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WO2025160368A1 - Utilisation d'un outil chirurgical pour silencier des petites fibres à l'intérieur d'un nerf à travers une ouverture chirurgicale - Google Patents

Utilisation d'un outil chirurgical pour silencier des petites fibres à l'intérieur d'un nerf à travers une ouverture chirurgicale

Info

Publication number
WO2025160368A1
WO2025160368A1 PCT/US2025/012914 US2025012914W WO2025160368A1 WO 2025160368 A1 WO2025160368 A1 WO 2025160368A1 US 2025012914 W US2025012914 W US 2025012914W WO 2025160368 A1 WO2025160368 A1 WO 2025160368A1
Authority
WO
WIPO (PCT)
Prior art keywords
pbm
target
dose
nerve
surgical tool
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/012914
Other languages
English (en)
Inventor
Michael Moffitt
Michael Jenkins
Andrew BUZZA
Stephen Lewis
Junqi ZHUO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Case Western Reserve University
Original Assignee
Case Western Reserve University
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Filing date
Publication date
Application filed by Case Western Reserve University filed Critical Case Western Reserve University
Publication of WO2025160368A1 publication Critical patent/WO2025160368A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0622—Optical stimulation for exciting neural tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3937—Visible markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • A61B90/13—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints guided by light, e.g. laser pointers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0626—Monitoring, verifying, controlling systems and methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/063—Radiation therapy using light comprising light transmitting means, e.g. optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0659—Radiation therapy using light characterised by the wavelength of light used infrared
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0662—Visible light

Definitions

  • This disclosure relates generally to treatment of one or more neurological disorders regulated by small fibers within a nerve (e.g., nociceptive pain) and more specifically to systems and methods that use a surgical tool to apply photobiomodulation (PBM) to a nerve within a surgical opening to silence conduction in small fibers (e.g., conveying nociceptive information).
  • PBM photobiomodulation
  • Neurological disorders can include a myriad of symptoms, including but not limited to nociceptive pain. Patients experience acute nociceptive pain following surgery, injury, or other nociceptive insult. In some patients, the acute nociceptive pain can undergo chronification and transition to chronic nociceptive pain.
  • the transition from acute nociceptive pain to chronic nociceptive pain occurs due to an imbalance between pain amplification and pain inhibition.
  • opioids can provide strong pain relief, opioids can have significant negative side effects. For instance, opioids can induce hyperalgesia if taken inappropriately and may cause opioid induced hypersensitivity (OIH), and this likely contributes to pain chronification. Additionally, opioids are highly addictive and patients can develop tolerance, physical dependence, and opioid use disorder, with the risk of death. Electrical nerve block can inhibit the small fibers of the pre-spinal nerves that convey nociceptive information, preventing and/or reducing chronification for an extended period of time.
  • Described herein are systems and methods that apply photobiomodulation (PBM) through a surgical tool to an operative site to silence at least one small fiber within at least one target nerve accessible through an operative site.
  • PBM photobiomodulation
  • the at least one small fiber can convey nociceptive information to the brain.
  • acute nociceptive pain can be silenced and chronification of the acute nociceptive pain can be slowed, halted, and/or prevented.
  • the present disclosure can include a system that can be used to deliver PBM to small fibers in a target nerve before, during, and/or after surgery at an operative site to silence small fibers conveying nociceptive information and prevent chronification of acute nociceptive pain.
  • the system can include a surgical tool and a controller.
  • the surgical tool can include an optical emitter, a body configured to hold the optical emitter, and, in some examples, a shield coupled to and/or incorporated into the body.
  • the body can be configured to direct a dose PBM to a PBM target through a surgical opening.
  • the shield is positioned to extend outward from the body to contain at least a portion of light of the dose of PBM.
  • the controller can set the dose of PBM at an amount for a time.
  • the present disclosure can include a method for delivering PBM to small fibers within a target nerve before, during, and/or after surgery at an operative site to silence small fibers conveying nociceptive information and prevent chronification of acute nociceptive pain, and/or reduce the need for significant amounts of opioids.
  • the method can be performed by a system comprising a processor.
  • Steps of the method can include detecting that a shield of a surgical tool is in sufficient contact with a patient’s body based on data recorded by at least one surface contact sensor; controlling an optical emitter to deliver a dose of PBM to a PBM target within a surgical opening, wherein the dose of PBM comprises an amount of light for a time, wherein the shield is configured to block at least a portion of the dose of PBM from being emitted outside the shield; and stopping, by the system, transmission of the dose of PBM to the PBM target before the entire dose of PBM has been applied when the data recorded by the at least one surface contact sensor indicates that the shield of the surgical tool is no longer in sufficient contact with the patient’s body.
  • the present disclosure can include a device for slowing, halting, and/or preventing chronification of acute nociceptive pain.
  • the device can include an optical emitter which can be coupled to a controller.
  • the device can also include a body configured to hold the optical emitter that is further configured to enter a patient’s skin through an opening in a patient’s skin and direct a dose of PBM to a PBM target.
  • the device can also include a means for estimating a proximity to the PBM target coupled to the controller.
  • FIG. 1 is a block diagram showing a system including a surgical tool that can apply photobiomodulation (PBM) to silence one or more small fibers within a target nerve through a surgical opening;
  • PBM photobiomodulation
  • FIG. 2 is a block diagram showing example configurations of the surgical tool of FIG. 1 ;
  • FIGS. 3 and 4 show examples of location systems that can be used to guide positioning of the surgical tool of FIG. 1 ;
  • FIGS. 5 and 6 show example configurations of the surgical tool of FIG. 1 ;
  • FIG. 7 shows an example illustration of the shield of FIGS. 5 and 6;
  • FIG. 8 is an example of the controller of FIG. 1 ;
  • FIG. 9 shows example configurations of sensors that can be used by the surgical tool of FIG. 1 ;
  • FIG. 10 is an example of a handle for the surgical tool of FIG. 1 ;
  • FIG. 11 shows another example of the shielding of the system of surgical tool of FIG. 1 ;
  • FIG. 12 shows example shapes of the bottom of the shield that can be used with the surgical tool of FIG. 1 ;
  • FIG. 13 is an example of a sterile sheath used with the surgical tool of FIG. 1 ;
  • FIG. 14 is an example of a needle system that can be added to the surgical tool of FIG. 1 ;
  • FIG. 15-18 are process flow diagrams showing methods for applying PBM within a surgical opening to silence one or more small fibers in a target nerve.
  • references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
  • the term “photobiomodulation”, abbreviated as “PBM”, can refer to the delivery of light signal(s) at one or more prescribed wavelengths and dosing schemes to an operative site including a predefined target area within a patient’s body through a surgical opening to achieve a desired physiological response (e.g., to prevent acute pain from becoming chronic pain).
  • PBM utilizes nonionizing light sources, including lasers, light emitting diodes, and/or broadband light sources and can be delivered by one or more emitters.
  • the light can have a wavelength between 250 nm and 1600 nm.
  • the wavelength can be in the visible range (e.g., from 400 nm to 700 nm) and/or nearinfrared range (e.g., from 700 nm to 1 100 nm) of the electromagnetic spectrum.
  • the term “surgery” can refer to a medical procedure that involves cutting into a patient’s body to create a “surgical opening”, “surgical incision”, or the like.
  • the surgery may include the use of a surgical tool (e.g., a scalpel) to create the surgical opening.
  • the surgery may include the use of a needle-type device to create a surgical incision prior to and/or instead of creating a surgical opening (e.g., using a scalpel).
  • a surgery can involve the treatment of a malady (e.g., an injury, disease, deformity, condition, or the like) by the physical removal, repair, readjustment, etc., of one or more sources of the malady (e.g., one or more organs, one or more parts of one or more organs, one or more tissues, or the like) through the surgical opening.
  • a malady e.g., an injury, disease, deformity, condition, or the like
  • sources of the malady e.g., one or more organs, one or more parts of one or more organs, one or more tissues, or the like
  • the terms “surgical opening”, “surgical incision”, or the like can refer to a cut or hole made in a portion of a patient’s body (e.g., through at least the patient’s skin) through which surgery can be performed at an “operative site”.
  • the term “surgical tool”, “surgical instrument”, or the like can refer to a device and/or part of a system for performing specific actions or carrying out desired effects during a surgery that is external to and/or removeable from a patient’s body.
  • a surgical tool can be inserted through a surgical opening to apply one or more PBM light signals to one or more target nerves within the patient’s body for therapeutic effect.
  • a nerve refers to a bundle of fibers that send messages from parts of the body to the brain and/or vice versa in the form of electrical signals.
  • a nerve can be a sensory nerve that includes sensory fibers, a motor nerve that includes motor fibers, a sensorimotor nerve that includes sensory and motor fibers, etc.
