WO2022147472A1

WO2022147472A1 - Integrated probe-ablation device and systems for sensory nerve ablation in a joint

Info

Publication number: WO2022147472A1
Application number: PCT/US2021/073195
Authority: WO
Inventors: Dragan GASTEVSKI
Original assignee: Dmg Group, Llc
Priority date: 2020-12-31
Filing date: 2021-12-30
Publication date: 2022-07-07

Abstract

Integrated probe-ablation provides a combined stimulation and ablation minimally invasive mechanism for delivering both bipolar electrical stimulation and laser ablation of afferent nerve fibers of a desired sensory nerve of a patient under only local anesthesia without having to withdraw the mechanism. A rigid cannula provides minimally invasive access for an integrated probe-ablation device to contact a target nerve tissue proximate a joint of the patient with a distal end having a working end surface that defines a perimeter to contact the target nerve tissue and position a captured portion between the perimeter and a bone structure of the joint. Electrodes proximate the working end surface contact and are controlled provide bipolar electrical stimulation to test by response of the patient whether the target nerve tissue is the desired sensory nerve, and an optical fiber emit laser then is controlled to emit light to ablate the captured portion.

Description

INTEGRATED PROBE-ABLATION DEVICE AND SYSTEMS

FOR SENSORY NERVE ABLATION IN A JOINT

TECHNICAL FIELD

The present disclosure relates generally to devices and systems for minimally invasive surgeries, and, more particularly, to an integrated probe-ablation device and systems for ablation of afferent nerve fibers proximate a joint of a patient that are associated with sensory nerves.

BACKGROUND

Sensory nerve ablation is a minimally invasive procedure that destroys the afferent nerve fibers carrying pain signals from sensory nerves to the brain, and may be used to reduce certain kinds of chronic pain by preventing or reducing transmission of pain signals. When a portion of an afferent nerve fiber is destroyed, damaged or removed so as to cause an interruption in pain signals along the nerve fiber, there can be a reduction in pain perceived from the associated sensory nerves. Non-medication, interventional techniques of this sort are important options for chronic pain in this time of an opiate crisis.

Current techniques and procedures for the management of pain by sensory nerve ablation in the spine involve the use of a local anesthetic selectively injected proximate a target sensory nerve as a diagnostic procedure. Depending upon the nature of the pain to be treated, the patient may observe immediate relief from the diagnostic injection of the local anesthetic or may be asked to monitor the pain for a period of time to determine whether the afferent nerve fibers in the target area are carrying the nerve signals from the sensory nerves associated with the pain. Once the target area associated with the pain is identified, the patient undergoes a minimally invasive procedure to ablate the specific nerve fiber believed to be associated with the pain.

Existing techniques and procedures for the minimally invasive ablation of a sensory nerve for pain management involve multiple steps to locate and confirm the proper somatic nerve fiber target and then ablate that nerve fiber target. Typically, the skin tissue proximate the target area is numbed without numbing the nervous tissue in the deeper tissue. An incision is made to facilitate placing a cannula in the target area. A stylet with a tracer that can be imaged under x-ray guidance is inserted into the cannula to assist the physician in guiding a distal end of the cannula into the target area. The stylet is removed, and a probe is then inserted into the cannula until the distal end of the probe is in close proximity to the target nerve fiber. The probe is first used to electrically stimulate the target nerve fiber at increasing low voltages delivered at two frequencies - 50 Hz for stimulating sensory nerves and 2 Hz for stimulating motor nerves. These stimulations are monitored to confirm by both patient and physician observation that the target nerve fiber is the appropriate afferent nerve fiber to be ablated in order to effect pain management treatment of the desired sensory nerve. Motor stimulation is used to rule out proximity to important, efferent nerves that are to be avoided. The target nerve fiber is then ablated using electromagnetic energy, thermal energy or chemicals such as alcohol. See, Senthelal S, Dydyk AM, Mesfin FB; “Ablative Nerve Block”. StatPearls [Internet], StatPearls Publ., updated Apr. 28, 2020, available at: https://www.ncbi.nlm.nih.gov/books/NBK499975/.

Given the extreme risks to health and quality of life by damage to off-target nerves, accurate target identification and highly focused ablation is necessary. The level of control necessary and the sensitivity of the target excludes nearly all external mapping options as appropriate tools for identifying target sensory nerves within nerve bundles, such as the spinal column. Further, many internal mapping tools are based on movement of target tissue or, in the case of many systems for identifying motor nerves, not refined enough to provide a tolerable experience for the patient who must remain awake and interactive with the surgeon for the identification of the target sensory nerves.

Although conventional techniques for sensory nerve ablation have been widely adopted, there remain challenges in assuring proper identification, capture, and confirmation of the intended target nerve fiber. The complexities of identifying proper sensory nerve targets may be further compounded at complex nerve junctions and bundles, such as the spinal cord, spinal nerve roots, and various nerve plexuses, due the proximity of non-target nerve to the target nerve. With current technology, in order to avoid damage to nearby efferent structures, many cases result in inadequate proximity to the target afferent nerve, inadequate energy emission, or inadequate lesion time, all resulting in inadequate afferent nerve lesioning and inadequate pain relief, with the aim of ultimately protecting the efferent nerve.

