Patent Publication Number: US-11395577-B2

Title: Applicator for a speculum accessory sleeve and use thereof

Description:
This application claims the benefit of and priority to, and is a division of, U.S. Non-Provisional application Ser. No. 15/588,439, filed May 5, 2018, now U.S. Pat. No. 10,456,016, which is incorporated herein by reference in its entirety. 
    
    
     BACKGROUND 
     The present invention relates generally to the field of a medical speculum, and more particularly to an applicator for applying a sleeve to a medical speculum. 
     A speculum is a medical tool used to provide visualization into a body cavity. Speculums or specula are traditionally used for viewing and accessing the vaginal cavity for gynecology patients. The traditional speculum consists of two blades with a hinge and a handle. The blades are inserted into the body cavity in a closed position, and separated by squeezing two pieces of the handle together or applying force to a lever attached to the handle, thereby dilating the vagina and providing visualization of and accessibility to the vagina, the cervix, and surrounding areas. Once opened, the speculum can be locked in an open position, e.g., by using a screw-based mechanism so an operator (e.g., physician, nurse, mid-wife, etc.) does not need to continue squeezing the pieces of the handle or the lever during the inspection. The operator can then proceed with inspecting the vagina, conducting a Pap smear, or any other medical procedures that may need to be provided. 
     The double blade design of speculum devices has been in use since the 1800s, and few changes have been made to the original design. The biggest changes with the double-blade design have been changes in the material from metal to plastic and the addition of internal lighting on some models of the speculum so that the operator does not have to rely on external lighting to gain a clear view of the vagina and the cervix. 
     There are drawbacks with the traditional two blade design. For one, tissue can enter between the blades once they are opened inside the vaginal cavity, a common occurrence that providers characterize as “side wall encroachment.” Women, especially obese women, women with multiple vaginal births, or those with vaginal laxity, may have extra tissue in the side walls of the vagina that may fall into the space between the two blades once opened. This can cause problems for operators, particularly in providing clear visualization of the vagina and cervix, which potentially limits the effectiveness of the procedure. Furthermore, with all patients, when trying to close the speculum blades, tissue and/or pubic hair may become pinched between the blades. Pinching is extremely painful for patients and difficult for the operator to avoid without removing the speculum in an open position, which causes significant discomfort to the patients as well. There are no satisfactory solutions for these problems, resulting in tremendous patient discomfort with the entire speculum experience. 
     In an attempt to limit sidewall encroachment and allow for better visualization of the vaginal walls and cervix, operators may attempt to place condoms or portions of medical gloves over the speculum. This is an unsatisfactory and ineffective approach as condoms and gloves were not designed to support the internal pressure of the vaginal walls, but to be as thin as possible. Furthermore, using these solutions can result in both condoms and glove fingers, or torn portions of them, being left behind in the vaginal cavity following removal of the speculum. Alternatively, operators may choose to use larger speculums to provide a larger viewing/accessing window to compensate for tissue entering the side of the speculum between the blades. However, increasing the size of the speculum can provide discomfort to patients. Moreover, while there are now different sizes of speculums offered for an examination, it can be hard to determine the correct size for a patient as the size of the patient does not necessarily correlate with the size of the speculum that should be used. 
     An additional drawback to the traditional speculum design is that speculums are traditionally made of metal, though some made with disposable plastic have been increasing in use. When the speculum is made of metal, it can feel cold to the patient upon entry to the vaginal cavity, especially in comparison to the internal temperatures of the body, which can result in discomfort for the patient during the procedure. This may result in the patient tensing up and making the procedure more painful. Even when made of plastic, the design of the speculum is generally the same as the traditional design (but for some differences that may exist in the locking mechanisms, wall thicknesses, consistencies between the types of plastic, etc.), meaning that even plastic speculums may face some of the same drawbacks as traditional speculums. 
     Embodiments herein generally relate to applicators for accessories to improve speculum devices, components of the same, and methods of making and using the same. The accessories overcome many drawbacks of existing speculum devices, and the applicators enable practitioners to easily position the accessories on speculum devices for use during a medical procedure. In one aspect, an applicator is provided for easy positioning of a sleeve accessory, either on an existing speculum design or an updated speculum design, to cover an insertion portion of the speculum. 
     SUMMARY OF THE INVENTION 
     One embodiment relates to an applicator for positioning a sleeve accessory on a medical speculum. The applicator has a flat, oblong shape with a distal end and a proximal end, the proximal end being broader than the distal end. Additionally, the distal end includes a first prong and a second prong. At least a portion of the distal end of the applicator is configured to slide into a lumen of a sleeve accessory to facilitate positioning of the sleeve accessory on a medical speculum. 
