Light-based vaginal therapy devices and methods for use

Abstract

To provide LED-based vaginal light therapy devices for bacterial and fungal infections.SOLUTION: A device 600 is provided including: a housing comprising a body 610 sized for introduction into a vagina and including a central region and tapering towards a distal end, and an appendage 620 extending proximally from the body configured such that the appendage extends from the vagina when the body is inserted therein; one or more light sources configured to emit light outwardly from the body; and a battery within the appendage configured to deliver electrical power to activate the one or more light sources.SELECTED DRAWING: Figure 9-1

Description

[Technical Field]

[0001] This application relates generally to medical devices, and more particularly to light-based vaginal phototherapy devices for the treatment of bacterial and fungal infections, and systems and methods for using such devices.

[0002] Related application data This application claims the benefit of co-pending provisional application Ser. No. 62 / 911,877, filed October 7, 2019, and provisional application Ser. No. 62 / 943,161, filed December 3, 2019, the entire disclosures of which are expressly incorporated herein by reference. [Background technology]

[0003] Vaginitis is characterized by vaginal inflammation resulting in discharge, itching, and pain. It is usually caused by an infection or a change in the normal balance of vaginal bacteria. Vaginitis can also result from a decline in estrogen levels after menopause. 75% of women experience a vaginal bacterial or fungal infection in any given year. Symptoms range from mucus-like discharge, itching, pain, and painful intercourse to odor. Vaginal infections often have multiple causes and can be difficult to treat. Maintaining a natural balance of yeast and bacteria is important. An imbalance in the system or the presence of other types of bacteria in the environment can lead to vaginitis. In fact, when one cause is treated, other pathogens may not respond to antibiotic treatment or may mutate and become resistant to antibiotic therapy. Occasionally, a decrease in beneficial bacteria can allow yeast, commonly Candida albicans, to proliferate and cause a yeast infection. Furthermore, changes in pH balance or the introduction of foreign bacteria into the vagina can lead to infectious vaginitis. Physical factors that contribute to the development of infection include a constantly moist vulva due to tight clothing, chemicals that come into contact with the vagina via scented tampons, antibiotics, birth control pills, or a diet that favors refined sugars and yeast.

[0004] Bacterial vaginosis, also known as dysbiosis or Gardnerella vaginitis, is a vaginal disease caused by excessive bacterial growth. Common symptoms include increased vaginal discharge, often with a fishy odor. The vaginal discharge is usually white or gray in color. Burning pain during urination may also occur. Itching is rare. Occasionally, there may be no symptoms. Bacterial vaginosis increases the risk of many other sexually transmitted infections, including HIV / AIDS. It also increases the risk of preterm labor in pregnant women. Bacterial vaginosis is caused by an imbalance of bacteria naturally present in the vagina. The diagnosis is suspected based on symptoms and confirmed by vaginal discharge testing, which reveals a higher-than-normal vaginal pH and a high number of bacteria. Bacterial vaginosis is often confused with candidal vaginosis. Treatment is usually with antibiotics. Bacterial vaginosis is the most common vaginal infection in women of reproductive age. The percentage of women affected varies and can be as high as 35%. Oral or vaginal antibiotics are effective in treating the condition. However, approximately 10% to 15% of women do not improve with initial antibiotic treatment, and recurrence rates of up to 80% have been documented. Estrogen-containing contraceptives reduce recurrence, but sexual activity with the same partner before and after treatment and inconsistent condom use increase recurrence rates. There is evidence of a link between bacterial vaginosis and increased rates of sexually transmitted diseases, including HIV / AIDS. Bacterial vaginosis is associated with up to a six-fold increase in HIV shedding. There is also a correlation between the lack of vaginal lactobacilli and infection with Neisseria gonorrhoeae and Chlamydia trachomatis. Bacterial vaginosis is a risk factor for viral shedding and herpesvirus type 2 infection. Bacterial vaginosis may also increase the risk of HPV infection or reactivation.

[0005] Candidiasis, more commonly known as a yeast infection, is commonly caused by the overgrowth of a fungus called Candida albicans in the vagina. Candida is a type of yeast. Yeast is always present in the vagina in small amounts, and symptoms only manifest when it overgrows. Candida can proliferate when an imbalance occurs, such as when the normal acidity of the vagina changes or when hormone levels change. Frequent yeast infections may be a sign of more serious health problems, such as diabetes or a compromised immune system. Recurrent infections can also result from antibiotic use. Recurrent vulvovaginal candidiasis affects at least 75 million women in the United States each year. Approximately 5–8% of women experience four or more episodes each year and are diagnosed with recurrent vulvovaginal candidiasis. Approximately 75% of all premenopausal women will develop thrush at some point in their lives. With the introduction of over-the-counter medications for the home treatment of yeast infections, many women choose to self-diagnose and self-treat, which means that the true incidence of yeast infections each year may be significantly under-reported.

[0006] Compared with antibacterial treatments, antifungal treatments are limited to a very small number of active pharmaceutical ingredients. Treatment of fungal infections can be topical or systemic. Topical antifungals are generally considered the first-line therapy for uncomplicated, superficial, and relatively localized fungal infections due to their high efficacy and low potential for systemic side effects. Systemic antifungals are absorbed and delivered to the body via the bloodstream. The oral route is usually the safest, most economical, and most comfortable route for systemic antifungal administration.

[0007] Topical antifungal creams and suppositories have fewer side effects than oral antifungal drugs because they are not readily absorbed systemically and exert only a localized effect on the genital area. Antifungal drugs affect the entire body, and side effects include nausea, headache, and abdominal pain. However, topical medications can be tedious and uncomfortable, while pills are relatively painless. Antifungal treatment is ineffective in up to 20% of cases. Thrush treatment is considered unsuccessful if symptoms do not resolve within 7–14 days. Furthermore, the incidence of resistance to antifungal drugs is increasing, and drug-resistant fungal strains are becoming a common cause of infection in high-risk patient groups, such as those with HIV / AIDS. For this reason, alternative antifungal strategies are actively sought.

[0008] Severe infections are difficult to treat and often require more aggressive and long-term treatment, such as chronic recurrent cases. Furthermore, adherence to the full course of treatment is essential, as incomplete treatment often leads to drug-resistant infections.

[0009] Although phototherapy for various bacterial, fungal or viral infections is commonly known, the treatment of such infections is generally achieved by chemotherapy or drug therapy, with the use of such treatments affecting the internal function of the vagina and uterus by causing harsh or undesirable chemical reactions, which may result in various complications, due to the chemicals used in the form of paste, gel or liquid.

[0010] Oral antifungal medications carry the risk of significant side effects, and many patients are allergic to them. Topical solutions can be messy and inconvenient. There are no existing products for treating yeast infections without the need for medications. Therefore, there is a need for products that allow for the rapid and easy treatment of yeast and bacterial infections without systemic effects. The continued and accelerating emergence of antibiotic-resistant microorganisms has led to a surge in interest and investment in phototherapy. Devices utilizing this new technology could rapidly gain acceptance for certain use cases and broad support among the general public wishing to avoid exposure to additional medications.

[0011] In view of the above, devices and methods for treating vaginal infections would be useful. Summary of the Invention

[0012] This application relates generally to medical devices, and more particularly to light-based vaginal phototherapy devices for the treatment of bacterial and fungal infections and / or prevention of such infections, for example, before / during pregnancy, as well as systems and methods for using such devices.

