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WO2025171068A1 - Dispositifs, systèmes, et procédés d'ablation de nerf intra-osseux - Google Patents

Dispositifs, systèmes, et procédés d'ablation de nerf intra-osseux

Info

Publication number
WO2025171068A1
WO2025171068A1 PCT/US2025/014681 US2025014681W WO2025171068A1 WO 2025171068 A1 WO2025171068 A1 WO 2025171068A1 US 2025014681 W US2025014681 W US 2025014681W WO 2025171068 A1 WO2025171068 A1 WO 2025171068A1
Authority
WO
WIPO (PCT)
Prior art keywords
introducer
handle
assembly
stylet
needle assembly
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/014681
Other languages
English (en)
Inventor
Bret BOUDOUSQUIE
Eric Hyman
Vincent Lambert
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Neurovasis Inc
Original Assignee
Neurovasis Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Neurovasis Inc filed Critical Neurovasis Inc
Publication of WO2025171068A1 publication Critical patent/WO2025171068A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1662—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1487—Trocar-like, i.e. devices producing an enlarged transcutaneous opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/0042—Surgical instruments, devices or methods with special provisions for gripping
    • A61B2017/00455—Orientation indicators, e.g. recess on the handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00339—Spine, e.g. intervertebral disc
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434—Neural system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • A61B2018/143—Needle multiple needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1475—Electrodes retractable in or deployable from a housing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Definitions

  • Certain embodiments described herein relate generally to intraosseous nerve ablation, including devices, systems, and methods therefor. Embodiments can be particularly well suited for basivertebral nerve ablation.
  • FIG. 1 is an elevation view of an embodiment of a system for intraosseous nerve ablation
  • FIG. 2A is an elevation view of an embodiment of an introducer that is compatible with embodiments of the system of FIG. 1 ;
  • FIG. 2B is a cross-sectional view of the introducer of FIG. 2A taken along the view line 2B-2B in FIG. 2A;
  • FIG. 3A is a perspective view of an embodiment of a cannula that is compatible with embodiments of the introducer of FIG. 2A;
  • FIG. 3B is a perspective view of the cannula of FIG. 3A during assembly, which depicts a collar being advanced onto a cannula tube for attachment thereto;
  • FIG. 3C is a perspective view of the proximal end of the cannula of FIG. 3A, the collar and cannula tube of FIG. 3B having been fixedly secured together;
  • FIG. 3D is an elevation view of a proximal end of the cannula of FIG. 3A;
  • FIG. 4A is an upper perspective view of an embodiment of a handle that is compatible with embodiments of the introducer of FIG. 2A;
  • FIG. 4B is a lower perspective view thereof
  • FIG. 4C is another upper perspective view thereof, the view being directed toward a side of the handle that is opposite from the side to which the views of FIGS. 4A and 4B are directed;
  • FIG. 4D is a cross-sectional view thereof taken along the view line 4D-4D in FIG. 4C;
  • FIG. 4E is another cross-sectional view thereof taken along the view line 4E- 4E in FIG. 4C;
  • FIG. 4F is a top plan view thereof
  • FIG. 5 is an elevation view of an embodiment of a trocar-tipped stylet assembly that is compatible with embodiments of the introducer of FIG. 2A;
  • FIG. 6 is a perspective view of a trocar-tipped stylet that is compatible with embodiments of the stylet assembly of FIG. 5;
  • FIG. 7A is an upper perspective view of a handle that is compatible with embodiments of the stylet assembly of FIG. 5;
  • FIG. 7 B is a lower perspective view thereof
  • FIG. 7C is a cross-sectional view thereof taken along the view line 7C-7C in FIG. 7B;
  • FIG. 8A is an elevation view of the stylet assembly of FIG. 5 coupled with the introducer of FIG. 2A;
  • FIG. 8B is a cross-sectional view thereof taken along the view line 8B-8B in FIG. 8A;
  • FIG. 8C is another cross-sectional view thereof taken along the view line 8C- 8C in FIG. 8A;
  • FIG. 9A is an elevation view of an embodiment of a bevel-tipped stylet assembly that is compatible with embodiments of the introducer of FIG. 2A;
  • FIG. 9B is an upper perspective view thereof directed toward an opposite side of the stylet assembly of FIG. 9A;
  • FIG. 90 is an elevation view of a distal tip of the stylet assembly of FIG. 9A;
  • FIG. 9D is an elevation view of the stylet assembly of FIG. 9A coupled with the introducer of FIG. 2A;
  • FIG. 9E is a top plan view of the stylet assembly of FIG. 9A coupled with the introducer of FIG. 2A;
  • FIG. 10C is an elevation view of an embodiment of a drill bit that is compatible with the drill assembly of FIG. 10A;
  • FIG. 10D is an elevation view of a proximal portion of the drill bit of FIG. 10C, with the drill bit having been rotated 90 degrees about a longitudinal axis thereof;
  • FIG. 10E is an elevation view of the drill assembly of FIG. 10A inserted through the introducer of FIG. 2A in a drilling arrangement;
  • FIG. 11 A is an elevation view of an embodiment of a needle assembly that is compatible with embodiments of the introducer of FIG. 2A, the needle assembly being in an undeployed or retracted state;
  • FIG. 11 B is another elevation view of the needle assembly rotated 90 degrees relative to the view of FIG. 11A, where the rotation is counterclockwise about a central longitudinal axis of the needle assembly as viewed in a proximal-to-distal direction;
  • FIG. 11 C is another elevation view of the needle assembly rotated 180 degrees relative to the view of FIG. 11 B, where the rotation is about the central longitudinal axis of the needle assembly;
  • FIG. 12B is another elevation view of the needle assembly in the deployed state with the needle assembly rotated 90 degrees relative to the view of FIG. 12A, where the rotation is clockwise about the central longitudinal axis of the needle assembly as viewed in a proximal-to-distal direction;
  • FIG. 13C is a cross-sectional view thereof taken along the view line 13C-13C in FIG. 13A;
  • FIG. 13D is an elevation view thereof
  • FIG. 13E is another elevation view thereof rotated 90 degrees relative to FIG.
  • FIG. 13F is another elevation view thereof rotated 180 degrees relative to FIG.
  • FIG. 14A is an upper perspective view of an embodiment of a spin collar that is compatible with embodiments of the needle assembly of FIG. 11 A;
  • FIG. 14B is a lower perspective view thereof
  • FIG. 14C is an elevation view thereof
  • FIG. 14D is a cross-sectional view thereof taken along the view line 14D-14D in FIG. 14A;
  • FIG 15A is an upper perspective view of an embodiment of a main hub that is compatible with embodiments of the needle assembly of FIG. 11 A;
  • FIG. 15B is another upper perspective view thereof
  • FIG. 15C is a lower perspective view thereof
  • FIG. 15D is an elevation view thereof
  • FIG. 15E is a cross-sectional view thereof taken along the view line 15E-15E in FIG. 15A;
  • FIG. 16A is a perspective view of a proximal end of an embodiment of an elongated tube that is compatible with the needle assembly of FIG. 11 A;
  • FIG. 16C is a perspective view of a distal end of the elongate member
  • FIG. 17A is a perspective view of an embodiment of a filament element or tine element that is compatible with embodiments of the needle assembly of FIG. 11 A;
  • FIG. 17B is an elevation view of an embodiment of a tine having a beveled end
  • FIG. 17C is an elevation view of an embodiment of a tine having a blunt end
  • FIG. 18C is a side elevation view thereof
  • FIG. 19A is a cross-sectional view of the needle assembly in a retracted state taken along the view line 19A-19A in FIG. 11A;
  • FIG. 19B is a cross-sectional view of the needle assembly in the retracted state taken along the view line 19B-19B in FIG. 11 C;
  • FIG. 19C is a cross-sectional view of the needle assembly in a deployed state taken along the view line 19C-19C in FIG. 12B;
  • FIG. 19D is an elevation view of a distal end of the needle assembly while in the deployed state
  • FIG. 19E is another elevation view of the distal end of the needle assembly while in the deployed state, the needle assembly shown rotated 90 degrees about a longitudinal axis thereof, where the rotation is clockwise about a central longitudinal axis of the main hub as viewed in a proximal-to-distal direction;
  • FIG. 29D is a perspective view of a packaging arrangement in which a sealing layer is attached to the retaining lid of FIG. 29C, which is positioned over the second tray of FIG. 29C, which is in turn positioned over the first tray of FIG. 29A, all of which are retained within a box;
  • FIG. 35B is a cross-sectional view thereof, taken along the view line 35B-35B in FIG. 35A;
  • FIG. 35C is a top plan view thereof
  • FIG. 35D is another perspective view thereof, with the handle rotated 180 degrees relative to FIG. 35A;
  • FIG. 36 is an embodiment of a biasing member compatible with the introducer of FIG. 34;
  • FIG. 37C is another perspective view thereof.
