WO2025137205A1

WO2025137205A1 - Integrated instrument assembly

Info

Publication number: WO2025137205A1
Application number: PCT/US2024/060923
Authority: WO
Inventors: Phillip Thompson; Anthony Dezan; Morton ALBERT; Nina ROMERO; Jonathan Betts
Original assignee: Vertos Medical Inc
Current assignee: Vertos Medical Inc
Priority date: 2023-12-20
Filing date: 2024-12-19
Publication date: 2025-06-26
Anticipated expiration: 2026-06-20

Abstract

Systems, devices, and methods for performing minimally invasive spinal procedures are described herein. The systems, devices, and methods may be used to percutaneously access the spinal canal and perform a spinal procedure. The systems and devices may integrate various instruments for performing the procedures, thus improving their ease of use, reducing procedural complexity, and minimizing procedure time.

Description

Integrated Instrument Assembly

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to U.S. Provisional Patent Application No. 63/612,952, filed December 20, 2023, the entire contents of which are hereby incorporated by reference as if fully set forth in this description.

TECHNICAL FIELD

[0002] This application generally relates to minimally invasive systems for accessing and treating the spinal canal. The systems may include an integrated device that combines various instruments used for performing spinal procedures. Methods for treating spinal conditions, e.g., spinal stenosis, using the systems and integrated devices are also described herein.

BACKGROUND

[0003] Spinal stenosis is a condition that may occur when the spinal canal narrows to compress the spinal cord or associated nerves roots. The condition may have various etiologies. For example, spinal stenosis may be caused by spinal degeneration, which often occurs with aging, but may also be due to disc herniation, osteoporosis, cancerous growth, or a congenital condition. Spinal stenosis may also be caused by subluxation, facet joint hypertrophy, osteophyte formation, underdevelopment of the spinal canal, spondylosis deformans, degenerative intervertebral discs, degenerative spondylolisthesis, degenerative arthritis, ossification of the vertebral accessory ligaments, or thickening of the ligamentum flavum. A less common cause of spinal stenosis, which usually affects patients with morbid obesity or patients on oral corticosteroids, is excess fat in the epidural space. The excessive epidural fat compresses the dural sac, nerve roots and blood vessels contained therein, often resulting in back and leg pain, or weakness and numbness of the legs. [0004] Spinal stenosis may affect the cervical, thoracic, or lumbar regions of the spine. In some cases, spinal stenosis may be present in all three regions. Lumbar spinal stenosis may cause lower back pain, abnormal sensations in the legs or buttocks, and loss of bladder or bowel control. Patients suffering from spinal stenosis may ty pically be treated first with exercise therapy, analgesics, or anti-infl ammatory medications. If these conservative treatment options fail, surgery may be required to decompress the spinal cord or nerve roots.

[0005] Traditional surgical procedures to correct stenosis in the lumbar region generally require a large incision to be made in the patient's back. Muscles and other supporting structures are then stripped away from the spine, exposing the posterior aspect of the vertebral column. A portion of the vertebral arch, often at the laminae, may then be removed (laminectomy or laminotomy). The procedure is usually performed under general anesthesia. Patients may be admitted to the hospital for approximately five to seven days depending on the age and overall condition of the patient. Thereafter, patients often require between six weeks and three months to recover from the procedure. Further, many patients need extended therapy at a rehabilitation facility to regain enough mobility to live independently.

[0006] When spinal stenosis is due to compression of the intervertebral foramina, the passages between vertebrae through which nerves pass laterally from the spinal cord to the body become narrowed. Foramina compression is often due to unwanted bone, ligament, or scar tissue formation in the passages. A foraminotomy may relieve the symptoms of nerve compression caused by foramen constriction, but typically involve making an incision in the back of the patient's then peeling away muscle to reveal the bone underneath, and cutting a small hole in the vertebra. Through this hole, using an arthroscope, the foramen can be visualized, and the impinging bone or disk material removed. Much of the pain and disability after an open foraminotomy or laminectomy results from the tearing and cutting of the back muscles, blood vessels, supporting ligaments, and nerves. Also, because the spine stabilizing back muscles and ligaments are stripped and detached from the spine, these patients frequently develop spinal instability' post-operatively.

[0007] Minimally invasive techniques, e g., percutaneous techniques, generally offer the potential for less post-operative pain and faster recovery compared to traditional open surgery. For example, percutaneous spinal procedures may be performed with local anesthesia, thereby sparing the patient the risks and recovery time required with general anesthesia. In addition, there may be less damage to the paraspinal muscles and ligaments with minimally invasive techniques, thereby reducing pain and the damage caused to stabilizing structures.

[0008] Various techniques for minimally invasive treatment of the spine have been developed. For example, microdiscectomy is one technique that includes making a small incision in the skin and deep tissues to create a portal to the spine. A microscope is then used to aid in the dissection of the adjacent structures prior to discectomy. Although the recovery time for this procedure is much shorter than traditional open discectomies, the technique is not relevant in treating other spinal disorders such as spinal stenosis. Arthroscopy using an optical catheter has also been proposed to treat spinal stenosis. These devices and techniques are limited by the small size of the spinal canal, and thus the operations may be generally difficult to perform and master.

[0009] Accordingly, it would be useful to have other systems, devices, and methods for performing minimally invasive spinal procedures. It would also be beneficial to have systems and methods for percutaneously accessing the spinal canal and performing a spinal procedure in multiple locations along the canal, e.g., bilaterally and/or at multiple levels, from a single access point. Systems and devices that integrate the instruments for performing the procedures would also be useful since they would improve ease of use, reduce procedural complexity, and minimize procedure time. [0010] It is with respect to these and other considerations that the disclosure made herein is presented.

SUMMARY

[0011] Within examples, described herein are systems and methods associated with an integrated instrument assembly for minimally invasive spinal procedures.

[0012] Within additional examples described herein, systems and methods are disclosed that relate to an integrated instrument assembly including a portal cannula, a depth guide, a funnel, and a working instrument. The portal cannula includes a proximal and a distal end. The depth guide can be coupled to a proximal end of the portal cannula. The funnel can be disposed within the depth guide. The working instrument is removably inserted through a channel of the funnel and into the portal cannula.

[0013] The features, functions, and advantages that have been discussed can be achieved independently in various examples or may be combined in yet other examples. Further details of the examples can be seen with reference to the following description and drawings.

BRIEF DESCRIPTION OF THE FIGURES

[0014] The novel features believed characteristic of the illustrative examples are set forth in the appended claims. The illustrative examples, however, as well as a preferred mode of use, further objectives and descriptions thereof, will best be understood by reference to the following detailed description of an illustrative example of the present disclosure when read in conjunction with the accompanying Figures.

[0015] Figure 1A illustrates a perspective view of an integrated device comprising a portal cannula, a portal grip, and a trocar, according to an example implementation.

[0016] Figure IB illustrates a perspective exploded view of the integrated device of Figure 1 A, according to an example implementation.

[0017] Figure 2A illustrates a side view of a portal cannula including a hub at its proximal end having a hexagonal cross-sectional shape, according to an example implementation.

[0018] Figure 2B illustrates an end view of the portal cannula of Figure 2A, according to an example implementation.

[0019] Figure 3A illustrates a side view of a portal cannula including a hub at its proximal end having a plurality of fins, according to an example implementation.

[0020] Figure 3B illustrates an end view of the portal cannula of Figure 3A, according to an example implementation.

[0021] Figure 4A illustrates a side view of a portal cannula including a hub at its proximal end having a circular cross-sectional shape and flanges that help limit further travel of a trocar, according to an example implementation.

[0022] Figure 4B illustrates an end view of the portal cannula of Figure 4A, according to an example implementation. [0023] Figure 5A illustrates a perspective view of an integrated device having a portal grip mounted on a portal cannula, according to an example implementation.

[0024] Figure 5B illustrates the portal grip of Figure 5A slid down to contact skin surface, according to an example implementation.

[0025] Figure 5C illustrates a front view of the portal grip of Figures 5A-5B including a plurality of surface features that may help a user grip and rotate a second component of the portal grip with respect to a first component, according to an example implementation.

[0026] Figure 5D illustrates a cross-sectional view of the portal grip of Figure 5C, according to an example implementation.

[0027] Figure 6A illustrates a front view of a lock assembly comprising a portal grip housing including rotating hemispheres and a conformable collet, according to an example implementation.

[0028] Figure 6B illustrates a cross-sectional view of the lock assembly of Figure 6A in a first state, according to an example implementation.

[0029] Figure 6C illustrates a cross-sectional view of the lock assembly of Figure 6A in a second state, according to an example implementation.

[0030] Figure 7A illustrates a front view⁷ of another lock assembly comprising a collet having a plurality of fingers separated by a plurality of channels, according to an example implementation.

[0031] Figure 7B illustrates a cross-sectional view- of the lock assembly of Figure 7A, according to an example implementation.

[0032] Figure 8A illustrates a front view of a split spiral cam of another locking assembly, according to an example implementation. [0033] Figure 8B illustrates a top view of the split spiral cam of Figure 8A, according to an example implementation.

[0034] Figure 8C illustrates a cross-sectional front view of a portal grip including the split spiral cam of Figures 8A-8B, according to an example implementation.

[0035] Figure 8D illustrates a cross-sectional top view of the portal grip of Figure 8C, according to an example implementation.

[0036] Figure 9A illustrates a split spiral cam including a toggle to aid with rotating the split spiral cam into locked and unlocked positions, according to an example implementation.

[0037] Figure 9B illustrates a perspective view of a portal grip having the split spiral cam of Figure 9A in a first position, according to an example implementation.

[0038] Figure 9C illustrates a perspective view of a portal grip having the split spiral cam of Figure 9A in a second position, according to an example implementation.

[0039] Figure 9D illustrates a top view of the portal grip of Figure 9B depicting the split spiral cam in the first position, according to an example implementation.

[0040] Figure 9E illustrates a top view of the portal grip of Figure 9C depicting the split spiral cam in the second position, according to an example implementation.

[0041] Figure 10A illustrates a front view of a portal grip in a first position, according to an example implementation.

[0042] Figure 10B illustrates a front view of the portal grip of Figure 10A in a second position, according to an example implementation.

[0043] Figure 10C illustrates a cross-sectional view⁷ of the portal grip of Figure 10A, according to an example implementation. [0044] Figure 10D illustrates a cross-sectional view of the portal grip of Figure 10B, according to an example implementation.

[0045] Figure 11 A illustrates a side view of a spherical portal grip housing for a locking assembly, according to an example implementation.

[0046] Figure 11B illustrates a collet comprising a plurality of jaws and a spring mount, according to an example implementation.

[0047] Figure 11C illustrates a spring of a locking assembly, according to an example implementation.

[0048] Figure HD illustrates a waist of a locking assembly, according to an example implementation.

[0049] Figure HE illustrates a perspective view of a locking assembly with collet jaws in a compressed configuration, according to an example implementation.

[0050] Figure 11F illustrates a perspective view of the locking assembly of Figure HE with the collet jaws in an uncompressed configuration, according to an example implementation.

[0051] Figure 12A illustrates a perspective view of a push button lock assembly, according to an example implementation.

[0052] Figure 12B illustrates a perspective cross-sectional view of the push button lock assembly of Figure 12A, according to an example implementation.

[0053] Figure 13 illustrates a side view of a trocar, according to an example implementation.

[0054] Figure 14A illustrates a depth guide in a first state, according to an example implementation.

[0055] Figure 14B illustrates the depth guide of Figure 14Ain a second state, according to an example implementation. [0056] Figure 14C illustrates the depth guide of Figure 14A in a third state, according to an example implementation.

[0057] Figure 15A illustrates a side view of an integrated device comprising a bone auger, according to an example implementation.

[0058] Figure 15B illustrates a cross-sectional view of the integrated device of Figure 15A, according to an example implementation.

[0059] Figure 15C illustrates a partial exploded view of a bone auger handle including a housing and an insert, according to an example implementation.

