A menstrual device and applicator with improved usability

Abstract

In one aspect, an applicator for placement of a menstrual device, the applicator being composed of a barrel and a plunger, the plunger being insertable into the barrel and movable inside the barrel, the barrel being a hollow tubal body having a wall encircling a shaft having a diameter, the hollow tubal body having a length between a distal end opening and a proximal end opening in the wall, preferably the barrel having two or more petal flaps attached to a wall or sharing a common base attached to the distal end of the wall, the petal flaps located on the circumference of the wall and each of the petal flaps having a free edge suspended over the distal opening. In another aspect, a system comprising the applicator and at least one foldable menstrual device. In a further aspect, methods of manufacturing the applicators and systems.

Description

[0001] A MENSTRUAL DEVICE AND APPLICATOR WITH IMPROVED USABILITY

[0002] Cross-Reference to Related Applications

[0003]

[0001] This application claims the benefit of priority to U.S. provisional patent application 63 / 677,047 filed July 30, 2024.

[0004] Technical Field

[0005]

[0002] This disclosure relates to products for menstruating users, including a menstrual device and applicator.

[0006] Background

[0007]

[0003] Cotton-based tampons and pads are examples of products that aid a menstruating user by absorbing menstrual fluid. Other options may include menstrual cups and discs which collect and retain menstrual fluid, instead of absorbing it. Menstrual cups hold and collect menses within the vaginal canal, while being suction sealed to the vaginal walls, for example, as described in U.S. Patents 8,795,248, 11,013,633 and U.S. Patent publication 2008 / 0077097. Menstrual discs are a discshaped device that is placed within the fornix and underneath the cervix in order to collect and retain menstrual fluid. While menstrual discs can be viewed as an improvement over a menstrual cup because a suction seal is not required in order for a menstrual disc to stay in place, a difficulty may arise during placement and removal because of the menstrual disc’s deeper placement in the body.

[0008]

[0004] In order to aid in placement and removal of a menstrual device, applicators have been developed, including those described in WO 2023 / 034401 Al.

[0009]

[0005] While applicators may be useful in placing a menstrual device, one of the concerns with menstrual device applicators is how to better control device deployment force when using an applicator and to avoid a fast and explosive deployment dynamic. Another concern is how to improve the durability and usability of applicators and menstrual devices which are intended to be reusable or disposable. Further concerns not only include discomfort with menstrual device insertion with an applicator but also a need for technical solutions that allow for compact applicator storage.

[0010]

[0006] Thus, there remains the need in the field for menstrual devices, including menstrual discs and applicators that would improve a placement and removal procedure, especially in application to reusable menstrual discs. In connection with reusable menstrual discs, additional concerns include how to improve a cleaning procedure, as well as folding and re-uploading the menstrual disc in an applicator after the menstrual disc has been cleaned.

[0011] Summary

[0012]

[0007] It is an objective of this disclosure to provide menstrual devices and applicators that address at least some of these needs.

[0013]

[0008] In one aspect, this disclosure provides an applicator for placement of a menstrual device, the applicator being composed of a barrel and plunger, the plunger being insertable into the barrel and movable inside the barrel, wherein the barrel is a hollow tubal body having a wall encircling a shaft having a diameter, the hollow tubal body having a length between a distal end and a proximal end, the hollow tubal body having a proximal end opening into the shaft and a distal end opening from the shaft, and wherein the plunger is a tubal body having a length between a distal end and a proximal end, the plunger being insertable through the proximal end opening into the shaft of the barrel and movable in the shaft along the length of the barrel, wherein the plunger has a proximal portion base having a diameter greater than the shaft of the barrel.

[0014]

[0009] In some embodiments, the barrel may have two or more petal flaps, and wherein the two or more petal flaps are either directly attached to the distal end of the wall or the two or more petal flaps are sharing a common base attached to the distal end of the wall, the petal flaps located on the circumference of the wall and each of the petal flaps having a free edge suspended over the distal opening

[0015]

[0010] Some embodiments include those, wherein the applicator may have a clicking mechanism between the barrel and the plunger, the clicking mechanism including one or more of the following: one or more protrusions located on the external surface of the plunger at or near the proximal end of the plunger and mirroring recesses / divots located on the internal surface of the barrel at or near the proximal end of the barrel; one or more recesses / divots located on the external surface of the plunger at or near the proximal end of the plunger and mirroring protrusions located on the internal surface of the barrel at or near the proximal end of the barrel; one or more protrusions are located on or near the distal end of the outer plunger surface and one or more mirroring recesses / divots are located on or near the proximal end of the inner barrel surface, or vice versa;

[0016] - the protrusions or recesses form a continuous structure around the full circumference; and / or any combination thereof; and wherein the clicking mechanism enables one or more of the following functions: i) a clicking occurs when a plunger is fully inserted into the barrel; ii) a clicking occurs when a plunger is first inserted into the barrel; and / or iii) a combination of i) and ii).

