Phototherapy devices and methods

The present disclosure relates to a phototherapy device that can deliver light to tissues to activate photoactive agents that have been applied to the tissues or that are included within a fiber optic tip member of the device which may be coupled to a light source using a sleeve. The present disclosure also relates to methods of phototherapy using the phototherapy device such as anti-bactericidal treatment, anti-fungal treatment, anti-parasitic treatment, anti-viral treatment.

BACKGROUND OF THE DISCLOSURE

Phototherapy has recently been recognized as having a wide range of applications in both the medical, cosmetic and dental fields for use in surgeries, therapies and examinations. Phototherapy is commonly used as a means of disinfecting target sites. Phototherapeutic techniques have been applied to kill bacteria in the oral cavity and for whitening teeth. Phototherapy is also used to promote wound healing, skin rejuvenation and to treat skin conditions such as acne. These techniques typically rely on the use of laser light sources. Lasers, however, can be very dangerous, particularly in clinical settings, and are typically expensive, large, cumbersome and complicated to use. Accordingly, there is a need for an improved phototherapy device.

SUMMARY OF THE DISCLOSURE

The present disclosure provides devices and methods useful in phototherapy including phototherapy device members and phototherapy kits that can utilize any light source, not necessarily lasers, but still provide effective treatment. The use of common clinical light sources such as LEDs or halogen bulbs may be more desirable for phototherapy than lasers due to the cost and other disadvantages associated with lasers. Thereby the phototherapy devices, device members, kits and methods of the present disclosure may simplify, complement and/or improve phototherapy regimens, such as for periodontal treatment, wound healing, collagen modulation, anti-bactericidal treatment, anti-fungal treatment, anti-parasitic treatment, anti-viral treatment, or anti-inflammatory treatment.

In certain embodiments, the present disclosure relates to a phototherapy device that can deliver light to the periodontal regions of the mouth to activate photoactive reagents that have been applied in periodontal pockets, e.g. between the gum and the tooth. The phototherapy device may comprise a fiber optic tip suitable for delivering light from a light source, such as a light emitting diode (LED), to periodontal regions of the mouth. The tip may be coupled to the light source using a sleeve that may help to maintain optical alignment. The present disclosure also relates to methods of treating and preventing periodontal disease using the phototherapy device to kill bacteria in a periodontal treatment region.

For purposes of clarity, and not by way of limitation, the devices, kits and methods of the present disclosure are described herein in the context of providing phototherapy for treatment or prevention of periodontal disease. However, it will be appreciated that the principles described herein may be adapted to a wide range of applications, such as for example in post extractive sockets, endodontic treatment in dental root canals, teeth whitening treatment, wound healing, key hole surgery/treatment or any antimicrobial or therapeutic application in hard to reach places of the body where a fiber optic may be useful. Uses for devices, methods and kits of the present disclosure also include for collagen modulation, anti-bactericidal treatment, anti-fungal treatment, anti-parasitic treatment, anti-viral treatment, or anti-inflammatory treatment. For example, the principles of this disclosure may be applied to phototherapeutic antibacterial treatment or tooth whitening between teeth. In addition, the principles may be applied to phototherapeutics in connection with orthodontics. More generally, the devices and methods described herein may be employed in any phototherapeutic treatment that requires the application of focused light, and in some cases, the application of light in generally closed and hard to reach sites of the mouth or other parts of the body. Accordingly, the devices, kits and methods disclosed herein may be performed instead of or in addition to conventional treatment methods, including subgingival debridement, supergingival debridement, scaling/root planning, wound healing, skin disorder treatment, topical and systemic treatments.

One aspect of the present disclosure provides a phototherapeutic device member. In some embodiments, the phototherapeutic device member comprises a flexible fiber optic tip member and an elastic tubular connector sleeve for mechanically coupling the flexible tip member to a light source. The flexible fiber optic tip member functions as a waveguide and transmits light along its length. The flexible fiber optic tip member may have a polymer core for transmitting light. The flexible fiber optic tip member may be made of any suitable material which can transmit light and has appropriate optical properties, such as a glass. The flexible fiber optic tip member can include a proximal end and a distal end, wherein the diameter of the proximal end is greater than the diameter of the distal end, and wherein the proximal end is curved to cause light entering the flexible tip member through the proximal end to converge. The elastic tubular connecting sleeve may include a proximal end having an opening and a distal end having an opening, the proximal end configured to be stretched and mechanically coupled to the light source. In use, the flexible fiber optic tip may be partially disposed within the elastic tubular connecting sleeve such that the distal end of the flexible fiber optic tip member extends distally through the opening in the distal end of the sleeve, and the proximal end of the flexible fiber optic tip member is disposed within the sleeve and between the proximal and distal ends of the sleeve, thereby positioning the flexible fiber optic tip member near the light source. The sleeve is configured to receive the flexible fiber optic tip such that the distal end of the flexible fiber optic tip member extends distally through the opening in the distal end of the sleeve, and the proximal end of the flexible fiber optic tip member is disposed within the sleeve and between the proximal and distal ends of the sleeve, thereby positioning the flexible fiber optic tip member near the light source.