[0060] Figure 15D illustrates a perspective view of the insert of the bone auger handle of Figure 15C, according to an example implementation.

[0061] Figure 15E illustrates an interior view of the bone auger handle housing, according to an example implementation.

[0062] Figure 15F illustrates a cross-sectional view of the insert connected to the bone auger handle housing, according to an example implementation.

[0063] Figure 15G illustrates a cross-sectional view of the integrated device of Figure 15 A, according to an example implementation.

[0064] Figure 15H illustrates an enlarged, cross- sectional view of a bone auger distal end with a lumen extending therethrough, according to an example implementation.

[0065] Figure 151 illustrates a partial, perspective cross-sectional view of the integrated device of Figure 15A, according to an example implementation.

[0066] Figure 16A illustrates a partial perspective exploded view of a trocar handle including a housing and an insert, according to an example implementation. [0067] Figure 16B illustrates a perspective view of the insert of the trocar handle of Figure 16 A, according to an example implementation.

[0068] Figure 16C illustrates a perspective interior view of the housing of the trocar handle of Figure 16 A, according to an example implementation.

[0069] Figure 16D illustrates a cross-sectional view of the insert of the trocar handle of Figure 16A connected to the housing of the trocar handle, according to an example implementation.

[0070] Figure 17A illustrates a perspective view of another integrated device comprising a portal cannula, a portal grip, and a trocar, according to an example implementation.

[0071] Figure 17B illustrates an exploded view of the integrated device of Figure 17A, according to an example implementation.

[0072] Figure 17C illustrates a connector for attaching a depth guide to a portal cannula hub of the integrated device of Figures 17A-17B, according to an example implementation.

[0073] Figure 17D illustrates a cross- sectional view of the integrated device of Figures 17A- 17B, according to an example implementation.

[0074] Figure 18A illustrates a side, perspective view of a portal cannula that may also be used as a bone auger, according to an example implementation.

[0075] Figure 18B illustrates a cross-sectional view of the device of Figure 18A, according to an example implementation.

[0076] Figure 18C illustrates an enlarged view of teeth at a distal tip of the device of Figure 18 A, according to an example implementation.

[0077] Figure 18D illustrates a trocar disposed within a lumen of the portal cannula of the device of Figure 18 A, according to an example implementation. [0078] Figure 19A illustrates a side view of a device comprising a trocar that may also be used as a bone auger, according to an example implementation.

[0079] Figure 19B illustrates a cross-sectional side view of the device of Figure 19A, according to an example implementation.

[0080] Figure 19C illustrates a perspective view of a distal tip of the device of Figure 19A, according to an example implementation.

[0081] Figure 19D illustrates a partial perspective cross-sectional view of the device of Figure 19A, according to an example implementation.

[0082] Figure 19E illustrates a cross-sectional side view of the device of Figure 19A, according to an example implementation.

[0083] Figure 19F illustrates a perspective view of a distal tip of the device of Figure 19A, according to an example implementation.

[0084] Figure 19G illustrates a sharp tip of the device of Figure 19A, according to an example implementation.

[0085] Figure 19H illustrates a cross-sectional view of the sharp tip of Figure 19G, according to an example implementation.

[0086] Figure 20 illustrates a portal cannula including multiple ports for the introduction of w orking instruments, according to an example implementation.

[0087] Figure 21 illustrates a cross-sectional view of an integrated device having a funnel, according to an example implementation.

[0088] Figure 22 illustrates a partial, transparent, perspective view⁷ of the integrated device of

Figure 21, according to an example implementation. [0089] Figure 23A illustrates a partial perspective view of the integrated device of Figures 21-

22 with the funnel positioned within a depth guide, and a trocar disposed through the funnel, according to an example implementation.

[0090] Figure 23B illustrates a partial side view of the integrated device of Figure 23A, according to an example implementation.

[0091] Figure 24A illustrates a perspective view of the funnel of the integrated device of Figures 21-22, according to an example implementation.

[0092] Figure 24B illustrates a perspective view of a metal insert of the funnel of Figures 24A, according to an example implementation.

[0093] Figure 25 illustrates an example kit, according to an example implementation.

[0094] Figure 26 is a flowchart of a method of using an integrated device, according to an example implementation.

DETAILED DESCRIPTION

[0095] Within examples, described herein are systems and devices that may be used to percutaneously access the spinal canal and perform minimally invasive procedures on the canal and/or surrounding tissues. Related systems, devices, and methods are described in U.S. Patent Application No. 18/335956, titled “Integrated Instrument Assembly”, filed on June 15, 2023, the entirety of which is incorporated by reference herein for all purposes and forms a part of this specification. The systems may include an assembly that integrates two or more devices of a surgical instrument kit into a single assembly to improve ease of use, reduce procedural complexity, and minimize procedure time, as mentioned above.

[0096] In some examples, the integrated assembly combines two or more devices or system components used to access a spinal region. For example, one or more of a portal cannula, trocar, depth guide, and stabilization component (e.g., a portal grip) may be removably coupled together (e.g., slidingly attached and/or attached via a snap-fit, interference fit, threaded connector, magnetic and/or other type of mechanical connector) to form the integrated assembly.

[0097] The stabilization component (e.g., the portal grip) may be configured to provide a fulcrum point for the portal cannula as well prevent or provide resistance against further advancement of the portal cannula into the body. Once the target depth of the portal cannula is set. working instruments such as a bone auger, bone rongeur, tissue sculptor, etc., may be advanced through the portal cannula.

[0098] In examples, disclosed herein is an integrated assembly including a funnel that provides several advantages over existing devices as described below with respect to Figures 21-25.

[0099] Figure 1 A illustrates a perspective view of an integrated device 100 comprising a portal cannula 102, a portal grip 104, and a trocar 106 having a trocar handle 108, and Figure IB illustrates a perspective exploded view of the integrated device 100, according to an example implementation. As used herein, the terms ‘‘integrated assembly'’ and “integrated device” are used interchangeably.

[00100] The integrated device 100 may also include a depth guide 110. A portion of the trocar 106 is configured to be disposed within the portal cannula 102. The depth guide 110 may be at least partially disposed within the trocar handle 108.

[00101] The portal cannula 102 may be the conduit through which working instruments, e.g., a bone auger, bone rongeur, or tissue sculptor, may be advanced to perform a spinal procedure. The portal cannula 102 may also be the conduit within which the trocar 106 is slidingly disposed when percutaneously accessing the spinal region.

[00102] The portal cannula 102 may have a proximal end, a distal end, and an outer surface. A lumen may extend within the portal cannula 102 from the proximal end to the distal end. Additionally, the portal cannula 102 may create a single access point via which working instruments may be advanced to perform spinal procedures, e.g., lumbar decompression. In some examples, lumbar decompression and other spinal procedures may be performed unilaterally, bilaterally, and/or at multiple levels through the single access point.

[00103] The portal cannula 102 may be made from stainless steel, nitinol, or alloys thereof. In some examples, the portal cannula 102 may comprise a hypotube. A coating may be placed on the outer cannula surface to provide anti-fouling and/or antimicrobial properties to the cannula. The coatings may generally comprise a polymeric material. Example polymeric materials may include without limitation, hydrophilic polymers, hydrophobic polymers, and mixtures of these two types of polymers.

[00104] The working length of the portal cannula 102 may vary depending on such factors as the particular spinal procedure being performed, the size of the patient, and/or patient age, and may range from about 6 centimeter (cm) to about 20 cm, including all values and sub-ranges therein. For example, the working portal cannula length may be about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, or about 20 cm. When additional length is needed, the working portal cannula length may range from about 21 cm to about 35 cm, including all values and sub-ranges therein.

[00105] For example, the working portal cannula length may be about 21 cm, about 22 cm, about 23 cm, about 24 cm, about 25 cm, about 26 cm, about 27 cm, about 28 cm, about 29 cm, about 30 cm, about 31 cm, about 32 cm, about 33 cm, about 34 cm, or about 35 cm. Accordingly, the portal cannula 102 may have an overall length ranging from about 6 cm to about 35 cm, including all values and sub-ranges therein. For example, the overall portal cannula length may be about 6 cm, about 7 cm, about 8 cm, about 9 cm. about 10 cm. about 11 cm, about 12 cm, about 13 cm. about 14 cm. about 15 cm. about 16 cm. about 17 cm. about 18 cm, about 19 cm, about 20 cm. about 21 cm. about 22 cm. about 23 cm. about 24 cm. about 25 cm, about 26 cm, about 27 cm. about 28 cm. about 29 cm. about 30 cm. about 31 cm. about 32 cm, about 33 cm, about 34 cm, or about 35 cm.

[00106] Similarly, the outside diameter (OD) and inside diameter (ID) of the portal cannula 102 may vary depending on such factors as the particular spinal procedure being performed, the size of the patient, and/or patient age. The portal cannula 102 may have an OD ranging from about 1.0 millimeter (mm) to about 30 mm, and an ID ranging from about 0.5 mm to about 29.5 mm, including all values and sub-ranges therein.

[00107] For example, the OD may be about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm. about 4.0 mm, about 4.5 mm, about 5.0 mm. about 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, about 5.5 mm, about 5.6 mm. about 5.7 mm, about 5.8 mm, about 5.9 mm, about 6.0 mm, about 7.0 mm, about 8.0 mm. about 9.0 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm. about 16 mm, about 17 mm, about 18 mm. about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm. The ID may be about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4. 1 mm, about 4.2 mm, about 4.3 mm, about 4.4 mm, about 4.5 mm, about 4.6 mm, about 4.7 mm, about 4.8 mm, about 4.9 mm, about 5.0 mm, about 5.5 mm, about 6.0 mm, about 6.5 mm, about 7.0 mm, about 7.5 mm, about 8.0 mm, about 8.5 mm, about 9.0 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, about 15 mm, about 15.5 mm, about 16 mm, about 16.5 mm, about 17 mm, about 17.5 mm, about 18 mm, about 18.5 mm, about 19 mm, about 19.5 mm, about 20 mm, about 20.5 mm, about 21 mm, about 21.5 mm, about 22 mm, about 22.5 mm, about 23 mm, about 23.5 mm, about 24 mm, about 24.5 mm, about 25 mm, about 25.5 mm, about 26 mm, about 26.5 mm, about 27 mm, about 27.5 mm, about 28 mm, about 28.5 mm, about 29 mm, or about 29.5 mm. In one example, the OD may be about 5.2 mm (0.203 inches), and the ID may be about 4.7 mm (0. 184 inches).

[00108] A hub may be coupled or fixed to the proximal end of the portal cannula 102 by any suitable method, for example, using a friction fit or an adhesive. In some examples, the hub may be over-molded onto the proximal end of the portal cannula 102. The hub may be made from various polymeric or metallic materials. Example polymeric materials may include without limitation, Acrylonitrile butadiene styrene (ABS) Polycarbonate, or ABS/Poly carbonate blends. Non- limiting examples of metals that the hub may be made from include stainless steel, nitinol, and alloys thereof.

[00109] The hub may include one or more features configured to limit travel of the trocar with respect to the portal cannula. The travel limit may be a useful safety feature in cases in which the depth guide 110 is removed to increase the working length of the instruments (e.g., when the surgeon treats multiple spinal levels) and the depth guide 110 is not reattached before inserting the trocar 106 to treat the next level. In this instance the hub may limit advancement of the trocar 106 so that its penetrating tip does not injure non-target anatomy.

[00110] For example, the size and/or shape of the hub may provide a surface against which the trocar handle 108 of the trocar 106 may contact to prevent further advancement of the trocar 106 through the portal cannula 102. In these instances, the diameter of at least a portion of the hub may be larger than the diameter of the distal portion of the trocar handle 108 to create an interference fit with the trocar handle 108 such that travel of the trocar 106 is limited.

[00111] In addition to having a larger diameter than the distal portion of the trocar handle 108, the hub may be variously shaped. For example, the cross-sectional shape of the hub may be a circle, hexagon, or square. In some examples, the hub may include a body and a plurality of fins that extend radially outwardly from the body to limit travel of the trocar 106. The number of fins may range from two to six. For example, the hub may include two, three, four, five, or six fins. In some examples, more than six fins may be included.

