Intraosseous nerve ablation devices, systems, and methods

Abstract

Certain systems for intraosseous nerve ablation can include an introducer that can be inserted into a bone. In some instances, the introducer can be selectively coupled with one or more instruments to assist in placement in or manipulation of the bone. A needle assembly can be selectively coupled to the introducer. The needle assembly can include deployable tines. In some instances, two introducers and two needle assemblies are placed at different sides of the intraosseous nerve. The needle assemblies can be, in some instances, operated in a bipolar mode to apply radiofrequency energy within the bone to ablate the intraosseous nerve.

Description

INTRAOSSEOUS NERVE ABLATION DEVICES, SYSTEMS, AND METHODSTECHNICAL FIELD

[0001] Certain embodiments described herein relate generally to intraosseous nerve ablation, including devices, systems, and methods therefor. Embodiments can be particularly well suited for basivertebral nerve ablation.BACKGROUND

[0002] Examples of known intraosseous nerve ablation, including basivertebral nerve ablation, along with known devices, systems, and methods therefor, are disclosed, for example, in U.S. Patent No. 6,699,242 of Heggeness, titled METHODS AND DEVICES FOR INTRAOSSEOUS NERVE ABLATION, which issued on March 2, 2004, and in U.S. Patent No. 6,907,884 of Pellegrino et al., titled METHOD OF STRADDLING AN INTRAOSSEOUS NERVE, which issued on June 21 , 2005. The examples provided in these patents, as well as other existing intraosseous nerve ablation devices, systems, and methods, suffer from a variety of limitations and / or drawbacks and / or could benefit from significant improvements. Embodiments disclosed herein address, remedy, resolve, and / or avoid at least some of such limitations and / or drawbacks and / or provide other advantageous improvements.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] The written disclosure herein describes illustrative embodiments that are nonlimiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:

[0004] FIG. 1 is an elevation view of an embodiment of a system for intraosseous nerve ablation;

[0005] FIG. 2A is an elevation view of an embodiment of an introducer that is compatible with embodiments of the system of FIG. 1 ;

[0006] FIG. 2B is a cross-sectional view of the introducer of FIG. 2A taken along the view line 2B-2B in FIG. 2A;

[0007] FIG. 3A is a perspective view of an embodiment of a cannula that is compatible with embodiments of the introducer of FIG. 2A;

[0008] FIG. 3B is a perspective view of the cannula of FIG. 3A during assembly, which depicts a collar being advanced onto a cannula tube for attachment thereto;

[0009] FIG. 3C is a perspective view of the proximal end of the cannula of FIG. 3A, the collar and cannula tube of FIG. 3B having been fixedly secured together;

[0010] FIG. 3D is an elevation view of a proximal end of the cannula of FIG. 3A;

[0011] FIG. 4A is an upper perspective view of an embodiment of a handle that is compatible with embodiments of the introducer of FIG. 2A;

[0012] FIG. 4B is a lower perspective view thereof;

[0013] FIG. 4C is another upper perspective view thereof, the view being directed toward a side of the handle that is opposite from the side to which the views of FIGS. 4A and 4B are directed;

[0014] FIG. 4D is a cross-sectional view thereof taken along the view line 4D-4D in FIG. 4C;

[0015] FIG. 4E is another cross-sectional view thereof taken along the view line 4E- 4E in FIG. 4C;

[0016] FIG. 4F is a top plan view thereof;

[0017] FIG. 5 is an elevation view of an embodiment of a trocar-tipped stylet assembly that is compatible with embodiments of the introducer of FIG. 2A;

[0018] FIG. 6 is a perspective view of a trocar-tipped stylet that is compatible with embodiments of the stylet assembly of FIG. 5;

[0019] FIG. 7A is an upper perspective view of a handle that is compatible with embodiments of the stylet assembly of FIG. 5;

[0020] FIG. 7 B is a lower perspective view thereof;

[0021] FIG. 7C is a cross-sectional view thereof taken along the view line 7C-7C in FIG. 7B;

[0022] FIG. 8A is an elevation view of the stylet assembly of FIG. 5 coupled with the introducer of FIG. 2A;

[0023] FIG. 8B is a cross-sectional view thereof taken along the view line 8B-8B in FIG. 8A;

[0024] FIG. 8C is another cross-sectional view thereof taken along the view line 8C- 8C in FIG. 8A;

[0025] FIG. 9A is an elevation view of an embodiment of a bevel-tipped stylet assembly that is compatible with embodiments of the introducer of FIG. 2A;

[0026] FIG. 9B is an upper perspective view thereof directed toward an opposite side of the stylet assembly of FIG. 9A;

[0027] FIG. 90 is an elevation view of a distal tip of the stylet assembly of FIG. 9A;

[0028] FIG. 9D is an elevation view of the stylet assembly of FIG. 9A coupled with the introducer of FIG. 2A;

[0029] FIG. 9E is a top plan view of the stylet assembly of FIG. 9A coupled with the introducer of FIG. 2A;

[0030] FIG. 10A is an elevation view of an embodiment of a drill assembly that is compatible with embodiments of the introducer of FIG. 2A;

[0031] FIG. 10B is a side elevation view of an embodiment of a handle that is compatible with the drill assembly of FIG. 10A;

[0032] FIG. 10C is an elevation view of an embodiment of a drill bit that is compatible with the drill assembly of FIG. 10A;

[0033] FIG. 10D is an elevation view of a proximal portion of the drill bit of FIG. 10C, with the drill bit having been rotated 90 degrees about a longitudinal axis thereof;

[0034] FIG. 10E is an elevation view of the drill assembly of FIG. 10A inserted through the introducer of FIG. 2A in a drilling arrangement;

[0035] FIG. 11 A is an elevation view of an embodiment of a needle assembly that is compatible with embodiments of the introducer of FIG. 2A, the needle assembly being in an undeployed or retracted state;

[0036] FIG. 11 B is another elevation view of the needle assembly rotated 90 degrees relative to the view of FIG. 11A, where the rotation is counterclockwise about a central longitudinal axis of the needle assembly as viewed in a proximal-to-distal direction;

[0037] FIG. 11 C is another elevation view of the needle assembly rotated 180 degrees relative to the view of FIG. 11 B, where the rotation is about the central longitudinal axis of the needle assembly;

[0038] FIG. 12A is an elevation view of the needle assembly of FIG. 11A in a deployed state, wherein the needle assembly is shown rotated 180 degrees relative to the view of FIG. 11 A;

[0039] FIG. 12B is another elevation view of the needle assembly in the deployed state with the needle assembly rotated 90 degrees relative to the view of FIG. 12A, where the rotation is clockwise about the central longitudinal axis of the needle assembly as viewed in a proximal-to-distal direction;

[0040] FIG 13A is an upper perspective view of an embodiment of an advancing hub that is compatible with embodiments of the needle assembly of FIG. 11 A, the advancing hub shown fixedly secured to a tine element;

[0041] FIG. 13B is a lower perspective view thereof where the advancing hub has been rotated 90 degrees relative to orientation depicted in FIG. 13A, where the rotation is counterclockwise about a longitudinal axis of the advancing hub as viewed in a proximal-to-distal direction;

[0042] FIG. 13C is a cross-sectional view thereof taken along the view line 13C-13C in FIG. 13A;

[0043] FIG. 13D is an elevation view thereof;

[0044] FIG. 13E is another elevation view thereof rotated 90 degrees relative to FIG.13D, where the rotation is clockwise about a longitudinal axis of the advancing hub as viewed in a proximal-to-distal direction;

[0045] FIG. 13F is another elevation view thereof rotated 180 degrees relative to FIG.13D;

[0046] FIG. 14A is an upper perspective view of an embodiment of a spin collar that is compatible with embodiments of the needle assembly of FIG. 11 A;

[0047] FIG. 14B is a lower perspective view thereof;

[0048] FIG. 14C is an elevation view thereof;

[0049] FIG. 14D is a cross-sectional view thereof taken along the view line 14D-14D in FIG. 14A;

[0050] FIG 15A is an upper perspective view of an embodiment of a main hub that is compatible with embodiments of the needle assembly of FIG. 11 A;

[0051] FIG. 15B is another upper perspective view thereof;

[0052] FIG. 15C is a lower perspective view thereof;

[0053] FIG. 15D is an elevation view thereof;

[0054] FIG. 15E is a cross-sectional view thereof taken along the view line 15E-15E in FIG. 15A;

[0055] FIG. 15F is another cross-sectional view thereof taken along the view line 15F- 15F in FIG. 15A;

[0056] FIG. 16A is a perspective view of a proximal end of an embodiment of an elongated tube that is compatible with the needle assembly of FIG. 11 A;

[0057] FIG. 16B is a perspective view of the proximal end of the elongate member that shows an attachment collar secured to the tube of FIG. 16A and a proximal end of an insulation layer that covers a portion of the tube;

[0058] FIG. 16C is a perspective view of a distal end of the elongate member;

[0059] FIG. 17A is a perspective view of an embodiment of a filament element or tine element that is compatible with embodiments of the needle assembly of FIG. 11 A;

[0060] FIG. 17B is an elevation view of an embodiment of a tine having a beveled end;

[0061] FIG. 17C is an elevation view of an embodiment of a tine having a blunt end;

[0062] FIG. 18A is a perspective view of an embodiment of a tip that is compatible with embodiments of the needle assembly of FIG. 11 A;

[0063] FIG. 18B is another perspective view thereof, with the tip rotated approximately 180 degrees about a longitudinal axis thereof, as compared with the orientation of FIG. 18A;

[0064] FIG. 18C is a side elevation view thereof;

[0065] FIG. 19A is a cross-sectional view of the needle assembly in a retracted state taken along the view line 19A-19A in FIG. 11A;

[0066] FIG. 19B is a cross-sectional view of the needle assembly in the retracted state taken along the view line 19B-19B in FIG. 11 C;

[0067] FIG. 19C is a cross-sectional view of the needle assembly in a deployed state taken along the view line 19C-19C in FIG. 12B;

[0068] FIG. 19D is an elevation view of a distal end of the needle assembly while in the deployed state;

[0069] FIG. 19E is another elevation view of the distal end of the needle assembly while in the deployed state, the needle assembly shown rotated 90 degrees about a longitudinal axis thereof, where the rotation is clockwise about a central longitudinal axis of the main hub as viewed in a proximal-to-distal direction;

[0070] FIG. 20A is an elevation view of an embodiment of a radiofrequency probe assembly that is compatible with embodiments of the needle assembly of FIG. 11 A;

[0071] FIG. 20B is a cross-sectional view thereof taken along the view line 20B-20B in FIG. 20A;

[0072] FIG. 21 A is a perspective view of the needle assembly of FIG. 19A, while in the retracted or undeployed state, being advanced into the introducer of FIG. 2A, the needle assembly and the introducer being in an uncoupled state at this stage;

[0073] FIG. 21 B is another perspective view of the needle assembly of FIG. 19A, while in the retracted or undeployed state, in a coupled state with the introducer of FIG. 2A;

[0074] FIG. 21 C is another perspective view of the needle assembly of FIG. 19A coupled to the introducer of FIG. 2A, wherein the needle assembly has been transitioned to the deployed state;

[0075] FIG. 21 D is another perspective view of the needle assembly of FIG. 19A coupled to the introducer of FIG. 2A, wherein the needle assembly remained in the deployed state while the probe assembly of FIG. 20A was coupled thereto;

[0076] FIG. 22A is a partially schematic elevation view of an illustrative procedure in which a pair of intraosseous nerve ablation systems, such as the system of FIG. 1 , are positioned in a vertebral body to effectuate bipolar ablation of a basivertebral nerve, the ablation being carried out between adjacently situated needle assemblies that have deployed tines;

[0077] FIG. 22B is an enlarged elevation view of another illustrative procedure such as that of FIG. 22A that depicts distal ends of needle assemblies that have been inserted into a vertebra through introducers to achieve a bipolar ablation of a basivertebral nerve;

[0078] FIG. 23A is a partially schematic top plan view of an illustrative procedure in which the distal ends of two respective sets of embodiments of introducers coupled with beveled stylet assemblies are advanced within a vertebra toward a median plane;

[0079] FIG. 23B is a partially schematic top plan view of a subsequent stage of the illustrative procedure of FIG. 23A in which the stylet assemblies have been removed from the introducers and replaced with needle assemblies, each needle assembly having subsequently been transitioned to a deployed state to advance a pair of tines toward the median plane;

[0080] FIG. 23C is an even further schematic view of an illustrative procedure similar to that of FIG. 23A, wherein two introducer / needle assembly pairings are shown in a placed state, ready for ablation, with an orientational plane of each pairing being rotated relative to a transverse plane of a patient;

[0081] FIG. 24A is a top plan view of another embodiment of an ablation assembly that includes an embodiment of a needle assembly coupled to an introducer and depicts both an orientational plane that passes through an orientational indicium of the ablation assembly and an attachment plane that passes through an attachment indicium of the ablation assembly;

[0082] FIG. 24B is a top plan view of another embodiment of an ablation assembly that includes further embodiments of orientational and attachment indicia;

[0083] FIG. 24C is a top plan view of yet another embodiment of an ablation assembly that includes further embodiments of orientational and attachment indicia;

[0084] FIGS. 25A-25J depict various stages of an illustrative method of performing a basivertebral nerve ablation using embodiments of devices such as those depicted in, e.g, FIG. 1 ;

[0085] FIG. 26 depicts an embodiment of a kit that includes two sets of devices, such as those of the system depicted in FIG. 1 , which can be used for bipolar ablation of a basivertebral nerve;

[0086] FIG. 27 is an elevation view of an embodiment of a system that is configured to perform bipolar ablation at two targets — such as, e.g., basivertebral nerve ablations at two levels — optionally simultaneously or substantially simultaneously;

[0087] FIG. 28 is an elevation view of another embodiment of a system for intraosseous nerve ablation;

[0088] FIG. 29A is a perspective view of an embodiment of a first tray that includes therein a plurality of needle assemblies and a plurality of RF probes as part of a system that may be used, for example, for bipolar ablation at two targets, optionally simultaneously or substantially simultaneously;

[0089] FIG. 29B is a perspective view of an embodiment of a second tray that includes therein a further portion of the system of FIG. 29A; in particular, a plurality of introducers that are coupled with a corresponding number of stylet assemblies, a plurality of further stylet assemblies, and a single hand drill, the second tray shown positioned over the first tray of FIG. 29A;

[0090] FIG. 29C is a perspective view of an embodiment of a retaining lid shown positioned over the second tray of FIG. 29B, which is shown positioned over the first tray of FIG. 29A;

[0091] FIG. 29D is a perspective view of a packaging arrangement in which a sealing layer is attached to the retaining lid of FIG. 29C, which is positioned over the second tray of FIG. 29C, which is in turn positioned over the first tray of FIG. 29A, all of which are retained within a box;

[0092] FIG. 30 is an elevation view of another embodiment of a system for intraosseous nerve ablation;

[0093] FIG. 31 is a perspective view of another embodiment of a needle assembly that is compatible with embodiments of the systems shown in the other drawings and described herein;

[0094] FIG. 32 is a perspective view of another embodiment of a probe assembly that compatible with embodiments of the systems shown in the other drawings and described herein;

[0095] FIG. 33 is an elevation view of another embodiment of a system for intraosseous nerve ablation;

[0096] FIG. 34 is a perspective view of an embodiment of an introducer that is compatible with the system of FIG. 33;

[0097] FIG. 35A is a perspective view of an embodiment of a handle that is compatible with the introducer of FIG. 34;

[0098] FIG. 35B is a cross-sectional view thereof, taken along the view line 35B-35B in FIG. 35A;

[0099] FIG. 35C is a top plan view thereof;

[0100] FIG. 35D is another perspective view thereof, with the handle rotated 180 degrees relative to FIG. 35A;

[0101] FIG. 36 is an embodiment of a biasing member compatible with the introducer of FIG. 34;

[0102] FIG. 37A is a perspective view of an embodiment of an actuator compatible with the handle of FIG. 35A and the biasing member of FIG. 36;

[0103] FIG. 37B is a top plan view thereof;

[0104] FIG. 37C is another perspective view thereof;

[0105] FIG. 38 is an elevation view of an embodiment of a handle compatible with embodiments of a trocar stylet assembly;

[0106] FIG. 39A is an elevation view of an embodiment of a handle compatible with embodiments of a beveled stylet assembly;

[0107] FIG. 38B is another elevation view thereof, the handle being rotated 180 degrees relative to FIG. 39A;

[0108] FIG. 39C is a top plan view thereof;

[0109] FIG. 40 is a perspective view of an embodiment of a needle assembly that is compatible with the system of FIG. 33, the needle assembly depicted in an undeployed state;

[0110] FIG. 41 is a perspective view of the needle assembly of FIG. 40 coupled with the introducer of FIG. 34, the needle assembly further being depicted in a deployed state; and

[0111] FIG. 42 is an elevation view of an illustrative embodiment of an adapter for coupling certain embodiments of probe assemblies with particular RF generator consoles.DETAILED DESCRIPTION

[0112] Embodiments of the present disclosure relate generally to intraosseous nerve ablation. Some embodiments are particularly well suited for the ablation of basivertebral nerves. General disclosures pertaining to the ablation of basivertebral nerves and certain known devices and systems for implementing such ablations are described, for example, in U.S. Patent No. 6,699,242 of Heggeness, titled METHODS AND DEVICES FOR INTRAOSSEOUS NERVE ABLATION, which issued on March 2, 2004, and in U.S. Patent No. 6,907,884 of Pellegrino et al., titled METHOD OF STRADDLING AN INTRAOSSEOUS NERVE, which issued on June 21 , 2005. The entire contents of each of the foregoing patents are hereby incorporated by reference herein. To the extent there is any conflict between this incorporated subject matter and the present written disclosure, the present written disclosure shall control.

[0113] The latter patent indicates that the location of the basivertebral nerve is somewhat well known. However, the basivertebral nerve is radiolucent and so its precise location is not easily identified by X-ray. The basivertebral nerve is also thin, thus making it challenging to place an electrode in close proximity thereto. Moreover, conventional RF needles appear to heat only a fairly limited volume of bone, thus misplacement of a needle tip vis-a-vis the basivertebral nerve may result in heating a volume of bone that does not contain the basivertebral nerve. Examples provided in the foregoing patents for addressing these and other issues suffer from a variety of limitations and / or drawbacks and / or could benefit from significant improvements. The same is true of other existing intraosseous nerve ablation devices, systems, and methods. Embodiments disclosed herein address, remedy, resolve, and / or avoid at least some of such limitations and / or drawbacks and / or provide other advantageous improvements over known systems for intraosseous nerve ablation, such as ablation of a basivertebral nerve within a vertebral body.

[0114] Intraosseous basivertebral nerve ablation (BVNA) can be a minimally invasive treatment for chronic back pain. The chronic back pain can be associated with Modic typel and type 2 vertebral endplate changes, which may be diagnosed, for example, in known manners. Other suitable diagnostic methods may be forthcoming. Embodimentsherein can be used for BVNA in one or more vertebrae of a patient who suffers from chronic back pain, such as after a diagnostic confirmation of Modic type 1 and / or type 2 vertebral endplate changes in the patient.

[0115] In certain embodiments of the present disclosure, a pair of needles are placed within a bone in proximity to an intraosseous nerve, such as within a vertebra in proximity to a basivertebral nerve. In the example of a vertebra, the needles may be positioned on opposite sides of a centrally located, vertical or longitudinal plane (e.g., the median plane or midsagittal plane) through the vertebra. For example, in some embodiments, a first needle in inserted through a first pedicle of a vertebral body and a second needle is inserted through a second pedicle of a vertebral body. Each needle may include a conductive element, such as a metal tip, at a distal end thereof via which radiofrequency (RF) energy may be delivered. In further embodiments, each needle includes a plurality of (e.g., two) filaments or tines that are deployed outwardly from the needle. For each needle, the tines may be electrically conductively coupled (e.g., via physical contact) with the electrically conductive element (e.g., tip), such that the tip and tines may operate in unison as a unitary electrode. With the tines deployed, the unitary electrode may, in some instances, have a multi-prong shape. The tines may be deployed generally toward the median plane. The multi-prong shape thus may extend toward the median plane. The two needles generally point toward (while being at an oblique angle to) the median plane. The multi-prong shape of each needle electrode may be generally directed toward the median plane and, thus, generally in the direction of the multi-prong shape of the other needle electrode. The tines thus may help to direct the respective electrodes of the pair of inserted needles closer to one another.

[0116] A pair of RF probes, each of which may be coupled to an RF generator, may be inserted into the pair of needles, respectively, to establish a bipolar circuit. RF energy may be applied between the two needles in a bipolar fashion to create a lesion, which can ablate the intraosseous nerve (e.g., the basivertebral nerve). For example, during an ablation procedure (e.g., at any given moment thereof) the electrode of one of the two needles may be the active electrode and the electrode of the other of the two needles may be the return electrode of the bipolar pair. In some embodiments, with the tines of each needle extended, the lesion may be formed more readily or more efficiently and / or may be sufficiently large to ablate the intraosseous nerve than could be achieved if the tines were not deployed. In some instances, certain arrangements disclosed herein can facilitate gaining access to, targeting of, and / or ablation of the basivertebral nerve.

[0117] Illustrative examples of needles that may be used in embodiments of procedures such as those described herein are provided, for example, in U.S. Patent No. 10,736,688 of Wright et al., titled METHODS AND SYSTEMS FOR RADIO FREQUENCY NEUROTOMY, which issued on August 11 , 2020, and in U.S. Patent No. 10,716,618 of Wright et al., titled SYSTEMS AND METHODS FOR TISSUE ABLATION, which issued on July 21 , 2020. The entire contents of each of the foregoing patents are hereby incorporated by reference herein. To the extent there is any conflict between this incorporated subject matter and the present written disclosure, the present written disclosure shall control.

