Patent Publication Number: US-2023141346-A1

Title: Infused undergarment

Description:
RELATED APPLICATION 
     In accordance with 37 C.F.R. § 1. 76, a claim, of priority is included in an Application Data Sheet filed concurrently herewith. Accordingly, the present invention claims priority based upon U.S. Provisional Patent Application No. 63/276,331, filed Nov. 5, 2021, entitled “INFUSED UNDERGARMENT”, the contents of which are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present disclosure is directed to the field of infection treatment and, in particular, to an infused undergarment that can be employed to increase colonization of  Lactobacillus  in women with vaginal infections. 
     BACKGROUND OF THE INVENTION 
     Vaginitis, infection or inflammation of the vagina or vulva, is a common issue recognized in gynecology offices all over the country. Whether originating from bacterial or yeast overgrowth, patients complain of discharge, itching, burning, or embarrassing odor. In many cases women report recurrent infections with no recourse for effective long term treatment or prevention. Currently, the best clinical advice is for these women to wear a cotton undergarment, send a culture, and a prescription for antibiotic or antifungal is given. However, this course of action is treating symptoms and does not resolve the underlying cause. When patients are presented with symptoms, cultures are sent to a laboratory for both pathologic organisms and normal flora bacteria. Anecdotal evidence shows a strong pattern can be seen in those with recurring yeast or bacterial infections, namely these women lacked colonization with  Lactobacillus.    
     At present, there are no formulations of probiotics that are designed to colonize the vagina directly. There are researchers attempting to develop a vaginal tablet; however, the use of a tablet will require FDA approval, a prescription from a physician to obtain it, and the task of the patient inserting themselves correctly. 
     It is widely accepted that the presence of  Lactobacillus  in the vagina plays a key role in maintaining pH levels, and serves an active role in host defense mechanisms against pathologic infection. By secreting hydrogen peroxide and antibacterial/antifungal molecules,  Lactobacillus  species have been shown to inhibit growth of  Candida  and bacteria known to cause bacterial vaginosis. In addition, vaginosis has been associated with decreased colony counts of  Lactobacillus,  suggesting that lack of colonization may lead to increased susceptibility to infection. 
     Products containing  Lactobacillus  are available on the market. However, they are sold in the form of oral tablets which are meant to travel the gut before attempting to reach the vaginal target via a contaminated route. 
     SUMMARY OF THE INVENTION 
     Disclosed is a delivery device for use in colonizing the vagina with  Lactobacillus  in patients who test positive for or report symptoms of vaginitis. The device consists of an infused undergarment employing a sponge impregnated with  Lactobacillus crispatus  Freeze Dried Powder. The sponge, having channels to direct the powder, is held in place by a mesh fabric sewn into the groin portion of the garment, which allows the one way delivery of the powder. The infused undergarment may also be used to help maintain normal flora of the vagina in the absence of symptoms in a prophylactic manner to prevent future infection. The infused undergarment is sealed in an opaque aluminum foil package to prevent light and environment air from degrading the effectiveness of the infused undergarment. 
     An objective of the invention is to colonize the vagina with  Lactobacillus crispatus  bacterium using a wearable garment impregnated with  Lactobacillus  powder. 
     Another objective of the invention is to provide a probiotic undergarment to provide women with symptomatic relief of symptoms such as itching, burning, discharge, and odor. 
     Still another objective of the invention is to provide a probiotic undergarment that can result in resolution of bacterial and yeast infection without use of supplemental antibiotics or antifungals. 
     Another objective of the invention is to use the  Lactobacillus  garment for colonizing the vagina, alleviating symptoms of vaginitis, and treating vaginitis with and without traditional antibiotics/antifungal drugs. 
     An advantage of an infused undergarment of the invention is that the product provides a noninvasive treatment that administers the probiotic directly to the vulva and vagina. The infused undergarment does not require any insertion of tablets or gels. As the product is not inserted into the body, the patient will not need to have a prescription for the treatment. The active component is composed solely of  Lactobacillus,  making allergic reaction less likely. 
     Another advantage of the infused undergarment of the invention is that there is no latex in the device, avoiding the risk of latex allergy. 
     Yet still another advantage of an infused undergarment of the invention is that it allows direct contact with an affected area, which is more effective than taking an oral supplement that has to pass through the digestive system. 
     Other objectives and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification, include exemplary embodiments of the present invention, and illustrate various objects and features thereof. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG.  1 A  is a front plane view of the infused undergarment of the instant invention; 
         FIG.  1 B  is a top view thereof; 
         FIG.  2 A  is a top view of the receptacle; 
         FIG.  2 B  is a side view thereof; 
         FIG.  3 A  is a top perspective view of the polyurethane foam member having a diamond shaped upper surface for powder distribution; 
         FIG.  3 B  is a cross sectional side view thereof; and 
         FIG.  4    is a top view of the foam member having a honeycomb shaped upper surface for powder distribution. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     While the present invention is susceptible of embodiments in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment with the understanding that the present disclosure is to be considered an exec exemplification of the invention and is not intended to limit the invention to the specific embodiments illustrated. 
     It is widely known that the presence of  Lactobacillus  in the vagina plays a key role in maintaining pH levels, and serves an active role in protecting against infection.  Lactobacillus  species have been shown to inhibit growth of  Candida  and bacteria known to cause bacterial vaginosis. In addition, vaginosis has been associated with decreased colony counts of  Lactobacillus,  suggesting that lack of colonization may lead to increased susceptibility to infection. 
