Instrument for performing photobiomodulation therapy and corresponding programmed method

Abstract

Embodiments relate to an instrument configured to perform photobiomodulation (PBM) therapy. The instrument includes a body having a light emitting head and a light source for emitting light through an emitting portion of the light emitting head. The light source is configured to simultaneously emit light at a plurality of peak wavelengths for photobiomodulation (PBM) therapy, and wherein the plurality of peak wavelengths fall within a spectral range of 615 nm to 1100 nm.

Description

Technical Field

[0001] The present invention relates to apparatus and methods for performing photobiomodulation (PBM) therapy. More particularly, but by no means exclusively, embodiments relate to a handheld device configured to generate PBM dental analgesia within a patient's oral cavity for use in conjunction with dental procedures. Background Art

[0002] In clinical practice, there are many procedures that are uncomfortable for patients and require injections of local anesthetics to allow for safe and effective procedures. Injection procedures are often associated with intense fear and anxiety. Similar concerns arise when using a lancet on the skin, administering an injection (such as a vaccine), or placing an intravenous line. These can all be painful and anxiety-inducing.

[0003] Additional examples include dental procedures such as placement of interdental wedges, orthodontic separators, and dental dam clamps, as well as scaling, fillings, dental injections, and oral surgical procedures such as frenectomy or tooth removal to treat a tongue tie.

[0004] Similarly, similar concerns about discomfort associated with penetration of the skin or mucous membranes exist for cosmetic procedures such as tattooing, tattoo removal, body piercing insertion, hair removal using laser or intense pulsed light, hair removal using electrolysis, filler and botulinum toxin injections, and skin needling. Finally, there is a range of uncomfortable self-performed procedures in the home setting, including hair removal by plucking and skin waxing.

[0005] The use of visible red and near infrared diode lasers and Nd:YAG lasers to modify response thresholds and induce analgesia has been described in the literature for over 25 years, and the use of diode laser units is not uncommon in physiotherapy, veterinary medicine, and to some extent in dentistry.

[0006] In patent document US2009 / 0082759 (Pryor et al.), a laser device for reducing pain and inflammation caused by skin injections is described. Applications listed for the device listed in this application include cosmetic injections such as botulinum toxin or dermal fillers, mesotherapy, vaccinations, etc. According to Pryor et al., laser application is provided via an optical wand or a flexible light emitting pad / bandage that is optically coupled to the fiber optics of a surgical diode laser system (i.e., in the form of a conventional mains-powered surgical diode laser mounted in a tabletop control panel). The optical wand may incorporate a rolling massage ball to promote a rolling and kneading action that can increase blood circulation during laser application.

[0007] A significant disadvantage of the device described by Pryor et al. is that the stick and pad design makes it suitable only for topical / dermal application. Not only is the stick design unsuitable for intraoral application, but the rollerball can easily trap dirt, dead skin, dander, and skin microorganisms within its housing, which can be transferred between patients if not disassembled and cleaned after each use.

[0008] Specifically in the field of dentistry, WO2022 / 060800 (Cyberdontics USA Inc.) describes an automated system for laser analgesia in conjunction with drilling by a dental drill under robot control. The laser runs in one or more cycles as needed to prevent or reduce the discomfort caused by the mechanical drilling process. However, the Cyberdontics application fails to provide any description of how the dental drill and laser can be configured to achieve the claimed benefits. In fact, the patent specification does not mention any details of the laser, drill, and housing configuration at all.

[0009] It would be advantageous to provide an apparatus for achieving PBM therapy of both skin and mucous membranes for use in a wide range of applications, including dental surgery, healthcare settings, cosmetic surgery, home settings, and veterinary care. It would also be advantageous if embodiments of the apparatus could be used without the need for a separate high-power laser source. Summary of the Invention

[0010] According to a first aspect of the present invention, a dental instrument is provided, comprising: a main body including a light emitting head; and a light source for emitting light through an emitting portion of the light emitting head, the light source being configured to simultaneously emit light at multiple peak wavelengths to perform photobiomodulation (PBM) therapy in a patient's oral cavity to assist in dental surgery, and wherein the multiple peak wavelengths fall within a spectral range of 615 nm to 1100 nm.

[0011] In an embodiment, the light source is configured to simultaneously emit light at three different wavelengths within a spectral range. For PBM analgesia, the first of the three different wavelengths is near infrared, falling within the range of approximately 900 nm to 1000 nm. This range is preferably approximately 920 nm to 980 nm. The second of the different wavelengths is also near infrared, preferably falling within the range of approximately 800 nm to 910 nm, and more preferably approximately 820 nm to 860 nm. The third of the different wavelengths can be visible red or near infrared, and preferably falls within the range of approximately 615 nm to 820 nm.

[0012] For analgesia, the light source is preferably controlled such that the first wavelength has a greater intensity than the light emitted at other wavelengths.

[0013] In an embodiment, the light source comprises a LED broadband emitter.

[0014] In an embodiment, the light source comprises a plurality of LEDs configured to emit light at respective peak wavelengths.

[0015] In an embodiment, the apparatus further comprises a controller configured to selectively control at least one of a pulse frequency and a pulse energy of the light source sufficient to produce dental analgesia.

[0016] In an embodiment, the light source is further configured to emit light at wavelengths in the visible and / or red spectrum for performing one or more additional dental functions selected from the group consisting of: white light inspection; near infrared (NIR) transillumination; fluorescence calibration; photocuring; photocoagulation and photodynamic therapy.

[0017] In an embodiment, the outer surface of the light emitting head may be sealed to prevent the ingress of matter present in the patient's oral cavity.

[0018] In an embodiment, the light source is configured to emit light through a tip of the head.

[0019] In an embodiment, the body includes a handle, and wherein the light emitting head is connected to the body via an elongated neck such that the head and at least a portion of the neck are configured for insertion into the patient's oral cavity. The neck and / or at least a portion of the light emitting head is curved or otherwise has a longitudinal axis that is offset relative to the longitudinal axis of the handle, thereby allowing the light emitting head to access a posterior region of the oral cavity. The light source is integrated into at least one of the head and neck of the instrument, and wherein the head / neck is configured to be removably coupled to the body via an electrical coupling, thereby allowing the light source to be powered and controlled. Alternatively, the light source may be integrated into the body, and wherein optical fibers within the neck and head act as light guides for transmitting the emitted light through and out of the head. The light source may include a cluster of emitters, and one or more lenses may be positioned in front of the light source for collimating the light.

