Multi-portal surgical systems, cannulas, and related technology
The multi-portal surgical system addresses the challenge of implanting interbody spacers by using endoscopic visualization and minimally invasive techniques to deliver and implant spacers with reduced trauma, enhancing precision and recovery.
Patent Information
- Application Number
- JP2022541192
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-11-18
- Filing Date
- 2020-09-09
- Publication Date
- 2025-08-05
- Estimated Expiration
- 2040-09-09
AI Technical Summary
Implanting interbody spacers at the intended site between vertebral bodies is difficult and conventional surgical techniques cause significant trauma, leading to prolonged recovery times and patient discomfort.
A multi-portal surgical system utilizing endoscopic visualization and minimally invasive techniques to deliver and implant interbody spacers, including distraction instruments and cannulas, with integrated tissue mapping and irrigation systems to minimize trauma and improve precision.
The system enables precise implantation of interbody spacers with reduced trauma, accelerating recovery and improving surgical outcomes by minimizing damage to non-target tissues and nerves.
Smart Images

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Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 16 / 565,403, filed September 9, 2019, and U.S. Patent Application No. 16 / 687,520, filed November 18, 2019, which are incorporated by reference herein in their entireties.
[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical systems and, more particularly, to systems, devices, and methods for performing multi-portal surgical procedures. [Background technology]
[0003] Individuals often suffer from damaged or displaced intervertebral discs and / or vertebral bodies due to trauma, disease, degenerative defects, or wear and tear over time. One consequence of this displacement or damage to the intervertebral disc or vertebral body can be chronic back pain. A common procedure for treating disc or vertebral body damage or disease may involve partial or complete removal of the intervertebral disc. An implant (commonly referred to as an interbody spacer) can be inserted into the cavity created where the disc was removed to help maintain spinal height and / or restore stability to the spine. Intervertebral body spacers can also provide lordotic correction to spinal curvature. An example of a commonly used interbody spacer is a fixed-size cage, typically filled with bone and / or bone growth-inducing material. [Prior art documents] [Patent documents]
[0004] [Patent Document 1] U.S. Patent No. 863,2594 [Patent Document 2] U.S. Patent No. 930,8099 [Patent Document 3] U.S. Patent No. 10,105,238 [Patent Document 4] U.S. Patent No. 10,201,431 [Patent Document 5] U.S. Patent Application Serial No. 16 / 565,403 [Patent Document 6] U.S. Patent Application Serial No. 16 / 687,520 Summary of the Invention [Problem to be solved by the invention]
[0005] Unfortunately, implanting an interbody spacer at its intended implantation site between vertebral bodies can be difficult. In addition, conventional surgical techniques can cause a significant amount of trauma at or near the implantation site, which can significantly increase recovery time and cause patient discomfort. Therefore, a need exists for improved surgical systems, visualization techniques, and / or related techniques. [Brief explanation of the drawings]
[0006] [Figure 1] FIG. 1 is a side view of a multi-portal surgical system according to an embodiment of the present disclosure. [Figure 2] 1 is a schematic superior view showing a surgical approach to the lumbar spine for performing an interbody fusion procedure. [Figure 3] FIG. 3 is an isometric view of the lumbar vertebrae of FIG. [Figure 4] FIG. 1 is a side view of a tissue removal device positioned between adjacent vertebrae and a visualization device positioned to visualize the working area in accordance with a disclosed embodiment of the present invention. [Figure 5] FIG. 1 is a side view of a distraction instrument with a collapsed expansion element positioned in an intervertebral space and a visualization device in accordance with a disclosed embodiment of the present invention. [Figure 6] FIG. 1 is a side view of a distraction device with an expanded expansion element contacting a vertebral endplate in accordance with a disclosed embodiment of the present invention. [Figure 7] 1 is a side view of a distraction device having an expansion element according to an embodiment of the present disclosure. FIG. [Figure 8] FIG. 1 is a side view of an instrument positioned between two vertebrae in accordance with an embodiment of the present disclosure. [Figure 9A] 1 is an anterior view of a subject's spine with an interbody spacer positioned between vertebrae in accordance with a disclosed embodiment of the present invention. [Figure 9B] 1 is an anterior view of a subject's spine with an interbody spacer positioned between vertebrae in accordance with a disclosed embodiment of the present invention. [Figure 9C] 1 is an anterior view of a subject's spine with an interbody spacer positioned between vertebrae in accordance with a disclosed embodiment of the present invention. [Figure 10A] FIG. 1 is a side view of an interbody spacer in a collapsed configuration. [Figure 10B] FIG. 2 is a side view of an interbody spacer in an expanded configuration. [Figure 11] 1 is a flow chart illustrating a method of performing spinal surgery in accordance with an embodiment of the present disclosure. [Figure 12] FIG. 1 illustrates a system for providing pre-operative, intra-operative, or post-operative assistance in accordance with an embodiment of the present disclosure. [Figure 13] 1 is a plan view of a surgical kit according to an embodiment of the present disclosure. [Figure 14] 1 is a perspective view of a tissue-mapping cannula according to an embodiment of the present disclosure. [Figure 14A] 15 is a perspective view of the distal end of the cannula of FIG. 14 having a lumen and a tissue-mapping probe according to an embodiment of the present disclosure. [Figure 14B] FIG. 15 is a perspective view of the proximal end of the cannula of FIG. 14. [Figure 14C] FIG. 15 is a longitudinal cross-sectional view of the cannula of FIG. 14. [Figure 15] FIG. 1 is an end view of the distal end of a cannula having multiple lumens and an array of tissue-mapping probes according to one embodiment of the present disclosure. [Figure 16] 1 is a side view of a cannula with a protruding tissue-mapping probe in accordance with an embodiment of the present disclosure. [Figure 17]1 is a side view of a surgical system having a cannula for circulating surgical irrigation fluid to map tissue in accordance with an embodiment of the present disclosure. FIG. [Figure 18] 1 is a side view of a cannula having a deployable dilator carrying a tissue-mapping probe in accordance with an embodiment of the present disclosure. [Figure 19] FIG. 19 is an enlarged top view of the cannula of FIG. 18 with the dilator in a deployed configuration. [Figure 20] 1 is a flow chart illustrating a method for performing multi-portal spinal surgery using circulatory irrigation flow and / or tissue-mapping in accordance with an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0007] The following disclosure describes various embodiments of medical systems and devices and related methods of use. At least some embodiments of surgical systems provide visualization capabilities. A series of instruments can be delivered through a portal site and used to alter tissue (e.g., shape, crush, separate, cut, debulk, destroy, fragment, or remove tissue), prepare implantation sites, implant devices, or combinations thereof. Instrument visualization can assist physicians in preventing or limiting trauma or damage to non-target organs and tissues. In endoscope-assisted surgery, devices can be precisely implanted using minimally invasive techniques to improve outcomes and reduce recovery time. To provide a thorough understanding of such embodiments of the present disclosure, certain details are recited in the following description and in FIGS. 1-20 . Other details, such as those describing well-known structures and systems often associated with surgical procedures, are not recited in the following description so as not to unnecessarily obscure the description of various embodiments of the present disclosure.
[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 interbody devices to distance vertebral bodies, restore spinal stability, provide lordosis correction, or combinations thereof. In spinal fusion procedures, interbody 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, such as to view the vertebrae (e.g., vertebral spacing, vertebral alignment, 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 a discectomy or interbody preparation procedure, etc. One or more devices (e.g., implants, fusion devices, etc.) can be delivered and placed within the patient. In some embodiments, a decompression procedure can be performed to minimize or reduce pressure on neural tissue, and can include removing tissue that contributes to stenosis, tissue pressing on neural tissue, or bulging sections of an intervertebral cartilage disc, etc. For example, a decompression procedure can be performed to enlarge the epidural space and reduce spinal cord compression.
[0010] One surgical method includes positioning a distraction instrument between adjacent vertebrae at a first portal site along the patient to enlarge the intervertebral space. A tissue removal device can be used to clear and prepare the enlarged intervertebral space for implantation. An intervertebral body fusion implant can be delivered into the enlarged intervertebral space. The expanding intervertebral body fusion implant is endoscopically viewed using an endoscopic instrument positioned at a second portal site along the patient. Endoscopic viewing can be used to evaluate whether the expanded intervertebral body fusion implant is in the desired location and to assist in the delivery of bone graft material or other steps to facilitate bone healing and spinal fusion. Other visualization techniques can be used in combination with endoscopic viewing. For example, fluoroscopy can be used in combination with endoscopic viewing.
[0011] In some embodiments, a multi-portal endoscope-assisted method for treating a subject includes performing at least a portion of a surgical procedure using a first portal site, at least a portion of the surgical procedure using an endoscope positioned through a second portal site spaced apart from the first portal site, the spacing of which 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 distracting adjacent vertebrae using a distraction instrument positioned at a first portal along the subject to enlarge an intervertebral space between the adjacent vertebrae. Delivering an interbody fusion implant into the enlarged intervertebral space. Positioning the interbody fusion implant directly between the vertebral bodies of the adjacent vertebrae under endoscopic visualization using an endoscopic instrument. The endoscopic instrument can be positioned at a second portal along the subject. The locations of the first and second portals can be selected based on the accessibility of the implantation site.
[0013] In yet another embodiment, a multi-portal method for treating a spine of a subject includes positioning a first cannula at a first port along the subject. A first vertebral body and a second vertebral body are distracted using one or more distraction instruments extendable through the first cannula. An interbody fusion implant can be moved through the first cannula toward an 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 interbody fusion implant can be visualized using an endoscopic instrument positioned at a second port along the subject.