One of these challenges stems from the pain caused by the conventional techniques used for sensory nerve ablation. Thermal energy in the form of high temperature radiofrequency ablation or cryoablation are the most common forms of ablation energy used for sensory nerve ablation. The temperatures used for these kinds of ablation energies can cause pain for the patient. For example, high power radiofrequency energy creates a lesion by heating tissue in excess of 80 degrees C for 1 - 2.5 minutes to destroy the tissue. As a result, this makes it quite difficult for an awake patient to remain perfectly still so as to avoid moving or dislodging the probe which is precisely lesioning over a nerve. The normal procedure for sensory nerve ablation also includes withdrawal of the probe after the target nerve fiber has been confirmed to allow for injection of a local anesthetic to numb the pain before applying the ablation energy. The need to withdraw and then reinsert the same probe or a different probe in order to deliver the ablation energy introduces the potential for the cannula to move or the probe to be not positioned in the same location upon reinsertion. It is not possible to retest sensory and motor stimulation after numbing as the nerves will no longer respond. As a result, there is the potential to lose contact with the target nerve fibers, resulting in either inadequate pain relief or motor dysfunction.

Another challenge of current sensory nerve ablation techniques and systems is that it is difficult to precisely target the ablation energy used and so the lesion sizes created can be larger than necessary to achieve the desired pain management treatment. Chemical, thermal, and electrical ablation energies tend to create zones of necrotic tissue that expand outward in all directions from the distal end of the probe. Radiofrequency (RF) devices are often favored for nerve ablation as RF energy does not directly stimulate nerves or heart muscle and therefore can often be used without the need for general anesthesia. The extent of any collateral damage caused by the outward spread of such RF energy from the distal end of a probe can be controlled to some extent by a cooling system, like the system seen in U.S. Pat. No. 9,078,663, or by complex grounding systems, such as the system of U.S. Pat. No. 10,111,703, but cannot be wholly avoided. This results in a zone of indeterminate necrosis and tissue damage. The result is unpredictable lesions that may be too light to lesion the target, or too strong as to lesion unintended surrounding tissue. In either case, patient outcomes are not predictable, which can result in either a failure to eliminate the nerve and associated pain, or unintended consequences, including paralysis. Various catheter-based systems for mapping in order to more accurately ablate tissue in the vasculature or internal organs have long been known, as described, for example, in U.S. Patent Nos. 4,785,815, 4,928,695, and 4,985,028 and U.S. Pat. Pub. 2015/0238259. Some devices, such as described in U.S. Patent No. 10,092,355 and U.S. Pat. Pub. 2018/0021089, try to incorporate sensing and ablation in the same catheter resulting in widely spaced electrodes on the probe to prevent interference between the sensing and ablation elements. Others, such as described in U.S. Pat. No. 5,500,012, may incorporate a lumen into the mapping catheter to allow for controlled introduction of the ablation catheter as a separate tool. Some of these devices incorporate feedback into the control of the ablation process, such as described in U.S. Pat. Nos. 6,663,622, 9,283,031 and 9,956,034. While such combined sensing and ablating approaches have proven effective for catheter-based ablation systems that are flexible in order to steer and navigate their integrated distal working ends to access the target internal tissue and that are performed under general anesthesia, these approaches have not been adopted for sensory nerve ablation that use rigid needles or cannulas to guide and access the target nerve fibers in the spinal cord while under only local anesthesia.

Thus, there exists a need in sensory nerve ablation systems for improved devices and systems which can provide highly specific targeting and ablation of nerve fibers while under only local anesthesia and that can decrease the potential for losing contact with the nerve fibers while also reducing the potential for collateral damage to surrounding tissue.

SUMMARY

Integrated probe-ablation systems, devices and methods in accordance with various embodiments can limit adverse effects and improve patient outcomes in minimally invasive sensory nerve ablation procedures that require the patient to remain awake to assist in target nerve fiber identification by reporting sensory experiences.

In embodiments, systems, methods and devices for integrated probe-ablation provide a combined stimulation and ablation minimally invasive mechanism for delivering both bipolar electrical stimulation and laser ablation of afferent nerve fibers of a desired sensory nerve of a patient under only local anesthesia without having to withdraw the mechanism. In various embodiments, a rigid cannula provides minimally invasive access for insertion of an integrated probe- laser ablation device to contact a target nerve tissue in a target area proximate a joint of the patient. The device includes a rigid shaft between a proximal portion and a distal end having a working end surface that defines a perimeter configured to contact the target nerve tissue and position a captured portion of the target nerve tissue between the perimeter and a bone structure of the affected joint. Each of at least a pair of electrical conductors extends through the shaft to an electrode proximate the working end surface. The electrodes are configured to contact and provide bipolar electrical stimulation to the captured portion of the target nerve tissue to test by response of the patient to provide active identification of whether the target nerve tissue is the desired sensory nerve. They also serve to rule out capture of motor nerves via motor nerve stimulation. At least one optical fiber extends through the shaft to a terminus end proximate the working end surface configured to emit laser light to ablate the captured portion of the target nerve tissue. A control system provides both electrical energy and laser energy to the proximal portion of the integrated probe-ablation device. In some embodiments, a temperature sensor in the form of a thermister, thermocouple, or similar device, may be included at the distal end of the integrated probe-ablation device to monitor target tissue temperatures. The necessity of the patient remaining awake for active identification of target nerve fibers is used to advantage for devices and systems integrating mapping and ablation with an integrated probe-ablation device in accordance with various embodiments. Not only does utilizing active patient identification minimize invasions into highly sensitive areas such as a combination sensory and motor nerve bundle; it also provides additional assurance that a target nerve fiber, identified by active patient feedback, is the exact nerve then being ablated. In various embodiments the targeting and ablation features are aligned on a single rigid probe such that the ablation element can maintain appropriate contact with the target nerve fiber during the entire process of locating, positioning, targeting, testing, and ablating the desired sensory nerve.

