Application of intra-operative therapy for post-operative pain management

Abstract

At least one therapy (e.g., one or more of photobiomodulation (PBM), pharmaceutical nerve block, electrical nerve block, temperature-based nerve block, etc.) can be delivered to a target nerve by a surgical tool through a surgical opening (e.g., during surgery) to manage post-operative pain. The at least one therapy can reduce or eliminate the need for analgesics to reduce post-operative pain. The at least one therapy can include at least one dose of light for PBM to selectively silence conduction in small fibers within the target nerve that are known to cause post-operative pain for a time (e.g., extending after the surgery). Doses of the at least one therapy can be determined and provided by a controller in communication with the surgical tool.

Description

NONPROVISIONAL APPLICATION APPLICATION OF INTRA-OPERATIVE THERAPY FOR POST-OPERATIVE PAIN MANAGEMENT Cross-Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 728,858, filed December 6, 2024, entitled “APPLICATION OF INTRA-OPERATIVE THERAPY FOR POST-OPERATIVE PAIN MANAGEMENT”, U.S. Provisional Application No.63 / 681,430, filed August 9, 2024, entitled “METHODS FOR DELIVERY OF INTRA-OPERATIVE THERAPY INCLUDING LIGHT TO TREAT POST- OPERATIVE PAIN AND REDUCE PAIN MEDICATION”, and U.S. Provisional Application No.63 / 624,906, filed January 25, 2024, entitled “METHODS FOR INTRA- OPERATIVE LIGHT DELIVERY TO TREAT POST-OPERATIVE PAIN AND REDUCE PAIN MEDICATIONS”. These provisional applications are hereby incorporated by reference in its entirety for all purposes. Government Funding

[0002] This invention was made with government support under NS121372 awarded by the National Institutes of Health. The government has certain rights in the invention. Technical Field

[0003] This disclosure relates generally to post-operative pain management and more specifically to systems and methods that provide at least one intra-operative therapy to at least one nerve during a surgical intervention to at least partially silence conduction of post-operative pain signals for a time after the surgical intervention. Background

[0004] Patients often experience significant post-operative pain after major surgeries (e.g., due to damage to one or more tissues during surgery). When post- operative pain is not adequately controlled it can impair patients’ quality of life and ability to function. Traditionally, post-operative pain is mitigated with prescribedanalgesics, such as opioids. While opioids can provide strong pain relief, opioids can have negative side effects, which can be mild such as constipation, nausea, and vomiting, or severe such as addiction, overdose and even death. In fact, opioids are so addictive that their use after surgery, even when initially prescribed, significantly drives new cases of long-term opioid use and abuse, contributing to the ongoing opioid epidemic. For instance, the rate of new persistent opioid use may be as high as 28% after opioids are prescribed for post-operative pain from several common orthopedic surgeries. In many cases, the pain-relieving effects of opioids can be reduced with prolonged use. In fact, for long-term opioid users, opioids may actually worsen the pain they were originally prescribed to treat. Thus, opioids can leave people with horrible addictions and still in pain. Summary

[0005] Described herein is a better way to manage post-operative pain. Systems and methods can apply a therapy (e.g., photobiomodulation (PBM) therapy) during surgery via a surgical tool to an operative site to at least partially silence conduction in at least one small fiber within at least one target nerve after the surgery. The at least one target nerve can be accessible through the operative site for a time and the at least one small fiber can be known to convey post-operative pain for the surgery the patient is undergoing. By at least partially silencing the conveyance of pain information to the brain for the time following the completion of the surgery, post-operative pain can be reduced, and the patient’s need for analgesics (such as opioids) can be reduced and even eliminated.

[0006] In an aspect, the present disclosure can include a system for reducing post- operative pain. The system can include a surgical tool and a controller. The surgical tool can include at least one optical emitter, a body, and a shield. The at least one optical emitter that can provide at least one dose of PBM. The body can hold the at least one optical emitter and direct the at least one dose of PBM to a PBM target (e.g., a target nerve) through a surgical opening during a surgical intervention. The controller can set the at least one dose of PBM at an amount for a time (per dose) to at least partially reduce post-operative pain for another time continuing after the surgical intervention iscomplete. The at least one dose of the PBM can be based on at least one aspect of the surgical intervention (e.g., type of surgery, surgical location, common post-operative pain for that type and / or location of surgery, patient demographics, etc.).

[0007] In another aspect, the present disclosure can include a method for reducing a patient’s post-operative pain with a system comprising a processor and a surgical tool that can provide at least one dose of PBM comprising an amount of PBM to be applied for a time. The processor can configure the at least one dose of PBM based on at least a type of surgical intervention. The at least one dose of PBM can be delivered via the surgical tool that is configured to apply the at least one dose of PBM to one or more nerves of the patient within a PBM target (e.g., target nerve(s)) having small fibers known to contribute to the post-operative pain. The post-operative pain of the patient can be reduced, thereby reducing the amount of analgesics prescribed for post- operative pain and leading to fewer side effects caused by the analgesics. In some instances, one or more additional types of therapy such as temperature based light therapy (e.g., cryotherapy and / or radiofrequency-based therapy) can be applied in combination with the at least one dose of PBM to increase the amount and / or length of pain reduction. Brief Description of the Drawings

[0008] The foregoing and other features of the present disclosure will become apparent to those skilled in the art to which the present disclosure relates upon reading the following description with reference to the accompanying drawings, in which:

[0009] FIG.1 is a block diagram showing a system including a surgical tool that can apply at least photobiomodulation (PBM) to silence one or more small fibers within a target nerve through a surgical opening;

[0010] FIG.2 is a block diagram of a controller of the system of FIG.1 and devices in communication with the controller;

[0011] FIG.3 is a block diagram of the controller of FIG.1;

[0012] FIGS.4 and 5 show block diagrams of example configurations of elements of the surgical tool of FIG.1;

[0013] FIG.6 shows an example configuration of the system of FIG.1;

[0014] FIG.7 shows another example configuration of the system of FIG.1;

[0015] FIG.8 shows example configurations of one or more sensors for the surgical tool of FIG.1;

[0016] FIG.9 shows a further example configuration of the system of FIG.1;

[0017] FIG.10 shows a graphical representation of pain relief with varying pain relief mechanisms;

[0018] FIGS.11 and 12 are process flow diagrams showing methods for applying one or more therapies to at least one target nerve within a surgical opening to reduce post-operative pain; and

[0019] FIG.13 is a process flow diagram showing a method for configuring at least one dose of a therapy to be applied to a patient during a surgical intervention to reduce post-operative pain. Detailed Description I. Definitions

[0020] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains.

[0021] As used herein, the singular forms “a,” “an,” and “the” can also include the plural forms, unless the context clearly indicates otherwise.

[0022] As used herein, the terms “comprises” and / or “comprising,” can specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups.

[0023] As used herein, the term “and / or” can include any and all combinations of one or more of the associated listed items.

