Device with sponge for applying a solution in a body orifice

Abstract

A device or system may include an applicator sheath configured to be placed into an orifice, a treatment sponge that is configured to be wetted with a solution. The device or system may include a wand configured to provide the solution to the treatment sponge and may further include a solution container containing the solution, wherein the solution container is configured to be in fluid communication with the wand and the treatment sponge is configured to be advanced through an opening in the applicator via the wand or solution container.

Description

031528.01707 P-30148 & P-30149 PREPARATION DEVICE, TREATMENT SPONGE AND METHODS OF USE CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of US Provisional Application No. 63 / 672164, titled “PREPARATION DEVICE AND METHOD OF USE” filed on July 16, 2024, and US Provisional Application No.63 / 672176 titled “CERVICAL TREATMENT SPONGE AND METHODS OF USE” filed on July 16, 2024. Both of the aforementioned applications are incorporated by reference herein. TECHNICAL FIELD

[0002] This disclosure is related to device, system, and method for preparation of a human or animal orifice; particularly for preparation of the vagina. BACKGROUND

[0003] Vaginal preparation is performed before vaginal procedures such as hysterectomy, dilation and curettage (D&C) suctions, c-sections, papanicolaou smear (PAP smear) tests, and / or preventative obstetrics gynecology (OB / GYN) appointments to name a few examples. The preparation usually involves internal vaginal preparation using a foam applicator on the end of a stick or elongated shaft. The foam applicator is saturated with an antiseptic and / or antibacterial solution and the internal and / or external surfaces of the vagina are swabbed to stop or slow the growth of microorganisms. This preparation is an important preparation step for a surgical procedure to reducing the bacterial load within the vagina and thereby reducing the risk for infection. Despite the criticality associated with vaginal preparation in improving patient outcomes, there are significant challenges and obstacles with the current practice and thus there is an unmet need for improved vaginal preparation. In addition to the preparation of the vagina itself, the cleaning of the cervix is important to ensure more thorough reduction in the level of microorganisms. The cervix functions as a barrier between the vagina and the uterus and ascension of microorganisms past the cervix has been linked to procedural infections. The function of the cervix and linkage to clinical outcomes drives the criticality that the vaginal side of the cervix (i.e., ectocervix) should be treated to minimize the number of microorganisms. 1 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149

[0004] As noted above, during preparation for a medical procedure, it may be desirable to provide an antimicrobial or disinfectant solution to the outer and / or inner surfaces of the vagina. Currently, there are significant challenges and obstacles with the current practice of providing solution, especially when attempting to apply solution to the inner surfaces of the vagina and / or the ectocervix and surrounding areas, for example. Conventionally, internal vaginal preparation is conducted using a device containing foam that has been wetted with an antiseptic solution. The device may include a rectangular piece of foam attached to a polymeric stick. Upon the attempting insert of the foam into the vagina to support the preparation, the foam pad will compress and some of the solution will subsequently be forced out of the foam pad. This results in a reduced total amount of solution that is actually inserted into the vagina and thereby having a decreased amount of antiseptic than initially within the foam. The effectiveness for the overall preparation can also be impacted by the aforementioned decrease of total amount of solution used caused by the insertion step. The internal preparation can also be performed by the healthcare practitioner soaking a standard gauze pad, then using forceps to grip the gauze pad and conduct the internal vaginal preparation. For both of the aforementioned application approaches, the actual application device causes the unique challenges described herein related to the antiseptic preparation of the cervix. Thus, there are currently significant challenges and obstacles with the current practice of providing solution, especially when attempting to apply solution to the inner surfaces of the vagina and / or the cervix / ectocervix and surrounding areas.

[0005] In addition to the challenges noted above, insertion of the foam pad into the vagina can result in some of the antiseptic solution being forced out of the foam pad and / or gauze. The solution that is expelled from the foam pad may cause a mess on and / or around the patient and / or may increase the workflow burden on the healthcare practitioner to address this expelled solution. Further, in order to address the expelled solution, a healthcare practitioner may use some type of wipe, pad, or towels in order to adsorb the excessive solution. The required use of these materials may add unnecessary additional waste and / or cost to the procedure. Thus, the current state of the art and the process described above is significantly limited in that the design of the devices could result in inadequate or less than optimal preparation of the internal surfaces of the vagina and especially of the cervix and ectocervix. 2 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149

[0006] Conventional devices also may require excessive force during the preparation procedure in order to insert the device into the vagina. In some cases, a patient’s anatomical characteristics can affect the amount of force required from the healthcare practitioner for insertion of the device. For example, patients with lower vagina tissue flexibility may require greater force and may further increase the risk of discomfort and / or injury. The aforementioned challenges may be particularly relevant to younger and more elderly patients in which the insertion of any device for the intravaginal preparation is more challenging based on the reduced flexibility of their vaginal anatomy. The force required from the healthcare practitioner for the insertion of the device can also result in the contamination of the solution application device. Since in some cases, the insertion of the device can require significant force, the healthcare practitioner is frequently required to brace the device or gain additional leverage to allow for the insertion. This can result in the healthcare practitioner touching a portion of the device that will be inserted, thereby potentially contaminating the device that is intended for the intravaginal preparation. This contamination can potentially introduce extrinsic material or microorganisms into the vagina, thereby adversely impacting the patient outcome.

[0007] An example source of contamination may be the foam on the end of a polymeric stick described above. The healthcare practitioner may initially only hold the polymeric stick (distal end of the foam). However, the healthcare practitioner may feel they cannot generate the required force for the insertion while only having one hand on the distal end. In order to gain more leverage, the healthcare practitioner may touch the middle of the polymeric stick with their other hand. After the insertion of the device has been completed, the middle of the polymeric stick ends up within the vagina. Therefore, the area of the polymeric stick that was contacted and potentially contaminated by the healthcare practitioner will be within the vagina potentially increasing a risk of infection.

[0008] Additional potential contamination may occur during the initial product set-up by the healthcare practitioners. When a practitioner adds antiseptic solution to the foam, the practitioner may inadvertently touch or contaminate the foam. The healthcare practitioner may also remove excess solution on the foam by squeezing by hand, prior to insertion into the vagina, there by contaminating the foam prior to insertion.

[0009] In addition to the disadvantages above conventional preparation devices may increase incidents of external contamination or microorganisms being transferred from 3 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 outside the vagina to inside the vagina during the compression of the sponge to insert the sponge. Upon insertion of the foam into the vagina, the foam will be compressed to a smaller size during the passage into the vaginal canal. Therefore, the rectangular foam will initially contact a larger area of the vagina (including some exterior surfaces) and then be compressed during the insertion step. As the foam contacts the exterior areas of the vagina that are not required for the insertion of the device, the foam pad may be exposed to external contamination or microorganisms that might be present extravaginally. This can result in contamination by microorganisms being subsequently pulled into the vagina during the insertion step.

[0010] Thus, the current state of the art and the process described above can introduce significant of contamination that is supported by literature and reports that have identified that microorganisms found within the vagina after a procedure can correspond to organisms that are commonly found extravaginally. These reports provide further confirmation that the current state of the art is significantly limited and that there is a need for improved treatment devices, systems, and methods for preparing the vagina and other body orifices or surgical orifices. SUMMARY

[0011] The following presents a simplified summary of one or more aspects of the technology disclosed herein in order to provide a basic understanding of such aspects. This summary is not an extensive overview of all contemplated aspects and is intended to neither identify key or critical elements of all aspects nor delineate the scope of any or all aspects. Its sole purpose is to present some concepts of one or more aspects in a simplified form as a prelude to the more detailed description that is presented later.

[0012] Aspects of the technology described herein relates to a system for applying a solution to internal surfaces of a orifice, the system including: an applicator with an applicator sheath configured to be placed into a patient orifice and a treatment sponge that is configured to be wetted with the solution; a wand configured to provide solution to the treatment sponge; a solution container containing the solution, wherein the solution container is configured to be in fluid communication with the wand and the treatment sponge; and wherein the applicator is slideably disposed on the wand and the treatment 4 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 sponge and the treatment sponge is configured to be advanced through an opening in the applicator via the wand.

[0013] In some aspects, the technology described herein relates to the system described above, wherein the treatment sponge is contained within the applicator in a compacted state and is configured to expand to an expanded state when advanced through the opening in the applicator.

[0014] In some aspects, the technology described herein relates to the system described above, wherein the applicator includes a flange with a diameter that is greater than the diameter of the applicator sheath, wherein the flange is configured to indicate that the applicator is currently positioned at a predetermined depth within the patient orifice.