In various embodiments, the joint having the desired sensory nerve is the vertebral facet-joint and the bone structure is a concavity formed between a superior articulating process and an adjacent transverse process of the vertebral facet-joint. In some embodiments, the joint is one of an amphiarthrosis joint and a diathroses joint. In some embodiments, the target nerve tissue is in a spinal column of the patient and the joint is one of a spinal joint, a sacroiliac joint, or an intradiscal space. In other embodiments, the target nerve tissue is in a joint capsule of the patient and the joint is a diathroses joint. Further embodiments include targeting innervation of peripheral joints, including but not limited to, the shoulder, hip, knee, and ankle.

In various embodiments, the working surface defines a generally concave shape within the perimeter that facilitates positioning of the captured portion of the target nerve tissue between the working end surface and the bone structure of the joint such that the captured portion extend at least partially into the generally concave shape. In other embodiments, the working surface is a generally flat shape within the perimeter. In other embodiments, the perimeter of the working end surface may include a rim around the working end surface that features protrusions, such as a serrated or scalloped pattern, that may be used to facilitate fixation of the distal working surface into the target nerve tissue in order to reduce movement of the working surface relative to the target nerve tissue.

In some embodiments, there is a single fiber optic for carrying the laser ablation energy. In other embodiments, there is a plurality of fiber optics for carrying the laser ablation energy. In variations, the terminus ends of the plurality of fiber optics are arranged in a linear, circular or generally X-shaped pattern. In various embodiment, the terminus end of a fiber optic is flush with the working surface. In other embodiments, the terminus end of a fiber optic is recessed a distance back from either or both of the working surface or a plane defined by the perimeter of the working surface to provide an effective focal length for delivery of laser energy to the captured portion of the target nerve tissue. In various embodiments, one or more reflective or diffusive elements can be operably positioned relative to the terminus end of a fiber optic to direct or diffuse laser energy.

In some embodiments, the integrated probe-ablation device further comprises at least one fluid channel extending through the shaft to an output port proximate the working end surface, and the control system can further comprise a fluid delivery system operably connected to the device to selectively deliver fluid from the output port to the captured portion of the target nerve tissue.

In embodiments, the integrated probe-ablation device provides a fiber optic ablation element that in various embodiments may be directionally deployed, or constrained to permit ablation of the target nerve fiber without negative impacts on target nerves surrounding to the target nerve fiber within the nerve bundle. Unlike other types of ablative energy sources, such as RF, thermal or chemical in which the ablation energy deploys outward from the probe in all directions, these embodiments enable focused and directed laser ablative energy to be used as the ablative energy source.

This form of directed laser ablation can significantly reduce the ablative time period, as there is an almost instantaneous emission of laser energy that causes photocoagulation of the target tissue. This reduction in ablation time directly reduces the risk of movement of the cannula and probe, and the patient as well. An almost instantaneous ablation time is a dramatic departure of current ablation times that start at 90 seconds, and only increase depending on the ablation technique.

In embodiments, the configuration of the distal end of the rigid integrated probeablation device provides stabilization for improved targeting of sensitive nerve fiber targets against bone such as the vertebral bone, for example, to improve the ability to capture and maintain continual contact with the nerve fiber target during the entire sensory nerve ablation procedure.

The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:

FIGS. 1 A-1B are views of a vertebral bone segment with associated nerves. FIG. 2 is a block diagram of the main components of an embodiment of an integrated probe-ablation system for sensory nerve ablation.

FIGS. 3A-3C are a series of cross-sectional schematic diagrams showing embodiments in the steps of positioning an integrated probe-ablation device proximate the target nerve tissue.

FIGS. 4A-4B are cross-sectional end and side views showing one embodiment of an integrated probe-ablation device.

FIG. 5 is a cross-sectional end view showing one embodiment of a flat end of an integrated probe-ablation device. FIG. 6 is a cross-sectional end view showing an alternative embodiment a concave end of an integrated probe-ablation device.

FIG. 7 is a cross-sectional end view showing an embodiment of a working surface of an integrated probe-ablation device.

FIG. 8 is a cross-sectional end view showing an alternative embodiment of a working surface of an integrated probe-ablation device.

FIG. 9 is a cross-section side view showing an embodiment of a distal portion of an integrated probe-ablation device.

FIG. 10 is a cross-section side view showing an alternative embodiment of a distal portion of an integrated probe-ablation device.

FIGS. 11A-1 IB are exploded cross-sectional end views showing one embodiment of a distal working end of an integrated probe-ablation device.

While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

DETAILED DESCRIPTION OF THE DRAWINGS

The present disclosure relates to a minimally-invasive neurosurgery probe-ablation system which is a combination of a nerve stimulation, as well as a sensory nerve ablation and a control method thereof, particularly for the selective ablation of afferent sensory nerve fibers of the peripheral nervous system, for purposes of pain management or treatment.

Amphiarthrosis (slightly movable) joints may be the primary target joints of procedures using devices embodying the present disclosure. Also known as cartilaginous joints, these joints are defined as two or more bones held so tightly together that only limited movement can take place. The vertebrae of the spine are good examples. Joints of this kind may have nerves running in narrow spaces between the two bones of the joint. These nerves may be particularly problematic to access due to the confines created by the surrounding bone.

