Controlled bone access and operator feedback feature

Abstract

Various embodiments of systems and methods for controllably accessing and modulating tissue (e.g., systems and methods for accessing and ablating nerves or other tissue within or around a vertebral body to treat chronic lower back pain) are described.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 329,814, filed on April 11, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] Various embodiments of systems, devices, and methods for performing diagnostic and / or therapeutic procedures (e.g., intraosseous nerve ablation) in bones (e.g., vertebral bodies) or body lumens or cavities or tissues to facilitate controlled access (e.g., systems and methods for accessing locations in or around vertebral bodies or other bones) are described herein. The systems, devices, and methods may incorporate tactile and / or audible operator feedback to provide additional confidence and ease of use. Background Art

[0004] Back pain is a very common health problem worldwide and a leading cause of work-related disability benefits and compensation. At any given time, nearly 30% of Americans are affected by low back pain, resulting in 62 million visits to hospitals, emergency departments, outpatient clinics, and physicians' offices each year. Back pain can be caused by strains of the muscles, ligaments, or tendons of the back and / or structural problems with the bones or discs. Back pain can be acute or chronic. Existing treatments for chronic back pain vary and include physical therapy and exercise, chiropractic care, injections, rest, medications (such as opioids, painkillers, or anti-inflammatory drugs), and surgical interventions (such as spinal fusion, discectomy (such as total disc replacement), or disc repair). Existing treatments can be expensive, addictive, temporary, ineffective, and / or can increase pain or require a long recovery time. In addition, existing treatments do not provide adequate relief for most patients, and only a small percentage of patients are eligible for surgery. Summary of the invention

[0005] Applicant's prior art ( of The present invention provides a safe and effective minimally invasive procedure that targets the basilar vertebral nerves and / or other intraosseous nerves located within the vertebral body or other bones (e.g., branches of the sinus vertebral nerves that innervate one or both endplates of one or more vertebral bodies) for relieving chronic vertebral low back pain or other back pain or pain associated with other bones or joints. As disclosed herein, various embodiments of the bone access tool incorporate features that facilitate controlled introduction and removal of various components of the bone access tool, while also facilitating operator feedback and ease of use.

[0006] Other bones may also be entered, such as those associated with the legs, arms, knees, hips, feet, wrists, and hands. The bone entry tool may facilitate curved entry into a location within a bone or a location within a bone. Alternatively, a straight bone entry may be implemented.

[0007] The bone access tool system or kit may optionally include one or more access tools (e.g., a stylet, cannula, curette, bone drill) configured to approach a target nerve to be treated (e.g., other branches of the basilar vertebral nerve and / or the sinus vertebral nerve and / or other intraosseous nerves). The kit may also or alternatively optionally include one or more treatment tools configured to modulate (e.g., ablate, stimulate, denervate, inhibit, necrotize, electroporate, molecularly dissociate) the target nerve. Optional treatment tools include one or a combination of the following: a radio frequency (RF) energy delivery device, a microwave energy delivery device, an ultrasonic energy delivery device, a cryogenic regulation device (e.g., a cryoablation device), a laser energy delivery device, a steam or vapor delivery device, and / or a drug eluting device (e.g., a chemical or fluid ablation device configured to elute a fluid (such as alcohol or phenol) that can denervate or ablate a nerve).

[0008] According to multiple embodiments, during the use of bone access tools, it is desirable to perform easy or simplified tool replacement without losing position, so as to facilitate ease of use, improve safety and effectiveness, and repeatability. At multiple points throughout the bone access procedure (e.g., positions in the vertebral body through the pedicle, around the pedicle, or outside the pedicle), the introduction of tools in other tools and the removal of the tools from other tools may cause inadvertent axial or translational or rotational movement of the tools or instruments (in which other tools are inserted or removed) (e.g., guide sleeves or curved sleeves), which may lead to incorrect placement if not paid attention to. In order to help prevent accidental movement and maintain part position and / or orientation during tool replacement, one or more brakes or other matching features may be included on certain interacting tools. According to multiple embodiments, adding one or more brakes or other matching features can provide many benefits. For example, adding brakes or other matching features can allow the operator to have tactile (and potentially auditory) feedback to identify when a tool component is in contact (or sufficiently close contact) with the face or surface (e.g., upper face or surface) of another tool component. As another example, adding one or more brakes or other mating features can significantly increase the friction of the assembly to prevent accidental movement when exchanging parts or tools. Brakes or other mating features can be used as anti-rotation and / or anti-backdrive features. As another example, adding brakes or other mating features can also provide the operator with more discrete tool control during insertion or retraction. If there are no brakes or other mating features, the operator may have to visually track the translation of the tools relative to each other. Alternatively or in addition to requiring the operator to visually observe one or more tool parts, if a tactile or audible click is provided to the operator, instructions (verbal or written) can be provided based on the number of clicks. The embodiments described herein can increase operator confidence and verification.

[0009] According to multiple configurations, a bone access system adapted to facilitate percutaneous access to a target treatment location within a bone includes a first instrument (e.g., an introducer cannula) having a proximal handle and a distal elongated tube extending from the proximal handle (e.g., along a longitudinal axis). The proximal handle of the first instrument (e.g., the introducer cannula) includes an opening (e.g., a central opening, a recess, or a cavity) located on an upper surface of the proximal handle (e.g., adapted to receive a portion of another tool or instrument sized and shaped to be at least partially inserted into or through the first instrument (e.g., the introducer cannula). The distal elongated tube of the first instrument (e.g., the introducer cannula) may include a lumen accessible via an opening (e.g., a central opening) of the proximal handle of the first instrument (e.g., the introducer cannula). The system also includes a second instrument (e.g., an access instrument, a diagnostic instrument, a therapeutic instrument) sized and configured to be inserted through the central opening and along the lumen of the first instrument (e.g., an introducer sheath) until a distal end portion of the second instrument (e.g., an access instrument) extends beyond the open distal tip of the first instrument (e.g., an introducer sheath). The first instrument (e.g., an introducer sheath) and the second instrument (e.g., an access instrument) together include a tactile feedback mechanism adapted to provide tactile feedback indicating interaction between the second instrument (e.g., an access instrument) and the first instrument (e.g., an introducer sheath).

[0010] In some configurations, the tactile feedback mechanism includes corresponding mating features (e.g., detent features) of the introducer cannula and the access instrument that are designed to interact when the corresponding mating features (e.g., detent features) are aligned. The corresponding mating features can be located at different locations or surfaces of the introducer cannula and the access instrument, or other tools or instruments (e.g., other cannulas, guide systems, endoscopic devices, diagnostic devices, therapeutic devices, etc.) configured to be interconnected to each other.

[0011] In some configurations, the tactile feedback mechanism includes a tooth or protrusion on one side and a plurality of grooves distributed on the other side to form a pattern (such as a circle), wherein the tooth or protrusion is adapted to engage with one of the plurality of grooves. For example, the tooth or protrusion may be formed on the introducer cannula and the plurality of grooves may be formed on the access instrument, or vice versa.

[0012] In some configurations, the tactile feedback mechanism includes corresponding magnets of the introducer cannula and the access instrument that are designed to interact with each other when the corresponding magnets are aligned.

[0013] In some configurations, the tactile feedback mechanism includes a hook and loop fastener.

[0014] In some configurations, the tactile feedback mechanism includes a wave washer adapted to provide an interference fit between the access instrument and the introducer cannula.

[0015] In some configurations, the tactile feedback mechanism includes a spring detent positioned within the central opening of the introducer cannula, the spring actuator being configured to interact with a corresponding detent feature of the access instrument.

[0016] In various configurations, the tactile feedback mechanism produces an audible click.

[0017] In some configurations, the tactile feedback mechanism causes a change in the amount of torque required to continue advancing the access instrument distally within the introducer sheath.

[0018] The access instrument may include a cannula having a pre-curved distal end portion. The access instrument may include a straight cannula or a therapeutic probe or a diagnostic instrument. The access instrument may include a proximal handle adapted to be struck or pressed by an operator to facilitate distal advancement of the access instrument. The introducer cannula and access instrument may be sized to facilitate access to an intraosseous location within a vertebral body through a percutaneous incision.

[0019] According to multiple configurations, a bone access system that facilitates percutaneous access to a target treatment location within a bone (such as within a vertebral body) includes an introducer sleeve having a proximal handle and a distal elongated tube extending from the proximal handle. The proximal handle of the introducer sleeve includes a central opening located in its upper surface. The upper surface (e.g., the central opening) of the proximal handle of the introducer sleeve includes one or more brakes (e.g., a first brake) or mating features that protrude radially inward from the inner surface of the central opening. The distal elongated tube of the introducer sleeve includes a lumen that can be entered via the central opening of the proximal handle of the introducer sleeve. The bone access system also includes an entry instrument that is sized and configured to pass through the central opening and be inserted along the lumen of the introducer sleeve until the distal end portion of the entry instrument extends beyond the open distal end of the introducer sleeve. The access instrument comprises an elongated shaft having a threaded proximal portion and a transmission (e.g., a gear) mechanically coupled to the threaded proximal portion, the transmission being adapted to translate proximally and distally along the threaded proximal portion via rotation of the gear. The access instrument may optionally include a substantially smooth (e.g., threadless) distal portion. The gear comprises an annular flange comprising a second actuator feature, the second brake feature being a plurality of actuator elements (e.g., grooves) spaced apart around a circumference (e.g., a cylindrical lateral surface) of a lower surface of the annular flange. The second brake feature is adapted to mechanically engage with one or more first brakes on a proximal handle of an introducer cannula (e.g., within a central opening) to provide tactile and / or audible feedback to an operator when the plurality of brake elements of the access instrument engage with the one or more first brakes (e.g., teeth) of the introducer cannula, thereby providing controlled advancement of the access instrument relative to the introducer cannula.

[0020] The second brake feature of the access instrument (e.g., annular flange) may include a plurality of grooves, notches, recesses, grooves, pits, or other mating features. Each of the plurality of notches, recesses, grooves, pits, or other mating features of the second brake feature may include a semicircular shape, a sawtooth shape, a triangular shape, a square shape, a sinusoidal shape, or other shapes. The first brake feature of the introducer sleeve (e.g., one or more brakes) may include teeth, protrusions, tabs, bosses, projections, or other mating features formed on or along the upper and / or inner surface of the introducer sleeve (e.g., around the central opening). In some embodiments, the second brake feature of the access instrument may include teeth, protrusions, tabs, bosses, projections, or other mating features, and the first actuation feature of the introducer sleeve may include a plurality of grooves, notches, recesses, grooves, pits, or other mating features, as long as the first brake feature and the second brake feature can be tactilely engaged.

[0021] In some configurations, the plurality of brake (e.g., notches or grooves) elements of the second brake feature may be evenly spaced around the circumference of the annular flange of the gear of the access instrument. In other configurations, the plurality of brake elements of the second brake feature are not evenly spaced.

[0022] One or more brakes (e.g., teeth) and multiple brake (e.g., groove) elements can produce an audible click when engaging and / or disengaging. The engagement between one or more brakes (e.g., teeth) of the introducer sleeve and a corresponding one of the multiple brake (e.g., groove) elements of the annular flange can increase the amount of torque required to disengage one or more brakes (e.g., teeth) from a corresponding one of the multiple brake (e.g., groove) elements. According to multiple embodiments, the increase in required torque can advantageously help prevent unintentional rotational and / or translational movement of one instrument or tool relative to another instrument or tool (e.g., when additional tools are inserted into or withdrawn from the entry instrument and / or the introducer sleeve).