  • the term “fiber” refers to an axon, which is a long slender projection of a nerve cell or neuron in vertebrate organisms having a diameter that corresponds to conduction velocity.
  • a fiber conducts electrical impulses transmitting information in one or more directions throughout the body and is classified depending on the type of fiber (e.g., sensory, motor, etc.), the diameter of the fiber and/or if myelin coating is present.
  • sensor fiber(s) refers to part of the peripheral nervous system (PNS) that conduct electrical impulses between a part of the body experiencing sensation and the brain/spinal cord. Sensory fibers have a range of fiber sizes.
  • sensory fibers can be classified as Aa (diameter 13-20 pm, conduction velocity 80-120 m/s, myelinated, associated with muscle spindle fibers and Golgi tendon organ); A[3 (diameter 6-12 pm, conduction velocity 33-75 m/s, myelinated, associated with all cutaneous mechanoreceptors); AS (diameter 1 -5 pm conduction velocity 3-30 m/s, thinly myelinated, associated with free nerve endings of tough and pressure, nociceptors of the neospinothalamic tract, cold thermoreceptors); and C (diameter 0.2-1 .5 pm, conduction velocity 0.5-2.0 m/s, unmyelinated, associated with nociceptors of the paleospinothalmic tract and warmth receptors).
  • a “small” sensory fiber can refer to an AS fiber and/or a C fiber.
  • the term “nociceptor” can refer to a sensory receptor that sends signals to the brain to produce the sensation of pain in response to noxious stimuli.
  • the term “neurological disorder” refers to a disorder that affects the brain and/or nerves of a patient. Neurological disorders can include, but are not limited to, abnormal and/or unwanted conduction regulated by small fibers within a nerve such that the patient feels nociceptive pain.
  • nociceptive pain can refer to a type of pain arising from damage to one or more body tissues (e.g., damaged by noxious stimuli such as physical stimuli, chemical stimuli, or thermal stimuli).
  • nociceptive pain can be due to an external injury.
  • Nociceptive pain can be acute and/or chronic.
  • acute pain can refer to pain that transient and usually disappears when the underlying cause has been treated or has healed.
  • chronic pain can refer to long standing pain that persists beyond the usual recovery period of an underlying cause or occurs along with a chronic health condition. Chronic pain can be continuous or can flare up in response to a trigger and can also be referred to as persistent pain.
  • the term “chronification” can refer to the progression of a pain from acute pain to chronic pain.
  • the chronification process can refer to an acute nociceptive pain that causes central sensitization and central pathological effects resulting in a chronic neuropathic pain.
  • some disorders e.g., back pain, arthritic pain, etc.
  • involve the chronic activation of nociceptors the results in chronic and persistent pain e.g., neuropathic pain).
  • the term “dosing scheme” can refer to a schedule of one or more doses of PBM (e.g., quantities of light of one or more wavelengths) to be delivered to a target area of a patient per a unit of time during surgery to treat the patient.
  • PBM e.g., quantities of light of one or more wavelengths
  • the term “patient” can refer to any warm-blooded organism, including, but not limited to, a human being, a pig, a rat, a mouse, a dog, a cat, a goat, a sheep, a horse, a monkey, an ape, a rabbit, a cow, etc.
  • a human being, a pig, a rat, a mouse, a dog, a cat, a goat, a sheep, a horse, a monkey, an ape, a rabbit, a cow, etc.
  • the terms patient and subject can be used interchangeably herein.
  • Photobiomodulation provides an attractive solution for silencing small fibers within target nerves accessible through a surgical opening to treat one or more neurological disorders (e.g., before, during, and/or after surgery).
  • small fibers may convey nociceptive pain information.
  • PBM has emerged as a treatment that may be able to prevent chronification of acute nociceptive pain to chronic nociceptive pain.
  • post-surgical pain can be mitigated through pharmaceutical means, such as use of opioids, or with electrical nerve blocks.
  • pharmaceutical means such as use of opioids, or with electrical nerve blocks.
  • both pharmacological means and electrical nerve block have significant and potentially dangerous side effects - such as, but not limited to, addiction and permanent tissue and/or nerve damage, respectively.
  • Opioids can contribute to opioid-induced hyperalgesia and possibly even contribute to chronification of pain.
  • PBM has been applied through implanted or external application of light.
  • Implanted devices are costly, require invasive surgery and leaving an electronic device in the body, have a limited lifespan and poor power use, etc.
  • External devices are faced with range, power, efficacy, and safety concerns, on top of problems with correctly estimating the amount of light actually delivered to the target area.
  • a specially configured surgical tool can be used to apply PBM to one or more nerves near an operative site, or innervating an operative site or injury site, to at least partially silence small fibers conveying nociceptive information.
  • the surgical tool can supply an adequate amount of light of PBM for a time to the one or more nerves without interference of occlusive materials between the skin and the operative site, while still being easily removable.
  • the surgical tool can be configured to protect onlookers from at least part of the light of the PBM through an attached safety mechanism. The silencing can persist for a period of several days, weeks, or months after the dose of PBM is applied, thus helping the patient’s body to go through the healing processes with reduced pain and/or inflammation.
  • Photobiomodulation generally refers to the delivery of light, at one or more prescribed wavelengths and one or more dosing schemes, to at least one nerve within and/or near a target area (referred to as, one or more “target nerves”) to achieve a desired physiological response.
  • the physiological response can be, in some instances, lessening or stopping nociceptive pain and/or preventing, slowing, and/or halting the chronification of nociceptive pain by at least partially silencing at least one small fiber within the target nerve(s) (e.g., small diameter sensory nerve fibers, small diameter sympathetic nerve fibers, etc.). Small fibers may also be found within nerve roots, neural ganglia, preganglionic fibers, etc. and can be responsible for conducting information beyond nociceptive pain, which may also be at least partially treated and/or ameliorated with the systems described herein.
  • the one or more target nerves including the small fibers can also and/or alternatively be a part of the white matter columns and/or gray matter laminae of the spinal cord.
  • small diameter fibers that can be at least partially silenced with the systems described herein include, but are not limited to: small diameter afferents within the laryngeal nerve network that are responsible for obstructive sleep apnea and abnormal hypoglossal nerve input, small diameter afferents within the laryngeal nerve network that are responsible for exacerbation of asthma and excessive vagal drive, cardiac small diameter sympathetic afferents that are responsible for cardiac arrhythmias for abnormal cardiac sympathetic and vagal drive, small diameter sympathetic afferents that are responsible for adverse changes in coronary blood flow via changes in activity of post-ganglionic sympathetic input, nasopharyngeal vagal afferents that have a negative effect on cerebral blood flow (especially during sleep, particularly REM sleep), nasopharyngeal vagal afferents that play a definitive role in the etiology of migraine headaches, carotid sinus nerve activity which plays a major role in expression of neuro
  • At least partially silencing certain small diameter sensory fibers can treat nociceptive pain.
  • the nociceptive pain can be acute post-surgical (e.g., post-operative) pain and/or post injury pain due to, for example, knee arthroplasty, hip arthroplasty, inguinal hernia repair, thoracotomy, sternotomy, limb amputation, back surgery, abdominal surgery, breast surgery, gynecological surgery, donor/recipient nephrectomy, and gastro-intestinal surgery, nociceptive back pain, and the like.
  • PBM can silence fibers that conduct signals for acute nociceptive pain and/or chronic pain.
  • PBM can also and/or alternatively at least substantially prevent and/or reduce the likelihood of chronification of acute nociceptive pain to chronic pain.
  • pain as used herein can refer to acute nociceptive pain, chronic nociceptive pain, and/or the process of chronification of nociceptive pain to neuropathic pain.
  • the use of PBM may reduce the need for significant amounts of opioids to be used by the patient during recovery, although examples of this application will be described with reference to pain for ease of description, it will be understood that PBM can applied to any small fibers to cause a desired effect on the patient.
  • light particularly PBM, can reduce (partially and/or fully) one or more physiological responses related to neurological disorders that are mediated by small fibers depending on the dosing scheme and the target nerve(s).
  • a system 100 can deliver PBM intraoperatively through a surgical opening using a surgical tool 10 that can be placed at least partially through the surgical opening to provide the PBM and can then be removed.
  • An external controller 16 in wired and/or wireless communication with the surgical tool 10 can at least configure and drive the PBM application.
  • a surgical tool can include the positive aspects of traditional fully implanted systems and external systems, while not suffering from the serious side effects and/or challenges.
  • the system 100 can directly apply PBM (e.g., without light modulating intervening tissues, may or may not be in direct contact with the one or more target nerves) without the need for invasive implantation or additional surgery and with a comparatively unlimited life span and improved power use.
  • the system 100 can also more accurately, precisely, and safely apply doses of PBM compared to traditional PBM systems.
