Integrated instrument assembly with enhanced instruments

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 with Enhanced InstrumentsCROSS REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to U.S. Provisional Patent Application No. 63 / 717,417, filed on November 7, 2024, the entire contents of which are herein 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 fatcompresses 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 typically be treated first with exercise therapy, analgesics, or anti-inflammatory 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 openforaminotomy or laminectomy results from the tearing and cutting of the back muscles, blood vessels, supporting ligaments, and nen es. 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 procedureswould 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 and various work instruments that can be used therewith. The disclosed work instruments include a bone rongeur and a tissue sculptor that enhance material collection.

[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 3 A 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 view- 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 view 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 14A in 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 15A, 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 1 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 working instruments, according to an example implementation.

[0087] Figure 21 illustrates an integrated assembly with a bone rongeur inserted through a portal cannula, according to an example implementation.

[0088] Figure 22 illustrates a side view of the bone rongeur of Figure 21, according to an example implementation.

[0089] Figure 23 illustrates an enlarged view of a distal end of a hook rod, according to an example implementation.

[0090] Figure 24 illustrates a cross-sectional side view of the bone rongeur of Figure 21, according to an example implementation.

[0091] Figure 25 illustrates an integrated assembly with a tissue sculptor inserted through a portal cannula, according to an example implementation.

[0092] Figure 26 illustrates a side view of the tissue sculptor of Figure 25, according to an example implementation.

[0093] Figure 27 illustrates an enlarged view of a distal end of a sculptor rod, according to an example implementation.

[0094] Figure 28 illustrates a cross-sectional side view of the tissue sculptor of Figure 25, according to an example implementation.

[0095] Figure 29 illustrates a cross-sectional side view of the tissue sculptor of Figure 25 in a triggered state, according to an example implementation.

[0096] Figure 30 illustrates a cross-sectional side view of the tissue sculptor of Figure 25 in a triggered state with a tissue capture chamber being full, according to an example implementation.

[0097] Figure 31 illustrates a perspective view of a distal end of a sculptor with a bottom spoon having a hybrid scoop, according to an example implementation,

[0098] Figure 32 illustrates a top view of the distal end of the sculptor of Figure 31 with the bottom spoon having the hybrid scoop, according to an example implementation.

[0099] and Figure 33 is a top view of the hybrid scoop shown in Figures 31-32, according to an example implementation.

[0100] Figure 34 illustrates a flowchart for a method of removing bone material from a patient using a bone rongeur, according to an example implementation.

[0101] Figure 35 illustrates a flowchart for a method of sculpting tissue from a patient using a tissue sculptor, according to an example implementation.

[0102] Figure 36 illustrates a flowchart for a method of removing bone material, according to an example implementation.

[0103] Figure 37 illustrates a flowchart for a method of tissue sculpting, according to an example implementation.DETAILED DESCRIPTION

[0104] 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. 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.

[0105] 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.

[0106] 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.

[0107] In examples, disclosed herein are work instruments including a bone rongeur and a tissue sculptor that provide several advantages over existing work instruments as described below with respect to Figures 21-30.

[0108] Figure 1A 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. The integrated device 100 may also include a depth guide 110.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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. Exemplary polymeric materials may include w ithout limitation, hydrophilic polymers, hydrophobic polymers, and mixtures of these two types of polymers.

[0113] The w orking 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 centimeters (cm) to about 20 cm, including all values and sub-ranges therein. For example, the w orking 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 additionallength is needed, the working portal cannula length may range from about 21 cm to about 35 cm, including all values and sub-ranges therein.

[0114] 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.

[0115] 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.

[0116] 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, about4.3 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).

[0117] 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. Exemplary polymeric materials may include without limitation, Acry lonitrile butadiene sty rene (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.

[0118] The hub may include one or more features configured to limit travel of the trocar yvith 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.

[0119] 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.

[0120] 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.

[0121] 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 plurality7of 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.

[0122] 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.

[0123] 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 portalcannula 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 show n as having three fins 304, any suitable number of fins may be employed.

[0124] 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.

[0125] 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.

[0126] 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 laminae. 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 theportal 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.

[0127] 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 be coupled 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.

[0128] 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, about2.5 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, about5.5 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.

[0129] 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. Exemplary polymers include without limitation, acrylonitrile butadiene styrene (ABS), polycarbonate, polycarbonate / ABS blends, and copolymers thereof. If a metal is employed, the metal may be, for example, stainless steel, nitinol. and alloys thereof.

[0130] 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.

[0131] 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 mayinclude a ball structure 504 comprising a first component 506, a second component 508, and a waist region 510.

[0132] 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.

[0133] 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.

[0134] 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.

[0135] 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.

[0136] 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 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.

[0137] 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.

[0138] 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.

[0139] 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, polycarbonate / ABS blends, and copolymers thereof.

[0140] 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.

[0141] Figure 6A 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 cross-sectional view of the lock assembly of Figure 6A in a second state, according to anexample 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.

[0142] 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.

[0143] 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.

[0144] 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.

[0145] 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.

[0146] 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.

[0147] 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.

[0148] 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.

[0149] 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 cannulawhen compressed. The fingers may also help ensure that the compressive force is evenly distributed on the portal cannula.

[0150] 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.

[0151] Figure 8A 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.

[0152] 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.

[0153] 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.

[0154] 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.

[0155] 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.

[0156] 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.

[0157] 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.

[0158] 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.

[0159] 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.

[0160] 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.

[0161] 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.

[0162] In the lateral orientation shown 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 1010 are shown in their uncompressed configurations.

[0163] 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.

[0164] In other examples, the lock assembly may compnse 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.

[0165] 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.

[0166] 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.

[0167] 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 show n 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 theplurality 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’‘.

[0168] Figure 11 F 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.

[0169] 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.

[0170] 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.

[0171] A spring 1206 and a spring cap 1212 may bias a button 1202 to an undepressed / locked state, as shoyvn 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 arroyv 1208, to loosen the clamp 1210 about a cannula portal 1204 on the opposing side, thereby releasing the portal grip 1200 from the portal cannula.

[0172] 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-finger-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 w ithdrawn, leaving the portal cannula within the percutaneously created passage.

[0173] 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, polycarbonate / ABS blends, and copolymers thereof.

[0174] Figure 13 illustrates a side view 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. A handle 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.

[0175] In this example implementation, the handle 1308 may provide a larger gnp area for improved handling of the trocar 1300 as well 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.

[0176] 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.

[0177] 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 plurality 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.

[0178] As show n 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.

[0179] 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.

[0180] 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).

[0181] 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.

[0182] 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).

[0183] Figure 17A illustrates a perspective 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 aresimilar to the portal cannula 520 and the portal grip 502, respectively, described in more detail with respect to Figures 5C-5D above.

[0184] 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 ahub 1706 at its proximal end 1708.

[0185] 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.

[0186] More specifically, the proximal end 1701 of the connector 1712 may be configured to be releasably coupled 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.

[0187] 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.

[0188] 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.

[0189] 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.

[0190] 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.

[0191] 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.

[0192] 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 safety7risks.

[0193] 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.

[0194] The bone auger may comprise a plurality7of 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.

[0195] 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.

[0196] 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 1.3mm, 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.

[0197] 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.