[0014] In some embodiments, the spinal implant delivery instrument includes an elongate body configured to be positioned in the cannula and a distractor assembly. The distractor assembly is coupled to the elongate body and can be movable 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 an 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 interbody fusion implant is delivered into the intervertebral space.
[0015] In yet another embodiment, a spinal implant delivery instrument includes an elongate body configured to be positioned in a cannula and a distractor assembly coupled to the elongate body. The distractor assembly is movable from a delivery state to an expanded state to distract the first and second vertebral bodies. The distractor assembly in the delivery state is configured for insertion into the intervertebral space and in the expanded state is configured to hold the distracted first and second vertebral bodies apart while the interbody fusion implant is delivered. The interbody fusion implant can be delivered from the distractor assembly into the intervertebral space. In some embodiments, a driver is releasably coupleable to a rotatable connection interface of the interbody fusion implant. The driver can be moved axially to move the interbody fusion implant directly between the first and second vertebral bodies. The driver is configured to expand the interbody fusion implant from a collapsed configuration to an expanded configuration. The distractor assembly can include jaws actuable to define a delivery gap through which the interbody fusion implant can be delivered.
[0016] In some embodiments, a multi-portal method for treating a subject's spine includes inserting multiple cannulas into the subject. The cannulas can be used to identify tissue, for example, to facilitate cannula / instrument placement and / or identify tissue (e.g., target tissue, non-target tissue, etc.). The cannulas can be used to circulate (e.g., continuously or intermittently) irrigation fluid (e.g., saline, water, etc.) through and around the surgical site. Tissue mapping and surgical site irrigation can be performed simultaneously or sequentially. In some embodiments, fresh irrigation fluid can be delivered through a first cannula by an irrigation system. The irrigation system can include one or more pumps that generate a desired counterpressure. To remove the irrigation fluid, another cannula can draw an optional vacuum to suck the irrigation fluid and unwanted material (e.g., blood, bone dust, loose tissue, etc.) from the subject. Additionally, pressurized irrigation fluid within the subject can help facilitate hemostasis. The cannulas can be used to generate a desired flow of irrigation fluid.
[0017] Irrigation fluid (e.g., flow of irrigation fluid into and / or out of the subject) can be monitored, e.g., to facilitate visualization, provide feedback to the clinician, etc. In some embodiments, irrigation fluid can be circulated periodically based on endoscopic visibility. For example, if the system of the present invention detects an excessive amount of bone dust, the system can automatically circulate irrigation fluid through the surgical site to remove the bone dust. In some embodiments, the clinician can control the timing of irrigation fluid circulation through a control pedal, hand controller, etc. Advantageously, the cannula can space the fluid lumen from the working lumen, allowing the flow rate of irrigation fluid to be increased or decreased without interfering with an instrument positioned in the working lumen, thereby enabling independent control of the instrument and irrigation.
[0018] The cannula can include, but is not limited to, sensors (e.g., flow sensors), flow diffusers, flow expanders, valves (e.g., one-way valves), fittings (e.g., fittings for connecting to hoses), connectors, and other fluidic components. For example, the proximal end of the cannula can have one or more fittings for connecting to a fluid line of an irrigation system. The distal end of the cannula can include a nozzle for directing flow in a desired direction. The configuration of the cannula can be selected based on the desired circulation. For example, to reduce or minimize trauma to tissue positioned immediately distal to the cannula, the cannula can have an outlet or nozzle configured to direct fluid laterally away from non-target tissue. The cannula can direct the flow of irrigation fluid toward a vacuum cannula. The cannula can also have one or more dilators, including mechanical or pneumatic dilators, etc.
[0019] In some embodiments, information obtained using the cannula can be used to guide instruments, evaluate the surgical procedure, or confirm whether the procedure is complete. In embodiments with a tissue-identifying probe, the cannula can be used to identify one or more types of tissue. For example, a nerve-sensing probe can be used to identify nerve tissue, allowing the surgeon to perform the procedure while minimizing or limiting impact on the nerve tissue. In some automatic detection embodiments, the system can automatically notify the user when the cannula is in contact with or adjacent to non-target tissue. The surgeon can then keep the cannula in a safe location. In some procedures, the cannula is used to map a route to the surgical site, the surgical site itself, or other desired locations.
[0020] The surgeon can manually rotate the cannula to map the tissue around and near the distal end of the cannula. In other embodiments, the cannula can have a distal end that automatically rotates to map the area. Such a cannula can include one or more motors, actuators, or the like.
[0021] In yet other embodiments, the cannula includes an elongate body and multiple lumens extending therethrough. One of the lumens can be a working lumen configured for passage of a surgical instrument therethrough. Another of the lumens can be a fluid lumen configured to provide a flow of surgical irrigation fluid to or from a surgical site. In some embodiments, the cannula can have an additional fluid lumen configured to provide a separate flow of irrigation fluid.
[0022] In multi-portal surgical techniques, two cannulas can be used to circulate irrigation fluid. In some embodiments, the fluid lumen of the first cannula can be connected to an irrigation fluid supply system. The irrigation fluid can flow through the fluid lumen and exit the distal end of the first cannula. The irrigation fluid can flow along the surgical site. The irrigation fluid can be withdrawn from the surgical site through the fluid lumen of the second cannula. In some embodiments, the first and / or second cannula can have two or more fluid lumens. The additional lumens can be connected to either the fluid supply system or the fluid return system. In this manner, either cannula can be configured to supply or return irrigation fluid. In yet another embodiment, the cannula can be configured to both supply and return irrigation fluid.
[0023] The irrigation fluid supply system can include one or more fluid supply reservoirs, pumps, flow monitors, pressure monitoring devices, flow control mechanisms, or the like. Similarly, the fluid return system can include one or more pumps, pressure monitoring devices, flow control mechanisms, return fluid containers, or the like. The supply system and return system can be components of an irrigation fluid control system. The irrigation fluid control system can provide monitors, such as flow monitors, pressure monitors, or the like. In some embodiments, the control system can selectively supply and return fluid through any one of the connected fluid lumens depending on the needs of the surgical procedure.
[0024] Additionally, the cannula can include one or more detectors, such as a tissue-mapping probe. The detector can be configured to output and / or receive energy to acquire information to identify tissue (e.g., tissue at or near the treatment site) and / or monitor treatment. In some embodiments, the detector is a nerve monitoring electrode configured to identify nerves, for example, using electromyography. Mapping the location of nerves is useful for guiding the position of cannulas, instruments, or other devices to reduce or avoid trauma to nerve tissue. The detector can be connected to a tissue-mapping system programmed to determine the location of the tissue. The tissue-mapping system can provide feedback regarding the tissue location, including, for example, an audible sound indicating proximity to a nerve or other tissue (e.g., target tissue, non-target tissue, etc.). In other embodiments, the tissue-mapping system can provide a visual indication of the tissue location. The visual indication can be, for example, an image or a tissue location identifier overlaid on image data (e.g., still image, video, etc.) provided by a visualization instrument, such as an endoscope or fiber optic viewing system.
[0025] In yet another embodiment, the cannula can include a deployable dilator. The dilator can be configured to expand the space or working volume, thereby facilitating visualization and / or the flow of irrigation fluid into or out of the cannula. The dilator can have a delivery configuration to minimize its profile during insertion into a subject. The dilator can be connected to or part of the distal end of the cannula so that the body of the dilator contacts the cannula body. In other embodiments, the dilator is connected to the cannula by a connector mechanism and extendibly engaged with the cannula body to extend the dilator a distance away from the cannula body, for example, before and / or during deployment. In yet other embodiments, the dilator is a separate device configured to be delivered through one of the working lumens of the cannula.
[0026] The dilator can include one or more tissue-mapping probes. These probes can be in place of or in addition to tissue-mapping probes located in the cannula body. The probes can be used to assist in positioning the cannula, deploying and / or positioning the dilator, inserting and using surgical instruments, and / or assessing the procedure (e.g., to determine if a nerve has been damaged or severed).
[0027] Embodiments of the present disclosure will now be described more fully with reference to the accompanying drawings, in which like numerals represent like elements throughout the several views and which illustrate exemplary embodiments. However, claimed embodiments may be embodied in many different forms and should not be construed as limited to the embodiments recited herein. The examples recited herein are non-limiting examples and are merely examples among other possible examples.
[0028] B. Multi-portal Surgical System FIG. 1 is a side view of a spinal surgery system 100 ("system 100") positioned along the spine of a human subject in accordance with an embodiment of the present disclosure. System 100 may include an instrument assembly 130 and a visualization assembly 160. Instrument assembly 130 may be used to perform at least a portion of a surgical procedure, while visualization assembly 160 provides visualization. Instrument assembly 130 may include instruments 110 and cannulas 120. Ports may be used to facilitate insertion of instrument assembly 130 and / or visualization assembly 160. For example, visualization assembly 160 may be positioned in an endoscope port, and instrument assembly 130 may be positioned in an instrument port.