  • the system 100 can apply PBM to one or more target nerves (shown as a target nerve for ease of illustration but should be understood can be one or more target nerves) within and/or near an operative site by surgical tool 10 that can be inserted at least partially through the surgical opening.
  • the PBM can be applied at any time during a surgery (e.g., at least one of before a surgical procedure, during a surgical procedure, after a surgical procedure, instead of an alternative surgical procedure, etc.) to at least partially silence small fibers conveying nociceptive information.
  • the system 100 can be used to apply PBM one or more times to the target nerve during one or more surgeries.
  • a single application of PBM can effectively silence the one or more small fibers within the target nerve to achieve the desired clinical outcome (e.g., reduction and/or stopping of nociceptive pain, reducing, stopping, and/or preventing chronification of nociceptive pain, etc.).
  • the system 100 can apply a first dose of PBM during a first procedure and the system can then apply a second dose of PBM (at a same or a different location on the target nerve) during either the first procedure or during a second procedure to increase a magnitude of the effect of the PBM, to recover (at least in part) an effect that has dissipated an amount since the first application, or the like.
  • the system 100 can be used to silence one or more small fibers in a target nerve for a trial period of time (e.g., several hours, days or weeks) to estimate whether a fully implantable PBM system would be effective as a chronic therapy for a given patient before incurring the surgical burden and expense of implanting a chronic fully implantable PBM system.
  • the system 100 can enable trialing a therapy before moving forward with an implantable device.
  • Application of the PBM by the system 100 can at least partially silence the one or more small fibers for a period of time longer than the time of application of the PBM (e.g., the silencing can begin based on the dose and can last for one or more hours, days, weeks, or months after the dose of PBM is applied).
  • the extended small fiber silencing (past the time of PBM application) can enable the patient’s body to go through inflammatory and healing processes with reduced pain, reduced central sensitization to nociceptive stimuli, and/or reduced peripheral sensitization, while simultaneously enabling the patient to continue to feel mechanical stimuli, as opposed to other methods that can remove the ability to feel mechanical stimuli (e.g., neurectomy, electrical block, etc.).
  • the application PBM by the system 100 may reduce, minimize, and/or eliminate the need for prescribing opioids after a surgery.
  • the surgical tool 10 can supply one or more doses of PBM to the target nerve through the surgical opening without the interference of occlusive materials (e.g., muscle, bone, fat, skin, implanted materials, etc.) in the path of the light of the PBM.
  • the one or more doses of PBM can include an amount of light of PBM to be applied for a time.
  • the controller 16 can control the configuration of the one or more doses and can control one or more parameters of the PBM.
  • the one or more parameters can include, but are not limited to, the amount of light, the time of application, the number of doses, the wavelength(s) of the light, the power of the light, if the light is applied in a continuous and/or pulsatile manner, or the like.
  • the dose of PBM can have at least one wavelength between 600 nm and 1200 nm.
  • the controller 16 can configure the one or more dose of PBM to silence conduction in at least one small diameter sensory nerve fiber for a period of time extending after the dose of PBM is applied.
  • the controller 16 can also and/or alternatively configure the one or more dose of PBM to provide varying onset and/or recovery timeframes for the silencing of the one or more small diameter fibers (e.g., at least one small diameter sensory nerve fiber) where larger doses might be used to extend the effects for longer periods of time.
  • the surgical tool 10 can be in communication, wired and/or wireless, with the controller 16 to, for instance, communicate features and/or parameters of the dose of PBM, to turn on and/or off the PBM application, to communicate one or more physiological parameters (e.g., temperature) and/or modulations to the dose of PBM in response to the one or more physiological parameters, to determine the position of the surgical tool (e.g., if the surgical tool is within the surgical opening, is in contact with the one or more target nerves, etc.) or the like.
  • the controller 16 can include at least a non-transitory memory (not shown) to store instructions and/or data and a processor (not shown) to execute one or more instructions.
  • the surgical tool 10 can be in communication, wired and/or wireless, with a controller 16 (as shown in FIG. 1 ) or can be embodied in a single housing with the controller 16 (as shown in, for example, FIGS. 5-7).
  • the system 100 can include an external device 18 that can be in wired and/or wireless communication with the controller 16 and/or the surgical tool 10.
  • the external device 18 can include at least a processor, and optionally a user interface, a display, or the like and can be, for example, a smart phone, a tablet, a computer, medical device, or the like, that can at least provide input to and/or receive a signal from the controller 16 and/or the surgical tool 10.
  • the external device 18 and/or the controller 16 can include a power source and communicatively connect the surgical tool 10 with the external device 18, letting the external device 18 act as the “controller”.
  • the surgical tool 10 and/or the controller 16, can in some instances transfer information to and/or from the external device 18.
  • the external device 18 can be an external computer connected to an electronic medical recording (EMR) system and can create a log for the patient's EMR regarding a dose of PBM applied to the patient.
  • the logged details can include, for example, the wavelength, power, spot size, duration, beginning/ending time, thermal measurement(s), optical image(s) of the target nerve for reference, or the like.
  • the external device 18 can be a surgical tracking system that can ensure a surgical plan for PBM application is followed by an operator of system 100 (e.g., doctor, medical professional, clinical technician, or the like.).
  • the surgical tracking system can be compatible with the surgical tool 10, for example, the surgical tracking system can automatically log a location where PBM is applied by the surgical tool (e.g., based on data from one or more sensor(s) (not shown) of system 100).
  • the external device 18 can be and/or can include an optical system that can visualize at least a portion of the surgical opening, operative site, and/or one or more target nerves.
  • the external device 18 can be a surgical planning system with an added polarization optical system (integrated within the surgical planning system and/or at least partially separate) to allow visualization of the surgical area in real time to help medical personnel identify the target nerve.
  • the external device 18 can be and/or can include an optical system used in the transmission/projection of the PBM light beam.
  • the PBM light can be projected by the optical system (e.g., using a digital micromirror device (DMD), one or more diffraction grating plates with predefined illumination patterns, or the like) to create a patterned illumination of PBM.
  • the patterned illumination can be patterned such that the PBM light can be delivered to desired location(s) on the target nerve(s), while tissues and/or regions of the patient’s body that the PBM is not meant to illuminate remain unaffected (e.g., the pattern can be switched based on the illumination pattern that best fits a given surgical scenario).
  • elements A and B shows block diagrams of two example configurations of the surgical tool 10 (e.g., 10a and 10b) that can deliver PBM in a safe and effective manner. It should be understood that these example configurations of elements A and B are for illustration purposes only and are not intended to be limiting or exclusive.
  • the surgical tools 10a and 10b can each include at least one optical emitter (e.g., optical emitter(s) 12) and a body 20 that can hold at least one optical emitter(s).
  • the body 20 can be shaped and/or positioned to direct the dose of PBM to a PBM target (e.g., the one or more target nerves) through the surgical opening (not shown in FIG. 2).
  • the body 20 can include, for example, a lumen configured to at least partially hold the optical emitter(s) 12 and direct the light of the PBM (see e.g., FIG. 6). In another example, the body 20 can be configured to at least partially hold the optical emitter(s) 12 to extend into a surgical opening (see e.g., FIG. 5).
  • the optical emitter(s) 12 can include at least one light source (e.g., LED, laser diode, etc.) that can emit at least one wavelength of light.
  • the optical emitter(s) 12 can deliver red and/or infrared light (e.g., light having wavelength(s) from 600 nm - 1200 nm).
  • the optical emitter(s) 12 can be connected to and/or can include at least one element that can create a light path such as an optical fiber, at least one light pipe, at least one lens, and/or any other kind of light transmission mechanism.
  • the surgical tools 10a, 10b can include a shield 14a, 14b that can be positioned to extend outward from the body 20 and can contain at least a portion of light of a dose of PBM within the shield.
  • FIG. 2, element A shows surgical tool 10a where the shield 14a is at least partially coupled (may be removable) to the body 20 and
  • FIG. 2, element B shows surgical tool 10b where the shield 14b is at least partially incorporated into the body 20.
  • the shields 14a, 14b can each prevent at least a portion of the light of PBM (at specific red and infrared wavelengths, for example) from reaching eyes and/or skin of onlookers and/or other tissues of the patient.
  • the shield 14a/14b can be transparent for at least one other wavelengths (e.g., wavelengths other than red and/or infrared) and can enable an operator and/or other onlookers to see the PBM target and/or the area around the PBM target.
  • the shield 14a or 14b can eliminate the need for safety goggles.
  • the shield 14a, 14b can be removably attached to the patient’s body inside and/or surrounding the surgical opening (e.g., using an adhesive, clips, or the like). In some instance, the shield 14a, 14b can only be placed in contact (not attached) with the patient’s body inside and/or surrounding the surgical opening.
