and other related areas or features. The position of the portal site relative to the instrument assembly 130 and the visualization assembly 160 can be selected based on the procedure to be performed and the optical properties of the visualization assembly 160 (e.g., field of view, zoom function, etc.), as described in conjunction with Figure 4.

[0030] Continuing to refer to Figure 1, the visualization assembly 160 may include a visualization device 140 and a cannula 150. The cannula 150 can assist the physician when switching between visualization devices. In some embodiments, the visualization assembly 160 can be used without the cannula 150. For example, the visualization device 140, in the form of a thin fiber optic endoscope, is positioned directly through an incision or endoscope port, etc. The visualization device 140 may include, but is not limited to, one or more endoscopes having fiber optics (e.g., optical fibers), lenses, imaging devices, working lumen, or light source controllers, etc., for direct viewing or viewing through a display 162. In some embodiments, the visualization device 140 may include a lumen through which fluid flows to clean the surgical site. For example, saline solution or another suitable fluid can be pumped through the visualization device 140 to remove tissue (e.g., loose tissue, bone powder, etc.) or other material that impairs visualization. The visualization device 140 can illuminate the body cavity and enable high-resolution video visualization. A light source (e.g., a laser, light-emitting diode, etc.) located near or at the proximal end of the optical fiber can be used to transmit light to the distal end, providing illumination. This allows the surgeon to safely navigate within the subject's body and illuminate specific anatomical structures to visualize vertebral interstitial spaces, vertebral structures, nerves, bone accumulations (e.g., accumulations that may irritate and compress nerves, contributing to nerve compression), etc. In some embodiments, the visualization optics for vision and illumination are contained within the distal tip of the visualization device 140. The configuration and functions of the visualization device 140 can be selected based on desired field of view, observation resolution, or pan / zoom capabilities, etc.

[0031] Figure 2 is a schematic top view along the lumbar spine of a human subject, illustrating exemplary techniques for performing an interbody fusion procedure suitable for system 100 in Figure 1. Figure 3 is an isometric projection of the lumbar spine in Figure 2. Referring to Figures 2 and 3, surgical instruments can be delivered through various routes, including anterior lumbar interbody fusion (ALIF) route 210, oblique lumbar interbody fusion (OLIF) route 220, lateral or extra-lateral lumbar interbody fusion (LLIF or XLIF) route 230, transforaminal lumbar interbody fusion (TLIF) route 240, and posterior lumbar interbody fusion (PLIF) route 250. Exemplary TLIF and PLIF procedures are described in relation to Figures 4-6.

[0032] Continuing to refer to Figures 2 and 3, the number and configuration of interbody fusion devices can be selected based on the fusion procedure to be performed. In one example of a TLIF procedure, a single small expandable or non-expandable interbody spacer can be implanted in the intervertebral space using the transforaminal pathway 240. In one example of a PLIF procedure, two interbody spacers can be delivered along the posterior pathway 250 and implanted in the intervertebral space. The two interbody spacers can work together to maintain the desired spacing between the vertebrae and may be larger than the TLIF spacer. In addition, multiple interbody spacers can provide lordosis correction by providing support at different heights. In one example of an LLIF procedure, a single relatively large interbody spacer can be delivered and implanted along the lateral pathway 230 to provide asymmetrical support. In one example of an ALIF procedure, an asymmetrical interbody spacer can be delivered along the anterior pathway 210 to provide support that aligns with the lordosis of the spine in that portion. Lateral approaches, transforaminal approaches, and anterior techniques can be used to access the cervical, thoracic, etc. The number of instruments, their configuration, implants, and surgical techniques can be selected based on the medical condition being treated.

[0033] Figure 4 is a detailed side view of an instrument assembly 130 positioned to perform a TLIF or PLIF procedure according to an embodiment of the disclosure of the present invention. The instrument assembly 130 may extend through port 472, and the visualization assembly 160 may extend through port 474. The illustrated instrument assembly 130 may extend through the subject's skin 460, through the subcutaneous tissue 462, and adjacent to or through the supraspinous ligament 464. The visualization assembly 160 has a field of view 213 suitable for viewing the spine and can be positioned using, for example, a transforaminal approach, a posterior approach, or a lateral approach. The illustrated visualization assembly 160 is positioned to view the intervertebral disc 430 and the tissue removal tip 470 of the instrument 110, which are shown between the spinous processes 450 and 454 of the vertebrae 440 and 444, respectively. In addition to or instead of endoscopic observation, fluoroscopy, MR imaging, CT imaging, direct visualization, or other visualization techniques may be used.

[0034] The tissue removal tip 470 can be advanced forward to remove tissue bulging from the intervertebral disc 430 or the intervertebral disc 430 (or other intervertebral discs), bone (e.g., thin flakes, lateral recess, articular surfaces including inferior articular surfaces), osteophytes (e.g., osteophytes associated with osteoarthritis), thickened ligamentous tissue, spinal tumors, displaced tissue (e.g., tissue displaced by spinal trauma), or other unwanted tissues including but not limited to those that cause or contribute to spinal nerve compression. One or more dilation procedures, decompression procedures, discectomies, microscopic discectomies, laminectomies, or combinations thereof can be performed using the instrument 110 in conjunction with other instruments (e.g., bone forceps, devalucas, scrapers, reamers, dilators, etc.). In procedures to treat stenosis, the instrument 110 can be used to remove tissue associated with central canal stenosis, lateral recess stenosis, and / or other types of stenosis. In some decompression procedures, instrument 110 may be a tissue removal device used, for example, to remove bone, separate the ligamentum flavum from one or both of the vertebrae 440, 444, cut or reduce the ligamentum flavum, remove loose tissue, and remove at least a portion of the intervertebral disc 430. Each stage may be performed using different instruments. The instruments may be selected to treat spinal nerve compression (e.g., spinal cord compression or spinal nerve root compression), herniated disc, osteoporosis, spinal stenosis, or other diseases or conditions, but are not limited to the following.

[0035] The instrument 110 and the visualization device 140 can be positioned along different paths. For example, the instrument 110 can be positioned along a posterior path, while the visualization device 140 can be positioned along a transforaminal or oblique path. Ports 472 and 474 are positioned in different vertical positions, with port 472 positioned directly behind the treatment site such that the longitudinal axis of the tissue removal device 110 lies in a plane substantially parallel to the cross-section of the subject. The visualization device 140 may be an endoscopic instrument including, but is not limited to, an optical fiber 480 suitable for imaging the ligamentum flavum, spinal cord, nerves branching from the spinal cord, ligaments, vertebrae 440, 444, intervertebral disc 430, or any other related features or anatomical structures while the instrument 110 is removing tissue (e.g., bone from vertebrae 440, 444 or tissue from intervertebral disc 430).

[0036] Figure 5 is a side view of a callus lengthening device positioned between two vertebrae after the intervertebral disc has been removed according to an embodiment of the disclosure of the present invention. The callus lengthening device 510 is positioned within a cannula 120 and includes positioners or stops 530, 534 and a dilator or callus lengthening device head 560 ("dilater 560"), shown in a partially dilated state but configured to push adjacent vertebrae 440, 444 apart. The dilation of the dilater 560 and positioners 530, 534 can be visualized endoscopically using a visualization device 140.

[0037] Positioners 530 and 534 are configured to assist in positioning the dilator 560, which can be inserted into the intervertebral space 570. For example, positioner 530 can contact the inferior vertebral notch 550 of the vertebral body 441, and positioner 534 can contact the superior vertebral notch notch 554 of the vertebral body 445. The elongated member 540 can be extended or retracted to position the dilator 560 in the desired location, while positioners 530 and 534 can remain relatively stationary relative to the vertebral bodies 441 and 445. Throughout this process, the positioners 530 and 534, the elongated member 540, and / or the dilator 560 can be viewed using a visualization device 140. The physician can verify the position of the dilator 560 relative to anatomical features before, during, and after dilation, thereby ensuring that the dilator 560 makes contact with the desired area of ​​the spine. The expander 560 can be deployed to push in the end plates of the adjacent vertebrae 440 and 444, thereby expanding the intervertebral space 570.

[0038] The positioners 530, 534 may include spikes, projections, or other movement-restricting elements. In some embodiments, the locking portion or projection may be directly connected to the elongated member 540 and can be deployed to engage with the end plate. The configuration, number, and position of the positioners may be selected based on the desired positioning relative to the spine.

[0039] The elongated member 540 can be connected to the expander 560 and may be a rod having one or more lumens through which fluid flows. The expander 560 can be inflated by pumping fluid (e.g., saline solution, gas, or another suitable fluid) through the elongated member 540. In the case of fluoroscopy, the fluid may include a contrast agent. The expander 560 may include, but is not limited to, one or more inflatable members, balloons, mechanical expanders, or wedge devices. The arrows indicate one of many possible expansion directions, and the expansion direction of the expander 560 is not limited to bidirectional expansion.

[0040] The ossification device 510 can also deliver an intervertebral fusion implant and function as a driver device. The ossification device 510 may have a shaft that can be connected to an intervertebral fusion implant. The shaft can be rotated to deploy the intervertebral fusion implant. Thus, U.S. Patents 863,2594, 930,8099, 10,105,238, and 10,201,431, which are incorporated by reference and constitute part of this application, disclose driver components that can be incorporated into the ossification device 510.

[0041] Figure 6 is a side view of a callus lengthening device 510 in which an inflated dilating element 560 holds the vertebral bodies 441, 445 in a separated state. The dilating level of the dilater 560 can be increased or decreased to increase or decrease the pressure applied to the end plates, respectively. The dilater 560 may include one or more roughenings, spikes, protrusions, or other features that can roughen, abrade, scrape, or otherwise affect the tissue. In some embodiments, the dilater 560 has a plurality of protruding spikes that can be used to roughen the opposing vertebral end plate surfaces to help restrict or substantially prevent the movement of the implanted device. The dilater 560 can be crushed and removed. Another dilater can be inserted into the already dilated intervertebral space 570 to further callus lengthen the vertebrae 440, 444. In this way, the vertebrae can be callus lengthened sequentially in a controlled manner until the desired amount of separation is achieved.