An example of an afferent nerve target supplying an amphiarthrosis joint is the intersection of the transverse process (TP) 112 and superior articular process (SAP) 114 of the corresponding vertebrae 110 as shown in FIGS. 1A-1B. As can be seen in these figures, the medial branch nerve 120 runs around the facet joint 122 as shown in FIG. IB. In this example, an intersection 116 of TP 112 and SAP 114 is a target nerve tissue location 220 that is accessed by an integrated probe-ablation device 202 as will be described in more detail. In various embodiments, a portion of a bone of the joint 122 can serve as a backstop for a distal end 203 of the integrated probe-ablation device 202 in accordance with these various embodiments. As shown in FIG. 2, an integrated probe-ablation system 200 according to embodiments of the present disclosure may generally comprise an integrated probe-ablation device 202, a stylet 204, and a cannula 206, with the integrated probe-ablation device 202 operably connected to a control system 210. In various embodiments, the control system 210 includes an electrical stimulation generator 212, a laser generator 214 and, in some embodiments, a fluid delivery system 216 having a fluid reservoir system 218 containing one or more of an anesthetic, irrigation fluid or cooling fluid.

In various embodiments, the control system 210 may be comprised of separate physical components that operably coordinate with one another, or may be a single physical device that is configured to provide the functionality of the electrical stimulation generator 212, the laser generator 214 and, in some embodiments the fluid delivery system 216. Detailed descriptions of various embodiments of the functionality of these system components can be found, for example, in U.S. Publ. Appl. No. 2015/0141978 Al (electrical stimulation), and U.S. Patent Nos. 9,844,410 (laser) and 8,585,697 (fluid delivery), the disclosures of which are hereby incorporated by reference.

In embodiments as shown, for example, in FIG. 2, the integrated probe-ablation device 202 includes a proximal portion 230 with a handle 232 and a distal end 240 that includes the distal end 203. A working end surface 242 at the distal end 240 as described with respect to FIG. 5 and FIG. 6, for example, defines both a perimeter 244 and an end shape 246 for interfacing with the target nerve tissue 222 such that one or both are configured to contact the target nerve tissue 222 and position a portion of the target nerve tissue 222 between the perimeter 244 and/or the end shape 246 and a bone structure of the joint 122. In embodiments, the distal end 240 and the proximal portion 230 are opposite portions of a shaft 234 that, in some embodiments, is generally rigid and extends into the handle 232.

The electrical stimulation generator 212 can be configured to be operably coupled proximate the handle 232 to at least the pair of electrical conductors 250 that provide electrical stimulation energy to the corresponding electrodes 252 as shown, for example, in FIGS. 4A- 4B in order to test whether the target nerve tissue 222 is the desired sensory nerve. The control system 210 can further include a laser generator 214, which can be configured to be operably coupled to at least the one optical fiber 260 proximate the handle to provide laser light to the fiber terminus end 262 as shown, for example, in FIGS. 4A-4B.

FIGS. 3A-3C show a cross-sectional sequence of one embodiment of the introduction and positioning of a rigid cannula 206 within a patient under only local anesthesia that provides access for the integrated probe-ablation device 202 to the target nerve tissue location 220. After an incision is made thru the skin 201, the stylet 204 is introduced into the rigid cannula 206 and is used to facilitate positioning of a distal end 207 of cannula 206 proximate the target nerve tissue location 220 as shown in FIG 3B. In embodiments, the cannula 206 provides a minimally invasive access channel having a diameter of between 1-7 mm to a target nerve tissue in a target area proximate a joint of the patient

In some embodiments, stylet 204 may include a tracer or marker proximate a distal end 205 of the stylet 204 to provide better visualization under x-ray or fluoroscopy imaging to position the distal end 207 of the cannula proximate the target nerve tissue location 220. In some embodiments, stylet 204 may include a driving tip at distal end 205 that can facilitate preservation of the distal end 207 of cannula 206. Once the cannula 206 is positioned proximate the target nerve tissue location 220, the stylet 204 is withdrawn and the integrated probe- ablation device 202 is inserted into the cannula 206. Once positioned, cannula 206 provides a channel through intervening tissue for directing the integrated probe-ablation device 202 to the target nerve tissue location 220 such that both electrical stimulation testing and, if the target nerve tissue location 220 is determined to be the desired target nerve tissue 222 as a result of the stimulation testing, laser ablation can be performed without the need to withdraw, move or reposition the distal end 203 of the probe-ablation device 202.

In embodiments, a distal end 203 of the probe-ablation device 202 engages the target nerve tissue location 220 to cause the nerve tissue 222 to be positioned between the distal ends 203 and 207 of the probe-ablation device 202 and the cannula 206, respectively, and a vertebral bone 110, or any other solid structure proximate the target nerve tissue location 220 as shown in FIG. 3C.

In some embodiments, for example as shown in FIGS. 11A-11B, a rim structure 290 along at least a portion of the perimeter 244 of the working end surface 242 has a set or protrusions 292 that are designed to facilitate penetration of the perimeter 244 of the working end surface 242 into the target nerve tissue 220 to reduce movement of the working end surface 242 relative to the target nerve tissue 220. the set of protrusions 292 on the rim structure 290 are formed in a pattern such as a serrated pattern as shown in FIG. 11 A or a scalloped pattern as shown in FIG. 1 IB in which the protrusions 292 penetrate deeper into contact with the target nerve tissue 220 as compared to the working end surface 242.

