Integrated radiofrequency device for intraosseous nerve ablation

Abstract

An integrated radio frequency (RF) ablation device that performs the functions of both a stylet and an RF probe includes an elongated shaft or tube having a distal resilient section, a proximal rigid section, and a handle at its proximal end that is attached to the proximal end of the elongated shaft or tube. The resilient section of the straight rod is configured to bend or flex but remains straight when not restrained or bent by an external force.

Description

[Technical Field]

[0001] Described herein are various implementations of, and methods of use for, RF ablation devices configured to be introduced into a vertebral body to perform radio frequency (RF) ablation on one or more nerves within the vertebral body, nerves innervating one or more end plates of the vertebral body, and / or nerves innervating an intervertebral disc adjacent to the vertebral body. The RF ablation device may include an integrated RF probe and stylet constructed to be capable of penetrating further into cancellous bone tissue within the vertebral body. [Background technology]

[0002] Chronic back pain is a serious condition that can significantly impact both physical and mental health. Back pain affects millions of people worldwide each year. According to the Centers for Disease Control and Prevention (CDC), 39.0% of adult Americans reported having back pain in 2019. Studies have shown that low back pain and neck pain account for the highest proportion of healthcare expenditures in the United States. Furthermore, low back pain is a leading cause of work-related disability. Back pain can result from strains in the back muscles, ligaments, or tendons and / or structural problems with the bones or spinal discs. Existing treatments for chronic back pain are diverse, including physical therapy and exercise, chiropractic care, injections, rest, and pharmacological therapies such as opioids, painkillers, or anti-inflammatory drugs. Patients with severe back pain may undergo surgical interventions such as spinal fusion surgery, discectomy (e.g., total disc replacement), or disc repair. Existing treatments can be costly, addictive, temporary, ineffective, and / or increase pain or require long recovery times. In addition, existing treatments do not provide adequate relief for the majority of patients, with only a small percentage being candidates for surgical treatment. Summary of the Invention

[0003] Applicant's existing technology (Intracept® procedure by Relievant®) provides a safe and effective minimally invasive procedure that targets intraosseous nerves (e.g., basivertebral nerves) for the relief of chronic low back pain. As disclosed herein, several embodiments provide additional modalities and methods for patient relief, as well as adjunctive techniques.

[0004] According to the present disclosure, an integrated radio frequency (RF) ablation device for ablation of one or more nerves (e.g., vertebral nerves) present within a vertebral body includes an RF probe having a distal end, an elongated shaft, tube, or rod having a distal resilient section, and a handle at a proximal end attached to the proximal end of the elongated shaft, tube, or rod. The distal end of the RF probe includes a distal tip electrode. At least a portion of the elongated shaft, tube, or rod includes a conductive material to function as a second electrode in a bipolar electrode configuration with the distal tip electrode. An insulating joint is disposed between the distal tip electrode and the distal end of the elongated shaft, tube, or rod to electrically isolate the components of the bipolar electrode configuration. Furthermore, the conductive material of the portion of the elongated shaft, tube, or rod may be covered by an insulating layer (e.g., a dielectric coating or a heat-shrink coating). The bipolar electrode is configured to apply radio frequency energy to generate heat sufficient to cause ablation of one or more nerves. The handle is capable of receiving a mechanical impact (e.g., from a mallet), which is configured to advance the RF probe into the vertebral body and form a path, e.g., a generally straight path or a curved path, within the cancellous bone tissue. Thus, the RF probe may be capable of being struck or driven with a mallet.

[0005] The elongate shaft, tube, or rod of the integrated RF ablation device may further include a proximal rigid section disposed between the distal resilient section and the handle. In some embodiments, the elongate shaft, tube, or rod is fixed to the handle such that rotating the handle also rotates the elongate shaft, tube, or rod. The handle may include an electrical connection port located on the handle head surface.

[0006] In some embodiments, the elongate shaft, tube, or rod may comprise a hypotube constructed from a rigid material, such as a metal (e.g., stainless steel, titanium, nickel, etc.), a metal alloy material such as the nickel-titanium alloy commonly known as Nitinol, a hard plastic, a ceramic, or another polymeric material. The distal, resilient portion of the elongate shaft, tube, or rod may have a plurality of slits formed in the hypotube to facilitate bending or deflection under force and recovery of the shape when the force is released. In some embodiments, the slits may be formed through a portion of the thickness of the hypotube and have a length significantly greater than its width. In some embodiments, the length of the slits is disposed substantially perpendicular to the longitudinal axis of the hypotube. In some implementations, the slits are arranged in a chevron pattern.

[0007] In some embodiments, the distal resilient section of the elongate shaft, tube, or rod is constructed of a flexible and resilient material, and the proximal rigid section is constructed of a hard and rigid material, so that the elongate shaft, tube, or rod does not buckle when the handle is struck. In some embodiments, the distal resilient section is pre-curved (e.g., by using a shape memory material and heat setting techniques) to have a slight curvature in its resting state. In some embodiments, the distal resilient section is not resilient, but instead is rigid.

[0008] A plurality of electrical wires extend within the elongate shaft, tube, or rod (e.g., hypotube) of the integrated RF ablation device to form an electrical connection between the distal end of the RF probe (e.g., at least one of the bipolar electrode pair) and the connection port of the handle. In some embodiments, the plurality of electrical wires may form an integrated braided cable, the distal end of which may be welded to the distal tip electrode to form the electrical connection. The electrical wires (e.g., braided cable) may be surrounded by an insulating layer within the hypotube to electrically insulate the electrode components of the bipolar electrode pair and thermally insulate at least a portion of the conductive outer surface of the hypotube.

[0009] In some embodiments, the RF probe of the integrated RF ablation device includes a bullet-shaped or bull-nose probe head to facilitate penetration into cancellous bone tissue when the handle is subjected to mechanical impact, hi some embodiments, the RF probe of the integrated RF ablation device includes a bevel-tipped or angled head.

[0010] According to the present disclosure, a method for accessing and ablating one or more nerves (e.g., vertebral nerves) within a vertebral body includes forming a curved path within the vertebral body with a curved cannula assembly, the curved path being directed toward a preselected or predefined target treatment region, removing a curved stylet (e.g., a J-shaped stylet) of the curved cannula assembly from an internal channel within the curved cannula of the curved cannula assembly, inserting an integrated RF (radio frequency) ablation device into the internal channel of the curved cannula and advancing the RF ablation device forward in a linear path beyond the open distal tip of the curved cannula. The method also includes ablating one or more nerves within the vertebral body with the integrated RF ablation device.

[0011] In some implementations, the method further includes monitoring the formation of the curved path by intraoperative visualization (e.g., fluoroscopy or other imaging modality) and determining whether the curved path has not reached (undershot) or has passed (overshot) a pre-selected target treatment area based on the surgical visualization monitoring. In response to determining that the curved path has not reached or passed, the method may further include terminating advancement of the curved cannula of the curved cannula assembly before the curved path reaches the target treatment area.