     Another embodiment relates to a method for positioning a sleeve accessory on a medical speculum. The method includes providing a medical speculum with a pair of bills, providing a sleeve accessory having a cylindrical sleeve body defining a lumen, and providing an applicator having a flat, oblong shape with a distal end and a proximal end, the proximal end being broader than the distal end. The distal end of the applicator includes a first prong and a second prong. The first prong and the second prong are configured to be folded into a first pocket and a second pocket, respectively, the first pocket and the second pocket configured to receive the bills of the medical speculum. The method further includes positioning the lumen of the sleeve accessory about the distal end of the applicator, sliding the bills of the speculum between the first pocket and the second pocket of the applicator to position the bills of the speculum in the lumen of the sleeve accessory; and removing the applicator from the lumen of the sleeve accessory. 
     Another embodiment relates to a kit. The kit includes a sleeve accessory having a cylindrical sleeve body defining a lumen, wherein the sleeve accessory is configured to be positioned on an insertion portion of a medical speculum, and an applicator having a flat, oblong shape with a distal end and a proximal end, the proximal end being broader than the distal end. The distal end includes a first prong and a second prong. The applicator is configured to slide, by the distal end of the applicator, at least partially into the lumen of the sleeve accessory to facilitate positioning of the sleeve accessory on the insertion portion of the medical speculum. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a side perspective view of a medical speculum on which a sleeve accessory according to various embodiments can be used. 
         FIG. 2  is a side view of the medical speculum of  FIG. 1 . 
         FIG. 3  is a side perspective view of a sleeve accessory positioned on a medical speculum, according to an example embodiment. 
         FIG. 4  is a side view of a sleeve accessory positioned on a medical speculum, according to an example embodiment. 
         FIG. 5  is a side perspective view of a sleeve accessory positioned on a medical speculum in an open position, according to an example embodiment. 
         FIGS. 6A and 6B  are bottom views of an applicator for a sleeve accessory, according to an example embodiment. 
         FIG. 6C  is a top view of the applicator of  FIGS. 6A and 6B  positioned in a sleeve accessory, according to an example embodiment. 
         FIG. 7A  is a side view of the applicator of  FIGS. 6A-6C  being used to position a sleeve accessory on a medical speculum, according to an example embodiment. 
         FIG. 7B  is a top perspective view of the applicator of  FIGS. 6A-6C  being used to position a sleeve accessory on a medical speculum, according to an example embodiment. 
         FIG. 7C  is a side view of the applicator of  FIGS. 6A-6C  being used to position a sleeve accessory on a medical speculum, according to an example embodiment. 
         FIG. 7D  is a top perspective view of the applicator of  FIGS. 6A-6C  being used to position a sleeve accessory on a medical speculum, according to an example embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     In the following detailed description, reference is made to the accompanying drawings, which form a part of the present disclosure. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. The detailed description is intended as a description of exemplary embodiments and is not intended to represent the only embodiments which may be practiced. The term “exemplary,” as used herein, means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other embodiments. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the Figures, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated by and form part of this disclosure. 
     Referring to the Figures generally, an applicator for a sleeve accessory, or modifier sleeve, for a medical speculum is shown. The sleeve accessory may be used on any traditional speculum or any new or updated speculum design, including speculums that may be specifically designed for use with the sleeve accessory according to the present embodiments. The sleeve has an expandable body portion and is configured to be removably attached to an insertion portion of a speculum. In certain uses, a practitioner may be able to select a speculum with a narrower profile than the practitioner would regularly select because the sleeve reduces some of the previously described shortcomings of the traditional speculum design, for example, the problem of vaginal side wall tissue falling into the user&#39;s line of sight during use. The applicator is then used by the practitioner to easily and quickly position the sleeve accessory onto the bills of a speculum with minimal direct handling of the sleeve. 
     Referring now to  FIG. 1 , a two-blade speculum is shown according to certain traditional designs. As shown, the speculum  200  has an upper bill  203  and a lower bill  205 , a handle  207 , and a lever  209 . The upper bill  203  and the lower bill  205  together comprise an elongated insertion portion  211 . The insertion portion  211 , which is expandable as described herein, may be inserted into the vaginal cavity of a female patient. During insertion, the upper bill  203  and the lower bill  205  are in a closed position, wherein there is a minimal amount of space between the two bills. Once inserted and in order to dilate the vaginal cavity, the bills  203  and  205  are separated into an open position by pressing the lever  209  towards the handle  207 . In accordance with typical speculum designs, the speculum  200  may be made of any sturdy biomaterial including metals and plastics. 