  • FIG. 39A is an elevation view of an embodiment of a handle compatible with embodiments of a beveled stylet assembly
  • FIG. 38B is another elevation view thereof, the handle being rotated 180 degrees relative to FIG. 39A;
  • FIG. 41 is a perspective view of the needle assembly of FIG. 40 coupled with the introducer of FIG. 34, the needle assembly further being depicted in a deployed state; and [00111] FIG. 42 is an elevation view of an illustrative embodiment of an adapter for coupling certain embodiments of probe assemblies with particular RF generator consoles.
  • Embodiments of the present disclosure relate generally to intraosseous nerve ablation. Some embodiments are particularly well suited for the ablation of basivertebral nerves.
  • General disclosures pertaining to the ablation of basivertebral nerves and certain known devices and systems for implementing such ablations are described, for example, in U.S. Patent No. 6,699,242 of Heggeness, titled METHODS AND DEVICES FOR INTRAOSSEOUS NERVE ABLATION, which issued on March 2, 2004, and in U.S. Patent No. 6,907,884 of Pellegrino et al., titled METHOD OF STRADDLING AN INTRAOSSEOUS NERVE, which issued on June 21 , 2005.
  • the entire contents of each of the foregoing patents are hereby incorporated by reference herein. To the extent there is any conflict between this incorporated subject matter and the present written disclosure, the present written disclosure shall control.
  • Intraosseous basivertebral nerve ablation can be a minimally invasive treatment for chronic back pain.
  • the chronic back pain can be associated with Modic typel and type 2 vertebral endplate changes, which may be diagnosed, for example, in known manners. Other suitable diagnostic methods may be forthcoming.
  • Embodiments herein can be used for BVNA in one or more vertebrae of a patient who suffers from chronic back pain, such as after a diagnostic confirmation of Modic type 1 and/or type 2 vertebral endplate changes in the patient.
  • a pair of needles are placed within a bone in proximity to an intraosseous nerve, such as within a vertebra in proximity to a basivertebral nerve.
  • the needles may be positioned on opposite sides of a centrally located, vertical or longitudinal plane (e.g., the median plane or midsagittal plane) through the vertebra.
  • a first needle in inserted through a first pedicle of a vertebral body and a second needle is inserted through a second pedicle of a vertebral body.
  • the introducer can provide a passageway (e.g., an established, secure, fixed, and/or direct passageway) into a bone, such as a vertebra.
  • the introducer can include a sheath, cannula, or tube through which a needle, or needle portion of a needle assembly, may be introduced into a bone, such as a vertebra.
  • the introducer can further include a handle. The needle can be advanced through the introducer into the bone, and a main hub of the needle can be selectively attached to the handle of the introducer.
  • the attachment between the main hub of the needle and the handle of the introducer can inhibit or prevent relative longitudinal (or stated otherwise, axial) movement between the needle and the introducer and/or can inhibit or prevent relative rotational movement between the needle and the introducer about a longitudinal axis of the needle/introducer assembly.
  • the needle e.g., a main hub of the needle
  • the introducer includes one or more connectors that interact with the needle to secure the needle to the introducer.
  • the one or more connectors may be selectively or releasably securable.
  • one or more tines or filaments of the needle assembly can be deployed into the bone (e.g., into cancellous bone) while an elongated member of the needle assembly remains substantially fixed (e.g., in longitudinal relation) relative to a sheath of the introducer.
  • This fixed relationship may aid in deployment of the tines, such as, for example, to prevent proximal movement of the needle assembly relative to the introducer, or “backing out” of the needle assembly, that might otherwise occur during tine deployment.
  • anchoring the needle assembly to an introducer that is fixed within the bone can assist with predictable deployment of the tines, as the reactive forces that the tips of the tines encounter as they push through the bone are counteracted by the anchored arrangement, thus inhibiting or preventing the needle assembly from moving proximally relative to the bone.
  • the tines can be more readily or more predictably advanced distally into bone than in certain arrangements in which there is no anchoring relative to a fixed introducer.
  • the introducer may further be selectively attachable to and/or usable with one or more stylet assemblies and/or a drill assembly, each of which may be used with and/or attached to the introducer sequentially (or stated otherwise, individually, or one at a time). That is, in certain embodiments, only one of a stylet assembly (or of multiple stylet assemblies), a drill assembly, and/or the needle assembly may be used with and/or attached to (e.g., selectively attached to and/or removably attached to) the handle of the introducer at any given time.
  • one or more stylet assemblies that are individually attachable to the introducer may be securely attached to the introducer so as to be both longitudinally (or stated otherwise, axially) and rotationally fixed relative thereto.
  • Each stylet assembly can include a handle which, when coupled with the handle of the introducer, can facilitate manipulation of the stylet/introducer assembly.
  • the stylet handle encompasses or extends about a significant portion of the introducer handle and defines a pair of extended wings that can be readily gripped by the hand of a user for rotational movement and or longitudinal advancement or retraction of the assembly.
  • the stylet handle can include a flat striking surface which may be configured to be hammered by a mallet to permit distal advancement of the stylet/introducer combination through bone.
  • a stylet assembly includes a trocar tip, such as a tri-faceted tip that comes to a distal point at the distal end of the stylet, with the point being positioned at or near a central longitudinal axis of the stylet.
  • a stylet assembly (which may be an alternative or additional stylet assembly, relative to the trocar-tipped stylet assembly) includes a beveled tip at the distal end of the stylet. The beveled tip, which may be formed from one or more angled grinds at the distal end of the stylet, may help in guiding or directing the stylet/introducer assembly as it is advanced through, e.g., cancellous bone.
  • the drill assembly does not attach to the introducer, but rather, a drill bit portion thereof may be inserted through the introducer and moved independently therefrom.
  • the drill assembly may be rotated and/or longitudinally advanced and retracted relative to the introducer.
  • the drill assembly can include a fluted distal end that can drill into bone.
  • the flutes can help in the removal of bone material, which can provide or assist in providing space for insertion of the needle.
  • the drill can be used to create a pathway through bone or to ream bone material (e.g., cancellous bone material) from at least a portion of a previously formed pathway through the bone.
  • the introducer e.g., the introducer handle
  • the introducer handle can include one or more orientation indicia that can indicate to a user an orientation of the introducer that will yield a particular orientation of the deployed tines, once a needle assembly has been coupled to the handle and the tines thereof have been deployed.
  • the orientation indicia may indicate a preferred or prescribed orientation relative to a median plane of a patient.
  • the one or more orientation indicia may be visual and/or tactile.
  • the orientation indicia may include one or more of visual markings and/or physical variations that are viewable and/or palpable or tactile.
  • one or more stylet assemblies that are couplable with the introducer each include one or more orientation indicia.
  • a handle of a trocar-tipped stylet assembly can include an orientation indicium which, when the handle is in a coupled state with a handle of the introducer, indicates to a user an ultimate orientation of the introducer that will yield a particular orientation of the deployed tines, once a needle assembly has been coupled to the handle and the tines thereof have been deployed.
  • the orientation indicium may indicate a preferred or prescribed orientation relative to a median plane of a patient.
  • an orientation indicium of the introducer and an orientation indicium of the stylet assembly are aligned (e.g., indicate the same direction, such as by pointing in the same direction) when the introducer and the stylet assembly are in a coupled state.
  • a bevel-tipped stylet assembly can include one or more orientation indicia, such as just described with respect to an illustrative trocar-tipped stylet assembly.
  • the bevel-tipped stylet assembly can include a deflection indicium, which can indicate to a user a deflection direction in which a tip of the bevel-tipped stylet tends to move as it is advanced through bone material.
  • the deflection indicium may be visual and/or tactile.
  • the bevel-tipped stylet assembly includes both an orientation indicium and a deflection indicium.
  • the orientation indicium and the deflection indicium indicate (e.g., point toward) the same direction.
  • the introducer e.g., the introducer handle
  • the introducer handle can include one or more attachment indicia that can indicate to a user a manner in which a needle assembly should be attached to the introducer in order to yield a particular orientation of the deployed tines, once the needle assembly has been coupled to the handle and the tines thereof have been deployed.
  • the one or more attachment indicia may be visual and/or palpable or tactile.
  • the attachment indicia may include one or more of visual markings and/or physical variations that are viewable and/or touchable.
  • the introducer cannula 112 can include, for example, a rigid tube 200 of any suitable material.
  • the cannula 112 comprises a tube 200 of rigid stainless steel.
  • the cannula 112 has a distal tip 202 opposite the handle 114.
  • the distal tip 202 is substantially flat or planar, such as may result from cutting a tube at a right angle to the longitudinal axis, or stated otherwise, from a right-angle transverse cut.
  • the tip 202 may be shaped in any suitable manner.
  • the securement member 210 may embed within the handle 114 during an overmolding procedure and/or may prevent separation of the handle 114 from the tube 200 during striking (e.g., via a mallet or hammer), pushing, pulling, rotation, and/or other manipulation of the handle 114 and/or one or more components attached thereto during insertion, positioning, and/or removal of the introducer 110 relative to a bone.
