Light-based vaginal therapy device and methods of use thereof

Abstract

Provided are light-based therapy devices, photosensitizers, and kits for treating vaginal bacterial and fungal infections. In one example, the device includes: a body sized for insertion into the vagina; and one or more light sources configured to emit light outward from the body. A photosensitizer source comprising curcumin is provided in conjunction with the device, for example, to enhance treatment, reduce power consumption, reduce treatment time, and / or reduce the total dose of light delivered. In one example, the photosensitizer comprises a carboxymethyl cellulose (CMC) carrier and curcumin mixed with or suspended with the CMC carrier, the curcumin concentration not exceeding about 2 millimoles (2.0 mM) or between about half a millimole and 2 millimoles (0.5–2.0 mM). In one example, the light source(s) may be configured to deliver light with wavelengths between about 425 nm and 475 nm and / or generate power below 50 milliwatts per square centimeter (50 mW·cm²).

Description

[0001] Relevant application data This application claims the benefit of co-pending U.S. Provisional Application Serial No. 63 / 543,265, filed October 9, 2023, and relates to U.S. Patent Nos. 10,004,918 and 11,207,544 and U.S. Application Serial No. 17 / 714,914, filed April 6, 2022, the entire disclosure of which is expressly incorporated herein by reference. Technical Field

[0002] This application relates generally to medical devices, and more specifically to light-based vaginal phototherapy devices for treating bacterial and fungal infections, as well as systems and methods for using such devices. Background Technology

[0003] Vaginitis is characterized by inflammation of the vagina, resulting in discharge, itching, and pain. The cause is usually an alteration of the normal balance of vaginal bacteria or an infection. Decreased estrogen levels after menopause can also lead to vaginitis. Up to 75% of women experience a bacterial or fungal infection in their vagina within a given year. Symptoms range from mucous discharge, itching, aching, pain during intercourse to odor. Vaginal infections often have multiple causes, which makes treatment challenging. Maintaining a balance between naturally occurring yeasts and bacteria is crucial. Vaginitis occurs when the system becomes unbalanced or when other types of bacteria are present in the environment. In fact, when one cause is treated, other pathogens can develop resistance, or mutations can occur when treated with antibiotics, leading to resistance to antibiotic therapy. Sometimes, a reduction in beneficial bacteria can lead to yeast (usually Candida albicans) infection. Candida albicans Yeast can multiply, leading to yeast infections. Additionally, changes in pH balance or the introduction of foreign bacteria into the vagina can also cause infectious vaginitis. Physical factors contributing to the development of infection include: tight clothing causing persistent vulvar moisture, chemicals coming into contact with the vagina via scented tampons, antibiotics, birth control pills, or a diet high in refined sugar and yeast.

[0004] Bacterial vaginosis, also known as vaginal bacterial infection or Gardnerella vaginitis, is a vaginal infection caused by an overgrowth of bacteria. Common symptoms include increased vaginal discharge, often with a fishy odor. The discharge is usually white or gray. Burning sensation during urination may also occur. Itching is uncommon. Occasionally, there may be no symptoms. Having bacterial vaginosis increases the risk of infection with many other sexually transmitted infections, including HIV / AIDS. It also increases the risk of premature birth in pregnant women. Bacterial vaginosis is caused by an imbalance of the bacteria naturally present in the vagina. A suspected diagnosis is made based on symptoms and can be confirmed by testing vaginal discharge and finding a higher than normal vaginal pH and a large number of bacteria. Bacterial vaginosis is often confused with vaginal yeast infections. It is usually treated with antibiotics. Bacterial vaginosis is the most common vaginal infection in women of reproductive age. At any given time, up to 35% of women can be affected. Oral or vaginal antibiotics are effective in treatment. However, about 10% to 15% of women do not improve after the first course of antibiotics, and a relapse rate of up to 80% has been recorded. Although estrogen-containing birth control pills reduce recurrence, sexual activity with the same partner before and after treatment, as well as inconsistent condom use, increases the recurrence rate. There is evidence that bacterial vaginosis is associated with increased rates of sexually transmitted infections such as HIV / AIDS. Bacterial vaginosis is associated with up to a 6-fold increase in HIV shedding. Vaginal lactobacilli ( lactobacilli The lack of ) and Neisseria gonorrhoeae ( Neisseria gonorrhoeae ) and Chlamydia trachomatis ( Chlamydia trachomatis Infection with bacterial vaginosis is also associated with HPV infection. Bacterial vaginosis is a risk factor for viral shedding and herpes simplex virus type 2 (HPV) infection. Bacterial vaginosis may increase the risk of HPV infection or reactivation.

[0005] Candidiasis, more commonly known as a yeast infection, is most often caused by an overgrowth of a fungus called Candida albicans in the vagina. Candida is a yeast, a type of fungus. Yeasts are always present in small amounts in the vagina, and symptoms only appear when they overgrow. Candida can proliferate when imbalances occur, such as when the normal acidity of the vagina changes or when hormone balance is altered. Frequent yeast infections can be a sign of more serious primary health problems, such as diabetes or a weakened immune system. Recurrent infections can also be caused by the use of antibiotic medications. Recurrent vulvovaginal candidiasis affects at least 75 million women in the United States each year. About 5–8% of women experience four or more episodes per year and are diagnosed with recurrent vulvovaginal candidiasis. About 75% of premenopausal women will develop thrush at some point in their lives. With the introduction of over-the-counter medications for home treatment of yeast infections, many women choose to self-diagnose and self-medicate, suggesting that the true incidence of yeast infections each year may be severely underreported.

[0006] Compared to antibacterial therapy, antifungal treatment is limited to very small amounts of drug substances. Treatment for fungal infections can be local or systemic. Local antifungal agents are generally considered first-line treatment for uncomplicated, superficial, and relatively localized fungal infections due to their high efficacy and low likelihood of systemic side effects. Systemic antifungal agents are absorbed and delivered into the body via the bloodstream. Oral administration is usually the safest, most economical, and easiest route for systemic antifungal medications.

[0007] Compared to oral antifungal medications, topical antifungal creams and suppositories have fewer side effects because they are less likely to be absorbed systemically and only have a localized effect on the genital area. Antifungal medications affect the entire body, and side effects can include nausea, headache, and abdominal pain. However, topical applications can be messy and uncomfortable, while pills are relatively simple. Treatment with antifungal medications is ineffective in up to 20% of cases. If symptoms do not resolve within 7–14 days, treatment for thrush is considered a failure. Furthermore, the incidence of antifungal resistance may be increasing, and drug-resistant fungal strains are increasingly becoming a common cause of infection in high-risk patient groups, such as those with HIV / AIDS. Therefore, alternative antifungal strategies are being actively sought.

[0008] Severe forms of infection are difficult to treat and often require more aggressive and long-term therapies, as are chronic relapsing cases. Furthermore, incomplete treatment often leads to drug-resistant infections, so the entire course of treatment should be adhered to.

[0009] While phototherapy is known for treating various bacterial, fungal, or viral infections, such infections are typically treated with chemotherapy or medication. The use of such treatments can affect the internal functioning of the vagina and uterus because chemicals used in paste, gel, or liquid form can cause unwanted chemical reactions that are harsh or lead to various complications.

[0010] Oral antifungal medications carry the risk of serious side effects, and many patients are allergic to or intolerant of these drugs. Topical solutions can be messy and inconvenient. Currently, there are no products that can treat yeast infections without medication. Therefore, there is a need for products that allow for rapid and simple treatment of both yeast and bacterial infections without systemic effects. With the continued and accelerating emergence of antibiotic-resistant microorganisms, interest and investment in phototherapy are increasing. Devices utilizing this emerging technology are likely to gain rapid acceptance in specific use cases, as well as broader support in the general population who simply wish 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 specifically to light-based vaginal phototherapy devices for treating bacterial and fungal infections and / or for preventing such infections (e.g., before / during pregnancy), as well as systems and methods for using such devices.

