WO2018022775A1 - Composants et dispositifs d'administration de photothérapie. - Google Patents

Composants et dispositifs d'administration de photothérapie. Download PDF

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Publication number
WO2018022775A1
WO2018022775A1 PCT/US2017/043988 US2017043988W WO2018022775A1 WO 2018022775 A1 WO2018022775 A1 WO 2018022775A1 US 2017043988 W US2017043988 W US 2017043988W WO 2018022775 A1 WO2018022775 A1 WO 2018022775A1
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WO
WIPO (PCT)
Prior art keywords
light
lllt
patient
treatment
light guide
Prior art date
Application number
PCT/US2017/043988
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English (en)
Inventor
Jack K. Zhang
Original Assignee
Zhang Jack K
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US15/645,467 external-priority patent/US20180008837A1/en
Application filed by Zhang Jack K filed Critical Zhang Jack K
Priority to BR112019001573A priority Critical patent/BR112019001573A2/pt
Priority to EP17749054.7A priority patent/EP3490671A1/fr
Priority to AU2017301811A priority patent/AU2017301811A1/en
Priority to CN201780059870.8A priority patent/CN109789313A/zh
Priority to CA3031991A priority patent/CA3031991A1/fr
Publication of WO2018022775A1 publication Critical patent/WO2018022775A1/fr
Priority to US16/110,688 priority patent/US20190083809A1/en
Priority to US17/064,017 priority patent/US20210093888A1/en
Priority to US17/203,308 priority patent/US11458329B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0616—Skin treatment other than tanning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/067—Radiation therapy using light using laser light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/065—Light sources therefor
    • A61N2005/0651—Diodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0659—Radiation therapy using light characterised by the wavelength of light used infrared

Definitions

  • the invention comprises componentry and devices for light therapy application to a patient in need thereof.
  • the present invention relates to control modules for light therapy devices, light guides, and light guide arrangements configured to deliver light therapy to one or more areas on a patient, related componentry.
  • the invention relates to configurations of light therapy delivery elements (e.g., bandages, garments, blankets, braces, inserts etc.) suitable to deliver therapeutic amounts of light therapy to one or more patient areas and associated tissues.
  • Methods and systems for delivering light therapy to a patient and treatment of associated medical indications are also set out herein.
  • Personalized LLLT dosage configurations and telemedicine LLLT treatment platforms and systems are also provided herein.
  • Low level light therapy relates, in some aspects, to the exposing of cells or tissue to low levels of red and near infrared (“NIR”) light.
  • NIR near infrared
  • LLLT is also known as “low level laser” or “cold laser” therapy, as the power densities used are lower than those needed to produce heating of tissue.
  • light application is at relatively low energy densities, typically below about 500 mW, as compared to other forms of laser therapy that are used for ablation, cutting, and thermally coagulating tissue.
  • Other types of LLLT can also apply wavelengths in the blue or ultraviolet regions, especially for treatment of conditions that occur at the skin surface, such as psoriasis or infection.
  • LEDs light emitting diodes
  • SLD super luminous diodes
  • LLLT is believed to affect a biological change in living tissue by inducing a photochemical reaction in the cell, a process referred to medically as “photobiomodulation” or "PBM.” From clinical observation, it appears that LLLT can hold a wide range of effects at the molecular, cellular, and tissue levels. In addition, the specific modes of action can vary among different applications. As reported in "Effects of Low-Power Light Therapy on Wound Healing: Laser LED, An Bras. Dermatol.
  • LLTT has been recognized to be efficacious to treat a wide variety of indications
  • LLLT nonetheless remains underutilized as a therapy for several reasons.
  • a less than optimal choice of parameters can result in reduced effectiveness of the treatment, or even adverse therapeutic outcomes.
  • the multiplicity of treatment variables that can affect LLLT treatment effectiveness likely contributes to the dearth of unambiguous and repeatable results that allow a LLLT treatment to be prescribed regularly in clinical settings. Indeed, many of the published results on LLLT treatments actually demonstrate negative clinical efficacy, possibly because of an inappropriate choice of light source and dosage for the patients being treated.
  • LaserWRAP® appears from a website representation
  • the device utilizes a polymeric light guide that appears to be in operational engagement with a laser, control module and battery.
  • the '669 Patent device appears to be configured to function much like a wearable, battery powered heating pad or TENS device. To this end, each example of the device use is directed toward general body areas, as opposed to specific medical indications that would give rise to a patient's area or body part needing to be treated in the first place.
  • the laser light is distributed along the interior length of the illustrated devices therein.
  • the '669 Patent provides no disclosure of an interface for a user to provide feedback other than a power switch. The device therefore can only apply a set dose that is generally defined irrespective of a specific patient.
  • the LLLT treatment device configuration of the '669 Patent and the referenced website description of a similar device should be considered "universal” or “generic" LLLT treatment device design that does not address selection of a specific medical indication, nor does it contemplate definition of specific dosage parameters for the selected indication and a specific patient or patient population.
  • the invention comprises componentry and devices for LLLT application to a patient in need thereof.
  • the devices of the present invention are wearable by a patient in need of treatment or the devices are otherwise highly portable.
  • the present invention relates to controller modules for light therapy devices, light guides, light guide arrangements, and light delivery componentry configured to deliver light therapy to one or more areas on a patient, related componentry, and configurations of light therapy delivery elements (e.g., bandages, garments, braces, inserts etc.) suitable to deliver light therapy to one or patient areas and tissues.
  • light therapy delivery elements e.g., bandages, garments, braces, inserts etc.
  • the inventions relate to a control module for application of LLLT to a patient in need of treatment, the control module comprising: a microprocessor, at least one light source, wherein the at least one light source is configurable to generate light in one or more wavelengths of from about 200 nm to about 1000 nm (or other wavelengths or wavelength ranges appropriate to effect LLLT treatment in a patient in need of treatment), a power source configured to provide power to the control module, a memory module, a communications module, at least one engagement port configured to provide engagement of a single light delivery element with the at least one light source, wherein the light delivery element is configured to deliver LLLT generated from the at least one light source directly or indirectly to one or more areas on a patient in need of treatment with LLLT, and a housing or containment structure configured to contain each of these components.
  • the LLLT device is powered by a battery.
  • the control module can comprise one or a plurality of light sources configured to deliver LLLT in one or more desired wavelengths to a patient in need of treatment.
  • the LLLT treatment device can further be configured to collect light emitted from a patient's wound or treatment area for collection in one or more sensors associated with the LLLT devices that can provide information about the effectiveness of a LLLT treatment.
  • control module is configured to store and/or deliver a LLLT prescription for a patient, whereby that prescription is suitable to provide a therapeutic amount of LLLT to the patient over individual treatment periods or throughout an overall treatment regimen.
  • the control module can be configured to store or transfer LLLT dosage information from a device or remote server associated with a provider prior to or during a LLLT treatment delivered to the patient.
  • Appropriate matching of a patient with a prescribed LLLT treatment and LLLT treatment device can be facilitated by incorporation of functionality that validates a LLLT delivery element associated with light guide element(s) as being authorized for use by a patient. If the validation is not successfully completed, LLLT treatment can be prevented from being delivered to the patient.
  • the control module can also comprise validation functionality, such as requiring a user to input an authorization code prior to the control module being activated.
  • the LLLT componentry, devices, and methods herein have applicability to a wide variety of medical and cosmetic indications.
  • Device configurations such as bandages, garments, braces, wraps, and body cavity inserts can be configured using the inventions herein.
  • Such devices and methods can have applicability to treating acute wound conditions resulting from surgeries, accidents or the like.
  • Chronic wounds are also treatable with the devices and methods herein.
  • Surface, body cavity, internal, mucosal, subcutaneous and other body areas are treatable with the inventions herein. Human and animal patients are treatable.
  • the LLLT componentry, devices and methods herein have utility in enhancing the time required for wound healing, as well as demonstrating reduction in the amount of swelling and pain in patients exhibiting a variety of medical indications. Disinfection of wounds to reduce infections is also possible with the inventions herein.
  • Figure 1 illustrates an implementation of the present invention whereby LLLT treatment is delivered to a patient.
  • Figure 2 illustrates a further implementation of the present invention whereby LLLT treatment is delivered and managed in a plurality of patients.
  • Figure 3 illustrates a further implementation of functional elements of a methodology of the present invention whereby LLLT treatment is delivered to a patient.
  • Figure 4 illustrates a further implementation of functional elements of a methodology of the present invention whereby LLLT treatment is delivered to a patient.
  • Figure 5 illustrates functionality of an implementation wherein two control modules are utilized to deliver LLLT to a patient.
  • Figure 6 illustrates a wearable LLLT treatment device in the form of a bandage or garment.
  • Figure 7 illustrates a further wearable LLLT treatment device in the form of a bandage or garment.
  • Figure 8 illustrates one form of light guide engagement.
  • Figure 9 illustrates a light guide end configuration
  • Figure 10 illustrates a LLLT device for treatment of a leg or knee area.
  • Figure 1 1 illustrates a LLLT device for treatment of an ankle or foot area.
  • Figure 12 illustrates a LLLT device for treatment of a hip and lower back area.
  • Figure 13 illustrates a LLLT device for treatment of an abdominal area.
  • Figure 14 illustrates a LLLT device for treatment of abdominal and pelvic areas.
  • Figure 15 illustrates a LLLT device for treatment of a pelvic area.
  • Figure 16 illustrates a LLLT device for treatment of a facial area.
  • Figure 17 illustrates a LLLT device for treatment of facial and neck areas.
  • Figure 18 illustrates a LLLT device for treatment of a breast area.
  • Figure 19 illustrates a LLLT device in the form of a bandage.
  • Figure 20 illustrates a LLLT device in the form of a bandage configurable to detect light emitted from a patient wound area.
  • Figure 21 illustrates a LLLT device for treatment in the form of an insertable vaginal light therapy device used with a light therapy delivery liner.
  • Figures 22 illustrates different views and componentry associated with an insertable vaginal light therapy device.
  • Figure 23 illustrates an implementation of light delivery in and through an implementation of an insertable vaginal light delivery device.
  • Figure 24 illustrates an implementation of a light therapy delivery liner in a patient in need of treatment.
  • Figures 25 illustrates different views and configurations of a light therapy delivery liner.
  • Figures 26 illustrates alternative implementations of insertable vaginal light delivery devices.
  • Figure 27 illustrates a further implementation of an insertable vaginal light delivery device.
  • Figure 28 illustrates a LLLT device for treatment of a nasal cavity and proximal regions.
  • Figure 29 illustrates componentry for use in a LLLT device for treatment of a nasal cavity and proximal regions.
  • Figure 30 illustrates a LLLT device for treatment of a bridge of a nose.
  • Figure 31 illustrates componentry for use in a LLLT device for treatment of a nasal cavity and proximal regions.
  • Figure 32 illustrates connection of LLLT componentry via an optical connector.
  • Figure 33 illustrates componentry for use in a LLLT device for treatment of facial and nasal cavity regions.
  • Figure 34 illustrates componentry for use in a LLLT treatment device having cooling or cushioning functionality.
  • Figure 35 illustrates a configuration of a LLLT device for scalp area treatment.
  • Figure 36 illustrates a configuration of a light guide arrangement for use in a scalp area treatment.
  • Figure 37 illustrates the Norwood Scale of hair loss measurement (prior art).
  • Figure 38 illustrates a hair loss configuration and a light guide arrangement for treatment thereof.
  • Figure 39 illustrates a configuration of a light guide arrangement and light travel patterning therein.
  • Figure 40 illustrates a configuration for a light guide arrangement for a scalp area LLLT treatment device.
  • Figure 41 shows a framework for validation of light guide elements for engagement ports in the LLLT treatment control module.
  • Figure 42 illustrates a light guide element configuration suitable for some implementations of the present invention.
  • Figure 43 illustrates a LLLT treatment device suitable for a knee or leg area.
  • Figure 44 illustrates a light guide element configuration suitable for some
  • Figure 45 illustrates a mouth area LLLT treatment device.
  • LLLT low level light therapy
  • application parameters such as emitted wavelength(s), pulse frequencies, duty cycle/pulse width, intensity, individual treatment duration, total treatment duration, number of individual treatments during a total treatment regimen, time between individual treatments in a total treatment regimen, first LLLT administration time from an event (such as a surgery), time-course dosage, maintenance treatments, with the goal of optimal treatment, management, and/or cure of wounds or delay/reverse tissue degeneration at one or more locations on a patient in need of such treatment, management, or cure.
  • Both humans and animals can comprise patients that can be treated according to the inventions herein.
  • LLLT as provided herein includes light generated by “low power” lasers (or “cold lasers”) and that generated by LED, SLDs, or a combination thereof.
  • Laser light, LED, and SLD light having therapeutic effects can be generated in a variety of wavelengths or wavelength ranges suitable for use in the inventions herein.
  • a “laser” is a device that emits light through a process of optical amplification based on the stimulated emission of photons. As would be recognized, the term “laser” originated as an acronym for light amplification by stimulated emission of radiation. The emitted laser light is notable for its high degree of spatial and temporal coherence. Lasers are classified as Class 1 , Class 2, Class 3, and Class 4 by the American National Standards Institute. Such classifications are detailed in publication ANSI 7136.1-2000, the disclosure of which is incorporated herein in its entirety by this reference. The present invention utilizes Class 1 , 2 and 3 lasers as light sources for LLLT.
  • a "light-emitting diode” comprises a two-lead semiconductor light source that is a p-n junction diode that emits light when activated. When a suitable voltage is applied to the leads, electrons are able to recombine with electron holes within the device, releasing energy in the form of photons. This effect is called “electroluminescence," and the color of the light (corresponding to the energy of the photon) is determined by the energy band gap of the semiconductor. LEDs are typically small and integrated optical components may be used to shape the light emitting pattern. LEDs can be provided that emit various wavelengths and intensities of light, thus making them suitable for the inventive light therapies herein.
  • wavelengths suitable for use in the present invention emit a beam of light that is non-collimated (less focused) and non-coherent.
  • LEDs have lower power levels (mW) than laser diodes.
  • the LED depth of penetration (up to several mm) makes them suited for the treatment of very superficial tissue.
  • SLD Super luminous diodes
  • the SLD can not be referred to as a laser because it does not comprise coherent light, which is a key parameter of laser light.
  • An SLD light beam is less focused than the laser diode, but more focused than the LED.
  • Super luminous diodes typically have lower power levels (mW) than laser diodes. The SLD depth of penetration (up to 1 cm) is less than the laser diode, but greater than what is typically seen with LED.
  • Light guides suitable for use herein can be fabricated from moldable optical silicone resins, such as those made by Krayden ® (Dow Corning, Corning NY). Suitable flexible light guides can also be fabricated from polyurethane, as set out in US Patent No. 7433565, the disclosure of which is incorporated herein in its entirety by this reference. Flexible light guides can also be made of clear TPE (thermoplastic elastomer) such as TPXTM
  • PMP Polymethylpentene
  • light guides suitable for delivering LLLT to an area of a patient in need of treatment can comprise light emitting fiber optic fibers having side diffusion features, as disclosed, for example, in US Patent Publication No. 20150148734, the disclosure of which is incorporated herein in their entireties.
  • Suitable side diffusing fiber optics are sold, for example, by Corning (Corning, NY) under the trade name Fibrance ® .
  • fiber optics can be utilized to deliver light from a PBM control module substantially without loss or transmission of light prior to delivery of such light to engagement with a light guide or light guide arrangement that is configurable to deliver LLLT proximally to the area on a patient being treated.
  • the fiber optic light transmission element which can comprise a first light transmission portion when directly engaged with the control module, can be engageable with at least one polymeric light guide element or side diffusing fiber optic element that is arranged deliver light proximally to one or more patient areas.
  • the at least one light guide or side diffusing fiber optic element is a "second light transmission portion" when not directly engaged with a control module but, rather, is engaged indirectly with the control module via a first light transmission portion.
  • a first light transmission portion can be comprised from a polymeric light guide, as long as the length of polymeric light guide that is not intended to deliver LLLT to an area of the patient is configurable to substantially not transmit light from the surface thereof, such as being coated etc.
  • a "light guide arrangement” can comprise one or more polymeric light guides or side diffusing fiber optic light delivery elements operationally and optically engageable with a control module (as such componentry is defined herein), where such light guide
  • arrangement is configurable to deliver LLLT to a patient in need of treatment when the arrangement is associated with a LLLT delivery element.
  • wounds can be characterized in various ways. For example, "acute wounds" are those that heal normally within a few weeks, while chronic wounds are those that linger for months or even years.
  • Wounds can also be characterized by the stage of healing and the functional parameters therewith.
  • the line of closure fills with clotted blood (hemostasis), and, following the progression, in order, of inflammation, proliferation and maturation.
  • the wound typically heals within a few weeks.
  • Wounds that heal by secondary union (or secondary intention) typically involve large tissue defects, with more inflammation and granulation. Granulated tissue is needed to close the defect, and is gradually transformed into stable scar tissue.
  • Such wounds are typically large open wounds as can occur from trauma, burns, and pressure ulcers. While surgical wounds are typically stitched, or stapled shut, which reduces the burden on the wound closing functionality, a subsequent infection or wound geometry can result in granulation occurring. While such a wound may require a prolonged healing time, but will not necessarily be chronic.
  • Mucosal healing such as in a vaginal cavity or nasal cavity, is mechanistically similar to that for the skin. However, associated scarring and wound closure rates are different in mucosal healing, possibly due to differences in apoptosis. If granulated tissue is torn or otherwise damaged during the healing process, bleeding can result.
  • a wound normal healing is not occurring, with progress stalled in one or more of the phases of healing.
  • a variety of factors, including age, poor health and nutrition, diabetes, incontinence, immune deficiency problems, poor circulation, and infection can all cause a wound to become chronic.
  • Typical chronic wounds include pressure ulcers, friction ulcers, and venous stasis ulcers.
  • Stage 3 and Stage 4 pressure ulcers are open wounds that can occur whenever prolonged pressure is applied to skin and tissues covering bony outcrops of the body.
  • Chronic wounds are also categorized, according to the National Pressure Ulcer Advisory Panel (NPUAP) relative to the extent of the damage.
  • NPUAP National Pressure Ulcer Advisory Panel
  • the present invention comprises devices and methods to treat, manage, and/or cure a patient in need of such treatment using LLLT.
  • the indications for which the patient can be in need of treatment for can include one or more of open wounds, closed wounds, or chronic wounds. Such wounds can be intentionally created (e.g., by way of a surgery etc.), accidentally caused, or chronic in nature.
  • the LLLT treatment devices of the present invention are configured to be wearable by a patient on a specific part of the body in need of treatment, and the LLLT can be applied with such devices over an extended period.
  • Such wearability has been found by the inventors herein to enhance the efficacy of LLLT in a patient in need of treatment over prior delivery methods, when such LLLT is applied in conjunction with one or more treatment parameters described herein.
  • the inventions herein enable application of a set of defined LLLT dosages over an extended period as applied by a wearable device, where the dosage is defined in relation to the medical condition/indication for which the patient is being treated.
  • the inventions relate to selection of one or more patient medical indications in need of treatment.
  • the methods and devices herein can also incorporate patient specific information into the definition and delivery of dosage to the patient.
  • the inventions herein can therefore also relate to identification of one or more patient-specific parameters, whereby information associated with such patient-specific parameters is incorporated into a patient LLLT treatment regimen. Patient feedback and compliance information can be generated for incorporation into the treatment regimen.
  • the devices and methods herein can also allow LLLT treatment protocol to be readily and timely monitored by a healthcare provider and, if applicable, modified during a treatment regimen, thereby enhancing patient outcomes.
  • the devices and methods of the present invention can provide enhanced information about the course and effects of a LLLT treatment program in a single patient, and among a plurality of patients, thereby improving the ability to manage LLLT in a single patient or in a population of patients by use of data associated with medical indication, dosage, treatment compliance, progress, outcome, physiological conditions, among other information. Therefore, in some aspects, the inventions herein relate to the generation of information associated with an applied LLLT treatment or program from the patient who is undergoing treatment for one or more medical indications suitable for treatment with LLLT, and incorporation of at least some of that patient generated information into a subsequent treatment for that patient, for another patient or for a group of patients.
  • the inventive LLLT treatment devices comprise at least one low level light source in operational engagement with at least one light guide configured to deliver a therapeutic amount of LLLT substantially proximal to a wound in need of treatment and, optionally, any areas associated with healing of the wound.
  • Such substantially proximal LLLT delivery is provided by incorporating the at least one light guide or light guide arrangement on or among a LLLT delivery element, as such terms are described in more detail herein.
  • PBM control modules suitable for use in the present invention are referred to as “photobiomodulation (“PBM”) control modules," which is a convenient framework for referring to the LLLT componentry suitable to provide operation of the treatment devices of the present invention.
  • PBM control modules suitable for use in the devices and methods of the present invention can comprise at least one light source suitable to generate a therapeutic amount of LLLT to a patient in need of treatment, at least one data communications module, at least one memory module, at least one light guide engagement port, and at least one battery power source. Operational engagement between and among these various components is provided by a controller associated with the PBM control module. Further description of the functionality of the inventive PBM control modules in described hereinafter. As discussed elsewhere herein, one or more sensors suitable to measure conditions of the patient or elsewhere can also be in operational engagement with the PBM control module.
  • the PBM control module can be configured in as one or more physical enclosures, such as a housing, in which each of the components are incorporated.
  • the various components of the PBM control module can be distributed in a band or strip of fabric or plastic envelope or the like to provide a containment structure. Therefore, as used herein, "PBM control module" is intended to mean the operational features of the individual components associated with this aspect of the LLLT treatment devices, not just a specific format or configuration in which the operational components can be arranged in a LLLT treatment device.
  • the components in the PBM control module should be configurable to substantially prevent moisture from contacting the internal operational components.
  • the PBM control module can be configurable to substantially enclose electrical connections and power functionality to substantially prevent such connections and functionality from contacting the skin or tissues of the patient being treated with the LLLT treatment device. Yet further, the components should be protectable from contamination, especially if the PBM control module is intended for re-use. In further aspects, the PBM control module may be configured for use in a single LLLT treatment for some medical applications.
  • At least one light guide engagement port is in operational communication with the at least one light source in the PBM control module.
  • Each of the light guide engagement ports associated with a PBM control module are configurable to allow the light source(s) to be in operational and optical engagement with an associated light guide or light guide arrangement, where each of the light guides or light guide arrangements are configurable to distribute a therapeutic dosage of LLLT treatment to a patient in need of such treatment when the patient is associated with the LLLT treatment device associated therewith.
  • each of the at least one engagement port can each, independently, be configurable to deactivate or close off each of the at least one light sources when there is no associated light guide or light guide arrangement engaged with a port. This can better ensure that battery power is not expended inadvertently by the LLLT treatment device being turned on when therapeutic use is not intended.
  • the device can also be configured to deactivate substantially all electrical functions when one or more of the light guides or all or part of the light guide arrangement(s) are not engaged an associated engagement port.
  • deactivation of the at least one light source when light guides or light guide arrangements are not engaged with the engagement port(s) can better ensure that harmful light, for example, laser light over class 1 is substantially prevented from contacting a person's eyes.
  • a wide variety of light guide and light guide arrangement configurations are suitable for use in the present invention, as long as such are configurable to dispense a desired therapeutic light therapy dosage in the inventive devices and methods described herein.
  • Application of appropriate therapeutic dosages has been found by the inventor herein to be enhanced by the ability to configure the LLLT treatment devices to provide an optimal amount of LLLT proximal to the area of the patient in need of treatment.
  • the patient's incision with Standard Medial Parapatellar Approach will be generally in a ⁇ " shape over patella (also known as the kneecap).
  • patella also known as the kneecap.
  • the surgically "internally wounded areas" inside the knee are more extensive.
  • the LLLT should at least be applied to the entire area substantially proximal to the incision and "internally wounded areas" in need of healing.
  • the inventor herein has determined that light guide or light guide arrangements configured to enable LLLT treatment to be applied proximally to both the external incision and the associated internally wounded areas can enhance the effectiveness of LLLT therapies. Moreover, it has been found that some LLLT delivery configurations that do not conform to allow LLLT to be applied proximally to each of the incision areas and associated "healing vital areas" can be even harmful when treating a patient post-surgically or for other wound healing in some situations.
  • the non-specific dosage deliverable from a "generic" LLLT delivery device will be unlikely to be effective to treat TKA in a specific patient having unique physical and medical characteristics.
  • a light guide that is not configured appropriately for a TKA patient could interfere with the required function of the part of the body requiring treatment.
  • a substantially non-flexible light guide delivery configuration in the course of delivering the light energy, can prevent the knee from bending, which is typically encouraged during recovery.