[0042] While the intervertebral fusion implant is delivered into the intervertebral space 570 through the ossification device 510, the dilator 560 can hold the two ossified vertebrae 441 and 445 apart. The intervertebral fusion implant can be positioned adjacent to the deployed dilator 560, and the dilator can be removed, for example, after the intervertebral fusion implant has been deployed.

[0043] The configuration of the instruments can be selected based at least partially on the distance from the portal site to the treatment site. The surgical procedure can be selected based on the stages performed. For example, TLIF and PLIF surgeries may include a decompression procedure in which tissue is removed along the posterior segment of the spine, in contrast to ALIF surgeries in which such a decompression procedure is not performed. Other types of procedures, including non-vertebral procedures, can be performed by modifying the systems and techniques described in relation to Figures 4-6.

[0044] Figure 7 is a side view of a callus lengthening device 700 having an expansion element according to an embodiment of the disclosure of the present invention. The device 700 may include control elements 710, 712, an elongated body 720, positioners 730, 740, and an expander assembly 758. The control elements 710, 712 can be actuated to deploy the positioners 730, 740 and / or the expander assembly 758. For example, a user can manually rotate the control elements 710, 712 to deploy each of the positioners 730, 740 independently. For example, the control element 710 can be used to rotate the positioners 730, 740 toward the outward-facing deployed position shown, away from the non-deployed position 732, 742 (shown by dashed lines) and the longitudinal axis 743 of the device 700.

[0045] The ossification device 700 can be used in a manner similar to that described above in relation to Figures 5 and 6. For example, the deployed positioners 730, 740 can lean against adjacent vertebrae. The expander assembly 758 has an expander or ossification device head 760 ("expander 760") that can be positioned at a desired location suitable for ossification of the vertebra. The expander assembly 758 may include an elongated body 750 fluid-coupled to a fluid line 751. The expander 760 can be attached to the distal end of the elongated body 750 so that fluid passes through the fluid line 751, through the elongated body 750, and is pumped into the expander 760.

[0046] Figure 8 is a side view of the instrument 800 positioned to ossify an adjacent vertebra according to an embodiment of the disclosure of the present invention. The description of the instrument described in relation to Figures 4-7 applies equally to instrument 800 unless otherwise specified.

[0047] The apparatus 800 may include an access device or cannula 810 and a callus lengthening assembly 828. The cannula 810 may function as an access device through which the callus lengthening assembly 828 can be delivered. The callus lengthening assembly 828 may include positioners 830, 834 configured for non-traumatic contact with the spine. The positioners 830, 834 may be inflatable members (e.g., inflatable balloons), mechanically expandable members, or other types of elements. The positioners 830, 834 may be configured to contact vertebral bodies, transverse processes, or spinous processes, etc. The callus lengthening assembly 828 may further include an expandable assembly 848 having a dilator 850 and an elongated body 852. The dilator 850 shown is in a crushed and deflated configuration or state. The dilator 850 can be expanded / inflated in a manner similar to the dilator 560 described in relation to Figures 5 and 6. A visualization device can be used to view the expander 850, positioners 830, 834, or other feature parts of the instrument before, during, and / or after the callus lengthening process. In some embodiments, the callus lengthening assembly 828 can function as a jaw portion, in which case the positioners 830, 834 can be used to grasp or define the delivery gap. In addition to or instead of this, the positioners 830, 834 can be inserted into the gap (e.g., cavity) and then moved away to widen the gap.

[0048] Figures 9A-9C are front views of an intervertebral spacer 910 between two vertebrae, viewed from the front of a subject, according to embodiments of the disclosure of the present invention. In Figure 9B, the intervertebral spacer 910 is in a laterally expanded configuration. In Figure 9C, the intervertebral spacer 910 is in a laterally and vertically expanded configuration. Generally, the intervertebral spacer 910 in a collapsed configuration can be delivered into the intervertebral space. After endoscopically observing the position of this intervertebral fusion implant, the implant can be moved from the collapsed configuration (Figures 9A and 10A) to the expanded configuration (Figures 9C and 10B). The expansion (e.g., lateral expansion, vertical expansion, or a combination thereof) can be observed using endoscopic instruments. The intervertebral spacer 910 can be an implant or an intervertebral fusion implant, etc., but is not limited to the following. Details of the operation of the intervertebral spacer 910 will be discussed in detail below.

[0049] Referring to Figure 9A, the intervertebral disc has been removed from the intervertebral space 907. The intervertebral spacer 910 can be delivered through a cannula such as the cannula 120 in Figures 1-7 or the cannula 810 in Figure 8, and the crushed intervertebral spacer 910 can be directly positioned between the end plates 912 and 914 of the vertebrae 440 and 444, respectively. The position of the crushed intervertebral spacer 910 can be confirmed by endoscopic observation. If the intervertebral spacer 910 is in an undesirable position, it can be moved to another position. Here again, the final position of the intervertebral spacer 910 can be confirmed using endoscopic observation.

[0050] Figure 9B shows the intervertebral spacer 910 after being expanded laterally under endoscopic observation. Advantageously, if unwanted displacement of the intervertebral spacer 910 occurs during the expansion process, the user can reposition the intervertebral spacer 910.

[0051] Figure 9C shows the intervertebral spacers 910 after being expanded perpendicularly to the end plates 912 and 914 of vertebrae 440 and 444, respectively. After full expansion, the intervertebral spacers 910 can be locked to prevent collapse. Optional material can be delivered into the intervertebral space 907 to promote or facilitate fusion. For example, material can be delivered into the intervertebral space 907 through a delivery device 920 (Figure 10A) connected to the intervertebral spacer 910. The material can be bone, bone growth-inducing material, cement, or other suitable material. Bone growth-inducing material can be configured to facilitate bone articular fixation. In some procedures, this material is delivered through a passage in the delivery device or driver device. In other procedures, the material can be delivered through another device. In some procedures, multiple intervertebral spacers are embedded in the intervertebral space 907. Details of the delivery device will be described in relation to Figures 10A and 10B.

[0052] Referring to Figure 10A, the intervertebral spacer 910 and delivery device 920 can be delivered through port 922 with or without a cannula 930. The device 920 may include a handle assembly 931, an elongated body 932, and a connector 934. The handle assembly 931 may include a grip 950 and one or more control elements 940 that are actuated to control the operation of the intervertebral spacer 910 and control its detachment from the intervertebral spacer 910. In some embodiments, the control elements 940 may include one or more dials, levers, triggers, or other movable elements. The elongated body 932 is connected to the handle 950 and extends to the connector 934. The elongated body 932 may function as a driver device and may include one or more rods, shafts, or other elements used to actuate the intervertebral spacer 910. In some embodiments, the driver device is inserted through the delivery device 920 and engages with the intervertebral spacer 910. The driver device can be rotated to gradually and controllably deploy the intervertebral spacer 910. The features, configuration, and function of the connector 934 can be selected based on the configuration of the intervertebral spacer 910.

[0053] Figure 10B is a side view of the expanded intervertebral spacer 910 after the delivery device 920 has been separated from the connection feature or connection interface 916 ("connection feature 916") of the intervertebral spacer 910. The expanded intervertebral spacer 910 can be locked into the expanded configuration. To reposition the intervertebral spacer 910, the delivery device 920 can be reconnected to the intervertebral spacer 910 and operated to unlock and crush the intervertebral spacer 910. The crushed intervertebral spacer 910 can be moved using the delivery device 920.

[0054] The delivery device 920 may include one or more distal connecting elements or features for detachable coupling to the intervertebral spacer. The connecting elements may be polygonal connectors (e.g., hexagonal projections) that are received by complementary polygonal recesses or features of the intervertebral spacer 910. The delivery device 920 may be detachably coupled to the intervertebral spacer 910 using other connectors. Accordingly, U.S. Patents 863,2594, 930,8099, 10,105,238, and 10,201,431, incorporated herein by reference, disclose delivery devices, intervertebral spacers, and connecting features, as well as methods for operating the delivery device and deploying the intervertebral spacer. The delivery device 920 can be a delivery device and includes features disclosed in U.S. Patents 863, 2594, 930, 8099, 10, 105, 238, and 10, 201, 431. Other types of implantable devices and delivery devices may be used. The configuration of the implant and the corresponding delivery device can be selected based on the procedure to be performed.

[0055] Figure 11 is a flowchart illustrating a method for treating a subject according to an embodiment of the disclosure of the present invention. In block 1002, incisions can be made in the subject's tissue to create first and second portal sites (i.e., entry points). In some embodiments, the first and second entry points can be located on the same side of the subject's median sagittal plane. In other embodiments, the first and second entry points can be located on opposite sides of the subject's median sagittal plane. In yet another embodiment, the incision may be made along the subject's median sagittal plane.

[0056] Ports can be positioned at each inlet. The size of the port can be selected based on the size of the incision and the tissue characteristics of the portal site. For example, the tubular body of the port can be long enough to extend through the subject's skin, fascia, and muscles. The access opening of the port can be made large enough to allow instruments to be inserted through the port, thereby preventing or suppressing tissue rupture. Instruments can be delivered into the patient's body through the incision without using a port. Such instruments may have a relatively small diameter to limit or suppress tissue rupture around the incision. In some procedures, ports can be placed in some incisions, and instruments can be placed in other incisions without ports. The physician can decide whether or not to place a port based on the instruments to be used and the location of the incision.

[0057] In block 1004, for example, the ossification device can be positioned at the first portal site by inserting it through the installed port. In some procedures, a cannula can be positioned at the port, and the ossification device can be delivered through the lumen of the cannula. In other embodiments, the ossification device can be inserted directly into the port without using a cannula. The use of the ossification device and cannula will be described in relation to Figures 5-8.