[0012] The method may include determining by intraoperative visualization (e.g., fluoroscopy or other imaging modality) whether the linear pathway formed by the integrated RF ablation device has reached the target treatment region. In response to determining that the pathway has reached the target treatment region, the method may include performing RF ablation with the RF ablation device. In some embodiments, the surgical visualization is fluoroscopic imaging.

[0013] In some implementations, an integrated RF ablation device comprises an RF probe including a distal end configured to function as a bipolar electrode, an elongated shaft, tube, or rod having a resilient portion attached to the distal end, and a handle at a proximal end, the handle being attached to the elongated shaft, tube, or rod. The resilient portion may be configured to bend or flex and may be able to restore its shape (e.g., via a shape-memory material). In some implementations, the RF ablation device may have a distal portion (e.g., the resilient portion) that is pre-curved (e.g., via a shape-memory material and shape-setting or heat-setting) so that a curved path is formed instead of a straight path. Different RF ablation devices may have different degrees of curvature as needed and / or desired.

[0014] In accordance with the present disclosure, the integrated RF ablation device may be part of a kit that includes an access tool, which may include an introducer cannula assembly and a curved cannula assembly. In some embodiments, the introducer cannula assembly includes an introducer cannula and an introducer stylet, and the curved cannula assembly includes a curved cannula (e.g., a cannula with a pre-curved or bendable distal end portion) and a J-stylet (e.g., a stylet with a pre-curved or bendable distal end portion).

[0015] It should be understood that the devices and methods summarized above and described in more detail below describe specific actions performed by a practitioner, but may also include direction of those actions by another party. Thus, actions such as "ablation" or "advancement" include "commanding the ablation or advancement." Further aspects of embodiments of the present disclosure are described below in this specification. With respect to the drawings, elements from one figure may be combined with elements from other figures. [Brief explanation of the drawings]

[0016] Some embodiments of the present disclosure may be more fully understood by reference to the following drawings, which are for illustrative purposes only. [Figure 1] FIG. 1 illustrates an exemplary set of access tools and treatment devices configured to access and ablate nerves within a vertebral body. [Figure 2] 2-5 are schematic diagrams illustrating steps in an exemplary procedural process for accessing a vertebral body and ablating a nerve within the vertebral body. [Figure 3] 2-5 are schematic diagrams illustrating steps in an exemplary procedural process for accessing a vertebral body and ablating a nerve within the vertebral body. [Figure 4] 2-5 are schematic diagrams illustrating steps in an exemplary procedural process for accessing a vertebral body and ablating a nerve within the vertebral body. [Figure 5] 2-5 are schematic diagrams illustrating steps in an exemplary procedural process for accessing a vertebral body and ablating a nerve within the vertebral body. [Figure 6] FIG. 6 is an elevational view of an exemplary integrated RF ablation device configured to access and ablate nerves within a vertebral body. [Figure 7] FIG. 7 is a cross-sectional view of the distal end of the exemplary integrated RF ablation device shown in FIG. [Figure 8] FIG. 8 is a detailed view of one example of a resilient portion proximal to the distal end of the exemplary integrated RF ablation device shown in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0017] Damaged or degenerated vertebral endplates can be a significant cause of chronic low back pain. Pain can be transmitted from the upper and lower endplates via one or more nerves (e.g., vertebral nerves that enter through an opening in the vertebral body, branch near the center of the vertebral body, and send nerves to innervate the upper and lower endplates). Therefore, this type of back pain can be called vertebrogenic back pain. The applicant's research and clinical trials have demonstrated that such vertebrogenic back pain can be treated by RF ablation. In some implementations, discogenic back pain can also be treated by applying ablative RF energy within the vertebral body.

[0018] A. Access Tools and Treatment Devices Applicants have developed procedures that target one or more nerves (e.g., vertebral nerves) within a vertebral body to relieve chronic low back pain and improve function. In some implementations, to perform such non-invasive RF ablation or other modulation procedures, a radio frequency (RF) ablation probe is introduced into a selected vertebral body. To modulate the entire nerve within a vertebral body, a small region near the center of the vertebral body where the vertebral nerve branches is typically pre-identified and targeted. The target region may be in the posterior half of the vertebral body.

[0019] FIG. 1 illustrates an exemplary embodiment of a set of access tools and treatment devices 100 for performing a non-invasive procedure to access a target treatment region within a vertebral body and ablate one or more nerves (e.g., vertebral nerves) therein. As shown in FIG. 1 , the tool set includes an introducer assembly 110 including an introducer cannula 112 and an introducer stylet 120, a curved cannula assembly 130 including a curved cannula 132 and a J-shaped stylet 140, a straight stylet 150, and a radio frequency (RF) energy delivery device 160, such as an RF probe. The access tool and treatment device 100 may be provided as a kit. In some embodiments, the kit of access tools and treatment devices 100 may optionally include one or more additional introducer cannulas 112, curved cannulas 132, and / or additional straight stylets 150, which may have a different length than the first straight stylet 150. In some embodiments, the kit may include at least two of all the access tools and at least two treatment devices. Optional additional access tools may be adapted to access one or more additional vertebrae during the procedure.

[0020] As shown in FIG. 1 , introducer cannula 112 includes a straight hypotube 114 at its distal end and an introducer handle 116 attached to the straight hypotube 114. The straight hypotube 114 may be constructed of a hard, rigid material, such as, for example, metal, hard plastic, ceramic, or a composite material. The introducer handle 116 at its proximal end may be constructed of a plastic material or other suitable material capable of withstanding impact from a mallet. Introducer stylet 120 includes a straight rod (not shown) with a sharpened tip 122 at its distal end and a first handle 124 attached to the straight rod at its proximal end. The straight rod (not shown) with the sharpened tip 122 may be constructed of a hard, rigid material, such as, for example, metal, hard plastic, or ceramic, and the first handle 124 may be constructed of a plastic material or a material capable of withstanding impact. The sharpened tip 122 may have a rounded, beveled, or trocar-like shape. Both the introducer handle 116 and the introducer cannula 112 have end-to-end internal channels configured to receive the introducer stylet 120 such that a sharp tip 122 at the distal end of the introducer stylet 120 protrudes from the open distal end of the straight hypotube 114 of the introducer cannula 112. Thus, when the introducer cannula assembly is used to form a channel within a vertebral body during an RF ablation procedure, the sharp tip 122 penetrates bone tissue and advances the hypotube 114. As seen in FIG. 1 , the sharp tip 122 of the introducer stylet 120 (and the connected straight rod) is slightly smaller than the internal channel of the straight tube 114 of the introducer cannula 112. Thus, the introducer stylet 120 can be freely inserted into and removed from the introducer cannula 112.

[0021] With respect to curved cannula assembly 130, curved cannula 132 comprises a straight tube section 134, a distal curved tube section 133 extending from straight tube section 134, and a proximal end 136. Proximal end 136 comprises an adjustment wheel 138 threadedly engaged with a threaded section 137. By rotating adjustment wheel 138, adjustment wheel 138 moves along the length of threaded section 137 of proximal end 136, thereby adjusting the distance between adjustment wheel 138 and the end face of proximal end 136. Curved distal tube section 133 of curved cannula 132 comprises an elastic or resilient material that can be bent or straightened and return to its original pre-curved shape.

