Integrated radiofrequency device for intraosseous nerve ablation

Abstract

An integrated radio frequency (RF) ablation device that performs the functions of a stylet and an RF probe. In one embodiment, an RF ablation device includes an elongate shaft or tube having a distal resilient section, a proximal rigid section, and a handle at a proximal end attached to the proximal end of the elongate shaft or tube. The resilient section of the straight bar is configured to bend or flex but remain straight when unconstrained by external forces or caused to bend.

Description

Technical Field

[0001] Various embodiments of radiofrequency (RF) ablation devices and methods of use thereof are described herein. The RF ablation devices are configured to be introduced into a vertebral body for performing RF ablation on one or more nerves within the vertebral body, nerves innervating one or more endplates of the vertebral body, and / or nerves innervating an intervertebral disc adjacent to the vertebral body. The RF ablation devices can include an integrated RF probe and stylet configured to further penetrate cancellous bone tissue within the vertebral body. Background Art

[0002] Chronic back pain is a serious condition that can significantly impact physical and mental health. Millions of people worldwide suffer from back pain each year. According to the U.S. Centers for Disease Control and Prevention (CDC), 39.0% of American adults reported experiencing back pain in 2019. Studies indicate that low back pain and neck pain are among the highest causes of healthcare spending in the United States. Furthermore, low back pain is a leading cause of work-related disability. Back pain can be caused by strains of the muscles, ligaments, or tendons in the back and / or structural problems with the bones or discs. Existing treatments for chronic back pain vary widely and include physical therapy and exercises, chiropractic care, injections, rest, and medications (such as opioids, painkillers, or anti-inflammatory drugs). Patients with severe back pain may require surgical intervention, such as spinal fusion, disc removal (e.g., total disc replacement), or disc repair. Existing treatments can be expensive, dependent, temporary, ineffective, and / or may increase pain or require a prolonged recovery time. Furthermore, existing treatments fail to provide adequate relief for most patients, and only a small fraction are eligible for surgery. Summary of the Invention

[0003] Applicant's prior art ( of Surgery) provides a safe and effective minimally invasive procedure that targets the intraosseous nerves (e.g., the vertebral base nerves) for relieving chronic low back pain. As disclosed herein, several embodiments provide additional relief modalities and methods and adjunctive technologies for patients.

[0004] According to the present disclosure, an integrated radiofrequency (RF) ablation device for ablating one or more nerves (e.g., vertebral base nerves) located within a vertebral body includes an RF probe having a distal end, a slender shaft, tube, or rod having a distal resilient section, and a handle at the proximal end, the handle being attached to the proximal end of the slender shaft, tube, or rod. The distal end of the RF probe includes a distal tip electrode. At least a portion of the slender shaft, tube, or rod contains a conductive material so as to serve as a second electrode of a bipolar electrode configuration having a distal tip electrode. An insulating coupling is positioned between the distal tip electrode and the distal end of the slender shaft, tube, or rod to electrically isolate the components of the bipolar electrode configuration. In addition, the conductive material of the portion of the slender shaft, tube, or rod can be covered by an insulating layer (e.g., a dielectric coating or a heat shrink coating). The bipolar electrode is configured to apply radiofrequency energy to generate heat sufficient to cause ablation of one or more nerves. The handle can receive a mechanical impact (e.g., from a mallet) configured to propel the RF probe within the vertebral body to form a path, such as a substantially straight path or a curved path, in the cancellous bone tissue. Thus, the RF probe can be hammerable, or capable of being hammered.

[0005] The elongated 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 elongated shaft, tube, or rod is secured to the handle such that turning the handle also causes the elongated shaft, tube, or rod to rotate. The handle may include an electrical connection port located on a surface of the handle head.

[0006] In some embodiments, the elongated shaft, tube or rod may include a hypotube made of a rigid material, such as a metal (e.g., stainless steel, titanium, nickel), a metal alloy material (e.g., nickel-titanium alloy commonly known as nitinol), a hard plastic, a ceramic or other polymeric material. The distal resilient section of the elongated shaft, tube or rod may have a slit formed on the hypotube so as to bend or flex under the action of a force and to restore its shape when the force is released. In some embodiments, the slit may be formed through a partial thickness of the hypotube, having a length significantly greater than the width. In some embodiments, the length direction of the slit is arranged substantially perpendicular to the longitudinal axis of the hypotube. In some embodiments, the slits are arranged in a herringbone pattern.

[0007] In some embodiments, the distal resilient section of the elongated shaft, tube, or rod is made of a flexible and resilient material, and the proximal rigid section is made of a hard and rigid material, so that when the handle is hammered, the elongated shaft, tube, or rod does not yield. In some embodiments, the distal resilient section is pre-bent (e.g., through the use of shape memory materials and heat setting techniques) to have a slight bend in a static state. In some embodiments, the distal resilient section is non-resilient and is rigid.

[0008] Within the elongated shaft, tube, or rod (e.g., a hypotube) of the integrated RF ablation device, a plurality of electrical wires extend to form an electrical connection between the distal end of the RF probe (e.g., at least one of the bipolar electrode pair) and a connection port at the handle. In some embodiments, the plurality of electrical wires form an integrated braided cable, and the distal end of the braided cable can be welded to the distal tip electrode to form the electrical connection. The electrical wires (e.g., a braided cable) can be surrounded by an insulating layer within the hypotube, thereby electrically isolating the electrode components of the bipolar electrode pair and thermally insulating 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 bullnose probe head to penetrate cancellous bone tissue when the handle receives a mechanical impact. In some embodiments, the RF probe of the integrated RF ablation device includes a beveled or angled head.

[0010] According to the present disclosure, a method for accessing a vertebral body and ablating one or more nerves (e.g., vertebral base nerves) within the vertebral body includes: forming a curved path within the vertebral body with a curved cannula assembly, the curved path pointing to a preselected or predetermined target treatment area; removing a curved stylet (e.g., a J-shaped stylet) of the curved cannula assembly from an internal passage in a curved cannula of the curved cannula assembly; inserting an integrated radiofrequency (RF) ablation device into the internal passage of the curved cannula, and advancing the RF ablation device forward in a straight path beyond the open distal end of the curved cannula. The method also includes ablating the one or more nerves within the vertebral body using the integrated RF ablation device.