[0020] The controller may be configured to set a duty cycle for the emitted light, and the duty cycle may be set by a user of the apparatus.

[0021] The controller may be configured to operate the light source in a pulsed mode. Pulsing may be achieved by chopping a continuous beam emitted by the light source.

[0022] In an embodiment, the emitting portion of the head has a 2 to 0.8cm 2 The dispersion of light emitted from the emitting portion of the head may have a maximum angle of about 10 degrees.

[0023] In an embodiment, the light source is controlled so that the irradiance for achieving analgesia is between about 8 and 12 joules / cm 2 between.

[0024] According to a second aspect, a detachable photobiomodulation (PBM) tip for a handheld dental device having a power supply and a controller is provided, the detachable PBM tip comprising: an elongated body having a first end and a second end, the second end being configured to be electrically and physically coupled to the body of the handheld dental curing device; a light source for emitting light through an emitting portion of a light emitting head, the light source being configured to simultaneously emit light at multiple peak wavelengths to perform photobiomodulation (PBM) therapy in a patient's mouth to coordinate a dental procedure, and wherein the multiple peak wavelengths fall within a spectral range of 615 nm to 1100 nm.

[0025] According to a third aspect, an apparatus configured to perform photobiomodulation (PBM) therapy is provided, the apparatus comprising: a body including a light-emitting head; and a light source for emitting light through an emitting portion of the light-emitting head, the light source being configured to simultaneously emit light at multiple peak wavelengths for performing photobiomodulation (PBM) therapy, wherein the multiple peak wavelengths fall within a spectral range of 615 nm to 1100 nm. The head may be connected to the body via a neck, and wherein the neck and / or a portion of the head is curved or otherwise has a longitudinal axis that is offset relative to a longitudinal axis of the handle.

[0026] According to a fourth aspect, a photobiomodulation (PBM) system is provided, comprising: an instrument according to any one of the above three aspects; and a remote controller configured to wirelessly communicate with an instrument controller for remotely controlling the instrument controller.

[0027] According to a fifth aspect, a dental instrument configured to perform photobiomodulation (PBM) therapy is provided, the dental instrument comprising: a main body including a light emitting head; and a light source for emitting light through an emitting portion of the light emitting head, the light source being configured to emit light at one or more wavelengths in a spectral range of 615 nm to 1100 nm to perform photobiomodulation (PBM) therapy in the patient's mouth to assist with dental surgery, and wherein the head is connected to the main body via a neck, and wherein a portion of the neck and / or the head is curved or otherwise has a longitudinal axis that is offset relative to the longitudinal axis of the handle, thereby allowing easy access to the position of the oral cavity.

[0028] According to a sixth aspect, there is provided a method of performing clinical surgery on a human patient or animal using an apparatus according to any of the apparatus described above, and such that, in use, a light source is used to illuminate an area on a mucous membrane or skin prior to administering a local anesthetic solution using an injection device to reduce discomfort associated with the injection.

[0029] According to a seventh aspect, there is provided a method of performing clinical surgery on a human patient or animal using an instrument according to any of the previously described aspects, and such that, in use, a light source is used to illuminate an area on a mucous membrane or skin to achieve analgesia and improve comfort during surgery.

[0030] According to an eighth aspect, there is provided a method of performing cosmetic surgery on a patient or animal using an apparatus according to any of the apparatus described above, and such that, in use, a light source is used to illuminate an area on a mucous membrane or skin for the purpose of achieving analgesia, improving comfort during surgery and / or causing an anti-inflammatory effect to control conditions such as mucositis.

[0031] According to a ninth aspect, there is provided a method of performing clinical surgery on a human patient or animal using an instrument according to any of the instruments described above, and such that, in use, a light source is used to illuminate the temporomandibular joint, either from the outside or inside of the mouth, for the purpose of achieving at least one of: analgesia, increased comfort during dental surgery, relief of spasm; causing an anti-inflammatory effect to control conditions such as temporomandibular joint dysfunction (TMD) or arthritis.

[0032] According to a tenth aspect, there is provided a method of performing clinical surgery on a human patient or animal using an instrument according to any of the instruments described above, and such that, in use, a light source is used to illuminate a joint or muscle for the purpose of achieving at least one of: analgesia, increased comfort during dental surgery, relief of spasm; causing an anti-inflammatory effect to control conditions such as arthritis, muscle fatigue or myositis.

[0033] According to an eleventh aspect, a method is provided for performing clinical surgery on a human patient or animal using an instrument according to any of the instruments described above, and such that, in use, a light source is used to illuminate the facial muscles and / or masticatory muscles for achieving at least one of: analgesia, increased comfort during action, improved mouth opening, relief of spasm, and causing anti-inflammatory effects and symptoms associated with temporomandibular joint dysfunction (TMD), bruxism, or masticatory myositis in animals. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0035] Figure 1is a schematic diagram of a treatment apparatus (in exploded view) according to an embodiment of the present invention;

[0036] Figure 2 is depicted by Figure 1 Schematic diagram of an example transmitter array of an instrument implementation;

[0037] Figure 3 It is shown for Figure 1 Schematic diagram of an example LED and lens configuration of an instrument;

[0038] Figure 4 is a schematic diagram of a therapeutic apparatus according to an alternative embodiment of the present invention;

[0039] Figure 5 yes Figure 4 Exploded view of the transmitter attachment head;

[0040] Figure 6 Shown for Figure 4 The corresponding coupling end of the instrument;

[0041] Figure 7 is a table showing transmitter wavelengths and corresponding operating modes; and

[0042] Figure 8 is a graph showing EPT scores for a randomized, single-blind clinical trial. DETAILED DESCRIPTION

[0043] Embodiments of the invention described herein relate to apparatus and methods for performing PBM therapy, including implementing PBM analgesia to attenuate injection pain and establish analgesia, allowing many surgeries to be performed without the need for prior injection of local anesthetic solutions, topical anesthetic creams, or other measures to control pain associated with the surgery. It should be understood that the therapy can be performed before, during, and / or after surgery as needed. Embodiments also extend to accelerating healing and reducing inflammation and swelling following surgical procedures, such as after tooth extraction or periodontal pocket debridement. Other applications include promoting hard tissue formation to seal the dental pulp or enhance osseointegration between bone and implants.