[0013] According to one example, a device, system, or kit for vaginal phototherapy for a user is provided, comprising: a housing including a body sized for insertion into the vagina; one or more light sources configured to emit light outward from the body; and a photosensitizer source comprising curcumin.

[0014] According to another example, a device, system, or kit for vaginal phototherapy for a user is provided, comprising: a housing including a body sized for insertion into the vagina; one or more light sources configured to emit light outward from the body; and a photosensitizer source comprising a carboxymethyl cellulose (CMC) carrier and curcumin mixed with or suspended with the CMC carrier, the curcumin concentration not exceeding about 2 millimoles (2.0 mM).

[0015] According to yet another example, a photosensitizer is provided for use in conjunction with a phototherapy device to deliver vaginal phototherapy to a user to treat one or more pathogens, said photosensitizer comprising: a carboxymethyl cellulose (CMC) carrier; and curcumin mixed with or suspended together with said CMC carrier, the curcumin concentration not exceeding about 2 millimoles (2.0 mM), for example having a concentration between about half a millimole and 2 millimoles (0.5-2.0 mM).

[0016] According to yet another example, a method for providing vaginal phototherapy for a user includes: providing a therapy device including a body, the body including one or more light sources; providing a photosensitizer including curcumin on the body or providing the photosensitizer in combination with the body; inserting the therapy device into the vagina; and activating the one or more light sources to emit light outward from the body.

[0017] In one example, the device herein may include: a housing comprising a body sized for insertion into the vagina and including a central region and tapering distally; and optionally, an attachment integrally formed with the body and extending proximally from the body, the attachment having sufficient length to protrude from the vagina when the body is fully inserted into the vagina, and formed of a malleable material such that the attachment can be manipulated into and maintain a desired shape; one or more light sources configured to emit light outward from the body; and a battery configured to deliver electrical energy to activate the one or more light sources.

[0018] These and other aspects of the examples herein will be better understood and appreciated when considered in conjunction with the following description and accompanying figures. However, it should be understood that while the following description points to the examples and their many specific details, it is given by way of illustration rather than limitation. Various changes and modifications can be made within the scope of the examples herein without departing from their spirit, and the examples herein include all such modifications. Attached Figure Description

[0019] Other objects, features, and advantages will arise from the following description of the examples and figures, in which those skilled in the art will observe: Figure 1A A perspective view of a light-based vaginal phototherapy device is shown.

[0020] Figure 1B A perspective view of a light-based vaginal phototherapy device with a USB cable is shown.

[0021] Figure 1C , Figure 1D and Figure 1EThey are Figure 1B The top view, side view, and front view of the device.

[0022] Figure 1F It shows Figure 1B A cross-sectional view of a light-based vaginal phototherapy device.

[0023] Figure 2 The image shows a vaginal phototherapy device placed inside a woman's vaginal cavity.

[0024] Figure 3 It is used for storing, charging and / or otherwise receiving phototherapy devices (such as...) Figures 1A-1F A cross-sectional view of an example cradle of the device shown, illustrating exemplary components of the phototherapy device and the cradle.

[0025] Figure 4A and Figure 4B This is a perspective view of an example of a tray in which a phototherapy device is stored, showing the tray's cover open and closed.

[0026] Figure 5A and Figure 5B This is a perspective view of another example of a bracket, showing the bracket's cover open and closed.

[0027] Figure 6A and Figure 6B This is a perspective view of another example of a bracket, showing the bracket's cover open and closed.

[0028] Figure 7 It is a perspective view that can be provided to facilitate insertion of an insertion tool into the user's vagina, such as... Figures 1A-1F The treatment device shown can be mounted on an insertion tool.

[0029] Figure 8 This is a perspective view of another example of a light-based vaginal phototherapy device.

[0030] Figures 9A-9D Another example of a light-based vaginal phototherapy device is shown.

[0031] Figure 10 It shows that it can be included Figures 9A-9D A schematic diagram of an exemplary component in the device.

[0032] Figure 11 This is a perspective view of yet another example of a light-based vaginal phototherapy device.

[0033] Figure 12A and Figure 12BAnother example of a system for light-based vaginal therapy is shown, which includes a therapy device sized for insertion into the vagina and an external controller that can be connected to the therapy device via an optical fiber cable, for example, to deliver light into the therapy device for delivering light therapy within the vagina. Detailed Implementation

[0034] In the following detailed description, reference is made to the accompanying drawings, which form a part of the description, and specific examples that may be implemented are shown therein by way of illustration. These examples are described in sufficient detail to enable those skilled in the art to implement them, and it should be understood that logical, mechanical, and other changes may be made without departing from the scope of these examples. Therefore, the following detailed description should not be construed as limiting.

[0035] When a range of values ​​is provided, it should be understood that each intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, is also specifically disclosed unless the context explicitly specifies otherwise. Every smaller range between any stated value or intermediate value within the stated range and any other stated value or intermediate value within that stated range is covered by this invention. The upper and lower limits of these smaller ranges may be independently included in or excluded from the range, and each range in which any one limit, neither limit, or both limits are included is also covered by this invention, subject to any specific exclusions within the stated range. When the stated range includes one or both limits, ranges excluding one or both of those included limits are also included in this invention.

[0036] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this invention, some potential and exemplary methods and materials are described hereafter.

[0037] It is important to note that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly specifies otherwise. Thus, for example, a reference to “compound” includes a plurality of such compounds, while a reference to “polymer” includes a reference to one or more polymers and their equivalents known to those skilled in the art, and so on.

[0038] This article presents certain ranges of numerical values ​​preceded by the term "approximately". The term "approximately" is used here to provide literal support for the exact number that follows it, as well as numbers that are close to or approximate to the number following the term. In determining whether a number is close to or approximate to a specific stated number, the unstated close or approximate number may be a number that provides a substantial equivalent to the specific stated number in the context in which it is presented.

[0039] The examples in this document provide a light-based vaginal phototherapy device that can be used to treat a variety of conditions, such as bacterial and fungal infections, chlamydia, etc. Alternatively, the devices and systems described herein can also be used to apply other forms of energy to the vaginal wall, for example, thereby tightening adjacent tissue. In one example, the device may include a body or housing, one or more light sources, switches or other actuators, flexible tethers, microchips or other controllers, and batteries or other power sources. Alternatively, the device may include a wireless communication interface, for example, including one or more antennas and / or circuitry for receiving commands from a remote electronic device (e.g., a user's mobile phone, tablet, or other device) via Bluetooth or other communication protocols.

[0040] Optionally, the body of the device described herein may be formed of a suitable medical-grade durable material that allows the emission of therapeutic light. Optionally, one end of the device may include a cervical support for placing the device against the cervix. In one example, one or more light sources may include a single or multiple LEDs provided on the LED body, for example, mounted to an outer surface, a recess in the outer surface, etc., thereby providing the device with a substantially smooth and / or non-invasive outer surface. Alternatively, other internal light sources may be provided, which may transmit light from the body, for example, via one or more optical fibers, lenses, through a transparent (transparent to the transmitted light) wall of the body, etc. (not shown). For example, the body may be formed entirely of a transparent material, or the desired area may be transparent, such that one or more LEDs within the body allow light to be transmitted through the transparent material to treat adjacent tissue. Alternatively, external light sources may be provided (e.g., within a controller), which deliver light to the device via one or more optical fiber cables, as further described elsewhere herein.

[0041] Each LED can emit light with wavelengths within the therapeutic zone of blue and / or red or violet light (e.g., bactericidal non-UV) wavelengths. In one example, the switch is a pressure-activated switch. A controller is housed within the main body and connects the battery to the light source(s) and further to the switch. The controller controls the duration of phototherapy and / or pulsed emission. Alternatively, the battery charge can be set to limit the duration of the device and / or other functions. For example, pulsed emission can stress the targeted bacteria or yeast and / or otherwise make the device more effective. The switch and the light source(s) draw power from the battery via a microchip. The switch controls the activation and deactivation of the light source(s).