  • the securement member 210 can interface with the handle material to maintain the handle 114 in fixed relation to the cannula 112, to prevent the handle 114 from being separated from the cannula 112, and/or to permit efficient transfer of forces when the handle 114 and the cannula 112 are placed under torsion, such as when the handle 114 is rotated (e.g., back and forth) about the central longitudinal axis and pushed distally for advancement of the introducer 110 into bone, or when the handle 114 is rotated (e.g., back and forth) about the central longitudinal axis and pulled proximally to remove the introducer 110 from bone.
  • torsion such as when the handle 114 is rotated (e.g., back and forth) about the central longitudinal axis and pushed distally for advancement of the introducer 110 into bone, or when the handle 114 is rotated (e.g., back and forth) about the central longitudinal axis and pulled proximally to remove the introducer 110 from bone.
  • the handle 114 of the introducer 110 can include a body 220 and a stem 222 that extends distally from the body 220.
  • a lumen 224 extends fully through the body 220 and the stem 222.
  • the central longitudinal axis ACL (FIGS. 2A and 2B) can extend through a center of the lumen 224.
  • the handle 114 includes a lock 238, which may alternatively be referred to a fastener, coupling interface, connector, connection interface, locking interface, etc.
  • the lock 238 may be of any suitable variety, and may be active or passive.
  • the lock 238 can comprise one or more of a catch, recess, receptacle, latch, catch, clamp, lock, snap, or any other suitable connection mechanism, whether mechanical, magnetic, electromagnetic, electromechanical, etc., which can maintain or assist in maintaining a fixed rotational orientation between the introducer 110 and a stylet assembly 120, 130.
  • the lock 238 comprises a recess 239 that can assist in maintaining either of the handles 124, 134 of the stylet assemblies 120, 130, respectively, in a rotationally locked orientation relative to the handle 114, as further discussed below. Stated otherwise, in some embodiments, the lock 238 can interact with a complementary locking element of either stylet assembly 120, 130 to achieve a rotational lock between the introducer 110 and the stylet assembly 120, 130.
  • the recess 239 that defines the lock 238 can include two ramped surfaces.
  • the steeper or more aggressively ramped surface i.e. , the left ramped surface of the recess 239 in FIG. 4E
  • the recess extends distally or inwardly away from a proximal surface of the handle 114, which proximal surface may be substantially planar in some embodiments.
  • the lock 238 is at an upper or proximal face of the handle 114.
  • the lock 238 and the stop 237 are associated with, and positioned at the outer ends of, the wings 232, 234, respectively (see, e.g., FIG. 4F).
  • the stop 237 prevents a stylet handle 124, 134 from rotating relative to the introducer handle 114 in a first direction (e.g., a rotational direction suitable for coupling the stylet handle 124, 134 to the introducer handle 114), and the lock 238 inhibits the stylet handle 124, 134 from rotating relative to the introducer handle 114 in a second direction that is opposite the first direction (e.g., a rotational direction suitable for decoupling the stylet handle 124, 134 from the introducer handle 114).
  • a first direction e.g., a rotational direction suitable for coupling the stylet handle 124, 134 to the introducer handle 114
  • the lock 238 inhibits the stylet handle 124, 134 from rotating relative to the introducer handle 114 in a second direction that is opposite the first direction (e.g., a rotational direction suitable for decoupling the stylet handle 124, 134 from the introducer handle 114).
  • the stop 237 can prevent a handle 124, 134 of a stylet assembly 120, 130 from rotating in a coupling direction more than intended, and can assist in ensuring a predetermined orientation between the stylet assembly 120, 130 and the introducer 110 when in a coupled state.
  • the lock 238 likewise can assist in achieving the predetermined orientation between the stylet assembly 120, 130 and the introducer 110 when in a coupled state.
  • the locking action provided at least in part by the lock 238 when that stylet assembly 120, 130 and the introducer 110 are in the coupled state can be selectively overcome when a user rotates the handle 124, 134 relative to the handle 114 in an opposite direction, or decoupling direction, with a sufficient force to achieve decoupling of the stylet assembly 120, 130 from the introducer 110.
  • the handle 114 may be said to define a keying interface 240 via which a predetermined rotational orientation may be achieved between the introducer 110 and each of the stylet assemblies 120, 130 when the introducer 110 and a respective one of the stylet assemblies 120, 130 are in a coupled state.
  • the introducer handle 114 can further include a connector 261 configured to interface with a connector of the needle assembly 150 to securely maintain the introducer 110 and the needle assembly 150 in a coupled state, as further discussed below.
  • the connector 261 may alternatively be referred to a fastener, lock, coupling interface, connection interface, locking interface, etc.
  • the connector 261 may be of any suitable variety, and may be active or passive.
  • the connector 261 can comprise one or more of a catch, recess, receptacle, latch, catch, clamp, lock, snap, or any other suitable connection mechanism, whether mechanical, magnetic, electromagnetic, electromechanical, etc.
  • the introducer 110 includes a first connector 226 via which the introducer 110 can be selectively connected to one or more of the stylet assemblies 120, 130, and further includes a second connector 261 via which the introducer 110 can be selectively connected to the needle assembly 150.
  • the connectors 226, 261 employ different attachment mechanisms from one another and are physically separated or spaced from one another.
  • the connector 226 for interfacing with the stylet assemblies 120, 130 is positioned at an internal region, or along an internal surface, of the introducer handle 114, whereas the connector 261 is positioned at an external region, or along an external surface, of the introducer handle 114.
  • the connectors 226, 261 are physically separate or physically distinct.
  • a common connector may be used for coupling the needle assembly 150 and one or more of the stylet assemblies 120, 130 to the introducer 110.
  • the connector 261 includes a pair of catches 262, 264 that are at diametrically opposite sides of the handle 114. Each catch 262, 264 may be referred to individually as a separate connector. The catches 262, 264 may also collectively be referred to as a connector 261 , or may interface with elements that may collectively and/or cooperatively couple therewith. The catches 262, 264 can be closer to the central longitudinal axis than are the lock 238 and the stop 237.
  • Catches 262, 264 that are of different sizes relative to one another can provide for rotational keying with the main hub 154 of the needle assembly 150, or stated otherwise, can require a single, predetermined rotational orientation between the needle assembly 150 and the introducer hub 114 in order for the needle assembly 150 to connect to the introducer hub 114, as discussed further below.
  • the indicium 270 can indicate to a user a deployment direction associated with the tines of the needle assembly.
  • the indicium 270 can alternatively or additionally indicate a desired orientation of the introducer 110 relative to the median (or midsagittal) plane of the patient. For example, in instances, it can be desirable to rotate the introducer around the central longitudinal axis thereof to achieve a minimum distance between the indicium 270 and the median plane of the patient when positioning the introducer within a vertebra of a patient.
  • the arrow 272 is positioned to point toward the median plane of the patient to result in deployment of tines from the needle assembly 150 generally toward the median plane, when the needle assembly 150 is attached to the introducer 110.
  • the indicium 270 may indicate the specific direction in which the orientational plane of the introducer 110 extends, but may not physically correspond with the orientational plane.
  • the indicium 270 may point in, or otherwise indicate, the direction in which the orientational plane extends, but may be physically spaced from the orientational plane.
  • the indicium 270 may be positioned on a surface of the handle 114 that the orientational plane does not pass through.
  • the handle 114 further includes one or more attachment indicia 280.
  • an attachment indicium 280 includes a vertically oriented raised rib 282 that extends along a portion of the stem 222.
  • the rib 282 visually and/or palpably indicates to a user which of the catches 262, 264 defined by the handle 114 are configured for attachment to the larger of corresponding connection elements of the needle assembly.
  • the catches 262, 264 are differently sized, which provides an alternative or additional attachment indicium 280, visual and/or palpable, by which a user can determine a manner or orientation in which the needle assembly 150 is configured to be attached to the introducer 110. That is, a user can visually perceive the difference in size of the catches 262, 264 to thereby determine the appropriate rotational orientation of the needle assembly 150 relative to the introducer 110. Alternatively and/or additionally, the user can touch one or more of the differently sized catches 262, 264 and thereby determine the appropriate orientation of the needle assembly 150 relative to the introducer 110 by feel.
  • the illustrated embodiment of the introducer handle 114 includes a sheath connector 290 to which a protective sheath may be secured (such as shown in FIG. 28), such as for packaging, shipment, and/or user protection during unpackaging of the introducer 110. Any suitable connection mechanism is contemplated.
  • the illustrated sheath connector 290 includes a distally projecting column 292 from which four longitudinally extending ribs 294 extend radially outwardly.
  • the connector 346 comprises an external raised thread 347 that is configured to complementarily engage the internal thread 227 of the connector 226 (see FIG. 8B).