[0044] Embodiments are particularly well suited for dental (especially intraoral) applications, and accordingly, the following detailed embodiments will be described in such context. However, it should be understood that embodiments can be extended to other applications, including for use in healthcare environments, cosmetic surgery, home environments, and veterinary care. For example, the instrument can be configured to irradiate joints to achieve analgesia, improve comfort during movement and exercise, relieve spasms, and cause anti-inflammatory effects and symptoms associated with arthritis. The joint can be, for example, the temporomandibular joint (irradiated from the outside or inside of the oral cavity) to alleviate the symptoms associated with temporomandibular joint dysfunction (TMD). In another non-limiting example embodiment, the instrument can be used to irradiate facial muscles and / or masticatory muscles for the treatment of bruxism, masticatory myositis, fatigue, etc.

[0045] Device Configuration

[0046] refer to Figure 1 , shows a first embodiment of a therapeutic instrument according to the present invention. The therapeutic instrument 10 is lightweight and is designed so that it is suitable for both skin application and intraoral application. More specifically, the therapeutic instrument 10 includes a body 12 having a handle portion 14. According to the illustrated embodiment, the body 12 is formed from any suitable material, such as a sturdy plastic or stainless steel. A housing 14a within the handle portion 14 is suitably configured to receive an integrated power source (not shown), such as a rechargeable battery.

[0047] The therapeutic device 10 further includes a head 16 connected to the body 12 via an elongated neck 18. According to the illustrated embodiment, the head 16 and at least a portion of the neck 18 are specifically configured for insertion into the patient's mouth, for example, for implementing PBM analgesia, as will be described in detail in subsequent paragraphs. In this regard, and as depicted in the figures, a portion of the neck 18 can be curved or otherwise have a longitudinal axis that is offset relative to the longitudinal axis of the handle portion 14, thereby allowing the head 16 to advantageously access the back area of ​​the mouth and other areas of the body that are difficult to access. In one embodiment, the head 16 can be rotatably coupled to the neck 18 to allow the light emitting portion of the head 16 (described in subsequent paragraphs) to be directed to a difficult-to-reach location. In another embodiment, both the head 16 and the neck 18 can be rotatable and coupled to the body 12. In yet another embodiment, the neck 18 can be formed from a flexible material that allows it to be bent into a desired shape.

[0048] The therapeutic apparatus 10 additionally incorporates a light source 20 that is configured to emit light through an emitting portion 22 of the head 16. Although the illustrated embodiment shows the emitting portion 22 located at the tip of the head 16 (and accordingly will be referred to hereinafter as the "emitting tip"), it should be understood that the emitting portion may be located in other areas of the head or body, depending on the desired implementation. The emitting tip 22 has an effective diameter in the range of approximately 6 mm to 10 mm, thereby providing a luminous flux of approximately 0.2 cm. 2 to 0.8cm 2 The effective light emission area is between 10 and 20 mm. The dispersion of light from the emission tip 22 will typically range from 6 mm to 10 mm. Optical, mechanical, and / or digital mechanisms (not shown) can be implemented individually or in combination to control the selection, shape, and diameter of the light beam and / or spot to reduce or increase the effective light emission.

[0049] Figure 1 The light source 20 is shown integrated into the nose portion 13 of the body 12 (eg, Figure 3 ) and includes at least one light emitter 28 configured to emit light for performing PBM therapy.

[0050] According to a preferred embodiment of the present invention, the light source is configured to simultaneously emit light at multiple wavelengths (and more preferably three wavelengths) for achieving PBM analgesia or other PBM therapies, as will be described in more detail in subsequent paragraphs.

[0051] according to Figure 1 In an embodiment, the neck 18 and head 16 are jointly configured to operate as a light guide for transmitting light emitted from the emitter 28 through the neck 18 and out the emitting tip 22. This can be achieved using any suitable light guiding medium, including utilizing one or more optical fibers for light transmission. Figure 3 As schematically shown in the exploded view of FIG, one or more lenses 34 (in this case two lenses 34a, 34b) are positioned in front of the emitter 28 for collimating the emitted light. In another embodiment, the light source 20 can be configured so that the light intensity decreases with distance from the end of the instrument to the target tissue.

[0052] like Figure 2 As shown, the example emitter array 28a…28n (hereinafter referred to as “emitter array 29”) can advantageously allow the instrument 10 to not only implement PBM therapy (including PBM analgesia), but also allow for additional procedures including, but not limited to, white light inspection, near infrared (NIR) transillumination, fluorescence verification of cavities and tooth-colored fillings, photocuring, photocoagulation, and photodynamic therapy.

[0053] It should be understood that the transmitters 28a to 28m may be arranged to Figure 2Different arrangements are shown, depending on the desired implementation. Table 1 below lists the corresponding wavelengths of the emitters.

[0054] Transmitter number Wavelength region wavelength 28a Near infrared 860nm 28b, 28c Visible-Red 770nm 28d, 28e Near infrared 950nm 28f, 28g Visible-Purple 405nm 28h, 28i Visible-cyan 460nm 28j, 28k Visible-Royal Blue 450nm 28l、28m Visible-white light 400-700nm

[0055] Table 1 - Transmitter array table.

[0056] Emitters 28a to 28e are provided primarily for inducing analgesia according to Table 1. It will be appreciated (and apparent from the above table) that higher irradiance values ​​may be achieved by providing two or more emitters emitting at the same wavelength.

[0057] In an alternative embodiment to that shown in the figures, light source 20 may include a single broadband emitter (e.g., Thorlabs model MBB2D1 manufactured by Thorlabs, Inc.: https: / / www.thorlabs.com / thorproduct.cfm?partnumber=MBB2D1) configured to simultaneously emit light at two or more different wavelengths. The light source may also include a combination of broadband emitters and single wavelength emitters, depending on the desired implementation.

[0058] A controller 30 is also provided (in this case housed within the body 12) and is configured to selectively control the emitters 28 to be on or off. The controller 30 may be further configured to control the intensity of light emitted by each of the emitters 28. According to the embodiments described herein, the controller 30 is configured to power the emitters 28 such that the irradiance is in the range of 2 to 12 joules / cm 2 It will be appreciated that the relative power and energy output can be controlled by selectively turning on / off emitters 28 of the same wavelength or by controlling the power supplied to each emitter 28 (depending on the instrument and emitter configuration).