[0011] In some embodiments, the method further includes monitoring the formation of the curved path via intraoperative visualization (e.g., fluoroscopy or other imaging modality), and determining, based on the surgical visualization, whether the curved path undershoots or overshoots a preselected target treatment area. In response to a determination that the curved path undershoots or overshoots, 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, via intraoperative visualization (e.g., fluoroscopy or other imaging modality), whether the linear path formed by the integrated RF ablation device reaches the target treatment area. In response to determining that the path reaches the target treatment area, the method may include performing RF ablation with the RF ablation device. In some embodiments, the surgical visualization is fluoroscopic imaging.

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

[0014] According to the present disclosure, the integrated RF ablation device can be part of a kit comprising an access tool, wherein the access tool can 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 having a pre-curved or bendable distal end portion) and a J-shaped stylet (e.g., a stylet having a pre-curved or bendable distal end portion).

[0015] The methods summarized above and described in further detail below describe certain actions taken by a practitioner; however, it should be understood that they may also include instructions for those actions by another party. Thus, an action such as "ablate" or "advance" includes "instructing to ablate or advance." Other aspects of the disclosed embodiments are discussed in the following sections of the specification. With respect to the drawings, elements from one drawing may be combined with elements from other drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Various embodiments of the present disclosure will be more fully understood by reference to the following drawings, which are provided for illustration purposes only:

[0017] Figure 1 A set of exemplary access tools and treatment devices configured to access and ablate nerves within a vertebral body are shown.

[0018] Figure 2-Figure 5 is a schematic diagram illustrating steps in an exemplary treatment procedure for accessing a vertebral body and ablating nerves within the vertebral body.

[0019] Figure 6 Shown is a front view of an exemplary integrated RF ablation device configured to enter a vertebral body and ablate nerves within the vertebral body.

[0020] Figure 7 yes Figure 6A cross-sectional view of the distal end of an exemplary integrated RF ablation device is shown.

[0021] Figure 8 yes Figure 6 A detailed view of an example of a resilient section is shown proximal to the distal end of an example integrated RF ablation device. DETAILED DESCRIPTION

[0022] Reference may be made to damaged or degenerated vertebral endplates, which may be an important source of lower back pain. Pain can be transmitted from the upper and lower endplates via one or more nerves (e.g., the vertebral basilar nerves, which enter through openings on the vertebral body and branch near the center of the vertebral body, sending nerves to innervate the upper and lower endplates). Therefore, this type of back pain may be referred to as vertebral back pain. The applicant's research and clinical trials have demonstrated that this type of vertebral back pain can be treated by RF ablation. In some embodiments, discogenic back pain may also be treated by applying ablative RF energy within the vertebral body.

[0023] A. Access tools and treatment devices

[0024] Applicants have developed procedures targeting one or more nerves within the vertebral body (e.g., the vertebral base nerves) to relieve chronic low back pain and improve function. In some embodiments, a radiofrequency (RF) ablation probe is introduced into a selected vertebral body to perform this non-invasive RF ablation or other modulation procedure. To modulate the entire nerve within the vertebral body, a small area near the center of the vertebral body, into which the vertebral base nerves branch, is typically pre-identified or targeted. The target area may be in the posterior half of the vertebral body.

[0025] Figure 1 An exemplary embodiment of a set of access tools and treatment devices 100 is shown for performing a non-invasive procedure to access a target treatment area within a vertebral body and to ablate one or more nerves therein (e.g., vertebral base nerves). Figure 1As shown, 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 radiofrequency (RF) energy delivery device 160 (such as an RF probe). The access tool and treatment device 100 can be provided as a kit. In some embodiments, the kit of access tool and treatment device 100 can 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 can include at least two of each access tool and at least two treatment devices. The optional additional access tool can be adapted to access one or more additional vertebrae during the treatment procedure.

[0026] like Figure 1 As shown, the introducer sleeve 112 includes a straight hypotube 114 with a distal end and an introducer handle 116 attached to the straight hypotube 114. The straight hypotube 114 can be made of a hard and rigid material, such as metal, hard plastic, ceramic or composite material. The introducer handle 116 at the proximal end can be made of a plastic material or another type of suitable material that can withstand the impact of a mallet. The introducer stylet 120 includes a straight rod (not shown) with a pointed end 122 at the distal end, and a first handle 124 attached to the straight rod at the proximal end. The straight rod (not shown) with a pointed end 122 can be made of a hard and rigid material, such as metal, hard plastic or ceramic, and the first handle 124 can be made of a plastic material or a material that can withstand impact. The pointed end 122 can be a rounded tip, a beveled tip or a trocar tip. The introducer handle 116 and the introducer cannula 112 together have an internal passage from end to end that is configured to receive an introducer stylet 120 such that a pointed tip 122 at the distal end of the introducer stylet 120 extends beyond the open distal end of the straight hypotube 114 of the introducer cannula 112. Thus, during an RF ablation procedure, when the introducer cannula assembly is used to form a channel in the vertebral body, the pointed tip 122 penetrates bone tissue and guides advancement of the hypotube 114. Figure 1 As can be seen in FIG, the pointed tip 122 of the introducer stylet 120 (and the connected straight rod) is slightly smaller than the interior passage of the straight tube 114 of the introducer cannula 112. Therefore, the introducer stylet 120 can be freely inserted into and removed from the introducer cannula 112.

[0027] Regarding the bending sleeve assembly 130, the bending sleeve 132 includes a straight tube section 134, a distal bending tube section 133 extending from the straight tube section 134, and a proximal end 136. The proximal end 136 includes an adjustment wheel 138 threaded onto a threaded section 137. By rotating the adjustment wheel 138, the adjustment wheel 138 moves along the length of the threaded section 137 of the proximal end 136, so that the distance between the adjustment wheel 138 and the end surface of the proximal end 136 can be adjusted. The distal bending tube section 133 of the bending sleeve 132 includes an elastic or resilient material that can be bent or straightened and can return to its original pre-bent shape.