The flexible fiber optic tip may be unitarily formed. The flexible fiber optic tip may be formed by moulding. Optionally, the flexible fiber optic tip is cut from a single block of polymer material. In some embodiments, the flexible fiber optic tip member has a rough surface formed such as by grating. The flexible fiber optic tip member may include a rough outer surface configured to allow a portion of light transmitted through the core to diffuse out through the outer surface. The flexible fiber optic tip can include an optical axis extending through the center of the polymer core from the proximal end to the distal end, and wherein light passing through the tip member travels along at least a portion of the optical axis. The polymer core of the flexible fiber optic tip may comprise polycarbonate or polymethymethacrylate. The flexible fiber optic tip may further comprise a photoactive agent which can absorb and emit light.

In some embodiments, an interior surface of the elastic tubular connector sleeve includes a plurality of ribs extending radially inwards (circumferentially) and configured to grip the light source or a catheter. The elastic tubular connector sleeve can be stretched around the light source or catheter and held in place by the ribs. In certain embodiments, the flexible fiber optic tip member is removable from the elastic tubular connector sleeve.

In some embodiments, a proximal region of the flexible fiber optic tip member is substantially conical having a base along the proximal end. The proximal end of the flexible fiber optic tip member may be convex shaped relative to the proximal portion of the flexible fiber optic tip member. A distal region of the tip member may be substantially cylindrical. The length from the proximal end to a distal end of the flexible fiber optic tip member is between about 10 mm and about 30 mm. The length may be much longer than this if a catheter is used. In which case the length of the flexible fiber optic tip member will be as long as the length of the catheter. The diameter at the distal end of the flexible fiber optic tip member is optionally between about 500 micron and about 1500 micron. Further, the diameter can vary along the length of the flexible fiber optic tip member. The diameter of the distal end of the flexible fiber optic tip members can vary according to the use. In certain embodiments, the distal end of the flexible fiber optic tip member may comprise a plurality of bristles, e.g. like brush. This may be useful in applications where debridement may be useful such as cleaning teeth, cleaning wounds, cleaning skin and the like.

In some embodiments, the light source to which the flexible fiber optic tip is coupled includes one or more light emitting diodes. Alternatively, the light source may include a halogen lamp. In some embodiments, the flexible fiber optic tip may be coupled to an end of a catheter.

A second aspect of the present disclosure, provides a device for phototherapy. In some embodiments, the device comprises a light source, a probe member having a flexible fiber optic tip member and an elastic tubular connector sleeve for mechanically coupling the probe member to the light source. The proximal end of the flexible fiber optic tip member may be curved to cause light entering the tip member through the proximal end to converge. The proximal end of the sleeve may be configured to be stretched and mechanically coupled to the light source. Optionally, the tip member is partially disposed within the sleeve and extends distally through a distal opening of the sleeve. The device may be used for treating/preventing periodontitis, in which case a distal end of the flexible fiber optic tip member is sized and/or shaped to be received in periodontal pockets. The device may also be used for treating tissues in hard to reach places, internal tissues and cavities such as through key-hole surgery, in which case the proximal end of the sleeve may be configured to be stretched and mechanically coupled to an end of a catheter. In this case, the flexible fiber optic tip member may extend along the length of the catheter and be attached to a light source at a proximal end of the catheter. A further sleeve according to the present disclosure may be provided for attaching to the light source at the proximal end of the catheter.

The flexible fiber optic tip may be unitarily formed. The flexible fiber optic tip may be formed by moulding. Optionally, the flexible fiber optic tip is cut from a single block of polymer material. In some embodiments, the flexible fiber optic tip member is grated to generate a rough surface. The flexible fiber optic tip member may include a rough outer surface configured to allow a portion of light transmitted through the core to diffuse out through the outer surface. The flexible fiber optic tip can include an optical axis extending through the center of the polymer core from the proximal end to the distal end, and wherein light passing through the tip member travels along a portion of the optical axis. The polymer core of the flexible fiber optic tip may comprise polycarbonate or polymethymethacrylate. The flexible fiber optic tip may further comprise a photoactive agent which can absorb light and emit as energy.

In some embodiments, an interior surface of the elastic tubular connector sleeve includes a plurality of ribs extending radially inwards (circumferentially) and configured to grip the light source. In certain embodiments, the flexible fiber optic tip member is removable from the sleeve.

In some embodiments, a proximal region of the flexible fiber optic tip member is substantially conical having a base along the proximal end. A distal region of the tip member may be substantially cylindrical. The length from the proximal end to a distal end of the flexible fiber optic tip member is between about 10 mm and about 30 mm. The length may be much longer than this if a catheter is used. In which case the length of the flexible fiber optic tip member will be as long as the length of the catheter. The diameter at the distal end of the flexible fiber optic tip member is optionally between about 500 micron and about 1500 micron. Further, the diameter can vary along the length of the flexible fiber optic tip member. The proximal end of the flexible fiber optic tip member may be convex shaped relative to the proximal portion of the flexible fiber optic tip member. Further, the diameter can vary along the length of the flexible fiber optic tip member. The diameter of the distal end of the flexible fiber optic tip members can vary according to the use. In certain embodiments, the distal end of the flexible fiber optic tip member may comprise a plurality of bristles, e.g. like brush. This may be useful in applications where debridement may be useful such as cleaning teeth, cleaning wounds, cleaning skin and the like.