  • a substantially non-flexible light guide delivery configuration can be uncomfortable or painful to wear for a specific treatment, thus discouraging patient compliance.
  • LLLT treatment applied to other areas not proximal to a wound area have been found to not be suitably effective, or may be wholly ineffective with inappropriate dosage, to enhance wound healing in that patient of a specific medical indication. Energy will thus be wasted, which will diminish the usability of the device because battery power will be depleted more quickly than if the LLLT delivery was provided efficiently.
  • the invention provides a wearable LLLT treatment device configured to provide a therapeutic dosage of LLLT to a person in need of treatment.
  • a wearable LLLT treatment device configured to provide a therapeutic dosage of LLLT to a person in need of treatment.
  • at least one substantially flexible light guide or light guide arrangement that is suitably conformable to the body area being treated is used.
  • the typical human skin surface has an average Shore A hardness from greater than zero to 30 or less, or greater 0 to about 20.
  • the materials used to fabricate polymeric light guides or light guide arrangements can have a Shore A hardness of from greater than 0 to about 30 for direct contact with skin in sensitive areas of the body for desirable comfort, flexibility, wearability and to prevent pressure injuries to the body.
  • the polymeric light guides or light guide arrangements can optionally be provided with a lining material positioned between the skin surface and the light guide or light guide arrangements to reduce patient friction, as long as the lining material suitably allows LLLT treatment to reach the patient.
  • a light guide or light guide arrangements can be fabricated from materials with Shore A hardness up to about 75, optionally with a light transmissive lining material positioned between the skin surface and the light guide.
  • harder materials that is having Shore A hardness of greater than about 75 can be appropriate.
  • vaginal dilators for vaginal therapy as discussed elsewhere herein can use materials in the about Shore A 80 to about 100 range. It is known to people in the art the various hardness scales can be used to express the same material characteristics. For clarity, the Shore A and Shore D scales are used for this disclosure as indicated.
  • Flexible polymeric light guides or light guide arrangements suitable for use herein can be fabricated from moldable optical silicone resins, such as those made by Krayden® (Dow Corning, Corning NY) or such as TPXTM Polymethylpentene (PMP) from Mitsui Chemicals America.
  • moldable optical silicone resins such as those made by Krayden® (Dow Corning, Corning NY) or such as TPXTM Polymethylpentene (PMP) from Mitsui Chemicals America.
  • PMP Polymethylpentene
  • Suitably flexible light guides or light guide arrangements can also be fabricated from polyurethane, as set out in US Patent No. 7,433,565, the disclosure of which is incorporated herein in its entirety by this reference.
  • Flexible light guides or light guide arrangements can also be made with appropriate hardness (optimally Shore A 0 to about 30 for most parts of the body, may be higher for less tactile sensitive or thicker skin, such as the soles of the feet) and high elasticity (up to about 500% deformation with tension). Materials suitable for use as light guides or light guide arrangements can be molded into lengths appropriate for various LLLT treatment devices of the present invention using known methods.
  • the cross- sectional area of a polymeric light guide or light guide arrangement must be appropriately sized.
  • the light guides can have dimensions of at least about 1 mm by about 3 mm in a cross section. In some applications, the inventor has found that larger dimensions may increase the risk of pressure wound to the skin of a treated patient.
  • each of the at least one light guide or light guide arrangement can emit light substantially uniformly along the length thereof. Optimally, such uniform distribution can better ensure that only a small portion of the light entering each of the light guides or light guide arrangements is lost prior to delivery of the LLLT to the wound and associated areas.
  • the light guide or light guide arrangement is configured to emit light substantially non-uniformly along the length thereof, with certain sections to side-emit light while other sections to be non-emitting.
  • polymeric light guides or light guide arrangements one or more areas on the interior surface thereof can be treated with a coating material to minimize light from exiting in areas where such light exit is not indicated.
  • Such coating is optimally a reflective or mirrored coating while leaving the remainder of the light guide or light guide arrangement areas free of such reflective coating to allow light to exit to reach the patient treatment area.
  • Such coating can be achieved using a physical vapor deposition process, such as evaporation or sputter deposition, or a chemical process such as chemical vapor deposition.
  • the advantages of such coating application can be, in some aspects: (1) enhancing the efficiency of delivered light to targeted area from the light source, thereby achieving the same level of light energy density with lower power/battery requirement, which can allow smaller and, therefore more comfortably wearable and discrete PB control modules; and (2) improving treatment outcomes by minimizing the effects of certain light wavelengths, (UV light for example), from unintentionally reaching areas on the patient where such light might cause damage or reduce LLLT treatment overall effectiveness.
  • certain light wavelengths UV light for example
  • fiber optics having side light emitting characteristics can be used in some implementations. When used, these side emitting fiber optics should also be suitably sized to enhance patient comfort during LLLT treatment.
  • Each of the at least one light guide or light guide arrangements are each, independently, operationally and optically coupled into an associated light guide
  • Each light guide engagement port is configured to allow light generated by the at least one light source to be suitably introduced into each of the at least one associated light guide or light guide arrangement for distribution along the length thereof to provide LLLT treatment to an area proximal to the patient area in need of treatment and, optionally, any areas associated with healing of the wound.
  • the light guides or light guide arrangements comprise an external diameter along the length therein.
  • the light guide or light guide arrangements can have an internal diameter and an external diameter.
  • a light guide or light guide arrangement can have an internal diameter along the length therein to allow air to travel through the light guide or light guide
  • a second, or terminal end, of each of the light guides or light guide arrangements can be coated to generate a total or partial mirror at one or more terminal ends of the light guide or light guide arrangement.
  • the plane of a terminal end of the light guide or light guide arrangement can also be angled to provide an angle at the terminal end of from about 65 degrees to about 85 degrees so that light reflected from the terminal end will travel in the opposite direction in the light guide or light guide arrangement.
  • the reflective coating at the end thereof can be in another shape, such as concave or convex mirror.
  • Such mirrored coating at the end of a light guide or light guide arrangement has been found by the inventor herein to enhance light delivery from a patient facing side of the light guide or light guide arrangement.
  • the LLLT treatment is suitably dispensed from the at least one flexible light guide or light guide arrangement in a location substantially proximal to the wound in need of being treated.
  • Each light guide or light guide arrangement can be configured to dispense LLLT from a patient facing side along a wound-facing side or relevant patient area substantially proximally to the selected treatment location on the patient, where the selected location comprises a medical indication in need of treatment.
  • the ability to provide a LLLT dosage substantially configured to treat a selected area of a patient in need of treatment can be facilitated by using more than one light guide or light guide arrangement, where each light guide or light guide arrangement, independently, can be conformable or placed proximally to the patient area(s) being treated.
  • Each of the at least one light guide or light guide arrangements are engageable with the LLLT delivery element prior to use by the patient, for example, at the point of manufacture or at the point of care, to ensure that the desired LLLT treatment dosage delivery parameters are suitably provided to allow accurate dosages to be provided for a specific type of patient and the associated patient indication(s).
  • the at least one light guide or light guide arrangement can be engageably attached to the LLLT delivery element at the time of manufacture in a configuration that is appropriate for a specific medical indication.
  • the LLLT treatment device can be pre-sized and pre-shaped for an assortment of patient relevant configurations for treatment of one or more specific medical indications.
  • a LLLT treatment device can come preconfigured for use in treating a knee replacement (TKA) post-surgical condition.
  • TKA knee replacement
  • the at least one light guide or light guide arrangement from which LLLT is delivered from the at least one light source in the PBM control module can be attached to the flexible brace material in the configuration that can distribute light in an area proximate to the incision in need to treatment with LLLT.
  • the LLLT delivery element In broader constructs, the LLLT delivery element
  • brace/garment/cast, bandage, insertable device can be provided for selection in range of shapes (e.g., small, medium, large etc.) to accommodate a range of wound sizes, wound types, patient sizes, and the like.
  • a therapeutic amount of LLLT treatment is suitably deliverable from the at least one light source to an associated light guide or light guide arrangement.
  • the connection between the at least one light source and a first end of each of the at least one light guide or light guide arrangement can be configured to result in low loss from the light source(s).
  • Direct connection of a polymeric light guide or light guide arrangement to an associated engagement port can reduce effectiveness of light transmission due to the patient, at least in part, to the presence of an air gap between the at least one light source and the engagement end of an associated light guide.
  • a connector made of flexible optically transparent silicone, glass or other suitably hard and clear material can be used to connect the at least one light source to each of the at least one light guide or light guide arrangement to provide an effective operational and optical engagement or communication between the light source and first end of each of an associated light guide or light guide arrangement.
  • Such optical connector is configured to have a diameter that is suitable to fit within each of the diameters of the engagement port and the light guide or light guide arrangement connectable therewith.
  • a light guide or light guide arrangement can comprise at least two levels of hardness incorporated therein.
  • a first section can comprise an area proximal to a light source engagement end having a Shore A hardness of greater than about 30 to greater than about 50, such as from about 60 to about 95.
  • a second portion of the light guide or light guide arrangement can be configured to be softer in the area that contacts the patient treatment areas, such as the incision or the skin.
  • the second portion can comprise a hardness rating more compatible with the hardness of normal skin tissue, for example greater than 0 to about 30 on the Shore A scale.
  • the light guide or light guide arrangement having two sections two or more of differing Shore A hardness ratings can be produced by connecting the harder section with the softer section using a two-step injection molding or an ultrasonic welding process. Alternatively, the two or more hardness sectioned light guide or light guide arrangement can be created at once with dual-material simultaneous injection or pour molding.
  • a LLLT treatment device can be configured with a plurality of light guides or light guide arrangements configured for treating a plurality of conditions with assurance for compliance, monitoring and adjustment for LLLT treatment effectiveness. Such plurality can each, independently, be associated with a corresponding engagement port on one or more PBM control modules, where each engagement port is, independently, in communication with one or more light sources configured to provide LLLT treatment to a patient in need of treatment thereof.
  • a provider can customize the treatment by prescribing and arranging at least one LLLT delivery element with associated light guides or light guide arrangements in a configuration to substantially match— that is, to conform to the size and shape of the patient area -in need of treatment. For example, a knee replacement patient in need of LLLT treatment can be specifically configured with a customized or patient-specific LLLT delivery element paired with specific dosage personalized for her specific needs.
  • the light delivery configurations herein can facilitate effective placement of a therapeutic dosage proximal to the patient area in need of treatment, as well as any associated "healing vital areas" (as such areas are described hereinafter), by the enhanced conformability of the LLLT light delivery to the area of the patient needing treatment.
  • a further benefit of the configuration of the PBM control module and the delivery of the LLLT treatment herein is that there is substantially no source of electricity in the areas proximal to the wounds in need of treatment, and any associated healing vital areas.
  • the LLLT treatment devices and methods substantially differ from those methodologies that incorporate powered laser or LED lights etc.
  • wounds are typically sensitive to temperature. Removing the lights or laser from the open wound reduces a potential point of discomfort for the patient leading to an improvement in compliance. In this regard, there is substantially no heat delivered from the light guides or light guide arrangements when these elements are delivering light to a patient treatment area.
  • Power or energy density of the light applied is a highly relevant parameter for the LLLT of the devices and methods herein.
  • power density can be adjustable by a number of methods such as increasing the power output from the light source, changing the coupling between the light source and each of the associated light guides or light guide arrangements, coating a portion of the light guides or light guide arrangements along a length thereof, or modifying the areas of the patient that are treated with LLLT.
  • an overall therapeutic dosage can range from about 0.1 J/cm 2 to about 15 J/cm 2 , with the amount of energy applied per individual dosage period depending, at least in part, on the patient's condition, location on the body, phenotype, BMI, among others parameters, being treated. For example, pain treatment provided shortly after a medical procedure may require a higher initial dosage.
  • a therapeutic dosage range for wound healing has been found to be from about 2 to about 5 J/cm 2 .
  • At least one aspect of the invention herein comprises selection of at light having a wavelength or wavelength range appropriate for treating of a patient wound or medical condition in need of treatment.
  • Depth of LLLT penetration into a patient's tissues in need of treatment can be enhanced by using wavelengths in the infrared range, increasing the power, and by using laser light that comprises a collimated beam, as opposed to SLD and LED that generally do not.
  • the PMB control module of the present invention for post-surgical care comprises at least one, or two, or three or more light generating components (i.e., light sources), a controller, on-board memory, one or more sensors, a communications module, a battery power source, at least one light guide engagement port, and a housing or other containment structure.
  • the light generating components which can be in the form of a laser diode or an LED or other suitable source, can be configured to generate light in one or a plurality of wavelengths or in wavelength ranges of from about 200 nm to about 1000 nm.
  • the light generating components can generate light in at least three wavelengths: for example, 590 nm, 650 nm, and 808 nm, individually or simultaneously.
  • the ratings on laser diodes used in the present invention can be from about 5 mW to about 250 mW and the rating for LED light sources can be from about 3 mW to about 120 mW.
  • the PBM control module is configurable to provide signaling and control to each of the components and functions associated with generation and monitoring of a LLLT treatment regimen.
  • the at least one light guide or light guide arrangement is in operational and optical engagement and, therefore, communication, with the PBM control module.
  • on-board memory can store the programs and instructions to execute the desired functions as well as storing the time, number of completed treatments, any information from the sensors and instructions from physicians or the remote servers associated with the LLLT treatment delivery system in response to changes detected or patient input received.
  • data associated with the operation of the LLLT treatment devices can be transmitted or delivered to a remote device and/or server substantially in real time.
  • data associated with operation of the devices can be stored in the on-board memory module for a period of time, and then transmitted to and from a remote device and/or server.
  • Such information associated with patient treatment can be valuable to manage treatment and outcome to monitor patient compliance and for the adjusting of treatment parameters based on real-time progress and feedback.
  • Data with respect to treatment duration and cycles can be used to facilitate billing including reduction of billing fraud by ensuring that a device was in fact used.
  • Sensors associated with a PBM control module can include, but are not limited to, identification sensors that are associated with the light guide or light guide arrangement engagement port(s), wound condition sensors, accelerometer, dosage, wavelength and temperature sensors.
  • the wireless communication module can employ any available technologies, such as Wi-Fi or Bluetooth®, with HIPPA compliance or secure encryption suitably present to enable authorized and predetermined data transmission between a PMB control module to another PMB control module, or to the server of the system, or directly to other devices to enable and to ensure optimal outcome with LLLT treatment.
  • the housing can be made of plastic or metal or a combination thereof.
  • the PBM control module can be powered by one or more batteries a rechargeable lithium ion battery having sufficient capacity to power the power module for a sufficient time to provide a wearable treatment.
  • the capacity of the battery can be suitable to provide at least about 6, 12, 18, or 36 hours of operation for the device between recharging.
  • Battery charging can be provided by a plug or wireless charger.
  • the battery pack can be exchanged to allow substantially continuous use for the device.
  • the battery capacity can be balanced between the need for long times between charges and the weight of the battery. In this regard, the battery capacity can be from about 0.5 Ah to about 3 Ah, with about 2 Ah being particularly suitable.
  • the PBM control module can be configurable to collect data associated with treatment compliance, healing progress, patient safety, as well as to activate, deactivate or modify certain functions or treatment parameters. Such intelligence can improve ongoing operation of the LLLT treatment devices and methods of the present invention. For instance, if an accelerometer is associated with the LLLT treatment device, generated accelerometer movement data may be used to trigger a delivery of LLLT to the knee to reduce pain as indicated by a patient's measured degree of mobility over time after the surgery.
  • a wound healing progress sensor associated with a PBM control module may be most effective when the room is dark.
  • the PBM control module can be configured to use information related to the combination of movement, temperature and ambient photo-sensor data to control the optic sensor designed to detect treatment progress using blue light reflection from the skin and wound when the patient is in a darkened environment.
  • the sensor can be configured with an opaque or black out material to create an artificially darkened microenvironment around the sensor.
  • software instructions associated with the PBM control module can be configured to perform some or all of the clinically appropriate treatment functions, such as treatment programs, data storage, sensor operation and a dosage meter.
  • the "dosage meter" feature can allow the PBM control module to better ensure patient safety by shutting off the light source to avoid over exposure and alert the provider, for override or for receipt of other instructions.
  • dosage provision limitation feature along with one or more associated features of light guide or light guide arrangement recognition, LLLT power limitation, sensor feedback and battery capacity limitation to a predetermined charge interval, can be useful provide a multi-layer of built-in safety measure for avoiding unintended "over-dose.”
  • the PBM control module can include functionality to generate new or to modify a prescription in real or near real time, based on patient feedback. Such modification can enable provider intervention in response to the delivered dosage history and compliance log of a patient.
  • a patient being treated for wound recovery after a Cesarean section can be provided with a Visual Analog Scale (VAS) pain tracking interface on the app on her mobile phone which interacts with PBM Control module.
  • VAS Visual Analog Scale
  • Such pain information can be used to allow remote monitoring of the patient via telemetry, for example. The patient then may be able to leave the hospital earlier with her baby.
  • the monitoring interface can incorporate a Global Rate of Change chart (GRC).
  • GRC Global Rate of Change chart
  • Information related to treatment time, time since treatment start, patient input, and the general trend, among other factors, can be used to recommend adjustments to the PBM control module operation, such as by being incorporated into software instructions, to improve pain treatment in one or more subsequent treatments.
  • a provider can remotely approve and enable the new treatment regimen, such as LLLT treatment dosage, and such new treatment can be delivered via updated instructions to the PBM control module for application of such new dosage to the patient.
  • the wearability of the LLLT treatment devices enable a plurality of dosage treatments to be administered to a patient in need of treatment during an overall treatment protocol.
  • the PBM control module can configure the one or more light sources to deliver light to the light guide arrangements, and thus the patient tissues in need of treatment, in continuous or pulsed mode during a particular dosage period.
  • the overall power delivered to the patient during a treatment period can be decreased by pulsing the light.
  • Overall power delivered to the patient during an individual dosage period can be varied by pulsing the light.
  • pulsed mode the average power delivered will decrease proportional to the pulse frequency that is selected. Setting the pulse frequency determine the number of pulses delivered per second during a pulsed LLLT treatment. Pulse frequency is measured in Hertz (Hz). When a low pulse frequency is selected the pause between laser pulses is greater so less power is delivered. When high pulse frequencies are selected there is less of a pause between laser pulses e.g., it is closer to continuous output.
  • the average (or mean) power is used to describe the net power delivered after factoring for both the on and off time of the beam.
  • Power density describes the average power per unit area of the light beam that reaches the tissues. It is measured in W/cm 2 or mW/cm 2 . The power density is determined by dividing the power level of the laser by the area that the beam is emitted from the light guides.
  • Energy is the power multiplied by the treatment time. It is measured in Joules (J). The amount of energy delivered in Joules does not account for the area of the laser beam or the area of the surfaces being treated.
  • Blue light in the range of from about 450 to about 495 nm is further known to be effective for disinfection. Since wound disinfection is also relevant to wound healing, light in this nm range is also contemplated with the LLLT treatment devices and methods of the present invention. Wavelengths in the UV spectrum can also be effective in disinfecting a wound when signs of infection is detected or confirmed by the healthcare provider. For a disinfection application, direct UV-emitting laser diodes are available at 375 nm are available to use. A UVC LED can be used for disinfection. For sensor applications, LED at about 365 nm or about 395 nm with up to about 20% input to light efficiency, and power outputs at these longer UV wavelengths are suitable.
  • a PMB control module(s) that is capable of delivering more than one light wavelength.
  • atopic dermatitis can be treated with a device using, for example, a combination of UVB and UVA wavelengths.
  • Multiple wavelengths can also be advantageous in the case of a wound farther below the surface since the use of light in the red spectrum to provide light energy to the tissue immediately below the skin; while the use of a light in the infrared range can travel deeper into the patient's body to aid in healing the broken bone, for example.
  • a deep tissue effective wavelength and wound relevant wavelengths can also be beneficial.
  • Different wavelengths such as a first, second, third, fourth etc. wavelengths or wavelength ranges, can be used for different stages of the wound healing.
  • red light near the about 650 nm range provide benefits of reduction in bruising and swelling.
  • red and near infrared of about 810 nm can provide significant pain relief at a higher dosage, as much as 15J/cm 2 delivered during the inflammatory phase during the first about 24 to about 72 hours depending on the individual patient's condition.
  • infrared spectrum near about 810 nm can improve wound closure by, for example, stimulating endothelia genesis, growth factor, myofibroblasts and collagen production to regains to the level of about 80% of the skin's original strength.
  • a combination of amber light at about 590 nm can be delivered with red light at near about 650 nm at a low level (0.1-1 J/cm 2 ) on a daily basis for up to about 120 days to reduce or prevent the formation of keloid or hypertrophic scars.
  • first light wavelength for a first-time period followed by a second, third, fourth etc. light wavelength at respective second, third fourth etc. time periods that are each, independently, different from one or more of the other applied wavelengths and/or time periods.
  • different applied wavelengths can be varied within multiple patient locations on the same patient during a single LLLT treatment regimen, for example one wavelength can be selected for the wound site, and one or more second wavelength grouping(s) for sites associated with healing of the wound site or for locations deeper below the skin surface, such as blood supply to and from the wound, or lymph nodes with drainage from the wound.
  • LLLT light delivery can be operated by the microprocessor that controls activation of the laser diode(s) or LED(s) or SLDs at predetermined duty cycles or frequencies in accordance with the treatment regimen(s) generated by a provider for that patient.
  • the software instructions associated with a LLLT treatment regimen or protocol can define a total treatment period, one or plurality of individual treatment periods to occur over the total treatment period and one or more wavelengths of light to be emitted by the light sources in each PMB control module for delivery to the patient from the light guide(s) or light guide arrangement, among other things.
  • the at least one light guide or light guide arrangement is configurable to be associated with a corresponding validation component, where the validation component is in operational engagement with the control model and the associated componentry, in this regard, prior to dispensing the LILT to a patient, the device is configured to validate thai each of the at least one light guide or light guide arrangements and/or control module are suitably configured in an appropriate delivery element.
  • the at least one light guide or light guide arrangement and/or PBM control module is validated as being appropriately configured to dispense a desired LLLT dosage to a patient, the device can be configured to proceed with a LLLT treatment. If the at least one light guide or light guide arrangement is not appropriately associated with the delivery element, the control module can be configured to not to deliver the LLLT.
  • one or more of the light guides or light guide arrangement configurable with one or more PBM control modules is each, independently, configurable to communicatively identify itself when the light guide or light guide arrangement engagement end is engaged with an associated engagement port.
  • instructions associated with the PBM control module can be configured to match or validate an associated light guide(s) or light guide arrangement(s) that is engaged with a corresponding engagement port. If the expected engagement port/light guide or light guide arrangement match is not generated when the light guide or light guide arrangement is engaged in the engagement port, the PBM can be configured to not activate. A signal can be sent to the provider and/or patient notifying them of the lack of validation.
  • each delivery element for use with the PBM control module and the LLLT delivery element is durably validatable via one or more methods.
  • each at least one light guides or light guide arrangements incorporated into the delivery element can incorporate a light guide/light guide arrangement identification tagging or code that is transmittabie to a signal receiver associated with the PBM control module.
  • Such tagging or identification can be by a validation module associated with a PBM control module suitably configured to read RFID information, bar code scanning, color coding, direct connection circuit (e.g., wires directly connected between the machine and a small chip on the mold), physical (such as physical teeth and groves as a key on a light guide) and active systems where communications (e.g., Wi-Fi, Bluetooth) are natively embedded with the at least one light guide or light guide arrangement.
  • the validation tag or code associated with a light guide/light guide arrangement and the validation module can be durably incorporated into the light guide or light guide arrangement during the molding process, for example.
  • the LLLT delivery element can incorporate an RFID tag etc. that is in operational communication with the validation module.
  • the light guide or light guide arrangement validation element and/or delivery element validation functionality can allow confirmation that a particular light guide or light guide arrangement and associated LLLT treatment delivery elements are authorized for use with the PBM control module and dosing instructions associated therewith.
  • an authorization code can be incorporated into software instructions provided to the PMB control module.
  • the PBM control module’s power source can be configured to lockout or otherwise disable any non- validatable light guides/light guide arrangements and associated LLLT delivery elements from being operational.
  • the PBM control module can be configured to render each of the components individually and collective inoperable unless either or both of the light guide(s) and/or LLLT delivery elements can be validated as authorized for use to provide a therapeutic patient treatment.
  • non-validatable (that is, non-approved or unregulated) LLLT treatment devices might not be configured to the necessary specifications needed to ensure that a patient will receive an appropriate dosage.
  • Such specifications can include parameters such as treatment time, total energy, energy density, power density, cycle time, light application frequency, light intensity, wavelength, among others.