     Referring now to  FIG. 2 , a side view of speculum  200  is shown. The upper bill  203  and the lower bill  205  may be configured in such a way that when in the closed position, the upper bill  203  and the lower bill  205  are wider near the handle  207  than near a body or end of the insertion portion  211 , i.e., the bills  203  and  205  distend quickly to create somewhat of a cone shape near the handle  207 , as shown in the side view of  FIG. 2 . The bills  203  and  205  may maintain a constant shape after the cone, forming the elongated insertion portion  211 . The upper bill  203  and the lower bill  205  of the elongated insertion portion  211  may have a uniform width or diameter as the bills  203  and  205  extend away from the handle  207 . In other embodiments, the proximal portion of the bills  203  and  205  near the handle  207  may be up to two times wider than the distal end of the bills  203  and  205 . 
     At a distal end of the elongated insertion portion  211 , away from the proximal handle  207 , the bills  203  and  205  may be rounded (e.g., the bills  203  and  205  may each be rounded, the ends of bills  203  and  205  closed together may form a rounded end, etc.). A rounded end may provide more comfort to a patient while receiving the speculum  200  in a cavity. The bills  203  and  205  may also be configured such that when in the closed position, the ends the bills  203  and  205  do not abut one another, creating a gap which helps to prevent tissue from becoming lodged in between the bills  203  and  205 . In one embodiment, the bills  203  and  205  may be of the same length such that when the bills  203  and  205  are closed, they form a smooth, continuous end to the insertion portion  211 . Alternatively, in another embodiment, one of the bills  203  and  205  may be longer than the other, such that when the bills  203  and  205  are in the closed position, the longer bill juts out from beneath or above the other bill. 
     As shown in  FIG. 2 , the handle  207  includes an upper portion and a lower portion. The upper portion of the handle  207  is coupled to bills  203  and  205 . The lower portion provides a location for the user to hold the speculum  200 . Coupled to the handle  207  is the lever  209 . The lever  209  includes a mechanism for opening and closing bills  203  and  205 . While the lever  209  is shown to be coupled to the upper portion of the handle  207 , the lever  209  may be coupled to the handle  207  at any location. In some embodiments, the speculum  200  may also include a mechanism for locking the bills  203  and  205  into an open position. 
     As described herein, using a sleeve accessory, such as sleeve accessory  301  shown in  FIG. 3 , with a medical speculum, such as speculum  200 , may overcome the previously described shortcomings of the traditional speculum in a variety of ways. First, the sleeve may be made of a rubber or other soft material that is warmer than the traditional metal speculum bills. As such, inserting a speculum with a sleeve accessory attached may be less shocking, and thus more comfortable, to a patient than a bare metal speculum. The material may be at least substantially transparent to allow for good visualization of the vaginal cavity through the speculum with attached sleeve. Furthermore, a slimmer profile speculum can be utilized because of the sleeve (e.g., because the sleeve allows for improved visualization such that a larger speculum is not necessary), which provides better comfort for the patient during the procedure, examination, or surgery involving the speculum. The sleeve moreover allows the speculum to be removed in a closed position while preventing the pinching of either tissues or pubic hair during the process, significantly improving patient comfort while reducing patient anxiety. Importantly, the sleeve also provides the side wall support between the upper bill and the lower bill of the speculum that allows the practitioner better and less impeded visualization into the vagina and cervix. When used during an electrosurgery, the sleeve accessory may additionally provide insulation to protect the vaginal walls of a patient during the electrosurgery procedure. Accordingly, using a sleeve accessory with a medical speculum may provide a number of benefits to the patient. Because of this, it would also be advantageous to practitioners to have an applicator tool to help them in quickly and correctly positioning a sleeve accessory on a medical speculum. A sleeve accessory may be the same or similar to those described in U.S. patent application Ser. No. 15/393,041 filed Dec. 28, 2016, which is incorporated by reference herein in its entirety. 
     Though specific reference is made in this specification to the elements or features of speculum  200 , it is understood that the accessory or modifier elements described herein, as well as any applicators for the accessory or modifier elements described herein, may be used with any speculum having an elongated and expandable insertion portion, such as any two-blade speculum design. The features herein used to describe speculum  200  may also be present on any other speculum on which the accessory or modifier elements described herein may be used. 