[0023] In some systems, the access instrument is a cannula having a pre-curved distal end portion. In some systems, the access instrument includes a proximal handle adapted to be struck or pressed by an operator to facilitate distal advancement of the access instrument.

[0024] In some configurations, the first detent feature (eg, one or more detents) of the introducer cannula consists of a single detent (eg, tooth) rather than a plurality of detents (eg, teeth).

[0025] In some configurations, the central opening of the introducer sheath can include an abutment member extending radially inwardly from an inner surface of the central opening, the abutment member adapted to abut a lower surface of an annular flange of a gear of an access instrument as the access instrument is advanced within the introducer sheath.

[0026] In some embodiments, the introducer cannula and access instrument are sized to facilitate access to an intraosseous location within a vertebral body through a percutaneous incision.

[0027] In some embodiments, the proximal handle of the introducer cannula can include a curved or angled insertion slot.

[0028] According to a plurality of embodiments, a bone access system comprises an introducer sleeve having an introducer handle at a proximal end and a distal elongated tube attached to the introducer handle and extending from the introducer handle along a longitudinal axis. The introducer handle comprises an abutment surface arranged around an upper surface or in an opening, a cavity or a recess in the upper surface. The abutment surface comprises a first mating feature (e.g., a brake feature) formed thereon or therein. The lumen extends from the introducer handle through the introducer sleeve along the longitudinal axis to the open distal end of the distal elongated tube. The system also comprises an access instrument having an instrument handle at a proximal end and a distal shaft portion attached to the instrument handle and extending from the instrument handle along the longitudinal axis. The distal shaft portion of the access instrument is configured to be received in the lumen of the introducer sleeve. The instrument handle comprises an abutment surface (e.g., a lower surface and / or a side surface) having a second mating feature (e.g., a brake feature) formed thereon or therein. The second mating feature is configured to mate with the first mating feature of the introducer sleeve. When the distal shaft portion of the access instrument is inserted into the lumen of the introducer sleeve from the proximal end and the abutment surface (e.g., the lower surface and / or the side surface) of the instrument handle approaches or contacts or touches the abutment surface of the introducer handle, the first mating feature (e.g., the stopper feature) of the abutment surface mates with the second mating feature (e.g., the stopper feature) of the abutment surface of the instrument handle.

[0029] The mating of the features can include a removable mating engagement that can be overcome by sufficient force (e.g., torque or pressure). For embodiments including brake features, when a first brake feature on an abutment surface engages a second brake feature on a lower surface of an instrument handle, the second brake feature resists rotation of the first brake feature about the longitudinal axis causing a tactile response. When a first brake feature on an abutment surface of an introducer handle engages a second brake feature on a corresponding abutment surface of an instrument handle, the second brake feature resists rotation of the first brake feature about the longitudinal axis causing an audible click response and / or a tactile response, thereby providing tactile or haptic feedback to the operator.

[0030] In some embodiments, when a first brake feature on the abutment surface engages a second brake feature on the lower surface of the instrument handle, the second brake feature resists rotation of the first brake feature about the longitudinal axis requiring overcoming a predetermined amount of torque to cause the brake features to disengage from each other, thereby providing a safety mechanism to prevent accidental or undesirable movement of the tools or instruments relative to each other until movement is desired.

[0031] In some embodiments, the access instrument further includes an extension extending distally from the instrument handle, the extension having external threads formed thereon. The access instrument may further include a wheel, the wheel including a hole along a central axis of the wheel, the hole including internal threads formed therein. The internal threads of the wheel may be configured to engage with the external threads of the extension. The wheel may be coupled to the extension, the internal threads of the wheel engaging with the external threads of the extension, such that rotating the wheel causes the wheel to translate distally or proximally along the access instrument.

[0032] In some embodiments, the first brake feature on the adjacent surface of the guide handle is one or more teeth, and the second brake feature on the adjacent surface of the instrument handle is a plurality of grooves, wherein each of the one or more teeth bites into one of the plurality of grooves when the first brake feature engages with the second brake feature.

[0033] In some embodiments, the first brake feature on the adjacent surface of the guide handle is a plurality of grooves, and the second brake feature on the adjacent surface of the instrument handle is one or more teeth, wherein each of the one or more teeth bites into one of the plurality of grooves when the first brake feature engages with the second brake feature.

[0034] A plurality of grooves may form a circle around the longitudinal axis of the introducer sleeve or access device. The plurality of grooves in the circle may be equal or evenly spaced, or spaced at appropriate intervals.

[0035] In some embodiments, a plurality of grooves are formed on a cylindrical lateral circumferential surface coaxial with the longitudinal axis.

[0036] The one or more teeth may be a single tooth, two teeth, three teeth, four teeth or more than four teeth.

[0037] In various configurations, the plurality of grooves may be semicircular, sawtooth, triangular, square, or sinusoidal in shape.

[0038] According to various embodiments, the introducer cannula and access instrument can be sized to facilitate access to an intraosseous location within a vertebral body through a percutaneous incision.

[0039] In some examples, the introducer sleeve for penetrating into the bone includes an introducer handle at the proximal end, the introducer handle includes an abutment surface arranged around the upper surface or in a groove or cavity of the upper surface, and the abutment surface has a first matching (e.g., brake) feature formed thereon or therein. The introducer sleeve also includes a distal elongated tube attached to the introducer handle and extending from the introducer handle along the longitudinal axis. The lumen extends from the introducer handle through the introducer lumen along the longitudinal axis to the open distal end of the distal elongated tube. The first matching (e.g., brake) feature is configured to cooperate with a second corresponding brake feature formed on an entry instrument suitable for at least partially inserting into the introducer sleeve.

[0040] In some embodiments, when the first brake feature on the abutment surface is configured to cooperate with the second brake feature on the access instrument, the second brake feature resists rotation of the first brake feature about the longitudinal axis causing a tactile response. In some embodiments, when the first brake feature on the abutment surface is configured to cooperate with the second brake feature on the access instrument, the second brake feature resists rotation of the first brake feature about the longitudinal axis causing an audible click response.

[0041] In some embodiments, the first brake feature on the abutment surface of the introducer handle is one or more teeth, and the second brake feature on the entry instrument is a plurality of grooves, wherein each of the one or more teeth bites into one of the plurality of grooves when the first brake feature engages with the second brake feature.

[0042] In other embodiments, the first brake feature on the abutment surface of the introducer handle is a plurality of grooves and the second brake feature on the entry instrument is one or more teeth, wherein each of the one or more teeth bites into one of the plurality of grooves when the first brake feature engages with the second brake feature.

[0043] In some examples, a bone access instrument for penetrating into a bone includes an instrument handle at a proximal end and a distal shaft portion extending from the instrument handle along a longitudinal axis. The instrument handle includes an abutment surface (e.g., a lower surface and / or a side surface) having a corresponding mating feature (e.g., a second brake feature) formed thereon or therein, the mating feature being configured to mate with a corresponding mating feature (e.g., a first brake feature) of an introducer sleeve. The distal shaft portion is configured to be received in a lumen formed in the introducer sleeve.

[0044] In some embodiments, when the second detent feature on the lower surface of the instrument handle is configured to cooperate with the first detent feature of the introducer cannula, the second detent feature causes a tactile response against rotation of the first detent feature about the longitudinal axis.

[0045] In some embodiments, when the second detent feature on the abutment surface of the instrument handle is configured to cooperate with the first detent feature of the introducer sleeve, the second detent feature resists rotation of the first detent feature about the longitudinal axis causing an audible click response.

[0046] In some embodiments, when the second detent feature on the abutment surface of the instrument handle is configured to cooperate with the first detent feature of the introducer sleeve, the second detent feature resists rotation of the first detent feature about the longitudinal axis requiring overcoming a predetermined amount of torque.

[0047] In some embodiments, the bone access instrument further comprises an extension portion extending distally from the instrument handle, wherein the extension portion has external threads formed thereon, the access instrument comprises a wheel having a hole along a central axis of the wheel, the hole having internal threads formed therein, the internal threads being configured to engage with the external threads of the extension portion. The wheel is coupled to the extension portion, the internal threads of the wheel engaging with the external threads of the extension portion, such that rotating the wheel causes the wheel to translate distally or proximally along the extension portion.

[0048] In some embodiments, the second brake feature on the lower surface of the instrument handle is one or more teeth, and the first brake feature on the adjacent surface of the guide handle is a plurality of grooves, wherein each of the one or more teeth bites into one of the plurality of grooves when the second brake feature engages with the first brake feature.

[0049] In some embodiments, the second brake feature on the lower surface of the instrument handle is a plurality of grooves, and the first brake feature on the adjacent surface of the guide handle is one or more teeth, wherein each of the one or more teeth bites into one of the plurality of grooves when the second brake feature engages with the first brake feature.

[0050] In some embodiments, a method for facilitating percutaneous access to a target treatment position (e.g., a vertebral body of a lumbar, sacral, thoracic or cervical spine) within a bone includes inserting the distal portion of an introducer assembly into at least the outer cortical region of the bone. The introducer assembly includes an introducer sleeve and an introducer stylet. The introducer sleeve includes a proximal introducer handle at a proximal end and a distal elongated tube attached to and extending from the introducer handle, the elongated tube defining a longitudinal axis. The introducer sleeve has a lumen formed from the proximal introducer handle to the distal end of the elongated tube. The introducer stylet is configured to be received in the lumen of the introducer sleeve. The method also includes removing the introducer stylet from the lumen of the introducer sleeve, and then inserting a bone access instrument or assembly (e.g., a curved sleeve assembly) into the lumen. The curved sleeve assembly may include a curved sleeve handle and a shaft portion extending from the curved sleeve handle, the shaft portion being configured to be received in the lumen, the shaft portion having a distal curved portion. The method also includes advancing at least a distal portion of the bone access instrument (e.g., a distal curved portion of the curved sleeve assembly) from the distal end of the introducer sleeve toward a target treatment location within the bone (e.g., an ablation location where a lesion or heating zone sufficient to ablate one or more nerves within the bone can be formed). The introducer handle includes a first brake feature formed thereon, and the bone access instrument (e.g., a component of the curved sleeve handle, such as a flange of a gear) includes a second brake feature formed thereon, the second brake feature being configured to cooperate with the first brake feature to provide tactile and / or audible feedback to an operator when the second brake feature and the first brake feature are engaged, thereby providing controlled advancement of the bone access instrument (e.g., the curved sleeve assembly) relative to the introducer sleeve.

[0051] In some embodiments, cooperation between the first detent feature of the introducer handle and the second detent feature of the bend cannula handle allows for radial positioning of the bend cannula assembly within the introducer cannula.

[0052] In some embodiments, a bone access instrument (e.g., a curved sleeve assembly) includes a gear or other translation mechanism coupled to a proximal portion of the bone access instrument (e.g., a curved sleeve handle). A lower flange or other member extending from the gear, or a lower surface of the gear itself, may include a second brake feature. Rotation of the gear or other translation mechanism may adjust the axial position of the gear on the proximal portion of the bone access instrument (e.g., the curved sleeve handle). The engagement of the gear with the introducer handle may limit the longitudinal position of the bone access instrument (e.g., the curved sleeve assembly) within the introducer sleeve.

[0053] In some embodiments, continued rotation of the gears or other translation mechanism provides further tactile and / or audible feedback via the interaction of the first brake feature with the second brake feature.

