Instruments and corresponding procedures for performing photobiomodulation therapy

Abstract

The embodiment relates to a device configured to perform photobiomodulation (PBM) therapy. The device comprises a main body having a light-emitting head and a light source for emitting light through the light-emitting portion of the light-emitting head. The light source is configured to emit light simultaneously at multiple peak wavelengths in order to perform photobiomodulation (PBM) therapy, and the multiple peak wavelengths are within the spectral range of 615 nm to 1100 nm.

Description

Technical Field

[0001] The present invention relates to an apparatus and method for performing photobiomodulation (PBM) therapy. More specifically, embodiments relate to, but are not limited to, a handheld device configured to produce a PBM dental analgesic effect in a patient's oral cavity in connection with a dental procedure.

Background Art

[0002] In clinical practice, there are numerous procedures that are uncomfortable for patients and require the injection of local anesthetics to be performed safely and effectively. Injection procedures are often accompanied by strong fear and anxiety. Similar concerns apply when using a lancet on the skin, administering an injection (such as a vaccine), or placing an intravenous line. All of these are painful and may induce anxiety.

[0003] Other examples include dental procedures such as interdental wedges, orthodontic separators, placement of dental dams, as well as oral surgical procedures such as scaling of teeth, filling of teeth, dental injections, and frenectomy or tooth extraction for the treatment of ankyloglossia.

[0004] Similarly, similar concerns regarding discomfort associated with penetration of the skin or mucosa exist in cosmetic procedures such as tattoos, tattoo removal, body piercing insertion, hair removal using lasers or intense pulsed light, hair removal using electrolysis, injection of fillers or botulinum toxin, and skin pricking. Finally, in a home environment, there are numerous uncomfortable self-administered procedures, including hair removal by plucking or waxing on the skin.

[0005] Techniques related to the adjustment of reaction thresholds and induction of analgesic effects using visible red and near-infrared diode lasers and Nd:YAG lasers have been reported in the literature for over 25 years. The application of diode laser devices has been widely popularized in the fields of physical therapy, veterinary medicine, and general medicine, and has also been adopted to some extent in dental treatment.

[0006] Patent document US2009 / 0082759 (Pryor et al.) discloses a laser device for reducing pain and inflammation caused by skin injections. Enumerated uses of the device enumerated in this application include cosmetic injections such as Botox or skin fillers, mesotherapy, and immunization. According to Pryor et al., the laser application is provided by either an optical wand or a flexible light-emitting pad / bandage optically coupled to the optical fiber of a surgical diode laser system (i.e., in the form of a conventional mains-powered surgical diode laser mounted on a desktop control panel). The optical wand may incorporate rolling massage balls that facilitate rolling and kneading motions that may increase blood circulation during laser irradiation.

[0007] A significant drawback of the device described by Pryor et al. is that the wand and pad design is only suitable for topical / skin application. Not only is the wand design unsuitable for intraoral application, but the rollerball can easily trap dirt, dead skin cells, dandruff, and skin microorganisms within its enclosure, potentially transferring them from patient to patient if not disassembled and cleaned after each use.

[0008] Focusing specifically on the dental field, WO2022 / 060800 (Cyberdontics USA Inc.) describes an automated system for laser analgesia associated with drilling teeth with a robotically controlled dental drill. The laser operates for one or more cycles as needed to prevent or reduce discomfort caused by the mechanical drilling process. However, Cyberdontics' application makes no explanation whatsoever as to how the dental drill and laser must be configured to achieve the claimed benefits. In fact, the patent specification does not provide any details about the configuration of the laser, drill, or housing. [Overview of the project] [Problems that the invention aims to solve]

[0009] It would be advantageous to provide a device that induces PBM therapy on both skin and mucous membranes for use in a variety of applications, including dental procedures, medical facilities, cosmetic procedures, home environments, and veterinary care. Furthermore, it would be advantageous if the device could be used without requiring a separate high-power laser light source. [Means for solving the problem]

[0010] Summary of the Invention According to a first aspect of the present invention, a dental instrument is provided comprising: a main body equipped with a light-emitting head; and a light source for emitting light through the light-emitting portion of the light-emitting head, configured to simultaneously emit light at multiple peak wavelengths in order to perform photobiomodulation (PBM) therapy in the oral cavity of a patient in conjunction with dental procedures, wherein the multiple peak wavelengths are within the spectral range of 615 nm to 1100 nm.

[0011] In one embodiment, the light source is configured to simultaneously emit light of three distinct wavelengths within a spectral range. To perform PBM analgesia, the first of the three distinct wavelengths is near-infrared, in the range of about 900 nm to 1000 nm. The range is preferably about 920 nm to 980 nm. One of the second of the distinct wavelengths is also near-infrared, preferably in the range of about 800 nm to 910 nm, and more preferably in the range of about 820 nm to 860 nm. One of the third of the distinct wavelengths is either visible red or near-infrared, preferably in the range of about 615 nm to 820 nm.

[0012] For pain relief, it is preferable to control the light source so that the intensity of the first wavelength is greater than that of the light emitted at other wavelengths.

[0013] In one embodiment, the light source includes an LED broadband emitter.

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

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

[0016] In one embodiment, the light source is further configured to emit light at wavelengths in the visible and / or red spectrum to perform one or more additional dental functions selected from the group including white light examination, near-infrared (NIR) transmitted illumination, fluorescence examination, photocuring, photocoagulation, and photodynamic therapy.

[0017] In one embodiment, the outer surface of the light-emitting head can be sealed to prevent the entry of substances present in the patient's oral cavity.

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

[0019] In one embodiment, the body includes a handle, and the light-emitting head is connected to the body via an elongated neck, with at least a portion of the head and neck configured to be inserted into the patient's oral cavity. At least a portion of the neck and / or light-emitting head is curved or has a longitudinal axis offset with respect to the longitudinal axis of the handle, thereby allowing the light-emitting head to access the posterior region of the oral cavity. The light source is incorporated into at least one of the head and neck of the instrument, and the head / neck is configured to be detachably connected to the body via an electrical coupling, thereby enabling power supply and control of the light source. Alternatively, the light source may be incorporated into the body, and optical fibers in the neck and head may function as optical guides for transmitting the emitted light through the head to the outside. The light source includes a group of emitters, and one or more lenses may be positioned in front of the light source to collimate the light.