[00112] The plurality of fins may also be variously angled with respect to the hub body. Each of the plurality of fins may have the same angle with respect to the hub body, or one or more of the fins may have a different angle than one or more other of the fins. Furthermore, the plurality of fins may be symmetrically or asymmetrically spaced about the hub body. Each of the plurality of fins may also have any length suitable to create an interference fit with the trocar handle 108 such that travel of the trocar 106 is limited, and each of the plurality of fins may have the same or different lengths.

[00113] Figure 2A illustrates a side view of a portal cannula 200 including a hub 202 at its proximal end 204 having a hexagonal cross-sectional shape, and Figure 2B illustrates an end view of the portal cannula 200 of Figure 2A, according to an example implementation. The hub 202 has a hexagonal cross-sectional shape as shown in Figure 2B.

[00114] Figure 3A illustrates a side view of a portal cannula 300 including a hub 302 at its proximal end 306 having a plurality of fins, and Figure 3B illustrates an end view of the portal cannula 300, according to an example implementation, the portal cannula 300 may have a base 308 from which a plurality of fins 304 outwardly extend. Although the base 308 is shown as having a hexagonal shape, it is understood that other shapes may be used. Similarly, although the base 308 is shown as having three fins 304, any suitable number of fins may be employed.

[00115] Figure 4A illustrates a side view of a portal cannula 400 including a circular hub 402 at its proximal end 406 having a circular cross-sectional shape and flanges that help limit further travel of a trocar, and Figure 4B illustrates an end view of the portal cannula 400, according to an example implementation. A ring 404 that extends circumferentially about the circular hub 402 may function as a stop that limits further travel (e.g., advancement) of the trocar.

[00116] The portal grip (e.g., the portal grip 104) may be configured to hold the portal cannula and may be slidably attached thereto. In use, the portal grip may be slid along the length of the portal cannula to a position that seats it against the skin surface and provides a target cannula length within the body. The portal grip may be locked at this position to prevent or provide resistance against further advancement of the portal cannula into the body. Once the target depth of the portal cannula is set, working instruments such as the bone auger, bone rongeur, tissue sculptor, etc., may be advanced through the portal cannula.

[00117] The portal grip may also function as a fulcrum point for the portal cannula, and thus may be configured for smooth manipulation, e.g., rotation, against the skin surface when moving the working instrument to position it between the lamina. Accordingly, some examples of the portal grip may be configured to include a housing having at least a portion that is spherically shaped so that the portal grip is atraumatic during pivoting or other movement against skin. In housings having other shapes, e.g., square or rectangular shapes, the comers may be radiused so that damage to the skin surface is prevented. The housing of the portal grip may also include a lumen and a lock assembly configured to releasably secure the portal grip at one or more positions along a length of the portal cannula.

[00118] When the housing of the portal grip has at least a portion that is spherically shaped, the housing may comprise a ball structure having a waist region. The ball structure may include a first component coupled to a second component comprising the waist region. The waist region may include a midsection having a smaller diameter than both ends thereof, giving the waist region an hour-glass profile. A proximal end of the waist region may be configured to couple to the depth guide. The hourglass shape of the waist region may accommodate various hand positions, and may provide a pinky finger rest for comfort as well as allow thumb and forefinger access to the depth guide when working instruments are used. Additionally, the smaller diameter portion of the waist region may help secure the position of the portal grip along the portal cannula.

[00119] The hemispheres of the ball structure may have a diameter ranging from about 0. 1 cm to about 10 cm, including all values and sub-ranges therein. For example, the ball structure diameter may be about 0.1 cm, about 0.5 cm, about 1.0 cm, about 1.5 cm, about 2.0 cm, about 2.5 cm, about 3.0 cm, about 3.5 cm, about 4.0 cm, about 4.5 cm, about 5.0 cm, about 5.5 cm, about 6.0 cm, about 6.5 cm, about 7.0 cm, about 7.5 cm, about 8.0 cm, about 8.5 cm, about 9.0 cm, about 9.5 cm, or about 10 cm. In some examples, e.g., when the portal cannula has a larger diameter, the diameter of the ball structure may be greater than 10 cm. As mentioned above, the waist region of the ball structure may include a midsection having a smaller diameter than both of its ends. The ends of the waist region may have a diameter that matches the ball structure, and thus may range from about 1.0 cm to about 10 cm, including all values and subranges therein. For example, the end diameters may be about 1.0 cm, about 1.5 cm, about 2.0 cm. about 2.5 cm, about 3.0 cm, about 3.5 cm, about 4.0 cm. about 4.5 cm, about 5.0 cm, about

5.5 cm, about 6.0 cm, about 6.5 cm, about 7.0 cm, about 7.5 cm, about 8.0 cm, about 8.5 cm, about 9.0 cm, about 9.5 cm, or about 10 cm. In some instances, the diameter of one or both ends of the waist region may be smaller than that of the ball structure. The midsection of the waist region may have a diameter that is smaller, for example, about half the diameter of the ball structure, ranging from about 0.5 cm to about 5.0 cm, including all values and sub-ranges therein. For example, the diameter of the midsection may be about 0.5 cm, about 1.0 cm, about

1.5 cm, about 2.0 cm, about 2.5 cm, about 3.0 cm, about 3.5 cm, about 4.0 cm, about 4.5 cm, or about 5.0 cm.

[00120] The components of the portal grip may be made from the same material or different materials. For example, in some examples, the components of the portal grip may be made from otherwise comprise a polymer and/or a metal. Example polymers include without limitation, acrylonitrile butadiene styrene (ABS). polycarbonate, poly carbonate/ AB S blends, and copolymers thereof. If a metal is employed, the metal may be, for example, stainless steel, nitinol, and alloys thereof.

[00121] The portal grip may be configured in various ways so that it may be releasably secured to the portal cannula. For example, at least a portion of the portal grip may be configured to rotate to releasably secure the portal grip to the portal cannula. In this instance, a housing having a partially spherical shape may be useful. The housing may include a first component coupled to a second component, where the first component may be configured to rotate with respect to the second component to releasably secure the portal grip at one or more positions along the length of the portal cannula. Coupling of the first component to the second component may be accomplished via, for example, a threaded connection. [00122] Figure 5A illustrates a perspective view of an integrated device 500 having a portal grip 502 mounted on a portal cannula, and Figure 5B illustrates the portal grip 502 slid down to contact skin surface, according to an example implementation. The portal grip 502 may include a ball structure 504 comprising a first component 506, a second component 508, and a waist region 510.

[00123] The waist region 510 may include a first end 512, a second end 514, and a smaller diameter midsection 516 therebetween. In some instances, the first end 512 may be a distal end of the waist region 510, and have a diameter larger than the smaller diameter midsection, but larger than the second end 514, which may be a proximal end of the waist region 510.

[00124] The portal grip 502 may be slidingly advanced along portal cannula 520 to a position that seats it against skin surface 522. The portal grip 502 may be locked at this position, as further described below, and function as a fulcrum point for the portal cannula 520.

[00125] In some examples, the second end 514 of the waist region 510 may include a plurality of ribs or other surface features (e g., nubs, bristles, texturization) that help a user grip and rotate the second component 508 with respect to the first component 506.

[00126] Figure 5C illustrates a front view of the portal grip 502 including a plurality’ of surface features that may help a user grip and rotate the second component 508 of the portal grip 502 with respect to the first component 506, according to an example implementation. As shown in Figure 5C, the second end 514 of the waist region 510 may be configured to include a plurality of ribs 524 that may aid the user in rotating the second component 508 with respect to the first component 506 about the portal cannula 520.

[00127] Figure 5D illustrates a cross-sectional view of the portal grip 502, according to an example implementation. As shown, the portal grip 502 includes a collet 526, described in more detail below, concentrically disposed about the portal cannula 520 that conforms to and 1 compresses against the outer surface of the portal cannula 520 to prevent movement of the portal grip 502 along the length of the portal cannula 520.

[00128] In examples, a portal grip (e.g., the portal grip 502) may include a housing containing a lock assembly that releasably secures the portal grip to a portal cannula at one or more positions. In general, the portal grip may be locked to the portal cannula at a position where the portal grip contacts the skin surface such that it may function as a fulcrum for the portal cannula.

[00129] Additionally, the lock assembly may be configured to maintain the position of the portal grip along the length of the portal cannula irrespective of additional lubricity from exposure to fatty lipids or a body fluid. The lock assembly may have various configurations and may be generally configured for use with a single hand.

[00130] In some examples, the lock assembly may include a collet configured to be concentrically disposed about the portal cannula. The collet may be configured to conform to and compress against the outer surface of the portal cannula to prevent movement of the portal grip along the length of the portal cannula. The collet may be made, for example, from polymeric materials. Non-limiting examples of polymeric materials include acrylonitrile butadiene styrene (ABS), polycarbonate, poly carbonate/ ABS blends, and copolymers thereof.

[00131] In one example, the collet may be circumferentially disposed about the portal cannula and configured to compress against the outer surface of the cannula when the first and second portal grip components are rotated, e.g. with right-handed threading (clockwise rotation to tighten and counterclockwise rotation to loosen). Ramps provided within one or both portal grip hemispheres may aid in collet compression.

[00132] Figure 6A illustrates a front view of a lock assembly comprising a portal grip housing including rotating hemispheres and a conformable collet. Figure 6B illustrates a cross-sectional view of the lock assembly of Figure 6A in a first state, and Figure 6C illustrates a crosssectional view of the lock assembly of Figure 6A in a second state, according to an example implementation. Particularly, a portal grip 600 may have a first component such as proximal hemisphere 602 including a ramp 604 coupled to a second component such as distal hemisphere 606 via a threaded connection 608.

[00133] Clockwise rotation of the proximal hemisphere 602 with respect to the distal hemisphere 606, as indicated by arrow 610, may cause the two hemispheres 602, 606 to translate axially towards each other, as shown by arrow 612. This axial translation may result in the ramp 604 compressing the collet 614. which is circumferentially disposed about a portal cannula 618 within a portal grip lumen 603, against a outer surface 616 of the portal cannula 618, as shown by arrows 620. As further engagement with the ramp 604 is achieved, compression of the collet 614 against an outer surface 616 of the portal cannula 618 may be increased, thereby temporarily locking the position of the portal grip 600 on the portal cannula 618.

[00134] In another example, a lock assembly may comprise a collet having a plurality of fingers spaced about a circumference of the collet. The plurality of fingers may include between two to six fingers. For example, the plurality of fingers may include two, three, four, five, or six fingers. In some cases, the collet may include more than six fingers (e.g., seven, eight, nine, ten, or more fingers). The plurality of fingers may be spaced apart by channels and symmetrically or asymmetrically spaced about the collet circumference.

[00135] In some examples, the collet comprises three fingers that are spaced 120 degrees about the collet circumference and three channels that are also spaced 120 degrees apart. The channels may provide space for the collet to compress against the portal cannula. Furthermore, the channels may include an open end and a closed end. The open ends of adjacent channels may be on opposite sides of the collet. [00136] The length of the fingers may generally be the same as the length of the collet, which may range from about 8 mm to about 20 mm, including all values and sub-ranges therein. For example, finger length may be about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm. In one example, the finger length may be about 9 mm. In some examples, the length of the fingers may be shorter than the length of the channel. In some instances, the length of the fingers may be longer than 20 mm.

[00137] Figure 7A illustrates a front view of another lock assembly comprising a collet 700 having a plurality of fingers 702 separated by a plurality of channels 704, according to an example implementation. As shown, the collet 700 may include a first end 706 and a second end 708.

[00138] Each of the plurality of channels 704 has an open end 710 and a closed end 712. The open ends 710 of adjacent channels may be disposed on different ends of the collet, e.g., an open end of a channel may be disposed on the first end 706 of the collet 700 and the closed end of the channel may be disposed on or facing the second end 708 of the collet 700.