  • the internal/external threading can be reversed.
  • the connector 346 can be a recessed or grooved thread, and the connector 226 can be a raised thread. Any other suitable connection mechanism or connection interface is contemplated.
  • the wing 334 includes a rotational stop 350 that interfaces with the stop 237 to prevent clockwise rotation (as viewed from above, or as viewed in a distal direction along the central longitudinal axis) of the handle 124 relative to the handle 114 when the stops 350, 237 are engaged, or stated otherwise, when the stops 350, 237 are in abutment with one another so as to interfere with one another.
  • the rotational stop 350 projects radially inward from an end of the wing 334.
  • the wing 332 includes a lock 360 that is configured to interact with the lock 238 of the introducer 110 to maintain the stylet assembly 120 in a fixed rotational orientation relative to the introducer 110.
  • the leading face (e.g., the right face in FIG. 8C) of the catch 362 can interact with the handle 114 to resiliently deflect the arm 361 upward.
  • the catch 362 seats within the receptacle 238, thus returning the arm 361 to a natural or undeflected state. This seated arrangement can assist in retaining the handles 124, 114 in a coupled state.
  • the catch 362 can have a more aggressive slant, which can correspond with a more aggressively slanted face of the receptacle 238.
  • This arrangement can require a predetermined amount of force in the opposite rotational direction to once again deflect the arm 361 upward to permit rotation of the handles 124, 114 relative to one another for disengagement.
  • FIG. 8B is a cross-sectional view of the trocar-tipped stylet assembly 120 coupled with the introducer 110. As shown, sufficient space exists within the cavity of the introducer handle 124 to receive the elongated stem at the distal end of the handle of the stylet assembly 120. As previously noted, in some embodiments, the elongated stem can be configured to retain thereon a shielding cover, such as may be used for packaging and shipping. In some embodiments, however, the trocar-tipped stylet assembly 120 and the introducer 110 may be shipped in a coupled state, such that a single shielding cover is instead placed on the elongated stem at the distal end of the introducer handle 114. One such arrangement is depicted, for example, in FIG. 29B.
  • the handle 124 can include a strike surface 380, which can be a substantially planar surface that is orthogonal to the central longitudinal axis.
  • a user can strike the strike surface 380, e.g., with a mallet, to advance the coupled stylet assembly 120 and introducer 110, as depicted in FIG. 8A, through bone.
  • the stylet assembly 120 and the introducer 110 may be sufficiently securely fastened to one another when in the coupled state to withstand significant force and high impact, such as during hammering of this attached system into bone.
  • the handle 134 of the beveled stylet assembly 130 can include any or all of the features discussed above with respect to the handle 124 of the trocar stylet assembly 120.
  • the handle 134 includes identical or substantially identical connection geometries as the handle 124.
  • each handle 124, 134 may couple to and decouple from the handle 114 of the introducer 110 in the same manner.
  • the handle 134 can include, for example a connector 446, such as the connector 346 described above, and a keying interface 470, such as the keying interface 370 described above.
  • the bevel-tipped stylet 132 can include a distal tip that includes at least a primary grind or bevel.
  • the primary grind may be at an acute angle relative to the central longitudinal axis of the stylet 132.
  • the primary grind extends from one side surface of the stylet 132 to or nearly to an opposite side surface of the stylet 132.
  • one or more small reverse grinds may be present.
  • the angled shape of the bevel-tipped stylet 132 can urge the beveled stylet assembly 130 and introducer 110, when coupled together (as shown in FIG. 9D), in a lateral direction during distal advancement.
  • the bevel-tipped stylet 132 may deflect the coupled system in a preferred deflection direction.
  • the bevel-tipped stylet 132 if advanced distally, could urge the coupled system in a rightward direction during such distal advancement, due to the forces at play at the beveled distal tip as the angled primary distal face of the stylet 132 presses against bone material.
  • the handle 134 may include one or more deflection indicia 495.
  • the handle 134 may include a printed, imprinted, raised, or any other variety of indicator that identifies the direction that the bevel-tipped stylet 132 may tend to urge the coupled stylet assembly 130/introducer 110 system during insertion or advancement through bone.
  • the one or more indicia 495 comprises a raised arrow 497 that points radially outward relative to the central longitudinal axis of the stylet assembly 130.
  • the deflection indicia 495 may serve as, or may simultaneously function as, an directional or orientational indicium 493, such as those discussed elsewhere herein.
  • the stylet assembly 130 it can be desirable for the stylet assembly 130 to urge the introducer 110 toward the median plane during advancement of the coupled stylet assembly 130/introducer 110 system within a vertebral body.
  • the introducer 110 may subsequently receive therethrough the needle assembly 150 for ablation of the basivertebral nerve.
  • the orientational indicium 493 can correspond with the orientational indicium 270 of the introducer 110 in any suitable manner.
  • the orientational indicium 493 may point in the same direction as the orientational indicium 270, thus indicating to the user the direction that the underlying (and potentially hidden) orientational indicium 270 may be pointing when the introducer 110 and the stylet assembly 130 are in a coupled state.
  • the handle 134 may include separate deflection and orientational indicia 495, 493.
  • the orientational indicia 495, 493 may nevertheless indicate the same direction, for reasons such as discussed above.
  • the handle 134 can include a bevel indicium 499, which can aid a user in distinguishing a bevel-tipped stylet assembly 130 from a trocar-tipped stylet assembly 120.
  • the bevel indicium 499 is a triangular marking. In the illustrated embodiment, the triangular marking does not accurately reflect a rotational orientation of the bevel.
  • the bevel indicium 499 can further indicate a rotational orientation and/or deflection direction of the bevel and may simultaneously serve as the deflection indicium (such as the deflection indicium 497).
  • FIGS. 9D and 9E depict the bevel-tipped stylet assembly 130 coupled with the introducer 110.
  • the orientational indicium 493 points in the same direction as the orientational indicium 270 of the introducer 110 when the beveltipped stylet assembly 130 is fully coupled with the introducer 110.
  • at least a portion of each of the orientational indicia 493 of the stylet assembly 130 and the orientational indicia 270 of the introducer 110 may be longitudinally aligned when these instruments are coupled together.
  • orientational indicium 493 of the stylet assembly 130 may be positioned substantially over, or substantially directly proximal to, at least a portion of the orientational indicium 270 of the introducer 110.
  • orientational indicia 270, 493 are radially offset from one another.
  • the orientational indicium 493 of the stylet assembly 130 may serve to independently or directly convey to a user the information conveyed by the orientational indicium 270 of the introducer 110 while these components are in a coupled state. Such may be beneficial to a user as the handle 134 of the stylet assembly 130 can otherwise obscure the orientational indicium 270 of the introducer 110 when the stylet assembly 130 and the introducer 110 are coupled to each other.
  • the orientational indicium 493 of the stylet assembly 130 may convey to the user information regarding the orientation of the orientational indicium 270 of the introducer 110, and thus may indirectly convey to the user convey to a user the information that is subsequently directly conveyed by the orientational indicium 270 of the introducer 270 when such becomes visible after decoupling of the stylet assembly 130 from the introducer 110.
  • a system 100 may be prepackaged with a trocar-tipped stylet assembly coupled with the introducer 110. This may, in some instances, streamline an early stage of using the system, such as in instances where the trocar-tipped stylet is typical used with the introducer 110 before any other instrument is used with the introducer 110.
  • the trocar-tipped stylet assembly 120 obscures the orientational indicium 270 of the introducer 110, it can be helpful for this stylet assembly 120 to include its own orientational indicium that corresponds with (e.g., conveys information regarding) the orientational indicium 270 of the introducer 1110.
  • FIG. 28 One example of a system in which both a trocar-tipped stylet assembly and a bevel-tipped stylet assembly include orientational indicia, such as the orientational indicia 492, is depicted in FIG. 28.
  • orientational indicia such as the orientational indicia 492
  • raised indicia are visible on the leftfacing wing of each stylet assembly.
  • the bevel-tipped stylet assembly 120 includes a bevel indicium 499 (FIG. 9B).
  • the orientational indicium 493 of stylet assembly 130 can comprise an arrow or other indicator that desirably points toward the median plane to aid a user in directing the assembled introducer 110 and stylet assembly 130 toward the median plane during insertion.
  • the orientational indicium 270 of the introducer 110 may remain pointing toward the median plane, which can ultimately result in deployment of tines from the needle assembly 250 toward the median plane, after the needle assembly 150 has been attached to the introducer 110.
  • the handle 144 may be sized to be readily gripped by a hand of a user, and may be ergonomically shaped to facilitation manipulation, such as rotation and/or distal advancement.
  • the handle 144 includes a friction enhancing pattern to assist in the manipulation thereof.
  • the handle 144 may be concavely shaped.
  • the handle 144 may be contoured to enhance grip.
  • the handle 144 of the drill assembly 140 includes a projection 460, which may provide a standoff relative to the handle 114 of the introducer 110.