[0013] According to an exemplary embodiment, a device for vaginal phototherapy is provided, the device including: a housing having a body sized for introduction into the vagina and including a central region and tapering toward a distal end; a tether, tail, or other appendage extending proximally from the body and configured to extend from the vagina when the body is inserted into the vagina; one or more light sources configured to emit light externally from the body at one or more wavelengths within a germicidal and / or sterilizing light range; and a battery within the appendage configured to provide power to operate the one or more light sources. Optionally, a controller and / or wireless communication interface for controlling operation of the one or more light sources can also be provided within the appendage. Further optionally, the one or more light sources can be provided within the appendage, and one or more optical fibers can extend from the appendage into the body to deliver light externally from the body.

[0014] According to another embodiment, there is provided a device for vaginal phototherapy of a user, the device including a housing, the housing being sized for introduction into the vagina, the housing comprising: a body having a proximal end, a distal end, and a central region, the body tapering from the central region toward the distal end; and a curved appendage integrally formed with the body, extending from the proximal end of the body, the appendage configured to extend from the vagina when the body is inserted into the vagina. The device further includes one or more light sources configured to emit light outward from the body at one or more wavelengths within a germicidal and / or disinfecting light range; a battery within the appendage; and a controller within the appendage, the controller connected to the battery and the one or more light sources for controlling operation of the one or more light sources.

[0015] According to another embodiment, there is provided a device for vaginal phototherapy of a user, the device comprising: a housing having a body sized for introduction into the vagina and including a central region and tapering towards a distal end; an appendage integrally formed with the body and extending proximally from the body, the appendage having a length sufficient to extend from the vagina when the body is fully inserted into the vagina and biased into a curved shape; one or more light sources configured to emit light outwardly from the body; and a battery configured to provide power to operate the one or more light sources.

[0016] According to yet another embodiment, there is provided a device for vaginal phototherapy of a user, the device comprising: a housing having a body sized for introduction into the vagina and including a central region and tapering towards a distal end; an appendage integrally formed with the body and extending proximally from the body, the appendage having a length sufficient to extend from the vagina when the body is fully inserted therein and formed of a malleable material so as to be able to be manipulated into and retain a desired shape; one or more light sources configured to emit light outward from the body; and a battery configured to provide power to operate the one or more light sources.

[0017] According to yet another embodiment, there is provided a device for vaginal phototherapy of a user, the device including a housing, the housing including: a body sized for introduction into a vagina, the body having a proximal end, a distal end, and a central region, the body tapering from the central region toward the distal end; and a curved appendage integrally formed with the body, extending from the proximal end of the body, the appendage configured to extend from the vagina when the body is inserted into the vagina. The device further includes one or more light sources configured to emit light outward from the body, a battery within the appendage, and a controller within the appendage, the controller connected to the battery and the one or more light sources for controlling operation of the one or more light sources.

[0018] According to another embodiment, there is provided a device for light treatment of a user, the device including: a body having an upper region and a lower region tapering from the upper region, the lower region sized to be inserted between the labia of a user to expose the vulva; one or more light sources configured to emit light outwardly from the body; and a battery configured to provide power to operate the one or more light sources.

[0019] According to yet another exemplary embodiment, there is provided a device for vaginal phototherapy of a user, the device including: a body sized for introduction into the vagina, the body including a proximal end and a distal end; one or more light sources mounted on or within the body, each configured to emit light externally from the body at one or more wavelengths within a germicidal and / or sterilizing light range; and a tether connected to the body and configured for removal of the device from the user's vagina. In one exemplary embodiment, the body is oval or elliptical, e.g., including rounded proximal and / or distal ends tapering from a central region.

[0020] Optionally, the device can include an atraumatic cervical support at a distal end of the body configured for placement against the cervix of the vagina, e.g., defining a recess or a flat surface at the distal end. Further, the device can include a controller within the body that controls operation of the one or more light sources and / or a switch, e.g., a pressure-activated switch, a motion-activated switch, or a capacitance-sensing switch, for activating and deactivating the one or more light sources.

[0021] In one embodiment, the exterior surface of the body may be substantially smooth. Alternatively, the body may include a plurality of depressions, e.g., rounded concave depressions, disposed on the surface to facilitate delivery of drugs, photosensitizer-based creams, and / or other agents to the exterior surface prior to introduction.

[0022] In one embodiment, the one or more light sources may include a plurality of LEDs or other lights mounted on the body, e.g., mounted substantially flush with the exterior surface of the body. In another embodiment, one or more internal light sources may be provided within the body, and a plurality of lenses may be mounted substantially flush with the exterior surface of the body.

[0023] The controller, when activated, may operate one or more light sources substantially continuously, automatically turn off one or more light sources after a preset treatment period, and / or pulse one or more light sources, e.g., repeatedly turn on and off one or more light sources, and / or alternate one or more light sources between different wavelengths to enhance treatment.

[0024] In another embodiment, instead of an external switch, an accelerometer or other motion sensor may be provided within the body coupled to the controller. For example, the controller may monitor signals from the motion sensor to identify pre-defined commands, such as activating or deactivating one or more light sources and / or directing the device into one or more operating modes. In one embodiment, a first distinct motion or set of motions is identified by the controller to switch the device, i.e., alternately activating and deactivating one or more light sources, and a second distinct motion or set of motions is identified to direct the controller to change operation between a menu of options. Alternatively, a different motion may be assigned to each desired command.

[0025] In yet another embodiment, an inductive charging circuit may be provided within the body, for example, coupled to a battery within the body, which may be used to power the controller and / or light source.

[0026] According to another embodiment, a system is provided that includes a vaginal phototherapy device and a cradle or case for storing the device when not in use. For example, the cradle can include a flat underside for placing the cradle on a table or other surface and an upper side including a cavity sized to receive the device. For example, the cavity can define a portion of the oval shape of the body of the device so that the device can be received in the cradle in a preset orientation. In one embodiment, the cavity can have a flat, concave, or convex underside that corresponds to the shape of the cervical support surface of the body, for example, so that the device can be accommodated in the cradle only with the cervical support surface inserted into the cavity first.

[0027] The cradle can include one or more features for interacting with the device. For example, the cradle can include an inductive charging circuit mounted adjacent the cavity to provide energy to the charging circuit of a device placed in the cavity. An exemplary embodiment of such a charging circuit is a circuit, including, for example, one or more magnets, coils, or other components, that generates a magnetic field that activates corresponding circuitry in the device to charge the device's battery. The charging circuit can be activated automatically when the device is placed in the cradle, or it can be selectively activated by the user by operating a switch, button, or other actuator. In one embodiment, the cradle can include control circuitry that periodically activates the charging circuit and identifies when the resulting magnetic field indicates the presence of a device in the cavity. Once the device is identified, the control circuit can activate the charging circuit for a preset time to charge the battery.

[0028] Alternatively, the controller within the device may include circuit components that change the magnetic field or wirelessly communicate to the cradle control circuitry when the controller determines that the battery is fully charged. When the cradle control circuitry detects the change in the magnetic field or other communication from the device controller, the control circuitry can deactivate the charging circuitry.

[0029] Optionally, the cradle can include one or more features to assist and / or facilitate cleaning of the device between uses. For example, to clean the device, the cradle can be provided with one or more light sources, e.g., to apply germicidal light, such as ultraviolet light or non-UV germicidal light, in one or more frequency ranges and / or to neutralize potential pathogens on the exterior surface of the body. In one embodiment, the cradle can include a lid or other enclosure, such that the device can be inserted into the cavity and the lid can be closed to activate the light source and process the device. For example, once the lid is closed, the light source can be automatically activated for a preset period of time to process the device therein. Optionally, the cradle can include a locking mechanism that automatically locks the lid upon closure until a preset time has elapsed, e.g., to ensure the device has been adequately cleaned and / or to prevent inadvertent exposure to light transmitted by the cradle.