[00139] Similarly, the closed ends 712 of adjacent channels may be disposed on or facing different ends of the collet 700. It should be appreciated that one or more channels may not extend the entire length of the collet 700 and the closed ends 712 of one or more channels may be inset from the end of the collet 700 as depicted in Figure 7A.

[00140] Although Figures 7A-7B show the collet 700 having six fingers and six channels symmetrically spaced about the circumference of the collet 700, in other examples, a lower number of channels may be used, and/or they may be asymmetrically spaced apart. The channels may provide space for the fingers of the collet 700 to expand against the portal cannula when compressed. The fingers may also help ensure that the compressive force is evenly distributed on the portal cannula.

[00141] Some examples of the lock assembly may include a cam lock. The cam lock may include a split spiral cam that may be configured to tighten around the portal cannula when rotated. The split spiral cam may be disposed within a notch in the housing of the portal grip, and coupled to either the first component (e.g., a proximal hemisphere) or the second component (e.g., a distal hemisphere) of the portal grip. In order for the split spiral cam to tighten upon application of a rotational force, the inner diameter friction of the cam against the portal cannula may be greater than the outer diameter friction of the cam against the portal grip housing. Similar to the collet, the split spiral cam may be made from, for example, polymeric materials. Non-limiting examples of polymeric materials include acrylonitrile butadiene styrene (ABS). polycarbonate, poly carbonate/ ABS blends, and copolymers thereof.

[00142] Figure 8 A illustrates a front view of a split spiral cam 800 of another locking assembly, and Figure 8B illustrates a top view of the split spiral cam 800, according to an example implementation. As shown, the split spiral cam 800 has a split 802 that forms two free ends 812, 814.

[00143] Figure 8C illustrates a cross-sectional front view of a portal grip 804 including the split spiral cam 800, and Figure 8D illustrates a cross-sectional top view of the portal grip 804, according to an example implementation. As shown in Figure 8C, when the split spiral cam 800 is provided within a groove 816 of a proximal hemisphere 818 of portal grip (804), rotation (e.g.. clockwise rotation) of the portal grip 804 in the direction of arrow 806 may tighten the split spiral cam 800 about portal cannula 820, thereby securing the portal grip 804 to the portal cannula 820. [00144] The split spiral cam 800 may have an inner diameter 808 and an outer diameter 810. The friction of the inner diameter 808 against the portal cannula 820 may be greater than the friction of the outer diameter 810 against the portal grip 804 upon rotation, as previously mentioned, so that the free ends 812, 814 of the split spiral cam 800 may tighten around the portal cannula 820 upon application of a rotational force.

[00145] In another example, and to aid with rotation and tightening of the split spiral cam, a toggle may be attached thereto to rotate the cam into the locked and unlocked positions.

[00146] Figure 9A illustrates a split spiral cam 904 including a toggle 900 to aid with rotating the split spiral cam into locked and unlocked positions, Figure 9B illustrates a perspective view of a portal grip having the split spiral cam 904 in a first position, Figure 9C illustrates a perspective view of the portal grip having the split spiral cam 904 in a second position, Figure 9D illustrates a top view of the portal grip depicting the split spiral cam 904 in the first position, and Figure 9E illustrates a top view of the portal grip depicting the split spiral cam 904 in the second position, according to an example implementation. Figures 9A-9E are described together.

[00147] When the toggle 900 is rotated within a slot 908 in a portal grip housing 910 from position A (shown in Figures 9B, 9D) in the direction of arrow 906 to position B (shown Figures 9C, 9E), the split spiral cam 904 may then also rotate within a corresponding cam rider groove 902 within the portal grip housing 910. Given the spiral geometry of the split spiral cam 904 and the cam rider groove 902. the outer surface of the cam rider groove 902 constricts around the split spiral cam 904 as the split spiral cam 904 is rotated to travel along the cam rider groove 902, thereby constricting and compressing the split spiral cam 904 against a portal cannula (not shown) within a central opening 905. [00148] In some examples, the portal grip itself may function as a toggle lever when axially aligned with the portal cannula to releasably secure the portal grip to the portal cannula.

[00149] Figure 10A illustrates a front view of a portal grip 1000 in a first position, and Figure 10B illustrates a front view of the portal grip 1000 in a second position, according to an example implementation. The portal grip 1000 is configured to function as a toggle lever.

[00150] More specifically, when the portal grip 1000 is in a lateral orientation, it may be free to slide along a portal cannula 1002 in the direction of the arrows. However, when flipped (e.g., rotated 90 degrees) to a vertical orientation, as shown in Figure 10B, the portal grip 1000 may be locked to the portal cannula 1002. Flipping the portal grip 1000 back to the lateral orientation unlocks it, allowing the portal grip 1000 to again be capable of sliding along the portal cannula 1002 to another position thereon.

[00151] When the portal grip 1000 functions as a toggle lever, the lock assembly may include one or more components within a housing of the portal grip 1000 that may be compressed to releasably secure the portal grip 1000 to the portal cannula 1002. In one example, the locking assembly may comprise a cam rider, a compliance member, a ramp, and any one of the collets described herein.

[00152] Figure 10C illustrates a cross-sectional view of the portal grip 1000 in the first position, and Figure 10D illustrates a cross-sectional view of the portal grip 1000 in the second position, according to an example implementation. As shown in Figures 10C-10D, a cam rider 1004 may be coupled to the housing of the portal grip 1000.

[00153] In the lateral orientation show n in Figure 10C, the cam rider 1004 and a ramp 1008 are shown in their initial configurations. A compliance member (e.g., an O-ring 1006) and collet 1 10 are shown in their uncompressed configurations. [00154] Upon rotation of the portal grip 1000 from the lateral to the vertical orientation, as shown in Figure 10D, the cam rider 1004 may be displaced in a downward direction, as shown by arrows “D”. Displacement of the cam rider 1004 may then compress the compliance member (e.g., O-ring 1006) and downw ardly displace the ramp 1008, which in turn compresses the collet 1010 against the portal cannula 1002 in the direction of arrow s “C”. Internal ramps 1012 on an aligning guide 1014 may also help compress the collet 1010 axially inward tow ards the surface of the portal cannula 1002.

[00155] In other examples, the lock assembly may comprise a portal grip housing configured to be slidably disposed on the collet. The portal grip housing may maintain the collet in the compressed (locked) state when entirely covering the collet, and may release the compression to transition the collet to the unlocked state when retracted, such that at least a portion of the collet is not covered by the portal grip housing.

[00156] Figure HAillustrates a side view of a spherical portal grip housing 1100 for a locking assembly, Figure 11B illustrates a collet 1102 comprising a plurality of jaws 1104 and a spring mount 1106, Figure 11C illustrates a spring 1108 of the locking assembly, and Figure 11D illustrates a w aist 1110 of the locking assembly, according to an example implementation. The spherical portal grip housing 1100 is configured to be mounted or coupled to the waist 1110.

[00157] The plurality' of jaws 1104 of the collet 1102 are configured to be biased to an expanded (unlocked) state via the spring 1108. The collet 1102 may be made from compressible materials as previously described.

[00158] Figure HE illustrates a perspective view of the locking assembly with the plurality' of jaws 1104 in a compressed configuration, according to an example implementation. When assembled, as shown in Figure HE, the spherical portal grip housing 1100 may be disposed about the collet 1102 and biased by the spring 1108 on the spring mount 1106 to hold the plurality of jaws 1104 (e.g., three jaws as depicted) in their compressed configuration. In this compressed configuration, the plurality' of jaws 1104 may releasably secure the spherical portal grip housing 1100 to the portal cannula (not shown). When repositioning is desired, the spherical portal grip housing 1100 may be retracted in the direction of arrow “R’‘.

[00159] Figure 1 IF illustrates a perspective view of the locking assembly with the plurality of jaws 1104 in an uncompressed configuration, according to an example implementation. As shown in Figure 1 IF, retraction of the spherical portal grip housing 1100 may remove the compressive force from the plurality of jaws 1104 such that they transition to their expanded state.

[00160] In other example implementations, the lock assembly may also comprise a pressable portion of a portal grip, such as a push button, and a clamp. In these examples, the push button may be depressed to compress a spring, which in turn unlocks the portal grip from the portal cannula. The push button may be released to lock the portal grip thereto.

[00161] Figure 12A illustrates a perspective view of a push button lock assembly, and Figure 12B illustrates a perspective cross-sectional view of the push button lock assembly of Figure 12A, according to an example implementation. The push button lock assembly includes a portal grip 1200 that may have a rectangular cross-sectional shape. The comers of the portal grip 1200 may be radiused so that movement thereof against the skin surface does not cause tissue damage.

[00162] A spring 1206 and a spring cap 1212 may bias a button 1202 to an undepressed/locked state, as shown in Figure 12B. When the button 1202 is depressed in the direction of arrow 1208 to overcome the force from the spring 1206, the clamp 1210 moves laterally, also in the direction of arrow 1208, to loosen the clamp 1210 about the portal cannula (not shown), which is disposed through portal 1204, on the opposing side, thereby releasing the portal grip 1200 from the portal cannula.

[00163]

[00164] The integrated devices described herein may include a trocar slidingly disposed within the portal cannula lumen. The trocar may comprise an awl or shaft having a proximal end, a distal end, and a distal tip that is generally sharp so that it may be used to percutaneously create a tunnel through tissue to a spinal region for performing a spinal procedure. A handle may be provided at the proximal end of the awl to help with trocar manipulation. In some examples, the handle may be T-shaped to accommodate a variety of hand postures, provide a more comfortable wrapped-fmger-controlled posture upon insertion and extraction of the trocar, as well as a more comfortable steering posture upon insertion. After access to the spinal region is created, the trocar may be withdrawn, leaving the portal cannula within the percutaneously created passage.

[00165] The awl or shaft may be made from metals such as, for example, stainless steel, nitinol, and/or alloys thereof. With respect to the trocar handle, it may be made from the same polymers as the portal grip and collet. These polymers include without limitation, acrylonitrile butadiene styrene (ABS), polycarbonate, poly carbonate/ ABS blends, and copolymers thereof.

[00166] Figure 13 illustrates a side view⁷ of a trocar 1300, according to an example implementation. The trocar 1300 has an awl 1302 having a proximal end 1304 and a distal end 1306. Ahandle 1308 (e.g., tee-shaped handle) may be attached to the proximal end 1304. The distal end 1306 may include a sharp tip 1310 for penetrating tissue.

[00167] In this example implementation, the handle 1308 may provide a larger grip area for improved handling of the trocar 1300 as w ell as increased comfort when the fingers of the user are distributed to hold the trocar 1300. For example, a portion of a grip 1312 on each side of the handle 1308 may be about 2.0 cm.

[00168] A handle of a trocar may be comprised of a single component or multiple parts that are coupled together. In an example in which the handle comprises multiple parts (e.g., two, three, four, or more), the parts may be coupled to one another via a snap-fit or interference fit connection, magnetic connection, and/or by amechanical connector, e.g., athreaded connector.

[00169] Figure 16A illustrates a partial perspective exploded view of a trocar handle including a housing 1602 and an insert 1604. Figure 16B illustrates a perspective view of the insert 1604, Figure 16C illustrates a perspective interior view of the housing 1602, and Figure 16D illustrates a cross-sectional view of the insert 1604 connected to the housing 1602 of the trocar handle, according to an example implementation. In an example, the insert 1604 may include a plurality⁷ of (e.g., two, three, four, or more) posts 1606 that couple to (e.g., may be received within) corresponding recesses 1608 in the housing 1602. In some examples, the posts 1606 and the recesses 1608 may be coupled to one another using an interference fit.

[00170] As shown in Figure 16C, the posts 1606 may have a cruciform cross-sectional profile, but other cross-sectional shapes may be used, e.g., circular, ovular, triangular, square, etc., as long as the post is capable of securely fitting within, or otherwise coupling to, the recess 1608. The insert 1604 and the housing 1602 may be made from polymers such as, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate, polycarbonate/ABS blends, and copolymers thereof, as examples.