[0058] In block 1006, the visualization device can be positioned at a second portal site by delivering it through a port. The visualization device can be placed with or without a cannula. The use of cannulas and ports is described in relation to Figures 1-7. In some embodiments, the visualization device can be a thin fiber optic visualization system that can be delivered through a portal site in the form of a small incision. In these procedures, a cannula may not be used because the diameter of the visualization device is small. The visualization device can be kept at the same portal site for most of the duration of the surgical procedure in which the spine is altered. For example, the visualization device can be positioned at a single portal site for at least 80% or 90% of the surgical period in which the instrument is positioned in the subject. The visualization device can be positioned inside the subject's body so that the intervertebral fusion device can be implanted without removing the endoscope from the subject. This can reduce the overall surgical time.

[0059] A steerable visualization device can be used to facilitate navigation around anatomical features. A steerable visualization device may include a flexible or rigid instrument having one or more illumination elements (e.g., optical fibers for illumination) or imaging elements (e.g., charge-coupled elements for imaging) suitable for visualization of the inside of an optical fiber scope or other inaccessible area. In some embodiments, the visualization device may be a rod-lens endoscope having an outer diameter of about 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 8 mm, or 10 mm or less and a length of about 15 cm, 20 cm, 30 cm, or 40 cm or less. The device may also have connectors (e.g., electrical connectors, fluid connectors, etc.), access ports (e.g., access ports connected to a lumen (e.g., a lumen through which the instrument can pass)), etc. In embodiments with angled lenses, the visualization instrument may have a lens angle of about 15 degrees, 30 degrees, or 45 degrees toward the light source. In other embodiments with angled lenses, the visualization instrument may have a lens of about 15 degrees, 30 degrees, or 45 degrees that is angled away from the light source. The lens angle can be selected based on the area to be viewed. In some posterior or lateral spinal procedures, a 0-degree lens can provide a wide-angle field of view suitable for observing nerve roots, spinal cord, and intervertebral spaces. Using a 30-degree or 45-degree lens endoscope with an angle directed towards the light source, for example, can provide a field of view angled toward the median sagittal plane, allowing observation of spinous processes, spinal cord, central intervertebral spaces, etc. Using a 30-degree or 45-degree lens endoscope with an angle directed away from the light source can provide a field of view angled toward lateral features such as nerve roots at the nerve foramina, lateral intervertebral spaces, or the spine.

[0060] In some procedures, multiple visualization instruments are used. In one procedure, multiple visualization instruments are positioned within the same port, which is large enough to allow relative movement between the endoscopic instruments. In other procedures, the endoscopic instruments are positioned in spaced-out ports. To provide bilateral observation, the first port and the first endoscopic instrument can be positioned on one side of the subject's midline sagittal plane, and the other port and the endoscopic instrument can be positioned on the opposite side of the midline sagittal plane. Multiple visualization instruments used in a single procedure may have different observational characteristics.

[0061] Implantation information for intervertebral fusion implants can be determined using images of the subject's spine. This implantation information may include, but is not limited to, recommended intervertebral fusion implants, expansion settings for intervertebral fusion implants, and / or recommended implantation locations for intervertebral fusion implants. The user may be presented with information for observation based on the analysis of image data, including information for repositioning or crushing the intervertebral fusion implant. In block 1008, tissue can be removed from the intervertebral space using a tissue removal device positioned at a first entrance. In block 1010, an osteogenesis device can be used to osteogenesis extend adjacent vertebrae, expanding the intervertebral space between adjacent vertebrae. In block 1012, an intervertebral spacer, such as an intervertebral fusion implant, can be delivered into the expanded intervertebral space. The intervertebral fusion implant can be delivered in a crushed configuration through the lumen of the osteogenesis device. In block 1014, the intervertebral fusion implant can be expanded laterally and vertically while positioning the driver instrument within the callus lengthening device positioned at the first entrance and while endoscopically observing in block 1016. Lateral and vertical expansion of the intervertebral fusion implant can be performed sequentially. For example, after expanding the intervertebral fusion implant horizontally, it can be expanded vertically to provide restoration of intervertebral disc height.

[0062] In block 1016, image data can be acquired using an endoscopic instrument. The image data can be video, still images, or other image data. To confirm the position of the expanded interbody fusion implant, image data can be acquired before, during, and / or after expansion and analyzed by endoscopic visualization, thereby increasing the effectiveness of the surgery by allowing the physician to visually evaluate the procedure. For example, a first image of the implantation site can be acquired using an endoscopic instrument. A second image of the implantation site can be acquired using an endoscopic instrument after the interbody fusion implant has been delivered. By analyzing the image data and based on the position of the expanded interbody fusion implant shown in the second image, it can be determined whether the expanded interbody fusion implant is positioned in the deployed position.

[0063] In some embodiments, the position of the expanded interbody fusion implant can be determined by comparing the first and second images. If the interbody fusion implant is mispositioned, the user can be notified of the mispositioning. This notification can be through an audible warning, a visual warning (e.g., a warning displayed on display 162 in Figure 1), or other appropriate notification means. In block 1018, the driver instrument can be separated from the locked expanded interbody fusion implant as described above in relation to Figure 10B. The implanted interbody fusion implant can be visualized to confirm proper positioning and deployment of the implant. Visualization can be used when performing additional procedures. Additional procedures may include, but are not limited to, delivering bone or growth-promoting material, etc., into the intervertebral space. Visualization can also be used to observe other procedures, such as fixation procedures involving pedicle screws or interspinous spacers, etc.

[0064] The method shown in Figure 11 can be performed using various systems disclosed herein. Additional instruments and steps may be performed as needed to provide treatment flexibility. For example, the decompression procedure may be performed before or after callus lengthening of the adjacent vertebra with block 1010. Visualization may be used during the decompression procedure to visually identify the target tissue and to ensure that non-target tissues (e.g., nerve tissue) are not injured. Although this method is described in relation to the implantation of interbody fusion implants, this method may also be performed to deploy and implant other devices. For example, a movable connectable intervertebral disc can be implanted using this method. In addition, a multi-portal system may be used to implant rigid or fixed interbody fusion devices. The actions and steps in the method shown in Figure 11 may be modified based on the characteristics of the implant to perform, for example, oblique lumbar interbody fusion procedures, lateral lumbar interbody fusion procedures, posterior lumbar interbody fusion procedures, transforaminal lumbar interbody fusion procedures, or anterior lumbar interbody fusion procedures.

[0065] Figure 12 shows a system 1110 for providing surgical assistance according to embodiments of the disclosure of the present invention. System 1110 can improve surgery by displaying image data, analyzing image data, suggesting stages in the surgical procedure, or analyzing implants. System 1110 may include hardware components that improve surgery using, for example, a surgical assistance system 1164. In various embodiments, the surgical assistance system 1164 may store patient information, acquire image data, analyze the information / data to obtain results, and use those results to provide feedback to the user. The surgical assistance system 1164 may analyze still images or videos from an input device 1120 to suggest implants for the procedure. For example, the surgical assistance system 1164 may recommend the number, size, and configuration of implants and the surgical procedure. Based on the recommendations, the surgical assistance system 1164 may also suggest surgical instruments, a surgical plan, and other information. The surgical plan may include (1) surgical stages, (2) the number, size, and / or location of ports, and / or (3) surgical approaches. For example, the surgical support system 1164 can annotate images (e.g., X-ray images, still images, videos, etc.) with insertion points along the skin of the proposed subject, surgical procedures (e.g., PLIF, ALIF, LLIF, etc.), access routes, etc. During the procedure, the surgical support system 1164 can provide the surgeon with warnings or other feedback.

[0066] System 1110 may include one or more input devices 1120 that provide input to a processor 1145 (e.g., CPU, GPU, HPU, etc.) and notify it of an action. The action can be mediated by a hardware controller that interprets signals received from the input devices and transmits the information to the processor 1145 using a communication protocol. The processor 1145 can be used to analyze data such as image data and determine whether the expanded interbody fusion implant is positioned in the deployed position based on the position of the expanded interbody fusion implant shown in the acquired images.

[0067] The input device 1120 may include, for example, a visualization device such as the visualization device 140 described in relation to Figures 1-6, an endoscopic instrument, an imaging device (e.g., a camera), a CRT machine, or an X-ray machine. Visualization allows, in some surgical embodiments, a surgeon to visually confirm the presence of vertebral bodies, intervertebral spaces, damaged / displaced tissue, intervertebral discs (including bulging portions), the presence of unwanted cartilage (e.g., cartilage accumulation), bone, or tissue causing nerve root compression and damage to normal bodily function. This information on unwanted material can be documented and recorded by storing image data in a computer database and immediately printing it as a color image (e.g., a photograph) for reference and record-keeping. The physician can use this information to formulate at least part of the surgical plan.

[0068] In addition to or instead of the above, the input device 1120 may include a mouse, keyboard, touch screen, infrared sensor, touchpad, wearable input device, camera or image-based input device, microphone, or other user input device. For example, a mouse can be used to select or manipulate image data captured by the visualization device. A keyboard can be used to annotate the image data. The number and configuration of input devices can be selected based on the physician's needs.

[0069] The processor 1145 can be a single processing unit or multiple processing units distributed across multiple devices, either within a single device or distributed across multiple devices. The processor 1145 can connect to other hardware devices using a bus, such as a PCI bus or SCSI bus. The processor 1145 can communicate with a hardware controller for a device such as the display 1130. Image data can be displayed using the display 1130. For example, the display 1130 can be connected to one or more visualization devices via a wired or wireless connection (Figure 1 shows a wired connection) and may correspond to the display 162 in Figure 1. The display 1130 can present information for observation by the user. The illustrated information may include information for implanting proposed implants, proposed surgical instruments, devices, repositioning intervertebral fusion implants, or crushing intervertebral fusion implants. This information can be overlaid on or inserted into images or videos. In some embodiments, the information may be annotations.

[0070] The display 1130 can provide the user with visual feedback in the form of shapes and characters. In some embodiments, the display 1130 includes an input device as part of the display, such as when the input device is a touch screen or when it includes an eye-direction monitoring system. In some embodiments, the display is separate from the input device. Examples of display devices include LCD screens, light-emitting diode (LED) screens, projection displays, holographic displays, or augmented reality displays (such as head-up or head-mounted displays). The display 1130 can provide high-definition visualization.