In embodiments, the target nerve tissue 222 is positioned relative to the distal ends 203 and 207 such that the nerve fibers are preferentially flattened to a degree in a direction generally perpendicular to a long axis of the cannula 206. In one embodiment, the target nerve tissue 222 is located at a vertebral facet-joint 122 and the bone structure is a concavity formed between a superior articulating process and an adjacent transverse process of the vertebral facet-joint 122. In some embodiments, the joint 122 is one of an amphiarthrosis joint and a diathroses joint. In other embodiments, the target nerve tissue 222 is in a spinal column of the patient and the joint 122 is one of a spinal joint, a sacroiliac joint or an intradiscal joint. In still other embodiments, the target nerve tissue 222 is in a joint capsule of the patient and the joint 122 is a diathroses joint.

In some embodiments, the laser energy is delivered from the fiber terminus end(s) 262 from the laser generator 214 for a short period of time is less than two seconds. In some embodiments, the working end surface 242 at the distal end 240 is maintained in contact with the target nerve tissue 222 adjacent the bone structure of the joint 122 and with the portion of the target nerve tissue location 220 positioned between the working end surface 246 and the bone structure of the joint 122 during the short period of time.

In various embodiments, the electrical generator 212 selectively provides electrical energy to the at least the pair of electrical conductors 250 to provides electrical stimulation energy to the electrodes of between 0-3 volts at a frequency selected from the set consisting of about 50 Hz for sensory simulation and about 2 Hz for motor stimulation to the electrodes for a period of a few seconds, to allow for the operator to observe the presence or absence of the desired response.

In various embodiments, the laser generator 214 selectively provides laser energy to the to at least the one optical fiber provides laser light energy to generate photocoagulation of the target nerve tissue to form a lesion having a width of at least 5 millimeters and a depth of at least 5 millimeters. In various embodiments, an outer diameter of the shaft 234 of the probe- ablation device 202 is less than 6 millimeters. In various embodiments, a diameter of the perimeter 244 of the working end surface 242 is at least 4 millimeters.

As shown in FIGS. 4A-4B, at least a pair of electrical conductors 250 extend through the shaft 234 from the handle 232 to the distal end 240 within an outer wall 236 of the shaft. Each electrical conductor may have an electrode proximate the distal end 240. In various embodiments, the electrical conductors 250 are operably connected to electrodes 252 to provide bipolar electrical stimulation to at least a portion of the target nerve tissue 222 positioned between the perimeter 244 and the bone structure of the joint 122. In some embodiments, each electrical conductors 250 is uniquely connected to one or more corresponding electrodes 252. In other embodiments, each electrical conductor 250 is selectively connected to one or more electrodes 252 to permit selectively testing between different effective pairs of electrodes 252 at the distal end 240 of the probe-ablation device 202.

Also extending through the shaft 234 from the handle 232 to the distal end 240 within the outer wall 236 of the shaft 234 is at least one optical fiber 260. Each optical fiber will have a fiber terminus end 262 proximate the distal end 240. The at least one optical fiber 260 can be operably connected to the laser generator 214 proximate the handle 232 and configured to emit laser light via a corresponding fiber terminus end 262 to ablate the portion of the target nerve tissue 222 positioned between the perimeter 244 and the bone structure of the joint 122. In some embodiments a thermister or thermocouple may exist to monitor target tissue temperature.

In some embodiments, one or more fluid ports 270 may also extend through the shaft 234 from the handle 232 to one or more output ports 272 proximate the distal end 240 within the outer wall 236 of the shaft 234. Such fluid port(s) 270 may be used to deliver medicaments via a liquid delivery out the distal end 240 and/or may be used to provide fluid cooling liquid to the output port(s) proximate distal end 240 either as a flush fluid delivery or a recirculated fluid delivery arrangement.

In various embodiments, electrical conductors 250, optical fiber(s) 260 and, optionally, fluid ports 270 may be arranged in various cross-sectional arrangements within outer wall 236. As shown in FIG. 4A, the optical fiber 260 is the largest diameter cross-sectional element within the shaft 234 and is centered within the outer wall 236, with the electrical conductors 250 and optional fluid port 270 having smaller cross-sectional diameters and positioned in generally outer annular space within the outer wall 236.

Various construction techniques for the fiber-ablation probe device 202 may be utilized including molding, over-molding, sheathing and extrusion techniques. It will be understood that variations and various combinations of cross-sectional diameter sizes, positions and numbers of electrical conductors, optical fiber(s) 260 and optional fluid port(s) 270, as well as open channels, support channels or internal structures may be provided depending the amount and timing of laser light, electrical stimulation signals or fluid communication that is desired. In the embodiment shown in FIGS. 4A-4B, for example, the optical fiber 260 represents the largest cross-sectional element to deliver light energy, whereas the electrical conducts 250 and the optional fluid port are smaller diameter channels. In some embodiments, there may be channels for the fiber(s) 260, conductors 250 and optional fluid port(s) 270 that may extended through the shaft 234 in a uniform cross-sectional position, and in other embodiments one or more of these channels may be in a spiral or twisted pattern along the length of the shaft.