     In one aspect, a practitioner may use a sleeve accessory adapted to be used with a speculum, such as speculum  200 , as follows. First, a user positions a sleeve accessory on an insertion portion of a speculum, such as insertion portion  211  on speculum  200 , while the speculum is in a closed position. In exemplary embodiments, the user positions the sleeve accessory on the insertion portion by using an applicator tool, such as the applicators described herein, which aids the practitioner in quickly and correctly positioning the sleeve accessory on the insertion portion of the speculum. The user then inserts the speculum with the attached sleeve accessory into a patient&#39;s vagina. The user sets the speculum to the open position, thereby separating bills of the insertion portion and stretching the sleeve accessory. Next, the user performs a medical procedure on the patient using the speculum in the open position. The medical procedure may be any obstetric or gynecological procedure, such as an examination of the vaginal cavity, a Pap smear, an insertion or removal of an intrauterine device (IUD), an insemination, a sexually transmitted infection (STI) testing, a tissue collection, a biopsy, or an electrosurgery. After the user completes the medical procedure, the user closes the speculum and removes the speculum from the patient. Finally, the user removes the sleeve accessory from the speculum (e.g., by rolling the sleeve accessory off, by using a removal device, etc.). 
       FIGS. 3-5  show examples of a sleeve accessory to be used with a speculum. The sleeve accessory may be the same or similar to those described in U.S. patent application Ser. No. 15/393,041 filed Dec. 28, 2016, which is incorporated by reference herein in its entirety.  FIG. 3  depicts a sleeve accessory  301  on the elongated insertion portion  211  of speculum  200 . As shown, the sleeve  301  is configured to be positioned on the elongated insertion portion  211 , to surround or enclose both bills  203  and  205 , while the bills are in a closed position. In some embodiments, the sleeve  301  has a cylindrical sleeve body. By “cylindrical” it is meant that the sleeve body has a continuous, longitudinal shape that surrounds a hollow area (e.g., a lumen or hollow sleeve channel) within an inner wall or surface of the cylinder. The cylindrical sleeve body is not limited to a circular cylinder and may instead have a cross-sectional shape that is a square, a rectangle, a circle, an oval, a triangle, and so on. In the embodiment shown, the sleeve  301  has a cylindrical shape with a proximal opening through which the insertion portion  211  can be inserted. In the embodiment shown, the shape of the sleeve  301  substantially matches the shape of the bills, or may be in another shape, on which the sleeve  301  is being positioned. As such, the cylindrical body of the sleeve  301  may have a uniform width or diameter between a distal end of the sleeve body and a proximal end of the sleeve body while the sleeve  301  is in an un-stretched or unexpanded state, to match a uniform width or diameter of the bills  203  and  205  extending away from the handle  207 . In one embodiment, the uniform diameter of the cylindrical body of the sleeve  301  may range between 0.25 inches and 3.0 inches. In other embodiments, the sleeve  301  may comprise a different natural shape than the shape of the bills  203  and  205 , and may also have a non-uniform width or diameter ranging between 0.25 and 3.0 inches when in an un-stretched or unexpanded state. 
     The sleeve  301  may be made of one or more compliant or partially compliant materials, such as latex, vinyl, natural and synthetic rubbers, silicone, nylon, polyethylene, polyurethane, polypropylene, and non-degradable or degradable elastomers. In preferred embodiments, the sleeve  301  may be made of a polyisoprene (PI), a polyurethane (PU), a thermoplastic polyurethane (TPU), a styrene copolymer (SBS), and/or a thermoplastic elastomer (TPE). The material of the sleeve  301  may range from completely transparent to translucent or frosty to opaque. Alternatively, the sleeve  301  may include a finish that ranges from completely transparent to translucent or frosty to opaque. Different finishes may be used for different types of gynecological examinations or procedures. For example, a thicker and/or more opaque sleeve may be used for a surgical procedure, such as an electrosurgery, while a thinner and/or more clear sleeve may be used for a gynecological examination or procedure. 
     The sleeve  301  or a portion of the sleeve  301  may optionally be coated with one or more bioactive or therapeutic agents, lubricants, or surface finishes. Examples of suitable bioactive or therapeutic agents include, but are not limited to, hormonal and non-hormonal contraceptive agents, cancer screening agents, vaginal spermicides, vaginal microbicides, antibacterial agents, antifungal agents, antiviral agents, anti-HIV agents, and cancer treatment agents, or combinations thereof. The bioactive or therapeutic agents may be in any suitable formulation that may be applied to the surface of a vaginal speculum, such as a liquid, gel and powder. 