In some embodiments, the device further comprises an actuating mechanism for moving at least the flexible fiber optic tip member relative to a treatment surface. For example, the actuating mechanism may further comprise a motor in communication with the flexible fiber optic tip member to move the flexible fiber optic tip member backwards and forwards across the treatment surface (substantially perpendicular to the optical axis), or to cause the flexible fiber optic tip member to vibrate.

In some embodiments, the light source to which the flexible fiber optic tip is coupled includes one or more light emitting diodes. Alternatively, the light source may include a halogen lamp. In some embodiments, the flexible fiber optic tip may be coupled to an end of a catheter.

Another aspect of the present disclosure provides a method=of treating and/or preventing periodontal disease. In some embodiments, the method comprises attaching to a light source having one or more light-emitting diodes a periodontal probe member, which comprises a flexible fiber optic tip member with a polymer or glass core for transmitting light, and an elastic tubular connector sleeve, for mechanically coupling the flexible tip member to a light source; introducing a composition comprising a photoactivating agent and oxygen-releasing agent into a periodontal treatment region; introducing the flexible fiber optic tip into the periodontal treatment region; and applying light through the flexible fiber optic tip member to activate the photoactivating agent in the periodontal treatment region. By “photoactivating agent” is meant a chemical compound which, when contacted by light irradiation, is capable of absorbing the light. The photoactivating agent readily undergoes photoexcitation and can then transfer its energy to other molecules or emit it as light. The terms “photoactivating agent”, “photoactive agent” and “chromophore” are used herein interchangeably herein.

Another aspect of the present disclosure provides a method for treating wounds. In some embodiments, the method comprises attaching to a light source having one or more light-emitting diodes a probe member, which comprises a flexible fiber optic tip member with a polymer or glass core for transmitting light, and an elastic tubular connector sleeve, for mechanically coupling the flexible tip member to a light source or a catheter; introducing a composition comprising a photoactivating agent and oxygen-releasing agent into a treatment region; introducing the flexible fiber optic tip member into the treatment region; and applying light through the flexible fiber optic tip member to activate the photoactivating agent in the treatment region.

Another aspect of the present disclosure provides a method for antibacterial treatment of a tissue site. In some embodiments, the method comprises attaching to a light source having one or more light-emitting diodes a probe member, which comprises a flexible fiber optic tip member with a polymer or glass core for transmitting light, and an elastic tubular connector sleeve, for mechanically coupling the flexible tip member to a light source or a catheter; introducing a composition comprising a photoactivating agent and an oxygen-releasing agent into a the tissue site; introducing the flexible fiber optic tip member into the tissue site; and applying light through the flexible fiber optic tip member to activate the photoactivating agent in the tissue site. The flexible fiber optic tip may be unitarily formed, such as by moulding. Optionally, the flexible fiber optic tip is cut from a single block of polymer material. In some embodiments, the flexible fiber optic tip member is grated to generate a rough surface. The flexible fiber optic tip member may include a rough outer surface configured to allow a portion of light transmitted through the core to diffuse out through the outer surface. The flexible fiber optic tip can include an optical axis extending through the center of the polymer core from the proximal end to the distal end, and wherein light passing through the tip member travels along a portion of the optical axis. The polymer core of the flexible fiber optic tip may comprise polycarbonate or polymethymethacrylate.

In some embodiments, an interior surface of the elastic tubular connector sleeve includes a plurality of ribs extending radially inwards (circumferentially) and configured to grip the light source or the catheter. In certain embodiments, the flexible fiber optic tip member is removable.

In some embodiments, a proximal region of the flexible fiber optic tip member is substantially conical having a base along the proximal end. The proximal end of the flexible fiber optic tip member may be convex shaped relative to the proximal portion of the flexible fiber optic tip member. A distal region of the tip member may be substantially cylindrical. The length from the proximal end to a distal end of the flexible fiber optic tip member is between about 10 mm and about 30 mm. The length may be much longer than this if a catheter is used. In which case the length of the flexible fiber optic tip member will be as long as the length of the catheter. The diameter at the distal end of the flexible fiber optic tip member is optionally between about 500 micron and about 1500 micron. Further, the diameter can vary along the length of the flexible fiber optic tip member. The diameter of the distal end of the flexible fiber optic tip members can vary according to the use. In certain embodiments, the distal end of the flexible fiber optic tip member may comprise a plurality of bristles, e.g. like brush. This may be useful in applications where debridement may be useful such as cleaning teeth, cleaning wounds, cleaning skin and the like.

The periodontal treatment region can be exposed to the light for a period of less than five minutes, such as between one minute and five minutes. The method may comprise exposing the periodontal treatment region to light for about 1-30 minutes, about 1-25 minutes, about 1-20 minutes, about 1-15 minutes, about 1-10 minutes. The method may be performed over several distinct periodontal treatment regions within the oral cavity. In such cases, each periodontal treatment region exposed to the light for a period of less than five minutes, such as between one minute and five minutes. The light may have a wavelength between about 400 nm and about 800 nm.