  • a distal end of the projection 460 may be sized so as not to fit within the cavity 225 of the handle 114 of the introducer 110. Instead, the distal end of the projection 460 may abut against an upper surface of the handle 114.
  • the standoff thus provided can permit the user’s fingers to be spaced from the handle 114 of the introducer by a sufficient distance so as not to contact the handle 114 when gripping and manipulating the handle 144.
  • FIGS. 10C and 10D are elevation views of the drill bit 142.
  • the drill bit 142 can include retention features, such as one or more notches 452.
  • the drill bit 142 can include a further notch 454 that may instead or additionally be used for alignment.
  • the notch 454 may be used during laser marking to provide the marks shown in FIG. 10D.
  • the proximal notch 454 may be used for longitudinal and/or rotational positioning to achieve a desired handle orientation relative to the drill bit.
  • the drill bit 142 can include depth markers 456 , which may be laser etched or otherwise applied to the drill bit 142.
  • the “0” depth marker indicates a point at which a distal tip of the drill bit 142 is positioned at (e.g., is flush with) a distal tip of the introducer cannula 112 when the drill bit 142 is positioned within the introducer 110 (e.g., in advancing toward a fully inserted position such as shown in FIG. 10E).
  • the “1” depth marker indicates one centimeter advancement past the distal tip of the introducer cannula
  • the “S” depth marker indicates a depth to which the needle assembly will extend when fully coupled with the introducer (e.g., after the drill bit is removed and replaced with the needle assembly 150).
  • a practitioner can determine from the depth markers or depth markings whether to drill to any of the marked or intermediate positions.
  • a distal end of the projection 460 of the handle 144 can abut against a proximal surface of the introducer handle. This can result in a hard stop beyond which the distal end of the drill bit 112 will not extend.
  • the needle assembly 150 includes the main hub 154 that is fixedly secured to the elongated member 152.
  • a tip 504 can be positioned at a distal end of the elongated member 152.
  • the tip 504 is fixedly secured to the elongated member 152.
  • the needle assembly 150 can further include a movable advancing hub 506 that can be advanced and retracted relative to the main hub 154 via rotation of a spin collar 508 in respectively opposite rotational directions.
  • the spin collar 508 can be rotated clockwise (as viewed from above), in a deployment direction, to advance the tines to their deployed state, and can be rotated counterclockwise (as viewed from above), in a retraction direction, to draw the tines back into their retracted state.
  • rotation of the spin collar 508 can yield corresponding longitudinal movement of the advancing hub 506.
  • Distal advancement of the advancing hub 506 can deploy tines 510, 511 (e.g., FIG. 12A), and proximal retraction of the advancing hub 506 can retract the tines 510, 511 (e.g., FIGS. 11 B and 11 C).
  • the advancing hub 506 can include a platform 540 with a pair of oppositely directed ribs 542.
  • the platform 540 can delimit proximal movement of a coupling element thereto, and the ribs 542 can securely retain the coupling element in a coupled arrangement with the advancing hub, which coupled arrangement can be overcome with sufficiently directed opposite rotational force.
  • the advancing hub 506 includes an interface 560 for interacting with the spin collar 508.
  • the interface 560 can include a groove 562 positioned between the platform 540 and an annular protrusion 564.
  • the advancing hub 506 includes a recess 570 that is configured to receive a locking pin that is fixedly secured to the main hub 154, as discussed further below (see FIG. 19B).
  • the recess 570 can be sufficiently long in a longitudinal direction to permit the advancing hub 506 to have a significant range of longitudinal movement relative to the locking pin as a distal end of the advancing hub 506 is moved longitudinally within the main hub 154.
  • the advancing hub 506 is configured to be restrained from rotational movement within the main hub 154.
  • a planar face 580 assists in restraining relative rotational movement between the advancing hub 506 and the main hub 154.
  • the planar face 580 can be keyed to a planar wall region of a cavity of the main hub 154 that receives the distal end of the advancing hub 506 (see FIGS. 15E and 19A).
  • the distal end of the advancing hub 506 is overmolded over a proximal end of a tine element 850.
  • the tine element 850 can be a unitary component, such as a single wire, which may be folded, and opposing ends of the wire can define a pair of tines (see FIG. 17A).
  • the illustrated advancing hub 506 includes a recess or annular groove 575 that is configured to receive a sealing member of any suitable variety, such as an elastomeric O-ring.
  • a sealing member of any suitable variety, such as an elastomeric O-ring.
  • An example of such is provided in FIGS. 19A-19C.
  • the spin collar 508 can include a central body 600 that defines a lumen 602.
  • the lumen 602 can include one or more internal threads 604.
  • the spin collar 508 can include a pair of oppositely projecting wings 610, 612.
  • the wings 610, 612 can facilitate application of torque to the spin collar 508, which can assist in the deployment of the tines 510, 511 into, e.g., cancellous bone.
  • a size of the wings 610, 612 and/or a pitch of the threads 604 may be selected to provide a desired mechanical advantage to facilitate deployment of the tines 510, 511 through, e.g., cancellous bone.
  • the spin collar 508 includes an annular protrusion, constriction, or movement ring 616 that can interact with the interface 560 of the advancing hub 506 to achieve longitudinal movement of the advancing hub 506 as the spin collar 508 is rotated.
  • the ring 616 can be sized to fit within, and spin relative to while remaining positioned within, the interface 560 of the advancing hub 506 as the spin collar 508 rotates. The keyed interaction of the advancing hub 506 and the internal sidewall of the main hub 154 can prevent the advancing hub 506 from rotating with the spin collar 508.
  • the spin collar 508 rotates relative to the advancing hub 506 and thereby advances distally or proximally along the helical track
  • the advancing hub 506 is pulled alongside the spin collar 508 via interaction of the ring 616 with the interface 560, thereby moving distally or proximally relative to the main hub 154 without rotating relative to the main hub 154.
  • a distal end of the spin collar 508 can include a pair of recesses 620, 622.
  • the recesses 620, 622 are identical to one another and are positioned diametrically opposite one another.
  • the recesses 620, 622 can receive therein ribs defined by the main hub 154, as discussed further below (see FIGS. 13A and 21 C).
  • the interaction of the recesses 620, 622 and the ribs can lock the spin collar 508 in place relative to the main hub 154, which can consequently lock the advancing hub 506 in place relative to the main hub 154 and maintain the tines 510, 511 in a fully deployed state.
  • the spin collar 508 is rotated clockwise, as viewed from above (e.g., viewed in a distal direction along the central longitudinal axis), in order to deploy the tines.
  • the recess 620 would move from right to left during advancement.
  • the left side of the recess 620 includes a ramp 630, whereas the right side of the recess 620 includes a stop 632.
  • the stop 632 can interface with a rib defined by the main hub 154 to prevent further clockwise rotation of the spin collar 508.
  • a bottom surface of the spin collar 508 can abut an upper surface of a platform defined by the main hub 154 to prevent further rotation of the spin collar 508 in the clockwise direction.
  • the main hub 154 can include a body 710.
  • a proximal projection 712 can extend proximally from the body 710, and a distal projection 714 can extend distally from the body 710.
  • a lumen 720 can extend longitudinally through an entirety of the main hub 154.
  • the proximal projection 712 includes external threading 730 that can interact with the threading of the spin collar 508 to translate rotation of the spin collar 508 into longitudinal movement of the spin collar 508 and, as a result, corresponding longitudinal movement of the advancing hub 506 in an equal or substantially equal amount.
  • the main hub 154 includes a connector 751 (FIG. 15C) that is configured to interact or cooperate with the connector 261 of the introducer 110 to selectively secure the needle assembly 150 to the introducer 110 in a fixedly attached state.
  • the connector 751 may alternatively be referred to a fastener, lock, coupling interface, connection interface, locking interface, etc.
  • the connector 751 may be of any suitable variety, and may be active or passive.
  • the connector 751 can comprise one or more of a catch, recess, receptacle, latch, catch, clamp, lock, snap, or any other suitable connection mechanism, whether mechanical, magnetic, electromagnetic, electromechanical, etc.
  • the distal ends of the latches 752, 754 include angled surfaces that interface with the rims 288 at the upper ends of the catches 262, 264 to deflect the lower ends of the latches 752, 754 radially outwardly during coupling of the needle assembly 150 to the introducer 110 (e.g., as the needle assembly 150 is advanced downward in FIG. 21 A). Once sufficient distal advancement of the needle assembly 150 is achieved relative to the introducer 110, the latches 752, 754 can resiliently return to or toward a resting state. In this coupled configuration (FIG.
  • each latch 752, 754 is further configured to interface with the undercut shelves of the catches 262, 264.
  • each latch 752, 754 includes a radially inwardly projecting latching surface 758, 759 (FIG. 15D) that abuts against a respective undercut shelf of the catches 262, 264 to prevent backing out of the needle assembly 150 (e.g., as the needle assembly 150 is transitioned from the retracted state of FIG. 21 B to the deployed state of FIG. 21 C).