[0015] In some aspects, the technology described herein relates to the system described above, wherein the applicator includes a gripping portion connected to the flange.

[0016] In some aspects, the technology described herein relates to the system described above, wherein the gripping portion includes a plurality of tactile features.

[0017] In some aspects, the technology described herein relates to the system described above, wherein the gripping portion has a diameter that is less than the diameter of the flange.

[0018] In some aspects, the technology described herein relates to the system described above, wherein the solution container contains an antiseptic solution.

[0019] In some aspects, the technology described herein relates to the system described above, wherein the antiseptic solution is a povidone iodine solution.

[0020] In some aspects, the technology described herein relates to the system described above, wherein the wand has an engaging portion, such as a cap with or without a spike, connected thereto that is configured to engage with the solution container, wherein the solution container includes a seal to seal the solution therein, wherein engaging the engaging portion with the solution container punctures the seal and provides fluid communication of the solution container with the wand and the treatment sponge.

[0021] In some aspects, the technology described herein relates to the system described above, wherein the treatment sponge is contained within the applicator in a compacted state and is configured to expand to an expanded state when advanced through the opening 5 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 in the applicator, and wherein the wand passes through the opening when the sponge is advanced and in the expanded state.

[0022] In some aspects, the technology described herein relates to the system described above, wherein the solution container is flexible or semi-flexible and providing pressure to the solution container causes wetting of the treatment sponge.

[0023] In some aspects, the technology described herein relates to the system described above, wherein the applicator sheath has a rounded tip.

[0024] The technology described herein further relates to method for treating a patient orifice via a treatment device that include any one or combination of the features described above, the method including: opening a fluid path between the solution container and the treatment sponge, via the wand, to wet the sponge with the solution; inserting the applicator sheath of the applicator into the patient orifice, via a grip portion, until a flange of the applicator contacts an area surrounding an opening of the orifice; advancing the treatment sponge through an opening of the applicator and treating the patient orifice with the solution via the treatment sponge.

[0025] In some aspects, the technology described herein relates to the methods described above, further including applying a sanitary solution to external surfaces that may contact the application device in association with treatment of the patient orifice.

[0026] In some aspects, the technology described herein relates to the methods described above, further including applying pressure to the solution container to cause the treatment sponge to be wetted with the solution from the solution container.

[0027] In some aspects, the technology described herein relates to the methods described above, further including removing the applicator portion and the treatment sponge from the patient orifice.

[0028] In some aspects, the technology described herein relates to the methods described above, further including retracting the treatment sponge into the opening of the applicator before removing the applicator from the patient orifice.

[0029] The technology described herein further relates to an orifice preparation device for applying a solution to internal surfaces of the orifice, the device including: an applicator comprising an applicator sheath and a flange adjacent to the applicator sheath, the 6 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 applicator configured to be placed into the orifice, wherein the applicator contains a treatment sponge that is configured to be wetted with the solution; a wand configured to advance the solution sponge and to provide the solution to the treatment sponge; a solution container containing the solution, wherein the solution container is configured to be in fluid communication with the wand and the wand is configured to provide the solution to the treatment sponge; and wherein the applicator is configured to slide toward a proximal end of the wand and the treatment sponge is configured to be advanced through an opening at a tip of the applicator, preferably a rounded tip, when advancing the wand.

[0030] In some aspects, the technology described herein relates to the device described above, wherein the solution container contains an antiseptic solution.

[0031] In some aspects, the technology described herein relates to the device described above, wherein the treatment sponge is contained within the applicator in a compacted state and is configured to expand to an expanded state when advanced through the opening in the applicator.

[0032] Aspects of the technology described herein that may be useable with any one or combination of the features described above relate to an applicator device for applying a solution to internal surfaces of an orifice, the device including: a main body configured to be placed into a patient's vagina, the main body having a proximal end, a distal end, and an outer surface; a concave portion at the distal end of the main body, wherein the concave portion is configured for application of solution to the patient's cervix; and optionally a wand connected to the main body.

[0033] Some aspects of the technology described herein further relates to the above- mentioned device, wherein the concave portion joins a top surface at the distal end of the main body.

[0034] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein the outer surface is a rounded surface.

[0035] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein the rounded outer surface joins the top surface at the distal end of the main body. 7 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149

[0036] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein the top surface is substantially ring- shaped.

[0037] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein the main body further includes a plurality of interruptions that extend from a portion of the concave portion to a portion of the outer surface.

[0038] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein the interruptions are any one or combination of slits, through holes, rectangular cut outs, oval cut outs, curved cut outs, or wedge-shaped cut outs.

[0039] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein at least the concave portion of the main body includes an absorbent material configured to absorb a solution.

[0040] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein the wand is formed of a rigid or semi-rigid material and extends from the proximal end of the main body.

[0041] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein the wand is embedded into a channel of the main body.

[0042] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein the wand is configured to provide a fluid pathway for a solution to wet the main body.

[0043] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein the wand is in fluid communication with a fluid container for containing the solution.

[0044] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein the fluid container contains a solution of one or combination of povidone iodine, chlorhexidine salts, octenidine salts, 8 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 hypochlorite solutions, hypochlorous acid, sodium lauryl sulfate, citric acid (aqueous), sodium citrate (aqueous), benzalkonium chloride, ethanol, or isopropanol.

[0045] Some aspects of the technology described herein further relate to any one or combination of the above-mentioned devices, wherein at least the concave portion of the main body includes one or a combination of a rayon, polyester, cotton, polyurethane, polyethylene, polypropylene, polystyrene, or ethylene-vinyl acetate.

[0046] Aspects described herein further relate to a method or applying a solution to the internal surfaces of a patient orifice, the method including: providing an applicator device, the device including: a main body configured to be placed into a patient orifice, the main body having a proximal end, a distal end, and an outer surface; a concave portion at the distal end of the main body, wherein the concave portion is configured for application of solution to the patient's cervix; and optionally a wand connected to the main body, the method further including: inserting the main body of the applicator device into the patient orifice and applying the solution to the patient's cervix by contacting the concave portion of the main body to the patient's cervix.

[0047] Some aspects of the method described herein further relate to the above-described method further including at least one of wetting the main body of the applicator device with the solution prior to inserting the main body into the patient orifice or providing the solution to the main body after inserting the main body of the applicator device into the patient orifice.

[0048] Some aspects of the method described herein further relate to any one or combination of the above-described methods, wherein the device further includes a container of the solution in fluid communication with the wand, wherein the method further includes applying pressure to the container of the solution to wet the main body of the application device with the solution.

[0049] Some aspects of the method described herein further relate to any one or combination of the above-described methods, wherein wetting the main body of the applicator includes applying the solution to the concave portion of the main body.

[0050] Some aspects of the method described herein further relate to any one or combination of the above-described methods, wherein the applicator device further includes one or more interruptions extending from the concave portion to the outer surface, and wherein 9 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 the method further includes rotating or applying pressure to the wand once the main body is inserted into the patient orifice so that at least a portion of the distal end of the main body separates at the one or more interruptions.

[0051] Some aspects of the method described herein further relate to any one or combination of the above-described methods, wherein the outer surface of the main body is a rounded outer surface, and the interruptions are any one or combination of slits, through holes, rectangular cut outs, oval cut outs, curved cut outs, or wedge-shaped cut outs.

[0052] To the accomplishment of the foregoing and related ends, the one or more aspects of the disclosure comprise the features hereinafter fully described and particularly pointed out in the claims. The following description and the annexed drawings set forth in detail include certain illustrative features of the one or more aspects. These features are indicative, however, of but a few of the various ways in which the principles of various aspects can be employed, and this description is intended to include all such aspects and their equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Features characteristic of aspects if the technology described herein are set forth as follows, in the appended claims, and in the drawings. In the descriptions that follow, like parts are marked throughout the specification and drawings with the same numerals, respectively. The drawing figures are not necessarily drawn to scale and certain figures can be shown in exaggerated or generalized form in the interest of clarity and conciseness. The disclosure itself, however, as well as a preferred mode of use, further objects and advances thereof, will be best understood by reference to the following detailed description of illustrative aspects when read in conjunction with the accompanying drawings.

[0054] Figures 1A and 1B show examples of a human genitourinary (GU) system.

[0055] Figure 2A shows one example of an apparatus and system according to aspects of the disclosure in a first configuration.

[0056] Figure 2B shows an example of the apparatus of Figure 2A in a second configuration.