[0029] A series of instruments can be delivered through the cannula 120 to perform the surgical procedure. In some procedures, the instrument 110 can be used to prepare the implantation site by, for example, moving an organ or tissue (e.g., moving neural tissue), removing tissue (e.g., removing the intervertebral disc 171, removing tissue that contributes to stenosis, etc.), preparing the vertebral body (e.g., roughening or shaping the vertebral end plate), etc. The instrument 110 can be removed, and a distraction instrument can be delivered through the cannula 120. The distraction instrument can distract the adjacent vertebrae 170, 172, thereby enlarging the intervertebral space. An interbody fusion implant can be delivered through the cannula 120 into the enlarged intervertebral space. In expandable embodiments, the interbody spacer or fusion implant can be expanded into contact with the vertebral end plates. During a procedure, visualization assembly 160 can provide endoscopic views of the delivery pathway, organs, tissue (e.g., neural tissue), implantation site, interbody fusion device (e.g., before, during, and / or after delivery), instruments, and other areas or features of interest. The location of the portal site relative to instrument assembly 130 and visualization assembly 160 can be selected based on the procedure being performed and the optical characteristics of visualization assembly 160 (e.g., field of view, zoom capabilities, etc.), as described in connection with FIG. 4 .
[0030] With continued reference to FIG. 1 , visualization assembly 160 can include visualization device 140 and cannula 150. Cannula 150 can assist the physician when switching between visualization devices. In some embodiments, visualization assembly 160 can be used without cannula 150. For example, visualization device 140, in the form of a thin fiber optic endoscope, is positioned directly through an incision, an endoscope port, or the like. Visualization device 140 can include one or more endoscopes having, but not limited to, fiber optics (e.g., fiber optics), lenses, imaging devices, working lumens, light controls, or the like for viewing directly or through display 162. In some embodiments, visualization device 140 can include lumens through which fluid can flow to irrigate the surgical site. For example, saline or another suitable liquid can be pumped through visualization device 140 to remove tissue (e.g., loose tissue, bone dust, etc.) or other material that impairs visualization. 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.) positioned near or at the proximal end of the optical fiber can be used to transmit light to the distal end to provide illumination, thereby allowing the surgeon to safely navigate within the subject's body and illuminate specific body anatomical structures to view vertebral spaces, vertebral structures, nerves, bony buildups (e.g., buildups that may irritate and press on nerves and contribute to nerve compression), etc. In some embodiments, visualization optics for vision and illumination are included within the distal tip of visualization device 140. The configuration and functionality of visualization device 140 can be selected based on desired field of view, observation resolution, pan / zoom capabilities, etc.
[0031] FIG. 2 is a schematic top view along the lumbar spine of a human subject, illustrating an exemplary technique for performing an interbody fusion procedure suitable for the system 100 of FIG. 1. FIG. 3 is an isometric view of the lumbar spine of FIG. 2. With reference to FIGS. 2 and 3, surgical instruments can be delivered through various pathways, including an anterior lumbar interbody fusion (ALIF) pathway 210, an oblique lumbar interbody fusion (OLIF) pathway 220, a lateral or polar lateral lumbar interbody fusion (LLIF or XLIF) pathway 230, a transforaminal lumbar interbody fusion (TLIF) pathway 240, and a posterior lumbar interbody fusion (PLIF) pathway 250. Exemplary TLIF and PLIF procedures are described in conjunction with FIGS. 4-6.
[0032] Continuing with reference to Figures 2 and 3, the number and configuration of interbody fusion devices can be selected based on the fusion procedure being performed. In one example of a TLIF procedure, a single small, expandable or non-expandable interbody spacer can be implanted into the intervertebral space using a transforaminal route 240. In one example of a PLIF procedure, two interbody spacers can be delivered along a posterior route 250 and implanted into the intervertebral space. The two interbody spacers can work together to maintain the desired spacing between the vertebral bodies 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 a lateral route 230 to provide asymmetric support. In one example of an ALIF procedure, an asymmetric interbody spacer can be delivered along an anterior route 210 to provide support that aligns with the lordosis of that portion of the spine. Lateral, transforaminal, and anterior techniques can be used to access the cervical, thoracic, and other spine. The number of instruments, instrument configuration, implants, and surgical technique can be selected based on the condition being treated.
[0033] FIG. 4 is a detailed side view of instrument assembly 130 positioned to perform a TLIF or PLIF procedure in accordance with an embodiment of the present disclosure. Instrument assembly 130 can extend through port 472, and visualization assembly 160 can extend through port 474. The illustrated instrument assembly 130 can extend through a subject's skin 460, through 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 spinal column and can be positioned using, for example, a transforaminal, posterior, or lateral approach. The illustrated visualization assembly 160 is positioned to view the intervertebral disc 430 and the tissue removal tip 470 of instrument 110, which are shown between the spinous processes 450, 454 of vertebrae 440, 444, respectively. Fluoroscopy, MR imaging, CT imaging, direct visualization, or other visualization techniques can be used in addition to or in place of endoscopic observation.
[0034] The tissue removal tip 470 can be advanced forward to remove other unwanted tissue from the disc 430 (or other intervertebral discs), including, but not limited to, bulging tissue, bone (e.g., lamina, lateral recess, articular facets including the inferior facet, etc.), osteophytes (e.g., osteophytes associated with osteoarthritis), thickened ligamentous tissue, spinal tumors, displaced tissue (e.g., tissue displaced by spinal trauma), or tissue that may cause or contribute to spinal nerve compression. Other instruments (e.g., rongeurs, debulkers, scrapers, reamers, dilators, etc.) can be used in conjunction with the instrument 110 to perform one or more dilation procedures, decompression procedures, discectomies, microdiscectomies, laminotomies, or combinations thereof. 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, the 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 debulk the ligamentum flavum, remove loose tissue, and remove at least a portion of the intervertebral disc 430. Each step may be performed using a different instrument. The instrument may be selected to treat, but is not limited to, spinal nerve compression (such as spinal cord compression or spinal nerve root compression), herniated disc, osteoporosis, stenosis, or other diseases or conditions.
[0035] The instrument 110 and 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. The ports 472, 474 are positioned at different superior and inferior positions, with the port 472 positioned directly posterior to the treatment site such that the longitudinal axis of the tissue removal device 110 is in a plane generally parallel to the subject's transverse plane. The visualization device 140 can be, but is not limited to, an endoscopic instrument including optical fibers 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 relevant feature or anatomical structure while the instrument 110 removes tissue (e.g., bone from vertebrae 440, 444 or tissue from intervertebral disc 430).
[0036] 5 is a side view of a distraction device with a collapsed dilator element positioned between two vertebrae after a disc has been removed according to a disclosed embodiment of the present invention. The distraction device 510 is positioned within the cannula 120 and has a positioner or stop 530, 534 and a dilator or distractor head 560 ("dilator 560"), shown in a partially expanded state but configured to push the adjacent vertebrae 440, 444 apart. The expansion of the dilator 560 and the positioner 530, 534 can be visualized endoscopically using the visualization device 140.
[0037] The locators 530, 534 are configured to aid in positioning the dilator 560, which can be inserted into the intervertebral space 570. For example, the locator 530 can contact the inferior intervertebral notch 550 of the vertebral body 441, and the locator 534 can contact the superior intervertebral notch 554 of the vertebral body 445. The elongated member 540 can be extended or retracted to position the dilator 560 at the desired location, while the locators 530, 534 can remain relatively stationary relative to the vertebral bodies 441, 445. Throughout this process, the visualization device 140 can be used to view the locators 530, 534, the elongated member 540, and / or the dilator 560. The physician can check the position of the dilator 560 relative to anatomical features before, during, and after expansion, thereby ensuring that the dilator 560 contacts the desired area of the spine. The dilator 560 can be deployed to compress the end plates of the adjacent vertebrae 440, 444, thereby enlarging the disc space 570.
[0038] The locators 530, 534 can include spikes, protrusions, or other migration restraining elements. In some embodiments, the detents or protrusions can be directly connected to the elongate member 540 and can be deployed to engage the endplates. The configuration, number, and location of the locators can be selected based on the desired positioning relative to the spine.
[0039] The elongate member 540 can be connected to the dilator 560 and can be a rod with one or more lumens through which fluid flows. Fluid (e.g., saline, gas, or another suitable fluid) can be pumped through the elongate member 540 to expand the dilator 560. In the case of fluoroscopy, the fluid can include a contrast agent. The dilator 560 can include, but is not limited to, one or more inflatable members, balloons, mechanical dilators, wedge devices, or the like. The arrow indicates one of many possible directions of expansion, and the expansion direction of the dilator 560 is not limited to two-way expansion.
[0040] The distraction instrument 510 can also deliver the interbody fusion implant and function as a driver instrument. The distraction instrument 510 can have a shaft connectable to the interbody fusion implant. The shaft can be rotated to deploy the interbody fusion implant. U.S. Pat. Nos. 863,2594, 930,8099, 10,105,238, and 10,201,431, which are hereby incorporated by reference and made a part of this application, disclose driver components that can be incorporated into the distraction instrument 510.
[0041] FIG. 6 is a side view of the distraction device 510, with the expanded dilator element 560 holding the vertebral bodies 441, 445 apart. The level of dilator 560 can be increased or decreased to increase or decrease the pressure applied to the endplates, respectively. The dilator 560 can include one or more roughnesses, spikes, protrusions, or other features that can roughen, abrade, scrape, or otherwise affect tissue. In some embodiments, the dilator 560 has multiple protruding spikes that can be used to roughen the opposing vertebral endplate surfaces to help limit or substantially prevent migration of the implanted device. The dilator 560 can be crushed and removed. Another dilator can be inserted into the already dilated intervertebral space 570 to further distract the vertebrae 440, 444. In this manner, vertebrae can be sequentially distracted in a controlled manner until the desired amount of separation is achieved.
[0042] The dilator 560 can hold the two distracted vertebral bodies 441, 445 apart while the interbody fusion implant is delivered to the disc space 570 through the distraction instrument 510. The interbody fusion implant can be positioned adjacent to the deployed dilator 560, and the dilator can be removed, for example, after the interbody fusion implant is deployed.