[0022] The outer diameters of distal curved tube section 133 and elongated straight tube section 134 are configured to be slightly smaller than the diameter of the interior channel of straight hypotube 114 of introducer cannula 112. In this manner, curved cannula assembly 130 can be inserted into and removed from hypotube 114. The diameter matching between distal curved tube section 133 and the interior channel of introducer cannula 112 is similar to the diameter matching between introducer stylet 120 and introducer cannula 112. Thus, resilient curved distal curved tube section 133 can be straightened and inserted into the interior channel of introducer cannula 112. The overall length of the distal curved tube section 133 and straight tube section 134 of the curved cannula 132 is configured such that, when fully engaged, the distal curved tube section 133 of the curved cannula 132 can at least partially pass through the straight hypotube 114 of the introducer cannula 112 and exit the open distal end of the hypotube 114. Upon exiting the open distal end of the straight hypotube 114, the distal curved tube section 133 of the curved cannula 132 regains its curved shape because it is constructed of a resilient material (e.g., a shape memory material).

[0023] When fully engaged, an adjustment wheel 138 on the proximal end 136 of the curved cannula 132 contacts the upper end surface of the introducer handle 116 of the introducer cannula 112. The length of the curved tube section 133 that extends from the straight hypotube 114 of the introducer cannula 112 depends on the position of the adjustment wheel 138 on the threaded section 137 on the proximal end 136. As shown in FIG. 1 , when the adjustment wheel 138 is moved to the lowest point on the threaded section 137, the length of the distal curved tube section 133 that extends from the open distal end of the straight hypotube 114 is the shortest. Conversely, when the adjustment wheel 138 is at the highest point on the threaded section 137, the length of the distal curved tube section 133 that extends from the open distal end of the straight hypotube 114 is the longest. When a channel is formed within the vertebral body during an RF ablation procedure, the distal curved tube section 133 helps to penetrate the bone tissue in a medial direction toward the central region of the vertebral body. The length of the medial passage can be adjusted by adjusting wheel 138 and mallet tapping of the curved cannula assembly.

[0024] In FIG. 1 , J-shaped stylet 140 comprises a rod portion (not shown) with a distal tip 142 and a second handle 144 attached to the rod portion (not shown). The distal portion of the rod portion (not shown) of J-shaped stylet 140 comprises an elastic or resilient material that can be curved and bent with the same or similar curvature as the distal curved tube portion 133 of curved cannula 132 and can return to its original shape. Curved cannula 132 includes an internal channel that extends its length from proximal end 136 through tube portions 134 and 133 to the distal end of curved tube portion 133. The rod portion (not shown) of J-shaped stylet 140 is slightly smaller than the internal channel formed in curved cannula 132. Thus, the J-shaped stylet 140 is configured to be received in the internal channel of the curved cannula 132 such that the distal tip 142 of the J-shaped stylet 140 protrudes slightly beyond the open distal end of the curved cannula 132. When the J-shaped stylet 140 is fully engaged with the curved cannula 132, the second handle 144 of the J-shaped stylet 140 contacts the proximal end 136 of the curved cannula 132, and the distal tip 142 of the J-shaped stylet 140 is slightly outside the open distal end of the curved tube portion 133. The distal tip 142 can comprise a hard and rigid material, such as a metal, and can be sharpened, for example, with a rounded tip, a beveled tip, or a trocar tip, to aid in the advancement of the curved tube portion 133 of the curved cannula 132 within the bone. The curved cannula 132 and the J-shaped stylet 140 may each include a straight proximal main section and a curved distal section. The position and curvature of the curved distal sections of the curved cannula 132 and the J-shaped stylet 140 may correspond to one another. The proximal end 136 of the curved cannula 132 and the second handle 144 of the J-shaped stylet 140 may each include markings or features to indicate the direction of the curve so that the curved sections can be aligned to correspond to one another and the curved tube section 133 of the curved cannula 132 and the distal tip 142 of the J-shaped stylet 140 can be steered together during a procedure.

[0025] In FIG. 1 , the straight stylet 150 comprises a straight rod 156 with a distal tip 152 and a third handle 154 attached to the straight rod 156. At least a distal portion of the straight rod 152 comprises an elastic or resilient material that is capable of bending and returning to its original shape. Furthermore, the outer diameter of the straight rod 156 of the straight stylet 150 may be similar to the outer diameter of the rod portion of the J-shaped stylet 140. Thus, the rod 156 can fit within the internal channel of the curved cannula 132, similar to the J-shaped stylet 140. When fully engaged, the distal tip 152 of the straight stylet 150 penetrates and exits the open distal end of the distal curved tube portion 133 of the curved cannula 132. Upon exiting the open distal end of the curved cannula 132, the distal portion of the straight stylet 150 returns to its original shape, either straight or another preformed shape. The curved cannula 132, J-shaped stylet 140, and straight stylet 150 are configured to allow the J-shaped stylet 140 and straight stylet 150 to be inserted into and removed from the curved cannula 132 during an ablation procedure. Structural considerations may include a diametric match between the internal channel of the curved cannula 132 and the rod portions of the J-shaped stylet 140 and straight stylet 150. The distal tip 152 may comprise a hard and rigid material, such as a metal, and may be sharpened, for example, with a blunt tip, bullet tip, bevel tip, or trocar tip. The J-shaped stylet 140 and straight stylet 150 may be constructed entirely or partially of a radiopaque material or may include a radiopaque marker band embedded in the distal tip to facilitate visualization under fluoroscopy or CT imaging.

[0026] The various proximal end features, including the introducer handle 116, first handle 124, proximal end 136, second handle 144, and third handle 154, may be constructed of similar materials and similarly attached to their corresponding tube or rod portions. For example, the introducer handle 116 may be constructed of an impact-resistant material, such as plastic, wood, aluminum alloy, or a composite material, so that, in the assembled state, the introducer assembly 110 is configured to receive an impact from a mallet, thereby causing the pointed tip 122 and the distal end of the straight hypotube 114 to penetrate and advance into a body part, such as the pedicle of a vertebra. If the introducer handle 116 is constructed of plastic, it may be insert molded with the straight hypotube 114, which may be constructed of metal, hard plastic, ceramic, or other suitably rigid material. In some implementations, the introducer 116 and hypotube 114 may be 3D printed from a polymer-, metal-, or alloy-based material. If the introducer handle 116 is constructed from wood, it can be machined and attached to the straight hypotube 114 with adhesive or an interference fit. Alternatively, if the introducer handle 116 is constructed from an aluminum alloy, it can be die-cast and attached to the straight hypotube 114 with adhesive, an interference fit, or a weld. The attachment of the introducer handle 116 to the straight hypotube 114 can be configured to ensure that no relative movement occurs between the two parts once attached. The first handle 124, the proximal end 136, the second handle 144, and the third handle 154 can be constructed similarly to the introducer handle 116 and attached to their corresponding tube or rod sections.