[0118] Certain embodiments described herein include an introducer to which the needle can be coupled. For example, the introducer can provide a passageway (e.g., an established, secure, fixed, and / or direct passageway) into a bone, such as a vertebra. The introducer can include a sheath, cannula, or tube through which a needle, or needle portion of a needle assembly, may be introduced into a bone, such as a vertebra. The introducer can further include a handle. The needle can be advanced through the introducer into the bone, and a main hub of the needle can be selectively attached to the handle of the introducer.

[0119] The attachment between the main hub of the needle and the handle of the introducer can inhibit or prevent relative longitudinal (or stated otherwise, axial) movement between the needle and the introducer and / or can inhibit or prevent relative rotational movement between the needle and the introducer about a longitudinal axis of the needle / introducer assembly. In various embodiments, the needle (e.g., a main hub of the needle) includes one or more connectors that interact with the introducer and / or the introducer includes one or more connectors that interact with the needle to secure the needle to the introducer. The one or more connectors may be selectively or releasably securable. With the main hub of the needle secured to the introducer, one or more tines or filaments of the needle assembly can be deployed into the bone (e.g., into cancellous bone) while an elongated member of the needle assembly remains substantially fixed (e.g., in longitudinal relation) relative to a sheath of the introducer. This fixed relationship may aid in deployment of the tines, such as, for example, to prevent proximal movement of the needle assembly relative to the introducer, or “backing out” of the needle assembly, that might otherwise occur during tine deployment. Stated otherwise, anchoring the needle assembly to an introducer that is fixed within the bone can assist with predictable deployment of the tines, as the reactive forces that the tips ofthe tines encounter as they push through the bone are counteracted by the anchored arrangement, thus inhibiting or preventing the needle assembly from moving proximally relative to the bone. Stated otherwise, the tines can be more readily or more predictably advanced distally into bone than in certain arrangements in which there is no anchoring relative to a fixed introducer.

[0120] The introducer may further be selectively attachable to and / or usable with one or more stylet assemblies and / or a drill assembly, each of which may be used with and / or attached to the introducer sequentially (or stated otherwise, individually, or one at a time). That is, in certain embodiments, only one of a stylet assembly (or of multiple stylet assemblies), a drill assembly, and / or the needle assembly may be used with and / or attached to (e.g., selectively attached to and / or removably attached to) the handle of the introducer at any given time.

[0121] In some embodiments, one or more stylet assemblies that are individually attachable to the introducer may be securely attached to the introducer so as to be both longitudinally (or stated otherwise, axially) and rotationally fixed relative thereto. Each stylet assembly can include a handle which, when coupled with the handle of the introducer, can facilitate manipulation of the stylet / introducer assembly. For example, in some embodiments, the stylet handle encompasses or extends about a significant portion of the introducer handle and defines a pair of extended wings that can be readily gripped by the hand of a user for rotational movement and or longitudinal advancement or retraction of the assembly. In some embodiments, the stylet handle can include a flat striking surface which may be configured to be hammered by a mallet to permit distal advancement of the stylet / introducer combination through bone. In some embodiments, a stylet assembly includes a trocar tip, such as a tri-faceted tip that comes to a distal point at the distal end of the stylet, with the point being positioned at or near a central longitudinal axis of the stylet. In other or further embodiments, a stylet assembly (which may be an alternative or additional stylet assembly, relative to the trocar-tipped stylet assembly) includes a beveled tip at the distal end of the stylet. The beveled tip, which may be formed from one or more angled grinds at the distal end of the stylet, may help in guiding or directing the stylet / introducer assembly as it is advanced through, e.g., cancellous bone.

[0122] In some embodiments, the drill assembly does not attach to the introducer, but rather, a drill bit portion thereof may be inserted through the introducer and moved independently therefrom. For example, the drill assembly may be rotated and / orlongitudinally advanced and retracted relative to the introducer. The drill assembly can include a fluted distal end that can drill into bone. In some instances, the flutes can help in the removal of bone material, which can provide or assist in providing space for insertion of the needle. For example, in some instances, the drill can be used to create a pathway through bone or to ream bone material (e.g., cancellous bone material) from at least a portion of a previously formed pathway through the bone.

[0123] In various embodiments, the introducer (e.g., the introducer handle) can include one or more orientation indicia that can indicate to a user an orientation of the introducer that will yield a particular orientation of the deployed tines, once a needle assembly has been coupled to the handle and the tines thereof have been deployed. In other or further instances, the orientation indicia may indicate a preferred or prescribed orientation relative to a median plane of a patient. In some embodiments, the one or more orientation indicia may be visual and / or tactile. For example, the orientation indicia may include one or more of visual markings and / or physical variations that are viewable and / or palpable or tactile.

[0124] In some embodiments, one or more stylet assemblies that are couplable with the introducer each include one or more orientation indicia. For example, in some embodiments, a handle of a trocar-tipped stylet assembly can include an orientation indicium which, when the handle is in a coupled state with a handle of the introducer, indicates to a user an ultimate orientation of the introducer that will yield a particular orientation of the deployed tines, once a needle assembly has been coupled to the handle and the tines thereof have been deployed. In other or further instances, the orientation indicium may indicate a preferred or prescribed orientation relative to a median plane of a patient. In some embodiments, an orientation indicium of the introducer and an orientation indicium of the stylet assembly are aligned (e.g., indicate the same direction, such as by pointing in the same direction) when the introducer and the stylet assembly are in a coupled state.

[0125] In some embodiments, a bevel-tipped stylet assembly can include one or more orientation indicia, such as just described with respect to an illustrative trocar-tipped stylet assembly. In other or further instances, the bevel-tipped stylet assembly can include a deflection indicium, which can indicate to a user a deflection direction in which a tip of the bevel-tipped stylet tends to move as it is advanced through bone material. The deflection indicium may be visual and / or tactile. In some embodiments, the bevel-tipped stylet assembly includes both an orientation indicium and a deflection indicium. In furtherembodiments, the orientation indicium and the deflection indicium indicate (e.g., point toward) the same direction.

[0126] In various embodiments, the introducer (e.g., the introducer handle) can include one or more attachment indicia that can indicate to a user a manner in which a needle assembly should be attached to the introducer in order to yield a particular orientation of the deployed tines, once the needle assembly has been coupled to the handle and the tines thereof have been deployed. In some embodiments, the one or more attachment indicia may be visual and / or palpable or tactile. For example, the attachment indicia may include one or more of visual markings and / or physical variations that are viewable and / or touchable.

[0127] In other or further embodiments, the needle assembly (e.g., the main hub of the needle assembly) can include one or more attachment indicia that can indicate to a user a manner in which a needle assembly should be attached to the introducer in order to yield a particular orientation of the deployed tines, once the needle assembly has been coupled to the handle and the tines thereof have been deployed. In some embodiments, the one or more attachment indicia may be visual and / or palpable or tactile. For example, the attachment indicia may include one or more of visual markings and / or physical variations that are viewable and / or palpable or tactile. In various examples, the attachment indicia may include printing, raised features, recessed features, and / or a variation in size and / or shape of certain features (e.g., in one embodiment, diametrically opposed latches are differently sized).

[0128] In some embodiments, both the introducer and the needle assembly include attachment indicia. In further embodiments, an attachment indicium of the needle assembly and an attachment indicium of the introducer are aligned with one another, matched together, approximated to each other, and / or brought into close proximity to yield a specified attachment that will yield the deployment orientation indicated by the orientation indicium of the introducer.

[0129] In some embodiments, an attachment indicium of a needle assembly does not directly, independently, or logically correlate with a deployment direction of the tines of the needle assembly. For example, in some embodiments, the attachment indicium may be located on a portion of the needle assembly (e.g., on a main hub of the needle) at a position that is angularly offset relative to a direction of deployment of each of the tines and / or relative to a direction of a common component of the deployment directions of the tines. In certain of such embodiments, in contrast, the orientation indicium of theintroducer does directly and / or logically correlate with a deployment direction of one or more of the tines of the needle assembly.

[0130] For example, in some embodiments, the orientation indicium indicates a direction of deployment of at least one of the tines, indicates a general direction of deployment of at least one of the tines, indicates a direction of a common component of the deployment directions of the tines, indicates a direction that bisects an acute angle defined by the deployed tines, and / or indicates a direction that extends through an interior of an acute angle defined by the deployed tines, whereas the attachment indicium of the needle assembly is angularly offset (e.g., angularly spaced from, relative to a central longitudinal axis of the needle assembly) relative to any or all of the foregoing items indicated by the orientation indicium. That is, the angular or rotational offset of the attachment indicium of the needle assembly may be such that, when the needle is attached to the introducer, an angular position of the attachment indicium of the needle assembly relative to a central longitudinal axis of the system does not coincide with one or more of a direction of a common component of the deployment directions of the tines, a direction that bisects an acute angle defined by the deployed tines, and / or a direction that extends through an interior of an acute angle defined by the deployed tines.

[0131] In some instances, the “directions” described above with respect to orientation, attachment, and / or deflection indicia, can be determined by way of a longitudinal plane that extends along a central longitudinal axis of the introducer and / or the needle assembly and extends in a direction identified or indicated by the relevant indicium. In some instances, the longitudinal plane may pass through the relevant indicium. The longitudinal plane may be said to subsume the central longitudinal axis, in that the central longitudinal axis is contained within the longitudinal plane. In further instances, the tines may deploy at opposite sides of the longitudinal plane.

[0132] In some embodiments, a needle assembly includes a spin collar that includes one or more laterally extending wings. The wings can enhance or facilitate application of torque to the spin collar to thereby enable and / or facilitate rotation of the spin collar for deployment of tines within bone. A threading arrangement of the spin collar may additionally or alternatively provide an appropriate mechanical advantage for reliable deployment of the tines.

[0133] In some embodiments, an RF probe usable with a needle assembly includes a connector that is configured to securely attach to a proximal end of the needle assembly. In other or further embodiments, a distal end of the needle assembly, whichcan include an electrically conductive tip, is configured to receive a distal end of an electrode of the RF probe to establish conductive contact therewith when the RF probe is inserted into the needle assembly. RF energy thus may be applied through the electrode of the RF probe and conducted away from the distal end of the probe by the conductive tip of the needle assembly.

[0134] In view of the foregoing, and in view of other disclosures hereafter, certain embodiments can facilitate or otherwise improve intraosseous nerve ablation. Some embodiments are particularly well suited for ablation of a basivertebral nerve within a vertebral body. In some embodiments, an introducer can be inserted into the bone and a needle assembly can then be secured to the introducer so as to thereby be securely anchored relative to a bone, which can facilitate deployment of electrode tines into the bone. For example, the anchoring can inhibit or prevent longitudinal backout of the needle assembly (i.e., inadvertent or undesired proximal movement) during tine deployment. In some embodiments, a winged spin collar enables and / or facilitates deployment of tines within bone (e.g., within cancellous bone). Some embodiments can include one or more indicia schemes that can facilitate and / or reliably yield a desired orientation of the system to achieve a tine deployment arrangement that can enable and / or facilitate lesion creation. Other or further embodiments can include a keyed configuration that permits the needle assembly to attach to the introducer in only a single rotational orientation. In some instances, an amount of time required to lesion the intraosseous nerve may be reduced, and in other or further instances, the lesion may cover a smaller volume while effectively ablating the intraosseous nerve, each of which may preserve or promote the health of surrounding bone tissue. These and / or other advantages will be apparent from the present written disclosure and / or the drawings.

[0135] With reference to FIG. 1 , in certain embodiments, a system 100 for intraosseous nerve ablation includes an introducer 110, a trocar stylet assembly 120 (which may also be referred to as a trocar assembly 120, a trocar-tipped stylet assembly 120, or more generally as a stylet assembly 120), a beveled stylet assembly 130 (when may also be referred to as a bevel assembly, a bevel-tipped stylet assembly 130, or more generally as a stylet assembly 130), a bone drill assembly 140, a needle assembly 150, and a radiofrequency probe assembly 160. As indicated by various broken arrows, the introducer 110 is selectively useable with each of the trocar stylet assembly 120, the beveled stylet assembly 130, the bone drill assembly 140, and / or the needle assembly 150. In particular, each of the trocar stylet assembly 120, the beveled stylet assembly130, the bone drill assembly 140, and / or the needle assembly 150 is configured to be used sequentially, individually, or one-at-a-time with the introducer 110, in any suitable order. Generally, the one or more of the stylet assemblies 120, 130 and / or the bone drill assembly 140 are used individually, in conjunction with the introducer 110, to form a pathway into a bone and the needle assembly 150 is subsequently inserted through the introducer such that a tip of the needle assembly is introduced into the pathway. The needle assembly 150 may then be actuated to deploy tines into the bone (e.g., along new pathways through the bone, or stated otherwise, along pathways separate from the pathway previous formed by one or more of the stylet assemblies 120, 130, and the bone drill assembly 140). The radiofrequency probe assembly 160 is insertable into the needle assembly 150, e.g., when the needle assembly 150 has been inserted into and coupled with the introducer 110, and can be used to energize the needle assembly 150 with radiofrequency (RF) electrical energy, as further discussed below.

[0136] In the illustrated embodiment, each of the trocar stylet assembly 120, the beveled stylet assembly 130, and the needle assembly 150 is selectively and reversibly securable to the introducer 110, as further discussed below. Stated otherwise, each of the assemblies 120, 130, 150 can be separately and individually connected to, attached to, interlocked with, or otherwise fixedly coupled with the introducer 110, and further, can be disconnected from, detached from, released from, or otherwise uncoupled from the introducer 110.

[0137] In some instances, one or more of the bone-access and / or manipulation instruments depicted in FIG. 1 (e.g., the trocar stylet assembly 120, the beveled stylet assembly 130, and / or the bone drill assembly 140) may not be present in the system 100. In other instances, one or more of the bone-access or manipulation instruments may be present in the system 100 but not used during a given procedure. For example, in some instances, the trocar stylet assembly 120 may be attached to the introducer 110 and, thusly coupled as a secure bone access assembly, may be advanced through soft tissue into contact with bone, and then advanced distally (potentially with the aid of a mallet or the like) and / or rotated back and forth (e.g., via manual manipulation) to pierce or cut through the an external region of the bone (a pedicle of a vertebra, a cortical layer, etc.) and subsequently proceed in and though cancellous bone. It may be possible for this assembly to reach a desired target within the bone. The trocar stylet assembly 120 may then be removed from the introducer 110 and the needle assembly 150 may thenbe advanced through and attached to the introducer 110 and deployed in manners such as discussed hereafter.

[0138] In other instances, only the beveled stylet assembly 130 may be used with the introducer 110 for bone access and / or placement. In other instances, only the drill 140 may be used with the introducer 110 for bone access and / or placement. In other instances, any suitable combination and / or order of usage of the trocar stylet assembly 120, the beveled stylet assembly 130, and / or the drill 140 may be used to achieve a desired positioning of the introducer 110 within the bone and / or to achieve a desired amount of clearance of bone material at a position beyond a distal tip of the introducer 110. For example, in some embodiments, the beveled stylet assembly 130 can be coupled with the introducer 110 to assist in directing the introducer 110, e.g., toward the median plane at any suitable stage of positioning the introducer 110 within a vertebra, as further discussed below. For example, once the trocar stylet assembly 120 has reached the cancellous bone, the trocar stylet assembly 120 may be removed from the introducer 110 and replaced with the beveled stylet assembly 130. The beveled stylet assembly 130 and the trocar 110 may then be advanced in concert (in unison, together, as one, etc.) through the cancellous bone.

[0139] In certain embodiments, one or more of the stylet assemblies 120, 130 and the needle assembly 150 are each configured to couple with the introducer 110 in a predetermined rotational orientation. Stated otherwise, each of these components may be fully attached to the introducer 110 in only a single relative rotational orientation, as discussed further below. In the illustrated embodiment, when the trocar-tipped stylet assembly 120 is in an attached or coupled state with the introducer 110, the stylet assembly 120 is in an orientation that is rotated 180 degrees about a central longitudinal axis of the stylet assembly 120 relative to what is shown in FIG. 1. In the illustrated embodiment, when the bevel-tipped stylet assembly 130 is in an attached or coupled state with the introducer 110, the stylet assembly 130 is in an orientation that is rotated 180 degrees about a central longitudinal axis of the stylet assembly 120 relative to what is shown in FIG. 1. In the illustrated embodiment, when the needle assembly 150 is in an attached or coupled state with the introducer 110, the needle assembly 150 is in an orientation that is rotated 90 degrees about a central longitudinal axis of the needle assembly 150 in a counterclockwise direction, as viewed in a proximal-to-distal direction, relative to what is shown in FIG. 1 . These orientations are discussed further below.

[0140] With continued reference to FIG. 1 , the introducer 110 can include a sheath, tube, or cannula 112. A handle 114 can be securely attached to a proximal end of the cannula 112. The trocar stylet assembly 120 can include a trocar-tipped stylet 122 and a handle 124 securely attached to a proximal end of the trocar-tipped stylet 122. The trocar-tipped stylet 122 can include a sharpened distal tip, which in some embodiments can be formed of, e.g., three planar grinds. The beveled stylet assembly 130 can include a bevel-tipped stylet 132 and a handle 134 securely attached to a proximal end of the bevel-tipped stylet 132. The bevel-tipped stylet 132 can include a sharpened distal tip, which in some embodiments can include at least a primary bevel. In some embodiments, additional smaller (e.g., reverse) ground surfaces may be present at the distal end of the bevel-tipped stylet 132. The drill 140 can include an elongated drill bit 142, which may also be referred to as a drill element, and a handle 144 securely attached to a proximal end of the drill bit 142. The drill bit 142 can include any suitable flute configuration or other drill configuration.

[0141] In some embodiments, the cannula 112 of the introducer 110 can be rigid, and may be formed of a relatively thick metal tube. For example, as further discussed below, in some instances, the cannula 112 is substantially rectilinear before, during, and after directional assistance provided by the beveled stylet assembly 130. Stated otherwise, the cannula 112 can be substantially rectilinear before receiving therein the bevel-tipped stylet 132, during use with the bevel-tipped stylet 132 as both are advanced concurrently together through bone material (e.g., through cancellous bone tissue) to achieve a desired position within a bone, after placement within the bone while the bevel-tipped stylet 132 remains positioned within the cannula 112, and after removal of the beveltipped stylet 132 from the cannula 112 while the cannula 112 remains positioned within the bone. In further instances, the cannula 112 can remain in a rectilinear configuration throughout use with the needle assembly 150.

[0142] With continued reference to FIG. 1 , the needle assembly 150 can include a needle 152 securely attached to a main hub 154. The radiofrequency probe assembly 160 can include an RF probe or RF electrode 162 attached to a housing or hub 164.

[0143] In some instances, the system 100 is used to ultimately position a distal end of the needle assembly 150 within a bone for an RF treatment. The introducer 110 may be positioned within the bone, and the needle assembly 150 may be inserted through the introducer 110 until a distal end thereof extends past the distal tip of the introducer 110.As further discussed below, tines may be deployed at the distal end of the needle assembly 150, and a radiofrequency ablation may thereafter be performed.

[0144] As further discussed below, in many embodiments, the system 100 may include a further introducer 110, a further set of stylet assemblies 120, 130, a further needle assembly 150, and a further radiofrequency probe assembly 160. In still further embodiments, the system 100 may include an additional bone drill assembly 140, whereas in other embodiments, only a single bone drill assembly 140 is present in the system. The additional introducer 110 and stylet assemblies 120, 130 (and optionally the bone drill assembly 140) can be used for placement of the additional needle assembly 150 in the bone such that the distal ends of both placed needle assemblies 150 are generally in proximity to one another. The needle assemblies 150 can be actuated to deploy respective sets of tines therefrom into the cancellous bone in further proximity to each other. The radiofrequency probes 160 can be coupled with the needle assemblies 150 and with a radiofrequency generator such that the needle assemblies 150 are operated as a bipolar pair. That is, the distal ends of the needle assemblies 150 may be sufficiently close to one another to permit bipolar radiofrequency ablation to occur therebetween.

[0145] Stated otherwise, in some embodiments, the system 100 includes a pair of needle assemblies 150, instruments via which the needle assemblies 150 can be placed in a bone, and instruments via which the needle assemblies 150 can be operated in a bipolar mode to effectuate bipolar radiofrequency ablation within the bone. In still further embodiments, the system 100 can include two pairs of needle assemblies 150, corresponding placement instruments, and corresponding energization instruments, such that the pairs of needle assemblies 150 can be placed with their distal tips (which can include deployed tines) positioned for the treatment of two different intraosseous treatment regions. In further embodiments, the different intraosseous treatment regions can be in different bones (e.g., different vertebrae). In some embodiments, the two pairs of needle assemblies 150 can effectuate bipolar radiofrequency ablation of the two different treatment regions during overlapping time periods (e.g., substantially concurrently or simultaneously).

[0146] FIGS. 2A-22 depict various illustrative embodiments of components of the system 100 in greater detail.

[0147] With reference to FIGS. 2A and 2B, in the illustrated embodiment, the introducer 110 includes the cannula 112 and the handle 114. An embodiment of thecannula 112 is shown in and described relative to FIGS. 3A-3D, while an embodiment of the handle 114 is shown in and described relative to FIGS. 4A-4F. The introducer 110 can define a central longitudinal axis ACL that longitudinally extends through a center of each of the cannula 112 and the handle 114. The central longitudinal axis ACL may also or alternatively be referred to as the longitudinal axis.

[0148] As shown in FIG. 2A, in various embodiments, a working length Lw of the introducer 110 can be defined as a distance from the distalmost surface of the handle 114 to the distal tip of the cannula 112. In various embodiments, some or all of which may be particularly well suited for use in BVNA procedures, the working length Lw of the introducer 110 is within a range of from about 10 to about 20 centimeters, from about 11 to about 15 centimeters, from about 16 to about 20 centimeters, from about 12 to about 14 centimeters, from about 17 to about 19 centimeters, or is about 13 centimeters or about 18 centimeters. In further embodiments, the working length is exactly 13 centimeters. In other embodiments, the working length is exactly 18 centimeters.