[0043] The instrument configuration can be selected based, at least in part, on the distance from the portal site to the treatment site. The surgical procedure can be selected based on the stage to be performed. For example, TLIF and PLIF procedures can include a decompression procedure in which tissue is removed along the posterior region of the spine, as opposed to ALIF procedures in which such a decompression procedure is not performed. The systems and techniques described in connection with Figures 4-6 can be modified to perform other types of procedures, including non-spinal procedures.
[0044] 7 is a side view of a distraction device 700 having dilator elements in accordance with an embodiment of the present disclosure. The device 700 may include control elements 710, 712, an elongate body 720, positioners 730, 740, and a dilator assembly 758. The control elements 710, 712 may be actuated to deploy the positioners 730, 740 and / or the dilator assembly 758. For example, a user may manually rotate the control elements 710, 712 to independently deploy each positioner 730, 740. For example, the control element 710 may be used to rotate the positioners 730, 740 to undeployed positions 732, 742 (shown in dashed lines) and away from the longitudinal axis 743 of the device 700 and toward the outward deployed position shown.
[0045] The distraction device 700 can be used in a manner similar to that described above in connection with Figures 5 and 6. For example, the deployed locators 730, 740 can rest against adjacent vertebrae. The dilator assembly 758 has a dilator or distractor head 760 ("dilator 760") that can be positioned at a desired location suitable for distracting the vertebrae. The dilator assembly 758 can include an elongate body 750 fluidly coupled to a fluid line 751. The dilator 760 can be attached to the distal end of the elongate body 750 so that fluid can be pumped through the fluid line 751, through the elongate body 750, and into the dilator 760.
[0046] 8 is a side view of an instrument 800 positioned to distract adjacent vertebrae in accordance with a disclosed embodiment of the present invention. The descriptions of the instrument described in connection with FIGS. 4-7 apply equally to instrument 800 unless otherwise indicated.
[0047] The instrument 800 can include an access device or cannula 810 and a distraction assembly 828. The cannula 810 can function as an access device through which the distraction assembly 828 can be delivered. The distraction assembly 828 can include locators 830, 834 configured for atraumatic contact with the spinal column. The locators 830, 834 can be expandable members (e.g., inflatable balloons), mechanically expandable members, or other types of elements. The locators 830, 834 can be configured to contact a vertebral body, transverse process, spinous process, or the like. The distraction assembly 828 can further include an expandable assembly 848 having a dilator 850 and an elongated body 852. The dilator 850 is shown in a collapsed, deflated configuration or state. The dilator 850 can be expanded / inflated in a manner similar to the dilator 560 described in connection with FIGS. 5 and 6 . A visualization device can be used to view the expander 850, the positioners 830, 834, or other features of the instrument before, during, and / or after the distraction process. In some embodiments, the distraction assembly 828 can function as jaws, in which case the positioners 830, 834 can be used to grasp or define the delivery gap. Additionally or alternatively, the positioners 830, 834 can be inserted into the gap (e.g., cavity) and then moved apart to widen the gap.
[0048] 9A-9C are anterior views of an interbody spacer 910 between two vertebrae, as viewed from the front of a subject, in accordance with an embodiment of the present disclosure. In FIG. 9B, the interbody spacer 910 is in a laterally expanded configuration. In FIG. 9C, the interbody spacer 910 is in a laterally and vertically expanded configuration. Generally, the interbody spacer 910 can be delivered to the intervertebral space in a collapsed configuration. After endoscopically viewing the position of the interbody fusion implant, the implant can be moved from the collapsed configuration (FIGS. 9A and 10A) to the expanded configuration (FIGS. 9C and 10B). The expansion (e.g., lateral expansion, vertical expansion, or a combination thereof) can be visualized using an endoscopic tool. The interbody spacer 910 can be, but is not limited to, an implant or an interbody fusion implant. Details of the operation of the interbody spacer 910 are discussed in more detail below.
[0049] Referring now to FIG. 9A, an intervertebral disc has been removed from intervertebral space 907. An interbody spacer 910 can be delivered through a cannula, such as cannula 120 of FIGS. 1-7 or cannula 810 of FIG. 8, to position the collapsed interbody spacer 910 directly between the end plates 912, 914 of vertebrae 440, 444, respectively. The position of the collapsed interbody spacer 910 can be confirmed using endoscopic visualization. If the interbody spacer 910 is in an undesired position, the interbody spacer 910 can be moved to a different location. Again, endoscopic visualization can be used to confirm the final position of the interbody spacer 910.
[0050] 9B shows interbody spacer 910 after lateral expansion under endoscopic visualization. Advantageously, the user can reposition interbody spacer 910 if the expansion process causes unwanted displacement of interbody spacer 910.
[0051] FIG. 9C shows the interbody spacer 910 after vertical expansion relative to the end plates 912, 914 of the vertebrae 440, 444, respectively. After full expansion, the interbody spacer 910 can be locked to prevent collapse. An optional material can be delivered to the intervertebral space 907 to promote or facilitate fusion. For example, the material can be delivered to the intervertebral space 907 through a delivery instrument 920 ( FIG. 10A ) connected to the intervertebral body spacer 910. The material can be bone, a bone growth-inducing material, cement, or other suitable material. The bone growth-inducing material can be configured to facilitate bone fusion. In some procedures, the material is delivered through a passageway in the delivery instrument or driver instrument. In other procedures, the material can be delivered through a separate instrument. In some procedures, multiple interbody spacers are implanted in the intervertebral space 907. Details of the delivery instrument are described in conjunction with FIGS. 10A and 10B.
[0052] 10A , interbody spacer 910 and delivery instrument 920 can be delivered through port 922 with or without the use of cannula 930. Instrument 920 can include a handle assembly 931, an elongated body 932, and a connector 934. Handle assembly 931 can include a grip 950 and one or more control elements 940 operable to control actuation and detachment of interbody spacer 910 from interbody spacer 910. In some embodiments, control element 940 can include one or more dials, levers, triggers, or other movable elements. Elongated body 932 is connected to handle 950 and extends to connector 934. Elongated body 932 can function as a driver instrument and can include one or more rods, shafts, or other elements used to actuate interbody spacer 910. In some embodiments, a driver instrument is inserted through delivery instrument 920 and engages interbody spacer 910. The driver instrument can be rotated to gradually and controllably deploy interbody spacer 910. The features, configuration, and functionality of connector 934 can be selected based on the configuration of interbody spacer 910.
[0053] 10B is a side view of the expanded interbody spacer 910 after the delivery instrument 920 has been separated from the connection feature or connection interface 916 ("connection feature 916") of the interbody spacer 910. The expanded interbody spacer 910 can be locked in the expanded configuration. To reposition the interbody spacer 910, the delivery instrument 920 can be reconnected to the interbody spacer 910 and actuated to unlock and collapse the interbody spacer 910. The delivery instrument 920 can be used to move the collapsed interbody spacer 910.
[0054] The delivery instrument 920 can include one or more distal connecting elements or features for releasably coupling to the interbody spacer. The connecting elements can be polygonal connecting portions (e.g., hexagonal protrusions) that are received by complementary polygonal recesses or features on the interbody spacer 910. Other connecting portions can be used to releasably couple the delivery instrument 920 to the interbody spacer 910. U.S. Pat. Nos. 863,2594, 930,8099, 10,105,238, and 10,201,431, which are hereby incorporated by reference, disclose delivery instruments, interbody spacers, and connecting features, as well as methods of actuating the delivery instruments and deploying the interbody spacers. The delivery instrument 920 can be a delivery instrument and include features disclosed in U.S. Patent Nos. 863,2594, 930,8099, 10,105,238, and 10,201,431. Other types of implantable devices and delivery instruments can be utilized. The configuration of the implant and corresponding delivery instrument can be selected based on the procedure being performed.
[0055] 11 is a flow chart illustrating a method of treating a subject according to an embodiment of the present disclosure. In block 1002, incisions may be performed in the subject's tissue to create first and second portal sites (i.e., portals). In some embodiments, the first and second portals may be positioned on the same side of the subject's midsagittal plane. In other embodiments, the first and second portals may be positioned on opposite sides of the subject's midsagittal plane. In still other embodiments, incisions may be performed along the subject's midsagittal plane.
[0056] A port can be positioned at each entrance. 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 muscle. The access opening of the port can be large enough to allow an instrument to be inserted through the port, thereby preventing or minimizing tissue tearing. Instruments can be delivered into the patient's body through the incision without utilizing a port. Such instruments can have a relatively small diameter to limit or minimize tissue tearing around the incision. In some procedures, ports can be placed in some incisions and instruments can be placed in other incisions without a port. The physician can decide whether to place a port based on the instrument to be utilized and the location of the incision.
[0057] In block 1004, a distraction device can be positioned at the first portal site, for example, by inserting the distraction device through the installed port. In some procedures, a cannula can be positioned in the port and the distraction device can be delivered through the lumen of the cannula. In other embodiments, the distraction device can be inserted directly into the port without the use of a cannula. The use of distraction devices and cannulas is described in connection with Figures 5-8.
[0058] In block 1006, a visualization device can be positioned at a second portal site by delivering the visualization device through a port. The visualization device can be placed with or without a cannula. The use of cannulas and ports is described in connection with FIGS. 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. For these procedures, a cannula may not be used due to the small diameter of the visualization device. The visualization device can remain at the same portal site for the majority of the surgical procedure during 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 time the instruments are positioned in the subject. The visualization device can be positioned within the subject's body so that the interbody fusion device can be implanted without removing the endoscope from the subject, thereby reducing the overall surgical time.