[0071] Other I / O devices 1140, such as network cards, video cards, audio cards, USB, FireWire or other external devices, cameras, printers, speakers, CD-ROM drives, DVD drives, disc drives, or Blu-ray devices, can also be connected to the processor. Other I / O devices 1140 may also include input ports for information from directly connected medical devices, such as MRI machines or X-ray machines. Furthermore, other I / O devices 1140 may include input ports for receiving data from these types of devices from other sources, such as over a network or from previously captured data stored, for example, in a database.

[0072] System 1110 may also include a communication device that can communicate wirelessly or via a wired connection using network nodes. The communication device can communicate with other devices or servers on the network, for example, using the TCP / IP protocol. System 1110 can utilize the communication device to distribute operations across multiple network devices.

[0073] The processor 1145 can access memory 1150, which is either located within a single device or distributed across multiple devices. Memory may include one or more hardware devices for volatile and non-volatile storage, and may include both read-only and writable memory. For example, memory may include random access memory (RAM), various caches, CPU registers, read-only memory (ROM), and writable non-volatile memory such as flash memory, hard drives, floppy disks, CDs, DVDs, magnetic storage devices, tape drives, and device buffers. Memory is not a propagating signal isolated from the underlying hardware; therefore, memory is non-transient. Memory 1150 may include program memory 1160 for storing programs and software such as the operating system 1162, the surgical assistance system 1164, and other application programs 1166. Memory 1150 may also include a data memory 1170 that can store, for example, implantation site information (e.g., level information, implant deployment information, etc.), surgical planning data, user options or preferences, image data, etc., and this data can be provided to the program memory 1160 or to any element of the system 1110.

[0074] Some implementations are operable in many other computer systems, environments, or configurations. Examples of computer systems, environments, and / or configurations suitable for use with the technology of the present invention may include, but are not limited to, personal computers, server computers, handheld or laptop devices, mobile phones, wearable electronic devices, tablet devices, multiprocessor systems, microprocessor-based systems, programmable home appliances, network PCs, minicomputers, mainframe computers, or distributed computer environments including any of the above systems or devices.

[0075] In the detailed description above, various embodiments of the device and / or process have been illustrated by using block diagrams, flowcharts, and / or examples. Those skilled in the art will understand that, insofar as such block diagrams, flowcharts, and / or examples include one or more functions and / or operations, each function and / or operation within such block diagrams, flowcharts, or examples can be implemented individually and / or collectively by a wide range of hardware, software, firmware, or substantially any combination thereof. In one embodiment, several parts of the subject matter described herein can be implemented by application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), digital signal processors (DSPs), or other integrated formats. However, it will be recognized by those skilled in the art that some aspects of the embodiments disclosed herein can be equally implemented in integrated circuits as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or substantially any combination thereof, and that the design of the circuits and / or the coding for the software and / or firmware falls well within the skill of those skilled in the art in light of the disclosures of the present invention. In addition, those skilled in the art will recognize that the mechanisms of the subject matter described herein can be distributed as various forms of program products and that the exemplary embodiments of the subject matter described herein are applicable regardless of the particular type of signal-carrying medium used to actually carry out distribution. Examples of signal-carrying media include, but are not limited to, recordable media such as floppy disks, hard disk drives, CDs, DVDs, digital tapes, and computer memory, and transmitting media such as digital and / or analog communication media (e.g., fiber optic cables, waveguides, wired communication links, wireless communication links, etc.).

[0076] C. Surgical Kit Figure 13 is a top view of surgical kit 1200 including the components described in relation to Figures 1-11, 14-16, and 18-19. Kit 1200 may include cannulas 120, 150 and a set of ports 1210. The physician can select the appropriate ports based on the location of the portal site and the instruments to be used. In an exemplary embodiment, set 1210 includes four ports. More or fewer ports may be provided, and they may be the same or different in size. Kit 1200 may include connectors (e.g., rigid connectors) for joining the cannulas (e.g., cannulas 120, 150, 1400) together. The cannulas can be joined together before expanding the intervertebral fusion device at the intervertebral implantation site.

[0077] Kit 1200 may further include several decompression devices. In the illustrated embodiment, Kit 1200 includes a weight-reducing device 1220 and a reamer 1222. When using a decompression device, the physician may select a port 1230 having a large opening 1232. Kit 1200 may also include a surgical scalpel, dilator, bone forceps, irrigation cannula, tissue detection or mapping cannula, dilator, or other surgical instruments. For example, Kit 1200 may include a visualization device 140, a callus lengthening device 510, a delivery or deployment device 920, and an implantable device 1238. The configuration and components of the kit can be selected based on the procedure to be performed. Exemplary components of the kit are described in relation to Figures 14-20. A biportal kit with tissue-mapping capabilities may have a tissue detection cannula, while a biportal kit with irrigation capabilities may have a cannula with an irrigation fluid penetration cannula. A biportal kit may have a cannula configured for both tissue-mapping and irrigation. In addition, one or more components of the kit may be disposable, and all or part of them may be made from metal, polymer, ceramic, composite material, or other biocompatible sterilizable material.

[0078] In some embodiments, Kit 1200 is a sterile, universal biportal spinal surgery kit for performing different procedures. In some biportal procedures, the first and second ports can be selected from Kit 1210 based on the subject's anatomical structure and the procedure to be performed. The first and second ports can be inserted into the subject's incision. Instrument cannulas (e.g., cannula 120, cannula 150, cannula 1400) can be inserted into the first port. Another cannula can be inserted into the second port. At least part of the procedure can be performed using instruments positioned within the instrument cannula (e.g., weight-reducing instrument 1220, reamer 1222, etc.), while visualization is provided by an imaging device positioned within the imaging cannula.

[0079] Surgical instruments can be selected based on the biportal spine procedure being performed. Instruments can be used to complete one, more, or all stages of a biportal spine procedure, using all or none of the instruments in the kit. A universal spine surgery kit can also contain instruments for intervertebral procedures, decompression procedures, fixation procedures, or a combination thereof. Surgical stages can be performed by sequentially inserting the instruments into instrument cannulas. Each instrument can be configured to fit within an instrument cannula, thereby allowing the same cannula to be used throughout the procedure. In other procedures, multiple cannulas can be sequentially positioned within the same port. The port can reduce or eliminate tissue rupture caused by cannula insertion, removal, or positioning.

[0080] In some embodiments, the surgical kit 1200 can be configured to perform a specific type of procedure. A physician can select the surgical kit 1200 based on the procedure to be performed.

[0081] In some procedures, the location of tissue can be mapped using one or more energy-emitting elements connected to the instrument cannula and / or imaging cannula. The energy-emitting elements may be tissue-mapping elements configured to identify the subcutaneous tissue of the subject. The mapping information can be used to position instruments, imaging devices, or cannulas, etc. Advantageously, mapping can be performed without introducing additional instruments to the subject, thereby reducing the complexity of the procedure or the risk of complications, etc. The tissues in question may be nerve tissue, connective tissue, or anatomical features (e.g., nerve roots, nerve branches, etc.). For example, mapping can be used to identify the location of nerve roots emerging from the vertebral foramen, spinal ganglia, or spinal nerves, etc.

[0082] The cannula can be configured to be fluid-coupled to one or more cleaning devices. Fluid coupling can be achieved using one or more accessories, connectors, hoses, or conduits, but is not limited to the following. The cleaning device may include one or more fluid control systems, pumps, vacuum or suction devices, conduits, sensors (e.g., flow sensors, fluid pressure sensors, blood sensors, etc.), controllers, or a combination thereof.

[0083] Kit 1200 may include one or more expanders that are part of the kit components or can be coupled to the kit components. The expanders can move from a non-expanded configuration to an expanded configuration, thereby increasing the working space within the subject's body. The expanders may be mechanical expanders, pneumatic expanders, or self-expanding expanders, etc.

[0084] Figure 14 is a perspective view of a cannula 1400 according to an embodiment of the disclosure of the present invention. The cannula 1400 can be used in a manner similar to the cannulas 120, 150, 810, and 930 described above in relation to Figures 1, 4-6, 10A, and 13. The cannula 1400 may include a distal end 1401, a proximal end 1402, and an elongated body 1404 having multiple lumens extending from the distal end 1401 to the proximal end 1402. The lumens can be used to deliver instruments to the surgical site, deliver fluid to a subject, or remove fluid from a subject. This allows for cleaning of the surgical site, while instruments can access the surgical site through the working lumen 1408. The working lumen 1408 may be configured to receive surgical instruments (e.g., callus lengthening devices, decompression devices, etc.), visualization devices, implantable devices, or other instruments used during the surgical procedure. The diameter of the working lumen 1408 can be approximately 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 8 mm, or 10 mm or less, and the outer diameter of the cannula 1400 can be approximately 3 mm, 4 mm, 5 mm, 6 mm, 8 mm, 10 mm, or 12 mm or less. Other cannula dimensions can be selected based on the access route, instrument dimensions, and procedure to be performed.

[0085] Figures 14A and 14B are perspective views of the distal end 1401 and proximal end 1402 according to embodiments of the disclosure of the present invention, respectively. Figure 14C is a longitudinal cross-sectional view of the cannula shown in Figure 14A. Referring here to Figure 14A, the distal end 1401 may include a first distal opening 1414, a second distal opening 1416, and an operating lumen opening 1418. The first and second openings 1414 and 1416 are positioned on either side of the operating lumen opening 1418, allowing fluid flow through them. This allows fluid flow to be maintained on both sides of the operating lumen 1408. The configuration, number, and position of the openings relative to the fluid flow can be selected based on the desired fluid flow. For example, increasing the number of openings and corresponding lumens can increase the flow rate of the lavage fluid within the subject's body.