[0017] [OH] In some preferred embodiments, the applicator may be further characterized by one or more of the following features:

[0018] - the plunger comprises a hollow, semi-solid, or solid body;

[0019] - the barrel is tapered toward its distal or proximal end;

[0020] - the barrel wall comprises an overlap rim located at the distal end of the barrel; the plunger and / or barrel includes one or more flat, raised, or recessed surfaces; at least one from the plunger and the barrel having an area composes of a different material, preferably the material being TPE; at least a portion of an external surface, at least a portion of an internal surface, or at least a portion or entirety of both surfaces of the barrel include a textured surface finish; an external surface, an internal surface, or both surfaces of the plunger include a textured surface finish;

[0021] - the barrel and / or plunger is made of plastic material formulated with a lubricant additive; a slip agent, preferably silicon oil or PTEE; a coating is applied to the internal surface, external surface, or both, of the barrel and / or plunger, or to the entire applicator; and / or any combination thereof.

[0012] In some embodiments, the applicator may be further characterized by one or more of the following features:

[0022] - the overlap rim is recessed;

[0023] - the overlap rim includes one or more protrusions extending distally from or near the overlap rim, the protrusions may have a spiral, straight, or any other suitable structure;

[0024] - the overlap rim includes one or more mechanical interlocks, preferably open holes, partial depth holes, perforations, grooves, channels, or other structures formed on or near the overlap rim or on protrusions extending distally from or near the overlap rim;

[0025] - the overlap rim has protrusions extending distally from the overlap rim, the protrusions having spiral, straight, or any other structure; the overlap rim has one or more mechanical interlocks, wherein the mechanical interlocks are holes being cut through at least a portion of the surface depth of the barrel overlap rim or wherein the mechanical interlocks are located on protrusions extending distally from the overlap rim; and / or

[0026] - the overlap rim has one or more cut-outs.

[0027]

[0013] Some embodiments of the applicator include those, wherein an external surface of the barrel and an external surface of the plunger contains one or more alignment marks located on an external or internal surface of the barrel and / or plunger, the alignment mark being configured to visually or tactilely indicate proper alignment between the two components.

[0028]

[0014] Some preferred embodiments of the applicator include those, wherein the barrel has the petal flaps injection molded with the barrel as a one piece, or the petal flaps are attached to a shared base that is attached to the barrel wall by two-shot molding, multi-shot molding or overmolding, or the petal flaps are attached to the barrel wall by two-shot molding, multi-shot molding or overmolding, or the petal flaps are attached individually to the barrel wall by other molding or bonding methods including thermal bonding, ultrasonic bonding, adhesive bonding, chemical adhesion, mechanical interlock fusion or any combination thereof

[0029]

[0015] Preferably, the shared base of the petal flaps being attached to an optional overlap rim of the barrel, the overlap rim optionally being recessed and comprising one or more mechanical interlocks, protrusions, or surface features configured to secure the shared base. Preferably, the protrusions may be straight, spiral, or any other shape and / or the protrusions are perforated.

[0030]

[0016] In some embodiments of the applicator, the overmold and barrel wall may be both made from the same or compatible polymeric or elastomeric material, or the overmold and barrel may be made from material pairs selected from TPE and PP or PE, LDPE and HDPE, or TPU and PU. In some preferred embodiments, the petal flap may include a thickened region on or within the flap body, optionally shaped as a rib, wedge, or ridge, and configured to facilitate structural reinforcement and / or return of the petal flap to its pre-deployment position.

[0031]

[0017] In some embodiments of the applicator, the clicking mechanism may include one or more additional surface features selected from a second recess, divot, groove, or relief area and positioned proximally to a first clicking feature, the additional surface feature being located on either the barrel or the plunger.