As shown in FIGS. 5-10, various embodiments with different arrangements and configurations of arrangement of elements at the distal end 240 are envisioned, depending on the orientation of the target nerve and the circumstances of the procedure. A flat tip (FIG. 5) or concave tip (FIG.6) are shown by way of example of different working end surfaces 242. Working end surface 242 can provide an orientation of the distal end 240 of the probe-ablation device 202 around or against the target nerve tissue location 220 in order to interface with the desired target nerve tissue 222 consistent with the specific nature of a given procedure.

For example, in some embodiments electrodes 252 may provide for active targeting of sensory nerves. Arrangement of stimulation terminals 308 outside of fiber optic terminals 306 can aide in ensuring that the target nerve tissue 222 identified by stimulation by the electrodes 252 is the exact nerve that will be ablated by operation of the fiber terminus ends 262. FIG. 7 and 8 show a cross-sectional end view of an example working surface 242 of embodiments of the present disclosure. Working surface 242 may generally be considered to be the surface(s) within the perimeter 244 of the distal end 240 that actively interface with the target nerve.

Various end shapes 246 of the working surface 242 are envisioned, according to the space constraints of the procedure site, the shape and orientation of the target nerve, and other procedural considerations. For example, in a procedure where fluid delivery may be a significant consideration, the end shape 246 of FIG. 7 may be preferable. FIG. 9 shows a cross- sectional side view of an embodiment substantially similar to the example embodiment of FIG. 7. The large central fluid port 272 can provide for direct and effective fluid delivery, and the circumferential arrangement of the fiber terminus ends 262 around the central output port 272 provides for fiberoptic ablation at the same target nerve site as the fluid delivery. Stimulation electrodes 252 can be arranged outside of fiber terminus ends 262, but inside the outer wall

236 to provide to one or more electrical stimulus signals that effectively surround the target nerve tissue location 220 to aide in identification of the target nerve tissue 222 by stimulation and observation of patient response.

In another example, a procedure may be particularly focused on ablation of a length of nerve in a minimal number of deliveries. In the example embodiment of FIG. 8, with the fiber terminus ends 262 distributed in a line across the working end surface 242, rather than that circular arrangement of FIG. 7, may be advantageous for such a procedure. The linear distribution of fiber terminus ends 262 in FIG. 8 may provide for ablation along a length of a target nerve, rather than focused ablation at a narrow target site. FIG. 10 shows a cross-sectional side view of an embodiment substantially similar to the example embodiment of FIG. 8.

In some embodiments, one or more optical fibers 260 may be used with multiple fiber terminus ends and optional optic elements or optical focal gap lengths may be used to deliver various combinations of focused or unfocused laser light from the working end surface 242. Fiber terminus ends 262 may abut, overlap, or be spaced apart on the working end surface 242 which may be desirable for continuous or focused laser LIGHT output. Other arrangements of fiberoptic elements are also envisioned, such as stacked, uniformly or randomly spaced, staggered, etc. For example, a staggered arrangement may be preferred in embodiments where a perfect circle arrangement for working end surface 262 is desired.

Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations, and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions. For example, embodiments are envisioned with an additional inner wall creating a double lumen between the central components and the outer wall, such that one of the two lumens may be used for the circulation of cooling fluid.

Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.

Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

For purposes of interpreting the claims, it is expressly intended that the provisions of

35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.

Claims

1. An integrated probe-ablation system for electrical stimulation and laser ablation of afferent nerve fibers of a desired sensory nerve of a patient under only local anesthesia, the system comprising: a rigid cannula configured to provide minimally invasive access to a target nerve tissue in a target area proximate a joint of the patient; an integrated probe-ablation device configured to be inserted into the cannula once a distal end of the cannula is positioned proximate the target nerve tissue, the integrated probeablation device having a proximal portion and a distal end and including: a handle at the proximal portion; a working end surface at the distal end, the working end surface defining a generally concave shaped cavity having a perimeter configured to contact the target nerve tissue and position a portion of the target nerve tissue between the perimeter and a bone structure of the joint; and a rigid shaft between the handle and the working end surface; at least a pair of electrical conductors extending through the shaft from the handle to the working end surface with each electrical conductor having an electrode proximate the working end surface that is configured to contact and provide bipolar electrical stimulation to the portion of the target nerve tissue positioned between the perimeter and the bone structure of the joint; at least one optical fiber extending through the shaft from the handle to the working end surface and having a terminus end proximate the working end surface that

22 is configured to emit laser light to ablate the portion of the target nerve tissue positioned in the generally concave shaped cavity defined by the working end surface; a control system configured to provide both electrical energy and laser energy to the integrated probe-ablation device without having to withdraw the integrated probe-ablation device from the cannula, the control system including: an electrical stimulation generator configured to be operably coupled to at least the pair of electrical conductors proximate the handle to provide electrical stimulation energy to the electrodes to test whether the target nerve tissue is the desired sensory nerve; and a laser generator configured to be operably coupled to at least the one optical fiber proximate the handle to provide laser light to the terminus end.

2. The integrated prove-ablation system of claim 1 , wherein the joint is the vertebral facetjoint and the bone structure is a concavity formed between a superior articulating process and an adjacent transverse process of the vertebral facet-joint.

3. The integrated prove-ablation system of claim 1, wherein the joint is one of an amphiarthroses joint and a diathroses joint.

4. The integrated prove-ablation system of claim 1, wherein the target nerve tissue is in a spinal column of the patient and the joint is one of a spinal joint, a sacroiliac joint or an intradiscal joint.

5. The integrated prove-ablation system of claim 1, wherein the target nerve tissue is in a joint capsule of the patient and the joint is a diathroses joint.