[0086] Referring here to Figure 14B, the proximal end 1402 may include a first proximal opening 1446 and a second proximal opening 1448. As shown in Figure 14C, the first fluid lumen 1441 extends between the distal opening 1414 and the proximal opening 1446, and the second fluid lumen 1412 extends between the distal opening 1416 and the proximal opening 1448. The diameter and configuration of the lumen can be selected based on the procedure to be performed. The configuration of the lumen 1408, 1410, and 1412 can be, for example, circular, elliptical, or polygonal (including rounded polygons). In addition, the cross-sectional shape of the lumen can be varied along the length of the lumen, for example, when a circular lumen terminates with a rectangular opening at the distal end 1401 of the cannula 1400.

[0087] Referring to Figure 14C, the working lumen 1408 can be substantially centered within the elongated body 1404, with its distal opening 1409 correspondingly centered in the plane of the distal end 1401, or it can be offset toward the side of the body 1404 depending on its configuration. Similarly, the fluid lumens 1410 and 1412 can be positioned within the cannula body 1404 such that their distal openings 1414 and 1416 are located in positions other than those shown. For example, the lumens 1410 and 1412 can be placed adjacent to each other on the same side of the cannula body 1404 to assist in coupling the proximal opening to the fluid control system. In addition, in various embodiments, any of the openings 1406, 1414, 1416, 1446, and 1448 can be positioned along the outer surface 1413 of the cannula body 1404.

[0088] Continuing to refer to Figure 14C, the fluid lumens 1410 and 1412 can, in some embodiments, be configured to allow surgical lavage fluid to flow in any direction. For example, the first fluid lumen 1410 can be configured to allow lavage fluid flow from a supply connected to the proximal end 1402 to the distal end 1401, while the second fluid lumen 1412 can be configured to allow lavage fluid flow from the distal end 1401 to the proximal end 1402. In various arrangements, both lumens 1410 and 1412 can be used to allow fluid to flow in the same direction, or only one lumen can be configured to allow fluid to flow while the other lumen is closed, capped, blocked, or not used to allow fluid to flow in any other way, or neither lumen can be configured to allow fluid to flow, and both are closed, capped, blocked, or not used to allow fluid to flow in any other way.

[0089] The cannula 1400 may have one or more tissue-mapping probes. Referring again to Figure 14A, the tissue-mapping probe 1420 may be configured to output energy (e.g., electrical energy, radio frequency energy, electromagnetic energy, ultrasonic energy, acoustic energy, etc.) useful for identifying the location of tissue at the treatment site. The interaction of energy with various tissues can provide a measurable response using various techniques. For example, the tissue-mapping probe 1420 may be a nerve monitoring electrode used in conjunction with electromyography (EMG) techniques. For example, the electrical signal emitted by electrode 1420 may depolarize a nearby nerve, causing a response of the innervated muscle that can be detected by the EMG system. Other techniques include, but are not limited to, ultrasound, fluoroscopy, Doppler imaging, and optical imaging. The configuration of the tissue-mapping probe 1420 may be suitable for locating various tissues including nerve tissue, dura mater, bone tissue, ligaments, ligamentum flavum, bone graft materials, and relevant areas such as tissue margins and tissue interfaces.

[0090] The placement of the tissue-mapping probe 1420 can be selected to support the tissue-mapping technique. For example, spaced probes 1420 positioned as shown in Figure 14A can provide directional information. The relevant tissue may respond more strongly to energy output from a nearby probe than from other probes positioned farther away on the cannula. The tissue-mapping probe 1420 can also be configured to release energy sequentially or in another suitable pattern so that tissue in each direction associated with a particular tissue-mapping probe can be explored in the same sequence or pattern. This allows tissue mapping to be performed without adjusting the position of the tissue-mapping probe 1420. For example, if the distal end 1401 of the cannula 1400 is positioned over a nerve root, the tissue-mapping probe 1420 can be used to detect the presence of the nerve root and additional information such as the size of the nerve root, the orientation of the nerve root, or the depth of the nerve root. Advantageously, mapping can be performed without physically contacting and damaging the nerve tissue. Nerve mapping can be performed to locate adjacent spinal nerves around the vertebral column.

[0091] Referring to Figures 14A and 14C, the transmit line 1430 coupled to the tissue-mapping probe 1420 may extend from the distal end 1401 to the proximal end 1402. The transmit line 1430 may include, but is not limited to, one or more wires, optical fibers, etc., and may be located within the sidewall of the body 1404. The transmit line 1430 may be configured to transmit energy, electrical signals, and / or optical signals, including various types of digital and analog signals. In some embodiments, the transmit line 1430 may be configured to transmit energy to one tissue-mapping probe and signals received from another tissue-mapping probe. Referring here to Figures 14B and 14C, the transmit line 1430 may be connected to an interface 1440 at the proximal end 1402. The interface 1440 may include, but is not limited to, one or more plugs, connectors, or other components that provide a connection point to the tissue-mapping system.

[0092] Figure 15 is a front elevation view of cannula 1500. The description of cannula 1400 in Figures 14-14C applies equally to cannula 1500 unless otherwise indicated. Cannula 1500 may have a tissue-mapping array 1520 in which tissue-mapping probes are arranged circumferentially around the distal surface 1502 of the distal end 1501. The increased number of tissue-mapping probes in Figure 15 can provide increased directional resolution for tissue-mapping. In addition, different probes can be configured to emit different types of energy. Other probes can also be configured to receive return signals.

[0093] The tissue-mapping array 1520 may include nerve monitor electrodes 1522, an ultrasonic transducer 1524, and a photoacoustic sensor 1526. The arrangement of multiple modalities of tissue-mapping can improve tissue positioning and visualization. The nerve monitor electrodes 1522 can assist in positioning the cannula to avoid contact with nerves during insertion, while the ultrasonic emitter and photoacoustic sensor can provide information relevant to the location of various tissues and tissue interfaces. The number (e.g., 5, 6, 8, 10, etc.), position, and configuration of tissue-mapping probes can be selected based on the mapping being performed. For example, increasing the number of electrodes can provide higher resolution mapping. In some embodiments, some probes may be arranged around the side surface of the distal end, while others are arranged on the distal surface 1502. The probes may be flush with the outer surface 1503 of the cannula body or slightly recessed into the cannula body. In other embodiments, the probes may extend beyond the surface 1503.

[0094] Figure 16 is a side view of a cannula including a tissue-mapping probe according to a particular embodiment of the disclosure of the present invention. The descriptions relating to cannulas 1400 in Figures 14-14C and the cannula in Figure 15 are equally applicable to cannula 1600 unless otherwise indicated. The tissue-mapping probe 1620 extends distally from the distal end 1631 of the cannula body 1604. The distance d by which the tissue-mapping probe 1620 extends from the body 1640 can be selected based on the desired clearance of the working lumen 1624 with respect to the lumen opening 1622 (shown by the dashed line). Such probe projection can assist techniques such as EMG during guided insertion of the cannula, in which case the probe can guide the cannula body and determine the location of the tissue before the cannula comes into contact with the tissue. In some embodiments, the distal end 1631 may have a distal surface 1632 that is generally inclined with respect to the longitudinal axis 1636 of the cannula 1600. For example, the illustrated surface 1632 may be non-orthogonal to the longitudinal axis 1636 to provide lateral clearance for the instrument. When the probe 1620 is adjacent to or in contact with tissue 1640 (shown by the dashed line), the instrument can be easily pushed laterally into the working lumen, as indicated by the arrow 1644. Advantageously, the probe 1620 can physically contact the tissue to help maintain the distance between the tissue 1640 and the working instrument. The configuration and position of the probe 1620 can be selected based on the desired mapping and tissue interaction. For example, the probe 1620 may have a blunt or rounded tip 1641 configured to slide non-invasively over the tissue. In other embodiments, the tip 1641 may be pointed or relatively sharp to puncture the tissue. In some procedures, the puncture probe 1620 can be inserted into the tissue to map the tissue beneath the exposed tissue surface.

[0095] Figure 17 is a detailed side view of cannulas 1720, 1721 positioned to perform a procedure according to an embodiment of the disclosure of the present invention. The cannulas 1720, 1721 are positioned at their respective ports 472, 474 and can extend through the skin 460 and subcutaneous tissue 462 of the subject. The cannulas 1720, 1721 can be inserted through their respective ports 472, 474 so that their distal ends are adjacent to or reach the treatment site 1750 (identified by a dashed line overall). Insertion can be guided by a tissue-mapping probe 1724 operably coupled to a tissue-mapping system 1740 through a transmission line 1744. The cannula 1720 may have the features of the cannula 1600 described in relation to Figure 16.

[0096] Cannulas 1720 and 1721 each have fluid lumens 1725 and 1726, respectively, configured to circulate surgical irrigation fluid to the treatment site 1750. Fluid lumen 1726 can be fluid-connected to a fluid supply system 1760. Fluid lumen 1725 can be fluid-connected to a fluid return system 1770 located at the proximal end of cannula 1720. In some embodiments, the fluid supply system 1760 and the fluid return system 1770 are elements of an integrated fluid control system. Systems 1760 and 1770 may include the components and features described in relation to system 1110.

[0097] The circulating fluid flow can be controlled and monitored by the fluid supply system 1760 and / or the fluid return system 1770. Flow can be present while the instrument assembly 130 and the visualization instrument 140 are positioned within the working lumens 1706 and 1708 of the cannulas 1720 and 1722, respectively. The irrigation fluid can improve visibility at the treatment site 1750 and provide improved control over fluid pressure and flow rate during the procedure. In various embodiments, the cannulas 1720 and 1722 can be configured as described above with respect to cannulas 1400, 1500, and 1600 discussed in relation to Figures 14A-C, 15, and 16, and as described below with respect to cannula 1800.