[0042] A tether (e.g., a flexible cable, rope, cord, loop, etc.) may be attached to one end of the body and may be of sufficient length to facilitate retrieval from the vagina and / or advance of the device. For example, the tether may be a flexible cord comprising a first end and a second end connected to the body, thereby defining a closed loop—which is of sufficient length to extend outside the vagina when the body is fully inserted into the vagina (e.g., against the cervix). Alternatively, a cannula or other insertion tool (not shown) may be provided for insertion and / or retrieval of the device.

[0043] As illustrated in the examples herein, one or more light sources may emit non-UV germicidal light in the wavelength range between blue and / or red or violet light wavelengths. For example, 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 reproduction of various bacterial and fungal strains or other pathogens that cause infection or virus.

[0044] According to one example, the controller controls the duration of the light pulses in a fast-on and / or fast-off manner. For example, once activated, the controller can keep one or more light sources active for a predetermined period of time, such as an hour or longer, and then automatically deactivate the light sources. Optionally, when the device is activated, the controller can cause the light sources to operate in pulses, for example, rapidly turning the light sources on and off multiple times per minute or per second. Alternatively or alternatively, the light sources can be pulsed between different wavelengths.

[0045] According to one example, the device is non-reusable and for single-use treatment of bacterial and fungal infections. Alternatively, the device is reusable and can be used to treat bacterial and fungal infections multiple times, and may include or be coupled to a cable to recharge the device. The reusable device has a washable or rinseable body.

[0046] Switch to the attached image. Figure 1A A perspective view of an example of an LED-based vaginal phototherapy device 100 is shown, which includes a body 102 carrying a plurality of light sources 103. Figure 1B A perspective view of an LED-based vaginal phototherapy device 100 with a USB connection cable 106 is shown. Figures 1C-1F Top view, side view, front view, and cross-sectional view of an LED-based vaginal phototherapy device 100 according to an example are shown respectively. About Figures 1A-1F The main body 102 of the phototherapy device 100 is primarily a plastic frame, which allows for the placement of single or multiple LEDs 103 on its outer surface. For example... Figure 1F As shown, battery 108, controller 107 and / or additional electronic controllers and circuits are positioned internally relative to LED 103.

[0047] Switch 104 may be located on the outer surface of body 102, for example, switch 104 may be actuated by the user to activate device 100 before insertion into the vagina. Alternatively, tether 105 may be coupled to a switch within the body, such that tether 105 may be pulled or otherwise manipulated to activate / deactivate light source 104. In another alternative, a pressure-activated switch (not shown) responsive to compressive pressure on body 102 may be provided within body 102, for example, such that device 100 may be automatically activated after insertion into the vagina and compression of body 102 by pressure from surrounding muscles.

[0048] Once assembled, device 100 is encapsulated in a suitable medical-grade plastic housing, which is completely sealed and serviceable. For example... Figure 1A The suitable tether 105 shown, or as... Figure 1B The mini USB cable 106 shown can be attached to a first or proximal end of the body 102 to assist the device 100 in insertion into and / or removal from the vagina. Optionally, a second or distal end of the device 100 may include a cervical support 101, such as a recessed portion or otherwise shaped portion for smoothly abutting against the cervix to place the device.

[0049] In one example, the length and diameter of the body 102 may be sized for full insertion into the vagina, for example, having a generally oval or oblong shape, i.e., the length is greater than the diameter. For example, the body 102 may have a length not exceeding about 3.5 inches and a maximum diameter not exceeding about 1.5 inches (e.g., at the central region of the body 102). Optionally, the body 102 may be available in multiple sizes (e.g., length and / or diameter), which may be provided based on the individual anatomy of an individual patient or user. Thus, the device may have any suitable size to address the size of the cavity into which it is inserted, for example, to position the device against the cervix and / or otherwise minimize migration during use. The surface of the body 102 may be either rigid or compressible, depending on user preference and the area of ​​use. Alternatively, the material of the body 102 may be flexible and / or extensible to allow the body 102 to conform to the vaginal cavity into which the device 100 is inserted. In one example, the body 102 has an ellipsoidal shape, for example, including a rounded proximal end, a distal end, a relatively large central region that is substantially midway between the proximal and distal ends, a proximal tapering region that tapers from the central region to the proximal end, and a distal tapering region that tapers from the central region to the distal end.

[0050] Figure 2 A vaginal phototherapy device is shown placed inside a woman's vagina. While device 100 is shown as an example, the methods described herein are equally applicable to all devices described herein. Regarding... Figure 2 The device 100 is fully inserted into the vaginal cavity 201, for example, so as to place the distal end against the cervix, while the proximal end is received in the vaginal cavity 201, so that the tether 105 or USB cable 106 extends out of the vaginal cavity 201.

[0051] Optional, such as Figure 7 As shown, an insertion tool 120 may be provided to facilitate the introduction of the device 100 into the vaginal cavity. Generally, the insertion tool 120 includes: a proximal end 122, which, for example, includes a handle (not shown) and / or is shaped to facilitate manipulation of the insertion tool 120; and a distal end 124, which, for example, includes one or more connectors and / or features for releasably engaging the proximal end of the body 102. Optionally, the insertion tool 120 may include a recess, for example, an elongated groove extending proximally from the distal end 124 of a tether 105 sized for receiving the device 100.

[0052] For example, the distal end 124 may have a concave recess corresponding to the shape of the body 102, such that the body can be partially positioned within the recess, and the tether 105 can be inserted into the recess. Optionally, the recess may provide sufficient interference fit with the tether 105 to prevent the tether from falling out and / or to keep the body in place against the distal end 124. Alternatively, the insertion tool 120 may include a post, hub, or other element (not shown) on which the tether 105 may be looped or wound once or multiple times to secure the tether 105 to the insertion tool 120, for example, to hold the device 100 on the distal end 124 with sufficient tension.

[0053] Alternatively or additionally, the insertion tool 120 may include one or more fingers, pawls, or other features (not shown) that may be received within corresponding features in the body 102 to secure the device 100 to the distal end 124. In this example, these features may be releasable, for example, using a button or other actuator (not shown) on the proximal end 122 of the insertion tool 120 to allow the device 100 to be released once positioned within the cavity.

[0054] The insertion tool 120 may be formed of a substantially rigid or ductile biocompatible material (e.g., metal, plastic, or composite material) with sufficient length to allow the distal end 124 to be inserted into the vaginal cavity while keeping the proximal end 122 outside the user's body, for example, between approximately 5 and 6 inches (12.5–15 cm). The insertion tool 120 may be substantially straight or may have a desired curved shape between the proximal end 122 and the distal end 124 to facilitate use.

[0055] Back Figure 2 Device 100 can be activated before or after insertion—for example, by activating an accelerometer-controlled switch, by activating a mechanical switch 104 on the body 102 before inserting device 100 into the vagina, etc., as described elsewhere herein, or device 100 can be activated by pressure—for example, after it reaches a predetermined position in the vaginal cavity 201, whereby one or more light sources begin to emit light. Alternatively, if the device includes a wireless communication interface (not shown), the device can be wirelessly controlled—for example, using a suitable interface, such as a telephone-based application that can be downloaded to the user's electronic device (not shown). Depending on the degree and type of infection (e.g., bacterial, fungal, or other infection), device 100 may remain in the vagina for a specific period, ranging from several minutes to several hours. During the treatment period, the user can resume normal activities, given the relatively small size and comfortable shape of device 100.

[0056] The phototherapy device 100 disclosed herein can provide harmless and / or highly effective treatment for vaginal infections. Because the device 100 does not react with any vaginal fluid, it can be used in any patient's condition. Furthermore, the device 100 has a relatively low cost and simple operating procedure, so it can be used even by individuals with physician consent. Optionally, one or more features of the device can be provided to address issues such as overuse and / or overexposure. For example, the battery capacity can be selected to limit the maximum period of time the device can be activated and / or require the shortest recharge time, or such parameters can be automatically controlled by a controller within the device.