[0028] The outer diameters of the distal curved tube segment 133 and the elongated straight tube segment 134 are slightly smaller than the diameter of the interior passageway of the straight hypotube 114 of the introducer cannula 112. In this manner, the curved cannula assembly 130 can be inserted into and removed from the hypotube 114. The diametrical fit between the distal curved tube segment 133 and the interior passageway of the introducer cannula 112 is similar to the diametrical fit between the introducer stylet 120 and the introducer cannula 112. Thus, the resiliently curved distal curved tube segment 133 can be straightened and inserted into the interior passageway of the introducer cannula 112. The combined length of the distal curved tube segment 133 and the straight tube segment 134 of the curved cannula 132 is configured such that, when fully engaged, the distal curved tube segment 133 of the curved cannula 132 can at least partially pass through the straight hypotube 114 of the introducer cannula 112 and be ejected from the open distal end of the hypotube 114. Once the open distal end of the straight hypotube 114 is pushed out, the distal curved tube section 133 of the curved sleeve 132 will resume its curved shape because it is made of a resilient material (eg, a shape memory material).

[0029] When fully engaged, the adjustment wheel 138 at the proximal end 136 of the curved sleeve 132 contacts the upper end surface of the introducer handle 116 of the introducer sleeve 112. The length of the curved tube section 133 that is pushed out of the straight hypotube 114 of the introducer sleeve 112 depends on the position of the adjustment wheel 138 on the threaded section 137 of the proximal end 136. Figure 1 As shown, when the adjustment wheel 138 is moved to the lowest point of the threaded section 137, the length of the distal curved tube section 133 protruding from the open distal end of the straight hypotube 114 is the shortest. On the other hand, when the adjustment wheel 138 is at the highest point of the threaded section 137, the length of the distal curved tube section 133 protruding from the open distal end of the straight hypotube 114 is the longest. During an RF ablation procedure, when forming a channel in the vertebral body, the distal curved tube section 133 facilitates central penetration of bone tissue toward the central region of the vertebral body. The length of the intermediate path can be adjusted by adjusting the adjustment wheel 138 and hammering the curved cannula assembly.

[0030] exist Figure 1 In the embodiment of the present invention, a J-shaped stylet 140 includes a shaft portion (not shown) with a distal tip 142 and a second handle 144 attached to the shaft portion (not shown). The distal portion of the shaft portion (not shown) of the J-shaped stylet 140 is curved, has the same or similar curvature as the distal curved tube segment 133 of the curved cannula 132, and includes an elastic or resilient material capable of bending and returning to its original shape. The curved cannula 132 includes an internal passageway extending from a proximal end 136 through the tube segments 134 and 133 and to a distal end at the curved tube segment 133. The shaft portion (not shown) of the J-shaped stylet 140 is slightly smaller than the internal passageway formed in the curved cannula 132. Therefore, the J-shaped stylet 140 is configured to be received in the internal passageway of the curved cannula 132 such that the distal tip 142 of the J-shaped stylet 140 slightly protrudes from 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 segment 133. The distal tip 142 can comprise a hard and rigid material, such as metal, and can be pointed, such as a rounded tip, a beveled tip, or a trocar tip, so that the distal tip can facilitate advancement of the curved tube segment 133 of the curved cannula 132 within the bone. The curved cannula 132 and the J-shaped stylet 140 can 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 can correspond to each other. The proximal end 136 of the curved sleeve 132 and the second handle 144 of the J-shaped stylet 140 can each include markings or features to indicate the orientation of the curved segments so that the curved segments can be aligned with each other accordingly and the curved tube segment 133 of the curved sleeve 132 and the distal end 142 of the J-shaped stylet 140 can be manipulated together during surgery.

[0031] exist Figure 1In the embodiment of the present invention, the straight stylet 150 includes a straight shaft 156 having a distal tip 152 and a third handle 154 attached to the straight shaft 156. At least the distal portion of the straight shaft 152 includes an elastic or resilient material that can bend and return to its original shape. In addition, the outer diameter of the straight shaft 156 of the straight stylet 150 can be similar to the outer diameter of the shaft portion of the J-shaped stylet 140. Therefore, the shaft 156 can be fitted into the internal channel of the curved cannula 132 like the J-shaped stylet 140. When fully engaged, the distal tip 152 of the straight stylet 150 passes through the open distal end of the distal curved tube segment 133 of the curved cannula 132. When pushed out of the open distal end of the curved cannula 132, the distal segment of the straight stylet 150 recovers its shape and becomes straight or another pre-formed shape. The curved cannula 132, J-shaped stylet 140, and straight stylet 150 are constructed in such a manner that the J-shaped stylet 140 and straight stylet 150 can be inserted into and removed from the curved cannula 132 during an ablation procedure. Construction considerations can include a diameter fit between the interior passage of the curved cannula 132 and the shaft portions of the straight stylet 150 and J-shaped stylet 140. The distal tip 152 can include a hard and rigid material, such as metal, and can be pointed, such as a rounded tip, a bullet-shaped tip, a beveled tip, or a trocar tip. The J-shaped stylet 140 and straight stylet 150 can be made of a radiopaque material in whole or in part, or include an embedded radiopaque marker band at the distal tip to facilitate visualization under fluoroscopic or CT imaging.

[0032] Various proximal end features, including the guide handle 116, the first handle 124, the proximal end 136, the second handle 144, and the third handle 154, can be made of similar materials and similarly attached to their corresponding tube or rod segments. For example, the guide handle 116 can be made of a material that can withstand impact, such as plastic, wood, aluminum alloy, or a composite material, because when assembled, the guide assembly 110 can be configured to receive an impact from a mallet so that the distal end of the pointed tip 122 and the straight hypotube 114 penetrate and advance into a body part, such as a pedicle of a vertebra. If the guide handle 116 is made of plastic, it can be insert molded with the straight hypotube 114, which can be made of metal, hard plastic, ceramic, or another suitable rigid material. In some embodiments, the guide 116 and hypotube 114 can be 3D printed with a polymer, metal, or alloy-based material. If the introducer handle 116 is made of wood, it can be machined and attached to the straight hypotube 114 by adhesive or interference fit attachment. On the other hand, if the introducer handle 116 is made of aluminum alloy, it can be made by die casting and attached to the straight hypotube 114 by adhesive, interference fit attachment, or welding. The attachment of the introducer handle 116 to the straight hypotube 114 can be configured to ensure that there is no relative movement 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 made similar to the introducer handle 116 and attached to their respective tube or rod segments.