[0030] According to yet another embodiment, there is provided a system for vaginal phototherapy of a user, the system including: a body sized for introduction into the vagina, the body including a proximal end and a distal end; one or more light sources mounted to the body, each configured to emit light externally from the body at one or more wavelengths within a germicidal and / or sterilizing light range; a tether connected to the body and configured to remove the device from within the user's vagina; and a photosensitizer configured to be activated by the one or more light sources.

[0031] According to yet another embodiment, there is provided a system for vaginal phototherapy of a user, the system including: a body sized for introduction into the vagina, the body including a proximal end and a distal end; one or more light sources mounted on the body, each configured to emit light outwardly from the body at one or more wavelengths within a germicidal and / or sterilizing light range; a tether connected to the body and configured to remove the device from within the user's vagina; and a test strip for determining the type of infection a patient has.

[0032] According to yet another embodiment, a method for vaginal phototherapy of a user is provided, the method including the steps of fully inserting a body into a vagina such that a tether extending from the body exits the vagina, and activating one or more light sources mounted on the body, each light source emitting light at one or more wavelengths outward from the body to provide phototherapy. After treatment, the body can be removed from within the vagina using the tether or the like.

[0033] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following description, while indicating preferred embodiments and many specific details thereof, is given by way of illustration and not limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein are intended to include all such modifications. [Brief explanation of the drawings]

[0034] Other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings. [Figure 1] FIG. 1A shows a perspective view of a light-based vaginal phototherapy device according to one embodiment herein. FIG. 1B shows a perspective view of a light-based vaginal phototherapy device with a USB cord according to one embodiment herein. FIG. 1C, FIG. 1D, and FIG. 1E are plan, side, and front views, respectively, of the device of FIG. 1B. FIG. 1F shows a cross-sectional view of the light-based vaginal phototherapy device of FIG. 1B. [Figure 2] FIG. 2 illustrates the placement of a vaginal phototherapy device within a woman's vaginal canal, according to one embodiment herein. [Figure 3]FIG. 3 is a cross-sectional view of an exemplary embodiment of a cradle for storing, charging, and / or otherwise receiving a light therapy device, such as the device shown in FIGS. 1A-1F, illustrating exemplary components of the light therapy device and the cradle. [Figure 4] 4A and 4B are perspective views of an exemplary embodiment of a cradle with a light therapy device stored therein, showing the cradle with the lid open and closed, respectively. [Figure 5] 5A and 5B are perspective views of another embodiment of a cradle, showing the cradle with its lid open and closed, respectively. [Figure 6] 6A and 6B are perspective views of another embodiment of a cradle, showing the cradle with its lid open and closed, respectively. [Figure 7] FIG. 7 is a perspective view of an insertion tool onto which a treatment device such as that shown in FIGS. 1A-1F is attached to facilitate insertion into a user's vagina. [Figure 8] FIG. 8 is a perspective view of another embodiment of a light-based vaginal phototherapy device. [Figure 9] 9A-9D show yet another embodiment of a light-based vaginal phototherapy device. [Figure 10] FIG. 10 is a schematic diagram illustrating exemplary components that may be included in the apparatus of FIGS. 9A-9D. [Figure 11] FIG. 11 is a perspective view of yet another embodiment of a light-based vaginal phototherapy device. DETAILED DESCRIPTION OF THE INVENTION

[0035] In the following detailed description, reference is made to the accompanying drawings, which form a part of this specification, and which show, by way of illustration, specific embodiments which may be practiced. The embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments, and it should be understood that logical, mechanical, and other changes may be made without departing from the scope of the embodiments. Therefore, the following detailed description is not to be taken in a limiting sense.

[0036] Embodiments herein provide light-based vaginal phototherapy devices that can be used to treat a variety of conditions, such as bacterial and fungal infections and chlamydia. Alternatively, the devices and systems herein may be useful for applying other forms of energy to the vaginal wall, for example, to tighten adjacent tissue. In one exemplary embodiment, the device may include a body or housing, one or more light sources, a switch or other actuator, a flexible tether, a microchip or other controller, and a battery or other power source. Alternatively, the device may include a wireless communication interface, including one or more antennas and / or circuitry for receiving commands from a remote electronic device, such as a user's mobile phone, tablet, or other device, for example, via Bluetooth or other communication protocol.

[0037] Optionally, the body can be formed of a suitable medical-grade, durable material capable of emitting therapeutic light. Optionally, one end of the device can include a cervical support for positioning the device against the cervix. In one exemplary embodiment, the light source can include one or more LEDs mounted on an LED body, e.g., mounted on the outer surface, e.g., within a recess in the outer surface, e.g., to provide a substantially smooth and / or atraumatic outer surface of the device. Alternatively, other internal light sources can be provided that can transmit light from the body through a transparent (to transmitted light) wall or the like (not shown) of the body, e.g., via one or more optical fibers, lenses, etc. For example, the body can be formed entirely of a transparent material, or desired regions can be transparent, thereby allowing one or more LEDs within the body to transmit light through the transparent material to treat adjacent tissue.

[0038] Each LED can emit light having a wavelength in the therapeutic light range within the blue and / or red or violet (e.g., germicidal, non-UV) wavelength range. In an exemplary embodiment, the switch is a pressure-activated switch. A controller is housed within the body and connects the battery to the light source and is further connected to the switch. The controller can control the duration of the light therapy and / or pulse the light. Alternatively, the battery charge can be set to limit the duration and / or other functions of the device. For example, pulsing the light can stress the target bacteria or yeast and / or make the device more effective. The switch and light source draw power from the battery via a microchip. The switch controls activation and deactivation of the light source.

[0039] A tether, e.g., a flexible cable, rope, cord, loop, etc., can be connected to one end of the body and have a length sufficient to facilitate removal and / or advancement of the device from the vagina. For example, in one embodiment, the tether is a flexible cord including first and second ends coupled to the body, defining a closed loop of sufficient length to extend out of the vagina when the entire body is inserted into the vagina, e.g., pressed against the cervix. Alternatively, a cannula or other insertion tool (not shown) can be provided to facilitate insertion and / or removal of the device.

[0040] According to exemplary embodiments, the light source may emit non-UV germicidal light having a wavelength ranging between blue and / or red or violet wavelengths. For example, according to one embodiment herein, an LED emitting light in the range of 405 nm to 470 nm may be used. Alternatively, the LED may emit light in the range of 620 nm to 750 nm, or the LED may emit light in the range of 380 nm to 450 nm. The emitted light may kill or limit the growth of various strains of bacteria, fungi, or other pathogens that contribute to infections or viruses.

[0041] According to one embodiment herein, the controller controls the duration of the light pulse in a fast on and / or off manner. For example, when activated, the controller can keep the light source activated for a preset period of time, e.g., one hour or more, and then automatically shut the light source off. Optionally, when the device is activated, the controller can pulse the light source, e.g., rapidly turning the light source off and on multiple times per minute or per second. Additionally or alternatively, the light source can pulse between different wavelengths.

[0042] According to one embodiment herein, the device is not reusable and is suitable for treating bacterial and fungal infections for single use. Alternatively, according to another embodiment herein, the device may be reusable and may be used multiple times to treat bacterial and fungal infections and may include or connect to a cable for recharging the device. Reusable devices have a washable or flushable body.

[0043] Referring to the drawings, FIG. 1A illustrates a perspective view of an exemplary embodiment of an LED-based vaginal phototherapy device 100 including a body 102 carrying multiple light sources 103. FIG. 1B illustrates a perspective view of an LED-based vaginal phototherapy device 100 with a USB cord 106, according to an embodiment herein. FIGS. 1C-1F illustrate top, side, front, and cross-sectional views, respectively, of an LED-based vaginal phototherapy device 100, according to an embodiment herein. With reference to FIGS. 1A-1F, the body 102 of the phototherapy device 100 primarily has a plastic frame structure that allows for the placement of single or multiple LEDs 103 on its exterior surface. As shown in FIG. 1F, a battery 108, a controller 107, and / or additional electronic controllers and circuitry are located internally relative to the LEDs 103.