[00171] A depth guide (e.g., the depth guide 110 of Figure IB) of any of the integrated devices described herein may be removably coupled to the hub of the portal cannula via any suitable connection, e.g., via a snap-fit or interference fit connection, magnetic connection, and/or by a mechanical connector, e.g., a threaded connector. The depth guide may be configured to transfer rotational movement into linear movement, and control the amount of extension of a working instrument from the portal cannula, as further described below. The depth guide (e.g., the depth guide 110 in Figure IB) of the integrated device may function by threading or unthreading two components to telescope them at user defined lengths. In addition, the depth guide may be detachable to facilitate the need for additional working length.

[00172] The depth guide may include a knob and a graduation scale that represents the disposition of instruments with respect to the distal tip of the portal cannula. The initial position of the depth guide may represent 15 mm of instrument extension from the portal cannula distal tip. Instrument extension may range from about 22.5 mm to about 10 mm (which allows the instrument to translate axially about 12.5 mm). Additionally, the depth guide may be configured to provide tactile feedback of depth with a click (e.g.. audible or non-audible) about every 2.5 mm of translation (e.g., every half knob rotation).

[00173] Figure 14A illustrates a depth guide 1400 in a first state, Figure 14B illustrates the depth guide 1400 in a second state, and Figure 14C illustrates the depth guide 1400 in a third state, according to an example implementation. The depth guide 1400 is shown attached to a hub 1402 of a portal cannula 1404.

[00174] The depth guide 1400 may include a knob 1406 and a graduation scale 1408. At the initial position shown in Figure 14A, the graduation scale 1408 may indicate that an instrument is extended about 15 mm from the portal cannula distal tip. When the knob 1406 is rotated counterclockwise to the full extent, the graduation scale 1408 may indicate that an instrument is extended about 10 mm from the portal cannula distal tip (see Figure 14B). When the knob 1406 is rotated clockwise to the full extent such that the knob 1406 contacts a portal cannula hub 1405, the depth guide 1400 may allow the maximum amount of instrument extension (see

Figure 14C). [00175] Figure 17Aillustrates aperspective view of another integrated device 1700 comprising a portal cannula 1702, a portal grip 1704, and a trocar, Figure 17B illustrates an exploded view of the integrated device 1700, Figure 17C illustrates a connector 1712 for attaching a depth guide 1710 to a hub 1706 of the portal cannula 1702 of the integrated device 1700, and Figure 17D illustrates a cross- sectional view of the integrated device 1700, according to an example implementation. The portal cannula 1702 and the portal grip 1704 are similar to the portal cannula 520 and the portal grip 502, respectively, described in more detail with respect to Figures 5C-5D above.

[00176] The portal grip 1704 may be slidingly attached to the portal cannula 1702 and may be held at a particular axial location along the portal cannula 1702 when in a locked configuration, for example, when collet 1724 shown in Figure 17D is compressed against the portal cannula 1702. The portal cannula 1702 may include a hub 1706 at its proximal end 1708.

[00177] A trocar 1714 including a handle 1716 at its proximal end and a sharp tip 1718 at its distal end may extend through the portal cannula 1702. Furthermore, the connector 1712 having a proximal end 1701 and a distal end 1703 may be used to releasably couple (e.g., attach and detach) the depth guide 1710 to the hub 1706.

[00178] More specifically, the proximal end 1701 of the connector 1712 may be configured to releasably couple to a distal end 1705 of the depth guide 1710. Coupling may be accomplished via a snap-fit or interference fit connection, by a threaded connection, or by a magnetic connection. As shown in Figures 17C-17D, the distal end 1703 of the connector 1712 may include detents 1720 configured to releasably couple (e.g., by a snap-fit connection) to the hub 1706. Although detents 1720 providing a snap-fit connection are shown in Figures 17C-17D, the distal end of the connector 1712 may attach and detach to the hub 1706 in other ways, e.g., by an interference fit connection, threaded connection, or a magnetic connection. [00179] In some examples, it may be desirable to guide the working instruments (e.g., a trocar or access auger) as they are inserted into the portal of the integrated devices. For example, a funnel may be positioned at the proximal end of the integrated device (e.g., within the depth guide) to facilitate insertion and removal of various working instruments.

[00180] Figure 21 illustrates a cross-sectional view of an integrated device 2100 having a funnel 2102, Figure 22 illustrates a partial, transparent, perspective view of the integrated device 2100, according to an example implementation. The integrated device 2100 may represent the integrated device 1700 having the depth guide 1400, for example.

[00181] In some examples, the funnel 2102 may be positioned within the depth guide 1400. For instance, the funnel 2102 may be positioned within the knob 1406 of the depth guide 1400 as shown in Figure 22. In other examples, the funnel 2102 may be positioned within the portal grip-

[00182] Figure 23 A illustrates a partial perspective view of the integrated device 2100 with the funnel 2102 positioned within the depth guide 1400, and a trocar 2104 disposed through the funnel 2102, and Figure 23B illustrates a partial side view of the integrated device 2100 of Figure 23 A, according to an example implementation. As shown, a working instrument such as the trocar 2104 may be inserted through the portal of the integrated device 2100, with the funnel 2102 configured as a guide for the trocar 2104.

[00183] In an example implementation, the funnel 2102 may be configured as a single component. For example, the funnel 2102 may be configured as a metal insert disposed within the depth guide 1400 or the portal grip. In other examples, the funnel 2102 may include more than one component.

[00184] Figure 24A illustrates a perspective view of the funnel 2102, according to an example implementation. As shown, the funnel 2102 may include a funnel housing 2106 and a metal insert 2108 disposed within the funnel housing 2106. Particularly, in an example, the funnel housing 2106 may include a channel 2110 extending therethrough, and the channel 2110 may receive the metal insert 2108 therein.

[00185] In an example, the funnel housing 2106 may include a conical portion 2112 and a cylindrical portion 2114 disposed belowthe conical portion 2112. The cylindrical portion 2114 may include a retaining feature, such as one or more protrusions 2116, configured to facilitate retaining the funnel 2102 within the integrated device 2100 (e.g., within the depth guide 1400), for example.

[00186] In an example, the funnel housing 2106, and particularly the conical portion 2112, may include a ledge 2118 configured to rest on a corresponding surface of the knob 1406 of the integrated device 1700 to position the funnel 2102 relative to the depth guide 1400 as shown in Figures 21-22. The ledge 2118 may reduce or eliminate the risk that the funnel 2102 falls into the integrated device 1700 during assembly and operation.

[00187] In some examples, the funnel housing 2106, and particularly the conical portion 2112, may include one or more protrusions 2120 extending downward from the ledge 2118. The protrusions 2120 can assist in aligning the funnel housing 2106 when positioned within the integrated device 1700. The funnel housing 2106, and particularly the cylindrical portion 2114, may include one or more slots such as slot 2122 to enable the funnel housing 2106 to click on the markings as the depth guide 1400 is advanced.

[00188] The metal insert 2108 is configured to have a shape similar to that of the funnel housing 2106 to enable the metal insert 2108 to be received within, and comply with, the internal geometry and shape of the funnel housing 2106. [00189] Figure 24B illustrates a perspective view of the metal insert 2108, according to an example implementation. As shown in Figure 24B, the metal insert 2108 may include a conical portion 2124 that generally corresponds to the conical portion 2112 of the funnel housing 2106.

[00190] The metal insert 2108 may also include a cylindrical portion 2126 that generally corresponds to the cylindrical portion 2114 of the funnel 2102. With this configuration, the metal insert 2108 may have a shape that generally corresponds to, and complies with, the inner surface configuration of the funnel housing 2106.

[00191] In examples, the metal insert 2108 may include a channel 2128 as shown in Figure 24B. The channel 2128 may receive tools or working instruments, such as the trocar 2104, therethrough during use.

[00192] In examples, the funnel housing 2106 can be made of a plastic material. For example, the funnel housing 2106 can be made of stainless steel.

[00193] The metal insert 2108 is configured to be made of a metallic material that is suitable for medical applications. For example, the metal insert 2108 can be made of stainless steel. Using a metallic material for the metal insert 2108 disposed with may advantageously reduce or eliminate the risk that tools or working instruments, such as the trocar 2104. being positioned within the integrated device 2100, create plastic shavings that might then be introduced into a patient's body.

[00194] In some examples, if the hardness of the metal insert 2108 is similar to or greater than a respective hardness of the metal of the working instrument (e.g., the trocar 2104 or access auger) inserted therethrough, flutes (or blades or other parts) of such working instrument may particulate off the working instrument as it is inserted into the integrated device 2100. This may represent a risk to a patient. In these example, it may be desirable to have the metal insert 2108 made of a softer material compared to the working instrument. For example, the metal insert 2108 may have a hardness that is less than 40 Rockwell C, indicating a relatively soft steel material.

[00195] Further, in examples, the funnel 2102 (e.g., the funnel housing 2106) may be configured to have a minimum or threshold length. If the funnel 2102 has a length smaller than such threshold length, when a working instrument is being pulled out of the integrated device, it might ■■catch." or get stuck with, the funnel housing 2106 during removal.

[00196] Such minimum threshold length may depend on the diameter of the funnel housing 2106 (e.g., the diameter of the cylindrical portion 2114) and/or the taper angle of the conical portion 2112. Having the funnel 2102 configured to be longer than such minimum threshold length may prevent ‘‘catching.” As an example for illustration, the minimum threshold length could be 0.625 inches in some applications.

[00197] In the examples where the funnel 2102 is disposed within the depth guide 1400, it may be desirable for a length of the funnel 2102 to be smaller than a maximum threshold length. If the length of the funnel 2102 exceeds such threshold length, it might interfere with operation of the depth guide 1400. For instance, the funnel 2102 might prevent or interfere with actuation of the snap fingers of the depth guide 1400.

[00198] The metal insert 2108 can be coupled to the funnel housing 2106 in various ways. In one example, the metal insert 2108 can be glued to the funnel housing 2106. Using a glue can advantageously be cost-effective. Other techniques may be used if the integrated device 2100 is expected to be subjected to temperature swings that might affect performance of the glue.

[00199] In another example, the metal insert 2108 may be swaged to the funnel housing 2106 to retain the metal insert 2108 therein. Swaging the metal insert 2108 into the funnel housing 2106 may involve a metal-forming process that uses compressive forces to deform and shape the metal insert 2108. In an example, the metallic material of the metal insert 218 is deformed as it is inserted into the funnel housing 2106 in such a way to prevent removal from the funnel housing 2106 once in position.

[00200] Another example method may involve press fitting the metal insert 2108 into the funnel housing 2106. A press fitting process may be a cost-effective method compared to other methods. In another example, a snap fitting technique may be used where the metal insert 2108 may have a feature that snaps into a corresponding feature in the funnel housing 2106 to retain the metal insert 2108 to the funnel housing 2106.

[00201] In another example, an over-molding process may be used. Such process may involve combining the metal insert 2108 with the funnel housing 2106, which are made of different material, into a single part or product (e.g., the funnel 2102).

[00202] For example, over molding may involve injection molding of the funnel housing 2106 (e.g., plastic material) on or about the metal insert 2108. The result is a single component with a combination of properties from the different materials. Advantageously, over molding can provide a safer, more secure and durable grip between the metal insert 2108 and the funnel housing 2106 in some applications.

[00203] Once the target depth of the portal cannula is set, working instruments may be advanced through the portal cannula to perform a spinal procedure. As previously mentioned, examples of working instruments may be bone augers, hand-operated mechanical biting instruments such as bone rongeurs, mechanical scooping devices such as tissue sculptors, power- operated mechanical instruments such as grinders and drills, and light guiding and/or visualization devices, e.g., endoscopes.

[00204] Other examples of working instruments may include suction and irrigation catheters, sensors, monitoring devices, and electric, magnetic, electromagnetic, vibration, sound, and kinetic energy delivering components such as RF probes, ultrasound probes, ablation devices, and energy delivering wires. In some instances, the working instrument may use streams of fluid to modify tissue. In one example, working instruments for performing a laminectomy and/or removing ligamentum flavum for the treatment of spinal stenosis are advanced. In this example, working instruments may include a bone auger, a bone rongeur, and a tissue sculptor.