[0198] The bone auger may be made from various materials having properties useful for coring bone, and which are biocompatible and corrosion resistant. Exemplary 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.

[0199] 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.

[0200] 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 Sei dinger technique. One or more dilators may be advanced over the guide wire to create a tissue tract prior to advancement of the bone auger.

[0201] 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.

[0202] 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.

[0203] 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.

[0204] 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.

[0205] 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. Ahandle 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.

[0206] Figure 15B illustrates a cross-sectional view of the integrated device of Figure 15A, 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-sectionalview taken along line B-B in Figure 15 A, and Figure 5G, 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.

[0207] Figure 15H illustrates an enlarged, cross- sectional view of the distal end 1504 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.

[0208] 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 down to a flat configuration as the distal tip 1520 travels through hard tissue.

[0209] 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.

[0210] 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 augerhandle may comprise, without limitation, acrylonitrile butadiene styrene (ABS), polycarbonate, polycarbonate / ABS blends, and copolymers thereof.

[0211] 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.

[0212] 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

[0213] 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).

[0214] Figure 18A 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.

[0215] The portal cannula 1800 may also include a lumen 1806 extending through a hub1808 at the portal cannula proximal end 1810 and through the distal end 1804. The lumen 1806may allow advancement of a trocar, guide wire, various working 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.

[0216] 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, atrocar 1816 may be disposed within (e.g., concentrically) the lumen of the portal cannula 1800.

[0217] 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 afew 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. Exemplary 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.

[0218] 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 filled 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.

[0219] Figures 19A-19H depict views of an exemplary 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.

[0220] 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.

[0221] 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.

[0222] 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.

[0223] 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.

[0224] 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.

[0225] 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.

[0226] 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.

[0227] 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.

[0228] 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.

[0229] In some examples, the portal cannula may include two 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 measuringdevices may be advanced through one or more lumens while a separate lumen may be used for application of irrigation and / or suction.

[0230] 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 slidingly 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.

[0231] 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.

[0232] 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.

[0233] 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 affects locking of the portal grip by tightening of the spiral cam around the outer surface of the portal cannula.

[0234] 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.

[0235] 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 or 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.

[0236] 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 / ora 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.

[0237] 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.

[0238] 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.

[0239] 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).

[0240] 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 threadsmay 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 mayrelease 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.

[0241] 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.

[0242] Figure 21 illustrates an integrated assembly 2100 with a bone rongeur 2102 inserted through a portal cannula 2104, according to an example implementation. The bone rongeur 2102 is configured to remove bone material and provides several advantages as described below.

[0243] Figure 22 illustrates a side view of the bone rongeur 2102, according to an example implementation. The bone rongeur 2102 has a handle 2200 having a handle housing 2202 with a gripper 2204 (e.g., an ergonomic pistol-style gripper).

[0244] The bone rongeur 2102 also has a trigger assembly 2206 that has a trigger lever 2208 pivotably coupled within the handle housing 2202 as described in more details below. The bonerongeur 2102 has a rongeur assembly 2210 having a tube 2212 in which a hook rod 2214 is disposed.

[0245] As described in more detail below, the tube 2212 is slidable axially relative to the handle housing 2202, while the hook rod 2214 is configured to remain stationary relative to the handle housing 2202. In other words, a distal end 2216 of the hook rod 2214 remains at a particular distance from a distal end 2218 of the handle housing 2202.

[0246] Figure 23 illustrates an enlarged view of the distal end 2216 of the hook rod 2214, according to an example implementation. As shown, the hook rod 2214 has a hook 2300 at the tip of the hook rod 2214.

[0247] The hook 2300 is configured to be anchored in a bone of a patient. The tube 2212 can then be advanced axially as described below to cut bone material from the patient.

[0248] Advantageously, in the example implementation of Figure 23, the hook 2300 faces downward. This may prevent interaction of the handle 2200 with the muscles of the patient while capturing bone material from the patient. In other words, the hook rod 2214 has a downbiting face to provide better access to the healthcare professional.

[0249] The hook 2300 has a shank 2302, a bend 2304, and a tip 2306 that bends inward as shown. With this configuration, the hook 2300 snaps onto lamina and may provide greater tactile engagement with the lamina.

[0250] Further, as shown, the hook rod 2214 has a plurality of serrations or ridges 2308 formed proximally from the hook 2300. The ridges 2308 may provide better grip and tissuetaking capabilities as the tube 2212 is advanced to cut into the bone.

[0251] In an example, the ridges 2308 may further be configured to have a roughened surface or texture to facilitates capturing bone tissue or causing the bone tissue to stick to the hook rod 2214 after capturing bone material. The texture or roughness can be implemented via severaltechniques. For example, the roughness may be a laser-generated roughness, which results from laser cutting or laser texturing. In another example, wire electrical discharge machining (EDM), which is a metal fabrication process that uses an electrically charged wire to cut or shape a conductive workpiece, might be used to impart roughness to the ridges 2308.

[0252] Referring back to Figure 22, the bone rongeur 2102 also has an ejector button 2220 that is configured to enable ejecting bone material that is captured by the bone rongeur 2102 as described below. For example, the ejector button 2220 may be a slide button that when moved or slide axially moves a rod to eject material captured by the rongeur assembly 2210.

[0253] Figure 24 illustrates a cross-sectional side view of the bone rongeur 2102, according to an example implementation. The trigger lever 2208 has a receptacle 2400 and a lever portion 2402. The trigger lever 2208 is pivotably coupled to the handle housing 2202 via a pivot 2404 (e.g., a metal pin). With this configuration, if a user places a hand inside the receptacle 2400 and squeezes the trigger lever 2208 (moves the trigger lever 2208 counter-clockwise) toward the gripper 2204, the trigger lever 2208 pivots about the pivot 2404 and the lever portion 2402 also rotates counter-clockwise.

[0254] The trigger assembly 2206 further includes a shuttle 2406 (e.g., a slidable block) that is coupled to the lever portion 2402. The shuttle 2406 is configured to move axially (along an axis of the tube 2212) within the handle housing 2202. Further, the tube 2212 is coupled to the shuttle 2406 such that the tube 2212 moves axially with the shuttle 2406.

[0255] As such, when the trigger lever 2208 is squeezed by the user, the lever portion 2402 causes the shuttle 2406 and the tube 2212 to move axially in a distal direction. The shuttle 2406 is spring-loaded via a spring 2408 that returns the shuttle 2406 and the tube 2212 in a proximal direction (to an un-triggered position shown in Figure 24) when the trigger lever 2208 is released.

[0256] Particularly, the spring 2408 is disposed about the tube 2212 such that its distal end rests against an internal web in the handle housing 2202 (and is thus fixed), while a proximal end of the spring 2408 rests against the shuttle 2406. This way, when the shuttle 2406 moves in the distal direction, the spring 2408 is compressed, and when the trigger lever 2208 is released, the spring 2408 is decompressed, pushing the shuttle 2406 and the tube 2212 coupled thereto in the proximal direction.

[0257] The tube 2212 is hollow as shown and accommodates the hook rod 2214 therein. The hook rod 2214 passes through the tube 2212 and is coupled at its proximal end to an anchoring block 2410 (which also operates as a guide block) that is affixed within the handle housing 2202. With this configuration, the tube 2212 is axially movable relative to the hook rod 2214, while the hook rod 2214 remains stationary.