[0059] Emitter 28 can be pulse-controlled by controller 30 to minimize heating during operation and prevent heat accumulation in teeth or tissue that may be discolored or stained, respectively. It should also be understood that emitter 28 can also be pulse-controlled, depending on the desired implementation / procedure. According to the illustrated embodiment, pulse control is achieved by modulating the pulse width, with the emitter operating in a chopped continuous wave mode. A particular advantage of this aspect is that a low duty cycle can be set for various operating modes (e.g., 25% or 50%), as will be described in more detail in subsequent paragraphs.

[0060] The controller 30 may also be configured to communicate with one or more sensors 31 located on or near the head 16 for determining instrument efficacy and for ensuring patient safety. For example, a temperature sensor (e.g., an infrared temperature sensor) and a contact sensor (e.g., an optical sensor, a capacitive sensor, or a resistive contact sensor) may be incorporated into the head 16. In this case, if the temperature recorded by the temperature sensor exceeds a predefined maximum value, the controller 30 may be programmed to shut down one or more of the emitters 28 for safety reasons. For certain applications (e.g., when used to irradiate a site on a mucous membrane or skin prior to an injection), the controller 30 may be programmed to turn on selected emitters only when the contact sensor indicates that the instrument is in contact with the mucous membrane / skin.

[0061] The sensor can also be used to determine the efficacy of the treatment. For example, as mentioned in the previous paragraph, the instrument 10 can be used to treat temporomandibular joint disorder (TMD). In this case, when applied to the joint being treated, the temperature recorded by the temperature sensor can be used to indicate an elevated temperature when local blood flow increases due to relaxation of the surrounding muscles, thereby indicating that the treatment is working.

[0062] The controller 30 may include a microprocessor or the like that implements program code (stored in memory) for performing the procedure according to predefined programs that selectively control transmitter operation, intensity, and duration. It should be understood that an interface that can communicate with the controller 30 can be provided on the instrument to allow the operator to switch between programs or manually control the operation of the transmitter 28. In one embodiment, the instrument controller 30 can be further connected to a remote monitor and / or controller (e.g., implemented as a mobile phone device, tablet computer, PC, etc.) via wired or wireless means (e.g., via Bluetooth, Wi-Fi, and over the Internet using a suitable wireless communication protocol, etc.) to remotely display and / or change settings.

[0063] according to Figure 1 In the embodiment shown in FIG, the neck 18 and head 16 are configured to operate as a light guide for transmitting light emitted from the emitter array 29 through the neck 18 and out the emitting tip 22. This can be achieved using any suitable light guiding medium, including utilizing one or more optical fibers for light transmission. Figure 3 As schematically shown in the exploded view of FIG, one or more lenses 34 (in this case two lenses 34a, 34b) are positioned in front of the emitter array 29 for collimating the emitted light. In another embodiment, the light source can be configured so that the light intensity decreases with distance from the end of the instrument to the target tissue.

[0064] Figures 4 to 61 ' shows a therapeutic instrument 10' according to an alternative embodiment of the present invention. In this embodiment, the instrument 10' has a pen-shaped body 12', wherein the majority of the neck 18' lies in substantially the same longitudinal plane as the body 12' (although it will be understood that the shape of the body may vary). Figure 1 ). A significant difference between the illustrated embodiments is that the light source 20' is not incorporated into the instrument body, but is located in the neck 18' and / or head 16'. For the first embodiment, the light source 20' comprises any of the following: an emitter array, a broadband emitter, or a combination of both.

[0065] In this case, one or more emitters 28' are integrated into a multi-component LED panel 55 that is disposed behind the emitting tip 22' of the head 16' (this is in the Figure 5 ). More specifically, a multi-component LED panel 55 contains multiple PBM emitters 28 in a single package and, depending on the application, can selectively emit light at different wavelengths (including simultaneous light emission at the three different peaks described above), from which light passes through a lens 56. The lens 56 is attached, for example, by threads. The LED panel 55 is held in place by set screws 57, which attach it to the thermal pad 54 and the aluminum heat sink 53. The body 12' of the instrument 10' also serves as a heat sink.

[0066] As shown, the head 16' has an angled design to easily allow PBM therapy (including analgesia) to be delivered into the mouth. According to the illustrated embodiment, the head 16' and neck 18' are detachable from the body 12' and take the form of a replaceable transmitter attachment 17. More particularly, the transmitter attachment 17 is connected to the body 12' via a suitable coupling 40. The coupling 40 can be, for example, a snap-on, plug-in, or screw-on coupling, which advantageously allows the light source in the transmitter attachment 17 to be powered and controlled by a battery / controller disposed in the body 12'. Figure 6The respective coupling ends of the instrument body and the transmitter attachment are shown. As shown, the attachment-side end includes a concentric conductor ring 41 that provides power to the transmitter and, if desired, a path for feedback from the light source (e.g., if a laser diode is used for the light source, a return path to the controller can be used to control the deviation of the wavelength). An example coupling suitable for use with the present invention is described in US 9,693,846 (Kerr Corporation), the contents of which are incorporated herein by reference. The detachable coupling 40 also allows the body 12' to power and control a set of different transmitter attachments 17a to 17n (i.e., each transmitter attachment having a transmitter and / or transmitter array having different wavelength combinations covering the range as described above for the first embodiment, thereby allowing the instrument to perform the same operation).

[0067] In yet another alternative embodiment (not shown), the transmitter attachment 17 can be coupled to existing equipment, such as a dental chair, a medical laser or dental laser system, or a power injection device. In this case, the existing equipment can be used to power and control the transmitter attachment 17 for performing the aforementioned functions. In a particular embodiment, the transmitter attachment 17 of the present invention can be configured to electrically and physically couple to a dental curing light designed for photopolymerization of dental materials (such as described in U.S. Patent No. 9,693,846). Such curing lights include a rechargeable battery, control circuitry, and standard accessories that incorporate an LED that emits visible blue light (typically in the 460nm to 480nm wavelength region). These lights are typically constructed specifically as standalone devices to be placed on a workbench or integrated into a dental chair. Thus, the provision of a transmitter attachment 17 with a light source configured to emit light at a wavelength in the range of 615nm to 1100nm allows the curing light to additionally operate as an instrument for performing PBM analgesia (as well as any of the other procedures described above).