     In some embodiments, lubricants may be applied to at least a portion of an inner surface of the sleeve  301  and/or to an outer surface of the sleeve  301 . When applied to the inner surface of the sleeve  301 , the lubricant may, e.g., aid in positioning the sleeve  301  on the insertion portion  211 . When applied to an outer surface of the sleeve, the lubricant may, e.g., help the speculum  200  with the attached sleeve  301  be more easily inserted into the patient. In other embodiments, the lubricant on the interior surface and/or exterior surface of the sleeve  301  may instead be, or may be combined with, a powder applied to the sleeve  301  or a surface texture finished into a material of the sleeve  301 . The powder and/or surface texture may likewise, e.g., aid the user in positioning the sleeve  301  on the insertion portion  211 , help the speculum  200  with the attached sleeve  301  be more easily inserted into the patient, and so on. In various embodiments, the sleeve  301  may come with lubricant and/or powder pre-applied, the sleeve  301  may come in a kit with lubricant and/or powder included for the user to apply to the sleeve  301 , the sleeve  301  may come with instructions that recommend types or brands of lubricants and/or powders for the user to apply to create the beneficial effects discussed above, etc. 
     As shown in  FIG. 3 , once positioned on the insertion portion  211 , the sleeve  301  surrounds the bills  203  and  205  and preferably has a snug fit around bill  203  and  205 . As such, sleeve  301  should not move along the bills  203  or  205  during insertion into the vagina or during a medical examination, procedure, or surgery being conducted on the vaginal or surrounding tissues. The sleeve  301  may additionally include ribbed details  310  that help the sleeve  301  remain securely fastened onto the insertion portion  211 . In one embodiment, the ribbed details may be limited to a portion of the sleeve  301  secured to the smaller, narrower, distal end of the insertion portion  211 . In other embodiments, the ribbed details may, additionally or alternatively, be limited to a portion of the sleeve  301  secured to the larger, proximal end of the insertion portion  211  near the handle  207 , or be distributed throughout the length of the sleeve  301 . In some embodiments, the ribbed details may instead be, or may be combined with, texture differences or lubrication differences provided on an inner surface of the sleeve  301  and/or gripping elements (e.g., such as flanges  505  shown in  FIG. 4 ) positioned on an inner surface of the sleeve  301  that may help the sleeve  301  remain securely fastened onto the insertion portion  211 . 
     The proximal opening of the sleeve  301 , as well as a distal opening included in some embodiments of the sleeve  301 , may have a ridged finish, shown as end ring  307 . The ridged finish may be provided to give the user a ridge to aid the user in positioning the sleeve  301  on the insertion portion  211 , to finish the end of the sleeve  301  so that the end of the sleeve  301  is less easily ripped or otherwise damaged, to provide additional tension to adhere the sleeve  301  to the insertion portion  211 , and so on. The ridged finish may be provided as an end ring  307 , which may be a rolled bead edge (i.e., similar to a condom) or may be formed from an encapsulated ring (i.e., a ring that is rolled into the end of the sleeve  301  and cured). In other embodiments, the ridged finish may be provided as a dip in the material of the sleeve  301 , a secondary dip in another polymer material (e.g., of a different thickness, durometer, color, etc.) attached to the sleeve  301 , an otherwise attached or adhered secondary material that finishes the opening(s), and so on. 
       FIG. 4  illustrates another embodiment of a sleeve accessory for a medical speculum, shown as sleeve  501 . Sleeve  501  is designed similarly to sleeve  301 , with a cylindrical sleeve body configured to be slid over an insertion portion of a speculum, such as insertion portion  211  of speculum  200 . Sleeve  501  may have many of the same features as described above with respect to sleeve  301 , such as an end ring  507 . Sleeve  501  also includes flanges  505  to help the sleeve remain securely fastened onto the insertion portion  211 . As shown in  FIG. 4 , similar to sleeve  301 , the cylindrical body of sleeve  501  has an open proximal end and an open distal end. However, in some embodiments, a sleeve accessory may instead have a closed distal end (e.g., the sleeve  501  may wrap around the distal end of the bills  203  and  205  so as to enclose the top portion of the bills  203  and  205 , or extend up to the distal end of the bills  203  and  205 ). In these embodiments, the sleeve accessory may further include a small hole or aperture (not shown) in the closed, distal end of the sleeve accessory, which may allow for visualization, tissue sampling, etc. through the otherwise closed distal end. Additionally, as shown in  FIG. 4 , the distal end of the sleeve  501  nearly reaches the distal end of the bills  203  and  205 . However, in other embodiments, a sleeve accessory may not reach the end of the bills  203  and  205  when the sleeve accessory is positioned on the bills  203  and  205  or may extend past the end of the bills  203  and  205 . 