[0033] The portions of the access tool, including the curved cannula 132, the J-shaped stylet 140, and the straight stylet 150, can be made of various resilient materials that can deform under the action of a force and restore their shape when the deforming force is released. For example, the curved tube segment 133 of the curved cannula 132 and the distal end portion of the J-shaped stylet 140 need to straighten when entering the internal passage of the introducer cannula 112 and should bend back to their initial curved shape once ejected from the open distal end of the straight hypotube 114 of the introducer cannula 112. Additionally, the distal portion of the shaft segment 156 of the straight stylet 150 needs to bend along the curved tube segment 133 when inserted into the internal passage of the curved cannula 132 and then straighten again once ejected from the open distal end of the curved tube segment 133. The flexibility and resiliency of the access tool can depend on its dimensions, particularly its cross-sectional dimensions, and the materials from which it is made. In certain embodiments, these flexible and rebound parts of entering tool can be made of 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 certain embodiments, when cross-sectional dimensions are relatively thick, they can also be made of one or more hard plastic elastomers, such as polyethylene-based polyolefin elastomer, polypropylene-based elastomer, thermoplastic polyester elastomer, thermoplastic polyurethane elastomer, acrylonitrile-butadiene rubber and thermoplastic vulcanizate polymer. For example, the distal portion of straight rod 156 can be a solid rod made of the plastic elastomer with higher Shore durometer measurement value. In certain embodiments, if the rebound tool part has a small cross-sectional dimension or tubular structure so that it is easy to bend, then they can be made of semi-rigid material, because when cross-sectional dimensions are enough small, suitable flexibility can be achieved. In addition, herringbone design or pattern can be applied, or the slit or hole that runs through the thickness can be used to make the rigid part more flexible. For example, if the straight tube section 134 and the curved tube section 133 of the curved sleeve 132 are made of a hard and rigid material, patterned through-thickness slits may be formed on the distal curved tubular structure to increase flexibility or bendability.

[0034] Figure 1Also shown is an RF ablation device 160 comprising a connection port 164 and a rod segment 166 attached to the connection port 164. The rod segment 166 comprises a flexible outer wall, such as a flexible plastic tubing, housing a wire internally to electrically connect the connection port 164 to an electrode at a distal end 162 of the RF ablation device 160. The 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 therapy. The rod segment 166 of the RF ablation device 160 can have an outer diameter substantially the same as the tube segments 133 and 134 of the J-shaped stylet 140 and the rod 156 of the straight stylet 150, and can be received in the internal passage of the curved cannula 132.

[0035] One or more access tools and treatment devices (e.g., RF ablation device 160) can include an indicator configured to alert a clinician to the current operating status of the treatment device. For example, the indicator can include a light ring disposed within or adjacent to the ablation probe 160, along the length of the treatment device, and extending around the circumference of the treatment device.

[0036] B. Treatment surgery

[0037] Figure 1The illustrated tool set 100 can be used to target the vertebral base nerves within the vertebral body to treat chronic low back pain. First, a patient with chronic low back pain can be examined to identify the specific vertebrae that are the source of the chronic low back pain. According to some embodiments, target or candidate vertebrae for treatment, such as one or more of the lumbar, sacral, cervical, or thoracic spine, can be identified prior to treatment. Studies have confirmed that Modic changes and associated endplate damage are closely associated with chronic low back pain. Thus, 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 features or features of pre-Modic changes (e.g., features that may lead to Modic changes, such as Type 1 Modic changes (e.g., inflammation and edema), or Type 2 Modic changes (e.g., bone marrow changes and increased visceral fat content). For example, images obtained via MRI can be used to identify (e.g., via application of one or more filters) initial signs or precursors of edema or inflammation at the vertebral endplates before formal characterization or diagnosis of Type 1 Modic changes. Thus, a vertebral body can be identified as a target candidate for treatment before Modic changes occur (or before a patient exhibits painful symptoms), allowing the patient to be proactively treated before chronic low back pain develops to prevent or reduce its likelihood. In this way, the patient will not have to suffer from debilitating low back pain for a period of time prior to treatment.

[0038] In some embodiments, biomarker levels of biomarkers (e.g., substance P, cytokines, or other compounds associated with inflammatory processes and / or pain) can be obtained from a patient (e.g., by drawing blood or by sampling cerebrospinal fluid) to determine whether the patient is a candidate for vertebral nerve ablation therapy. Cytokine biomarker samples can be obtained from multiple different intervertebral discs, vertebral bodies, or intervertebral foramina of a patient and compared to each other to determine the target vertebra for treatment. Other biomarkers can also be assessed. In some embodiments, samples are obtained and compared over a period of time to determine changes in levels over time. For example, over a period of time, biomarkers can be measured and compared weekly, bimonthly, monthly, every 3 months, or every 6 months to analyze trends or changes over time. If significant changes between biomarker levels are noted (e.g., indicative of a pre-modic change or a change in modic change as described above), treatment can be recommended and implemented to prevent or treat back pain. Biomarker levels (e.g., substance P or cytokine protein levels) can be measured using various 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 injection of anti-cytokine immunoglobulins, multiplex fluorescent microsphere immunoassays, homogeneous time-resolved fluorescence assays, bead-based techniques, interferometry, flow cytometry, etc.) Cytokine proteins can be measured directly or indirectly (e.g., by measuring mRNA transcripts).

[0039] In some embodiments, preoperative visualization of the vertebral body (e.g., using bilateral fluoroscopic images or anterior-posterior and lateral fluoroscopic images) can be used to illustrate and preselect a target treatment area within the vertebral body. The target treatment area can be identified as the location where the end of the channel guide needle transects the basilar foramen of the vertebral basilar region (based on the images). The target treatment area can be a location or area between 30% and 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 lumbar, sacral, thoracic, or cervical. Multiple vertebral bodies can be treated. Other intraosseous nerves can also be treated.

[0040] The treatment procedure can be monitored by intraoperative visualization, such as fluoroscopic imaging, ultrasound imaging, CT imaging, or MRI imaging, to track the progress of the treatment in real time. A small incision is made in the lower back of the patient to be treated. Figure 2As shown, the incision can be located on top of a pedicle 214 of a target vertebra 200 having a vertebral body 210 containing a vertebral base nerve 212. A target treatment area 216 is typically pre-identified near the center of the vertebral body 210, where the vertebral base nerve branches into multiple axon terminals to innervate the superior and inferior endplates. In some embodiments, the target treatment area 216 is located in the posterior half of the vertebral body. In some embodiments, the target treatment area 216 is between 30% and 50% of the distance between the posterior wall of the vertebral body and the anterior wall of the vertebral body. Figure 1 As shown and described in conjunction with the figure, the introducer assembly 110 comprising an introducer sleeve 112 and an introducer stylet 120 assembled together is inserted into the incision. Thus, when the impact from the mallet is received on the first handle 124, the sharp distal end 122 of the introducer stylet 120 penetrates into the pedicle 214, guiding the straight hypotube 114 of the introducer sleeve 112 into the pedicle 214 to form a basement hole, path or channel. When it is determined from monitoring imaging (e.g., fluoroscopic imaging) that the distal end of the straight hypotube 114 of the introducer sleeve 112 has reached a predetermined position (e.g., the outer boundary of the vertebral body or the boundary between the cortical bone and cancellous bone of the vertebral body), the introducer stylet 120 is removed from the internal passage of the introducer sleeve 112 and a curved sleeve assembly 130 is inserted into the internal passage of the introducer sleeve, the curved sleeve assembly comprising a curved sleeve 132 and a J-shaped stylet 140 assembled together.