[0020] The controller may be configured to set the duty cycle of the emitted light, which may be set by the user of the device.

[0021] The controller may be configured to operate the light source(s) in pulse mode. The pulsing may be achieved by chopping a continuous wave beam emitted from the light source(s).

[0022] In one embodiment, the effective diameter of the light emitting portion of the head is about 0.2 cm 2 ~0.8 cm 2 The divergence of the light emitted from the light emitting portion of the head may be at most about 10 degrees.

[0023] In one embodiment, the light source is controlled such that the irradiance for causing an analgesic effect is about 8 - 12 joules / cm 2 Thereby controlled.

[0024] According to a second aspect, there is provided a detachable photobiomodulation (PBM) chip for a handheld dental device having a power source and a controller, the detachable PBM chip being an elongated body having a first end and a second end, the second end being configured to be electrically and physically connected to the body of the handheld dental treatment device, the elongated body, and a light source for emitting light through the light emitting portion of the light emitting head, the light source being configured to emit light simultaneously at a plurality of peak wavelengths for performing photobiomodulation (PBM) therapy in a patient's oral cavity during a dental procedure, the plurality of peak wavelengths being within a spectral range of 615 nm to 1100 nm.

[0025] According to a third aspect, there is provided an instrument configured to perform photobiomodulation (PBM) therapy, the instrument comprising a body having a light emitting head and a light source for emitting light through the light emitting portion of the light emitting head, the light source being configured to emit light simultaneously at a plurality of peak wavelengths for performing photobiomodulation (PBM) therapy, the plurality of peak wavelengths being within a spectral range of 615 nm to 1100 nm. The head may be connected to the body via a neck, and a part of the neck and / or the head may be curved or have a longitudinal axis offset with respect to the longitudinal axis of the handle.

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

[0027] According to a fifth aspect, an instrument configured to perform photobiomodulation (PBM) therapy is provided, the dental instrument comprising a body having a light-emitting head, and a light source for emitting light through the light-emitting portion of the light-emitting head, the light source being configured to emit light at one or more wavelengths within a spectral range of 615 nm to 1100 nm for performing photobiomodulation (PBM) therapy in a patient's oral cavity in connection with a dental procedure, the head being connected to the body via a neck, with a part of the neck and / or the head being curved or having a longitudinal axis offset with respect to the longitudinal axis of the handle, thereby enabling easy access to locations within the oral cavity, and the light source.

[0028] According to a sixth aspect, a method of performing a clinical procedure on a human patient or an animal using an instrument according to any of the preceding instruments, wherein, in use, the light source is used to irradiate a site on the mucosa or skin prior to administering a local anesthetic solution using an injection device, and a method for reducing discomfort associated with the injection is provided.

[0029] According to a seventh aspect, a method of performing a clinical procedure on a human patient or an animal using an instrument according to any of the preceding aspects, wherein, in use, the light source is used to irradiate a site on the mucosa or skin, and a method for achieving an analgesic effect and improving comfort during the procedure is provided.

[0030] According to an eighth aspect, a method of performing a cosmetic procedure on a patient or an animal using an instrument according to any of the preceding aspects, wherein, in use, the light source is used to irradiate a site on the mucosa or skin, and a method for achieving an analgesic effect, improving comfort during the procedure, and / or inducing an anti-inflammatory effect to manage conditions such as mucositis is provided.

[0031] According to the ninth aspect, a method is provided for performing a clinical procedure on a human patient or animal using an instrument described in any of the preceding aspects, wherein, during use, a light source is used to irradiate the temporomandibular joint from the outside or inside of the oral cavity, and the method is such as to achieve at least one of the following: analgesia, improvement of comfort during dental procedures, relief of spasms, induction of anti-inflammatory effects for managing conditions such as temporomandibular joint disorder (TMD) or arthritis.

[0032] According to the tenth embodiment, a method is provided for performing a clinical procedure on a human patient or animal using an instrument described in any of the preceding embodiments, wherein, during use, the light source is used to irradiate a joint or muscle, and the method is such as to achieve at least one of the following: analgesia, improvement of comfort during dental procedures, relief of spasms, induction of anti-inflammatory effects for managing conditions such as arthritis, muscle fatigue or myositis.

[0033] According to the 11th embodiment, a method is provided for performing a clinical procedure on a human patient or animal using the apparatus described in any of the preceding embodiments, wherein, during use, a light source is used to irradiate the facial muscles and / or masticatory muscles, and the method is such as to achieve at least one of the following: analgesia, improvement of functional comfort, improvement of mouth opening, relief of spasms, and anti-inflammatory effects and induction of symptoms associated with temporomandibular joint disorder (TMD), bruxism, or masticatory myositis in animals.

[0034] Embodiments of the present invention are described herein by reference only to the accompanying drawings. [Brief explanation of the drawing]

[0035] [Figure 1] This is a schematic diagram (exploded view) of a medical device relating to one embodiment of the present invention. [Figure 2] This is a schematic diagram showing an example of an emitter array implemented by the device shown in Figure 1. [Figure 3] Figure 1 is a schematic diagram showing an example of the configuration of the LED and lens in the device. [Figure 4]This is a schematic diagram of a therapeutic device according to another embodiment of the present invention. [Figure 5] Figure 4 is an exploded view of the emitter attachment head. [Figure 6] Figure 4 shows the various connecting ends of the device. [Figure 7] This table shows the emitter wavelength and the corresponding operating mode. [Figure 8] This graph shows EPT scores from a randomized, single-blind clinical trial. [Modes for carrying out the invention]

[0036] Embodiments of the present invention described herein relate to instruments and methods for performing PBM therapy, which include reducing injection pain and establishing analgesia by inducing a PBM analgesic effect, thereby enabling a number of procedures to be performed without the need for pre-injection of local anesthetic solution, local anesthetic cream, or other means to control pain of associated procedures. It is understood that the therapy can be performed before, during, and / or after the procedure, as needed. Embodiments also extend to accelerating postoperative healing, such as after tooth extraction or after debridement of periodontal pockets, and reducing inflammation or swelling. Other uses include promoting hard tissue formation to seal the dental pulp, or promoting hard tissue formation to enhance osseointegration between bone and implant.