[0044] Switch 104 may be located on the exterior of body 102 and may be activated by a user to activate device 100, for example, prior to vaginal insertion. Alternatively, tether 105 may be coupled to a switch within the body such that it is pulled or otherwise manipulated to activate / deactivate light source 104. Still alternatively, a pressure-activated switch (not shown) may be provided within body 102 that responds to compressive pressure on body 102, such that device 100 is automatically activated upon insertion into the vagina and pressure from surrounding muscles compressing body 102, for example.

[0045] Once assembled, device 100 is encased in a suitable medical-grade plastic housing and completely sealed until ready for use. A suitable tether 105, as shown in FIG. 1A, or a mini-USB cable 106, as shown in FIG. 1B, can be attached to the first or proximal end of body 102 to aid in insertion and / or removal of device 100 into or from the vaginal canal. Optionally, the second or distal end of device 100 can include a cervical support 101, e.g., a concave or other shaped recess, to facilitate positioning of the device against the cervix.

[0046] In one exemplary embodiment, the length and diameter of the body can be sized to be fully inserted into the vagina, e.g., a generally oval or elliptical shape with the length greater than the diameter. For example, the body 100 can have a length of approximately 3.5 inches or less and a maximum diameter of approximately 1.5 inches or less, e.g., at the central region of the body 100. Optionally, the body 100 can be available in multiple sizes, e.g., lengths and / or diameters, provided to individual patients or users based on their individual anatomy. Thus, the device can have any appropriate size to accommodate the size of the cavity to be inserted, e.g., to position the device relative to the cervix and / or to minimize movement during use. The surface of the body 102 can be hard or collapsible based on user preference and area of ​​use. In one exemplary embodiment, the body 100 is oval, e.g., including a rounded proximal end, a distal end, a relatively large diameter central region approximately midway between the proximal and distal ends, a proximal tapered region that tapers from the central region toward the proximal end, and a distal tapered region that tapers from the central region toward the distal end.

[0047] 2 illustrates placement of a vaginal phototherapy device within a woman's vaginal canal, according to one embodiment herein. With reference to FIG. 2, the device 100 is fully inserted into the vaginal canal 201, for example, with the distal end positioned against the cervix and the proximal end positioned within the vaginal canal 201, with the tether 105 or USB cable 106 extending from the vaginal canal 201.

[0048] Optionally, an insertion tool 120 can be provided to facilitate introduction of device 100 into the vaginal canal, as shown in FIG. 7. Generally, insertion tool 120 includes a proximal end 122 that may include, for example, a handle (not shown) and / or be shaped to facilitate manipulation of insertion tool 120, and a distal end 124 that may include, for example, one or more connectors and / or features for releasably engaging the proximal end of body 102. Optionally, insertion tool 120 can include a recess, for example, an elongated groove, extending proximally from distal end 124 that is sized to receive tether 105 of device 100.

[0049] For example, in one embodiment, distal end 124 has a concave recess corresponding to the shape of body 102, such that the body rests partially within the recess and tether 105 is inserted into the groove. Optionally, the groove can provide a sufficient interference fit with tether 105 to prevent the tether from falling out and / or to hold the body in place relative to distal end 124. Alternatively, insertion tool 120 can include a post, hub, or other element (not shown) around which tether 105 can be looped or wrapped one or more times to secure tether 105 to insertion tool 120, e.g., with sufficient tension to hold device 100 at distal end 124.

[0050] Additionally or alternatively, insertion tool 120 may include one or more fingers, detents, or other features (not shown) that are received within corresponding features on body 102 to secure device 100 at distal end 124. In this embodiment, for example, a button or other actuator (not shown) on proximal end 122 of insertion tool 120 may be used to release the features, thereby releasing device 100 once it is positioned within the cavity.

[0051] The insertion tool 120 can be formed from a substantially rigid or flexible biocompatible material, such as metal, plastic, or a composite material, having a length sufficient to insert the distal end 124 into the vaginal canal, for example, about 5-6 inches (12.5-15 cm), while holding the proximal end 122 outside the user's body. The insertion tool 120 can be substantially straight, or can have a desired curved shape between the proximal and distal ends 122, 124, for ease of use.

[0052] Returning to FIG. 2 , the device 100 can be activated before or after introduction, for example, by activating an accelerometer-controlled switch, or, as described elsewhere herein, by activating a mechanical switch 104 on the main body 100 before inserting the device 100 into the vagina. Alternatively, the device 100 can be activated by pressure, causing the light source to begin emitting light, for example, after reaching a preset position within the vaginal canal 201. Alternatively, if the device includes a wireless communication interface (not shown), the device can be controlled wirelessly, for example, using a phone-based application downloaded to the user's electronic device (not shown). The device 100 is left in the vagina for a specific period of time, ranging from several minutes to several hours, depending on the severity and type of infection (e.g., bacterial, fungal, or other infection). During the treatment period, the relatively small size and comfortable shape of the device 100 allow the user to resume normal activities.

[0053] The phototherapy device 100 disclosed herein can provide harmless and / or effective treatment for vaginal infections. Because the device 100 does not react with vaginal fluids, the device 100 can be used for any patient condition. Furthermore, the device 100's relatively low cost and simple usage procedures allow for individual use after a physician's approval. Optionally, one or more features of the device can be provided to address concerns such as overuse and / or overexposure. For example, the battery capacity can be selected to limit the maximum duration the device can operate and / or require a minimum charging time, or such parameters can be automatically controlled by a controller within the device.

[0054] 3 and 4, another embodiment of a phototherapy device 200 is shown that is configured substantially similarly to the previous embodiment, including, for example, an oval-shaped body 202 that contains the internal components of the device 200 in a sealed environment, and a flexible tether 205 extending from one end of the body 202. As with other embodiments herein, the body 202 can include a central region 202a that defines a maximum diameter that tapers toward a proximal end 202b and a distal end 202c. As shown, the proximal end 202b is rounded, while the distal end 202c includes a cervical support surface 202d that may have, for example, a flat shape as shown, or a concave, convex, or other shape (not shown) that abuts the cervix (not shown) to facilitate placement of the body 202 within the vagina.

[0055] Generally, device 200 includes one or more light sources, e.g., one or more LEDs 203, a controller 207, and a battery 208, similar to the previously described embodiments. Additionally, device 200 includes an accelerometer or other motion sensor 210 within body 202 coupled to controller 207, instead of an external switch. For example, controller 207 can monitor signals from motion sensor 210 to identify pre-set commands, e.g., activate or deactivate LEDs 203 and / or guide device 200 through one or more operating modes. Exemplary motions include moving the body back and forth in a linear motion, rotating the body, etc. In one embodiment, a first distinct motion or set of motions is identified by controller 207 to switch device 200, i.e., alternately activate and deactivate LEDs 203. A second distinct motion or set of motions may be identified to instruct the controller 207 to vary actuation between a menu of options, for example, between a continuous actuation profile and one or more pulsed actuation profiles, to vary the light frequency delivered by one or more light sources, etc. Thus, each time the second motion is repeated, the controller 207 may vary the operation of the LED 203 between a series of options. Alternatively, a different motion may be assigned to each desired command.