[0041] like Figure 3 As shown, when the curved segment 133 of the curved sleeve 132 is pushed out from the open distal end of the straight sea wave tube 114, the curved segment is transformed into a curved configuration (for example, based on its pre-bent shape memory properties or characteristics). Then, the second handle 144 is hammered to further drive the distal curved tube segment 133 of the curved sleeve 132 forward along a curved path aimed at the target treatment area 216. The sharp distal tip 142 of the rod segment of the J-shaped tube needle 140 slightly penetrates the open distal end of the distal curved tube segment 133 of the curved sleeve 132, cuts through the bone tissue, and advances the open distal end of the distal curved tube segment 133 when the second handle 144 is hammered. The direction in which the distal curved tube segment 133 is pointed can be manipulated or radially adjusted by rotating the second handle 144. As shown Figure 3 As shown, advancement is stopped when monitoring imaging shows that the open distal end of the distal curved tube segment 133 has reached or nearly reached the target treatment area 216. At this point, a herniated path or passage is formed through the pedicle 214 and into the vertebral body 210 by the access tool (e.g., introducer cannula assembly 110 and curved cannula assembly 130).

[0042] exist Figure 4In the embodiment of the present invention, the J-shaped stylet 140 is removed from the inner channel of the curved cannula 132, and the flexible RF ablation device 160 is inserted into the inner channel of the curved cannula 132. When the distal end 162 of the flexible RF ablation device 160 is pushed out from the open distal end of the curved tube section 133, the distal end is positioned at the target treatment area 216. At this time, RF ablation can be performed. The distal end 162 includes a bipolar electrode pair to generate radiofrequency (RF) energy, which can cause the temperature in the cancellous bone tissue surrounding the target treatment area 216 to rise rapidly. The thermal energy can be conducted to the surrounding cancellous bone tissue by heat transfer, thereby heating the cancellous bone portion. According to several embodiments, thermal energy can be applied within a specific frequency range and with a sufficiently high temperature and a sufficiently long duration to heat the cancellous bone so as to ablate or modulate the vertebral base nerves extending through the cancellous bone of the vertebral body. In some embodiments, modulation includes permanent ablation, or killing of nerves, or cell perforation, such as electroporation. In some embodiments, modulation includes temporary denervation or inhibition. In some embodiments, modulating comprises stimulating or killing nerves in the absence of tissue necrosis.

[0043] For RF ablation, the temperature of the cancellous bone portion (e.g., the target treatment area) surrounding the RF probe 162 can be raised to a temperature in the range of about 70 degrees Celsius to about 115 degrees Celsius (e.g., between 70 degrees Celsius and 85 degrees Celsius, between 75 degrees Celsius and 90 degrees Celsius, between 70 degrees Celsius and 80 degrees Celsius, between 75 degrees Celsius and 85 degrees Celsius, between 80 degrees Celsius and 100 degrees Celsius, between 90 degrees Celsius and 115 degrees Celsius, overlapping ranges thereof, or any value within the ranges). The temperature ramp rate can range from 0.1 degrees Celsius / second to 5 degrees Celsius / second. The treatment time can be in the range of about 10 seconds to about 1 hour (e.g., from 10 seconds to 2 minutes, from 30 seconds to 90 seconds, from 1 minute to 5 minutes, from 2 minutes to 8 minutes, from 5 minutes to 15 minutes, from 10 minutes to 20 minutes, from 15 minutes to 30 minutes, from 30 minutes to 1 hour, overlapping ranges thereof, or any value within the recited ranges). Pulsed energy (e.g., pulsed RF) can be delivered as an alternative to or in sequence to continuous RF energy. To apply the RF energy, the applied frequency can be in the range of 350 kHz to 650 kHz. The power of the RF energy can be in the range of 5 W to 30 W. According to several embodiments, the heat treatment dose (e.g., using a cumulative equivalent minute (CEM) 43 degrees Celsius model) is between 200 and 300 CEM.

[0044] Back to Figure 3As the distal end of the bending assembly 130 (including the distal tip 142 of the J-shaped stylet 140) is advanced through the cancellous bone tissue of the pedicle 214 and the vertebral body 210, monitoring imaging (e.g., intraoperative fluoroscopy) may indicate that the distal end of the bending assembly 130 will miss the target treatment area 216 (e.g., the desired trajectory required to reach the target treatment area 216 will deviate). For example, the protruding path or trajectory of the distal end of the distal bending tube segment 133 may be below the target treatment area 216 (e.g., too far posterior) or fail to reach the area, as shown in FIG. Figure 5 As shown. This undershoot may be due to, for example, a slight deviation in the penetration direction of the straight hypotube 114 into the pedicle 214, an insufficient penetration distance of the straight hypotube 114 into the pedicle 214, and / or a curvature of the distal curved tube segment 133 that is slightly sharper than the projected curvature (e.g., due to low density due to osteopenia or osteoporosis). In this case, the advancement of the curved cannula assembly 130 can end or stop before full advancement, or can be retracted a short distance, and the J-shaped stylet 140 can be removed from the interior passage of the curved cannula 132. In some embodiments, the straight stylet 150 is then inserted into the interior passage of the curved cannula 132. When the distal tip 152 of the straight stylet 150 passes through the open distal end of the curved cannula 132, the distal tip straightens and advances forward in a straight path, rather than following the curved trajectory of the distal curved tube segment 133. Since no further curvature is added to the distance between the open distal end of the distal curved tube segment 133 and the target treatment area 216, the distal tip 152 of the straight stylet can reach the target treatment area 216, thereby correcting the undershoot problem, such as Figure 5 At this point, the straight stylet 150 is removed from the curved cannula 132 and the RF ablation device 160 is inserted for ablation therapy.