6. The integrated probe-ablation system of claim 1 , wherein the integrated probe-ablation device further comprises at least one fluid channel extending through the shaft from the handle to an output port proximate the working end surface, and the control system further comprises a fluid delivery system operably connected to the handle to selectively deliver fluid from the output port to the portion of the target nerve tissue.

7. The integrated probe-ablation system of claim 1, wherein a portion of the target nerve tissue extends at least partially into the generally concave shaped cavity when the target nerve tissue is positioned between the perimeter and the bone structure.

8. The integrated probe-ablation system of claim 1 , wherein the integrated probe-ablation device further comprises a temperature sensor at the distal end to monitor a temperature of the target nerve tissue.

9. The integrated probe-ablation system of claim 1, wherein the perimeter of the working end surface includes a rim around the working end surface having a set of protrusions used to facilitate penetration of the working end surface into the target nerve tissue to reduce movement of the working end surface relative to the target nerve tissue.

10. The integrated probe-ablation system of claim 9, wherein the set of protrusions of the rim around the working end surface are formed in a pattern selected from one of a serrated pattern or a scalloped pattern.

11. An integrated probe-ablation device for electrical stimulation and laser ablation of afferent nerve fibers of a desired sensory nerve of a patient under only local anesthesia, the device being configured to be inserted into a rigid cannula configured to provide minimally invasive access to a target nerve tissue in a target area proximate one of an amphiarthroses joint and a diathroses joint of the patient and configured to be operably coupled to an electrical stimulation generator that provides electrical stimulation energy to selectively test whether a target nerve tissue is the desired sensory nerve and to a laser generator that provides laser light to selectively ablate the target nerve tissue, the integrated probe-ablation device comprising: a rigid shaft configured to be selectively insertable into the rigid cannula and having a proximal portion and a distal end with a working end surface at the distal end configured to contact the target nerve tissue and position a portion of the target nerve tissue between the working end surface and a bone structure of the joint; at least a pair of electrical conductors extending through the shaft from the proximal portion to the working end surface with each electrical conductor having an electrode proximate the working end surface that is configured to contact and provide bipolar electrical stimulation to the portion of the target nerve tissue positioned between the working end surface and the bone structure of the joint; and at least one optical fiber extending through the shaft from the proximal portion to the working end surface and having a terminus end proximate the working end surface that is

25 configured to emit laser light to ablate the portion of the target nerve tissue positioned between the working end surface and the bone structure of the joint, the integrated prove-ablation device being configured to provide both electrical energy and laser to the target nerve tissue without having to withdraw the integrated probe-ablation device from the cannula.

12. The integrated prove-ablation device of claim 11, wherein the joint is the vertebral facet-joint and the bone structure is a concavity formed between a superior articulating process and an adjacent transverse process of the vertebral facet-joint.

13. The integrated prove-ablation device of claim 11, wherein the target nerve tissue is in a spinal column of the patient and the joint is one of a spinal joint, a sacroiliac joint or an intradiscal joint.

14. The integrated prove-ablation device of claim 11, wherein the target nerve tissue is in a joint capsule of the patient and the joint is a diathroses joint.

15. The integrated prove-ablation device of claim 11, wherein the working end surface defines a generally concave shaped cavity having a perimeter configured to contact the target nerve tissue and position a portion of the target nerve tissue between the perimeter and a bone structure of the joint.

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16. The integrated probe-ablation system of claim 13 , wherein the perimeter of the working end surface includes a rim around the working end surface having a set of protrusions used to facilitate penetration of the working end surface into the target nerve tissue to reduce movement of the working end surface relative to the target nerve tissue.

17. The integrated probe-ablation system of claim 16, wherein the set of protrusions of the rim around the working end surface are formed in a pattern selected from one of a serrated pattern or a scalloped pattern.

18. The integrated probe-ablation system of claim 11, wherein the integrated probeablation device further comprises a temperature sensor at the distal end to monitor a temperature of the target nerve tissue.

19. A method for integrated electrical stimulation and laser ablation of afferent nerve fibers of a desired sensory nerve of a patient under only local anesthesia, the method comprising: inserting a rigid cannula through a skin of the patient to provide minimally invasive access with a distal end of the cannula positioned proximate a target nerve tissue in a target area proximate a joint of the patient; inserting an integrated probe-ablation device having a rigid shaft between a proximal portion and a distal end into the cannula until a working end surface at the distal end contacts the target nerve tissue adjacent a bone structure of the joint and positions a portion of the target nerve tissue between the working end surface and the bone structure of the joint, wherein the integrated probe-ablation devices includes:

27 at least a pair of electrical conductors extending through the shaft from the proximal portion to the working end surface with each electrical conductor having an electrode proximate the working end surface that is configured to contact and provide bipolar electrical stimulation to the portion of the target nerve tissue positioned between the perimeter and the bone structure of the joint; and at least one optical fiber extending through the shaft from the handle to the working end surface and having a terminus end proximate the working end surface that is configured to emit laser light to ablate the portion of the target nerve tissue positioned in the generally concave shaped cavity defined by the working end surface; selectively providing electrical energy to at least the pair of electrical conductors to provide electrical stimulation energy to the electrodes to determine whether the target nerve tissue is the desired sensory nerve based on observation and experience of the patient in response; and within a short period of time after the target nerve tissue is determined to be the desired sensory nerve, and without withdrawing the integrated probe-ablation device from the cannula, selectively providing laser energy to the to at least the one optical fiber to provide laser light energy to the terminus end to ablate the target nerve tissue with laser energy.