[0149] It may be desirable for an external dimension of the cannula 112 to be relatively small, yet an interior of the cannula 112 may be sufficiently spacious to allow for the insertion therethrough of a robust needle assembly 150 (e.g., a needle assembly 150 that includes robust tines for insertion through cancellous bone tissue). In various embodiments, at least some of which may be particularly well suited for use in BVNA procedures, the cannula 112 may be sized at 10 gauge (e.g., a thin-walled 10-gauge tube), while one or more of the stylets, drill bits, and / or needles (e.g., the needle portion of a needle assembly 150) passable through the cannula 112 may be sized at 12 gauge or smaller.

[0150] With reference to FIGS. 2A, 2B and 3A, the introducer cannula 112 can include, for example, a rigid tube 200 of any suitable material. For example, in some embodiments, the cannula 112 comprises a tube 200 of rigid stainless steel. The cannula 112 has a distal tip 202 opposite the handle 114. In some embodiments, the distal tip 202 is substantially flat or planar, such as may result from cutting a tube at a right angle to the longitudinal axis, or stated otherwise, from a right-angle transverse cut. In other embodiments, the tip 202 may be shaped in any suitable manner. For example, in some embodiments, the tip 202 may include an edge break or be sharpened, rounded, radiused, or finished in any suitable manner. The tip 202 may include, for example, a circular chamfer or an otherwise rounded chamfer around a full circumference, or at least a portion of a circumference, thereof.

[0151] With reference to FIGS. 2B and 3A, the tube 200 can be an elongated hollow cylinder that extends between a distal end 204 and a proximal end 206 and defines a lumen 207 therethrough. In various embodiments, inner and outer diameters of the tube 200 may be substantially constant along a full length of the tube 200. In certain embodiments, the tube 200 may be sufficiently thick to oppose, be resistant to, or avoid bending under forces associated with placement and use of the tube 200 in bone via the componentry of the system 100. For example, in some embodiments, a thickness and / or material makeup of the tube 200 can be such that the tube 200 remains substantially rectilinear after placement within a bone (e.g., vertebral body), even after having been guided toward a median plane of a patient.

[0152] In some embodiments, the tube 200 comprises stainless steel (e.g., 304 stainless steel) and is sized at 10 gauge. In some embodiments, the 10-gauge size of the tube 200 may be a thin-walled 10 gauge, such that an inner diameter is sufficiently large to permit passage therethrough of instruments sized at, e.g., 12 gauge or smaller. For example, in some embodiments, the tube 200 may have an outer diameter of 0.134 inches (or approximately 0.134 inches), may have a thickness of 0.01 inches (or approximately 0.01 inches), and may have an inner diameter of 0.114 inches (or approximately 0.114 inches). An inner diameter of 0.114 inches is slightly larger than the nominal outer diameter of a 12-gauge device, which is 0.109 inches. In certain embodiments, the tube 200 is sized at 10 gauge and may have a thickness (e.g., a “thin walled” thickness of 0.01 inches) that is sufficient to maintain rigidity of the tube 200 while permitting passage, or in some embodiments, sliding passage therethrough of one or more stylet assemblies 120, 130, the drill 140, and / or the needle assembly 150, one or more of which may have an outer diameter of, e.g., 12 gauge or smaller.

[0153] With reference to FIGS. 2A and 3A, in certain embodiments, the introducer cannula 112 includes a plurality of depth markings 209 at an exterior thereof to provide visual information to a user regarding the depth to which the cannula 112 has been positioned within a patient. In the illustrated embodiment, the depth markings 209 are provided in one-centimeter increments and are measured from the distal tip of the introducer cannula 112. In various embodiments, the depth markings 209 are laser etched into the tube 200.

[0154] With reference to FIGS. 2B-3D in some embodiments, the proximal end 206 of the tube 200 includes a securement member 210 via which the tube 200 can be securely and fixedly attached to the handle 114. That is, the securement member 210 can causethe handle 114 to remain securely attached to the tube 200 when the handle 114 is used to apply tension and / or torsion forces to the tube 200. For example, the securement member 210 may embed within the handle 114 during an overmolding procedure and / or may prevent separation of the handle 114 from the tube 200 during striking (e.g., via a mallet or hammer), pushing, pulling, rotation, and / or other manipulation of the handle 114 and / or one or more components attached thereto during insertion, positioning, and / or removal of the introducer 110 relative to a bone.

[0155] FIGS. 3B, 3C, and 3D depict a proximal end of an embodiment of the cannula 112. In this embodiment, the cannula 112 includes a tube 200 that has a notch or cutout 212 at the proximal end 206 thereof. In various embodiments, the cutout 212 can be used during manufacture to ensure a desired length of the tube 200 extends past a distal end of the handle 114. In other or further instances, the cutout 212 can be used during manufacture to ensure a desired rotational orientation of the tube 200 relative to the handle 114.

[0156] In some embodiments, the securement member 210 includes the cutout 212. For example, as further discussed below, in some instances, the cutout 212 may fill with handle material during an overmolding process, which arrangement can assist in maintaining the tube 200 fixedly secured to the handle 114.

[0157] In the illustrated embodiment, the attachment member 210 further includes a collar 214 welded to the tube 200. The collar 214 can include windows 215, which can define edges and retention surfaces that can fill with handle material during an overmolding process, such as previously described. The surfaces that border the windows 215 and the proximal and distal surfaces of the collar 214 can interact with the handle material, once hardened, to maintain a secure and fixed attachment between the handle 114 and the cannula 112.

[0158] In some instances, one of the windows 215 of the collar 214 can be aligned with the cutout 212, as shown in FIGS. 3C and 3D. In further instances, an alignment pin may be positioned through the aligned window 215 and cutout 212 during manufacture.

[0159] In some embodiments, during manufacture, a pin may be placed within the tube 200 and may internally obscure the cutout 212. The handle 114, which may be formed of any suitable material (such as any suitable polymeric material), may be overmolded onto the tube 200. In this process, the handle material may fill the cutout 212 and the windows 215. The pin may be removed after overmolding.

[0160] The handle 114 thus may be securely attached to the tube 200 via the cutout 212 and the collar 214. For example, the walls and edges of the cutout 212, the walls and edges of the windows 215, and the proximal and distal surfaces of the collar 214 can interact with the handle material to prevent the handle 114 from being separated from the tube 200 and / or to permit efficient transfer of forces when the handle 114 and the tube 200 are placed under compression and / or tension. For example, the securement member 210 can interface with the handle material to maintain the handle 114 in fixed relation to the cannula 112 when the handle 114 is tapped, malleted, or hammered for distal advancement of the introducer 110 into bone or when the handle 114 is pulled proximally to remove the introducer 110 from bone. As a further example, the securement member 210 can interface with the handle material to maintain the handle 114 in fixed relation to the cannula 112, to prevent the handle 114 from being separated from the cannula 112, and / or to permit efficient transfer of forces when the handle 114 and the cannula 112 are placed under torsion, such as when the handle 114 is rotated (e.g., back and forth) about the central longitudinal axis and pushed distally for advancement of the introducer 110 into bone, or when the handle 114 is rotated (e.g., back and forth) about the central longitudinal axis and pulled proximally to remove the introducer 110 from bone.

[0161] In the illustrated embodiment, a proximal end of the collar 214 is substantially flush with a proximal end of the tube 200, as shown in FIGS. 3C and 3D. In other embodiments, a length of the tube 200 may extend proximal to the proximal end of the collar 214. Stated otherwise, the collar 214 may be positioned over the tube 200 such that a proximal end of the collar 214 is distally spaced from the proximal end of the tube 200.

[0162] With reference to FIGS. 4A-4C, the handle 114 of the introducer 110 can include a body 220 and a stem 222 that extends distally from the body 220. In the illustrated embodiment, a lumen 224 extends fully through the body 220 and the stem 222. The central longitudinal axis ACL (FIGS. 2A and 2B) can extend through a center of the lumen 224.

[0163] With reference to FIG. 4D, in the illustrated embodiment, the lumen 224 includes an enlarged receptacle 225 at a proximal end thereof. The receptacle 225 can be configured to receive therein a stem or other portion of other components of the system 100 (see, e.g., FIGS. 1 , 8B, 21 A, and 21 B). The receptacle 225 can include a connector 226 that is configured to selectively attach the handle 114 to the handles 124,134 of the stylet assemblies 120, 130, respectively. The connector 226 may alternatively be referred to a fastener, lock, coupling interface, connection interface, locking interface, etc. The connector 226 may be of any suitable variety, and may be active or passive. In various embodiments, the connector 226 can comprise one or more of a catch, recess, receptacle, latch, catch, clamp, lock, snap, or any other suitable connection mechanism, whether mechanical, magnetic, electromagnetic, electromechanical, etc.

[0164] In the illustrated embodiment, the connector 226 comprises an internal or recessed thread 227, which may extend helically about the central longitudinal axis and may be configured to interface with, e.g., a raised helical thread of each of the handles 124, 134 of the stylet assemblies 120, 130, respectively. The connector 226 can assist in coupling the handle 114 with handles or hubs of one or more other system components, as discussed elsewhere herein. In other embodiments, the connector 226 may include a raised helical thread that may interface with, e.g., a recessed helical thread of each of the handles 124, 134. Any other suitable connector or connection interface is contemplated.

[0165] With reference again to FIGS. 4A-4C, the body 220 can include lateral extensions or wings 232, 234 that extend transversely outward and away from the central longitudinal axis in opposite directions. An outer end of the wing 234 includes a notch or recess 236. As shown in FIG. 4C, the recess 236 can include an abutment surface or stop 237. The stop 237 can delimit an amount of rotation either of the handles 124, 134 of the stylet assemblies 120, 130, respectively, can have in a rotational direction as they are coupled with the introducer handle 114 (see, e.g., FIG. 8A), as discussed further below. The stop 237 can be, in some embodiments, substantially planar. The stop 237 can extend vertically, or longitudinally, to delimit rotation of either handle 124, 134 about the central longitudinal axis.

[0166] With reference to FIGS. 4A, 4E, and 4F, in the illustrated embodiment, the handle 114 includes a lock 238, which may alternatively be referred to a fastener, coupling interface, connector, connection interface, locking interface, etc. The lock 238 may be of any suitable variety, and may be active or passive. In various embodiments, the lock 238 can comprise one or more of a catch, recess, receptacle, latch, catch, clamp, lock, snap, or any other suitable connection mechanism, whether mechanical, magnetic, electromagnetic, electromechanical, etc., which can maintain or assist in maintaining a fixed rotational orientation between the introducer 110 and a stylet assembly 120, 130. In the illustrated embodiment, the lock 238 comprises a recess 239 that can assist inmaintaining either of the handles 124, 134 of the stylet assemblies 120, 130, respectively, in a rotationally locked orientation relative to the handle 114, as further discussed below. Stated otherwise, in some embodiments, the lock 238 can interact with a complementary locking element of either stylet assembly 120, 130 to achieve a rotational lock between the introducer 110 and the stylet assembly 120, 130.

[0167] As shown in FIG. 4E, the recess 239 that defines the lock 238 can include two ramped surfaces. In some embodiments, the steeper or more aggressively ramped surface (i.e. , the left ramped surface of the recess 239 in FIG. 4E) can assist in preventing rotational movement of a handle 124, 134 in the direction of this ramped surface (see FIG. 8C) once an associated connector of either handle 124, 134 is positioned therein, as discussed below. In the illustrated embodiment, the recess extends distally or inwardly away from a proximal surface of the handle 114, which proximal surface may be substantially planar in some embodiments. The lock 238 is at an upper or proximal face of the handle 114. In the illustrated embodiment, the lock 238 and the stop 237 are associated with, and positioned at the outer ends of, the wings 232, 234, respectively (see, e.g., FIG. 4F).

[0168] In some embodiments, the stop 237 prevents a stylet handle 124, 134 from rotating relative to the introducer handle 114 in a first direction (e.g., a rotational direction suitable for coupling the stylet handle 124, 134 to the introducer handle 114), and the lock 238 inhibits the stylet handle 124, 134 from rotating relative to the introducer handle 114 in a second direction that is opposite the first direction (e.g., a rotational direction suitable for decoupling the stylet handle 124, 134 from the introducer handle 114). For example, the stop 237 can prevent a handle 124, 134 of a stylet assembly 120, 130 from rotating in a coupling direction more than intended, and can assist in ensuring a predetermined orientation between the stylet assembly 120, 130 and the introducer 110 when in a coupled state. As further discussed below, the lock 238 likewise can assist in achieving the predetermined orientation between the stylet assembly 120, 130 and the introducer 110 when in a coupled state. Further, the locking action provided at least in part by the lock 238 when that stylet assembly 120, 130 and the introducer 110 are in the coupled state can be selectively overcome when a user rotates the handle 124, 134 relative to the handle 114 in an opposite direction, or decoupling direction, with a sufficient force to achieve decoupling of the stylet assembly 120, 130 from the introducer 110.

[0169] With reference to FIG. 4F, the handle 114 may be said to define a keying interface 240 via which a predetermined rotational orientation may be achieved between the introducer 110 and each of the stylet assemblies 120, 130 when the introducer 110 and a respective one of the stylet assemblies 120, 130 are in a coupled state. Stated otherwise, the keying interface 240 may permit the introducer 110 and a respective one of the stylet assemblies 120, 130 to be fully coupled together in only a single rotational or angular orientation relative to one another. In the illustrated embodiment, the keying interface 240 includes each of the lock 238 and the stop 237, which function as previously described.

[0170] With reference to FIGS. 4A, 4C, and 4F, the introducer handle 114 can further include a connector 261 configured to interface with a connector of the needle assembly 150 to securely maintain the introducer 110 and the needle assembly 150 in a coupled state, as further discussed below. The connector 261 may alternatively be referred to a fastener, lock, coupling interface, connection interface, locking interface, etc. The connector 261 may be of any suitable variety, and may be active or passive. In various embodiments, the connector 261 can comprise one or more of a catch, recess, receptacle, latch, catch, clamp, lock, snap, or any other suitable connection mechanism, whether mechanical, magnetic, electromagnetic, electromechanical, etc.

[0171] Accordingly, in the illustrated embodiment, the introducer 110 includes a first connector 226 via which the introducer 110 can be selectively connected to one or more of the stylet assemblies 120, 130, and further includes a second connector 261 via which the introducer 110 can be selectively connected to the needle assembly 150. In the illustrated embodiment, the connectors 226, 261 employ different attachment mechanisms from one another and are physically separated or spaced from one another. The connector 226 for interfacing with the stylet assemblies 120, 130 is positioned at an internal region, or along an internal surface, of the introducer handle 114, whereas the connector 261 is positioned at an external region, or along an external surface, of the introducer handle 114. The connectors 226, 261 are physically separate or physically distinct.

[0172] In other embodiments, a common connector may be used for coupling the needle assembly 150 and one or more of the stylet assemblies 120, 130 to the introducer 110. For example, one such common connector arrangement is discussed with respect to FIGS. 33-41.

[0173] In the illustrated embodiment, the connector 261 includes a pair of catches 262, 264 that are at diametrically opposite sides of the handle 114. Each catch 262, 264 may be referred to individually as a separate connector. The catches 262, 264 may also collectively be referred to as a connector 261 , or may interface with elements that may collectively and / or cooperatively couple therewith. The catches 262, 264 can be closer to the central longitudinal axis than are the lock 238 and the stop 237. The catches 262, 264 can be spaced from the wings 232, 234, or may be said to be at or adjacent internal ends of the wings 232, 234. In some embodiments, the catches 262, 264 are configured for selective connection with the main hub 154 of the needle assembly 150, whereas the lock 238 and the stop 237 are configured for interaction with the respective handles 124, 134 of the trocar stylet assembly 120 and the beveled stylet assembly 130.

[0174] In the illustrated embodiment, the catches 262, 264 are substantially mirror images of one another when viewed in cross-section through a central longitudinal axis of the handle 114, as depicted in FIG. 4D. The catches 262, 264 can include receptacles at lower or distal ends thereof into which catch portions of resilient arms of the main hub 154 can seat (see FIGS. 21 A and 21 B). Stated otherwise, in the illustrated embodiment, the catches 262, 264 generally have the same shelf-like undercut geometry for connection to the connectors of the needle assembly 150, as further discussed below. The receptacles at the base or distal ends of the catches 262, 24 can extend radially inwardly to the same depth. As shown in the cross-sectional view of FIG. 4D, the catches 262, 264 may also have the same length (e.g., in a longitudinal or proximal-to-distal dimension). Thus, as previously mentioned, in the illustrated embodiment, the receptacles 262, 264 are substantially mirror images of one another when viewed in cross-section through the central longitudinal axis of the handle 114. Other geometries are also contemplated.

[0175] In the illustrated embodiment, however, the catches 262, 264 are not fully identical to each other, as they are differently sized in another dimension. As is evident from, e.g., FIGS. 4A, 4C, and 4F, in the illustrated embodiment, catch 262 is larger than catch 264. More particularly, catch 262 has a greater width than does the catch 264, or stated otherwise, the catch 262 is wider in a transverse dimension (as opposed to the longitudinal and radial dimensions depicted in FIG. 4D) than the catch 264. FIG. 4F provides a top plan view of the catches 262, 264 and depicts the catch 262 having a width I / I / 7 that is greater than a width W2 of the catch 264. Catches 262, 264 that are of different sizes relative to one another can provide for rotational keying with the main hub154 of the needle assembly 150, or stated otherwise, can require a single, predetermined rotational orientation between the needle assembly 150 and the introducer hub 114 in order for the needle assembly 150 to connect to the introducer hub 114, as discussed further below.

[0176] With reference to FIG. 4F, the handle 114 may be said to define a keying interface 260 via which a predetermined rotational orientation may be achieved between the introducer 110 and the needle assembly 150 when these components are in a coupled state. Stated otherwise, the keying interface 260 may permit the introducer 110 and the needle assembly 150 to be fully coupled together in only a single rotational or angular orientation relative to one another. In the illustrated embodiment, the keying interface 260 includes the differently dimensioned catches 262, 264, which function as previously described

[0177] When the needle assembly 150 is connected with the introducer 110 in the predetermined rotational orientation, tines can be deployed at the distal end of the needle assembly 150 in a predetermined orientation relative to the introducer 110, as discussed further below. The ultimate direction of this tine deployment relative to the introducer 110 thus can be predetermined and can be indicated on the introducer 110.

[0178] In the illustrated embodiment, the introducer 110 includes a first keying interface 240 via which the introducer 110 can be rotationally locked to one or more of the stylet assemblies 120, 130 in a predetermined rotational orientation, and further includes a second keying interface 260 via which the introducer 110 can be selectively connected to the needle assembly 150 in a predetermined rotational orientation. In the illustrated embodiment, the keying interfaces 240, 260 employ different locking mechanisms from one another and are physically separated or spaced from one another. The keying interface 240 for interacting with the stylet assemblies 120, 130 is radially spaced from a central longitudinal axis of the introducer handle 114, and is positioned at ends of wings that extend from a central body of the introducer handle 114, whereas the keying interface 260 is positioned more centrally, or closer to the central longitudinal axis of the introducer handle 114. The keying interfaces 240, 260 are physically separate or physically distinct.

[0179] In other embodiments, a common keying interface may be used for achieving a predetermined rotational orientation between (1 ) each of the needle assembly 150 and one or more of the stylet assemblies 120, 130 and (2) the introducer 110. For example,one such common keying interface arrangement is discussed with respect to FIGS. 33- 41.

[0180] With reference to FIGS. 4A and 4C, the introducer handle 114 can include a directional or orientational indicium 270. The orientational indicium 270 can include any suitable visual and / or tactile element that can communicate information to a user. For example, in various embodiments, the indicium 270 may include one or more of a raised region (e.g., relative to adjacent portions of the handle 114), recessed region, colored region, printed element (e.g., graphical representation of any suitable variety), etc. Such options apply equally to other indicia described herein. The orientational indicium 270 in the illustrated embodiment includes an arrow 272 pointed radially outward relative to a central longitudinal axis of the handle 114. The arrow 272 may be printed (e.g., pad printed) or otherwise affixed to the handle. For example, in some embodiments the arrow 272 or other indicator can be physically formed with the handle 114, such as, for example, by being integrally formed therewith. For example, in some embodiments, the arrow 272 or other indicator may be a raised or recessed object formed during molding of the handle 114.

[0181] As discussed further below, the indicium 270 can indicate to a user a deployment direction associated with the tines of the needle assembly. In certain embodiments, the indicium 270 can alternatively or additionally indicate a desired orientation of the introducer 110 relative to the median (or midsagittal) plane of the patient. For example, in instances, it can be desirable to rotate the introducer around the central longitudinal axis thereof to achieve a minimum distance between the indicium 270 and the median plane of the patient when positioning the introducer within a vertebra of a patient. In the illustrated embodiment, the arrow 272 is positioned to point toward the median plane of the patient to result in deployment of tines from the needle assembly 150 generally toward the median plane, when the needle assembly 150 is attached to the introducer 110.

[0182] As further discussed below (e.g., with respect to FIGS. 23B-24C), in some embodiments, the indicium 270 may be physically located on the handle 114 such that the indicium 270 itself physically corresponds with a desired rotational orientation of the introducer 110. For example, as previously noted, in the illustrated embodiment, a preferred rotational orientation of the introducer 110 is achieved when the indicium 270 is in its closest possible proximity to the median plane of the patient.