[0024] As used herein, the terms “first,” “second,” etc. should not limit the elements being described by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequenceof operations (or acts / steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

[0025] It will be understood that when an element is referred to as being "on," "attached" to, "connected" to, "coupled" with, "contacting," etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, "directly on," "directly attached" to, "directly connected" to, "directly coupled" with or "directly contacting" another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0026] As used herein, the term “therapy”, can refer to the delivery of one or more stimuli or agents intended to at least partially relieve symptoms of a disorder (e.g., post- operative pain). Herein, therapy can refer to light-based therapy, electricity-based therapy, temperature-based therapy, or the like. Photobiomodulation (PBM) is one example of a light-based therapy. Electrical nerve block is one example of an electricity- based therapy. Radio frequency (RF) and cryotherapy are examples of temperature- based therapies.

[0027] As used herein, 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 reduce acute nociceptive pain, or to prevent acute pain from becoming chronic pain). PBM utilizes non-ionizing light sources, including lasers, light emitting diodes, and / or broadband light sources and can be delivered by one or more emitters. In some examples, the light can have a wavelength between 250 nm and 1600 nm. However, as an example, the wavelength can be in the visible range (e.g., from 400 nm to 700 nm) and / or near-infrared range (e.g., from 700 nm to 1100 nm) of the electromagnetic spectrum.

[0028] As used herein, the term “heat”, also referred to as “heat therapy”, can refer to the therapeutic application of one or more heat signals to at least a portion of the body of a patient (including one or more target nerves) that results in an increase in tissue temperature. Heat therapy can be applied by the same optical emitter(s) as the photobiomodulation and / or a separate heat mechanism (e.g., another optical emitter, a radio frequency (RF) ablation tool, a focused ultrasound, a resistive heating device, or the like). For example, heat therapy can include the use of one or more wavelengths of infrared light of 1300 nm or greater.

[0029] As used herein, the term “’cold”, also referred to as “cold therapy”, can refer to the therapeutic application of one or more temperature lowering signals to at least a portion of the body of a patient (including one or more target nerves) that results in a decrease in tissue temperature. As an example, cold therapy can include cryoneurolysis.

[0030] As used herein, the term “surgery” (also referred to as “operation” or “surgical intervention”) can refer to a medical procedure that involves cutting into or otherwise entering a patient’s body to create a “surgical opening”, “surgical incision”, or the like and / or causing localized alteration or transposition of live human tissue with a surgical tool. In some instances, the surgery may include the use of a surgical tool (e.g., a scalpel) to create the surgical opening. In other instances, 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.

[0031] As used herein, 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”.

[0032] As used herein, 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 carryingout desired effects during a surgery that is external to and / or removeable from a patient’s body. One example of 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.

[0033] As used herein, the term “neural tissue” refers to the tissues that make up the nervous system and controls one or more bodily functions. Neural tissue can include, but is not limited to, tissue within the brain, tissue within the ganglia, tissue within the spinal cord, tissue within one or more of the nerves, or the like.

[0034] As used herein, the term “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. For example, 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.

[0035] As used herein, 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 correlates with conduction velocity. Generally, 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.

[0036] As used herein, the term “sensory 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. For example, sensory fibers can be classified as Aα (diameter 13-20 µm, conduction velocity 80-120 m / s, myelinated, associated with muscle spindle fibers and Golgi tendon organ); Aβ (diameter 6-12 µm, conduction velocity 33-75 m / s, myelinated, associated with all cutaneous mechanoreceptors); Aδ (diameter 1-5 µm 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 µm, conduction velocity 0.5-2.0 m / s, unmyelinated, associated withnociceptors of the paleospinothalamic tract and warmth receptors). A “small” sensory fiber can refer to an Aδ fiber and / or a C fiber.

[0037] As used herein, the term “dosing scheme” can refer to a schedule of one or more doses of therapy (such as quantities of light of one or more wavelengths for PBM, or the like for other therapy types) to be delivered to a target area (e.g., target nerve(s)) of a patient per a unit of time during surgery to treat the patient or in the perioperative period before or after the surgery. In some instances, one or more booster doses (using the injection paradigm) can be applied a time(s) after the surgery.

[0038] As used herein, the term “dose” can refer to a quantity and / or an intensity of a treatment and a duration of the treatment to be given at one time. In some instances, the dose can, additionally or alternatively, be at least partially defined by a wavelength or other parameter of the therapy.

[0039] As used herein, 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. The terms patient and subject can be used interchangeably herein. II. Overview

[0040] Traditionally, post-surgical pain has been mitigated with prescribed analgesics to be used for a period of time following a surgical intervention. A commonly prescribed analgesic is opioids, which can treat pain effectively but have many significant negative side effects. One particularly negative side effect is the risk of a patient becoming addicted to opioids and contributing to the opioid epidemic in the US. Non-addictive therapy solutions that can be administered during a surgical intervention provide an attractive alternative for post-operative pain relief compared to using prescription opioids for days, weeks, or months post-surgery. Photobiomodulation (PBM) particularly provides an attractive solution due to its limited known negative side effects and ability to be easily and quickly administered during a surgical intervention while providing long-term beneficial effects.

[0041] Described herein are systems and methods that provide at least one intra- operative therapy to at least one nerve during a surgical intervention to at least partiallysilence conduction of post-operative pain signals for a time after the surgical intervention. The benefits for post-operative pain management with the systems and methods described herein is two-fold: (1) they can reduce the amount of analgesics, such as opioids, that need to be prescribed for post-operative pain relief and (2) they can provide post-operative pain relief in a non-addictive manner before post-operative pain is ever felt by a patient. A specially configured surgical tool can be used to apply the at least one intra-operative therapy within an operative site. As an example, the intra-operative therapy can include at least a light therapy (such as PBM). The surgical tool can supply an adequate amount of light therapy (e.g., of PBM) for a time to one or more nerves without interference of occlusive materials when applied during surgery for more efficient and precise dosages. Furthermore, the surgical tool can be configured to protect onlookers from at least part of the light of the PBM through an attached shielding mechanism. The at least partial silencing of conduction of the small fibers known to carry post-operative pain signals can last for several days, weeks, or months after the surgical intervention, thus reducing a patient’s post-operative pain and still allowing the patient normal bodily functions (e.g., feeling other sensations and / or motor impulses). III. Systems

[0042] Described herein is a system 100 (FIG.1) that can apply at least one therapy (e.g., light, temperature, electrical, pharmaceutical, or the like) to one or more targets (e.g., neural tissue, one or more nerves, spinal cord, brain, or the like) that is accessible through a surgical opening to at least partially silence conduction of post- operative pain signals originating from and / or traveling through the target. The target can be one or more target nerves, where each of the target nerve(s) can include small diameter fibers (often specifically transmitting pain signals) and can, in some instances, also include larger diameter fibers (transmitting other signals). It should be noted that smaller diameter fibers can be referred to herein as “small fibers” and larger diameter fibers can be referred to herein as “large fibers”. Small fibers can be found within the length of nerves, nerve roots, neural ganglia, preganglionic fibers, etc. and can be responsible for conducting sensory information, including signals that create feelings of post-operative pain. The one or more target nerves including the small fibers can alsoand / or alternatively be a part of the white matter columns and / or gray matter laminae of the spinal cord. Conduction in the small fibers can be inhibited without substantially affecting conduction in large fibers (e.g., with application of one or more therapy signals).

