Tools for creating spinal channels in radiofrequency ablation and methods of making and using same

Abstract

A tool device for forming a channel in a spine for performing nerve ablation, comprising: a ram having a distal end portion comprising a tip for creating a channel in the spine and a bendable portion for guiding the tip within the spine along a curved path; comprising a casing body, the casing body being straight along the entire length of the casing body and configured to receive and straighten the bendable portion of the tamper bar; and a tool interface including a fixed casing attachment coupled to the first casing and a movable head coupled to the ram, the movable head configured to move toward or away from the fixed casing attachment, and the bendable part of the tamping rod extends out of the first sleeve or retracts into the first sleeve.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Serial No. 63 / 413,122, filed on October 4, 2022, which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to the field of radiofrequency (RF) ablation and methods of preparing for RF ablation. The present disclosure also relates to a tool for creating a spinal channel for RF ablation, and methods of making and using the tool. Background Art

[0004] Radiofrequency (RF) generators and electrodes can be used to relieve pain or modify function. Radiofrequency ablation (RFA) is a safe, reliable method of blocking pain signals, such as those from irritated facet joints in the spine, articular nerves in the knee, and the femoral and obturator nerves in the hip. RF current is used to heat a small area of ​​nerve tissue, thereby blocking pain signals from a specific area. RF ablation is designed to provide long-lasting pain relief.

[0005] Vertebral nerve ablation (BVN) can be used, for example, to treat discogenic back pain or other conditions. The vertebral nerves are ablated using RF energy. Typically, the roots of the vertebral nerves are located near the center of the patient's spinal body (e.g., approximately 50% / 50% cranial to caudal, 50% / 50% left to right, and 60%-75% / 25%-40% anterior to posterior). In at least some embodiments, to access the ablation target, the clinician can pass through the pedicles of the spine (left or right) and then turn to the midline. In addition to the pedicles, an extrapedicle approach can also be used. A channel is created through the bone and then electrodes are inserted into the bone for ablation. Creating a curved channel within the spine to access the vertebral nerves is challenging. Summary of the invention

[0006] One aspect is a tool device for forming a channel in a spine to perform nerve ablation. The tool device includes: a tamper having a distal end portion and a proximal end portion, wherein the distal end portion includes: a tip configured to create a channel in the spine and a bendable portion coupled to the tip and configured to guide the tip along a curved path within the spine; a first cannula, which includes a cannula body defining a lumen through which the tamper can extend, wherein the cannula body is straight along the entire length of the cannula body, and the first cannula is configured to receive the bendable portion of the tamper and straighten the bendable portion when the bendable portion is received in the first cannula; and a tool interface, the tool interface including a fixed cannula attachment coupled to the first cannula and a movable head coupled to the tamper, the movable head configured to move toward or away from the fixed cannula attachment to extend or retract the bendable portion of the tamper from or into the first cannula, respectively.

[0007] In at least some aspects, the first sleeve is a ram rod sleeve, and the tool apparatus further includes an access tool including an access tool handle and an access tool sleeve, wherein the access tool sleeve is straight along an entire length of the access tool sleeve, and the access tool is configured to receive the ram rod sleeve within the access tool sleeve.

[0008] In at least some aspects, the tool apparatus further includes an access tool having an access tool handle and a first cannula.

[0009] In at least some aspects, the tool interface further includes a rotatable collar disposed between the fixed sleeve attachment and the movable head. In at least some aspects, the movable head includes a threaded rod. In at least some aspects, the rotatable collar includes a lumen having a threaded portion, the lumen being configured to receive and interact with the threaded rod of the movable head. In at least some aspects, the rotating collar moves the movable head away from the fixed sleeve attachment or toward the fixed sleeve attachment depending on the direction of rotation. In at least some aspects, the fixed sleeve attachment includes a shaft, and when the movable head moves toward the fixed sleeve attachment, the movable head or the rotatable collar slides along the shaft to extend the bendable portion of the tamping bar out of the first sleeve.

[0010] In at least some aspects, the movable head includes an impact element to receive an impact from a hammer or mallet. In at least some aspects, the bendable portion of the tamping bar is defined by a notch relative to the axis and the end, and is offset relative to the central axis of at least one of the axis or the end of the tamping bar. In at least some aspects, the bendable portion is bent away from the notch. In at least some aspects, the bendable portion of the tamping bar defines a release path along the bendable portion. In at least some aspects, the tool device further includes at least two traction wires attached to the end of the tamping bar to manually guide the tamping bar to form a channel.

[0011] Another aspect is a method for forming a channel in the spine to perform nerve ablation. The method includes inserting an access tool cannula of an access tool into the spine of a patient, wherein the access tool cannula is straight; inserting a tamper cannula of a tamper tool into the access tool cannula of the access tool, wherein the tamper cannula is straight; and operating a tool interface of the tamper tool to extend a distal end portion of the tamper bar beyond the distal end of the tamper cannula to form a channel, wherein the distal end portion of the tamper bar includes a tip configured to create a channel in the spine and a bendable portion coupled to the tip and configured to guide the tip along a curved path within the spine, wherein the bendable portion is biased to bend when located outside the tamper cannula, wherein the bendable portion is straight within the tamper cannula before extending beyond the distal end of the tamper cannula.