  • light wavelengths such as UVC
  • too little or too much application of light therapy can result in harm to patients or lack of benefits from an applied LLLT treatment.
  • Software instructions associated with the PBM control modules of the present invention can be configurable to identify the treatment delivery element and light guide or light guide arrangement configurations engagable with the communications module via a unique identification code that is transmittable to and detectable by a light guide or light guide arrangement identification signal receiver associated with the PBM control module as authorized for use.
  • instructions associated with the PBM control module is configurable to lockout the LLLT treatment device from use, such as by deactivating one or more aspects of the PBM control module, such as power source and/or light source until the mismatch is corrected by attaching an authorized light guide or light guide arrangement.
  • the instructions optionally include an override that can allow the device to allow operation without the at least one light guide or light guide arrangement having an authorized identifier code, however, that override should only be operable by the device
  • Each of the delivery elements and/or light guides or light guide arrangements used in a particular treatment can be identified, with data representing type, size, configuration, and authenticated serial number that a PBM control module can use to associate with a treatment, a legitimate purchase of the treatment element by a patient, a medical institution, or a provider, therefore, as being authorized for use.
  • Such delivery elements and/or light guides/light guide arrangements will not be registerable for use with another patient’s LLLT treatment, thereby reducing the possibility that the device will be reused in an unauthorized manner.
  • the LLLT delivery element (e.g., brace/cast, bandage, or insertable element) can also be configured with a unique identification code that can be transmittable to the communications module.
  • the LLLT treatment device can therefore be configured to be inoperable unless the delivery element is suitably matched to a unique LLLT delivery element identifier defined as authorized for use with the PBM control module, and any associated LLLT patient treatment regimen.
  • the LLLT delivery element identification code can allow a match to be ensured prior to the delivery of a LLLT dosage to a patient.
  • the software instructions associated with the LLLT treatment devices of the present invention can be configurable to identify the delivery element engaged with the communications module via a delivery element identification code that is transmittable to a delivery element identification signal receiver associated with the PBM control module as authorized for use in the delivery element.
  • the software associated with the LLLT treatment device is configurable to notify the server, provider or other parties of such incidents of attempt for unauthorized use, to lockout the communications device from use, such as by deactivating the power source and/or light source until the delivery element mismatch is corrected.
  • the software optionally includes an override that can allow the device to operate without the delivery element identification code being authorized. However, that override should only be operable by the device manufacturer or the medical provider with proper authorization.
  • the PBM control module can be configured to be
  • LLLT delivery element can be provided. That is, a single PBM control module can be used for the brace, garment, blanket,
  • a PBM control module can be registered to or otherwise identifiable with a single patient. Stored and acquired patient personal and health record information can deployed as needed for that patient in accordance with a first LLLT treatment associated with a first PBM control module. Subsequent LLLT treatments using the first PBM control module, which can be used with the same or different LLLT delivery elements engageable with the first module, can utilize patient health information stored or otherwise configured therein, including information associated with the response of that patient to prior LLLT treatments, can be deployed for subsequent treatments associated with that PBM control module and patient.
  • a PBM control module can also be assigned to a group of patients.
  • a PBM control module can be maintained in location away from open wounds, to remain free of contamination.
  • the PBM control module can also be treatable to reduce or eliminate contamination between uses or users, such as by wiping down with disinfectant, placing in a disinfection cabinet or the like.
  • a sterilizable or disposable cover may be used to protect the PBM from contamination.
  • the cover can optionally include anti-microbial materials such as triclosan or silver.
  • a specific LLLT delivery element identifiably assigned to each user that can be specifically associated with each person’s condition, size, BMI, skin tone, among other information, and the PBM control module interchangeable therewith, by detecting the LLLT delivery element associated with a particular patient, for example, to enable automatic personalized light dosage delivery. Because the LLLT delivery element likely comes into contact with the patient’s bodily fluids or the like, it can be desirable that each of LLLT delivery element is uniquely matched to each patient to reduce or eliminate the possibility of patient cross-contamination.
  • RFID or other signaling capability can be implemented in the LLLT delivery element to lock out or otherwise disable the PBM control module unless the appropriate matching with a LLLT delivery element is achieved.
  • the patient or provider can be required to enter a password that is generated to allow the PBM control module to activate, even when the appropriate matching between the light guide and PBM control module is provided via RFID, electrical connection or otherwise.
  • the LLLT treatment devices and methods of the present invention have broad application in treating a wide variety of patient medical or aesthetic indications in need of treatment.
  • Table 1 below provides a non-limiting list of medical and aesthetic indications that can be effectively treated for improved post-surgical recovery.
  • the present invention comprises selecting a patient medical indication in need of treatment, such as one or more medical or aesthetic indications identified in Table 1, providing a LLLT treatment device comprising a PBM control module comprising at least one light source configurable to deliver a wavelength or wavelength range of LLLT to a patient area in need of treatment,
  • the LLLT is delivered to the patient via one or more light guides or light guide arrangements in engaged with a corresponding engagement ports on the PBM control module.
  • the at least one light guide or light guide arrangement can be attached or mounted to a knee garment, a hip garment, a wrist garment, an ankle garment etc., where such a garment (or brace) is generally configurable to surround an area on the body. Similar configurations for this LLLT delivery element would comprise a brace or a cast. As would be recognized, such garments (or braces) are useful for joint replacement or other surgeries, where structural support proximal to the patient area being treated can be desirable. In this regard, a properly configured LLLT treatment dosage, has been found to greatly enhance the healing, as measured by pain measurement, swelling, bruising, mobility recovery, etc.
  • LLLT delivery element configurations can be beneficial for repetitive stress injuries, muscle strains, fractures, breaks or the like.
  • the LLLT delivery element can also function, at least in part, to provide compression.
  • compression can enhance healing, thus potentially resulting in further improvements in healing.
  • a LLLT treatment device that, at least in part, can be compression device, such as an inflatable sleeve over a leg or an arm, include one or more light guides or light guide arrangements configured to provide light therapy in a post-surgery environment to prevent DVT (deep vein thrombosis) and improve circulation of lymphatic and blood flow.
  • a LLLT treatment device that, at least in part, incorporates compression along with LLLT treatment can be a sports bra-like garment that can include one or more light guides or light guide arrangements configured to provide light therapy in a post-surgery environment to enhance healing of the breast area after mastectomy, augmentation, or reduction surgeries.
  • a LLLT treatment device that, at least in part, incorporates compression along with LLLT treatment can be incorporated along with the garment, so that any incision areas can be treated with at least one light guide or light guide arrangement oriented proximally to the incision(s), and any associated healing areas, for example, armpit lymph nodes, can be treated with light guides or light guide arrangements that are suitably configured to apply therapeutic light proximal thereto. Still further, proper compression combined with LLLT treatment would be appropriate for a stress or strain injury associated with pain, for example.
  • the at least one light guide or light guide arrangement can be attached to or mounted on or otherwise associated with the LLLT delivery element, where the element is configured in the form of a garment/brace/cast, bandage, or the like.
  • the at least one light guide or light guide arrangement will substantially not be evenly distributed along a length and or width of a patient facing side of the delivery element. Rather, the light
  • any associated LLLT delivery can be arranged to provide the desired light distribution proximal to the wound in need of treatment (and any associated healing vital areas).
  • the at least one light guide or light guide arrangement When the at least one light guide or light guide arrangement is incorporated into a LLLT delivery element that is in the form of a brace or garment or cast, the at least one light guide or light guide arrangement can be glued, sewn, mounted, ultrasonically welded or otherwise durably attached to the delivery element.
  • the at least one light guide or light guide arrangement can be attached to the LLLT delivery element by incorporating each of the light guides with a plurality of loops, where a first and second side of each loop is durably attached to a patient facing side of the delivery element, where such durable attachment can be by sewing, adhesive, ultrasonic welding, or the like. Such attachment can also be used for other LLLT device configurations herein.
  • an aspect of the present invention relates to the LLLT being delivered substantially proximally to the wound or patient area in need of treatment (and any areas associated with wound healing) whereby the light guide(s)/light guide arrangements are configured to fit to the general shape of the body area (and any associated areas) where a wound or treatment area is located. It follows that, in use, any association of the light guide(s)/light guide arrangements with the LLLT delivery element can substantially not reduce the flexibility and, therefore, conformability, to the patient area(s) being treated.
  • the light guide(s)/light guide arrangements can be durably attached to the delivery element so that movement from the desired light placement is minimized during patient movement when she is wearing the LLLT treatment device.
  • the at least one light guide or light guide arrangement can be attached to or mounted on or proximal to a LLLT delivery element that is in the form of a garment.
  • a LLLT delivery element that is in the form of a garment.
  • a patient who has undergone facial surgery e.g., a face lift or reconstruction surgery
  • an absorbent gauze or sponge will generally be placed on the wound to absorb the fluids.
  • the LLLT treatment device of the present invention can comprise a garment or bandage that overlies the sterile and absorbent material, also called the primary dressing.
  • any material that covers a patient area should be suitably transmissive to the LLLT being applied.
  • the absorbent material can be combined with a window or opening to allow both LLLT to be delivered to the patient area and wound exudate to be absorbed.
  • the absorbent material can be changed regularly, and the PBM control module re-used for that patient.
  • the present invention further provides devices and methods to enhance the healing and to reduce pain after facial surgery at both the incision area and in areas associated therewith that are prone to swelling.
  • a garment or bandage can be configurable with one or more light guides to suitably deliver LLLT to a patient who has been subjected to surgery in the face or jaw.
  • Such treatment can optionally comprise compression and heat and/or cold therapy to further enhance healing and reduce swelling.
  • the facial and neck area LLLT treatment device can comprise a patient facing side from which LLLT can be delivered from at least one light guide/light guide arrangement.
  • the bandage is suitably stretchable and conformable to provide a suitable fit to the various areas of the face and neck.
  • At least one light guide or light guide arrangement is configured to deliver light from a patient facing side of the device.
  • the at least one light guide or light guide arrangement is in operational and optical engagement with a PBM control module that is mountable in a location that is comfortable for the patient. In this regard.
  • the LLLT delivery device for treatment of head and neck areas can be comprised of a flexible elastic material for securing the device around the head of patient.
  • Suitable fasteners can be used to provide securing, such as Velcro®, clips, snaps, elastic or other straps or the like.
  • the head and neck areas LLLT treatment device is configured to provide suitable coverage of a patient’s face, including at least the sides proximal to the cheeks and, optionally, over and behind one or both of patient’s ears.
  • the amount of coverage needed for a specific patient is largely dependent on at least the amount and number of incisions in the patent’s head and neck areas, and the response of the patient to the procedure.
  • the head and neck area LLLT device can futher be configured to provide cold therapy in conjunction with LLLT treamtent.
  • a portion of the head and neck area device can be configured to be fillable with crushed ice or liquid gel that is freezable, to allow a combination of LLLT treatment, compression and cold therapy to areas on the face and neck where such combination treatment is indicated.
  • one or more removable ice packs can be secured to head and neck area device to suitably apply cold therapy to one or more areas on the patient.
  • head and neck area LLLT treatment deivice is securable around the head of patients with an illuminatible patient side proximally situated at or near one or more areas indicated for at least LLLT treatment, including, but not limitde to but not limited to the face, neck, tooth, gum, jaw, tonsillectomy or
  • TMJ temporomandibular joint
  • need of LLLT treatment can be illuminated with light having in the spectrum of about 630 nm to about 1000 nm, for example.
  • instructions can be configured to generate a first LLLT treatment protocol whereby light from the at least one light source at a wavelength of 650 nm at 60 mW, in a continuous wave for about 120 seconds and including a pulsing mode of about 15 or about 30 or about 60 or about 90 or about 120 seconds of pulsing at each of 4 Hz, 10 Hz, 60 Hz and 1000 Hz, or variations thereof.
  • the PBM control module can direct the first treatment protocol to be repeated from time to time, for example, every 15, 30 60, 120 or 240 minutes, with an off cycle in between each cycle. Based on the postoperative days, the number of cycles can be repeated per the need of energy density and total energy level and optimized to each skin type to provide a LLLT treatment protocol for a patient in need of treatment thereof.
  • a first covering material can form a second side that is away from the patient facing side.
  • the first covering material can be cushioned or the like to improve patient comfort.
  • the patient facing side can comprise a material that allows LLLT to be emitted therefrom.
  • the at least one light guide or light guide arrangement can be incorporated between a light transmitting material and the covering material, optionally with an absorbent material interspersed therein, as discussed in more detail in the Figures hereinafter.
  • the LLLT treatment dosage applied to the relevant patient areas can then be delivered from the patient facing side.
  • material that covers the wound or associated body area can be light diffusing, such as a non-woven material.
  • a suitable non-woven fabric can be a polypropylene-based material.
  • the light diffusing material can comprise a sheet or web structure bonded (e.g., via mechanical, thermal or chemical bonding) together by entangling fibers or filaments. Film perforation can also be used.
  • the wound- contacting material that is light diffusing can also comprise woven fibers, foams/sponges, and the like.
  • the LLLT delivery can be integrated into the garment or bandage itself, whereby the integrated garment optionally incorporates a absorbent material (e.g., gauze, sponge, etc.) and any covering material.
  • the at least one light guide or light guide arrangement can be associated with the PBM control module via the light guide engagement port(s) to allow the garment to be regularly changed and disposed of, but also to allow reuse of the operational components of the PBM control module.
  • the prescribed LLLT dosage may be continued without interruption when a new, that is, fresh,
  • garment/bandage comprising a suitable light guide configuration is placed on the patient
  • the garment/light guide or light guide arrangement combination is itself absorbent.
  • the LLLT treatment devices When configured in the form of a bandage or garment for wound treatment, the LLLT treatment devices substantially do not form an air-tight seal to the wound. Still further, during LLLT treatment with the devices of the present invention, the wound undergoing treatment is exposed to air during treatment thereof.
  • the LLLT delivery element can comprise an insertable device that incorporates at least one light guide in operable engagement with the PBM control module.
  • the PBM control module can be configured to be interchangable with any of the brace, bandage, garment and the insertable form of the LLLT delivery element.
  • the insertable devices can be comprised of medical grade plastic.
  • the inventor herein has determined that application of light therapy, such as LLLT, can enhance healing of wounds in the vaginal cavity and vulvar regions, such as is relevant during male to female sex reassignment, while also being effective in reducing post- operative pain and inflammation. Yet further, the present invention can be utilized to enhance blood flow in female genital tissue, both within the vaginal cavity and in and around the vulvar region. As such, the inventor herein has further determined that LLLT can be effective in“vaginal rejuvenation,” as well as in addressing infections or post-birth injuries to the vulva or vaginal region that can occur, such as in some vaginal deliveries. Areas proximal to the female genitalia, such as the bladder and the anal area can also be therapeutically treated with light therapy according to the devices and methods herein.
  • light therapy such as LLLT
  • the LLLT devices of the present invention are configurable to be wearable by a patient within the vaginal cavity and/or in the vulvar region, as well as areas proximal thereto, in a patient in need of treatment, and the LLLT can be applied with such devices over an extended period, as directed by a medical provider.
  • Such wearability has been found by the inventor herein to improve treatment compliance and enhance the efficacy of light therapy in a patient in need of treatment over prior LLLT delivery methods to the female genital region, when such LLLT is applied in accordance with in conjunction with one or more treatment parameters described herein.
  • the inventive LLLT devices comprise at least one low level light source in operational engagement with at least one light guide configured to deliver a therapeutic amount of LLLT substantially proximal to one or more locations at or near to the female genital area (whether naturally occurring female genitalia or reconstructed as in a male to female sex
  • a variety of light wavelengths can be appropriate for LLLT female genital area treatments herein.
  • light in the ultraviolet, various visible ranges, and infrared light are each, individually, indicated for treatment of a wound, injury or medical indication at certain stages and associated healing areas.
  • at least one aspect of the invention herein comprises selection of at least one light wavelength range appropriate for treating of a female genital area wound or female genital area condition in need of treatment.
  • Wavelengths in the UV spectrum can also be effective in disinfecting a wound when signs of infection is detected or confirmed by the healthcare provider.
  • the various wavelengths can be generated by a light source as would be known to one of ordinary skill in the art or can be determined through use of the inventive devices herein without undue experimentation by one of ordinary skill in the art.
  • the inventive female genital area LLLT delivery device can comprise an insertable device configured to fit in the vaginal cavity where the device is substantially comprised of optically clear polymeric material, such as silicone, acrylic, or polycarbonate.
  • optically clear polymeric material such as silicone, acrylic, or polycarbonate.
  • Such medical grade materials are“hypoallergenic.”
  • Optical clarity allows light of desired wavelength(s) and dosage(s) to travel from a light source in and through the device by way of one or more light guides or light guide arrangements for transmission to the vaginal cavity area for LLLT treatment thereof.“Optically clear” means that substantially all of the light emitted from the at least one light guide or light guide arrangement is then transmitted out of the surface of the therapeutic device. This means that there is
  • At least one light scattering layer can be created on the surface of the transparent core or an additional material can be embedded in the vaginal insert to enhance light diffusion. Such“discontinuities” are described in more detail hereinafter in relation to the Figures.
  • the size of the vaginal insert can be varied depending on the physical parameters of the patient being treated.
  • the provider can measure, either subjectively or objectively, the approximate size of the patient’s vaginal cavity.
  • the provider will select the vaginal insert as sized for the patient being treated with LLLT.
  • the outer surface of the vaginal cavity insert should be substantially approximate to the dimensions of the reconstructed vaginal cavity in a sex reassignment or the dimensions of the cisgender patient’s vaginal cavity for use in a rejuvenation treatment or other suitable indications.
  • the overall length of the vaginal insert may have a smaller variation than that of a cisgender female because the vaginal cavity is being constructed from surgical norms. This is due to the limitations of the male body parts that are used to create the reconstructed vagina.
  • the depth of a typical neovagina created from male to female sex reassignment surgery is generally be between about 11 and 12 cm, as provided by the parameters of Dennovarri’ fascia, from which the neovagina is partially constructed. This is within the range of the natural female vagina.
  • vaginal cavities may be greater.
  • a 1996 study of the vaginas of 39 Caucasian women found the following ranges of dimensions: lengths: 6.9 to 15 cm; widths: 4.8 to 6.3 cm; and introital diameters: 2.4 to 6.5 cm.
  • a 2003 study measured vaginal surface areas ranging from 66 to 107 cm 2 with a mean of 87 cm 2 and a standard deviation of 7.8 cm 2 .
  • the vaginal insert may be provided in a variety of lengths of from about 4 cm to about 15 cm and the diameter at the widest point can be from about 2 cm to about 10 cm.
  • the shape of the vaginal insert can generally be cylindrical. For comfort, the interior end can be rounded.
  • the insert can generally have a tapered configuration, as indicated by the general shape of a natural vaginal cavity, that is, wider at the anterior end (i.e., the part of the vaginal insert proximal to the vaginal opening), with a gradual reduction in the vaginal insert diameter moving toward the interior end (i.e., the part of the vaginal insert that is proximal to the internal end of the vagina, which would be the cervix in a cisgender woman, but would be absent in a male to female sex reassignment patient).
  • An advantage of the present invention is the wearability, comfort, safety and conformability to the treated vaginal cavity area. Moreover, treatment times, including dilation without applied light therapy, can be extended and/or made more convenient.
  • the vaginal insert can incorporate a rim or tab integrally formed with the vaginal insert proximate to the anterior end thereof.
  • the rim is sized and shaped to be comfortable for the patient, but to still enable the use thereof.
  • the rim or tab can be generally shaped as a teardrop, which has been found to comprise a balance between function and comfort for the patient.
  • the size and shape of the rim and tab can be varied, or even not included on the vaginal insert, without departing from the scope and content of the invention.
  • at least some of an anterior end of the vaginal insert can be situated outside the vaginal cavity.
  • the controller and associated light guide(s) or light guide arrangement(s) can be located within the structure of the vaginal insert, that is integrated within the vaginal insert itself, such as at or near the anterior end thereof.
  • the controller and associated light guides or light guide arrangements can be present as a separate set of componentry for engagement with the vaginal insert.
  • the inventive LLLT devices and methods can enhance the effectiveness of such therapies by the applied LLLT stimulating the tissue, and thus growth of new, more elastic tissue, thereby tightening and enhancing feeling in the vaginal cavity area of a woman in need of treatment.
  • Such treatment can also enhance the function of the female bladder by increasing muscle tone of areas proximal thereto.
  • LLLT/dilation combination therapy used in conjunction with a light therapy delivery liner can substantially improve the long-term outcomes of internal and external structures of a reconstructed external female genital area (i.e., the vulvar area), by enhancing wound healing over prior art methodologies.
  • Use of the light therapy delivery liner can improve wound healing of the vulvar region when used alone, such as would be indicated with an episiotomy, for example.
  • Extended lengths for the light therapy delivery liner can allow treatment of hemorrhoids along with the vulvar areas, or hemorrhoids can be treated without attendant treatment of the vulvar areas.
  • LLLT light therapy applied both internally and externally to the vulvar regions can also be useful to treat vaginal fungal infections, and the methods and devices of the present invention also incorporate this treatment modality.
  • the light therapy delivery liner can be sized and shaped for the comfort of the patient.
  • the liner can generally be narrower at the front end (i.e., the area proximal to the clitoral area of the female genitalia) and wider at the back end.
  • the corners are optimally rounded, again to enhance comfort.
  • the shape can also approximate that of a panty liner or sanitary pad, as appropriate.
  • the delivery liner can be provided in a variety of sizes.
  • the length can be from about 20 to about 35 cm and the width can be from about 8 to about 16 cm at the widest end (i.e., in the area proximal to the rectum) and about 1 to about 10 cm at the narrowest part (i.e., in the area proximal to the clitoral area).
  • the size and shape of the liner can be modified to enhance comfort.
  • Soft and flexible materials should be used, such as silicone that has a Shore hardness of from about 0 to about 30, or from 15 to about 25.
  • the light therapy delivery liner can incorporate an indentation sized and shaped to allow the anterior end of the vaginal insert to engage therein.
  • an indentation sized and shaped to allow the anterior end of the vaginal insert to engage therein.
  • the at least one (or one or more) light guides or light guide arrangements can be configured to enhance patient comfort, and thus wearability and patient compliance.
  • the at least one light guide or light guide arrangement is configured proximal to the anterior end of the vaginal insert, whereby the at least one light guide or light guide arrangement entry into the vaginal insert is at a position on the vaginal insert that is external to the vaginal cavity when the vaginal insert is in the patient’s vaginal cavity.
  • the surface of the vaginal insert is substantially smooth.
  • One or more optical guides are utilized with the light therapy delivery liner.
  • the optical guides are engaged with the liner to enhance wearability and patient comfort.
  • the optical guides can be engaged with the liner at a front or a back end.
  • the present invention comprises an insert and/or liner from which LLLT is provided in a known or regulated dosage amount, such as by a dosed light source.
  • the wavelength(s) of light applied to the female genital regions in need of treatment can be any wavelength(s) of light applied to the female genital regions in need of treatment (that is vaginal cavity and/or vulvar areas and, optionally, areas proximal to these areas)
  • a single light guide or light guide arrangement can be configured to emit light proximal to the wound and the additional area(s). If the applied wavelengths are different, it can be beneficial to deliver the respective wavelengths with two different light guides.
  • One or more light sources can be used to deliver the singular or multiple wavelengths through one or more light guides or light guide arrangements.
  • light reflected or emitted from vaginal cavity tissues while the vaginal insert device is inserted therein can be collected in one or more light guides or light guide arrangements operationally engaged with the vaginal insert for evaluation of such reflected or emitted light in a suitable sensor associated with the controller, such as photodetector with optical filters for desired wavelengths or the like.
  • a suitable sensor associated with the controller such as photodetector with optical filters for desired wavelengths or the like.
  • wounds may reflect or emit light in different wavelengths that can indicate the phases of healing.
  • wounds that are not healing correctly can reflect or emit light in wavelengths that can provide information about such inadequate healing progress or presence of infection.
  • the inventions herein can be configured to allow such reflected or emitted light to be collected in one or more light guides or light guide arrangements in operational engagement with an evaluation device suitable for measuring the wavelength of light so reflected or emitted.
  • an evaluation device suitable for measuring the wavelength of light so reflected or emitted.
  • Such detected light energy from the wound during healing can provide timely and accurate information and can be utilized to determine the healing progress of any wound healing, including in the female genital area undergoing treatment with the LLLT treatment devices herein. If the reflected or emitted light and associated evaluation thereof indicates that healing is occurring faster or slower than expected, the LLLT dosages can be timely modified, or the treatment stopped if appropriate.