[0045] Because the use of a straight stylet adds an extra tool change, thereby increasing the overall procedure time, many clinicians may choose to skip the straight stylet insertion step in the case of an undershoot and simply attempt to achieve a straight path out of the open distal end of the curved cannula 132 using the flexible RF ablation device 160. However, this may result in damage to the flexible RF ablation device and may still result in placement outside the target treatment area, which may result in ineffective ablation of the vertebral nerves, meaning that the patient may still experience back pain.

[0046] C. Integrated RF device

[0047] According to some embodiments, including a straight stylet 150 in each tool set 100 may result in unnecessary additional product costs and medical waste. Furthermore, as previously mentioned, inserting a straight stylet 150 adds another tool exchange, which increases the duration of the overall treatment procedure. According to some embodiments, it would be advantageous if the RF ablation device 160 had greater strength and durability, enabling it to further penetrate cancellous bone tissue without requiring a path previously formed by another tunneling instrument. In this way, the need for a straight stylet 150 can be eliminated. Figure 5 The steps shown in FIG include inserting the straight stylet 150 into the curved cannula 132 and removing the straight stylet 150 from the curved cannula 132. However, as Figure 1 The RF ablation device 160 of the illustrated configuration may not be suitable for performing such a task. For example, the RF ablation device 160 is not hammerable, or cannot be hammered because it does not have a proximal surface configured to receive the mechanical impact of a hammer, and the shaft segment 166 is flexible and unsuitable for transmitting the mechanical impact to advance the distal tip 162 through bone tissue. Furthermore, the distal tip 162 may break upon impact and may be difficult to remove from the patient.

[0048] Figure 6 A front view of an exemplary embodiment of an integrated RF ablation device 170 is shown having a straight, elongated shaft, tube, or rod including a proximal rigid section 176 disposed between a proximal hammerable handle 174 and a resilient portion 190. The resilient portion 190 is disposed proximal to a distal end portion 180 that includes an RF electrode or probe head 172 at the distal tip. The rigid section 176 can be made of a rigid material, such as metal, hard plastic, ceramic, polymer, or composite material, to transmit mechanical motion and impact when the proximal handle 174 is hammered. The resilient section 190 is configured to be flexible and resilient such that it can bend to advance through the distal curved tube section 133 of the curved sleeve 132 and can also return to its straight shape once the resilient section 190 is no longer subject to action (e.g., by being constrained within the distal curved tube section 133 of the curved sleeve 132). In some embodiments, the distal resilient portion 190 can be pre-curved to have a slight bend in a resting state when not acted upon by any force or constraint (e.g., via shape memory material and heat setting). The proximal handle 174 can be made of plastic, polymer, wood, or aluminum alloy and can be attached to the rigid section 176 of the elongated shaft, tube, or rod by insert molding, adhesives, interference attachment, welding, or other suitable methods, similar to the above-described combination of the rigid section 176 and the elongated shaft. Figure 1The attachment method described herein is described. By attachment, the proximal handle 174 is fixed to the rigid section 176 so that turning or rotating the proximal handle 174 causes the elongated shaft, tube, or rod including the rigid section 176 to also turn or rotate. The proximal handle 174 includes a connection port (not shown) to facilitate electrical connection to an energy source (not shown), such as a radiofrequency generator. The connection portion (not shown) may be located on the handle head surface ( Figure 6 ), or located at a side surface of the handle 174. When located on the handle head surface, the connection port is preferably recessed so that it is not damaged by the impact of the mallet. In some embodiments, the connection port is not used until the integrated RF ablation device 170 has been advanced to its final position before activation. The connection port may include, for example, a pogo or spring-loaded electrical connector, or may include an electrical connection port of other conductive material or type. The connection port may include an O-ring seal or other sealing mechanism to prevent blood from entering the handle 174.

[0049] Figure 7 It shows Figure 6 A side cross-sectional view of the internal structure of the distal end portion 180 and a portion of the rebound portion 190 of the RF ablation device 170 shown. It can be seen that the distal RF electrode 172 includes a bullet-shaped, bullnose or other rounded, beveled or beveled pointed, tapered or beveled probe head made of a conductive (e.g., metal) material, which has the advantage of being suitable for a path through cancellous bone tissue. One or more electrical conductors or wires 186 are shown attached to the distal RF electrode 172, for example by welding, so that the distal RF electrode 172 becomes one electrode in 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 are connected to an energy source (e.g., an RF generator) via a connection port. A portion of the rebound section 190 of the hypotube 182 (e.g., the portion not coated with insulation) forms the other "electrode" of the bipolar electrode pair, as Figure 7As shown. The distal end of the hypotube 182 or the resilient section 190 can be spaced approximately 2 mm (or other suitable distance) from the proximal end of the distal tip electrode 172. During the ablation treatment procedure, a high-frequency current flows between the two electrodes to generate thermal energy (heat) to the surrounding cancellous bone tissue. The external hypotube 182 can extend to cover the entire length of the slender shaft, tube or rod, including the rigid section 176 and the resilient section 190. Inside the hypotube 182 can be an insulating layer 188, which can be in the form of an inner tube made of an insulating material, holding one or more conductors or wires 186 inside and isolating one or more conductors or wires from the hypotube 182. Multiple electrical wires 186 can be braided to form an integral braided cable that extends inside and along the insulating layer 188 to connect the distal RF electrode 172 to a connection port (not shown) on the proximal handle 174. In some embodiments, the insulating layer 188 is a flexible plastic extrusion, such as an extruded tubing made of low density polyethylene (LDPE), polyimide, polyamide (PA), polyvinyl chloride (PVC), silicone, or polyurethane. In some embodiments, the insulating layer 188 can be coated on the core of the braided wires 186. In some embodiments, the insulating layer 188 is formed by anodizing. In some embodiments, the insulating layer 188 can be a heat shrink tubing that is shrunk to the braided wires 186, such as a tubing made of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), or a block copolymer such as In some embodiments, the braided cable can be replaced with a nitinol core or other structure. A temperature sensor 184 (e.g., a thermocouple or thermistor) can be included inside the hypotube 182 and configured to measure the temperature of the RF electrode 172 and / or surrounding bone tissue. One or more additional temperature sensors can also be positioned at different additional locations along the RF ablation device. The distal RF electrode 172 can be attached to the hypotube 182 of the resilient portion 190 by a coupling section 185, which can be encapsulated by an adhesive (e.g., epoxy resin) to form an interconnected neck structure. Alternatively, the coupling section 185 can be a prefabricated ring connected by interference fit, adhesive or welding. The coupling section 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 bending.