[0012] In at least some aspects, operating the tool interface includes driving a movable head of the tool interface toward a fixed sleeve attachment of the tool interface, wherein the tamping bar is coupled to the movable head. In at least some aspects, the method further includes operating the tool interface of the tamping bar tool to retract a bendable portion of the tamping bar into the tamping bar sleeve and straighten the bendable portion within the tamping bar sleeve after forming the channel. In at least some aspects, operating the tool interface to retract the bendable portion includes rotating a rotatable collar of the tool interface to move the movable head of the tool interface away from the fixed sleeve attachment of the tool interface, wherein the tamping bar is coupled to the movable head.

[0013] On the other hand, a tamper tool for forming a channel in the spine to perform nerve ablation. The tamper tool includes a tamper having a distal end portion and a proximal end portion, wherein the distal end portion includes a tip configured to create a channel in the spine and a bendable portion coupled to the tip and configured to guide the tip along a curved path within the spine; a tamper sleeve, which includes a sleeve body defining a lumen through which the tamper can extend, wherein the tamper sleeve is configured to receive the bendable portion of the tamper, wherein the bendable portion of the tamper is biased to bend when located outside the tamper sleeve; and a tool interface, the tool interface including a fixed sleeve attachment coupled to the tamper sleeve, a movable head coupled to the tamper, and a rotatable collar, the rotatable collar being configured to move the movable head toward or away from the fixed sleeve attachment to extend or retract the bendable portion of the tamper from a first sleeve into the first sleeve, respectively.

[0014] In at least some aspects, the movable head includes a threaded rod, and the rotatable collar includes a lumen having a threaded portion configured to receive and interact with the threaded rod. In at least some aspects, the fixed sleeve attachment includes a shaft, and when the movable head moves toward the fixed sleeve attachment, the movable head or the rotatable collar slides along the shaft to extend the bendable portion of the tamping bar out of the tamping bar sleeve. In at least some aspects, the tamping bar sleeve is straight and is configured to straighten the bendable portion of the tamping bar when the bendable portion is received in the tamping bar sleeve.

[0015] Another aspect is a method for forming a channel in the spine to perform nerve ablation. The method includes inserting an access tool sleeve of an access tool into the spine of a patient; inserting a tamper sleeve of one of the above-mentioned tamper tools into the access tool sleeve of the access tool; and driving a movable head of the tool interface toward a fixed sleeve attachment of the tool interface so that a distal end portion of the tamper extends out of a distal end of the tamper sleeve to form a channel, wherein the distal end portion of the tamper includes a tip configured to create a channel in the spine and a bendable portion coupled to the tip and configured to guide the tip along a curved path within the spine, wherein the bendable portion is biased to bend when located outside the tamper sleeve. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings.In the drawings, like reference numerals refer to like parts throughout the various views unless otherwise specified.

[0017] For a better understanding of the present invention, reference will be made to the following detailed description, which should be read in conjunction with the accompanying drawings, in which:

[0018] FIG1 is a schematic side view of components of one embodiment of a conventional RF ablation system;

[0019] Figure 2 is a schematic perspective view of one embodiment of an access tool and a probe;

[0020] Figure 3 is a schematic side view of one embodiment of a tamping bar tool;

[0021] Figure 4A is connected to Figure 2 Close to the tool Figure 3 A schematic side view of a tamping tool of , wherein the tamping bar of the tamping tool is retracted;

[0022] Figure 4B is connected to Figure 2 Close to the tool Figure 3 A schematic side view of a tamping rod tool of , wherein the tamping rod of the tamping rod tool is retracted before the tamping rod is extended;

[0023] Figure 4C is connected to Figure 2 Close to the tool Figure 3 A schematic cross-sectional side view of a tamping rod tool of , wherein the tamping rod of the tamping rod tool is extended;

[0024] Figure 4D yes Figure 3 Three schematic side views of a tamping rod tool of , showing the tamping rod retracted into a tamping rod sleeve of the tamping rod tool;

[0025] Figure 4E Two schematic perspective views showing a tool interface of another embodiment of a tamper tool, with the tamper in a retracted position (left) or an extended position (right);

[0026] Figure 4F Two schematic perspective views showing a tool interface of another embodiment of a tamper tool, with the tamper in a retracted position (left) or an extended position (right);

[0027] Figure 4G Two schematic perspective views showing a tool interface of yet another embodiment of a tamping bar tool, with the tamping bar tool in a retracted position (left) or an extended position (right);

[0028] Figure 5 is a schematic side view of a distal portion of a tamper of a tamper tool;

[0029] FIG. 6A to FIG. 6G are perspective views of various embodiments of the end of a tamping bar of a tamping bar tool;

[0030] Fig. 7A is a schematic perspective view of a distal portion of one embodiment of a tamper bar;

[0031] Figure 7B is a schematic perspective view of a distal portion of another embodiment of a tamper with a release passage;

[0032] Fig. 8A is a schematic side view of a distal end portion of a first embodiment of a tamper having a cutout portion defining a bendable region of the tamper;

[0033] Figure 8B is a schematic side view of a distal portion of a second embodiment of a tamper having a cutout portion defining a bendable region of the tamper, wherein the bendable region is offset in one direction from a central axis of the tamper shaft and in another direction from a central axis of a tip of the tamper;

[0034] Figure 8C is a schematic side view of a distal portion of a third embodiment of a tamper bar, wherein two opposing cutout portions define a bendable region of the tamper bar;

[0035] Fig.8D yes Figure 8C a cross-sectional view of the bendable region of the tamper bar shown;

[0036] Fig. 8E is a schematic side view of a distal portion of a fourth embodiment of a tamper bar, wherein the bendable region of the tamper bar has a variable thickness;