       FIG. 5  illustrates a sleeve accessory, shown as sleeve  601 , positioned on speculum  200 . Sleeve  601  is configured similarly to sleeves  301  and  501  discussed above, with a cylindrical sleeve body surrounding a lumen configured to receive an insertion portion of a speculum, such as insertion portion  211  of speculum  200 , and open proximal and distal ends framed by end rings  607 . As shown in  FIG. 5 , once positioned on the speculum  200 , when a force is applied to the lever  209  and the bills  203  and  205  of the speculum  200  separate, the sleeve  601  expands from a first state to a second state (i.e., from an unexpanded state to an expanded state). When the bills  203  and  205  separate, the sleeve  601  may stretch to accommodate the increase in distance between bills  203  and  205 . Beneficially, the expansion of the sleeve  601  provides side wall retention for tissue encroachment from the side walls of the vagina, allowing the user to maintain an uninterrupted view of the vaginal cavity and cervix while viewing the vaginal cavity and cervix through the speculum  200 . The expansion of the sleeve  601  also works to prevent vaginal tissue or pubic hair from entering the opening between the bills  203  and  205 , as the bills  203  and  205  may cause pinching of the tissue or pubic hair that is painful for the patient when the bills  203  and  205  are returned to the closed position at the conclusion of the procedure, examination, or surgery. Additionally, when the bills  203  and  205  are closed, the sleeve  601  may return to its original state (e.g., the first state). 
       FIGS. 6A-6C  illustrate an applicator  700  for a sleeve accessory (e.g., sleeve accessory  301 ,  501 , and/or  601 ), according to one embodiment. The applicator  700  is used by a practitioner to facilitate the positioning of a sleeve accessory onto a medical speculum, such as speculum  200 . A bottom view of the applicator  700  is shown in  FIGS. 6A and 6B . As illustrated in  FIG. 6A , according to one embodiment, the applicator  700  is flat and roughly oblong, with a broader proximal end  702  and a narrower distal end  704 . The proximal end includes a tab  706  that may be pulled away from the main body of the applicator  700 , while the distal end  704  splits into a first prong  708  and a second prong  710 . 
     The applicator  700  further includes a first flap  712  and a second flap  714  formed into the sides of the applicator  700 , where the first flap  712  is configured to fold at a first fold line  716  and the second flap  714  is configured to fold at a second fold line  718 , as shown by the arrows of  FIG. 6A .  FIG. 6B  illustrates the applicator  700  with the first flap  712  folded over the first fold line  716  and the second flap  714  folded over the second fold line  718 . As shown in  FIG. 6B , when the flaps  712  and  714  are folded over, the first flap  712  forms a first pocket  720  within the first prong  708  and the second flap  714  forms a second pocket  722  within the second prong  710 . 
     The applicator  700  may be made of a stiff, noncompliant or minimally compliant material or of a flexible, more compliant material. Thus, the applicator  700  may be made of paper, cardboard, paperboard, or corrugated fiberboard. Alternatively, the applicator  700  may be made of natural or synthetic rubbers or of a plastic, such as latex, vinyl, silicone, polyethene, polyurethane, polypropylene, polycarbonate, or non-degradable or degradable elastomers. In some embodiments, the applicator  700  may be designed for a single use and be disposable. In other embodiments, the applicator  700  may be designed to be reusable (e.g., be designed to be sterilizable for reuse). 
     A top view of the applicator  700  positioned within a sleeve accessory, shown as sleeve  801 , is illustrated in  FIG. 6C . The sleeve  801  is designed similarly to sleeves  301 ,  401 ,  501 , and  601 , with a cylindrical sleeve body configured to be slid over an insertion portion of a speculum, such as insertion portion  211  of speculum  200 . The sleeve  801  further includes an open proximal end  802  framed by an end ring  807  and an open distal end  804 . However, other embodiments of sleeve  801  may include a closed distal end, one or more gripping elements (e.g., similar to ribbed details  310  or flanges  505 ), one or more coatings, one or more surface finishes, and so on, as described above with respect to sleeves  301 ,  501 , and  601 . 