  • Such sensor data and measurement of healing progress can be desirable in near-real time monitoring the healing progress within a vaginal cavity because the patient may be highly sensitive during healing, and timely adjustment of treatment may reduce pain while the patient is being treated at home before a thorough in-office patient evaluation by a medical provider. Light reflected or emitted from the vulvar regions can also be evaluated, although it will be easier for a provider to visually evaluate the healing progress of such external genital areas.
  • LLLT treatment devices for nasal and/or sinus indications are provided, such as a rhinoplasty or sinus-area surgeries, such as septoplasty, rhinoplasty, and tonsillectomy etc.
  • a rhinoplasty or sinus-area surgeries such as septoplasty, rhinoplasty, and tonsillectomy etc.
  • a nasal insert that suitably delivers LLLT treatment to the interior of the nose (e.g., nasal and, optionally, areas proximal thereto).
  • the nasal insert has an outer
  • the nasal insert can also comprise an inner diameter that is configured to allow air to travel therein to enhance patient comfort post- procedure.
  • the nasal insert is removably engageable with a PBM control module. When engaged with the PBM control module, LLLT is delivered to the interior of the nose. It can be beneficial to mount the PBM control module in a location away from the patient’s face.
  • the PBM control module can be engaged with a first light transmission portion that is flexible and allows LLLT to be transmitted with minimal loss. This can be
  • the fiber optic can be operationally and optically engageable with a light guide arrangement, or second light transmission portion, that is suitably configured to be delivered to the interior of a patient’s nose.
  • a magnetized connection can be used, as described further herein in the Figures.
  • the nasal insert can be used in conjunction with a support that is configured to cover the patient’s nose.
  • This support can be shaped to provide support to the bridge of the nose.
  • LLLT treatment can be delivered to a patient facing side of the support from a suitably configured light guide arrangement.
  • a fiber optic can be used to deliver LLLT effectively and efficiently from the PBM control module to the light guide arrangement.
  • LLLT treatment Due to the anti-inflammatory properties of red and NIR light, when LLLT treatment is supplied to the affected patient areas immediately post-surgery, post-operative swelling will be minimized and breathing through the nose will be made possible. This LLLT treatment will also be helpful to alleviate the nasal congestion caused by swelling tissue inside the nasal cavity but constrained by the bone structure around it, potentially reducing tissue necrosis and improve success rate and comfort for the patients. Light energy has also been documented to accelerate the healing of surgical wound and shortening recovery time. LLLT treatment can also provide analgesic effect, relieving pain after a surgery.
  • the insertable LLLT element can comprise a device to aid healing after oral surgery, such as the upper or lower areas of the mouth.
  • the invention further comprises devices and methods for treatment of mouth areas after procedures such as tonsillectomy, in conjunction with orthodontic procedures, bone grafts, dental implants, gingivitis correction, and other mouth area procedures.
  • procedures such as tonsillectomy, in conjunction with orthodontic procedures, bone grafts, dental implants, gingivitis correction, and other mouth area procedures.
  • mouthpieces can be configured to deliver LLLT from at least one PBM control module, via suitable light transmission portions, such as fiber optics and/or suitable light guides/light guide arrangements.
  • suitable light transmission portion is operationally and optically engaged with each of the upper or lower mouthpieces, which are optically transmissive, and having Shore A Hardness of about 20 to about 95.
  • the mouthpieces can be configured to fit over the teeth or palate, with or without coverage of the all or part of the upper teeth. In a further aspect, the mouthpiece can be configured to fit over the lower teeth. In either case, LLLT treatment can be delivered to proximally to the mouth area from the light transmissive portion of the mouthpiece. Reflective material can be incorporated in an interior portion of the mouthpiece to enhance light delivery. Discontinuities can also be incorporated to enhance light scattering and diffusion as discussed elsewhere herein.
  • a softer material between Shore A hardness of about 20 to about 80 can be used to fabricate mouthpieces having grooves, to facilitate fitting onto the teeth.
  • harder materials such as those in the Shore D hardness range of about 70 to about 95 can be more suitable for clear and less visible braces, which are designed to have a grove(s) that fit tightly to the teeth for orthodontal alignments.
  • LLLT mouth device configurations can be optimized to treat various conditions. For example, when an entire mouthpiece surface is configured to transmit light delivered from a PBM control module, the mouthpiece can function as clear braces to enhance correction of the teeth position. Upper and lower mouthpieces can be configured to allow light to be delivered from a single PBM control module. When red light is applied to the mouth interior at from about 640 nm to about 670 nm dosed at about 0.2 to about 1J/cm 2 /day, LLLT can speed up teeth movement as well as reduce the pain and discomfort from wearing the brace. Still further, LLLT treatment can reduce the pain and swelling after surgeries to the uvula, tonsil and palate. LLLT treatment can reduce the pain and swelling after surgeries to the gum, or as ongoing treatment to gingivitis.
  • the light guides can be arranged to deliver light substantially proximally to the areas associated with healing of an incision, but where the incision is not readily reachable by the light guides or light guide arrangements, notwithstanding their flexibility.
  • a treatment modality is for removal of third molars (wisdom teeth) where the incisions should remain substantially untouched and where it would often be difficult to comfortably fit a treatment device to the interior of a patient’s mouth.
  • LLLT treatment can be applied extra-orally, proximally to the patient’s face proximally to the sites where the third molars have been removed, and further to the lymph and carotid areas in the patient’s neck area to provide stimulation of those areas to enhance healing, reduce pain and swelling.
  • the wearable/portable LLLT treatment devices and methods of the present invention can be used to treat skin conditions, such as psoriasis, fungal infections etc. As disclosed in US Patent Application No.
  • the appropriate wavelength to treat psoriasis is from about 300 nm to about 320 nm.
  • infections are typically treated using wavelengths of about 255 to about 320 nm.
  • the devices and methods of the present invention can also incorporate light sources that generate LLLT in these ultraviolet ranges, especially UV-C from a PBM control module equipped with an appropriate light source.
  • LLLT has been shown to be effective in anti-aging treatments.
  • the LLLT has been shown to increase cell regeneration, such as to slow or even reverse the effects of photoaging.
  • Such anti-aging LLLT is disclosed in US Patent No.
  • the LLLT delivery element for anti-aging processes, as well as acne treatment can be in the form of a plastic mask with a Shore A hardness of about 0 to about 10 and reflectively coated on the side facing away from the face, wherein the at least one light guide or light guide arrangement is arranged proximal to the patient’s facial areas.
  • the present invention can employ light at from about 800 to about 900nm range for treatment “around the eye”.
  • the devices and methods of the present invention can be used to treat medical indications in the head and neck area with lymph node clusters and typical lymph drain in the face and mouth.
  • the flow of lymph fluid can be enhanced to reduce swelling and improve healing.
  • the devices of the present invention further incorporate light treatment of areas on the patient that are in locations on the patient that are not the actual wound area, or a“second treatment modality.”
  • the delivery element can further include LLLT in areas associated with healing of the wound area, such as blood vessels, lymph nodes, nerves or acupuncture pressure points. Such areas can be those areas of the patient that are therapeutically associated with healing functions of the incision.
  • the wavelengths of light applied proximally in the first treatment modality can be the same or different from the wavelengths of light applied to areas associated with the second treatment modality. Areas suitable for treatment in a second treatment modality can comprise one or more lymph areas and/or one more blood vessel areas on the patient. If the wavelengths applied for the first and second treatment modalities are the same, a single light guide/light guide arrangement can be configured to emit light proximally to both the areas of treatment for the first and second treatment modalities, where the light guide or light guide arrangement is operationally engaged with the PBM control module as disclosed elsewhere
  • the light can be provided from separate light guides/light guide arrangement, where each light guide/light guide arrangement is operationally engaged with the PBM control module as discussed elsewhere herein.
  • the devices of the present invention further incorporate light treatment of patient areas that are in locations on the patient that are not the actual wound area.
  • the LLLT delivery element can further include application of LLLT in“healing vital areas,” that is, areas associated with healing of the wound area, such as blood vessels, lymph nodes, nerves or acupuncture pressure points. Such areas can be those on the patient that are therapeutically associated with wound healing functions or tissue regeneration in the female genital regions.
  • the LLLT delivery device can incorporate additional LLLT in a location away from the wound area where the additional LLLT is provided at an area proximal to those one or more areas of the patient that are associated with increasing blood flow to the area proximal to the wound or desired tissue regeneration.
  • infrared and red light beams will penetrate to various depths, depending on wavelength (for example, the 830 nm wavelength will penetrate to a depth of nearly 5 cm).
  • the laser beam at a low power under 200 mW or so
  • nitric oxide a vasodilator
  • the laser will “desensitize” local nociceptors, thereby decreasing or even eliminating pain at the site.
  • the groin area with blood vessels to and lymphatic nodes/ducts that drains from the knee area after surgery can be treated with LLLT substantially simultaneously with an application of a LLLT treatment of the area substantially proximal to the wound area.
  • the light delivery element for example, a knee brace or bandage configured with one or more flexible light guides/light guide arrangements substantially conformable to the knee incision area
  • the light delivery element can also incorporate LLLT treatment delivered from light guide(s) or light guide arrangement(s) operationally and optically engaged with a PBM control module configurable to provide LLLT treatment of the same or a different wavelength in an area substantially proximal to the lymphatic system located in a lymph drainage location from the wound site, as well as blood vessel areas associated with the knee and incision area.
  • the LLLT treatment device can include an aspect that is configured in an area proximal to the neck area with blood vessels to the facial tissues and superficial lymph nodes that receive lymph drain from most of the facial tissues.
  • Different patients may react differently to light therapy, such that a particular light therapy dose may be more effective for one patient than for another.
  • This between-patient variability can be substantial. For this reason, in some aspects, basing a light therapy dosage on the patient's observed initial condition may not result in optimum dosing for any one particular patient.
  • the variability of a particular patient's response to light therapy may be small in comparison to the between-patient variability.
  • aspects of the present invention therefore further comprise one or more monitoring events during a scheduled treatment regime, wherein after application of a selected LLLT treatment for a patient, a provider can observe the healing (or lack thereof) of the patient’s wound or other medical indication, and, optionally, make an adjustment of the applied LLLT treatment dosage in response to an observation in real time.
  • Such in-treatment observation can be made remotely with the aid of the data from sensors and/or imaging devices associated with a PBM control module and that may be incorporated in associated devices, thus allowing a dosage modification to be provided substantially timely without need for the patient to visit a provider’s office.
  • a dosage can be calculated based not only on the patient's initial indicated dosage, but also on the patient’s prior responses to light therapy doses.
  • an initial dosage and treatment time is defined by the medical provider.
  • the appropriate LLLT treatment device configuration e.g., brace, garment, bandage, insertable element
  • all or part of the LLLT treatment device can be purchased by the patient in an“over the counter” environment, which can be either physically or electronically virtual.
  • the LLLT treatment devices are provided to the patients at no or substantially reduced cost, with the definition and administration of a treatment dosage provided to a patient when the patient fills a digital“prescription” from a provider, the“light medicine” in the form of data or software instructions are deliverable to the device.
  • the person can be required to register the device via an app or online prior to the device being activatable for use.
  • the person can be provided with a code to
  • the provision module can transmit the“photonic medicine” to the PBM control module associated with that patient via software instructions that include operational parameters for patient LLLT treatment and dosage appropriate for the patient as defined by the patient’s input.
  • Existing treatment programs already stored in the memory on the PBM control module can be operated via a set of parameters assigned to the specific patient by the medical provider, including one or more of the wavelength or wavelengths, wavelength ranges, pulsing frequency, light output power, intra-day sessions, length of treatment session time, session irradiation time, intra-session intermission time, treatment days, total session numbers, total treatment days, total irradiation time, time-course and variation between sessions, as well as sensor activation instructions, among other information.
  • the software instructions can include both a new program and operational data to the PBM control module.
  • the dosage can also be modified from time to time if the patient provides further input as the treatment progresses.
  • the components of the device can be deactivated from use so as to prevent reuse of the LLLT treatment device without proper device and patient management of a patient by a provider. Reactivation of the device can only occur if the person reengages with the app or the online registration program, so as to provide updated medical conditions.
  • the PBM control module can store and/or transmit to a remote device all information, including data and images from sensors, treatment progress input, patient profile data, as well as the prescribed treatment details in a data warehouse for further analysis with machine learning and artificial intelligence to improve human light therapy knowledge and understanding.
  • the data communication system associated with the LLLT treatment device for transmitting data to and from the light therapy device comprises a wireless data communication system that includes LTE, WiFi, or Bluetooth ® -enabled transceiver.
  • the LLLT treatment device of the present invention substantially does not require the patient to be stationary during treatment, as is necessary with conventional light therapy devices, such as handheld light treatments, light boxes or the like. To the contrary, the LLLT treatment devices of the present invention are fully wearable and portable in accordance with being battery powered.
  • Encryption such as VPN, IPSec, SSH (Secure Shell), SSL (Secure Sockets Layer), etc.
  • SSL Secure Sockets Layer
  • the wearable LLLT treatment device is configurable to dispense one or more therapeutic dosages of LLLT treatment to a patient in need of such treatment, whereby the generated dosage of LLLT is defined or approved by a provider prior to and, optionally, during a treatment.
  • the amount of LLLT treatment appropriate to provide a therapeutic dosage as indicated by selection of one or more wounds or physiological condition present in the patient.
  • the LLLT treatment device of the present invention is configurable to allow a provider to monitor and, optionally, to modify the delivery of one or more individual LLLT treatments in a total LLLT treatment regimen and, in some aspects, the treatment results via communications capability as discussed in detail herein.
  • the post-operative LLLT treatment appropriate for recovery can be significantly different, both in terms of treatment delivery element, wavelength, and dosage. Even though breast augmentation ostensibly appears to be similar to breast reconstruction because an implant is placed in the patient’s chest area, her recovery time may be considerably different than breast reconstruction surgeries. Breast reduction may have an even different recovery time due to the variation in the incision type, size, removal of native tissue, etc.
  • a further aspect of the devices and methods of the present invention can be the selection and/or identification of a sub- category of a surgery-type. So, provider prescribing or approval of LLLT treatments after surgery can be an aspect of the invention.
  • the course of healing of a wound or other physical malady in a patient may also vary within a patient regimen.
  • a wound heals such as with a surgical incision
  • four stages of healing are present and follow four processes: hemostasis, inflammation, proliferation and maturation.
  • the four phases are recognized to be different molecular- biologically, some phases can occur with overlapping in time. For example, on post-op day after a Cesarean delivery, while some tissue on the abdominal skin the might be
  • hemostasis is the process of the wound being closed by clotting. Even though the action of hemostasis happens very quickly, a patient may experience this phase as long as three days after an extensive surgery and for which PBM provision module or a provider may consider when prescribing LLLT treatment.
  • light wavelengths in the visible red spectrum of from about 650 nm to about 1,000nm can be beneficial when delivered at dosages of from about 2 to about 5 Joule/cm 2 per day for the first about 48 hours depending on the areas of the body to reduce the occurrence of bruising and swelling.
  • a patient with skin color type II on a Fitzpatrick scale with an incision wound of about 35 centimeters long around the upper portion of the face such as after a rhytidectomy, or facelift, which also has a large amount of mobilized tissue dressing on post-op day and post-op day 1, and on post-op day 2 and 3, exudates and absorbent dressing.
  • a prescription with a combination of about 650 nm and about 810 nm at about 3J/cm 2 on post-op day 1, 2J/cm 2 on post-op day 2 can be used during the hemostasis phase while transitioning into inflammatory phase.
  • treatment provisional system may recommend a modified prescription to increase the amount dose to 2.5J/cm 2 on post-op day 2 to be approved by provider.
  • LLLT treatment can enhance wound healing.
  • the physiological process for each of these stages are different.
  • LLLT treatment of the present invention can be varied in treatment parameters as healing progresses in an individual patient.
  • the LLLT of the present invention can be defined in accordance with the expected length of each of the stages of wound healing.
  • the LLLT treatment protocol can be selected, observed, modified, managed and/or tuned to account for at least one, or two, or three stages of wound healing, or for any other relevant parameters.
  • the present invention comprises identification of a wound treatment phase, based on sensor data, image or patient input and application of an appropriate wavelength(s) of light, and dose to optimize, enhance or augment healing of the wound during that phase.
  • Inflammation begins right after the injury when the injured blood vessels leak transudate (made of water, salt, and protein) causing localized swelling. Inflammation both controls bleeding and prevents infection. The fluid engorgement allows healing and repair cells to move to the site of the wound. During the inflammatory phase, damaged cells, pathogens, and bacteria are removed from the wound area. These white blood cells, growth factors, nutrients and enzymes create the swelling, heat, pain and redness commonly seen during this stage of wound healing.
  • the LLLT treatment can be provided to
  • light wavelengths in the visible red spectrum at from about 650 nm to about 900 nm can be beneficial when delivered at dosage of from about 1 to about 5 Joule/cm 2 per day for the first about 48 to about 72 hours depending on the areas of the body.
  • a LLLT treatment regimen having a combination of about 650 nm and about 810 nm at 5J/cm 2 on post-op day 1, 4J/cm 2 on post-op day 2 and 3J/cm 2 on post-op day 3 can be used during the inflammatory phase.
  • Higher dose may be recommended for the same wound for a patient with skin color type V on a Fitzpatrick scale.
  • sensor data obtained from treatment can provide information about the level of exudate presence, which can be correlated to the progression of inflammatory phase.
  • sensors associated with the PBM control module provide information signaling the presence of a higher than normal amount exudate on post-op day 2, increase the amount of LLLT treatment to about 2.5J/cm 2 on post-op day 3.
  • the invention also is adjustable to incorporate parameters such as the size of the wound as well as the location of the wounds on the body during each phase of healing due to matters related to relevant tissue structure (e.g., thickness of dermis, subdermal fat, depth of incision, mobilized tissues, closure technique, affected organs, as well as other factors).
  • a patient with skin color type II on a Fitzpatrick scale could have four wounds of about 5 centimeters each near the eyes, such as after a blepharoplasty, on both the upper and lower eyelid.
  • a prescription with 810 nm at 2J/cm 2 on post-op day 1, 1.5J/cm 2 on post-op day 2 and 1J/cm 2 on post-op day 3 can be used during the inflammatory phase, or modifications of such dosage may be specifically indicated by the patient’s individual condition.
  • the proliferative phase of wound healing occurs when the wound is rebuilt with new tissue made up of collagen and extracellular matrix.
  • the wound contracts as new tissues are built.
  • a new network of blood vessels is constructed so that the granulation tissue can be healthy and receive sufficient oxygen and nutrients.
  • Myofibroblasts cause the wound to contract by gripping the wound edges and pulling them together using a mechanism similar to that of smooth muscle cells.
  • the LLLT treatment can be provided to be effective to enhance healing during the proliferation process.
  • light wavelengths in the visible red spectrum of from about 650 nm to about 900 nm can be beneficial when delivered at dosage of from about 0.1 to about 4 Joule/cm 2 per day for the proliferation phase depending on the nature of the wound and locations of the body.
  • Cesarean delivery typically starting on post-op day 4 after discharge from the hospital, with possible exudates and absorbent dressing.
  • a prescription with a combination of 25% energy from 650 nm and 75% energy from 810 nm at a combined 2J/cm 2 on post-op day 4 to day 10. If the patient reports higher than normal pain will be kept at 3J/cm 2 on post-op day 4 to day 10. Higher dose on 810 nm to increase the tissue penetration considering the depth of tissue to be affected. Further, sensor data from treatment device will report on the level of exudate presence and change in skin color from light reflection, which may be correlated to the healing progression and infection.
  • the PBM control module can use generated sensor data indicating a higher than normal amount“pink” tissue on post- op day 4, after sending question to patient to confirm the sensor data validity, to recommend an additional or modified treatment amount, such as to generate LLLT application in the UV- C spectrum at from about 250 to about 270 nm with a dose to 1 mW/cm 2 , for about 60 seconds twice daily starting on post-op day 5 for six days to the provider for approval.
  • the PBM control module receives and completes the new prescription via software instructions by incorporating regular monitoring by sensors and/or patient feedback.
  • the maturation phase (also called the“remodeling stage”) occurs when collagen is remodeled from Type III to Type I and the wound fully closes. The cells that had been used to repair the wound but which are no longer needed are removed by apoptosis, or programmed cell death. When collagen is laid down during the proliferative phase, it is disorganized and the wound is thick. During the maturation phase, collagen is aligned along tension lines and water is reabsorbed so the collagen fibers can lie closer together and cross-linking. Depending on the wound type and area on the body, remodeling begins at about 21 days after an injury and can continue for a year or more.
  • the LLLT of the present invention can be provided to be effective to enhance healing during the maturation phase of a wound healing process.
  • the invention also take consideration for size of the wound, patient scar history, patient skin type, age and other profile data as well as the location of the wounds on the body during the maturation phase of healing because of the tissue location and patient profile matters significantly during this phase, especially to minimize the development of abnormal scars, such as keloids and hypertrophic scars.
  • keloid scars occur in about 15 to about 20% of individuals with African, Asian or Latino ancestry.
  • a patient with skin color type VI on a Fitzpatrick scale has a wound of about 5 centimeters on the chest.
  • patient variability can significantly affect recovery time. Failure to progress in the stages of wound healing can lead to chronic wounds. Physiological features that can progress to chronic wounds can include venous disease, infection, diabetes and metabolic deficiencies of the elderly. Moreover, the general physical condition of the patient prior to surgery can affect the rate that a patient will heal. For example, a patient who is more willing to engage in physical therapy may recover more quickly from joint replacement surgery (e.g., knee, hip, ankle etc.) than a person who is not.
  • joint replacement surgery e.g., knee, hip, ankle etc.
  • Such patients may be identified by weight, age, lifestyle (e.g., active, sedentary, etc.), other medical conditions (e.g., obesity, arthritis, depression, diabetes, etc.).
  • a further aspect of the present invention can incorporate selection and/or identification of at least one patient specific (or personalized) patient condition prior to providing of a LLLT dosage to a patient in need of treatment, where information about such condition is incorporated into the LLLT treatment regimen provided to that patient.
  • a LLLT treatment scalp area treatment device can comprise a cap or hat configured to incorporate LLLT treatment.
  • the cap or hat is associated with a LLLT guide arrangement a PBM control module.
  • the light guide arrangement can be permanently attached to the hat or cap or removably mounted therein.
  • the PBM control module is mountable to the hat or cap, and can be removable for servicing.
  • a concave side, patient facing side, of the light guide arrangement configurable to approximate the shape of a user’s scalp area and a convex side, or cap/facing side, of the light guide arrangement is on a side opposite the scalp.
  • the LLLT operational aspects can be configured to be substantially concealed in a baseball cap or a hat for discrete treatment and/or to contain the LLLT treatment within an area and/or to provide additional structure for the light guide arrangement and PBM control module.
  • a light guide arrangement can be worn alone to provide therapeutic benefit.
  • the light guide arrangement can also be placed inside a separate head covering as desired by the user.
  • At least one light guide arrangement is in operational and optical engagement with at least one PBM control module configured with at least one light source that can emit light at from about 630 nanometers to about 1,000 nanometers, for example.
  • Blood supply to the scalp is believed to be one of the key factors for healthy hair growth.
  • Traditional hats or caps when worn with a tight band, reduce or cut off the blood supply by applying pressure to the six arteries to the top of scalp, which in term may worsen
  • the present invention provides a design of hat or cap band that reduces pressure to areas with blood vessel and lessens the negative effect of tightly worn hat to the health of hair.
  • the regions between the blood vessels in the scalp area have been found to be optimal areas of support to the hat or cap band.
  • Cushioning can also be placed in one or more areas on the hat or cap band to reduce pressure on scalp area blood vessels.
  • the cap areas on the front of the head and on the back of head are also optimal areas of support to reduce overall pressure from wearing of the cap or hat.
  • a feedback system can be beneficial to allow users to monitor the progress of hair growth to encourage compliance at home.
  • the present invention provides for a sensor or sensors associated with the LLLT scalp area device within the hat for easy and frequent monitoring of hair growth by consumers at home.
  • An optional monitoring system can also include a
  • componentry for: (1) capturing images included opening and scalp photograph, time stamp, (2) saving images; (3) analyzing the captured images for hair density; and (4) providing meaningful visual presentations from the analysis of captured images.
  • the PBM control module can be fully or substantially concealed in the rim or along the interior of the hat.
  • the various components that together comprise the PBM control module is optically coupled to the light guide arrangement that can be configured to spread out over a larger surface of scalp area by comprising a flexible structure that is adjustable to the unique size and shape of a person’s head.