[0183] Moreover, in some embodiments, an orientational plane of the introducer 110 may be defined as a longitudinal plane that (1 ) subsumes the central longitudinal axis of the introducer 110 (i.e., the central longitudinal axis of the introducer 110 extends along the orientational plane) and (2) extends in the specific direction indicated by the indicium 270. The orientational plane may correspond with a general deployment direction of the tines of the needle (as further discussed below). In some instances, the indicium 270 may physically correspond with the desired rotational orientation of the introducer 110 in that the orientational plane of the introducer 110 extends through the indicium 270 itself.

[0184] In other embodiments, the indicium 270 may indicate the specific direction in which the orientational plane of the introducer 110 extends, but may not physically correspond with the orientational plane. For example, the indicium 270 may point in, or otherwise indicate, the direction in which the orientational plane extends, but may be physically spaced from the orientational plane. For example, the indicium 270 may be positioned on a surface of the handle 114 that the orientational plane does not pass through.

[0185] With reference to FIG. 4A, in some embodiments, the handle 114 further includes one or more attachment indicia 280. In the illustrated embodiment, an attachment indicium 280 includes a vertically oriented raised rib 282 that extends along a portion of the stem 222. In the illustrated embodiment, the rib 282 visually and / or palpably indicates to a user which of the catches 262, 264 defined by the handle 114 are configured for attachment to the larger of corresponding connection elements of the needle assembly.

[0186] As previously discussed, in the illustrated embodiment, the catches 262, 264 are differently sized, which provides an alternative or additional attachment indicium 280, visual and / or palpable, by which a user can determine a manner or orientation in which the needle assembly 150 is configured to be attached to the introducer 110. That is, a user can visually perceive the difference in size of the catches 262, 264 to thereby determine the appropriate rotational orientation of the needle assembly 150 relative to the introducer 110. Alternatively and / or additionally, the user can touch one or more of the differently sized catches 262, 264 and thereby determine the appropriate orientation of the needle assembly 150 relative to the introducer 110 by feel.

[0187] With reference to FIG. 4A, in the illustrated embodiment, the upper end of each connection interface 262, 264 includes a chamfered or angled rim 288 that can assist in aligning the corresponding connection elements (e.g., latches) of the needle assembly150. Stated otherwise, the angled or chamfered upper rims 288 can help guide the connection interfaces of the needle assembly 150 into the longitudinal channel portions of the catches 262, 264 to facilitate attachment of the needle assembly 150 to the introducer 110. For example, in some embodiments, the shorter portions of the rims 288 that border either side of each catch 262, 264, which are the most radially distanced from the central longitudinal axis of the handle 114, can be particularly well suited for assisting in achieving a predetermined rotational orientation between the needle assembly 150 and the introducer 110. In some embodiments, the longer sections of the rims 288 that are closest to the central longitudinal axis may assist in deflecting latches of the needle assembly 150 outwardly during insertion of the needle assembly 150 into the introducer 110, as discussed further below.

[0188] With continued reference to FIG. 4A, the illustrated embodiment of the introducer handle 114 includes a sheath connector 290 to which a protective sheath may be secured (such as shown in FIG. 28), such as for packaging, shipment, and / or user protection during unpackaging of the introducer 110. Any suitable connection mechanism is contemplated. The illustrated sheath connector 290 includes a distally projecting column 292 from which four longitudinally extending ribs 294 extend radially outwardly.

[0189] With reference to FIG. 5, the trocar stylet assembly 120 will now be described. The illustrated trocar stylet assembly 120 includes the trocar-tipped stylet 122 and the handle 124.

[0190] With reference to FIG. 6, the trocar-tipped stylet 122 can include an elongated shaft 300 that extends between a proximal end 306 and a distal end 304. The distal end 304 can include a sharpened tip 302, which can be configured for cutting bone. In some embodiments, the distal tip 302 can include a plurality of (e.g., three) beveled faces that meet at a point along the central longitudinal axis of the stylet.

[0191] In some embodiments, the proximal end 306 of the shaft 300 can include one or more retention features 308 that can promote secure attachment between the handle 124 and the trocar-tipped stylet 122. In the illustrated embodiment, the retention features 308 include a pair of oppositely positioned notches or grooves that can fill in with a polymeric material of which the handle 124 is formed during an overmolding procedure. Stated otherwise, the retention features 308 can receive handle material therein during manufacture. The retention features 308 can aid in maintaining the handle 124 and thestylet 122 securely attached to one another, even under compression, tension, and / or torsion during insertion into a bone and / or removal therefrom.

[0192] In the illustrated embodiment, a further notch 309 is included on the stylet 122, which is positioned proximal to the retention features 308. The notch 309 may be used for proper positioning and alignment during manufacture. In some instances, an alignment pin may be positioned within the notch 309 during manufacture, which may result in a window 310 (FIG. 7A) in the handle 124 after manufacture.

[0193] The handle 124 of the trocar stylet assembly 120 is depicted in detail in FIGS.5 and 7A-7C. In certain embodiments, the handle 124 can include an upper body 330 that extends laterally outwardly to define two wings 332, 334. The wings 332, 334 can be downturned, or extend distally, at the extremities thereof. As shown, e.g., in FIG. 8A, the body 330 can encompass an upper end and side ends of the handle 114 of the introducer 110 when these components are coupled together.

[0194] With reference to FIG. 5, a neck, extension, or protrusion 340 can extend distally from the body 330. In the illustrated embodiment, the protrusion 340 is sized to be received within the receptacle 225 of the handle 114 of the introducer 110. The protrusion 340 can include any suitable connector 346 for coupling with the connector 226 of the handle 114 of the introducer 110. The connectors 346, 226 can cooperate to securely join the stylet assembly 120 and the introducer 110 together. The connection provided by the connectors 346, 226 may be selectively releasable.

[0195] In the illustrated embodiment, the connector 346 comprises an external raised thread 347 that is configured to complementarily engage the internal thread 227 of the connector 226 (see FIG. 8B). In other embodiments, the internal / external threading can be reversed. For example, the connector 346 can be a recessed or grooved thread, and the connector 226 can be a raised thread. Any other suitable connection mechanism or connection interface is contemplated.

[0196] In the illustrated embodiment, the wing 334 includes a rotational stop 350 that interfaces with the stop 237 to prevent clockwise rotation (as viewed from above, or as viewed in a distal direction along the central longitudinal axis) of the handle 124 relative to the handle 114 when the stops 350, 237 are engaged, or stated otherwise, when the stops 350, 237 are in abutment with one another so as to interfere with one another. In the illustrated embodiment, the rotational stop 350 projects radially inward from an end of the wing 334.

[0197] In the illustrated embodiment, the wing 332 includes a lock 360 that is configured to interact with the lock 238 of the introducer 110 to maintain the stylet assembly 120 in a fixed rotational orientation relative to the introducer 110. The illustrated lock 360 includes a resilient arm 361 that includes a catch 362. The arm 361 can be anchored to the body 330 at an end opposite the free end so as to be cantilevered from the body 330. In some embodiments, the catch 362 is positioned at a free or unattached end of the arm 361 , which may be positioned opposite the anchored end of the arm 361. In the illustrated embodiment, the arm 361 projects radially or laterally outwardly, relative to the central longitudinal axis, from the body and is substantially horizontal in the orientation depicted in FIG. 5. The catch 362 can extend downwardly from the end of the arm 361 , or may be said to project distally in a longitudinal direction.

[0198] With continued reference to FIG. 5, the handle 124 may be said to define a keying interface 370 via which a predetermined rotational orientation may be achieved between the introducer 110 and the stylet assembly 120 when the introducer 110 and the stylet assembly 120 are in a coupled state. In the illustrated embodiment, the keying interface 370 includes each of the stop 340 and the lock 360, which function as previously described. The keying interface 370 of the stylet assembly 120 and the keying interface 240 of the introducer 110 can interact with one another to achieve the predetermined or unique rotational orientation.

[0199] With reference to FIG. 8C, during coupling of the handle 124 of the trocar stylet assembly 120 to the handle 114 of the introducer 110, which is facilitated by the rotational interaction of the connectors 226, 346 as previously discussed (see FIG. 8B), the leading face (e.g., the right face in FIG. 8C) of the catch 362 can interact with the handle 114 to resiliently deflect the arm 361 upward. With further rotation, the catch 362 seats within the receptacle 238, thus returning the arm 361 to a natural or undeflected state. This seated arrangement can assist in retaining the handles 124, 114 in a coupled state. The left face (in FIG. 8C) of the catch 362 can have a more aggressive slant, which can correspond with a more aggressively slanted face of the receptacle 238. This arrangement can require a predetermined amount of force in the opposite rotational direction to once again deflect the arm 361 upward to permit rotation of the handles 124, 114 relative to one another for disengagement.

[0200] FIG. 8B is a cross-sectional view of the trocar-tipped stylet assembly 120 coupled with the introducer 110. As shown, sufficient space exists within the cavity of the introducer handle 124 to receive the elongated stem at the distal end of the handleof the stylet assembly 120. As previously noted, in some embodiments, the elongated stem can be configured to retain thereon a shielding cover, such as may be used for packaging and shipping. In some embodiments, however, the trocar-tipped stylet assembly 120 and the introducer 110 may be shipped in a coupled state, such that a single shielding cover is instead placed on the elongated stem at the distal end of the introducer handle 114. One such arrangement is depicted, for example, in FIG. 29B.

[0201] With reference to, e.g., FIGS. 7A, 8B, and 8C, the handle 124 can include a strike surface 380, which can be a substantially planar surface that is orthogonal to the central longitudinal axis. A user can strike the strike surface 380, e.g., with a mallet, to advance the coupled stylet assembly 120 and introducer 110, as depicted in FIG. 8A, through bone. The stylet assembly 120 and the introducer 110 may be sufficiently securely fastened to one another when in the coupled state to withstand significant force and high impact, such as during hammering of this attached system into bone.

[0202] With reference again to FIG. 5, the illustrated embodiment of the stylet handle 114 includes a sheath connector 390 to which a protective sheath may be secured (such as shown in FIG. 28), such as for packaging, shipment, and / or user protection during unpackaging of the stylet assembly 120. Any suitable connection mechanism is contemplated. The illustrated sheath connector 390 includes a distally projecting column 392 from which four longitudinally extending ribs 394 extend radially outwardly.

[0203] With reference to FIG. 9A, in some embodiments, the handle 134 of the beveled stylet assembly 130 can include any or all of the features discussed above with respect to the handle 124 of the trocar stylet assembly 120. In some embodiments, the handle 134 includes identical or substantially identical connection geometries as the handle 124. For example, each handle 124, 134 may couple to and decouple from the handle 114 of the introducer 110 in the same manner. The handle 134 can include, for example a connector 446, such as the connector 346 described above, and a keying interface 470, such as the keying interface 370 described above.

[0204] As previously noted, the bevel-tipped stylet 132 can include a distal tip that includes at least a primary grind or bevel. The primary grind may be at an acute angle relative to the central longitudinal axis of the stylet 132. In some embodiments, the primary grind extends from one side surface of the stylet 132 to or nearly to an opposite side surface of the stylet 132. In some embodiments, one or more small reverse grinds may be present.

[0205] In some embodiments, the angled shape of the bevel-tipped stylet 132 can urge the beveled stylet assembly 130 and introducer 110, when coupled together (as shown in FIG. 9D), in a lateral direction during distal advancement. Stated otherwise, the bevel-tipped stylet 132 may deflect the coupled system in a preferred deflection direction. For example, in the orientation depicted in FIG. 9D, the bevel-tipped stylet 132, if advanced distally, could urge the coupled system in a rightward direction during such distal advancement, due to the forces at play at the beveled distal tip as the angled primary distal face of the stylet 132 presses against bone material.

[0206] With reference to FIGS. 9A and 9B, in some embodiments, the handle 134 may include one or more deflection indicia 495. For example, the handle 134 may include a printed, imprinted, raised, or any other variety of indicator that identifies the direction that the bevel-tipped stylet 132 may tend to urge the coupled stylet assembly 130 / introducer 110 system during insertion or advancement through bone. In some embodiments, it may be desirable to orient the coupled system such that the deflection indicium or indicia 495 is / are pointed toward the median plane of the patient, such as when the system is inserted through a pedicle of a vertebral body for the ultimate ablation of a basivertebral nerve. In some embodiments, the one or more indicia 495 comprises a raised arrow 497 that points radially outward relative to the central longitudinal axis of the stylet assembly 130.

[0207] In some embodiments, the deflection indicia 495 may serve as, or may simultaneously function as, an directional or orientational indicium 493, such as those discussed elsewhere herein. For example, in the illustrated embodiment, it can be desirable for the stylet assembly 130 to urge the introducer 110 toward the median plane during advancement of the coupled stylet assembly 130 / introducer 110 system within a vertebral body. The introducer 110 may subsequently receive therethrough the needle assembly 150 for ablation of the basivertebral nerve. It may be desirable for the general deployment direction of the needle tines to be toward the median plane, or stated otherwise, in the same direction that the bevel tip previously urged advancement of the stylet assembly 130 / introducer 110 system.

[0208] The orientational indicium 493 can correspond with the orientational indicium 270 of the introducer 110 in any suitable manner. For example, in various embodiments, the orientational indicium 493 may point in the same direction as the orientational indicium 270, thus indicating to the user the direction that the underlying (and potentiallyhidden) orientational indicium 270 may be pointing when the introducer 110 and the stylet assembly 130 are in a coupled state.

[0209] In some embodiments, the handle 134 may include separate deflection and orientational indicia 495, 493. In certain of such embodiments, the orientational indicia 495, 493 may nevertheless indicate the same direction, for reasons such as discussed above.

[0210] With reference to FIG. 9B, in some embodiments, the handle 134 can include a bevel indicium 499, which can aid a user in distinguishing a bevel-tipped stylet assembly 130 from a trocar-tipped stylet assembly 120. In the illustrated embodiment, the bevel indicium 499 is a triangular marking. In the illustrated embodiment, the triangular marking does not accurately reflect a rotational orientation of the bevel. In other embodiments, the bevel indicium 499 can further indicate a rotational orientation and / or deflection direction of the bevel and may simultaneously serve as the deflection indicium (such as the deflection indicium 497).

[0211] FIG. 9C depicts a distal end of the beveled stylet 132. In various embodiments, the bevel can define an angle a relative to a longitudinal axis of the stylet 132. In various embodiments, the angle a is within a range of from about 30 to about 60 degrees, from about 40 to about 50 degrees or is about 45 degrees. Other angles are contemplated.

[0212] FIGS. 9D and 9E depict the bevel-tipped stylet assembly 130 coupled with the introducer 110. In the illustrated embodiment, the orientational indicium 493 points in the same direction as the orientational indicium 270 of the introducer 110 when the beveltipped stylet assembly 130 is fully coupled with the introducer 110. In some embodiments, at least a portion of each of the orientational indicia 493 of the stylet assembly 130 and the orientational indicia 270 of the introducer 110 may be longitudinally aligned when these instruments are coupled together. For example, in some embodiments, at least a portion of the orientational indicium 493 of the stylet assembly 130 may be positioned substantially over, or substantially directly proximal to, at least a portion of the orientational indicium 270 of the introducer 110. In the illustrated embodiment, the orientational indicia 270, 493 are radially offset from one another.

[0213] The orientational indicium 493 of the stylet assembly 130 may serve to independently or directly convey to a user the information conveyed by the orientational indicium 270 of the introducer 110 while these components are in a coupled state. Such may be beneficial to a user as the handle 134 of the stylet assembly 130 can otherwise obscure the orientational indicium 270 of the introducer 110 when the stylet assembly130 and the introducer 110 are coupled to each other. In some instances, the orientational indicium 493 of the stylet assembly 130 may convey to the user information regarding the orientation of the orientational indicium 270 of the introducer 110, and thus may indirectly convey to the user convey to a user the information that is subsequently directly conveyed by the orientational indicium 270 of the introducer 270 when such becomes visible after decoupling of the stylet assembly 130 from the introducer 110.

[0214] In the illustrated embodiment of the system 100, the trocar-tipped stylet assembly 120 does not include an orientational indicium 493 such as that of the beveltipped stylet assembly 130 (see FIG. 1 and compare, e.g., FIGS. 7A and 9B). In other embodiments, however, the trocar-tipped stylet assembly 120 does include such an orientational indicium. For example, in some instances, it may be advantageous to include an orientational indicium such as the orientational indicium 493 on the trocar- tipped stylet assembly 120 to convey information regarding the underlying orientational indicium 270 of the introducer 110 when the trocar-tipped stylet assembly 120 is coupled with the introducer 110 (such as in the arrangement of FIG. 8A) for reasons such as previously discussed. Indeed, in some instances a system 100 may be prepackaged with a trocar-tipped stylet assembly coupled with the introducer 110. This may, in some instances, streamline an early stage of using the system, such as in instances where the trocar-tipped stylet is typical used with the introducer 110 before any other instrument is used with the introducer 110. In embodiments where the trocar-tipped stylet assembly 120 obscures the orientational indicium 270 of the introducer 110, it can be helpful for this stylet assembly 120 to include its own orientational indicium that corresponds with (e.g., conveys information regarding) the orientational indicium 270 of the introducer 1110.

[0215] One example of a system in which both a trocar-tipped stylet assembly and a bevel-tipped stylet assembly include orientational indicia, such as the orientational indicia 492, is depicted in FIG. 28. In this embodiment, raised indicia are visible on the leftfacing wing of each stylet assembly. In some instances, it may be advantageous to include features that distinguish the handles of the stylet assemblies 120, 130 from each other, particularly in instances where they may bear substantially identical orientational indicia. As previously noted, in some embodiments, the bevel-tipped stylet assembly 120 includes a bevel indicium 499 (FIG. 9B).

[0216] In the illustrated embodiment, the orientational indicium 493 of stylet assembly 130 can comprise an arrow or other indicator that desirably points toward the medianplane to aid a user in directing the assembled introducer 110 and stylet assembly 130 toward the median plane during insertion. Upon removal of the stylet assembly 130 from the introducer 110, the orientational indicium 270 of the introducer 110 may remain pointing toward the median plane, which can ultimately result in deployment of tines from the needle assembly 250 toward the median plane, after the needle assembly 150 has been attached to the introducer 110.

[0217] FIG. 10A is an elevation view of an embodiment of the drill assembly 140. As previously noted, in some embodiments, the drill bit 142 includes a fluted distal tip 450. The flutes may be configured to drill into cortical and / or cancellous bone. In some instances, the flutes may retain therein cut portions of the bone to thereby pull the cut portions out of the bone.

[0218] With reference to FIG. 10B, in some embodiments, the handle 144 may be sized to be readily gripped by a hand of a user, and may be ergonomically shaped to facilitation manipulation, such as rotation and / or distal advancement. In some embodiments, the handle 144 includes a friction enhancing pattern to assist in the manipulation thereof. In some embodiments, the handle 144 may be concavely shaped. The handle 144 may be contoured to enhance grip.

[0219] With continued reference to FIG. 10B and 10E, in the illustrated embodiment, the handle 144 of the drill assembly 140 includes a projection 460, which may provide a standoff relative to the handle 114 of the introducer 110. For example, a distal end of the projection 460 may be sized so as not to fit within the cavity 225 of the handle 114 of the introducer 110. Instead, the distal end of the projection 460 may abut against an upper surface of the handle 114. In various embodiments, the standoff thus provided can permit the user’s fingers to be spaced from the handle 114 of the introducer by a sufficient distance so as not to contact the handle 114 when gripping and manipulating the handle 144.

[0220] The drill assembly 140 can advantageously assist in breaching cortical bone, in some instances. In other or further instances, the drill assembly 140 can permit removal of cancellous bone via retraction thereof through the introducer 110. In various instances, the drill assembly 140 may be used before one or more of the stylet assemblies 120, 130, intermittently between uses of one or more of the stylet assemblies 120, 130, and / or after the use of one or more of the stylet assemblies 120, 130.

[0221] FIGS. 10C and 10D are elevation views of the drill bit 142. With reference to FIG. 10C, the drill bit 142 can include retention features, such as one or more notches452. In some embodiments, the drill bit 142 can include a further notch 454 that may instead or additionally be used for alignment. For example, in some instances, the notch 454 may be used during laser marking to provide the marks shown in FIG. 10D. In other or further instances, the proximal notch 454 may be used for longitudinal and / or rotational positioning to achieve a desired handle orientation relative to the drill bit.

[0222] As shown in FIG. 10D, in some embodiments, the drill bit 142 can include depth markers 456 , which may be laser etched or otherwise applied to the drill bit 142. In the illustrated embodiment, the “0” depth marker indicates a point at which a distal tip of the drill bit 142 is positioned at (e.g., is flush with) a distal tip of the introducer cannula 112 when the drill bit 142 is positioned within the introducer 110 (e.g., in advancing toward a fully inserted position such as shown in FIG. 10E). In the illustrated embodiment, the “1” depth marker indicates one centimeter advancement past the distal tip of the introducer cannula, and the “S” depth marker indicates a depth to which the needle assembly will extend when fully coupled with the introducer (e.g., after the drill bit is removed and replaced with the needle assembly 150). A practitioner can determine from the depth markers or depth markings whether to drill to any of the marked or intermediate positions.

[0223] With reference again to FIG. 10E, a distal end of the projection 460 of the handle 144 can abut against a proximal surface of the introducer handle. This can result in a hard stop beyond which the distal end of the drill bit 112 will not extend. In some embodiments, a length of the drill bit 112 is such that when the drill handle 144 abuts against the introducer handle 114, the distal tip of the drill bit 112 will penetrate no further than a distance that is only slightly greater than a depth to which the distal tip of the needle assembly 150 will extend when it is coupled to the introducer 110. For example, in some embodiments, the drill bit 112 is prevented from extending beyond the distal tip of the drill bit 112 to a depth that exceeds the predetermined depth of the needle assembly 150 by no greater than 1 , 2, 3, 4, or 5 millimeters, or about 1 , 2, 3, 4, or 5 millimeters.