[0098] The tissue-mapping probe 1724 can be used to map tissue near the treatment site 1750 while the instrument assembly 130 and the visualization instrument 140 are positioned within the cannulas 1720 and 1722, respectively. In this way, in some embodiments, the physician can accept periodic or continuous updates regarding the location of tissue near or within the treatment site 1750 as the surgical procedure progresses. The tissue-mapping system 1740 can be an element of the system 1110 for providing surgical assistance, as described above in relation to Figure 12. The tissue-mapping system 1740 may include, but is not limited to, one or more displays, computers, computer devices, processors, displays, or combinations thereof. Information regarding the location of tissue (e.g., tissue location information determined by the energy output by the tissue-mapping probe 1724) and / or information regarding the visualization of the treatment site 1750 (e.g., visualization information obtained through the visualization instrument 140) can be processed, combined, and presented to the physician to improve the surgery. In some embodiments, the tissue-mapping system 1740 provides visualization of the tissue location at the treatment site 1750, and this visualization can be overlaid on image data (e.g., still images, videos, etc.) obtained from a visualization device. The procedure in Figure 17 may use other cannulas, ports, or components described herein.

[0099] Figure 18 is a side view of a cannula 1800 according to an embodiment of the disclosure of the present invention. Figure 19 is a top view of the cannula 1800 with the cannula body 1801 indicated by a dashed line. The cannula 1800 may include a dilator or spacer 1810 ("dilator 1810") connected to the distal end 1803 of the elongated body 1801 of the cannula 1800. The dilator 1810 may have a retracted configuration (as shown in Figure 18) and an unfolded configuration (as shown in Figure 19). The dilator 1810 can be moved in parallel with respect to the distal end 1803 (Figure 18) via a movable coupler 1811. The movable coupler 1811 can be moved away from the distal end 1803 as indicated by arrow 1813 in Figure 18. In some procedures, the coupler 1811 is slidably positioned within the side wall of the elongated body 1801, allowing the physician to manually push the dilator 1810 distally. In other embodiments, the coupler 1811 is fixedly coupled to the elongated body 1801. For example, the coupler 1811 can be a rod integrally formed with or coupled to the elongated body 1801. In yet another embodiment, the coupler 1811 can be rotatably coupled to the distal end 1803. This allows the spacer 1810 to rotate relative to the elongated body 1801. For example, the dilator 1810 can rotate around the longitudinal axis 1811 of the coupler 1811. The configuration of the coupling arrangement can be selected based on the desired mobility of the dilator 1810.

[0100] The expander 1810 may have a movable coupling body that can move between a ring-shaped or helical configuration and an expansion configuration. Figure 18 shows the expander 1810 in a helical configuration. The movable coupling segments are connected through joints or pivots and can move toward the expansion configuration in Figure 19. The segmented sections of the body of the expander 1810 may be connected by joints 1823 (as identified in Figure 19), which may include one or more hinges, joints, or living hinges, but are not limited to the following. The expander 1810 may include tissue-mapping elements, contact sensors, anchors, or other features for engaging with or contacting tissue. In some embodiments, the expander 1810 may include one or more deployable arms or tines to allow for further expansion of the spacer 1810. In the deployed state, the expander can generate a working volume at the treatment site in the subject.

[0101] In other embodiments, the dilator may be an expandable cone, funnel, or other suitable shape to provide an increased working volume near or at the treatment site. The dilator allows visualization of the volume partially enclosed by the dilator when in the deployed configuration. For example, a visualization device positioned within a second cannula near cannula 1800 can visualize the internal area of ​​the spacer by looking into the unenclosed side of the dilator 1810. In some embodiments, the dilator 1810 may have an opening, window, or other opening to allow visualization of the partially enclosed area.

[0102] The dilator 1810 may have a tissue-mapping probe 1824 positioned on the outer surface of the segment. The tissue-mapping probe 1824 may be configured to output energy, similar to the tissue-mapping probes 1420, 1520, and 1620 described above in relation to Figures 14A-16. The tissue-mapping probe 1824 may be an addition to a tissue-mapping probe 1822 (Figure 18) positioned at the distal end of the cannula 1800. The tissue-mapping probe 1824 may assist in the deployment of the dilator 1810, assist in the positioning and orientation of the dilator 1810, and provide feedback to avoid contact with nerve tissue or other tissues.

[0103] Figure 20 is a flowchart illustrating a method 2000 for treating a subject according to an embodiment of the disclosure of the present invention. In block 2002, the subject's tissue is incised and a port is positioned at the site of the incision. Block 2002 can be similar to block 1002 described above in relation to Figure 11. In block 2004, a first cannula can be positioned at a port at a first location within the subject's tissue. An instrument, such as a callus lengthening instrument, can be inserted through the working lumen of the cannula. The use of callus lengthening instruments and cannulas is discussed in relation to Figures 5-8. Various additional embodiments of the cannula are discussed in relation to Figures 14A-16 and Figures 18-19.

[0104] In block 2006, a visualization device can be inserted through a second cannula positioned in the second portal region. The use of the visualization device in the second portal region is discussed above in relation to Figure 11 in relation to an embodiment in which the visualization device can be used together with the second cannula located in the second portal region.

[0105] In optional block 2008, a spacer can be deployed at the treatment site. The dilator can increase the working volume at the treatment site, improve the flow of irrigation fluid, improve visibility, and / or assist in tissue mapping. For example, the dilator can be configured to improve visibility and / or allow access to the surgical site while maintaining the dilation configuration. The dilator can be engaged with and disengaged from the cannula body. The deployment of the dilator is discussed above in relation to Figures 18 and 19.

[0106] In Block 2010, the location of tissue in or near the treatment site within a subject can be determined using tissue-mapping probes on the first and / or second cannulas. The tissue-mapping probes and tissue-mapping systems are discussed above in relation to Figures 14A-19. In some embodiments, the tissue-mapping system can provide information in addition to the image data provided by the endoscopic instrument. This information can be combined with the visualized image data to provide an image overlay or other representation of the tissue locations within the subject. The tissue-mapping information can be used if additional procedures are performed.

[0107] In Block 2012, lavage fluid can be circulated to the treatment site through first and second cannulas. The fluid lumen of the first cannula can be fluid-connected to a fluid supply system to supply fluid at a controlled pressure or flow rate. The fluid lumen of the second cannula can be fluid-connected to a fluid return system to return fluid from the treatment site. The deployed dilator can help control the fluid flow by providing a controlled boundary of the working volume at the treatment site. In some embodiments, the first and second cannulas may have additional fluid lumens that can be connected to a fluid control system. The fluid control system can then be used to configure the fluid lumens to supply or return lavage fluid. Thus, the first cannula may have, for example, both a fluid lumen configured to supply lavage fluid and a fluid lumen configured to return lavage fluid, while the second cannula may have a fluid lumen configured to return lavage fluid and a fluid lumen configured not to supply or return lavage fluid.

[0108] Procedure 2013 describes various stages in blocks 2014–2020, including the stages of removing tissue from the treatment site, moving the intervertebral fusion implant to the implant site, expanding the implant, and visualizing the expansion. These stages are similar to those in blocks 1008–1016 described above in relation to Figure 11. The stages can be removed and performed in different orders.

[0109] The components discussed herein can be mixed and adapted to provide desired functionality. For example, the cannula and instrument described in relation to Figures 1 and 13 may include tissue expanders, tissue-mapping elements, visualization devices, or other features that provide desired functionality. Components can be integrated into the instrument and cannula, or they may be separate components. For example, the expander 1810 described in relation to Figures 18 and 19 can be coupled to other cannulas discussed herein using clamps, pin connectors, or other suitable connection arrangements. This allows the expander 1810 to be coupled to a wide range of different types of cannulas. In addition, the distal sections of the instrument, cannula, and expander may have a non-invasive design to reduce or suppress tissue injury. As an example, the expander 1810 in Figures 18 and 19 may have a rounded distal section to assist in sliding along tissue, thereby suppressing or preventing tissue injury. In other embodiments, the expander and cannula may have relatively sharp edges to facilitate tissue cutting, scraping, or other operations. The kit may contain both invasive and non-invasive instruments, allowing the user to choose how the tissue is affected or not affected by the instruments and cannula. While the lumen is within the cannula, another tube may be connectable to the cannula. For example, a bone removal tube may include a connector or clamp for detachable connection to the cannula.

[0110] The above detailed description relating to embodiments of the technology of the present invention is not intended to be comprehensive or to limit the technology of the present invention to the forms disclosed above. While specific embodiments of the technology of the present invention and examples relating to the technology of the present invention have been described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology of the present invention as will be recognized by those skilled in the art. For example, while the steps are presented in a given order, in alternative embodiments the steps may be performed in a different order. Features derived from various systems, methods, and apparatus can be combined with features disclosed in U.S. Patent Nos. 863, 2594, 930, 8099, 10, 105, 238, 10, 201, 431, U.S. Patent Application No. 16 / 565, 403, and U.S. Patent Application No. 16 / 687, 520, which are thus incorporated by reference as part of this application. Modifications of the implant are conceivable. For example, the intervertebral spacer 910 (Figures 9A–9C) may include different total heights covering a range of intervertebral disc heights. In other examples, the intervertebral spacer 910 may include different lordosis angles and / or kyphosis angles. In yet another example, the intervertebral spacer 910 may include other patterns or features such as spikes or protrusions on the bone contact surface that provide stability and / or resistance to positional shift. The implant may be made from metal, polymer, ceramic, composite, or other biocompatible, sterilizable material. Different materials may be combined into what is described herein as a single component. The surgical kit may include components discussed in relation to, for example, Figures 1-11, 14-16, and 18-19. The kit may include cannulas, ports, fluid components, tissue-mapping elements, dilators, or combinations thereof.

[0111] The systems, components, and instruments disclosed herein may be disposable or reusable. For example, ports, instruments, or cannulas may be disposable to prevent cross-contamination. The term “disposable,” as used herein to describe a system or component (or combination of components) such as an instrument, tool, or distal tip or head, is a broad term and generally means that such a system or component is used a finite number of times and then discarded, but is not limited to the following. Some disposable components are used only once and then discarded. In other embodiments, components and instruments are non-disposable and can be used multiple times. In some kits, all components may be disposable to prevent cross-contamination. In some other kits, components (e.g., all or some components) may be reusable.