[0037] Fig. 9A is a schematic side view of a distal portion of a fifth embodiment of a tamper bar, wherein a cutout portion defines a bendable region of the tamper bar and a linear region between the bendable region and the shaft of the tamper bar;

[0038] Fig. 9B is a schematic side view of a distal portion of a sixth embodiment of a tamper bar, wherein a cutout portion defines a bendable region of the tamper bar and a straight region between the bendable region and the distal end of the tamper bar;

[0039] Fig. 10A is a schematic side view of a distal portion of a seventh embodiment of a tamper bar, wherein the bendable region of the tamper bar is formed using a bendable tubular member;

[0040] Fig. 10B yes Fig. 10A A cross-sectional view of a bendable region of a tamping rod;

[0041] Fig. 10C is a schematic side view of a distal portion of an eighth embodiment of a tamper bar, wherein a bendable region of the tamper bar is defined by a plurality of notched teeth;

[0042] Fig. 10D is a schematic side view of a distal portion of a ninth embodiment of a tamper bar, wherein a bendable region of the tamper bar is defined by a plurality of micro-cuts;

[0043] Fig.10E is a schematic side view of a distal portion of a tenth embodiment of a tamper bar, wherein the bendable region of the tamper bar is formed using a bendable tubing and a probe extending through the bendable tubing and having a tip of the tamper bar at a distal end of the probe;

[0044] Fig.10F Shows Fig.10E a distal portion of the tamping rod, wherein the probe further extends out of the bendable tubular member;

[0045] Fig.11A is a schematic side view of a distal portion of an eleventh embodiment of a tamper bar having a bendable region and having a traction wire attached to the distal end for guiding the tamper bar;

[0046] Fig. 11B is a schematic side view of one embodiment of a handle for operating a pull line;

[0047] Fig. 11C is a schematic side elevational view of an end portion of a twelfth embodiment of a tamper having an opening therein for receiving bone fragments or particles;

[0048] Fig. 12A and Fig. 12B is a schematic side view of another embodiment of a tool interface that utilizes a rack and pinion arrangement to extend a tamper bar ( Fig. 12A ) and the retracted tamper ( Fig. 12B )

[0049] Fig. 12C and Fig.12D is a schematic side view of another embodiment of a tool interface that utilizes another device to extend the tamping rod ( Fig. 12C ) and the retracted tamper ( Fig.12D ); and

[0050] Fig.13 yes Figure 3 A schematic side view of a tamping tool of Figure 2 An access tool wherein a locking mechanism is used to lock the tamping bar tool to the access tool. DETAILED DESCRIPTION

[0051] The present disclosure relates to the field of radiofrequency (RF) ablation and methods of preparing for RF ablation. The present disclosure also relates to a tool for creating a spinal channel for RF ablation, and methods of making and using the tool.

[0052] FIG. 1 shows an embodiment of a conventional RF ablation system 100, which includes an RF generator 102, an RF electrode 104, a cannula 106, a ground pad 107, and an optional extension cable 109. The cannula 106 includes a cannula interface 108, an insulating shaft 110, and an active end 112. The insulating shaft 110 is hollow for receiving the RF electrode 104. When inserted, the RF electrode 104 contacts and excites the active end 112 of the cannula 106 to produce RF ablation. The RF electrode 104 includes an electrode shaft 114, an electrode interface 116, a cable 118 electrically coupled to the electrode shaft 114, and a connector 120, which is used to connect to a port 122 of the RF generator 102 to excite the electrode shaft 114 through the cable 118 and the connector 120. The optional adapter or extension 109 includes a cable 119 and connectors 117a, 117b for coupling the RF electrode 104 to the RF generator 102. It will be appreciated that other RF ablation systems utilize the RF electrode 104 to perform ablation in place of or in addition to the cannula 106 .

[0053] The RF generator 102 can include one or more ports 122 and at least one screen 130. In at least some embodiments, each port 122 is associated with a portion of the screen 130 (or a different screen) and can receive a connector 120 from the RF electrode 104. Information such as current, voltage, status, time, temperature, power, impedance, etc. or any combination thereof can be displayed on the screen 130. In at least some embodiments, each port 122 corresponds to an independent path for operating the RF electrode 104. The RF generator 102 also includes a ground port 121 for attachment to a ground pad 107.

[0054] Examples of RF generators and RF ablation systems and methods of making and using RF generators and RF ablation systems can be found in, for example, U.S. Patent Nos. 9,717,552; 9,956,032; 10,111,703; 10,136,937; 10,136,942; 10,136,943; 10,194,971; 10,342,606; 10,363,063; 10,588,687; 10,631 ,915; 10,639,098; and 10,639,101; and U.S. Patent Application Publication Nos. 2014 / 0066917; 2014 / 081260; 2014 / 0121658; 2021 / 0121224; 2021 / 0236191; 2022 / 0202484; 2022 / 0202485; and 2022 / 0226039, all of which are incorporated herein by reference in their entirety.

[0055] Vertebral nerve ablation (BVN) can be used, for example, to treat discogenic back pain or other diseases. The vertebral nerves are ablated using RF energy. Typically, the roots or central confluence of the main vertebral nerve intraspinal branches are located near the center of the patient's spinal body (e.g., approximately 50% / 50% cranial to caudal, 50% / 50% left to right, and 60%-75% / 25%-40% anterior to posterior.) In at least some embodiments, in order to approach the ablation target, a channel is created through the vertebrae and then electrodes are inserted into the vertebrae for ablation. In at least some embodiments, in order to form the channel, the clinician uses a tool to pass through the pedicles of the spine (left or right) and then turn to the midline. In addition to the pedicles, extrapedicle approaches can also be used.