[0054] The first brake feature and / or the second brake feature may include a plurality of brake elements. The first brake feature may include a single element and the second brake feature may include a plurality of brake elements, or vice versa. The respective brake elements may include concave elements (e.g., notches, grooves, recesses, etc.) or convex elements (e.g., protrusions, projections, teeth, etc.) such that the brake elements of the respective components are configured to removably engage with each other when sufficient torque is provided to disengage.

[0055] In some embodiments, pushing a distal portion of a bone access instrument (e.g., a curved distal portion of a curved sleeve assembly) out of the distal end of an introducer sleeve includes tapping a proximal handle (e.g., a curved sleeve handle) of the bone access instrument. The method may also include advancing a therapeutic instrument through the access instrument and performing a therapeutic procedure in the bone. The therapeutic procedure may include applying thermal energy sufficient to modulate (e.g., ablate) one or more nerves at a target treatment location. The method may include advancing a diagnostic instrument through the access instrument and performing a diagnostic procedure in the bone. The bone may be a vertebral body, and the therapeutic procedure may be a therapeutic procedure to treat chronic lower back pain or other back pain.

[0056] Furthermore, in some embodiments, the methods described herein can be used in conjunction with tools inserted into tissue other than bone or into body lumens, cavities, recesses, or spaces (e.g., endoscopic, laparoscopic, intravascular, or intraluminal procedures).

[0057] According to various embodiments, the systems and methods described herein advantageously do not rely on visual observation alone to access a treatment and / or diagnostic location.Tactile and / or auditory feedback can facilitate controlled access.

[0058] The methods described herein may also include one or more diagnostic and / or therapeutic steps after controllable proximity to the diagnostic and / or therapeutic position. In some embodiments, the therapeutic surgery after entering the bone may include regulation of the nerves in or around the bone. As used herein, the term "regulation" or "neuromodulation" should be given its ordinary meaning, and should also include ablation, permanent denervation, temporary denervation, destruction, blocking, inhibition, electroporation, therapeutic stimulation, diagnostic stimulation, inhibition, necrosis, desensitization or other effects on tissue. Neuromodulation refers to the regulation of nerves (structure and / or function) and / or neurotransmission. Regulation is not necessarily limited to nerves, and may include effects on other tissues, such as tumors or other soft tissues.

[0059] Multiple embodiments of the disclosed technology have one or more of the following advantages: (i) tactile feedback to identify interaction between components of a bone access system or kit; (ii) auditory feedback to identify interaction between components of a bone access system or kit; (iii) prevention of unintentional movement or translation between components of a bone access system or kit; (iv) discrete control of relative motion between components of a bone access system or kit; and / or (v) ease of use of accessing bone using a bone access system or kit.

[0060] In order to summarize the purpose of the present disclosure, some aspects, advantages and novel features of the disclosed embodiments are described herein. It should be understood that, according to any specific embodiment of the disclosure provided herein, not all such advantages may be achieved. Therefore, the embodiments described herein can be implemented or performed in a manner that realizes or optimizes an advantage or a group of advantages as taught or suggested herein, without having to realize other advantages taught or suggested herein.

[0061] The methods summarized above and further described 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 "applying thermal energy" includes "indicating the application of thermal energy." 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

[0062] Various embodiments of the present invention will be more fully understood with reference to the following drawings, which are provided for illustration purposes only:

[0063] Figure 1 An example of a kit or system of access tools configured to access a vertebral body or other bone is shown.

[0064] Figure 2A yes Figure 1 A side view of an introducer sheath of the kit or system is shown. Figure 2B is a top view of the introducer cannula.

[0065] Figure 3A yes Figure 1 A side view of the curved sleeve of the kit or system is shown. Figure 3B is a close-up side view of the proximal end portion of the curved cannula.

[0066] Figure 3C and Figure 3D Shows the use of Figure 1 The illustrated kit or system operates the gears of the bending sleeve at different stages of a bone access method to facilitate arresting or advancing the bending sleeve assembly within the introducer sleeve.

[0067] Figure 3E A side view of a curved cannula inserted into an introducer cannula is shown, wherein the introducer cannula is transparent.

[0068] Figure 4A A close up side view of an example of a gear showing a bent sleeve, depicting the brake element of the gear.

[0069] Figure 4B A perspective top view of a portion of a proximal handle of an introducer sheath is shown, depicting an example of an actuator element of the introducer sheath.

[0070] Figure 4C A side view of a curved sleeve is shown, the curved sleeve comprising Figure 4A The insertion shown in Figure 4B The gears within the proximal handle of the introducer cannula are shown, with the introducer cannula being transparent.

[0071] Figure 4D A side cross-sectional view of the proximal portion of the curved sleeve is shown.

[0072] Figure 5A , Figure 5B , Figure 5C and Figure 5D Other examples of brake elements for gears showing curved sleeves.

[0073] Figure 6 Examples of a bending cannula and an introducer cannula are shown that include magnets to facilitate controlled introduction and removal of the bending cannula within the introducer cannula.

[0074] Figure 7 An example of an introducer sleeve and a bending sleeve in combination with the use of a spring brake mechanism is shown.

[0075] Figure 8 and Fig. 9 Examples of interference designs are shown that incorporate the use of bonding materials or interference fit methods to vary the tactile feedback when the gears of the bending sleeve contact the introducer sleeve.

[0076] Figure 10A-10E Shows the use of Figure 1 The illustrated kit or system includes one or more access tools for various steps of a method for accessing and treating tissue within a vertebral body. DETAILED DESCRIPTION

[0077] Various embodiments described herein relate to systems, devices and methods that contribute to controlled access to positions within the skeleton. In some embodiments, for diagnostic or therapeutic purposes (e.g., treatment or prevention of chronic lower back pain), intraosseous nerves (e.g., vertebral basilar nerves and / or other intraosseous nerves branching from the sinus vertebral nerve) in the skeleton (e.g., vertebral body) close to the spine. The vertebral body can be located at any position of the spine (e.g., cervical, thoracic, lumbar and / or sacral). Multiple vertebral bodies can be entered simultaneously or sequentially. Multiple vertebral bodies can be located in a single spinal segment (e.g., two adjacent vertebral bodies in a sacral spinal segment (e.g., S1 and S2) or a lumbar segment (e.g., L3, L4 and / or L5) or a thoracic segment or a cervical segment), or in different spinal segments (e.g., L5 vertebrae in a lumbar segment and S1 vertebrae in a sacral spinal segment). In addition to the vertebral body, the intraosseous nerves in the skeleton can also be regulated. For example, nerves within the humerus, radius, femur, tibia, calcaneus, tarsal bones, hip, knee, and / or phalanges can be accessed. In some embodiments, the shoulder is treated. In various embodiments, the devices and methods described herein are used for diagnosis and / or treatment of back pain, nerve stimulation or ablation, intravascular or intraluminal applications, and endoscopic applications.

[0078] In some embodiments, one or more of the modulated nerves are extraosseous nerves located outside of a vertebral body or other bone (e.g., at a location before the nerve enters a bone foramen or after it exits a bone foramen). Other tissues in addition to or in place of nerves (e.g., tumors or other cancerous tissue or fractured bones) may also be treated or otherwise affected. Portions of nerves in or on an intervertebral disc between adjacent vertebral bodies or one or more vertebral endplates may be modulated.

[0079] Nerves or other tissues may be modulated to treat one or more indications, including but not limited to chronic lower back pain, upper back pain, acute back pain, joint pain, intrabone tumors and / or fractures. Pain may originate from one or more vertebrae and / or from one or more intervertebral discs. Nerve modulation may also be combined with bone fusion or arthrodesis to provide a synergistic effect or a fully integrated "one and done" treatment without the need for further surgery or minimally invasive intervention. In some embodiments, the devices and methods described herein facilitate non-bone diagnosis and treatment, such as intracavitary or tissue access (e.g., intravascular, endoscopic, intestinal, esophageal, etc.).

[0080] According to various embodiments, the systems and methods described herein for treating back pain or facilitating neuromodulation of intraosseous nerves can be implemented without surgical resection, without general anesthesia, without cooling (e.g., without cooling fluids), and / or with little to no blood loss. In some embodiments, the systems and methods described herein for treating back pain or facilitating neuromodulation of intraosseous nerves facilitate simple re-treatment when necessary. According to various embodiments, successful treatment can be performed in challenging or difficult-to-access locations, and access methods can be varied based on the bone structure or different bone anatomy. One or more of these advantages also apply to treatment of tissues outside the spine (e.g., other orthopedic applications or other tissues).

[0081] The entry tool can include an introducer assembly, which includes an outer sleeve and a sharp stylet, an inner sleeve configured to be introduced through the outer sleeve, and / or one or more additional stylets, a curette or a drill bit, to help enter the intraosseous position in the vertebral body or other bones. The entry tool (for example, an outer sleeve, an inner sleeve, a stylet, a curette, a drill bit) can have a pre-bent distal end portion, or can be actively manipulated or bendable. Any entry tool can have a beveled or other sharp end, or they can have a blunt or rounded atraumatic distal end. A curved drill bit can be used to help form a curved entry path in the bone. A straight entry tool can also be used. In some embodiments, any entry tool can be advanced on the guide wire.

[0082] The access tool can be made of a variety of flexible materials (e.g., ethylene vinyl acetate, polyethylene, polyethylene-based polyolefin elastomers, polyetheretherketone, polypropylene, polypropylene-based elastomers, styrene butadiene copolymers, thermoplastic polyester elastomers, thermoplastic polyurethane elastomers, thermoplastic vulcanized rubber polymers, metal alloy materials such as nitinol, and / or the like). Combinations of two or more of these materials may also be used. The access tool may include a herringbone design or pattern or slits along the distal end portion to increase flexibility or bendability. Any access tool can be rotated manually or automatically (e.g., using a robotic control system) to facilitate a desired trajectory.

[0083] In some embodiments, the outer sleeve assembly (for example, introducer assembly) comprises a straight outer sleeve and is configured to be received in the straight stylet in the outer sleeve. The outer sleeve assembly can be first inserted to penetrate the outer cortical shell of the bone, and a conduit is provided for further entering the tool of the inner cancellous bone. The inner sleeve assembly can include a sleeve with a prebend or a manipulable distal end portion and a stylet with a corresponding prebend or a manipulable distal end portion. A plurality of stylets with a distal end portion of different curvatures can be provided in the kit and selected therefrom by the clinician. Alternatively, the inner sleeve assembly can be configured to keep straight and not curved.

[0084] refer to Figure 1 In one embodiment, a kit or system 100 of an entry tool (e.g., a bone entry tool) may include an introducer assembly 110 consisting of an introducer sleeve 112 and an introducer stylet 114, and a curved sleeve assembly 210 consisting of a curved sleeve 212 and a corresponding curved stylet or J-shaped stylet 214.

[0085] The introducer sheath 112 may include a proximal introducer handle 116 and a distal elongated tube 118 (e.g., a hypotube) extending along a longitudinal axis from the introducer handle 116. The illustrated introducer handle 116 may include a "chimney" or "T-handle" design configuration adapted to provide adequate finger clearance and grip to facilitate removal of the introducer sheath 112. However, alternative design configurations of the proximal handle may also be incorporated in addition to the "chimney" or "T-handle" design.