[0043] As shown in FIG.1, a system 100 can deliver the at least one therapy (e.g., light, temperature, electrical, pharmaceutical, or the like) intraoperatively through a surgical opening using a surgical tool 10 in communication with a controller 16. It should be noted that the at least one therapy can be applied through the surgical opening at any time during a surgical intervention (e.g., as long as the surgical opening is open). It should be noted that the system 100 will be described herein primarily for the application of photobiomodulation (PBM) as the therapy to PBM targets, but it should be understood that at least one other therapy type, such as other light therapies, temperature-based therapies, electrical-based therapies, pharmaceutical therapies or the like, can be applied alone, in combination with each other, or in combination with the PBM.

[0044] The surgical tool 10 can be placed at least partially through the surgical opening to provide the at least one therapy to the target nerve(s) and can then be removed. This may be done repeatedly with one or more PBM targets. It should be understood that a single surgical opening and single target nerve are shown in FIG.1 for ease of illustration only and that more than one surgical opening and / or target nerves for therapy to be applied to are considered. The controller 16 can be in wired and / or wireless communication with the surgical tool 10 and can at least configure and drive the application of the at least one therapy. It should be noted that the surgical tool 10 can be shaped and configured based on the type of therapy delivered. In some instances, an external device 18 can be in wired and / or wireless communication with the surgical tool 10 and / or the controller 16 to send and / or receive information related to the at least one therapy, the patient, or the like. While each component of the system 100 is shown separately it should be understood that in other instances, the controller 16 can be at least partially embodied in the surgical tool 10 and / or the external device 18 and that the surgical device 10 can include one or more connected portions.

[0045] Generally, PBM refers to the delivery of light at one or more prescribed wavelengths (e.g., from 250 nm to 1600 nm, from 500 nm to 1200 nm, from 400 nm to 700 nm, from 700 nm to 1100 nm, or the like) and one or more dosing schemes to achieve a reduction of post-operative pain in an area of the patient’s body downstream from the target nerve(s). The system 100 can directly apply PBM to target nerve(s) without interference from intervening tissues, which can modulate light and impact the effectiveness of the treatment. A single target nerve is shown in FIG.1 for ease of illustration but it should be understood that one or more target nerves are possible. It should be noted that the PBM (and / or at least one therapy) can be applied at any time during a surgical intervention (e.g., as long as the surgical opening is open).

[0046] When PBM is applied, the surgical tool 10 can include at least one optical emitter to provide the at least one dose of PBM (however an emitter can be chosen based on the therapy type being applied), a body configured to hold the at least one optical emitter and to direct the at least one dose of PBM through the surgical opening, and a shield coupled to and / or incorporated into the body to contain at least a portion of light of the at least one dose of PBM (e.g., for user safety). The surgical tool 10 can apply the PBM with direct contact to a portion of the target nerve(s), with at least some space between nerve(s) and the surgical tool, with at least some non-significantly light modulating biological substances between the target nerve(s) and the surgical tool, or the like. The system 100 is notable for not needing invasive implantation or additional surgery and for having a comparatively unlimited life span (for non-single use components such as the light generation mechanism) and improved power use. The system 100 can also more accurately, precisely, and safely apply doses of PBM compared to traditional PBM systems.

[0047] The system 100 can apply PBM to one or more target nerves (and / or to one or more positions on the one or more 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 surgical intervention, which is known to leave patients with post-operative pain. The system 100 can be used to apply PBM one or more times to the target nerve(s) with at least one optical emitter to provide the dose(s)of PBM and a body that holds the optical emitter and directs the dose(s) of PBM to a given PBM target (e.g., one or more of the target nerves or other neural tissue). In some instances, a single application of PBM can effectively silence (or partially silence) conduction of pain signals within the target nerve to achieve reduction in post-operative pain. In other instances, 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. In other instances (such as for research and / or testing purposes), the system 100 can be used to at least partially silence at least a portion of conduction in the target nerve for a trial period of time (e.g., several hours, days or weeks) to determine the effect. In further instances, the system 100 can provide PBM and at least one other type of therapy to the target nerve(s) during the same surgical intervention. For example, the PBM can be applied with radio frequency (RF) (heat), cryoneurolysis (cold), or electrical therapy for a longer and / or greater level of pain reduction. The post-operative pain can be carried to the brain by at least smaller fibers within the one or more target nerves, which can also include one or more larger fibers (carrying signals other than pain signals, such as motor signals, or the like). PBM (and / or other therapy types) can selectively at least partially silence conduction in at least one small fiber within the target nerve(s) while permitting conduction (as normal or similar to normal) in larger fibers within the target nerve(s). A simple example is shown in enlarged Box A, where conduction in S (the smaller fiber) is stopped (X) and conduction in L (the larger fiber) is permitted to continue.

[0048] 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 be based on the dose and can last for one or more hours, days, weeks, or months after the dose of PBM is applied and the surgical intervention is ended). In some instances, the extended small fiber silencing (past the time of PBM application) can enable the patient’s body to go through inflammatory and healingprocesses with reduced pain, and / or reduced peripheral sensitization, while simultaneously enabling the patient to continue to feel mechanical stimuli (e.g., responses transmitted in larger fibers), as opposed to other methods that can remove the ability to feel mechanical stimuli (e.g., neurectomy, etc.). While not wishing to be bound by theory, the application PBM by the system 100 may reduce, minimize, and / or eliminate the need for prescribing opioids after a surgery.

[0049] Box A shows conduction in a small diameter fiber being at least partially silenced by the system 100 while not affecting, or minimally affecting, conduction in at least one larger diameter fiber. The small diameter fiber can be a sensory fiber. It should be understood that this is only one example for illustrative purposes and depending on the target nerve(s) the fibers may be different (e.g., only small fibers, a mix of small fibers and larger fibers, different fiber locations and / or conduction directions, etc.) and affected differently. As illustrated, conduction in large nerve fibers can be either an upstream or downstream directions, such that the large nerve fibers can be motor fibers (conducting mechanical signals to muscles) (e.g., Aα, Aβ, or some Aδ) that are larger than C fibers and / or some Aδ fibers, that can conduct sensory signals other than pain. It should be understood that the nerve can have multiple nerve fibers (of varying sizes) that can each conduct in different directions; the two-headed arrows signify unidirectional conduction in either direction in one nerve (depending on nerve type and location) and / or, if physiologically possible, bi-directional conduction in a single fiber. The PBM should be applied to the at least one nerve that innervates the area that is surgically manipulated. Candidate nerves can include, but are not limited to median, ulnar, radial and branches thereof; sciatic, peroneal, tibial, sural, saphenous, and branches thereof; dorsal root ganglia; trigeminal ganglia, supraorbital, infraorbital, mandibular and branches thereof; greater occipital, lesser occipital, and branches thereof; or the like depending on the location of the surgical intervention. For example, in a carpal tunnel release surgery a median nerve and / or a palmar cutaneous branch of the median nerve and / or of the ulnar nerve can be targeted for PBM application.

[0050] 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. For instance, 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 configure the one or more dose of PBM based at least on an aspect of the surgical intervention to at least partially reduce post operative pain for extended period of time after the surgical intervention.

[0051] As previously noted, the surgical tool 10 can be in bi-directional communication, wired and / or wireless, with the controller 16. The controller 16 can, for instance, communicate to the surgical tool 10 features and / or parameters of the dose of PBM, turn on and / or off the PBM application and / or communicate modulations to the dose of PBM in response to the one or more physiological parameters (received by the controller 16 from a sensor, manual input, database, or the like). The controller 16 can 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. It should be understood that the surgical tool 10 can be in communication, wired and / or wireless, with a controller 16 (as shown in FIG.1) and / or can be embodied in a single housing that can include the controller 16 (as shown in, for example, FIGS.6 and 7).