The composition may be introduced on a gingiva within the oral cavity, or a portion thereon. The composition may be introduced near at least one tooth, preferably on at least one tooth. The composition may be introduced between a gingiva and a tooth.

The oxygen-releasing agent may be hydrogen peroxide, carbamide peroxide or benzoyl peroxide. The photoactivating agent can be xanthene derivative dye, an azo dye, a biological stain or a carotenoid. Xanthene derivative dyes may be a fluorene dye, a fluorone dye or a rhodole dye. Optionally, the fluorene dye is a pyronine dye, such as pyronine Y or pyronine B, or a rhodamine dye, such as rhodamine B, rhodamine G or rhodamine WT. In some embodiments, the fluorone dye is fluorescein or a fluorescein derivative, such as phloxine B, rose Bengal, merbromine, eosin Y, eosin B or erthrosine B, preferably eosin Y. Optionally, the azo dye is methyl violet, neutral red, para red, amaranth, carmoisine, allura red AC, tartrazine, orange G, ponceau 4R, methyl red or murexide-ammonium purpurate. The biological stain may be saffranin O, basic fuchsin, acid fuchsin, 3,3′ dihexylocarbocyanine iodide, carminic acid or indocyanine green. In some embodiments, the carotenoid is crocetin, a-crocin, zeaxanthine, lycopene, α-carotene, β-carotene, bixin, fucoxanthine, or a mixture of carotenoid compounds, such as saffron red powder, annatto extract or brown algae extract.

Another aspect of the present disclosure provides a method for phototherapeutic treatment, and which differs from the above method in that the flexible fiber optic tip member comprises a photoactive agent in the polymer or glass core. In some embodiments, the method comprises attaching to a light source having one or more light-emitting diodes a probe member, which comprises a flexible fiber optic tip member with a polymer or glass core for transmitting light and a photoactive agent, and an elastic tubular connector sleeve, for mechanically coupling the flexible tip member to a light source; introducing the flexible fiber optic tip member into the treatment region; and applying light through the flexible fiber optic tip member to activate the photoactive agent. When the photoactive agent is activated by the light, the flexible fiber optic tip member may fluoresce and or activate oxygen-releasing agents in the treatment region.

From a yet further aspect, there is provided a kit for phototherapy comprising a plurality of flexible fiber optic tip members, having a polymer or a glass core for transmitting light, the flexible tip member including a proximal end and a distal end, wherein the diameter of the proximal end is greater than the diameter of the distal end, and wherein the proximal end is curved to cause light entering the flexible tip member through the proximal end to converge; and an elastic tubular connector sleeve, for receiving at least a portion of one of the plurality of flexible fiber optic tip members and for mechanically coupling the flexible tip member to a light source, wherein the sleeve includes a proximal end having a first opening and a distal end having a second opening, the proximal end configured to be stretched and mechanically coupled to the light source.

The plurality of flexible fiber optic tip members may have different size and shape distal ends suitable for different applications. The plurality of flexible fiber optic tip members may include a photoactive agent in a polymer matrix. In certain embodiments, the kit further comprises a biophotonic composition comprising a photoactive agent. The composition may optionally include an oxygen-releasing agent.

DETAILED DESCRIPTION

The devices, kits and methods described herein will now be described with reference to certain illustrative embodiments. However, the disclosure is not to be limited to these illustrated embodiments which are provided merely for the purpose of describing the devices, kits and methods of the disclosure and are not to be understood as limiting in anyway.

FIG. 1depicts a phototherapeutic device in accordance with present disclosure. The phototherapeutic device comprises a flexible fiber optic tip member100coupled to a light source300with an elastic tubular connector sleeve200. The flexible fiber optic tip member100will be discussed in greater detail in the descriptions ofFIG. 2A-FIG. 2D. The elastic tubular connector sleeve will be discussed in greater detail in the descriptions ofFIG. 3AandFIG. 3B.

The light source300may be any light source commonly found in a clinical setting, including, for example, light sources for photocuring. In some embodiments, the light source300comprises an elongated cable of a suitable length to permit a dental professional to work in a patient's mouth. Optionally, the light source300provides actinic light. In some embodiments, the light source300comprises light emitting diodes. Alternatively, the light source300may comprise a halogen lamp. In some embodiments, the light source300is configured to provide light at a wavelength that will activate a photoactivating agent. By “actinic light” is meant light energy emitted from a specific light source (e.g., lamp, LED, or laser) and capable of being absorbed by matter (e.g. the photoactivating agent). In a preferred embodiment, the actinic light is visible light. The light source300may provide visible light or ultraviolet light. In some embodiments, the light source300provides visible light having a wavelength between about 400 nm and about 800 nm. Furthermore, the light source300should have a suitable power density. Suitable power density for non-collimated light sources (LED, halogen or plasma lamps) are in the range from about 50 mW/cm2to about 200 mW/cm2, about 30-150 mW/cm2, A light beam from the light source300may travel from the light source to the proximal end110of a flexible fiber optic tip member100along the optical axis190to the distal end120for delivery to a periodontal treatment region. In certain embodiments, the light source300may emit a continuous beam of light or a pulsed beam of light.