[0258] The tube 2212 further accommodates an ejector rod 2412 therein. Particularly, the ejector rod 2412 extends axially through the tube 2212 to a back or proximal end of the handle housing 2202 to be coupled to an ejector block 2414. The ejector block 2414 is in turn coupled to the ejector button 2220 shown in Figure 22.

[0259] The bone rongeur 2102 further includes an ejector spring 2415 that spring-loads the ejector block 2414. Particularly, a distal end of the ejector spring 2415 rests against the anchoring block 2410, while a proximal end of the ejector spring 2415 rests against the ejector block 2414.

[0260] When a user slides the ejector button 2220 in the distal direction, the ejector block 2414 moves therewith, which in turn moves the ejector rod 2412 in the distal direction. The ejector spring 2415 may then return the ejector block 2414 and the ejector rod 2412 in the proximal direction when the ejector button 2220 is released.

[0261] In operation, the user pulls the trigger lever 2208 and squeezes it against the gripper 2204. This causes the trigger lever 2208 to rotate about the pivot 2404, causing the lever portion 2402 to rotate about the pivot 2404 counter-clockwise, pushing the shuttle 2406 in the distal direction.

[0262] The shuttle 2406 then pushes the tube 2212 coupled thereto in the axial direction, toward the hook 2300, which is anchored in a patient bone (e.g., lamina). Bone material cut by the action of the tube 2212 against the hook 2300 is directed to a chamber 2416 formed within the tube 2212.

[0263] The chamber 2416 is formed or bounded radially between the hook rod 2214 and the interior surface of the tube 2212, and is the bounded axially between the distal end of the ejector rod 2412 and the distal end of the tube 2212. When the user releases the trigger lever 2208, the spring 2408 returns the tube 2212 back to the un-triggered position.

[0264] After the user takes multiple bites (multiple trigger squeezes), the chamber 2416 may become full. The user may then withdraw the bone rongeur 2102 from the portal cannula 2104 of the integrated assembly 2100 (see Figure 21). The user may then slide the ejector button 2220 in the distal direction, causing the ejector block 2414 and the ejector rod 2412 to move in the distal direction, ejecting the stored bone material from the chamber 2416. The user may then re-insert the bone rongeur 2102 into the portal cannula 2104 of the integrated assembly 2100 to repeat the process.

[0265] The bone rongeur 2102 may provide several advantages. As mentioned above, the hook 2300 faces downward, which may provide the healthcare professional or user with better access to the bone.

[0266] Also, the hook rod 2214 remains stationary, anchored in the bone, during operation, and the bone material capture is accomplished by action of the tube 2212. Thus, the distancebetween the hook 2300 and the handle housing 2202 remains fixed. This way, no tool is advanced into the body of the patient during operation, but rather the axial movement of the tube 2212 performs the material capture, while the hook 2300 remains affixed to the bone. Also, the overall length of the bone rongeur 2102 remains the same during operation.

[0267] The bone rongeur 2102 further enables performing multiple bites or multiple triggers in a single pass (while the bone rongeur 2102 is inside the integrated assembly 2100) until the chamber 2416 is full. This is preferable and more efficient over having to remove the rongeur after every pass or trigger to clean it.

[0268] Also, the ridges 2308 may provide better trip and tissue-taking capability. Also, their roughness may enhance capturing bone material as the material may better stick to the hook rod 2214 as the tube 2212 moves axially. The configuration of the hook 2300 also may enhance snapping and anchoring the hook rod 2214 into the bone, providing enhanced tactile engagement with the bone. Further, the configuration of the trigger lever 2208 being pivotable about the handle housing 2202 may provide enhanced mechanical advantage and less user fatigue.

[0269] Other instruments may then be used once enough bone material has been removed. For example, a tissue sculptor may be inserted through the portal cannula 2104 of the integrated assembly 2100 to remove tissue (fat or ligaments).

[0270] Figure 25 illustrates the integrated assembly 2100 with a tissue sculptor 2500 (medical tissue sculptor) inserted through the portal cannula 2104, according to an example implementation. The tissue sculptor 2500 is configured to remove tissue material and provides several advantages as described below.

[0271] Figure 26 illustrates a side view of the tissue sculptor 2500, according to an example implementation. The tissue sculptor 2500 has a handle 2600 having a handle housing 2602 with a gripper 2604 (e.g., an ergonomic pistol-style gripper).

[0272] The tissue sculptor 2500 also has a trigger assembly 2606 that has a trigger lever 2608 pivotably coupled within the handle housing 2602 as described in more details below. The tissue sculptor 2500 has a sculptor assembly 2610 having a tube 2612 in which a sculptor 2614 is disposed.

[0273] The sculptor 2614 is configured for surgical tissue manipulation procedures. The sculptor 2614 may comprise an elongated structure or elongates shaft (or a sculptor rod) with a distal end 2616 configured to sculpt tissue.

[0274] As described in more detail below, the tube 2612 is slidable axially relative to the handle housing 2602, while the sculptor 2614 is configured to remain stationary relative to the handle housing 2602. In other words, a distal end 2616 of the sculptor 2614 remains at a particular distance from a distal end 2618 of the handle housing 2602.

[0275] Figure 27 illustrates an enlarged view of the distal end 2616 of a sculptor rod of the sculptor 2614, according to an example implementation. As shown, the sculptor 2614 has an upper ski-tip 2700 and a bottom spoon 2702 having a scoop 2704.

[0276] The upper ski-tip 2700 may be positioned at the distal end 2616 of the sculptor 2614 as shown. The upper ski -tip 2700 may feature a rounded, curved profile that tapers toward the distal end of the sculptor 2614. In some cases, the upper ski-tip 2700 may provide a smooth surface for tissue interaction during surgical procedures.

[0277] As shown, the bottom spoon 2702 is bent or disposed at a downward angle, while the scoop 2704 bends upward at a particular angle. The upper ski-tip 2700 also bends upward at a respective angle that may be different from the particular angle of the scoop 2704.

[0278] The tissue sculptor 2500 may be advanced within the portal cannula 2104 until the bottom spoon 2702, and particularly the scoop 2704 is anchored in the tissue of the patient. The angle of the upper ski-tip 2700 may be different from the angle of the scoop 2704 such that when the scoop 2704 is anchored in the tissue, the upper ski -tip 2700 may contact the skin of the patient, without piercing the tissue. Rather, the upper ski-tip 2700 has a smooth curved surface that contacts the tissue, without irritating it. The tube 2612 can be then advanced as described in more details below to cut tissue.

[0279] Referring back to Figure 26, the tissue sculptor 2500 also has an indicator assembly 2620, which is configured to indicate that enough tissue material has been captured by the tissue sculptor 2500 as described below. For example, the indicator assembly 2620 may be configured to be depressed or slid inward when it is possible to capture more material, and remain protruding or extending outward when a material chamber is full and the tissue sculptor 2500 is ready to removed and cleaned. The indicator assembly 2620 can then be used to eject material captured by the tissue sculptor 2500.