[0224] FIGS. 11A-11 C depict an embodiment of the needle assembly 150 in an undeployed or retracted state, and FIGS. 12A and 12B depict the needle assembly 150 in a deployed or advanced state. As discussed further below, in the undeployed state, a pair of tines 510, 511 are fully retracted and positioned at an interior of an elongated member; in the deployed state, the pair of tines 510, 511 extend outwardly relative to the elongated member, each being at an acute angle relative to a central longitudinal axis ofthe needle assembly 150. Moreover, the deployed tines 510, 511 define an acute angle that extends therebetween.

[0225] With reference to FIGS. 11 B and 12B, in the illustrated embodiment, the needle assembly 150 includes the main hub 154 that is fixedly secured to the elongated member 152. A tip 504 can be positioned at a distal end of the elongated member 152. In some embodiments, the tip 504 is fixedly secured to the elongated member 152. The needle assembly 150 can further include a movable advancing hub 506 that can be advanced and retracted relative to the main hub 154 via rotation of a spin collar 508 in respectively opposite rotational directions. For example, in the illustrated embodiment, the spin collar 508 can be rotated clockwise (as viewed from above), in a deployment direction, to advance the tines to their deployed state, and can be rotated counterclockwise (as viewed from above), in a retraction direction, to draw the tines back into their retracted state. Moreover, rotation of the spin collar 508 can yield corresponding longitudinal movement of the advancing hub 506. Distal advancement of the advancing hub 506 can deploy tines 510, 511 (e.g., FIG. 12A), and proximal retraction of the advancing hub 506 can retract the tines 510, 511 (e.g., FIGS. 11 B and 11 C).

[0226] FIGS. 13A-13F depict an embodiment of the advancing hub 506. In the illustrated embodiment, the advancing hub 506 includes a connector 530 that defines a proximal end of a lumen 532 (FIG. 13C). In some embodiments, at least an interior surface of a proximal end of the lumen 532 is configured to receive a luer therein for optional fluid transfer, such as for delivery of any of an anesthetic, saline, etc. The connector 530 can include external threads 534. In various embodiments, the connector 530 can be a luer connector (e.g., may be compliant with one or more applicable ISO luer standards).

[0227] The advancing hub 506 can include a platform 540 with a pair of oppositely directed ribs 542. In some embodiments, the platform 540 can delimit proximal movement of a coupling element thereto, and the ribs 542 can securely retain the coupling element in a coupled arrangement with the advancing hub, which coupled arrangement can be overcome with sufficiently directed opposite rotational force.

[0228] For example, in some embodiments, the probe 160 can include, e.g., a spin collar as a coupling element that can couple with the connector 530 (see FIGS. 20A and 21 D) and interface with the platform 540 and ribs 542, as further discussed below. In other or further embodiments, a fluid delivery element, such as a syringe, may include a coupling element (e.g., a spin collar or a fixed distal end) that is configured to couple withthe connector 530, platform 540, and / or ribs 542 in a same or similar manner as that discussed below with respect to the probe 160.

[0229] In some embodiments, the advancing hub 506 includes an interface 560 for interacting with the spin collar 508. For example, the interface 560 can include a groove 562 positioned between the platform 540 and an annular protrusion 564.

[0230] In the illustrated embodiment, the advancing hub 506 includes a recess 570 that is configured to receive a locking pin that is fixedly secured to the main hub 154, as discussed further below (see FIG. 19B). The recess 570 can be sufficiently long in a longitudinal direction to permit the advancing hub 506 to have a significant range of longitudinal movement relative to the locking pin as a distal end of the advancing hub 506 is moved longitudinally within the main hub 154.

[0231] In some embodiments, the advancing hub 506 is configured to be restrained from rotational movement within the main hub 154. In the illustrated embodiment, a planar face 580 assists in restraining relative rotational movement between the advancing hub 506 and the main hub 154. As discussed further below, the planar face 580 can be keyed to a planar wall region of a cavity of the main hub 154 that receives the distal end of the advancing hub 506 (see FIGS. 15E and 19A).

[0232] In some embodiments, the distal end of the advancing hub 506 is overmolded over a proximal end of a tine element 850. In some embodiments, the tine element 850 can be a unitary component, such as a single wire, which may be folded, and opposing ends of the wire can define a pair of tines (see FIG. 17A).

[0233] With reference to FIG. 13C, the illustrated advancing hub 506 includes a recess or annular groove 575 that is configured to receive a sealing member of any suitable variety, such as an elastomeric O-ring. An example of such is provided in FIGS. 19A-19C.

[0234] With reference to FIGS. 14A-14D, the spin collar 508 can include a central body 600 that defines a lumen 602. The lumen 602 can include one or more internal threads 604. In certain embodiments, the spin collar 508 can include a pair of oppositely projecting wings 610, 612. The wings 610, 612 can facilitate application of torque to the spin collar 508, which can assist in the deployment of the tines 510, 511 into, e.g., cancellous bone. A size of the wings 610, 612 and / or a pitch of the threads 604 may be selected to provide a desired mechanical advantage to facilitate deployment of the tines 510, 511 through, e.g., cancellous bone.

[0235] In the illustrated embodiment, the spin collar 508 includes an annular protrusion, constriction, or movement ring 616 that can interact with the interface 560 of the advancing hub 506 to achieve longitudinal movement of the advancing hub 506 as the spin collar 508 is rotated. In particular, the ring 616 can be sized to fit within, and spin relative to while remaining positioned within, the interface 560 of the advancing hub 506 as the spin collar 508 rotates. The keyed interaction of the advancing hub 506 and the internal sidewall of the main hub 154 can prevent the advancing hub 506 from rotating with the spin collar 508. Accordingly, as the spin collar 508 rotates relative to the advancing hub 506 and thereby advances distally or proximally along the helical track, the advancing hub 506 is pulled alongside the spin collar 508 via interaction of the ring 616 with the interface 560, thereby moving distally or proximally relative to the main hub 154 without rotating relative to the main hub 154.

[0236] In the illustrated embodiment, a distal end of the spin collar 508 can include a pair of recesses 620, 622. In the illustrated embodiment, the recesses 620, 622 are identical to one another and are positioned diametrically opposite one another. The recesses 620, 622 can receive therein ribs defined by the main hub 154, as discussed further below (see FIGS. 13A and 21 C). The interaction of the recesses 620, 622 and the ribs can lock the spin collar 508 in place relative to the main hub 154, which can consequently lock the advancing hub 506 in place relative to the main hub 154 and maintain the tines 510, 511 in a fully deployed state.

[0237] In the illustrated embodiment, the spin collar 508 is rotated clockwise, as viewed from above (e.g., viewed in a distal direction along the central longitudinal axis), in order to deploy the tines. Thus, in FIG. 14C, the recess 620 would move from right to left during advancement. The left side of the recess 620 includes a ramp 630, whereas the right side of the recess 620 includes a stop 632. The stop 632 can interface with a rib defined by the main hub 154 to prevent further clockwise rotation of the spin collar 508. In other or further instances, a bottom surface of the spin collar 508 can abut an upper surface of a platform defined by the main hub 154 to prevent further rotation of the spin collar 508 in the clockwise direction.

[0238] In order to retract the tines, the spin collar 508 is rotated counterclockwise. The ramp 630, interacting with the rib of the main hub 154, can resist this counterclockwise motion. Similar resistance can be present for the recess 622. Application of a sufficient torque can overcome this resistance and ultimately permit counterclockwise rotation of the spin collar 508 for tine retraction.

[0239] With reference to FIG. 15B, in certain embodiments, the main hub 154 includes a pair of ribs 700, 702 and a platform 704, which can interact with the spin collar 508 in manners such as just described.

[0240] With reference generally to FIGS. 15A-15F, the main hub 154 can include a body 710. A proximal projection 712 can extend proximally from the body 710, and a distal projection 714 can extend distally from the body 710. A lumen 720 can extend longitudinally through an entirety of the main hub 154.

[0241] In the illustrated embodiment, the proximal projection 712 includes external threading 730 that can interact with the threading of the spin collar 508 to translate rotation of the spin collar 508 into longitudinal movement of the spin collar 508 and, as a result, corresponding longitudinal movement of the advancing hub 506 in an equal or substantially equal amount.

[0242] The lumen 720 can include therein a rotationally restrictive element that can interact with the advancing hub 506 to prevent rotation of the advancing hub 506 relative to the main hub 154. A shown in, e.g., FIGS. 15B and 15E, in the illustrated embodiment, the rotationally restrictive element includes a planar wall 740 that interacts with the surface 580 of the advancing hub 506 in manners such as previously described. This interaction is also depicted in FIG. 19A.

[0243] In the illustrated embodiment, the main hub 154 includes a connector 751 (FIG. 15C) that is configured to interact or cooperate with the connector 261 of the introducer 110 to selectively secure the needle assembly 150 to the introducer 110 in a fixedly attached state. The connector 751 may alternatively be referred to a fastener, lock, coupling interface, connection interface, locking interface, etc. The connector 751 may be of any suitable variety, and may be active or passive. In various embodiments, the connector 751 can comprise one or more of a catch, recess, receptacle, latch, catch, clamp, lock, snap, or any other suitable connection mechanism, whether mechanical, magnetic, electromagnetic, electromechanical, etc.

[0244] The connector 751 and the connector 261 of the introducer 110, described above may, in some embodiments, be configured to provide a secure connection that is particularly strong in preventing relative longitudinal movement between these instruments. For example, when the connectors 751 , 261 are in a connected state, they may be particularly effective in preventing the needle assembly 150 from moving proximally relative to the introducer 110. Stated otherwise, the connectors 751 , 261 can prevent backing out of the needle assembly 150, such as may occur due to reactiveforces from cancellous bone during deployment of the tines into the cancellous bone. The connectors 751 , 261 may provide a secure attachment that can facilitate and / or maintain predictability of tine deployment.

[0245] In the illustrated embodiment, the connector 751 comprises a pair latches 752, 754, or attachment members, that are configured to selectively secure the main hub 154 to the handle 114 of the introducer 110. In particular, the latches 752, 754 are configured to selectively attach to the catches 262, 264, respectively, of the handle 114, as previously discussed.

[0246] In the illustrated embodiment, the latches 752, 754 are formed as arms that are attached to the body 710 via projections 753, 755, respectively. The projections 753,755 may permit, or give rise to, resilient deflection of the arms 752, 754. In the illustrated embodiment, the distal ends of the latches 752, 754 include angled surfaces that interface with the rims 288 at the upper ends of the catches 262, 264 to deflect the lower ends of the latches 752, 754 radially outwardly during coupling of the needle assembly 150 to the introducer 110 (e.g., as the needle assembly 150 is advanced downward in FIG. 21 A). Once sufficient distal advancement of the needle assembly 150 is achieved relative to the introducer 110, the latches 752, 754 can resiliently return to or toward a resting state. In this coupled configuration (FIG. 21 B), the latches 752, 754 are further configured to interface with the undercut shelves of the catches 262, 264. In particular, each latch 752, 754 includes a radially inwardly projecting latching surface 758, 759 (FIG. 15D) that abuts against a respective undercut shelf of the catches 262, 264 to prevent backing out of the needle assembly 150 (e.g., as the needle assembly 150 is transitioned from the retracted state of FIG. 21 B to the deployed state of FIG. 21 C). When and if desired to decouple the needle assembly 150 from the introducer 110, such as in some instances after an ablation procedure is complete, the needle assembly 150 can be transitioned from the deployed state back to the retracted state, and the upper ends of the latches 752, 754 can be compressed radially inwardly to cause the lower ends of the latches 752, 754 to deflect radially outwardly again and thereby release the latches 752, 754 from the catches 262, 264, thereby permitting removal of the needle assembly 150 from the introducer 110.

[0247] In the illustrated embodiment, the arm 752 can include an attachment indicium756 that can visually demonstrate to a user an orientation in which the main hub 154 can be attached to the introducer 110 in order to achieve a desired deployment direction of the tines 510, 511 . In the illustrated embodiment, the attachment indicium 756 is a raisedrib that extends substantially vertically along the arm 758. As previously discussed regarding the indicia disclosed herein, other visual and / or palpable indicia are contemplated.

[0248] In the illustrated embodiment, the different sizes of the arms 752, 754 can provide a further attachment indicium that can visually demonstrate to a user an orientation in which the main hub 154 can be attached to the introducer 110 in order to achieve a desired deployment direction of the tines 510, 511. In the illustrated embodiment, the arm 752 is larger than the arm 754, and may be readily perceivable to a user visually and / or palpably as the larger arm.

[0249] Moreover, as previously discussed, in some embodiments, the catches 262, 264 of the introducer 110 can be differently sized. The differently sized catches 262, 264 thus may similarly be an attachment indicium associated with the handle 114 of the introducer 110.

[0250] Further, in some embodiments, the catch 264 may be sufficiently small that the larger arm 752 of the main hub 154 cannot fit therein. Accordingly, it may only be possible for the larger arm 752 of the main hub 154 to fit within the larger catch 262 of the handle 114 of the introducer 110. This connection arrangement may be referred to as keyed arrangement that only permits a single rotational orientation of the main hub 154 relative to the handle 114. Stated otherwise, the catches 262, 264 and the arms 752, 754 may be configured to connect in only a single rotational state that ensures a predictable deployment of the tines relative to the directional or orientational indicia of the handle 114.

[0251] Stated otherwise the main hub 154 may be said to define a keying interface 757 (FIG. 15B) via which a predetermined rotational orientation may be achieved between the needle assembly 150 and the introducer 110 when these instruments are in a coupled state (see FIG. 21 B). In the illustrated embodiment, the keying interface 757 includes each of the latches 752, 754, which function as previously described. The keying interface 757 of the needle assembly 150 and the keying interface 260 of the introducer 110 (FIG. 4F) can interact with one another to achieve the predetermined or unique rotational orientation.

[0252] In some embodiments, the main hub 154 can include a pair of windows 770 through which a locking pin 790 (FIG. 19B) can be received to prevent removal of the advancing hub 506 from the main hub 154 after these latter components have been assembled together.

[0253] With reference to FIG. 15C, the illustrated embodiment of the main hub 154 includes a sheath connector 790 to which a protective sheath may be secured (such as shown in FIG. 28), such as for packaging, shipment, and / or user protection during unpackaging of the needle assembly 150. Any suitable connection mechanism is contemplated. The illustrated sheath connector 70 includes a distally projecting column 792 from which four longitudinally extending ribs 794 extend radially outwardly.

[0254] With reference to FIGS. 16A-16C, the elongated member 152 can include a rigid tube 800 of any suitable material. In some embodiments, the tube 800 includes a stainless-steel tube that is resistant to bending. A proximal end of the tube 800 can include any suitable configuration for securely attaching to the main hub 154, such as in manners previously described with respect to the tube 200 and the handle 114. For example, in the illustrated embodiment, the proximal end of the tube 800 includes a cutout 812 and a collar 814, which can resemble and function in the same manner as the cutout 212 and the collar 214 discussed above. The tube 800 can define a lumen 830 that extends through a full length thereof.

[0255] In some embodiments, the tube 800 comprises an insulation layer 820, which can be applied in any suitable manner. In some embodiments, the insulation layer 820 is spray coated onto the tube 800. In other embodiments, the insulation layer 820 is formed by dipping.

[0256] With reference to FIG. 16C, a distal end of the insulation layer 820 may have a taper, which may be a gradual taper. In some embodiments, the distalmost tip of the insulation layer 820 is close to the outer surface of the tube 800. Such a configuration can facilitate advancement of the elongated member 152 into bone and / or through cancellous bone. In some embodiments, the insulation layer 820 is robust and resistant to being pulled from the tube 800, scraped, tom, or otherwise damage during insertion or removal.

[0257] In some embodiments, a distal end of the tube 800 includes filament or tine slots 804a, 804b, which can permit the passage of the tines 510, 511 therethrough. The tine slots 804a may, for example, function in manners such as the filament slots disclosed in U.S. Patent No. 10,716,618.

[0258] FIG. 17A depicts an embodiment of a tine element 850 that can include the deployable tines 510, 511 at a distal end thereof. In the illustrated embodiment, the tine element 850 comprises an elongated rigid metallic wire that is bent substantially at a midpoint thereof. The wire may comprise stainless steel or any other suitable conductivematerial. As previously discussed, the bent end of the tine element 850 may be joined to (e.g., molded within) the advancing hub 506.

[0259] With reference to FIG. 17B, in some embodiments, one or more of the tines 510, 511 have sharpened distal tips. One such sharpened tine 511 a is shown. In some embodiments, an orientation of the bevel of the sharpened tips can substantially correspond with an orientation of a primary bevel of the tip 504 (see FIG. 18C) and / or a primary bevel of the tip 504 (see FIG. 18C).

[0260] With reference to FIG. 17C in some embodiments, one or more of the tines 510, 511 have dull or unsharpened distal tips. One such unsharpened tine 511 b is shown. For example, in some embodiments, the distal tips may be cut to length, but no bevel applied thereto.

[0261] FIGS. 18A-18C depict an embodiment of the tip 504. The tip 504 may be formed of any suitable material, such as, for example stainless steel. The tip 504 can include a head 901 at a distal end and a proximal protrusion 902 or neck that extends proximally from the head. The proximal protrusion 902 can have a reduced diameter, as compared with the head, and may be sized to fit within the tube 800. The head 901 remains exposed at the distal end of the tube 800.

[0262] In various embodiments, the tip 504 can include a pair of filament lumens or tine guide 906a, 906b that can deflect the tines 510, 511 outwardly along a straight path that defines an angle relative to the central longitudinal axis of the needle assembly 150. In some embodiments, the tine element 850 is sufficiently rigid to permit each tine 510, 511 to substantially retain a rectilinear shape as it is deflected outwardly by ramps at the distal ends of the tine guides 906a, 906b (FIGS. 19D, 19E), even as the tines 510, 511 pass through cancellous bone.

[0263] The tip 504 can further include a probe lumen 906c configured to receive a distal end of the RF electrode 162. A ramp 910 and a chamfered upper end of the probe lumen 906c can assist in guiding the RF electrode 162 into the probe lumen 906c as the RF probe assembly 160 is coupled to the needle assembly (e.g., into the arrangement depicted in FIG. 21 D), particularly where the tine guides 906a, 906b are unavailable to receive the RF electrode 162 therein due to the presence of the tines 510, 511 therein.

[0264] When the RF electrode 162 is positioned within the probe lumen 906c, with the RF probe assembly 160 and the needle assembly 150 in a coupled state, physical contact between the electrically conductive RF electrode 162 and the electrically conductive tip 504 establishes electrical communication between these components. Likewise,physical contact between the electrically conductive tip 504 and the electrically conductive tines 510, 511 and / or electrically conductive portions of the tine element 850 immediately adjacent thereto establishes electrical communication between these components. Such physical contact may be between the tine element 850 (including at least a portion of the respective tines 510, 511 ) and the longitudinally extending channels of the tine guides 906a, 906b and / or the ramps at the distal ends of those channels. Further, physical contact between the electrically conductive tip 504 (e.g., the proximal extension 902 thereof) and the electrically conductive tube 800 establishes electrical communication between these components. As shown in FIG. 16C, a distal end portion of this tube 800 may not be covered by the insulative coating 820. These electrically connected components, including the exposed distal end of the tube 800, may all be at the same electrical potential due to the various regions of physical contact just described. They may all function together or in unison as a single, unitary, or common electrode during an ablation procedure. For example, as discussed further below, one such single, unitary, or common electrode of a first needle assembly 150 may serve as an active electrode, while a second such single, unitary, or common electrode of a second needle assembly 150 that is positioned near the first needle assembly 150 may serve as a return electrode during a bipolar ablation procedure. When the tines 510, 511 are extended, the tines 510, 511 thus may increase a size and / or otherwise alter the shape of this unitary electrode (compare FIG. 21 B to FIG. 21 C).

[0265] With reference to FIG. 18C, in some embodiments, a distalmost end of the tip 504 can include a primary bevel 915. In some instances, the needle assembly 150 can be configured to couple with the introducer 110 such that an orientation of the primary bevel 915 of the tip 504 corresponds with an orientation of the primary bevel of a beveled stylet assembly 130 that had previously been coupled with the introducer 110.

[0266] FIGS. 19A and 19B depict the needle assembly 150 in the retracted state, and FIGS. 19C-19E depict the needle assembly 150 in the deployed state. In the illustrated embodiment, a sealing member 940 is retained in the annular groove 575 of the advancing hub 506, as previously described. The sealing member 940 can be, for example, an O-ring. As shown in FIG. 19C, when the advancing hub 506 is advanced distally to the advanced or deployed state, the advancing hub 506 compresses the sealing member 940 against a proximal end of the main hub 154, which can yield a fluid- tight seal. A fluid-tight fluid conduit 949 thus may extend from a proximal end of the advancing hub 506 to the tip 504. The conduit 949 includes the lumen 532 of theadvancing hub 506, the lumen 575 of the main hub 154, and the lumen 830 of the tube 800, all of which may be in fluid communication with each other.

[0267] With continued reference to FIG. 19C, the conduit 949 may receive therein the RF electrode 162 when the RF probe assembly 160 is coupled to the needle assembly 150. In particular, the electrode 162 may be advanced through the lumens 532, 575, and 830 and into the probe lumen 906c of the tip 504, as previously described.

[0268] FIGS. 19D and 19E depict the tines 510, 511 fully deployed. In some embodiments, the distal tips of the fully deployed tines 510, 511 extend to substantially the same distal distance as does the tip 504 of the needle assembly 150 (e.g., as measured relative to the introducer handle). Stated otherwise, in the illustrated embodiment, the distal tips of the fully deployed tines 510, 511 can be substantially even with the distal tip of the needle when fully deployed. Stated otherwise, in the distal tips of the fully deployed tines 510, 511 and the distalmost point of the tip 504 can define a plane that is substantially orthogonal to a central longitudinal axis of the needle assembly 150.