[0027] Portions of the access tool, including curved cannula 132, J-shaped stylet 140, and straight stylet 150, may be formed from various resilient materials capable of deforming under force and then returning to their original shape when the force is removed. For example, curved tube portion 133 of curved cannula 132 and the distal end portion of J-shaped stylet 140 must be straightened when entering the interior channel of introducer cannula 112 and should curve back to their original curved shape when exiting the open distal end of straight hypotube 114 of introducer cannula 112. Furthermore, the distal portion of rod portion 156 of straight stylet 150 must bend along curved tube portion 133 when inserted into the interior channel of curved cannula 132 and then straighten again when exiting the open tip of curved tube portion 133. The flexibility and resilience of an access tool may depend on its dimensions, particularly its cross-sectional dimensions, and the material from which it is constructed. In some embodiments, these flexible and resilient portions of the access tool may be constructed from one or more plastic materials, such as polyamide (PA), polyethylene terephthalate (PET), polycarbonate (PC), polyoxymethylene (POM), acrylonitrile butadiene styrene (ABS), polyethylene (PE), polypropylene (PP), and polyimide (PI). In some embodiments, when the cross-sectional dimensions are relatively large, they may be constructed from one or more of hard plastic elastomers, such as polyethylene-based polyolefin elastomers, polypropylene-based elastomers, thermoplastic polyester elastomers, thermoplastic polyurethane elastomers, nitrile butadiene rubber, and thermoplastic vulcanizate polymers. For example, the distal portion of the straight rod 156 may be a solid rod constructed from a plastic elastomer with a high Shore durometer measurement. In some embodiments, when the resilient tool portion has a small cross-sectional dimension or a tubular structure to facilitate bending, the resilient tool portion may be constructed from a semi-rigid material, since adequate flexibility can be achieved when the cross-sectional dimension is sufficiently small.Additionally, the flexibility of the rigid portion can be increased by applying a chevron design or pattern, or through-thickness slits or holes. For example, if the straight tube portion 134 and the curved tube portion 133 of the curved cannula 132 are constructed of a hard and rigid material, patterned through-thickness slits can be formed on the distal curved tubular structure to increase flexibility or bendability.

[0028] 1 also shows RF ablation device 160 including a connection port 164 and a rod portion 166 attached to connection port 164. Rod portion 166 includes a flexible outer wall, such as a flexible plastic tube, that houses wires therein for electrically connecting connection port 164 to electrodes at distal end 162 of RF ablation device 160. RF ablation device 160 is configured to apply RF power or energy sufficient to cause ablation or other modulation of tissue (e.g., one or more nerves) for pain relief treatment. Rod portion 166 of RF ablation device 160 can have approximately the same outer diameter as tube portions 133 and 134 of J-shaped stylet 140 and rod 156 of straight stylet 150 and can be received in the internal channel of curved cannula 132.

[0029] One or more of the access tools and treatment devices (e.g., RF ablation device 160) may include indicators configured to alert the clinician to the current operating state of the treatment device. For example, the indicators may include a light ring disposed along the length of and extending around the treatment device 160, e.g., within or adjacent to the ablation probe 160.

[0030] B. Treatment Procedures A toolset 100 such as that shown in FIG. 1 can be used to target vertebral nerves within a vertebral body for the treatment of chronic low back pain. A subject patient with chronic low back pain can be first examined to determine the specific vertebrae or vertebrae causing the chronic low back pain. According to some implementations, target or candidate vertebrae for treatment, e.g., one or more of the lumbar, sacral, cervical, or thoracic vertebrae, can be identified prior to treatment. Research has demonstrated that Modic degeneration and associated endplate damage are strongly correlated with chronic low back pain. Therefore, one or more visualization modalities (e.g., magnetic resonance imaging (MRI), computed tomography (CT), X-ray, fluoroscopic imaging) can be used to determine whether a vertebral body or vertebral endplate exhibits active Modic or pre-Modic degeneration characteristics (e.g., characteristics likely to lead to Modic degeneration, such as type 1 Modic degeneration, e.g., inflammation and edema, or type 2 Modic degeneration, e.g., bone marrow changes and increased visceral fat content). For example, images acquired via MRI can be used to identify early signs or precursors of edema or inflammation in the vertebral endplates (e.g., via application of one or more filters) prior to formal characterization or diagnosis as Type 1 Modic degeneration. Thus, vertebral bodies can be identified as potential targets for treatment before Modic degeneration occurs (or before pain symptoms appear in the patient), allowing patients to be proactively treated before chronic back pain develops to prevent or reduce its likelihood. In this way, patients do not need to suffer from back pain for a period of time before treatment is performed.

[0031] In some implementations, to determine whether a patient is a candidate for vertebral nerve ablation procedures, levels of biomarkers (e.g., substance P, cytokines, or other compounds associated with inflammatory processes and / or pain) may be obtained from the patient (e.g., via a blood draw or cerebrospinal fluid sample). Cytokine biomarker samples may be taken from multiple different discs or vertebral bodies or foramina of the patient and compared to each other to determine which vertebral bodies are targeted for treatment. Other biomarkers may be similarly assessed. In some implementations, samples are obtained over a period of time and compared to determine changes in levels over time. For example, biomarkers may be measured weekly, bimonthly, monthly, quarterly, or six months over a period of time and compared to analyze trends or changes over time. If significant changes are observed between biomarker levels (e.g., changes indicative of pre-Modic or Modic degeneration as described above), treatment to prevent or treat back pain may be recommended and implemented. Biomarker levels (e.g., substance P or cytokine protein levels) can be measured using a variety of in vivo or in vitro kits, systems, and techniques (e.g., radioimmunoassay kits / methods, enzyme-linked immunosorbent assay kits, immunohistochemistry techniques, array-based systems, bioassay kits, in vivo administration of anti-cytokine immunoglobulins, multiplexed fluorescent microsphere immunoassays, homogeneous time-resolved fluorescent assays, bead-based techniques, interferometry, flow cytometry, etc.). Cytokine proteins can be measured directly or indirectly, for example, by measuring mRNA transcripts.

[0032] In some implementations, the target treatment region within the vertebral body can be identified and preselected using preoperative visualization of the vertebral body (e.g., using bilateral fluoroscopic images or both anterior-posterior and lateral fluoroscopic images). The target treatment region can be identified (based on the images) as the location where the tip of the channeling stylet crosses the vertebral foramen. The target treatment region can be a location or region 30% to 50% of the distance between the posterior border or wall of the vertebral body and the anterior border or wall of the vertebral body. The vertebral body can be in the lumbar, sacral, thoracic, or cervical spine. Multiple vertebral bodies can be treated. Nerves within other bones can also be treated.