[0056] Additionally or alternatively, device 200 (or any of the other devices herein) may include inductive charging circuitry 212 within body 202, for example, coupled to battery 208. In one exemplary embodiment, charging circuitry 212 may include one or more magnets, coils, capacitors, and / or other components (not shown) that are actuated by an external magnetic field to generate a current and charge battery 208, as further described elsewhere herein.

[0057] 3 and 4, a cradle or case 220 can be provided for storing a phototherapy device such as device 200 when not in use, e.g., as part of a system or kit provided to a user. Cradle 220 generally includes a housing or base 222 and, optionally, a lid, cover, or other enclosure 230. Base 222 generally includes a flat lower surface 222a for placing cradle 220 on a table or other surface (not shown) and an upper surface 222b including a cavity 224 sized to receive device 200. For example, cavity 224 can define a portion of the oval shape of body 202 of device 200 to at least partially receive device 200 within cradle 220, e.g., in a preset orientation. In one embodiment, cavity 224 can have an elongated oval shape, for example, sized to receive body 202 sideways, with proximal end 202b and distal end 202c of body 202 at opposite ends of cavity 224, as shown in FIGS. 3 and 4. Alternatively, cavity 224 can have tapered sidewalls terminating in a flat, concave, or convex underside (not shown), e.g., corresponding to the shape of cervical support surface 202d of body 202, such that device 200 can be received in cradle 220 only with cervical support surface 202d inserted first into cavity 224. Alternatively, cavity 224 can have other shapes, such as hemispherical or partial spheroidal, or other shapes (not shown), that are larger than the largest dimension of body 202, thereby allowing device 200 to be placed in cradle 220 in any orientation.

[0058] Additional cradle embodiments are shown in Figures 5 and 6. For example, Figures 5A and 5B show a cradle 320 that includes a base 322 having a cavity 324 for receiving a light therapy device 200 and a lid 330 that can be rotated and slid into the base 322 to place and / or remove the device 200 from the cavity 324. Figures 6A and 6B show yet another embodiment of a cradle 420 that includes a base 422 and a pair of clamshells or other housing members 430a, 430b that can be opened and closed to receive the light therapy device 200 within the cavity defined by the clamshells 430a, 430b.

[0059] 3 and 4 , if the cradle 220 includes the lid 230, the lid 230 may include a cavity 232 that corresponds to the cavity 224 of the base 222, for example, to provide a sealed chamber when the lid 230 is closed on the housing 222. The lid 230 may be coupled to the base 222 by one or more hinges (not shown), for example, to allow the lid 230 to swing between an open position and a closed position. Alternatively, the lid 230 may be separable from the base 222 and may include one or more cooperating connectors, such as tabs, detents, grooves, etc. (not shown), that allow the lid 230 to be removably secured on the base 222 to enclose the chamber.

[0060] Optionally, cradle 200 may include one or more features for interacting with device 200, for example, as shown in Figure 3. For example, cradle 220 may include inductive charging circuitry 226 mounted adjacent cavity 224 for providing energy to charging circuitry 212 of device 200 disposed in cavity 224. For example, charging circuitry 226 may be configured to generate a magnetic field that activates charging circuitry 212 in device 200, including, for example, one or more magnets, coils, or other components (not shown), to charge the device's battery.

[0061] In one embodiment, the cradle charging circuitry 226 may be activated automatically when the device 200 is placed in the cradle 220, or may be selectively activated by a user, for example, by activating a switch, button, or other actuator (not shown). For example, the cradle 220 may include a control circuit 228 that periodically activates the cradle charging circuitry and identifies when the resulting magnetic field indicates that the device 200 is present within the cavity 224. Once the device 200 is identified, the control circuit 228 activates the cradle charging circuitry 226 for a preset time period in order to charge the battery 208 of the device 200.

[0062] Alternatively, the controller 207 of the device 200 may include a circuit component (not shown) that changes the magnetic field or wirelessly communicates to the cradle control circuitry 228 when the controller 207 determines that the battery 208 is fully charged. When the cradle control circuitry 228 detects a change in the magnetic field or other communication from the device controller 207, the control circuitry 228 may deactivate the cradle charging circuitry 226.

[0063] Optionally, cradle 220 may include one or more features to assist and / or facilitate cleaning of device 200 between uses, for example, in addition to or instead of inductive charging circuitry 226. For example, as shown in FIG. 3 , one or more light sources 232 may be provided on or within cradle 220 to clean device 200, e.g., to emit germicidal and / or sterilizing light of one or more frequency ranges, such as ultraviolet light or non-UV germicidal light, and / or to neutralize potential pathogens on the exterior surface of device 202. In one embodiment in which cradle 220 includes lid 230, device 200 may be inserted into the cavity, lid 230 may be closed to activate light source 232, and device 200 may be treated. For example, cradle 220 may include a sensor (not shown) coupled to control circuitry 228 to detect when lid 230 is closed (and device 200 is placed in cavity 224). Once the control circuitry 228 determines that the lid 230 is closed, the control circuitry 228 can automatically activate the light source 232, e.g., for a preset time period, to process the device 200. Optionally, the cradle 220 can include a locking mechanism (not shown) that automatically locks the lid 230 when closed until a preset time period has elapsed, e.g., to ensure that the device 200 has been adequately cleaned and / or to prevent inadvertent exposure to the light transmitted by the light source 232.

[0064] In another embodiment, the phototherapy device and cradle can include a magnetic switch or other activation circuit that automatically activates the device when removed from the cradle. For example, the cradle can include circuitry that generates a magnetic field or other energy, and the device can include a sensor internally that detects the presence and / or absence of the field / energy. Thus, when the device is removed from the cradle, the device's controller can detect the removal and automatically activate the LED, for example, immediately or after a preset time delay. Such a time delay can allow sufficient time for the device to be inserted and / or allow the controller to verify whether the device is returned to the cradle within a preset time period, thereby preventing accidental activation if the device is dropped from the cradle, for example.

[0065] In yet another embodiment, a device having a motion sensor can be used to wake the device. For example, if the controller detects no motion from the motion sensor for a preset time threshold, the controller can conclude that the device is in a cradle or is not in use. When motion is detected, the controller can automatically activate an LED, for example, immediately or after a preset delay.

[0066] According to one embodiment herein, the device may be useful in treating fungal and bacterial vaginosis, chlamydia, and / or other diseases. In the case of bacterial vaginosis, the bacteria are adversely affected by the light-based treatment of the device 100, so no additional photosensitizers need to be used.

[0067] As an adjunct, device 100 helps remove or reduce unwanted microorganisms and forms the basis of an alternative to conventional treatments. Device 100 may also be useful for patients interested in non-pharmacological therapies. Patients who cannot tolerate oral or topical azole therapy, as well as immunocompromised patients with recurrent yeast or bacterial infections, can be treated with device 100. Optionally, any of the devices can be used as a cleansing device for use before conception, for example, to help avoid problems with bacterial vaginosis that may adversely affect pregnancy.

[0068] According to one embodiment herein, the device may be useful for treating fungal and bacterial infections. Fungal infections include infections caused by yeast, particularly but not limited to Candida albicans, and bacterial infections include infections primarily caused by Gardnerella. A patient must first determine whether they have a fungal or bacterial infection. This can initially be determined through a doctor's examination.

[0069] According to one exemplary embodiment, the device may be sold with test strips, for example, as part of a treatment kit or system. The test strips may be used to determine fungal and bacterial infections in patients according to embodiments herein. Bacterial and fungal infections may be treated using device 100 as an alternative to medications, irrigation solutions, or chemicals prescribed by a physician.

[0070] According to another embodiment, in the case of fungal infections, the device can be used in conjunction with a photosensitizer, which may be beneficial in the case of yeast infections. Photosensitizers include porfimer sodium (Photofrin), 5-aminolevulinic acid or ALA (Levulan), and methyl aminolevulinate [MAOP] (Metvix).