[0056] In at least some embodiments, a straight passage through the pedicle to the vertebral body is created using an approach tool. In addition to the pedicle, an extrapedicle approach can also be adopted. Then a tamping rod tool is used to create a curved passage on the bone. The tamping rod tool described herein can be used to create a curved passage in a hard medium (such as bone). In at least some embodiments, the tamping rod tool can create a curved passage with enough curvature for various anatomical structures presented by patient diversity (e.g., differences in age, sex, size, etc., or the presence of a disease or obstacle, such as scoliosis, which may change bone shape, density, homogeneity, vertebral form, etc.). In at least some embodiments, the tamping rod tool can create a curved passage within the entire spinal level range (e.g., at least from L3 to S1).

[0057] In at least some embodiments, the tamping rod of the tamping rod tool is straight to travel down the pedicle. In at least some embodiments, a portion of the tamping rod is bent as the tamping rod enters the vertebral body. For example, a portion of the tamping rod is bent toward the midline. In at least some embodiments, the tamping rod tool is durable enough to withstand the drilling action of the clinician with a hammer, and is also flexible enough to rotate.

[0058] In at least some embodiments, the tamping rod tool retains the ability to carve a curved passageway over multiple uses. Many ablation procedures involve ablating 2, 3, 4 or more spinal layers. In addition, sometimes drilling a passageway is unsuccessful due to bone deformation, anatomical structure or other factors, and the tamping rod tool may be used multiple times on a single spinal layer.

[0059] Figure 2 One embodiment of an access tool 232 is shown in which a stylet 234 is inserted into the open lumen of an access tool cannula 235 of the access tool, leaving a stylet handle 236 of the stylet outside of the access tool and adjacent to an access tool cannula handle 238 of the access tool. The distal end 237 of the stylet 234 can have any suitable shape, including but not limited to a bevel, diamond, trocar, etc.

[0060] Figure 3 An embodiment of a tamper tool 240 is shown, which includes a tamper sleeve 242 that fits into the open lumen of an approach tool sleeve 235; a tamper 244 that extends through the tamper sleeve and can be retracted into and extended from the distal end of the tamper sleeve; and a tool interface 246 that is attached to the proximal end of the tamper sleeve. Tamper sleeve 242 and approach tool sleeve 235 are straight and not curved. In particular, the distal end portions of tamper sleeve 242 and approach tool sleeve 235 are not curved.

[0061] The distal portion 260 of the tamper 244 includes a tip 262, a bendable portion 264, and a shaft 266 (see also Figure 5 ). In at least some embodiments, the tamper bar 244, or at least the bendable portion 264 of the tamper bar, is constructed of nitinol, spring steel, or any other suitable flexible metal or other material. In at least some embodiments, the bendable portion 264 is biased to bend unless a force is applied to straighten the bendable portion. In at least some embodiments, the bendable portion 264 of the tamper bar 244 can be bent and held by a fixture and then heat set in an oven (e.g., heat set in a hot salt bath at 520° C. (or any other suitable temperature) for 8 minutes) to bias the bendable portion 264 to bend. In at least some embodiments, a polymeric material can be overmolded, heat shrunk, or otherwise disposed on the bendable portion 264 to provide a consistent cross-sectional size.

[0062] Figure 3 2 shows one embodiment of a type of tool interface 246 that includes a fixed sleeve attachment 248, a rotatable collar 250, and a movable head 252. In at least some embodiments, the tamper sleeve 242 is attached to the fixed sleeve attachment 248 of the tool interface 246. Figure 4A As shown, the movable head optionally includes an impact element 253 attached to a threaded rod 254, and optionally includes a handle 251. The collar 250 includes a lumen 256 with a threaded portion that interacts with the threaded rod 254, and the fixed sleeve attachment 248 includes a shaft 249 that fits within the lumen 256 of the collar. The threaded rod 254 is attached to the proximal portion 258 of the tamper 244.

[0063] In operation, Figure 2 As shown, the probe 234 is inserted into the access tool 232, and the combination is then inserted into the left or right pedicle. After passing through the pedicle, the probe 234 is removed. In addition to the transpedicular approach, an extrapedicular approach using the access tool 232 can be used, in which case the probe 234 is removed after entering the spine.

[0064] The tamping rod tool 240 is then obtained, wherein the tamping rod 244 is retracted into the tamping rod sleeve 242. Figure 4A As shown, tamping bar sleeve 242 of tamping bar tool 240 is inserted into access tool sleeve 235 of access tool 232 .

[0065] In at least some embodiments, ram bar sleeve 242 and access tool sleeve 235 of access tool 232 are arranged such that the distal ends of ram bar sleeve 242 and access tool sleeve 235 terminate at or near the same location in the spine when ram bar sleeve 242 is fully inserted into access tool sleeve 235. In at least some embodiments, ram bar sleeve 242 and access tool sleeve 235 of access tool 232 are arranged such that the distal end of ram bar sleeve 242 extends beyond the distal end of access tool sleeve 235 when ram bar sleeve 242 is fully inserted into access tool sleeve 235.

[0066] The collar 250 is rotated to retract the collar away from the fixed sleeve attachment 248, as shown. Figure 4B The movable head 252 is then struck (with a hammer or mallet) or otherwise manipulated to push the movable head 252 and collar 250 toward the fixed sleeve attachment 248, as shown. Figure 4C The movable head 252 and collar 250 combination slides along the axis 249 of the fixed sleeve attachment 248. In at least some embodiments, as Figure 4C As shown, when the collar 250 is pushed against the fixed sleeve attachment 248, the shaft 249 or other portion of the fixed sleeve attachment 248 acts as a stop.