[0052] In some instances, 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, acomputer, a 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. In some instances, the external device 18 and / or the controller 16 can include a power source and / or connection to a power source. In some instances, the surgical tool 10 and the external device 18 can be communicatively connected, letting the external device 18 act as the “controller” for at least one of the functions of the surgical tool. In other instances, the surgical tool 10 and / or the controller 16 can transfer information to and / or from the external device 18. In some instances, 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 and / or details of the surgical intervention. 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. Details of the surgical intervention can include, for example, the location of the surgery, the type of surgery, surgical notes, notes about where damage was found and / or done as part of the procedure, patient demographic information, or the like. In other instances, 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).

[0053] In another instance, 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. For example, 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. In another instance, the external device 18 can be and / or can include an optical system used in the transmission / projection of the PBM light beam. For instance, the PBM lightcan 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). In other instances, the light used to show the candidate PBM-treated area may be done with another wavelength that is in the visible portion of the spectrum, where PBM is sometimes done with light in the visible range and often with light outside the visible range.

[0054] Shown in FIG.2 are example inputs and outputs of the controller 16. The controller 16 can include memory 20 for storing instructions and / or data and processor 22 for executing the stored instructions. The controller 16 can be in wired and / or wireless communication with one or more components noted in FIG.2 and may require one or more intermediaries that are not shown. The components of FIG.2 may be part of the external device 18 and / or the surgical tool 10 of FIG.1 and / or embodied as entirely separate devices. 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.2, such as the surgical tool, an external device, or the like. The controller 16 can be in communication with one or more optical emitter(s) 12 (part of surgical tool 10) for providing the at least one dose of PBM and a user interface 24 for inputting information into the controller. The controller 16 can, in some instances, can also be in communication with a display 26, sensor(s) 28, temperature management device(s) 30, and / or other therapy delivery device(s) 40. 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.2. In some instances, the controller 16 can be in bidirectional communication with one or more optical emitter(s) 12 (or other type of emitter based on the type of therapy).

[0055] The controller can at least set the at least one dose of PBM at an amount for a time (e.g., a period of time of application), which can be selected based at least on an aspect of the surgical intervention, a property of the patient, or the like, and in orderto at least partially reduce post-operative pain of the patient for another time (e.g., an extended period of time following the application time) after the surgical intervention. As an example, the controller 16 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. Optionally, in instances where the controller 16 operates as a closed loop system, the controller can be in unidirectional and / or bidirectional communication with the one or more other components within and / or linked to the surgical tool (e.g., sensor(s) 28, temperature management device 30, other therapy delivery device(s) 40 that may also use at least a portion of the surgical tool) to provide feedback to the controller and / or receive a command from the controller.

[0056] The controller 16 and / or the external device (e.g., external device 18 of FIG. 1) can receive feedback related to the therapy application and / or the surgical intervention. In response to receiving the feedback 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 and / or accounts for real-time changes to the predetermined surgical intervention. The controller 16 can include and / or be connected to a user interface 24 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). In some instances, the controller 16 can include and / or be connected to a display 26 to show visualizations of one or more outputs, alerts, medical and / or prescription information, nerve visualizations, or the like.

[0057] The one or more sensor(s) 28 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. In some instances, the controller 16 can alter a dose of the PBM in response to the feedback from a photodetector and / ora 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 can determine, 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).

[0058] As another example, the one or more sensor(s) 28 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 detected temperature(s) 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 pre- determined 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. In another instance, the controller 16 can control whether or not the optical emitter(s) 12 can turn on based on 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.

[0059] In a further example, the temperature management device(s) 30 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 temperaturemanagement device(s) 39 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) 30 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 optical emitter 12, the PBM target and / or tissue adjacent the PBM target. It should be noted that the temperature management device(s) 30 can be connected to the temperature sensor(s) directly and / or via the controller 16.

[0060] In another instance, the one or more sensor(s) 28 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. For example, the shield (described in more detail later) can include 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 or a tip of the surgical tool) is not in sufficient contact with the tissue.

[0061] In some instances, 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. For example, 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 28).

[0062] FIG.3 shows the controller 16 in greater detail, the controller can include a memory 20 and a processor 22, which can be separate devices and / or embodied in a single device like a microprocessor. The memory 20 can be a non-transitory memory and can store one or more instructions and / or data. The processor 22 can access the memory 20 to execute the one or more instructions, including receive an input 32, determine at least one dose 34, configure the dose 36, and output the dose 38 to an energy source / optical emitter (not shown). The controller 16 can receive an input 32 from the one or more sensor(s) (e.g., sensor(s) 28 of FIG.2), manual input from a user, or the like. The manual input can include, for instance, patient demographic information (e.g., gender, weight, height, age, race, diagnosis, overall health status, or the like), type of surgical intervention and / or location, typical responses to the surgical intervention, nerve accessibility (e.g., can be direct contact and / or distance to nerve), damage amount (e.g., greater than normal tissue damage could increase pain prognosis), and the like.

[0063] One or more types of the manual input may be saved in memory as data with connected parameter configuration suggestions and selected by the user when the controller 16 determines the at least one dose 34 of PBM to be applied to reduce the patient’s post-operative pain. In the case of more than one dose, the controller 16 can also determine a dosage scheme for applying multiple doses over the course of a surgical intervention (e.g., to keep nerve temperatures in a safe zone, for more effective pain reduction, application at a plurality of locations, or the like). The dose (or dosage scheme) can be determined in order to at least partially reduce post-operative pain for a time extending beyond the time of application. The determination can be based on at least the type of surgical intervention the patient is undergoing and the location of the surgical intervention. The determination can further be based on one or more of: patient demographic information, common post-operative pain amounts and / or locations for a similar patient (similar demographics, similar surgery type, location, and damage amount), one or more properties of the nerve to be selectively blocked by the application of PBM, and / or the like. For example, the amount of PBM applied for the time (e.g., the application time) can be varied based on the amount of post-operativepain associated with the type of surgical intervention for a sample of patients similar to the current patient. After the dose is determined 34, the controller 16 can configure the dose 36 by configuring the optimal parameter configuration(s) for the PBM to meet the dose requirements to reduce the patient’s post-operative pain. The one or more parameters can include wavelength(s) of the light signal, power of the energy source, intensity of the light signal, duration of application, dosing scheme (including continuous wave versus pulsatile, number of dosages to be applied in a given time, or the like), maximum temperature threshold of the nerve, spot size of the light signal, timing of the application (e.g., pulses, mixing different wavelengths and / or intensities or the like), etc.), duty cycle, and the like. The dose can then be output to the energy source(s) / optical emitter(s) to provide the PBM to the PBM target. After the time to drive delivery of the application and / or transfer the energy and / or the parameters to deliver the application of the PBM light signal, the connection between the external components and the internal components can be removed to at least partially clear the surgical field.