[0068] According to any of the previously described embodiments, the outer surface of the instrument 10, 10' can be sealed to prevent contamination (e.g., there are no openings or joints through which liquids, etc. can pass), allowing for quick and easy cleaning and sterilization. In an embodiment, a disposable cannula can be fitted to the instrument during use to prevent cross-contamination, and the head 16' can be removed for sterilization. Additionally, a window made of a suitable transparent or translucent material (e.g., sapphire) can be removably placed on top of the lens 56 or the emitting tip 22 (either within the cannula or separately therefrom), which can be removed after exposure for sterilization or replacement between patients.

[0069] Where the PBM therapy is non-dental, it will be appreciated that the light source may be incorporated into the body directly or via any suitable coupling (ie omitting the elongated neck which is particularly advantageous for intra-oral applications).

[0070] PBM model

[0071] In PBM, it is understood that the effects of light are based on the regulation of several metabolic, biochemical, and photophysical processes within cells. The analgesic action of PBM occurs primarily through the interaction of light with nerves and nociceptors. The reported effects of PBM include: reducing excitability and inhibiting the electrical response of nociceptors (pain receptors); reducing the hyperpolarization of nerve cell membranes and inhibiting neural responses; prolonging the latency of compound action potentials, resulting in nerve conduction block; and impaired axonal flow within nerves. However, a more fundamental problem lies in the optimization of wavelength for analgesia.

[0072] Regarding penetration, to maximize effectiveness, it is necessary to select a wavelength of light that penetrates deeply into the target tissue and is able to enter absorption by the target molecules. For strong transmission, it is known that the transmission of light through tissue is highly wavelength-specific. An "optical window" exists in tissue in the approximate range of 500 nm to 1200 nm. In this spectral region, there are no major absorbers, and therefore light delivered to the surface will penetrate deeply into the tissue and be widely scattered, especially when using longer wavelengths. Light can penetrate to depths of up to 30 mm, depending on the choice of wavelength and the characteristics of the target tissue.

[0073] To ensure strong PBM action for analgesia, it is necessary to select a wavelength that corresponds to the known absorption spectrum of the target molecule chromophore (light-absorbing molecule), because peaks in the absorption spectrum represent regions of increased absorption efficiency.

[0074] The inventors have discovered that wavelengths in the range of 615 nm to 1100 nm are optimal for PBM action. More specifically, the inventors have discovered that simultaneously emitting light at two or more peak wavelengths within this spectrum can provide therapeutic benefits superior to conventional single-wavelength techniques. Preferably, emitting light at three peak wavelengths falling within the 615 nm to 1100 nm spectral range has been shown to produce effective results for a range of PBM therapies, particularly PBM analgesia.

[0075] Preferably, to induce analgesia, the light dose (total irradiance delivered by the apparatus 10) is between 8 and 12 joules / cm 2 Furthermore, the light source is preferably configured so that the relative power distribution is biased towards higher near-infrared wavelengths, which have been shown to be most effective for inducing analgesia. For example, 8 joules are from the 950 nm emitter, and 2 joules are each for the 860 nm and 770 nm emitters (thus producing a total light dose of 12 joules).

[0076] At least one of the wavelengths is near infrared, preferably falling within the spectral range between about 900 nm and 1000 nm, and more preferably between about 920 nm and 980 nm. A second of the wavelengths is also near infrared, preferably falling within the spectral range between about 800 nm and 910 nm, and more preferably between about 820 nm and 880 nm. Depending on the application, a third of the wavelengths may be near infrared or visible infrared, falling within the spectral range between about 615 nm and 820 nm. For PBM analgesia, the third wavelength may be toward the higher end of the range (e.g., around 770 nm), while for other PBM therapies (such as for muscle relaxation), it may be more desirable to have a power distribution biased toward one of the lower wavelengths (such as about 700 nm). Through extensive testing, it was found that simultaneously emitting light with wavelengths falling within the aforementioned ranges produced effective PBM and penetrated through both soft and hard tissues, including bone, enamel, and dentin.

[0077] The present invention is further described below by way of non-limiting examples.

[0078] Example: PBM for analgesia

[0079] The inventors conducted a randomized, single-blind clinical trial as part of their testing. A total of 13 healthy young adults received PBM therapy using the subject instrument 10 (operating at three peak wavelengths of approximately 770 nm, 860 nm, and 950 nm) and three commercial diode lasers with wavelengths of 660 nm, 808 nm, and 904 nm, respectively. Electroendodontic testing (EPT) was used to quantify the reactivity of the subject's dental pulp to determine the response threshold. All four light sources were operated with the same 8 mm spot size and matched for energy density and total irradiance. A total of 12 joules of light dose was delivered to each subject's premolars from the buccal side and then from the lingual side, and EPT assessments were repeated at 1, 2, 5, and 20 minutes to assess the analgesia of PBM (an increase in the EPT score indicates analgesia). The trial used a repeated measures design, evaluating the same tooth with all four light sources but on different days. Figure 8 A graph showing the final EPT scores for each light source is shown in FIG. As can be seen, the analgesic effect of the subject device 10 was superior to that of the other individual laser light sources, with a greater increase in the EPT score at 2 minutes and a longer duration of the increased EPT score compared to the other light sources. The analgesic effect produced by the subject device 10 stabilized at 5 minutes and declined around 20 minutes. Additional in vitro studies demonstrated that the broadband emission from the subject device 10 better penetrated through normal-colored teeth as well as discolored teeth to reach the dental pulp. Furthermore, no subjects experienced any heat or discomfort from the subject device 10.

[0080] Another clinical trial conducted by the inventors included a responder analysis (showing the degree of variation) and data on discomfort caused by the light source. Again, the trial included test subjects using the apparatus 10 (operated at the same three peak wavelengths described above) and three commercial diode lasers with wavelengths of 660 nm, 808 nm, and 904 nm, respectively. The trial included a total of 10 adult subjects (4 males, 6 females) ranging in age from 22 to 63 years old. The mean age was 30.9 years old, and the median age was 24.5 years old. A total of 33 teeth were used in a repeated measures design. All teeth were premolars (24 first premolars and 9 second premolars). Site pairings included: 4 subjects with 2 MX premolars and 2 MD premolars (2 matched pairs); 2 subjects with all 4 MX premolars (2 matched pairs); 1 subject with 3 mandibular premolars (1 matched pair); 2 subjects with 2 MD premolars (unmatched); and 1 subject with a single premolar. At the subject level, all 10 subjects showed positive responses to Subject Instrument 10.