The light source300may additionally include a control box attached to a flexible fiber optic waveguide to allow a dental professional to place the free end of the fiber optic waveguide in or near a patient's mouth. The control box of light source300may include a lamp, a transformer and a control board, which allows dental professionals to control variables such as light intensity and voltage. Light source300may be controlled by a foot pedal, which leaves the dental professionals hands free to operate the fiber optic waveguide in addition to any other dental tools. Light source300may also include a time-delay, such that the light transmitted through the fiber optic wave guide stays on after the foot pedal is released.

FIG. 2Adepicts a flexible fiber optic tip member100in accordance with the present disclosure. The flexible fiber optic tip member100has a polymer core along with a proximal end110configured for coupling to the light source300and a distal end120configured for insertion into a periodontal treatment region. The flexible fiber optic tip member100is configured to have a conical portion140proximal to a cylindrical portion150. The conical portion140may have its base at the proximal end110. The conical portion140will be configured to comprise a curved structure130to focus the light transmitted from the light source300into the cylindrical portion150. Further, the flexible fiber optic tip member100is configured such at that light traverses through the polymer core along the optical axis190.

FIG. 2Bdepicts an additional flexible fiber optic tip member100in accordance with the present disclosure. The flexible fiber optic tip member100inFIG. 2Bcomprises a ridge feature160, which may be configured to be disposed in the distal opening250of the elastic tubular connecting sleeve to help the flexible fiber optic tip member100in place near the light source300. The flexible fiber optic tip member100has a polymer core along with a proximal end110configured for coupling to the light source300and a distal end120configured for insertion into a periodontal treatment region. The flexible fiber optic tip member100is configured to have a conical portion140proximal to a cylindrical portion150. The cylindrical portion150can be configured to comprise a ridge160proximal to a flexible portion170which terminates at the distal end120. The distal end120may comprise a rounded tip121. The conical portion140may have its base at the proximal end110. The conical portion140will be configured to comprise a curved structure130to focus the light transmitted from the light source300into the cylindrical portion150. Further, the flexible fiber optic tip member100is configured such at that light traverses through the polymer core along the optical axis190.

FIG. 2Cdepicts a further flexible fiber optic tip member100in accordance with the present disclosure. The flexible fiber optic tip member100inFIG. 2Ccomprises a ridge feature160, which may be configured to be disposed in the distal opening250of the elastic tubular connecting sleeve to help the flexible fiber optic tip member100in place near the light source300. Further the flexible fiber optic tip member100inFIG. 2Ccomprises a narrowing region180, along which the diameter of the cylindrical portion150varies along the length of the cylindrical portion150. The flexible fiber optic tip member100has a polymer core along with a proximal end110configured for coupling to the light source300and a distal end120configured for insertion into a periodontal treatment region. The flexible fiber optic tip member100is configured to have a conical portion140proximal to a cylindrical portion150. The cylindrical portion150can be configured to comprise a ridge160proximal to a flexible portion170which terminates at the distal end120. The flexible portion170may contain a narrowing region180, wherein the diameter of the proximal end of the narrowing region180is greater than the diameter of the distal end for the narrowing region180. The narrowing region180may traverse the entire length for the flexible portion170, running from the ridge160to the distal end120. The conical portion140may have its base at the proximal end110. The conical portion140will be configured to comprise a curved structure130to focus the light transmitted from the light source300into the cylindrical portion150. Further, the flexible fiber optic tip member100is configured such at that light traverses through the polymer core along the optical axis190.

FIG. 2Ddepicts another flexible fiber optic tip member100in accordance with the present disclosure. The flexible fiber optic tip member100inFIG. 2Dcomprises a rough outer surface123and a rough tip122, which allows light traversing through the flexible fiber optic tip member100to diffuse. The flexible fiber optic tip member100has a polymer core along with a proximal end110configured for coupling to the light source300and a distal end120configured for insertion into a periodontal treatment region. The flexible fiber optic tip member100is configured to have a conical portion140proximal to a cylindrical portion150. The cylindrical portion150can be configured to comprise a ridge160proximal to a flexible portion170which terminates at the distal end120. The distal portion of flexible portion170may include a rough outer surface123configured to allow a portion of light transmitted through the flexible portion170to diffuse out through the rough outer surface123. Similarly, the distal end120may comprise a rough tip122configured to allow a portion of light transmitted through the distal end120to diffuse out through the rough tip122. The flexible fiber optic tip member100may be grated to generate the rough outer surface123or the rough tip122. The conical portion140may have its base at the proximal end110. The conical portion140will be configured to comprise a curved structure130to focus the light transmitted from the light source300into the cylindrical portion150. Further, the flexible fiber optic tip member100is configured such at that light traverses through the polymer core along the optical axis190.

Regarding any ofFIG. 2A-2D, the flexible fiber optic tip member100may be unitarily formed. In some embodiments, the flexible fiber optic tip member is cut from a single block of polymer material. In some embodiments, the polymer core includes polycarbonate. In some embodiments, the flexible fiber optic tip member100comprises polymeric materials such as, for example, any of polycarbonate, polystyrene, polyacrylate and polymethylmethacrylate materials. In some embodiments, the flexible fiber optic tip member100comprises glass materials such as, for example, any of quartz, silica glass, borosilicate glass, lead glass, and fluoride glass materials.