  • LLLT treatment devices of the present invention include, but not limited to, acute orthopedic conditions such as sprains, strains, post-surgical pain, a whiplash injury, muscular back pain, cervical or lumbar radiculopathy, tendinitis, and chronic conditions such as osteoarthritis, rheumatoid arthritis, frozen shoulder, neck and back pain, epicondylitis, carpal tunnel syndrome, tendinopathy, fibromyalgia, plantar fasciitis, post tibial fracture surgery and chronic regional pain syndrome are amenable to treatment with LLLT.
  • acute orthopedic conditions such as sprains, strains, post-surgical pain, a whiplash injury, muscular back pain, cervical or lumbar radiculopathy, tendinitis
  • chronic conditions such as osteoarthritis, rheumatoid arthritis, frozen shoulder, neck and back pain, epicondylitis, carpal tunnel syndrome, tendinopathy, fibromyalgia, plantar fasciitis, post tibial fracture surgery and chronic regional pain
  • LLLT dental conditions producing pain such as orthodontic procedures, dentine hypersensitivity, and third molar surgery respond well to treatment with LLLT.
  • Neuropathic pain conditions can also be treated such as post herpetic neuralgia, trigeminal neuralgia, and diabetic neuropathy.
  • effectiveness of LLLT treatment for orthodontic procedures, dentine hypersensitivity, and third molar surgery respond well to treatment with LLLT.
  • Neuropathic pain conditions can also be treated such as post herpetic neuralgia, trigeminal neuralgia, and diabetic neuropathy.
  • LLLT that is applied with light in the range of from about 650 to about 1,000 nm.
  • the devices and methods of the present invention can incorporate selection of at least one patient-specific physical or medical parameter to be incorporated into the software instructions prior to or during administration of one or more LLLT.
  • the provider can input into a user interface (as discussed in more detail hereinafter) at least one of aspect of a patient’s medical or physical condition, prior to the administration of a first LLLT dosage.
  • the provider or the patient in some aspects
  • Sensors can be incorporated in or associated with the LLLT treatment devices to allow patient vital signs to be collected.
  • one or more sensors can provide real time or substantially real time measurement of one or more of a patient’s heart rate, pulse, temperature, blood glucose reading, and the like.
  • These one or more sensors can be incorporated on the LLLT delivery element or associable with the PBM control module(s), as discussed hereinafter. Alternatively, separately configured sensors can be in
  • individual medical monitoring and treatment equipment associated with the patient can be associated with the communications capability of the LLLT treatment devices to enhance the data available for analysis of the progress and effectiveness of LLLT treatment.
  • the data collection and transmission capability can enhance monitoring and management of such patient’s medical condition in a medical telemetry environment.
  • glucose monitoring capability can be associated with the LLLT treatment device, such as by placing a glucose monitor for the patient in communications engagement with the LLLT treatment device. If patient glucose level data transmitted to the provider can be relevant to indicate that the patient’s healing is slower or faster than expected, the provider can adjust the LLLT dosage to obtain the desired rate of wound healing. Additionally, for patients with chronic wounds caused by diabetes, enhanced knowledge of how glucose levels over time may (or may not) affect wound healing and associated LLLT can enhance management of long term patient care.
  • Accelerometer data such as that generated by a fitness device (e.g., FitBit® or the like) can be transmitted to the communications componentry of the LLLT. Accelerometer- containing sensor capability can also be incorporated into the LLLT treatment devices. As would be recognized, accelerometer data can be useful to monitor patient activity, which can provide useful information about the mobility of the patient which, in turn, can provide
  • patient mobility data transmitted to a provider remotely can provide objective information about the speed of healing of a patient receiving LLLT after surgery. If mobility data transmitted indicates that the patient’s healing is slower or faster than expected, the provider can adjust the LLLT dosage to obtain the desired rate of wound healing.
  • the PBM control module is engageable to wearable devices in addition to LLLT treatment, and such devices can be in communications engagement with patient treatment information.
  • the communications engagement can be with a patient personal health record and/or a database of treatment information aggregated from a plurality of patients.
  • auxiliary devices can include ultrasound bone growth stimulators, radio frequency treatment device, TENS units, cold-therapy device, compression treatment device, and the like. Data obtained from such auxiliary devices can be utilized to generate a knowledge base that can be used to optimize treatment for a patient or group of patients for use in subsequent LLLT treatment applications.
  • the communications capability of the LLLT treatment devices of the present invention can also be configured to receive other collectable information that might be relevant to the effectiveness of patient wound healing.
  • information generated by a Wi-Fi enabled scale can be transmitted to the LLLT treatment device for transfer to a provider.
  • the patient’s home or care facility conditions (cold, hot, humidity) as measurable by Wi-Fi enabled environmental sensors can be collected by the LLLT treatment device for transmission to the provider.
  • information can be collected for transmission to the provider to indicate whether the patient is obtaining the necessary nutrition needed to effect healing.
  • Such capability can be especially relevant for homebound patients with chronic diseases, such as diabetes. As would be recognized, such chronic patients often experience associated chronic wounds that are slow to heal, or even that wholly fail to heal.
  • sensors can be incorporated with the LLLT treatment device to receive information generated from a wound during the LLLT treatment process.
  • sensors capable of reading a wavelength of light can be configured with the devices.
  • the wound may emit one or more wavelengths of light having characteristics with known association with the healing of the wound. For example, when a photo-sensor is equipped to detect the reflection of the same treatment red-light detectable near the connecting end of a light guide on post-operative day zero from a C-section wound dress over the incision will generate a reflection value A, which the Value A can be co-related to post-operative day.
  • a reflection value B which has the combined reflection of the wound (with greater reflection) and the surrounding skin (with lesser reflection) can be detected with similar data correlation.
  • a reflection value C can be detected with similar components.
  • the average total reflection value trend can exhibit a decline over time, at a typical rate over the post-op recovery period. A slower decline may signal a delayed or sub-optimal wound healing. A sudden increase in generated reflection value many therefore indicate infection.
  • an embodiment of the invention is equipped with a photo- sensor capable of detecting the infrared light emitted from the incision and surrounding area.
  • a data correction with post-op day, patient profile, and post-op care protocol can result in observable data trends. A change in trend might indicate events, including healing speed, infection, wound contraction, compliance, etc.
  • excitation light such as blue or UV can be employed to detect bio-fluorescence from the tissue for healing analysis.
  • a total treatment regimen can comprise a plurality of individual treatments defined over a treatment period.
  • the specific treatment regimen provided to a patient will be defined by a provider prior to and, in some respects, during a treatment that is underway.
  • the time appropriate for a LLLT treatment regimen will be dependent, at least in part, on the type of wound or physiological malady being treated with LLLT. For example, post-surgical LLLT treatment to enhance wound healing in oral surgery will take about 6 days from surgical event to substantial healing. Recovery for knee replacement surgery may take up to about 90 days. Recovery from breast augmentation surgery may take up to about 50 days.
  • the LLLT treatment of the present invention therefore incorporates selection and/or identification of a specific wound of physical malady in need of treatment.
  • a specific wound of physical malady for example, knee replacement, hip replacement, oral surgery, breast surgery, abdominal surgery, facial surgery, vaginal surgery, nasal surgery, burns, cuts, or bruising (or any other applicable treatment types), can first be selected and/or identified as the applicable medical or cosmetic indication for which LLLT treatment is being prescribed.
  • treatment duration may be indefinite.
  • Aesthetic/cosmetic treatment e.g., vaginal rejuvenation, hair growth, anti-aging
  • Information can be collected and stored or transmitted of one or a plurality of dose applications, for example, each dose, a plurality of doses provided to a patient over a period such as daily, every other day, weekly, biweekly or monthly.
  • dose applications for example, each dose, a plurality of doses provided to a patient over a period such as daily, every other day, weekly, biweekly or monthly.
  • the medical provider can observe the patient in person or through medical telemetry using an imaging device present at the patient’s location, where the camera is in communication with the provider via the Internet for example.
  • the provider can rate the patient’s healing, pain rating, etc. after application of one or more LLLT treatments.
  • Information associated with a change in wound rating or condition using the Bates-Jenson Wound Assessment Tool, for example, or wound assessment pain rating etc. can be monitored and plotted or otherwise correlated against the dosage to characterize the patient’s response to LLLT over the course of a treatment regimen.
  • Wound rating or condition, and the progress (or lack thereof) in wound healing can be obtained via imaging. Review of those images can be by a medical technician or similar who is trained to grade or rate the healing level as shown in the images, or the technician can use a standardized image rating for grading. Alternatively, the wound condition and progress of healing can be graded or rated automatically using computer image analysis. Information about the wound healing obtained from images, can be included in patient medical records, as well as used for diagnosis by the medical provider. Still further, the wound healing information from images of the patient can also be used for management and modification of the LLLT dosage from a prior LLLT prescribed to the patient.
  • the provider can generate an initial LLLT treatment prescription including dosage to be applied to the patient using the inventive LLLT treatment devices. Instructions associated with such dosage is transmitted to or loaded on (such as via a computer, wirelessly or USB connection) into the PBM control module.
  • the PBM control module can activate the treatment and other componentry to provide the LLLT treatment to the patient as defined by the treatment plan generated by the provider.
  • the provider can review information collected by the LLLT treatment device and transmitted to a control or operations center (such as on a remote device accessible by the provider). The provider can review such data to determine whether dosage modifications are indicated. The provider can also collect information about the progress of the treatment in person, where such in person observation can also be incorporated into data associated with the patient’s LLLT treatment.
  • prescription and/or dosage adjustments can be indicated in relation to one or more of the following for generation of initial LLLT treatment dosage, management thereof and possible modification during a patient treatment protocol: cause of a wound (e.g., surgical, cut/tear, burn etc.); size of incision or wound; wound type (e.g., laparoscopic vs. open surgeries or chronic), depth of affected areas and tissue type (e.g., organ, bone, muscle, skin), location on the body; other area on the body being treated associated with healing of wound (e.g., blood supply, lymph ducts, nerves, etc.); type of wound dressing
  • a wound e.g., surgical, cut/tear, burn etc.
  • wound type e.g., laparoscopic vs. open surgeries or chronic
  • tissue type e.g., organ, bone, muscle, skin
  • location on the body e.g., other area on the body being treated associated with healing of wound (e.g., blood supply, lymph ducts, nerves, etc.);
  • phase of healing primary physiological indication of each phase of each phase (e.g., pain, swelling, bruising, contraction, infection, scarring etc.); the type of LLLT delivery element (e.g., type of light guide configuration, indication); size of LLLT delivery element; patient profile and characteristics (e.g., BMI, body part/cavity sizes, skin tone, skin texture, age etc.); patient compliance history (e.g., length of previously completed treatments, time of day for typical device use, patient input during treatment with VAS pain scale, GRC and other feedback mechanisms; biphasic dosage response of light therapy; sensor information (e.g., environmental conditions, incision condition and patient health and activity data acquired between start of LLLT treatment regimen and current observation).
  • primary physiological indication of each phase of each phase e.g., pain, swelling, bruising, contraction, infection, scarring etc.
  • the type of LLLT delivery element e.g., type of light guide configuration, indication
  • size of LLLT delivery element e.g., size of LL
  • the collected data from a prior treatment protocol can be consulted to determine the dose that has historically resulted in effective healing, pain improvement etc.
  • a new LLLT treatment dosage designed for the patient can then be generated and delivered to the patient during one or more subsequent treatments.
  • the pertinent information about the new LLLT treatment dosage is also recorded, as well as any response thereto, and becomes historical data to be used in the calculation of future doses for that patient.
  • the characterization of the patient's response to LLLT can be incorporated into further dosage determination for that patient or for a relevant patient population.
  • the LLLT treatment device can incorporate preset
  • the operations can be stored in the PBM control module, to allow the LLLT treatment information for a patient to be provided substantially without the need for external communications.
  • Such self-sustained operation can be useful when the LLLT treatment device is operated in a location where wireless communications access is not available.
  • the operations of the LLLT treatment device and related patient information when no wireless communication is available can be stored within the LLLT treatment device machine.
  • the LLLT treatment device can also suitably incorporate communication ports, for example USB ports, or the like to allow the device to use downloaded operational instructions, and to upload stored operational parameters.
  • the PBM control module housing and/or the LLLT delivery element can provide information to the patient or provider, such as by a touchscreen.
  • the PBM control module can be associated with a computerized program that is available in “app” form on a smartphone, tablet or the like.
  • Such communication can be from the LLT device to the smartphone, tablet, etc. using Bluetooth ® as discussed elsewhere herein.
  • the LLT device can be connected to a remote smartphone, tablet, etc. device, such as that of a
  • the patient and medical provider can be provided with a user interface to facilitate operation of the PBM control module from a remote device or server.
  • the respective user interfaces for the patient and the medical provider may differ due to the need for a different level of information for each of them.
  • the patient may be provided with minimal information, such as duration of a dose of LLLT treatment, how many doses will occur that day, how much more time for treatment etc.
  • the provider user interface can include additional information that can facilitate the provider’s continued treatment of the patient.
  • the patient user interface can be configured to push questions to the patient during the treatment period. If the patient responds that they are in more or less pain than expected, the medical provider can use such information to further design dosage regimes for that patient, as well as for other patients in need of treatment. The patient can also be provided an opportunity to review the calculated dosage before it is administered.
  • administration of LLLT to the patient may be feedback controlled, and tailored to the patient's particular physiology and real-time condition.
  • the data stored in or uploaded from the PBM control module, the inventive LLLT treatment devices and associated methods of the present invention provide the additional benefit of enhancing the body of provider knowledge regarding the appropriate dosing regimens and efficacy of LLLT treatments that have heretofore not been attainable.
  • the components of the PBM control module can be deactivated to substantially prevent reuse of the device without the definition of an appropriate dosage for a patient.
  • the PBM control modules of the present invention can be made operable only during the course of a defined patient treatment period.
  • the device can be activated, for example, but generation of a code from the device for input into an app or online, whereby instructions can be sent to the device with appropriate activation instructions.
  • the patient LLLT treatment can be provided as described elsewhere herein.
  • the provider can monitor, manage, and, if appropriate, modify the dosage of a patient’s LLLT treatment via such a remote device.
  • the provider can also use messaging (e.g., text or email) or telephone capability to communicate with the patient during treatment.
  • the provider can review the wound being treated in real time using video capabilities and imaging.
  • any patient medical information will be securely stored, for example, in the in the cloud.
  • cloud computing has emerged as one optimization of traditional data processing methodologies.
  • a computing cloud is defined as a set of resources (e.g., processing, storage, or other resources) available through a network that can serve at least some traditional datacenter functions for an enterprise.
  • a computing cloud often involves a layer of abstraction such that the applications and users of the computing cloud may not know the specific hardware that the applications are running on, where the hardware is located, and so forth. This allows the computing cloud operator some additional freedom in terms of implementing resources into and out of service, maintenance, and so on.
  • Computing clouds may include public computing clouds, such as Microsoft® Azure, Amazon® Web Services, and others, as well as private computing clouds.
  • patient 100 in need of LLLT treatment can be associated with a PBM control module 105, where such control module is in operational engagement with remote device or server 110.
  • Such operational engagement can be via Wifi, Bluetooth, RFID etc. or can be by periodic wired engagement with a device (e.g., computer, tablet, etc.) [not shown] via USB etc. in a local network or through an intranet or the internet though wired or wireless communications networks existing today or that may be developed in the future.
  • PBM control module 105 is in operational engagement with at least one light source 115, communications module 120, battery 125, microcontroller 130, and optional sensor(s) 135 module.
  • Controller 130 generally incorporates at least a microprocessor 140 and memory 145.
  • a wearable LLLT device When in operational engagement with at least one optical waveguide [not shown]— referred to herein as a“light guide” or“light guide arrangement” herein--and at least one LLLT delivery element [not shown], a wearable LLLT device [not shown] can be provided in a number of configurations, as discussed hereinafter.
  • Patient 100 can also be engaged with one or more patient monitoring device(s) 150, such as devices capable of obtaining and transmitting information relevant to user input, surveys, treatment adherence questions, medical condition, treatment compliance, physical activity, emotional state, food intake or the
  • monitoring device(s) 150 are meant to comprise an expansive definition of devices that exist today or that can be devised in the future, but for illustration, can include a sensor cluster embedded in the treatment device or light guide, or a separate a mobile device configured with user input and tracking functionality (e.g., smartphone), fitness tracker (e.g., Fitbit®), wireless vital sign tracker (e.g., blood pressure monitor, heart rate monitor, glucose monitor) etc.
  • Monitoring device(s) 150 can be continuously or periodically in communication with remote device or server 110 and/or with PBM control module 105.
  • Medical and or other relevant information from data from patient 100 can be transmitted to 110 from PBM control module 105 directly, from monitoring device(s) 150 directly, or PBM control module 105 and monitoring device(s) 150 can transmit data to and from each other, and, from time to time, pertinent data can be transmitted to remote device or server 110.
  • Collected patient 100 data can be stored on PBM control module 105 via memory 145, and/or on any memory capability present on monitoring device(s) 150, for transmission to remote device or server 110 or a local device [not shown], as appropriate.
  • Figure 2 illustrates functional elements of a LLLT telemedicine platform 200, engaged over the Internet or wide area network with a plurality of PBM control modules 105a,105b .. .105n associated with a pluality of patients 100a, 100b ...100n, who can each,
  • Platform 200 comprises a number of interconnected modules, such as a dosage information module 205, dosage provision module 220, payer module 215, and healthcare provider module 210, all of which can comprise machine learning-related instructions related to LLLT treatment delivery to patient 100a etc.
  • Platform 200 may be on a computer cloud, shown as“Internet,” or an operational or functional component of a device (e.g., computer, tablet, smart phone) [not shown] the various aspects of Fig.2.
  • Dosage information module 205 can further be in communication with payer module 215, via remote device or server 110 [not shown] for example, which can be associated with an insurance company computer system or database 235 or the like, but such payer module 215 need be utilized only when third party payer is required for a prescribing and provision a LLLT treatment.
  • Dosage provision module 220 in communication with dosage information module 205, is configurable to provide instructions for the operation of one or a plurality of PBM control modules 105a etc. before, during or after when patients 100a etc. are being treated with a LLLT device 230a etc.
  • Dosage provision module 220 and dosage delivery information module 205 comprises a significant aspect of artificial intelligence enabled LLLT treatment development and machine learning algorithms and associated knowledge basess to deliver highly effective
  • LLLT treatment dosage can be defined and delivered to PBM control module 105a etc. via instructions or the like generated by dosage provision module 220 that where such instructions can include
  • patient information associated with, among other things, information about one or more patients 100a etc., including parameters associated with their medical condition, physical condition, age, weight, ethnicity, skin color, physical activity level, preexisting condition, etc.
  • patient information can be generated by a medical provider or other professional 225 via healthcare provider module 210, and/or delivered from patient 100a etc. via direct user input and/or from patient, caregiver, etc, or collection and transmission of patient 100a etc. data collected from monitoring device(s) 150a etc.
  • FIG. 3 illustrates an exemplary personalized clinical LLLT treatment delivery implementation of the present invention comprising a plurality of clinical function elements 305 in LLLT clinical delivery framework 300, some of which can be optional.
  • Data can be input from 310, which can be one or more device(s) configured to obtain information relevant to the treatment of patient 100. Such information can be generated from provider 225 input, or from patient 100 input, and/or data generated from monitoring device(s) 150.
  • LLLT treatment device 315 includes PBM control module [not shown], and at least one light guide or light guide arrangement [not shown] and at least one LLLT delivery element [not shown] in operational engagement therewith.
  • LLLT treatment device 315 can be operationally engaged with the plurality of clinical functions 305 that can comprise one or more of LLLT treatment program module 320, LLLT dosage meter 325, patient data sensor module 330, and LLLT patient treatment data collection module 335.
  • LLLT treatment program 320 can incorporate a defined amount of LLLT treatment deliverable to patient 100 as prescribed by provider 225, for example.
  • Such treatment program module 320 can include dosage instructions suitable to generate LLLT treatment to wearable LLLT device 315 placed on patient 100, where such dosage provides instructions relevant to, for example, duration for each total LLLT treatment regimen, number of individual LLLT treatments in each total treatment regimen, duration of each treatment in each treatment regimen, time between LLLT treatments in each treatment in a total treatment regimen, wavelength(s) of light provided in each treatment in a total treatment regimen, etc.
  • provider 225 selects a LLLT treatment regimen for patient 100 from available patient information, and such treatment is deliverable from a skin- touchable or wearable LLLT treatment device 315 when such device 315 is placed on patient 100 in the form of a garment or an infrared blanket.
  • Fig.4 illustrates a dosage operational framework 400 for an implementation of the present invention.
  • PBM control module 105 can be in a LLLT dosage delivery mode, where dosage delivery instructions 405 can comprise a LLLT dosage prescription for patient 100 as defined by a provider 225 at the start of a treatment regimen.
  • LLLT treatment dosage instructions 405 provided to PBM control module 105 can, from time to time, be modified/updated by provider 225 from reviewing or processing of ongoing treatment information 410.
  • Such ongoing treatment information can comprise operational
  • wearable device 315 can be configured with sensors [not shown] to monitor patient 100 for compliance, for example, where such sensor information can be incorporated in operational information 415, such as by communication of wearable device 315 with one or more other components present in operational framework 400.
  • operational information 415 can also be derived from patient 100 input, such as how she is feeling, for example on a recognized pain scale, emotional state etc.
  • Fig.5 provides a further implementation 500 of the present invention.
  • Wearable LLLT device 505 here illustrated as a shirt garment but that can comprise any suitable format (e.g., shirt, pants, brace, sock, bandage, insert, or a combination thereof), can comprise more than one PBM control module, here shown as 510 and 515.
  • PBMs 510 and 515 are each, independently, shown as in operational control with light guide arrangements 520 and 525, respectively.
  • Each of or both of PBM control modules 510 and 515 can each, independently, be configured with more than one light guide arrangement, where such more than one light guide arrangement can be in operational and optical engagement with at least one light source [not shown] that is configured in each of 510 and 515.
  • PBM control modules 510 and 515 can each, independently or in communication with each other be configured with more than light source [not shown], a configuration that can be desirable when more than one light guide arrangement [not shown] is used, and multiple wavelengths of light are provided for treatment of patient 100.
  • dosage instructions can be generated by provider 225, and/or patient 100 by way of device(s) 310 that can be configured to communicate directly with PBM control modules 510 and 515 and/or by way of remote device or server 110, for example.
  • PBM control modules 510 and 515 are shown in a position away from wearable LLLT device 505, as would be recognized, in significant implementations, 510 and 515 can be permanently integrated into or otherwise associated (such as by mounting or other securable connection) with wearable LLLT device 505 such that light guides 510 and 515 are arranged so that treatment of the area(s) [not shown] on patient 100 in need of treatment can be affected.
  • LLLT delivery element 605 comprises, for example, a garment or bandage configuration having patient facing side 610 wherein LLLT light guides 615 and 620 are shown arranged proximally to patient facing side 610 [not shown] so as to allow LLLT treatment delivered from 615 and 620 to reach a patient [not shown] in use.
  • PBM control module 625 comprises, among other things, at least one light
  • engagement port 635 is engageably attachable to light guide 615 at first end 650a and engagement port 645 is engageably attachable to light guide 615 at second end 650b.
  • Engagement port 640 is engageably attachable to light guide 620 at first end 655.
  • optical couplers [not shown] can be used, for example, as discussed elsewhere herein.
  • PBM control module 625 is shown here with a single light source 630 to provide light to and through the various light guides 615 and 620, however, more than one light source, each capable of delivering different wavelengths, can be used, where such one or more light sources are configurable to allow transmission of a therapeutic amount of LLLT to a patient in need of treatment.
  • Power switch 660 is shown on housing 665, however, other forms of power activation, such as remote activation, can be used.
  • LLLT treatment delivery element 605 can incorporate fasteners etc. [not shown] on outer surface 670 opposite to patient facing side 610 [not shown] for retaining device 600 in a relatively fixed position on a patient’s body.
  • FIG. 7 illustrates a further implementation of the present invention.
  • Wearable or skin-touchable LLLT device 700 comprises PBM control module 705 removably or permanently engageable with LLLT delivery element 710 in the form of a garment, blanket, or bandage. Such engagement can be removable or substantially permanent, with the former allowing PBM control module 705 to be switched out for use with alternate LLLT treatment protocols, for servicing, or the like.
  • LLLT delivery element 710 comprises patient facing side 715 and outer side 720 [not shown].
  • Patient facing side 715 incorporates light guide 725a and light guide 725b, where 725a and 725b are operationally and optically engagable with light guide engagement ports 730a and 730b at ends 735a and 735b, and light guide 740 is operationally and optically engageable with light guide engagement port 750 at end 755.
  • Such operational and optical engagement can be via optical connectors [not shown].