[0280] Figure 28 illustrates a cross-sectional side view of the tissue sculptor 2500, according to an example implementation. The trigger lever 2608 has a receptacle 2800 and a lever portion 2802. The trigger lever 2608 is pivotably coupled to the handle housing 2602 via a pivot 2804 (e.g., a metal pin). With this configuration, if a user places a hand inside the receptacle 2800 and squeezes the trigger lever 2608 (moves the trigger lever 2608 counter-clockwise) toward the gripper 2604, the trigger lever 2608 pivots about the pivot 2804 and the lever portion 2802 also rotates counter-clockwise.

[0281] The trigger assembly 2606 further includes a shuttle 2806 (e.g., a slidable block) that is coupled to the lever portion 2802. The shuttle 2806 is configured to move axially (along an axis of the tube 2612) within the handle housing 2602. Further, the tube 2612 is coupled to the shuttle 2806 such that the tube 2612 moves axially with the shuttle 2406.

[0282] As such, when the trigger lever 2608 is squeezed by the user, the lever portion 2802 causes the shuttle 2806 and the tube 2612 to move axially in a distal direction. The shuttle 2806 is spring-loaded via a spring 2808 that returns the shuttle 2806 and the tube 2612 in a proximal direction (to an un-triggered or released position shown in Figure 28) when the trigger lever 2608 is released.

[0283] Particularly, the spring 2808 is disposed about the tube 2612 such that its distal end rests against an internal web in the handle housing 2602 (and is thus fixed), while a proximal end of the spring 2808 rests against the shuttle 2806. This way, when the shuttle 2806 moves in the distal direction, the spring 2808 is compressed, and when the trigger lever 2608 is released, the spring 2808 is decompressed, pushing the shuttle 2806 and the tube 2612 coupled thereto in the proximal direction.

[0284] The tube 2612 is hollow as shown and accommodates the sculptor 2614 therein. The sculptor 2614 passes through the tube 2612 and is coupled at its proximal end to an anchoring block 2810 that is affixed within the handle housing 2602. With this configuration, the tube 2612 is axially movable relative to the sculptor 2614, while the sculptor 2614 remains stationary.

[0285] The tube 2612 further accommodates an ejector rod 2812 therein. Particularly, the ejector rod 2812 extends axially through the tube 2612 to a back or proximal end of the handle housing 2602 to be coupled to the indicator assembly 2620.

[0286] Particularly, the indicator assembly 2620 may include an indicator block 2813 and an ejector block 2814. The ejector rod 2812 is coupled to the ejector block 2814 (e.g., the ejector rod 2812 may be wedged inside a channel formed in the ejector block 2814 as shown). This way, the ejector block 2814 and the ejector rod 2812 move axially together.

[0287] The tissue sculptor 2500 further includes an ejector spring 2815 that spring-loads the ejector block 2814. Particularly, a distal end of the ejector spring 2815 rests against the anchoring block 2810, while a proximal end of the ejector spring 2815 rests against the ejector block 2814.

[0288] When a user presses the ejector block 2814 inward in the distal direction, the ejector block 2814 moves the ejector rod 2812 in the distal direction to disposed of capture material. The ejector spring 2815 may then return the ejector block 2814 and the ejector rod 2812 in the proximal direction when the ejector block 2814 is released.

[0289] The tissue sculptor 2500 may further include a pin 2816. The pin 2816 is coupled to the shuttle 2806 and configured to move therewith. For example, the pin 2816 may be wedged into (via an interference fit) a channel formed in the shuttle 2806 such that the shuttle 2806 and the pin 2816 move together. Notably, in the un-triggered state shown in Figure 28, the pin 2816 interfaces with the indicator block 2813 and acts as a stop for it. This way, the indicator block2813 is prevented from moving in the distal direction.

[0290] Further, the tissue sculptor 2500 may include an extension spring 2818. A distal end of the extension spring 2818 may be affixed (e.g., mounted around a pin formed in the handle housing 2602). On the other hand, a proximal end of the extension spring 2818 is coupled to the indicator block 2813.

[0291] Notably, if the indicator block 2813 is moved in the distal direction, the ejector block2814 is configured to move therewith in the distal direction. However, the ejector block 2814 can move in the distal direction without the indicator block 2813. For example, the ejector block 2814 may have a ledge 2820 (e.g., a shoulder) that interfaces with the indicator block 2813. With this configuration, if the indicator block 2813 is forced to move in the distal direction, the indicator block 2813 interacts with the ledge 2820, thereby causing the ejectorblock 2814 therewith. However, if the ejector block 2814 is pressed by a user in the distal direction, it can move without the indicator block 2813.

[0292] In operation, the user pulls the trigger lever 2608 and squeezes it against the gripper 2604. This causes the trigger lever 2608 to rotate about the pivot 2804, causing the lever portion 2802 to rotate about the pivot 2804 counter-clockwise.

[0293] Figure 29 illustrates a cross-sectional side view of the tissue sculptor 2500 in a triggered state, according to an example implementation. As shown, the lever portion 2802 has rotated about the pivot 2804. thereby pushing the shuttle 2806 in the distal direction.

[0294] The shuttle 2806 then pushes the tube 2612 coupled thereto in the axial direction, thereby squeezing the upper ski-tip 2700 and the bottom spoon 2702 (which is anchored in a patient tissue) together. Tissue material cut by the extension of the tube 2612 is directed to a chamber 2822 formed within the tube 2612 at the distal end of the ejector rod 2812.

[0295] As the shuttle 2806 moves in the axial direction, the pin 2816 moves therewith. The extension spring 2818 then pulls the indicator block 2813 in the axial direction as well. As such, in this state, the indicator block 2813 moves inward into the handle housing 2602 (compare the position of the indicator block 2813 in Figure 29 to its position in Figure 28). Due to the ledge 2820, the ejector block 2814 also moves in the distal direction. When the user releases the trigger lever 2608, the spring 2808 returns the shuttle 2806, the tube 2612, and the indicator assembly back to the un-triggered position of Figure 28.

[0296] After the user takes multiple scoops (multiple trigger squeezes), the chamber 2822 may become full. The indicator assembly 2620 is configured to provide an indication that the chamber 2822 is full.

[0297] Figure 30 illustrates a cross-sectional side view of the tissue sculptor 2500 in a triggered state with the chamber 2822 being full, according to an example implementation.Once the chamber 2822 is full, the ejector rod 2812 is prevented from moving in the distal direction when the user squeezes the trigger lever 2608.

[0298] As such, even though the extension spring 2818 pulls the indicator block 2813 in the distal direction, and the indicator block 2813 attempts to push the ejector block 2814 in the distal direction, the ejector block 2814 cannot move in the distal direction due to the ejector rod 2812 being blocked from moving via the tissue material in the chamber 2822. Thus, the indicator block 2813 remains protruding outward as shown in Figure 30 (compared to Figure 29), thus providing an indication to the user that the chamber 2822 is full and needs to be evacuated before tissue sculpting can resume.

[0299] The user may then withdraw the tissue sculptor 2500 from the portal cannula 2104 of the integrated assembly 2100 (see Figure 25). The user may then click on or push the ejector block 2814 in the distal direction, causing the ejector block 2814 and the ejector rod 2812 to move in the distal direction, ejecting the stored tissue material from the chamber 2822. The user may then re-insert the tissue sculptor 2500 into the portal cannula 2104 of the integrated assembly 2100 to repeat the process.