[0032]

[0018] In some embodiments of the applicator, the plunger and / or barrel base may be flared out.

[0033]

[0019] In some embodiments of the applicator, the barrel wall may be cylindrical or elliptical and / or may include one or both of the barrel and plunger may include one or more flat surfaces, optionally configured to mirror each other.

[0034]

[0020] In some preferred embodiments, the plunger may include one or more flat surfaces, and the clicking mechanism comprises one or more protrusions located on or adjacent to one or more flat or curved surfaces of the plunger.

[0035]

[0021] In some preferred embodiments, the barrel may include one or more slits or notches located in the proximal portion of the barrel wall, the slits or notches optionally spaced at an angular position around the circumference.

[0036]

[0022] In some embodiments, the proximal end of the barrel may include a curved contour extending around all or a portion of the circumference, optionally accompanied by one or more curved flaps with a flat or outwardly protruding grip regions located adjacent to or beneath the curved contour.

[0037]

[0023] In some embodiments, one or more components of the applicator, including the barrel, plunger, overmold, petal flaps, may be made of or coated with a biocompatible antimicrobial, antifungal, or biofilm-resistant additive.

[0038]

[0024] In another aspect, this disclosure provides a system comprising one or more of the applicators according to this disclosure and at least one foldable menstrual device having a bowl-like reservoir formed by a curved wall and capable of containing a volume of menstrual discharge, the foldable menstrual device having a bottom surface opposite to an opening to the reservoir, the curved wall having a rim located around the circumference of a distal edge of the curved wall.

[0039]

[0025] Some embodiments of the system include those, wherein a portion of the curved wall adjacent to the rim is thickened relative to the rest of the wall, the thickening being internal, external, or both; and / or the menstrual device includes a pull feature selected from a pull string, pull tab, or integrally molded grip located on or near the rim or wall. In some embodiments of the system, the menstrual device may comprise one or more alignment marks located on an internal and / or an external surface of the menstrual device.

[0040]

[0026] In some embodiments, one or more components of the foldable menstrual device may be made of or coated with a biocompatible antimicrobial, antifungal, or biofilm-resistant additive.

[0041]

[0027] Some preferred embodiments of the system include those, wherein at least a portion of an external surface, at least a portion of an internal surface, or at least a portion or entirety of both surfaces on the barrel, plunger, foldable menstrual device and / or the menstrual device rim include a textured surface finish.

[0042]

[0028] In some embodiments, the foldable menstrual device may be made of fluorosilicone and / or comprises one or more friction lowering agents, including PTFE, silicone oil, slip agents or coatings including parylene or silicone conformal coatings, the agents being incorporated into the material and / or applied onto any portion of the menstrual device, including the rim, inner surface, outer surface, or entirety of the device.

[0043]

[0029] Some embodiments of the method of manufacturing the system include those, wherein one or more components of the system are made by a method comprising injection molding, two-shot molding, multi-shot molding, insert molding, comolding, compression molding, over-molding, heat bonding / sealing / staking, radiofrequency sealing, ultrasonic / thermal impulse / radiofrequency welding, dip molding, thermoforming, vacuum forming and / or compression molding.

[0044]

[0030] Some embodiments of the method include those, wherein the method further comprises forming mechanical interlocks in the overlap rim of the barrel and applying a material of petal flaps or overmold, wherein the material contacts, surrounds, or at least partially permeates the interlocks.

[0045] Brief Description Of The Drawings

[0031] Fig. 1A is a side view of one embodiment of an applicator according to this disclosure, showing a plunger fully inserted into a barrel.

[0046]

[0032] Fig. IB is a cross-sectional view along the longitudinal axis of the embodiment of Fig. 1A.

[0047]

[0033] Fig. 1C is an enlarged view of the base portion of the embodiment of the applicator according to Fig. 1A.

[0048]

[0034] Fig. ID is a cross-sectional view of the embodiment of Fig. 1C.

[0049]

[0035] Fig. IE is a schematic depicting a cross-sectional view of the plunger being positioned in the barrel pre-snap (the left panel), at snap (the central panel) and postsnap (the right panel) - only proximal portions of the barrel and plunger are shown.

[0050]

[0036] Fig. IF depicts the proximal portion of the plunger showing protrusions.