[0086] The introducer stylet 114 is configured to be received in the lumen of the introducer cannula 112 in such a manner that the distal end 125 of the introducer stylet 114 extends from the open distal end 122 of the introducer cannula 112, thereby forming a combined introducer assembly 110. The introducer stylet 114 includes a proximal first handle 126 and a distal elongated member 127. The first handle 126 includes an upper surface suitable for being struck with a mallet and a lower surface suitable for facilitating removal of the introducer stylet 114 by an operator. The length of the distal elongated member 127 can be in the range of 8 mm to 14 mm (e.g., 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 13.5 mm, 14 mm). The introducer stylet 114 can be a bevel tip, a trocar tip, a cone tip and / or a diamond tip. The distal end portion 132 of the introducer stylet 114 can optionally include a scalloped section to provide a release mechanism for bone compression. The scalloped section can be designed to have a side profile similar to an hourglass generally. The distal end 125 of the distal end portion 132 can include a full diameter to be suitable for separating bones (for example, pedicle bone, cortical bone of vertebral body). When bone is decomposed by the distal end 125 of the distal end portion 132, bone fragments or debris may be loaded into the gap between the inner surface of the distal end portion 132 of the introducer stylet 114 and the introducer sleeve 112, causing the introducer stylet 114 to be more difficult to remove from the introducer sleeve 112. According to various embodiments, the scalloped section of the introducer stylet 114 can advantageously provide a location for bone fragments and pieces to fall into during removal of the introducer stylet 114 to facilitate easier removal of the introducer stylet 114 .

[0087] The curved cannula 212 includes a proximal second handle 216 (e.g., an instrument handle, a curved cannula handle), a wheel feature 221 (e.g., a gear), and a threaded proximal extension 220 extending distally from the proximal second handle 216 (e.g., an instrument handle). The gear 221 is arranged around the extension 220 and translates when the gear 221 rotates. The curved stylet 214 includes a proximal handle 226. The curved stylet 214 can be one of a plurality of access instruments that can be received in the lumen of the curved cannula 212 in such a way that the distal tip of the curved stylet 214 extends from the open distal tip 222 of the curved cannula 212, thereby combining to form the curved cannula assembly 210. The curved cannula 212 and the curved stylet 214 can each include a straight proximal body portion and a curved distal end portion 225, 227. The curvatures of the curved distal end portions 225, 227 of the curved cannula 212 and the curved stylet 214 can correspond to each other. The kit or system 100 can optionally include a straight stylet (not shown) that is a flexible channel stylet configured to be delivered through the curved cannula 212 and then form and maintain a straight or substantially straight path when exiting the open distal end 222 of the curved cannula 212.

[0088] An access tool (e.g., a bone access tool) can be provided as a kit that optionally additionally includes one or more additional introducer cannulas, one or more additional introducer stylets (e.g., having different ends, such as one having a beveled end and one having a diamond or cannula tip), one or two or more additional curved cannulas (e.g., having a curved distal end portion with a different curvature than the first curved cannula), additional curved stylets (e.g., having a different curvature or a different design to enter hard bone), an introducer drill bit, and / or additional straight stylets (e.g., having a different length than the first straight stylet). Some kits may include optional additional access tool components or accessory kit modules that are suitable for accessing one or more additional vertebrae in the same spinal segment or a different spinal segment. Kit 100 may also include one or more (e.g., at least two) treatment devices (e.g., a radiofrequency energy delivery probe).

[0089] In some embodiments, the entry tool (e.g., kit 100) can be specially designed and suitable for facilitating entry into hard non-osteoporotic bone (e.g., bone around or within the vertebral body, such as cervical, thoracic, lumbar or sacral vertebrae). Hard bone can be determined based on bone density test, compression strength determination, compression modulus determination, imaging mode, or determined based on the operator's sense of touch when advancing into the instrument. In some embodiments, hard bone can be determined as bone (e.g., T score is greater than or equal to -1) with a bone mineral density score within the standard deviation of a normal healthy young adult. In some embodiments, hard bone can be identified as bone with a compression strength greater than 4MPa and / or a compression modulus greater than 80MPa for cancellous bone and bone with a compression strength greater than 5.5MPa and / or a compression modulus greater than 170MPa for cortical bone. Some kits can include at least two of each entry instrument. Some kits can include optional additional components or attached kit modules (e.g., guide drill bits and curved stylets 214 specifically configured to enter hard bone) for entering hard bone.

[0090] Figure 2A for Figure 1 A side view of the introducer sheath 112 of the kit or system 100 is shown. Figure 2B is a top view of the introducer sheath 112 .

[0091] The introducer handle 116 includes a lower portion 113 (e.g., a projection or flange) extending downward from the lower surface of the crossbar portion 115. The introducer handle 116 includes an upper central opening 120 (e.g., a recess, a cavity) configured to facilitate the linear axial insertion of the introducer stylet 114 or other entry tools (e.g., a linear entry tool). The upper central opening 120 can be positioned to correspond to (e.g., coaxial with) the central lumen of the elongated tube 118 extending through the introducer cannula 112, so that the entry instrument (e.g., the introducer stylet 114, the steerable cannula or the steerable stylet) is inserted therethrough. The introducer handle 116 can also include a coupling feature 121 (e.g., a recess, a notch, a groove, a lug) to facilitate the coupling or cooperation of the second handle 216 of the introducer stylet 114 with the introducer handle 116 of the introducer cannula 112. The coupling feature 121 can be adapted to prevent rotation of the introducer stylet 114 and / or to ensure that the distal tip 125 of the introducer stylet 114 extends beyond the open distal tip 122 of the tube 118 of the introducer cannula 112 to enable the distal tip 125 of the introducer stylet 114 to penetrate the bone. The upper surface of the introducer handle 116 of the introducer cannula 112 can also include a curved lateral slot 117 and a curved ramp 141 to facilitate insertion of the curved cannula assembly 210 into the introducer handle 116 and then into and along the central lumen of the tube 118.

[0092] exist Figure 3A In the embodiment of the present invention, the central lumen of tube 118 extends from the introducer handle 116 to the open distal end 122 of tube 118. Tube 118 can be flared or tapered so that the diameter of tube 118 is not constant along its entire length. For example, the diameter can suddenly decrease at a distance (e.g., 1-3 cm) from the lower edge of the lower portion 113 (e.g., a protrusion or flange) of the introducer handle 116, and then continue to have a constant diameter on the far side of the sudden flare 119. In another embodiment, the diameter can gradually decrease (e.g., uniformly taper) from the starting point of the flare 119 to the open distal end 122 of tube 118 along the length of tube 118. The central lumen of tube 118 can be coated with a medical grade silicone lubricant to improve the insertion and removal of tools therein. The outer diameter of the tube 118 can be in the range of 3 mm to 5 mm (e.g., from 3.0 mm to 4.0 mm, from 4.0 mm to 4.4 mm, from 4.2 mm to 4.5 mm, from 4.4 mm to 5.0 mm, overlapping ranges thereof, or any value within the range). The introducer handle 116 can include one or more markings 130 that provide a reference for the bending direction of the distal end portion of the bending sleeve assembly 120 as it is inserted into the tube 118 and withdrawn from the open distal end 122 of the tube 118.

[0093] like Figure 3B As shown, the introducer handle 116 may also include one or more first detents or mating elements 128 that may engage and interact with corresponding second detents or mating features 228 of the curved sleeve 212. The one or more first detents or mating features 128 may include detents, teeth, nubs, or protrusions extending radially inwardly from an inner radial surface of a recess in the introducer handle 116 of the introducer sleeve 112, the outer diameter of a portion of the curved sleeve 212 being configured to press against or abut the inner radial surface when the introducer sleeve 112 is inserted into the upper central opening 120 and central lumen of the tube 118 of the introducer sleeve 112.

[0094] Figure 3A yes Figure 1 A side view of the curved sleeve 212 of the kit or system 100 is shown. Figure 3B is a close-up side view of the proximal end portion of the curved sleeve 212.

[0095] The curved cannula 212 includes a second handle (e.g., an instrument handle) 216, a threaded proximal extension 220, a wheel (e.g., a gear) 221, and a substantially smooth distal portion including a rigid support portion 223 and a distal shaft portion 224 that is more flexible (e.g., made of a polymer material) than the rigid support portion 223. The second handle 216 may include a curved slot and a curved ramp configured to facilitate insertion of the curved stylet 214 into the central lumen of the curved cannula 212 and extending along the central lumen from the second handle 216 to an open distal end 222 of the distal shaft portion 224. The central lumen of the curved cannula 212 may be coated with a medical grade silicone lubricant to improve insertion and removal of tools.

[0096] In the illustrated example, gear 221 includes a hole coaxial with the central axis of gear 221. The hole has internal threads formed therein that are configured to interconnect with corresponding external threads of threaded proximal extension 220, such that rotation of gear 221 causes controlled proximal and distal translation of gear 221 along threaded proximal extension 220. Threaded proximal extension 220 is sized such that when gear 221 is in its most distal position (e.g., Figure 3A 1 ), when the curved sleeve assembly 210 is fully inserted therein, the distal end 222 of the curved sleeve 212 does not extend beyond the open distal end 122 of the introducer sleeve 112. The gear 221 can rotate (e.g., freely rotate) around the threaded proximal extension 220. The threads can include three threads, and the gear 221 can be configured to pass through the entire length of the threaded proximal extension 220 through four complete rotations of the gear 221. Other thread counts and rotation times are also possible.

[0097] The rigid support portion 223 may include a biocompatible metal or other rigid material, such as stainless steel, titanium, platinum, and / or the like, to provide additional support to the curved cannula 212 during insertion of the curved stylet 214 and when striking the second handle 216. The distal shaft portion 224 may be composed of a thermoplastic shape memory polymer material (such as polyetheretherketone (PEEK), polyurethane, polyamide (PA), polycarbonate (PC), polyethylene terephthalate (PET), and / or the like), and the distal end portion 225 is pre-bent (e.g., shape-set) to have a predetermined curvature in a "resting" unconstrained configuration.

[0098] See also Figure 3B, the gear 221 includes a lower flange 229 (e.g., an annular flange) extending downwardly from the lower surface of the gear 221. The lower flange 229 may include a hole having an inner circumferential or annular surface formed in the center. The inner circumferential surface of the central hole of the lower flange 229 may include threads that engage with threads on the proximal extension 220. The lower flange 229 includes a second brake or mating element 228 corresponding to one or more first brakes or mating elements 128 of the introducer sleeve 112. The second brake or mating element 228 may include a brake feature or element suitable for (e.g., sized and shaped to) mechanically interacting or engaging with one or more corresponding mating features of the introducer sleeve 112 or the first brake feature 128 (e.g., a brake), such as a groove, recess, notch, or a shaped pattern.

[0099] Figure 3C and Figure 3D Shows the use of Figure 1 The illustrated kit or system 100 illustrates the operation of the gear 221 of the curved sleeve 212 at different stages of the bone access method to facilitate the arrestment or advancement of the curved sleeve assembly 210 within the introducer sleeve 112. Figure 3C As shown, the gear 221 is rotated until it is in its most distal position along the threaded proximal extension 220. The position of the gear 221 can be configured before the curved sleeve assembly 210 is inserted into the introducer sleeve 112 to prevent the curved distal end portions 225, 227 of the curved sleeve assembly 210 from being accidentally pushed out of the sleeve 112. Figure 3D As shown, the gear 221 is rotated along the threaded proximal extension portion 220 to its most proximal position to enable the curved sleeve assembly 210 to be fully inserted into the introducer sleeve 112 so that the curved distal end portions 225, 227 of the curved sleeve assembly 210 extend out of the introducer sleeve 112 and extend along a curved path within the cancellous bone region of the vertebral body or other bone.