  • the arm 752 can include an attachment indicium
  • the catch 264 may be sufficiently small that the larger arm 752 of the main hub 154 cannot fit therein. Accordingly, it may only be possible for the larger arm 752 of the main hub 154 to fit within the larger catch 262 of the handle 114 of the introducer 110.
  • This connection arrangement may be referred to as keyed arrangement that only permits a single rotational orientation of the main hub 154 relative to the handle 114. Stated otherwise, the catches 262, 264 and the arms 752, 754 may be configured to connect in only a single rotational state that ensures a predictable deployment of the tines relative to the directional or orientational indicia of the handle 114.
  • the main hub 154 may be said to define a keying interface 757 (FIG. 15B) via which a predetermined rotational orientation may be achieved between the needle assembly 150 and the introducer 110 when these instruments are in a coupled state (see FIG. 21 B).
  • the keying interface 757 includes each of the latches 752, 754, which function as previously described.
  • the keying interface 757 of the needle assembly 150 and the keying interface 260 of the introducer 110 (FIG. 4F) can interact with one another to achieve the predetermined or unique rotational orientation.
  • the elongated member 152 can include a rigid tube 800 of any suitable material.
  • the tube 800 includes a stainless-steel tube that is resistant to bending.
  • a proximal end of the tube 800 can include any suitable configuration for securely attaching to the main hub 154, such as in manners previously described with respect to the tube 200 and the handle 114.
  • the proximal end of the tube 800 includes a cutout 812 and a collar 814, which can resemble and function in the same manner as the cutout 212 and the collar 214 discussed above.
  • the tube 800 can define a lumen 830 that extends through a full length thereof.
  • a distal end of the insulation layer 820 may have a taper, which may be a gradual taper. In some embodiments, the distalmost tip of the insulation layer 820 is close to the outer surface of the tube 800. Such a configuration can facilitate advancement of the elongated member 152 into bone and/or through cancellous bone. In some embodiments, the insulation layer 820 is robust and resistant to being pulled from the tube 800, scraped, tom, or otherwise damage during insertion or removal.
  • one such single, unitary, or common electrode of a first needle assembly 150 may serve as an active electrode, while a second such single, unitary, or common electrode of a second needle assembly 150 that is positioned near the first needle assembly 150 may serve as a return electrode during a bipolar ablation procedure.
  • the tines 510, 511 When the tines 510, 511 are extended, the tines 510, 511 thus may increase a size and/or otherwise alter the shape of this unitary electrode (compare FIG. 21 B to FIG. 21 C).
  • the tines of the needle assemblies can be extended toward or substantially toward the median plane MP.
  • the minimum distance DTINE between a tine of one needle assembly and the closest tine of the contralateral needle assembly, when the needle assemblies are positioned for ablation and/or during ablation thereby can be smaller than any of the distances recited above with respect to the minimum tip distance DTIP.
  • DTINE can be smaller than DTIP by any of about 1 , 2, 3, 4, 5, 6, 7, or 8 millimeters.
  • a size of the angle 6 can generally increase with decreasing vertebral level. That is, for a particular patient, or on average for a group of patients, the relative size of the angle 5 at each level can be such that 5n ⁇ 5L2 ⁇ 5L3 ⁇ 5L4 ⁇ 5LS ⁇ 6si .
  • the angle 5 at the various levels can be as follows: at level L1 , within a range of from any of about 40, 45, 50, or 55 to about 60 degrees; from any of about 40, 45, or 50 degrees to about 55 degrees; from about 40 or 45 degrees to about 50 degrees; or from about 40 degrees to about 45 degrees; or about 49, 50, 51 , or 52 degrees; at level L2, within a range of from any of about 45, 50, 55, or 60 to about 65 degrees; from any of about 45, 50, or 55 to about 60 degrees; from about 45 or about 50 to about 55 degrees; or from about 45 degrees to about 50 degrees; or about 51 , 52, 53, 54, or 55 degrees; at level L3, within a range of from any of about 50, 55, 60, or 65 to about 70 degrees; from any of about 50, 55, or 60 to about 65 degrees; from about 50 or about 55 to about 60 degrees; or from about 50 degrees to about 55 degrees; or about 58
  • Various embodiments of systems and methods disclosed herein can advantageously assure effective and/or complete thermal coagulation of the BVN plexus irrespective of factors that may compromise precise device placement, such as patient anatomy and/or vertebral level.
  • FIG. 23A is a partially schematic top plan view of an illustrative procedure in which the distal ends of two introducers 110 coupled with beveled stylet assemblies 130 have been advanced within a vertebra V toward the median plane MP.
  • the coupled introducers 110 and stylet assemblies 130 have been advanced to their respective final destinations (e.g., prior to removal of the stylet assemblies 130 from the introducers 110 before subsequently coupling of needle assemblies 150 with the placed introducers 110, as shown in FIG. 23B).
  • the bevel-tipped stylet assemblies 130 can assist in urging the introducers 110 toward the median plane MP.
  • the central longitudinal axis of each introducer 110/stylet assembly 130 pairing is aligned with (e.g., subsumed within) a transverse plane TP that is orthogonal to the medial plane MP.
  • This schematic depiction is primarily used to facilitate the present discussion, as it may not be possible or practical in some instances to achieve such a perfectly aligned arrangement in practice, e.g., due to anatomical constraints.
  • each introducer 110/stylet assembly 130 paired system may be tilted from what is shown (e.g., the handles of the coupled instruments may be positioned higher or lower than the transverse plane TP, while the distal tip of the stylet assembly 130 remains positioned on the transvers plane TP) and/or rotated about a central longitudinal axis of the introducer 110/stylet assembly 130.
  • each stylet assembly 130 can include a deflection indicium 493, which in the present embodiment, is simultaneously an orientational indicium 495 that corresponds with (e.g., indicates the same rotational direction as) the underlying orientational indicium 270 of the introducer 110 (see FIGS. 9E and 23B).
  • the arrow that serves as both the deflection indicium 493 and the orientational indicium 495 in each of the two illustrated embodiments of the bevel-tipped stylet assemblies 130 will hereafter be referred to as the orientational indicium 495.
  • Each orientational indicium 495 provides information (e.g., visual, tactile) to a user regarding an orientational direction 1052.
  • the orientational direction 1052 can represent a general or composite direction in which the tines will ultimately be deployed, and may in some instances be referred to as a deployment direction.
  • the introducer 110/stylet assembly 130 system can desirably be rotated such that the orientation direction 1052 points toward the median plane MP. Given that the median plane MP extends over a large space, a variety of rotational orientations may technically point toward the median plane MP, albeit distantly in some instances.
  • the orientation direction 1052 may be desirable for the orientation direction 1052 to point directly to the median plane, meaning that a straight line extending in the orientational direction 1052 from (1 ) a fixed point within the introducer 110/stylet assembly 130 system that is positioned on the central longitudinal axis of said system to (2) the median plane MP yields the shortest possible straight line between said fixed point and the median plane MP.
  • the orientation indicium 495 can convey information regarding the orientational direction 1052 in any suitable manner.
  • the orientational indicium 495 is an arrow that points in the orientational direction 1052.
  • the orientation direction 1052 of each stylet assembly 130 points directly to the median plane MP. Accordingly, in the illustrated arrangement, for each stylet assembly 130, an orientational plane 1054 that subsumes the central longitudinal axis the stylet assembly 130 and extends in the orientational direction 1052 indicated by the orientational indicium 495 is orthogonal to the median plane MP. Moreover, in the illustrated arrangement, the central longitudinal axes of both stylet assemblies 130 are aligned along the transverse plane TP, such that said orientational planes 1054 of both systems are coplanar with the transverse plane TP.
  • one or more of the introducer 110/sty let assembly 130 pairs may be rotated about the central longitudinal axis thereof, such that the orientational plane 150 may be at an angle 91 or 62, respectively, relative to the transverse plane TP.
  • smaller combined (absolute) values of 91 and 92 may yield ablation fields of a desired shape and size when the tines 510, 511 are deployed.
  • relatively smaller combined (absolute) values of 91 and 92 may yield relatively broader, more controlled, and/or more predictably sized and/or shaped ablation fields.
  • FIG. 23B depicts the same arrangements as those of FIG. 23A.
  • this image depicts a later stage of the same procedure depicted in FIG. 23A.
  • the stylet assemblies 130 have been removed and replaced with needle assemblies 150 while the introducers 110 remained in the vertebra V of the patient, substantially unmoved.
  • each orientational plane 1054 passes between or bifurcates the tines 510, 511 of each respective needle assembly 150.
  • the transverse plane TP passes between or bifurcates each pair of deployed tines 510, 511 .
  • FIG. 23C schematically depicts a different procedure that is at the same stage as that depicted in FIG. 23B.