[0269] In other embodiments, the fully deployed tines 510, 511 may extend distally beyond the distalmost point of the tip 504. In still other embodiments, the fully deployed tines 510, 511 may not extend distally as far as the needle tip 504.

[0270] With reference to FIG. 19D, the deployed tines can define an angle [3 relative to a central longitudinal axis of the needle assembly 2150 when fully extended. In various embodiments, the angle [3 can be within a range of from about 5 to about 20 degrees, from about 5 to about 15 degrees, from about 10 degrees to about 12 degrees, or can be about 11 degrees. In some embodiments, the angle [3 is 11 plus or minus 3 degrees.

[0271] As previously discussed, an exposed length of the tube 800, the tines 510, 511 , and the exposed tip 504 can function collectively or together as a unitary electrode, or stated otherwise, may all be at the same electrical potential due to the various regions of physical contact, and thereby, electrical connections among certain electrically conductive components of the needle assembly 150. In various embodiments, a length LE of this common electrode, which may be referred to as an active length of the needle assembly 150, may be within a range of from about 5 millimeters to about 20 millimeters, from about 7 millimeters to about 15 millimeters, from about 9 to about 12 millimeters, or from about 10 to about 11 millimeters, or may be about 10 millimeters or about 11 millimeters. In some embodiments, the length LE is 10.5 millimeters.

[0272] With reference to FIG. 19E, the deployed tines 510, 511 can define an angle y between them when fully extended. In various embodiments, the angle y can be within a range of from about 10 to about 25 degrees, from about 10 to about 20 degrees, from about 15 to about 17 degrees, or can be about 16 degrees. In some embodiments, the angle y is 16 plus or minus 3 degrees.

[0273] FIGS. 20A and 20B depict an embodiment of the RF probe assembly 160. The probe assembly 160 includes the hub 164 and the RF electrode 162. A cable 950 is attached to the hub 164, and the cable 950 runs to a connector 952. The connector 952 can be configured to connect the radiofrequency probe assembly 160 directly to an RF generator (e.g., the RF generator 1010 of FIG. 22A), or indirectly to an RF generator via an intermediary adapter cable (e.g., the adapter cable in FIG. 43), to control delivery of RF energy via the radiofrequency probe assembly 160. In the illustrated embodiment, the probe 160 includes a connector 970, which can include an internally threaded spin collar 972. The spin collar 972 can interface with a proximal end of the needle assembly 150 to advance the RF electrode 162 a predetermined distance within the needle assembly 150. In the illustrated embodiment, the spin collar 972 includes a pair of recesses 980, which can interact with the ribs 542 of the advancing hub 506 of the needle assembly 150 in substantially the same manner that the recesses 620, 622 of the spin collar 508 interact with the ribs 700, 702 of the main hub 154, as described above.

[0274] FIG. 22A depicts a system 1000 for intraosseous nerve ablation, which is shown in a ready state for bipolar ablation of a basivertebral nerve BVN (depicted schematically) of a patient P. The system 1000 includes an RF generator 1010 and two embodiments of the systems 100 previously described. Stated otherwise, two sets of introducers 110 have been advanced through two respective pedicles of a vertebra V of the patient (e.g., such as in manners described below with respect to the illustrative method of which stages are depicted in FIGS. 25A-25J). Two needle assemblies 150 have been interlocked with the two introducers 110, respectively, and the tines of these needle assemblies 150 have subsequently been deployed. Two RF probe assemblies 160 have further been interlocked with the needle assemblies 160 to thereby establish electrical communication between the RF probe assemblies 160 and the electrodes at the distal tips of the respective needle assemblies 150 in manner such as previously described.

[0275] The RF probe assemblies 160 have been electrically coupled with the RF generator 1010, or stated otherwise, have been attached to two ports 1015 of the RFgenerator 1010. The RF generator 1010 is configured to control delivery of RF energy through the RF probe assemblies 160, and hence through the needle assemblies 150, to achieve bipolar ablation of the basivertebral nerve BVN.

[0276] The various systems and methods disclosed herein may be used for ablation of the basivertebral nerve BVN within the vertebral body V, or may be used for ablation of multiple basivertebral nerves within multiple vertebral bodies (e.g., concurrently). For example, two additional systems 100 may be placed within an additional vertebral body, and may coupled to two additional ports 1015 of the RF generator.

[0277] The vertebral body or bodies may be at one or more levels of the lumbosacral spine (L1 -S1 ). In some instances, it can be desirable for a single system to be usable within any of the vertebra of the lumbosacral spine.

[0278] For example, with reference to FIG. 22B, within each vertebra V, a treatment region R can encompass a portion of the basivertebral nerve, the ablation of which can relieve chronic vertebrogenic pain of the patient. For example, the treatment region R can include therein or can encompass at least a portion of the basivertebral nerve plexus. The treatment region R may also be referred to as a target zone. Systems and methods described herein, which can include deployed tines, can provide for an enlarged treatment region R, as compared to when the tines are in a retracted state. The deployed tines thus can increase the size of an ablation, yield a more complete ablation, and / or provide a greater likelihood of successful treatment of the basivertebral nerve.

[0279] In various embodiments, a center of the treatment region R is positioned at the center of each of a vertical midline and a lateral midline of a vertebral body. For example, in the anteroposterior view, a center of the treatment region R can be 50 percent superiorinferior and 50 percent medial-lateral. In other or further embodiments, the center of the treatment region R can be approximately 40 percent across the vertebral body width from the posterior wall. In various embodiments, it can be desirable for at least a center of the treatment region R to be positioned about 30 percent to about 50 percent, about 30 percent to about 45 percent, about 30 percent to about 40 percent, about 35 percent to about 50 percent, about 35 percent to about 45 percent, about 35 percent to about 40 percent, about 40 percent to about 50 percent, or about 40 percent to about 45 percent anterior of the posterior wall of the vertebral body.

[0280] For each of the forgoing positions of the treatment region R, the tips of the needle assemblies can be distanced from one another by an amount suitable for ablating, or efficiently ablating, at a least a sufficient portion of the treatment region for lesionformation at the BVN plexus. Stated otherwise, a minimum distance between the non- tined portion of the needle assemblies, or a minimum distance between the tips DTIP (which may extend between the distalmost points of the tips of the needle assemblies), can be sufficiently small to permit effective RF ablation between the tips. In various embodiments, at least some of which occur within the treatment region positions previously recited, the tip distance DTIP when the needle assemblies are properly positioned for ablation can be from any of about 5, 10, 15, or 20 millimeters to about 25 millimeters; from any of about 5, 10, or 15 millimeters to about 20 millimeters; from either about 5 or about 10 millimeters to about 15 millimeters; or from about 5 millimeters to about 10 millimeters.

[0281] In various embodiments, the tines of the needle assemblies can be extended toward or substantially toward the median plane MP. In various embodiments, the minimum distance DTINE between a tine of one needle assembly and the closest tine of the contralateral needle assembly, when the needle assemblies are positioned for ablation and / or during ablation thereby, can be smaller than any of the distances recited above with respect to the minimum tip distance DTIP. For example, in various embodiments and orientations thereof, DTINE can be smaller than DTIP by any of about 1 , 2, 3, 4, 5, 6, 7, or 8 millimeters.

[0282] In various embodiments, the longitudinal axes of the needle assemblies when positioned for ablation (e.g., within any suitable combination of the parameters discussed in the four preceding paragraphs) can form an angle 5 therebetween. In various embodiments, when a pair of needle assemblies are positioned within a vertebra of the lumbosacral region of the spine, the angle 5 can be within a range of from any of about 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100 to about 105 degrees; 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90 or 95 to about 100 degrees; 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, or 90 to about 95 degrees; from any of about 40, 45, 50, 55, 60, 65, 70, 75, 80, or 85 to about 90 degrees; from any of about 40, 45, 50, 55, 60, 65, 70, 75, or 80 to about 85 degrees; from any of about 40, 45, 50, 55, 60, 65, 70, or 75 to about 80 degrees; from any of about 40, 45, 50, 55, 60, 65, or 70 to about 75 degrees; from any of about 40, 45, 50, 55, 60, or 65 to about 70 degrees; from any of about 40, 45, 50, 55 or 60 to about 65 degrees; from any of about 40, 45, 50, or 55 to about 60 degrees; from any of about 40, 45, or 50 to about 55 degrees; from about 40 or 45 degrees to about 50 degrees; or from about 40 to about 45 degrees.

[0283] In practice, a size of the angle 6 can generally increase with decreasing vertebral level. That is, for a particular patient, or on average for a group of patients, the relative size of the angle 5 at each level can be such that 5n < 5L2 < 5L3 < 5L4 < 5LS < 6si . In various instances, which may depend on, e.g., patient-to-patient anatomy, the angle 5 at the various levels can be as follows: at level L1 , within a range of from any of about 40, 45, 50, or 55 to about 60 degrees; from any of about 40, 45, or 50 degrees to about 55 degrees; from about 40 or 45 degrees to about 50 degrees; or from about 40 degrees to about 45 degrees; or about 49, 50, 51 , or 52 degrees; at level L2, within a range of from any of about 45, 50, 55, or 60 to about 65 degrees; from any of about 45, 50, or 55 to about 60 degrees; from about 45 or about 50 to about 55 degrees; or from about 45 degrees to about 50 degrees; or about 51 , 52, 53, 54, or 55 degrees; at level L3, within a range of from any of about 50, 55, 60, or 65 to about 70 degrees; from any of about 50, 55, or 60 to about 65 degrees; from about 50 or about 55 to about 60 degrees; or from about 50 degrees to about 55 degrees; or about 58, 59, 60, 61 , 62, or 63 degrees; at level L4, within a range of from any of about 55, 60, 65, 70, 75, or 80 to about 85 degrees; from any of about 55, 60, 65, 70, or 75 to about 80 degrees; from any of about 55, 60, 65, or 70 to about 75 degrees; from any of about 55, 60, or 65 to about 70 degrees; from about 55 or about 60 to about 65 degrees; or from about 55 to about 60 degrees; or about 68, 69, 70, 71 , 72, or 73 degrees; at level L5, within a range of from any of about 75, 80, 85, or 90 to about 95 degrees; from any of about 75, 80, or 85 to about 90 degrees; from about 75 or about 80 to about 85 degrees; or from about 75 to about 80 degrees; or about 82, 83, 84, 85, 86, 87, or 88 degrees; and / or at level S1 , within a range of from any of about 75, 80, 85, 90, 95, or 100 to about 105 degrees; from any of about 75, 80, 85, 90, or 95 to about 100 degrees; from any of about 75, 80, 85, or 90 to about 95 degrees; from any of about 75, 80, or 85 to about 90 degrees; from about 75 or about 80 to about 85 degrees; or from about 75 to about 80 degrees; or about 85, 86, 87, 88, 89, 90, 91 , 92, 93, 94, 95 or 96 degrees.

[0284] Various embodiments of systems and methods disclosed herein can advantageously assure effective and / or complete thermal coagulation of the BVN plexus irrespective of factors that may compromise precise device placement, such as patient anatomy and / or vertebral level.

[0285] FIG. 23A is a partially schematic top plan view of an illustrative procedure in which the distal ends of two introducers 110 coupled with beveled stylet assemblies 130 have been advanced within a vertebra V toward the median plane MP. The coupledintroducers 110 and stylet assemblies 130 have been advanced to their respective final destinations (e.g., prior to removal of the stylet assemblies 130 from the introducers 110 before subsequently coupling of needle assemblies 150 with the placed introducers 110, as shown in FIG. 23B).

[0286] As previously discussed, the bevel-tipped stylet assemblies 130 can assist in urging the introducers 110 toward the median plane MP. In the illustrated schematic depiction, the central longitudinal axis of each introducer 110 / stylet assembly 130 pairing is aligned with (e.g., subsumed within) a transverse plane TP that is orthogonal to the medial plane MP. This schematic depiction is primarily used to facilitate the present discussion, as it may not be possible or practical in some instances to achieve such a perfectly aligned arrangement in practice, e.g., due to anatomical constraints. Indeed, in many instances, each introducer 110 / stylet assembly 130 paired system may be tilted from what is shown (e.g., the handles of the coupled instruments may be positioned higher or lower than the transverse plane TP, while the distal tip of the stylet assembly 130 remains positioned on the transvers plane TP) and / or rotated about a central longitudinal axis of the introducer 110 / stylet assembly 130.

[0287] As previously discussed, each stylet assembly 130 can include a deflection indicium 493, which in the present embodiment, is simultaneously an orientational indicium 495 that corresponds with (e.g., indicates the same rotational direction as) the underlying orientational indicium 270 of the introducer 110 (see FIGS. 9E and 23B). For convenience, the arrow that serves as both the deflection indicium 493 and the orientational indicium 495 in each of the two illustrated embodiments of the bevel-tipped stylet assemblies 130 will hereafter be referred to as the orientational indicium 495.

[0288] Each orientational indicium 495 provides information (e.g., visual, tactile) to a user regarding an orientational direction 1052. The orientational direction 1052 can represent a general or composite direction in which the tines will ultimately be deployed, and may in some instances be referred to as a deployment direction. In some instances, the introducer 110 / stylet assembly 130 system can desirably be rotated such that the orientation direction 1052 points toward the median plane MP. Given that the median plane MP extends over a large space, a variety of rotational orientations may technically point toward the median plane MP, albeit distantly in some instances. Accordingly, in many embodiments, it may be desirable for the orientation direction 1052 to point directly to the median plane, meaning that a straight line extending in the orientational direction 1052 from (1 ) a fixed point within the introducer 110 / stylet assembly 130 system that ispositioned on the central longitudinal axis of said system to (2) the median plane MP yields the shortest possible straight line between said fixed point and the median plane MP. The orientation indicium 495 can convey information regarding the orientational direction 1052 in any suitable manner. For example, in the illustrated embodiment, the orientational indicium 495 is an arrow that points in the orientational direction 1052.

[0289] In the illustrated embodiment, the orientation direction 1052 of each stylet assembly 130 points directly to the median plane MP. Accordingly, in the illustrated arrangement, for each stylet assembly 130, an orientational plane 1054 that subsumes the central longitudinal axis the stylet assembly 130 and extends in the orientational direction 1052 indicated by the orientational indicium 495 is orthogonal to the median plane MP. Moreover, in the illustrated arrangement, the central longitudinal axes of both stylet assemblies 130 are aligned along the transverse plane TP, such that said orientational planes 1054 of both systems are coplanar with the transverse plane TP.

[0290] In other instances, one or more of the introducer 110 / sty let assembly 130 pairs may be rotated about the central longitudinal axis thereof, such that the orientational plane 150 may be at an angle 91 or 62, respectively, relative to the transverse plane TP. In some instances, it may be desirable to keep 61 and 92 to small values. For example, in some instances, smaller combined (absolute) values of 91 and 92 may yield ablation fields of a desired shape and size when the tines 510, 511 are deployed. In some instances, relatively smaller combined (absolute) values of 91 and 92 (compare, e.g., FIGS. 23B versus 23C) may yield relatively broader, more controlled, and / or more predictably sized and / or shaped ablation fields.

[0291] FIG. 23B depicts the same arrangements as those of FIG. 23A. In particular, this image depicts a later stage of the same procedure depicted in FIG. 23A. In this stage, the stylet assemblies 130 have been removed and replaced with needle assemblies 150 while the introducers 110 remained in the vertebra V of the patient, substantially unmoved.

[0292] In the illustrated arrangement, each orientational plane 1054 passes between or bifurcates the tines 510, 511 of each respective needle assembly 150. Moreover, in the illustrated arrangement, the transverse plane TP passes between or bifurcates each pair of deployed tines 510, 511 .

[0293] FIG. 23C schematically depicts a different procedure that is at the same stage as that depicted in FIG. 23B. In this procedure, the introducers 110 are rotated relative to the transverse plane TP. In particular, the orientational plane 1054 that subsumes thecentral longitudinal axis of the left introducer 110 and extends in the orientational direction 1052 thereof defines an angle 91 relative to the transverse plane TP, and the orientational plane 1054 that subsumes the central longitudinal axis of the right introducer 110 and extends in an orientational direction 1052 thereof defines an angle 62 relative to the transverse plane TP.

[0294] Although the introducers 110 and needle assemblies 150 would be introduced into a vertebra V at angles (e.g., so as to pass through the pedicles of the vertebra) such as previously described, to facilitate the present discussion, these instruments are shown in a top plan view, making their relative rotations more apparent. The tines 510, 511 , which would be obscured in such a view, are shown schematically as enlarged rectangles. Thus, for the sake of discussion, the introducers 110, needle assemblies 150, deployed tines 510, 511 are depicted two-dimensionally. Stated otherwise, the present discussion focuses on those portions of the foregoing instruments and components, as projected onto a two-dimensional plane that is mutually orthogonal to the median plane MP and the transverse plane TP (e.g., the plane of the page).

[0295] Each tine 510, 511 may define, or may be represented by, a tine vector 1060, 1061 , respectively. In the illustrated embodiment, the tine vectors 1060, 1061 extend radially from a central longitudinal axis ACL of the needle assembly 150. For a given needle assembly 150, addition of the tine vectors 1060, 1061 (e.g., using the central longitudinal axis ACL as the origin) yields a deployment direction component 1065, which in the instant case, is fully aligned with the orientational direction 1052. The deployment direction component 1065 may alternatively be referred to as a tine deployment direction, a common tine deployment direction, and / or a general tine deployment direction. Moreover, the orientational direction 1052 of each introducer 110 may also or alternatively be referred to as the deployment direction. Similarly, the orientational plane 1054 may also or alternatively be referred to as the deployment plane.

[0296] In the illustrated embodiment, for each needle assembly 150 when coupled with its respective introducer 110, the deployed tines 510, 511 extend at opposite sides of the orientational plane 1054. Stated otherwise, the orientational plane 1054 passes between or bifurcates the deployed tines 510, 511 .

[0297] With continued reference to FIG. 23C, the needle assemblies 150 and their introducers 110 include attachment indicia, such as described previously herein, which can indicate to a user an attachment direction 1066 in which the instruments are to be rotationally aligned to achieve coupling. An attachment plane 1068 is also shown foreach system. The attachment plane 1068 subsumes the central longitudinal axis ACL of the system and extends in the attachment direction 1066 of that system. In the illustrated embodiment, the orientational plane 1054 and the attachment plane 1068 of each system are substantially orthogonal to each other.

[0298] FIGS. 24A-24C show further embodiments of coupled introducer 110 / needle assembly 150 systems and the orientational directions attachment directions defined thereby. In FIG. 24A, the orientational indicium 270 includes an arrow such as previously described that points in the orientational direction 1052. In this instance, an orientational plane that subsumes the central longitudinal axis and extends in the direction indicated by the orientational indicium 270 would extend through the orientational indicium 270 itself. Similarly, an attachment plane that subsumes the central longitudinal axis and extends in an attachment direction 1066 indicated by the attachment indicium 280 would extend through the attachment indicium 280 itself.

[0299] In the illustrated embodiment, the indicia 270, 280 are physically spaced apart from one another. Moreover, they are angularly spaced or angularly displaced from each other, relative to the central longitudinal axis. Likewise, the directions they indicate are angularly separated or angularly displaced from one another. In the illustrated embodiment, the angular displacement is 90 degrees. Other angular displacements are possible.

[0300] In FIG. 24B, the orientational indicium 270 includes a pair of rectangles that signify a pathway through which the orientational direction 1052 passes. Similarly, the attachment indicium 280 includes a pair of ovals that signify a pathway through which the attachment direction 1066 passes. In this instance, an orientational plane that subsumes the central longitudinal axis and extends in the direction indicated by the orientational indicium 270 would extend through the orientational indicium itself 270, while passing between individual features of the orientation indicium 270. Similarly, an attachment plane that subsumes the central longitudinal axis and extends in an attachment direction 1066 indicated by the attachment indicium 280 would extend through the attachment indicium 280 itself, while passing between individual features of the attachment indicium 280.

[0301] In FIG. 24C, the orientational indicium 270 includes an offset arrow that points in the orientational direction 1052. Similarly, the attachment indicium 280 includes an offset arrow that points in the attachment direction 1066. In this instance, an orientational plane that subsumes the central longitudinal axis and extends in the direction indicatedby the orientational indicium 270 would extend alongside the orientational indicium 270, without passing through the orientation indicium 270 itself. Similarly, an attachment plane that subsumes the central longitudinal axis and extends in an attachment direction 1066 indicated by the attachment indicium 280 would extend alongside the attachment indicium 280, without passing through attachment indicium 280 itself.

[0302] FIGS. 25A-25J depict stages of illustrative methods with which embodiments of systems described herein, such as, e.g., the system 100, are compatible. In general, a pathway into the vertebra V can be created using the introducer 110 coupled with the trocar stylet assembly 120, the beveled stylet assembly 130, and / or the drill assembly 140.

[0303] In some methods, the introducer 110 may initially be coupled with the trocar- tipped stylet assembly 120, whereas in other methods, these instruments are provided in a pre-coupled state. In some methods, the trocar stylet assembly 120 and the introducer 110 are advanced through the skin of the patient to the vertebra without first making an incision in the skin. In other methods, an incision may first be made in the patient. In either case, the introducer 110 and the trocar stylet assembly 120, while in a coupled state, can be advanced through the skin of the patient and, as shown in FIG. 25A, through a pedicle of the vertebra V. This and other stages may be performed under suitable imaging, such as under fluoroscopy, to ensure proper advancement and placement. In some instances, a mallet is used to tap on the proximal end of the handle of the trocar stylet assembly 120 to advance the coupled devices.

[0304] In some embodiments, upon passing through cortical bone, the trocar-tipped stylet assembly 120 is rotated counterclockwise (as viewed from above) relative to the introducer 110 to disconnect these instruments from each other, while the introducer 110 remains substantially fixed relative to the patient. The trocar stylet assembly 120 can be retracted proximally to be fully removed from the introducer 110, while the introducer 110 remains in place within the bone, as depicted in FIG. 25B. Removal of the stylet assembly 120 may leave open a tract 1150 that the stylet assembly 120 has created in the bone.