The rough outer surface123or rough tip122of the flexible fiber optic tip member100may be generated by any suitable method, including sandpapering and/or grating the surface of the flexible fiber optic tip member100. The rough outer surface123or rough tip122of the flexible fiber optic tip member100may be generated by sandblasting techniques.

In certain embodiments, flexible fiber optic tip member100may be removed from phototherapeutic periodontal device and disposed of, to be replaced by a fresh flexible fiber optic tip member100in order to avoid cross contamination, for example, between different periodontal diseased tissue or between patients. The length of the flexible fiber optic tip member100may be between about 10 mm and about 30 mm. The length of the flexible fiber optic tip member100may be between longer than about 30 mm, and be trimmed to size by the user.

Still referring to any ofFIG. 2A-2D, the curved structure130may be convex relative to the proximal end110. In other words, the curved structure130curves toward from the light source300, which allows the flexible fiber optic tip member100to focus light received from the light source300along the optical axis190for traversal along the cylindrical portion150of the flexible fiber optic tip member100. Any suitable degree of curvature may be used as desired so that light is allowed to propagate and focus into the optical fiber. In some embodiments, the diameter of the proximal end100of the flexible fiber optic tip member is the same size as the diameter of the light source300. In some embodiments, the diameter of the proximal end100of the flexible fiber optic tip member is the greater than the diameter of the light source300, which allows the flexible fiber optic tip member100to prevent any light from escaping. In certain embodiments, the distance between the curved surface130and the light source300may be selected such that light from the light source300is focused into the fiber optic tip member100. For example, the curved surface130may be touching or in minimal contact or in near proximity to the light source300.

Still referring to any ofFIG. 2A-2D, the cylindrical portion150of the flexible fiber optic tip member100may have a diameter of about 0.75-1.0 mm at its proximal end and a diameter of about 0.05-0.2 mm at its distal end120. In some embodiments, the diameter at the distal end120of the flexible fiber optic tip member100is between about 500 micron and about 1500 micron. The cylindrical portion150and/or the flexible portion170of the flexible fiber optic tip member100may be sufficiently flexible so as to allow insertion of the distal end120into small spaces such as periodontal pockets, dental root canals, tooth cavities, oral lesions, and other hard to reach sites. The flexible fiber optic tip member100and, in particular, the distal end120may be configured to deliver and focus light directly to a periodontal treatment region to provide treatment, and/or to activate a photoactivating agent in a composition as will be described below. In certain embodiments, the flexible fiber optic tip member100and, in particular, the distal end120may be configured to disperse light in all directions and from both the distal end120and/or along a portion of the cylindrical portion150or the flexible portion170to aid in treatment. In some embodiments, the dispersal light in all directions is achieved by providing a rough end122or a rough outer surface123, as shown inFIG. 2D.

Still referring to any ofFIG. 2A-2D, the ridge160may be configured to be partially disposed within the distal opening250of the elastic tubular connecting sleeve200. In some embodiments, the diameter of the proximal end of the ridge160is greater than the diameter of the distal opening250of the elastic tubular connecting sleeve200. In some embodiments, the diameter of the distal end of the ridge160is less than the diameter of the distal opening250of the elastic tubular connecting sleeve200. In some embodiments, the diameter of the ridge160may be between 5 mm and 10 mm.

FIG. 3Adepicts the assembly of a phototherapeutic device in accordance with the present disclosure. The proximal end110of the flexible fiber optic tip member100is coupled to the light source300. The distal end120of the flexible fiber optic tip member100passes through the elastic tubular connector sleeve200and extends beyond the distal end220of the elastic tubular connector sleeve200. The proximal end210of the elastic tubular connector sleeve200will extend beyond the proximal end110of the flexible fiber optic tip member100and will couple to the light source300. The elastic tubular connector sleeve200will have one or more flexible ridges230which will allow for attachment to the light source300and will firmly hold the flexible fiber optic tip member100in place. When full assembled, the proximal end110of the flexible fiber optic tip member100will be disposed within the elastic tubular connector sleeve200, such that the proximal end110of the flexible fiber optic tip member100is between the proximal end210and the distal end220of the elastic tubular connector sleeve200.

FIG. 3Bdepicts an elastic tubular connector sleeve200in accordance with the present disclosure. The elastic tubular connector sleeve200comprises a proximal end210, configured for coupling to a light source300, and a distal end220, configured to house the cylindrical portion150of a flexible fiber optic tip member100. The proximal end210comprises a proximal opening240and the distal end220comprises a distal opening250. A light source300will be coupled to the elastic tubular connector sleeve through the proximal opening240. The cylindrical portion150and distal end120of a flexible fiber optic tip will extend through the distal opening250. The tubular connector sleeve comprises one or more flexible ridges230which will allow for attachment to the light source300and may help hold the flexible fiber optic tip member100firmly in place.