20. The method of claim 19, wherein the short period of time is less than two seconds.

21. The method of claim 19, wherein the working end surface at the distal end is maintained in contact with the target nerve tissue adjacent the bone structure of the joint and with the

28 portion of the target nerve tissue positioned between the working end surface and the bone structure of the joint during the short period of time.

22. The method of claim 19, wherein selectively providing electrical energy to the at least the pair of electrical conductors provides electrical stimulation energy of between 0-3 volts at a frequency selected from the set consisting of about 50 Hz for sensory simulation and about 2 Hz for motor stimulation to the electrodes for a period of a few seconds, to allow for the operator to observe the presence or absence of the desired response.

23. The method of claim 19, wherein selectively providing laser energy to the to at least the one optical fiber provides laser light energy to generate photocoagulation of the target nerve tissue to form a lesion having a width of at least 5 millimeters and a depth of at least 5 millimeters.

24. An integrated probe-ablation system for combined electrical stimulation and laser ablation of afferent nerve fibers of a desired sensory nerve of a patient under only local anesthesia, the system comprising: a rigid cannula that provides minimally invasive access channel having a diameter of between 1-7 mm to a target nerve tissue in a target area proximate a joint of the patient; an integrated probe-ablation device having a rigid shaft between a proximal portion and a distal end, the distal end having a working end surface that defines a perimeter configured to contact the target nerve tissue and position a captured portion

29 of the target nerve tissue between the perimeter and a bone structure of the joint, the device including: at least a pair of electrical conductors that extend through the shaft to corresponding electrodes proximate the working end surface; and at least one optical fiber that extends through the shaft to a terminus end proximate the working end surface, wherein the electrodes are configured to contact and provide bipolar electrical stimulation to the captured portion of the target nerve tissue to perform a test by a response of the patient of whether the target nerve tissue is the desired sensory nerve, and wherein the at least one fiber optic is configured to emit laser light to ablate the captured portion of the target nerve tissue during a short period of time if the response confirms that the target nerve tissue is the desired sensory nerve, and wherein the working end surface at the distal end is configured to be maintained in contact with the target nerve tissue adjacent the bone structure of the joint and with the captured portion of the target nerve tissue positioned between the working end surface and the bone structure of the joint during both test and the short period of time, such that the integrated probe-ablation device can deliver both bipolar electrical stimulation and laser ablation of afferent nerve fibers of the desired sensory nerve of the patient without having to withdraw the integrated probe-ablation device from the cannula; and a control system operably coupled to the integrated probe-ablation device to provide both electrical energy and laser energy to the integrated probe-ablation device.

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25. The system of claim 24, wherein the working end surface defines a generally concave shape within the perimeter that facilitates positioning of the captured portion of the target nerve tissue between the working end surface and the bone structure of the joint such that the captured portion extend at least partially into the generally concave shape.

26. The system of claim 25, wherein the perimeter of the working end surface includes a rim around the working end surface having a set of protrusions used to facilitate penetration of the working end surface into the target nerve tissue to reduce movement of the working end surface relative to the target nerve tissue.

27. The integrated probe-ablation system of claim 26, wherein the set of protrusions of the rim around the working end surface are formed in a pattern selected from one of a serrated pattern or a scalloped pattern.

28. The system of claim 24, wherein the working end surface defines a generally flat shape within the perimeter.

29. The system of claim 24, wherein the at least one fiber optic is a plurality of fiber optics.

30. The system of claim 29, wherein the plurality of fiber optics are arranged in a pattern on the working end surface selected from one of a linear pattern, a circular pattern or a generally

X-shaped pattern.

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31. The system of claim 24, wherein the terminus end of at least one fiber optic is flush with the working surface.

32. The system of claim 24, wherein the terminus end of at least one fiber optic is recessed a distance back from the working surface to provide an effective focal length for delivery of laser energy to the captured portion of the target nerve tissue.

33. The system of claim 24, wherein the terminus end of at least one fiber optic is recessed a distance back from a plane defined by the perimeter of the working surface to provide an effective focal length for delivery of laser energy to the captured portion of the target nerve tissue.

34. The system of claim 24, further comprising one or more optical elements that are operably positioned relative to the terminus end of at least one fiber optic to alter emission of the laser energy.

35. The system of claim 34, wherein the one or more optical elements are selected from the set consisting of a diffusive element or a deflective element.

36. The system of claim 24, wherein the control system is configured to selectively provide electrical energy to the at least the pair of electrical conductors as electrical stimulation energy of 0-3 volts at a frequency selected from the set consisting of about 50 Hz for sensory

32 simulation and about 2 Hz for motor stimulation to the electrodes for a period of several seconds.

37. The system of claim 24, wherein the control system is configured to selectively provide laser energy to the to at least the one optical fiber provides laser light to generate photocoagulation of the target nerve tissue to form a lesion having a width of at least 5 millimeters and a depth of up to 5 millimeters.

38. The system of claim 24, wherein the diameter of the cannula is less than 6 mm and a diameter of the perimeter of the working end surface is at least 4 mm.

39. The system of claim 24, wherein the integrated probe-ablation device further comprises a temperature sensor at the distal end to monitor a temperature of the target nerve tissue and wherein the control system selectively provides laser energy in response to the temperature sensor.

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