  • the shield 14a, 14b can be any shape and/or material that can contain at least a portion of the light of the dose of PBM (e.g., the material may include glass and/or one or more polymers that can be processed to maintain transparency but that include one or more dyes to make the shield 14a, 14b at least partially opaque to specific wavelengths and/or intensities).
  • the shield 14a, 14b can be conical and extending outward from a shaft of the surgical tool 10a, 10b, a portion of a face and/or a layer of the surgical tool, a surgical drape-like design in any shape configured to spread over at least the surgical opening, or the like.
  • the shield 14a, 14b can be at least partially stiff and/or malleable.
  • the shield 14a, 14b can be shaped so as to not disrupt and/or contact the PBM target and can be made of a material that is soft, bendable, and/or flexible (e.g., as shown and described in further detail with respect to FIG. 1 1 ).
  • a system 300 can include a part of the body 20 of the surgical tool 10 that can be shaped as a shaft and guiding light sources 32 (shown as three but can be any number one or greater) that can facilitate aiming the PBM.
  • the guiding light sources 32 can illuminate a target location (e.g., where the PBM should be applied) on the PBM target (e.g., the one or more target nerves).
  • the guiding light sources can illuminate (shown by the dotted lines and dashed circle) an approximate spot size for the optical emitter(s) 12 to deliver the dose of PBM to the PBM target.
  • the guiding light sources 32 can be positioned at equal distances on a patient facing side of the surgical tool 10 around the light emitter(s) 12 and/or the opening for the light path 34 (depending on the positioning of the light emitter(s) 12.
  • the guiding light sources 32 can be in any other configuration on and/or within the surgical tool 10 capable of illuminating a target location on the PBM target (e.g., one or more target nerves).
  • the guiding light sources 32 can each be a small, visible light emitter (e.g., a light source such as an LED or laser diode, an end of a light pipe, an end of an optical fiber, or the like) that can provide an aimed illumination.
  • the guiding light sources 32 can illuminate the target nerve with at least one wavelength of light.
  • the at least one wavelength of light can be different from the wavelength used for the PBM (e.g., to differentiate the spot size and/or to make the illumination of the approximate spot size visible through a shield).
  • the shield (not shown in FIG. 3) can have a high optical density for wavelength(s) of the PBM from the optical emitter(s) 12 and a lower optical density for the guiding light from the guiding light sources 32.
  • the spot size can change with distance between the guiding light sources 32, optical emitter(s) 12, and/or light path 34 and the PBM target.
  • the spot size from the guiding light sources 32 can take into account the numerical aperture of the optical emitter(s) 12.
  • the guiding light sources 32 can be angled, powered, and/or sized to take into account the numerical aperture of the optical emitter(s) 12.
  • the guiding light sources 32 can be configured to not exceed power levels of the optical emitter(s) 12 and/or will not emit light at the same wavelength as the optical emitter 12(s).
  • the PBM light and the guiding light can be delivered through the same light pipe and emitter (e.g., light source) but at different wavelength(s) and/or power(s) (which can help account for numerical aperture properties).
  • the guiding light (from the guiding light sources 32) can be delivered independent of and/or simultaneous with the PBM light (from the optical emitter(s) 12).
  • the guiding light sources 32 and the optical emitter(s) 12 can be controlled by separate controls (e.g., on a user interface of the surgical tool, controller, and/or external device, not shown).
  • elements A and B each show an alternate system for providing aiming and PBM light beams to a PBM target (e.g., target nerve) using a single light source 40 (as opposed to the multiple light sources discussed with respect to FIG. 3).
  • the light source 40 (taking the place of optical emitter(s) 12) can be an LED, a laser diode, a white light source, or the like connected to an optical fiber that can deliver both the PBM light beam and at least one aiming light beam.
  • the optical fiber is a double cladding optical fiber and in system 450, illustrated in FIG. 4, element B, the optical fiber is a dual optical fiber.
  • the light source 40 can provide an output beam that can be divided into at least one PBM beam and at least one aiming beam (depending on amount of cladding).
  • the double cladding optical fiber can include a center core 42 and an outer core 44 that can be any shape annular to the center core (e.g., concentric lumens).
  • the center core 42 can be separated from the outer core 44 by middle cladding 46.
  • the outer edge of the outer core 44 can be defined by the outer cladding 48.
  • the center core 42 and the outer core 44 are generally described with a circular cross section (e.g., a transverse cut face of the system 400 is shown) but can be any shape that can facilitate aiming and PBM illumination.
  • the aiming beam can be emitted through the outer core 44 and the PBM beam can be emitted through the center core 42.
  • the output beam divergence angle controlled by the inner core 42 and the outer core 44 (or the numerical aperture, NA, of the light source into the inner core 42 and outer core 44) can be designed so that the two light beam spot sizes match at the given target distance.
  • the divergence angle and/or numerical aperture can be altered (e.g., manually and/or mechanically by a command from the controller and/or external device).
  • the optical fiber is a dual optical fiber 43 (e.g., side by side lumens) that can deliver both the PBM beam and the aiming beam from the single light source 40.
  • Both of the dual optical fibers 43 can have a small diameter (same and/or different) and can be co-located closely so that the spot size and/or locations of both the PBM beam and the aiming beam are similar. While dual optical fibers are shown to produce a single PBM and aiming beam each, any number of optical fibers can be grouped together to produce any number of PBM and/or aiming beams.
  • the numerical apertures of each of the dual optical fibers 43 can be chosen and/or adjust such that the spot size of the PBM beam and the aiming beam substantially match.
  • one or more lenses or diffraction gratings 45 and/or one or more light altering elements 47 can, optionally, be positioned at the emission end(s) of one or more of the dual optical fibers 43 to adjust the numerical apertures (NA) so that the spot sizes match more closely.
  • the lens or diffraction grating 45 can be a gradient refractive index (GRIN) lens, a diffraction grating plate, or the like.
  • the lens or diffraction grating 45 and/or other one or more light altering elements 47 can be adjusted and/or altered to change the numerical aperture of each of the dual optical fibers 43.
  • Diffraction grating plates can, optionally, produce a patterned illumination for either the PBM beam and/or the aiming beam.
  • FIGS. 5 and 6 illustrated are examples of surgical devices 500, 600 (e.g., which can be used as surgical tool 10) in use within a surgical opening.
  • Each surgical device 500, 600 includes at least the optical emitter 12 and the shield 14 as described with respect to FIG. 2.
  • Surgical devices 500, 600 can, in some instances, at least partially include the controller 16 and/or can include circuitry in communication (wired and/or wireless) with the controller and/or an external device 18 (neither shown in FIGS. 5 and 6) described with respect to FIG. 1
  • the surgical devices 500, 600 are each capable of applying PBM intraoperatively and at least partially “silencing” conduction in one or more small fibers within a target nerve (or one or more target nerves) (and thereby stopping and/or reducing a physiological response, like pain) for a period that can lasts longer than the time of application (e.g., for several hours, days, weeks, months, or the like, beyond the surgical application of PBM.
  • the surgical devices 500, 600 can be configured for single use (sterile) and/or multiuse (fully sterilizable and/or able to be covered with a sterile covering, e.g., with a sterile sheath 1302 as shown in FIG. 13).
  • Both surgical devices 500, 600 can include indicators, such as a power button, one or more buttons to start/stop, enable, set/unset, light delivery, or the like, a button to adjust the dose parameters (e.g., cycle through preset doses), etc. and/or a more complex user interface (e.g., touch screen or keys) for mode complex adjustments.
  • the surgical devices 500, 600 can include a display, audio output, and or tactile output (not shown) that can be used, for example, to convey the dose of PBM that is presently set, state information, and the like.
  • Each surgical device 500, 600 can have a handle 58 (e.g., that can include the indicators, display (not shown), and/or user interface (not shown) and a shaft body 52 with a distal end 54 (further from the surgical opening and adjacent the handle) and a proximal end 56 (closer to the surgical opening) and a length of the shaft body therebetween.
  • proximal and distal as used herein are defined with respect to the patient undergoing surgery. It will be understood that proximal and distal will have opposite meanings when taken from the operator (e.g., surgeon, doctor, etc.) perspective.
  • the optical emitter(s) 12 can be positioned at least partially in the shaft body 52. As shown in FIG. 5, the optical emitter(s) 12 can be positioned at least partially in the shaft body 52 (e.g., within a lumen of the shaft body) and closer to the proximal end 56 of the shaft body 52 of the surgical device 500. As shown in FIG. 5, the optical emitter(s) 12 can at least partially extend out of the proximal end 56 of the shaft body 52 and into the surgical opening. In FIG. 5, the shield 14 can be located on the shaft 52 distal to the optical emitter(s) 12 such that the one or more emitter(s) can be placed into the surgical opening and the shield 14 can cover the surgical opening.