[0057] Figure 2C shows an example of the apparatus of Figures 2A-2B in a third configuration. 10 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149

[0058] Figure 2D shows a cross-section view of the apparatus of Figures 2A-2C.

[0059] Figure 2E shows an enlarged partial view of the apparatus of Figures 2A-2D.

[0060] Figure 3A shows a partial view of the Apparatus of Figures 2A-2D.

[0061] Figure 2B shows an enlarged partial view of the apparatus of Figures 2A-3A in the third configuration.

[0062] Figure 3C is an enlarged cross section view of the apparatus of Figures 2A-3B.

[0063] Figures 3A and 3B show examples of an applicator device according to aspects of the disclosure.

[0064] Figure 13 is a flowchart of one example method of using a system or apparatus described herein.

[0065] Figure 14A shows one example of a cervical treatment apparatus according to aspects of the disclosure.

[0066] Figure 14B shows an isometric view one example of a cervical treatment apparatus according to aspects of the disclosure.

[0067] Figure 15A shows one example of an alternative configuration of the cervical treatment apparatus of Figures 14A-14B.

[0068] Figure 15B shows one example of an alternative configuration of the cervical treatment apparatus of Figures 14A-15A.

[0069] Figure 16 shows one example of an alternative configuration of the cervical treatment apparatus described herein.

[0070] Figure 17 is a side view with hidden-lines showing contours of the cervical treatment apparatus of Figures 14A-15A.

[0071] Figure 18 is a top view of the cervical treatment apparatus of Figures 14A-17.

[0072] Figure 19A is an isometric view of a cervical treatment apparatus

[0073] Figure 19B is a side view with hidden lines showing contours of the cervical treatment apparatus of Figure 19A. 11 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 DETAILED DESCRIPTION

[0074] The detailed description set forth below in connection with the appended drawings is intended as a description of various configurations and is not intended to represent the only configurations in which the concepts described herein can be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of various concepts. However, it will be apparent to those skilled in the art that these concepts can be practiced without these specific details. In some instances, well known structures and components are shown in block diagram form in order to avoid obscuring such concepts. I. Terminology

[0075] Reference throughout this specification to one aspect, an aspect, one example or an example means that a particular feature, structure or characteristic described in connection with the embodiment or example may be a feature included in at least example of the present disclosure. Thus, appearances of the phrases in one aspect, in an aspect, one example or an example in various places throughout this specification are not necessarily all referring to the same example. Furthermore, the particular features, structures or characteristics may be combined in any suitable combinations and / or subcombinations in one or more embodiments or examples.

[0076] In the above disclosure, the term “substantially” or “approximately” may be used as a modifier for a geometric relationship between elements or for the shape of an element or component. While the terms substantially or approximately are not limited to a specific metric and may cover any metric that is understood by one of ordinary skill in the art to be an acceptable variation, some examples are provided as follows. In some examples, the terms substantially or approximately may include a variation of less than 10% of the dimension of the object or component, or a variation of less than 5% of the object or component. These examples are not intended to be limiting and may be increased or decreased based on the understanding of acceptable limits to one of ordinary skill in the art. In this disclosure, terms such as “a,” “an,” and “the” are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration. The terms “a,” “an,” and “the” are used interchangeably with the term at least one. The phrases “at least one of” and “comprises at least one of” followed by a list 12 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 refers to any one of the items in the list and any combination of two or more items in the list. All numerical ranges are inclusive of their endpoints and non-integral values between the endpoints unless otherwise stated.

[0077] The terms “first,” “second,” “third,” and “fourth” are used in their relative sense only. In particular, in some aspects certain components may be present in interchangeable and / or identical multiples (e.g., pairs). For these components, the designation of first, second, third, and / or fourth may be applied to the components merely as a matter of convenience in the description of one or more of the aspects of the disclosure.

[0078] The terms “disposed on,” “disposed along,” “disposed with,” or “disposed toward” and variations thereof may define one element can be integral with another element, or that one element can be a separate structure bonded to or placed with or placed near another element.

[0079] The term “at,” for example when referring to something being located at a specific location, is intended to include any one or more of: proximate, on, near, adjacent to, or within the specific location.

[0080] The term "distal end" refers to a portion of a device that is situated farthest from the user or operator during normal operation. In the context of a device intended for insertion into a body, the distal end is the part that is inserted first. This distal end is typically designed to interact with the target area or tissue within the body.

[0081] The term "proximal end" refers to the portion of the medical device that is closest to the user or operator during normal operation. In the context of a device intended for insertion into a body, the proximal end may remain outside the body and may be accessible to the user.

[0082] Additionally, references to “one aspect” or “an aspect” of the present disclosure are not intended to be interpreted as excluding the existence of additional features or components, either described in this application or that would have been understood by one of ordinary skill in the art after reading this disclosure, that also incorporate the recited features.

[0083] For purposes of the disclosure, directional terms are expressed generally with relation to a standard frame of reference when the aspects or articles described herein are 13 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 in an in-use orientation. In some examples, the directional terms are expressed generally with relation to a left-hand coordinate system. II. Overview

[0084] Described in detail below are examples of a device, system and method used to facilitate and ensure cleanliness and / or sterility of a device that will be insertion into the vaginal anatomy, body orifice, or surgical site or orifice, and to overcome one or more of the shortcomings described above. One disclosed device and system includes a foam or other absorbent material (the terms foam or absorbent material may be used interchangeably throughout this disclosure) contained within a cylindrical or annular shield or as an applicator to facilitate ease of insertion of the foam into the body orifice. Once the applicator is inserted into the body orifice, the foam is deployed from an opening at an end of the applicator by retracting the shield and / or advancing the foam out of the opening at the end of the applicator thereby exposing the foam and any solution contained therein to the inner surfaces of the orifice allowing for the preparation of internal surfaces of the vagina or other orifice. The device my further include a wand with a fluid path therein that extends from and is in fluid communication with a container. The distal end of the wand may connect to and may be in fluid communication with an inside portion of the foam allowing for saturation of the foam or other absorbent material before it is deployed and / or after it is deployed.

[0085] In another aspect of the disclosure described in detail below, a uniquely shaped and / or contoured absorbent applicator and / or device, system, and method is disclosed that overcomes disadvantages of currently systems for preparation or treatment of a patient’s GU system. A device according to aspects of the disclosure allows for improved efficiency of treatment, preparation, and / or post treatment of a patients GU system and especially of the cervix and areas surrounding the cervix. In one example, the uniquely shaped and / or contoured absorbed applicator may be analogous with the foam described in the above overview. III. Detailed Examples

[0086] Figures 1A and 1B show examples of a human genitourinary (GU) system 100 for reference in this disclosure. A GU system typically includes an external portion, i.e., vulva 109, a vaginal opening 108, and a vagina 106. A cervix 104 is at the distal end of the 14 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 vagina and the ectocervix 130 includes an opening that is a passage to the cervix 104 and uterus 110. As shown in Figures 1A and 1B, the ectocervix 130 is the vaginal internal facing side of the cervix that generally has a convex, semi-spherical, or bulged shape and extends into the vagina 106. Frequently, there is an annular or semi-annular concave portion or crease (e.g., as indicated by references 131a and 131b) where the ectocervix 130 connects with the walls of the vagina 106.

[0087] The unique shape of the ectocervix 130 and crease(s) and / or concave portion 131a and / or 131b can cause challenges when preparing the vagina by conventional methods, especially the area surrounding the ectocervix 130.

[0088] It is noted that while examples described below are provided in the context of treatment of the vagina, the devices and methods described herein are applicable to the treatment of any body cavity and may be used before, during, and / or after a surgical procedure. For example, the aspects described herein are applicable to treatment or preparation of the rectum or anus or any body cavity. Further, the apparatus and methods described herein are further applicable to treatment of the urethra either in preparation for, during insertion and / or post treatment of a foley catheter to name another non-limiting example. Further, aspects of the disclosure are applicable to treatment of body and / or surgical cavities of humans and / or any animal. Some additional examples of applicable treatments and / or procedures for use of the apparatus, system, and methods described herein include but are not limited to: vaginal procedures such as hysterectomy, dilation and curettage (D&C) suctions, c-sections, papanicolaou smear (PAP smear) tests, preventative obstetrics gynecology (OB / GYN) appointments, endometrial biopsies, intrauterine device (IUD) insertion and / or removal, implantable contraceptive insertion and removal, cervical biopsies, cryotherapy treatments, colposcopy treatments, loop electrosurgical excision procedure (LEEP), myomectomy, pelvic organ prolapse treatments, hysteroscopy (operative and diagnostic), salpingo-oophorectomy, vaginal birth, and / or surgeries requiring vaginal access, to name a few examples.