     As illustrated in  FIG. 6C , the applicator  700  is positioned within the sleeve  801 . In an exemplary embodiment, the applicator  700  and the sleeve  801  are packaged together with the applicator  700  pre-inserted into the sleeve  801  as shown in  FIG. 6C . However, in other embodiments, a user may need to slide or otherwise position the applicator  700  into the sleeve  801 . In various embodiments, as shown, the applicator  700  is designed such that the oblong shape of the applicator  700 , with the broader proximal end  702  narrowing to the distal end  704 , fits the shape of the sleeve  801 , which may also narrow from the broader proximal end  802  to the narrower distal end  804 . Accordingly, the applicator  700  may be easily positioned within the sleeve  801  until the prongs  708  and  710  abut the walls of the sleeve  801 . In some embodiments, the prongs  708  and  710  may create friction between the applicator  700  and walls of the sleeve  801  such that there is at least some resistance to the applicator  700  being slid out from the sleeve  801 . Additionally, the tab  706  is configured to be tucked over the top edge (e.g., over the end ring  807 ) of the proximal end  802  of the sleeve  801  once the applicator  700  has been slid into the sleeve  801 . Thus, the tab  706  and/or the resistance created by friction between the prongs  708  and  710  and the walls of the sleeve  801  may prevent the applicator  700  from inadvertently sliding out of the sleeve  801 . Instead, once the applicator  700  is inserted into the sleeve  801 , at least a small force may need to be applied to remove the applicator  700  from the sleeve  801 . 
     Additionally, the prongs  708  and  710  are configured such that when the applicator  700  is inserted into the sleeve  801 , the prongs  708  and  710  hold the interior of the sleeve  801  at least partially open. In this way, the prongs  708  and  710  allow a user to easily slide an insertion portion of a medical speculum into the interior of sleeve  801 . Furthermore, the prongs  708  and  710  are spaced apart such that the space between the first fold line  716  and the second fold line  718  are at least as wide as the insertion portion of the medical speculum. As such, the insertion portion may be slid in between the prongs  708  and  710  and through the pockets  720  and  722  formed in the prongs  708  and  710 . Thus, the prongs  708  and  710  of the applicator  700  may guide the insertion portion of the medical speculum into the lumen of sleeve  801 . 
     As shown in  FIG. 6C , in some embodiments, the distal ends  704  of the prongs  708  and  710  may not reach the distal end  804  of the sleeve  801 . However, in other embodiments, the applicator  700  may be configured such that the ends of the prongs  708  and  710  meet the distal end  804  of the sleeve  801 , or the applicator  700  may be configured such that the ends of the prongs  708  and  710  extend past the distal end  804  of the sleeve  801 . 
       FIGS. 7A-7D  illustrate a process of using the applicator  700  to position the sleeve  801  on a medical speculum, such as speculum  200 . First, the user removes an applicator  700  and a sleeve  801  from packaging intended to keep the sleeve  801  sterile. In exemplary embodiments, the applicator  700  and the sleeve  801  are packaged together with the applicator  700  pre-inserted into the sleeve  801  (e.g., as shown in  FIG. 6C ). In such embodiments the user may, for example, remove the applicator  700  and sleeve  801  combination from the packaging by grasping the broad, proximal end  702  of the applicator and pulling the applicator  700  and sleeve  801  combination from the packaging. In this way, the user may remove the applicator  700  and sleeve  801  from the packaging without directly handling the sleeve  801 , which may help keep the sleeve  801  sterile. However, in other embodiments, the applicator  700  and the sleeve  801  may be packaged in separate packaging or may be packaged together but without the applicator  700  pre-inserted into the sleeve  801 . In such embodiments, the user may remove the applicator  700  and the sleeve  801  from the packaging and insert the applicator  700  (e.g., by the distal end  704  of the applicator  700 ) at least partially into the sleeve  801 , as shown in  FIG. 6C . 
     With the applicator  700  positioned in the sleeve  801 , the prongs  708  and  710  of the applicator  700  hold the interior of the sleeve  801  at least partially open. Further, the applicator  700  should not inadvertently slide out of the sleeve  801  once inserted into the sleeve  801 . Thus, the user then grasps the applicator  700  by the broad, proximal end  702 , thereby holding the sleeve  801 . Next, holding the speculum  200  by the handle  207 , the user inserts the insertion portion  211  of the speculum  200  into the lumen of the sleeve  801  through the proximal end  802  of the sleeve  801 .  FIGS. 7A and 7B  illustrate the insertion portion  211  of the speculum  200  being inserted into the sleeve  801 , with  FIG. 7A  showing a side view of the speculum  200  being inserted into the sleeve  801  and  FIG. 7B  showing a top perspective view of the speculum  200  being inserted into the sleeve  801 . In  FIGS. 7A and 7B , the speculum  200  is inserted by pushing the sliding the speculum  200  into the sleeve  801  in the direction of the arrows shown in  FIGS. 7A and 7B . Further, as shown in  FIGS. 7A and 7B , the applicator  700  is designed such that the insertion portion  211  may be inserted in between the prongs  708  and  710  and through the pockets  720  and  722  created by the prongs  708  and  710 , such that the flaps  712  and  714  envelop the sides of the bills  203  and  205  once speculum  200  is inserted. 