[0037] The embodiments are particularly suited to dental (especially intraoral) applications, and therefore the detailed embodiments described below are described in such a context. However, it is understood that the embodiments are extendable to other applications, including use in medical facilities, cosmetic procedures, home settings, and veterinary care. For example, the device may be configured to irradiate joints to achieve analgesic effects, improve comfort during movement and exercise, relieve spasms, and induce anti-inflammatory effects and symptoms associated with arthritis. The joint may be, for example, the temporomandibular joint (irradiated from the outside or inside of the oral cavity), which can alleviate symptoms associated with temporomandibular joint disorder (TMD). In yet another non-limiting embodiment, the device may be used to irradiate facial and / or masticatory muscles to treat bruxism, masticatory myositis, fatigue, etc.

[0038] Device Configuration Referring to Figure 1, a first embodiment of a therapeutic device according to the present invention is shown. The therapeutic device 10 is lightweight and designed to be suitable for both skin and oral applications. More specifically, the therapeutic device 10 comprises a body 12 having a handle portion 14. According to the illustrated embodiment, the body 12 is formed of any suitable material such as high-strength plastic or stainless steel. The housing 14a within the handle portion 14 is appropriately configured to house an integrated power source (not shown), such as a rechargeable battery.

[0039] The treatment device 10 further comprises a head 16 connected to a body 12 via an elongated neck 18. According to the illustrated embodiment, at least a portion of the head 16 and the neck 18 is configured to be inserted into the patient's oral cavity in order to produce a PBM analgesic effect, in particular, as will be described in detail in the following paragraphs. In this regard, as shown in the figure, a portion of the neck 18 may be curved or have a longitudinal axis offset with respect to the longitudinal axis of the handle portion 14, thereby allowing the head 16 to advantageously access the posterior region of the oral cavity and other areas of the body that are difficult to access. In one embodiment, the head 16 can be rotatably connected to the neck 18 so that the light-emitting portion of the head 16 (described in the following paragraphs) can be directed to hard-to-reach locations. In another embodiment, both the head 16 and the neck 18 may be rotatable and connected to the body 12. In yet another embodiment, the neck 18 may be formed of a flexible material that can be bent into a desired shape.

[0040] The treatment device 10 also incorporates a light source 20 configured to emit light through a light-emitting section 22 of the head 16. In the illustrated embodiment, the light-emitting section 22 is shown located on the tip of the head 16 (and therefore referred to hereafter as the "light-emitting tip"), but it is understood that, depending on the desired implementation, the light-emitting section may be located in other areas of the head or body. The effective diameter of the light-emitting tip 22 is in the range of approximately 6 to 10 mm, which results in a diameter of approximately 0.2 cm 2 ~0.8cm 2 It provides an effective light-emitting area. The dispersion of light from the light-emitting chip 22 is generally in the range of 6 to 10 mm. Optical, mechanical, and / or digital mechanisms (not shown) may be implemented separately or together to control the selection, shape, diameter, and / or spot of the beam, thereby reducing or increasing the effective light emission.

[0041] The light source 20 shown in Figure 1 (as depicted in more detail in Figure 3) is incorporated into the nose portion 13 of the main body 12 and comprises at least one photoemitter 28 configured to emit light for performing PBM therapy.

[0042] In a preferred embodiment of the present invention, the light source is configured to emit light simultaneously at multiple wavelengths (more preferably three wavelengths) to achieve PBM analgesia or other PBM therapy, which will be described in more detail in the following paragraphs.

[0043] According to the embodiment of Figure 1, the neck 18 and head 16 are configured together to act as an optical guide for transmitting light emitted from the emitter 28 through the neck 18 to the outside of the light-emitting chip 22. This may be achieved using any suitable optical guide medium, including the use of one or more optical fibers for optical transmission. As schematically shown in the exploded view of Figure 3, one or more lenses 34 (in this case, two lenses 34a, 34b) are positioned in front of the emitter 28 to collimate the emitted light. In another embodiment, the light source 20 may be configured so that the light intensity decreases with respect to the distance from the end of the instrument to the target tissue.

[0044] As shown in Figure 2, the exemplary arrangement of emitters 28a...28n (hereinafter referred to as "emitter arrangement 29") may advantageously enable the instrument 10 to perform not only PBM therapy (including PBM analgesic effect) but also additional procedures including, but not limited to, white light examination, near-infrared (NIR) transmitted illumination, fluorescence examination of caries and tooth-colored fillings, photocuring, photocoagulation, and photodynamic therapy.

[0045] Depending on the desired implementation, emitters 28a to 28m may be arranged in a configuration different from that shown in Figure 2. Table 1 below shows the wavelengths of each emitter. [Table 1]

[0046] According to Table 1, emitters 28a-28e are provided primarily to induce analgesic effects. It will be understood that to achieve higher irradiance values, two or more emitters emitting at the same wavelength may be provided (and as is evident from the table above).

[0047] In alternative embodiments to those shown in the figure, the light source 20 may comprise a single broadband emitter configured to emit light simultaneously at two or more distinct wavelengths (e.g., Thorlabs model MBB2D1 from Thorlabs: https: / / www.thorlabs.com / thorproduct.cfm?partnumber=MBB2D1). Depending on the desired implementation, the light source may comprise a combination of a broadband emitter and individual wavelength emitters.