[0089] Figures 2A-2D show examples of a system and apparatus according to aspects of the disclosure. The preparation system or device 200 may include an applicator 210 (hereinafter interchangeably referred to as an applicator), an elongated shaft or wand 232 and / or a solution container 220. The wand 232 may have a distal end 232a and a proximal end 232b. Further, the device 200 may include a sponge 230 (hereinafter interchangeably 15 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 referred to as a treatment sponge and / or an absorbent member) at or near a distal end 232a of the wand 232. The solution container 220 may be in fluid communication with the wand 232, and the wand 232 may have an inner passage 235 (Figures 2D and 2E), to channel solution from the solution container 220 to the treatment sponge 230 (as indicated by the arrows 233a-233c (Figures 2B-2E) .

[0090] Referring to Figures 2A-2E, the distal end of the wand 232a may for example have one or more fluid passageways 234 (e.g., a series of openings as described in further detail below with respect to Figures 3A-6E) to allow solution to impregnate or infuse the sponge 230 either due to the force of gravity (i.e., if the solution container 220 is held at a position higher than the sponge 230) and / or due to pressure being applied by a user by squeezing (e.g., applying a squeezing force as indicated by arrows SS in Figure 2D) or otherwise applying pressure to the container 220 containing a solution therein. In an alternative example, the wand 232 and / or the solution container 220 may be separate components from the applicator 210 and / or the sponge 230. In another alternative example, the wand 232 and the solution container 220 may be a single, integral (i.e., not separate) components.

[0091] In one alternative example, the wand 232 may be inserted into the sponge 230 to provide solution contained in the solution container 220 to the sponge 230 and / or to advance the sponge 230 through an opening 214 of the applicator 210, preferably after the applicator 210 is placed in a patient’s vagina or body orifice or surgical orifice.

[0092] The sponge 230 may be disposed on the end of the wand 232 over one or more fluid passages disposed toward the distal end 232a of the wand 232. The sponge 230 may for example be formed of any one or combination of rayon, polyester, cotton, polyurethane, polyurethane / polyester blends, polystyrene, polyethylene. In one example implementation, the sponge 230 may for example be formed of a hydrophilic material. One example of a hydrophilic material is a hydrophilic polyester that is configured to wipe fluid dry from a surface while maintaining water holding capacity and instantaneous wet- out. In some examples, the sponge 230 may further be formulated with antimicrobial properties to eliminate odors. Some non-limiting examples A, B and / or C of hydrophilic materials that may be used to form the sponge 230 and their properties are provided in the table that follows: 16 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 Density Permeability Tensile Tear Elongation IFD Wet-out Volume lbs / ft3 ft3 / min / ft2 psi lb / in % 25% psi 65%psi seconds swell % A1.9 85 32 4.0 420 0.58 - <103B 3.8 85 25 2.9325 0.65 - <103C 2.2 - 27 4.0 410 0.55 - <5 -

[0093] Further, the sponge 230 may be light in color or may be translucent to allow a user to easily visualize if the sponge 230 has been saturated by the solution contained within the solution container 220.

[0094] As shown in the examples illustrated in Figures 2B, 2C, 3B, and 3C, the sponge 230 may for example by cylindrically shaped and may have one or more dimensions that are larger than the outer dimensions of the applicator 210 when in an expanded / natural state. In one example implementation, the sponge 230 may be analogous with or may share features with the sponge / applicator described below with respect to Figures 14A-19B. Further, it is noted that the sponge 230 may be any practical shape and may have cross- sections shaped as a rectangle, square, triangle, star-like shapes, oval, trapezoidal, octagonal, hexagonal, and / or any geometric or organic shape(s) without departing from the scope of this disclosure.

[0095] Figures 2A-2C show three stages of operation of the device 200. As noted above, the device 200 may include the aforementioned applicator 210. The applicator 210 may include a hollow applicator sheath 212 and / or a hollow grip portion or exterior portion 216. The applicator sheath 212 may have an outer dimension (e.g., radius or diameter) that is one or more orders of magnitude smaller than a dimension of the sponge 230. Thus, as best shown in Figures 2D and 2E, the sponge 230 may be compressed within the hollow portion of the applicator sheath 212 and / or the grip portion or exterior portion 216. The grip portion or exterior portion 216 may have a grip portion or exterior portion 216 and a flange 218. The grip portion or exterior portion 216, flange 218 and / or the applicator sheath 212 may be formed as one unitary structure.

[0096] The applicator sheath 212 may further include an opening 214 configured to have the sponge 230 passed therethrough to advance the sponge 230 into a body cavity. The opening 214 may for example be at a curved or rounded end 215 of the applicator 210. 17 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 The curved or rounded end 215 may further facilitate ease of insertion of applicator into a body cavity or orifice. As shown in Figures 2A-2C, the applicator 210 may also be configured to be slideably constrained on the wand 232 allowing the solution container 220 and / or wand 232 to be advanced in direction AA with respect to the applicator 210 to push the sponge 230 through the opening 214 (e.g., as shown in Figure 2B) until the sponge 230 is fully pushed through the opening 214 and naturally expands to a natural state (e.g., as shown in Figure 2C). Thus, when in use during preparation of the vagina, the aforementioned features of the device 200 allows for the sponge 230 to expand after the applicator sheath 212 of the applicator 210 has been placed into cavity or orifice opening (e.g., vaginal opening 108 in Figure 1A) preventing the aforementioned challenges and disadvantages associated with current methods and apparatuses for preparing the vagina or other body orifice.

[0097] Figure 3A shows one example of a wand 232 and wand tip 242 that may be pressed into and / or bonded to the sponge 230. The wand tip 242 may for example have one or more contact area features 243 for increasing the surface contact area with an inner opening of the sponge 230. In one example, the contact area features may for example be annular protrusions that are configured to prevent separation of sponge 230 from the wand 232. The sponge 230 may for example be press fit and / or adhered or bonded to the wand tip 242 and / or the wand 232. Some examples of methods of connecting the sponge 230 to the wand 232 include but are not limited to any one or combination of press-fitting, gluing or otherwise adhering, solvent welding, pinning, and / or friction or heat welding. It is noted that while the contact area features 243 are shown as annular protrusions, any type of surface feature(s) that increase the contact surface area and / or friction between the opening of the sponge 230 and the wand tip 242 may be implemented without departing from the scope of the disclosure. Further, in some examples, the contact area features 243 may be omitted and the 230 may be connected using any one or more known connection methods (including but not limited to the examples listed above).

[0098] In some examples, the wand tip 242 may be a separate component that is connected to the wand 232 so that a fluid path 248 within the wand tip 242 is in fluid communication with the inner passage 235 of the wand 232. In some examples, the wand tip 242 may be press fit over the wand tip 242. Some examples of methods of connecting wand tip 242 to the wand 232 include but are not limited to any one or combination of press-fitting, gluing 18 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 or otherwise adhering, solvent welding, and / or friction or heat welding or the like. In some examples, the wand tip 242 may be formed as a unitary structure with the wand 232.

[0099] The wand 232 may further have connected thereto a solution container lid 262. The solution container lid 262 may for example have a collar 264 that is configured to be connected at or near a proximal end 232b of the wand 232. The collar 264 may for example be permanently connected to the wand 232 so that a fluid communication path exists between the solution container lid 262 (and thus the solution container that is connected thereto) and the wand 232. Some examples of methods of connecting the collar 264 of the solution container lid 262 to the wand 232 include but are not limited to any one or combination of press-fitting, gluing or otherwise adhering, solvent welding, and / or friction or heat welding or the like. In some examples, the wand 232 and the solution container lid 262 may be formed as a unitary structure.

[0100] The solution container lid 262 may further include tactile or gripping features 267 to increase friction between a user’s hand and / or glove and to prevent a user’s hand from slipping when the solution container lid 262 is pressed onto or screwed onto the solution container 220. Additional examples of details of the solution container lid 262 are described in further detail below with respect to Figures 9 and 12.

[0101] The wand 232, solution container lid 262, and the wand tip 242 may be formed of any suitable rigid or semi-rigid material. In some examples, any one or combination of the wand 232, solution container lid 262, and / or the wand tip 242 may be formed of a polycarbonate or acrylonitrile butadiene styrene (ABS) plastic. Any one of combination of the wand 232, solution container lid 262, and / or the wand tip 242 may be formed of a translucent or semi-translucent material to allow a use to easily see if solution is present or flowing through the passages therein.