[0033] To track the progress of the treatment live, the procedure can be monitored by intraoperative visualization, such as fluoroscopic imaging, ultrasound imaging, CT imaging, or MRI imaging. A small incision is made in the lumbar region of the patient to be treated. As shown in FIG. 2, the incision may be located above the pedicle 214 of the target vertebra 200, which has a vertebral body 210 with a vertebral nerve 212 therein. The target treatment region 216 is typically pre-identified near the center of the vertebral body 210, where the vertebral nerve branches into multiple axon endings and innervates the superior and inferior endplates. In some implementations, the target treatment region 216 is located in the posterior half of the vertebral body. In some implementations, the target treatment region 216 is 30% to 50% of the distance between the posterior wall of the vertebral body and the anterior wall of the vertebral body. An introducer assembly 110, including an assembled introducer cannula 112 and introducer stylet 120, as shown and described in FIG. 1, is inserted into the incision. Thus, upon impact from the mallet onto the first handle 124, the sharp distal tip 122 of the introducer stylet 120 penetrates into the pedicle 214 and advances the straight hypotube 114 of the introducer cannula 112 into the pedicle 214, forming a foramen, passageway, or channel. Once monitoring imaging, e.g., fluoroscopic imaging, determines that the distal end of the straight hypotube 114 of the introducer cannula 112 has reached a predetermined location (e.g., the outer border of a vertebral body or the border between the cortical and cancellous bone of a vertebral body), the introducer stylet 120 is removed from the interior channel of the introducer cannula 112, and the curved cannula assembly 130, including the curved cannula 132 and J-shaped stylet 140 assembled together, is inserted into the interior channel of the introducer cannula 112.

[0034] As shown in FIG. 3 , the curved section 133 of the curved cannula 132 transitions to a curved configuration (e.g., based on its pre-curved shape memory properties or characteristics) upon exiting the open distal end of the straight hypotube 114. The second handle 144 is then impacted, further driving the distal curved tube section 133 of the curved cannula 132 to advance forward along a curved path toward the target treatment area 216. The sharp distal tip 142 of the rod portion of the J-shaped stylet 140 protrudes slightly from the open distal end of the distal curved tube section 133 of the curved cannula 132, cutting bone tissue and advancing the open distal end of the distal curved tube section 133 as the second handle 144 is impacted. The direction in which the distal curved tube section 133 is pointing can be adjusted steerably or radially by turning the second handle 144. 3, advancement is halted when monitoring imaging indicates that the open distal end of distal curved tube portion 133 has reached or nearly reached the target treatment area 216. By this point, the intended pathway or channel has been formed by the access tools (e.g., introducer cannula assembly 110 and curved cannula assembly 130) through the pedicle 214 and into the vertebral body 210.

[0035] In FIG. 4 , the J-shaped stylet 140 has been removed from the inner channel of the curved cannula 132, and a flexible RF ablation device 160 has been inserted into the inner channel of the curved cannula 132. When the distal end 162 of the flexible RF ablation device 160 emerges from the open distal end of the curved tube section 133, it is positioned at the target treatment region 216. At this point, RF ablation can be performed. The distal end 162 is equipped with a bipolar electrode pair for generating radiofrequency (RF) energy that can rapidly increase the temperature of the cancellous bone tissue surrounding the target treatment region 216. The thermal energy can be transferred to the surrounding cancellous bone tissue by thermal conduction, thereby heating the cancellous bone portion. According to some implementations, thermal energy can be applied within a specific frequency range at a sufficiently high temperature and for a sufficient duration to heat the cancellous bone such that vertebral nerves extending through the cancellous bone of the vertebral body are ablated or modulated. In some implementations, the modulation includes permanent ablation or denervation, or cell perforation, such as electroporation. In some implementations, the modulation includes temporary denervation or inhibition. In some implementations, the modulation includes stimulation or denervation without tissue necrosis.

[0036] For RF ablation, the temperature of the cancellous bone portion (e.g., the target treatment area) surrounding the RF probe 162 may be increased to a range of about 70 degrees Celsius to about 115 degrees Celsius (e.g., 70 degrees Celsius to 85 degrees Celsius, 75 degrees Celsius to 90 degrees Celsius, 70 degrees Celsius to 80 degrees Celsius, 75 degrees Celsius to 85 degrees Celsius, 80 degrees Celsius to 100 degrees Celsius, 90 degrees Celsius to 115 degrees Celsius, overlapping ranges thereof, or any value within the recited range). The temperature increase rate may be in the range of 0.1 degrees Celsius / second to 5 degrees Celsius / second. The treatment time may be in the range of about 10 seconds to about 1 hour (e.g., 10 seconds to 2 minutes, 30 seconds to 90 seconds, 1 minute to 5 minutes, 2 minutes to 8 minutes, 5 minutes to 15 minutes, 10 minutes to 20 minutes, 15 minutes to 30 minutes, 30 minutes to 1 hour, overlapping ranges thereof, or any value within the recited range). Pulsed energy (e.g., pulsed RF) may be delivered as an alternative to or in addition to continuous RF energy. When radiofrequency energy is applied, the applied frequency may range from 350 kHz to 650 kHz. The power of the radiofrequency energy may range from 5 W to 30 W. According to some embodiments, the thermal dose (e.g., cumulative equivalent minutes (CEM) using a 43°C model) is 200 to 300 CEM.

[0037] 3 , as the distal end of the curve assembly 130, including the distal tip 142 of the J-shaped stylet 140, advances through the pedicle 214 and cancellous bone tissue of the vertebral body 210, monitoring imaging (e.g., intraoperative fluoroscopy) may indicate that the distal end of the curve assembly 130 misses (e.g., deviates from) the target treatment region 216. For example, as shown in FIG. 5 , the intended path or trajectory of the distal end of the distal curve tube portion 133 may be below (e.g., too posterior to) or may not reach (undershoot) the target treatment region 216. This undershoot may be due, for example, to a slight misalignment in the direction of entry of the straight hypotube 114 into the pedicle 214, the straight hypotube 114 not having advanced deep enough into the pedicle 214, and / or the curvature of the distal curved tube section 133 being slightly steeper than expected (e.g., due to low bone density due to osteopenia or osteoporosis). In this case, advancement of the curved cannula assembly 130 may be terminated or stopped before full advancement or may be pulled back a short distance, and the J-shaped stylet 140 may be removed from the inner channel of the curved cannula 132. In some implementations, the straight stylet 150 is then inserted into the inner channel of the curved cannula 132. As the distal tip 152 of the straight stylet 150 passes through the open distal end of the curved cannula 132, it straightens and advances forward in a linear path rather than following the curved trajectory of the distal curved tube section 133. Because no further curvature is added to the distance between the open distal end of the distal curved tube section 133 and the target treatment area 216, the distal tip 152 of the straight stylet can reach the target treatment area 216 and correct the undershoot problem, as shown in Figure 5. At this point, the straight stylet 150 is removed from the curved cannula 132 and an RF ablation device 160 is inserted for the ablation procedure.

[0038] Because the use of a straight stylet requires an additional tool change and adds time to the overall procedure, many clinicians may choose to skip the step of inserting the straight stylet in an undershoot situation and simply attempt to use the flexible RF ablation device 160 to achieve a straight path beyond the open distal end of the curved cannula 132. However, this may result in damage to the flexible RF ablation device and may still not be positioned in the target treatment area, meaning that the vertebral nerves will not be effectively ablated and the patient may still experience back pain.