[0064] The at least one dose of PBM is applied for a given duration (e.g., time) to selectively inhibit at least a portion of conduction of the at least one small diameter sensory fiber within the nerve while allowing conduction in larger diameter fibers. The block of conduction of the at least one small diameter sensory fiber carries over for another time significantly longer than the time of application (e.g., extends for a time period longer than the application of the PBM light signal) without affecting conduction of the at least one larger diameter fiber within the nerve. In such a manner, post- operative pain can be reduced and / or silenced altogether before the effects of the PBM wear off. For example, the time period of application can be an hour or less (e.g., the time period can be shorter including 45 minutes or less, 30 minutes or less, 20 minutes or less, 15 minutes or less, 10 minutes or less, 5 minutes or less, 2 minutes or less, or the like) and the other time period (the carryover time of the effect from the specific direct PBM configuration) can be at least a day (e.g., the other time can extend for at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 10 days, at least 15 days, at least 20 days, at least 25 days, at least 50 days, or more).

[0065] FIG.4, elements A and B, shows block diagrams of two example configurations of the surgical tool 10 that can deliver at least PBM during a surgical intervention to at least partially reduce post-operative pain. It should be noted that additional therapy types may also be concurrently and / or consecutively applied with the same device (e.g., optical emitter(s) 12) such as a heat or another light therapy (e.g., radiofrequency (RF) therapy or the like) to expand the effect of the PBM therapy. 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 tool of both elements A and B can include at least one optical emitter (e.g., optical emitter(s) 12) and a body 42 that can hold at least one optical emitter(s). The body 42 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.4). The body 42 can include, for example, a handle and a shaft that can include 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. 6). 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. As an example, the optical emitter(s) 12 can deliver red and / or infrared light (e.g., light having wavelength(s) from 600 nm – 1200 nm). In some instances, (not shown in FIG.2, see e.g., FIGS.5 and 9) the optical emitter(s) 12 can be connected to and / or can include at least one optical 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.

[0066] As shown in FIG.4, elements A and B, the body 42 can include a shield 14 incorporated into the body (element A) and / or a shield coupled to the body (element B). In either configuration, the shield can contain at least a portion of light of the dose of PBM within the shield. The shield 14 can 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. For instance, the shield 14 can be opaque to at least one wavelength of the dose of PBM, but transparent to at least oneother wavelength of light (e.g., can be at least partially visually transparent) and can enable an operator and / or other onlookers to see the PBM target and / or the area around the PBM target. The shield can eliminate the need for safety goggles. In some instances, the shield 14 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 other instance, the shield can be placed in contact (not attached) with the patient’s body inside and / or surrounding the surgical opening. One or more sensor(s) 28 can also be included in and / or on the shield 14 and / or the body 42 of the surgical device 10 in any configuration – dependent on type of sensor.

[0067] The shield 14 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 at least partially opaque to specific wavelengths and / or intensities). For example, the shield 14 can be conical and extending outward from a shaft of the surgical tool 10a (as shown in FIGS.6 and 7), a portion of a face and / or a layer of the surgical tool (as shown in FIG.9, a surgical drape-like design in any shape configured to spread over at least the surgical opening, or the like. The shield 14 can be at least partially stiff and / or malleable. In some instances, the shield 14 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 (not shown). In some instances, the distal end of the device body 42 can touch the nerve and serve as a shield in the sense the light (at harmful levels) does not escape and is not dangerous to clinician eyes (such that an independent shield 14 may not be needed). In other instances, the shield 14 with desirable properties (like the transparency to see the nerve) can be integrated into or onto the tip of the device.

[0068] FIG.5, elements A and B, show block diagrams of two additional example configurations of the surgical tool 10 that can deliver at least PBM during a surgical intervention to at least partially reduce post-operative pain using optical element(s) 52. The shield 14 from FIG.4 is omitted only for ease of illustration and understanding but should be understood as still present as part of surgical tool 10. It should be understoodthat these example configurations of elements A and B are for illustration purposes only and are not intended to be limiting or exclusive. Similar to FIG.4, it should be noted that additional therapy types may also be concurrently and / or consecutively applied with the same device (e.g., optical emitter(s) 12) such as RF therapy to expand the effect of the PBM therapy. The surgical tool of both elements A and B can include at least one optical emitter (e.g., optical emitter(s) 12) and a body 42 that can hold at least one optical emitter(s). The optical element(s) 52 can be at least partially integrated into the body 42 (element A) and / or separate but connected to the body (element B) depending on the shape and / or configuration of the surgical instrument 10 and the nerve(s) being targeted. The optical element(s) 52 can be connected (e.g., light can be transmitted) with the optical emitter(s) 12 to at least direct the dose of PBM. The optical element(s) 52 can include at least one optical fiber, at least one light pipe, at least one lens, and / or at least one diffraction grating to further direct the dose of PBM.

[0069] FIG.6 shows an example configuration of the system 100 as handheld surgical tool 60. The body of the surgical tool 60 can include a shaft 64 (having at least one lumen extending therethrough, not shown in FIG.6) and a handle 62 attached to a distal end of a shaft (relative to the patient), where a proximal (to the patient) end of the shaft can be positioned near and / or in contact with a PBM target. The controller 16 can be at least partially embedded in the handle 62. The shield 14 can be at least partially embodied in the handle 62 and / or the shaft 64, examples of both are shown in dotted lines. The optical emitter(s) 12 can be positioned at least partially in the shaft 64 (e.g., at least partially within a lumen of the shaft). Non-limiting example optical emitter(s) 12 locations are shown in FIG.6 in dashed line. In one instance an optical emitter can be positioned at and / or near a connection between the handle 62 and the shaft 64, at least partially in the shaft 64. In this example a light pipe of optical fiber may be positioned in the shaft 64 to further direct light from the optical emitter(s) 12 down and out of the shaft to the PBM target. In another instance, the optical emitter(s) 12 can be positioned entirely within the shaft 64. In a further instance, the optical emitter(s) 12 can be positioned at least partially out of the shaft 64 to directly provide PBM to a PBM target.

[0070] FIG.7 shows another example handheld surgical tool 70, which similar to FIG.6 has a shaft and a handle and a controller at least partially embedded in the handle. Handheld surgical tool 70 includes a single use sterile sheath 72 that can be positioned to cover at least a portion of the surgical tool. While not shown a portion of the surgical tool 70 (or surgical tool 10) can additionally and / or alternatively be sterile for single use and / or sterilizable. The handheld surgical tool 70 includes shield 14 that can be movable at least up or down the shaft. The shield 14 can have an adjustable position along the length of the shaft 62 (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. In fact, in some instances, the shield can be sterile and / or may be coverable by a sterile covering.

[0071] FIG.7, element A shows the shield 14 in an “up” configuration that can be used to position the surgical tool 70. FIG.7, element B shows the shield 14 in a “down” position that can be used to provide the PBM to the PBM target. It should be understood that while not shown for ease of illustration the handheld surgical tool 70 includes optical emitter(s) 12 for providing the PBM during the surgical intervention to at least partially silence conduction in one or more small fibers within the target. And thereby reducing (or eliminating) a patient’s post-operative 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 handheld surgical tool 70 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. In some instances, the handheld surgical tools 70 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.

[0072] FIG.8 shows example locations for sensor(s) on a patient proximal end of surgical tool 80 (e.g., that can be surgical tool 10, 60, or 70 or needle 210 (describedwith respect to FIG.9)). It should be understood that the examples of FIG.8 are merely for illustrative purposes and that any other sensor positions and / or number of sensor(s) are contemplated. For example, the sensors in FIG.8, elements A, B, and C may be utilized either apart or together in any combination.