The proximal end210of the elastic tubular connector sleeve200is configured for coupling to a light source300, such that the light source300passes through the proximal opening240and is partially disposed within the elastic tubular connector sleeve200. The proximal end210may be elastic, such that the diameter of the proximal opening240can be increased by mechanical stretching. Accordingly, the diameter of the proximal opening240may be the same or smaller than the diameter of the light source300, such that the proximal end210must be stretched to dispose the light source300in the proximal opening240. Alternatively, the proximal end210may be rigid, such that the diameter of the proximal opening240is greater than the diameter of the light source300. In such embodiments, the one or more flexible ridges230keep the light source300partial disposed within the elastic tubular connector sleeve200. In some embodiments, the elastic tubular connector sleeve200has multiple layers, including a rigid outer layer and an elastic inner layer that firmly grasps the light source300.

The distal end220of the elastic tubular connector sleeve200is configured to allow the flexible fiber optic member100to extend through the distal opening250. The distal end220may be configured such that the cylindrical portion150of the flexible fiber optic member100passes through the distal opening250. Alternatively, the distal end220may be configured such that the conical portion140of the flexible fiber optic member100passes through the distal opening250. In further embodiments, the distal end220may be configured such that the ridge160of the flexible fiber optic member100is partially disposed in the distal opening250. In some embodiments, the distal end220is elastic, such that the diameter of distal opening250may be increased by mechanical stretching. In such embodiments, the diameter of the distal opening250may be the same or smaller than the diameter of the conical portion140or the cylindrical portion150of the flexible fiber optic tip member100, such that the distal end220must be stretched to extend flexible fiber optic tip member100through the distal opening250. Alternatively, the distal end220may be rigid, such that the diameter of the distal opening250is greater than the diameter of the conical portion140or the cylindrical portion150of the flexible fiber optic tip member100. In such embodiments, the one or more flexible ridges230may keep the flexible fiber optic tip member100firmly disposed within the elastic tubular connector sleeve200. Alternatively, the length of the elastic tubular connecting sleeve200may be short enough that when the flexible fiber optic tip member100is partial disposed within the connecting sleeve200and the connecting sleeve200is coupled to the light source300, the flexible fiber optic tip100does not have room to move and is firmly held in place within the connecting sleeve200. In some embodiments, the flexible fiber optic tip100is contacting the light source300. In other embodiments, the flexible fiber optic tip100is contacting the light source300, such as less than about 1 mm away from the light source300.

The one or more flexible ridges230may be concentrically disposed within the elastic tubular connecting sleeve200. Alternatively, the flexible ridge230may be a single ridge helically disposed within the elastic tubular connecting sleeve200. The one or more flexible ridges230may be rigid. In such embodiments, the elastic tubular connecting sleeve200may be snapped onto the light source using a lip/clip method. Alternatively, the elastic tubular connecting sleeve200may be screwed on to the light source300using a threaded system. Alternatively, the one of more flexible ridges230may be elastic, such that the proximal end210of the elastic tubular connecting sleeve200may be mechanically stretched for coupling to the light source300.

FIG. 4depicts a process of treating or preventing periodontal disease400in accordance with the present disclosure. The process400comprises an attachment401, wherein a flexible fiber optic tip100is attached to a periodontal light source300to generate a phototherapeutic device. Preferably, an elastic tubular connecting sleeve200is used to attach the flexible fiber optic tip100to the light source300, as shown inFIG. 1andFIG. 3A. The process400further comprises a composition introduction402, wherein a composition comprising a photoactivating agent and optionally an oxygen-releasing agent is introduced into a periodontal treatment region. The process400further comprises a flexible tip member introduction403, wherein the flexible fiber optic tip member100of the phototherapeutic device is inserted into the periodontal treatment region. The process400further comprises an activation404, wherein light from the flexible fiber optic tip member100activates the photoactivating agent.

In one example, upon activation with light from the flexible fiber optic tip100, the photoactivating agent absorbs energy from the light and releases some of the absorbed light energy as a fluorescent light. Without being bound to theory, it is thought that fluorescent light emitted by photoactivated chromophores may have therapeutic properties due to its femto-second or pico-second emission properties which may be recognized by biological cells and tissues, leading to favourable biomodulation. Furthermore, the emitted fluorescent light has a longer wavelength and hence a deeper penetration into the tissue than the activating light. Irradiating tissue with such a broad range of wavelength, including in some embodiments the activating light which passes through the composition, may have different and complementary therapeutic effects on the cells and tissues.

In another example, the composition also comprises an oxygen-releasing agent. In this case, the photoactivating agent may transfer at least some of the absorbed light energy to the oxygen-releasing agent, which in turn can produce oxygen radicals such as singlet oxygen. These are distinct applications of these agents and differs from the use of chromophores as simple stains or as a catalyst for photo-polymerization.

Suitable photoactivating agents include, but are not limited to, the following:

Chlorophyll Dyes

Methylene Blue Dyes

Azo Dyes

In certain embodiments, the composition of the present disclosure includes any of the chromophores listed above, or a combination thereof, so as to provide a biophotonic impact at the application site. Photoactive agent compositions may increase photo-absorption by the combined dye molecules or may enhance photo-biomodulation selectivity. In some embodiments, the combination of photoactive agents may be synergistic. In some embodiments, the two or more photoactive agents are both xanthene dyes, for example, Eosin Y as a first chromophore and any one or more of Rose Bengal, Erythrosin, Phloxine B as a second chromophore. It is believed that these combinations have a synergistic effect as Eosin Y can transfer energy to Rose Bengal, Erythrosin or Phloxine B when activated. This transferred energy is then emitted as fluorescence or by production of reactive oxygen species. By means of synergistic effects of the chromophore combinations in the composition, chromophores which cannot normally be activated by an activating light (such as a blue light from an LED) can be activated through energy transfer from chromophores which are activated by the activating light. In this way, the different properties of photoactivated chromophores can be harnessed and tailored according to the cosmetic or the medical therapy required.