[0051]

[0037] Fig. 1G is a cross-sectional view of the proximal portion of the barrel showing indentations.

[0052]

[0038] Fig. 1H is a side view of an embodiment of the applicator according to this disclosure with a notch on the barrel, with the plunger fully inserted into the barrel.

[0053]

[0039] Fig. 1J is a side view of an embodiment of the applicator according to this disclosure with a curved contour on the proximal portion of the barrel, with the plunger fully inserted into the barrel.

[0054]

[0040] Fig. 2A is an isometric view of one embodiment of the barrel with an overmold.

[0041] Fig. 2B is an isometric view of the embodiment of the barrel of Fig. 2A without an overmold.

[0055]

[0042] Fig. 2C depicts a distal portion of a barrel embodiment with different overlap rim styles.

[0056]

[0043] Fig. 2D depicts a distal portion of an embodiment of a barrel with an overmold.

[0044] Fig. 2E depicts the embodiment of Fig. 2D rotated at 90 degrees around its long central axis.

[0057]

[0045] Fig. 2F depicts a distal portion of an embodiment of a barrel according to this disclosure, showing the overlap rim.

[0058]

[0046] Fig. 2G depicts a distal portion of an embodiment of an overmold having a spiral (serpentine-like) structure with mechanical interlocks extending from the barrel. The left panel depicts the spiral, serpentine-like interlock structure extending from the barrel. The right panel depicts the resulting overmolded petal covering that spiral structure, showing how the overmold bonds to the barrel. Together, the left panel and the right panel depict the before and after of overmolding.

[0047] Fig. 2H depicts various manufacturing methods of filling the mechanical interlock.

[0059]

[0048] Fig 3 is a cross-sectional view of one embodiment for an overmold having a thickened area underneath the petal flap.

[0060]

[0049] Fig. 4A is an isometric view of one embodiment of a plunger according to this disclosure.

[0061]

[0050] Fig. 4B is a cross-sectional view of an interface between the plunger of Fig. 4A and the menstrual disc pull string.

[0062]

[0051] Fig. 4C is a perspective view of the interface of Fig. 4B.

[0063]

[0052] Fig. 5A is an isometric view of one embodiment of a menstrual device according to this disclosure.

[0064]

[0053] Fig. 5B is a cross-sectional side view of the embodiment of Fig. 5A.

[0065]

[0054] Fig. 5C is a zoomed view at the thickened wall area located proximally to the device rim and underneath the disc rim in Fig. 5B.

[0066] Detailed Description

[0067]

[0055] It is an objective of this disclosure to provide menstrual devices and applicators with improved durability, usability and better deployment dynamics.

[0068]

[0056] In this disclosure, the term “about” means plus / minus 10 percent of a value. For example, about 100 means the range from 90 to 110.

[0069]

[0057] In this disclosure, the same element may be included in different embodiments. In these different embodiments, the same element is preferably denoted with the same reference number.

[0070]

[0058] In this disclosure the following abbreviations may be used: thermoplastic elastomer (TPE) polypropylene (PP) polyethylene (PE) high density polyethylene (HDPE) low density polyethylene (LDPE) polyurethane (PU) thermoplastic polyurethane (TPU)

[0071]

[0059] In this disclosure, any one of embodiments may be practiced with one or more of other embodiments, unless stated otherwise.

[0072] Applicator

[0060] In one aspect, this disclosure provides an applicator for placing a menstrual device such as a menstrual disc or menstrual cup, the applicator with improved usability and durability. In particularly preferred embodiments, the applicator is reusable.

[0073]

[0061] Referring to Figs. 1A-1 J, some embodiments of an applicator according to this disclosure, generally (10), are shown, having a barrel (12) and a plunger (14) insertable into the barrel (12), the plunger (14) being movable along the longitudinal axis (12D / 12P) inside the barrel (12).

[0074]

[0062] With reference to Figs. 1A-1E, 1G-1J and further to Figs. 2A-2F, the barrel (12) may be a hollow tubal body having a wall (16) encircling a shaft (18) having a diameter (D). The hollow tubal body (12) has a length (L) between a distal end (12D) and a proximal end (12P) of the hollow tubal body (12). When the applicator (10) is in use with a menstrual disc loaded, a user may insert the distal end (12D) first into the vaginal canal and pushing the plunger (14) through the shaft (18) in order to deploy and place a menstrual disc.