[0048] A controller 30 is also provided (in this case, housed within the main unit 12) and is configured to selectively control the on / off state of the emitters 28. The controller 30 may be further configured to control the intensity of light emitted from each emitter 28. According to the embodiments described herein, the controller 30 controls the irradiance depending on the therapy, ranging from 2 to 12 joules / cm². 2 The emitter 28 is configured to be powered within a certain range. It is understood that the relative power and energy output may be controlled (depending on the device and emitter configuration) by selectively turning on / off emitters 28 of the same wavelength, or by controlling the power supplied to each emitter 28.

[0049] The emitter 28 may be pulse-controlled by the controller 30 to minimize heating during operation and prevent heat buildup in teeth or tissues that may be discolored or stained. It is also understood that the emitter 28 may be pulse-controlled depending on the desired implementation / treatment. According to the illustrated embodiment, pulse control is achieved by modulating the pulse width, and the emitter operates in chopped continuous wave mode. A particular advantage of this embodiment is that a low duty cycle can be set to implement various operating modes (e.g., 25% or 50%), which will be described in detail in the following paragraphs.

[0050] The controller 30 may also be configured to communicate with one or more sensors 31 located on or near the head 16 in order to determine the effectiveness of the instrument and to ensure patient safety. For example, a temperature sensor (e.g., an infrared temperature sensor) and a contact sensor (e.g., a light sensor, or 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 predetermined maximum value, the controller 30 may be programmed to turn off one or more emitters 28 for safety reasons. For specific applications (e.g., when used to irradiate a mucous membrane or skin site before injection), the controller 30 may be programmed to turn on a selected emitter only if the contact sensor indicates that the instrument is in contact with the mucous membrane / skin.

[0051] The sensor may also be used to determine the therapeutic effect. For example, as mentioned in the previous paragraph, the device 10 may be used to treat temporomandibular joint dysfunction (TMD). In this case, the temperature recorded by the temperature sensor may be used to indicate the temperature rise when the surrounding muscles relax and local blood flow increases when the device is applied to the joint being treated, thereby indicating that the treatment is working effectively.

[0052] The controller 30 may include a microprocessor or the like that executes program code (stored in memory) for implementing a procedure according to a predetermined program (selectively controlling the operation, intensity, and duration of the emitter). It is understood that the device may be provided with an interface that can communicate with the controller 30 in order for the operator to switch programs or to manually control the operation of the emitter 28. In one embodiment, the device controller 30 may be further connected by wired or wireless (e.g., via the Internet using Bluetooth, Wi-Fi, and appropriate wireless communication protocols) to a remote monitor and / or controller (e.g., implemented as a mobile phone device, tablet, PC, etc.) to remotely view and / or change settings.

[0053] According to the embodiment shown in Figure 1, the neck 18 and head 16 are configured to act as optical guides for transmitting light emitted from the emitter array 29 through the neck 18 to the outside of the light-emitting chip 22. This may be achieved using any suitable optical guide medium, including the use of one or more optical fibers for optical transmission. As schematically shown in the exploded view of Figure 3, one or more lenses 34 (in this case, two lenses 34a, 34b) are positioned in front of the emitter array 29 to collimate the emitted light. In another embodiment, the light source may be configured so that the light intensity decreases with distance from the edge of the instrument to the target tissue.

[0054] Figures 4 to 6 show a treatment device 10' according to an alternative embodiment of the present invention. In this embodiment, the device 10' has a pen-shaped body 12', and most 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 be the same as that of the embodiment shown in Figure 1). A notable difference between the illustrated embodiments is that the light source 20' is located in the neck 18' and / or head 16' instead of being incorporated into the device body. Similar to the first embodiment, the light source 20' comprises either an emitter array, a broadband emitter, or a combination of the two.

[0055] In this case, one or more emitters 28' are incorporated into a multi-component LED panel 55 located behind the light-emitting chip 22' of the head 16' (this is most clearly shown in Figure 5). More specifically, the multi-component LED panel 55 contains multiple PBM emitters 28 in a single package and, depending on the application, can selectively emit light of different wavelengths (including simultaneous emission at the three separate peaks described above) from the emitters through a lens 56. The lens 56 is mounted, for example, by screw threads. The LED panel 55 is secured in place with fixing screws 57 and is attached to a thermal conductive pad 54 and an aluminum heatsink 53. The body 12' of the fixture 10' also functions as a heatsink.

[0056] As shown in the figure, the head 16' has an angled design to facilitate delivery of PBM therapy (including analgesic effects) within the oral cavity. In the illustrated embodiment, the head 16' and neck 18' are detachable from the body 12' and take the form of a replaceable emitter attachment 17. More specifically, the emitter attachment 17 is connected to the body 12' via a suitable coupling 40. The coupling 40 may be, for example, a snap-in, plug-in, or screw-in coupling, which is advantageous as it allows power supply and control of the light source in the emitter attachment 17 by a battery / controller located within the body 12'. Figure 6 shows the coupling ends of the instrument body and the emitter attachment. As shown in the figure, the attachment-side end includes a concentric ring 41 that supplies power to the emitter and, if necessary, provides a channel for feedback from the light source (for example, if a laser diode is used as the light source, a return channel to the controller may be used to control wavelength deviation). An example of a coupling suitable for use in the present invention is described in U.S. Patent No. 9,693,846 (Kerr Corporation), the contents of which are incorporated herein by reference. The detachable coupling 40 also allows the main body 12' to power and control a series of different emitter attachments 17a to 17n (i.e., each having an emitter and / or emitter array including different wavelength combinations covering the range described above in the first embodiment, thereby enabling the device to perform the same operation).

[0057] In yet another alternative embodiment (not shown), the emitter attachment 17 can be coupled to an existing instrument such as a dental chair, a medical laser or dental laser system, or an electric syringe. In this case, the existing instrument can be used to power and control the emitter attachment 17 for performing the functions described above. In certain embodiments, the emitter attachment 17 of the present invention may be configured to be electrically and physically coupled to a dental curing lamp designed for photopolymerization of dental materials (such as those described in U.S. Patent No. 9,693,846). Such a curing lamp includes a standard attachment incorporating a rechargeable battery, a control circuit, and an LED emitting visible blue light (typically in the 460-480 nm wavelength range). These lights are typically made specifically as standalone devices placed on a bench or integrated into a dental chair. Thus, by providing an emitter attachment 17 having a light source configured to emit light in the wavelength range of 615 nm to 1100 nm, the curing lamp can additionally operate as an instrument for performing PBM analgesia (and any of the other aforementioned operations).