[0059] Steerable visualization devices can be used to facilitate navigation around anatomical features. Steerable visualization devices can include fiber optic scopes or other flexible or rigid instruments having one or more illumination elements (e.g., optical fibers for illumination) or imaging elements (e.g., charge-coupled elements for imaging) suitable for visualizing the interior of otherwise inaccessible areas. In some embodiments, the visualization device can 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 can also have connectors (e.g., electrical connectors, fluid connectors, etc.), access ports (e.g., access ports connected to lumens (e.g., lumen through which instruments can pass), etc.). In embodiments with angled lenses, the visualization instrument can have a lens angle of about 15 degrees, 30 degrees, or 45 degrees toward the light source. In other angled lens embodiments, the visualization instrument can have a lens angled about 15 degrees, 30 degrees, or 45 degrees away from the light source. The angle of the lens can be selected based on the area to be viewed. In some posterior or lateral spine procedures, a 0-degree lens can provide a wide-angle view suitable for viewing nerve roots, the spinal cord, and the intervertebral space. A 30-degree or 45-degree lens endoscope angled toward the light source can be used to provide an angled view toward the midsagittal plane, for example, to view the spinous processes, spinal cord, and central areas of the intervertebral space. A 30-degree or 45-degree lens endoscope angled away from the light source can be used to provide an angled view toward the spine or lateral features, such as nerve roots at the neural foramina or lateral areas of the intervertebral space.
[0060] Some procedures utilize multiple visualization instruments. 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 apart ports. To provide bilateral viewing, a first port and a first endoscopic instrument can be positioned on one side of the subject's midsagittal plane, and the other port and endoscopic instrument can be positioned on the opposite side of the midsagittal plane. Multiple visualization instruments used in a single procedure can have different viewing characteristics.
[0061] Images of the subject's spine can be used to determine implantation information for an interbody fusion implant. The implantation information can include, but is not limited to, a recommended interbody fusion implant, an expansion setting for the interbody fusion implant, and / or a recommended implantation location for the interbody fusion implant. A user can be presented with information for review based on an analysis of the image data, including information for repositioning the interbody fusion implant or for collapsing the interbody fusion implant. In block 1008, tissue can be removed from the intervertebral space using a tissue removal device positioned in the first portal. In block 1010, a distraction instrument can be used to distract adjacent vertebrae and enlarge the intervertebral space between the adjacent vertebrae. In block 1012, an interbody spacer, such as an interbody fusion implant, can be delivered into the enlarged intervertebral space. The interbody fusion implant can be delivered in a collapsed configuration through the lumen of the distraction instrument. In block 1014, the interbody fusion implant can be expanded laterally and vertically while positioning a driver instrument within the distraction instrument positioned in the first portal and while viewing endoscopically in block 1016. The lateral and vertical expansion of the interbody fusion implant can be performed sequentially. For example, after expanding the interbody fusion implant horizontally, the interbody fusion implant can be expanded vertically to provide disc height restoration.
[0062] In block 1016, image data may be acquired with an endoscopic instrument. The image data may be video, still images, or other image data. Image data may be acquired and analyzed with endoscopic visualization before, during, and / or after expansion to confirm the position of the expanded interbody fusion implant, thereby enhancing the effectiveness of the procedure by allowing the physician to visually evaluate the procedure. For example, a first image of the implantation site may be acquired with an endoscopic instrument. A second image of the implantation site may be acquired using the endoscopic instrument after delivery of the interbody fusion implant. The image data may be analyzed to determine whether the expanded interbody fusion implant has been positioned in the deployed position based on the position of the expanded interbody fusion implant shown in the second image.
[0063] In some embodiments, the first and second images can be compared to determine the position of the expanded interbody fusion implant. If the interbody fusion implant is mispositioned, the user can be notified of the mispositioning. This notification can be via an audible alert, a visual alert (e.g., an alert displayed on display 162 of FIG. 1), or other suitable notification means. In block 1018, the driver instrument can be separated from the locked, expanded interbody fusion implant, as described above in connection with FIG. 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, including, but not limited to, delivering bone or growth-promoting materials, etc., to the intervertebral space. Visualization can also be used to monitor other procedures, such as fixation procedures involving pedicle screws or interspinous spacers, etc.
[0064] The method of FIG. 11 can be performed using various systems disclosed herein. Additional instruments and steps can be performed as needed to provide treatment flexibility. For example, a decompression procedure can be performed before or after distraction of the adjacent vertebrae in block 1010. Visualization can be used during the decompression procedure to visually identify the target tissue and ensure that non-target tissue (e.g., neural tissue) is not traumatized. While the method is described in connection with implanting an interbody fusion implant, the method can also be performed to deploy and implant other devices. For example, the method can be used to implant a mobile interbody fusion implant. Additionally, a multi-portal system can be used to implant rigid or fixed interbody fusion devices. The acts and steps in the method of FIG. 11 can be modified based on the characteristics of the implant to perform, for example, an oblique lumbar interbody fusion procedure, a lateral lumbar interbody fusion procedure, a posterior lumbar interbody fusion procedure, a transforaminal lumbar interbody fusion procedure, or an anterior lumbar interbody fusion procedure.
[0065] FIG. 12 illustrates a system 1110 for providing surgical assistance in accordance with an embodiment of the present disclosure. The system 1110 can improve surgery by displaying image data, analyzing the image data, suggesting steps in a surgical procedure, analyzing implants, or the like. The system 1110 can include hardware components that improve surgery using, for example, a surgical assistance system 1164. In various aspects, the surgical assistance system 1164 can store patient information, acquire image data, analyze the information / data to obtain results, and use the results to provide feedback to the user. The surgical assistance system 1164 can analyze still images or videos from the input device 1120 to suggest implants for a procedure. For example, the surgical assistance system 1164 can recommend the number, size, and configuration of implants and the surgical procedure. Based on the recommendations, the surgical assistance system 1164 can additionally suggest surgical instruments, a surgical plan, and other information. The surgical plan can include (1) surgical stages, (2) the number, size, and / or location of ports, and / or (3) a surgical approach. For example, the surgical assistance system 1164 can annotate images (e.g., x-rays, still images, videos, etc.) with suggested insertion points along the subject's skin, surgical procedure (e.g., PLIF, ALIF, LLIF, etc.), access paths, etc. During the procedure, the surgical assistance system 1164 can provide alerts or other feedback to the surgeon.
[0066] The system 1110 may include one or more input devices 1120 that provide input to and inform actions of a processor 1145 (e.g., a CPU, GPU, HPU, etc.). Actions may be mediated by a hardware controller that interprets signals received from the input devices and communicates the information to the processor 1145 using a communication protocol. The processor 1145 may be used to analyze data, such as image data, to determine whether the expanded interbody fusion implant has been positioned in a 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 connection with FIGS. 1-6 , an endoscopic instrument, an imaging device (e.g., a camera), a CRT machine, or an X-ray machine. Visualization, in some surgical embodiments, allows the surgeon to visually identify vertebral bodies, vertebral spacing, damaged / displaced tissue, discs (including bulging areas), the presence of unwanted cartilage (e.g., cartilage buildup), bone, or tissue causing nerve root compression and damage to normal bodily function. This unwanted material information can be documented and recorded by storing the image data in a computer database and immediately printing a color image (e.g., a photograph) for reference and record keeping. The physician can use this information to develop at least a portion of the surgical plan.
[0068] Additionally or alternatively, the input devices 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 may be used to select or manipulate image data captured by the visualization device. A keyboard may be used to annotate image data. The number and configuration of input devices may be selected based on the physician.
[0069] The processor 1145 can be a single processing unit or multiple processing units within one device or distributed across multiple devices. The processor 1145 can be connected to other hardware devices using a bus, such as a PCI bus or a SCSI bus. The processor 1145 can communicate with a hardware controller for a device, such as a display 1130. The display 1130 can be used to display image data. For example, the display 1130 can correspond to the display 162 of FIG. 1, which can be connected to one or more visualization devices through a wired or wireless connection (FIG. 1 shows a wired connection). The display 1130 can present information for viewing by a user. The illustrated information can include proposed implant information, proposed surgical instruments, information for implanting a device, information for repositioning an interbody fusion implant, information for collapsing an interbody fusion implant, etc. This information can be overlaid on or inserted into an image or video. In some embodiments, the information can be annotations.
[0070] The display 1130 can provide graphical and textual visual feedback to the user. In some implementations, the display 1130 includes an input device as part of the display, such as when the input device is a touch screen or includes an eye gaze monitoring system. In some implementations, the display is separate from the input device. Examples of display devices are LCD display screens, light-emitting diode (LED) display screens, projection displays, holographic displays, or augmented reality displays (such as head-up display devices or head-mounted devices), etc. The display 1130 can provide high-definition visualization.
[0071] Other I / O devices 1140, such as a network card, video card, audio card, USB, Firewire or other external device, camera, printer, speaker, CD-ROM drive, DVD drive, disk drive, or Blu-ray device, may also be connected to the processor. Other I / O devices 1140 may also include input ports for information from directly connected medical equipment such as MRI machines, X-ray machines, etc. Other I / O devices 1140 may also include input ports for receiving data from these types of devices over a network or from other sources, such as from previously captured data stored in a database.
[0072] The system 1110 may also include communication devices capable of wireless or wired-based communication using network nodes. The communication devices may communicate with another device or server over a network using, for example, the TCP / IP protocol. The system 1110 may utilize the communication devices to distribute operations across multiple network devices.