[0075]

[0063] The length (L) and the diameter (D) of the barrel (12) are configured to fit within the vaginal canal and to extend sufficiently inside the vaginal canal for placement of a menstrual device, including a menstrual disc. In embodiments, the length (L) may be in the range from about 80 to about 120 mm. In embodiments, the barrel (12) may be tapered toward the distal end (12D) such that a diameter (D2) near the distal end (12D) is smaller than a diameter (DI) near the proximal end (12P). In some embodiments, the (DI) diameter may be in the range from about 15 to about 20 mm and the (D2) diameter may be the same as the (DI) diameter, or if the barrel (12) is tapered, then the (D2) diameter may be less than the (DI) diameter.

[0076]

[0064] The hollow tubal body of the barrel (12) has a proximal end opening (24) to the shaft (18) and a distal end opening (26) from the shaft (18).

[0077]

[0065] In some embodiments, at its distal end (12D), the barrel (12) may have two or more, e.g. 2, 3, or 4 petal flaps (22s) located around the distal opening (26) from the barrel (12). One petal flap (22) may be located opposite to another petal flap (22) on the circumference of the wall (16) when there is an even number, e.g. 2 or 4, of petals. Petal flaps (22s) may be suspended over the distal opening (26) when in their closed position. In some embodiments, each of the petal flaps (22) may be attached with one edge (22P) to the distal portion of the wall (16) and each petal flap (22) has a free edge (22D) which may be slightly tapered and / or slightly curved toward the central axis (12D / 12P) of the barrel (12). In other embodiments, the free edge (22D) is the opposite edge to the attached edge (22P) wherein the two or more petal flaps (22) may have a shared base (30) with which the petal flaps (22s) are attached to the wall (16). When in their closed position and as shown in Fig. 2A, the petal flaps (22s) may suspend over the distal opening (26) of the barrel (12). If pressed against their internal surfaces, for example as is when a menstrual device is being released from the barrel (12), the petal flaps (22s) are capable of assuming an open position in which the free edges (22D) of the petal flaps (22s) are moved away from each other, opening an exit from the barrel shaft (18) for the menstrual device to be released.

[0078]

[0066] In some embodiments, the overmold (34) with petal flaps (22s) may be attached to the barrel wall (16) by overmolding, two-shot molding, or by multi-shot molding. In other embodiments, the petal flaps (22s) and the barrel wall (16) may be molded as a one-piece item. In some embodiments, the petal flaps (22s) and the barrel wall (16) may be made of the same material. This said, overmolding, two shot or multi-shot molding is preferably to be used in cases when the overmold (34) and the barrel wall (16) are made from different materials.

[0079]

[0067] Some embodiments of a barrel with overmold, generally (32), are shown in Figs. 2A, 2D and 2E. In some embodiments of the barrel with an overmold, generally (32), petal flaps (22s) may be molded as an overmold (34) onto the wall (16) of the barrel (32). The overmold (34) may be made of an elastomeric polymer, preferably a thermoplastic polymeric material, one suitable example of which may be a thermoplastic elastomer (TPE), but other thermoplastic polymeric materials may be also used. One of the reasons to use an elastomeric polymer is to enhance petal flexibility and for the elastomeric polymer's material property / ability to return to its original shape which is useful for reusability and durability. Thus, the petal flaps (22s) according to this disclosure may have an improved capacity for returning to its original pre-deployment shape after placement of the menstrual device has been completed.

[0080]

[0068] An overmolding manufacturing process for some embodiments of the barrel with overmold (32) may involve application of a thermoplastic polymeric material, e.g., a thermoplastic elastomer, for the overmold (34) over the barrel wall (16) material, e.g., a polypropylene, which can also be a thermoplastic polymer in some embodiments in order to create a strong chemical bond between an overlap base portion (30) of the petal flaps (22s) and the barrel wall (16).

[0081]

[0069] In order to improve the durability of a connection point for an overmold (34), the wall (16) may include an overlap rim (28) to which the overlap base portion (30) of the petal flaps (22s) may be attached.