  • the shield 14 can have an adjustable position along the length of the shaft body 52 (e.g., can be manually and/or mechanically adjusted (e.g., motorized) to take into account the size and/or depth of the surgical opening) such that the shield 14 can touch the skin and/or other tissue of the patient to stop the escape of at least a portion of the PBM light.
  • an adjustable position along the length of the shaft body 52 e.g., can be manually and/or mechanically adjusted (e.g., motorized) to take into account the size and/or depth of the surgical opening
  • the one or more optical emitter(s) 12 can be positioned in the shaft (e.g., within a lumen of the shaft) closer to the distal end 54 and the at least the PBM light can be conveyed through a light path 62 (e.g., created by one or more lumen, one or more optical fibers, one or more light pipes, or the like) to the PBM target.
  • the optical emitter(s) 12 can be positioned to not directly contact the PBM target in this manner. It should be noted that in this configuration the heat generated from the one or more optical emitters(s) 12 can be further from a patient’s tissue than in other configurations so PBM may be able to be applied longer and/or at greater powers.
  • the shield 14 can be positioned more proximal the surgical opening (e.g., closer to the proximal end 56) in example 600 because the shield need only block the light emitted from the light path at the proximal end 56 (e.g., the shaft body 52 can block the escape of the light before that point). Similar to FIG. 5, the shield 14 can have an adjustable position along the length of the shaft body 52 (e.g., can be manually and/or mechanically adjusted (e.g., motorized) to take into account the size and/or depth of the surgical opening) such that the shield 14 can touch the skin and/or other tissue of the patient to stop the escape of at least a portion of the PBM light.
  • an adjustable position along the length of the shaft body 52 e.g., can be manually and/or mechanically adjusted (e.g., motorized) to take into account the size and/or depth of the surgical opening
  • FIG. 7 illustrated is a condition where the shield 14a (such as described in FIG. 2, element A) is coupled to the body e.g., the shaft of the surgical tool and can have an adjustable position on the shaft (referred to as A shield up and B shield down).
  • the shield 14a can slide up and down along the length of the shaft of the surgical tool.
  • the shield 14a can be locked into place (e.g., with a set screw or other attachment/locking mechanism) at a desired location on the shaft.
  • the shield 14a can be moved manually and/or may be automatically moved (e.g., by one or more motorized components (not shown) in communication with the controller (not shown)).
  • the shield 14a is shown shaped like a cone but can have any shape that would perform the functionality of the shield to contain at least a portion of light of the dose of the PBM.
  • the shield 14a can have lifted regions around the shield’s periphery such that the shield cannot compress at least a portion of the one or more target nerves at the shield edges.
  • the shield 14a can be translucent to one or more wavelengths of light to enable one or more clinician(s) to see the position of the one or more optical emitter(s), the location the PBM will be delivered, and/or one or more aiming light beams (as described earlier with respect to FIGS. 3 and 4).
  • the shield 14a can simultaneously be at least partially, but preferably entirely, opaque to at least the wavelength(s) of light emitted for PBM, thus, protecting eyes and tissues outside a target area from the PBM.
  • the shield 14a In the down position, B, the shield 14a can contact at least a portion of the tissue of the patient (inside or outside and over the surgical opening, e.g., skin, muscle, bone, organ, etc.).
  • the shield 14a can, in some instances, removably attach to the tissue of the patient with suction, adhesion, or the like to hold the surgical tool in place during the PBM application. In some instances, as described in further detail with respect to FIGS.
  • the surgical tool can include one or more sensors (not shown) as part of the shield 14a that can send one or more signals back to the controller (not shown) that can control, based on the position of the shield (e.g., up or down, contacting the tissue sufficiently, etc.), whether PBM can be applied at a given time. For example, if the shield is not down and/or sufficiently in contact with the tissue, then the PBM cannot be applied and an alert (audible, visual, and/or tactile) may be generated instead.
  • an alert audible, visual, and/or tactile
  • the outer diameter of the tip of the shaft can have properties similar to the shield as described with regard to FIGS. 5-7.
  • the tip is used as the shield, there could also be contact sensors around the periphery of this tip to ensure proper contact / shielding.
  • FIG. 8 Shown in FIG. 8 are example inputs and outputs of the controller 16.
  • the controller 16 (which can include at least a memory and a processor, not shown) can be in wired and/or wireless communication with every component noted in FIG.
  • the controller 16 may in some instances be embodied at least partially in a same housing as one or more of the components shown in FIG. 8, which may be the surgical tool, an external device, or the like.
  • the controller 16 can be in communication with at least one or more optical emitter(s) 12 and a user interface 88.
  • the controller 16 can, in some instances, can also be in communication with a display 86, sensor(s) 82, and/or temperature management device(s) 84.
  • the controller 16 can be configured as a closed loop and/or an open loop system with at least one of the components shown in FIG. 8.
  • the controller 16 can be in bidirectional communication with one or more optical emitter(s) 12.
  • the controller 14 can regulate the on/off time of the one or more optical emitter(s) 12, one or more dose parameters for the PBM applied by the optical emitter(s), or the like, in an open or closed loop system.
  • the controller 16 can be in unidirectional and/or bidirectional communication with one or more other components within and/or linked to the surgical tool (e.g., sensor(s) 82 and/or temperature management device 84) to provide feedback to the controller and/or receive a command from the controller.
  • the feedback can be received by the controller 16 and/or an external device (not shown, but in communication with at least the controller and the one or more other components).
  • the controller 16 and/or the external device can, for example, reconfigure at least one of the PBM parameters more precisely so that the light signal delivered to and/or received at the PBM target matches a predetermined prescription and/or surgical plan.
  • the controller 16 can include and/or be connected to a user interface 88 to receive one or more user input to change the operation of the controller and/or alter the dose (e.g., before and/or during the surgery based on the feedback, and/or manual commands in an open loop).
  • the controller 16 can include a display 86 to show visualizations of one or more outputs, alerts, medical and/or prescription information, or the like.
  • the one or more sensor(s) 82 can include, but are not limited to, a temperature sensor, a photodetector, a reflector, an electrode, a pressure sensor, or the like.
  • the feedback can include, but is not limited to, temperature information of the PBM target and/or surrounding tissues, light information (wavelength, power, amount, etc.), current, impedance, pressure and/or force, or the like.
  • the controller 16 can alter a dose of the PBM in response to the feedback from a photodetector and/or a reflector, or the like, for example, if it is determined not enough light or too much light is reaching the PBM target at a time (per a prescription stored in memory), then the light can be made more intense and/or applied for a longer time or made less intense and/or applied for a shorter time etc. In another example, if the controller 16 determines, based on the feedback, one or more incorrect wavelengths were detected (e.g., by a photodetector and/or reflector) then the controller can alter the one or more wavelength of the light being applied during the PBM dose. In some instances, the controller 16 can control delivery of multiple applications of PBM to one or more distinct PBM targets (e.g., distinct locations) along or within a given target nerve at multiple target nerves (e.g., to broaden the coverage).
  • a photodetector and/or a reflector or the like, for example, if it
  • the one or more sensor(s) 82 can include a temperature sensing component (e.g., a thermocouple, a thermistor, a blackbody radiation sensor, or the like) configured to detect a temperature of tissue at the PBM target and/or proximal the PBM target.
  • the temperature sensor(s) can be coupled to the controller 16 and can send the temperature to the controller at a given time and/or in response to a query from the controller.
  • the controller 16 can determine and/or alter the PBM dose parameters in response to the feedback based on a predetermined temperature management limit (e.g., set for safety of the patient, the operative site, or the like before a threshold level of damage occurs) and/or prevent application of PBM if a detected temperature is above the threshold until the detected temperature decreases to a safe level.
  • the controller 16 can stop delivery of the dose of PBM at any time during application if the temperature of the tissue recorded by the temperature sensor is higher than the pre-set threshold.
  • the controller 16 can control whether or not the optical emitter(s) 12 can turn on based on a temperature feedback. For example, in order to turn on the one or more optical emitter(s) 12, the temperature should be within a pre-specified range and/or lower than a pre-set threshold.
  • the temperature management device(s) 84 can be in and/or on at least a portion of the surgical tool adjacent and/or near the one or more optical emitter(s) 12 and/or the tissue near the temperature sensor(s).
  • the temperature management device(s) 84 can be, for instance, one or more heat sink elements, Peltier modules, or other types of cooling or heat distribution devices.
  • the temperature management device(s) 84 can reduce the temperature of at least a portion of the surgical tool and/or the tissue if the temperature sensor(s) detect a temperature over a pre-determined threshold.
  • the temperature device can physically cool and/or move heat away from the at least one of the optical emitter, the PBM target and/or tissue adjacent the PBM target. It should be noted that the temperature management device(s) 84 can be connected to the temperature sensor(s) directly and/or via the controller 16.