[0102] The assembled or unitarily constructed wand 232, solution container lid 262, and wand tip 242 may be optimized in length to suit a wide variety of anatomies. The wand 232, solution container lid 262, and wand tip 242 may have a length LLL. In some examples the length LLL may be 5-12 inches. In another example implementation, length LLL may be 7-10 inches. In another example implementation, length LLL may be approximately 9 inches. 19 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149

[0103] The sponge 230 and one or more fluid passageways 234 of the wand tip 242 may be optimized improve solution distribution in the sponge 230 when solution is supplied to the fluid path 248 via the solution container (e.g., by gravity and / or if a user squeezes the solution container). In one example, the aforementioned solution distribution may be optimized to saturate the entire sponge 230 while the sponge is compressed / contained within the applicator 210 (e.g., as shown in Figure 2D and 2E). In one example, the locations and sizes of the one or more fluid passageways 234 may optimized so that solution evenly saturates the entire sponge 230 before excess solution leaks from the sponge 230 and / or out of opening 214 of the applicator 210 when the sponge 230 is contained therein. Figures 3A-4D show examples of a first fluid passageway 234a and a second fluid passageway 234b that may ensure even saturation of the sponge 230. As shown in the example illustrations of Figures 3A-3D, the first fluid passageway 234a and second fluid passageway 234b may arranged at different locations along the central axis of the fluid path 248 and the first fluid passageway 234a may be arranged approximately 180 degrees from the second fluid passageway 234b. Further, either one of or both of the first fluid passageways 234a and / or 234b may be fan-shaped to improve the saturation distribution within the sponge 230. Figure 4D shows one example of an angle 266a of the opening. In some example implementations, angle 266a may be 45-120 degrees. In another example implementation, angle 266a may be 75-100 degrees. In yet another example, angle 266a may be approximately 90 degrees.

[0104] Figures 5A-5E illustrate an alternative wand tip 242a that may be implemented with the system and apparatus described herein. The wand tip 242a includes with first fluid passageway 234c and second fluid passageway 234d. The arrangement (i.e., along the axis of the inner passage 235 and / or around the circumference of the alternative wand tip 242a may share features with or may be similar to or identical to the configuration described above. The first fluid passageway 234c and second fluid passageway 234d may for example be fan shaped as shown in Figures 5B-5E. Figure 5D shows one example of an angle 266b of the first fluid passageway 234c and / or second fluid passageway 234d. In some example implementations, angle 266c may be 90-230 degrees. In another example implementation, angle 266c may be 130-200 degrees. In yet another example, angle 266c may be approximately 180 degrees. 20 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149

[0105] Figures 6A-6C illustrate another alternative wand tip 242b that may be implemented with the system and apparatus described herein. The want tip 242b includes a series of fluid passageways 234e located along the axis of the inner passage 235 and about a circumference of the first fluid passageway 234b. In the example illustrated in Figures 6A- 6C, five (5) rows of nine (9) passages are arranged at approximately 72 degree increments around the circumference of wand tip 242b. It is noted that while the implementation in Figures 6A-6B has forty five (45) passages, any number of passages may be implemented without departing from the scope of this disclosure. For example, each row of passages may include 2-20 passages and / or 2-10 rows of passages may be arranged around the circumference of the wand tip 242b.

[0106] The aforementioned examples of port placement and configuration may optimize the saturation of the sponge 230 so that when a user squeezes the solution container 220 until solution begins to drip from the end of the sponge 230 (e.g., out through the opening 214 of the applicator 210) the entire sponge 230 is fully saturated providing a simple and intuitive indication that the sponge 230 is fully saturated with solution before the sponge 230 is deployed though the opening 214 of the applicator 210.

[0107] Figures 7A-8A show examples of a solution containers 220 that may be connected or may be connectable to the solution container lid 262. Figure 7A shows an example of a related art solution container 120 with a solution container body portion 119. The related art solution container 120 may for example have a threaded engagement portion 123 that is configured to thread into corresponding threads of an engaging portion 222 of the solution container lid 262. The solution container 120 may contain a solution therein (examples described below) and may have a seal 172 at an opening thereof to contain or otherwise seal-off the inside of the solution container 120 until the device 200 is ready for use. The seal 172 may comprise any one or combination of a foil, polymeric film, an aluminum substrate and / or other similar sealing system.

[0108] Figure 7B illustrates another example of a solution container 220a that may be connected or may be connectable to the solution container lid 262. The solution container of Figure 7A includes a threaded engagement portion 223 that may share features with or may be analogous to the threaded engagement portion 123 described above. The main body portion 219a of the solution container may gradually taper to the opening at the end of the solution container 220a. The example solution container 220a of Figure 7B provides 21 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 an advantage over the related art solution container 120 in that the gradual taper of the neck portion 221a of solution container 220a prevents solution from pooling or otherwise getting trapped in the neck portion 221a of the solution container 220a as the solution therein is dispensed. For example, the related art solution container 120 includes a neck portion 121 with an abrupt transition between the solution container body portion 119 and the threaded engagement portion 123 at the opening, which may cause fluid 50 to pool at the neck portion 121 and prevent solution from fully draining from the solution container 120 and into the wand 232. On the other hand, the gradual taper of the neck portion 221a of the solution container 220a in Figure 7B prevents such pooling thus improving efficiency and / or decreasing the effort required to dispense all of the solution in the solution container via the sponge 230.

[0109] The solution container 220b shown in Figures 7C and 8 includes features that are similar to or analogous to the features described above with respect to the solution container 220a. Like the solution container 220a described above, a neck portion 221a of solution container 220b also gradually tapers to the threaded engagement portion 223 near the opening of the solution container 220b and also prevents pooling of the solution therein as described above. The solution container 220b further provides advantages in that the bottle is shaped ergonomically (i.e., with a base that is smaller in diameter than the middle section of the solution container 220 to fit more comfortably into a user’s hand.

[0110] In addition to the features described above, the solution container 220b further includes a container locking feature 270 that prevents the solution container 220b from being unscrewed and / or removed from the solution container lid 262 once it has been securely connected. The container locking feature 270 helps to prevent leaks at the interface of the solution container threaded engagement portion 223 and the solution container lid engaging portion 222 by ensuring that the threads are fully engaged and that the threads to not loosen due to rotation of the solution container lid 262 and / or the solution container 220b once the engaging portion 222 and the threaded engagement portion 223 are fully engaged. In some examples, the container locking feature 270 may be configured to lockingly engage with a solution container lid locking feature 266 (Figure 9). Additional aspects and advantages of the container locking feature 270 are described in further detail below with respect to Figure 9. It is noted that while the container locking feature 270 is only shown on the solution container 220b of Figures 7B and 8, a similar or identical 22 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 container locking feature may be implemented into any of the solution container configurations described herein and alternatives thereof without departing from the scope of this disclosure.

[0111] The solution containers 220a and / or 220b described above may for example be semi- rigid or flexible containers. For example, the solution containers 220a and / or 220b may be formed of polycarbonate, acrylonitrile butadiene styrene (ABS), polyethylene terephthalate glycol (PETG), polymethyl methacrylate, or polyvinyl chloride (PVC), polyolefin such as a polyethylene, polypropylene, cyclic olefin copolymer, copolymers of polypropylene, and copolymers of polyethylene to name a few non-limiting examples. The solution containers 220a and / or 220b may be blow-molded. The solution container(s) may be translucent or semi-translucent to allow a user to easily visualize the amount of solution contained therein. A flexible or semi-flexible container 220a and / or 220b may be formed of any material that can be deformed without permanent (i.e., plastic) deformation and / or breakage. In some examples, a flexible or semi-flexible container may be configured to return to its original shape after being deformed (e.g., squeezed) by a user.

[0112] The solution containers 220, 220a and / or 220b described herein may contain an antiseptic such as povidone iodine, biguanides such as chlorhexidine salts, octenidine salts, hypochlorite solutions, hypochlorous acid, sodium lauryl sulfate, citric acid (aqueous), sodium citrate (aqueous), benzalkonium chloride, ethanol, isopropanol, etc. The solution therein may include a dye or other coloring agent to allow a user to easily visualize the solution both within the device 200 and / or to ensure that the sponge is adequately saturated with solution before insertion of the applicator 210 into the vagina or other body cavity or surgical orifice. As noted above, in some examples, the solution containers 220a and / or 220b may be sealed via any one or combination of a polymeric film, aluminum or other foil, substrates thereof, or other similar sealing system.