[0073] The processor 1145 can access memory 1150, which may be located within the device or distributed across multiple devices. Memory may include one or more of a variety of 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 propagated signal separate from the underlying hardware; therefore, memory is non-transitory. Memory 1150 may include program memory 1160, which stores programs and software, such as an operating system 1162, a surgical support system 1164, and other application programs 1166. The memory 1150 can also include a data memory 1170 that can contain, for example, implantation site information (e.g., level information, implant deployment information, etc.), surgical planning data, user options or preferences, image data, etc., which can be provided to the program memory 1160 or to any element of the system 1110.
[0074] Some implementations are operational with many other computer systems, environments, or configurations. Examples of computer systems, environments, and / or configurations suitable for use with the techniques of the invention include, but are not limited to, personal computers, server computers, handheld or laptop devices, mobile phones, wearable electronics, tablet devices, multiprocessor systems, microprocessor-based systems, programmable consumer electronics, network PCs, minicomputers, mainframe computers, or distributed computing environments that include any of the above systems or devices.
[0075] The foregoing detailed description has illustrated various embodiments of devices and / or processes through the use of block diagrams, flow charts, and / or examples. To the extent that such block diagrams, flow charts, and / or examples include one or more functions and / or operations, those skilled in the art will appreciate that each function and / or operation within such block diagrams, flow charts, or examples can be individually and / or collectively implemented by a wide variety of hardware, software, firmware, or substantially any combination thereof. In one embodiment, portions of the subject matter described herein can be implemented by an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), a digital signal processor (DSP), or other integrated format. However, those skilled in the art will recognize that some aspects of the embodiments disclosed herein may equally be embodied in integrated circuits, in whole or in part, 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 as substantially any combination thereof, and that designing circuitry and / or writing code for software and / or firmware is well within the skill of one of ordinary skill in the art in light of the present disclosure. Additionally, those skilled in the art will recognize that the mechanisms of the subject matter described herein can be distributed as program products in various forms, and that exemplary embodiments of the subject matter described herein apply regardless of the particular type of signal-bearing medium actually used to effect the distribution. Examples of signal bearing media include, but are not limited to: recordable-type media such as floppy disks, hard disk drives, CDs, DVDs, digital tape, computer memory, and transmission-type media such as digital and / or analog communications media (e.g., fiber optic cables, wave guides, wired communications links, wireless communications links, etc.).
[0076] C. Surgery Kit FIG. 13 is a top view of a surgical kit 1200 including the components described in connection with FIGS. 1-11, 14-16, and 18-19. Kit 1200 can include cannulas 120, 150 and a set of ports 1210. The physician can select the appropriate port based on the location of the portal site and the instruments to be utilized. In the exemplary embodiment, set 1210 includes four ports. A greater or fewer number of ports can be provided and can be the same or different sizes. Kit 1200 can include connectors (e.g., rigid connectors) for coupling the cannulas (e.g., cannulas 120, 150, 1400) to one another. The cannulas can be coupled to one another before expanding the interbody fusion device at the intervertebral implantation site.
[0077] The kit 1200 can further include multiple vacuum instruments. In the illustrated embodiment, the kit 1200 includes a debulking instrument 1220 and a reamer 1222. When utilizing a vacuum instrument, the physician can select a port 1230 with a larger opening 1232. The kit 1200 can also include a scalpel, a dilator, a rongeur, an irrigation cannula, a tissue detection or mapping cannula, a dilator, or other surgical instruments. For example, the kit 1200 can include a visualization device 140, a distraction instrument 510, a delivery or deployment instrument 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 conjunction with FIGS. 14-20. A biportal kit with tissue-mapping capabilities can include a tissue-detection cannula, while a biportal kit with irrigation capabilities can include a cannula with an irrigation fluid penetration cannula. A biportal kit can include a cannula configured for both tissue-mapping and irrigation. Additionally, one or more of the components of the kit may be disposable and may be made in whole or in part from metal, polymer, ceramic, composite, or other biocompatible, sterilizable material.
[0078] In some embodiments, kit 1200 is a sterile, universal biportal spinal surgery kit for performing different procedures. For some biportal procedures, a first port and a second port can be selected from set 1210 based on the subject's anatomy and the procedure to be performed. The first and second ports can be inserted into an incision in the subject. An instrument cannula (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 a portion of the procedure can be performed using an instrument (e.g., debulking instrument 1220, reamer 1222, etc.) positioned within the instrument cannula, 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. The instruments can be used to complete one, several, or all of the stages of a biportal spine procedure, utilizing all or none of the surgical instruments in the kit. A universal spine surgery kit can also have instruments for interbody procedures, decompression procedures, fixation procedures, or a combination thereof. The instruments can be inserted sequentially into the instrument cannulas to perform the surgical steps. Each instrument can be configured to fit within the instrument cannula, allowing the same cannula to be used throughout the procedure. In other procedures, multiple cannulas can be positioned sequentially within the same port. The port can reduce or eliminate tissue tearing caused by cannula insertion, removal, or positioning.
[0080] In some embodiments, the surgical kit 1200 can be configured to perform a particular 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 the imaging cannula. The energy-emitting elements can be tissue-mapping elements configured to identify subcutaneous tissue of the subject. The mapping information can be used to position an instrument, an imaging device, a cannula, or the like. Advantageously, the mapping can be performed without introducing additional instruments into the subject, thereby reducing the complexity of the procedure or the risk of complications. The tissue of interest can 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 exiting the vertebral foramen, spinal ganglia, spinal nerves, etc.
[0082] The cannula can be configured to be fluidly coupled to one or more irrigation devices. Fluid coupling can be achieved using, but is not limited to, one or more fittings, connectors, hoses, or conduits. The irrigation devices can 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 combinations thereof.
[0083] The kit 1200 can include one or more expanders that are part of or connectable to a kit component. The expanders can be moved from an unexpanded configuration to an expanded configuration, thereby increasing the working space within the subject. The expanders can be mechanical expanders, pneumatic expanders, self-expanding expanders, or the like.
[0084] FIG. 14 is a perspective view of a cannula 1400 in accordance with an embodiment of the present disclosure. The cannula 1400 can be used in a manner similar to the cannulas 120, 150, 810, and 930 described above in connection with FIGS. 1, 4-6, 10A, and 13. The cannula 1400 can include a distal end 1401, a proximal end 1402, and an elongate 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 a surgical site, deliver fluids to or remove fluids from a subject, etc. This allows for irrigation of the surgical site while allowing instruments to access the surgical site through a working lumen 1408. The working lumen 1408 can be configured to accept surgical instruments (e.g., distraction instruments, vacuum instruments, etc.), visualization instruments, implantable devices, or other instruments used during a 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 size, and procedure being performed.
[0085] 14A and 14B are perspective views of a distal end 1401 and a proximal end 1402, respectively, according to an embodiment of the present disclosure. FIG. 14C is a longitudinal cross-sectional view of the cannula shown in FIG. 14A. Referring now to FIG. 14A, the distal end 1401 can include a first distal opening 1414, a second distal opening 1416, and an actuation lumen opening 1418. The first and second openings 1414, 1416 can be positioned on either side of the actuation lumen opening 1418 to allow fluid flow therethrough, thereby maintaining fluid flow on both sides of the actuation lumen 1408. The configuration, number, and location of the openings relative to the fluid flow can be selected based on the desired fluid flow. For example, the number of openings and corresponding lumens can be increased to increase the flow rate of irrigation fluid within the subject's body.
[0086] 14B, the proximal end 1402 can include a first proximal opening 1446 and a second proximal opening 1448. As shown in FIG. 14C, a first fluid lumen 1441 extends between the distal opening 1414 and the proximal opening 1446, and a second fluid lumen 1412 extends between the distal opening 1416 and the proximal opening 1448. The diameter and configuration of the lumens can be selected based on the procedure being performed. The configuration of the lumens 1408, 1410, 1412 can be, for example, circular, elliptical, or polygonal (including rounded polygonal). Additionally, the cross-sectional shape of the lumens can vary along the length of the lumens, for example, when a circular lumen terminates in a rectangular opening at the distal end 1401 of the cannula 1400.
[0087] 14C , the working lumen 1408 can be substantially centered within the elongate body 1404 with its distal opening 1409 correspondingly centered in the plane of the distal end 1401, or can be offset toward the side of the body 1404 depending on the configuration. Similarly, the fluid lumens 1410, 1412 can be positioned within the cannula body 1404 such that their distal openings 1414, 1416 are located in other locations than those shown. For example, the lumens 1410, 1412 can be located adjacent to each other on the same side of the cannula body 1404 to help couple the proximal opening to a fluid control system. Additionally, according to various embodiments, any of the openings 1406, 1414, 1416, 1446, 1448 can be positioned along the outer surface 1413 of the cannula body 1404.
[0088] 14C , the fluid lumens 1410, 1412, according to some embodiments, can be configured to allow surgical irrigation fluid to flow in any direction. For example, the first fluid lumen 1410 can be configured to allow irrigation 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 irrigation fluid flow from the distal end 1401 to the proximal end 1402. In various arrangements, both lumens 1410, 1412 can be used to allow fluid flow in the same direction, only one lumen can be configured to allow fluid flow while the other lumen is closed, capped, blocked, or otherwise not used to allow fluid flow, or neither lumen can be configured to allow fluid flow, both can be closed, capped, blocked, or otherwise not used to allow fluid flow.