[0039] C. Integrated RF Devices According to some embodiments, including a straight stylet 150 in each tool set 100 can result in undesirable additional commodity costs and medical waste. Additionally, as previously mentioned, inserting the straight stylet 150 requires an additional, separate tool exchange, which increases the overall time of the procedure. According to some embodiments, it is advantageous if the RF ablation device 160 has increased strength and durability so that it can further penetrate cancellous bone tissue without a pathway previously created by a separate channeling instrument. In this manner, the steps shown in FIG. 5 , including inserting and withdrawing the straight stylet 150 from the curved cannula 132, can be omitted. However, an RF ablation device 160 constructed as shown in FIG. 1 may not be suitable for performing such a task. For example, RF ablation device 160 cannot be struck or driven with a mallet because it does not have a proximal face configured to receive the mechanical impact of a mallet and rod portion 166 is flexible and not adapted to transmit the mechanical impact to advance distal tip 162 through tissue. Additionally, distal tip 162 may break upon impact and may be difficult to retrieve from the patient.

[0040] 6 is an elevational view of an exemplary embodiment of an integrated RF ablation device 170 having a straight, elongated shaft, tube, or rod with a proximal rigid section 176 disposed between a mallet-strikeable proximal handle 174 and a resilient section 190. The resilient section 190 is disposed proximal to a distal end portion 180 comprising an RF electrode or probe head 172 at its distal tip. The rigid section 176 may be constructed of a rigid material, such as a metal, hard plastic, ceramic, polymer, or composite material, to transmit mechanical movement and impact during impact of the proximal handle 174. The resilient section 190 is constructed to be flexible and resilient, allowing it to bend as it advances through the distal curved tube section 133 of the curved cannula 132 and to regain its straight shape when it is no longer acted upon (e.g., by being constrained within the distal curved tube section 133 of the curved cannula 132). In some implementations, the distal resilient portion 190 may be pre-curved (e.g., via a shape-memory material and heat-setting) to have a slight curvature in its resting state when not acted upon by any force or constraint. The proximal handle 174 may be constructed of plastic, polymer, wood, or aluminum alloy and may be attached to the rigid portion 176 of the elongate shaft, tube, or rod by insert molding, adhesive, interference fit attachment, welding, or another suitable method, similar to the attachment methods described above in connection with FIG. 1 . Upon attachment, the proximal handle 174 is secured to the rigid portion 176, and turning or rotating the proximal handle 174 also turns or rotates the elongate shaft, tube, or rod, including the rigid portion 176. The proximal handle 174 includes a connection port (not shown) for facilitating electrical connection to an energy source (not shown), such as a radiofrequency generator. The connection port (not shown) may be located on the handle head surface (right side in FIG. 6 ) or on the side of the handle 174. If located on the handle head surface, the connection port is preferably recessed so that it is not damaged from the impact of the mallet.In some implementations, the connection port is not utilized until integrated RF ablation device 170 is advanced to its final position prior to activation. The connection port may comprise, for example, a pogo or spring-loaded electrical connector, or other conductive material or type of electrical connection port. The connection port may include an O-ring seal or other sealing mechanism to prevent blood from entering handle 174.

[0041] FIG. 7 is a side cross-sectional view showing the internal structure of the distal tip portion 180 and a portion of the resilient portion 190 of the RF ablation device 170 shown in FIG. 6 . As can be seen, the distal RF electrode 172 comprises a bullet-shaped, blunt-tipped, or other rounded, bevel-tipped, tapered, or chamfered probe head constructed of a conductive (e.g., metallic) material, which has the advantage of being adapted for navigating a path through cancellous bone tissue. Inside the distal RF electrode 172, one or more electrical conductors or wires 186 are shown attached to the distal RF electrode 172, e.g., by welding, making the distal RF electrode 172 one of a bipolar electrode pair. The one or more electrical conductors or wires extend from the distal RF electrode 172 to the proximal handle 174 and connect to an energy source (e.g., an RF generator) via a connection port. As shown in FIG. 7 , a portion of the resilient portion 190 of the hypotube 182 (e.g., the portion not covered by insulation) forms the other “electrode” of the bipolar electrode pair. The distal end of the hypotube 182 or resilient portion 190 may be spaced approximately 2 mm (or other suitable distance) from the proximal end of the distal tip electrode 172. During an ablation procedure, radiofrequency current flows between the two electrodes to generate thermal energy (heat) in the surrounding cancellous bone tissue. The outer hypotube 182 may extend over the entire length of the elongated shaft, tube, or rod, including the rigid portion 176 and the resilient portion 190. Inside the hypotube 182, there may be an insulating layer 188, which may be in the form of an inner tube constructed of an insulating material that holds one or more conductors or wires 186 inside and insulates the one or more conductors or wires from the hypotube 182. Multiple electrical wires 186 are braided to form an integrated braided cable that extends inside and along the insulating layer 188 and can connect the distal RF electrode 172 to a connection port (not shown) on the proximal handle 174.In some implementations, the insulating layer 188 is a flexible plastic extrusion, such as an extruded tube made of low-density polyethylene (LDPE), polyimide, polyamide (PA), polyvinyl chloride (PVC), silicone, or polyurethane. In some implementations, the insulating layer 188 may be coated onto the core of the braided wire 186. In some implementations, the insulating layer 188 is formed by anodization. In some implementations, the insulating layer 188 may be heat-shrink tubing, made of, for example, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), or a block copolymer such as PEBAX®, that is shrunk onto the braided wire 186. In some implementations, the braided cable may be replaced with a nitinol core or other structure. A temperature sensor 184, such as a thermocouple or thermistor, may be included inside the hypotube 182 and configured to measure the temperature of the RF electrode 172 and / or the surrounding bone tissue. One or more additional temperature sensors may be positioned at various additional locations along the RF ablation device. The distal RF electrode 172 may be attached to the hypotube 182 of the resilient section 190 by a joint 185, which may be potted with an adhesive, e.g., epoxy, to form an interconnected neck structure. Alternatively, the joint 185 may be a pre-fabricated ring connected by an interference fit, adhesive, or welding. The joint 185 insulates and electrically isolates the distal RF electrode 172 from the conductive portion of the hypotube 182 that forms the other electrode, and is strong and durable enough to withstand impact and flexing.

[0042] FIG. 8 illustrates a detailed elevation view of the hypotube 182 of the resilient section 190. As can be seen, slits 192 are formed in the wall of the hypotube 182. Each slit 192 has a length significantly greater than its width, and the length of the slit is substantially perpendicular to the longitudinal axis of the hypotube 182 along its length. The slits 192 can have other shapes, such as circular or square holes, or a combination of different shapes. The slits 192 can be formed partially or entirely through the thickness of the hypotube 190 and can have a chevron or other pattern around the hypotube 182. The exterior surface of the hypotube 182 can be constructed of a nickel-titanium alloy (e.g., nitinol), stainless steel, or another type of electrical conductor, such as spring steel or a molded or extruded plastic doped with a conductive material. In some implementations, only the distal portion of the hypotube 182 (e.g., the most distal 4 mm or other suitable length) is conductive, and the resilient portion 190 or the entire length of the hypotube 182 is not conductive (e.g., the remaining length is covered or coated with an insulating layer, such as a dielectric or heat-shrink coating). The slits 192 can be formed by laser cutting, machining, rolling, or another type of suitable forming method. Such placement of the slits 192 may be adapted to weaken the hypotube 182 to uniformly promote bending of the hypotube 182 in all directions, or to facilitate bending in one direction or two opposing directions. In some embodiments, the entire hypotube 182 of the elongate shaft, tube, or rod, including the distal resilient portion 190 and the proximal rigid portion 176, is constructed of the same rigid and conductive material. The slits 192 are formed only in the resilient portion 190, thereby making bending of the resilient portion 190 easier, while the remaining rigid portion 176 remains rigid. In some embodiments, the proximal rigid portion 176 is covered by an insulating layer.In some embodiments, the hypotube 182 of the resilient section 190 may comprise a more flexible conductive material compared to the rigid section 176, which has greater stiffness at the end that connects the proximal handle 174 of the integrated RF ablation device 170.