[0058] According to any of the embodiments described above, the outer surfaces of the instruments 10, 10' may be sealed to prevent contamination in order to allow for quick and easy cleaning and disinfection (for example, without openings or joints through which liquids, etc., can pass). In one embodiment, a disposable sleeve can be fitted to the instrument during use to prevent cross-contamination, and the head 16' can be removed for sterilization. Furthermore, a window made of a suitable transparent or translucent material such as sapphire can be detachably positioned inside or outside the sleeve, above the lens 56 or light-emitting chip 22, and this window can be removed and sterilized after exposure or exchanged between patients.

[0059] When PBM therapy is performed outside of dentistry, it is understood that the light source can be incorporated directly into the main unit or via any suitable connector (i.e., one that omits the elongated neck portion which is particularly advantageous for intraoral application).

[0060] PBM mode In photoblinding (PBM), the effects of light are understood to be based on the regulation of several metabolic, biochemical, and photophysical processes within cells. The analgesic effect of PBM is primarily caused by light interacting with nerves and pain receptors. Effects reported to induce analgesia by PBM include decreased excitability and suppression of electrical responses of pain receptors, decreased hyperpolarization of nerve cell membranes and suppression of nerve responses, prolongation of complex action potential latency leading to nerve conduction block, and impairment of intraneuronal axonal transport. However, a more fundamental challenge is optimizing the wavelength for analgesia.

[0061] Regarding penetration, to achieve maximum effectiveness, it is necessary to select a light wavelength that allows for deep penetration into the target tissue and is absorbed by the target molecule. It is well known that strong penetration depends highly on the wavelength of light transmitted through tissue. Tissues have an "optical window" in the range of approximately 500–1200 nm. Because there are no major absorbers in this spectral region, light irradiated onto the surface penetrates deep into the tissue and diffuses widely, especially when longer wavelengths are used. Depending on the wavelength selection and the characteristics of the target tissue, light can penetrate to a depth of up to 30 mm.

[0062] To ensure a potent PBM (photodynamic body) effect for pain relief, it is necessary to select wavelengths that correspond to the known absorption spectra of the target molecule's chromophore (light-absorbing molecule), because the peaks in the absorption spectrum represent regions of high absorption efficiency.

[0063] The inventors have discovered that wavelengths within the range of 615 nm to 1100 nm are optimal for PBM (Physical-to-Body) effects. More specifically, the inventors have found that emitting light with two or more peak wavelengths within this spectrum simultaneously yields superior therapeutic effects compared to conventional single-wavelength techniques. Preferably, emitting light with three peak wavelengths within the 615 nm to 1100 nm spectral range has been demonstrated to produce effective results for various PBM therapies, particularly PBM analgesia.

[0064] To induce analgesic effects, the light dose (total irradiance delivered by device 10) must be 8-12 joules / cm². 2 It is preferable that the light source be configured to focus on higher near-infrared wavelengths where the relative power distribution has been shown to be most effective in inducing analgesic effects. For example, a configuration with 8 joules from a 950 nm emitter and 2 joules each from 860 nm and 770 nm emitters (thus a total ray dose of 12 joules) is possible.

[0065] At least one of the wavelengths is near-infrared, preferably in the spectral range of about 900 nm to 1000 nm, more preferably in the range of about 920 nm to 980 nm. A second wavelength is also near-infrared, preferably in the spectral range of about 800 nm to 910 nm, more preferably in the range of about 820 nm to 880 nm. Depending on the application, a third wavelength is either near-infrared or visible infrared, in the range of about 615 nm to 820 nm. For PBM analgesia, the third wavelength may be directed towards the higher end of the range (e.g., about 770 nm), but for other PBM therapies such as muscle relaxation, it may be more desirable to focus the power distribution on one of the lower wavelengths (e.g., about 700 nm). Extensive testing has shown that emitting light with wavelengths within the above ranges simultaneously yields effective PBM that penetrates both soft and hard tissues, including bone, tooth enamel, and dentin.

[0066] The present invention will be further described below with reference to non-limiting embodiments.

[0067] Example: PBM for pain relief As part of the study, the inventors conducted a randomized, single-blind clinical trial. A total of 13 healthy young adult subjects were exposed to PBM therapy using both the control device 10 (operating at three peak wavelengths of approximately 770 nm, 860 nm, and 950 nm) and three commercially available diode lasers with wavelengths of 660 nm, 808 nm, and 904 nm, respectively. Subjects' pulp responsiveness was quantified using electropulp testing (EPT), and a response threshold was established. All four light sources were operated with the same spot size of 8 mm, and energy density and total irradiance were matched. A total of 12 joules of light dose was delivered to each subject's premolar from the buccal side, then from the lingual side, and EPT assessments were repeated at 1, 2, 5, and 20 minutes to evaluate the analgesic effect of PBM (an increase in EPT score indicates analgesia). The study used a repeated measures design, and the same tooth was evaluated with all four light sources, but on different days. Figure 8 shows a graph illustrating the EPT scores for each light source. As can be seen, the analgesic effect of device 10 was superior to that of the other individual laser light sources. Compared to the other light sources, the increase in the EPT score at 2 minutes was larger, and the duration of the increase in the EPT score was longer. The analgesic effect of device 10 stabilized at 5 minutes and decreased at approximately 20 minutes. Other in vitro studies have demonstrated that broadband irradiation from device 10 penetrates not only discolored teeth but also teeth with normal color, reaching the pulp. Furthermore, subjects did not experience any heat or discomfort from device 10.