  • the introducers 110 are rotated relative to the transverse plane TP.
  • the orientational plane 1054 that subsumes the central longitudinal axis of the left introducer 110 and extends in the orientational direction 1052 thereof defines an angle 91 relative to the transverse plane TP
  • the orientational plane 1054 that subsumes the central longitudinal axis of the right introducer 110 and extends in an orientational direction 1052 thereof defines an angle 62 relative to the transverse plane TP.
  • the introducers 110 and needle assemblies 150 would be introduced into a vertebra V at angles (e.g., so as to pass through the pedicles of the vertebra) such as previously described, to facilitate the present discussion, these instruments are shown in a top plan view, making their relative rotations more apparent.
  • the tines 510, 511 which would be obscured in such a view, are shown schematically as enlarged rectangles.
  • the introducers 110, needle assemblies 150, deployed tines 510, 511 are depicted two-dimensionally. Stated otherwise, the present discussion focuses on those portions of the foregoing instruments and components, as projected onto a two-dimensional plane that is mutually orthogonal to the median plane MP and the transverse plane TP (e.g., the plane of the page).
  • Each tine 510, 511 may define, or may be represented by, a tine vector 1060, 1061 , respectively.
  • the tine vectors 1060, 1061 extend radially from a central longitudinal axis ACL of the needle assembly 150.
  • a deployment direction component 1065 which in the instant case, is fully aligned with the orientational direction 1052.
  • the deployment direction component 1065 may alternatively be referred to as a tine deployment direction, a common tine deployment direction, and/or a general tine deployment direction.
  • the orientational direction 1052 of each introducer 110 may also or alternatively be referred to as the deployment direction.
  • the orientational plane 1054 may also or alternatively be referred to as the deployment plane.
  • the deployed tines 510, 511 extend at opposite sides of the orientational plane 1054. Stated otherwise, the orientational plane 1054 passes between or bifurcates the deployed tines 510, 511 .
  • the needle assemblies 150 and their introducers 110 include attachment indicia, such as described previously herein, which can indicate to a user an attachment direction 1066 in which the instruments are to be rotationally aligned to achieve coupling.
  • An attachment plane 1068 is also shown for each system. The attachment plane 1068 subsumes the central longitudinal axis ACL of the system and extends in the attachment direction 1066 of that system. In the illustrated embodiment, the orientational plane 1054 and the attachment plane 1068 of each system are substantially orthogonal to each other.
  • FIGS. 24A-24C show further embodiments of coupled introducer 110/needle assembly 150 systems and the orientational directions attachment directions defined thereby.
  • the orientational indicium 270 includes an arrow such as previously described that points in the orientational direction 1052.
  • an orientational plane that subsumes the central longitudinal axis and extends in the direction indicated by the orientational indicium 270 would extend through the orientational indicium 270 itself.
  • an attachment plane that subsumes the central longitudinal axis and extends in an attachment direction 1066 indicated by the attachment indicium 280 would extend through the attachment indicium 280 itself.
  • the indicia 270, 280 are physically spaced apart from one another. Moreover, they are angularly spaced or angularly displaced from each other, relative to the central longitudinal axis. Likewise, the directions they indicate are angularly separated or angularly displaced from one another. In the illustrated embodiment, the angular displacement is 90 degrees. Other angular displacements are possible.
  • the orientational indicium 270 includes a pair of rectangles that signify a pathway through which the orientational direction 1052 passes.
  • the attachment indicium 280 includes a pair of ovals that signify a pathway through which the attachment direction 1066 passes.
  • an orientational plane that subsumes the central longitudinal axis and extends in the direction indicated by the orientational indicium 270 would extend through the orientational indicium itself 270, while passing between individual features of the orientation indicium 270.
  • an attachment plane that subsumes the central longitudinal axis and extends in an attachment direction 1066 indicated by the attachment indicium 280 would extend through the attachment indicium 280 itself, while passing between individual features of the attachment indicium 280.
  • the orientational indicium 270 includes an offset arrow that points in the orientational direction 1052.
  • the attachment indicium 280 includes an offset arrow that points in the attachment direction 1066.
  • an orientational plane that subsumes the central longitudinal axis and extends in the direction indicated by the orientational indicium 270 would extend alongside the orientational indicium 270, without passing through the orientation indicium 270 itself.
  • an attachment plane that subsumes the central longitudinal axis and extends in an attachment direction 1066 indicated by the attachment indicium 280 would extend alongside the attachment indicium 280, without passing through attachment indicium 280 itself.
  • FIGS. 25A-25J depict stages of illustrative methods with which embodiments of systems described herein, such as, e.g., the system 100, are compatible.
  • a pathway into the vertebra V can be created using the introducer 110 coupled with the trocar stylet assembly 120, the beveled stylet assembly 130, and/or the drill assembly 140.
  • the introducer 110 may initially be coupled with the trocar- tipped stylet assembly 120, whereas in other methods, these instruments are provided in a pre-coupled state.
  • the trocar stylet assembly 120 and the introducer 110 are advanced through the skin of the patient to the vertebra without first making an incision in the skin.
  • an incision may first be made in the patient.
  • the introducer 110 and the trocar stylet assembly 120 while in a coupled state, can be advanced through the skin of the patient and, as shown in FIG. 25A, through a pedicle of the vertebra V. This and other stages may be performed under suitable imaging, such as under fluoroscopy, to ensure proper advancement and placement.
  • a mallet is used to tap on the proximal end of the handle of the trocar stylet assembly 120 to advance the coupled devices.
  • the trocar-tipped stylet assembly 120 upon passing through cortical bone, is rotated counterclockwise (as viewed from above) relative to the introducer 110 to disconnect these instruments from each other, while the introducer 110 remains substantially fixed relative to the patient.
  • the trocar stylet assembly 120 can be retracted proximally to be fully removed from the introducer 110, while the introducer 110 remains in place within the bone, as depicted in FIG. 25B. Removal of the stylet assembly 120 may leave open a tract 1150 that the stylet assembly 120 has created in the bone.
  • the bevel-tipped stylet assembly 130 is then advanced distally through the introducer 110. Upon full distal advancement, the beveltipped assembly 130 is then rotated clockwise (as viewed from above) relative to the introducer 110 to achieve a secure connection thereto. [00306] With reference to FIG. 25D, the bevel-tipped stylet assembly 130 and the introducer 110, while still coupled with each other, can be advanced further through the cancellous bone. In some instances, the bevel-tipped stylet assembly 130 can assist in urging the introducer 110 toward the midline as the coupled devices are advanced distally, as previously described. In some instances, a mallet is used to tap on the proximal end of the handle of the bevel-tipped stylet assembly 130 to advance the coupled devices.
  • the bevel-tipped stylet assembly 130 can decoupled and removed from the introducer 110, such as depicted in FIG. 25E.
  • the stylet assembly 130 is rotated counterclockwise and retracted proximally from the introducer 110, while the introducer 110 remains in place.
  • the bone drill 140 such as to ream material from the bone.
  • the hand drill 140 can be inserted into the introducer 110 after either of the stylet assemblies 120, 130 have been removed therefrom. In the illustrated embodiment, this occurs after use of the bevel-tipped stylet assembly 130.
  • the drill 140 can be rotated and retracted to ream a desired amount of material from the vertebral body.
  • the drill 140 may then be removed from the introducer 110. This may leave an expanded, extended, and/or otherwise altered tract 1150 beyond the distal tip of the introducer 110.
  • the needle assembly 150 can be advanced through the introducer 110 with the tines in an undeployed state.
  • the needle assembly 150 can be advanced distally by a sufficient amount to be securely attach to the introducer 110, such as in manners previously discussed.
  • the tines can be deployed in manners such as previously discussed. As shown, the tines can extend further toward the median plane MP, than does the distal tip of the needle portion of the needle assembly 150.
  • Sufficient RF energy may be applied in appropriate amounts and for an appropriate time to ablate the basivertebral nerve of the subject vertebra.
  • the tines can then be retracted (e.g., by rotation of the spin collar in an opposite direction) and then the needle assemblies and introducers can be removed.
  • FIGS. 25A-25J Further examples of methods can include some or all of the foregoing steps in any suitable order, including in the order depicted in FIGS. 25A-25J. Further illustrative examples of methods that can use some or all of the foregoing steps in any suitable order and/or systems and devices disclosed herein will now be described. While many of the devices in this following disclosure do not use reference numbers specific to the drawings, it is understood that like-named instruments and features described above with respect to FIGS. 1 -25J may be suitably used in these methods. Further systems and methods described below with respect to, e.g., FIGS. 26-43 may also or alternatively be used.
  • a basivertebral nerve ablation (BVNA) system is indicated for the ablation of the basivertebral nerves in the L3 through S1 vertebrae for the relief of chronic back pain that has not responded to conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as, but not limited to, inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
  • Type 1 Modic change changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals
  • target placement for the therapeutic devices is to position the distal ends of the needle assemblies, at the same vertebral level, oriented towards midline.