[0057] Go to Figure 3 Figure 4 illustrates another example of a phototherapy device 200, which is generally similar in construction to the previous examples, including, for example, an elongated body 202 and a flexible tether 205 extending from one end of the body 202, which houses the internal components of the device 200 within a sealed environment. Similar to other examples herein, the body 202 may include a central region 202a defining a maximum diameter that tapers towards 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, for example having a flat shape as shown, or a concave, convex, or other shape (not shown) that facilitates placement of the body 202 against the cervix (not shown) within the vagina.

[0058] In general, device 200 includes one or more light sources, such as one or more LEDs 203, a controller 207, and a battery 208, similar to the previous example. Additionally, device 200 includes an accelerometer or other motion sensor 210 within the body 202, coupled to the controller 207 rather than an external switch. For example, the controller 207 can monitor signals from the motion sensor 210 to identify predetermined commands, such as activating or deactivating the LED 203, and / or guiding device 200 through one or more operating modes. Exemplary movements may include moving the body back and forth in a linear motion, rotating the body, etc. In one example, a first distinct movement or group of movements can be identified by the controller 207 to switch device 200, i.e., alternately activating and deactivating the LED 203. A second distinct movement or group of movements can be identified to guide the controller 207 to modify activation between option menus (e.g., between continuous activation profiles and one or more pulsed activation profiles), thereby changing the light frequency transmitted by the one or more light sources, etc. Thus, each time the second movement is repeated, the controller 207 can modify the operation of the LED 203 between option sequences. Alternatively, each desired command can be assigned a different motion.

[0059] Alternatively or additionally, device 200 (or any other device herein) may include an inductive charging circuit 212 within body 202—for example, coupled to battery 208. In one example, charging circuit 212 may include one or more magnets, coils, capacitors, and / or other components (not shown) that can be activated by an external magnetic field to generate current to charge battery 208, as further described elsewhere herein.

[0060] like Figure 3 As shown in Figure 4, a bracket or case 220 may be provided for storing a phototherapy device (such as device 200) when not in use, for example, as part of a system or kit available to a user. Generally, the bracket 220 includes a housing or base 222 and optionally a cover, shroud, or other enclosure 230. The base 222 generally includes: a flat lower surface 222a for placing the bracket 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, the cavity 224 may define a portion of the elongated shape of the body 202 of device 200 such that device 200 can be at least partially received in the bracket 220—for example, in a predetermined orientation. In one example, cavity 224 may have an elongated, strip-like shape—for example, sized to laterally receive body 202 such that the proximal end 202b and distal end 202c of body 202 are positioned at opposite ends of cavity 224, as shown. Figure 3 As shown in Figure 4. Alternatively, cavity 224 may have tapered sidewalls terminating at a flat, concave, or convex lower surface (not shown), for example, a shape corresponding to the cervical support surface 202d of body 202, such that device 200 can only be received in bracket 220 if cervical support surface 202d is first inserted into cavity 224. Alternatively, cavity 224 may have other shapes, such as a hemispherical or partially spherical shape or other shapes (not shown) larger than the maximum size of body 202, such that device 200 can be placed in bracket 220 in any orientation.

[0061] Figures 5 and 6 show further examples of the bracket, which can be used in conjunction with any of the devices described herein. For example, Figure 5A and Figure 5B A bracket 320 is shown, which includes a base 322 having a cavity 324 for receiving a light therapy device 200, and a cover 330 that can be rotatably slid into the base 322 to allow the device 200 to be placed in and / or removed from the cavity 324. Figure 6A and Figure 6BAnother example of a bracket 420 is shown, which includes a base 422 and a pair of clamshell members or other outer shell members 430a, 430b, which can be opened and closed to receive the phototherapy device 200 within a cavity defined by the clamshells 430a, 430b.

[0062] Back Figure 3 As shown in Figure 4, if the bracket 220 includes a cover 230, the cover 230 may include a cavity 232 corresponding to a cavity 224 within the base 222, thereby providing a closed chamber when the cover 230 is closed on the housing 222. The cover 230 may be coupled to the base 222 via one or more hinges (not shown), for example, such that the cover 230 can pivot between an open position and a closed position. Alternatively, the cover 230 may be separable from the base 222, and one or more mating connectors (e.g., tabs, pawls, grooves, etc. (not shown)) may be provided to allow the cover 230 to be removably secured to the base 222 to close the chamber.

[0063] Optionally, the bracket 200 may include one or more features for interacting with the device 200—for example, such as Figure 3 As shown in the diagram. For example, the bracket 220 may include an inductive charging circuit 226 mounted adjacent to the cavity 224 for supplying energy to the charging circuit 212 of the device 200 placed in the cavity 224. For example, the charging circuit 226 may be configured to generate a magnetic field that activates the charging circuit 212 within the device 200—for example, which includes one or more magnets, coils, or other components (not shown)—to charge the device's battery.

[0064] In one example, when device 200 is placed in base 220, bracket charging circuit 226 may be automatically activated or selectively activated by a user—for example, via an actuation switch, button, or other actuator (not shown). For example, bracket 220 may include control circuitry 228 that periodically activates the bracket charging circuitry and identifies when the generated magnetic field indicates the presence of device 200 in cavity 224. Once device 200 is identified, control circuitry 228 may activate bracket charging circuitry 226 for a predetermined period to charge battery 208 of device 200.

[0065] Alternatively, the controller 207 in device 200 may include circuitry (not shown) that modifies the magnetic field or otherwise wirelessly communicates with the bracket control circuitry 228 when the controller 207 confirms that the battery 208 is fully charged. When the bracket control circuitry 228 detects the modified magnetic field or other communication from the device controller 207, the control circuitry 228 may deactivate the bracket charging circuitry 226.

[0066] Optionally, for example, in addition to or instead of the inductive charging circuit 226, the bracket 220 may also include one or more features to assist and / or facilitate cleaning of the device 200 between uses. For example, such as Figure 3 As shown, one or more light sources 232 may be provided on or within the holder 220 for cleaning the device 200, for example, by applying germicidal light and / or bactericidal light (such as ultraviolet or non-ultraviolet germicidal light) in one or more frequency ranges and / or otherwise neutralizing latent pathogens on the outer surface of the body 202. In one example where the holder 220 includes a cover 230, the device 200 may be inserted into the cavity and the cover 230 may be closed to activate one or more light sources 232 to treat the device 200. For example, the holder 220 may include a sensor (not shown) coupled to control circuitry 228 to detect when the cover 230 is closed (and the device 200 is located within the cavity 224). When control circuitry 228 confirms that the cover 230 is closed, control circuitry 228 may automatically activate one or more light sources 232, for example, for a predetermined period of time, to treat the device 200. Optionally, the bracket 220 may include a locking mechanism (not shown) that automatically locks the cover 230 once it is closed, for example, until a predetermined period of time has elapsed to ensure that the device 200 has been adequately cleaned and / or to prevent unintentional exposure to light transmitted by one or more light sources 232.

[0067] In another example, the light therapy device and holder may include a magnetic switch or other activation circuitry that automatically activates the device once it is removed from the holder. For example, the holder may include circuitry that generates a magnetic field or other energy, and the device may include sensors that detect the presence and / or absence of the field / energy. Therefore, when the device is removed from the holder, the device's controller may detect the removal and automatically activate an LED (e.g., immediately or after a predetermined time delay). Such a time delay allows sufficient time for device insertion and / or allows the controller to confirm that the device has been returned to the holder within the predetermined time, thus preventing accidental activation—if the device falls out of the holder, etc.

[0068] In another example, a device with a motion sensor can be used to activate the device. For example, if the controller detects no movement from the motion sensor for a predetermined time threshold, the controller can infer that the device is in the holder or is not being used. Once movement is detected, the controller can automatically activate the LED (e.g., immediately or after a predetermined delay).

[0069] According to one example, device 200 (or any other device described herein) can be used to treat fungal and bacterial vaginosis, candidiasis, chlamydia, and / or other conditions. In the case of bacterial vaginosis, no additional photosensitizer is required because the bacteria are negatively affected by the light-based therapy of device 200.