[0067] like Figure 3 As shown, the movable head 252 and the collar 250 are pushed toward the fixed sleeve attachment 248 to extend the ram rod 244 out of the ram rod sleeve 242 to form a channel into the vertebra. When the ram rod 244 extends out of the ram rod sleeve, the bendable portion 264 of the ram rod 244 bends to form a curved channel in the spine.

[0068] After the channel is created, the collar 250 is rotated while maintaining contact with the fixed sleeve attachment 248 so that as the collar 250 is rotated and the threaded rod 254 is translated upward, the movable head 252 moves away from the collar 250, as shown in FIG. Figure 4D 242. This retracts the tamping rod 244 into the tamping rod sleeve 242. The retraction of the tamping rod 244 causes the tamping rod to straighten within the straight tamping rod sleeve 242. The tamping rod tool 240 is then removed from the access tool 232. In at least some embodiments, the access tool 232 may also be used with the sleeve 106 or the RF electrode 104 (or both) of the RF ablation system 100 (see FIG. 1). In at least some embodiments, the tamping rod 244 may include one or more electrodes, for example, at the distal end 262 ( Figure 5 ) on or near, and can be used as a monopolar or bipolar RF electrode to perform RF ablation. In at least some embodiments, the tamping rod sleeve 242 can serve as a return electrode.

[0069] In at least some embodiments, tamping bar tool 240 may include a stopper that prevents tamping bar 244 from being pulled too far into tamping bar sleeve 242. This may prevent or inhibit distal end 262 ( Figure 5 ) drill into the inner wall of the tamping rod sleeve 242.

[0070] Figure 4E Another embodiment of a tool interface 246 is shown, which includes a movable head 252 having an impact element 253 and a threaded rod 254, a fixed sleeve attachment 248, and a rotatable collar 250 having a lumen 256 with a threaded portion. In at least some embodiments, as Figure 4E As shown, the rotatable collar 250 may not move upward or downward relative to the fixed sleeve attachment 248. Figure 4E In the figure, the left figure shows the tool interface 246 with the tamping rod retracted into the tamping rod sleeve, and the right figure shows the tool interface with the tamping rod extended out of the tamping rod sleeve.

[0071] Figure 4F Another embodiment of a tool interface 246 is shown, which includes a movable head 252 with an optional impact element 253, a fixed sleeve attachment 248 with a threaded rod 254, and a rotatable collar 250, which functions similarly to Figure 4E The tool interface 246 is shown. In at least some embodiments, as Figure 4F As shown, the rotatable collar 250 does not move upward or downward relative to the fixed sleeve attachment 248. Figure 4F In the figure, the left figure shows the tool interface 246 with the tamping rod retracted into the tamping rod sleeve, and the right figure shows the tool interface with the tamping rod extended out of the tamping rod sleeve.

[0072] Figure 4G 246, which includes a movable head 252 with an optional impact element 253, a fixed sleeve attachment 248, and a cam handle 255. In at least some embodiments, as Figure 4G As shown, the rotatable handle 255 is operated to translate the movable head 252 (which is attached to the tamper bar) upward or downward. Figure 4G In the figure, the left figure shows the tool interface 246 with the tamping rod retracted into the tamping rod sleeve, and the right figure shows the tool interface with the tamping rod extended out of the tamping rod sleeve.

[0073] Although the examples described herein include ram rod sleeve 242, it should be understood that in other embodiments, the ram rod sleeve is not present and access tool sleeve 235 may be used in place of any of the functions described herein for the ram rod sleeve. For example, access tool sleeve 235 may straighten ram rod 244 when the ram rod is received in the access tool sleeve.

[0074] Go to Figure 5and a tamping rod 244, wherein in at least some embodiments, the distal end 262 of the tamping rod is pointed. Figure 5 As shown, in at least some embodiments, the end 262 includes an inclined surface 261 in the direction of the bend 259 of the bendable portion 264 to assist in bending. Examples of other inclined surfaces 261 of the end 262 are shown in FIG. 6A to FIG. 6G and includes a beveled end ( Fig. 6A ), curved end( Figure 6B , which can contribute to a sharp tip), a multifaceted tip ( Figure 6C ), open the end ( Fig.6D ), double wedge-shaped end ( Fig. 6E ), curved double wedge end ( Fig. 6F ) or blunt tip ( Figure 6G ). It will be appreciated that any other suitable end 262 may be used. Similar ends may be used for Figure 2 The end 237 of the probe 234 .

[0075] like Figure 5 As shown, in at least some embodiments, the bendable portion 264 has a smaller thickness 263 in the plane of the bend than the portion of the end 262 and the shaft 266 immediately adjacent to the bendable portion. In at least some embodiments, the lateral width 263 is at least 0.042 inches (or about 1 mm). In at least some embodiments, the thickness 263 of the bendable portion 264 in the plane of the bend is less than the width of the bendable portion in the plane perpendicular to the bend.

[0076] In at least some embodiments, the bendable portion 264 bends at an angle of at least 60, 65, 70, 75, 80, 85 or 90 degrees when fully extended from the ram rod sleeve 242. In at least some embodiments, the bendable portion 264 bends at an angle of no more than 100 or 90 degrees when fully extended from the ram rod sleeve 242.

