Componentry and devices for light therapy delivery and methods related thereto

Abstract

The invention comprises componentry and devices for light therapy application to a patient in need thereof. The present invention relates to controllers for light therapy devices, light delivery elements, light guides, light guide arrangements configured to deliver personalized light therapy to one or more patients, with related componentry, dosage, and configurations of light therapy delivery elements (e.g., bandages, garments, braces, inserts etc.) suitable to deliver light therapy to one or more patient body areas and associated tissues, as well as sensors for monitoring treatment progress and dosage optimization. Methods of delivering light therapy to a patient and treatment of associated medical indications are also set out herein. Personalized LLLT dosage configurations and telemedicine LLLT treatment platforms and systems are also provided herein.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of co-pending U.S. Utility application Ser. No. 16 / 110,688, filed Aug. 23, 2018, which claims priority to, and the benefit of, PCT Application No. PCT / US / 2017 / 043988 (hereafter “the PCT '988 application”), filed Jul. 26, 2017, which is hereby incorporated by reference in its entirety. The PCT '988 application claims priority to US Provisional Patent Application Nos. 62 / 494,065 filed on Jul. 27, 2016; 62 / 496,714 filed on Oct. 27, 2016; 62 / 498,401 filed on Dec. 27, 2016, 62 / 499,612 filed on Jan. 31, 2017; and 62 / 499,674 filed on Feb. 3, 2017. The PCT '988 application also claims priority to U.S. Utility application Ser. No. 15 / 645,467, filed Jul. 10, 2017. The disclosures of each of these applications are incorporated herein in their entireties by this reference. All references cited herein are incorporated by reference.FIELD OF THE INVENTION[0002]The invention comprises componentry and devices for light t...

AI Technical Summary

Benefits of technology

[0181]An advantage of the present invention is the wearability, comfort, safety and conformability to the treated vaginal cavity area. Moreover, treatment times, including dilation without applied light therapy, can be extended and / or made more convenient. The patient experiences enhanced wearability during treatment because the self-contained, that is, on board power, controller, light source(s), and, optionally, sensors allow concealment of the device during use and thus, enhanced privacy and comfort.

[0182]Application of LLLT treatment to the vaginal cavity via an insertable device that is wearable by the patient for an extended period, can improve the healing process during the phases of wound healing. Treatment compliance can also be enhanced. To facilitate removal and insertion, the vaginal insert can incorporate a rim or tab integrally formed with the vaginal insert proximate to the anterior end thereof. The rim is sized and shaped to be comfortable for the patient, but to still enable the use thereof. To this end, the inventor herein has found that the rim or tab can be generally shaped as a teardrop, which has been found to comprise a balance between function and comfort for the patient. However, the size and shape of the rim and tab can be varied, or even not included on the vaginal insert, without departing from the scope and content of the invention. In some aspects, at least some of an anterior end of the vaginal insert can be situated outside the vaginal cavity. In some aspects, the controller and associated light guide(s) or light guide arrangement(s) can be located within the structure of the vaginal insert, that is integrated within the vaginal insert itself, such as at or near the anterior end thereof. In other aspects, the controller and associated light guides or light guide arrangements can be present as a separate set of componentry for engagement with the vaginal insert.

[0183]In the case of rejuvenation or enhancing the internal structure of the vaginal cavity, the inventive LLLT devices and methods can enhance the effectiveness of such therapies by the applied LLLT stimulating the tissue, and thus growth of new, more elastic tissue, thereby tightening and enhancing feeling in the vaginal cavity area of a woman in need of treatment. Such treatment can also enhance the function of the female bladder by increasing muscle tone of areas proximal thereto.