[0300] The tissue sculptor 2500 may provide several advantages. When the chamber 2822 is not full, triggering the trigger lever 2608 causes the indicator block 2813 to move axially inward, this providing a tissue capture confirmation, which provides tissue taking endpoint confidence to the user. When the indicator block 2813 does not move inward upon squeezing the trigger, the user is informed that the chamber 2822 is full and needs evacuation.

[0301] Further, with the configuration of the tissue sculptor 2500 having the upper ski-tip 2700 and the bottom spoon 2702, no scooping motion is required. Rather, axial motion of the tube 2612 performs the tissue capture action.

[0302] Further, the configuration and angles of the upper ski-tip 2700 and the bottom spoon 2702 provide a wider “mouth'’ and natural open orientation, which may provide more tissue capture with every bite (every7trigger squeeze). Also, as mentioned above, the difference in the angles of the upper ski-tip 2700 and the bottom spoon 2702 may avoid injuring or irritating the patient.

[0303] In some examples, the bottom spoon 2702 may have a different configuration to enhance tissue sculpting. For instance the scoop of the bottom spoon 2702 may be configured as a “spork” or hybrid spoon-like scoop with two to four fork-like tines / prongs.

[0304] Figure 31 illustrates a perspective view of the distal end 2616 of the sculptor 2614 with the bottom spoon 2702 having a hybrid scoop 3100, Figure 32 illustrates a top view of the distal end 2616 of the sculptor 2614 with the bottom spoon 2702 having the hybrid scoop 3100, and Figure 33 is a top view of the hybrid scoop 3100, according to an example implementation. Figures 31-33 are described together.

[0305] As shown, the distal end 2616 is at the end of a sculptor rod configured as an elongated shaft 3101.

[0306] The hybrid scoop 3100 may function for tissue manipulation and resection during surgical procedures. The design of the hybrid scoop 3100 may enable the medical tissue sculptor to perform gentle tissue manipulation, as the configuration may be suitable for use as a mild tissue sculptor. The spatial relationship between the sculptor 2614, the upper ski-tip 2700, the bottom spoon 2702, and the hybrid scoop 3100 may provide a surgical instrument assembly with multiple functional surfaces positioned at strategic locations along the length of the assembly.

[0307] The hybrid scoop 3100 may include a detailed structure that incorporates multiple slots and prongs to enhance surgical functionality. The hybrid scoop 3100 may comprise aspoon-like structure having a proximal end and a distal end, where the distal end may be positioned toward the terminal end of the bottom spoon 2702.

[0308] For example, the hybrid scoop 3100 can have one or more slots that extend longitudinally through the spoon-like structure of the hybrid scoop 3100. In some cases, only one slot may be formed in the hybrid scoop 3100.

[0309] In the example implementation of Figures 31-33, a first slot 3102 may extend longitudinally through the spoon-like structure of the hybrid scoop 3100. In some cases, a second slot 3104 may also extend longitudinally through the spoon-like structure parallel to the first slot 3102. The first slot 3102 and the second slot 3104 may be formed through the material of the hybrid scoop 3100 to create openings that divide the structure into separate sections or prongs.

[0310] As shown in Figure 33, the first slot 3102 and the second slot 3104 may divide the spoon-like structure into three separate prongs. A first prong 3106 may be positioned at the top of the scoop structure, while a second prong 3108 may be located in the middle section. A third prong 3110 may be positioned at the bottom of the structure. In some cases, the second prong 3108 may be positioned between the first prong 3106 and the third prong 3110.

[0311] The first slot 3102 may separate the first prong 3106 from the second prong 3108, creating a distinct division between these structural elements. The second slot 3104 may separate the second prong 3108 from the third prong 3110, providing a similar division between these components. In some cases, the slots may be positioned to bolster or enhance tissue retainment capabilities of the surgical instrument during surgical procedures.

[0312] With continued reference to Figure 33, the hybrid scoop 3100 may transition from the pronged section to a broader solid spoon portion 3112. The three separate prongs may be positioned at the distal end of the hybrid scoop 3100, while the broader solid spoon portion3112 may be positioned at the proximal end. In some cases, the broader solid spoon portion 3112 may be positioned proximal to the first prong 3106, second prong 3108, and third prong 3110, and may provide structural support for the hybrid scoop 3100

[0313] The manufacturing change from one solid spoon to multiple prongs may create additional cutting surfaces for tissue resection. Each of the first prong 3106, second prong 3108, and third prong 3110 (and associated sharp points) may provide multiple cutting surfaces that facilitate tissue resection during surgical procedures. The first slot 3102 and second slot 3104 may facilitate tissue retainment, while the three separate prongs may provide distinct cutting surfaces for enhanced surgical functionality, and one or more corresponding tines or prongs such as prong 3106, prong 3108. and prong 3110.

[0314] The slots 3102, 3104 formed in the hybrid scoop 3100 may be manufactured using wire EDM cutting. Wire EDM cutting may provide a precise manufacturing method for creating elongated openings through the material of the spoon-like structure. In some cases, wire EDM cutting may enable the formation of slots with controlled dimensions and smooth edges that enhance the functionality7of the surgical instrument.

[0315] The wire EDM process may involve the use of a thin wire electrode that cuts through the material using electrical discharges. This manufacturing technique may allow for the creation of narrow, elongated slots that extend longitudinally through the spoon-like structure without compromising the structural integrity of the surrounding material. In some cases, wire EDM cutting may provide manufacturing precision that enables the formation of slots with consistent width and depth characteristics.

[0316] Each prong created by the slot formation may provide a cutting surface for tissue resection during surgical procedures. The cutting surfaces may be formed along the edges of each prong, where the material has been separated by the slot formation process. In some cases,multiple prongs may provide multiple cutting surfaces that enhance the tissue resection capabilities of the surgical instrument compared to a single solid spoon configuration.

[0317] The cutting surfaces of the prongs may enable the surgical instrument to perform tissue resection through mechanical interaction with tissue structures. Each prong may function as a distinct cutting element, allowing the surgeon to engage tissue from multiple angles or positions during a surgical procedure. In some cases, the presence of multiple cutting surfaces may provide enhanced control and precision during tissue manipulation and resection operations.

[0318] The slots formed through the spoon-like structure may facilitate tissue retainment during surgical procedures. The openings created by the slots may allow tissue fragments or fluids to be captured and held within the spaces between the prongs. In some cases, the slots may function as retention features that prevent tissue from sliding off the surface of the surgical instrument during manipulation procedures.

[0319] The tissue retainment functionality may be enhanced by the positioning and dimensions of the slots relative to the overall structure of the hybrid scoop 3100. The slots may create spaces that accommodate tissue fragments of various sizes, allowing the surgical instrument to maintain contact with tissue during resection and removal procedures. In some cases, the combination of cutting surfaces and tissue retainment features may provide a surgical instrument with enhanced functionality for tissue sculptor applications.

[0320] Figure 34 illustrates a flowchart for a method 3200 of removing bone material from a patient using the bone rongeur 2102, according to an example implementation. The method 3200 begins with step 3202, where the bone rongeur 2102 is inserted through a portal cannula of an integrated assembly. The process then proceeds to step 3204, where the hook 2300 of the hook rod 2214 is anchored in bone of the patient.