  • the one or more sensor(s) 82 can include at least one surface contact sensor (e.g., an impedance sensor, a pressure sensor, or the like) configured to detect pressure and/or impedance indicative of whether at least a portion of the surgical tool (e.g., the shield, a target facing side of the surgical tool, the optical emitter(s) 12, or the like) is in contact with tissue around and/or above the PBM target.
  • the shield can include the at least one surface contact sensor and the at least one surface contact sensor can detect if the shield is in contact with the tissue (inside the surgical opening or surrounding the surgical opening.
  • the controller 16 can stop delivery of the dose of PBM at any time during PBM application and/or prevent the start of delivery of the dose of PBM if the at least one surface contact sensor detects that the at least the portion of the surgical tool (e.g., the shield) is not in sufficient contact with the tissue.
  • the at least one surface contact sensor detects that the at least the portion of the surgical tool (e.g., the shield) is not in sufficient contact with the tissue.
  • the controller 16 can perform a self-calibration mode to ensure that the amount of light being delivered by the surgical tool is appropriate (e.g., before use of the surgical tool).
  • the light calibration data can be used to constrain the maximum amount of current that the surgical tool can provide to the one or more optical emitter(s) 12 until the next calibration.
  • the number of uses after a calibration can be limited by the controller 16 and/or the surgical tool to force the calibration to happen with a certain frequency.
  • the calibration can include one or more additional component(s) with specific sensors required for the calibration (which may, in some instances, be the sensors 82).
  • FIG. 9, elements A and B show example configurations 900 and 950, respectively, of the proximal end of a shaft of a surgical tool (e.g., surgical tool 10) with sensor(s) 94 integrated with and/or coupled to at least a portion of the surgical tool (e.g., the shield 14).
  • the sensor configurations shown in 900 and 950 are for illustration purposes only and are not meant to be limiting and may be used alone and/or in combination in a surgical tool.
  • the sensor(s) 94 could be introduced in any portion of the double cladding optical fiber and/or the dual optical fibers described with respect to FIG. 4.
  • the senor(s) 94 can be positioned directly on the shield 14 and/or a target facing side of the surgical tool (e.g., surgical tool 10).
  • the sensor(s) 94 can include, but are not limited to, a temperature sensor, a photodetector, a reflector, an electrode, a pressure sensor, a camera, an optical sensor, or the like.
  • the sensor(s) 94 can be in communication (wired and/or wireless) with at least a controller, as described with respect to at least FIG. 8.
  • the sensor(s) 94 can be located in an attachment coupled to (removably and/or permanently) the shaft of the surgical tool.
  • the sensor(s) 94 can be attached to a secondary shaft (e.g., one a face, extending through a lumen of the secondary shaft, etc.) adjacent the shaft of the surgical tool such that the sensor(s) can be positioned adjacent the PBM target.
  • the sensor(s) 94 can include a camera, a thermistor or thermocouple, or the like.
  • the sensor(s) 94 can be, for example, a camera that can measure temperature changes on the target nerve and/or the surrounding tissue.
  • the camera can be affixed to a housing of one of the one or more optical emitter(s) (e.g., optical emitter(s) 12).
  • the body of the surgical tool can include a first shaft element configured to hold the optical emitter and a second shaft element configured to hold the sensor(s) 94.
  • the temperature measurement can be based on measurement of light at a different wavelength than the light used for PBM (e.g., blackbody radiation detection).
  • the temperature detection can be in closed loop control (e.g., with the controller 16), such that the dose of PBM can only be delivered when the temperature is below a predetermined threshold and/or within a predetermined safety range.
  • the controller can prevent PBM from starting and/or stop a dose of PBM during application if an unsafe temperature is sensed that may damage tissue. In some instance, the controller can resume the dose of PBM when the temperature is sensed to be low enough to not cause tissue damage.
  • the controller can estimate safety of the tissue by taking into account both the sensed temperature and the duration, wavelength, power, and/or intensity of the PBM.
  • the senor(s) 94 can include an optical imaging element utilized to visualize the PBM target and/or tissue surrounding the PBM target.
  • the optical imaging element can be, but is not limited to, a camera, and optical coherence tomography (OCT) probe, an ultrasound probe, or the like.
  • OCT could make use of a dual fiber approach (as described in FIG. 9, element A) or a double clad fiber approach (such as described with respect to FIG. 4) that includes single mode delivery (OCT) in the middle and multimode (PBM) in the outer part of the fiber.
  • OCT single mode delivery
  • PBM multimode
  • the same fiber could also be used for both optical imaging and PBM application or a multiple fiber bundle approach could also be considered.
  • the sensors 94 can be affixed to a portion of the shield 14.
  • the sensors 94 (shown as two, but can be any number one or greater) can be affixed to one or more support structures extending from a portion of the shield 14.
  • the sensors 94 can be designed to contact the surface of tissue and/or in other instances the sensors 94 can be designed to penetrate into the tissue to measure temperatures deeper in the tissue.
  • the sensors 94 can be in contact with tissue surrounding the PBM target (e.g., the one or more target nerves), and not the PBM target itself.
  • the sensor 94 can be a thermistor or thermocouple, or the like that can be in communication with a controller (e.g., controller 16, not shown). In some instances, the sensors 94 can a part of a separate module (e.g., including support structure, circuitry, etc.) that can be coupled to the surgical device.
  • the electrical module can be sterile, and in one example can include a portion into which a non-sterile surgical tool can be inserted.
  • the temperature detection can be in closed loop control (e.g., with the controller 16), such that the dose of PBM can only be delivered when the temperature is below a predetermined threshold and/or within a predetermined safety range.
  • the controller can prevent PBM from starting and/or stop a dose of PBM during application if an unsafe temperature is sensed that may damage tissue. In some instance, the controller can resume the dose of PBM when the temperature is sensed to be low enough to not cause tissue damage.
  • the controller can estimate safety of the tissue by taking into account both the sensed temperature and the duration, wavelength, power, and/or intensity of the PBM.
  • the temperature that is recorded can be used by the controller to maintain a safe tissue temperature. Detection of one or more temperatures high enough to damage tissue can lead to the controller ending the PBM. As long as the temperature is low enough not to damage the tissue (based on a preset threshold), the controller can permit the PBM to proceed.
  • the temperature that is recorded can also be used by the controller to estimate a level of safety based on the temperature, the duration of light application, wavelength of the light, power of the light, intensity of the light, and the like.
  • FIG. 10 illustrated is another example 1000 of the surgical tool (e.g., surgical tool 10) with a handle 104 particularly shaped for gripping the surgical tool.
  • the handle 104 can be attached to a distal end of the shaft and may include one or more materials that facilitate gripping the handle 104.
  • At least a portion of the controller 16 can be at least partially embedded within the handle.
  • the handle 104 can be configured to shield at least one operator from heat generated by the surgical tool and/or the application of the PBM.
  • FIG. 11 illustrated is an example of the surgical tool 1100 that can contain at least a part of the light of the PBM within a shield 14 such that, that PBM only turns on when at least the shield 14 is sufficiently in contact with the skin and/or other tissue.
  • the shield 14 can be flexible and can extend out from the body of the surgical tool (e.g., light path 62, which can include a fiber optic cable).
  • a patient facing side of the shield 14 can include two or more electrodes 116.
  • the shield 14 can be any shape capable of containing at least a part of the light of the PBM and the electrodes 116 can be any number two or more at any position on the shield.
  • the electrodes 116 can be in communication (wired and/or wireless) with the controller 16 and can form an impedance monitor circuit.
  • the impedance measurement circuit can determine based on the impedance of the electrodes whether the surgical tool 1100 (e.g., the shield 14) is in sufficient contact with the body to contain at least a part of the light of the PBM.
  • the electrodes 116 can be replaced with other sensors, such as pressure sensors, that can be used to determine if the shield 14 is in sufficient contact with the body. Illumination may only be possible if the controller determines the shield 14 and/or the surgical tool 1100 is sufficiently in position.
  • the shield 14 can also include one or more suction devices and/or adhesive patches configured to facilitate attaching the surgical tool in place.
  • the controller 16 can stop a dose of PBM mid-application, such that a partial dose can be given, due to lack of force or excess impedance, and the dose can be resumed when the force or impedance are within a predetermined range. In some instances, the dose cannot be resumed and another dose cannot be given without a reset of the system (e.g., the controller 16 and/or the surgical device 1100). In some instances, the controller 16 can have a dose counting function to count how long the therapy has been applied and/or how much accumulated dose has been applied. Accumulated dose can have two modes: (1 ) counting dose for each power level and (2) counting the total dose of all power levels together, assuming under a predetermined power threshold, it is the dose rather than the power that matters for therapeutic effect.
  • FIG. 12 shows other example shapes of a shield 14c, d from a bottom perspective.
  • element A the shield 14c is in a diamond shape
  • element B the shield 14d is in a hexagon shape.