[00205] The integrated assembly (including, e.g., the portal cannula with a trocar removably disposed therein, a portal grip slidingly coupled to the portal cannula, and depth guide attached to the portal cannula, e.g., by a snap-fit connection) and one or more working instruments may be provided together in a kit. In some examples, the kit may include some (e.g., two or more) of the components of the integrated assembly preassembled together.

[00206] For example, the kit may include the portal cannula and portal grip preassembled together, or the kit may include the portal cannula and trocar preassembled together, etc. In other examples, the integrated assembly (e.g., portal cannula with a trocar removably disposed therein, portal grip slidingly coupled to the portal cannula, and depth guide attached to the portal cannula) may be provided fully assembled (e.g., all components are integrated together) in the kit. In further examples, the kit may provide the components of the integrated assembly separately so that they may be assembled just before use.

[00207] In some examples, the bone auger may be designed for safety. In such examples, forward advancement of the bone auger may be controlled to avoid rapid and inadvertent forward penetration which may result in damage to blood vessels, nerves, and surrounding tissues.

[00208] In some examples, the bone auger may include a rounded tip shape for safety when performing a laminectomy. The rounded tip may be polished, rough, or fluted. Additionally, the rounded tip of the bone auger may include a small flat surface at the distal most portion of the tip that is substantially perpendicular to the axis of the auger to further reduce safety risks. [00209] Other features such as the number of flutes and the helix angle may improve auguring efficiency during bone auger rotation. Furthermore, features such as helix angle, rake angle, and flute depth may improve material extraction. The flute design may be chosen to achieve multiple purposes including one or more of, without limitation, engaging with bone to advance, grinding on the bone to remove hard tissue, packing the removed hard tissue inside the hollow space between the flutes to minimize the amount of bone chip left at the treatment site, and minimizing the number of times cleaning is required.

[00210] The bone auger may comprise a plurality of flutes that may function as cutting edges along the circumference of the auger. In some examples, the number of flutes may range from 1 to 100 flutes, including all values and sub-ranges therein. In some examples, the number of flutes may range from 10 to 20 flutes. For example, the bone auger may include 10. 11. 12. 13, 14. 15, 16, 17, 18, 19, or 20 flutes.

[00211] The flutes may have a rake angle relative to the normal of the helical axis ranging from about -30 degrees to about 30 degrees. For example, the rake angle may be about -30 degrees, about -20 degrees, about -10 degrees, about 0 degrees, about 10 degrees, about 20 degrees, or about 30 degrees.

[00212] Additionally, the depth of the flutes may range from about 0.10 mm to about 2 mm, including all values and sub-ranges therein. For example, flute depth may be about 0.10 mm, about 0.20 mm, about 0.30 mm. about 0.40 mm, about 0.50 mm, about 0.60 mm. about 0.70 mm, about 0.80 mm, about 0.90 mm, about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm. about 1.6 mm, about 1.7 mm, about 1.8 mm. about 1.9 mm, or about 2.0 mm.

[00213] The plurality' of flutes may also have a helix angle ranging from about 5 degrees to about 60 degrees from the central axis of the bone auger, including all values and sub-ranges therein. For example, the helix angle may be about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, or about 60 degrees. The helix angle may define the frequency flute wrapping around the auger shaft.

[00214] The bone auger may be made from various materials having properties useful for coring bone, and which are biocompatible and corrosion resistant. Example materials may include without limitation, stainless steel and alloys thereof. In one example, 304L Stainless (no heat treatment) may be used. In another example, 17-4PH Stainless Steel Heat Treated to H900 specification may be employed.

[00215] Some examples of the integrated devices may comprise a bone auger having a lumen and any one of the portal grips described herein slidingly coupled thereto. The bone auger may function as a portal cannula, allowing a trocar, guide wire, various working instruments, or other devices used for access, diagnosis, monitoring, and/or treatment to be inserted through the bone auger lumen. In addition to the bone auger, the trocar and/or working instrument may also include a lumen. The bone auger may include threads (flutes), as described above, at its distal end.

[00216] In use, the bone auger may be placed into or near a target treatment area of the spine over a guide wire, e.g., using the Seidinger technique. One or more dilators may be advanced over the guide wire to create a tissue tract prior to advancement of the bone auger.

[00217] The one or more dilators may have a cutting tip and/or threads that allow for grinding and removal of hard tissue. In one example, a guide wire may first be inserted and advanced into or near a target treatment area. [00218] The size of the guide wire may be selected such that it is small enough to pass through calcified structures to reach the target treatment area. The bone auger may then be inserted over the guide wire.

[00219] Upon rotation, the threads of the bone auger may be used to remove bone and/or calcified structures and create a path to the treatment area. Thereafter, the guide wire may be removed and the bone auger may be used as the portal cannula through which working instruments, e.g., tissue removal instruments, may be advanced to the target treatment zone.

[00220] In some examples a trocar may be disposed within the bone auger lumen and its sharp tip used to create access to the target treatment area. The trocar may or may not include a lumen. When a lumen is present, both the bone auger and trocar may be advanced to the target treatment area over a guide wire. The components of the integrated device described above may be provided pre-assembled in a kit, or as separate components for assembly by the user.

[00221] Figure 15A illustrates a side view of an integrated device comprising a bone auger 1500, according to an example implementation. The bone auger 1500 may have a proximal end 1502 and a distal end 1504. Threads 1506 may be provided at the distal end 1504 to help create access to a target treatment area through bone and/or calcified structures by rotation of the bone auger 1500. A handle 1510 may be included at the proximal end 1502 of the bone auger 1500 that may be gripped to help with rotation of the bone auger 1500.

[00222] Figure 15B illustrates a cross-sectional view of the integrated device of Figure 15 A, and Figure 15G illustrates a cross-sectional side view of the integrated device of Figure 15 A, according to an example implementation. As shown in Figure 15B, which is a cross-sectional view taken along line B-B in Figure 15 A, and Figure 15G, which is a cross- sectional view' of the entire device, the bone auger 1500 may have a lumen 1508 extending through the handle at the proximal end 1502 and through the distal end 1504. Thus, once access is created, working instruments may be advanced through the lumen 1508 and to the target treatment area to perform a procedure or surgery.

[00223] Figure 15H illustrates an enlarged, cross- sectional view of the distal end 1 04 of the bone auger 1500 with the lumen 1508 extending therethrough, and Figure 151 illustrates a partial, perspective cross-sectional view of the integrated device of Figure 15A, according to an example implementation. As shown in Figure 15H, teeth 1518 may be included at a distal tip 1520 to further aid with grinding and penetration of hard tissue, e.g., bone.

[00224] In some examples, the teeth 1518 may be configured to flatten as the bone auger 1500 is advanced through hard tissue. In these instances, one or more of the teeth 1518 may have dimensions (e.g., size, shape, thickness) that allow' them to transition to a flat configuration as the distal tip 1520 of the bone auger 1500 passes through hard tissue, or one or more of the teeth 1518 may be made from a material capable of being filed dow n to a flat configuration as the distal tip 1520 travels through hard tissue.

[00225] While depicted above with teeth 1518, in some examples, the distal tip 1520 of the bone auger 1500 may not have teeth and may instead have continuous circumferential edge. An enlarged, cross-sectional view is also provided of the handle in Figure 151, which shows the lumen 1508 extending therethrough.

[00226] The handle of the bone auger may be variously sized and shaped. For example, the handle may have a cross-sectional shape like a T, L, or C, or may be spherical, oval, triangular, rectangular, or square. The bone auger handle may be made from the same polymer as or a different polymer than the portal grip, collet, and trocar handle. For example, the bone auger handle may comprise, without limitation, acrylonitrile butadiene styrene (ABS), polycarbonate, poly carbonate/ ABS blends, and copolymers thereof. [00227] The handle may be comprised of a single component or multiple parts that are coupled together. In an example in which the handle comprises multiple parts (e.g., two, three, four, or more), the parts may be coupled to one another via a snap-fit or interference fit connection, magnetic connection, and/or by a mechanical connector, e.g., a threaded connector.

[00228] In some examples, as shown in Figures 15C-15F, the handle 1510 may include two parts, a housing 1512 and an insert 1514. The insert 1514 may include a plurality of posts 1516 (e.g., two, three, four or more) that couple to corresponding recesses 1517 in the housing 1512 by, for example, an interference fit. In one example, the posts 1516 may have a cruciform cross- sectional profile, but other cross-sectional shapes may be used, e.g.. circular, ovular, triangular, square, etc., as long as the post is capable of securely fitting within recess 1517.

[00229] In other examples, the distal end of the portal cannula may be configured with one or more features of the bone augers described herein (e.g., threads) such that the portal cannula may act as a bone auger and create a path through hard tissue structures (e.g., bone, calcified tissues).

[00230] Figure 18 A illustrates a side, perspective view' of a device having a portal cannula 1800 that may also be used as a bone auger. Figure 18B illustrates a cross-sectional view' of the device of Figure 18A, Figure 18C illustrates an enlarged view of teeth at a distal tip of the device of Figure 18 A, and Figure 18D illustrates a trocar disposed within a lumen of the portal cannula 1800 of the device of Figure 18A. according to an example implementation. The portal cannula 1800 may comprise threads 1802 at its distal end 1804.

[00231] The portal cannula 1800 may also include a lumen 1806 extending through a hub 1808 at the portal cannula proximal end 1810 and through the distal end 1804. The lumen 1806 may allow advancement of a trocar, guide wire, various w orking instruments, or other devices used for access, diagnosis, monitoring, and/or treatment. In some examples, as shown in Figure 18C, teeth 1812 may be included at the distal tip 1814 to further aid with grinding and/or penetration of hard tissue, e.g., bone, as described above with respect to the bone auger.

[00232] In some instances, the portal cannula 1800 may function as both a trocar and a bone auger and may be configured to include both a sharp tip to allow penetration of soft tissue followed by threads configured to create a path through hard tissue. For example, as shown in Figure 18D, a trocar 1816 may be disposed within (e.g., concentrically) the lumen of the portal cannula 1800.

[00233] Although shown as being conically shaped, the trocar tip 1818 may be configured to have other geometric shapes, e.g., a pyramidal shape. The trocar tip 1818 may be a temporary structure, as further described below. The threads may be initially covered and/or the space between the threads may be initially filled with any biocompatible material that may be bioabsorbable, biodegradable, or dissolvable such that the portal cannula may be inserted without the threads interfering with the penetration through soft tissue (e.g., using the sharp trocar tip 1818). The bioabsorbable, biodegradable, or dissolvable materials may contain medications or other substances to treat the patient, e.g., reduce inflammation, control bleeding, reduce post-op pain, apply anesthesia, etc.. These substances may be released from the material as it absorbs, degrades, or dissolves. The materials employed may be configured to absorb, degrade, or dissolve within a few seconds to minutes (e.g., about 5 seconds to about 10 minutes), depending on the particular procedure, surgery, or tissue at the target treatment area. Example biocompatible materials that may be used include without limitation, one or more of metallic materials such as magnesium, zinc, and alloys thereof, and iron-based alloys, polymeric materials such as poly(L-lactide) and salicylic acid, and ceramic materials such as calcium phosphate.

[00234] In a further example, the distal end of the trocar may be configured to include a sharp tip to penetrate soft tissue and threads positioned proximally of the sharp tip, similar to those described above for the bone auger to allow for grinding and removal of hard tissue and to create a path through hard tissue structures. The threads may be initially covered and/or the space between the threads may be initially fdled with any biocompatible material that may be bioabsorbable, biodegradable, or dissolvable, and that allows for insertion of the trocar without the threads interfering with the penetration through soft tissue. The biocompatible material may be any of those described above with respect to the portal cannula. In other examples, the material may be one that breaks apart (e.g., fractures) or is stripped off upon contact with hard tissue but not soft tissue. Upon removal of the material, the threads may be exposed to engage with hard tissue. In some examples, the tip of the trocar may be made of a softer bioabsorbable material that may be shaped into the cutting tip of the trocar to initially allow penetration of the trocar into soft tissue but which becomes blunted when engaged with hard tissue.