[0068] Another clinical trial conducted by the inventors included responder analysis (showing the degree of change) and data on discomfort caused by the light source. Again, the test involved testing the control device 10 (operating at the same three peak wavelengths mentioned above) against three commercially available diode lasers with wavelengths of 660 nm, 808 nm, and 904 nm, respectively. This test included a total of 10 adult subjects (4 males and 6 females) aged between 22 and 63 years. The mean age was 30.9 years, and the median age was 24.5 years. A total of 33 teeth were used in the repeated measures design. All teeth were premolars (24 first premolars and 9 second premolars). Site pairing included four subjects with two MX premolars and two MD premolars (two paired sets), two subjects with a total of four MX premolars (two paired sets), one subject with three mandibular premolars (one paired set), two subjects with two MD premolars (no paired sets), and one subject with one premolar. At the subject level, a total of 10 subjects showed a positive response to the target device 10. [Table 2]

[0069] As shown in Table 2 above, the response rate at the site level was 30 / 33 (91%), and the EPT score increased by at least 25%. The control device 10 outperformed all three lasers in both actual EPT score changes and percentage changes from baseline. This study consisted of 132 experiments (33 teeth x 4 light sources). There were a total of 29 events causing discomfort. Of these events, none were caused by the control device 10, demonstrating that it does not cause discomfort or sensation in any subject. Discomfort events occurred primarily with the 808nm and 904nm lasers, consistently in the same person and on the same tooth, and were more common in women than in men.

[0070] An emitter with a suitable visible red wavelength, such as 635 nm or 685 nm, can power an active emitter simultaneously while performing PBM analgesia (or other treatment), but can also power it at a relatively low intensity to provide a visible indication of the proper operation of the instrument 10. In terms of intensity, the controller 30 is configured to control the light source 20 to deliver light to the target tissue at an intensity suitable for producing a PBM effect. The controller 30 may also control the light source to illuminate a site in a desired manner when visible red and near-infrared light is used for transmitted illumination of soft or hard tissue for clinical examination purposes.

[0071] Referring to the table in Figure 7, the controller 30 can selectively control each emitter 28a...28n individually or in combination with other emitters to perform therapeutic actions. From this table, it can be understood that by turning on multiple emitters simultaneously, the therapy can be enhanced or simultaneous functions can be performed. For example, to perform the first preferred analgesic mode (PBM analgesia 1 with maximum analgesic effect), the controller 30 turns on the 950, 860, and 770 nm emitters (for the reasons described above). The second analgesic mode (PBM analgesia 2 with moderate analgesic effect) is performed by the controller turning on both the 950 nm and 860 nm emitters. When performing PBM analgesia 3 (lowest analgesic effect), the controller 30 turns on only the 950 nm emitter.

[0072] Examples of PBM operating modes: The following describes in detail four representative applications in clinical dental practice. In each of these four situations, the light-emitting tips 22, 22' have an effective end diameter of 8 mm and provide an area of ​​0.50 square centimeters. To irradiate with light in contact mode, the light-emitting tips 22, 22' are positioned on the target tooth or oral soft tissue and held in place by hand with light pressure. To prevent contamination by saliva or other fluids, a disposable clear sleeve is placed over the tip. In the following examples, the light dispersion from the light-emitting tips 22, 22' is a maximum of 10 degrees. In these examples, the irradiance used for analgesia is approximately 10 joules per square centimeter (however, as mentioned in the previous paragraph, depending on the treatment mode, the irradiance at the 950 nm wavelength may be higher than that at lower wavelengths by turning on multiple 950 nm emitters). The controller 30 is configured to operate emitters 28a-28e in pulse mode at a frequency of 50 Hz and a duty cycle of less than 100%. According to the embodiments described herein, the duty cycle may be set to either 25% or 50%. As previously stated, a lower duty cycle has the advantage of minimizing heating of the emitters 28a-28e during operation, preventing heat buildup in teeth or tissues that may be severely discolored or highly pigmented, respectively. A lower duty cycle of 25% may be selected and used when the target teeth or areas are discolored or pigmented, respectively. For example, a 25% duty cycle may be used for patients with dark teeth / mucosa / skin. By avoiding the use of continuous wave mode and superpulse mode, overheating of surface areas and deep tissues is prevented, respectively, ensuring that the irradiation procedure is not affected by heat and therefore painless to the patient. It is understood that duty cycles other than 25% and 50% may be used depending on the desired application and the individual patient's condition.

[0073] If the total optical output delivered through the light-emitting chips 22, 22' for each wavelength is 1.0 watt, the effective output supplied to the tissue at a 25% or 50% duty cycle is either 0.25 watts or 0.5 watts for each wavelength. Therefore, for each site or tooth, a fluence of 10 joules per square centimeter can be achieved with a suitable and convenient irradiation time of 20 seconds (for a 25% duty cycle) or 10 seconds (for a 50% duty cycle).

[0074] In its first application, before initiating scaling of the tooth to remove calcified deposits using a manual or electric scaling device, the tooth and adjacent soft tissue are treated with instrument 10, 10' to reduce discomfort during the procedure by raising the threshold at which pain receptors in the pulp and soft tissue respond to external stimuli. Each tooth, sensitive to compressed air from a dental triple syringe, is treated pre-procedure with PBM analgesia 2, illuminating the pulp through the exposed sensitive dentin area. The gingival tissue is treated with PBM analgesia 3, gradually moving the light-emitting tip 22, 22' at a speed of 1-2 mm per second to cover the area where the scaler will be used.

[0075] In the second application, before removing carious tooth structure using handheld instruments with a non-traumatic restorative technique (a technique initially proposed by the World Health Organization to deliver dental treatment to developing countries where advanced dental care is unavailable, but later developed into a more widely applicable temporary restorative method adopted by the American Academy of Pediatric Dentistry), the tooth is treated with the device using PBM Analgesia 1 to reduce sensation that occurs when accessing the healthy inner dentin, which is the vital tooth structure of the tooth, during the caries removal process. If discomfort occurs during caries removal, further doses can be applied through the upper bone and soft tissue to reach the pulp. Next, the tooth with the formed cavity is treated a second time using instruments 10 and 10' in the same setting, allowing the cavity cleaning and filling material placement procedures to be performed with minimal discomfort. After placing the filling material and adjusting the occlusion at the end of the procedure, the tooth is finally treated with PBM Analgesia 3 to reduce the probability of postoperative discomfort. In this setting, 950nm provides the PBM effect. Additionally, visible light from other emitters within the device can be used to assist in the curing, solidification, or hardening of the selected restorative material.