[0082]

[0070] As shown in Figs. 2B, 2C and 2F, the overlap rim (28) may have a wall thickness lesser than that of the rest of the wall (16) such that the external surface of the overlap rim (28) may be recessed in comparison to the rest of the surface of the wall (16). Preferably and as is shown in Figs. 1A, 2A and 2D, when the overmold (34) are molded over the overlap rim (28), a diameter of the overlap base portion (30) of the petal flaps (22s) may be the same in some embodiments as the diameter of the wall (16) proximal to the overlap base portion (30).

[0083]

[0071] To address a concern related to the durability of a connection point between the wall (16) and the overmold (34), specifically for the overlapped area (30) between a plastic substrate of the wall (16) and the petal flaps (22s) and to prevent the overmold (34) from dislodging or popping from the barrel wall (16), some embodiments may include certain features which improve adhesion and mechanical bond of the overmold (34) to the overlap rim (28).

[0084]

[0072] In at least some embodiments and as is shown in Fig. 2C, one or more mechanical interlocks (33 s) may be added over one or more surfaces of the overlap rim (28) on the wall (16). In the embodiment of Fig. 2C, the mechanical interlocks (33 s) are shown as holes throughout the overlap rim (28). As shown in Fig. 2H, different manufacturing methods of filling the mechanical interlock (33) may include a thermoplastic elastomer (TPE) material of the overmold (34) and a polypropylene (PP) material of the barrel (12), e.g. TPE on the outside, PP on the inside and / or PP sandwiched by TPE.

[0085]

[0073] The size and placement of the holes (33 s) on the overlap rim (28) may be adjusted as may be needed in order to vary the strength of the mechanical bond between the overmold (34) and overlap rim (28). In these embodiments, the mechanical interlocks (33 s) may include one or more open holes, partial depth holes, perforations, grooves, channels, or other structures formed on or near the overlap rim (28) or on protrusions extending distally from or near the overlap rim (28) or being cut through at least a portion of the surface depth of the barrel overlap rim (28) such that a material of the overmold (34) can permeate into the mechanical interlocks (33s).

[0086]

[0074] In some embodiments and as is shown in Fig. 2G, the protrusions extending distally from the wall (16) may include one or more mechanical interlocks (33s). The protrusions may be a perforated structure, such that a thermoplastic material of petal flaps (22s) may penetrate the perforations and improve adhesion. In some embodiments, the protrusions may be spiral (“serpentine-like” or “snake-like”) structures, wherein the structure may or may not fully extend from the barrel wall entirely into the petal flaps (22s). The petal material may fully or partially cover the entirety of the extended structure (33). Geometry of the “serpentine-like” or “snakelike” structures can also be altered to provide either uniform support across the petal flaps (22), or variable support along its length. The inclusion of protrusions may provide more strength and structure to the petal flaps (22s) to prevent deformation and increase durability with repeated usage.

[0087]

[0075] In yet additional alternative embodiments, the barrel overlap rim (28) may comprise at least one cut-out (36) in the overlap area wall (28) and preferably at least two cut-outs (36s), preferably located opposite or substantially opposite to each other, relative to the central axis (12D / 12P).

[0088]

[0076] Further embodiments may include increasing the overlapping area of the overmold (34) for more surface / contact and / or selecting a compatible polymeric material for the overmold (34) such that it would have a stronger mechanical and / or chemical bond to the barrel wall (16). For example, an embodiment in Fig. 2F includes a single cut-out (36) in the barrel overlap area (28) in which a petal material can permeate through. The overlap base portion (30) can either partially or fully cover the barrel overlap rim (28). The single cut-out (36) may be placed in any region of the overmolding area (28). This is another example of a mechanical interlock design as shown in the central panel of Fig. 2C.

[0089]

[0077] Examples of suitable polymeric material pairs include, but are not limited to, thermoplastic elastomer (TPE) for the overmold (34) and polypropylene (PP) for the barrel wall (16), low density polyethylene (LDPE) for the overmold (34) and high density polyethylene (HDPE) for the barrel wall (16), or thermoplastic polyurethane (TPU) for the overmold (34) and polyurethane (PU) for the barrel wall (16). TPE for the overmold (34) and PE for the barrel wall (16) also can create a good bond and therefore are also suitable.