[0321] Following the anchoring step, the method 3200 continues to step 3206, where the trigger lever 2208 is squeezed against the gripper 2204. This action leads to step 3208, where the tube 2212 is moved axially relative to the stationary hook rod. The axial movement of the tube 2212 enables step 3210, where bone material is captured through the interaction between the moving tube and the anchored hook rod.

[0322] The method 3200 concludes with step 3212, where the captured bone material is stored in the chamber 2416 formed within the tube 2212 . The flowchart shows a sequential process where each step flows directly to the next step, creating a linear progression from insertion of the bone rongeur through the final storage of captured bone material. The method 3200 demonstrates the operational sequence for using a bone rongeur to remove bone material in a controlled manner through the integrated assembly system.

[0323] Figure 35 illustrates a flowchart for a method 3300 of sculpting tissue from a patient using the tissue sculptor 2500, according to an example implementation. The method 3300 begins with step 3302, where the tissue sculptor 2500 is inserted through a portal cannula of an integrated assembly. The process then proceeds to step 3304, where the sculptor 2614 is positioned with the upper ski -tip 2700 contacting the skin of the patient.

[0324] The method 3300 continues to step 3306, where the bottom spoon 2702 having the scoop 2704 of the hybrid scoop 3100 is anchored in tissue of the patient. Following this positioning, the process moves to step 3308, where the trigger lever 2608 is squeezed against the gripper 2604. This action leads to step 3310, where the tube 2612 is moved axially relative to the sculptor 2614 (which remains axially stationary).

[0325] The method 3300 then proceeds to step 3312, where tissue material is captured through the axial movement of the tube 2612. Finally, the process concludes with step 3314, where the captured tissue material is stored in the chamber 2822 formed within the tube 2612.

[0326] The flowchart shows a sequential process where each step flows directly to the next step in the tissue sculpting procedure. The method 3300 demonstrates the operational sequence for using a tissue sculptor device, from initial insertion through final material storage, providing a systematic approach to tissue removal during surgical procedures.

[0327] Figure 36 illustrates a flowchart for a method 3400 of removing bone material from a patient using the bone rongeur 2102 with a ridged hook rod (the hook rod 2214 with the ridges 2308), according to an example implementation. The method 3400 begins with step 3402, where the bone rongeur 2102 with ridged hook rod is inserted through a portal cannula. The process then proceeds to step 3404, where the hook with roughened ridges is anchored in bone of the patient.

[0328] Following the anchoring step, the method 3400 continues to step 3406, where the trigger lever 2208 is squeezed to move the tube 2212 axially. The process then advances to step 3408, where bone material is captured using the ridged hook rod. After the bone material capture step, the method 3400 reaches decision point 3410, which determines whether the chamber 2416 is full.

[0329] If the chamber 2416 is full (Yes branch), the method 3400 proceeds to step 3412, where the ejector button 2220 is actuated to eject the stored material. If the chamber 2416 is not full (No branch), the method 3400 continues to step 3414, where bone material capture continues. The flowchart demonstrates the sequential operation of the bone rongeur 2102, highlighting the decision-making process for chamber management and the continuous cycle of bone material removal and ejection when necessary.

[0330] Figure 37 illustrates a flowchart for a method 3500 of tissue sculpting using the tissue sculptor 2500 with the hybrid scoop 3100, according to an example implementation. The method 3500 begins with step 3502, where the tissue sculptor 2500 with hybrid scoop 3100 isinserted through a portal cannula. The process then proceeds to step 3504, which involves positioning the sculptor 2614 with angled upper ski -tip 2700 and the bottom spoon 2702.

[0331] The method 3500 continues to step 3506, where the hybrid scoop 3100 with multiple prongs is anchored in tissue. Following this positioning, the process moves to step 3508, which involves squeezing the trigger lever 2608 to move the tube 2612 axially relative to the sculptor 2614 (which remains axially stationary).

[0332] The method 3500 then reaches a decision point at step 3510, where the healthcare professional determines whether the indicator block 2813 moves inward. This decision point creates two possible pathways in the flowchart. If the indicator block 2813 moves inward (Yes branch), the method 3500 proceeds to step 3512, where tissue sculpting continues with prong cutting surfaces. If the indicator block 2813 does not move inward (No branch), the method 3500 moves to step 3514, where the full chamber is evacuated when the indicator remains protruding.

[0333] The flowchart demonstrates the operational sequence for tissue sculpting procedures, incorporating the hybrid scoop design with multiple prongs for enhanced tissue manipulation and resection capabilities. The decision-making process at step 3510 provides feedback regarding chamber capacity, allowing the operator to determine when evacuation is required before continuing the tissue sculpting procedure.

[0334] 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 variety7of different configurations, all of which are contemplated herein.

[0335] 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.

[0336] 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 earned out in a particular order.

[0337] 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.

[0338] 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.

[0339] 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 ordistributed components or in conjunction with other components, in any suitable combination and location.

[0340] 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.

[0341] Embodiments of the present disclosure can thus relate to one of the enumerated example embodiment (EEEs) listed below.

[0342] EEE l is a bone rongeur comprising: a handle having a handle housing with a gripper; a shuttle mounted within the handle housing such that the shuttle is axially movable within the handle housing; a trigger lever pivotably coupled to the handle housing and coupled to the shuttle, such that squeezing the trigger lever against the gripper causes the trigger lever to pivot and move the shuttle; a tube disposed partially within the handle housing, wherein the tube is coupled to the shuttle and movable therewith; and a hook rod disposed partially within the handle housing, and extending through a portion of the tube, wherein the hook rod is stationary, and the tube is movable relative to the hook rod, wherein the hook rod comprises a hook for capturing bone material upon axial movement of the tube relative to the hook rod, and wherein the hook faces downward and bend inward to facilitate anchoring the hook rod of a bone of a patient.

[0343] EEE 2 is the bone rongeur of EEE 1, wherein the hook rod further comprises: a plurality7of ridges formed proximal from the hook.

[0344] EEE 3 is the bone rongeur of EEE 2, wherein the plurality of ridges have a roughened surface or texture to facilitate capturing bone tissue and causing the bone tissue to stick to the plurality7of ridges.

[0345] EEE 4 is the bone rongeur of any of EEEs 1-3, further comprising: an ejector rod disposed partially within the handle housing and extending through a respective portion of the tube, wherein the ejector rod is coupled to an ejector block disposed within the handle housing.

[0346] EEE 5 is the bone rongeur of EEE 4, further comprising: an ejector button mounted to the handle and coupled to the ejector block such that actuating the ejector button causes the ejector block and the ejector rod to move axially within the tube.

[0347] EEE 6 is the bone rongeur of EEE 5, further comprising: a chamber formed within the tube distal from the ejector rod, wherein bone material captured by movement of the tube relative to the hook rod is stored in the chamber, and wherein axial movement of the ejector rod via actuating the ejector button causes the bone material to be ejected from the chamber.

[0348] EEE 7 is a tissue sculptor comprising: a handle having a handle housing with a gripper; a shuttle mounted within the handle housing such that the shuttle is axially movable within the handle housing; a trigger lever pivotably coupled to the handle housing and coupled to the shuttle, such that squeezing the trigger lever against the gripper causes the trigger lever to pivot and move the shuttle; a tube disposed partially within the handle housing, wherein the tube is coupled to the shuttle and movable therewith; and a sculptor disposed partially within the handle housing, and extending through a portion of the tube, wherein the sculptor is stationary7, and the tube is movable relative to the sculptor, wherein the sculptor comprises an upper ski-tip and a bottom spoon having a scoop for capturing bone material upon axial movement of the tube relative to the sculptor.