[0071] Optionally, any of the devices herein can be enhanced with the use of probiotics, for example, to help replenish essential bacteria and fungi for the microbiome.

[0072] According to another exemplary embodiment, device 100 (or any of the devices herein) can provide low-power, long-term treatment so as to be safer for mucosal tissue. For example, the device can be inserted overnight and removed in the morning, i.e., several hours later. Alternatively, the device can be inserted for a relatively short treatment, e.g., 30-60 minutes, after which the device can be removed. In an exemplary embodiment, the one or more light sources can be monochromatic or multi-colored LEDs and / or can use pulsed or non-pulsed light.

[0073] In one exemplary embodiment, device 100 may be configured for multiple uses, such that device 100 can be washed and inserted into the vagina multiple times, for example, over the course of several days or other treatment. Alternatively, device 100 may be a disposable device, i.e., discarded after being used for a single treatment.

[0074] For multiple use, device 100 can include a rechargeable battery and cord to facilitate removal of the device from the vagina and to serve as a connection to a suitable power source for recharging the device. Alternatively, like other devices herein, device 100 can include inductive charging circuitry (not shown) for cordless, wireless inductive charging.

[0075] According to one embodiment herein, the phototherapy device includes one or more LEDs as a light source for irradiating the vaginal wall with light. The device further includes a battery housed within a 100% sealed housing or LED body. The battery, like the LED, can be connected to the controller and function as a power source. A microchip controls the duration of phototherapy. The device can include a printed circuit or a suitable electronic circuit or hub to interconnect the switch, LED, microchip, and battery. The device further includes a switch to activate the device and initiate phototherapy. The device also includes a tether for removing the device during phototherapy. The tether can be suitably replaced with a USB cord or a charging cord to make the device suitable for multiple uses.

[0076] 8, another embodiment of a light therapy device 500 is shown, configured generally similarly to the previous embodiment. This light therapy device includes, for example, an oval-shaped body 510 that contains the internal components of the device 500 in a sealed environment, and a flexible tether 520 extending from one end of the body 510. As with other embodiments herein, the body 510 can include a central region 512 defining a maximum diameter that tapers toward a proximal end 514 and a distal end 516, for example, having rounded proximal and distal ends 514 and 516 such that the body 510 defines an oval shape.

[0077] Additionally, device 500 includes one or more light sources, for example, one or more LEDs 518 mounted on a circuit board or other substrate 519 within body 510 configured to deliver light to the tissue surrounding the body. For example, body 510 may include a plurality of lenses, windows, or other transparent features (not shown) spaced apart in the walls of body 510 to allow light from the one or more LEDs 518 to pass through the walls and reach the surrounding tissue. Alternatively, a plurality of LEDs or other light sources may be mounted directly to the walls of body 510 (not shown).

[0078] Unlike the previously described embodiments, the tether 520 includes an elongate member 522 carrying an outer housing 524, e.g., having the outer housing at a free end 522a of the elongate member 522. The outer housing 524 may include a battery 528 for powering one or more components of the device 500, e.g., one or more LEDs 518. The outer housing 524 may also include a controller 530 connected to the battery and one or more LEDs 518, e.g., via one or more wires or other leads 526 extending from the body 302, through the elongate member 322, and into the outer housing 324. Alternatively, the controller may be disposed within the body 510, e.g., mounted on a circuit board that includes the one or more LEDs 518. Alternatively, the outer housing 524 may be separate from the elongate member 522, and the free end 522a and the housing 524 may include a connector for removably coupling the housing 524 to the elongate member 522, for example, before or after inserting the body 510 into the vagina, e.g., an electrical and / or mechanical connector for connecting components within the housing 524 to the lead 526.

[0079] Optionally, device 500 may also include a wireless communication interface 532, e.g., a transmitter / receiver, that communicates via radio frequency (RF) signals, e.g., using Bluetooth or other wireless protocols. For example, interface 532 may be connected to controller 530 to allow device 500 to be activated and / or deactivated remotely, e.g., using an application on a mobile phone or other electronic device, as in other embodiments herein. Alternatively, outer housing 524 may include a switch (not shown) for activating and / or deactivating one or more LEDs 518 during use.

[0080] In another option, elongate member 522 of tether 520 can be malleable, e.g., tether 520 can be manipulated by a user but have sufficient flexibility to substantially maintain an applied shape to tether 520, e.g., a curved shape as shown in FIG. 8, thereby facilitating placement of outer housing 524 in a desired position to minimize discomfort when body 510 is inserted into a user's vagina during treatment. Alternatively, tether 520 can be biased into a preset shape, e.g., a curved shape as shown, but can be sufficiently flexible to facilitate manipulation of tether 520, e.g., to facilitate insertion and removal of body 510. In yet another alternative, tether 520 can be substantially rigid, e.g., configured into a curved shape or other desired shape.

[0081] Device 500 can be used similarly to other embodiments herein by inserting body 510 fully into a user's vagina, for example, until distal end 516 is positioned adjacent the cervix, with tether 520 extending from the vagina. The user can then activate one or more LEDs 518, for example, remotely or by manipulating a switch on outer housing 524. If elongated member 522 of tether 520 is malleable, it can be manipulated to move outer housing 524 to a desired position relative to the user's body, for example, adjacent the vaginal entrance, thereby minimizing discomfort during treatment.

[0082] 9A-9D , another embodiment of a light therapy device 600 is shown, configured generally similarly to the previous embodiment. The light therapy device includes an elongated body 610 sized for insertion into a user's vagina, for example, to deliver light therapy. In the illustrated example, the body 610 includes a central region 612 defining a maximum diameter that tapers toward a proximal end 614 and a distal end 616 of the body 610, e.g., having a rounded distal end 616 such that the body 610 defines a generally oval shape. Such an oval and / or other rounded shape, as with other embodiments herein, can facilitate entry into the vagina and / or improve user comfort. Additionally, the device 600 also includes a tail or appendage 620 that extends from the proximal end 614 of the body 610 and terminates, for example, at a proximal tip 632 of the device 600, which can remain outside the user's vagina during use.

[0083] Device 600 includes one or more electrical components mounted within appendage 620, e.g., on a circuit board or flexible PCB substrate 626 adjacent proximal tip 632, as shown by the dotted lines in FIGS. 9A and 9B . As with the previous embodiment, device 600 includes one or more light sources 618 configured to deliver light to tissue surrounding the body. In one embodiment, one or more light sources 618 include one or more LEDs mounted on substrate 626 and can deliver light into body 610, e.g., via one or more optical fibers (not shown). Alternatively, one or more light sources 618 may be disposed directly within body 610, e.g., on one or more additional substrates mounted within body 610, similar to device 500 shown in FIG. 8 and / or other embodiments herein.

[0084] For example, the body 610 may include a plurality of lenses, windows, or other transparent features (not shown) spaced apart on a wall of the body 610 to deliver light from the one or more light sources 618 through the wall to the surrounding tissue. Alternatively, a plurality of LEDs or other light sources may be mounted directly on a wall (not shown) of the body 610. In a further alternative, one or more regions of the body 610 may be translucent or transparent to light transmitted from the interior to the exterior of the body 610 by the one or more light sources 618.