[0076] In another application, the injection site for inferior alveolar nerve block is treated immediately before injection with PBM analgesia 3 using instrument 10, 10' to reduce pain as the needle penetrates the mucous membrane and soft tissue.

[0077] Another application is the area where the clamp is fixed to the tooth due to the compression of the tooth itself and the displacement of the adjacent gingival soft tissue. Next, the clamp is used to stabilize the dental dam before restorative or endodontic treatment. Alternatively, the clamp device can also be used to firmly attach the intraoral component of a laser dental drill to the tooth surface, thereby treating the tooth. The clamped tooth is treated by irradiating the pulp through the crown with light using PBM Analgesia 2 immediately before clamping. If the tooth already has a large restoration such as a full crown, PBM Analgesia 1 is used to irradiate the pulp through the upper layers of bone and soft tissue. The gingival tissue is treated with PBM Analgesia 3, moving the tip slowly at 1-2 mm / second to cover the area where the clamp compresses the gingival tissue.

[0078] In another application, intraoral or extraoral sites can be irradiated with one or a combination of the various PBM analgesic or therapeutic modes shown in Figure 7 before, during, and / or after treatment, which are advantageous for, for example, enhancing perfusion, reducing inflammation, reducing swelling, relieving postoperative pain, and promoting healing, hard / soft tissue regeneration, and osseointegration with implants.

[0079] Although the present invention has been described above in the context of providing PBM therapy to humans, the invention is not limited thereto, and embodiments are also applicable to providing and using appropriately configured devices as described herein for animals.

[0080] Through one or more of the embodiments described above, various advantages can be obtained, including, but not limited to, the following: By using LEDs with optimized wavelengths in the 615-1100nm range, we ensure the potent activation of the primary target of PBM in cellular mitochondria; To provide a generally applicable, simple device that can reduce or eliminate the need for local or injectable anesthetics in medical facilities, cosmetic procedures, home environments, and veterinary care; To enable provision as a standalone device, or as an emitter attachment that can be detachably connected to existing devices such as dental curing lamps, dental chairs, medical or dental laser systems, or electric syringes; To enable light delivery to hard-to-reach areas of the oral cavity and other body regions by allowing light delivery along or away from the longitudinal axis of the device, including perpendicular angles; To provide a lightweight, handheld, and portable device with a simpler and more robust design than existing PBM devices; The entire device can be easily housed in a disposable sheath, and the surface can be wiped with detergent / disinfectant products to remove contamination, thus providing an instrument suitable for infection control measures; To provide general-purpose instruments suitable for use on humans and non-human animals; Features such as variable operating modes, portability, compactness, lightweight design, and battery power enable its application to a wide variety of uses, including medical facilities, cosmetic procedures, home environments, and veterinary care.

[0081] In this specification, the term “to include” should be understood in its “open” sense, i.e., “to contain,” and not limited to its “closed” sense, i.e., “to consist only of.” The corresponding meanings shall be attributed to the occurrence of the corresponding words “contain,” “included,” and “containing.”

[0082] The above description provides with respect to several embodiments that may share common characteristics and features. It is understood that one or more features of any one embodiment may be combined with one or more features of other embodiments. Furthermore, any single feature or combination of features in any embodiment may constitute additional embodiments.

[0083] Furthermore, the above describes only some embodiments of the present invention, and modifications, alterations, additions, and / or changes can be made without departing from the scope and spirit of the disclosed embodiments, and the embodiments are illustrative and not limiting.

[0084] Furthermore, while the present invention has been described in relation to what is currently considered the most practical and preferred embodiment, it should be understood that the present invention is not limited to the disclosed embodiments, but rather is intended to encompass a variety of modifications and equivalent configurations that fall within the spirit and scope of the invention. Also, the various embodiments described above can be implemented in conjunction with other embodiments; for example, aspects of one embodiment can be combined with aspects of another embodiment to realize yet another embodiment. Furthermore, each independent feature or component of any assembly can constitute an additional embodiment.

Claims

1. Dental instruments, The main unit has a light-emitting head, A light source for emitting light through the light-emitting portion of the light-emitting head, wherein the light source is configured to emit light simultaneously at multiple peak wavelengths for performing photobiomodulation (PBM) therapy in the oral cavity of a patient in conjunction with dental procedures, and the multiple peak wavelengths are within the spectral range of 615 nm to 1100 nm. A dental instrument equipped with [a specific feature / feature].

2. The dental instrument according to claim 1, wherein the light source is configured to emit light simultaneously at three separate wavelengths within the spectral range.

3. The dental instrument according to claim 2, wherein, in order to perform PBM analgesia, the first of the three individual wavelengths is near-infrared in the range of approximately 900 nm to 1000 nm.

4. The dental instrument according to claim 3, wherein the range is approximately 920 nm to 980 nm.

5. The dental instrument according to claim 3 or claim 4, wherein the second wavelength among the individual wavelengths is near-infrared in the range of approximately 800 nm to 910 nm.

6. The dental instrument according to claim 5, wherein the second wavelength among the individual wavelengths is in the range of approximately 820 nm to 880 nm.

7. The dental instrument according to claim 5 or claim 6, wherein the third wavelength among the individual wavelengths is either visible red or near-infrared in 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 intensity of the first wavelength is greater than that of light emitted at other wavelengths.

9. The dental instrument according to any one of the prior claims, wherein the light source includes an LED broadband emitter.

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

11. The dental instrument according to any one of the prior claims, further comprising a controller configured to selectively control at least one of the pulse frequency and pulse energy of the light source sufficient to produce a dental analgesic effect.