[0100] Figure 3EA side view of the curved sleeve 212 inserted into the introducer sleeve 112 is shown, wherein the introducer handle 116 of the introducer sleeve 112 is transparent to facilitate viewing of the interior. When the lower flange 229 of the gear 221 of the curved sleeve 212 is advanced distally within the opening 120 of the introducer sleeve 112 by rotating the gear 221 to move the gear 221 proximally, the second brake element 228 of the lower flange 229 of the gear 221 may eventually engage or interact with the corresponding one or more first brakes 128 of the introducer sleeve 112. Once the curved sleeve 212 is fully inserted into the introducer sleeve 112 and the open distal end 222 of the curved sleeve 212 contacts the cancellous tissue in the bone, the gear 221 may be disposed a distance above the upper surface of the introducer handle 116 of the introducer sleeve 112. When the gear 221 on the curved sleeve 212 is turned downward, the gear 221 rotates freely until it contacts the upper face of the introducer sleeve 112. Once in range, the second brake element 228 (e.g., notch) on the gear 221 engages with one or more first brake features 128 (e.g., teeth) on the top side of the introducer sleeve 112. When this engagement occurs, a tactile click can be felt. This tactile click can advantageously allow an operator (e.g., a surgeon or other clinician) to recognize that the gear 221 is now engaged with the introducer handle 116 of the introducer sleeve 112. Once the first click is felt, further rotation of the gear 221 can cause the curved sleeve 212 to retract relative to the open distal end 122 of the introducer sleeve 112. When this retraction occurs, tactile clicks at regular intervals can continue to be felt. If the operator decides to turn or rotate gear 221 upward (e.g., proximally) to further advance curved sleeve 212 distally within introducer sleeve 112, once gear 221 (e.g., second brake 228 of lower flange 229 of gear 221) passes the engagement range with first brake 128, gear 221 is able to turn or rotate freely again.

[0101] According to various embodiments, the brake features 128, 228 can advantageously allow tool changes without loss of axial or longitudinal position. For example, at various points throughout a bone access and / or treatment procedure, the introduction and removal of parts (e.g., access instruments, including the curved sleeve 212 and the curved stylet 214) from the curved sleeve 212 may result in unintentional axial movement of the curved sleeve 212 (e.g., further driving the curved sleeve 212 into or retracting it from the patient's body). The brake features 128, 228 can help prevent such unintentional or accidental movement and can help maintain part position during tool changes.

[0102] As previously described, the brake features 128, 228 can provide tactile (and potentially audible) feedback to the operator to identify when the gear 221 is in contact with the upper face of the introducer sleeve 112. In addition, when engaged, the first brake feature 128 can add significant friction to the assembly to prevent accidental movement when replacing parts but not during normal rotation of the gear 221. This friction can be created in a variety of ways, including using different shapes (sinusoidal shapes, circular shapes, sawtooth shapes, square shapes, etc.), such as Figure 5A-5D The brake features 128, 228 can also function as anti-rotation / backdrive features that prevent accidental loosening of the gear 221 when undesired (e.g., during adjustment and / or when axial pressure is applied to the curved sleeve 212 when inserting a mating tool such as a treatment probe or a straight stylet). In some embodiments, the brake features 128, 228 can also provide the operator with more discrete control of the access tool during insertion or retraction.

[0103] For example, the operator can precisely control the rotation of the gear 221 because the gear can be moved in a click-like manner if desired. Without the brake elements 128, 228, the operator would have to visually track the translation of the bending sleeve 212 relative to the introducer sleeve 112 by tracking the number of threads exposed or by tracking the rotation of the gear 221 (e.g., one rotation or 360 degrees of the gear 221 can correspond to 6 mm of axial translation (advance or retraction)). The brake elements 128, 228 can advantageously allow tactile feedback to occur at a fixed rotation (e.g., a tactile shock every 90 degrees can correspond to a known axial translation (e.g., retraction or advancement) distance). Tactile and / or audible feedback can make communication with the operator easier or increase the operator's confidence that the procedure is being performed correctly based on the instructions. For example, instead of instructions requiring the operator to visually observe one or more tool components (such as "turn the gear down one and a half turns"), the instructions can be based on tactile and / or auditory feedback that does not require the operator to visually observe the tool components (e.g., "turn the gear 6 clicks").

[0104] Figure 4A and Figure 4B A close-up view of the gear 221 and the upper surface of the introducer cannula 112 is shown. Figure 4A A close-up side view of an example of a gear 221 of a curved sleeve 212 is shown, the gear including a lower flange 229 and a second brake element 228. Figure 4AIn the embodiment of the present invention, the second brake member 228 is a groove or notch formed around the lateral circumferential surface of the lower flange 229. The number of second brake elements 228 can vary. The second brake elements 228 can be evenly spaced to form a circle of equally spaced brake elements. The number of brake elements 228 and the spacing of the second brake elements 228 can be adapted to correspond to a certain axial translation distance of the gear 221 along the threaded extension 220 of the curved sleeve 212, or to correspond to a certain degree of rotation of the gear 221. For example, it can be indicated to the operator that each click of the rotation of the gear 221 is equivalent to a certain angle and a certain translation distance of the gear 221 along the threaded extension 220. In other examples, the brake elements can be unequally spaced.

[0105] Figure 4B A perspective top view of a portion of the introducer handle 116 of the introducer sleeve 112 is shown, showing an example of a first brake element 128 of the introducer sleeve 112. The opening 120 of the introducer sleeve 112 may include an abutment member 440 extending inwardly from the inner diameter of the opening 120 to provide an upper surface with which the lower surface of the lower flange 229 of the gear 221 may contact. The abutment member 440 may be one of the coupling features 121 of the introducer sleeve 112. The abutment member 440 may include a boss extending continuously around at least a portion of the circumference of the opening 120 of the introducer sleeve 112. The abutment member 440 may extend around the entire circumference of the opening 120, except for a portion defined by a lateral slot adapted to facilitate insertion of a curved distal end portion of the curved sleeve assembly 210. The abutment member 440 may alternatively be discontinuous and may include discrete, separate members positioned around the circumference. The abutment member 440 can provide friction when the gear 221 rotates. Figure 4B As shown, the first brake element 128 may extend upwardly from the abutment member 440. The first brake element 128 may be a tooth or protrusion located at or near a lateral circumferential surface of the opening 120 that is configured to bite into or cooperate with one of the grooves of the second brake element 228.

[0106] The opening 120 may also include an internal ramp 442 configured to provide a mechanical advantage when the first handle 126 is rotated (e.g., 120 degrees counterclockwise) to assist in removing the introducer stylet 114 from the introducer sleeve 112 (e.g., reduce the removal force) (particularly when bone fragments have been loaded into the gap between the introducer stylet 114 and the introducer sleeve 112, making removal more difficult). The introducer sleeve 112 may include a single first brake element 128 (e.g., a tooth), or may include multiple first brake elements 128. The number and location of the brake elements 128 may vary. As an example, there may be two first brake elements 128 positioned 180 degrees or substantially 180 degrees apart. A first brake element 128 (e.g., a tooth, a notch, a groove, a protrusion) may additionally or alternatively appear on a proximal (or upward-facing) adjacent surface 441 formed by the adjacent member 440 and interact with a bottom surface of the lower flange 229 of the gear 221 (e.g., a corresponding second brake element 228 on the bottom surface). Figure 4D A side cross-sectional view of a proximal portion of an embodiment of a curved sleeve 212 including a gear 221 is shown. Figure 2B and Figure 4D In some embodiments, the proximal or upward-facing surface of the opening 120 of the tube 118 of the introducer sleeve 112 can have a first brake element 128 (not shown) that is formed to interact with an inner surface 444 of the gear 221 (e.g., a corresponding second brake element 228 on an inner surface of the lower flange 229 of the gear 221).

[0107] Figure 4C A side view of a curved sleeve 212 is shown, which includes Figure 4A The insertion shown in Figure 4B The gear 221 within the introducer handle 116 of the introducer sleeve 112 is shown, wherein the introducer sleeve 112 is transparent. When the gear 221 is rotated to translate the gear 221 distally, the one or more first brake elements 128 of the introducer sleeve 112 will eventually engage with the second brake element 228 of the lower flange 229 of the gear 221. Figure 4C The first brake element 128 of the introducer sleeve 112 is shown engaged with the second brake element 228 of the lower flange 229 of the gear 221 .

[0108] Figure 4A-4DThe shape and arrangement of the first brake element 128 on the introducer handle 116 of the introducer sleeve 112 and the shape and arrangement of the second brake element 228 on the lower flange 229 of the curved sleeve 114 shown in the figure can be reversed to achieve the same braking function. For example, the first brake element 128 can be a circle of equally spaced grooves formed on the abutment surface 441 of the abutment portion 440 or formed on the lateral circumferential surface of the opening 128. The second brake element 228 can be one tooth or two or more teeth formed on the distal surface of the lower flange 229 or formed on the lateral circumferential surface to bite into or cooperate with the corresponding groove of the first brake element 128.

[0109] Figure 5A , Figure 5B , Figure 5C and Figure 5D Other examples of brake elements 228 of gears 221 of bending sleeves 212 are shown. Figure 5A A second brake element 228 is shown having a triangular shape; Figure 5B A second brake element 228 is shown having a sawtooth shape; Figure 5C A second brake element 228 is shown having a sinusoidal shape; Figure 5D A second brake element 228 is shown having a semicircular shape. Other different shapes may be used as needed and / or desired. Different shapes may provide different amounts of friction and different levels of tactile or audible feedback. According to various embodiments, Figure 5A-5D Each second stopper element 228 in the embodiment is annular in shape, with the stopper elements equally spaced around the circumference of the lower flange 229 of the curved sleeve 114. In some embodiments, the annular shaped stopper elements can be disposed in the opening 120 of the introducer handle 116 of the introducer sleeve 112.

[0110] According to various embodiments, the brake or mating element 128, 228 may include structures other than formed features in the mating plastic component (e.g., brakes or brake elements or features). Other mating structures may still provide one or more benefits of the brake elements or features described above. Other mating structures may not include physical engagement or mating.

[0111] refer to Figure 6 , other mating structures can include magnets 650 of the same or opposite polarity, suitable for producing tactile feedback (a change in feel or resistance) within range (e.g., close enough to produce magnetic interaction). The mating structure can also increase the required additional force to avoid unintended movement (e.g., advancement or retraction) of the bending sleeve 212 relative to the introducer sleeve 112. The number of magnets 650 can vary as needed and / or desired.

[0112] In various embodiments, other mating structures may be used in conjunction with one or more leaf, wave or coil springs and / or molded plastic to cause the ball or lever arm to produce a tactile effect and / or audible click or sound that can be felt by the operator. Figure 7 A spring brake mechanism 760 is schematically shown, which is adapted to engage a ball on a lever arm with a corresponding mating feature (e.g., a second brake 228, not shown) on the lower flange 229 of the gear 221 of the curved sleeve 212. Alternatively, a leaf spring, wave spring, or compression spring may be used to apply force to the brake around the diameter of the gear 221. Alternatively, an axial or radial friction clutch mechanism may be implemented. Active mechanisms (such as button locks, bayonet locks, pull pins, etc.) may also be employed to prevent movement between various tools during insertion and retraction, and to provide a tactile change when the components of the curved sleeve 212 and the introducer sleeve 112 interact.