     Referring to  FIGS.  1 A and  1 B , illustrated is an infused undergarment  10  having a preferred use to increase colonization of  Lactobacillus  in women with vaginal infections. The undergarment  10  is formed with a waist opening  12  at the top  14  of the undergarment  10 . A left leg opening  16  is formed at the bottom left  18  of the undergarment  10 , and a right leg opening  20  is formed at the bottom right  22  of the undergarment  10 . A crotch portion  25  is positioned between the left leg opening  18  and the right leg opening  20 . The infused undergarment  10  is preferably in the shape of a panty, wherein a receptacle  26  is placed in the crotch portion  25  along the inner surface  28  of the panty. While a panty is depicted, the receptacle can be constructed and adopted to work in an undergarment as small as a thong. The undergarment  10  is constructed of a microfiber material having quick drying and moisture wicking properties. In one embodiment, the undergarment is constructed of a microfiber material having a 50% Polyester and 50% Elasterell blended fabric. In another embodiment, the undergarment is constructed of a microfiber material comprising 25% to 50% Elastane. In one embodiment, the receptacle  26  is formed integral with the undergarment  10 . In another embodiment, the receptacle  26  is attached to the inner surface  28  of the crotch area. 
     Referring to  FIGS.  2 A and  2 B , depicted is the receptacle  26  having a substantially rectangular shape with an upper wall  30  and a lower wall  32  to create a cavity therebetween  34 ; the upper wall  30  including an elongated opening extending a length between the left and right leg openings  16 ,  20 . Should the receptacle  26  not be formed integral to the undergarment  10 , the preferred material remains the same as the undergarment, wherein the receptacle  26  is attached by thread. 
     Referring to  FIGS.  3 A and  3 B , depicted is a polyurethane foam member  40  to be placed within the receptacle  26 . The foam member  40  is an open cell powder-absorbent pad, preferably polyurethane flexible foam made of isocyanates and polyether or polyester polyols. The foam member  40  has an upper surface  42  and a lower surface  44 ; the upper surface  42  having grooves  46  arranged in a diamond pattern with a depth between 1 mm and 3 mm. One skilled in the art will recognize that the pattern need not be limited to a diamond shape, rather a pattern that has grooves forming a depth is used to hold the powder wherein leg movement operates to help move the powder. For instance in another embodiment a foam member  50  may have an upper surface  52  having grooves  54  with a depth between 1 mm and 3 mm forming a hexagonal or honeycomb pattern  56  as depicted in  FIG.  4   . 
     A predetermined amount of  Lactobacillus crispatus  freeze dried powder is infused in the foam member  40 . The  Lactobacillus crispatus  freeze dried powder is transferred through the groove  46  for dispersion through an elongated opening  35 . The foam member  40  and receptacle  26  cause movement of the powder to be distributed along the grooves  46  and pass through the elongated opening  35  as a result of leg movement by the individual wearing the undergarment  10 . The process allows woman to increase the colonization of  Lactobacillus  in addressing vaginal infections comprising the steps of: 
     Step 1: providing an undergarment  10  defined by a waist opening  12  at the top  14  of the undergarment, a left leg opening  16  at the bottom left  18  of the undergarment, a right leg opening  20  at the bottom right  22  of the undergarment, and a crotch portion  25  in between the left leg opening  16  and the right leg opening  20 , and having a receptacle  26  formed integral or attached to said crotch section  25 . The receptacle  26  having an elongated opening  35  extending a length between said left leg opening  16  and right leg opening  20 . 
     Step 2: inserting a polyurethane foam member  40  having a predetermined amount of  Lactobacillus crispatus  Freeze Dried Powder infused in the foam member  40  into said receptacle  26 . 
     Step 3: positioning said undergarment  10  on a woman&#39;s torso, wherein the individual wearing said undergarment  10  is treated with a release of said  Lactobacillus crispatus  freeze dried powder through said elongated opening  35  during leg movement for treatment of vaginal infections. 
     Step 4: repeating Steps 1-3 for ten consecutive days. 
     The foam member  40  with the  Lactobacillus crispatus  freeze dried powder operates in combination with grooves to expel the powder from the receptacle  26  through the opening  35 . The leg movement of the individual allows movement of powder within the receptacle  26  and what could be described as a pump. The  Lactobacillus crispatus  freeze dried powder is flowable with good handling and packaging characteristics and formulate to retain functional attributes of the native biomolecule. In the preferred process stated above, the treatment is sold as a kit with ten individual packages of undergarments, The infused undergarment is stored in a sealed aluminum foil package. Sealing of the undergarment allows ease of use by simply opening of the package. The undergarments can be cleaned and reuse wherein the infused foam replacement member would be provided in sealed aluminum packages and inserted into a receptacle of undergarment. 
     The use of the word “a” or “an” when used conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more” or “at least one.” The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternative are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.” 
     The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a device that “comprises,” “has,” “includes” or “contains” one or more steps or elements, possesses those one or more steps or elements, but is not limited possessing only those one more elements. 
     Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes” or “contains” one or more features, possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed. 
     It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein. 
     One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures, and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary, and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.