[0050] The hypotube 182 of the rebound portion 190 is Figure 8182 is shown in a detailed front view. It can be seen that the slits 192 are formed in the wall of the hypotube 182. Each slit 192 has a length that is significantly greater than the width, and the length direction of the slit is substantially perpendicular to the longitudinal axis of the hypotube 182, which is in the length direction of the hypotube 182. The slits 192 can be other shapes, such as round holes or square holes, or a combination of different shapes. The slits 192 can be formed through part of the thickness or the entire thickness of the hypotube 190, and can also adopt a herringbone pattern or another pattern around the circumference of the hypotube 182. The outer surface of the hypotube 182 can be made of a nickel-titanium alloy (such as Nitinol), stainless steel or another type of electrical conductor, such as spring steel, molded or extruded plastic doped with a conductive material. In some embodiments, only the distal portion of the hypotube 182 (e.g., the distal-most 4 mm or other suitable length) is conductive, rather than the entire length of the rebound section 190 or the hypotube 182 (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 suitable forming method. This arrangement of the slits 192 can be suitable for weakening the hypotube 182 so as to uniformly promote bending of the hypotube 182 in all directions, or so as to promote bending in one direction or two relative directions. In some embodiments, the hypotube 182 of the entire slender shaft, tube or rod (including the distal rebound section 190 and the proximal rigid section 176) is made of the same rigid and conductive material. The slits 192 are formed only on the rebound section 190, thereby allowing the rebound section 190 to bend more easily, but maintaining the rigidity of the remaining rigid sections 176. In some embodiments, the proximal rigid section 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 than the more rigid section 176 connecting the proximal handle 174 of the integrated RF ablation device 170 to the end.

[0051] when Figure 5132 (shown by the dashed line) is below (or too posterior to) the target treatment area 216, which is typically about 30% to 50% of the distance between the posterior wall of the vertebral body and the anterior wall of the vertebral body, when properly configured during the ablation procedure. The advancement of the curved cannula 132 is then terminated or stopped before the open distal end reaches the target treatment area 216, or the curved cannula 132 is retracted. The J-shaped stylet 140 can be removed from the interior passage of the curved cannula 132. The integrated RF ablation device 170 can then be inserted into the interior passage of the curved cannula 132. When the distal RF electrode 172 of the integrated RF device 170 passes through the open distal end of the curved cannula 132, the distal RF electrode transforms into a straight shape and travels along a straight or substantially straight path toward the target treatment area 216. The advancement path between the open distal end of the distal curved tube section 133 of the curved sleeve 132 and the target treatment area 216 no longer increases in curvature. Therefore, the distal RF electrode 172 can advantageously reach the target treatment area 216 to address Figure 5 At this point, RF ablation of the vertebral base nerve or other intraosseous nerves can be performed. Thus, the additional steps of inserting and removing the straight stylet 150 can be advantageously eliminated.

[0052] In some embodiments, the integrated RF device 170 can be constructed from a rigid, elongated shaft, tube, or rod that is rigid throughout its entire length and lacks any laser cuts for flexibility or flexure. This means that both the proximal and distal segments 176, 190 of the elongated shaft, tube, or rod are rigid. For example, the entire elongated shaft, tube, or rod, including the proximal and distal segments 176, 190 (which are elastic or flexible as described above and, in this embodiment, rigid), can be made from nitinol tubing or rod, a spring, doped molded or extruded plastic, stainless steel, or other metal or metal alloy. In some configurations, neither the proximal nor distal segments 176, 190 include slits, cutouts, or other features that reduce rigidity. An integrated device 170 having a rigid, elongated shaft, tube, or rod as described herein can have the advantage of forming a straight channel within a bone (e.g., a vertebra). In some embodiments, the integrated RF device 170 includes a solid, straight entry probe with a sharp, beveled / diamond-shaped tip that allows for both entry and ablation. The integrated RF device 170 can include an inner hypotube and an outer ring electrode hypotube laser-welded to the distal tip electrode, wherein the inner hypotube and the outer hypotube are electrically insulated from each other. As previously described, all portions except the distal-most portion of the outer ring electrode, which forms the outer hypotube, can be coated with an insulating layer or coating. In some embodiments, the distal segment 190 can be formed with a pre-curved shape that is slightly curved or bent rather than completely straight.

[0053] D. in conclusion

[0054] In some embodiments, the system includes multiple features that exist as a single feature (as opposed to multiple features). For example, in one embodiment, the system includes a single RF generator, a single introducer cannula with a single stylet, a single curved cannula with a single J-shaped stylet, a single RF energy delivery device or probe, and a single bipolar electrode pair. A single thermocouple (or other device for measuring temperature) may also be included. In alternative embodiments, multiple features or components are provided.

[0055] In some embodiments, the system includes one or more of the following: a device for tissue modulation (e.g., an ablation or other type of modulation catheter or delivery device), a device for monitoring temperature (e.g., a thermocouple, a thermistor, an infrared sensor), a device for imaging (e.g., MRI, CT, fluoroscopy), a device for access (e.g., an introducer assembly, a curved cannula, a drill bit, a curette), etc.

[0056] Although certain embodiments and examples have been described herein, various aspects of the methods and apparatus shown and described in this disclosure may be combined and / or modified in different ways to form further embodiments. Furthermore, the methods described herein may be practiced using any apparatus suitable for performing the steps described. Furthermore, the disclosure (including accompanying drawings) of any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc. disclosed herein in conjunction with the various embodiments may be used in all other embodiments set forth herein. The section headings used herein are intended solely for 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.

[0057] Although 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. However, it should be understood that the embodiments are not limited to the particular forms or methods disclosed, but on the contrary, the embodiments will cover all modifications, equivalents and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. None of the methods disclosed herein need to be performed in the order described. The methods disclosed herein include certain actions taken by the practitioner; however, the methods may also include instructions of such actions by any third party, whether express or implied. For example, an action such as "applying thermal energy" includes "indicating the application of thermal energy."