[0085] The appendages 620 can be integrally formed with the body 610, e.g., by one or more moldings, castings, machining, or other methods of forming them together from plastic, metal, and / or composite materials to provide a unitary housing for the device 600. The appendages 620 can have a sufficient length and desired shape to extend proximally from the body 610 to facilitate manipulation of the device 600, e.g., during insertion and / or removal. For example, the length of the appendages 620 can be longer than the body 610. Optionally, the material of the appendages 620 can be malleable, e.g., flexible enough to allow the appendages 620 to be manipulated by a user yet substantially maintain an applied shape to the appendages 620, e.g., a curved shape as shown in FIGS. 9A-9D, thereby facilitating placement of the appendages 620 in a desired position when the body 610 is inserted into a user's vagina during treatment. Alternatively, appendage 620 may be biased into a preset shape, e.g., a curved shape as shown, but may be sufficiently flexible to facilitate manipulation of appendage 620, e.g., to facilitate insertion and removal of device 600. In this alternative, appendage 620 automatically returns to the preset shape, e.g., a curved shape, upon release. In yet another alternative, appendage 620 may be substantially rigid, e.g., set into a curved or other desired shape.

[0086] Referring to FIG. 10 , exemplary components mounted on a substrate 626 or the like within the appendage 620 are shown, which are positioned outside the user's body when, for example, the main body 610 of the device 600 is inserted into the user's vagina. For example, a battery 628 can be provided to power the light sources, and a controller 630 can be connected to the battery 628 and the one or more light sources 618 to control operation of the light sources 618. Optionally, a wireless communication interface 632 can also be provided, e.g., a transmitter / receiver that communicates via radio frequency (RF) signals using Bluetooth or other wireless protocols, as in other embodiments herein. For example, the interface 632 can be connected to the controller 630 to enable remote activation and / or deactivation of the device 600, e.g., using an application on a mobile phone or other electronic device, as in other embodiments herein. Alternatively, the appendage 620 can include a switch (not shown) and / or use an operational control for activating and / or deactivating the device 600 during use, as in other embodiments herein.

[0087] The appendage 620 can include a connector 629, for example at or adjacent the proximal tip 632, that connects to the battery 628 and / or controller 630, thereby allowing a cable (not shown) to be removably connected to the device 600, for example, to charge the battery 628 and / or to program the controller 630. Alternatively, the device 600 can include an inductive charging circuit within the appendage 620, as in other embodiments herein, and the connector 629 can be omitted.

[0088] Device 600 can be used similarly to other embodiments herein by inserting body 610 into a user's vagina, for example, until the distal end is positioned adjacent the cervix (not shown), and appendage 620 extends from the vagina (not shown). The user can then activate one or more light sources 618, for example, remotely or by operating a switch on appendage 620. If appendage 620 is malleable, it can be manipulated to move appendage 620 to a desired position relative to the user's body, for example, adjacent the vaginal entrance, thereby minimizing discomfort during treatment.

[0089] Optionally, device 600 can include various regions, which can include separate light sources and / or can be activated independently, e.g., separately or simultaneously, to treat one or more areas of the user's body, including, e.g., the entrance region and / or the external genitalia. For example, as shown in FIG. 9A , body 610 can include an annular region 612a extending distally from, e.g., appendage 620, to a distal region 612b of body 610, which can include one or more light sources that can be activated to deliver light externally along annular region 612a to treat the vaginal cavity. Optionally, distal region 612b can include one or more light sources that can be independently activated to deliver light distally from body 610, e.g., toward the user's cervix.

[0090] Additionally or alternatively, appendage 620 can include one or more regions containing one or more additional light sources that can be activated to treat the vaginal canal and / or external regions, e.g., the vulva, labia majora, and / or labia minora, e.g., to treat vulvovaginitis. In the illustrated example, appendage 620 includes proximal region 620a that extends at least partially along the upper, concave surface of appendage 620, which can enable treatment of external anatomical structures.

[0091] In one embodiment, a set of LEDs can be provided on substrate 626, and the light can be split and delivered to each region via one or more optical fibers, lenses, etc., for delivery to various regions, e.g., sequentially, simultaneously, and / or otherwise. Alternatively, separate light sources can be provided in each region, which can be separated from one another by partitions to prevent light from leaking from one region to another. Again, the separate light sources can be activated sequentially, simultaneously, or otherwise. For example, with body 610 fully inserted into the user's vaginal cavity and appendage 620 extending proximally from the vagina, the user can selectively activate device 600 to deliver light into the vaginal cavity via body 610 and / or through one or more regions of appendage 620, along the vaginal canal and / or external genitalia.

[0092] 11 illustrates another example of a phototherapy device that may be configured for external placement adjacent to the vagina, e.g., to provide treatment to the external surface of the vagina, e.g., to treat vulvovaginitis. Unlike previous embodiments, device 700 may include one or more light sources, e.g., one or more LEDs and / or windows, along its concave surface, which may be positioned relative to the user's external anatomical structure and activated for phototherapy. Additionally, device 700 may include one or more other components similar to other embodiments herein, e.g., a controller, a battery, a wireless communication interface, an inductive charging circuit, a connector, etc. (not shown).

[0093] The device 700 includes a body having a fixed shape, e.g., an upper region 712 and a lower region 714 that tapers from the upper region 712. The lower region 714 can have a tapered shape and / or a pronounced shape and / or tip configured to separate the labia to facilitate exposure of the vulva for phototherapy. Thus, while holding the upper region 712, the lower region 714 of the device 700 can be inserted between the user's labia to expose the vulva, after which one or more light sources can be activated to provide phototherapy to the vulva and / or other exposed areas. As shown, the body can include a slightly convex outer surface 722 and a slightly concave inner surface 724, e.g., shaped to position the device against the user's genitals. Optionally, the one or more light sources can emit light only from the inner surface 722, e.g., along the lower region 714, to provide phototherapy to exposed anatomical structures.

[0094] According to embodiments herein, the device can be useful for killing or inactivating target species to prevent them from replicating. The device can also be used as an adjunct therapy to existing known treatments, potentially reducing drug or chemical-based treatments. When used in conventional therapies, the device may shorten treatment times.

[0095] As such, the device can provide a non-drug-based alternative therapy based on safe germicidal light, and when introduced to the area, provides a safe and effective method of treating and controlling both yeast and bacterial infections. In some applications, the effectiveness of the device may be enhanced by the use of a photosensitizer. For example, the photosensitizer can be provided on the exterior surface of the body 102 or within a pocket or feature (not shown) configured to receive the photosensitizer. Alternatively, the photosensitizer can be introduced separately into the vagina, for example, using a known applicator (not shown). The device can be used in combination with standard systemic medications or topical cream-based treatments to shorten the duration of an outbreak.

[0096] It is to be understood that the terms or phrases used herein are for purposes of description and not of limitation. Although the embodiments herein have been described with reference to exemplary embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the claims.

Claims

1. 1. An apparatus for vaginal phototherapy of a user, comprising: a housing having a body sized for introduction into the vagina, the body including a central region and tapering toward a distal end, and an appendage extending proximally from the body and configured to extend from the vagina when the body is inserted into the vagina; one or more light sources configured to emit light outwardly from the body; a battery within the accessory configured to provide power to operate the one or more light sources.

2. 10. The apparatus of claim 1, The apparatus further comprising a controller in the accessory connected to the battery and in communication with the one or more light sources to control operation of the one or more light sources.

3. 10. The apparatus of claim 1, The device further comprising a wireless communication interface within the accessory for communicating with a remote device.

4. 10. The apparatus of claim 1, A device wherein the appendages are malleable such that the appendages can be manipulated into a desired shape and retain the desired shape.

5. 10. The apparatus of claim 1, A device wherein the appendage is biased into a curved shape yet is sufficiently flexible to facilitate manipulation of the device during use.

6. 10. The apparatus of claim 1, The device, wherein the body tapers proximally from the central region toward the appendages.

7. 10. The apparatus of claim 1, A device characterized in that the body and the appendage are integrally formed.