[0077] In at least some embodiments, a smaller or larger length of the bendable portion 264 can result in a smaller or larger radius of curvature. In at least some embodiments, a smaller radius of curvature may be desirable for spinal layers having smaller or more laterally oriented pedicles or smaller spinal bodies. In at least some embodiments, a larger radius may be desirable for spinal layers having larger or more medially oriented pedicles or larger spinal bodies.

[0078] In at least some embodiments, at least a portion of edge 267 of bendable portion 264 is relieved inwardly toward the center of bendable portion 264 relative to distal end 262 and adjacent portions of shaft 266, such as Fig. 7AIn at least some embodiments, the edge 267 of the bendable portion 264 is released. This can facilitate the retraction of the ramming rod 244 into the ramming rod sleeve 242.

[0079] In at least some embodiments, distal portion 260 of ram 244 defines a notch 265 between tip 262 and shaft 266. Notch 265 can be described as a portion of ram 264 that is removed or absent when considered relative to adjacent portions of tip 262 and shaft 266. This results in bendable portion 264 having a thinner portion of ram 244 than adjacent portions of tip 262 and shaft 266. In at least some embodiments, bendable portion 264 is defined by notch 265 to facilitate bending. Figure 5 and Fig. 7A As shown, in at least some embodiments, the bendable portion 264 bends away from the cutout 265 .

[0080] In at least some embodiments, the cross-section of the bendable portion 264 can have a D-shape or be substantially D-shaped. In at least some embodiments, the straight portion of the D-shape is defined by the cutout 265. In at least some other embodiments, the cross-section of the bendable portion 264 can be circular, oval, square, rectangular, tetrahedron, hexagonal, octagonal, or any other suitable shape. In at least some embodiments, a circular or other shape (e.g., square, hexagonal, octagonal, etc.) having similar dimensions in multiple directions may help actively manipulate the bending of the bendable portion 264 in different directions. A rectangular or oval cross-section may cause a preferential bending direction.

[0081] In at least some embodiments, the bendable portion 264 includes a release passage 243 extending along at least a portion of the bendable portion 264, such as Figure 7B The lateral cross-sectional profile of the release passage 264 may be curved (eg Figure 7B As shown), square, triangle, pentagon, hexagon, octagon or any other suitable regular or irregular shape.

[0082] like Figure 5 and Fig. 8A As shown, in at least some embodiments, the bendable portion 264 is offset relative to the central axis 277 of the adjacent portion of the shaft 266. Fig. 8A As shown, in at least some embodiments, the bendable portion 264 is offset from the central axis 277' of the adjacent portion of the end 262. Figure 5 and Fig. 8AAs shown, in at least some embodiments, the bendable portion 264 deviates toward the inside of the bend. In at least some embodiments, it has been found that this bend or bend direction creates a smooth channel. However, it should be understood that the bendable portion 264 can be designed to bend in another direction so that the deviation is toward the outside of the bend.

[0083] In at least some embodiments, the bendable portion 264 of the tamper 244 can be offset from the central axis of the shaft 266 in one direction and offset from the distal end 262 in an opposite direction, such as Figure 8B In at least some embodiments, this arrangement can reduce the strain on the bendable portion 264.

[0084] like Figure 8C As shown, in at least some embodiments, tamper 244 includes a complementary cutout 265' opposite cutout 265. In at least some embodiments, bendable portion 264 is offset relative to central axis 277 of an adjacent portion of shaft 266, or may be centered relative to the central axis of an adjacent portion of the shaft. Fig.8D One embodiment of a cross section of a bendable portion 264 defined by a cutout 265 and a supplementary cutout 265 ′ is shown.

[0085] In at least some embodiments, the bendable portion 264 has a uniform thickness along the length of the bendable portion 264 (optionally, except for a relatively short region adjacent to the end 262 or the shaft 266 or both). Fig. 8E As shown, in at least some embodiments, the bendable portion 264 has a thickness that varies along the length of the bendable region. Fig. 8E In the embodiment of the present invention, the thickness of the bendable portion 264 decreases from the distal end to the proximal end of the bendable portion. When the tamping rod 244 leaves the tamping rod sleeve 242, this device can facilitate more aggressive bending, and as the tamping rod continues to leave the tamping rod sleeve, the flexibility increases. It should be appreciated that other patterns of thickness variation can be used, including but not limited to increasing thickness from the distal end to the proximal end, or increasing thickness and then decreasing thickness along the length of the tamping rod (or vice versa). These changes in thickness can occur along the entire bendable portion 264 or along one or more portions of the bendable portion.

[0086] like Fig. 9A As shown, in at least some embodiments, in addition to the bendable portion 264, the cutout 265 also defines at least one straight segment 269. Fig. 9AAs shown, in at least some embodiments, the straight section 269 can be disposed adjacent the shaft 266. In at least some embodiments, such positioning of the straight section 269 can provide strain relief for the ram bar 244, particularly when the ram bar 244 is positioned in or retracted into the ram bar sleeve 242.

[0087] like Fig. 9B As shown, in at least some embodiments, straight section 269 can be positioned adjacent end 262. In at least some embodiments, such positioning of straight section 269' can help clear the channel formed by tamping bar 244 when the tamping bar is retracted into tamping bar sleeve 242. In at least some embodiments, such positioning of straight section 269' can help form a channel having an elliptical cross-section.

[0088] Other arrangements of bendable portion 264 may be used. For example, Fig. 10A and Fig. 10B As shown, the bendable portion 264 can be made of a tube of a bendable material, such as nitinol. In at least some embodiments, the bendable portion 264 is at least partially made of a tube of a bendable material, such as nitinol. Fig. 10C The plurality of cutout teeth 271 shown or Fig. 10D A set of micro-cuts 273 are shown as defining.