[0073] FIG.8, element A shows an example where sensor(s) 28 (two are shown, but can be any number one or greater, can be positioned on the proximal end of the shaft of surgical tool 80 (e.g., on the face of the proximal end) and / or as part of a separate second shaft dedicated to the sensor(s) 28 and connected to the shaft of the surgical tool 80 (one sensor on one secondary shaft is shown, but the numbers of sensors and secondary shafts can be any number one or greater, and there can be more than one sensor per secondary shaft). The sensor(s) 28 can be, for example, surface contact sensors (pressure and / or impedance sensors) to determine the tip of the surgical tool 80 is in contact with the PBM target, optical sensors to determine a location of the PBM target, temperature sensors to determine a temperature of the PBM target before, during, and / or after PBM application, or the like.

[0074] FIG.8, element B shows two sensor(s) 28 (but can be any number one or greater) positioned on a portion of the shield 14 (and can be positioned at any location on the shield 14 depending on the sensor(s) function(s)). Sensor(s) 28 on a shield 14 can include surface contact sensors (force and / or pressure sensors and / or impedance sensors and / or optical sensors) to determine the shield 14 is properly positioned to block at least part of the light of PBM, temperature sensors to determine the temperature of tissues around the PBM target, or the like. FIG.8, element C shows three sensor(s) 28 (but can be any number one or greater) positioned on and edge and / or rim of the shield 14 of a surgical tool 80 that may be positioned around, beneath, and / or at least partially within the PBM target and / or tissue surrounding the PBM target. The sensor(s) 28 can be any of the sensors previously described. For instance, the sensors 28 can be electrodes that can detect contact with the tissue of, around, above, and / or beneath the PBM target.

[0075] FIG.9 shows another configuration of system 200 that can include a base control device housing at least a controller 216 and at least one optical emitter 212connected to a needle 210 via a fiber optic cable 218. The system 200 can be used for applying at least one therapy to at least one target nerve within / through an opening (the opening can be formed during a surgical intervention (e.g., a surgical opening), for the purpose of applying the at least one therapy, formed by an injury, or the like) to reduce and / or eliminate the patient’s post-operative pain. The controller 216 can include at least a memory 220 and a processor 222 (similar to memory 20 and processor 22 of system 100) to store instructions and / or data and execute the instructions, respectively. The controller 216 can be in wired and / or wireless connection with a user interface 224 and / or a display 226. In some instances, the controller 216, the user interface 224, and / or the display 226 can be embodied in a single housing. The display can include visual elements (e.g., screen(s), indicators, or the like) and / or audio elements (e.g., speaker, etc.). The user interface 224 can include, but is not limited to buttons, keyboard, touch screen, mouse, microphone, or the like. At least one optical emitter 212 can be in wired and / or wireless communication with the controller 216 and at least one fiber optic cable 218 (via a fiber optic cable port 230). The at least one optical emitter 212 may be partially embodied in a housing with the controller 216 and / or may be housed separately. The fiber optic cable 218 can connect the optical emitter with a needle 210, which can have a lumen running through an entire length of the needle (from the top to the working tip). The fiber optic cable 218 can be, in some instances, fed through at least a portion of the needle lumen (shown) and / or can be connected via a port to the needle (not shown). A shield 214 (shown in dotted lines) can be a portion of the needle 210 and / or can be positioned around at least a portion of the fiber optic cable 218 (shown as a trapezoid but can be any shape and can be movable up or down the length of the fiber optic cable). It should be noted that in most cases that use the needle model, a shield is not strictly necessary because the skin serves the role of the shield. It should be noted that skin does a great job of scattering light.

[0076] The needle 210 can be at least partially placed through the opening for the surgical intervention and positioned to deliver the PBM to the PBM target(s) within and / or reachable through the surgical opening. The light of the PBM (or energy of other nerve block therapies) can be provided from the at least one optical emitter 212 throughthe fiber optic cable 218 and the needle 210 directly to the PBM target(s) with reduced intervening tissues and / or materials in the way that would interfere with the treatment. It should be noted that the needle 210 may be used to make a part of the surgical opening and / or for other steps during the surgical intervention. In other instances, the needle 210 can be used to create the opening when appropriate medical care does not require a surgical opening but still results in post-treatment pain, pain is referred, or the like. For example, if a broken bone is being set (e.g., light therapy could be applied in advance of the manipulation to lessen post-setting pain), before or at the same time as giving a patient a shot that typically causes acute pain, putting an out of place joint back into place (e.g., before the joint is forced back into place), before application of heat or cold for other therapeutic purposes (e.g., that are non-damaging but otherwise cause acute pain), or the like.

[0077] Additionally, it should be noted that needle 210 can be any sharp surgical instrument including a lumen and may not in fact be a needle. In some instances, the needle 210 may be able to at least partially puncture a nerve sheath of a PBM target for even closer direct application of PBM to the fibers within. By applying the PBM to target nerve(s) during a surgical intervention, at dosages determined by the controller (as discussed previously), the system 200 can reduce and / or eliminate post-operative pain and reduce and / or eliminate the need for prescription opioids. It should be noted that the control device of system 200 may also support RF and / or cryoneurolysis capabilities that can be used consecutively and / or concurrently with PBM. In some instances, the control device of system 200 may also and / or alternatively support electrical and / or pharmaceutical nerve block capabilities for use with at least PBM. The active elements of the various forms of therapy could be applied via the needle 210, another needle 210, or a specialized device (not shown).

[0078] FIG.10 is a graphical representation of different pain management schemes for relieving pain during a surgery and post-operative pain. Traditional local anesthetics (such as lidocaine, etc., shown as the dashed line on the graph) can be applied to form a very strong surgical block (that can block all sensation and may block motor functions as well) for tens of minutes to several hours without need for re-application. Thistraditional use of local anesthetic wears off quickly after the surgical intervention leaving the patient to then deal with post-operative pain. Opioids (not shown on the graph for ease of illustration) are traditionally prescribed to deal with the post-operative pain and can be taken and / or administered every few hours and / or at a given rate (depending on if the surgical intervention is in-patient or out-patient and the type of opioid prescribed). Opioids include a number of negative side-effects including risks of addiction and overdose. Instead of opioids, PBM (or another type of light therapy) can be applied during the surgical intervention to inhibit nociceptor activity (especially c-fibers) for at least several days to provide non-opioid pain relief during the recovery period (e.g., after the traditional local anesthetic has worn off) and slowly tapering off (shown as the solid line on the graph). In some instances, additional therapies can also be applied that are more aggressive and cause a level of damage that can compromise target nerve(s) to create a disruption that can last longer (e.g., weeks to months) and / or provides stronger pain relief (shown as the dotted line on the graph). However, the more aggressive therapies can carry additional risks such as damage that can cause long-term numbness or tingling, thermal burns in addition to the intended lesions, and / or inadvertent bleeding. Radiofrequency ablation and cryoneurolysis are examples of the additional more aggressive therapies that can be used in combination with the PBM and traditional approaches. In other instances (not shown), PBM and RF ablation and / or cryoneurolysis can be used without traditional anesthetic blocks (avoiding the numbness and immobility caused by pharmacological blocks). Rather, acute pain at the time of the surgical intervention can be treated with some combination of PBM and / or RF ablation and / or cryoneurolysis and then another combination of PBM and / or RF ablation and / or cryoneurolysis can be applied to manage any post-operative pain. While not discussed in detail, it should be understood that various other types of electrical and / or pharmaceutical nerve blocks may be used in addition to the methods described herein and / or alternatively to RF and / or cryoneurolysis. IV. Methods