8. 10. The apparatus of claim 1, 10. The device, wherein the one or more light sources include one or more LEDs within the appendage and one or more fiber optic elements extending from the one or more LEDs to the interior of the body to deliver light from the body to the exterior.

9. 10. The apparatus of claim 1, 10. The device according to claim 9, wherein the body comprises a plurality of lenses on a wall of the body for transmitting light from the one or more light sources outward from the body.

10. 10. The apparatus of claim 1, 10. A device, wherein the body comprises a material that is translucent or transparent to light transmitted from the one or more light sources outwardly from the body.

11. 10. The apparatus of claim 1, 10. The device, wherein the one or more light sources are configured to emit light at one or more wavelengths within a germicidal or sterilizing light range.

12. 10. The apparatus of claim 1, 10. The device, wherein the housing includes a plurality of regions, and the one or more light sources include one or more light sources configured to deliver light independently from each of the plurality of regions.

13. 13. The apparatus of claim 12, The device, wherein the plurality of regions includes a first region that includes a central region of the body and a second region that extends partially along the appendage.

14. 14. The apparatus of claim 13, The device, wherein the first region is configured to deliver light radially outward from an annular wall of the central region.

15. 14. The apparatus of claim 13, The device, wherein the second region comprises a surface on one side of the appendage.

16. 16. The apparatus of claim 15, The device, wherein the appendage is biased into a curved shape and the surface extends along a concave portion of the appendage.

17. 10. The apparatus of claim 1, The device, wherein the appendage is configured to transmit light from the one or more light sources out of at least a portion of the appendage.

18. 18. The apparatus of claim 17, The device, wherein the appendage has a curved shape and the appendage is configured to transmit light from the one or more light sources outwardly from a concave portion of the appendage.

19. 1. An apparatus for vaginal phototherapy of a user, comprising: a housing having a body sized for introduction into the vagina, the body including a central region and tapering toward a distal end, and an appendage integrally formed with the body and extending proximally from the body, the appendage having a length sufficient to extend from the vagina when the body is fully inserted into the vagina and biased into a curved shape; one or more light sources configured to emit light outwardly from the body; a battery configured to provide power to operate the one or more light sources.

20. 1. An apparatus for vaginal phototherapy of a user, comprising: a housing having a body sized for introduction into the vagina, including a central region and tapering toward a distal end, and an appendage integrally formed with and extending proximally from the body, the appendage having a length sufficient to extend from the vagina when the body is fully inserted therein and formed of a malleable material so as to be able to be manipulated into and retain a desired shape; one or more light sources configured to emit light outwardly from the body; a battery configured to provide power to operate the one or more light sources.

21. 21. The device according to claim 19 or 20, The apparatus further comprising a controller in the accessory connected to the battery and in communication with the one or more light sources to control operation of the one or more light sources.

22. 21. The device according to claim 19 or 20, The device, wherein the one or more light sources include an LED within the appendage and one or more optical fibers extending from the appendage into the body.

23. 21. The device according to claim 19 or 20, The device further comprising a wireless communication interface within the accessory for communicating with a remote device.

24. 21. The device according to claim 19 or 20, The device, wherein the body defines an elliptical shape that tapers proximally from the central region toward the appendages.

25. 10. The apparatus of claim 1, 10. The device, wherein the housing includes a plurality of regions, and the one or more light sources include one or more light sources configured to deliver light independently from each of the plurality of regions.

26. 26. The apparatus of claim 25, The device, wherein the plurality of regions includes a first region that includes a central region of the body and a second region that extends partially along the appendage.

27. 27. The apparatus of claim 26, The device, wherein the first region is configured to deliver light radially outward from an annular wall of the central region.

28. 27. The apparatus of claim 26, The device, wherein the second region comprises a surface on one side of the appendage.

29. 1. An apparatus for vaginal phototherapy of a user, comprising: A housing, a) a body sized for introduction into the vagina, the body including a proximal end, a distal end, and a central region, the body tapering from the central region toward the distal end; b) a housing formed integrally with the body and having a curved appendage extending from a proximal end of the body, the appendage configured to extend from the vagina when the body is inserted therein; one or more light sources configured to emit light outwardly from the body; a battery within the appendage; a controller within the accessory connected to the battery and to the one or more light sources for controlling operation of the one or more light sources.

30. 30. The apparatus of claim 29, The device further comprising a connector on the appendage for connecting the battery to an external power source to charge the battery.

31. 30. The apparatus of claim 29, The device further comprising an inductive charging circuit within the accessory connected to the battery for wirelessly recharging the battery with an external inductive charger.

32. 30. The apparatus of claim 29, A device wherein the appendages are malleable such that the appendages can be manipulated into a desired shape and retain the desired shape.

33. 30. The apparatus of claim 29, A device wherein the appendage is biased into a curved shape yet is sufficiently flexible to facilitate manipulation of the device during use.

34. 30. The apparatus of claim 29, The device, wherein the one or more light sources are further configured to deliver light outwardly from a portion of the appendage.

35. 35. The apparatus of claim 34, A device wherein a portion of the appendage includes a concave surface extending proximally from the body.

36. 36. The device according to claim 34 or 35, The device, wherein the controller is configured to operate the one or more light sources to deliver light independently from portions of the body and the appendage.

38. 1. An apparatus for phototherapy of a user, comprising: a body having an upper region and a lower region tapering from the upper region, the lower region sized to be inserted between a user's labia to expose the vulva; one or more light sources configured to emit light outwardly from the body; a battery configured to provide power to operate the one or more light sources.

39. 39. The apparatus of claim 38, The device, wherein the body includes an outer surface extending between the upper region and the lower region, and an inner surface opposite the outer surface.

40. 40. The apparatus of claim 39, The device, wherein the inner surface defines a concave shape between the upper region and the lower region.

41. 41. The device of claim 39 or 40, The one or more light sources are configured to emit light from the interior surface.

42. 1. A system for vaginal phototherapy of a user, comprising: i) a treatment device comprising: a) a housing having a body sized for introduction into a vagina, the body including a proximal end, a distal end and a central region, the body tapering from the central region toward the distal end, and a curved appendage integrally formed with the body and extending from the proximal end of the body, the appendage configured to extend from the vagina when the body is fully inserted into the vagina; b) one or more light sources configured to emit light outwardly from the body; and c) a battery within the appendage; and d) a controller within the accessory connected to the battery and the one or more light sources for controlling operation of the one or more light sources; e) a treatment device having a wireless communication interface connected to the controller; ii) a portable electronic device including a wireless communication interface for transmitting commands to the treatment device via the wireless communication interface of the treatment device, and a user interface that allows a user to select commands to be sent to the treatment device.

43. 1. A method for vaginal phototherapy of a user, comprising: providing a treatment device including a body containing one or more light sources; inserting the treatment device into the vagina so that the distal end of the body is positioned adjacent to the cervix and the appendage extending from the proximal end of the body exits the vagina; activating the one or more light sources to emit light outwardly from the body; and removing the treatment device from the vagina using the appendage.

44. 44. The method of claim 43, The method, wherein each light source emits light at one or more wavelengths for treating fungal or bacterial vaginosis.

45. 44. The method of claim 43, The method, further comprising activating the one or more light sources to emit light from a region of the appendage.

46. 46. ​​The method of claim 45, wherein the one or more light sources are activated to emit light from the region of the appendage independently of light emitted from the body.

47. 44. The method of claim 43, The method, wherein inserting the treatment device includes releasing the appendage when the body is fully inserted into the vagina.

48. 44. The method of claim 43, the appendage is formed from a malleable material; The method, wherein inserting the treatment device includes moving and manipulating the appendage extending from the vagina into a desired shape.

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