[0113] In some embodiments, a bonding material may be incorporated to change the tactile feedback when the gear 221 contacts the introducer sleeve 112. This may manifest as a change in the input force required by the operator (e.g., until the gear 221 contacts, the torque required for advancement is minimal, however, once in range, additional or increased torque may be required for advancement). Examples of such bonding mechanisms may include the use of elastic materials, hook and loop fasteners, and / or interference fits between parts or components. Figure 8 An embodiment is shown incorporating a resilient ring 870 located on or within the inner diameter of the lower contact surface of the lower flange 229 of the gear 221 to provide interference with features of the introducer sleeve 112 . Fig. 9 Schematically illustrates a top cross-sectional view of the introducer sleeve 112, wherein the gear 221 of the curved sleeve 212 engages with the introducer sleeve 112. The interference mechanism (e.g., one or more first mating features 980) may include one or more interference features to provide a friction or interference fit between the components. The one or more interference features may be made of the same material as the gear 221 or an elastomer or other material.

[0114] Figure 10A-10E An embodiment of steps of a method of using an access tool to facilitate percutaneous access (e.g., minimally invasively through a percutaneous incision) to a location within a vertebral body 500 for treatment (e.g., modulation of an intraosseous nerve, such as a basal vertebral nerve, bone cement delivery for treatment of a vertebral fracture, and / or bone tumor ablation) is shown. Fig. 10AAfter the introducer stylet 114 is inserted and aligned and engaged in the introducer sleeve 112, the distal portion of the introducer assembly 110 (including the distal end 125 of the introducer stylet 114 and the distal end 122 of the introducer sleeve 112) is inserted (via a percutaneous incision in the skin) through the pedicle 502 of the adjacent vertebral body 500 by knocking the first handle 126 of the introducer stylet 114.

[0115] refer to Fig. 10B , the introducer assembly 110 may then be tapped to advance the distal tip 122 of the introducer cannula 112 to an entry site in (or within) the cancellous bone region 504 of the vertebral body 500. The introducer stylet 114 may then be removed from the introducer cannula 112.

[0116] The curved sleeve assembly 210 can then be inserted into the introducer sleeve 112 with the gear 221 in the distal-most position to prevent the curved sleeve assembly 210 from being accidentally pushed out of the open distal end 122 of the introducer sleeve 112 prematurely. Fig. 10C , after rotating the gear 221 to transitionally or translationally move the gear 221 to a more proximal position, the curved sleeve assembly 210 can be tapped to push the collectively curved distal end portions 225, 227 of the curved sleeve assembly 210 together out of the distal tip 122 of the introducer sleeve 112 and along a curved path within the cancellous bone region 504. As described above, as the curved sleeve assembly 210 is advanced within the introducer sleeve 112, the brake elements 128, 228 or other mating structures will eventually engage one another. Subsequently, the brake elements 128, 228 can facilitate controlled movement and provide tactile and / or audible feedback. Reference Fig. 10D , the curved stylet 214 can then be removed from the curved cannula 212, while the curved cannula 212 remains in place. According to various embodiments, the path formed by the existing instrument can advantageously allow the curved cannula assembly 210 to have a leading edge and begin to bend immediately upon exiting the open distal end 122 of the introducer cannula 112.

[0117] If another straight path other than the curved path is needed to reach the target treatment location, a straight stylet can be inserted through the curved cannula 212 so that the distal channel end of the straight stylet extends beyond the open distal end of the curved cannula 212 and extends along a straight path toward the target treatment location (e.g., an intervertebral nerve trunk or an intervertebral foramen). In some embodiments, a straight stylet may not be needed and this step can be skipped.

[0118] refer to Fig.10E, a treatment device 501 (e.g., a flexible bipolar RF probe) can be inserted through the curved cannula 212 (after removing the straight stylet (if used) or the curved stylet 214) and pushed out of the open distal end of the curved cannula 212 to the target treatment location. The treatment device 501 can then perform the desired treatment. For example, if the treatment device 501 is a RF probe, the treatment device 501 can be activated to modulate (e.g., ablate, denervate, stimulate) an intraosseous nerve (e.g., a spinal nerve or other intraosseous nerve within a vertebral body or a nerve innervating a vertebral endplate) or a tumor within the vertebral body 500. After the treatment device 501 is removed from the curved cannula 212, bone cement, or other agents, or a diagnostic device (such as a nerve stimulation device or an imaging device to confirm ablation of the nerve) can optionally be delivered through the curved cannula 212. As described above, the detents or other mating features 128, 228 can prevent unintentional movement of the curved cannula 212 relative to the introducer cannula 112 during insertion and removal of the curved cannula 214, straight cannula, or treatment device 501 therein.

[0119] The treatment device (e.g., a treatment probe) can be any device capable of modulating tissue (e.g., nerves, tumors, bone tissue). Any energy delivery device capable of delivering energy can be used (e.g., RF energy delivery devices, microwave energy delivery devices, laser devices, infrared energy devices, other electromagnetic energy delivery devices, ultrasonic energy delivery devices, etc.). The treatment device 501 can be a radiofrequency energy delivery device. The RF energy delivery device can include a bipolar electrode pair located at the distal end portion of the device. The bipolar electrode pair can include an active terminal electrode and a loop electrode spaced apart from the active terminal electrode. The RF energy delivery device can include one or more temperature sensors (e.g., thermocouples, thermistors) located on an external surface of the shaft of the energy delivery device or embedded in the shaft. According to various embodiments, the RF energy delivery device can be free of internal circulation cooling.

[0120] In some embodiments, a water jet cutting device can be used to modulate (e.g., denervate) nerves. For example, a water jet cutter can be configured to produce a very fine cutting stream formed by a very high pressure water jet. For example, the pressure can be in the range of 15MPa to 500MPa (e.g., 15MPa to 50MPa, 30MPa–60MPa, 50MPa–100MPa, 60MPa–120MPa, 100MPa–200MPa, 150MPa–300MPa, 300MPa–500MPa, overlapping ranges thereof, or any value within the range). In some embodiments, a chemical neuromodulation tool injected into a vertebral body or at an endplate can be used to ablate or otherwise modulate nerves or other tissues. For example, a chemical neuromodulation tool can be configured to selectively adhere to a nerve or endplate. In some embodiments, a local anesthetic (e.g., a liposomal local anesthetic) can be used inside or outside a vertebral body or other bone to denervate or block a nerve. In some embodiments, brachytherapy can be used to place radioactive materials or implants within the vertebral body to deliver radiation therapy sufficient to ablate or otherwise denervate the vertebral body. In some embodiments, chymopapain injection and / or dextranase injection (e.g., under local anesthesia) can be used. Phototherapy can be used to ablate or modulate nerves after a chemical or targeted agent has bonded to a specific nerve or vertebral endplate.

[0121] According to a plurality of embodiments, thermal energy can be applied in the cancellous bone portion of the vertebral body (e.g., by one or more radio frequency (RF) energy delivery devices coupled to one or more RF generators). Thermal energy can be conducted to the surrounding cancellous bone by heat transfer, thereby heating the cancellous bone portion. According to a plurality of embodiments, thermal energy is applied within a specific frequency range, and has sufficient temperature and sufficient duration to heat the cancellous bone, thereby regulating the basal vertebral nerves extending through the cancellous bone of the vertebral body. In a plurality of embodiments, regulation includes permanent ablation or denervation or cell perforation (e.g., electroporation). In some embodiments, regulation includes temporary denervation or inhibition. In some embodiments, regulation includes stimulation or denervation that does not cause tissue necrosis.

[0122] For thermal energy, the temperature range of the thermal energy can be about 70 degrees Celsius to about 115 degrees Celsius (e.g., about 70 degrees Celsius to about 90 degrees Celsius, about 75 degrees Celsius to about 90 degrees Celsius, about 83 degrees Celsius to about 87 degrees Celsius, about 80 degrees Celsius to about 100 degrees Celsius, about 85 degrees Celsius to about 95 degrees Celsius, about 90 degrees Celsius to about 110 degrees Celsius, about 95 degrees Celsius to about 115 degrees Celsius, or overlapping ranges thereof). The temperature ramp range can be 0.1-5 degrees Celsius / second (e.g., 0.1-1.0 degrees Celsius / second, 0.25-2.5 degrees Celsius / second, 0.5-2.0 degrees Celsius / second, 1.0-3.0 degrees Celsius / second, 1.5-4.0 degrees Celsius / second, 2.0-5.0 degrees Celsius / second). Treatment times can be in the range of about 10 seconds to about 1 hour (e.g., 10 seconds to 1 minute, 1 minute to 5 minutes, 5 minutes to 10 minutes, 5 minutes to 20 minutes, 8 minutes to 15 minutes, 10 minutes to 20 minutes, 15 minutes to 30 minutes, 20 minutes to 40 minutes, 30 minutes to 1 hour, 45 minutes to 1 hour, or overlapping ranges thereof). Pulsed energy can be delivered as an alternative to continuous energy or in sequence. For radiofrequency energy, the energy applied can be in the range of 350kHz to 650kHz (e.g., from 400kHz to 600kHz, from 350kHz to 500kHz, from 450kHz to 550kHz, 500kHz to 650kHz, overlapping ranges thereof, or any value within the range, such as 450kHz±5kHz, 475kHz±5kHz, 487kHz±5kHz). The power of the radiofrequency energy may range from 5W to 30W (e.g., from 5W to 15W, from 5W to 20W, from 8W to 12W, from 10W to 25W, from 15W to 25W, from 20W to 30W, from 8W to 24W, and their overlapping ranges or any values ​​within the ranges). According to various embodiments, the thermal therapy dose (e.g., using a cumulative equivalent minute (CEM) 43 degrees Celsius thermal dose calculation metric model) is between 200CEM and 300CEM (e.g., between 200CEM and 240CEM, between 230CEM and 260CEM, between 240CEM and 280CEM, between 235CEM and 245CEM, between 260CEM and 300CEM) or greater than a predetermined threshold (e.g., greater than 240CEM). The CEM number may represent an average thermal cumulative dose value at a target treatment area or location, and may represent a number representing an expected dose for a specific biological endpoint. Thermal injury may occur through necrosis or apoptosis.

[0123] Cooling can be provided selectively to prevent surrounding tissue from being heated during a neuromodulation procedure. A cooling fluid can be circulated internally from and to a fluid reservoir through a delivery device in a closed loop (e.g., using an inflow lumen and an outflow lumen). The cooling fluid can include pure water or a saline solution having a temperature sufficient to cool the electrode (e.g., 2-10 degrees Celsius, 5-10 degrees Celsius, 5-15 degrees Celsius). Cooling can be provided by the same instrument used to deliver thermal energy (e.g., heat) or a separate instrument. According to multiple embodiments, cooling is not used.

[0124] In some embodiments, ablative cooling (e.g., for cryoneurolysis or cryoablation) may be performed on nerves or bone tissue rather than heating. The temperature and duration of cooling may be sufficient to modulate nerves within the bone (e.g., ablation or local freezing due to excessive cooling). Cooler temperatures may disrupt the myelin coating or sheath around the nerves. Cooler temperatures may also advantageously reduce pain perception. Cooling may be delivered using a hollow needle under fluoroscopy or other imaging modalities.

[0125] In some embodiments, one or more fluids or agents can be delivered to the target treatment site to regulate nerves. For example, the agent can include bone morphogenetic protein. In some embodiments, the fluid or agent can include chemicals (e.g., chemical ablators, alcohol, phenols, nerve inhibitors or nerve stimulants) for regulating nerves. The fluid or agent can be delivered using a hollow needle or injection device under fluoroscopy or other imaging methods.