[0113] Figure 9 illustrates a solution container lid 262 and part of the solution container 220 The solution container lid 262 may have a puncture feature 263, such as a spike or protrusion, that punctures or otherwise opens the seal (e.g., seal 272) when the solution container lid 262 and / or the solution container 220a and / or 220b are rotated and / or pushed together into engagement with each another. The puncturing of the film may allow the solution in the solution container 220a and / or 220b to flow into the wand 232 via a lid passage 268. The aforementioned aspects allow the solution in the solution container 220 23 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 to remain sealed within the solution container 220 and prevent the solution from undesirably transferring to the sponge 230 or otherwise leaking from the solution container 220 until the device 200 is ready to be used by a practitioner.

[0114] As noted above, the solution container 220 may include a container locking feature 270 that is configured to engage with the solution container lid locking feature 266. In addition to preventing removal and / or unwanted rotation of the solution container 220 with respect to the 262 or vice versa during use, the engagement of the solution container lid locking feature 266 with the container locking feature 270 may prove tactile and / or audible feedback (e.g., a click sound), when the engaging portion 222 and the threaded engagement portion 223 are fully engaged and the solution from the solution container 220 is ready to be dispensed to the sponge 230. In addition to the advantages above, the aforementioned features may ensure that the solution container 220 is not easily removed thus preventing potential contamination of the solution within the solution container 220 and / or the fluid pathways within the device 200.

[0115] Figures 10 and 11 show close-up views and Figure 12 shows a close-up cross sectional view of an example implementation of the applicator 210 described above. The applicator 210 may for example be analogous with or share features with the applicator 210 described above with respect to Figures 2A -2E. The applicator 210 may include a grasping or grip portion 216 with protrusions or other tactile features 217 to provide increased grip for a practitioner during placement of the applicator 210 . Further, the applicator 210 may include a flange 218 configured to further assist with correct placement of the applicator 210 and device / system associated therewith (e.g., device 200). The flange 218 may be sized to provide a stopping point when the applicator sheath 212 is placed into a patient’s vagina 106 (Figure 1) or other body or surgical orifice. For example, the applicator sheath 212 may be placed partially into the vaginal canal 106 and until the flange 218 contacts the vaginal opening 108 and / or the vulva 109 indicating to a practitioner that the device 200 is correctly positioned.

[0116] In some examples, the flange 218 may have a diameter DD that is greater than a diameter BB of the grip portion or exterior portion 216 and also greater than a diameter CC of the applicator sheath 212. Further, diameter CC of the applicator sheath 212 may be less than the diameter BB of the grip portion or exterior portion 216. In some examples the applicator sheath 212 may have a length LL that is optimized to extend far enough into 24 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 the vagina 106 to prevent the difficulties and disadvantages described above without extending so far into the vagina 106 as to prevent the ability to apply solution to the inner surfaces of the vagina 106. In some examples, the length LL may be 0.25 inches to 4 inches. In yet another example, the length LL may be from 0.5 inches to 2.5 inches.

[0117] As shown in Figures 2A-2E, and 10-12, the applicator 210 may include an opening 214 configured to have the sponge 230 passed therethrough (e.g., as shown in Figures 2B and 2C) after the applicator sheath 212 is placed into the vagina 106 or other body or surgical cavity. In some examples, the opening may have a series of flexible petals, serrations, or rounded teeth 213 that are configured to flex outward (i.e., to temporarily enlarge the diameter of the opening 214) and allow the sponge 230 to be easily advanced out of the applicator 210 once the applicator 210 is placed in the desired position and a user wishes to advance the sponge 230 to apply solution to the internal surfaces of the vagina 106 and / or the ectocervix 130 or other body or surgical cavity. In some example implementations, the tip portion of the applicator may be made of a different, and more flexible, material than the remainder of the applicator portion.

[0118] In some examples, the applicator sheath 212 may contain or have coated thereon a lubricant to aid with or otherwise improve efficiency of insertion. The lubricant may include any one or combination of any water based (e.g., comprising any one of combination of propylene glycol, hydroxyethylcellulose), silicone based, and / or oil based (e.g., comprising petroleum) or the like.

[0119] As shown in the cross sectional illustration of Figure 12, the applicator 210 may include an inner cavity 236 that may be configured to contain part of the sponge 230 when in the contained configuration (as shown in Figures 2A, 2D, and 2E) and that may have an inner diameter that is configured to at least partially fit over the solution container lid 262 when in the deployed configuration (as shown in Figure 2C). The outer diameter of the solution container lid 262 and the inner diameter of the inner cavity 236 may be dimensioned to provide a frictional or press fit engagement between the solution container lid 262 and the inner surface of the inner cavity 236. In some examples, the solution container lid 262 may include one or more friction protrusions or tabs 269a and / or 269b (Figure 3A) that provide frictional engagement with the inner surface of the inner cavity 236. The aforementioned press-fit or friction fit may ensure that the applicator 210 does not inadvertently separate from the solution container lid 262 and / or slide down the wand 25 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 232 which could cause unintended contact to the labia mojora or other external surface of a body orifice or surgical site after the user presses the two into engagement, which may further simplify the application of the solution after the sponge 230 is deployed into the desired location of the vagina or other body or surgical cavity.

[0120] The applicator 210 may further include a stop feature or indicator 219. The indicator 219 may be configured to butt against or otherwise engage with or contact a portion of the solution container lid 262 which may provide a user with a tactile indication that the applicator 210 is engaged with the solution container lid 262.

[0121] The applicator 210 may be formed of any suitable rigid or semi-rigid material. For example, the applicator 210 may be formed of a low-density polyethylene (LDPE). Some other examples of materials that can be used to form the 210 include but are not limited to plastics such as polycarbonate or acrylonitrile butadiene styrene (ABS) plastic. The applicator 210 may be formed of a translucent or semi-translucent material to allow a user to easily see if solution has saturated the sponge 230 contained within the applicator 210.

[0122] Figure 13 shows example steps of using the device 200 according to aspects of the disclosure. It is noted that the steps described below are only intended as an example and additional steps may be added and / or steps may be omitted without departing from the scope of this disclosure. Furter, the order of steps is not intended to be limiting, steps described below may be rearranged without departing from the scope of this disclosure.

[0123] In step 300, a practitioner may apply a sanitary solution to the external surfaces that may contact the device 200 during use. The practitioner may then provide a treatment device 200 that may be analogous with or may share features with any of the aforementioned devices.

[0124] In step 302, a practitioner may unseal the device 200 and / or screw the solution container 220 into the solution container lid 262 to puncture a seal or otherwise open a fluid path between the solution container 220 and the sponge 210 via the wand 232. In some alternative examples, the aforementioned seal may be punctured by twisting the solution container 220 until a tactile or audible indication is provided from engagement of the solution container lid locking feature 266 with the solution container lid locking feature 266 that the solution container 220 and the solution container lid 262 are fully engaged. In another example, the solution container 220 and the solution container lid 262 may be 26 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 pressed together to engage and seal the solution container 220 with the solution container lid 262.

[0125] In step 303, the practitioner may squeeze the solution container 220 until solution begins to drip from the opening 214 of the applicator 210 which indicates that the sponge 230 contained therein is fully saturated with the solution. As an alternative to or in addition to the indication above, the practitioner may visually confirm that the sponge 230 is fully saturated through a translucent or semi-translucent portion of the applicator 210.

[0126] In step 304 the practitioner may hold the grip portion or exterior portion 216 of the applicator 210 and may place the applicator sheath 212 into a patient’s vagina 106 or other body cavity or surgical orifice until the flange 218 contacts the patient’s vaginal opening 108 and / or vulva 109 or the surfaces surrounding the body cavity or surgical cavity to indicate that the applicator 210 is at a predetermined depth.

[0127] In step 306, the practitioner advances the solution container 220 and / or the wand 232 in direction AA (Figure 2A) causing the sponge 230 to pass through the opening 214 of the applicator 210 (e.g., as shown in Figures 2B and 3C) and causing the expansion of the sponge 230.

[0128] In step 308, the practitioner may hold the device so that the force of gravity provides the sponge 230 to be further saturated with solution and / or squeeze or otherwise apply pressure to the solution container 220 to cause solution to transfer from the sponge 230 to the inner surfaces of the vagina or body cavity or surgical cavity. In an alternative aspect, the wand 232, which may be a separate component from the sponge 230 may be inserted into the sponge 230 to provide solution to wet the sponge 230 and / or to advance the sponge as described in step 306 above.