     Once the insertion portion  211  has been inserted into the lumen of the sleeve  801 , the user grasps the proximal end  702  of the applicator  700  and, still holding the speculum  200  by the handle  207 , pulls the applicator  700  out from the lumen of the sleeve  801 .  FIGS. 7C and 7D  illustrate the applicator  700  being removed from the sleeve  801 , with  FIG. 7C  showing a side view of the speculum  200  with the applicator  700  being removed and  FIG. 7D  showing a top perspective view of the speculum  200  with the applicator  700  being removed. The applicator  700  is removed in the direction of the arrows shown in  FIGS. 7C and 7D . As discussed above, once inserted into the sleeve  801 , friction may exist between the prongs  708  and  710  of the applicator  700  and the walls of the sleeve  801 . Thus, when the applicator  700  is removed from the sleeve  801 , this friction may pull the sleeve  801  more fully and more securely onto the insertion portion  211  of the speculum  200 . For example, by comparing  FIGS. 7A and 7B  with  FIGS. 7C and 7D , one can see that the act of pulling the applicator  700  out from the sleeve  801  has caused the distal end  804  of the sleeve  801  to be pulled past the distal ends of the bills  203  and  205 . The user continues to pull the applicator  700  until it is completely removed from the sleeve  801 , at which point the sleeve  801  is fully positioned on the insertion portion  211  of the speculum  200 . 
     In some embodiments, an applicator (e.g., applicator  700 ), a sleeve accessory (e.g., sleeve accessory  301 ,  501 ,  601 , or  801 ), and/or a medical speculum (e.g., speculum  200 ) may be provided in a kit form. In one embodiment, the kit may include one applicator, one accessory sleeve, and/or one speculum. In another embodiment, the kit may include a plurality of speculums of varying lengths and widths and of varying expansion capabilities (i.e., capable of opening the bills in different ways, to different opening lengths, etc.), one or more sleeves configured to fit the plurality of speculums, and one or more applicators configured to fit the one or more sleeves and position the one or more sleeves on the one or more speculums. In yet another embodiment, the kit may further include accessories related to the needs of the examination procedure, for example, an IUD insertion device, a disposable electrosurgery tool, etc. In yet another embodiment, a plurality of applicators can be provided loosely in a large package or box. 
     The foregoing description details certain embodiments of the systems, devices, and methods disclosed herein. It will be appreciated, however, that no matter how detailed the foregoing appears in text, the devices and methods can be practiced in many ways. As is also stated above, it should be noted that the use of particular terminology when describing certain features or aspects of the technology should not be taken to imply that the terminology is being re-defined herein to be restricted to including any specific characteristics of the features or aspects of the technology with which that terminology is associated. The scope of the disclosure should therefore be construed in accordance with the appended claims and any equivalents thereof. 
     It will be appreciated by those skilled in the art that various modifications and changes may be made without departing from the scope of the described technology. Such modifications and changes are intended to fall within the scope of the embodiments, as defined by the appended claims. It will also be appreciated by those of skill in the art that parts included in one embodiment are interchangeable with other embodiments; one or more parts from a depicted embodiment can be included with other depicted embodiments in any combination. For example, any of the various components described herein and/or depicted in the Figures may be combined, interchanged or excluded from other embodiments. 
     With respect to the use of any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity. 
     It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the terms “comprising” and “having” should, respectively, be interpreted as “comprising at least” and “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an.” In general, “a” and/or “an” should be interpreted to mean “at least one” or “one or more”; the same holds true for the use of definite articles used to introduce claim recitations. 
     Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, etc.” is used, in general, such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general, such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.” 
     The technology disclosed herein has numerous applications and while particular embodiments of the technology have been described in detail, it will be apparent to those skilled in the art that the disclosed embodiments may be modified given the design considerations discussed herein. Therefore, the foregoing description is to be considered exemplary rather than limiting, and the true scope of the invention is that defined in the following claims.