[0112] To the extent circumstances permit, singular or plural terms may also encompass plural or singular terms, respectively. In addition, with respect to a list of two or more items, unless the word “or” is explicitly limited to mean only a single item that is exclusive to the other items, the use of “or” in such a list should be interpreted as encompassing (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. In addition, the term “including” is used throughout to mean including at least the enumerated features, and therefore a larger number of the same features and / or other features of additional types are not excluded. Similarly, while certain embodiments have been described herein for illustrative purposes, it will be acknowledged that various modifications can be made without departing from the art of the present invention. In addition, while advantages associated with certain embodiments of the art of the present invention have been described in relation to those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily need to exhibit such advantages to fall within the scope of the art of the present invention. Accordingly, the disclosure of the present invention and related art may encompass other embodiments not expressly shown or described herein. [Explanation of symbols]

[0113] 100 Spinal Surgery Systems 120, 150 cannulas 130, 160 Equipment Assembly 140 Visualization Devices 171 Intervertebral disc

Claims

1. A system for treating the spine of a subject, Instrument cannula, A delivery device including a long, slender body and a callus lengthening device head, Includes, The callus extension head is deliverable through the instrument cannula and configured to controlly extend the callus of an adjacent vertebra, and is configured to provide a delivery path for delivering the intervertebral fusion device into the intervertebral space between the callus-extended adjacent vertebrae while the elongated body extends through the instrument cannula. A system characterized by the following features.

2. The system according to claim 1, further comprising a deployment device configured to be delivered through the instrument cannula to deploy the intervertebral fusion device.

3. The aforementioned dispensing device is, At least one stop, the callus extension head is insertable into the intervertebral space while the at least one stop is positioned to contact at least one vertebral body of the adjacent vertebrae, A control element controls the operation of the callus extension head so that it presses against the end plate of the adjacent vertebra to expand the intervertebral space, The system according to claim 1, characterized in that it includes the following:

4. The system according to claim 1, characterized in that the callus extension head includes one or more expandable members and / or wedge devices.

5. The system according to claim 1, further comprising one or more discectomy instruments that can be delivered through the instrument cannula for performing a discectomy.

6. The system according to claim 1, further comprising an intervertebral fusion device having an interface element detachably connectable to the delivery device, wherein the delivery device is operable to extend the intervertebral fusion device in a first direction and in a second direction different from the first direction.

7. The system according to claim 1, further comprising an endoscopic cannula configured to be positioned at a second port in order to provide access for endoscopic observation of the treatment site along the spine while the delivery device is positioned on the subject.

8. The system according to claim 1, further comprising one or more tissue removal tools configured to remove intervertebral tissue of adjacent vertebrae.

9. The system according to claim 1, further comprising an endoscope.

10. The system according to claim 1, further comprising an intervertebral fusion device configured to be transmitted through the elongated body.

11. The system according to claim 1, characterized in that the callus lengthening head is movable from a delivery state configured for insertion into the intervertebral space between adjacent vertebrae to an expanded state configured to hold the callus-lengthened adjacent vertebrae apart while the intervertebral fusion implant is delivered from the delivery device into the intervertebral space.

12. The system according to claim 1, further comprising a driver which is detachably connectable to a rotatable connection interface of the intervertebral fusion device and moves axially to move the intervertebral fusion device directly between adjacent vertebral bodies of the adjacent vertebrae, wherein the driver is configured to expand the intervertebral fusion device from a crushed configuration to an unfolded configuration.

13. The system according to claim 1, wherein the callus lengthening head includes an inflatable member that can be inserted into the intervertebral space, and the inflatable member is configured to push apart the adjacent vertebral bodies when the inflatable member is inflated in the intervertebral space.

14. The system according to claim 1, wherein the callus extension head includes at least one stop that is movable toward an unfolded position away from the longitudinal axis of the callus extension assembly, and the at least one stop in the unfolded position is configured to contact one side of the adjacent vertebral bodies while the callus extension head extends the vertebral body.

15. The system according to claim 1, characterized in that it is configured to perform any one of the methods of claims 21 to 54.

16. A long, slender body configured to be positioned on the cannula, A callus extension assembly, which is connected to the elongated main body and is movable from an extended state to an extended state for callus extension of the first and second vertebral bodies, Includes, A spinal implant delivery device characterized in that, in the delivery state, the ossified

17. The spinal implant delivery device according to claim 16, further comprising a driver that is detachably connectable to a rotatable connection interface of the intervertebral fusion device and moves axially to move the intervertebral fusion device directly between the first and second vertebral bodies, wherein the driver is configured to expand the intervertebral fusion device from a crushed configuration to an unfolded configuration.

18. The spinal implant delivery device according to claim 16, wherein the callus extension assembly includes a jaw portion having a first contact member and a second contact member that define an delivery gap through which the intervertebral fusion device can be delivered when the callus extension assembly is in the expanded state.

19. The spinal implant delivery device according to claim 16, wherein the callus lengthening assembly includes an inflatable member that can be inserted into the intervertebral space, the inflatable member being configured to push the first and second vertebral bodies apart when the inflatable member is inflated in the intervertebral space.

20. The spinal implant delivery device according to claim 16, wherein the ossoidal extension assembly includes at least one stop that is movable toward an unfolded position away from the longitudinal axis of the ossoidal extension assembly, and the at least one stop in the unfolded position is configured to contact one side of the first and second vertebral bodies while the ossoidal extension assembly ossoidals the first and second vertebral bodies.

21. A multi-portal method for treating the spine of a subject, The steps include: extending the adjacent vertebrae by ossification using a ossification lengthening device positioned at a first entrance along the subject, thereby expanding the intervertebral space between the adjacent vertebrae; The steps include delivering the intervertebral fusion implant into the enlarged intervertebral space, The steps include: expanding the intervertebral fusion implant, which is directly positioned between the vertebral bodies of the adjacent vertebrae, while endoscopically observing the intervertebral fusion implant using an endoscopic instrument positioned at a second entrance along the subject; A method characterized by including

22. A step of expanding the intervertebral fusion implant in the lateral and vertical directions using a driver instrument, The steps include observing the lateral and vertical expansion of the intervertebral fusion implant through the endoscopic instrument, The steps include separating the driver instrument from the intervertebral fusion implant that has been extended in the lateral and vertical directions, The multi-portal method according to claim 21, further comprising the following:

23. The steps include: delivering the intervertebral fusion implant through the distal portion of the callus lengthening device; The steps include expanding the intervertebral fusion implant while the driver device is positioned within the callus extension device positioned at the first entrance, After the intervertebral fusion implant is in a locked, expanded configuration, the driver device is separated from the intervertebral fusion implant. The multi-portal method according to claim 22, further comprising the following:

24. The multi-portal method according to claim 22, further comprising the step of incising the tissue of the subject to form the first and second entrances positioned on the same side of the median sagittal plane of the subject.

25. The multi-portal method according to claim 22, further comprising the step of incising the tissue of the subject to form the first and second entrances positioned on both sides of the median sagittal plane of the subject.

26. The multi-portal method according to claim 21, further comprising the step of sequentially expanding the intervertebral fusion implant in the lateral and vertical directions using a driver instrument positioned at the first entrance.

27. The step of expanding the intervertebral fusion implant is, The steps include: expanding the intervertebral fusion implant horizontally, After expanding the intervertebral fusion implant horizontally, the intervertebral fusion implant is expanded vertically to provide intervertebral disc height restoration. The multi-portal method according to claim 21, characterized by including the following:

28. The multi-portal method according to claim 21, further comprising the step of confirming the position of the expanded intervertebral disc fusion implant based on the endoscopic observation.

29. The steps include: acquiring image data of the intervertebral fusion implant using the endoscopic instrument; The step of analyzing the image data to determine whether the intervertebral fusion implant is poorly positioned, The multi-portal method according to claim 21, further comprising the following:

30. The multi-portal method according to claim 29, further comprising the step of notifying the user of the mispositioning in response to the determination that the expanded intervertebral fusion implant is mispositioned.

31. The multi-portal method according to claim 29, further comprising the step of presenting information for observation by a user based on the analysis of the image data, wherein the presented information includes at least one of the following: information for repositioning the intervertebral fusion implant or information for crushing the intervertebral fusion implant.

32. The steps include positioning the first port at the first inlet, Steps include: feeding the callus extension device through the first port and moving the distal end of the callus extension device toward the intervertebral space; The steps include expanding the distal end of the callus extension device in order to push the adjacent vertebrae apart, The multi-portal method according to claim 21, further comprising the following:

33. The steps include positioning at least one stop of the callus lengthening device adjacent to at least one of the adjacent vertebrae, The steps include inserting the dilator into the intervertebral space while the at least one stop is positioned to contact the vertebral body of at least one of the adjacent vertebrae, The step of deploying the expander so as to press it against the end plate of the adjacent vertebra and thereby expand the intervertebral space, The multi-portal method according to claim 21, further comprising the following:

34. The multi-portal method according to claim 33, characterized in that the expander includes one or more inflatable heads and / or wedge devices.

35. The steps include: delivering the intervertebral fusion implant, which is in a collapsed configuration, into the enlarged intervertebral space through the lumen of the callus lengthening device; After observing the intervertebral fusion implant located in the intervertebral space through the endoscopic instrument, the step of moving the intervertebral fusion implant from the compressed configuration to the expanded configuration, The multi-portal method according to claim 21, further comprising the following:

36. The multi-portal method according to claim 21, further comprising the step of performing a discectomy between adjacent vertebrae before expanding the intervertebral fusion implant.

37. The steps include: acquiring a first image of the implantation site using the aforementioned endoscopic instrument; The steps include: after delivering the intervertebral fusion implant into the enlarged intervertebral space, acquiring a second image of the implantation site using the endoscopic instrument; Based on the position of the expanded intervertebral fusion implant shown in the second image, the step of determining whether or not the expanded intervertebral fusion implant is positioned in the deployed position, The multi-portal method according to claim 21, further comprising the following:

38. The step of comparing the first image and the second image, A step of determining the position of the expanded intervertebral fusion implant based on the above comparison, The multi-portal method according to claim 37, further comprising the following:

39. The multi-portal method according to claim 37, further comprising the step of displaying the first image and the second image through an electronic screen.