[0089] Another embodiment of the tamping rod 244 includes a bendable portion 264 made of a bendable tubing (such as a nitinol tubing) and a probe 280 extending through the bendable portion 264 and forming a distal end 262, such as Fig.10E As shown. Fig.10F As shown, in at least some embodiments, the probe 280 can further extend beyond the bendable portion 264. Fig.10F As shown, in at least some embodiments, the portion 281 of the probe 280 extending beyond the bendable portion is straight.

[0090] like Fig.11A As shown, in at least some embodiments, the tamping rod 244 can include one or more pull wires 275. In at least some embodiments, each pull wire 275 is attached to the end 262 (or the bendable portion 264) and extends through the shaft 266 (or outside the shaft but within the tamping rod sleeve 242) to the tool interface 246. The pull wire 275 can be used to manipulate the end 262 or the bendable portion 264. The tamping rod 244 can include Fig.11A One or more pull wires 275a, 275b, 275c, 275d are shown.

[0091] For example, in Fig.11AIn the embodiment of the present invention, the tamping rod 244 can include one or both of the pull lines 275a, 275b, which can be used to change the bending amount of the bendable portion 264. Pulling the pull line 275a can increase the bending. Pulling the pull line 275b can reduce the bending. As another example, in Fig.11A In the embodiment, the tamper 244 may include one or both of the traction wires 275c, 275d, which may be used to change the lateral direction of the bendable portion 264 (lateral relative to the bending direction). Fig. 11B An embodiment of a handle 283 is shown, which can be rotated relative to a fixed element 285 and is attached to two pull wires 275 (e.g., pull wires 275a, 275b or pull wires 275c, 275d) to operate the pull wires. In at least some embodiments, the handle 283 and the fixed element 285 can be part of (or adjacent to) a tool interface.

[0092] like Fig. 11C As shown, in at least some embodiments, tamping rod 244 can include an opening 265 at a proximal end of tip 262. When tamping rod 244 is retracted into tamping rod sleeve 242, bone fragments or other particles can collect in opening 265 to at least partially clear the channel created by the tamping rod.

[0093] Other arrangements of tool interface 246 may be used. For example, Fig. 12A and Fig. 12B The tool interface 246 with the rack and pinion mechanism is shown in an extended (left) and retracted (right) state. Fig. 12A and Fig. 12B The tool interface 246 includes a movable head 252 with an impact element 253, and a fixed sleeve attachment 248 with a rack 249 (e.g., a shaft) having teeth 249a. The movable head 252 is attached to the proximal portion of the tamper bar 244. In place of a collar, Fig. 12A and Fig. 12B The tool interface 246 has a pinion 250' with a handle 250a and a circular gear 250b with a toothed portion 250c that engages with a toothed portion 249a of a shaft 249. The pinion 250' is attached to the movable head 252, and operation of the pinion 250' can move the movable head 252 upward to a retracted state ( Fig. 12B ) or move down to the expanded state ( Fig. 12A In at least some embodiments, when the ram bar 244 extends out of the ram bar sleeve 242, the pinion 250' disengages from the rack 249.

[0094] In at least some embodiments, Fig. 12A and Fig. 12BThe fixed sleeve attachment 248 of the tool interface 246 includes a movement limiting shaft 270 with a stop 272 (such as a pin, rod, or the like), and the movable head 252 includes a guide rail 274 along which the stop 272 moves. The movement of the movable head 252 away from the fixed sleeve attachment 248 is limited by the guide rail 274 and the stop 272. When the stop 272 reaches the end of the guide rail 274, the movable head 252 cannot move further from the fixed sleeve attachment 248.

[0095] Fig. 12C and Fig.12D Another arrangement of the tool interface 246 is shown in an extended (left) and retracted (right) state. Fig. 12C and Fig.12D The tool interface 246 includes a movable head 252 having an optional impact element 253 and a grip 251 (or handle), and a fixed sleeve attachment 248. The movable head 252 is attached to the proximal portion of the tamper bar 244. In at least some embodiments, Fig. 12C and Fig.12D The fixed sleeve attachment 248 of the tool interface 246 includes a movement limiting shaft 270 with a stop 272 (such as a pin, rod, or the like), and the movable head 252 includes a lumen 278 along which the stop 272 moves. The movement of the movable head 252 away from the fixed sleeve attachment 248 is limited by the stop 272. When the stop 272 reaches the stop portion 279 of the lumen 278, the movable head 252 cannot move further from the fixed sleeve attachment 248. The clinician can use the handle 251 of the movable head 252 to separate the movable head from the fixed sleeve attachment.

[0096] like Fig.13 As shown, in at least some embodiments, tool interface 246 includes a locking mechanism 288 to lock the tool interface to access tool 232. For example, fixed sleeve attachment 248 of tool interface 246 can be locked to handle 238 of access tool 232. Any suitable locking mechanism 288, including, for example, a detent plate and groove on handle 238, a plate that creates a frictional attachment or other attachment, etc. or any combination thereof. In at least some embodiments, locking mechanism 288 can prevent or reduce rotational or axial misalignment between fixed sleeve attachment 248 and handle 238.

[0097] The above specification provides a description of the structure, manufacture and use of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.