[0070] The devices described herein can be used as adjuncts to help eliminate or reduce unwanted microorganisms and form the basis for alternative traditional therapies. One or more devices may also be used for patients interested in non-pharmacological treatments. One or more devices may be used to treat patients who cannot tolerate oral or topical azole therapies, as well as immunocompromised patients with recurrent yeast or bacterial infections. Optionally, any device may be used as a cleansing device—for example, before pregnancy to help avoid bacterial vaginosis problems that may negatively impact pregnancy.

[0071] As an example, the device described in this article can be used to combat both fungal and bacterial infections. Fungal infections include those caused by yeasts, particularly (but not limited to) Candida albicans, while bacterial infections include those primarily caused by Gardnerella vaginalis. The patient must first determine whether they have a fungal or bacterial infection. This can be determined through a doctor's tests.

[0072] According to one example, the device may be sold together with test strips, for example, as part of a kit or system for treatment. According to the example herein, the test strips can be used to determine whether a patient has a fungal or bacterial infection. The device 100 can be used as an alternative to medications, rinsing solutions, or chemicals prescribed by a doctor to treat both bacterial and fungal infections.

[0073] According to another example, in the case of fungal infection, the device can be used with a photosensitizer. In the case of yeast infection, a photosensitizer can be beneficial. Photosensitizers include porfimer sodium (Photofrin), 5-aminolevulinic acid or ALA (Levulan), and methyl aminolevulinate [MAOP] (Metvix).

[0074] Optionally, any device described herein may also be enhanced with probiotics, such as bacteria and fungi necessary to help supplement the microbiome.

[0075] According to another example, device 100 (or any device herein) can provide low-power, long-duration therapy for greater safety to mucosal tissue. For example, the device may be inserted overnight and removed in the morning, i.e., several hours later. Alternatively, the device may be inserted for relatively short-duration treatment, e.g., thirty to sixty (30-60) minutes, after which the device may be removed. For example, the light source(s) may be monochromatic or multicolor LEDs, and / or pulsed or non-pulsed light may be used.

[0076] In one example, device 100 may be configured for multiple uses, for example, such that device 100 can be cleaned and inserted into the vagina multiple times—for example, over several days or other treatment procedures. Alternatively, device 100 may be a disposable device, i.e., a device that can be discarded after a single treatment use.

[0077] For multiple uses, device 100 may include a rechargeable battery and a connecting cable that facilitates removal of the device from the vagina and serves as a connection to a suitable power source for recharging the device. Alternatively, as with other devices herein, device 100 may include an inductive charging circuit (not shown) for wireless inductive charging without a connecting cable.

[0078] According to one example, the phototherapy device includes one or more LEDs as a light source for projecting light onto the vaginal wall. The device further includes a battery housed within a 100% sealed housing or LED body. The battery may be connected to a controller and the LEDs and act as a power source for both. A microchip controls the duration of the phototherapy. Printed circuitry or suitable electronic circuitry or a connection hub may be provided in the device for interconnecting the switch, LEDs, microchip, and battery. The device further includes a switch to activate the device and begin phototherapy. The device also includes a tether for retrieving the device during phototherapy. The tether is suitably replaced by a USB cable or a charging cable to allow for multiple uses of the device.

[0079] Go to Figure 8 Another example of a phototherapy device 500 is shown, which is generally similar in construction to the previous examples, for example, including an elongated body 510 and a flexible tether 520 extending from one end of the body 510, the body 510 housing the internal components of the device 500 within a sealed environment. Similar to other examples herein, the body 510 may include a central region 512 defining a maximum diameter that tapers towards a proximal end 514 and a distal end 516, for example, having rounded proximal and distal ends 516 such that the body 510 defines an ellipsoidal shape.

[0080] Additionally, the device 500 includes one or more light sources, such as one or more LEDs 518 mounted on a circuit board or other substrate 519 within the body 510 and configured to deliver light to tissue surrounding the body. For example, the body 510 may include a plurality of lenses, windows, or other transparent features (not shown) spaced apart from each other in the walls of the body 510 to allow light from the LED(one or more) 518 to pass through the walls and be delivered to the surrounding tissue. Alternatively, the plurality of LEDs or other light sources may be mounted directly in the walls of the body 510 (not shown).

[0081] Unlike the previous example, the tether 520 includes an elongated member 522 that carries a housing 524—for example, at the free end 522a of the elongated member 522. The housing 524 may include one or more components of the device 500, such as a battery 528 for supplying power to one or more LEDs 518. A controller 530 may also be provided within the housing 524, for example, coupled to the battery and one or more LEDs 518 via one or more wires or other leads 526 extending from the body 302 through the elongated body 322 to the housing 324. Alternatively, the controller may be located within the body 510, for example, mounted on a circuit board including one or more LEDs 518. Alternatively, the housing 524 may be separate from the elongated member 522, and the free end 522a and the housing 524 may include connectors for (e.g., before or after the body 510 is inserted into the vagina) to removably attach the housing 524 to the elongated member 522, such as electrical and / or mechanical connectors for attaching components within the housing 524 to the lead 526.

[0082] Optionally, device 500 may also include a wireless communication interface 532, such as a transmitter / receiver communicating via radio frequency (RF) signals (e.g., using Bluetooth or other wireless protocols). For example, interface 532 may be coupled to controller 530, thereby allowing device 500 to be remotely activated and / or deactivated—e.g., using an application on a mobile phone or other electronic device, similar to other examples herein. Alternatively, housing 524 may include a switch (not shown) for activating and / or deactivating LED(s) 518 during use.

[0083] In another option, the elongated member 522 of the tether 520 can be extensible, for example, flexible enough that the tether 520 can be manipulated by the user but substantially maintains the shape applied to the tether 520, for example... Figure 8 The curved shape shown facilitates positioning of the outer shell 524 in the desired location to minimize discomfort when the body 510 is inserted into the user's vagina during treatment. Alternatively, the tether 520 may be biased into a predetermined shape, such as the curved shape shown, but may be flexible enough to facilitate manipulation of the tether 520, for example, thereby facilitating the insertion and removal of the body 510. In yet another alternative, the tether 520 may be substantially rigid, for example, set to a curved or other desired shape.

[0084] The device 500 can be used similarly to other examples herein—for example, by fully inserting the body 510 into the user's vagina, e.g., until the distal end 516 is positioned adjacent to the cervix, and the tether 520 extends from the vagina. The user can then activate one or more LEDs 518—e.g., remotely or by manipulating a switch on the housing 524. If flexible, the elongated member 522 of the tether 520 can be manipulated to move the housing 524 to a desired position, e.g., adjacent to the vaginal opening against the user's body, to minimize discomfort during treatment.

[0085] Go to Figures 9A-9D Another example of a phototherapy device 600 is shown, which is generally similar in construction to the previous examples, including, for example, an elongated body 610 sized for insertion into a user's vagina to deliver phototherapy. In the example shown, 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, for example, having a rounded distal end 616 such that the body 610 generally defines an ellipsoidal shape. Such an ellipsoidal shape and / or other rounded shapes facilitate easy insertion into the vagina and / or enhance user comfort, similar to other examples herein. Additionally, the device 600 includes a tail or appendage 620 extending from the proximal end 614 of the body 610, for example, terminating at a proximal tip 632 of the device 600, which can remain outside the user's vagina during use.

[0086] Device 600 includes one or more electrical components—for example, mounted on a circuit board or flexible PCB substrate 626 within accessory 620, such as adjacent to proximal tip 632, as... Figure 9A and Figure 9B As shown by the dashed lines in the diagram. Similar to the previous example, device 600 includes one or more light sources 618 configured to deliver light to tissue surrounding the body. In one example, the light sources 618 may include one or more LEDs mounted on substrate 626 (e.g., via one or more optical fibers (not shown) entering the body 610) to deliver light to one or more LEDs within the body 610. Alternatively, the light sources 618 may be located directly within the body 610, for example, on one or more additional substrates mounted within the body 610, such as those similar to... Figure 8 And / or the device 500 shown in other examples herein.