[0126] One or more treatment devices (e.g., probes) may be used simultaneously or sequentially. For example, the distal end portions of two treatment devices may be inserted into different locations within a vertebral body or other bone, or into different vertebral bodies or bones. The radiofrequency treatment probe may include multiple electrodes configured to function as a monopolar or monopolar electrode or bipolar electrode pair. The treatment device may also be pre-bent or bendable so that a bent stylet is not required, or may have a sharp distal tip so that an additional sharp stylet is not required. In some embodiments, any or all of the access tools and treatment devices are MR compatible for visualization under MR imaging.

[0127] According to various embodiments, a method of facilitating ablation of one or more nerves within a vertebral body includes applying radiofrequency energy to a location within the vertebral body according to the following treatment parameters: a frequency between 400 kHz and 600 kHz (e.g., between 400 kHz and 500 kHz, between 450 kHz and 500 kHz, between 470 kHz and 490 kHz, between 500 kHz and 600 kHz, overlapping ranges thereof, or any value within the ranges); a target temperature between 60 degrees Celsius and 90 degrees Celsius (e.g., between 60 degrees Celsius and 80 degrees Celsius, between 65 degrees Celsius and 75 degrees Celsius, between 70 degrees Celsius and 80 degrees Celsius, between 80 degrees Celsius and 90 degrees Celsius, overlapping ranges thereof, or any value within the ranges); , any value within a range); a temperature ramp between 0.5 degrees Celsius and 3 degrees Celsius per second (e.g., between 0.5 and 1.5 degrees Celsius per second, between 1.0 and 2.0 degrees Celsius per second, between 1.5 and 3 degrees Celsius per second, overlapping ranges thereof, or any value within the range, such as 0.5 degrees Celsius per second, 1 degree Celsius per second, 1.5 degrees Celsius per second, 2 degrees Celsius per second, 2.5 degrees Celsius per second, 3 degrees Celsius per second); and an effective energy delivery time between 1 minute and 20 minutes (e.g., between 1 minute and 5 minutes, between 5 minutes and 15 minutes, between 10 minutes and 20 minutes, between 10 minutes and 15 minutes, overlapping ranges thereof, or any value within the range).

[0128] In some embodiments, the gear may be replaced by another translation mechanism, such as a sliding mechanism, a ratchet mechanism, a push-pull mechanism, or the like.

[0129] in conclusion

[0130] 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 probe, 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. Multiple features or components are provided in alternative embodiments.

[0131] 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 temperature monitoring (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), a device for actuation (e.g., a threaded knob or screw actuation mechanism, a sliding actuator, a pull-wire actuator, a lever, a hydraulic actuator, a pneumatic actuator, an electric actuator, a button actuator, a mechanical linear actuator, etc.).

[0132] Although certain embodiments and examples have been described herein, various aspects of the methods and devices shown and described in this disclosure may be combined and / or modified in different ways to form more embodiments. In addition, the methods described herein may be implemented using any device suitable for performing the steps. In addition, the disclosure (including drawings) of any specific features, aspects, methods, properties, characteristics, qualities, attributes, elements, 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 only to improve 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.

[0133] Although the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the accompanying drawings and are described in detail herein. However, it should be understood that the embodiments are not limited to the specific forms or methods disclosed, but on the contrary, the embodiments will cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the various embodiments described and the appended claims. Any method disclosed herein does not need to be performed in the order described. The methods disclosed herein include certain actions taken by the practitioner; however, these methods may also include any third party's express or implied indication of these actions. For example, an action such as "applying thermal energy" includes "indicating the application of thermal energy."

[0134] The terms "top", "bottom", "first", "second", "upper", "lower", "height", "width", "length", "end", "side", "horizontal", "vertical" and similar terms may be used herein; it should be understood that these terms refer only to the structures shown in the figures and are only used to help describe the embodiments of the present disclosure. The terms "proximal" and "distal" are relative directional terms. For example, the distal end of a device or component is the end of the component farthest from the operator during normal use. The distal end or end does not necessarily mean the farthest end. The proximal end refers to the opposite end, or the end closest to the operator during normal use. Various embodiments of the present disclosure have been presented in a range format. It should be understood that the description in the range format is merely for convenience and brevity and should not be construed as an immutable limitation on the scope of the invention. The ranges disclosed herein include any and all overlaps, sub-ranges and combinations thereof, as well as individual numerical values ​​within the range. For example, for example, descriptions of a range from 70 to 115 degrees should be considered to have specifically disclosed sub-ranges, such as from 70 to 80 degrees, from 70 to 100 degrees, from 70 to 110 degrees, from 80 to 100 degrees, etc., and individual 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 the term "approximately" or "approximately" include the numbers listed. For example, "about 2:1" includes "2:1." For example, the terms "about," "approximately," and "substantially" used herein represent an amount close to the amount that still performs the desired function or achieves the desired result.

Claims

1. A bone access system adapted to facilitate percutaneous access to a target treatment site within a bone, the system comprising: an introducer cannula comprising a proximal handle and a distal elongated tube extending from the proximal handle; wherein the proximal handle of the introducer sleeve includes a central opening in an upper surface thereof, wherein the central opening of the proximal handle of the introducer sleeve includes one or more detents protruding radially inwardly from an inner surface of the central opening, and wherein the distal elongated tube of the introducer sheath comprises a lumen accessible through a central opening of the proximal handle of the introducer sheath; and an access instrument sized and configured to be inserted through the central opening and along the lumen of the introducer sheath until a distal end portion of the access instrument extends beyond the open distal tip of the introducer sheath, wherein the access instrument comprises an elongated shaft having a threaded proximal portion and a substantially smooth distal portion, and wherein the gear is mechanically coupled to the threaded proximal portion and adapted to translate proximally and distally along the threaded proximal portion via rotation of the gear, wherein the gear comprises an annular flange, and wherein the annular flange includes a plurality of brake elements spaced circumferentially around a lower surface of the annular flange, the brake elements being adapted to mechanically engage with one or more brakes within a central opening of a proximal handle of the introducer sleeve to provide tactile and / or audible feedback to an operator when the plurality of brake elements of the access instrument engage with the one or more brakes of the introducer sleeve, thereby providing controlled advancement of the access instrument relative to the introducer sleeve.

2. The bone access system according to claim 1, wherein: The plurality of detent elements of the annular flange include notches or recesses.

3. The bone access system according to claim 1, wherein: The one or more detents include protrusions formed along an inner surface of the central opening.

4. The bone access system according to any one of claims 1 to 3, wherein: The plurality of brake elements include a semicircular shape, a sawtooth shape, a triangle shape, a square shape, or a sinusoidal shape.

5. The bone access system according to any one of claims 1 to 3, wherein: The one or more brakes and the plurality of brake elements produce an audible click when engaged and / or disengaged.

6. The bone access system according to any one of claims 1 to 3, wherein: Engagement between the one or more brakes and the corresponding one of the plurality of brake elements increases an amount of torque required to disengage the one or more brakes from the corresponding one of the plurality of brake elements.

7. The bone access system according to any one of claims 1 to 3, wherein: The access instrument includes a cannula having a pre-curved distal end portion.

8. The bone access system according to any one of claims 1 to 3, wherein: The access instrument includes a proximal handle adapted to be struck or pressed by an operator to facilitate distal advancement of the access instrument.

9. The bone access system according to any one of claims 1 to 3, wherein: The one or more brakes consist of a single brake.

10. The bone access system according to any one of claims 1 to 3, wherein: The plurality of brake elements are evenly spaced around a circumference of the annular flange of the gear of the access instrument.

11. The bone access system according to any one of claims 1 to 3, wherein: The introducer cannula and the access instrument are sized to facilitate access to an intraosseous location within a vertebral body through a percutaneous incision.

12. The bone access system according to any one of claims 1 to 3, wherein: The central opening of the introducer sheath includes an abutment member extending radially inwardly from an inner surface of the central opening, the abutment member being adapted to abut a lower surface of an annular flange of a gear of the access instrument as the access instrument is advanced within the introducer sheath.

13. The bone access system according to any one of claims 1 to 3, wherein: The proximal handle of the introducer cannula includes a curved insertion slot.

14. A bone access system adapted to facilitate percutaneous access to a target treatment site within a bone, the system comprising: an introducer cannula comprising a proximal handle and a distal elongated tube extending from the proximal handle; wherein the proximal handle of the introducer sleeve includes a central opening in an upper surface thereof, and wherein the distal elongated tube of the introducer sheath comprises a lumen accessible through a central opening of the proximal handle of the introducer sheath; and an access instrument sized and configured to be inserted through the central opening and along the lumen of the introducer sheath until a distal end portion of the access instrument extends beyond the open distal tip of the introducer sheath, Wherein, the introducer cannula and the access instrument include a tactile feedback mechanism adapted to provide tactile feedback indicative of interaction between the access instrument and the introducer cannula.

15. The bone access system of claim 14, wherein: The tactile feedback mechanism includes corresponding detent features of the introducer cannula and the access instrument, the detent features being designed to interact with each other when the corresponding detent features are aligned.

16. The bone access system of claim 14, wherein: The tactile feedback mechanism includes corresponding magnets of the introducer cannula and the access instrument, the corresponding magnets being designed to interact with each other when the corresponding corresponding magnets are aligned.

17. The bone access system of claim 14, wherein: The tactile feedback mechanism includes a hook and loop fastener.

18. The bone access system of claim 14, wherein: The tactile feedback mechanism includes a wave washer adapted to provide an interference fit between the access instrument and the introducer cannula.

19. The bone access system of claim 14, wherein: The tactile feedback mechanism includes a spring detent within the central opening of the introducer cannula, the spring detent being configured to interact with a corresponding detent feature of the access instrument.

20. The bone access system according to any one of claims 14 to 19, wherein: The tactile feedback mechanism produces an audible click.

21. The bone access system according to any one of claims 14 to 19, wherein: The tactile feedback mechanism causes a change in the amount of torque required to continue advancing the access instrument distally within the introducer sheath.

22. The bone access system according to any one of claims 14 to 19, wherein: The access instrument includes a cannula having a pre-curved distal end portion.

23. The bone access system according to any one of claims 14 to 19, wherein: The access instrument includes a proximal handle adapted to be struck or pressed by an operator to facilitate distal advancement of the access instrument.

24. The bone access system according to any one of claims 14 to 19, wherein: The introducer cannula and the access instrument are sized to facilitate access to an intraosseous location within a vertebral body through a percutaneous incision.

25. A bone access system comprising: an introducer cannula including an introducer handle at a proximal end, a distal elongated tube attached to and extending from the introducer handle along a longitudinal axis, the introducer handle including an abutment surface disposed about an upper surface, the abutment surface having a first detent feature formed thereon, wherein a lumen extends along the longitudinal axis from the introducer handle through the introducer cannula to an open distal end of the distal elongated tube; an access instrument comprising an instrument handle at a proximal end, a distal shaft portion attached to and extending from the instrument handle along the longitudinal axis, the distal shaft portion configured to be received in a lumen of an introducer sheath, wherein the instrument handle comprises an abutment surface having a second detent feature formed thereon, the second detent feature configured to mate with a first detent feature of the introducer sheath; and Wherein, when the distal shaft portion of the access instrument is inserted into the lumen of the introducer sleeve from the proximal end and the abutment surface of the instrument handle approaches or contacts the abutment surface of the introducer handle, the first brake feature on the abutment surface cooperates with the second brake feature on the abutment surface of the instrument handle.

26. The bone access system of claim 25, wherein: When the first detent feature on the abutment surface of the introducer handle engages the second detent feature on the abutment surface of the instrument handle, the second detent feature causes a tactile response against rotation of the first detent feature about the longitudinal axis.