[0081] Non-responders 25％ 50％ 100％ 150％ 200％ 660nm 23 5 4 1 0 0 808nm 24 7 2 0 0 0 904nm 7 5 13 3 2 3 Subject Instrument 10 3 3 7 9 2 9

[0082] Table 2: EPT increase achieved in 33 teeth.

[0083] As shown in Table 2 above, at the site level, the response rate was 30 / 33 (91%), with an increase in EPT score of at least 25%. For the actual EPT score change and the percentage change from baseline, Subject Instrument 10 was superior to all 3 lasers. The study consisted of 132 experimental runs (33 teeth x 4 light sources). The total number of events causing discomfort was 29. None of these events were caused by Subject Instrument 10, which was proven not to cause any discomfort or sensation to any subject. The discomfort events mostly occurred with the 808nm and 904nm lasers, were consistent in the same tooth in the same person, and were more common in women than in men.

[0084] When performing PBM analgesia (or other therapy), an emitter of a suitable visible red wavelength (such as 635 nm or 685 nm) can be energized simultaneously with the active emitter, but at a relatively low intensity, to provide a visible indication of proper operation of the instrument 10. Regarding intensity, the controller 30 is configured to control the light source 20 to deliver light to the target tissue at an intensity suitable for achieving PBM action. When transillumination of soft or hard tissue using visible red and near-infrared light for clinical examination purposes is performed, the controller 30 can also control the light source in a desired manner to illuminate the site.

[0085] refer to Figure 7, the controller 30 can selectively control each emitter 28a...28n, individually or in combination with other emitters, to perform therapeutic operations. It should be understood from the table that turning on multiple emitters simultaneously can be used to enhance therapy or perform simultaneous functions. For example, to perform the first preferred analgesia mode (PBM Analgesia 1, which has the greatest analgesic effect), the controller 30 will turn on the 950nm, 860nm and 770nm emitters (for the reasons described above). The second analgesia mode (PBM Analgesia 2, which has a moderate analgesic effect) is performed by the controller turning on both the 950nm and 860nm emitters. To perform PBM Analgesia 3 (the lowest analgesic effect), the controller 30 will only turn on the 950nm emitter. Examples of PBM operating modes:

[0086] Four indicative applications in clinical dental practice are described in detail below. For each of the four cases, the emitter tip 22, 22' has a terminal effective diameter of 8 mm, providing an area of ​​0.50 square centimeters. To provide illumination with light in contact mode, the emitter tip 22, 22' is positioned against the target tooth or oral soft tissue and held stationary by hand using low pressure. A disposable transparent cannula covers the tip to prevent contamination by saliva or other fluids. In the following examples, the dispersion of light from the emitter tip 22, 22' has a maximum angle of 10 degrees. In these examples, the irradiance used for analgesia is approximately 10 joules per square centimeter (although as stated in the previous paragraph, the irradiance for the 950 nm wavelength can be greater than that for lower wavelengths, for example, by turning on multiple 950 nm emitters, depending on the treatment mode). The controller 30 is configured to operate the emitters 28a to 28e in a pulsed mode with a frequency of 50 Hz and a duty cycle of less than 100%. According to the embodiments described herein, the duty cycle can be set to 25% or 50%. As previously discussed, a lower duty cycle is beneficial in minimizing heating of the light emitters 28a to 28e during operation and preventing heat buildup in teeth or tissues that may be severely discolored or heavily stained, respectively. A lower duty cycle option of 25% may be used when the target tooth or site is discolored or stained, respectively. For example, a 25% duty cycle may be used for patients with dark teeth / mucosa / skin. Avoiding the use of continuous wave mode and ultra-pulsed mode prevents excessive heating of superficial areas and deep tissue locations, respectively, to ensure that the irradiation procedure will be free of thermal effects and, therefore, will be painless for the patient. It will be understood that duty cycles other than 25% and 50% may be used depending on the desired application and individual patient circumstances.

[0087] With a total optical power of 1.0 Watt delivered by the emitting tip 22, 22' for each wavelength, the effective power delivered to the tissue at a 25% or 50% duty cycle is 0.25 Watt or 0.5 Watt for each wavelength, so that a fluence of 10 joules per square centimeter can be achieved for each site or tooth in a suitably convenient exposure time of 20 seconds (at 25% duty cycle) or 10 seconds (at 50% duty cycle).

[0088] In the first application, before scaling with a manually operated or powered scaling device to remove calcified deposits, the tooth and adjacent soft tissue are treated with instruments 10, 10' to reduce discomfort during the procedure by raising the threshold at which nociceptors in the dental pulp and soft tissue will react to external stimuli. Each tooth sensitive to compressed air from a dental triple syringe is treated prior to the procedure using PBM analgesia 2, with light directed toward the pulp through an area of ​​exposed, sensitive dentin. Gum tissue is treated using PBM analgesia 3, with the emitting tip 22, 22' slowly moved at a speed of 1 to 2 mm / second to cover the area where the scaler will be used.

[0089] In a second application, before starting to remove decayed tooth structure using a non-invasive restorative technique (a technique initially promoted by the World Health Organization to provide dental care in developing countries without access to complex dental treatment, but later developed into a more widely applicable temporary therapeutic restoration adopted by the American Academy of Pediatric Dentistry) using manual instruments, a tooth is treated with a device using PBM analgesia 1 to reduce the sensation that occurs when the vital, internal, healthy dentin of the tooth is reached during the cavity removal process. If discomfort occurs during cavity removal, a further dose can be applied through the overlying bone and soft tissue to reach the pulp. The tooth with the prepared cavity is then treated a second time using instruments 10, 10' using the same setup, so that the procedure of irrigating the cavity and placing the filling material can be performed with minimal discomfort. At the end of the procedure, when the filling has been placed and the bite has been adjusted, the tooth is treated a final time using PBM analgesia 3 to reduce the possibility of post-operative discomfort. In this setup, 950nm provides the PBM effect. In addition, visible light from other emitters in the device can be used to help cure, solidify, or harden the selected restorative material.

[0090] In yet another application, the injection site of a mandibular block injection is treated with PBM analgesia 3 immediately prior to administering the injection to reduce the pain of the needle penetrating the mucosal soft tissue.