[0079] Another aspect of the present disclosure can include methods (FIGS.11-13) for applying PBM to a PBM target (e.g., one or more target nerves) within a surgicalopening to at least partially silence conduction in one or more small fibers in the one or more target nerves known to contribute to post-operative pain. The methods can reduce and / or eliminate post-operative pain, thereby reducing and / or eliminating a need for analgesics, such as opioids. The small fibers within the target nerve(s) can be, for instance, small diameter sensory nerve fibers, small diameter sympathetic nerve fibers, or the like that enervate a region undergoing a surgical intervention. Small fibers may also be found within nerve roots, neural ganglia, preganglionic fibers, or the like. Depending on the type of surgical intervention, candidate nerves can include median, ulnar, radial and branches thereof; sciatic, peroneal, tibial, sural, saphenous, and branches thereof; dorsal root ganglia; trigeminal ganglia, supraorbital, infraorbital, mandibular and branches thereof; greater occipital, lesser occipital, and branches thereof; or the like. PBM applied during a surgical procedure offers significant advantages over post-surgery analgesics – including, but not limited to not requiring take home use and compliance with prescription instructions, not being addictive, and not having other significant negative side effects.

[0080] For purposes of simplicity, the methods are shown and described as being executed serially; however, it is to be understood and appreciated that the present disclosure is not limited by the illustrated order as some steps could occur in different orders and / or concurrently with other steps shown and described herein. Moreover, not all illustrated aspects may be required to implement the method, nor is the method necessarily limited to the illustrated aspects.

[0081] Referring now to FIG.11, illustrated is a method 300 for applying at least one therapy to at least one target nerve within an opening (the opening can be formed during a surgical intervention (e.g., a surgical opening), for the purpose of applying the at least one therapy, formed by an injury, or the like) to reduce and / or eliminate the patient’s post-operative pain or, in some instances another type of acute pain not directly related to the surgical intervention (e.g., from setting a broken bone, from receiving a painful shot, from popping a joint back into place, or the like). In some instances, the therapy can include light therapy. At 302, at least one dose of at least one therapy (e.g., at least photobiomodulation (PBM) having one or more wavelengthsfrom 500 nm to 1200 nm in length) can be configured based on at least a type of the surgical intervention occurring to the patient (it should be understood, however, that this step may be optional). The at least one dose can include an amount of the therapy (e.g., PBM) for a time (e.g., application time). The at least one dose of the at least one therapy can be configured by a system comprising at least a processor (e.g., processor 22 or 222 of controllers 16 or 216). Configuring the at least one dose of the at least one therapy can include configuring one or more parameters. For PBM, the one or more parameters can include wavelength(s) of the light signal, power of the energy source, intensity of the light signal, duration of application, dosing scheme (including continuous wave versus pulsatile, number of dosages to be applied in a given time, or the like), maximum temperature threshold of the nerve, spot size of the light signal, timing of the application (e.g., pulses, mixing different wavelengths and / or intensities or the like), etc.), duty cycle, and the like.

[0082] At 304, the at least one dose of the at least one therapy (e.g., at least PBM) can be delivered to at least one PBM target via a surgical tool (e.g., surgical tool 10, 60, 70, or 210 described above in FIGS.1-9). The surgical tool can apply the at least one dose of the at least one therapy (e.g., at least PBM) to one or more target nerves having small fibers known to contribute to post-operative pain for the particular surgical intervention and / or one or more positions on the one or more target nerves. The surgical tool can be physically coupled to the controller (e.g., comprising the processor). The surgical tool can include at least one optical emitter configured to at least emit the at least one dose of therapy (e.g. PBM), a body configured to hold the at least one optical emitter, and a shield coupled to and / or incorporated into the body to contain at least a portion of light of the at least one dose of therapy (e.g., PBM). The controller and / or the surgical tool may be further configured to provide additional therapies in combination with PBM such as traditional pharmaceutical nerve blocks, electrical nerve blocks, radiofrequency ablation, and / or cryoneurolysis. The surgical tool can direct the at least one dose of the at least one therapy (e.g., at least PBM) to the PBM target through the surgical opening via at least the body of the surgical tool. At least one optical element such as light pipe(s), fiber optical cable(s), lens(es), or the like canfurther direct the at least one therapy (e.g., at least PBM) to the PBM target. At 306, the need for post-operative (or post-medical care that is non-surgical) analgesics (such as opioids) can be reduced (or even eliminated) by reducing and / or eliminating post- operative pain, also leading to fewer negative side effects or potential side effects caused by analgesics for the patient. The post-operative (or post-medical care that is non-surgical) pain can be reduced by at least partially silencing conduction in small fiber(s) carrying post-operative pain information to the brain with the at least one dose of the at least one therapy (e.g., at least PBM).

[0083] Referring now to FIG.12, illustrated is a method 400 for applying at least two therapies to at least one target nerve within a surgical opening (during a surgical intervention) to reduce and / or eliminate the patient’s post-operative pain. The method 400 can, for instance, combine PBM therapy with radiofrequency ablation, cryoneurolysis, or the like for a stronger and / or longer lasting relief of post-operative pain. At 402, at least one dose of a first type of therapy can be configured (e.g., by a system including at least a processor) based on at least a type of surgical intervention being done on the patient. It should be understood, however, this step may be optional. At 404, at least one dose of a second type of therapy, which can be the same as or different from the first type, can be configured (e.g., by a system including at least a processor) based on at least the type of surgical intervention and the at least one dose of the first type of therapy. The two types of therapy can be separate doses of PBM applied at the same and / or different locations. In other instances, the two types of therapy can be at least two of traditional pharmaceutical block, PBM, radiofrequency ablation, and cryoneurolysis. At 406, the at least one dose of the first and the second types of therapy can be delivered via a surgical tool like those described above in FIGS. 1-9. For example, the deliveries can be concurrent, consecutive, overlapped, and / or time staggered.

[0084] Referring now to FIG.13, illustrated is a method 500 for configuring at least one dose of a therapy to be applied to a patient during a surgical intervention to reduce post-operative pain after the surgical intervention. It should be noted that method 500 can be repeated for different doses and / or different types of therapies. The method 500can be done by a system including at least a processor (such as a controller including a non-transitory memory and a processor, like controller 16). At 502, the type and location of the surgical intervention can be determined. Information can be input manually by a user, selected from a stored list, and / or determined based on information from one or more sensors (e.g., optical sensors in a given operating suite). In some instances, the at least one dose can be at least partially pre-configured based on at least the type and location of the surgical intervention. The at least one dose may be further configured based on additional data as described herein.