[0305] With reference to FIG. 25C, the bevel-tipped stylet assembly 130 is then advanced distally through the introducer 110. Upon full distal advancement, the beveltipped assembly 130 is then rotated clockwise (as viewed from above) relative to the introducer 110 to achieve a secure connection thereto.

[0306] With reference to FIG. 25D, the bevel-tipped stylet assembly 130 and the introducer 110, while still coupled with each other, can be advanced further through the cancellous bone. In some instances, the bevel-tipped stylet assembly 130 can assist in urging the introducer 110 toward the midline as the coupled devices are advanced distally, as previously described. In some instances, a mallet is used to tap on the proximal end of the handle of the bevel-tipped stylet assembly 130 to advance the coupled devices.

[0307] Upon reaching a desired depth within the bone, the bevel-tipped stylet assembly 130 can decoupled and removed from the introducer 110, such as depicted in FIG. 25E. In some embodiments, the stylet assembly 130 is rotated counterclockwise and retracted proximally from the introducer 110, while the introducer 110 remains in place.

[0308] At any suitable stage during placement of the introducer 110, it may be desirable to use the bone drill 140, such as to ream material from the bone. For example, in some instances, it may be desirable to ream material from the tract 1150 and / or to extend and / or expand the tract 1150.

[0309] With reference to FIG. 25F, the hand drill 140 can be inserted into the introducer 110 after either of the stylet assemblies 120, 130 have been removed therefrom. In the illustrated embodiment, this occurs after use of the bevel-tipped stylet assembly 130. The drill 140 can be rotated and retracted to ream a desired amount of material from the vertebral body.

[0310] With reference to FIG. 25G, the drill 140 may then be removed from the introducer 110. This may leave an expanded, extended, and / or otherwise altered tract 1150 beyond the distal tip of the introducer 110.

[0311] With reference to FIG. 25H, the needle assembly 150 can be advanced through the introducer 110 with the tines in an undeployed state. The needle assembly 150 can be advanced distally by a sufficient amount to be securely attach to the introducer 110, such as in manners previously discussed.

[0312] With reference to FIG. 25I, the tines can be deployed in manners such as previously discussed. As shown, the tines can extend further toward the median plane MP, than does the distal tip of the needle portion of the needle assembly 150.

[0313] With reference to FIG. 21 J, the same or similar series of steps described with respect to FIGS. 21A-25I can be repeated or otherwise performed through the second pedicle of the vertebra V, and the tines of a second needle assembly 150 are deployed.Thereafter, a bipolar RF ablation can proceed with the distal end of one of the needle assemblies 150 (e.g., the tines and tip, and in some instances an uninsulated distal end of the elongated tube) acting collectively as a unitary active electrode and the distal end of the other needle assembly 150 (e.g., the tines and tip, and in some instances an uninsulated distal end of the elongated tube) acting collectively as a unitary return electrode (e.g., at any given moment during the bipolar ablation procedure).

[0314] Sufficient RF energy may be applied in appropriate amounts and for an appropriate time to ablate the basivertebral nerve of the subject vertebra. The tines can then be retracted (e.g., by rotation of the spin collar in an opposite direction) and then the needle assemblies and introducers can be removed.

[0315] Further examples of methods can include some or all of the foregoing steps in any suitable order, including in the order depicted in FIGS. 25A-25J. Further illustrative examples of methods that can use some or all of the foregoing steps in any suitable order and / or systems and devices disclosed herein will now be described. While many of the devices in this following disclosure do not use reference numbers specific to the drawings, it is understood that like-named instruments and features described above with respect to FIGS. 1 -25J may be suitably used in these methods. Further systems and methods described below with respect to, e.g., FIGS. 26-43 may also or alternatively be used.

[0316] In certain embodiments, a basivertebral nerve ablation (BVNA) system is indicated for the ablation of the basivertebral nerves in the L3 through S1 vertebrae for the relief of chronic back pain that has not responded to conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as, but not limited to, inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

[0317] In some embodiments, the system includes access instruments, which can include cannulas and stylets (e.g., trocar- or bevel- tipped) intended to interlock and be hammered into separate pedicles through the cortical bone to reach the softer cancellous bone, creating points of entry to the target vertebral body in a bilateral configuration. If the stylet has trouble penetrating the cancellous bone, the hand drill provided may be used to core out the space that may be desired for the device. The stylet or other accessinstruments are used individually with and / or through the introducer, and are ultimately removed from the cannula, thus allowing the user to insert a needle assembly, which can include an expandable electrode (e.g., that includes deployable tines) into the introducer cannula, lock it into place, and deploy the tines using the spin collar. An RF probe is inserted into the needle assembly and locked into place. In some instances, adapter cables allow for connection of the RF probe to a compatible RF generator for energy delivery between the active distal ends of adjacently positioned needle assemblies.

[0318] In some illustrative methods, it can be desirable to position an RF ablation device between 30-50% anterior to the posterior wall of the vertebral body in the lateral view, across the midline of the target vertebral body in the anteroposterior (AP) view, situated between the upper and lower endplates.

[0319] In some instances, target placement for the therapeutic devices is to position the distal ends of the needle assemblies, at the same vertebral level, oriented towards midline. In some embodiments, the active tips (e.g., which can include the needle tip, tines, and a distal portion of a tube of the needle assembly) are placed 1.5 ± 0.5 centimeters apart from each other; in other embodiments, the active tips are placed 1.0 ± 0.5 centimeters apart from each other. In various embodiments, the distalmost points of the tips of the needle assemblies are separated from each other by a distance that is within a range of from about 5 to about 20 millimeters, from about 5 to about 15 millimeters, from about 5 to about 10 millimeters, from about 10 to about 20 millimeters, from about 10 to about 15 millimeters, or from about 15 to about 20 millimeters, or by a distance that is within any of the ranges of from exactly 5 to 20, 5 to 15, 5 to 10, 10 to 20, 10 to 15, or 15 to 20 millimeters. Any individual value or subset of ranges from within any of the foregoing ranges is also contemplated. For example, in various embodiments, the separation distance is 8, 8.5, 9, 9.5, 10, 10.5, 11 , 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, or 20 millimeters.

[0320] In various embodiments, the system may be used at any vertebral level of the lumbosacral spine, or stated otherwise, at any of levels L1 through S1 . For example, in some embodiments, the system may be positioned within any of levels L1 through S1 and a tip separation distance at any of such levels can be within one or more of the above-identified ranges.

[0321] In some embodiments, the stylets (trocar-tipped and / or bevel-tipped) have the same protruding length from the distal end of the introducer as does the fully inserted needle assembly.

[0322] In some instances, each procedural step may be verified using imaging in the anteroposterior (AP) and lateral views. The AP view may be recommended in some instances to identify the endplates, spinous processes, and pedicles, to ensure a direct anteroposterior view, and to ensure entry to the pedicle. Trajectory (oblique) view may be recommended in some instances to obtain a view parallel to the pedicle (e.g., 10 to 25 degrees ipsilateral, depending on the vertebral level). Lateral view may be recommended in some instances to determine the depth and superoinferior device position within the vertebral body.

[0323] In some methods, an initial stage includes identifying the target vertebral body. The pre-assembled trocar-tipped stylet and introducer cannula can be used to enter through an incision and target pedicle access. A surgical mallet can be used to drive the access instrument through the pedicle.

[0324] Once access through the pedicle has been attained, the trocar-tipped stylet can be replaced with a 45-degree bevel-tipped stylet. The cancellous bone of the vertebral body can be entered working lateral to medial until the tip of the bevel-tipped stylet is approximately 0.75 cm ± 0.25 cm from midline while being placed 30% - 50% anterior to the posterior wall of the vertebral body.

[0325] The access instruments (e.g., the stylet / introducer combination) can be rotated such that the arrow on the top of the stylet handle points towards (e.g., points directly towards) midline. If the stylet has trouble penetrating the cancellous bone, the hand drill can be used to core out the space into which a distal end of the RF needle assembly can be positioned. In some instances, the hand drill has markings on it to prevent additional penetration depth and may include a positive stop (e.g., due to interference with the introducer handle) at, e.g., 3.0 mm distal to the eventual position of the distal tip of the RF needle.

[0326] The stylet (trocar-tipped or bevel-tipped) or hand drill can be removed from the introducer while the introducer remains in place within the bone, and the RF needle assembly can be inserted into the introducer cannula. Before insertion, it can be verified that the tines are in the retracted position. The RF needle assembly can be inserted until the snap tabs, or latches, of the main hub lock in place in the connectors, or catches, of the introducer handle. The snap tabs on the side of RF needle assembly can be different widths, allowing only unidirectional device insertion.

[0327] The spin collar of the RF needle assembly can be turned clockwise (i.e., as viewed from above, or in the proximal-to-distal direction) to deploy the tines. In someembodiments, the spin collar will bottom out and give tactile feedback when the tines are fully deployed.

[0328] An RF probe can be inserted into the RF needle assembly and, in some embodiments, a lock collar thereof can be rotated clockwise until tactile feedback, indicating the probe is locked in place, is felt.

[0329] The foregoing steps can be repeated to place a second introducer, RF needle assembly, and RF probe on the opposite side at the same vertebral level, or stated otherwise, to place these components through the other pedicle of the same vertebra.

[0330] In other or further methods, the foregoing steps may be repeated to place a further pair of introducers, RF needle assemblies, and RF probes in a further vertebra, such as at an adjacent or non-adjacent vertebral level.

[0331] In some instances, connectors of the RF probes are connected to the appropriate ports of a compatible RF generator. In other instances, connectors of the RF probes are connected to adapters, which adapters are in turn connected to appropriate ports of a compatible RF generator. The RF generator can be operated to perform an RF ablation using appropriate time and temperature parameters. For example, in some instances, RF ablation may take place for three to four minutes at a temperature of 85 degrees Celsius. In various methods, an ablation of the BVN may be completed at a temperature of no greater than about 85 degrees Celsius or about 85 degrees Celsius; and for a period, during which RF energy is supplied to the needle assemblies, of no greater than about 3, 3.5, 4, 4.5, 5, 5.5, or 6 minutes or no greater than exactly 3, 3.5, 4, 4.5, 5, 5.5, or 6 minutes.

[0332] After the ablation is performed, or after the ablations are performed (e.g., simultaneously or substantially simultaneously, in some instances) the needle assemblies and cannulae can be removed from the patient.

[0333] In some embodiments, RF ablations can take place at multiple levels concurrently, simultaneously, or substantially simultaneously. For example, in some embodiments, a pair of needle assemblies may be placed within a vertebral body at any of levels L1 through S1 , and a second pair of needle assemblies may be placed within a different vertebral body at any of the remaining levels L1 through S1. In some embodiments, all four needle assemblies may be simultaneously coupled with four respective ports of an RF generator (such as either the RF generator 1010). Each of the two pairs of needle assemblies may be operated in a bipolar ablation mode. In some embodiments, the RF generator can operate both pairs of needle assemblies in aconcurrent or simultaneous fashion. For example, the first pair of needle assemblies can ablate a first basivertebral nerve within a first vertebra for a first time period and the second pair of needle assemblies can ablate a second basivertebral nerve within a second vertebra for a second time period, and the first and second time periods may overlap (e.g., fully overlap or partially overlap). In some instances, neither pair of needle assemblies is energized at the same instant. For example, the generator may rapidly alternate energization of the first and second pairs of needle assemblies. Nevertheless, the first and second time periods may represent, for example, total treatment periods over which ablative energy is applied to the respective needle assembly pairs.

[0334] In some instances, the first and second vertebrae may be contiguous, or stated otherwise, may be adjacent to one another (e.g., L1 and L2, L2 and L3, L3 and L4, L4 and L5, L5 and S1 ). In other instances, the first and second vertebrae may be spaced from one another be at least one additional vertebra (e.g., L1 and one of L3, L4, L5, or S1 ; L2 and one of L4, L5, or S1 ; L3 and either L5 or S1 ; or L4 and S1 ).

[0335] With reference to FIG. 26, certain embodiments of a kit 1200 can includes two sets of instruments (e.g., introducers 110, stylet assemblies 120, 130, needle assemblies 150, and RF probe assemblies 160), such as those discussed above with respect to the system 100, that share a single drill assembly 140. The system 1200 can be used, for example, for bipolar ablation of an intraosseous nerve in manners such as previously discussed. In some embodiments, fewer components may be present in the kit 1200. For example, in some embodiments, a single trocar-tipped stylet assembly 120 or a single bevel-tipped stylet assembly 130 may be present in the kit 130. In other embodiments, multiple drill assemblies 150 may be present.

[0336] The kit 1200 includes instructions for use 1202, which can include instructions to a user on how to carry out any of the procedures or methods disclosed herein. For example, in some embodiments, the instructions for use 1202 may include images and / or written instructions the same as or similar to any of FIGS. 25A-25J herein and the text accompanying the same. It is noted that any of the systems, subsets of the systems, or multiples of the systems disclosed herein may be included in embodiments of kits, which kits may include instructions for use 1202.

[0337] With reference to FIG. 27, certain embodiments of an intraosseous nerve ablation system 1300 include the generator 1010 and four sets (full or partial) of introducers 110, stylet assemblies 120, 130, needle assemblies 150 and RF probe assemblies 160, such as those described with respect to the system 100 depicted in FIG.1 . In the illustrated embodiment, the trocar-tipped stylet assemblies 120 are provided in a pre-coupled state with the introducers 110. The system 1300 may include instructions for use 1302, which may provide instructions for using the instruments in procedures, methods, and manners such as discussed above. In further embodiments, the system 1300 may include one or more drills 140 (not shown in FIG. 27).

[0338] The system 1300 can be configured to perform two separate bipolar radiofrequency ablation procedures. Stated otherwise, the system 1300 can include a sufficient number of components (e.g., single-use instruments) to effectuate two separate RF ablation procedures. For example, the system 1300 can permit the targeting and ablation of two different intraosseous ablative regions within a patient. In some instances, the ablative regions may be within two different vertebrae. For example, the system 1300 may be used to target two different basivertebral nerves in two respective vertebrae. In some instances, the basivertebral nerves may be treated serially in two different procedures. In other instances, the two levels of basivertebral nerve ablation may be performed in a single procedure, and in further instances, two separate ablations via the four needle assemblies 150 may overlap in time, occur simultaneously, occur concurrently, etc.

[0339] With reference to FIG. 28, in some embodiments, an intraosseous nerve ablation system 1400 includes an introducer 110, stylet assemblies 120, 130, a needle assembly 150, an RF probe assembly 160 and a drill 140, such as previously described. The illustrated system 1400 further includes protective covers 1402, 1404, 1406, 1408, 1410. The covers 1402, 1404, 1406, 1408, 1410 can shield the sharpened distal tips of the components to which they are attached. This shielding can protect the sharpened tips and / or the packaging in which the system 1400 is shipped during shipping and / or can protect practitioners from inadvertent contact during initial use (e.g., removal of the components from the packaging).

[0340] As noted, in some embodiments, the packaging can include two, or in other instances, four of each of the introducers 110, stylet assemblies 120, 130, needle assemblies 150, and radiofrequency probe assemblies 160, such as for use with a single bipolar ablation target region or two separate bipolar ablation target regions, respectively.

[0341] In FIG. 28, the protective covers 1402, 1404, 1406, 1408, 1410 are shown removed from various components of the system 1400. As previously discussed, the distal ends of handles of the introducer 110 and of the stylet assembly 130, and a main hub of the needle assembly 150, can include an attachment configuration. In theillustrated embodiment, each attachment configuration comprises a plurality (e.g., 4) of longitudinally extending ribs that provide an interference fit with the covers 1402, 1404, 1406, 1408. In some embodiments, the handle of the trocar-tipped stylet assembly 120 can likewise include the same attachment configuration as the handle of the bevel stylet assembly 130. In some instances, the trocar stylet assembly 120 is prepackaged in an assembled state with the introducer 110, such that a separate cover is not used with the stylet assembly 120. This can reduce material costs of the system. The handles of the assemblies 120, 130 can nevertheless be the same in some embodiments, such as to achieve efficiencies in molding the handles.

[0342] In the illustrated embodiment, the cover 1410 extends over the fluted end of the drill bit. The cover 1410 can be attached to the distal end of the drill bit via an interference fit.

[0343] FIG. 29A is a perspective view of an embodiment of a first tray 1510 that includes therein a plurality of needle assemblies 150 and a plurality of RF probe assemblies 160. In the illustrated embodiment, four needle assemblies 150 and four RF probe assemblies 160 can be included in the kit, although only two of the RF probe assemblies 160 are shown. In some instances, the packaged kit may be used to ablate multiple (e.g., two) vertebral levels.

[0344] FIG. 29B is a perspective view of an embodiment of a second tray 1520 that includes therein a plurality of (i.e., four) introducers 110 that are coupled with a corresponding number of (i.e., four) trocar-tipped stylet assemblies 120, a plurality of (i.e., four) bevel-tipped stylet assemblies 130, and a single hand drill 140. The second tray 1520 is shown positioned over the first tray 1510. In some embodiments, the second tray 1520 may be snap-fit to the first tray 1510. In the illustrated embodiment, the second tray 1520 defines an upper surface that is substantially flush with an upper surface of the first tray 1510 and may be retained in place via the other packaging components herein described.

[0345] FIG. 29C is a perspective view of an embodiment of a retaining lid 1530 shown positioned over the second tray 1520, which is shown positioned over the first tray 1510. In some embodiments, the retaining lid 1530 may be snap fit to the second tray 1520. In the illustrated embodiment, the retaining lid 1530 defines an upper surface that is substantially flush with the upper surfaces of the first tray 1510 and the second tray 1520 and may be retained in place via the other packaging components herein described.

[0346] FIG. 29D is a perspective view of a packaging arrangement in which a sealing layer 1540 (e.g., a layer of Tyvek) is attached (e.g., sealed) to at least the upper surface of the first tray 1510. The packaging with the kit included therein can be inserted into and retained within a box 1550. In some embodiments, instructions for use are included in the kit.

[0347] With reference to FIG. 30, certain embodiments of an intraosseous nerve ablation system 1600 include instruments similar to those discussed above with respect to the system 100. The reader will readily see correspondence between these instruments and those of the system 100, such that numbering and naming the instruments is unnecessary. In the illustrated embodiment, certain of the instruments include handles 1614, 1624, 1634 and a main hub 1654 that are devoid of sheath connectors.

[0348] FIGS. 31 and 32 depict embodiments of a needle assembly 1750 and an RF probe assembly 1760 that have a connection interface that differs from the connection interface described above with respect to the needle assembly 150 and the RF probe assembly 1760. In particular, the RF probe assembly 1760 includes a connector 1770 that is configured to be inserted within a lumen of the needle assembly 1750, but is devoid of a locking spin collar. An upper surface of an annular flange portion of the needle assembly 1750 is devoid of locking ribs that might otherwise interface with such a locking spin collar.

[0349] With reference to FIG. 33, in some embodiments, a system 2100 can include an introducer 2110, a trocar-tipped stylet assembly 2120, a bevel-tipped stylet assembly 2130, and a needle assembly 2150. These instruments can resemble like-named and like-numbered instruments of the system 100 in many respects. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to “21.” Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the system 2100 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and / or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the system 2100. Any suitable combination of the features and variations of the same described with respect to the system 2100 can be employed with the system 100 (and other systems herein described), and vice versa.

[0350] The system 2100 can further include a hand drill 140 and an RF probe assembly 160, which may be substantially the same as these like-numbered instruments described previously.

[0351] With reference to FIGS. 34A-37C, the introducer 2110 includes a handle 2114 fixedly secured to an introducer cannula 2112. As with other embodiments disclosed herein, the introducer 2110 includes an orientation indicium 2270.

[0352] The handle 2114 includes an attachment interface that differs from the handle 114 described above. In particular, the handle 2114 includes a connector 2226 that is configured to selectively interlock with each of the stylet assembly 2130 and the needle assembly 2150 in the same manner. The handle 2114 further includes a keying interface 2240 via which a predetermined rotational orientation may be achieved between the introducer 2110 and each of the stylet assembly 2130 and the needle assembly 2150 in the same manner (i.e., when the introducer 2110 and either of the stylet assembly 2130 and the needle assembly 2150 are in a coupled state).

[0353] In the illustrated embodiment, the connector 2226 includes a locking actuator 2300 that is biased toward a locked configuration by a biasing member 2302, such as a coil spring. The handle 2114 includes a cavity 2304, and the locking actuator 2300 includes a locking rim 2306 that projects into the cavity 2304 when the actuator 2300 is in the locked configuration. The locking actuator 2300 further defines an enlarged opening 2310 that is sized to permit passage therethrough of the elongated member of either the stylet assembly 2130 or the needle assembly 2150 when the actuator 2300 is laterally displaced, against the bias provided by the biasing member 2302, to an open configuration. In some embodiments, the locking actuator 2300 is automatically transitioned to the open configuration as either the stylet assembly 2130 or the needle assembly 2150 is advanced therethrough. In further embodiments, a user may press on the actuator 2300 to overcome the biasing force of the bias member 2302 to transition the actuator 2300 to the open state, e.g., either for coupling or decoupling an instrument with the introducer 2110.

[0354] In the illustrated embodiment, the keying interface 2140 includes the cavity 2304 and a longitudinally extending flat wall 2320 along one side thereof.

[0355] With reference to FIGS. 34 and 38, a handle 2124 of the trocar-tipped stylet assembly 2120 can be significantly different from the handle 124 discussed above. In this embodiment, the handle 2124 includes a strike surface at an upper end of a body thereof. In some embodiments, a stem that extends distally from the body is configuredto remain at an exterior of the handle 2114 of the introducer 2110. The handle 2124 of the stylet assembly 2120, in this embodiment, does not obscure the orientation indicium 2270 of the introducer handle 2114 when these instruments are coupled together. Stated otherwise, the orientation indicium 2270 remains visually perceivable when the instruments are thusly coupled.