[0091] In a further application, the area on the tooth to which the clamp will be fixed is caused by compression of the tooth itself and displacement of the adjacent gingival soft tissue. The clamp is then used to stabilize the dental rubber dam prior to restorative or endodontic dental surgery. Alternatively, a clamping device can also be used to firmly attach the intraoral component of the laser dental drill to the tooth surface, allowing the tooth to be treated. Immediately before the clamp is placed, the tooth to be clamped is treated using PBM analgesia 2, with light being directed through the crown to the pulp. If the tooth already has a large restoration, such as a full crown, PBM analgesia 1 is used, with light applied through the overlying bone and soft tissue to reach the pulp. The gingival tissue is treated using PBM analgesia 3, with the tip moving slowly at a speed of 1mm / second to 2mm / second to cover the area where the clamp will compress the gingival tissue.

[0092] In yet another application, the invention can be used before, during, and / or after surgery. Figure 7 One or a combination of the various PBM analgesia or therapy modes shown in the present invention can be used to advantageously irradiate an intraoral or extraoral area, for example, to enhance perfusion, reduce inflammation, reduce swelling, relieve postoperative pain, and promote healing, hard / soft tissue regeneration and bone integration with implants.

[0093] While the present invention has been described in the context of providing PBM therapy to humans, the invention is not limited thereto and embodiments extend to providing and using appropriately configured apparatus as methods for use with animals as described herein.

[0094] Various advantages arise from one or more of the aforementioned embodiments, including but not limited to:

[0095] By using LEDs at optimized wavelengths ranging from 615nm to 1100nm, robust activation of key PBM targets located in cellular mitochondria is ensured;

[0096] Provide a universally applicable, simple instrument that reduces or eliminates the need for topical or injectable anesthetics in healthcare settings, cosmetic procedures, home settings, and veterinary care;

[0097] Available as a standalone instrument or as a transmitter attachment that removably couples to existing equipment such as a dental curing light, dental chair, medical or dental laser system, or power injection device;

[0098] Allows light to be delivered along or away from the long axis of the device, including at right angles, thereby enabling delivery to the mouth and other difficult-to-access body areas;

[0099] Provide a lightweight, handheld and portable instrument that has a simpler and more robust design than existing PBM devices;

[0100] Provides an instrument suitable for addressing infection control concerns, as the entire device can be easily enclosed in a disposable sheath and the surface can be wiped with a cleaning / disinfecting product for decontamination;

[0101] Provide general-purpose instruments suitable for use with humans and non-human animals;

[0102] It is suitable for a range of different applications, including use in healthcare settings, cosmetic surgery, home environments and veterinary care due to features including variable modes of motion, portability, compactness, lightweight body and use of battery power.

[0103] In the present specification, the word "comprising" is to be understood in its "open" sense, i.e. the sense of "including", and is therefore not limited to its "closed" sense, i.e. the sense of "consisting only of". Corresponding meanings are to be ascribed to the corresponding words "comprise", "comprised" and "comprises" where they appear.

[0104] The previous description is provided in relation to several embodiments that may have common properties and features. It should be understood that one or more features of any one embodiment may be combined with one or more features of other embodiments. In addition, any single feature or combination of features in any one embodiment may constitute an additional embodiment.

[0105] Furthermore, the foregoing describes only some embodiments of the present invention, and changes, modifications, additions and / or variations may be made thereto without departing from the scope and spirit of the disclosed embodiments, which are intended to be illustrative rather than restrictive.

[0106] Furthermore, while the present invention has been described in conjunction with what are presently considered to be the most practical and preferred embodiments, it should be understood that the present invention is not limited to the disclosed embodiments, but rather is intended to encompass various modifications and equivalent arrangements within the spirit and scope of the present invention. Furthermore, the various embodiments described above may be implemented in conjunction with other embodiments; for example, aspects of one embodiment may be combined with aspects of another embodiment to implement additional embodiments. Furthermore, each individual feature or component of any given assembly may constitute an additional embodiment.

Claims

1. A dental instrument comprising: a main body including a light emitting head; as well as A light source for emitting light through the emitting portion of the light emitting head, the light source being configured to simultaneously emit light at multiple peak wavelengths to perform photobiomodulation (PBM) therapy in the patient's mouth to assist in dental surgery, and wherein the multiple peak wavelengths fall within a spectral range of 615nm to 1100nm. 2 . The dental instrument of claim 1 , wherein the light source is configured to simultaneously emit light at three different wavelengths within the spectral range.

3. The dental instrument of claim 2, wherein for PBM analgesia, a first wavelength of the three different wavelengths is near infrared falling within the range of approximately 900 nm to 1000 nm. The dental instrument of claim 3 , wherein the range is approximately 920 nm to 980 nm.

5. The dental instrument of claim 3 or claim 4, wherein a second of the different wavelengths is near infrared falling within the range of approximately 800 nm to 910 nm.

6. The dental instrument of claim 5, wherein the second of the different wavelengths falls within the range of approximately 820 nm to 880 nm.

7. The dental instrument of any one of claims 5 or 6, wherein a third of the different wavelengths is visible red or near infrared falling within the range of approximately 615 nm to 820 nm.

8. The dental instrument according to any one of claims 2 to 7, wherein the light source is controlled such that the first wavelength has a greater intensity than light emitted at other wavelengths.

9. The dental instrument of any preceding claim, wherein the light source comprises a LED broadband emitter.

10. The dental instrument of any one of claims 1 to 8, wherein the light source comprises a plurality of LEDs configured to emit light at respective peak wavelengths.

11. The dental instrument of any preceding claim, further comprising a controller configured to selectively control at least one of a pulse frequency and a pulse energy of the light source sufficient to produce dental analgesia.

12. A dental instrument according to any of the preceding claims, wherein the light source is further configured to emit light at a wavelength in the visible and / or red spectrum for performing one or more additional dental functions selected from the group consisting of: white light inspection; near infrared (NIR) transillumination; fluorescence calibration; light curing; photocoagulation and photodynamic therapy.

13. A dental instrument according to any preceding claim, wherein an outer surface of the light emitting head is sealable for preventing ingress of matter present in the patient's oral cavity.

14. The dental instrument of any preceding claim, wherein the light source is configured to emit light through a tip of the head.

15. The dental instrument of any one of the preceding claims, wherein the body comprises a handle, and wherein the light emitting head is connected to the body via an elongated neck such that the head and at least a portion of the neck are configured for insertion into a patient's mouth.