[0085] At 504, patient demographic information can be determined (however, it should be understood that this step may be optional). The patient demographic information can be manually input, selected from a stored list, and / or determined based on information from one or more sensors (e.g., optical sensors, scale, colorimeter, or the like). Patient demographic information can include, but is not limited to gender, weight, height, age, race, diagnosis, overall health status, or the like. At 506 the typical duration and / or expected severity of post-operative pain associated with the surgical intervention for a patient of similar demographics can be accounted for (e.g., further configuring the at least one dose). Other information that can be accounted for can include typical responses to the surgical intervention, nerve accessibility (e.g., can be direct contact and / or distance to nerve), damage amount (e.g., greater than normal tissue damage could increase pain prognosis), information received from one or more sensor(s) (e.g., sensor(s) 28) and the like. Sensor data (e.g., pressure data, force data, optical data, impedance data, temperature data, or the like) can be received by the system and used to configure and / or modulate the at least one dose of the at least one therapy (e.g., at least PBM).

[0086] At 508, the at least one dose of the at least one therapy can be configured. In the case of more than one dose and / or more than one therapy type, the controller 16 can also determine a dosage scheme for applying multiple doses over the course of a surgical intervention (e.g., to keep nerve temperatures in a safe zone, for more effective pain reduction, application at a plurality of locations, or the like). The dose (or dosage scheme) can be determined in order to at least partially reduce post-operative pain for atime extending beyond the time of application. The determination can be based on at least the type of surgical intervention the patient is undergoing and the location of the surgical intervention. The determination can further be based on one or more of: patient demographic information, common post-operative pain amounts and / or locations for a similar patient (similar demographics, similar surgery type, location, and damage amount), one or more properties of the nerve to be selectively blocked by the application of PBM, and / or the like. For example, the amount of PBM applied for the time (e.g., the application time) can be varied based on the amount of post-operative pain associated with the type of surgical intervention for a sample of patients similar to the current patient. The configuring can include configuring the optimal parameter configuration(s) for at least PBM to meet the dose requirements to reduce the patient’s post-operative pain. The one or more parameters can include wavelength(s) of the light signal, power of the energy source, intensity of the light signal, duration of application, dosing scheme (including continuous wave versus pulsatile, number of dosages to be applied in a given time, or the like), maximum temperature threshold of the nerve, spot size of the light signal, timing of the application (e.g., pulses, mixing different wavelengths and / or intensities or the like), etc.), duty cycle, and the like. At 510, the at least one dose of the at least on therapy can then be output to the energy source(s) / optical emitter(s) to be provided to the target nerve(s).

[0087] Specifically, for at least PBM, the at least one dose of PBM can be applied for a given duration (e.g., time) to selectively inhibit at least a portion of conduction of the at least one small diameter sensory fiber within the nerve while allowing conduction in larger diameter fibers. The block of conduction of the at least one small diameter sensory fiber carries over for another time significantly longer than the time of application (e.g., extends for a time period longer than the application of the PBM light signal) without affecting conduction of the at least one larger diameter fiber within the nerve. In such a manner, post-operative pain can be reduced and / or silenced altogether before the effects of the PBM wear off. For example, the time period of application can be an hour or less (e.g., the time period can be shorter including 45 minutes or less, 30 minutes or less, 20 minutes or less, 15 minutes or less, 10 minutes or less, 5 minutes orless, 2 minutes or less, or the like) and the other time period (the carryover time of the effect from the specific direct PBM configuration) can be at least a day (e.g., the other time can extend for at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 10 days, at least 15 days, at least 20 days, at least 25 days, at least 50 days, or more).

[0088] From the above description, those skilled in the art will perceive improvements, changes, and modifications. Such improvements, changes and modifications are within the skill of one in the art and are intended to be covered by the appended claims.

Claims

The following is claimed:

1. A system comprising: a surgical tool comprising: at least one optical emitter configured to provide a dose of PBM; a body configured to hold the at least one optical emitter and to direct the dose of PBM to a PBM target through a surgical opening during a surgical intervention; and a controller configured to set the dose of PBM at an amount for a time to at least partially reduce post-operative pain for another time after the surgical intervention.

2. The system of claim 1, wherein the controller is further configured to select the dose based on one or more properties of a nerve to be selectively blocked.

3. The system of claim 1, wherein the amount for the time varies based on an amount of post-surgical pain associated with the type of surgical intervention for a sample of patients.

4. The system of claim 1, wherein the surgical tool is shielded by a shield coupled to and / or incorporated into the body to contain a portion of light of the dose of PBM within the shield.

5. The system of claim 1, wherein the dose of PBM is configured to selectively block sensory fibers within the PBM target for the other time.

6. The system of claim 1, wherein the body of the surgical tool further comprises a shaft and a handle attached to a distal end of a shaft, wherein the controller is at least partially embedded in the handle and the at least one optical emitter is configured to be positioned at least partially in the shaft.

7. The system of claim 1, further comprising at least one force sensor, impedance sensor, or optical sensor configured to detect an indication of whether at least a portion of the surgical tool is in contact with tissue around and / or above the PBM target.

8. The system of claim 1, wherein at least a portion of the surgical tool is sterile for single use and / or at least a portion of the surgical tool is configured to be covered with a sterile sheath.

9. The system of claim 1, wherein the shield is opaque to at least one wavelength of the dose of PBM, but transparent to at least one other wavelength of light.

10. The system of claim 1, wherein the dose of PBM comprises at least one wavelength of from 500 nm to 1200 nm.

11. The system of claim 1, wherein the at least one optical emitter is coupled to at least one optical fiber, at least one light pipe, at least one lens, and / or at least one diffraction grating to further direct the dose of PBM.

12. A method comprising: configuring, by a system comprising a processor, at least one dose of photobiomodulation (PBM) based on at least a type of surgical intervention, wherein the dose comprises an amount of PBM for a time; and delivering, by the system, the at least one dose of PBM via a surgical tool, wherein the surgical tool is configured to apply the at least one dose of PBM to one or more nerves and / or one or more positions on the one or more nerves of a patient within a PBM target having small fibers known to contribute to post-operative pain, wherein an amount of analgesics prescribed to the patient for post-operative pain is reduced leading to fewer side effects caused by the analgesics.

13. The method of claim 12, further comprising physically coupling the surgical tool to the controller, wherein the surgical tool comprises: at least one optical emitter configured to emit the at least one dose of PBM; and a body configured to hold the at least one optical emitter.

14. The method of claim 13, further comprising directing the at least one dose of PBM to the PBM target through a surgical opening using the body.

15. The method of claim 12, wherein configuring the at least one dose of PBM further comprises configuring at least one parameter comprising one or more wavelengths, a power density, and / or a total energy so that the small fibers known to contribute to the post-operative pain are at least partially inhibited for a time beyond the delivering of the at least one dose of PBM. 16, The method of claim 12, wherein the at least one dose of PBM further comprises a parameter comprising one or more wavelengths from 500 nm to 1200 nm.

17. The method of claim 12, wherein the analgesics comprise opioids.

18. The method of claim 12, further comprising selecting, by the system, the at least one dose of PBM, wherein the at least one dose of PBM is pre-configured based on at least one aspect of the surgical intervention.

19. The method of claim 12, further comprising determining, by the system, the at least one dose of PBM, the one or more nerves, and / or the one or more positions on the one or more nerves based on a likelihood the surgical intervention will lead to post- operative pain.

20. The method of claim 12, further comprising determining, by the system, the at least one dose of PBM based on a typical duration and / or expected severity of post- operative pain associated with the surgical intervention.

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