[0349] EEE 8 is the tissue sculptor of EEE 7, wherein material captured by the sculptor is stored in a chamber within the tube, and wherein the tissue sculptor further comprises: an indicator assembly configured to provide an indication that the chamber requires evacuation before resuming tissue sculpting.

[0350] EEE 9 is the tissue sculptor of EEE 8, further comprising: an ejector rod disposed, at least partially, within the tube and coupled to the indicator assembly, wherein the chamber is formed at a distal end of the ejector rod, and wherein the ejector rod is prevented from moving axially when the chamber requires evacuation, thereby providing the indication via the indicator assembly.

[0351] EEE 10 is the tissue sculptor of EEE 9, wherein the indicator assembly comprises: an indicator block; and an ejector block, wherein the ejector rod is coupled to the ejector block, wherein the indicator block is configured to move axially with the tube until a time when the chamber requires evacuation, at which time the indicator block is prevented from moving, thereby providing the indication.

[0352] EEE 11 is the tissue sculptor of EEE 10, wherein the ejector block coupled to the ejector rod is configured to move with the indicator block in a distal direction, wherein when the chamber requires evacuation and the ejector rod is prevented from moving axially, the ejector block is prevented from moving axially, and the indicator block is in turn is prevented from moving, thereby providing the indication.

[0353] EEE 12 is the tissue sculptor of EEE 11, wherein the ejector block has a ledge that interfaces with the indicator block such that axial movement of the indicator block in the distal direction causes the ejector block to move therewith, and wherein the ejector block is movable in the distal direction without the indicator block.

[0354] EEE 13 is the tissue sculptor of EEE 12, wherein pressing the ejector block axially, causes the ejector rod to move therewith, thereby ejecting material in the chamber.

[0355] EEE 14 is the tissue sculptor of any of EEEs 10-13, further comprising: an extension spring that is coupled to the indicator block and configured to move the indicator block axially when the shuttle moves axially before the chamber requires evacuation.

[0356] EEE 15 is the tissue sculptor of any of EEEs 7-14, wherein the bottom spoon is bent at a downward angle, while the scoop bends upward at a particular angle, and wherein the upper ski -tip bends upward at a respective angle that is different from the particular angle of the scoop.

[0357] EEE 16 is a surgical instrument comprising: an elongated shaft; and a hybrid scoop disposed at a distal end of the elongated shaft, the hybrid scoop including a spoon-like structure having at least one slot extending longitudinally through the spoon-like structure to form at least a first prong and a second prong, wherein the at least one slot separates the first prong from the second prong.

[0358] EEE 17 is the surgical instrument of EEE 16, wherein the at least one slot comprise a first slot and a second slot extending longitudinally through the spoon-like structure to form the first prong, the second prong, and the third prong, wherein the first slot separates the first prong from the second prong, and the second slot separates the second prong from the third prong.

[0359] EEE 18 is the surgical instrument of any of EEEs 16-17, wherein the first slot and the second slot are formed by wire electrical discharge machining (EDM) cutting.

[0360] EEE 19 is the surgical instrument of any of EEEs 16-18, wherein the first prong and the second prong each provide a cutting surface for tissue resection.

[0361] EEE 20 is the surgical instrument of any of EEEs 16-19, w herein the at least one slot facilitates tissue retainment during surgical procedures.

[0362] EEE 21 is the surgical instrument of any of EEEs 16-20, wherein the hybrid scoop transitions from the first prong and the second prong to a broader solid spoon portion.

[0363] EEE 22 is the surgical instrument of EEE 21, wherein the broader solid spoon portion is positioned proximal to the first prong and second prong.

[0364] EEE 23 is a medical tissue sculptor comprising: a sculptor rod; an upper ski-tip positioned at a distal end of the sculptor rod; a bottom spoon extending from the distal end of the sculptor rod; and a hybrid scoop formed at a terminal end of the bottom spoon, the hybrid scoop comprising at least one elongated slot formed through a scoop portion to create at least a first prong and a second prong for tissue manipulation and resection.

[0365] EEE 24 is the medical tissue sculptor of EEE 23, wherein the at least one elongated slot is formed by wire electrical discharge machining (EDM) cutting.

[0366] EEE 25 is the medical tissue sculptor of any of EEEs 23-24, wherein the first prong and the second prong each provide a cutting surface for tissue resection.

[0367] EEE 26 is the medical tissue sculptor of any of EEEs 23-25, wherein the at least one elongated slot facilitates tissue retainment during surgical procedures.

[0368] EEE 27 is the medical tissue sculptor of any of EEEs 23-26, wherein the hybrid scoop transitions from the first prong and the second prong to a scoop portion that is broad and solid.

[0369] EEE 28 is the medical tissue sculptor of EEE 27, wherein the at least one elongated slot extends longitudinally through the scoop portion.

[0370] EEE 29 is the medical tissue sculptor of any of EEEs 27-28, wherein the scoop portion is positioned proximal to the first prong and the second prong.

[0371] EEE 30 is a hybrid scoop for a surgical instrument, the hybrid scoop comprising: a spoon-like structure having a proximal end and a distal end; a first elongated slot extendinglongitudinally through the spoon-like structure; a second elongated slot extending longitudinally through the spoon-like structure parallel to the first elongated slot, wherein the first elongated slot and the second elongated slot divide the spoon-like structure into three separate prongs that provide multiple cutting surfaces for tissue resection and facilitate tissue retainment.

[0372] EEE 31 is the hybrid scoop of EEE 30, wherein the first elongated slot and the second elongated slot are formed by wire EDM cutting.

[0373] EEE 32 is the hybrid scoop of any of EEEs 30-31. wherein the three separate prongs comprise a first prong, a second prong positioned between the first prong and a third prong, wherein the first elongated slot separates the first prong from the second prong and the second elongated slot separates the second prong from the third prong.

[0374] EEE 33 is the hybrid scoop of EEE 32, wherein each of the first prong, second prong, and third prong provides a distinct cutting surface for tissue resection.

[0375] EEE 34 is the hybrid scoop of any of EEEs 30-33, wherein the spoon-like structure transitions from the three separate prongs at the distal end to a broader solid spoon portion at the proximal end.

[0376] EEE 35 is the hybrid scoop of EEE 34, wherein the broader solid spoon portion is positioned proximal to the three separate prongs and provides structural support for the hybrid scoop.

[0377] EEE 36 is a method of removing bone material from a patient, the method comprising: inserting a bone rongeur through a portal cannula of an integrated assembly, wherein the bone rongeur comprises a handle having a handle housing with a gripper, a shuttle mounted within the handle housing, a trigger lever pivotably coupled to the handle housing and coupled to the shuttle, a tube coupled to the shuttle, and a hook rod extending through a portion of the tube;anchoring a hook of the hook rod in bone of the patient, wherein the hook faces downward and bends inward; squeezing the trigger lever against the gripper to cause the trigger lever to pivot and move the shuttle; moving the tube axially relative to the stationary hook rod to capture bone material; and storing the captured bone material in a chamber formed within the tube.