[0184]Moreover, LLLT / dilation combination therapy used in conjunction with a light therapy delivery liner can substantially improve the long-term outcomes of internal and external structures of a reconstructed external female genital area (i.e., the vulvar area), by enhancing wound healing over prior art methodologies. Use of the light therapy delivery liner can improve wound healing of the vulvar region when used alone, such as would be indicated with an episiotomy, for example. Extended lengths for the light therapy delivery liner can allow treatment of hemorrhoids along with the vulvar areas, or hemorrhoids can be treated without attendant treatment of the vulvar areas. Moreover, LLLT light therapy applied both internally and externally to the vulvar regions can also be useful to treat vaginal fungal infections, and the methods and devices of the present invention also incorporate this treatment modality.

[0185]The light therapy delivery liner can be sized and shaped for the comfort of the patient. In this regard, the liner can generally be narrower at the front end (i.e., the area proximal to the clitoral area of the female genitalia) and wider at the back end. The corners are optimally rounded, again to enhance comfort. The shape can also approximate that of a panty liner or sanitary pad, as appropriate. To accommodate the various sizes of patients who will be treated with LLLT provided from the liner, the delivery liner can be provided in a variety of sizes. Generally, the length can be from about 20 to about 35 cm and the width can be from about 8 to about 16 cm at the widest end (i.e., in the area proximal to the rectum) and about 1 to about 10 cm at the narrowest part (i.e., in the area proximal to the clitoral area). If additional areas of the external female genitalia are being treated, the size and shape of the liner can be modified to enhance comfort. Soft and flexible materials should be used, such as silicone that has a Shore hardness of from about 0 to about 30, or from 15 to about 25.

[0186]The light therapy delivery liner can incorporate an indentation sized and shaped to allow the anterior end of the vaginal insert to engage therein. When a patient is wearing both the vaginal insert and the liner simultaneously, such engageable fit can improve comfort and wearability, especially when the liner is kept in place by well-fitting undergarments.

Problems solved by technology

Although LLTT has been recognized to be efficacious to treat a wide variety of indications, LLLT nonetheless remains underutilized as a therapy for several reasons.

First, since the underlying biochemical mechanisms are poorly understood today, many use cases remain anecdotal and reported results are largely empirical in nature.

A less than optimal choice of parameters can result in reduced effectiveness of the treatment, or even adverse therapeutic outcomes.

The multiplicity of treatment variables that can affect LLLT treatment effectiveness likely contributes to the dearth of unambiguous and repeatable results that allow a LLLT treatment to be prescribed regularly in clinical settings.

Indeed, many of the published results on LLLT treatments actually demonstrate negative clinical efficacy, possibly because of an inappropriate choice of light source and dosage for the patients being treated.

Outside of these thresholds, the light is either too weak to have any effect, or is so strong that its harmful effects outweigh its benefits.

For example, it has been reported that too low of a dose does not promote biological effects, and doses that are too high result in the inhibition of cellular functions.

Notwithstanding this knowledge, to date, there has been no meaningful resolution of dosage parameters for specific medical indications.

Delivery systems associated with LLLT treatment have not lent themselves to well-defined dose application of LLLT to a patient in need of treatment.

Lasers have typically been difficult to implement outside of the clinical setting due to need to generate and reliably deliver an effective dose of laser light to a patient.

Moreover, the periodic and longitudinal nature of LLLT treatment has made it generally infeasible to treat people cost effectively.

Until recently, lasers and the associated componentry have been expensive and have required mains power to generate suitable energy to power the componentry.

Notwithstanding these myriad of proposed LLLT treatment implementations, which include both “cold laser” and LED light sources, wearable LLLT treatment devices have not been widely introduced for use by patients for treatments of pain, wounds, and other forms of therapeutic activity.

Moreover, there is no remote communications capability incorporated into the LaserWRAP device nor are there any sensor means to collect data for treatment compliance, progress or dosage effectiveness monitoring.

As a result, there is no way for a provider to monitor patient usage and treatment progress after the LLLT treatment starts, nor is there any way for the provider to manage, such as by modifying the dosage during a longitudinal treatment that occurs outside of a healthcare facility.

There also is no way to collect data during the treatment regimen related to the progression of treatment.

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