[0089] The cannula 1400 can include one or more tissue-mapping probes. Referring again to FIG. 14A , the tissue-mapping probe 1420 can 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 the energy with various tissues can provide a measurable response using various techniques. For example, the tissue-mapping probe 1420 can be a nerve monitoring electrode used with electromyography (EMG) technology. For example, the electrical signal emitted by the electrode 1420 can depolarize nearby nerves and cause a response in innervated muscles that can be detected by an EMG system. Other techniques include, but are not limited to, ultrasonography, fluoroscopy, Doppler imaging, and optical imaging. The configuration of the tissue-mapping probe 1420 can be suitable for locating various tissues, including nerve tissue, dura mater, bone tissue, ligaments, ligamentum flavum, bone graft materials, and related areas such as tissue margins and tissue interfaces.
[0090] The placement of the tissue-mapping probe 1420 can be selected to aid in the tissue-mapping technique. For example, spaced probes 1420 positioned as shown in FIG. 14A can provide directional information. The relevant tissue may respond more strongly to the energy output from a nearby probe than to the energy output from other probes positioned farther away on the cannula. The tissue-mapping probe 1420 can also be configured to emit energy sequentially or in another suitable pattern, so that tissue in each direction associated with a particular tissue-mapping probe can be probed 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, when 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, orientation, or depth of the nerve root. Advantageously, mapping can be performed without physically contacting or damaging nerve tissue. Nerve mapping can be performed to locate spinal nerves around and adjacent to the spinal column.
[0091] 14A and 14C, a transmission line 1430 coupled to the tissue-mapping probe 1420 can extend from the distal end 1401 to the proximal end 1402. The transmission line 1430 can include, but is not limited to, one or more wires, optical fibers, etc., and can be positioned within a sidewall of the body 1404. The transmission line 1430 can be configured to transmit energy, electrical signals, and / or optical signals, including various types of digital and analog signals. In some embodiments, the transmission line 1430 can be configured to transmit energy to one tissue-mapping probe and transmit signals received from another tissue-mapping probe. Now referring to FIGS. 14B and 14C, the transmission line 1430 can connect to an interface 1440 at the proximal end 1402. The interface 1440 can include, but is not limited to, one or more plugs, connectors, or other components that provide a connection point to a tissue-mapping system.
[0092] FIG. 15 is a front elevational view of cannula 1500. The description of cannula 1400 in FIGS. 14-14C applies equally to cannula 1500 unless otherwise indicated. Cannula 1500 can have a tissue-mapping array 1520 with tissue-mapping probes circumferentially arranged around a distal surface 1502 of a distal end 1501. The increased number of tissue-mapping probes of FIG. 15 can provide increased directional resolution for tissue mapping. Additionally, 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 can include neural monitoring electrodes 1522, ultrasound transducers 1524, and photoacoustic sensors 1526. The arrangement of multiple modalities for tissue mapping can improve tissue localization and visualization. The neural monitoring electrodes 1522 can assist in positioning the cannula to avoid contact with nerves during insertion, while the ultrasound emitters and photoacoustic sensors can provide information related 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 to be performed. For example, the number of electrodes can be increased to provide higher resolution mapping. In some embodiments, some probes can be arranged around the sides of the distal tip, while other probes are arranged on the distal face 1502. The probes can be flush with the outer surface 1503 of the cannula body or slightly recessed into the cannula body. In other embodiments, the probes can extend beyond the face 1503.
[0094] FIG. 16 is a side view of a cannula including a tissue-mapping probe according to certain embodiments of the present disclosure. The descriptions of cannula 1400 in FIGS. 14-14C and the cannula in FIG. 15 apply equally to cannula 1600 unless otherwise indicated. Tissue-mapping probe 1620 extends distally from distal end 1631 of cannula body 1604. The distance d that tissue-mapping probe 1620 extends from body 1640 can be selected based on the desired clearance relative to lumen opening 1622 (shown in dashed lines) of working lumen 1624. Such probe protrusion can assist techniques such as EMG during guided insertion of the cannula, where the probe can guide the cannula body and determine the location of the tissue before the cannula contacts the tissue. In some embodiments, distal end 1631 can have a distal face 1632 that is generally angled relative to longitudinal axis 1636 of 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 in dashed lines), the instrument can be easily pushed laterally into the working lumen, as indicated by arrow 1644. Advantageously, the probe 1620 can physically contact the tissue to help maintain spacing 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 can have a blunt or rounded tip 1641 configured to slide non-invasively over tissue. In other embodiments, the tip 1641 can be pointed or relatively sharp for piercing the tissue. In some procedures, the puncturing probe 1620 can be inserted into tissue to map tissue underlying an exposed tissue surface.
[0095] 17 is a detailed side view of cannulae 1720, 1721 positioned to perform a procedure in accordance with an embodiment of the present disclosure. The cannulas 1720, 1721 are positioned in respective ports 472, 474 and can extend through the subject's skin 460 and through the subcutaneous tissue 462. The cannulas 1720, 1721 can be inserted through the respective ports 472, 474 so that their distal ends are adjacent to or lead to a treatment site 1750 (generally identified by a dashed line). 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 can have features of the cannula 1600 described in connection with FIG. 16.
[0096] Cannulae 1720, 1721 each have a fluid lumen 1725, 1726 configured to circulate surgical irrigation fluid to treatment site 1750. Fluid lumen 1726 can be fluidly connected to a fluid supply system 1760. Fluid lumen 1725 can be fluidly connected to a fluid return system 1770 at the proximal end of cannula 1720. In some embodiments, fluid supply system 1760 and fluid return system 1770 are elements of an integrated fluid control system. Systems 1760, 1770 can include the components and features described in connection with system 1110.
[0097] Circulating fluid flow can be controlled and monitored by fluid supply system 1760 and / or fluid return system 1770. Flow can exist while instrument assembly 130 and visualization instrument 140 are positioned within working lumens 1706, 1708 of cannulas 1720, 1722, respectively. Irrigation fluid can improve visibility at treatment site 1750 and provide improved control over fluid pressure and flow rate during the procedure. In various embodiments, cannulas 1720, 1722 can be configured as described above with respect to cannulas 1400, 1500, and 1600 and below with respect to cannula 1800 discussed in connection with FIGS. 14A-C, 15, and 16.
[0098] The tissue-mapping probe 1724 can be used to map tissue near the treatment site 1750 while the instrument assembly 130 and visualization instrument 140 are positioned within the cannulas 1720, 1722, respectively. In this manner, some embodiments allow the physician to receive periodic or continuous updates regarding the location of tissue near or at the treatment site 1750 as the surgical procedure progresses. The tissue-mapping system 1740 can be an element of the system for providing surgical assistance 1110, as described above in connection with FIG. 12 . The tissue-mapping system 1740 can include, but is not limited to, one or more displays, computers, computing devices, processors, displays, or combinations thereof. Information regarding the location of the 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 procedure. In some embodiments, tissue-mapping system 1740 provides visualization of tissue location at treatment site 1750, which can be overlaid on image data (e.g., still images, video, etc.) obtained from a visualization instrument. Other cannulas, ports, or components described herein can be used in the procedure of FIG.
[0099] FIG. 18 is a side view of a cannula 1800 in accordance with an embodiment of the present disclosure. FIG. 19 is a top view of the cannula 1800, with the cannula body 1801 shown in dashed lines. The cannula 1800 can include a dilator or spacer 1810 ("dilator 1810") connected to the distal end 1803 of the elongate body 1801 of the cannula 1800. The dilator 1810 can have a stored configuration (as shown in FIG. 18) and a deployed configuration (as shown in FIG. 19). The dilator 1810 can translate relative to the distal end 1803 (FIG. 18) through a movable coupler 1811. The movable coupler 1811 can move away from the distal end 1803, as shown by arrow 1813 in FIG. 18. In some procedures, the coupler 1811 is slidably disposed within the sidewall of the elongate body 1801, allowing the physician to manually push the dilator 1810 distally. In other embodiments, the coupler 1811 is fixedly coupled to the elongate body 1801. For example, the coupler 1811 can be a rod integral with or coupled to the elongate body 1801. In yet another embodiment, the coupler 1811 can be rotatably coupled to the distal end 1803, allowing the spacer 1810 to rotate relative to the elongate body 1801. For example, the dilator 1810 can rotate about 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 can have a movably connectable body that can move between a ring-shaped or spiral configuration and an expanded configuration. FIG. 18 shows the expander 1810 in a spiral configuration. The movably connectable segments are connected through joints or pivots and can move toward the expanded configuration of FIG. 19. The segmented sections of the expander 1810 body can be connected by joints 1823 (identified in FIG. 19), which can include, but are not limited to, one or more hinges, joints, living hinges, or the like. The expander 1810 can include tissue-mapping elements, contact sensors, anchors, or other features for engaging or contacting tissue. In some embodiments, the expander 1810 can include one or more deployable arms or tines to enable further expansion of the spacer 1810. In the deployed state, the expander can create a working volume at a treatment site within a subject.
[0101] In other embodiments, the dilator can 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 instrument positioned within a second cannula proximal to cannula 1800 can visualize the interior area of the spacer by peering through the unenclosed side of dilator 1810. In some embodiments, dilator 1810 can have an aperture, window, or other opening to allow visualization of the partially enclosed area.
[0102] The dilator 1810 can have a tissue-mapping probe 1824 positioned on the outer surface of the segment. The tissue-mapping probe 1824 can be configured to output energy similar to the tissue-mapping probes 1420, 1520, 1620 described above in connection with FIGS. 14A-16. The tissue-mapping probe 1824 can be in addition to the tissue-mapping probe 1822 (FIG. 18) positioned at the distal end of the cannula 1800. The tissue-mapping probe 1824 can aid in the deployment of the dilator 1810, aid in positioning and orienting the dilator 1810, and provide feedback to avoid contact with neural or other tissue.