  • Light sources 760 and 775 are configurable to emit light in the red, infrared, green or amber wavelengths so as to deliver light in such wavelengths to light guide 725a and 725b, respectively, at patient facing side 715.
  • Light source 765 is configurable to emit light in the green or amber wavelengths for certain treatments or in the UVC or blue wavelengths from light guide 740 so as to help prevent or treat infection during the healing of a wound.
  • LLLT delivery can be localized from light guide 740 at patient facing side 715 at a plurality of light delivery nodes 770a, 770b, and 770c, which can be generated by cladding with opaque coating at least part of an interior or exterior surface of light guide 740 except for such locations where light delivery is desired.
  • Such coating which can be via a reflective or mirrored coating applied to light guide 740, can be configurable substantially prevent light from exiting except at specific locations on a light guide.
  • sensor cluster 780 can comprise one or more of a skin conductivity sensor, a temperature sensor, an oxygen saturation sensor, or a photo sensor.
  • sensor cluster 780 When in operational engagement with light guide 790, sensor cluster 780 allows collection of skin conductivity, temperature, oxygen saturation, or light reflection or emission from the patient’s wound and, when in operational engagement, can transmit such patient emitted light to sensor 785, which can be any and all aforementioned sensor data to optimize the operation of PBM control module 705 for LLLT treatment application.
  • light source 775 can be configured to deliver light at a different wavelength from that delivered by 760.
  • a wavelength of 970 nm for treating deeper tissue can be delivered by 760 to the wound of a patient, alternating or simultaneously delivered, with a wavelength of 650 nm for treating tissue closer to a patient’s skin surface [not shown].
  • the LLLT dosage amount delivered can be the same or different from each of the light sources 760 and 775.
  • Fig.8a and 8b illustrate an exemplary low loss optical connector configuration suitable for use in the present invention.
  • PBM control module 805 is configured with light source 810, wherein 810 is operationally and optically engaged with engagement port 815.
  • Low loss optical connector 820 is sized to be engageable with engagement port 815 and light guide 825 at terminal end 830.
  • low loss optical coupler 820 operates to connect engagement port 815 to light guide 825 at connection point 830 with substantially low level of air gap and resulting in reduced loss to about 3dB loss of light energy from light source 810 into 825.
  • Fig.9a illustrates an exemplary partial view of a light guide configuration suitable for use in the present invention.
  • light guide 900 has outer surface 905 and interior surface 910.
  • Light guide 900 has terminal end 915 where light would not travel farther when provided by a light source [not shown] is operationally and optically engaged with light guide 900.
  • Fig.9b illustrates a further partial view of a light guide configuration suitable for use in the present invention.
  • Light guide 920 has outer surface 925 and interior surface 930.
  • Terminal end 935 comprises exterior angle ⁇ 1 , which is less than 90 degrees.
  • ⁇ 1 is less than 90 degrees.
  • 940a will be reflected/deflected off interior end surface 945 as 940b, which will then be reflected/deflected off of interior surface 950 as 940c.
  • the angular configuration of terminal end 935 can enhance light energy distribution from light guide 920 when incorporated into a LLLT delivery element [not shown].
  • the interior surface 945 of terminal end 935 can be treated with a reflective material to enhance this behavior.
  • the LLLT treatment devices of the present invention can be utilized in LLLT delivery elements that are configurable to provide LLLT treatment as well as, in some
  • implementations support, to enhance healing and reduce pain.
  • LLLT treatment devices can be useful in to treat one or more of a patient’s knee, ankle, hip, back, wrist, elbow etc.
  • suitably configured delivery elements are associable with light guides and PBM control modules.
  • a notable feature of each of the implementations of the present invention is that there is substantially no electrical energy proximal to the site of the patient injury or area undergoing treatment.
  • power, and associated electrical connections and componentry can centralized and located in the PBM control module.
  • the PBM control module(s) can be removably engageable with the delivery element, such as being securably mountable on or proximal to the delivery element.
  • PBM control modules can be permanently engaged with a LLLT delivery element, also.
  • FIG. 10a illustrates a LLLT device configured to treat a patient at or around the area of the knee, for example, in post-operative care after a total knee arthroplasty (TKA), as discussed previously.
  • patient 1000 is shown wearing LLLT knee device 1005 on her leg 1010.
  • Device 1005 is shown with 2 PBM control modules 1015a and 1015b that are in operational engagement to provide LLLT treatment to patient 1000, but one or two or more PBM control modules can be used, as appropriate for a treatment protocol.
  • Device 1005 is removably securable to leg 1010 by fasteners 1020a, 1020b, 1020c, 1020d, 1020e, and 1020f which can be Velcro® type fasteners, straps, clips, etc. More or fewer fasteners can be used.
  • FIG. 10b illustrates device 1005 from the knee area of leg 1010 and below. Knee incision 1025 is shown below device 1005. While knee incision 1025 is visible in Fig.10b, as would be recognized, typically such an incision could be covered with an absorbent bandage [not shown], as long as such bandage allowed delivery of LLLT treatment to knee incision 1025 as needed. Knee support area 1030 is can also be configured to cover knee incision 1025 during healing. An absorbent bandage or other suitable material can be placed below knee support area 1030, as long as the material [not shown] will allow LLLT treatment to suitably reach knee incision 1025.
  • Knee area support 1030 is securable in use by fasteners 1035a and 1035b, which can be Velcro® type fasteners, straps, clips, etc.
  • Device sides 1040a and 1040b are secured to lower leg 1045 by fasteners 1020a, 1020b and 1020c. More or fewer fasteners and different fastener types can be used as long as such arrangement allows device 1005 to remain secured on lower leg 1045 during treatment.
  • Fig.10c illustrates another view of device 1005 on leg 1010 wherein light guide arrangement 1050 is shown in operational and optical engagement with PBM control module 1015a at engagement port 1055. Note that light guide arrangement 1050 is configured to dispense light from a patient facing side [not shown] of device 1005 not just in the area
  • leg 1010 proximal to knee incision 1025, but also along a substantial portion of leg 1010 at lower leg 1045 and thigh area 1060 so as to allow LLLT treatment to be delivered to areas of leg 1010 known to be associated with enhancing healing, such as the lymph areas [not shown] below the knee area and blood vessels [not shown] above, behind, and below the knee area, which are associated“healing vital areas.”
  • such“healing vital areas” can be treated with different light wavelengths than that used to treat the area proximal to knee incision 1025.
  • a single PBM control module capable of dispensing LLLT in suitable wavelengths to treat knee incision 1025 as well as such“healing vital areas” [not shown] can also be used when suitably configured with appropriate configuration of light guide arrangement 1050 to deliver LLLT to areas proximal to those needing treatment in patient 1000.
  • Fig.11 illustrates a LLLT device configured to treat a patient at or around the area of the ankle or foot, for example, in post-operative care after ankle or foot surgery.
  • a patient 1100 is shown wearing LLLT lower extremity device 1105 on her lower leg 1110.
  • Lower extremity device 1105 can be configured as a soft garment, sock, a shoe, or a brace of hard material with load supporting features.
  • Fig.11b illustrates lower extremity device 1105 in closeup whereby device 1105 is secured to lower leg 1110 by fasteners 1115a, 1115b, 1115c, 1115d, 1115e, 1115f and 1115g, which can be Velcro® type fasteners, clips, straps, etc. More or fewer fasteners and different fastener types can be used as long as such arrangement allows device 1105 to remain secured on lower leg 1110 during treatment. Areas 1120a and 1120b are open can, in some aspects, improve the ability of patient 1100 to walk while wearing device 1105 by enhancing lower limb flexibility during wearing of device 1105.
  • PBM control module 1125 is shown in engagement with light guide arrangement 1130 at engagement port area 1135, where 1130 is configured to deliver LLLT treatment to ankle area incision 1140 from patient facing side [not shown] of device 1105. More than one PBM control module 1125 can be used in device 1105 as appropriate for a treatment, especially when“healing vital areas” may be relevant as discussed previously.
  • Fig.11c illustrates a rear view of lower extremity LLLT device 1105.
  • Device sides 1145a and 1145b are securable with fasteners 1115e, 1115f and 1115g on device outer surface 1150.
  • Lower extremity LLLT device 1105 can have bottom portion 1155 for treatment to the sole of the foot with, for example, with plantar fasciitis or heal spur surgeries, to further enhance the ability of patient 1000 to walk while wearing device 1105.
  • Figure 12 illustrates a LLLT device configured to treat a patient at or around the area of the hip joint and lower back, for example, in post-operative care after hip replacement or lower lumbar surgery.
  • a patient 1200 is shown wearing LLLT hip and
  • lower back device 1205 on an area proximal to an incision [not shown] around the hip [not shown] or lower back 1210.
  • Light guides 1215 and 1220 are shown whereby LLLT treatment can be delivered, as further shown in Fig.12b and 12c, from patient facing side 1225 proximal to hip [not shown] and lower back 1210 when device 1205 is worn by patient 1200.
  • PBM control module 1230 is engageable with light guides 1215 and 1220 at engagement port area 1235.
  • Fasteners 1240a and 1240b can be Velcro® type fasteners, straps, clips, etc. configured on outer surface 1245, for example.
  • Fig.12c illustrates device 1205 from front of patient 1200 whereby hip and lower back device 1205 is secured by fasteners 1240a and 1240b to bring device ends 1250a and 1250b together for wearing. More or fewer fasteners and different fastener types can be used as long as such configuration allows hip and lower back device 1205 to remain secured on patient 1200 during a LLLT treatment.
  • PBM control module 1230 is shown configured to dispense LLLT to light guides 1215 and 1220 patient facing side 1225 of device 1205. While only one PBM control module 1230 is shown in Fig.12c, more than one PBM control module can be used as appropriate for a treatment, especially when“healing vital areas” may be relevant as discussed previously.
  • An absorbent bandage or other suitable material [not shown] can be placed proximal between patient facing side 1225 and the area of hip [not shown] or lower back 1210 that may have an incision [not shown], as long as at least some of the bandage material will allow LLLT to suitably reach thereto for treatment.
  • Hip and lower back device 1205 can also be useful to treat hip arthritis and lower back pain.
  • LLLT suitable to treat such indications can be generated from PBM 1230 to be delivered from patient facing side 1225 using light guides 1215 and 1220 configured to dispense LLLT treatment in one or more areas proximal to hip [not shown] and lower back 1210.
  • Fig.13 illustrates patient 1300 having abdominal LLLT device 1305 proximal to abdominal region 1310.
  • Light guide arrangement 1320 is configured to deliver LLLT treatment as portions 1320a and 1320b and second light guide 1325, along with 1325, is configured to deliver a therapeutic amount of LLLT from patient facing side 1330 [not shown].
  • PBM control module 1335 is in operational and optical engagement with light guide arrangements 1320 and 1325 at light guide engagement ports 1340a,1340b, 1340c.
  • Outer device surface 1345 comprises fasteners 1350a and 1350b, which can be Velcro® type fasteners, straps, etc.
  • Device 1305 can be used to, for example, treat incisions proximal to the abdominal/pelvic region, or can be used to treat pain or other conditions proximal thereto that can be benefited from LLLT treatment provided at one or more wavelengths.
  • Figure 14 illustrates a further implementation of a compression binder for an abdominal/pelvic area LLLT treatment device, such as would be useful for cosmetic surgery, such as to enhance healing rate and to reduce pain for abdominal area liposuction and or “tummy tucks.”
  • Patient 1400 is shown with device 1405 worn proximal to abdominal/pelvic area 1410.
  • First PBM control module 1415 is shown in operational and optical engagement with light guide arrangement 1420 on outer surface 1425, which is configured to deliver LLLT treatment proximal to abdominal incision 1430.
  • PBM control module 1415 can be removably or permanently mountable on outer surface 1425.
  • Second PBM control module 1435 is shown in operational and optical engagement with light guide arrangement 1440 to provide a therapeutic amount of LLLT treatment to areas proximal to pelvic incision 1445. While Fig. 14 is shown with two PBM control modules 1415 and 1435, suitable arrangements using one or three or more PBM control modules are also contemplated. Also, one or more light guide arrangements [not shown] can be configured to deliver a therapeutic amount of LLLT treatment to one or more additional areas covered by device 1405, where such LLLT treatment can comprise the same or different light wavelengths than the LLLT treatment delivered to areas proximal to incisions 1430 and 1445.
  • Figs.15 a and 5b illustrate an implementation of a pelvic area LLLT treatment that can, for example, have utility for post-operative care after a C-section or other pelvic area surgery.
  • Fig.15a shows patient 1500 wearing pelvic LLLT device 1505 proximal to pelvic area 1510 so as to deliver a therapeutic amount of LLLT treatment to pelvic incision 1515.
  • PBM control module 1520 is in operational and optical engagement with light guide arrangement 1525, whereby light guide arrangement 1525 is engaged with PBM control module 1520 at light guide engagement ports 1530a, 1530b, and 1530c (shown in extended length to enhance visibility) to deliver LLLT treatment from patient facing side 1535 [not shown], thereby providing a therapeutic amount of LLLT treatment to one or more areas proximal to incision 1515.
  • Device outer surface 1540 is engagable with belt outer side 1545 via fasteners 1550a and 1550b, which can be Velcro®, straps, clips, snaps etc. More or fewer fasteners can be used.
  • fasteners 1550a and 1550b which can be Velcro®, straps, clips, snaps etc. More or fewer fasteners can be used.
  • device 1505 is shown without a holder in Fig. 15a, but a holder can be useful to secure PBM control module 1520, especially when 1520 is configured to be removable from device 1505, as discussed in
  • Fig.15b illustrates a side view of pelvic LLLT device 1505 on patient 1500.
  • PBM control module 1520 is shown as removably insertable into PBM control module holder 1550.
  • PBM control module holder 1550 is shown in a holster format, but other formats can also be suitable to allow PBM 1520 to be removed for servicing or for use in other LLLT devices.
  • Device belt second end 1555 is shown with engageable light guide connectors 1560a, 1560b, and 1560c that are engageable with engagement ports 1530a, 1530b, and 1530c.
  • Other suitable device belt 1545 configurations are also contemplated.
  • Fig.16 illustrates a further implementation of the LLLT treatment devices of the present invention whereby post-surgical indications associated with the facial and neck regions can be therapeutically treated.
  • patient 1600 having facial region 1605, neck region 1610, and chin region 1615 can be treated with LLLT head and neck device 1620 in conjunction with a rhytidectomy, otherwise known as a“facelift.”
  • PBM control module 1625 is in operational and optical engagement with light guide arrangement 1630 by removable engagement with engagement ports 1635a, 1635b and 1635c, whereby light guide arrangement 1630 is configurable to provide a therapeutic amount of LLLT to patient 1600 from patient facing side 1640 to treat at least patient regions 1605, 1610, and 1615.
  • Outer device surface 1645 comprises first and second ends 1650 and 1655, each comprising fastener pairs 1660a and 1660b that can comprise Velcro®, straps, buttons, clips, snaps, etc.
  • Device 1620 is shown with functionality to provide LLLT treatment to at least some of the patient areas typically associated with a facelift, for example, exemplary neck area incision 1665, mouth area incision 1670, cheek area incision 1675 and ear area incision 1680, however, the various aspects of device 1620 can be configured to treat more or fewer areas, on one or both sides of the facial, chin and neck regions 1605, 1610, and 1615 of patient 1600.
  • an additional PBM control module [not shown] can be configured to apply a therapeutic amount of LLLT to the temple 1685 and/or forehead 1690 regions as indicated, and the size and shape of device 1605 can be adjusted or extended to provide appropriate coverage of the areas in need of LLLT treatment.
  • One or more ice packs 1695 having suitable light transmissive region 1695b can be incorporated to cover one or more of patient 1600 incisions 1665, 1670, 1675, 1680 etc. as needed.
  • Fig.17 illustrates a use of a neck and face area LLLT treatment device, in the form of a compression garment, or used without compression, worn by patient 1700.
  • Device 1705 is positioned on patient 1700 so that light guide arrangement 1710 can deliver LLLT as indicated, for example areas proximal to chin area 1715 and ear area 1720.
  • Light guide arrangement 1725 is suitably configured, for example, to treat areas proximal to neck area 1730.
  • PBM control module 1735 is operationally and optically engaged to light guide arrangement 1710, for example, with multiple hardness areas, using the highly flexible light guide design disclosed herein, at engagement ports 1740a, 1740b, and 1740c.
  • PBM control module 1745 [not shown] can be suitably configured to deliver LLLT to light guide arrangement 1725, or PBM control module 1735 can be suitably configured to deliver LLLT to both light guide arrangements 1710 and 1725.
  • Fig.18 illustrates a further implementation of a LLLT treatment device of the present invention, whereby a therapeutic amount of LLLT can be applied to the breast and proximal regions of a patient in need of treatment thereof, such as in a mastectomy, breast
  • patient 1800 is shown with chest area LLLT device 1805 configured to fit proximal to at least one breast 1810a and, optionally, a second breast 1810b.
  • PBM control module 1815 is in operational and optical engagement with light guide arrangement 1820 via engagement port 1825.
  • Light guide arrangement 1820 is configurable to deliver a therapeutic amount of LLLT treatment on a patient facing side [not shown] to areas proximal to at least breast 1810a, including lymph node area 1830 proximal to underarm area 1835, which comprises a“healing vital area,” as discussed elsewhere herein.
  • chest area LLLT device 1805 can be secured with chest strap 1840, for example, which can also incorporate one or more optional additional securing straps, such as shoulder straps 1845a and 1845b.
  • Chest area LLLT treatment device 1805 can suitably incorporate back closure pairs 1850 and 1855 (e.g., fasteners such as Velcro®, straps, clips, hooks etc.), however, closure pairs can also be incorporated in a front portion 1860.
  • Fig.18 illustrates chest area device 1805 as having LLLT treatment provided only to one breast 1810a, however, it would be recognized that device 1805 can suitably be configured to provide LLLT treatment to breast 1810b, also.
  • Fig.19 illustrates a further implementation of a LLLT device herein in the form of a bandage or blanket or garment that can be placed proximal to an area on a patient in need of LLLT treatment.
  • Device 1900 comprises first covering 1905 comprising a translucent or transparent material suitable for delivery of LLLT from light guide arrangement 1910 at patient facing side 1915.
  • a close proximity or contact of first covering 1905 with light guide arrangement 1910 is implemented, for example, with a sprayed adhesive or pressure from tension within the material for covering 1905 so that frustrated total internal reflection or light transmission is achieved for at least some—for example, a percentage—of the surface of light guide arrangement 1910 in the desired are for treating the patient.
  • about 5 to about 90% of a given are for light scattering through frustrated total internal reflection or transmission may be desirable.
  • Second covering 1920 comprises a material that is substantially opaque to light being delivered from light guide arrangement 1910 so that light is delivered substantially only in the direction of patient facing side 1915.
  • Second covering 1920 can comprise a thick material, such as fabric and/or cushioned material (e.g., foam) to enhance patient comfort in use on an outer side 1925 [not shown].
  • Light guide terminal ends 1930 and 1935 are operationally and optically engageable with a PBM control module [not shown] via light guide engagement ports [not shown] connectable with optical connectors [not shown] in light guide ends 1940 and 1945.
  • First covering 1905 and second covering 1920 are connectably attached via seal 1950 to enclose substantially all of light guide arrangement 1910 therein. Seal 1950, which
  • Fig.20 shows another implementation of a bandage or blanket or garment LLLT treatment device of the present invention.
  • Device 2000 has first covering 2005 that is translucent or transparent to allow substantially all light delivered by light guides 2010 and 2015 (shown by directional arrows out of light guides 2010 and 2015) to be delivered from patient facing side 2020 when device 2000 is suitably configured for use.
  • Second covering 2025 can comprise a thick material, such as fabric and/or cushioned material (e.g., foam) to enhance patient comfort in use.
  • Light guides 2010 and 2015 are operationally and optically engageable with a PBM control module [not shown] at engagement ports [not shown].
  • Light guide 2030 is configurable to transmit light generated from a patient wound [not shown] to a sensor [not shown] associated with the PBM control module [not shown] to collect light reflected or generated from a patient’s wound (shown by directional arrows into light guide 2030) when device 2000 is in use. As discussed elsewhere herein, such light generated from patient wounds can be helpful in assessing the effectiveness and stage of healing, such as by providing information about infections, etc.
  • seal 2035 securely attaches first covering interior side 2040 to second covering interior side 2045. Seal 2035 and proximal arrangement of light guides 2010, 2015, and 2030 with first cover 2005 can be by sewing, gluing, ultrasonic welding, etc.
  • vaginal light therapy insert 2110 can provide enhanced post-surgical healing.
  • the present invention includes a vaginal light therapy insert 2110, which can be fabricated of medical grade, optically transmitting clear material such as acrylic,
  • Vaginal light therapy insert 2110 has interior end 2115 that is configured to reach proximally to interior end 2120 of vaginal cavity 2105.
  • Vaginal light therapy insert 2110 has anterior end 2125 that is configured to facilitate removal of vaginal light therapy insert 2110 from vaginal cavity 2105, as necessary.
  • Vaginal light therapy insert 2110 is operationally and optically engaged with PBM control module 2130 via at least one light guide 2135 for transferring LLLT into vaginal light therapy insert 2110 for subsequent transmission to vaginal cavity 2105 etc.
  • PBM control module 2130 can include at least one light source [not shown] that emits light in the blue, green, red to near-infrared wavelengths for various stages and indications during an overall treatment protocol.
  • PBM control module 2130 is operationally engaged with at least one light source [not shown] that, as discussed elsewhere herein, is regulated as to power level,
  • wavelength, duty cycle, pulsing frequencies to deliver desired dosages in a dosage period and in an overall treatment protocol.
  • light at about 650 nm to about 700 nm for red and about 830 nm to about 980 nm in the infrared range can be introduced to the vaginal cavity 2105 from vaginal light therapy insert 2110 at a dosage of from about 0.5 to about 21 Joule/cm 2 /day immediately post-surgery to promote healing during the early stages of recovery and to reduce pain and swelling in a male to female sex reassignment patient.
  • the wavelengths associated with green can be administered at from about 0.5 to about 2.5 Joule/cm 2 /day intermittently or simultaneously with other wavelengths, or can be used for treatment of vaginal or vulva rejuvenation, overactive bladder (OAB) syndrome, vaginal dilation, vaginismus or vulvodynia, conditions that can be associated with patients other than sex reassignment patients needing post-surgical healing assistance.
  • the wavelengths associated with blue from about 410 nm to about 495 nm, can be used at about 210 to about 900 mW/cm 2 to an actually or potentially infected area during wound healing.
  • Vaginal light therapy insert 2110 can be incorporated in vaginal cavity 2105 for extended periods to enhance healing thereof and to reduce the possibility that vaginal cavity 2105 will collapse, such as is an adverse post-surgical complication in male to female sex reassignment, for example. Operationally, when vaginal light therapy insert 2110 is inserted into vaginal cavity 2105 during dilation—that is, post-operatively--the dimensions of vaginal light therapy insert 2110 are configured to provide the effect of dilation. For vaginal rejuvenation, vaginal light therapy insert is also appropriately sized for therapeutic effectiveness and patient comfort.
  • Vaginal light therapy insert 2110 can also be used in conjunction with vulvar area light therapy delivery liner 2140 having first and second sides 2145 and 2150, respectively.
  • First side 2145 is configured to, for example, to deliver light to vulvar regions 2155 and 2160 of patient 2100.
  • Light therapy delivery liner 2140 can be removed as needed for patient 2100 to urinate etc.
  • Light therapy delivery liner 2140 is operationally and optically engaged with PBM control module 2130 via at least one light guide 2165.
  • the light source(s) [not shown] that are each, independently, engaged with vaginal light therapy insert 2110 and light therapy delivery liner 2140 from within PBM control module 2130 can be the same or different.
  • Light therapy delivery liner 2140 can also be used alone as indicated by a medical provider in some cases, such as with perineum tears that can occur in vaginal births.
  • LLLT is delivered through at least one light guide 2135 to interior device portion 2170 and/or through first side 2145 so to allow light energy reach vaginal cavity 2105 and vulvar regions 2155 and 2160.
  • Light therapy delivery liner 2140 is optimally sized to maintain the comfort and privacy of patient 2100 during healing. Wearability of light therapy delivery liner 2140, as well as vaginal light therapy insert 2110, can be enhanced by patient’s 2100 wearing of undergarments [not shown] that can keep light therapy delivery liner 2140 in place which, in turn, can further secure light therapy delivery liner 2140 in vaginal cavity 2105.
  • LLLT treatment dosages can be applied to either or both vaginal cavity 2105 and vulvar regions 2155 and 2160 as prescribed by a medical provider.