[0043] When properly constructed, the situation shown in FIG. 5 may occur during an ablation procedure when, for example, the intended path or trajectory of the curved cannula 132 (indicated by the dashed line) undershoots (or extends too far back) the target treatment region 216, which is typically approximately 30% to 50% of the distance between the posterior wall of the vertebral body and the anterior wall of the vertebral body. Advancement of the curved cannula 132 is then terminated or stopped before the open distal end reaches the target treatment region 216, or the curved cannula 132 is retracted. The J-shaped stylet 140 may be removed from the inner channel of the curved cannula 132. The integrated RF ablation device 170 may then be inserted into the inner channel of the curved cannula 132. Once the distal RF electrode 172 of the integrated RF device 170 clears the open distal end of the curved cannula 132, it transitions to a straight shape and follows a linear or generally linear path toward the target treatment region 216. No additional curves are added to the advancement path between the open distal end of the distal curved tube portion 133 of the curved cannula 132 and the target treatment region 216. Thus, the distal RF electrode 172 can advantageously reach the target treatment region 216, reflecting the state shown in FIG. 5 . At this point, RF ablation of the vertebral nerve or other intraosseous nerve can be performed. Thus, the extra step of inserting and withdrawing the straight stylet 150 can be advantageously omitted.

[0044] In some embodiments, the integrated RF device 170 may be constructed using a rigid elongated shaft, tube, or rod that is rigid along its entire length without laser cuts for flexibility or bending. This means that both the proximal 176 and distal 190 portions of the elongated shaft, tube, or rod are rigid. For example, the entire elongated shaft, tube, or rod, including both the proximal 176 and distal 190 portions (which are resilient or flexible, but are rigid in this embodiment), may be constructed of nitinol tube or rod, spring, doped molded or extruded plastic, stainless steel, or other metal or metal alloy. In some configurations, neither the proximal 176 nor the distal 190 portions have slits, cuts, or other features that weaken their rigidity. An integrated device 170 with a rigid elongated shaft, tube, or rod as described herein may have the advantage of forming straight channels in bone, e.g., vertebrae. In some embodiments, the integrated RF device 170 includes a solid, straight access probe with a sharp bevel / diamond tip to enable access and ablation. The integrated RF device 170 may include an inner hypotube laser-welded to the distal tip electrode and an outer ring electrode hypotube, the inner and outer hypotubes being electrically insulated from one another. As previously mentioned, all but the most distal portion of the outer hypotube forming the outer ring electrode may be coated with an insulating layer or coating. In some implementations, the distal section 190 may be formed with a pre-curved shape, having a slight curve or bend, instead of being completely straight.

[0045] D. Conclusion In some implementations, the system includes various features that exist as a single feature (as opposed to multiple features). For example, in one embodiment, the system includes a single radiofrequency generator, a single introducer cannula with a single stylet, a single curved cannula with a single J-shaped stylet, a single radiofrequency energy delivery device or probe, and a single bipolar electrode pair. A single thermocouple (or other means for measuring temperature) may also be included. In alternative embodiments, multiple features or components are provided.

[0046] In some implementations, the system includes one or more of a means for tissue adjustment (e.g., an ablation or other type of adjustment catheter or delivery device), a means for temperature monitoring (e.g., a thermocouple, thermistor, infrared sensor), a means for imaging (e.g., MRI, CT, fluoroscopy), a means for access (e.g., an introducer assembly, a curved cannula, a drill, a curette), and the like.

[0047] While specific embodiments and examples have been described herein, aspects of the methods and devices shown and described in this disclosure may be combined and / or modified differently to form further embodiments. Furthermore, the methods described herein may be practiced using any device suitable for performing the steps described. Furthermore, the disclosure herein (including the figures) of particular features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. associated with various embodiments may be used in all other embodiments described herein. Section headings used herein are provided solely to enhance readability and are not intended to limit the scope of the embodiments disclosed in a particular section to the features or elements disclosed in that section.

[0048] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are described in detail herein. It should be understood, however, that the embodiments are not limited to the particular forms or methods disclosed; on the contrary, the embodiments are intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various described embodiments and the appended claims. Any methods disclosed herein need not be performed in the order described. Methods disclosed herein include specific acts performed by a practitioner, but may include, expressly or implicitly, third-party instructions regarding those acts. For example, an act such as "applying thermal energy" includes "commanding the application of thermal energy."

[0049] Various embodiments of the present disclosure are presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the present invention. The ranges disclosed herein encompass any and all overlapping, subranges, and combinations thereof, as well as individual numerical values ​​within the range. For example, a description of a range such as 70 to 115 degrees should be considered to specifically disclose subranges such as 70 to 80 degrees, 70 to 100 degrees, 70 to 110 degrees, and 80 to 100 degrees, as well as individual numerical values ​​within that range, e.g., 70, 80, 90, 95, 100, 70.5, 90.5, and any integer or non-integer increments therebetween. Terms such as "up to," "at least," "greater than," "less than," "between," and the like, include the recited numerical values. Numerical values ​​preceded by terms such as "about" or "approximately" are inclusive of the stated numerical value. For example, "about 10" includes "10." For example, as used herein, the terms "approximately," "about," and "substantially" describe an amount close to the stated amount that still performs the desired function or achieves the desired result.

Claims

1. 1. A device for performing radio frequency (RF) ablation of one or more nerves within a vertebral body, comprising: a handle at the proximal end, the handle being sized and adapted to receive mechanical impact from the mallet; a distal tip electrode at the distal end; an elongated tube extending from the handle to the distal end and having a distal resilient section, a portion of the distal resilient section including a conductive material configured to function as a second electrode of a bipolar electrode pair with the distal tip electrode; an insulating joint portion disposed between the distal tip electrode and the distal end of the elongated tube; A device comprising:

2. The device of claim 1 , wherein the elongate tube further comprises a proximal rigid section disposed between the distal resilient section and the handle.

3. The device of claim 2 , wherein at least a portion of the proximal rigid portion is covered by an insulating layer.

4. The device of claim 2 or 3, wherein the elongated tube is fixed to the handle.

5. The device of any one of claims 2 to 4, wherein the handle includes an electrical connection port.

6. The device of claim 5 , wherein the connection port is located on a handle head surface.

7. The device of claim 6 , wherein the connection port is recessed into the handle head surface.

8. 8. The device of claim 2, wherein the elongate tube comprises a hypotube constructed of a rigid conductive material, and the resilient portion of the elongate tube comprises a slit formed on the hypotube.