[0129] In step 310, the practitioner may advance the sponge further in direction AA and / or twist the solution container 220 and / or wand 232 to apply solution to the internal surfaces of the vagina 106 and / or the ectocervix 130 or other body cavity or surgical cavity.

[0130] In step 312, once the practitioner judges that the solution is properly applied, the practitioner may then remove the device 200 from the patient and discard or otherwise dispose of the device 200. 27 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149

[0131] In some examples, the treatment sponge may be retracted back into the opening 214 prior to removal of the device from the patient’s vagina or other body cavity or surgical cavity.

[0132] Figures 14A-18 provide specific configurations of a sponge which may be implemented as the sponge 230 described above. Figures 15A and 15B show example implementations with treatment devices that may share features with or may be identical to the treatment devices 200 described above.

[0133] Turning to Figures 14A, 14B, 17, and 18, the treatment sponge 230 has a main body with a proximal end 230b and a distal end 230a, and may for example be cylindrically shaped or rounded. At least the concave portion 237 (described in more detail below) of the device 230 may for example comprise any one or combination of rayon, polyester, cotton, polyurethane, polyethylene, neoprene foam, natural, latex or synthetic based foams, polystyrene, or ethylene-vinyl acetate. Further, the sponge 230 and or any portions thereof may be formed of the materials described in detail with respect to the table provided above. As previously mentioned, the above materials are not intended to be limiting, and the sponge 230 may for example be formed of any known material that is capable of absorbing or otherwise capable of being wetted by a solution or liquid. Further, the material could include additives to make the resulting device more hydrophobic or hydrophilic. The hydrophobic additive may be advantageous a non-aqueous irrigation solution, and the hydrophilic additive may be advantageous if an aqueous irrigation solution is used.

[0134] Turning to Figures 14B and 16, the sponge 230 may further include a concave portion 237. With reference to Figure 4, the concave portion 237 may for example be semi- spherical and may have a radius RR. In some examples, the radius RR may be 0.1 inches - 1.25 inches. In yet another example, the radius RR may be from 0.25 inches - 0.75 inches. It is noted that the above dimensions are provided merely as examples and are thus not intended to be limiting. The radius RR may be any reasonable dimension, and may have any radius that corresponds with the typical average or mean radius of a cervix. Further, the sponge 230 may have a circular cross-section with a width or diameter WW. In some examples, the diameter WW may be 0.3 inches - 1.75 inches. In yet another example, the diameter WW may be from 0.5 inches - 1.25 inches. It is noted that while a semi-spherical concave portion is shown, the shape is not intended to be limited and can by any shape. 28 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 Additional non-limiting examples include a cylindrical concave portion, a rectangular concave portion, a hexagonal concave portion or other known shapes and / or cross- sections.

[0135] With reference to Figure 14B and 16, concave portion 237 may intersect or otherwise join a top surface 238 of the sponge 230. In some examples, the top surface 238 may for example be flat or substantially flat. In some examples, the top surface 238 may intersect or otherwise join the outer surface 231 of the sponge 230. As shown in the examples views of sponge 230 shown in Figures 2B and 5A, the top surface 238 may be ring-shaped. In some examples, the top surface 238 and the outer surface 231 may be substantially perpendicular and the top surface 238 and a surface or portion of a surface of the concave portion 237 may be non-perpendicular or oblique, slanted, or diagonal with respect to the top surface 238. The top surface 238 and / or the concave portion 237 may be configured to correspond with or otherwise easily contact (i.e., with less effort that the aforementioned square or rectangular sponge), and apply solution to, the surfaces of a patient’s ectocervix (i.e., 130 in Figures 1A and / or 1B) and / or the anatomy surrounding the ectocervix (e.g., folds or concavities 131a and / or 131b, where the cervix meets the vaginal walls). Thus, when the device 230 is wetted or saturated with a solution (e.g., as described above), the solution can be applied not only to the inside of the vagina, but can also be more efficiently to the cervix since the concave portion 237 is configured to contour to the ectocervix and thereby allow pressure to be applied causing solution to be transferred from the wetted concave portion 237 of the sponge 230 to the surfaces of the ectocervix. The shape of the concave portion 237 further ensures that a user can efficiently apply improved pressure distribution to the ectocervix and to further ensure reproducibility of the preparation of a patient’s ectocervix.

[0136] With reference to Figures 14A-18, the sponge 230 may further include one or more interruptions, such as slits or cuts, 235a-235d. The one or more interruptions 235a-235d may extend through the main body from a portion of the concave portion 237 to a portion of the outer surface 231. The interruptions 235a-235d may for example separate the device 230 into individual sections or “arms,” e.g., 238a-238d referenced in Figure 18. The individual arms 238a-238d may be configured to deflect or otherwise expand in the direction indicated by the dashed arrows in Figure 14B when pressure is applied to the concave portion 237 and / or the top surface 238. For example, the sponge 230 may be 29 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 configured so that the arms 238a-238d may naturally rest or be biased to remain in the configuration shown in Figure 14B until pressure or rotational force is applied to the sponge 230. Once the sponge 230 is within a patient’s vagina, the arms 238a-238d may for example contour to or otherwise be placed in contact with a patient’s cervix or ectocervix 130 (Figures 1A and 1B), and / or if a rotation force is applied by a user to the wand 232, the friction force of the sponge 230 with the inner surfaces of the patient’s vagina and / or the pressing force of the concave portion 237 and / or the concave portion 237 and / or the outer surface 231 may cause the arms 238a-238d to deflect outward as indicated by the arrows shown in Figures 14B. This deflection may further ensure that the surfaces, and thus the solution that is contained within or that has wetted the sponge 230 fully contacts the inner surfaces of the vagina, and especially the ectocervix 130 (Figures 1A and 1B) and / or the folds or concave portions 131a and / or 131b where the cervix meets the walls of the vagina 106. Once the aforementioned pressure and / or friction forces are released (i.e., if a practitioner starts to withdraw the sponge 230 from contact with the cervix and or the vagina, the arms 238a-238d may naturally return to the non-deflected or non-expanded state shown in the Figures. It is noted that while a plurality of slits or cutouts are described as examples of the interruptions above, the disclosure is not limited to the shown slits or cut-outs. Alternative interruptions within the scope of this disclosure include any one or combination of, through holes, rectangular cut outs, oval cut outs, curved cut outs, or wedge-shaped cut outs. Further, it is noted that while four slits or cuts 235a-235d are shown forming four arms 238a-238d, this disclosure is not limited to four arms 238a- 238d. Any number of slits and / or corresponding arms may be included without departing from the scope of this disclosure. For example, the disclosed sponge 230 may include any number from two (2) to thirty (30) slits and / or arms.

[0137] In addition to the advantages described above, the aforementioned deflection or parting of the arms 238a-238d may provide tactile or positive feedback to the practitioner to further ensure proper cleaning and application of solution to the ectocervix and surrounding areas. For example, the practitioner may be able to feel a difference in pressure when initially contacting the cervix and a sudden decrease in pressure once the arms 238a-238d deflect. This positive feedback or tactile indication may provide further assurance to the practitioner that they have properly contacted the cervix and that the arms 30 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 238a-238d have contacted the areas surrounding the vaginal walls and the ectocervix (e.g., areas indicated by references 131a and / or 131b in Figures 1A and 1B).

[0138] Further, in some examples the density of the materials of the sponge 230 may be varied for select locations in order to further support the effective cleaning of the cervix. For example, the material within the contour of the concave portion 237 may have a higher density than other materials in the device 230 in order to allow the practitioner to provide higher force on the cervix. This increase in the pressure could help physically clean the surface of the ectocervix. In addition, the friction coefficient of the material at the concave portion 237 may be configured to be higher than other portions of the sponge 230 by altering the porosity of the material. The increased friction can further improve efficiency of removing any material and / or microorganisms that might be present on or surrounding the ectocervix or in the vagina.

[0139] In another example implementation, the sponge 230 may include individual fingers or brush-shaped sections to further improve access to the area between the vaginal wall and the ectocervix (e.g., indicated by reference numbers 131a and 131b in Figures 1A and 1B). In one example, the material towards the ends or distal portion of the individual fingers may be formed to have a higher density on the outer edges of the material and / or at the exterior of the individual fingers. The increased density of the material may provide an increased rigidity to the individual fingers and help ensure that the individual fingers could be forced into the folds or areas surrounding the endocervix.