[0058] Various embodiments of the present disclosure have been presented in the format of ranges. It should be understood that the description of the range format is merely for convenience and brevity, and should not be construed as an unchangeable limitation on the scope of the present invention. The ranges disclosed herein include any and all overlaps, subranges, and combinations thereof, as well as individual numerical values ​​within the range. For example, a description of a range from 70 to 115 degrees should be considered to include specifically disclosed subranges, such as from 70 to 80 degrees, from 70 to 100 degrees, from 70 to 110 degrees, from 80 to 100 degrees, and the like, as well as individual numerical values ​​within the range, such as 70, 80, 90, 95, 100, 70.5, 90.5, and any whole and partial increments therebetween. Language such as "up to," "at least," "greater than," "less than," "between," etc., includes the numbers listed. Numbers beginning with terms such as "approximately" include the numbers listed. For example, "approximately 10" includes "10." For example, the terms "about," "approximately," and "substantially" as used herein represent an amount that approaches the stated amount and still performs a desired function or achieves a desired result.

Claims

1. An apparatus for performing radiofrequency (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 a mechanical impact from the mallet; a distal tip electrode at the distal end; an elongated tube extending from the handle to the distal end, the elongated tube having a distal resilient section, wherein the portion of the resilient section comprising the conductive material is configured to function as a second electrode of a bipolar electrode pair having the distal tip electrode; as well as An insulating coupling section is positioned between the distal electrode and the distal end of the elongated tube.

2. The device according to claim 1, wherein The elongated tube also includes a proximal rigid section disposed between the distal resilient section and the handle.

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

4. The device according to claim 2 or 3, wherein: The elongated tube is secured to the handle.

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

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

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

8. The device according to any one of claims 2 to 7, wherein The elongated tube comprises a hypotube made of a rigid conductive material, and wherein the resilient section of the elongated tube has a slit formed on the hypotube.

9. The device according to claim 8, wherein The hypotube is connected to the insulating coupling.

10. The device according to claim 8 or 9, wherein The rigid conductive material is nickel titanium alloy.

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

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

13. The device according to claim 12, wherein The length direction of the slit is arranged to be substantially perpendicular to the longitudinal axis of the hypotube.

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

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

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

17. An apparatus according to any preceding claim, wherein The distal tip electrode includes a bullet-shaped configuration or a beveled pointed configuration at the distal end.

18. The device according to claim 5, wherein A plurality of electrical wires extend within the elongated tube to connect the distal electrode to the connection port at the handle.

19. The device according to claim 18, wherein The plurality of electrical wires are braided to form a unitary braided cable.

20. The apparatus according to claim 18, wherein A nitinol rod or core extends within the elongated tube to connect the distal tip electrode to the connection port at the handle.

21. The device according to claim 18 or 19, wherein The plurality of electrical wires are surrounded by an insulation layer.

22. An apparatus according to any preceding claim, wherein The distal resilient section is configured to bend, but remain straight when not caused to bend.

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

24. An apparatus for performing radiofrequency (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 a mechanical impact from the mallet; a distal tip electrode at the distal end; an elongated tube extending from the handle to the distal end, the elongated tube having a distal section, wherein the portion of the distal segment comprising the conductive material is configured to function as a second electrode of a bipolar electrode pair having the distal tip electrode; as well as An insulating coupling section is positioned between the distal electrode and the distal end of the elongated tube.

25. The apparatus according to claim 24, wherein The elongated tube also includes a proximal rigid section disposed between the distal section and the handle.

26. The device according to claim 25, wherein The distal section is made of a rigid material.

27. The apparatus according to claim 24, wherein The distal section is flexible.

28. The device according to claim 26 or 27, wherein The distal section is pre-formed to have a straight shape.

29. The device according to claim 26 or 27, wherein The distal section is pre-formed with a slight curve.

30. A method of ablating a nerve within a vertebral body of a subject, the method comprising: forming a curved path in the vertebral body with a curved cannula assembly, the curved path pointing to a preselected target treatment area; monitoring the formation of the tortuous pathway using an intraoperative imaging modality; removing the J-shaped stylet from the interior passageway in the curved cannula of the curved cannula assembly; inserting an integrated radiofrequency (RF) ablation device into the interior passage of the curved cannula and advancing a distal end of the RF ablation device out of the open distal end of the curved cannula in a straight path; determining whether the linear path reaches the preselected target treatment area using the intraoperative imaging modality; and RF ablation is performed using the RF ablation device.

31. The method according to claim 30, wherein The intraoperative imaging modality is fluoroscopic imaging.

32. The method according to claim 30 or 31, wherein The integrated RF ablation device comprises: a bipolar RF probe comprising an elongated tube having a resilient distal section configured to flex but remain straight when not caused to flex; distal tip electrode; an insulating coupling section located between a distal end of the resilient distal section and the distal tip electrode, wherein at least a portion of the elongated tube proximal to the insulating coupling section comprises a conductive material, the at least a portion being adapted to form a bipolar electrode pair with the distal tip electrode; and A handle is located at the proximal end, the handle being attached to the proximal end of the elongated tube.

33. The method according to claim 32, wherein The handle is capable of receiving mechanical impact (eg, from a mallet).

34. The method according to claim 32 or 33, wherein The elongated tube also includes a rigid section disposed between the resilient section and the handle.

35. The apparatus of claim 34, wherein: At least a portion of the rigid section is covered by an insulating layer.

36. The method according to any one of claims 32 to 35, wherein The elongated tube is secured to the handle.

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

38. The method of claim 34, wherein: The elongated tube comprises a hypotube made of a rigid conductive material, and wherein a resilient section of the elongated tube has a slit formed on the hypotube, the slit being adapted to facilitate flexing of the resilient section.

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

40. The method of claim 30, wherein: The length of the slit is significantly greater than its width.

41. The method according to claim 40, wherein The length direction of the slit is arranged to be substantially perpendicular to the longitudinal axis of the hypotube.

42. The method of claim 37, wherein: A plurality of electrical wires extend within the elongated tube to connect the distal tip electrode to an electrical connection port at the handle.

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

44. The method according to claim 42 or 43, wherein The plurality of electrical wires are surrounded by an insulation layer.

45. The method according to any one of claims 32 to 44, wherein The RF probe includes a bullet-shaped probe head or a beveled pointed probe head.

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

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

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

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

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

51. A method of entering a vertebral body and ablating one or more nerves within the vertebral body as described and illustrated herein.

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