9. The device of claim 8 , wherein the hypotube is connected to an insulating joint.

10. 10. The device of claim 8 or 9, wherein the rigid conductive material is a nickel-titanium alloy.

11. The device of any one of claims 8 to 10, wherein the slit is formed through at least a portion of the thickness of the hypotube.

12. A device according to any one of claims 8 to 11, wherein the slit has a length that is significantly greater than its width.

13. 13. The device of claim 12, wherein the length of the slit is aligned substantially perpendicular to the longitudinal axis of the hypotube.

14. The device of any one of claims 8 to 13, wherein the slits are arranged in a chevron pattern.

15. The device according to any one of claims 2 to 14, wherein the resilient portion is made of a flexible and resilient material.

16. A device according to any one of claims 2 to 14, wherein the rigid portion is made of a hard and rigid material.

17. 10. The device of any one of the preceding claims, wherein the distal tip electrode comprises a bullet-shaped or bevel-tip configuration at the distal end.

18. The device of claim 5 , wherein a plurality of electrical wires extending through the elongate tube connect the distal tip electrode to the connection port of the handle.

19. 20. The device of claim 18, wherein the plurality of electrical wires are braided to form an integrated braided cable.

20. 20. The device of claim 18, wherein a nitinol rod or core extending within the elongate tube connects the distal tip electrode to the connection port of the handle.

21. 20. The device of claim 18 or 19, wherein the plurality of electrical wires are surrounded by an insulating layer.

22. 10. The device of any one of the preceding claims, wherein the distal resilient portion is configured to bend but remains straight when not bent.

23. The device of any one of claims 1 to 21, wherein the distal resilient section is pre-curved to have a slight curvature.

24. 1. A device for performing radio frequency (RF) ablation of one or more nerves within a vertebral body, comprising: a handle at the proximal end, the handle being sized and adapted to receive mechanical impact from the mallet; a distal tip electrode at the distal end; an elongated tube extending from the handle to the distal end and having a distal portion, a portion of the distal portion including a conductive material configured to function as a second electrode of a bipolar electrode pair with the distal tip electrode; an insulating joint portion disposed between the distal tip electrode and the distal end of the elongated tube; A device comprising:

25. 25. The device of claim 24, wherein the elongate tube further includes a proximal rigid section disposed between the distal section and the handle.

26. 26. The device of claim 25, wherein the distal portion is constructed of a rigid material.

27. 25. The device of claim 24, wherein the distal portion is flexible.

28. 28. The device of claim 26 or 27, wherein the distal portion is pre-shaped to have a straight shape.

29. 28. The device of claim 26 or 27, wherein the distal portion is pre-shaped to have a slight curvature.

30. 1. A method of ablating a nerve within a vertebral body of a subject, comprising: forming a curved pathway within the vertebral body with a curved cannula assembly directed toward a preselected target treatment area; monitoring the formation of said curved pathway using an intraoperative imaging modality; removing the J-shaped stylet from the internal channel within the curved cannula of the curved cannula assembly; inserting an integrated RF (radio frequency) ablation device into the interior channel of the curved cannula and advancing a distal end of the RF ablation device in a linear path out of the open distal end of the curved cannula; determining, using the intraoperative imaging modality, whether the linear path reaches the preselected target treatment area; Performing RF ablation using the RF ablation device A method comprising:

31. 31. The method of claim 30, wherein the intraoperative imaging modality is fluoroscopic imaging.

32. The integrated RF ablation device comprises: a bipolar RF probe comprising an elongated tube having a distal resilient section, the resilient section configured to deflect but remaining straight when undeflected; a distal tip electrode; an insulating joint between a distal end of the distal resilient section and the distal tip electrode, wherein at least a portion of the elongate tube proximal to the insulating joint comprises a conductive material adapted to form a bipolar electrode pair with the distal tip electrode; a handle at the proximal end, the handle being attached to the proximal end of the elongated tube; 32. The method of claim 30 or 31, comprising:

33. 33. The method of claim 32, wherein the handle is capable of receiving mechanical impact (e.g., from a mallet).

34. 34. The method of claim 32 or 33, wherein the elongate tube further comprises a rigid section disposed between the resilient section and the handle.

35. 35. The device of claim 34, wherein at least a portion of the rigid portion is covered by an insulating layer.

36. The method of any one of claims 32 to 35, wherein the elongate tube is fixed to the handle.

37. The method of any one of claims 32 to 36, wherein the handle includes an electrical connection port.

38. 35. The method of claim 34, wherein the elongate tube comprises a hypotube constructed of a rigid conductive material, and the resilient portion of the elongate tube has slits formed thereon adapted to facilitate deflection of the resilient portion.

39. 39. The method of claim 38, wherein the slit is formed through at least a portion of the thickness of the hypotube.

40. 31. The method of claim 30, wherein the slit has a length that is significantly greater than its width.

41. 41. The method of claim 40, wherein the length of the slit is aligned substantially perpendicular to the longitudinal axis of the hypotube.

42. 38. The method of claim 37, wherein a plurality of electrical wires extending through the elongate tube connect the distal tip electrode to the electrical connection port on the handle.

43. 43. The method of claim 42, wherein the plurality of electrical wires are braided together to form a braided cable.

44. 44. The method of claim 42 or 43, wherein the plurality of electrical wires are surrounded by an insulating layer.

45. A method according to any one of claims 32 to 44, wherein the RF probe comprises a bullet-shaped probe head or a bevel-tip shaped probe head.

46. 1. A kit for accessing and ablating one or more nerves within a vertebral body, comprising: an introducer assembly including an introducer cannula and an introducer stylet, the introducer assembly adapted to form a linear access pathway through the pedicle to the boundary of the vertebral body; a curved cannula assembly including a curved cannula having a pre-curved distal end and a J-shaped stylet having a pre-curved distal end corresponding to the pre-curved distal end of the curved cannula, the curved cannula assembly adapted to form a curved path from the straight access path to a predetermined target treatment area within the cancellous bone portion of a vertebral body; 1. An integrated radiofrequency ablation probe, comprising: a handle at the proximal end, the handle being sized and adapted to receive mechanical impact from the mallet; a distal tip electrode at the distal end; an elongated tube extending from the handle to the distal end and having a distal resilient section, a portion of the distal resilient section including a conductive material configured to function as a second electrode of a bipolar electrode pair with the distal tip electrode; an insulating joint portion disposed between the distal tip electrode and the distal end of the elongated tube; an integrated radiofrequency ablation probe, A kit comprising:

47. 47. The kit of claim 46, wherein the distal resilient portion of the integrated radiofrequency ablation probe is configured to bend when inserted through the curved cannula but remain straight when advanced out the open distal end of the curved cannula.

48. 47. The kit of claim 46, wherein the distal resilient portion of the integrated radiofrequency ablation probe is configured to have a pre-curved shape in a rest configuration.

49. An integrated radiofrequency ablation device as herein described and illustrated.

50. A kit of tools for accessing and ablating one or more nerves within a vertebral body as described and illustrated herein.

51. A method for accessing and ablating one or more nerves within a vertebral body as described and illustrated herein.

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