[0103] FIG. 20 is a flow chart illustrating a method 2000 of treating a subject according to an embodiment of the present disclosure. In block 2002, an incision is made in the subject's tissue and a port is positioned at the incision. Block 2002 may be similar to block 1002 described above in connection with FIG. 11. In block 2004, a first cannula may be positioned at the port at a first location within the subject's tissue. An instrument, such as a distraction instrument, may be inserted through the working lumen of the cannula. Use of distraction instruments and cannulas is discussed in connection with FIGS. 5-8. Various additional cannula embodiments are discussed in connection with FIGS. 14A-16 and 18-19.
[0104] A visualization device may be inserted through a second cannula positioned at the second portal site in block 2006. Use of a visualization device at the second portal site is discussed above in connection with FIG. 11 with respect to an embodiment in which a visualization device may be used with a second cannula at the second portal site.
[0105] In optional block 2008, a spacer can be deployed at the treatment site. The dilator can expand the working volume at the treatment site, improve irrigation fluid flow, improve visualization, and / or assist in tissue-mapping. For example, the dilator can be configured to enhance visibility and / or access the surgical site and remain in an expanded configuration. The dilator can be engageable and disengageable with the cannula body. Deployment of the dilator is discussed above in connection with FIGS. 18 and 19.
[0106] In block 2010, tissue-mapping probes on the first and / or second cannulas can be used to determine the location of tissue at or near the treatment site within the subject. Tissue-mapping probes and tissue-mapping systems are discussed above in connection with FIGS. 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 indication of the tissue location within the subject. The tissue-mapping information can be used when additional procedures are performed.
[0107] In block 2012, irrigation fluid can be circulated to the treatment site through the first and second cannulas. The fluid lumen of the first cannula can be fluidly 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 fluidly connected to a fluid return system to return fluid from the treatment site. A deployed dilator can assist in controlling fluid flow by providing a controlled boundary of the working volume at the treatment site. According to some embodiments, the first and second cannulas can 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 irrigation fluid. Thus, for example, the first cannula can have both a fluid lumen configured to supply irrigation fluid and a fluid lumen configured to return irrigation fluid, while the second cannula can have a fluid lumen configured to return irrigation fluid and a fluid lumen configured to neither supply nor return irrigation fluid.
[0108] In procedure 2013, blocks 2014-2020 describe various steps, including removing tissue from the treatment site, moving the interbody fusion implant to the implant site, expanding the implant, and visualizing the expansion. These steps are similar to the steps in blocks 1008-1016 described above in connection with FIG. 11. Steps may be omitted or performed in a different order.
[0109] The components discussed herein can be mixed and matched to provide desired functionality. For example, the cannulas and instruments described in connection with FIGS. 1 and 13 can include tissue dilators, tissue-mapping elements, visualization devices, or other features that provide desired functionality. The components can be integrated into the instruments and cannulas, or can be separate components. For example, the dilator 1810 described in connection with FIGS. 18 and 19 can be coupled to other cannulas discussed herein using clamps, pin connectors, or other suitable connection arrangements, thereby allowing the dilator 1810 to be coupled to a wide variety of cannula types. Additionally, the distal sections of the instruments, cannulas, and dilators can have atraumatic designs to reduce or prevent tissue injury. As an example, the dilator 1810 of FIGS. 18 and 19 can have a rounded distal section to aid in sliding along tissue, thereby reducing or preventing tissue injury. In other embodiments, the dilators and cannulas can have relatively sharp edges to facilitate cutting, scraping, or otherwise actuating tissue. The kit can have both invasive and non-invasive instruments to allow the user to select how the tissue is affected or not affected by the instruments and cannula. While the lumen is within the cannula, another tube can be connectable to the cannula. For example, a bone dust removal tube can include a connector or clamp for detachably connecting to the cannula.
[0110] The above detailed description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. While specific embodiments of and examples of the present technology have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications are possible within the scope of the present technology. For example, while steps may be presented in a given order, steps may be performed in a different order in alternative embodiments. Features from various systems, methods, and instruments may be combined with features disclosed in U.S. Pat. Nos. 863,2594, 930,8099, 10,105,238, 10,201,431, U.S. Patent Application No. 16 / 565,403, and 16 / 687,520, all of which are hereby incorporated by reference. Variations in implants are contemplated. For example, the interbody spacer 910 (FIGS. 9A-9C) may include different overall heights to cover a range of disc heights. In other examples, the interbody spacer 910 can include different lordotic and / or kyphotic angles. In still other examples, the interbody spacer 910 can include other patterns or features, such as spikes or protrusions on the bone-contacting surface, that provide stability and / or resistance to shifting. The implant can be made from metal, polymer, ceramic, composite, or other biocompatible, sterilizable materials. Different materials can be combined into what is described herein as a single piece. A surgical kit can include, for example, the components discussed in connection with FIGS. 1-11, 14-16, and 18-19. The kit can include cannulas, ports, fluidic components, tissue-mapping elements, dilators, or combinations thereof.
[0111] The systems, components, and instruments disclosed herein can be disposable or reusable. For example, a port, instrument, or cannula can be disposable to prevent cross-contamination. As used herein, the term "disposable" when applied to 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, without limitation, that such system or component is used a finite number of times and then discarded. 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 can be disposable to prevent cross-contamination. In some other kits, components (e.g., all or some of the components) can be reusable.
[0112] Where the context permits, singular or plural terms may also encompass the plural or singular terms, respectively. Additionally, unless the word "or" with respect to a list of two or more items is expressly limited to refer only to a single item exclusive of the other items, the use of "or" in such a list shall be interpreted to include (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term "comprises" is used throughout to mean the inclusion of at least the recited features, and thus does not exclude a greater number of the same features and / or other features of additional types. Similarly, while specific embodiments have been described herein for illustrative purposes, it will be appreciated that various modifications can be made without departing from the technology of the present invention. Additionally, while advantages associated with certain embodiments of the technology of the present invention have been described in connection with those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages to fall within the scope of the technology of the present invention. Accordingly, the present disclosure and related technology may encompass other embodiments not expressly shown or described herein. [Explanation of symbols]
[0113] 100 Spine Surgery System 120, 150 cannula 130, 160 Instrument assembly 140 Visualization Devices 171 Intervertebral disc
Claims
1. 1. A system for treating a spine of a subject, comprising: an instrument cannula; a delivery tool including an elongate body, a distractor head, and at least one positioner; Including, the distractor head is deliverable through the instrument cannula and configured to controllably distract adjacent vertebrae and to provide a delivery path for delivery of an interbody fusion device to the distracted intervertebral space between the adjacent vertebrae while the elongate body extends through the instrument cannula; the at least one locator is movable away from a longitudinal axis of the delivery instrument toward a deployed position, the at least one locator in the deployed position configured to contact a lateral surface of one of the adjacent vertebrae while the distractor head distracts the adjacent vertebra; the elongate body is configured to extend or retract to position the distractor head while the at least one locator remains stationary relative to the adjacent vertebrae. A system characterized by:
2. 10. The system of claim 1, further comprising a deployment instrument configured to be delivered through the instrument cannula to deploy the interbody fusion device.
3. 10. The system of claim 1, wherein the delivery instrument includes a control element that controls actuation of the distractor head so that the distractor head presses against the endplates of the adjacent vertebrae to enlarge the intervertebral space.
4. 10. The system of claim 1, wherein the distractor head includes one or more expandable members and / or wedging devices.
5. 10. The system of claim 1, further comprising one or more discectomy instruments deliverable through the instrument cannula to perform the discectomy.
6. 10. The system of claim 1, further comprising an interbody fusion device having an interface element releasably coupleable to the delivery instrument, the delivery instrument operable to expand the interbody fusion device in a first direction and in a second direction different from the first direction.
7. 10. The system of claim 1, further comprising an endoscopy cannula configured to be positioned in a second port to provide access for endoscopic viewing of a treatment site along the spine while the delivery instrument is positioned in the subject.
8. 10. The system of claim 1, further comprising one or more tissue removal tools configured to remove tissue between the vertebral bodies of the adjacent vertebrae.
9. The system of claim 1 further comprising an endoscope.
10. The system of claim 1 , further comprising an interbody fusion device configured to be delivered through the elongate body.
11. 10. The system of claim 1, wherein the distractor head is movable from a delivery state configured for insertion into an intervertebral space between the adjacent vertebrae to an expanded state configured to hold the distracted adjacent vertebrae apart while the interbody fusion device is delivered from the delivery instrument into the intervertebral space.
12. 10. The system of claim 1, further comprising a driver releasably coupleable to the rotatable connection interface of the interbody fusion device and adapted to move axially to move the interbody fusion device directly between adjacent vertebrae of the adjacent vertebrae, the driver configured to expand the interbody fusion device from a collapsed configuration to an deployed configuration.
13. 10. The system of claim 1, wherein the distractor head includes an expandable member insertable into the intervertebral space, the expandable member configured to push the adjacent vertebrae apart when the expandable member in the intervertebral space is expanded.
14. The system described in claim 1, characterized in that the delivery device further includes at least one control element operable to move the at least one positioner toward the deployed position.
15. The system described in claim 1, characterized in that the at least one positioner includes a first positioner and a second positioner, and the delivery device further includes (i) a first control element rotatable to move the first positioner toward a first deployed position, and (ii) a second control element rotatable to move the second positioner toward a second deployed position.
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