[0140] As shown in Figures 15A and 15B and as described in detail above with respect to Figures 1A-13, the sponge 230 may be implemented into the device 200 described above.

[0141] In one example implementation of the disclosure illustrated in Figure 16, a device 400 including the sponge 230 may include a wand 432 connected to the sponge 230. The wand 432 may be adhered or otherwise fastened to the sponge 230 using method including gluing or melting, ultrasonic welding, sewing and / or pinning to name a few examples. For example, the wand 432 may be adhere or embedded into a channel 255 (Figure 17) with an opening 256 at a proximal end of the sponge 230. The wand 432 may be a rigid or semi- rigid formed of an appropriate material for use in the medical setting. In some examples, the wand 432 may be solid and the device 400 may either be provided with or may be used with a solution and / or tray 501 for wetting the sponge 230. 31 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149

[0142] In one example implementation of the disclosure, one or more devices 400 according to the disclosure and as described herein may be provided with a kit 500 containing any combination of one or more of the following: one or more tray(s) 501 for containing a solution and / or for clean-up purposes, sanitary or high-level disinfected fabric or sheets (not shown) for preparing or otherwise setting up for a procedure; glove(s) (not shown) for use by a practitioner; one or more containers of solution 420 for saturating or wetting the sponge 230. The one or more containers 420 of solution may be single use bottles, pouches, and / or other containers. In some examples, the solution 420 may share features with or may be analogous with the solution container(s) 120, 220, 220a, and / or 220b described above. The solution container 420 may include a cap 421 and / or a seal as descried in the implementations above. The solution contained within the aforementioned containers may be one or a combination of an antiseptic such as povidone iodine, biguanides such as chlorhexidine salts, octenidine salts, hypochlorite solutions, hypochlorous acid, iodine povacrylex, sodium lauryl sulfate, citric acid (aqueous), sodium citrate (aqueous), benzalkonium chloride, ethanol, isopropanol, etc. Any combination or all of the components described above may be enclosed in a pouch or bag and may be subject to a sterilization, sanitizing and / or a high-level disinfecting process.

[0143] Further, the kit described above may include additional components or features that are not specifically listed here without departing from the scope of this disclosure. Further, the components described above, or any combination of the features described herein could be labeled clearly with numbers and / or color coded and / or may include any combination of written and / or pictographic instructions thereon so that the practitioner can readily comprehend the steps for use of the device or features thereof. In some examples, a related procedure and / or method for using the kit, including the device 200 and / or 400 may be described in instructions provided with the device and any additional components included therewith. The instructions may be provided as a pamphlet or as written instructions on the packaging of the kit or system. The aforementioned instructions may also be provided as digital content (provided by accessing information on a network, such as a webpage on the Internet). In one example, any one of the component systems, the packaging of the system components and / or any components provided therewith may include a web address and / or a quick response “QR” code for accessing instructions and / or 32 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 digital content related to methods of use thereof. In addition, the instructions may also be provided by salesperson via marketing materials to name another non-limiting example.

[0144] Figures 18A and 18B show examples of an alternative sponge 630 that may be substituted for the sponge 230 described above. The sponge 630 may for example be similar to or analogous with the sponge 230 described above but may omit the interruptions 235a-235d described above.

[0145] The alternative sponge 630 may for example be connected to or otherwise used at as part of a treatment device (e.g., similar to device 200) and may include a wand (not shown, but similar or analogous with wand 232 described above), The sponge 630 has a proximal end 630b and a distal end 630a, and may for example be cylindrically shaped. At least the concave portion 637 (described in more detail below) of device 630 may for example comprise of the aforementioned materials.

[0146] The sponge 630 may further include a concave portion 637. With reference to Figures 19A and 19B, the concave portion 637 may for example be semi-spherical and may have a radius RRR. In some examples, the radius RRR may be 0.1 inches – 1.25 inches. In yet another example, the radius RRR may be from 0.25 inches – 0.75 inches. It is noted that the above dimensions are provided merely as examples and are thus not intended to be limiting. The radius RRR may be any reasonable dimension, and may have any radius that corresponds with the typical average or mean radius of a cervix. Further the sponge 630 may have a circular cross-section with a width or diameter WWW. In some examples, the diameter WWW may be 0.3-1.75 inches. In yet another example, the diameter WWW may be from 0.5 inches -1.25 inches.

[0147] The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. All structural and functional equivalents to the elements of the various aspects described herein that are known or later come to be known 33 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase “means for.” 34 AFSDOCS:303172295.1

Claims

031528.01707 P-30148 & P-30149 CLAIMS What is claimed is:

1. A system for applying a solution to internal surfaces of an orifice, the system comprising: an applicator comprising an applicator sheath configured to be placed into a patient orifice, and a treatment sponge that is configured to be wetted with the solution; a wand configured to provide solution to the treatment sponge; a solution container containing the solution, wherein the solution container is configured to be in fluid communication with the wand and the treatment sponge; and wherein the applicator is slideably disposed on the wand and in contact with the treatment sponge and the treatment sponge is configured to be advanced through an opening in the applicator.

2. The system of claim 1, wherein the treatment sponge is contained within the applicator in a compacted state and is configured to expand to an expanded state when advanced through the opening in the applicator.

3. The system of claim 1, wherein the applicator includes a flange with a diameter that is greater than the diameter of the applicator sheath, wherein the flange is configured to indicate that the applicator is positioned at a predetermined depth within the patient orifice.

4. The system of claim 3, wherein the applicator includes a gripping portion connected to the flange.

5. The system of claim 4, wherein the gripping portion includes a plurality of tactile features.

6. The system of claim 5, wherein the gripping portion has a diameter that is less than the diameter of the flange. 35 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 7. The system of claim 1, wherein the solution container contains an antiseptic solution.

8. The system of claim 7, wherein the antiseptic solution is a povidone iodine solution.

9. The system of claim 7, wherein the wand has an engaging portion connected thereto that is configured to engage with the solution container and the solution container includes a seal to seal the solution therein, wherein engaging the engaging portion with the solution container punctures the seal and enables the fluid communication of the solution container with the wand and the treatment sponge.

10. The system of claim 1, wherein the treatment sponge is contained within the applicator in a compacted state and is configured to expand to an expanded state when advanced through the opening in the applicator, and wherein the wand passes through the opening when the sponge is advanced and in the expanded state.

11. The system of claim 1, wherein the solution container is flexible or semi-flexible and providing pressure to the solution container causes saturation of the treatment sponge.

12. The system of claim 1, wherein the applicator sheath has a rounded tip.

13. A method for treating a patient orifice, the method comprising: providing a treatment device comprising: an applicator comprising an applicator sheath, a flange and a grip portion, a treatment sponge, contained within the applicator, that is configured to be wetted with solution, a wand configured to provide the solution to the treatment sponge and a solution container containing the solution; 36 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 opening a fluid path between the solution container and the treatment sponge, via the wand, to wet the sponge with the solution; inserting the applicator sheath of the applicator into the patient orifice, via the grip portion, until the flange of the applicator contacts an outer surface of the orifice; advancing the treatment sponge through an opening of the applicator; and treating the inner surfaces of the orifice with the solution, via the treatment sponge.

14. The method of claim 13, further comprising applying a sanitary solution to external surfaces that may contact the application device in association with treatment of the patient orifice.

15. The method of claim 13, further comprising applying pressure to the solution container to cause the treatment sponge to be wetted with the solution from the solution container.

16. The method of claim 13, further comprising removing the applicator portion and the treatment sponge from the patient orifice.

17. The method of claim 16, further comprising retracting the treatment sponge into the opening of the applicator before removing the applicator from the patient orifice.

18. A preparation device for applying a solution to internal surfaces of an orifice, the device comprising: an applicator comprising an applicator sheath and a flange adjacent to the applicator sheath, the applicator configured to be placed into the orifice, wherein the applicator contains therein a treatment sponge that is configured to be wetted with the solution; a wand configured to provide the solution to the treatment sponge; a solution container containing the solution, wherein the solution container is configured to be in fluid communication with the wand; and 37 AFSDOCS:303172295.1031528.01707 P-30148 & P-30149 wherein the applicator is configured to be moved from distal end to a proximal end of the wand and the treatment sponge is configured to be advanced through an opening at a rounded tip of the applicator via the wand.

19. The device of claim 18, wherein the solution container contains an antiseptic solution.

20. The device of claim 18, wherein the treatment sponge is contained within the applicator in a compacted state and is configured to expand to an expanded state when advanced through the opening in the applicator. 38 AFSDOCS:303172295.1

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