  • the LLLT dose provided to a patient in need of treatment can have a duty cycle that is provided to from about 8 minutes on and about 30 minutes off for about three cycles per treatment on day 21, day 2 and day 3 postoperative, then drop to 2 cycles per treatment on about day 4 to about 8 post-op, thereafter one cycle per treatment until about day 24 for a sex-reassignment patient, for example.
  • the light source(s) [not shown] can provide light to either or both of vaginal cavity 2105 or vulvar regions 2155 and 2160 at substantially the same times and wavelengths, or light LLLT treatment wavelengths or dosages can vary.
  • overactive bladder conditions, hemorrhoids or the like shorter periods of use, such as once or twice a day to achieve a dosage of from about 0.3 to about 3.5 Joule/cm 2 /day inside the vagina to provide therapeutic benefits to a bladder 2175 or hemorrhoids proximal to the anal area 2180 for a defined period, such as about 30 minutes, about 60 minutes or about 2120 minutes per day may be indicated by the medical provider depending on the individual patient, however, variation of treatment times will not modify the inventive effects of the invention.
  • Figs.22a, 22b, 22c illustrate first, second, and third views of vaginal light therapy insert 2200, wherein Vaginal light therapy insert 2200 is rotated 90 degrees between 22a and 22b, and 22c is a bottom view thereof.
  • Vaginal light therapy insert 2200 is capable of both dilation and light energy delivery as shown.
  • Light guide 2205 is optically engaged with vaginal light therapy insert 2200 by incorporation of light guide end 2210 into interior 2215 of vaginal light therapy insert 2200 proximal to vaginal light therapy insert anterior end 2220 at vaginal light therapy insert engagement port 2225.
  • Figure 22b omits light guide 2205 to better illustrate engagement port 2225.
  • vaginal light therapy insert 2200 can be configured having a rim 2230, here shown, as one example, in the approximate shape of water drop, whereby rim 2230 will substantially prevent the totality of vaginal light therapy insert 2200 from wholly entering vaginal cavity 2105 when inserted therein, while also making vaginal light therapy insert 2200 easier to handle and extract.
  • Vaginal light therapy insert 2200 can be configured as an elongated portion 2235 with outer surface 2240 that together substantially conform to a diameter of a patient’s vaginal cavity 2105 with a
  • vaginal light therapy insert 2200 can be configured as needed for each patient, as discussed in more detail herein.
  • vaginal light therapy insert 2200 can be fabricated from optically clear, medical grade polymers.
  • interior region 2215 of vaginal light therapy insert 2200 that is proximal to outer surface 2240 can incorporate particles or added imperfections to generate discontinuity areas in one or more locations in vaginal light therapy insert 2200.
  • discontinuity areas here shown as 2250 and 2255 have been found, in some aspects, to enhance light scattering light from interior 2215 so as to improve the distribution of light to patient tissues [not shown] in use.
  • surface discontinuity can be in the form of 2255, which is configured to enhance light delivery at the entrance of vaginal opening area [not shown].
  • discontinuity area 2255 has been found to facilitate the light concentrated radiation at the end of the vaginal opening area to reduce the occurrence of a post-surgical complication called“contracture.”
  • discontinuity area 2255 can also increase the light intensity at the area of opening of a patient’s vagina, reducing the complication called“ring scar contraction” around the vaginal opening area.
  • Incorporated air bubbles or particles inside vaginal light therapy insert 2200 can also be used to create discontinuity area 2250 while surface imperfections can be used to create discontinuity area 2255, and vice versa.
  • FIG. 23 illustrates vaginal light therapy insert 2300 configured to minimize light loss so as to maximize light energy delivery to patient tissue needing treatment thereof when vaginal light therapy insert 2300 is inserted in a vaginal cavity 2105.
  • Light guide 2305 is incorporated within and is operationally and optically engaged with vaginal light therapy insert 2300 through anterior end 2310.
  • Light guide 2305 terminates at interior device portion 2315 of vaginal light therapy insert 2300 such that light exiting light guide 2305 at terminal end 2320 enters interior device portion 2315 to generate a light dominant-path, where more than 50% of light energy travels, at an optimum angle ⁇ 2, which is configured to be greater than a critical angle for material from which vaginal light therapy insert 2300 is constructed.
  • Variations of light guide 2305 placement and the resulting light transmission can be determined for a specific indication and/or patient need can be discerned by one of ordinary skill in the art without undue experimentation. As discussed previously, discontinuities can be incorporated into vaginal light therapy insert 2300, shown here as 2330 and 2335.
  • vaginal light therapy insert 2300 is fabricated from a polycarbonate material with a refractive index of 1.6, for sections of vaginal light therapy insert 2300 outside of vaginal cavity 2105 when a majority of vaginal light therapy insert 2300 is inserted in vaginal cavity 2105, the refractive index of air, the critical angle of acrylic to air is about 38 degrees.
  • a critical angle is the angle of incidence above which total internal reflection occurs.
  • light guide 2305 By configuring light guide 2305 to comprise a dominant light path angle ⁇ 2 to be greater than about -38 degrees, the light entering interior device portion 2315 will substantially be reflected at interior surface 2335 so as to allow light beam 2340 to travel within and through interior device portion 2315 of vaginal light therapy insert 2300 to exit vaginal light therapy insert 2300 at 2345, for example.
  • ⁇ 2 the dominant light path angle
  • a dominant light path angle ⁇ 2 can be provided to be less than the critical angle of acrylic to water.
  • the placement of light guide 2305 in interior device portion 2315 can be arranged to provide a light path configuration having the following formula to enhance the therapeutic benefits of light energy.
  • ⁇ critical A is the critical angle the vaginal light therapy insert 2300 material to air and ⁇ critical B is the critical angle the vaginal light therapy insert 2300 material to vaginal mucosa.
  • ⁇ critical B is the critical angle the vaginal light therapy insert 2300 material to vaginal mucosa.
  • light beam 2340 can travel along a dominant path upon exiting light guide 2305 at 230.
  • a vagina mucosa with a refractive index of about 1.23 with more than about 15% less than the refractive index of vaginal light therapy insert 2300 total internal reflection of light becomes possible with a critical angle of about 54 degrees.
  • light beam 2340 reaching interior surface 2345 light beam 2340 will be reflected back into interior device portion 2315.
  • insert surface 2345 a portion of light beam 2340 can enter the vaginal cavity tissue [not shown] for therapeutic effect.
  • Configuration of the light guide 2305 and associated light beam 2340, in conjunction with the LLLT dosage provided from PBM control module 2130 can substantially reduce loss of light energy in light beam 2340 when traveling through interior device portion 2315 for subsequent delivery to a patient.
  • cladding/scattering layer [not shown] can be incorporated proximal to interior surface 2345 to further distribute the light substantially evenly over the mucosa tissue.
  • ⁇ 2 can deviate from the light dominant path formula:
  • light beam 2340 can be directed at a cluster of light scattering particles 2335 to generate a more randomized beam pattern for light delivery to patient tissues [not shown].
  • ⁇ 2 can be optimized for delivery to desired target tissue areas.
  • Figure 24 illustrates the relative position of patient 2400 to light therapy delivery liner 2405 and the anatomic structure of at least vulvar region 2410, shown here with dotted lines.
  • Patient 2400 is wearing light therapy delivery liner 2405 that incorporates first light guide 2415, optionally, second light guide 2420 and third light guide 2425, which can be used to deliver additional energy or light at a different wavelength than light delivered via 2415, or to transmit light from the light therapy delivery liner 2405 to associated sensors [not shown] for analysis.
  • Light therapy delivery liner 2405 has a first side 2425 [not shown] proximal to vulvar region 2410, from which light therapy is delivered thereto.
  • First side 2425 [not shown] can be in direct contact with vulvar region 2410, or a bandage [not shown] or absorbent material [not shown] can be located between first side 2425 [not shown] and vulvar region 2410.
  • any such bandage or absorbent material should be light transmissive to allow light therapy to be suitably applied to vulvar region 2410.
  • Second side 2430 will be proximal to the patient’s undergarments etc. in use.
  • Second side 2430 is optimally configured to substantially prevent light from exiting therefrom, so as to minimize light loss. Accordingly, second side 2430 can be coated with an optically opaque and reflective material. Still further, second side 2430 can be coated or otherwise treated with a semi-reflective material.
  • Light guide 2415 and (if present) light guides 2420 and 2425 are operationally and optically engaged with light therapy delivery liner 2405 and PBM control module 2130.
  • light therapy delivery liner 2405 When light therapy delivery liner 2405 is placed proximal to vulvar and anal area, light energy can be delivered from PBM control module 2130 to help accelerate wound healing resulting from sex reassignment surgery, laceration or episiotomy from baby delivery or other forms of injury, such as infection, which can occur in vulvar region 2410, or hemorrhoids that can occur in anal region 2435.
  • light therapy delivery liner 2405 is shown with extended length to cover both vulvar region and anal region 2435, however, if treatment is for the vulvar regions only, the length will be shorter. Shape and size can be selected to provide optimum fit for a patient, and the condition being treated.
  • Figures 25a, 25b, and 25c illustrate light therapy delivery liner configurations that can be placed proximate to female vulva area to accelerate healing, reduce pain, and swelling.
  • the size and shape of light therapy delivery liner 2505 can be selected to conform to an identified patient vulvar region shape and size, such as having a wider rear portion 510 (which may be worn proximate to the patient’s vulva region 2410 or anal region 2435 or shorter as needed for a specific therapeutic configuration) and a narrower front portion 2515 (which may be worn proximate to the patient’s clitoral region).
  • light therapy delivery liner 2505 can be configured to approximate an elongated triangle shape with a contoured edge so as to improve comfort and wearability.
  • First side 2530 which is, in use, placed proximal to the patient’s vulvar region 2410 and, optionally, anal region 2435, is configured to allow light to be delivered from PBM control module 2130, where that light source is in operational and optical communication with light guide 2520 and (optionally) light guides 2525 and 2565, which can be used to deliver additional energy or light at a different wavelength than light delivered by light guide 2520, or to transmit light beam 2555 from light therapy delivery liner 505 as beam 560 back to sensors [not shown] associated with PBM control module 2130 for analysis to determine, for example, tissue condition, treatment progress, compliance and dose-response.
  • Light therapy delivery liner 2505 can be configured from optically clear silicone rubber with a Shore A hardness of greater than about 0 to about 30.
  • 2545 is a side view of light therapy delivery liner 2505, where first side 2530 is shown as contoured along the length thereof, and first end 2515 is shown terminating in a somewhat curved configuration so as to enhance comfort in wearability.
  • light therapy delivery liner 2550 incorporates surface or imbedded discontinuities 2555a, 2555b and 2555c to enhance light scattering, which can be beneficial in some implementations.
  • discontinuities can be provided by impregnating particles in the surface of light therapy delivery liner 2550.
  • discontinuities 2555a, 2555b and 2555c can be generated by etching the mold with sand or other particle-type etching to achieve discontinuity configurations desirable for light scattering.
  • Discontinuity areas 2555a, 2555b and 2555c can be configured to increase or enhance the light exiting light therapy delivery liner 2545 for treatment of vulvar tissues and, optionally, anal tissues.
  • discontinuity areas 2555a and 2555b are configured to provide light energy to the groin regions of the patient in use, especially to the area with
  • Discontinuity area 2555c can enhance healing of the area proximal to the vaginal opening.
  • light can be introduced to region 2410 at a dosage of from about 0.3 to about 5 Joule/cm 2 /day with red wavelengths of from about 650 nm to about 700 nm and about 830 nm to about 980 nm in the infrared range immediately post-surgery or shortly after childbirth to promote healing during the early stages of recovery and to reduce pain and swelling.
  • the wavelengths associated with green can be administered at about 0.3 to about 3 Joule/cm 2 /day, intermittently or simultaneously with other wavelengths, or can be used for treatment of vaginal or vulva area rejuvenation, overactive bladder (OAB) syndrome, vaginismus or vulvodynia, conditions that can be associated with patients needing therapeutic assistance.
  • OAB overactive bladder
  • the wavelengths associated with blue from about 410 nm to about 495 nm, can be used with at about 10 to about 70 mW/cm 2 .
  • vaginal light therapy insert 2600 can be operationally configured with a light source 2605, controller 2610, associated housing 2615 and removable battery 2620 proximal to an anterior end 2625 of vaginal light therapy insert 2600.
  • Vaginal light therapy insert 2600 is configured from optically clear material.
  • Light source 2605 can be a LED or other suitable light source that is configurable emit a therapeutic wavelength of light. In use, light source 2605 emits light with desired wavelength into and through the optically clear interior potion 2630 to be emitted from outer surface 2635.
  • Discontinuities 2640 can optionally be incorporated in one or more locations on vaginal light therapy insert 2600 to enhance light scattering.
  • vaginal light therapy insert 2645 incorporates LED 2605 or other suitable light source, LED 2650 is operationally connected via wire 2660 to controller 2665, which is powered by or connected to battery power [not shown] and can have wireless
  • connection 2670 is removably engagable with controller 2665, but such connection can be permanent, as appropriate.
  • Discontinuities 2640 and 2675 can be incorporated as discussed herein in any portion of the devices illustrated in Figs.26a and 26b.
  • Vaginal light therapy inserts 2600 and 2645 each, independently, can further be configured with sensors 2680 and 2685 that are in operational engagement with the respective controllers 2610 and 2665.
  • Vaginal light therapy insert 2700 is configured with light guide 2705 from which therapeutic light is emitted at 2710 as light beam 2715, which provides therapeutic light when it reaches the patient’s vaginal tissue [not shown].
  • Light guide 2705 is in operational and optical communication with PBM control module 2130.
  • vaginal tissue [not shown] condition such as temperature, infection, oxygen level, dryness, wetness, coloration, smoothness, and others can be analyzed in various methods, such as with reflected light, or emitted light of one or more wavelengths from bioluminescence or fluorescence associated with the healing process.
  • Light detection from vaginal cavity 2105 during healing here shown for simplicity as tissue reflected or emitted beam 2720 and tissue reflected or emitted beam 2725 can travel through outer device surface 2730 into interior 2735 for collection by light guides 2710 and 2740.
  • Such collected light beams 2720 and/or 2725 are transmitted to analysis device 2745, which can be a photodetector or other suitable sensor-containing equipment, to evaluate the healing level and effectiveness of the relevant area.
  • Analysis device 2745 can be a photodetector or other suitable sensor-containing equipment, to evaluate the healing level and effectiveness of the relevant area.
  • Figure 27 is shown with two light guides, 2705 and 2740, where 2705 can be used to both emit LLLT and to collect light from the vaginal cavity tissue, however, other
  • FIG. 28 illustrates a further implementation of a LLLT treatment device for use in nasal area surgery.
  • Patient 2800 having nose 2805, nasal cavity 2810 and sinus area cavities 2815 and 2820 is shown with wearable nasal LLLT treatment device 2825 inserted in nasal cavity 2810.
  • Nasal LLLT treatment device 2025 has first light transmission portion 2830, which can be, for example, a fiber optic suitable to transmit light from PBM control module [not shown] when 2830 is suitably engaged therewith.
  • First light transmission portion 2830 can also comprise a polymeric material capable of total internal reflection or is suitably coated so as to substantially prevent light transmission from portion 2830 prior to entry thereof into nasal cavity 2810.
  • Nasal LLLT treatment device 2825 has second light transmission portion 2835 that, in use, extends inside nasal cavity 2810.
  • Light transmission portions 2830 and 2835 are removably engaged with each other at connection 2840, as discussed further in relation to Fig.29, for example.
  • Light transmission portions 2830 and 2835 can, when assembled to allow light to travel within the assembled structure, and suitably comprise“light guides” or“light guide arrangements” in accordance with the present invention.
  • second light transmission portion 2835 should be configured from a flexible material, such as a silicone polymer or other polymeric material having a Shore A hardness of from about 20 to about 65.
  • the air passage within 2835 should be structured to remain open when materials of different hardness are used.
  • Second light transmission portion 2835 is configured to be inserted into nasal cavity 2810 substantially immediately after a surgical procedure, such as a rhinoplasty or sinuplasty, and to stay in place for at least some of the healing process post-surgery.
  • Patient 2800 can be assisted in breathing by addition of an opening 2845 located in the wall of
  • second light transmission portion 2835 such as at a location exterior to nose 2805.
  • opening 2845 is in communication with internal diameter 2850 configured within second light transmission portion 2835 to terminate in end 2855, where end 2855 is positioned in nasal cavity 2810 in use to enable sufficient air flow to and from the nasal cavity 2810 to facilitate the normal breathing of patient 2800.
  • Engagement of 2830 with 2835 completes a light guide arrangement path 2860 that allows light to travel from a PBM control module [not shown] through portion 2830 and into second light transmission portion 2835 so as to provide LLLT treatment to nasal cavity 2810 and, in some implementations, sinus area cavities 2815 and 2820.
  • a cross-section of second portion 2835 is shown in Fig.28c, which shows interior diameter 2850 that allows air to travel through to facilitate patient 2800 breathing, while still allowing light to reach 2810 etc. from light guide arrangement path 2860.
  • light guide arrangement path 2860 can comprise a reflective interior coating and/or an angle of at less than about 85 degrees can be configured into end 2865, to assist in light being reflected into light guide arrangement path 2860 to provide light emission to nasal cavity 2810.
  • light guide arrangement path 2860 can comprise a reflective exterior coating and/or end 2865 with no or partial coating, to provide light emission from end 2865 to the nasophanyx region 2870 of the nasal cavity 2810 for treatment.
  • Figs.29a and 29b illustrates a configuration of a nasal LLLT device of the present invention.
  • assembled nasal device 2905 is shown placed in patient nose 2910.
  • First light transmission portion 2915 is engaged with second light transmission portion 2920 at connection 2925.
  • first light transmission portion 2915 is in operational and optical engagement with a PBM control module [not shown].
  • Second light transmission portion 2920 is shown with interior diameter 2935 for allowing air to flow into patient’s nose 2910 when second light transmission portion 2920 is engaged with first light transmission portion 2915.
  • first and second light transmission portions 2915 and 2920 can be in an unconnected configuration 2940. Opening 2945 is proximal to magnetized portion 2950 whereby first light transmission end 2960 is magnetically engageable therewith.
  • Use of a magnet as shown herewith has been found to enhance operability and patient compliance by enabling connection 2925 between portions 2915 and 2920 to be created and broken easily and substantially without requiring twisting or snapping action that might result in pain to patient or disruption of healing processes.
  • Figs.30a and 30b illustrate a nasal LLLT treatment device 3005 that is placeable over patient’s outer nose 3010 in conjunction with a septoplasty or rhinoplasty, for example.
  • Device 3005 which is suitably fabricated from bio-compatible material that is light transmissive, has support structure 3015 having inner surface 3020 that remains light
  • First light transmission portion 3025 can be a fiber optic component or the like, as discussed previously.
  • Second light transmission portion 3030 has first exterior side 3035 and second exterior side 3040 [not shown] that are reflectively coated to reduce light exiting from sides 3035 and 3040. Together, 3035 and 3040 approximates the shape of the bridge [not shown] of nose 3010.
  • Device 3005 has connection 3045 configured to engage with support end engagement port 3050. Connection 3045 is made by engagement of first transmission portion end 3055 with engagement port 3050 to allow light to be transmitted into support structure 3015 in use.
  • Engagement port 3050 can be magnetized by including magnets, such as shown in 3060a and 3060b, proximal to engagement port 3050.
  • First transmission portion end 3055 can comprise suitable material to be magnetically engageable with engagement port 3050.
  • first light transmission portion 3025 is suitably engaged with support 3015 to form connection 3045 and portion 3025 is operationally and optically engaged with a PBM module [not shown] LLLT will be emitted to areas proximal to the skin and bridge [not shown] of nose 3010.
  • Fig.31 illustrates an implementation for a nasal insert 3105 configured to distribute LLLT treatment to areas proximal to the nostrils [not shown] and nasal cavity [not shown] and keep the airway path [not shown] from closing by providing support to the surrounding tissue [not shown], such as after a rhinoplasty, for example.
  • Nasal insert 3105 comprises a first nasal insert portion 3110 configured to be engagable with a first light transmission portion [not shown], which can be fiber optic, that is configurable to transmit light from a PBM control module [not shown] via suitable connections [not shown].
  • First nasal insert portion 3110 can be cladded with material, such as a polymer of lower refractive index or via metal vapor deposition to be substantially non-transmissive to light.
  • First nasal insert potion 3110 is engageable at end 3115 with second nasal insert portion 3120 at second nasal insert portion end 3125.
  • Second nasal insert portion made from light transmissive material, has first nasal stem 3130 and second nasal stem 3135 from which LLLT treatment can be delivered when nasal insert 3105 is configured for use.
  • First and second nasal stems 3130 and 3135 are engaged at bend 3140.
  • First nasal stem end 3130 is configured with air hole 3150 in communication with air hole 3160.
  • Second nasal stem 3135 is configured with air hole 3155 in communication with air hole 3165.
  • Fig 31b illustrates a cross section 3170 of a nasal stem in accordance with Fig.31a whereby inner diameter 3175 is configured to allow air flow in use, and the area 3180 between inner diameter 3175 and outer diameter 3170 is configured to allow light to travel therein and to exit at surface 3185, for example, to allow patient nasal tissue [not shown] to be suitably treated with LLLT treatment in use.
  • Nasal insert 3105 is sized for patient comfort while still allowing suitable LLLT treatment.
  • nasal stems 3130 and 3135 can be any suitable LLLT treatment.
  • silicone polymer having a Shore Hardness of from about 20 to about 65.
  • Figs.32a and 32b show a quick connect and low loss optical coupling connector for providing treatment dosage to a PBM control module to for delivery to a patient.
  • Engagement configuration 3205 for connecting light guide sections 3210 and 3230.
  • Engagement configuration 3205 has alignment features 3215 and 3220 configured within light guide interior 3225 and alignment features 3235 and 3240 configured within light guide interior 3245.
  • Alignment features 3215, 3220, 3235, and 3240 are configured to assist in aligning light guide section 3210 and with light guide section 3230.
  • the alignment is achieved by the location of magnets 3215 (N) and 3320 (S) to match the polarity of magnets 3235 (S) and 3240 (N).
  • FIG.32b engagement of light guides 3210 and 3230 is shown with optical connector core 3245, made of a pliable and light transmissive material, to generate an efficient optical coupling connection [not shown] by substantially eliminating or minimizing optical loss from air gaps at the point of connection.
  • optical connector core 3245 made of a pliable and light transmissive material
  • Fig.33 illustrates a combination LLLT treatment comprising a patient 3300 with a first LLLT treatment device 3305 configured around patient head sides 3310a and 3310b and chin 3315 in conjunction with nasal LLLT treatment device 3320 configured in patient nose 3325 within nostrils 3330 and 3330b.
  • PBM control module 3335 can be positioned proximally to patient crown 3340, for example, or other suitable area.
  • Light guide arrangement 3345 is engaged at engagement port 3345a via optical connector [not shown] with PBM control module 3335 so as to deliver a dosage of LLLT treatment to patient 3300 from patient facing side 3350 [not shown] of treatment device 3305 at head side 3310a around chin area 3315 to head area 3310b to be further engagable with PBM control module 3335 at 3345b.
  • Light guide arrangement 3355 is engageable with PBM control module 3335 at 3355a and configured to engage with connection 3360 which is, in turn, engaged with first light transmission portion 3365, which can be a fiber optic.
  • Light transmission portion 3365 is engaged with nasal insert 3370 at connection 3375 to provide a path for LLLT treatment as detailed elsewhere herein when nasal insert 3370 is inserted into patient nostrils 3330a and 3330b and PBM module 3335 is operationally and optically engaged therewith.
  • one PBM control module and a plurality of light guide arrangements 3345 and 3355 are configured with 3305, but different PBM control module and light guide arrangements are contemplated.
  • Fig.34a illustrates a LLLT treatment device configuration 3405 comprising a treatment component 3410 fabricated from a substantially soft material, such as that having
  • Component 3410 is fabricated from a light transmissive material, such as silicone polymer.
  • Light transmission portion 3415 which can be a fiber optic or polymeric light guide, has interior end 3420 embedded in component 3410 for distributing LLLT treatment therefrom for further transmission into and from an interior [not shown] of component 3410.
  • Light transmission portion 3415 is operationally and optically engageable to a PBM control module [not shown] via connection 3425.
  • Figs.34b and 34c show a variation 3430 having discontinuities 3435 in component 3430 that function to scatter light from 3430. Such discontinuities 3435 can be in the interior of 3430 and/or can be placed on the surface of 3430.
  • Fig.34b is a side view
  • Fig.34c is a top view of 3430, each of which show exemplary placement of discontinuities 3435.