12. The dental instrument according to any one of the prior claims, wherein the light source is further configured to emit light at wavelengths in the visible spectrum and / or the red spectrum for performing one or more additional dental functions selected from the group including white light examination, near-infrared (NIR) transmitted illumination, fluorescence examination, photocuring, photocoagulation, and photodynamic therapy.

13. The dental instrument according to any one of the prior claims, wherein the outer surface of the light-emitting head can be sealed to prevent the entry of substances present in the patient's oral cavity.

14. The dental instrument according to any one of the prior claims, wherein the light source is configured to emit light through the tip of the head.

15. The dental instrument according to any one of the prior claims, wherein the main body is equipped with a handle, and the light-emitting head is connected to the main body via an elongated neck, so that at least a portion of the head and the neck can be inserted into the oral cavity of a patient.

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

17. The dental instrument according to claim 16, wherein the light source is incorporated into at least one of the head and the neck of the instrument, and the head / neck is configured to be detachably connected to the main body via an electrical coupling, thereby supplying power to the light source and enabling control of the light source.

18. The dental instrument according to claim 15 or 16, wherein the light source is incorporated into the main body, and the optical fiber(s) in the neck and head function as an optical guide for transmitting the emitted light to the outside through the head.

19. The dental instrument according to claim 18, wherein the light source comprises a group of emitters, and one or more lenses are positioned in front of the light source to collimate the light.

20. The dental instrument according to any one of the prior claims as dependent on claim 11, wherein the controller is configured to set the duty cycle of the emitted light.

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

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

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

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

25. The dental instrument according to any one of claims 20 to 24, wherein the controller operates the light source(s) in pulse mode.

26. The dental instrument according to claim 25, wherein the pulsation is achieved by chopping a continuous wave beam emitted from the light source(s).

27. The effective diameter of the light-emitting part of the head is approximately 0.2 cm. ２ ~0.8cm ２ A dental instrument according to any one of the prior claims.

28. The dental instrument according to claim 27, wherein the dispersion of light emitted from the light-emitting part of the head is at a maximum angle of approximately 10 degrees.

29. The irradiance required to produce an analgesic effect is approximately 8–12 joules / cm². ２ The dental instrument according to any one of the prior claims, wherein the light source is controlled to such an extent.

30. A removable photobiomodulation (PBM) chip for a handheld dental device having a power supply and controller, wherein the removable PBM chip is An elongated body having a first end and a second end, wherein the second end is configured to be electrically and physically connected to the body of the handheld dental hardening device, A light source for emitting light through the light-emitting portion of the light-emitting head, wherein the light source is configured to simultaneously emit light at multiple peak wavelengths in order to perform photobiomodulation (PBM) therapy in the oral cavity of a patient in conjunction with dental procedures, and the multiple peak wavelengths are within the spectral range of 615 nm to 1100 nm, A PBM chip equipped with this feature.

31. The PBM chip according to claim 30, wherein the light source is configured to simultaneously emit the light described in any one of claims 2 to 8.

32. A device configured to perform photobiomodulation (PBM) therapy, comprising a main body equipped with a light-emitting head, A light source for emitting light through the light-emitting portion of the light-emitting head, wherein the light source is configured to simultaneously emit light at multiple peak wavelengths for performing photobiomodulation (PBM) therapy, and the multiple peak wavelengths are within the spectral range of 615 nm to 1100 nm. An instrument equipped with the necessary features.

33. The apparatus according to claim 32, wherein the light source is configured to simultaneously emit the light described in any one of claims 2 to 8.

34. The apparatus according to claim 32 or 33, wherein the head is connected to the main body via a neck, and the neck and / or a part of the head is curved or has a longitudinal axis offset with respect to the longitudinal axis of the handle.

35. A photobiomodulation (PBM) system, The apparatus according to any one of claims 1 to 29 or 32 to 34, A remote controller configured to communicate wirelessly with the device controller for remote control of the aforementioned device, A PBM system equipped with this feature.

36. The photobiomodulation system according to claim 35, wherein the remote controller is configured to cause the instrument controller to perform PBM according to an individual patient program.

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

38. The photobiomodulation system according to 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, The main unit has a light-emitting head, A light source for emitting light through the light-emitting portion of the light-emitting head, wherein the light source is configured to emit light at one or more wavelengths within the spectral range of 615 nm to 1100 nm for performing photobiomodulation (PBM) therapy in the oral cavity of a patient in conjunction with dental procedures, and the head is connected to the body via a neck, and the neck and / or a portion of the head, which is curved or has a longitudinal axis offset with respect to the longitudinal axis of the handle, allows easy access to locations in the oral cavity. A dental instrument equipped with [a specific feature / feature].

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

41. A method of performing a clinical procedure 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 irradiate a site on the mucous membrane or skin of the human patient or animal in order to achieve an analgesic effect, to improve comfort during the procedure, and / or to induce an anti-inflammatory effect in order to manage a condition such as mucositis.

42. A method of using the apparatus according to any one of claims 1 to 39, wherein the light source is used to irradiate a joint or muscle from the outside or inside of the oral cavity in order to achieve at least one of the following: to induce an analgesic effect, to improve the patient's comfort during an associated procedure, to relieve spasms, or to induce an anti-inflammatory effect to manage a condition such as temporomandibular joint disorder (TMD), muscle fatigue, myositis, or arthritis.

43. A method of using the device according to any one of claims 1 to 39, wherein the light source is used to irradiate the facial muscles and / or masticatory muscles in order to achieve at least one of the following: to induce an analgesic effect, to improve the patient's comfort during an associated procedure, to improve mouth opening, to relieve spasms, and to induce symptoms and anti-inflammatory effects associated with temporomandibular joint disorder (TMD), bruxism, or masticatory myositis in animals.

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

45. A method for inducing analgesic effects, Providing the apparatus or system described in any one of claims 1 to 39, Controlling a light source to irradiate a mucous membrane or skin area of ​​a human patient or animal, wherein the irradiance to produce an analgesic effect is approximately 8 to 12 joules / cm². ２ Controlling the light source to achieve this, Methods that include...

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