27. The bone access system of claim 25, wherein: When the first detent feature on the abutment surface of the introducer handle engages the second detent feature on the abutment surface of the instrument handle, the second detent feature resists rotation of the first detent feature about the longitudinal axis causing an audible click response.

28. The bone access system of claim 25, wherein: When the first detent feature on the abutment surface of the introducer handle engages the second detent feature on the abutment surface of the instrument handle, the second detent feature resists rotation of the first detent feature about the longitudinal axis requiring overcoming of a predetermined amount of torque.

29. The bone access system according to any one of claims 25 to 28, wherein: The access instrument also includes an extension portion extending distally from the instrument handle, the extension portion having external threads formed thereon; a wheel, the wheel including a hole along a central axis of the wheel, the hole having internal threads formed therein, the internal threads of the wheel being configured to engage with the external threads of the extension portion, wherein the wheel is coupled to the extension portion, the internal threads of the wheel engage with the external threads of the extension portion, and wherein rotation of the wheel causes the wheel to translate distally or proximally along the extension portion.

30. The bone access system of claim 29, wherein: The first brake feature on the abutment surface of the introducer handle is one or more teeth, and the second brake feature on the abutment surface of the instrument handle is a plurality of grooves, wherein each of the one or more teeth bites into one of the plurality of grooves when the first brake feature engages with the second brake feature.

31. The bone access system of claim 29, wherein: The first brake feature on the abutment surface of the introducer handle is a plurality of grooves, and the second brake feature on the abutment surface of the instrument handle is one or more teeth, wherein each of the one or more teeth bites into one of the plurality of grooves when the first brake feature engages with the second brake feature.

32. The bone access system of claim 30 or 31, wherein: The plurality of grooves form a circle around the longitudinal axis.

33. The bone access system of claim 32, wherein: The plurality of grooves in the circle are equally spaced.

34. The bone access system of claim 32, wherein: The plurality of grooves are formed on a cylindrical lateral circumferential surface coaxial with the longitudinal axis.

35. The bone access system of claim 32, wherein: The one or more teeth are a single tooth.

36. The bone access system of claim 32, wherein: The one or more teeth are two or more teeth.

37. The bone access system of claim 30 or 31, wherein: Each of the plurality of grooves includes a semicircular shape, a sawtooth shape, a triangle shape, a square shape, or a sinusoidal shape.

38. The bone access system of any one of claims 25 to 28, wherein: The access instrument includes a cannula having a pre-curved distal end portion.

39. The bone access system of any one of claims 25 to 28, wherein: The introducer cannula and the access instrument are sized to facilitate access to an intraosseous location within a vertebral body through a percutaneous incision.

40. An introducer cannula for penetrating into a bone, comprising: an introducer handle at the proximal end, the introducer handle including an abutment surface disposed about the upper surface, the abutment surface having a first detent feature formed thereon; a distal elongated tube attached to the introducer handle and extending from the introducer handle along a longitudinal axis; wherein a lumen extends along a longitudinal axis from the introducer handle through the introducer cannula to an open distal end of the distal elongated tube; and Wherein, the first brake feature is configured to cooperate with a second brake feature formed on the access instrument.

41. The introducer cannula of claim 40, wherein: When the first detent feature on the abutment surface is configured to mate with the second detent feature on the access instrument, the second detent feature induces a tactile response against rotation of the first detent feature about the longitudinal axis.

42. The introducer cannula of claim 40, wherein: When the first detent feature on the abutment surface is configured to cooperate with the second detent feature on the access instrument, the second detent feature causes an audible click response against rotation of the first detent feature about the longitudinal axis.

43. The introducer cannula of claim 40, wherein: When the first brake feature on the abutment surface is configured to cooperate with the second brake feature on the access instrument, the second brake feature resisting rotation of the first brake feature about the longitudinal axis requires overcoming a predetermined amount of torque to disengage the second brake feature from the first brake feature.

44. The introducer cannula of claim 40, wherein: The first brake feature on the abutment surface of the introducer handle is one or more teeth, and the second brake feature on the access instrument is a plurality of grooves, wherein each of the one or more teeth bites into one of the plurality of grooves when the first brake feature engages with the second brake feature.

45. The introducer cannula of claim 40, wherein: The first brake feature on the abutment surface of the introducer handle is a plurality of grooves, and the second brake feature on the access instrument is one or more teeth, wherein each of the one or more teeth bites into one of the plurality of grooves when the first brake feature engages with the second brake feature.

46. ​​An introducer cannula according to claim 44 or 45, wherein: The plurality of grooves form a circle around the longitudinal axis.

47. The introducer sleeve of claim 46, said plurality of grooves in said circle being equally spaced.

48. The introducer cannula of claim 46, wherein: The plurality of grooves are formed on a cylindrical lateral circumferential surface coaxial with the longitudinal axis.

49. An introducer sheath according to claim 44 or 45, wherein: The one or more teeth are a single tooth.

50. An introducer cannula according to claim 44 or 45, wherein: The one or more teeth are two or more teeth.

51. An introducer cannula according to claim 44 or 45, wherein: Each of the plurality of grooves includes a semicircular shape, a sawtooth shape, a triangle shape, a square shape, or a sinusoidal shape.

52. A bone access instrument for penetrating into a bone, comprising: an instrument handle at the proximal end, the instrument handle including an abutment surface having a second detent feature formed thereon, the second detent feature configured to mate with the first detent feature of the introducer cannula; a distal shaft portion extending from the instrument handle along a longitudinal axis; and Wherein, the distal shaft portion is configured to be received in a lumen formed in the introducer sleeve.

53. The bone access instrument of claim 52, wherein: When the second detent feature on the abutment surface of the instrument handle is configured to cooperate with the first detent feature of the introducer cannula, the second detent feature causes a tactile response against rotation of the first detent feature about the longitudinal axis.

54. The bone access instrument of claim 52 or 53, wherein: When the second detent feature on the abutment surface of the instrument handle is configured to cooperate with the first detent feature of the introducer sleeve, the second detent feature causes an audible click response against rotation of the first detent feature about the longitudinal axis.

55. The bone access instrument of claim 52 or 53, wherein: When the second brake feature on the abutment surface of the instrument handle is configured to cooperate with the first brake feature of the introducer sleeve, the second brake feature resists rotation of the first brake feature about the longitudinal axis requiring overcoming a predetermined amount of torque to disengage the first brake feature from the second brake feature.

56. The bone access instrument of claim 52 or 53, wherein: The bone access instrument also includes an extension portion extending distally from the instrument handle, wherein the extension portion has external threads formed thereon; a wheel including a hole along a central axis of the wheel, wherein the hole has internal threads formed therein, the internal threads being configured to engage with the external threads of the extension portion, wherein the wheel is coupled to the extension portion, the internal threads of the wheel engage with the external threads of the extension portion, and wherein rotation of the wheel causes the wheel to translate distally or proximally.

57. The bone access instrument of claim 56, wherein: The second brake feature on the abutment surface of the instrument handle is one or more teeth, and the first brake feature on the abutment surface of the introducer handle is a plurality of grooves, wherein each of the one or more teeth bites into one of the plurality of grooves when the second brake feature engages with the first brake feature.

58. The bone access instrument of claim 56, wherein: The second brake feature on the abutment surface of the instrument handle is a plurality of grooves, and the first brake feature on the abutment surface of the introducer handle is one or more teeth, wherein each of the one or more teeth bites into one of the plurality of grooves when the second brake feature engages with the first brake feature.

59. The bone access instrument of claim 57 or 58, wherein: The plurality of grooves form a circle around the longitudinal axis.

60. The bone access instrument of claim 59, wherein: The plurality of grooves in the circle are equally spaced.

61. The bone access instrument of claim 59, wherein: The plurality of grooves are formed on a cylindrical lateral circumferential surface coaxial with the longitudinal axis.

62. The bone access instrument of claim 57 or 58, wherein: The one or more teeth are a single tooth.

63. The bone access instrument of claim 57 or 58, wherein: The one or more teeth are two or more teeth.

64. The bone access instrument of claim 57 or 58, wherein: Each of the plurality of grooves includes a semicircular shape, a sawtooth shape, a triangle shape, a square shape, or a sinusoidal shape.

65. The bone access instrument of any one of claims 52 to 64, wherein: The access instrument includes a cannula having a pre-curved distal end portion.

66. A method for facilitating percutaneous access to a target treatment site within a bone, the method comprising: inserting a distal portion of an introducer assembly into at least an outer cortical region of the bone, wherein the introducer assembly comprises an introducer cannula and an introducer stylet, the introducer cannula having a proximal introducer handle at a proximal end and a distal elongated tube attached to and extending from the introducer handle, the elongated tube defining a longitudinal axis, the introducer cannula having a lumen formed therethrough from the proximal introducer handle to a distal end of the elongated tube, the introducer stylet being configured to be received in the lumen; removing the introducer stylet from the lumen of the introducer cannula; inserting a bend cannula assembly into the lumen, wherein the bend cannula assembly includes a bend cannula handle and a shaft portion extending from the bend cannula handle, the shaft portion being configured to be received in the lumen, the shaft portion having a distal bend; pushing a distal curved portion of the curved sleeve assembly out of the distal end of the introducer sleeve toward a target treatment location within the bone; and wherein the introducer handle has a first brake feature formed thereon, and wherein the bend cannula handle has a second brake feature formed thereon, the second brake feature being configured to cooperate with the first brake feature to provide an operator with tactile and / or audible feedback when the second brake feature engages the first brake feature, thereby providing controlled advancement of the bend cannula assembly relative to the introducer cannula.

67. The method of claim 66, wherein: The cooperation between the first detent feature of the introducer handle and the second detent feature of the bend cannula handle allows for radial or axial positioning of the bend cannula assembly within the introducer cannula.

68. The method of claim 66, wherein: The bend cannula assembly further includes a gear coupled to the bend cannula handle, wherein a lower flange of the gear includes the second brake feature, wherein the gear is configured to adjust an axial position on the bend cannula handle, and wherein engagement of the gear with the introducer handle defines a longitudinal position of the bend cannula assembly within the introducer cannula.

69. The method of claim 68, wherein: Continued rotation of the gear provides further tactile and / or audible feedback via the interaction of the first brake feature with the second brake feature.

70. The method according to any one of claims 66 to 69, wherein: The second brake feature includes a plurality of second brake elements.

71. The method of claim 70, wherein: The second plurality of brake elements include notches or grooves, and wherein the first brake element includes protrusions configured to engage with the notches or grooves until a sufficient amount of torque is applied to disengage the protrusions from the corresponding notches or grooves.

72. The method of any one of claims 66 to 69, wherein: The first brake feature includes a plurality of first brake elements.

73. The method of claim 72, wherein: The plurality of first brake elements include notches or grooves, and wherein the second brake element includes protrusions configured to engage with the notches or grooves until a sufficient amount of torque is applied to disengage the protrusions from the corresponding notches or grooves.

74. The method of any one of claims 66 to 69, wherein: Pushing the distal curved portion of the curved cannula assembly out of the distal tip of the introducer cannula includes tapping the curved cannula handle.

75. The method of any one of claims 66 to 69, further comprising advancing a therapeutic instrument through the access instrument and performing a therapeutic procedure within the bone.

76. The method of claim 75, wherein: The therapeutic procedure includes applying radiofrequency energy sufficient to ablate one or more nerves within the bone.

77. The method of any one of claims 66 to 69 or 76, wherein: The bone is a vertebral body.

78. A controlled bone access system as herein described and / or illustrated.

79. A method of controllably accessing a bone (eg, a vertebral body) using a controlled bone access system as described and / or illustrated herein.

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