  • Fig.34d shows a clear liquid or gel filling is incorporated in an interior area 3440 of component 3445 to provide a soft and resilient (e.g.,“pillow-like”) feel thereto.
  • Light transmission portion 3415 having end 3420 is operationally and optically engaged with a PBM control module [not shown] via connection 3425.
  • Component 3445 can be fabricated from a soft material that is light transmitting.
  • An optical fiber interior end 3420 is incorporated in 3440 and in contact with exposed to the liquid or gel filling therein.
  • Surface discontinuities [not shown] for light scattering can be incorporated in either or both the interior 3440 or in the surface 3450 of component 3445.
  • Such design can be beneficial as water or gel is highly transmissive and conforms well with complex body contours, such as on the face to provide comfort, and can be used in combination with hot and cold therapy to the same area, for example.
  • FIG.35a A LLLT treatment device for human head hair growth, restoration and/or scalp healing (collectively scalp LLLT treatment device) is illustrated in Fig.35a.
  • Patient 3500 is wearing LLLT scalp treatment device 3505 having an exterior surface 3510 and a scalp facing side 3515 [not shown].
  • PBM control module 3520 is configured to be removably mountable or permanently mountable to cap 3505, such as at a rear portion 3525.
  • PBM control module 3520 is operationally and optically engageable with light guide arrangement 3330, here shown with cap 3505 partially cut away in Fig.35b.
  • Light guide arrangement 3330 is configured to treat substantially most or all of scalp 3335 with LLLT treatment being delivered from a patient facing side 3340 [not shown] of light guide arrangement 3330.
  • scalp LLLT treatment device 3505 is configured as a baseball cap, however, it is to be understood that any cap or hat configuration can be used, as long as the intended scalp LLLT treatment can be effected therefrom.
  • PBM control module 3520 is visible as a housing at rear portion 3525 in Fig.35a. However, more discrete configurations, such as with a smaller format PBM control module design [not shown] or by embedding various componentry in a flexible housing [not shown] that could be fully hidden inside cap 3505.
  • the LLLT treatment is delivered via light guide arrangement directly and with substantially no electrical connections are in contact with the scalp or areas proximal thereto.
  • the light source(s) are substantially separated from the location where the LLLT treatment is delivered to the patient’s scalp, such as being configured to be wholly generated from a light source(s) that is incorporated in housing or other containment structure that is separate and connectable to a light guide arrangement configured to deliver LLLT therefrom.
  • Fig.36 illustrates an exemplary configuration of a light guide configuration to provide LLLT treatment to patient 3600 with light guide arrangement 3605 positioned proximal to patient scalp area 3610.
  • Light guide arrangement 3605 is configured to deliver light to substantially all of scalp area 3610 on patient 3600, as shown in Figs.36a and 36b.
  • the light guide arrangement side 3605 facing away from the scalp area 3610 can be coated with optically reflective material, and the scalp facing side [not shown] can be configured to contact with or be adhered to light transmissive particles, synthetic microfibers, fiber segments, or can comprise surface discontinuities sufficient to cause light scattering during delivery of LLLT treatment to scalp 3610.
  • PBM control module 3615 is shown engaged with light guide arrangement 3605 at connection 3620.
  • Fig.37 shows the Norwood Scale, which is a standardized prior art method for assessing for assessing the amount, type, and pattern of hair loss.
  • a patient’s hair loss can be determined according to a standardized assessment such as the Norwood scale, and a light guide arrangement having a light delivery pattern appropriate to deliver LLLT treatment to the patient in substantially all locations associated with the determined hair loss.
  • Methodology associated with the present invention comprises selecting an amount of hair loss in a patient according to the Norwood Scale or other standardized methodology and defining a LLLT treatment protocol to provide a therapeutic treatment therefore.
  • Beneficial dosages for promoting hair growth with red and/or near-infrared light wavelengths can be in the range of about 0.5J/cm 2 /day to 10J/cm 2 /day depending on the degree of hair loss, hair thickness, color of existing hair, and other factors.
  • the non-invasive and discrete nature of the scalp area LLLT treatment device of the present invention allows the device to be worn as needed by a patient, thus enhancing the usability and effectiveness of the scalp treatment protocols in the present invention.
  • Fig.38a shows patient 3800 having a level of male pattern baldness on the Norwood Scale as shown in Fig.37 of about 5 as seen by the amount of scalp 3805 and forehead 3815 that are free of hair 3810 covering.
  • Fig.38b illustrates an exemplary light guide arrangement 3820 having a plurality of light guide arrangement elements 3830a, 3830b, 3830c, 3830d, 3830e, 3835a, 3835b, 3835c, 3835d, and 3835e configured with central light
  • Central light guide arrangement components 3840a and 3840b are removably or permanently engageable with PBM control module 3845 at engagement ports 3850a and 3850b [not shown]. Other light guide arrangements and engagements to one or more PBM control modules are contemplated.
  • Fig.39 discloses a further implementation of a light guide arrangement 3905 that can be used to treat the scalp area of a patient [not shown] in need of treatment.
  • Light guide elements 3910, 3915, and 3920 are configured to comprise light guide arrangement 3905 so as to deliver LLLT treatment to a substantial portion of a patient’s scalp [not shown] in use.
  • Light guide elements 3910, 3915, and 3920, which are in communication with each other at one or more locations, are operationally and optically engageable with light sources 3925, 3930, and 3935, which can be three lasers, LEDs or SLDs, for example.
  • Such light sources 3925, 3930, and 3925 can be configured in a single PBM control module [not shown] or two or more PBM control modules [not shown].
  • light guide arrangement 3905 When light guide arrangement 3905 is operationally and optically engaged with light sources 3925, 3930, and 3935 at light guide element ends 39403945, and 3950, a therapeutic amount of LLLT treatment is deliverable to a patient [not shown].
  • Use of more than one, such as two or three, light sources can be beneficial to better ensure that the entire patient scalp area is exposed to enough LLLT treatment while at the same time minimizing heat generation that could cause discomfort or overheat the componentry.
  • additional light sources can increase the total amount of light energy available to be distributed to the patient’s scalp area during a treatment without requiring the use of a single light source that has enough power, and the associated power requirements therefore, to be able to fully distribute light through the full surface area of a light guide arrangement such as 3905.
  • Such light energy is shown traveling through at least part of light elements 3910 and 3920. More or fewer light sources can suitably be used.
  • Light guide arrangement 3905 can be configured in various shapes from optically suitable polymer (such as TPXTM Polymethylpentene (PMP) from Mitsui Chemicals America, or Thermoplastic polyurethane (TPU)) or silicone (Dow Corning’s line of optical moldable silicones) to achieve the objectives of the present invention. Side emitting fiber optics can also be used. Light guide arrangements can be custom designed for a patient by measuring the scalp area of a patient and fabricating a light guide arrangement that delivers LLLT treatment from a patient facing side thereof in an amount that covers substantially all of the surface area of the scalp area in need of treatment.
  • optically suitable polymer such as TPXTM Polymethylpentene (PMP) from Mitsui Chemicals America, or Thermoplastic polyurethane (TPU)
  • silicone Dow Corning’s line of optical moldable silicones
  • Light guide arrangement 3905 and any individual light guide elements, such as 3910, 3915, and 3920, associated therewith are configurable to substantially evenly distribute light to a patient’s scalp for treatment thereof.
  • one or more parts of light guide arrangement 3905 and associated light guide elements such as 3910, 3915 and 3920) are configurable for collecting the reflection of light from the scalp for analysis of treatment progress and dosage response. Progress of scalp area treatment can be monitored from time to time in this regard.
  • light guide arrangement 3905 can be engagable to a filtered photo-sensor [not shown] associated with PBM control module [not shown] for detecting reflected or emitted light generated from the patient scalp or hair [not shown].
  • a magnifying digital imager [not shown] can be incorporated into device 3905 to be in communication with a PMB control [not shown] to generate images of the patient scalp during a treatment.
  • imaging information can be useful for remote improving treatment compliance, and remote monitoring of scalp conditions, as well as dosage and response optimization.
  • Fig.40 illustrates a further implementation of the present invention suitable for hair growth or similar treatments.
  • scalp area treatment device 4000 configured to fit within a hat 4005 as illustrated.
  • PBM control module 4010 is configured with at least one light source, shown here as laser diodes 4015a and 4015b, can also comprise two or more, or three or more, or four or more, or five or more, or seven or more diodes, LEDs or SLDs.
  • Light sources 4015a and 4015b are shown operationally and optically engaged with light guide arrangement 4020 with mirror 4025 suitably configured to optically transmit light from 4015a and 4015b into and from light guide arrangement 4020 to a scalp area [not shown] in use.
  • mirror 4025 is shown as cone shaped in Fig. 40a, where such shape has been found to enhance light delivery from light guide arrangement 4020.
  • Light guide arrangement 4020 is made from material that is light transmissive from treatment side 4045 (Fig.40c), substantially flexible and suitably shaped to conform to areas proximal to the top of a patient’s head [not shown] so as to allow LLLT treatment to be delivered from treatment side 4045.
  • light guide arrangement 4020 is optically engaged to mirror 4025.
  • Mirror 4025 is configured to receive light emitted from at least one light source, here shown as 4015a and 4015b.
  • a light beam such as shown by 4030, which is generated from at least one light source 4015a and 4015b at the instruction of PBM control module 4010 and is transmitted within light guide arrangement 4020, reaches interior light guide arrangement surface 4035 at a greater angle of incidence than the critical angle, light beam 4030 will be reflected back into light guide arrangement 4020 to for further travel therein.
  • a light beam such as 4040 reaches treatment side 4045 at an angle less than the critical angle, or at a designated scattering area, it will travel
  • interior light guide arrangement surface 4035 can be coated with reflective material form designated scattering spots or areas configured to increase amount of light deliverable to light guide arrangement surface 4050 so as to increase the amount of light reaching the patient’s scalp area.
  • Fig.41 illustrates a further implementation of the present invention comprising light guide arrangement validation functionality to confirm that a light guide arrangement is properly matched with an associated PBM control module and to generate any associated LLLT treatment dosage, deliver appropriate personalized treatment, activate monitoring sensors, log treatment history, and provide treatment instructions.
  • Fig.41a shows a simplified light guide/module diagram 4105 with PBM control module 4110 having engagement ports 4115 and 4120. Engagement ports 4115 and 4120 are configurable to recognize and validate only light guide elements, here shown as 4125 and 4130, that are properly configured for engagement with PBM control module 4110.
  • light guide elements 4125 and 4130 each, independently, comprise validation signaling capability 4135 and 4140 that is readable by componentry [not shown] associated with PBM control module 4010.
  • Such validation signaling capability 4135 and 4130 can comprise RFID, bar code scanning, holographic scanning, physical patterns, mechanical patterns, defraction gratings, QR codes, color coding, direct connection circuits (e.g., wires directly connected between the machine and a small chip on the mold), physical (such as physical teeth and groves as a key on a light guide) etc.
  • instructions associated with PBM control module 4010 can require that a signal provided by 4135 and 4140 match an expected signal defined by the software instructions, for example.
  • PBM control module 4110 will be configurable to activate the componentry therein, so as to generate operational and optical engagement between PBM control module 4110 and light guide elements 4125 and 4130 so as to allow LLLT treatment to be delivered to a patient [not shown] who is wearing a LLLT treatment device [not shown] having 4105 associated therewith.
  • 4145 shows an implementation where validation does not occur and, therefore, LLLT treatment is not delivered to a patient [not shown] who is wearing a LLLT treatment device [not shown] associated with 4145.
  • software instructions associated with PBM control module 4110 have configured engagement ports 4115 and 4120 to expect a first signal 456 from light guide element 4125 and a second signal XYZ from light guide element 4130.
  • first light guide signal componentry 4135 is generating signal 123
  • second light guide signaling componentry 4140 is generating signal ABC.
  • each of light guide elements 4125 and 4130 are shown having signaling capability, in some implementations, at least one light guide element end is validatable with a corresponding engagement port in an associable PBM control module.
  • PBM control modules can also be used with multiple LLLT delivery elements, whereby software instructions provided to a PBM control module can be automatically and intelligently configured for different LLLT delivery elements and/or light guide arrangements.
  • Fig.42 illustrates a light guide arrangement 4205 configured to allow light provided from a PBM control module [not shown] by way of single light guide engagement stem 4210 to be delivered to a LLLT delivery element [not shown] by way of a plurality of light guide stems, such as with 4215, 4220, 4225, and 4230 that branch from stem 4210.
  • light enters light guide stem end 4235 by way of operational and optical engagement with a PBM control module [not shown] at an 100% energy level as delivered from one or more light sources [not shown] associated therewith.
  • a partial amount of this light energy is delivered to each of light guide stems 4215, 4220, 4225, and 4230 and travels along the lengths of each for delivery to a patient [not shown] via an associated LLLT delivery element [not shown].
  • light energy delivered to 4215, 4220, 4225, and 4230 is at 35%, 25%, 15%, and 25%, respectively, as measured by the original 100% light energy delivered from the PBM control module [not shown] at stem end 4235 when end 4235 is operationally and optically engaged therewith.
  • the amount of energy delivered to each of 4215, 4220, 4225, and 4230 can be modified by changing the angle of separation and/or the distances between each of 4215, 4220, 4225, and 4230 as shown, for example, by 4240, 4245 and 4250.
  • the amount of light energy delivered into each of stem 4215, 4220, 4225, and 4230 and, therefore, to the patient [not shown] can also be modified by variation in one or more cross- sectional areas thereof, application of and/or variations in reflective coatings thereto, creating variations in attenuation, and application of light scattering characteristics thereto, such as by adding discontinuities to the interiors or surfaces as discussed elsewhere herein. More or fewer stems can also be generated, which will affect the amount of light transmitted through each stem, as would be recognized from Fig.42.
  • Fig.43 illustrates a LLLT treatment device for post-operative care after a surgery of the leg, such as a total knee arthroplasty, or TKA.
  • Device 4305 comprises a patient facing side 4310, comprising a transparent or translucent first cover material 4315 beneath which
  • each of 4320a and 4320d are operationally and optically engageable with each other at connection 4325a and further in operational and optical engagement with PBM control module 4330a via light guide element 4335a.
  • Each of 4320b and 4320c are operationally and optically engageable with each other at connection 4325b and further in operational and optical engagement with PBM control module 4330b via light guide element 4335b.
  • First cover material 4315 comprises patient facing side 4310 is a transparent or translucent material comprising light transmissive fibers suitable to engage with light guides for light scattering and contact with the skin of the patient to allow LLLT to be delivered to the patient’s leg and knee areas [not shown] and associated“healing vital areas” [not shown], as discussed previously.
  • Second cover material 4340 can comprise a fabric material or the like.
  • fasteners 4350a, 4350b, and 4350c can be configured in the form of, for example, Velcro®, elastic straps, clips, hooks etc.
  • PBM control modules 4330a and 4330b can be removably or permanently mountable to device 4305 and configured to fit comfortably proximal to back of patient’s leg [not shown] or the like. More or fewer light guide elements and/or PBM control modules can suitably be used.
  • Figs.44a, 44b, and 44c show an exemplary configuration of a light guide element 4405 that can be used in the LLLT treatment device illustrated in Fig.43. Front, side, and cross-sectional views, respectively, are provided for illustration in Figs.44a, 44b, and 44c.
  • light guide element 4405 has first section 4410 having end 4415.
  • Light guide element 4405 is further configured in the shape of a loop at a second end 4420.
  • Looped second end 4420 has sides 4425a and 4425b that comprise, for example, light delivery scattering areas 4430, 4435a, 4435b, 4435c, 4440, 4445a, 4445b, and 4445c, as well as others.
  • light delivery scattering areas 4430, 4435a, 4435b, 4435c, 4440, 4445a, 4445b, and 4445c can be generated in light guide elements depending on the needs of the patient being treated and the design of a LLLT treatment appropriate for the patient.
  • groupings of light delivery scattering areas can be provided in various locations on a patient on each of loop sides 4425a and 4425b, as shown with 4435a, b and c and 4445a, b, and c, respectively.
  • end 4415 is operationally and optically engaged with a PBM control module, as discussed elsewhere herein.
  • the loop section of light guide element 4405 can be configured from light transmissive material having lower durometers, for example, Shore A hardness of about 30 to enhance patient comfort
  • section near end 4415 can be configured from light transmissive material having lower durometers, for example Shore A hardness of about 90 to enhance connectablity of end 4415 with a PBM control module.
  • Such multi-hardness light guide design is contemplated for other sizes and shapes of light guide arrangement.
  • a light guide or light guide arrangement can be configured with two or more Shore A hardness ratings, where a higher Shore A hardness is present at or near a connection end thereof.
  • light guide element side view 4420 has a low height profile as compared to the width.
  • the height can be from about 1 mm to about 3 mm and the width from about 5 to about 12 mm.
  • the delivery scattering areas can also be suitably raised from surface 4455 of loop side 4425a, for example.
  • Fig.44c further illustrates this raised profile with light delivery opening 4430.
  • LLLT treatment will be delivered from a PBM control module [not shown] into end 4415 to travel through 4410 and into 4420a and 4420b.
  • the light will exit light guide element 4405 to provide LLLT treatment to a portion of the patient’s body area being treated.
  • a lower height to width ratio improves the comfort and safety to the patient in use, and also operates to reduce the occurrence of pressure injuries to the skin.
  • a reflective coating [not shown] can be present on all or part of outer surface 4460 of light guide element 4405 to enhance light transmission through and out of the various light delivery openings.
  • Fig.45 wearable LLLT devices for treatment on the teeth in conjunction with procedures such as tonsillectomy, orthodontia, dental implants, bone grafting, gingival flap and other mouth area procedures are illustrated.
  • patient 4500 is shown with device 4505 positioned in mouth 4510 and having lower mouthpiece 4515 and upper mouthpiece 4520.
  • First light transmission portion 4525 which can be a fiber optic or other suitable light conveyance material, is in operational and optical engagement with PBM control module 4530.
  • First light transmission portion 4525 is operationally and optically engaged at connection 4535 to second light transmission portion 4540 with second light transmission portion 4540 being suitably operationally and optically engaged and detachably attached to a rim [not shown] of either or both of lower and upper mouthpieces 4515 and 4520 so the such second light transmission portion 4540 can substantially move as one piece when the mouth opens and closes without 4520 dangling from mouthpieces 4515 and 4520.
  • Connection 4535 can comprise a magnetic connection, as discussed previously.
  • Lower mouthpiece 4515 is configurable to fit over or be positioned proximally to the lower teeth (if present) [not shown] and gums [not shown] of mouth 4510 to deliver LLLT treatment to one or more of patient gums, teeth, gums, lower surface of tongue etc.
  • Upper mouthpiece 4520 is configurable to fit over, or to be positioned proximally to the upper teeth
  • each are independently, made from optically transmissive material with hardness in the range of Shore A Hardness of about 20 to about 95.
  • Mouthpieces 4515 and 4520 can be suitably used together to provide treatment to an upper and lower portion of patient mouth 4510.
  • each of 4515 and 4520 can be operationally and optically engaged with PBM control module 4530, such as by providing two light transmission portion engagement ports [not shown] or by configuring an additional PBM control module [not shown] to engage with 4515 or 4520, as appropriate.
  • Either of lower and upper mouthpieces 4515 and 4520 can be configured with grooves 4550 on a tooth facing side, as shown on Fig.45b. Further in relation to Fig.45b, second light transmission portion end 4555 is in operational and optical engagement with the interior 4560 of mouthpiece 4565.
  • Mouthpiece 4565 can be fabricated from a softer material, for example, from Shore D hardness of about 20 to about 80 so as to facilitate one form of placement of 4565 of on patient teeth [not shown] via grooves 4550.
  • harder materials such as those in the Shore D hardness range of about 70 to about 95 can be more suitable for clear and less visible braces, which are designed to have groove(s) 4550 that fit tightly to the teeth for orthodontal alignments.
  • two of the mouth pieces, each engaged with a dosed light source can be designed and used simultaneously for both the upper and lower teeth for LLLT treatment.
  • Fig.45c illustrates mouthpiece 4570 wherein second light transmission portion 4575 can be configured on an outer surface of 4570, and is in operational and optical engagement with PBM control module 4530 [not shown] so as to deliver LLLT treatment into an interior of 4570 to be delivered to mouth areas [not shown] proximal thereto.
  • At least some of the interior [not shown] of either or both of mouthpieces 4565 and 4570 can comprise a reflective coating enhance LLLT transmission therefrom.
  • reflective materials or discontinuities can be incorporated on or in the mouthpiece configurations to further enhance light transmission therefrom.
  • LLLT mouth device configurations can be optimized to treat various conditions. For example, when an entire mouthpiece surface is configured to transmit light delivered from a PBM control module, the mouthpiece can function as clear braces to enhance correction of the teeth position. Upper and lower mouthpieces can be configured to allow light to be delivered from a single PBM control module. When red light is applied to the mouth interior at from about 640 nm to about 670 nm dosed at about 0.2 to about 1J/cm 2 /day, LLLT treatment can speed up teeth movement as well as reduce the pain and discomfort from wearing braces. For another example, when ends 4585a and 4585b of mouth piece 4570
  • LLLT can reduce the pain and swelling after surgeries to the gum, or as ongoing treatment to gingivitis.
  • Table 2 below provides general parameters for a LLLT treatment device of the present invention.
  • LLLT treatment protocol was application of light at 650 nm and 880 nm delivered at 160 mW over an 120 cm 2 area adjacent to the extraction site of each patient.
  • Each patient was subjected to daily LLLT treatment, 3 times each day, with 28 minutes of light exposure each treatment.
  • EXAMPLE 4 Total Knee Arthroplasty (TKA)
  • One patient with a TKA incision was treated with LLLT treatment post-surgery at 650 nm and 810 nm delivered at 320 mW over an area of 560 cm 2 proximal to the incision area with an inventive knee and leg area treatment device as described further herein.
  • Daily LLLT treatments were given to the patient 3 times each day, with 40 minutes light exposure each treatment.
  • Results The treated patient had a minimum of bruising and started walking unassisted since at post-operative day 3. Patient reached a range of motion of 0-120 degrees by post-operative day 28. Patient reported significantly less pain than expected in the opinion of the attending clinicians.

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Abstract

L'invention comprend des composants et des dispositifs d'application de photothérapie à un patient. L'invention porte sur des contrôleurs de dispositifs de photothérapie, des éléments de distribution de lumière, des guides de lumière, des dispositifs de guidage de lumière configurés pour délivrer une photothérapie personnalisée, avec des composants, un dosage et des éléments d'administration de photothérapie (par exemple, des bandages, des vêtements, des appareils orthopédiques, des inserts, etc.) approprié pour fournir une photothérapie à une, ou plusieurs zones, du corps, ainsi que des capteurs pour surveiller l'évolution du traitement et l'optimisation du dosage. L'invention porte également sur les méthodes d'administration, les indications médicales, sur le dosage LLLT personnalisé et sur les plateformes et les systèmes de traitement LLLT de télémédecine.
PCT/US2017/043988 2016-07-27 2017-07-26 Composants et dispositifs d'administration de photothérapie. WO2018022775A1 (fr)

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BR112019001573A BR112019001573A2 (pt) 2016-07-27 2017-07-26 conjunto de componentes e dispositivos para aplicação de terapia de luz e métodos relacionados aos mesmos
EP17749054.7A EP3490671A1 (fr) 2016-07-27 2017-07-26 Composants et dispositifs d'administration de photothérapie
AU2017301811A AU2017301811A1 (en) 2016-07-27 2017-07-26 Componentry and devices for light therapy delivery and methods related thereto
CN201780059870.8A CN109789313A (zh) 2016-07-27 2017-07-26 用于光疗递送的部件和装置及其相关的方法
CA3031991A CA3031991A1 (fr) 2016-07-27 2017-07-26 Composants et dispositifs d'administration de phototherapie.
US16/110,688 US20190083809A1 (en) 2016-07-27 2018-08-23 Componentry and devices for light therapy delivery and methods related thereto
US17/064,017 US20210093888A1 (en) 2016-07-27 2020-10-06 Componentry and devices for light therapy delivery and methods related thereto
US17/203,308 US11458329B2 (en) 2016-07-27 2021-03-16 Componentry and devices for light therapy delivery and methods related thereto

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US201662498401P 2016-12-27 2016-12-27
US62/498,401 2016-12-27
US201762499612P 2017-01-31 2017-01-31
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US201762499674P 2017-02-03 2017-02-03
US62/499,674 2017-02-03
US15/645,467 US20180008837A1 (en) 2016-07-11 2017-07-10 Light therapy delivery devices and methods for the female genitalia and areas proximal thereto
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AU2017301811A1 (en) 2019-03-21

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