[0087] For example, the body 610 may include a plurality of lenses, windows, or other transparent features (not shown) spaced apart from each other in the walls of the body 610 to allow light from one or more light sources 618 to pass through the walls and be delivered to the surrounding tissue. Alternatively, a plurality of LEDs or other light sources may be mounted directly in the walls of the body 610 (not shown). In another alternative, one or more areas of the body 610 may be translucent or transparent to light transmitted from the interior of the body 610 to the exterior by one or more light sources 618.

[0088] Attachment 620 may be integrally formed with body 610 to provide a unitary housing of device 600—for example, by one or more of molding, casting, machining, or otherwise formed together with plastic, metal, and / or composite materials. Attachment 620 may have sufficient length and a desired shape extending proximally from body 610 to facilitate manipulation of device 600 (e.g., during insertion and / or removal). For example, attachment 620 may have a length longer than body 610. Optionally, the material of attachment 620 may be ductile, for example, flexible enough that attachment 620 can be manipulated by a user but substantially maintains the shape applied to attachment 620, for example, as... Figures 9A-9D The curved shape shown facilitates positioning of the attachment 620 in the desired location during treatment when the body 610 is inserted into the user's vagina. Alternatively, the attachment 620 may be biased into a predetermined shape, such as the curved shape shown, but may be flexible enough to facilitate manipulation of the attachment 620, for example, thereby facilitating insertion and removal of the device 600. In this alternative, the attachment 620 will automatically return to the predetermined (e.g., curved) shape once released. In yet another alternative, the attachment 620 may be substantially rigid, for example, set to a curved or other desired shape.

[0089] Go to Figure 10Exemplary components are shown that can be carried on substrate 626 or otherwise housed within accessory 620, for example, to position the components outside the user's body when the body 610 of device 600 is inserted into the user's vagina. For example, battery 628 may be provided for supplying power to light sources, and controller 630 may be coupled to battery 628 and one or more light sources 618 to control the operation of one or more light sources 618. Optionally, wireless communication interface 632 may also be provided, for example, a transmitter / receiver communicating via radio frequency (RF) signals (e.g., using Bluetooth or other wireless protocols), similar to other examples herein. For example, interface 632 may be coupled to controller 630, for example, thereby allowing device 600 to be remotely activated and / or deactivated—for example, using an application on a mobile phone or other electronic device, similar to other examples herein. Alternatively, accessory 620 may include a switch (not shown) and / or use motion controls for activating and / or deactivating device 600 during use, similar to other examples herein.

[0090] Attachment 620 may include connector 629—for example, on or near proximal tip 632—which may be coupled to battery 628 and / or controller 630, for example, such that a cable (not shown) may be removably connected to device 60 to recharge battery 628 and / or program controller 630. Alternatively, device 600 may include inductive charging circuitry within attachment 620, similar to other examples herein, and connector 629 may be omitted.

[0091] The device 600 can be used similarly to other examples herein—for example, by inserting the body 610 into the user's vagina, e.g., until it is positioned distally near the cervix, and the attachment 620 protrudes from the vagina (not shown). The user can then activate one or more light sources 618—e.g., remotely or by manipulating a switch on the attachment 620. If flexible, the attachment 620 can be manipulated to move it to a desired position, e.g., adjacent to the vaginal opening against the user's body, to minimize discomfort during treatment.

[0092] Optionally, the device 600 may include different areas that may include separate light sources and / or be activated independently (e.g., individually or simultaneously), such as one or more areas of the user's body for treating, including the vaginal opening area and / or external genitalia. For example, as Figure 9AAs shown, the body 610 may include an annular region 612a—for example, a distal region 612b extending distally from the attachment 620 to the body 610—which may include one or more light sources that can be activated to deliver light outwardly along the annular region 612a to treat the vaginal cavity. Optionally, the distal region 612b may also include one or more light sources that can be independently activated to deliver light distally from the body 610 (e.g., toward the user's cervix).

[0093] Alternatively or additionally, attachment 620 may include one or more regions comprising one or more additional light sources that can be activated for treating vaginal cavity and / or external regions, such as the vulva, labia majora, and / or labia minora, for example, for treating vulvovaginitis. In the example shown, attachment 620 includes a proximal region 620a extending at least partially along the upper concave side of attachment 620, which allows for treatment of external anatomical structures.

[0094] In one example, a single group of LEDs may be provided on substrate 626, and the light from these LEDs may be split and delivered to corresponding areas via one or more optical fibers, lenses, etc., for example, thereby delivering light to different areas sequentially, simultaneously, and / or otherwise. Alternatively, individual light sources may be provided in each area, and these light sources may be separated from each other by partitions to prevent light leakage from one area to another. Individual light sources may again be activated sequentially, simultaneously, etc. For example, with body 610 fully inserted into the user's vaginal cavity and attachment 620 extending proximally outside the vagina, the user may selectively activate device 600 to deliver light within the vaginal cavity via body 610 and / or via one or more areas on attachment 620 along the canal and / or external genitalia.

[0095] Optionally, device 600 (or any other device herein) may include one or more sensors 640, for example, carried on body 610 and / or accessory 620. For example, a pH sensor 640 may be provided on body 610 and coupled to controller 630, which may process signals from pH sensor 640 to identify one or more conditions. For example, if controller 630 detects that the pH in a user's vagina is greater than 4.5 (or other threshold), controller 630 may infer that the user has bacterial vaginosis or that a Trichomonas organism is present. Optionally, device 610 may include an output device 642 coupled to processor 630, such as an indicator light, display, etc., which may provide output to notify the user—for example, by changing color or displaying text messages. For example, light 642 may be mounted on accessory 620 of device 610 so that the user can easily see the indication when processor 630 activates light 640 during use of device 610. Alternatively, the light may be provided on a tether, cable, or other component extending from the body of the therapeutic device, such as being provided in Figures 1A-11 F, Figure 3 and Figure 8 The device shown is attached to the tether 105 or cable 106.

[0096] Alternatively or additionally, one or more temperature sensors (not shown) may be provided on device 610 (or any other device)—for example, coupled to controller 630—to detect the basal temperature inside the user's vagina. For example, a temperature sensor mounted on the outer surface of device 610 may be coupled to processor 630 to provide signals that can be analyzed by processor 630 to monitor one or more conditions of the user. In one example, processor 630 may monitor the user's temperature to track the user's menstrual cycle—for example, by tracking the user's basal body temperature. Alternatively or additionally, other sensors (also not shown) may be provided on device 610 to aid in such analysis and / or diagnosis.

[0097] Alternatively or additionally, if device 610 includes communication interface 632, data from pH sensors, temperature sensors, etc. (or analysis performed by controller 730) can be transmitted to external devices, such as mobile phones, tablets, or other electronic devices including applications that can notify the user. Optionally, the application on the electronic device can provide the user with additional interfaces and / or functions and / or transmit user-related information (e.g., indications of bacterial vaginosis) to the user's healthcare provider, for example, thereby recording the information in the patient's health record and / or facilitating the provider's treatment of the user.

[0098] Optionally, such an application (e.g., based on detected pH and / or diagnosis of bacterial vaginosis or other conditions) may provide the user with additional guidance—for example, in relation to the frequency and / or duration of use of the device 610.

[0099] Additionally, if device 610 includes a temperature sensor, processor 630 can provide such information to an electronic device, for example, to a software application, which can provide the user with an output about their basal body temperature, for example, to facilitate ovulation monitoring, for pregnancy guidance, and so on.

[0100] Figure 11 Another example of a phototherapy device is shown, which can be configured to be placed externally adjacent to the vagina, for example, to provide therapy to the outer surface of the vagina, such as treating vulvovaginitis. Unlike the previous examples, device 700 may include one or more light sources, such as one or more LEDs and / or windows, along its concave surface, which can be positioned against and activated for phototherapy against the user's external anatomy. Additionally, device 700 may include one or more other components, similar to other examples herein, such as a controller, battery, wireless communication interface, inductive charging circuitry, connectors, etc. (not shown).