  • the active tips e.g., which can include the needle tip, tines, and a distal portion of a tube of the needle assembly
  • the active tips are placed 1.5 ⁇ 0.5 centimeters apart from each other; in other embodiments, the active tips are placed 1.0 ⁇ 0.5 centimeters apart from each other.
  • the distalmost points of the tips of the needle assemblies are separated from each other by a distance that is within a range of from about 5 to about 20 millimeters, from about 5 to about 15 millimeters, from about 5 to about 10 millimeters, from about 10 to about 20 millimeters, from about 10 to about 15 millimeters, or from about 15 to about 20 millimeters, or by a distance that is within any of the ranges of from exactly 5 to 20, 5 to 15, 5 to 10, 10 to 20, 10 to 15, or 15 to 20 millimeters. Any individual value or subset of ranges from within any of the foregoing ranges is also contemplated.
  • the separation distance is 8, 8.5, 9, 9.5, 10, 10.5, 11 , 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, or 20 millimeters.
  • the system may be used at any vertebral level of the lumbosacral spine, or stated otherwise, at any of levels L1 through S1 .
  • the system may be positioned within any of levels L1 through S1 and a tip separation distance at any of such levels can be within one or more of the above-identified ranges.
  • each procedural step may be verified using imaging in the anteroposterior (AP) and lateral views.
  • the AP view may be recommended in some instances to identify the endplates, spinous processes, and pedicles, to ensure a direct anteroposterior view, and to ensure entry to the pedicle.
  • Trajectory (oblique) view may be recommended in some instances to obtain a view parallel to the pedicle (e.g., 10 to 25 degrees ipsilateral, depending on the vertebral level). Lateral view may be recommended in some instances to determine the depth and superoinferior device position within the vertebral body.
  • an initial stage includes identifying the target vertebral body.
  • the pre-assembled trocar-tipped stylet and introducer cannula can be used to enter through an incision and target pedicle access.
  • a surgical mallet can be used to drive the access instrument through the pedicle.
  • the trocar-tipped stylet can be replaced with a 45-degree bevel-tipped stylet.
  • the cancellous bone of the vertebral body can be entered working lateral to medial until the tip of the bevel-tipped stylet is approximately 0.75 cm ⁇ 0.25 cm from midline while being placed 30% - 50% anterior to the posterior wall of the vertebral body.
  • the stylet (trocar-tipped or bevel-tipped) or hand drill can be removed from the introducer while the introducer remains in place within the bone, and the RF needle assembly can be inserted into the introducer cannula. Before insertion, it can be verified that the tines are in the retracted position. The RF needle assembly can be inserted until the snap tabs, or latches, of the main hub lock in place in the connectors, or catches, of the introducer handle. The snap tabs on the side of RF needle assembly can be different widths, allowing only unidirectional device insertion.
  • the foregoing steps may be repeated to place a further pair of introducers, RF needle assemblies, and RF probes in a further vertebra, such as at an adjacent or non-adjacent vertebral level.
  • connectors of the RF probes are connected to the appropriate ports of a compatible RF generator.
  • connectors of the RF probes are connected to adapters, which adapters are in turn connected to appropriate ports of a compatible RF generator.
  • the RF generator can be operated to perform an RF ablation using appropriate time and temperature parameters. For example, in some instances, RF ablation may take place for three to four minutes at a temperature of 85 degrees Celsius.
  • an ablation of the BVN may be completed at a temperature of no greater than about 85 degrees Celsius or about 85 degrees Celsius; and for a period, during which RF energy is supplied to the needle assemblies, of no greater than about 3, 3.5, 4, 4.5, 5, 5.5, or 6 minutes or no greater than exactly 3, 3.5, 4, 4.5, 5, 5.5, or 6 minutes.
  • the needle assemblies and cannulae can be removed from the patient.
  • the first pair of needle assemblies can ablate a first basivertebral nerve within a first vertebra for a first time period and the second pair of needle assemblies can ablate a second basivertebral nerve within a second vertebra for a second time period, and the first and second time periods may overlap (e.g., fully overlap or partially overlap).
  • neither pair of needle assemblies is energized at the same instant.
  • the generator may rapidly alternate energization of the first and second pairs of needle assemblies.
  • the first and second time periods may represent, for example, total treatment periods over which ablative energy is applied to the respective needle assembly pairs.
  • the cover 1410 extends over the fluted end of the drill bit.
  • the cover 1410 can be attached to the distal end of the drill bit via an interference fit.
  • a system 2100 can include an introducer 2110, a trocar-tipped stylet assembly 2120, a bevel-tipped stylet assembly 2130, and a needle assembly 2150. These instruments can resemble like-named and like-numbered instruments of the system 100 in many respects. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to “21.” Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the system 2100 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows.
  • the system 2100 can further include a hand drill 140 and an RF probe assembly 160, which may be substantially the same as these like-numbered instruments described previously.
  • the introducer 2110 includes a handle 2114 fixedly secured to an introducer cannula 2112. As with other embodiments disclosed herein, the introducer 2110 includes an orientation indicium 2270.
  • the connector 2226 includes a locking actuator 2300 that is biased toward a locked configuration by a biasing member 2302, such as a coil spring.
  • the handle 2114 includes a cavity 2304, and the locking actuator 2300 includes a locking rim 2306 that projects into the cavity 2304 when the actuator 2300 is in the locked configuration.
  • the locking actuator 2300 further defines an enlarged opening 2310 that is sized to permit passage therethrough of the elongated member of either the stylet assembly 2130 or the needle assembly 2150 when the actuator 2300 is laterally displaced, against the bias provided by the biasing member 2302, to an open configuration.
  • the locking actuator 2300 is automatically transitioned to the open configuration as either the stylet assembly 2130 or the needle assembly 2150 is advanced therethrough.
  • a user may press on the actuator 2300 to overcome the biasing force of the bias member 2302 to transition the actuator 2300 to the open state, e.g., either for coupling or decoupling an instrument with the introducer 2110.
  • the keying interface 2140 includes the cavity 2304 and a longitudinally extending flat wall 2320 along one side thereof.
  • a handle 2124 of the trocar-tipped stylet assembly 2120 can be significantly different from the handle 124 discussed above.
  • the handle 2124 includes a strike surface at an upper end of a body thereof.
  • a stem that extends distally from the body is configured to remain at an exterior of the handle 2114 of the introducer 2110.
  • the handle 2124 of the stylet assembly 2120 in this embodiment, does not obscure the orientation indicium 2270 of the introducer handle 2114 when these instruments are coupled together. Stated otherwise, the orientation indicium 2270 remains visually perceivable when the instruments are thusly coupled.
  • the distally extending stem may be configured to be received within the cavity 2304 of the introducer handle 2114.
  • the handle 2124 may instead be substantially identical to a handle 2134 of the trocar- tipped stylet assembly 2130, which is discussed hereafter.

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Abstract

Certains systèmes d'ablation de nerf intra-osseux peuvent comprendre un introducteur qui peut être inséré dans un os. Dans certains cas, l'introducteur peut être sélectivement accouplé à un ou plusieurs instruments pour aider à la mise en place ou à la manipulation de l'os. Un ensemble aiguille peut être sélectivement accouplé à l'introducteur. L'ensemble aiguille peut comprendre des dents déployables. Dans certains cas, deux introducteurs et deux ensembles aiguilles sont placés sur différents côtés du nerf intra-osseux. Les ensembles aiguilles peuvent être, dans certains cas, actionnés dans un mode bipolaire pour appliquer de l'énergie radiofréquence à l'intérieur de l'os pour effectuer une ablation du nerf intra-osseux.
PCT/US2025/014681 2024-02-05 2025-02-05 Dispositifs, systèmes, et procédés d'ablation de nerf intra-osseux Pending WO2025171068A1 (fr)

Applications Claiming Priority (8)

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US63/555,388 2024-02-19
US202463661107P 2024-06-18 2024-06-18
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US202463694040P 2024-09-12 2024-09-12
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210177502A1 (en) * 2010-05-21 2021-06-17 Stratus Medical, LLC Devices and methods for radiofrequency neurotomy
US20210267632A1 (en) * 2019-09-12 2021-09-02 Relievant Medsystems, Inc. Accessing and treating tissue within a vertebral body
US20220015775A1 (en) * 2012-11-05 2022-01-20 Relievant Medsystems, Inc. Methods of navigation and treatment within a vertebral body

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210177502A1 (en) * 2010-05-21 2021-06-17 Stratus Medical, LLC Devices and methods for radiofrequency neurotomy
US20220015775A1 (en) * 2012-11-05 2022-01-20 Relievant Medsystems, Inc. Methods of navigation and treatment within a vertebral body
US20210267632A1 (en) * 2019-09-12 2021-09-02 Relievant Medsystems, Inc. Accessing and treating tissue within a vertebral body

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