[00235] Figures 19A-19H depict views of an example device comprising a trocar 1900 that may also be used as a bone auger. Particularly. Figure 19A illustrates a side view of a device comprising the trocar 1900 that may also be used as a bone auger, according to an example implementation. The trocar 1900 may include a proximal end 1902. a distal end 1904, a handle 1906 at the proximal end 1902, and threads 1910 and a sharp tip 1908 at the distal end 1904. The sharp tip 1908 may be a temporary structure configured to be detached, e.g.. by breaking, fracturing, or dissolving, after penetration through soft tissue and/or placement at the target treatment area.

[00236] As shown in Figures 19G-19H, the sharp tip 1908 of the trocar 1900 may have a portion configured to temporarily cover the threads 1910. As noted above, although shown as being conically shaped, the sharp tip 1908 may be configured to have other geometric shapes, e.g., a pyramidal shape.

[00237] Referring to Figures 19B-19D, the trocar 1900 may also include a lumen 1912 extending through the sharp tip 1908 and through the handle 1906. The lumen 1912 may allow advancement of a guide wire, various working instruments, or other devices used for access, diagnosis, monitoring, and/or treatment. In some examples, the sharp tip 1908 may instead be provided as part of another device that is advanced through the lumen 1912 of the trocar 1900.

[00238] For example, referring to Figures 19E-19F, an elongate needle 1914 may be advanced and retracted within lumen 1912. In this example, the sharp needle tip 1909 may also be a temporary structure configured to be detached, e.g., by breaking, fracturing, or dissolving, after penetration through soft tissue and/or placement at the target treatment area.

[00239] In another example, the integrated device may include one or more tips (e g., a trocar tip, a bone auger tip) that may be replaced with the same or a different tip. For example, the portal cannula of the integrated device may be configured at its distal end to attach to a sharp trocar tip to penetrate soft tissue.

[00240] Thereafter, the trocar tip may be replaced (e g., switched) with a blunt bone auger tip to help pass the portal through hard tissue structures without risking damage from the sharp trocar tip. Once access to the target treatment area has been created, the bone auger tip may be removed and the portal cannula reinserted.

[00241] In some examples, the one or more tips may be configured to allow penetration with a trocar, a bone auger, or working instruments. For example, the tip(s) may be equipped with a mechanism such as a push button, pull lever, or sliding doors at the tip to open the pathway for working instruments once the portal cannula is at the target treatment area. In other examples, the tip(s) may include a centrally disposed softer material in a lumen thereof through which working instruments may be advanced and retracted.

[00242] The integrated assembly device may also be configured to allow for the removal of an existing depth guide and attachment of another component, e.g., a connector, to the top of the portal cannula that allows insertion of multiple working instruments sequentially or simultaneously into the portal cannula. The connector may facilitate the sequential or simultaneous insertion of visual tools such as endoscopes, energy delivery devices, sensors, and/or other monitoring devices. It may also provide access for irrigation and suction catheters.

[00243] Figure 20 illustrates a portal cannula 2000 including multiple ports for the introduction of working instruments, according to an example implementation. An integrated device may comprise the portal cannula 2000 including a connector 2002 attached thereto via hub 2006.

[00244] The connector 2002 may include multiple ports 2004 configured for the sequential or simultaneous introduction of various working instruments into the portal cannula 2000, and/or for providing irrigation and/or suction through the portal cannula 2000. In some examples, the connector 2002 may include control mechanisms such as valves 2008 to adjust working parameters. In some examples, the connector may include a power source for any energy delivery' devices that may be used.

[00245] In some examples, the portal cannula may include tw o or more lumens for simultaneous insertion of some of working instruments and application of irrigation and/or suction. For example, visualization devices (e.g., an endoscope) may be inserted through one lumen while suction and/or irrigation is deployed through a second lumen to keep the field of view open for better visualization. In some examples, one or a plurality' of working instruments, and/or measuring devices may be deployed through the same, or one or more different lumens, than the visualization devices, simultaneously or sequentially. In some examples, visualization devices may not be used, and one or a plurality of working instruments, and/or measuring devices may be advanced through one or more lumens while a separate lumen may be used for application of irrigation and/or suction.

[00246] In some examples, the integrated device and/or w orking instruments can be packaged as a kit, for example. Figure 25 illustrates an example kit, according to an example implementation. As shown, the kit can include an integrated device 2500 including a trocar, depth gauge, portal grip, and/or portal cannula, according to implementations of the present disclosure. In some examples, the kit can include a bone auger 2502, a bone rongeur 2504, and/or a tissue sculptor 2506, according to embodiments of the present disclosure.

[00247] Methods for accessing a spinal region in a patient are also described herein. The methods may generally include percutaneously introducing a portal cannula of the integrated assembly into the spinal region. The portal cannula may be cannulated with a trocar when introduced. The portal cannula may comprise a distal tip and a proximal hub, with a portal grip shdingly disposed therebetween. After introduction, the portal cannula distal tip may be advanced to a target depth in the spinal region. Once at the target depth, the method may further include removing the trocar, sliding the portal grip along the portal cannula to contact a skin surface of the patient, and locking the portal grip at a position on the cannula to thereby hold or brace the portal cannula distal tip at the target depth. The locked position of the portal grip may be maintained along the length of the portal cannula upon exposure to fatty lipids and/or a body fluid, which may increase the lubricity of the portal cannula surface.

[00248] The single access point created by the portal cannula may be used to perform a spinal procedure at multiple spinal levels and/or both sides of the spine. For example, after a procedure is performed on one side of the spine, the portal grip may be unlocked, a trocar may be reinserted into the portal cannula, and the portal cannula may be repositioned on the other side of the spine. The portal grip may then be slid along the portal cannula to again contact the skin surface of the patient and may be re-locked at this position.

[00249] The portal grip may include a housing, and rotation of at least a portion of the housing may lock the position of the portal grip on the cannula. When a portion of the housing is spherically shaped, it may comprise a first component coupled to a second component. In this instance, locking the portal grip may include rotating the first component with respect to the second component. In other instances, locking the portal grip may include rotating the housing into axial alignment with the portal cannula.

[00250] When the portal grip includes a locking assembly, the locking assembly may comprise a collet concentrically disposed about the portal cannula, and locking the portal grip may include compressing the collet against an outer surface of the portal cannula. Instead of a collet, the locking assembly may include a spiral cam that generally effects locking of the portal grip by tightening of the spiral cam around the outer surface of the portal cannula.

[00251] The methods described herein may further include unlocking the portal grip from the portal cannula. Unlocking may be achieved in various ways. For example, unlocking may be accomplished by rotating at least a portion of the housing or by rotating the housing out of axial alignment with the portal cannula. Once unlocked, the portal grip may be slidingly advanced or retracted to a second position along the cannula, and then locked to the portal cannula at the second position. Locking and unlocking the portal grip and changing the position of the portal grip may both be accomplished using a single hand.

[00252] In some examples, the methods may include removably coupling the portal cannula to one or more system components. The one or more system components may be a trocar, portal grip, and/or a depth guide. When a depth guide is employed, the method may include receiving feedback, e.g., tactile feedback, when ascertaining an insertion depth using the depth guide. Coupling of the portal cannula to the one more system components may be achieved in various ways. For example, the proximal end of the portal cannula may be releasably coupled to the trocar by a threaded hub. Additionally or alternatively, the hub may include an outer ring that limits advancement of the trocar.

[00253] The methods may be used to perform various spinal procedures. For example, the methods may be used to remove a portion of a ligamentum flavum of the patient, to treat spinal stenosis, and/or to perform a laminectomy. Once percutaneous access to a spinal region is obtained with the systems described herein, instruments may be advanced through a lumen of the portal cannula to perform the procedure. For example, a bone auger, bone rongeur, and/or a tissue sculptor may be deployed through the lumen. The methods may further include percutaneously accessing the spinal canal and performing a spinal procedure in multiple locations along the canal, e.g., bilaterally and/or at multiple levels, from a single access point.

[00254] In some examples, the method may first include positioning the patient on the surgical or procedure table in a prone position. The patient may then be draped and prepped in the usual sterile fashion. Anesthesia may be achieved using local or regional anesthesia, and IV sedation. Next, the target spinal region on the patient may be identified and marked with ink. Fluoroscopy and/or surface landmarks may also be used to identify the target region. In some instances, an epidurogram, myelogram, or other nerve highlighting, using contrast media or other suitable material, may be performed under radiography to identify the anatomy.

[00255] An integrated assembly comprising a trocar disposed within a portal cannula, a portal grip, and a depth guide, as described herein, may then be used to percutaneously access the target spinal region, e.g., the spinal region in which ligamentum flavum is to be removed. The integrated device may be inserted through the skin and tunneled through tissue until the target spinal region is reached. In some examples, the tunneling may be accomplished under image guidance, e.g., under fluoroscopic guidance.

[00256] Next, the trocar may be removed from the portal cannula, leaving a distal end of the portal cannula in the target region, e.g., the interlaminar space. Once the portal cannula is positioned, the portal grip may be slid down the cannula to contact the skin surface and locked into place. In some examples, prior to positioning of the portal grip, the distal end of the portal cannula may be used as a bone auger to create a path through hard tissue structures (e.g., bone, calcified tissues). [00257] In these examples, the portal cannula may include threads at its distal end, as described above. The threads may be initially covered and/or the space between the threads may be initially filled with any biocompatible material that may be bioabsorbable, biodegradable, or dissolvable such that the portal cannula may be inserted without the threads interfering with its insertion. The bioabsorbable, biodegradable, or dissolvable materials may release medications or other substances to treat the patient, e.g., reduce inflammation, control bleeding, reduce postop pain, apply anesthesia, etc. These substances may be released from the material as it absorbs, degrades, or dissolves. The materials employed may be configured to absorb, degrade, or dissolve within a few seconds to minutes (e.g., about 5 seconds to about 10 minutes), depending on the particular procedure, surgery, or tissue at the target treatment area.

[00258] Working instruments may next be advanced through the portal cannula to perform the spinal procedure, e.g.. perform a lamin otomy or a laminectomy and debulk the ligamentum flavum. Examples of working instruments may be bone augers, hand-operated mechanical biting instruments such as bone rongeurs, mechanical scooping devices such as tissue sculptors, power-operated mechanical instruments such as grinders and drills, and light guiding and/or visualization devices, e.g., endoscopes.

[00259] Other examples of working instruments may include suction and irrigation catheters, sensors, monitoring devices, and electric, magnetic, electromagnetic, vibration, sound, and kinetic energy delivering components such as RF probes, ultrasound probes, ablation devices, and energy delivering wires. In some instances, the working instrument may use streams of fluid to modify tissue.

[00260] If the procedure is to be performed bilaterally or on multiple vertebral levels, the portal grip may be unlocked and the portal cannula withdrawn so that it may be repositioned to a provide access to the next spinal region. For example, upon withdrawal, a trocar may be reinserted into the portal cannula, and the portal cannula may be retracted but not removed from the patient’s back. Once repositioned in the spinal region, the trocar may be removed and the portal grip may then be slid along the portal cannula to again contact the skin surface of the patient, and the portal grip may be re- locked at this position. After completion of the spinal procedure, e.g., adequate debulking of the ligamentum flavum has been achieved, the portal grip may be unlocked and the portal cannula and the portal grip may be removed. The wound may then be closed with a sterile adhesive bandage.

[00261] In some examples, the bone auger may be used as a portal cannula to access the target treatment area. In these variations, the bone auger and trocar may include a lumen extending therethrough for the passage of a guide wire, various working instruments, or other devices used for access, diagnosis, monitoring, and/or treatment, as previously described herein. For example, the bone auger including a lumen may first be used to create access through hard tissue (e.g.. bone, calcified tissue) and then one more working instruments, e.g.. a bone rongeur and/or a tissue sculptor, may be deployed through the lumen.