[0101] Device 700 includes a body with a fixed shape, for example, including an upper region 712 and a lower region 714 tapering from the upper region 712. The lower region 714 may have a tapered and / or pronounced shape and / or a pointed tip, which may be configured to separate the labia to facilitate vulvar exposure for phototherapy. Thus, when the upper region 712 is held, the lower region 714 of device 700 can be inserted between the user's labia to expose the vulva, whereby one or more light sources can be activated to deliver phototherapy to the vulva and / or other exposed areas. As shown, the body may include a slightly convex outer surface 722 and a slightly concave inner surface 724, for example, shaped to abut against the user's pubic region to position the device. Optionally, one or more light sources may emit light only from the inner surface 722 (e.g., along the lower region 714) to deliver phototherapy to exposed anatomical structures.

[0102] Go to Figures 12A-12B This illustrates another example of a light-based therapy system, comprising a light therapy device 800 and an external controller 850, the light therapy device 800 being generally similar in construction to the previous example. For example, as... Figure 12AAs shown, the device 800 may include an elongated body 810 sized for insertion into a user's vagina to deliver phototherapy. In the example shown, the body 810 includes a central region 812 defining a maximum diameter tapering toward a proximal end 814 and a distal end 816 of the body 810, for example, having rounded proximal and distal ends 816 such that the body 810 generally defines an ellipsoidal shape. Such an ellipsoidal shape and / or other rounded shapes facilitate easy insertion into the vagina and / or enhance user comfort, similar to other examples herein. Optionally, the device may also include a tether, cable, tail, and / or attachment (not shown) extending from the proximal end 814 of the body 810—for example, which may remain outside the user's vagina during use, similar to other examples herein.

[0103] In the system shown, device 800 does not include an internal light source, but instead, as shown in the figure... Figure 12B As shown, one or more LEDs or other light sources 818 are provided within a controller 850, which may include a processor and / or other electronics 830 to operate the device 800. Such external light sources 818 can reduce heat generated within the body 810, which can increase the comfort of users of the device 800. For example, an optical fiber cable 820 may extend from the controller 850 to a proximal end 814 of the body 810, which may include one or more optical fibers for delivering light from the one or more light sources 818 into the body 810 for outward transmission from the device 800. The one or more light sources 818 may include one or more LEDs, OLEDs, etc.

[0104] In one example, cable 820 may include multiple optical fibers that can be optically coupled to corresponding optical fibers within body 810. These corresponding optical fibers include ends fixed to body 810—for example, fixed to the inner surface of body 810—for delivering light through corresponding lenses, filters, etc., mounted on the walls of body 810. For example, light from one or more light sources 818 may pass through corresponding lenses and be delivered through each individual optical fiber to deliver light into the vagina of the object.

[0105] Alternatively, such as Figure 12AAs shown, one or more optical fibers may be optically coupled to a ray shaper 822 mounted within the body 810. The ray shaper 822 may be configured to split incident light into multiple beams and / or otherwise disperse the incident light, which may be transmitted radially outward from the ray shaper 822. In this alternative, the body 810 may be substantially transparent (at least within the wavelength range of the light transmitted by the light source 818), allowing light to pass through the body 810 and be directed outward to surrounding tissue, for example, as indicated by the ray “r”. In this alternative, the cable 820 may, as needed, include one or more optical fibers, allowing light to be delivered to and transmitted by the ray shaper 822.

[0106] Cable 820 may be permanently connected to body 810, or alternatively, body 810 may include a connector (not shown) to which one end of cable 820 may be coupled to deliver light from one or more light sources 818. Similarly, cable 820 may be permanently connected to controller 850, or alternatively, controller and cable may include mating connectors to allow cable 820 to be removably coupled to controller 850, for example, Figure 12B Connector 854 is shown.

[0107] Optionally, the controller 850 may include one or more additional components, such as battery 832 or other power sources—that operate the electrical components of the controller 850. Alternatively or additionally, the controller 850 may include cables for connection to an external power source (not shown), for example, to charge battery 832 and / or directly power the controller 850. Alternatively or additionally, the controller 850 may include inductive charging circuitry (not shown), for example, similar to other devices described elsewhere herein.

[0108] Additionally, the controller 850 may optionally include a user interface 842, such as an output device, such as a display, keyboard, and other types of interactive interfaces. For example, the user interface 842 may include one or more input devices, such as a microphone, keyboard, touchscreen, etc., and one or more output devices, such as a display, speaker, light indicator, etc.

[0109] Further optionally, the controller 850 may include (e.g., coupled to the processor 840) a memory for storing data related to the operation of the device 800 and / or data related to one or more sensors (not shown) – if provided on the device 800, for example, similar to other devices described herein. The controller 850 may also include a wireless communication interface, for example, for receiving instructions and / or for transmitting information to remote electronic devices, similar to other devices described herein.

[0110] Optionally, device 800 may include one or more sensors (not shown), such as a pH sensor, a temperature sensor, etc., similar to other devices described herein. Optionally, device 800 may include one or more additional components that provide additional functionality. For example, device 800 may include a vibration generator that can be activated by a user via controller 850 to generate vibrations, for example, thereby promoting tissue expansion and / or exposing tissue to light emitted by device 800.

[0111] In one example, components of controller 850 may be housed within housing 852 to provide a lightweight, portable controller 850 that can be carried and / or worn by a user. For example, housing 852 may include one or more clips, straps, etc. (not shown) such that controller 850 can be attached to a user and / or their clothing. For example, a user may insert device 800 into their vagina and attach controller 850 to their underwear or other clothing item, securing straps around their legs or waist, thereby allowing device 800 to provide phototherapy discreetly. The user may program or manually activate device 800 as needed—for example, using user interface 842 of controller 850. Optionally, information may be provided and / or transmitted via controller 850 to a remote electronic device that may present the user with information relevant to the use of device 800, similar to other devices described herein.

[0112] Based on the examples in this article, light-based therapeutic devices are provided that can be used to kill or inactivate a targeted species, thereby preventing the species from replicating. One or more devices may also be used as adjunctive therapies to existing known treatments, potentially allowing for a reduction in drug- or chemical-based therapies. If the device is used in conjunction with conventional therapies, the treatment time may be reduced.

[0113] Optionally, the effectiveness of any device described herein may be enhanced by the use of a photosensitizer. For example, a photosensitizer may be applied to the outer surface of body 102 or to pockets or features (not shown) configured to receive the photosensitizer. Optionally, the outer surface of one or more devices may include one or more features, such as pockets, recesses, etc., spaced apart from each other on the outer surface of the device, into which a photosensitizer and / or other drugs or agents may be applied prior to use. Such pockets, recesses, or other features may facilitate the delivery of one or more agents distributed on the surface of the device while minimizing the wiping away of the agent during insertion. Alternatively, the photosensitizer or other agent may be introduced into the vagina alone—for example, using a known applicator (not shown). One or more devices may be used in conjunction with standard systemic medications or cream-based topical therapies to shorten the duration of the event.

[0114] For example, photosensitizers including curcumin can be used in conjunction with any light-based therapeutic device described herein, for example, by being applied directly to the outer surface of the device and / or delivered independently but in conjunction with the use of the device. In one example, curcumin can be mixed with a carrier agent to produce a water-soluble material for use as a photosensitizer. The material can be applied to the outer surface of the device, for example, into a recess in the outer surface, as described above, before the device is introduced into the user's vagina.

[0115] Examples of carrier agents that can be used include dimethyl sulfoxide (DMSO), carboxymethyl cellulose (CMC), etc. In one example, a photosensitizer comprising a CMC carrier and a sufficient amount of curcumin mixed with or carrying therein in suspension, thereby providing a concentration not exceeding about 2 mmol (2.0 mM) or between about half a mmol and 2 mmol (0.5–2.0 mM). Optionally, the carrier may also provide a lubricant that facilitates introduction and / or additionally reduces discomfort during device use.