[0378] EEE 37 is the method of EEE 36, further comprising: actuating an ejector button mounted to the handle to cause an ejector block and an ejector rod to move axially within the tube; and ejecting the stored bone material from the chamber via axial movement of the ejector rod.

[0379] EEE 18 is the method of any of EEEs 16-17, wherein the hook rod comprises a plurality of ridges formed proximal from the hook, and w herein the plurality of ridges have a roughened surface or texture that facilitates capturing bone tissue and causing the bone tissue to stick to the plurality of ridges.

[0380] EEE 39 is a method of sculpting tissue from a patient, the method comprising: inserting a tissue sculptor through a portal cannula of an integrated assembly, wherein the tissue sculptor comprises a handle having a handle housing with a gripper, a shuttle mounted within the handle housing, a trigger lever pivotably coupled to the handle housing and coupled to the shuttle, a tube coupled to the shuttle, and a sculptor extending through a portion of the tube; positioning the sculptor such that an upper ski-tip contacts skin of the patient and a bottom spoon having a scoop is anchored in tissue of the patient; squeezing the trigger lever against the gripper to cause the trigger lever to pivot and move the shuttle; moving the tube axially relative to the stationary sculptor to capture tissue material; and storing the captured tissue material in a chamber formed within the tube.

[0381] EEE 40 is the method of EEE 39, further comprising: monitoring an indicator assembly to determine when the chamber requires evacuation, wherein the indicator assemblyprovides an indication when the chamber is full; and evacuating the chamber when the indication is provided.

[0382] EEE 41 is the method of EEE 40, wherein monitoring the indicator assembly comprises observing movement of an indicator block, wherein the indicator block moves axially inward when the chamber may capture more material and remains protruding outward when the chamber requires evacuation.

[0383] EEE 42 is the method of any of EEEs 39-41, wherein the bottom spoon is bent at a downward angle, the scoop bends upward at a particular angle, and the upper ski-tip bends upward at a respective angle that is different from the particular angle of the scoop.

[0384] EEE 43 is the method of any of EEEs 39-42, wherein the scoop comprises a hybrid scoop having at least one elongated slot formed through a scoop portion to create at least a first prong and a second prong for tissue manipulation and resection.

[0385] EEE 44 is the method of EEE 43, wherein the at least one elongated slot comprises a first slot and a second slot extending longitudinally through the scoop portion to form the first prong, the second prong, and a third prong, wherein the first slot separates the first prong from the second prong, and the second slot separates the second prong from the third prong.

[0386] EEE 45 is the method of EEE 44, wherein each of the first prong, second prong, and third prong provides a cutting surface for tissue resection, and wherein the first slot and second slot facilitate tissue retainment during the tissue sculpting.

Claims

CLAIMSWhat is claimed is:

1. A bone rongeur comprising: a handle having a handle housing with a gripper: a shuttle mounted within the handle housing such that the shuttle is axially movable within the handle housing; a trigger lever pivotably coupled to the handle housing and coupled to the shuttle, such that squeezing the trigger lever against the gripper causes the trigger lever to pivot and move the shuttle; a tube disposed partially within the handle housing, wherein the tube is coupled to the shuttle and movable therewith; and a hook rod disposed partially within the handle housing, and extending through a portion of the tube, wherein the hook rod is stationary, and the tube is movable relative to the hook rod, wherein the hook rod comprises a hook for capturing bone material upon axial movement of the tube relative to the hook rod, and wherein the hook faces downward and bend inward to facilitate anchoring the hook rod of a bone of a patient.

2. The bone rongeur of claim 1. wherein the hook rod further comprises: a plurality of ridges formed proximal from the hook.

3. The bone rongeur of claim 2, wherein the plurality of ridges have a roughened surface or texture to facilitate capturing bone tissue and causing the bone tissue to stick to the plurality of ridges.

4. The bone rongeur of claim 1, further comprising:an ejector rod disposed partially within the handle housing and extending through a respective portion of the tube, wherein the ejector rod is coupled to an ejector block disposed within the handle housing.

5. The bone rongeur of claim 4, further comprising: an ejector button mounted to the handle and coupled to the ejector block such that actuating the ejector button causes the ejector block and the ejector rod to move axially within the tube.

6. The bone rongeur of claim 5, further comprising: a chamber formed within the tube distal from the ejector rod, wherein bone material captured by movement of the tube relative to the hook rod is stored in the chamber, and wherein axial movement of the ejector rod via actuating the ejector button causes the bone material to be ejected from the chamber.

7. A tissue sculptor comprising: a handle having a handle housing with a gripper; a shuttle mounted within the handle housing such that the shuttle is axially movable within the handle housing; a trigger lever pivotably coupled to the handle housing and coupled to the shuttle, such that squeezing the trigger lever against the gripper causes the trigger lever to pivot and move the shuttle; a tube disposed partially within the handle housing, wherein the tube is coupled to the shuttle and movable therewith; anda sculptor disposed partially within the handle housing, and extending through a portion of the tube, wherein the sculptor is stationary, and the tube is movable relative to the sculptor, wherein the sculptor comprises an upper ski-tip and a bottom spoon having a scoop for capturing bone material upon axial movement of the tube relative to the sculptor.

8. The tissue sculptor of claim 7, wherein material captured by the sculptor is stored in a chamber within the tube, and wherein the tissue sculptor further comprises: an indicator assembly configured to provide an indication that the chamber requires evacuation before resuming tissue sculpting.

9. The tissue sculptor of claim 8, further comprising: an ejector rod disposed, at least partially, within the tube and coupled to the indicator assembly, wherein the chamber is formed at a distal end of the ejector rod, and wherein the ejector rod is prevented from moving axially when the chamber requires evacuation, thereby providing the indication via the indicator assembly.

10. The tissue sculptor of claim 9, wherein the indicator assembly comprises: an indicator block; and an ejector block, wherein the ejector rod is coupled to the ejector block, wherein the indicator block is configured to move axially with the tube until a time when the chamber requires evacuation, at which time the indicator block is prevented from moving, thereby providing the indication.

11. The tissue sculptor of claim 10, wherein the ej ector block coupled to the ej ector rod is configured to move with the indicator block in a distal direction, wherein when thechamber requires evacuation and the ejector rod is prevented from moving axially, the ejector block is prevented from moving axially, and the indicator block is in turn is prevented from moving, thereby providing the indication.

12. The tissue sculptor of claim 11, wherein the ejector block has a ledge that interfaces with the indicator block such that axial movement of the indicator block in the distal direction causes the ejector block to move therewith, and wherein the ejector block is movable in the distal direction without the indicator block.

13. The tissue sculptor of claim 12, wherein pressing the ejector block axially, causes the ejector rod to move therewith, thereby ejecting material in the chamber.

14. The tissue sculptor of claim 10, further comprising: an extension spring that is coupled to the indicator block and configured to move the indicator block axially when the shuttle moves axially before the chamber requires evacuation.

15. The tissue sculptor of claim 7, wherein the bottom spoon is bent at a downward angle, while the scoop bends upward at a particular angle, and wherein the upper ski-tip bends upward at a respective angle that is different from the particular angle of the scoop.

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