Claims

1. A tool device for forming a channel in a spine to perform nerve ablation, the tool device comprising: a tamp rod comprising a distal end portion and a proximal end portion, wherein the distal end portion comprises a tip configured for creating a passage in a spine and a bendable portion coupled to the tip and configured to guide the tip along a curved path within the spine; a first cannula including a cannula body defining a lumen through which the ram can extend, wherein the cannula body is straight along an entire length of the cannula body, and the first cannula is configured to receive a bendable portion of the ram and to straighten the bendable portion when received in the first cannula; and A tool interface includes a fixed sleeve attachment coupled to the first sleeve and a movable head coupled to the tamping bar, the movable head being configured to move toward or away from the fixed sleeve attachment to respectively extend or retract a bendable portion of the tamping bar from or into the first sleeve.

2. The tool device according to claim 1, wherein: The first sleeve is a ram rod sleeve, and the tool apparatus further includes an access tool including an access tool handle and an access tool sleeve, wherein the access tool sleeve is straight along an entire length of the access tool sleeve, and the access tool is configured to receive the ram rod sleeve within the access tool sleeve.

3. The tool apparatus of any one of claims 1 or 2, further comprising an access tool comprising an access tool handle and the first sleeve.

4. The tool device according to any one of claims 1 to 3, wherein: The movable head includes an impact element to receive an impact from a hammer or mallet.

5. The tool device according to any one of claims 1 to 4, wherein: The tool interface further includes a rotatable collar disposed between the fixed sleeve attachment and the movable head.

6. The tool device according to claim 5, wherein: The movable head comprises a threaded rod, wherein the rotatable collar optionally comprises a lumen having a threaded portion, the lumen being configured to receive and interact with the threaded rod of the movable head, wherein, optionally, rotating the collar moves the movable head away from or toward the fixed sleeve attachment depending on the direction of rotation.

7. The tool device according to claim 5, wherein: The fixed sleeve attachment includes a shaft along which the movable head or rotatable collar slides when the movable head moves toward the fixed sleeve attachment to extend the bendable portion of the tamper bar out of the first sleeve.

8. The tool device according to any one of claims 1 to 7, wherein: The bendable portion of the tamper bar is defined by a notch relative to the shaft and the end, and the bendable portion is offset relative to a central axis of at least one of the shaft or the end of the tamper bar, wherein the bendable portion optionally bends away from the notch.

9. The tool device according to any one of claims 1 to 8, wherein: The bendable portion of the tamper bar defines a release path along the bendable portion.

10. The tool device according to any one of claims 1 to 9, further comprising at least two pulling wires attached to the ends of the tamping rod to manually guide the tamping rod to form a channel.

11. A tamper tool for forming a channel in a spine to perform nerve ablation, the tamper tool comprising: a tamp rod including a distal end portion and a proximal end portion, wherein the distal end portion includes a tip configured for creating a passage in a spine and a bendable portion coupled to the tip and configured to guide the tip along a curved path within the spine; a tamping rod sleeve comprising a sleeve body defining a lumen through which the tamping rod can extend, wherein the tamping rod sleeve is configured to receive a bendable portion of the tamping rod, wherein the bendable portion of the tamping rod is biased to bend when positioned outside of the tamping rod sleeve; and A tool interface comprising a fixed sleeve attachment coupled to the tamping bar sleeve, a movable head coupled to the tamping bar, and a rotatable collar configured to move the movable head toward or away from the fixed sleeve attachment to respectively extend or retract a bendable portion of the tamping bar from or into the tamping bar sleeve, wherein, optionally, the tamping bar sleeve is straight and is configured to straighten the bendable portion of the tamping bar when the bendable portion is received in the tamping bar sleeve.

12. A method for forming a channel in a spine to perform nerve ablation, the method comprising: inserting an access tool cannula of an access tool into the patient's spine, wherein the access tool cannula is straight; inserting a sleeve of a tamper tool into an access tool sleeve of the access tool, wherein the tamper sleeve is straight; and A tool interface of the tamping bar tool is operated to extend the distal end portion of the tamping bar out of the distal end of the tamping bar sleeve to form a channel, wherein the distal end portion of the tamping bar includes a tip configured for creating a channel in the spine and a bendable portion coupled to the tip and configured to guide the tip along a curved path within the spine, wherein the bendable portion is biased to bend when located outside the tamping bar sleeve, and wherein the bendable portion is straight within the tamping bar sleeve before extending out of the distal end of the tamping bar sleeve.

13. The method according to claim 12, wherein: Operating the tool interface includes driving a movable head of the tool interface toward a fixed sleeve attachment of the tool interface, wherein the tamper is coupled to the movable head.

14. The method according to any one of claims 12 or 13, further comprising operating a tool interface of the tamping rod tool to retract the bendable portion of the tamping rod into the tamping rod sleeve and straighten the bendable portion within the tamping rod sleeve after forming the channel, wherein Optionally, operating the tool interface to retract the bendable portion comprises rotating a rotatable collar of the tool interface to move a movable head of the tool interface away from a fixed sleeve attachment of the tool interface, wherein the tamper is coupled to the movable head.

15. A method for forming a channel in a spine to perform nerve ablation, the method comprising: inserting an access tool cannula of an access tool into the patient's spine; inserting the tamping bar sleeve of the tamping bar tool according to claim 11 into the access tool sleeve of the access tool; and The movable head of the tool interface is driven toward the fixed sleeve attachment of the tool interface so that the distal end portion of the tamping bar extends out of the distal end of the tamping bar sleeve to form a channel, wherein the distal end portion of the tamping bar includes a tip configured for creating a channel in the spine and a bendable portion connected to the tip and configured to guide the tip along a curved path within the spine, wherein the bendable portion is biased to bend when located outside the tamping bar sleeve.

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