  • the electrode(s) 116 can be positioned at intervals around the edges of the shields 14c, d.
  • the electrode(s) 116 can be positioned at corners of the shields 14c, d periphery (as shown) along the edges(s), and/or as best determined to measure impedance at appropriate positions (e.g., positions that should be in contact with tissue); At least one electrode 116 can also be positioned near the opening of the light delivery path 62. In one example, electrode 116 can be in a ring around an end of the optical emitter 12 and/or the opening. While not shown in FIG. 12 it should be understood that the shields 14c, d can include one or more adhesive or suction portions for connecting to the skin. The adhesive and/or suction portions can be on any area of the shields 14c, d not blocking an electrode 116 and/or an optical emitter 12.
  • At least a portion of the surgical tool can be sterilizable (e.g., via ETO, autoclave, UV, or the like).
  • at least a portion of the surgical tool may not be sterilizable but can be compatible with a custom-built, single use sterile sheath 130 (shown in FIG. 13) that can be used to cover at least the non-sterile portion of the device from the surgical field.
  • the sterile sheath 130 can be designed to fit at least a portion of the surgical tool, for example to align a tip of the surgical tool with a transparent window of the sterile sheath such that light can be conveyed across and through the sheath to the tissue with minimal or no attenuation.
  • the shield can be integrated into the sterile sheath 130, such that at least a portion of the sterile sheath 130 can be rigid while another portion of the sterile sheath 130 can be non-rigid (e.g., flexible like a plastic bag).
  • the shield can be positioned over the sterile sheath 130 (e.g., if this shield is sterilizable and/or single use.
  • the sterile sheath 130 can be composed of one or more different materials, such as glass, one or more polymers, etc.
  • the sterile sheath 130 can be single use or can be sterilizable.
  • the sterile sheath 130 can be provided separately in a sterile container (e.g., double barrier Tyvek or the like) to facilitate holding of the sheath by a sterile operator while a non-sterile operator positions the surgical tool inside the sterile sheath.
  • the sterile sheath 130 can include one or more handles (not shown) to facilitate placement of the surgical tool into the sterile sheath.
  • the sterile sheath 130 can include a mechanism to close the sterile sheath around a non-sterile surgical tool (e.g., slider, Ziplock, adhesive, etc.).
  • a mechanism can be sleeve that can be placed around a baggy portion of the sterile sheath 130 to close the sterile sheath such that an exterior of the full assembly can be sterile.
  • the sterile sheath 130, the surgical tool itself, and/or a holder for the surgical tool can include at least one ultraviolet light source that can sterilize the sterile sheath and/or the surgical tool prior to use.
  • a needle apparatus 1400 that can be used for an alternate approach to reaching one or more target nerves in a less invasive surgery (e.g., instead of cutting an entire opening).
  • a hole can be created in the body of the patient (e.g., at least the skin) by a needle apparatus 1400 that can be coupled to a surgical tool (as described above).
  • the needle apparatus 1400 can include at least a cannula and a needle or other sharp instrument that can be positioned within the cannula.
  • the needle can be removed and a styletlike system element to deliver PBM, or to perform a related function, or both can be positioned in the cannula.
  • a targeting and/or visualization system can be used to confirm the needle apparatus’s approach to the PBM target prior to application of the PBM (e.g., the tracking can be done via electrical stimulation (shown), visualization via ultrasound, OCT, another imaging approach, of the like).
  • electrical stimulation can be applied using a stylet or needle assembly 1400 shown in FIG. 14,
  • the needle assembly 1400 can include a needle, a cannula, and electrodes including at least one stimulating electrode that can be positioned near the proximal (sharp) end of the needle while at least one return electrode can be on the cannula and/or at a more distal end of the needle).
  • proximal and distal as used herein are defined with respect to the patient undergoing surgery. It will be understood that proximal and distal will have opposite meanings when taken from the operator (e.g., surgeon, doctor, etc.) perspective.
  • the electrodes can electrically excite and/or measure nerve activity to confirm adequate proximity to the one or more target nerves.
  • the needle can be removed from the cannula and replaced with one or more stylet-like optical elements (not shown, e.g., a light pipe, an assembly with a light source at the tip, and/or the like) and then PBM can be delivered through the surgical tool.
  • a shield is not shown in FIG. 14, it should be noted that, a shield can still be used and can be removably attached to the cannula as a support. Alternatively, for deep penetrations, a shield may not be required and the cannula can include markings to help estimate whether or not a penetration is suitably deep to not need a shield.
  • a stylet-like transducer for OCT imaging (such as, on-axis front-facing OCT) can be placed in the cannula, and in one example, the stylet-like assembly for doing OCT may also support delivery of PBM therapy (the optical emitter(s) may do both - for example, the light used for each can have different properties and may be delivered from the same or different optical emitter(s)). In this way, the medical professional can see the target with OCT and then, when in the correct position, deliver the light required for PBM therapy.
  • PBM therapy the optical emitter(s) may do both - for example, the light used for each can have different properties and may be delivered from the same or different optical emitter(s)
  • FIGS. 15- 18 Another aspect of the present disclosure can include methods (FIGS. 15- 18) for applying PBM to a PBM target (e.g., one or more target nerves) within a surgical opening to at least partially silence conduction in one or more small fibers in the one or more target nerves to produce a physiological response.
  • the physiological response can be treating neurogenic pain associated with one or more neurological disorders by silencing the small fibers within the target nerve (e.g., small diameter sensory nerve fibers, small diameter sympathetic nerve fibers, etc.).
  • small fibers may also be found within nerve roots, neural ganglia, preganglionic fibers, etc.
  • small diameter fibers that can be silenced are: small diameter afferents within the laryngeal nerve network that are responsible for obstructive sleep apnea and abnormal hypoglossal nerve input, small diameter afferents within the laryngeal nerve network that are responsible for exacerbation of asthma and excessive vagal drive, cardiac small diameter sympathetic afferents that are responsible for cardiac arrhythmias for abnormal cardiac sympathetic and vagal drive, small diameter sympathetic afferents that are responsible for adverse changes in coronary blood flow via changes in activity of post-ganglionic sympathetic input, nasopharyngeal vagal afferents that have a negative effect on cerebral blood flow (especially during sleep, particularly REM sleep), nasopharyngeal vagal afferents that play a definitive role in the etiology of migraine headaches, carotid sinus nerve activity which plays a major role in expression of neurogenic hypertension, carotid sinus nerve input to the brainstem (nu).
  • White matter columns and/or gray matter laminae of the spinal cord may also include the one or more target nerves.
  • silencing certain small diameter sensory fibers can treat nociceptive pain.
  • the nociceptive pain can be acute post-surgical (e.g., post-operative) pain and/or post injury pain due to, for example, knee arthroplasty, hip arthroplasty, inguinal hernia repair, thoracotomy, sternotomy, limb amputation, back surgery, abdominal surgery, breast surgery, gynecological surgery, donor/recipient nephrectomy, and gastro-intestinal surgery, nociceptive back pain, and the like.
  • PBM can silence fibers causing acute nociceptive pain and/or chronic pain. In fact, PBM may be able to at least substantially prevent and/or reduce the likelihood of chronification of acute nociceptive pain to chronic pain.
  • pain can refer to acute nociceptive pain, chronic nociceptive or neuropathic pain, and/or the process of chronification of nociceptive pain.
  • PBM can be used on any small fiber to cause a desired effect.
  • controller 16 is entirely removeable from the operative site after the PBM delivery. It should be understood that the controller 16 is described as working in a closed loop, the controller 16 may also work in an open loop (user-in-the-loop) system.
  • an optical emitter e.g., one or more optical emitters 12
  • the shield can be configured to substantially block at least a portion of the light used for PBM, such as the wavelength(s) of the PBM, while potentially allowing other wavelengths of light to pass (removing the need for safety glasses).
  • an optical fiber and/or light pipe connected to the optical emitter as part of the surgical tool can be inserted into the surgical opening (depending on the configuration of the surgical tool).
  • the surgical tool can be used to create the surgical opening prior to insertion and can include a needle, a scalpel, a retractor, or the like (e.g., such as the needle apparatus of FIG. 14).
  • a location of the PBM target can be determined prior to insertion of the surgical tool and/or concurrently with insertion of the surgical tool by imaging a portion of the patient’s body (e.g., OCT, ultrasound, camera, etc.).
  • the surgical tool can include and/or be coupled to the imaging component.
  • the surgical tool can be used to deliver PBM to at least one small diameter sensory nerve fiber (within the one or more target nerves) for a time period (e.g., application time).
  • the PBM can be a predetermined and/or controllable dose with one or more parameters such as wavelength, power, timing, pulsatility, intensity, or the like.