[0356] In other embodiments, the distally extending stem may be configured to be received within the cavity 2304 of the introducer handle 2114. In still other embodiments, the handle 2124 may instead be substantially identical to a handle 2134 of the trocar- tipped stylet assembly 2130, which is discussed hereafter. In such embodiments, it may be desirable for the handle 2134 to include a bevel indicium in manners such as previously discussed to aid in distinguishing the stylet assemblies 2120, 2130 from one another.

[0357] With reference to FIGS. 34 and 39A-39C, the handle 2134 of the bevel-tipped stylet assembly 2130 can include a distally projecting post 2400. The post 2400 can include a connector 2410 and a keying interface 2470.

[0358] The connector 2410 is configured to cooperate with the connector 2226 of the introducer 2110 to securely attach the stylet assembly 2130 and the introducer 2110 together. In the illustrated embodiment, the connector 2410 includes a groove 2412 sized to receive therein the locking rim 2306 of the actuator 2300.

[0359] The keying interface 2470 is configured to cooperate with the keying interface 2240 of the introducer 2110 to achieve a predetermined rotational orientation between these instruments. In the illustrated embodiment, the keying interface 2470 includes the post 2400 itself, which is received into the cavity 2304 of the introducer handle 2114, and a longitudinally extending flat wall 2472 that is positioned to slide against, abut, or otherwise face the wall 2320 of the introducer handle 2114.

[0360] With reference to FIG. 39C, the stylet assembly handle 2134 can further include an arrow indicator. In the illustrated embodiment, the arrow indicator may serve simultaneously as an orientation indicium 2450 and a deflection indicium 2452, in the illustrated embodiment, in manners such as previously discussed.

[0361] With reference to FIGS. 34, 40, and 41 , a main hub 2154 of the needle assembly 2150 can include a distally projecting post 2400 such as the identical post 2400 previously described. The post 2400 can include a connector 2410 and a keying interface 2470.

[0362] The connector 2410 is configured to cooperate with the connector 2226 of the introducer 2110 to securely attach the needle assembly 2150 and the introducer 2110 together. The keying interface 2470 of the needle assembly 2150 is configured to cooperate with the keying interface 2240 of the introducer 2110 to achieve a predetermined rotational orientation between these instruments.

[0363] With reference to FIG. 40, the needle assembly 2150 further includes an orientation indicium 2500. As shown in FIG. 41 , both indicia 2270, 2500 are visually perceptible in this configuration. In the illustrated embodiment, the orientation indicium 2500 is aligned with the orientation indicium 2270 of the introducer 2110 when the needle assembly 2150 is coupled thereto. For example, a plane that subsumes the central longitudinal axis of the needle assembly 2150 and that of the introducer 2110 and that extends in the direction commonly indicated by each of the orientation indicia 2270, 2500 extends through each of the indicia 2270, 2500 in the illustrated embodiment. This orientational plane may further be identified as a deployment plane for reasons previously discussed. For example, in the illustrated embodiment this thusly described plane also extends centrally between the deployed tines.

[0364] It is noted that the central longitudinal axes of the various instruments disclosed herein, when they are coupled together (e.g., either of a stylet assembly or a needle assembly coupled to an introducer), can be aligned, such that they define a single such longitudinal axis. The instruments may be said to be concentrically arranged, nested, etc. For example, a stylet or a needle tube may be concentrically nested within the introducer tube, such that they share a common central longitudinal axis.

[0365] FIG. 42 depicts an illustrative embodiment of an adapter 2700 that may be used with certain embodiments of probe assemblies disclosed herein and certain embodiments of RF generators, in manners such as previously discussed.EXAMPLES

[0366] The present paragraph recites illustrative examples of systems, kits, and methods that correspond with various embodiments of the foregoing written description and / or the illustrative drawings. The descriptive phrases included in these examples are applicable to and fully supported by the foregoing disclosure.Example 1 . A system comprising: an introducer comprising:a cannula configured to be positioned within a bone of a patient, the cannula defining a central longitudinal axis; a handle coupled to the cannula and configured to be positioned at an exterior of the patient when a distal end of the cannula is within the bone; and an orientation indicium configured to be positioned at the exterior of the patient when the distal end of the cannula is within the bone, wherein a longitudinal plane that subsumes the central longitudinal axis defined by the cannula extends through the orientation indicium; and a needle assembly comprising: an elongated member configured to be inserted through the cannula of the introducer; a plurality of tines movable from a retracted position in which at least a portion of each tine is positioned within the elongated member to a deployed position in which each tine extends outwardly from the elongated member; and a hub attached to the elongated member, the hub being configured to attach to the handle when the elongated member is inserted through the cannula of the introducer such that, when the plurality of tines are in the deployed position, a first tine is positioned at a first side of the longitudinal plane and a second tine is positioned at a second side of the longitudinal plane that is opposite the first side.Example 2. A system comprising: an introducer comprising: a cannula configured to be positioned within a bone of a patient, the cannula defining a central longitudinal axis; a handle coupled to the cannula and configured to be positioned at an exterior of the patient when a distal end of the cannula is within the bone; and an orientation indicium configured to be positioned at the exterior of the patient when the distal end of the cannula is within the bone, wherein a longitudinal plane that subsumes the central longitudinal axis defined by the cannula extends through the orientation indicium; and a needle assembly comprising: an elongated member configured to be inserted through the cannula of the introducer; a plurality of tines movable from a retracted position in which at least a portion of each tine is positioned within the elongated member to a deployedposition in which each tine extends outwardly from the elongated member such that a distal tip of the tine is spaced from the elongated member; and a hub attached to the elongated member, the hub being configured to attach to the handle when the elongated member is inserted through the cannula of the introducer such that, when the plurality of tines are in the deployed position, the longitudinal plane is spaced away from the distal tip of each tine.Example 3. A system comprising: an introducer comprising: a cannula configured to be positioned within a bone of a patient, the cannula defining a central longitudinal axis; and a handle coupled to the cannula and configured to be positioned at an exterior of the patient when a distal end of the cannula is within the bone, the handle comprising: an orientation indicium; and an attachment indicium separate from and / or angularly displaced from the orientation indicium about the central longitudinal axis; and a needle assembly comprising: an elongated member configured to be inserted through the cannula of the introducer; a pair of tines movable from a retracted position in which at least a portion of each tine is positioned within the elongated member to a deployed position in which each tine extends outwardly from the elongated member such that a distal tip of the tine is spaced from the elongated member; and a hub attached to the elongated member and comprising an attachment indicium, the hub being configured to attach to the handle when the elongated member is inserted through the cannula of the introducer such that: the attachment indicia of the handle and the hub indicate a matching orientation with each other; and when the pair of tines are in the deployed position, the pair of tines define an acute angle that projects radially outwardly relative to the central longitudinal axis and is bifurcated by a plane that subsumes the central longitudinal axis and that passes through the orientation indicium.Example 4. A system comprising: an introducer comprising:a cannula configured to be positioned within a bone of a patient, the cannula defining a central longitudinal axis; and a handle coupled to the cannula and configured to be positioned at an exterior of the patient when a distal end of the cannula is within the bone, the handle comprising: an orientation indicium; and an attachment indicium separate from and / or angularly displaced from the orientation indicium about the central longitudinal axis; and a needle assembly comprising: an elongated member configured to be inserted through the cannula of the introducer; a pair of tines movable from a retracted position in which at least a portion of each tine is positioned within the elongated member to a deployed position in which each tine extends outwardly from the elongated member such that a distal tip of the tine is spaced from the elongated member; and a hub attached to the elongated member and comprising an attachment indicium, the hub being configured to attach to the handle when the elongated member is inserted through the cannula of the introducer such that: the attachment indicia of the handle and the hub indicate a matching orientation with each other; and when the pair of tines are in the deployed position, each tine defines a separate tine vector such that a summation of the tine vectors yields a deployment direction vector that is substantially aligned with a plane that both subsumes the central longitudinal axis and passes through the orientation indicium.Example 5. The system of Example 4, wherein an additional plane that subsumes the central longitudinal axis and passes through the attachment indicium of the hub is angularly displaced from the deployment direction vector about the central longitudinal axis.Example 6. The system of Example 4 or Example 5, wherein there is either no angular displacement or only a small angular displacement about the central longitudinal axis between the deployment direction vector and the plane that both subsumes the central longitudinal axis and passes through the orientation indicium.Example 7. The system of Example 6, wherein the small angular displacement about the central longitudinal axis is smaller than an angular displacement about the central longitudinal axis that exists between the deployment direction vector and the additional plane that subsumes the central longitudinal axis and passes through the attachment indicium of the hub.Example 8. A system comprising: an introducer comprising: a cannula configured to be positioned within a bone of a patient, the cannula defining a central longitudinal axis; and a handle coupled to the cannula and configured to be positioned at an exterior of the patient when a distal end of the cannula is within the bone, the handle comprising an orientation indicium; and a needle assembly comprising: an elongated member configured to be inserted through the cannula of the introducer; a pair of tines movable from a retracted position in which at least a portion of each tine is positioned within the elongated member to a deployed position in which each tine extends outwardly from the elongated member such that a distal tip of the tine is spaced from the elongated member; and a hub attached to the elongated member and comprising an attachment indicium, the hub being configured to attach to the handle when the elongated member is inserted through the cannula of the introducer such that: the attachment indicium is angularly displaced from the orientation indicium about the central longitudinal axis; and when the pair of tines are in the deployed position, each tine defines a separate tine vector such that a summation of the tine vectors yields a deployment direction vector that is substantially aligned with a plane that both subsumes the central longitudinal axis and passes through the orientation indicium.Example 9. The system of Example 8, wherein an additional plane that subsumes the central longitudinal axis and passes through the attachment indicium of the hub is angularly displaced from the deployment direction vector about the central longitudinal axis.Example 10. The system of Example 8 or Example 9, wherein there is either no angular displacement or only a small angular displacement about the central longitudinal axis between the deployment direction vector and the plane that both subsumes the central longitudinal axis and passes through the orientation indicium.Example 11 . The system of Example 10, wherein the small angular displacement about the central longitudinal axis is smaller than an angular displacement about the central longitudinal axis that exists between the deployment direction vector and the additional plane that subsumes the central longitudinal axis and passes through the attachment indicium of the hub.Example 12. A system comprising: an introducer comprising: a cannula configured to be positioned within a bone of a patient, the cannula defining a central longitudinal axis; and a handle coupled to the cannula and configured to be positioned at an exterior of the patient when a distal end of the cannula is within the bone, the handle comprising: an orientation indicium; and an attachment indicium separate from and / or angularly displaced relative to the orientation indicium; and a needle assembly comprising: an elongated member configured to be inserted through the cannula of the introducer; a pair of tines movable from a retracted position in which at least a portion of each tine is positioned within the elongated member to a deployed position in which each tine extends outwardly from the elongated member such that a distal tip of the tine is spaced from the elongated member; and a hub attached to the elongated member and comprising an attachment indicium, the hub being configured to attach to the handle when the elongated member is inserted through the cannula of the introducer such that: the attachment indicia of the handle and the hub indicate a matching orientation with each other; and the orientation indicium indicates a direction that extends between an acute angle, relative to the central longitudinal axis, that is defined by the pair of tines when in the deployed position.Example 13. The system of Example 12, wherein the attachment indicium of the hub indicates a direction that is outside of the acute angle defined by the pair of tines when in the deployed position.Example 14. The system of any preceding Example, wherein the bone of the patient is a vertebra and the orientation indicium is configured to be directed substantially toward a median plane of the patient when the distal end of the cannula is within the vertebra.Example 15. A system comprising: a first introducer and a second introducer each comprising: a cannula configured to be positioned within a respective one of two pedicles of a vertebra of a patient; a handle coupled to the cannula and configured to be positioned at an exterior of the patient when a distal end of the cannula is within the vertebra; and an orientation indicium configured to be positioned at the exterior of the patient and directed substantially toward a median plane of the patient when the distal end of the cannula is within the vertebra; and a first needle assembly and a second needle assembly, each needle assembly comprising: an elongated member configured to be inserted through the cannula of a respective one of the first and second introducers; a pair of tines movable from a retracted position in which at least a portion of each tine is positioned within the elongated member to a deployed position in which each tine extends outwardly from the elongated member; and a hub attached to the elongated member, the hub being configured to attach to the introducer handle of the respective one of the first and second introducers when the elongated member is inserted through the cannula of the respective one of the first and second introducers such that, when the pair of tines are in the deployed position, a direction of each tine includes a component that points toward the median plane, wherein, when the pair of tines of each of the first and second needle assemblies are in the deployed position, a further plane that intersects the median plane extends between distal tips of the pair of tines of the first needle assembly and further extends between distal tips of the pair of tines of the second needle assembly.Example 16. A method comprising:inserting a first cannula of a first introducer through a first pedicle of a vertebra of a patient such that a first handle attached to the first cannula remains at an exterior of the patient and such that an orientation indicium of the first introducer also remains at the exterior of the patient and is directed substantially toward a median plane of the patient; inserting a second cannula of a second introducer through a second pedicle of the vertebra such that a second handle attached to the second cannula remains at the exterior of the patient and such that an orientation indicium of the second introducer also remains at the exterior of the patient and is directed substantially toward the median plane; after said inserting the first and second cannulas, advancing a distal end of a first needle assembly and a distal end of a second needle assembly through the first and second cannulas of the first and second introducers, respectively, each needle assembly comprising: an elongated member; a pair of tines movable from a retracted position in which at least a portion of each tine is positioned within the elongated member to a deployed position in which each tine extends outwardly from the elongated member; and a hub attached to the elongated member; attaching the hub of the first needle assembly to the first handle of the first introducer; attaching the hub of the second needle assembly to the second handle of the second introducer; and deploying the pair of tines from the first needle assembly and the pair of tines from the second needle assembly such that a direction of each tine includes a component that points toward the median plane and such that an additional plane that intersects the median plane extends between distal tips of the pair of tines of the first needle assembly and further extends between distal tips of the pair of tines of the second needle assembly. Example 17. The method of Example 16, wherein the first and second needle assemblies each further comprises a tip electrically coupled and in physical contact with the pair of tines thereof such that the tip and the pair of tines define a common electrode. Example 18. The method of Example 17, wherein the additional plane extends through tips of the first and second needle assemblies when the handles of the first and second needle assemblies are attached to the first and second handles of the first and second introducers, respectively.Example 19. The method of Example 17 or Example 18, further comprising delivering bipolar RF energy to the vertebra via the needle assemblies, with the common electrode of one of the first and second needle assemblies acting as an active electrode and the common electrode of the other of the first and second needle assemblies acting as a return electrode.Example 20. The method of any of Examples 16 through 19, further comprising delivering bipolar RF energy to the vertebra via the needle assemblies to ablate a basivertebral nerve that is within the vertebra.Example 21 . A system comprising: an introducer comprising: a cannula configured to be positioned within a bone of a patient, the cannula defining a central longitudinal axis; and a handle coupled to the cannula and configured to be positioned at an exterior of the patient when a distal end of the cannula is within the bone, the handle comprising a first connector; and a needle assembly comprising: an elongated member configured to be inserted through the cannula of the introducer; a pair of tines movable from a retracted position in which at least a portion of each tine is positioned within the elongated member to a deployed position in which each tine extends outwardly from the elongated member such that a distal tip of the tine is spaced from the elongated member; and a hub attached to the elongated member and comprising a second connector configured to be selectively attached to the first connector of the handle, wherein the first and second connectors are keyed to permit attachment of the needle assembly to the cannula in only a single rotational orientation, relative to the central longitudinal axis.

[0367] Further examples are derived from the foregoing examples as follows. In some other or additional examples, a recited plane or longitudinal plane in any of the foregoing examples, rather than passing through the recited indicium, may instead pass alongside said indicium or even extend away from said indicium. In still other or additional examples, the recited plane or longitudinal plane may instead be said to extend in the direction indicated by the relevant indicium, i.e., without regard to whether the plane passes through or alongside said indicium.

[0368] Each of the claims below is incorporated into the present disclosure. In addition, further examples are formed by making the incorporated claims dependent from any of the foregoing examples. Any suitable combination of the various features of the various embodiments disclosed herein is contemplated. Moreover, any suitable combination of the various features of the various embodiments disclosed herein are also contemplated.

[0369] The term “coupled to” can mean connected to in any suitable fashion, whether that coupling is direct or indirect. Separate components may be coupled to each other. Moreover, in some instances, where separately identified components are integrally formed from a unitary piece of material, or stated otherwise, are included together in a monolithic element, those elements may also be said to be coupled to one another.

[0370] The recitation of the term “about” can be removed from any value recited herein. For example, the recitation of the approximate range of “about 10 to about 20 millimeters” equally discloses the exact range of “10 to 20 millimeters.” Moreover, for any recitation of a range of values herein, it is understood that any individual value within that range and / or any subset of ranges within that range is equally disclosed.

[0371] Although the foregoing detailed description contains many specifics for the purpose of illustration, a person of ordinary skill in the art will appreciate that many variations and alterations to the following details can be made and are considered to be included herein. Accordingly, the foregoing embodiments are set forth without any loss of generality to, and without imposing limitations upon, any claims set forth. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0372] Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows.

Claims

CLAIMS1 . A system comprising: an introducer comprising: a cannula configured to be positioned within a bone of a patient, the cannula defining a central longitudinal axis; a handle coupled to the cannula and configured to be positioned at an exterior of the patient when a distal end of the cannula is within the bone; and an orientation indicium that identifies a direction; and a needle assembly comprising: an elongated member configured to be inserted through the cannula of the introducer; a plurality of tines movable from a retracted position in which at least a portion of each tine is positioned within the elongated member to a deployed position in which each tine extends outwardly from the elongated member; and a hub attached to the elongated member, the hub being configured to attach to the handle when the elongated member is inserted through the cannula of the introducer such that, when the plurality of tines are in the deployed position, a first tine is positioned at a first side of a longitudinal plane that subsumes the central longitudinal axis and extends in the direction identified by the orientation indicium, and a second tine is positioned at a second side of the longitudinal plane that is opposite the first side.

2. The system of claim 1 , wherein the longitudinal plane extends through the orientation indicium.

3. The system of claim 1 , wherein the orientation indicium is positioned on the handle of the introducer.

4. The system of claim 1 , wherein the handle and the hub are keyed such that only a single predetermined rotational orientation of the needle assembly relative to the introducer is possible when the hub is attached to the handle.

5. The system of claim 1 , further comprising a stylet assembly configured to attach to the handle of the introducer when the needle assembly is not present within the introducer.

6. The system of claim 5, wherein the handle of the introducer comprises a first connector configured to secure the stylet assembly to the introducer and comprises asecond connector via which the hub of the needle assembly is configured to attach to the handle.

7. The system of claim 6, wherein the first connector is separate and physically spaced from the second connector.

8. The system of claim 5, wherein the handle of the introducer comprises a first keying interface via which the stylet assembly is fully securable to the introducer in only one predetermined rotational orientation and further comprises a second keying interface via which the hub of the needle assembly is configured to attach to the handle in only one predetermined rotational orientation.

9. The system of claim 8, wherein the first keying interface is separate and physically spaced from the second keying interface.

10. The system of claim 5, wherein the handle of the introducer comprises a connector configured to secure the stylet assembly to the introducer, wherein the hub of the needle assembly is configured to attach to the handle via the connector.11 . The system of claim 5, wherein the handle of the introducer comprises a keying interface via which the stylet assembly is fully securable to the introducer in only one predetermined rotational orientation, wherein the hub of the needle assembly is configured to attach to the handle in only one predetermined rotational orientation via the keying interface.

12. The system of claim 5, wherein the stylet assembly comprises a handle that is configured to obscure from view the orientation indicium of the introducer when the stylet assembly is attached to the handle of the introducer.

13. The system of claim 12, wherein the stylet assembly comprises an orientational indicium that identifies the direction identified by the orientational indicium of the introducer.

14. The system of claim 5, wherein the stylet assembly comprises a trocar-tipped stylet.

15. The system of claim 5, wherein the stylet assembly comprises a bevel-tipped stylet.

16. The system of claim 15, wherein the bevel-tipped stylet is configured to urge a distal end of the cannula in a deflection direction when the stylet assembly is attached to the handle of the introducer and both the stylet assembly and the introducer are advanced together distally through the bone.

17. The system of claim 16, wherein the stylet assembly comprises a deflection indicium that identifies the deflection direction.

18. The system of claim 16, wherein the deflection direction is the same as the direction identified by the orientation indicium.

19. The system of claim 1 , wherein the orientation indicium is visually perceivable when the hub of the needle assembly is attached to the handle of the introducer.

20. The system of claim 1 , further comprising a radiofrequency probe assembly configured to be inserted into the elongated member of the needle assembly to provide radiofrequency energy to the plurality of tines.21 . The system of claim 1 , wherein the direction identified by the orientation indicium is configured to be pointed toward a median plane of the patient when the introducer is positioned within the bone of the patient.

22. A method of using the system of claim 1 , the method comprising: advancing the introducer into the bone of the patient such that the direction of the points toward a median plane of the patient; and attaching the hub of the needle assembly to the handle of the introducer.

23. The method of claim 22, wherein the bone is a vertebra.

24. The method of claim 22, further comprising deploying the plurality of tines at an interior of the bone.

25. The method of claim 22, wherein both the handle of the introducer and the plurality of tines of the needle assembly are positioned at a first side of the median plane.

26. The method of claim 25, further comprising: positioning a further needle assembly within the bone such that a plurality of tines of the further needle assembly are positioned at a second side of the median plane that is opposite the first side of the median plane; and conducting a bipolar ablation across the median plane via transfer of radiofrequency energy between the plurality of tines of the needle assembly and the plurality of tines of the further needle assembly.

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