[0116] Curcumin can enhance photo-based treatments against pathogens such as Candida albicans and Gardnerella vaginalis by improving one or more treatment parameters, such as reducing power requirements, treatment duration, and / or the total dose of light delivered to the user, compared to devices without curcumin. For example, where previous photo-based therapy devices were found to be more effective at wavelengths of approximately 405 nm, the use of a curcumin-based photosensitizer allows for a further shift away from near-ultraviolet wavelengths. For instance, wavelengths between approximately 425 nm and 475 nm (approximately 430 nm to 450 nm) and / or a narrow band concentrated around 445 nm to 450 nm can be used to effectively treat the target pathogen without significantly affecting other desired bacteria that may be present in the vagina, such as Lactobacillus. Specifically, light with wavelengths between approximately 445 nm and 450 nm maximizes curcumin activation to enhance treatment of vaginal infections.

[0117] Furthermore, it was found that shifting the light wavelength of the therapy device allows for a significant reduction in total power compared to previous light-based therapy devices, for example, by up to 75%. For instance, where previously, a power level of 50 to 60 milliwatts per square centimeter of therapy device surface area (50-60 mW / cm²) was found to be required for adequate phototherapy, curcumin-based phototherapy can be effective—where the device delivers less than 50 milliwatts per square centimeter (50 mW / cm²), for example, no more than about 25 milliwatts per square centimeter of therapy device surface area (25 mW / cm²), or no more than about 20 milliwatts per square centimeter (20 mW / cm²), or no more than about 10 milliwatts per square centimeter (10 mW / cm²). For some pathogens, a power level of about 5 to 6 milliwatts per square centimeter (5-6 mW / cm²) may be sufficient to treat the pathogen, significantly reducing the power requirements of the therapy device, which can reduce heat (which could otherwise cause user discomfort), treatment time, and / or total dose.

[0118] Optionally, the device can be configured to deliver phototherapy in a pulsed rather than substantially continuous manner once activated, which enhances activation of the curcumin-based photosensitizer while reducing power consumption and / or heat generation during use. For example, pulses with a duty cycle of no more than fifty percent (50%) combined with a curcumin-based photosensitizer can deliver sufficient light to effectively treat a variety of pathogens.

[0119] It should be understood that the wording or terminology used herein is for descriptive purposes and not for limitation. Therefore, although the examples herein have been described with reference to exemplary embodiments, those skilled in the art will recognize that the examples herein can be implemented with modifications that fall within the scope of the claims.

Claims

1. A device for vaginal phototherapy for a user, the device comprising: An outer shell, the outer shell comprising a body, the body being sized for insertion into the vagina; One or more light sources, the light sources being configured to emit light outward from the body; as well as A photosensitizer source, wherein the photosensitizer includes curcumin.

2. The apparatus of claim 1, wherein the housing includes an outer surface configured to receive the photosensitizer.

3. The apparatus of claim 2, wherein the outer surface includes a plurality of recesses or depressions configured to receive the photosensitizer.

4. The apparatus of claim 1, wherein the photosensitizer has a curcumin concentration of no more than about 2 millimoles (2.0 mM).

5. The apparatus according to claim 4, wherein the concentration of curcumin is between about half a millimole and 2 millimoles (0.5-2.0 mM).

6. The apparatus according to any one of claims 1-5, wherein the one or more light sources are configured to deliver light with wavelengths between about 425 nanometers and 475 nanometers.

7. The apparatus of claim 6, wherein the one or more light sources are configured to deliver light with wavelengths between about 440 nanometers and 450 nanometers.

8. The apparatus of claim 6, wherein the one or more light sources are configured to deliver light concentrated in a narrow band of about 445 nanometers to about 450 nanometers.

9. The apparatus according to any one of claims 1-5, wherein the one or more light sources are configured to generate power of less than 50 milliwatts per square centimeter of the body surface area (50 mW / cm2).

10. The apparatus of claim 9, wherein the one or more light sources are configured to generate a power of not more than about 25 milliwatts per square centimeter (25 mW / cm2).

11. The apparatus of claim 9, wherein the one or more light sources are configured to generate a power of not more than about 10 milliwatts per square centimeter (10 mW / cm2).

12. The apparatus of claim 9, wherein the one or more light sources are configured to generate a power of about 5 to 6 milliwatts per square centimeter (5-6 mW / cm2).

13. The apparatus according to any one of claims 1-5, wherein the photosensitizer comprises a carboxymethyl cellulose (CMC) carrier.

14. The apparatus of claim 14, wherein the curcumin is mixed with or suspended together with the CMC carrier.

15. A device for vaginal phototherapy for a user, the device comprising: An outer shell, the outer shell comprising a body, the body being sized for insertion into the vagina; One or more light sources, the light sources being configured to emit light outward from the body; as well as The photosensitizer source includes a carboxymethyl cellulose (CMC) carrier and curcumin mixed or suspended with the CMC carrier, wherein the curcumin concentration does not exceed about 2 millimoles (2.0 mM).

16. The apparatus of claim 15, wherein the concentration of curcumin is between about half a millimole and 2 millimoles (0.5-2.0 mM).

17. The apparatus of claim 15 or 16, wherein the one or more light sources are configured to deliver light with wavelengths between about 425 nanometers and 475 nanometers.

18. The apparatus of claim 17, wherein the one or more light sources are configured to deliver light with wavelengths between about 440 nanometers and 450 nanometers.

19. The apparatus of claim 17, wherein the one or more light sources are configured to deliver light concentrated in a narrow band of about 445 nanometers to about 450 nanometers.

20. The apparatus of claim 15 or 16, wherein the one or more light sources are configured to generate power of less than 50 milliwatts per square centimeter of the body surface area (50 mW / cm2).

21. The apparatus of claim 20, wherein the one or more light sources are configured to generate a power of not more than about 25 milliwatts per square centimeter (25 mW / cm2).

22. A photosensitizer used in conjunction with a phototherapy device to deliver vaginal phototherapy to a user for the treatment of one or more pathogens, said photosensitizer comprising: Carboxymethyl cellulose (CMC) carrier; and Curcumin mixed with or suspended together with the CMC carrier, wherein the curcumin concentration does not exceed about 2 millimoles (2.0 mM).

23. The photosensitizer according to claim 22, wherein the concentration of curcumin is between about half a millimole and 2 millimoles (0.5-2.0 mM).

24. A kit for vaginal phototherapy for a user, the kit comprising: A phototherapy device comprising a body sized for insertion into the vagina, and one or more light sources configured to emit light outward from the body; as well as The photosensitizer source includes a carboxymethyl cellulose (CMC) carrier and curcumin mixed or suspended with the CMC carrier, wherein the curcumin concentration does not exceed about 2 millimoles (2.0 mM).

25. A method for vaginal phototherapy for a user, the method comprising: A therapeutic device is provided, the therapeutic device comprising a body, the body including one or more light sources; A photosensitizer comprising curcumin is provided on the main body, or the photosensitizer is provided to be combined with the main body; Insert the therapeutic device into the vagina; as well as Activate the one or more light sources to emit light outward from the body.

26. The method of claim 25, wherein providing the sensitizer comprises applying the photosensitizer to the outer surface of the body prior to inserting the therapeutic device into the vagina.

27. The method of claim 25, wherein the photosensitizer has a curcumin concentration of no more than about 2 millimoles (2.0 mM).

28. The method of claim 27, wherein the concentration of curcumin is between about half a millimole and 2 millimoles (0.5-2.0 mM).

29. The method according to any one of claims 25-28, wherein the one or more light sources are configured to deliver light with wavelengths between about 425 nanometers and 475 nanometers.

30. The method of claim 28, wherein the one or more light sources are configured to deliver light with wavelengths between about 440 nanometers and 450 nanometers.

31. The method of claim 28, wherein the one or more light sources are configured to deliver light concentrated in a narrow band of about 445 nanometers to about 450 nanometers.

32. The method according to any one of claims 25-28, wherein the one or more light sources generate power of less than 50 milliwatts per square centimeter of the surface area of ​​the subject (50 mW / cm2).

33. The method of claim 31, wherein the one or more light sources generate a power of no more than about 25 milliwatts per square centimeter (25 mW / cm2).

34. The method according to any one of claims 25-28, wherein the photosensitizer comprises a carboxymethyl cellulose (CMC) carrier.

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