16. The dental instrument of claim 15, wherein at least a portion of the neck and / or light emitting head is curved or otherwise has a longitudinal axis that is offset relative to the longitudinal axis of the handle, thereby allowing the light emitting head to access a posterior region of the oral cavity.

17. The dental instrument of claim 16, wherein the light source is integrated into at least one of the head and neck of the instrument, and wherein the head / neck is configured to be removably coupled to the body via an electrical coupling, thereby allowing the light source to be powered and controlled.

18. The dental instrument of claim 15 or 16, wherein the light source is integrated into the body, and wherein optical fibers within the neck and head act as light guides for transmitting the emitted light through and out of the head.

19. The dental instrument of claim 18, wherein the light source comprises a cluster of emitters, and wherein one or more lenses are positioned in front of the light source for collimating the light.

20. A dental instrument according to any preceding claim when dependent on claim 11, wherein the controller is configured to set a duty cycle for the emitted light.

21. The dental instrument of claim 20, wherein the duty cycle is set to less than 100%.

22. The dental instrument of claim 21, wherein the duty cycle is set to less than 60%.

23. The dental instrument of claim 22, wherein the duty cycle is set to 50% or less.

24. A dental instrument according to any one of claims 20 to 23, wherein the duty cycle is set by a user of the instrument.

25. The dental instrument of any one of claims 20 to 24, wherein the controller operates the light source in a pulsed mode.

26. The dental instrument of claim 25, wherein pulsing is achieved by chopping a continuous beam emitted by the light source.

27. The dental instrument of any one of the preceding claims, wherein the emitting portion of the head has a 2 to 0.8cm 2 The effective diameter between.

28. The dental instrument of claim 27, wherein the dispersion of light emitted from the emitting portion of the head has a maximum angle of about 10 degrees.

29. The dental instrument of any one of the preceding claims, wherein the light source is controlled so that the irradiance for achieving analgesia is between about 8 and 12 joules / cm 2 between.

30. A detachable photobiomodulation (PBM) tip for a handheld dental device having a power source and a controller, the detachable PBM tip comprising: an elongated body having a first end and a second end, the second end configured to be electrically and physically coupled to a body of a handheld dental curing device; a light source for emitting light through the emitting portion of the light emitting head, the light source being configured to simultaneously emit light at a plurality of peak wavelengths to perform photobiomodulation (PBM) therapy within the patient's oral cavity in conjunction with a dental procedure, and The plurality of peak wavelengths fall within a spectral range of 615 nm to 1100 nm.

31. The PBM tip of claim 30, wherein the light sources are configured to simultaneously emit light as claimed in any one of claims 2 to 8.

32. An apparatus configured to perform photobiomodulation (PBM) therapy, comprising: a main body including a light emitting head; as well as A light source for emitting light through the emitting portion of the light emitting head, the light source being configured to simultaneously emit light at multiple peak wavelengths for photobiomodulation (PBM) therapy, and wherein the multiple peak wavelengths fall within a spectral range of 615 nm to 1100 nm.

33. The apparatus of claim 32, wherein the light sources are configured to simultaneously emit light as claimed in any one of claims 2 to 8.

34. An instrument according to any one of claims 32 to 33, wherein the head is connected to the body via a neck, and wherein a portion of the neck and / or head is curved or otherwise has a longitudinal axis that is offset relative to the longitudinal axis of the handle.

35. A photobiomodulation (PBM) system comprising: An apparatus according to any one of claims 1 to 29 or 32 to 34; A remote controller is configured to wirelessly communicate with the instrument controller for remotely controlling the instrument controller.

36. The photobiomodulation system of claim 35, wherein the remote controller is configured to cause the instrument controller to perform PBM according to a patient-specific program.

37. The photobiomodulation system of claim 35 or claim 36, wherein the remote controller comprises a portable smart device.

38. The photobiomodulation system of any one of claims 35 to 37, wherein the remote controller is configured to communicate with the instrument controller via the Internet.

39. A dental instrument configured to perform photobiomodulation (PBM) therapy, comprising: a main body including a light emitting head; as well as a light source for emitting light through an emitting portion of the light emitting head, the light source being configured to emit light at one or more wavelengths in a spectral range of 615 nm to 1100 nm to perform photobiomodulation (PBM) therapy within the patient's oral cavity in conjunction with a dental procedure, and wherein the head is connected to the body via a neck, and wherein a portion of the neck and / or the head is curved or otherwise has a longitudinal axis that is offset relative to a longitudinal axis of the handle, thereby allowing easy access to the oral cavity.

40. A method of performing clinical surgery on a human patient or animal using the apparatus or system according to any one of claims 1 to 39, wherein the light source is used to illuminate a site on the mucous membrane or skin of the human patient / animal prior to administering a local anesthetic solution using an injection device to reduce discomfort associated with the injection.

41. A method of performing clinical surgery on a human patient or animal using an apparatus according to any one of claims 1 to 39, wherein the light source is used to illuminate a site on the mucous membrane or skin of the human patient / animal to achieve analgesia; increase comfort during the surgery and / or induce an anti-inflammatory effect to control conditions such as mucositis.

42. A method of using an instrument according to any one of claims 1 to 39, wherein the light source is used to illuminate a joint or muscle, whether from the outside or inside of the mouth, to achieve at least one of the following: causing analgesia to improve patient comfort during collaborative surgery; relieving spasm; causing an anti-inflammatory effect to control conditions such as temporomandibular joint dysfunction (TMD), muscle fatigue, myositis or arthritis.

43. A method of using an instrument according to any one of claims 1 to 39, wherein the light source is used to illuminate facial muscles and / or masticatory muscles to achieve at least one of the following: causing analgesia, improving patient comfort during collaborative surgery, improving mouth opening, relieving spasm and causing anti-inflammatory effects and symptoms associated with temporomandibular joint dysfunction (TMD), bruxism or masticatory myositis in animals.

44. A method of using an apparatus according to any one of claims 1 to 39, wherein the light source is used to illuminate a site to achieve at least one of: enhancing perfusion; reducing inflammation; reducing swelling; reducing postoperative pain; and promoting healing, hard / soft tissue regeneration and / or bone integration with an implant.

45. A method of causing analgesia; Providing an apparatus or system according to any one of claims 1 to 39; The light source is controlled to illuminate a site on a mucous membrane or skin of a human patient or animal, and wherein the light source is controlled such that the irradiance for achieving analgesia is between about 8 and 12 joules / cm 2 between.

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