[00262] In other examples, the trocar may be used as a portal cannula in addition to providing access through soft tissue. In these variations, the trocar may include a lumen extending therethrough for the passage of a guide wire, various working instruments, or other devices used for access, diagnosis, monitoring, and/or treatment, as previously described herein.

[00263] Additionally, the trocar may include threads proximal to its sharp tip configured to create a path through hard tissue structures (e.g., bone, calcified tissues). In the same manner described above with respect to the portal cannula, the threads may be initially covered and/or the space between the threads may be initially filled with any biocompatible material that may be bioabsorbable, biodegradable, or dissolvable such that the portal cannula may be introduced through soft tissue without the threads interfering with its insertion. [00264] Thus, when employed during a procedure or surgery, the sharp tip of the trocar may first be used to penetrate soft tissue followed by passage through hard tissue after removal (e.g., absorption, degradation, dissolution) of the biocompatible material with the assistance of the threads. The passage through hard tissue may in some instances transform the sharp tip of the trocar into an atraumatic tip (e.g., a blunt or rounded tip shape), or fracture (e.g., break apart) the sharp tip.

[00265] Figure 26 is a flowchart of a method 2200 of using an integrated device, according to an example implementation. For example, the method 2200 can be used for assembling and using the integrated device 2100.

[00266] The method 2200 may include one or more operations, or actions as illustrated by one or more of blocks 2202-2210. Although the blocks are illustrated in a sequential order, these blocks may in some instances be performed in parallel, and/or in a different order than those described herein. Also, the various blocks may be combined into fewer blocks, divided into additional blocks, and/or removed based upon the desired implementation.

[00267] At block 2202, the method 2200 includes providing a portal cannula (e.g., the portal cannula 1404) of an integrated device (e.g., the integrated device 2100) for accessing a spinal region of a patient, wherein the portal cannula has a proximal end and a distal end.

[00268] The term “providing” as used herein, and for example with regard to the portal cannula or other components of an integrated device, includes any action to make the portal cannula or any other component available for use, such as bringing the portal cannula to an apparatus or to a work environment for further processing (e.g., mounting other components).

[00269] At block 2204, the method 2200 includes mounting a depth guide 1400 to the proximal end of the portal cannula. [00270] At block 2206, the method 2200 includes positioning the funnel 2102, at least partially, within the depth guide 1400, wherein the funnel 2102 has a channel (e.g.. the channel 2110, 2128) formed therethrough.

[00271] At block 2208, the method 2200 includes inserting a working instrument (e.g., the trocar 2104) through the channel of the funnel 2102 and into the portal cannula.

[00272] At block 2210, the method 2200 includes advancing the depth guide 1400 to set a depth of the working instrument within the spinal region.

[00273] The method 2200 can further include any of the steps or operations described above.

[00274] The detailed description above describes various features and operations of the disclosed systems with reference to the accompanying figures. The illustrative implementations described herein are not meant to be limiting. Certain aspects of the disclosed systems can be arranged and combined in a wide variety of different configurations, all of which are contemplated herein.

[00275] Further, unless context suggests otherwise, the features illustrated in each of the figures may be used in combination with one another. Thus, the figures should be generally viewed as component aspects of one or more overall implementations, with the understanding that not all illustrated features are necessary for each implementation.

[00276] Additionally, any enumeration of elements, blocks, or steps in this specification or the claims is for purposes of clarity. Thus, such enumeration should not be interpreted to require or imply that these elements, blocks, or steps adhere to a particular arrangement or are carried out in a particular order.

[00277] Further, devices or systems may be used or configured to perform functions presented in the figures. In some instances, components of the devices and/or systems may be configured to perform the functions such that the components are actually configured and structured (with hardware and/or software) to enable such performance. In other examples, components of the devices and/or systems may be arranged to be adapted to, capable of, or suited for performing the functions, such as when operated in a specific manner.

[00278] By the term ‘'substantially’’ or ‘'about” it is meant that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those with skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.

[00279] The arrangements described herein are for purposes of example only. As such, those skilled in the art will appreciate that other arrangements and other elements (e.g., machines, interfaces, operations, orders, and groupings of operations, etc.) can be used instead, and some elements may be omitted altogether according to the desired results. Further, many of the elements that are described are functional entities that may be implemented as discrete or distributed components or in conjunction with other components, in any suitable combination and location.

[00280] While various aspects and implementations have been disclosed herein, other aspects and implementations will be apparent to those skilled in the art. The various aspects and implementations disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope being indicated by the following claims, along with the full scope of equivalents to which such claims are entitled. Also, the terminology used herein is for the purpose of describing particular implementations only, and is not intended to be limiting.

[00281] Embodiments of the present disclosure can thus relate to one of the enumerated example embodiment (EEEs) listed below. [00282] EEE 1 is an integrated device for accessing a spinal region of a patient, the integrated device comprising: a portal cannula comprising a proximal end and a distal end; a depth guide coupled to the proximal end of the portal cannula; a funnel disposed within the depth guide; and a working instrument configured to be removably inserted through a channel of the funnel and into the portal cannula, and wherein the depth guide is advanced to determine a depth of the working instrument within the spinal region.

[00283] EEE 2 is the integrated device of EEE 1, wherein the funnel comprises: a funnel housing; and a metal insert disposed within the funnel housing.

[00284] EEE 3 is the integrated device of EEE 2, wherein the funnel housing comprises: a conical portion; and a cylindrical portion coupled to the conical portion.

[00285] EEE 4 is the integrated device of EEE 3, wherein the depth guide comprises a knob, and wherein the conical portion comprises a ledge that rests against the knob of the depth guide to position the funnel within the depth guide.

[00286] EEE 5 is the integrated device of any of EEEs 3-4, wherein the metal insert comprises: a respective conical portion; and a respective cylindrical portion coupled to the respective conical portion, such that a shape of the metal insert complies with internal geometry’ of the funnel housing.

[00287] EEE 6 is the integrated device of any of EEEs 3-5, wherein the conical portion comprises one or more protrusions to facilitate aligning the funnel housing when positioned within the depth guide.

[00288] EEE 7 is the integrated device of EEE 6, wherein the conical portion comprises a ledge that rests against the depth guide, and wherein the one or more protrusions extend from the ledge. [00289] EEE 8 is the integrated device of any of EEEs 3-7, wherein the cylindrical portion comprises a retaining feature configured to facilitate retaining the funnel within the depth guide.

[00290] EEE 9 is the integrated device of EEE 8, wherein the retaining feature comprises one or more protrusions.

[00291] EEE 10 is the integrated device of any of EEEs 3-9, wherein the funnel housing comprises one or more slots configured to enable the funnel housing to click on respective markings as the depth guide is advanced.

[00292] EEE 11 is the integrated device of any of EEEs 2-10, wherein the funnel housing is made of a plastic material.

[00293] EEE 12 is the integrated device of any of EEEs 2-11, wherein the metal insert is made of a metallic material having a hardness value that is smaller than a respective hardness value of the working instrument.

[00294] EEE 13 is the integrated device of any of EEEs 2-12, wherein the metal insert is coupled to the funnel housing via a glue.

[00295] EEE 14 is the integrated device of any of EEEs 2-13, wherein the metal insert is coupled to the funnel housing via press fitting.

[00296] EEE 15 is the integrated device of any of EEEs 2-14, wherein the metal insert is coupled to the funnel housing via snap fitting.

[00297] EEE 16 is the integrated device of any of EEEs 2-15, wherein the funnel housing is made of a plastic material molded over the metal insert via an over-molding process.

[00298] EEE 17 is the integrated device of any of EEEs 2-16, wherein the channel is formed in the metal insert. [00299] EEE 18 is the integrated device of any of EEEs 1-17, wherein the funnel comprises a funnel housing having a conical portion and a cylindrical portion coupled to the conical portion, wherein the funnel has a minimum threshold length that is based on a taper angle of the conical portion and a diameter of the cylindrical portion.

[00300] EEE 19 is a method of forming and using the integrated device of any of EEEs 1-18. For example, the method comprises: providing a portal cannula of an integrated device for accessing a spinal region of a patient, wherein the portal cannula has a proximal end and a distal end; mounting a depth guide to the proximal end of the portal cannula; positioning a funnel, at least partially, within the depth guide, wherein the funnel has a channel formed therethrough; inserting a working instrument through the channel of the funnel and into the portal cannula; and advancing the depth guide to set a depth of the working instrument within the spinal region.

[00301] EEE 20 is the method of EEE 19, wherein the funnel comprises a funnel housing, and a metal insert disposed within the funnel housing, wherein inserting the working instrument through the channel of the funnel comprises: inserting the working instrument through the metal insert.

Claims

CLAIMS What is claimed is:

1. An integrated device for accessing a spinal region of a patient, the integrated device comprising: a portal cannula comprising a proximal end and a distal end: a depth guide coupled to the proximal end of the portal cannula; a funnel disposed within the depth guide; and a working instrument configured to be removably inserted through a channel of the funnel and into the portal cannula, and wherein the depth guide is advanced to determine a depth of the working instrument within the spinal region.

2. The integrated device of claim 1. wherein the funnel comprises: a funnel housing; and a metal insert disposed within the funnel housing.

3. The integrated device of claim 2. wherein the funnel housing comprises: a conical portion; and a cylindrical portion coupled to the conical portion.

4. The integrated device of claim 3, wherein the depth guide comprises a knob, and wherein the conical portion comprises a ledge that rests against the knob of the depth guide to position the funnel within the depth guide.

5. The integrated device of claim 3, wherein the metal insert comprises: a respective conical portion; and a respective cylindrical portion coupled to the respective conical portion, such that a shape of the metal insert complies with internal geometry of the funnel housing.

6. The integrated device of claim 3, wherein the conical portion comprises one or more protrusions to facilitate aligning the funnel housing when positioned within the depth guide.

7. The integrated device of claim 6, wherein the conical portion comprises a ledge that rests against the depth guide, and wherein the one or more protrusions extend from the ledge.

8. The integrated device of claim 3, wherein the cylindrical portion comprises a retaining feature configured to facilitate retaining the funnel within the depth guide.

9. The integrated device of claim 8, wherein the retaining feature comprises one or more protrusions.

10. The integrated device of claim 3, wherein the funnel housing comprises one or more slots configured to enable the funnel housing to click on respective markings as the depth guide is advanced.

11. The integrated device of claim 2, wherein the funnel housing is made of a plastic material.

12. The integrated device of claim 2, wherein the metal insert is made of a metallic material having a hardness value that is smaller than a respective hardness value of the working instrument.

13. The integrated device of claim 2, wherein the metal insert is coupled to the funnel housing via a glue.

14. The integrated device of claim 2, wherein the metal insert is coupled to the funnel housing via press fitting.

15. The integrated device of claim 2, wherein the metal insert is coupled to the funnel housing via snap fitting.

16. The integrated device of claim 2, wherein the funnel housing is made of a plastic material molded over the metal insert via an over-molding process.

17. The integrated device of claim 2, wherein the channel is formed in the metal insert.

18. The integrated device of claim 1 , wherein the funnel comprises a funnel housing having a conical portion and a cylindrical portion coupled to the conical portion, wherein the funnel has a minimum threshold length that is based on a taper angle of the conical portion and a diameter of the cylindrical portion.

19. A method comprising: providing a portal cannula of an integrated device for accessing a spinal region of a patient, wherein the portal cannula has a proximal end and a distal end; mounting a depth guide to the proximal end of the portal cannula; positioning a funnel, at least partially, within the depth guide, wherein the funnel has a channel formed therethrough; and inserting a working instrument through the channel of the funnel and into the portal cannula; and advancing the depth guide to set a depth of the working instrument within the spinal region.

20. The method of claim 19, wherein the funnel comprises a funnel housing, and a metal insert disposed within the funnel housing, wherein inserting the working instrument through the channel of the funnel comprises: inserting the working instrument through the metal insert.