As discussed above, the photoactivating agent stimulates the oxygen-releasing agent in the composition to produce oxygen radicals. Bacteria are extremely sensitive to exposure to oxygen radicals, such that the production of oxygen radicals converts the composition into a bactericidal composition. Peroxide compounds are oxygen-releasing agents that contain the peroxy group (R—O—O—R), which is a chainlike structure containing two oxygen atoms, each of which is bonded to the other and a radical or some element. When a biophotonic composition of the present disclosure comprising an oxygen-releasing agent is illuminated with light, the chromophores are excited to a higher energy state. When the chromophores' electrons return to a lower energy state, they emit photons with a lower energy level, thus causing the emission of light of a longer wavelength (Stokes' shift). In the proper environment, some of this energy transfer is transferred to oxygen or the reactive hydrogen peroxide and causes the formation of oxygen radicals, such as singlet oxygen. The singlet oxygen and other reactive oxygen species generated by the activation of the biophotonic composition are thought to operate in a hormetic fashion. That is, a health beneficial effect that is brought about by the low exposure to a normally toxic stimuli (e.g. reactive oxygen), by stimulating and modulating stress response pathways in cells of the targeted tissues. Endogenous response to exogenous generated free radicals (reactive oxygen species) is modulated in increased defense capacity against the exogenous free radicals and induces acceleration of healing and regenerative processes. Furthermore, activation of the composition will also produce an antibacterial effect. The extreme sensitivity of bacteria to exposure to free radicals makes the composition of the present disclosure a de facto bactericidal composition.

Suitable oxygen-releasing agents for preparation of the active medium include, but are not limited to:

Hydrogen peroxide (H2O2) is the starting material to prepare organic peroxides. H2O2is a powerful oxidizing agent, and the unique property of hydrogen peroxide is that it breaks down into water and oxygen and does not form any persistent, toxic residual compound. Hydrogen peroxide for use in this composition can be used in a gel, for example with 6% hydrogen peroxide. A suitable range of concentration over which hydrogen peroxide can be used in the present composition is from about 0.1% to about 6%.

Urea hydrogen peroxide (also known as urea peroxide, carbamide peroxide or percarbamide) is soluble in water and contains approximately 35% hydrogen peroxide. Carbamide peroxide for use in this composition can be used as a gel, for example with 16% carbamide peroxide that represents 5.6% hydrogen peroxide. A suitable range of concentration over which urea peroxide can be used in the present composition is from about 0.3% to about 16%. Urea peroxide brakes down to urea and hydrogen peroxide in a slow-release fashion that can be accelerated with heat or photochemical reactions. The released urea [carbamide, (NH2)CO2)], is highly soluble in water and is a powerful protein denaturant. It increases solubility of some proteins and enhances rehydration of the skin and/or mucosa.

Benzoyl peroxide consists of two benzoyl groups (benzoic acid with the H of the carboxylic acid removed) joined by a peroxide group. It is found in treatments for acne, in concentrations varying from 2.5% to 10%. The released peroxide groups are effective at killing bacteria. Benzoyl peroxide also promotes skin turnover and clearing of pores, which further contributes to decreasing bacterial counts and reduce acne. Benzoyl peroxide breaks down to benzoic acid and oxygen upon contact with skin, neither of which is toxic. A suitable range of concentration over which benzoyl peroxide can be used in the present composition is from about 2.5% to about 5%.

Specific oxygen-releasing agents that that are preferably used in the materials or methods of this disclosure include, but are not limited to hydrogen peroxide, carbamide peroxide, or benzoyl peroxide. Inclusion of other forms of peroxides (e.g. organic or inorganic peroxides) should be avoided due to their increased toxicity and their unpredictable reaction with the photodynamic energy transfer.

In certain embodiments, the photoactivating agent may be incorporated in the matrix of the flexible fiber optic tip. In this way, the flexible fiber optic tip can be made to fluoresce on activation with a light. An oxygen-releasing agent may also be included within the matrix of the flexible fiber optic tip. The concentration of the photoactive agent to be used can be selected based on the desired intensity and duration of the biophotonic activity from the flexible fiber optic tip. For example, some dyes such as xanthene dyes (e.g. Eosin Y and Fluorescein) reach a ‘saturation concentration’ after which further increases in concentration do not provide substantially higher emitted fluorescence. Further increasing the photoactive agent concentration above the saturation concentration can reduce the amount of activating light passing through the solid biophotonic. Therefore, if more fluorescence is required for a certain application than activating light, a high ‘saturation’ concentration of the photoactive agent can be used. However, if a balance is required between the emitted fluorescence and the activating light, a concentration close to or lower than the saturation concentration can be chosen.