40. The steps include: acquiring one or more images of the subject's spine using the endoscopic instrument; The process further includes the step of determining implantation information for the intervertebral fusion implant based on the one or more images, The aforementioned embedded information, Recommended intervertebral body fusion implants, The extended setting value for the intervertebral fusion implant, or Recommended implantation location for the aforementioned intervertebral fusion implant, The multi-portal method according to claim 21, characterized by including at least one of the following.

41. A multi-portal method for treating the spine of a subject, The steps include positioning the first cannula at a first portal site along the subject, The steps include: extending the callus of the first and second vertebral bodies using a callus lengthening device extending through the first cannula; The steps include moving the intervertebral fusion implant through the first cannula toward the intervertebral implantation site between the first and second vertebral bodies that has been lengthened by callus, The steps include visualizing at least a portion of the intervertebral implantation site and at least a portion of the intervertebral fusion implant using an endoscopic instrument positioned at a second portal site along the subject, A method characterized by including

42. The method according to 41, further comprising the step of expanding the intervertebral fusion implant while endoscopically visualizing the intervertebral fusion implant using the endoscopic instrument positioned at the second portal site.

43. The method according to 41, characterized in that the first and second portal portions are positioned to perform at least one of oblique lumbar interbody fusion, transverse lumbar interbody fusion, posterior lumbar interbody fusion, transforaminal lumbar interbody fusion, or anterior lumbar interbody fusion.

44. The method according to 41, further comprising the step of inserting a bone graft material configured to promote bone joint fixation into the expanded intervertebral fusion implant.

45. The method according to 41, further comprising the step of visualizing at least a portion of the intervertebral fusion implant throughout most of the expansion process for restoring the intervertebral disc space between the first and second vertebral bodies.

46. The method according to 41, further comprising the step of connecting the first cannula and the second cannula to each other before expanding the intervertebral fusion device at the intervertebral implantation site.

47. A multi-portal endoscopic-assisted method for treating the spine of a subject, A step of performing at least a portion of a surgical procedure by using a first port to access the spine of the subject, A step of visualizing at least a portion of the surgical procedure using an endoscope positioned through a second port, wherein the first port and the second port are spaced apart from each other along the skin of the subject; A method characterized by including

48. The method according to 47, characterized in that the endoscope is positioned within the subject so that an intervertebral fusion device can be implanted without removing the endoscope from the subject.

49. The method according to 47, characterized in that the endoscope is positioned through the second port for most of the duration of the surgical procedure in which the spine is modified, and the surgical procedure is part of a minimally invasive spinal surgery.

50. The method according to 47, characterized in that the surgical procedure is an oblique lumbar interbody fixation procedure, a transverse lumbar interbody fixation procedure, a posterior lumbar interbody fixation procedure, a transforaminal lumbar interbody fixation procedure, or an anterior lumbar interbody fixation procedure.

51. The method according to 47, further comprising the step of sequentially delivering instruments into the subject through the first port in order to perform the portion of the surgical procedure.

52. The method according to 47, further comprising the step of making an incision in the skin of the subject to form the first port.

53. The method according to 47, further comprising the step of performing a discectomy through the first port.

54. The method according to 47, further comprising the step of removing at least most of the intervertebral disc of the subject.

55. A system configured to perform any one of the methods of claims 21 to 54.

56. A slender body including a proximal end and a distal end, The plurality of tubular bodies extending from the proximal end to the distal end of the elongated body include a first fluid lumen configured to provide a flow of fluid through it and a working lumen configured to allow surgical instruments to pass through, One or more tissue-mapping probes are positioned at the distal end of the elongated body and configured to release energy, A cannula characterized by including

57. The cannula according to claim 56, further comprising at least one transmitting line located within the elongated body and electrically coupled to the one or more tissue-mapping probes, wherein the one or more tissue-mapping probes are positioned around the distal end of the working lumen and are configured to release energy to identify nerve tissue while the surgical instrument is positioned in the working lumen.

58. The cannula according to claim 56, wherein the plurality of lumens further include a second fluid lumen configured to provide a flow of fluid through it.

59. The first fluid lumen is configured to provide a flow of irrigation fluid into the surgical site from the proximal end to the distal end. The second fluid lumen is configured to provide a flow of irrigation fluid from the surgical site through the distal end to the proximal end. The cannula according to feature 58.

60. The cannula according to claim 58, characterized in that the proximal end of the cannula is connected to a surgical irrigation fluid supply system, thereby fluidically connecting the first fluid lumen and / or the second fluid lumen to the surgical irrigation fluid supply system.

61. The cannula according to claim 56, characterized in that the one or more tissue-mapping probes are spaced circumferentially apart around the distal end of the cannula.

62. The cannula according to claim 56, characterized in that it includes one or more tissue-mapping probes and nerve monitoring electrodes.

63. The cannula according to claim 56, wherein the one or more tissue-mapping probes are operably coupled to at least one transmitting line extending along the elongated body.

64. The cannula according to claim 56, wherein the at least one transmission line is operably connectable to a tissue mapping system programmed to identify tissue at least partially based on the output from the one or more tissue mapping probes.

65. The cannula according to claim 56, characterized in that the at least one transmission line is configured to transmit electrical signals and / or optical signals.

66. A multi-portal method for treating the spine of a subject, The steps include positioning a first cannula, which includes a first fluid lumen configured to provide a flow of cleaning fluid through it, at a first portal site along the subject, The steps include positioning a second cannula, which includes a second fluid lumen configured to provide a flow of cleaning fluid through it, at a second portal site along the subject, The steps include mapping one or more locations of tissue within the subject using at least one tissue-mapping probe coupled to the first cannula and / or the second cannula, The steps include: circulating a cleansing fluid through the first and second cannulas through the treatment site, and removing tissue from the treatment site using one or more instruments positioned through the first cannula; The step of moving the implant towards the intervertebral space implantation site through the first cannula, The steps include visualizing at least a portion of the intervertebral space implantation site and at least a portion of the implant using an endoscopic instrument inserted through the second cannula, A method characterized by including

67. The method according to 66, characterized in that the step of mapping the one or more locations in the tissue includes the step of receiving a response signal with the at least one tissue-mapping probe.

68. The method according to 66, wherein the step of mapping the one or more locations in the tissue includes the steps of transmitting a stimulus signal from the at least one tissue-mapping probe and receiving a response signal with a sensor placed in the subject.

69. The method according to 68, characterized in that the stimulus signal is an electrical signal, an optical signal, or an ultrasonic signal.

70. The method according to 66, characterized in that the tissue includes nerve tissue, bone, fascial tissue, and / or connective tissue.

71. The method according to 66, further comprising the step of deploying the dilator through the first cannula to the treatment site so that the dilator increases the volume of the working space within the subject.

72. The method according to 71, wherein the dilator is further configured to enable visualization of the treatment site and the intervertebral implantation site using the endoscopic instrument extending through the second cannula.

73. The method according to 71, characterized in that the expander includes one or more movable coupling segments on which at least one tissue-mapping probe is disposed.

74. A method for performing a biportal spinal procedure using a sterile universal biportal spinal surgery kit, which includes a set of ports, surgical instruments, instrument cannulas, and imaging cannulas, A step of selecting a first port and a second port from the set of ports based on the biportal spinal procedure performed on the subject, The steps include inserting the first port and the second port into the subject, The steps include positioning the instrument cannula at the first port, The steps include positioning the imaging cannula at the second port, A step of performing at least a portion of the biportal spine procedure, using at least one of the surgical instruments positioned on the instrument cannula, while observing the at least one of the surgical instruments using an imaging device positioned on the imaging cannula; A method characterized by including

75. A step of selecting at least one of the surgical instruments based on the biportal spine procedure, A step in which the biportal spine procedure is completed without using all of the surgical instruments in the kit, The method according to 74, further comprising:

76. The method according to 74, further comprising the step of sequentially inserting the surgical instruments into the instrument cannula in order to perform the steps of the biportal spine procedure.

77. The method according to 74, characterized in that the surgical instruments include a decompression device, a callus lengthening device, bone forceps, and a reamer.

78. A step of mapping the location of nerve tissue using one or more energy-releasing elements coupled to the instrument cannula and / or the imaging cannula, A step of positioning the instrument cannula and / or the imaging cannula using the mapping, The method according to 74, further comprising:

79. The method according to 74, characterized in that the instrument cannula and the imaging cannula are configured to be fluidly coupled to one or more cleaning devices.

80. The method according to 74, further comprising the step of using one or more tissue-mapping elements coupled to the instrument cannula or the imaging cannula and configured to identify tissue beneath the skin of the subject.

81. The method according to 74, characterized in that the biportal spinal procedure is a spinal decompression procedure or an intervertebral fusion procedure.

82. The steps include positioning one or more dilators from the surgical instruments within the subject, The steps include moving the expander from a non-expanded configuration to an expanded configuration, thereby increasing the working space within the subject, The method according to 74, further comprising:

83. A kit for multi-portal spinal surgery techniques, A plurality of cannulas, each containing a working lumen, a first fluid lumen, a second fluid lumen, and at least one probe, Multiple surgical ports, each having a size that can accept at least one of the aforementioned multiple cannulas, A kit characterized by including the following:

84. The kit according to claim 83, characterized in that the surgical port is configured to extend through the skin and fascia of the subject.

85. The kit according to claim 83, characterized in that it is a sterile universal spinal surgery kit.

86. At least one surgical instrument, A package for holding the plurality of cannulas, the plurality of ports, and at least one surgical instrument, The kit according to claim 83, further comprising the following:

87. The kit according to claim 86, characterized in that the at least one surgical instrument includes a callus lengthening device, a delivery device, a surgical scalpel, a dilator, bone forceps, a weight reduction device, and / or a reamer.

88. The kit according to claim 83, further comprising at least one implantable device.

89. The kit according to claim 83, further comprising a visualization device.

Images