  • conduction of signals related to pain and/or inflammation in the at least one small diameter sensory nerve fiber can be at least partially silenced for another time period that is longer than the application time of the PBM.
  • the other time period can be hours, days, weeks, or even months longer than the application time of the PBM depending on at least the dose of the PBM and the at least one small diameter sensory nerve fiber.
  • the patient’s body can be enabled to go through the healing process (e.g., for the surgery and/or for the cause of the surgery) with reduced pain and/or neurogenic inflammation. While not wishing to be bound by theory, it is thought that reducing pain and/or neurogenic inflammation during and following surgery can reduce the likelihood of chronification of nociceptive pain and/or the intensity of chronic pain.
  • the surgical tool can be aimed to a PBM target using a non-therapeutic wavelength.
  • the surgical tool can include one or more guiding light emitters (such as FIG. 3) and/or structures for splitting light from a single light emitter (e.g., the optical emitter) for both the PBM and aiming light (such as FIG. 4).
  • the aiming light can be a non-therapeutic wavelength(s).
  • the non-therapeutic wavelength(s) of the aiming light can be visible through a shield of the surgical tool, while the PBM light can be entirely, substantially, and/or at least partially blocked.
  • the spot size of the light source can be adjusted based on the aiming. For example, the numerical apertures of the guiding light emitter(s) and/or the single light source can be altered (e.g., by changing angles of light direction, using lenses, diffraction gratings, other light altering elements or the like). For instance, the spot size can be adjusted to more accurately and/or precisely apply the PBM to the PBM target and not surrounding tissues.
  • a surgical tool can be utilized to apply a plurality of doses of PBM to one or more distinct locations along and/or within the PBM target and/or a plurality of PBM targets.
  • the aiming and spot size adjusting functions of the surgical tool (which can be manual and/or automatically controlled via a controller comprising at least processor) can be adjusted for each of the plurality of doses of PBM according to a prescription for the patient. For example, during a single surgical procedure at least two doses of PBM can be applied to the one or more PBM targets (e.g., giving the one or more PBM targets time to cool down between doses, for surgical reasons, for improved outcomes, etc.). [0095] In FIG.
  • the surgical tool of the PBM system can include and/or be in communication with a controller comprising at least a processor that can run at least safety instructions for the PBM application.
  • a shield e.g., shield 14
  • it can be detected when a shield (e.g., shield 14) of a surgical tool is in sufficient contact with a patient’s body to contain at least a portion of the light of the PBM based on data recorded by at least one surface contact sensor (e.g., on the shield 14).
  • the at least one surface contact sensor can be a pressure sensor, a force sensor, an impedance sensor, or the like in communication with the controller.
  • the controller can store at least one predetermined threshold for pressure, force, impedance, or the like that can be used to determine if the contact of the shield is sufficient.
  • the controller can determine based on the data recorded by the at least one surface contact sensor compared to the stored thresholds whether the shield and/or surgical tool is in sufficient contact with the patient’s body.
  • the optical emitter e.g., one or more optical emitters 12
  • the optical emitter can be controlled to deliver a dose of PBM to the PBM target (e.g., one or more target nerves including at least one small diameter sensory nerve fiber) within the surgical opening.
  • the shield of the surgical tool can block at least a portion of the dose of PBM from being emitted outside the shield, protecting eyes and/or skin of operators and/or the patient.
  • transmission of the dose of PBM to the PBM target can be stopped (e.g., by the controller and/or the operator) before the entire dose of PBM has been applied when the data recorded by the at least one surface contact sensor indicates that the shield of the surgical tool is no long in sufficient contact with the patient’s body.
  • the system including the surgical tool in response to the transmission of the dose of PBM being stopped can be reset to start another dose of PBM (which may be recalculated based on the amount of the prior dose applied) to mitigate overdosing.
  • the shield is resettled (e.g., back in sufficient contact) the delivery of the dose of PBM can be continued.
  • the system can also be in communication with an electronic medical record (EMR) of a patient and can communicate information regarding the dose of PBM delivered to the PBM target, if the dose was interrupted, if the system was reset and what the new dose was, or the like)
  • an optical emitter e.g., one or more optical emitters 12
  • the dose of PBM can have one or more parameters, including but not limited to, wavelength, power, intensity, timing, pulsatility, or the like.
  • a temperature of tissue within the surgical opening and/or surrounding the surgical opening can be detected. The tissue can be near and/or adjacent the PBM target. Additionally and/or alternatively, the temperature near the optical emitter and/or of at least a portion of the surgical tool can also be detected.
  • the temperature can be detected by one or more temperatures sensors (e.g., thermocouples, thermistors, blackbody radiation sensors, or the like). If the temperature is less than the threshold (e.g., a preset value stored in the controller 16), the optical emitter can be controlled (e.g., by the controller) to deliver the dose of PBM to the PBM target within the surgical opening. However, if the temperature is greater than the threshold, transmission can be stopped (e.g., by the controller). After the transmission is stopped, the transmission can be restarted based on a user action and/or based on the sensed temperature falling beneath the threshold at a later time.
  • the threshold e.g., a preset value stored in the controller 16
  • the optical emitter can be controlled (e.g., by the controller) to deliver the dose of PBM to the PBM target within the surgical opening.
  • transmission can be stopped (e.g., by the controller). After the transmission is stopped, the transmission can be restarted based on a user action and/
  • the transmission of the PBM dose may be restarted from the point where it stopped, one or more parameters of the dose of PBM can be altered based on the original temperature reading causing the stop and the original dose parameters, or a dose of PBM may be completely restarted.
  • one or more temperature management devices e.g., one or more heat sink elements, Peltier modules, or other types of cooling or heat distribution devices
  • can be used to cool and/or reduce the heat at and/or near the one or more sites of the temperature sensing e.g., the tissue, the PBM target, near the optical emitter, in a portion of the surgical tool, etc.

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Abstract

Une photobiomodulation (PBM) peut être administrée à de petites fibres à l'intérieur d'un nerf cible avant, pendant et/ou après une chirurgie (à l'aide d'un outil chirurgical et d'un dispositif de commande) pour silencier de petites fibres à l'intérieur du nerf cible en vue de traiter un ou plusieurs troubles neurologiques (par exemple, la douleur nociceptive). Par le silençage de petites fibres transportant des informations nociceptives, la douleur nociceptive aiguë peut être atténuée et la chronicisation de la douleur nociceptive aiguë peut être ralentie, arrêtée et/ou empêchée. L'outil chirurgical comprend un émetteur optique, un corps conçu pour tenir l'émetteur optique, ainsi qu'un écran couplé au corps et/ou incorporé dans celui-ci. Le corps peut diriger une dose de PBM vers une cible à travers une ouverture chirurgicale. L'écran peut être positionné pour s'étendre vers l'extérieur à partir du corps et pour contenir au moins une partie de la lumière en excès de la dose de PBM. Le dispositif de commande peut régler la dose de PBM à une certaine quantité pendant un moment.
PCT/US2025/012914 2024-01-25 2025-01-24 Utilisation d'un outil chirurgical pour silencier des petites fibres à l'intérieur d'un nerf à travers une ouverture chirurgicale Pending WO2025160368A1 (fr)

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US202463624856P 2024-01-25 2024-01-25
US63/624,856 2024-01-25
US202463572412P 2024-04-01 2024-04-01
US63/572,412 2024-04-01

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070129776A1 (en) * 2005-10-20 2007-06-07 Light Sciences Llc External wearable light therapy treatment systems
US20110066213A1 (en) * 2009-05-01 2011-03-17 Maik Huttermann Light therapy treatment
US20120239016A1 (en) * 2011-02-03 2012-09-20 TRIA Beauty, Inc Radiation-Based Dermatological Devices and Methods
US20210121712A1 (en) * 2017-05-31 2021-04-29 Teijin Pharma Limited Phototherapeutic apparatus
US20210145376A1 (en) * 2013-09-20 2021-05-20 Radux Devices, LLC Lock-block shield device
US20210322782A1 (en) * 2020-04-16 2021-10-21 Pathy Medical, Llc Therapeutic lighting devices and methods

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070129776A1 (en) * 2005-10-20 2007-06-07 Light Sciences Llc External wearable light therapy treatment systems
US20110066213A1 (en) * 2009-05-01 2011-03-17 Maik Huttermann Light therapy treatment
US20120239016A1 (en) * 2011-02-03 2012-09-20 TRIA Beauty, Inc Radiation-Based Dermatological Devices and Methods
US20210145376A1 (en) * 2013-09-20 2021-05-20 Radux Devices, LLC Lock-block shield device
US20210121712A1 (en) * 2017-05-31 2021-04-29 Teijin Pharma Limited Phototherapeutic apparatus
US20210322782A1 (en) * 2020-04-16 2021-10-21 Pathy Medical, Llc Therapeutic lighting devices and methods

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