[0090]

[0078] With reference to Fig- 3, in order to improve durability of petal flaps, to minimize the risk of petal flaps not returning to their original shape immediately after deployment and also to prevent the shape warping with multiple uses, some embodiments of the barrel (32) may include an overmold (40) with petal flaps (42) of varying thickness. In these embodiments, a thickened area (44) may be incorporated on the internal surface (421) of the petal flap (42), at and / or proximally to the free edge (42D) of the petal flap (42). With the thickened area (44) on the internal surface (421) of the petal flap (42), the petal flap (42) may be more likely to return to its original shape of being curved inward, following each deployment.

[0091]

[0079] In some alternative embodiments, the barrel (32) may be made with petal flaps (22s) from a single mold instead of an overmold (34 or 40) onto the barrel wall (16). In these alternative single piece barrels, petal flaps (22s) may be made from the same material as the rest of the barrel (12). Suitable materials may include, but are not limited to, PP, PE and / or TPE. In some embodiments, the petal flaps (22s) may have a thinner thickness in comparison to the barrel wall (16). This configuration with thinner petal flaps allows for the petal flaps to maintain a high level of flexibility and comfort during usage. In some embodiments of the barrel (32), the barrel wall (16) has a certain thickness in the proximal portion and then the thickness may gradually decrease along the wall length and / or in the petal flaps (22s).

[0092]

[0080] The applicator (10) may include a clicking mechanism between the barrel (12) and the plunger (14), details of one embodiment of which are shown in Figs. 1D-1G, which may be referred to as “snaps.” The clicking mechanism includes two or more protrusions (56s) located on the external surface (14E) of the plunger hollow tubal body (14), in the proximal portion of the plunger (14) and preferably near or at the proximal end (14P), and mirroring recesses / divots (58) located on the internal surface of the barrel (12) at or near the proximal end (12P) of the barrel (12). In some embodiments, the protrusion (56) may extend around the whole circumference of the hollow tubal body (14). In other embodiments, two or more discrete protrusions (56) may be located on the circumference of the hollow tubal body (14). The barrel (12) may have a matching shape for recesses / divots (58). Specifically, if the protrusion (56) runs around the whole circumference of the plunger (14), then the indentation may be a continuous indentation around the circumference of the barrel hollow tubal body (12). In the embodiments with discrete protrusions (56s), mirroring recesses / divots (58s) may be located on the internal surface of the barrel hollow tubal body (12).

[0093]

[0081] In some embodiments, the location may be in the reverse: protrusions (56) may be located on the internal surface of the barrel (12) and the mirroring recesses / divots (58s) may be located on the external surface of the plunger (14).

[0094]

[0082] In some embodiments, the clicking mechanism may also be located at or near the distal end (14D) of the outer plunger (14) surface and the proximal end (12P) of the inner barrel (12) surface, allowing for a clicking to happen when the plunger (14) is first inserted into the barrel (12). Thus, the clicking mechanisms according to this disclosure may accomplish one or more of the following functions: i) a clicking occurs when the plunger (14) is fully inserted into the barrel (12) to allow users to keep the plunger (14) and barrel (12) together for compact storage; ii) the clicking occurs when the plunger (14) is first inserted into the barrel (12) to prevent users from accidentally dropping or losing the plunger (14) from the barrel (12); and / or iii) a combination of i) and ii).

[0095]

[0083] To allow the clicking mechanism between the barrel (12) and the plunger (14) to snap together more smoothly and with a minimal force, an additional second recess / divot (60) may be added on the inner surface of the barrel (12), positioned proximally to the first recess / divot (58) where the snap occurs, one embodiment of which is shown in Figs. ID, IE and 1G. This extra space in the form of the second recess / divot removes at least some of pre-snap / pre-clicking friction and when performing the snap. Additionally, while the second recess / divot (60) may be on the inner surface of the barrel (12) in some embodiments, it is also contemplated that in some other embodiments that a similar friction-reducing structure (60) may alternatively be located on the outer surface of the plunger (14). In such an embodiment, the functional relationship remains the same, providing clearance to reduce pre-snap friction, but with the geometry reversed. This variation is also within the scope of the invention.

[0096]

[0084] In any embodiment of the barrel (12), the wall (16) may be generally cylindrical or elliptical. In some embodiments, the wall (16) may further include two flat surfaces (13), opposite to each other, in the proximal portion of the wall (16). The flat surfaces (13) are mirroring each other and are located opposite to each other (180 degrees) on the wall (16). The flat surfaces (13) may be referred to as the barrel grip areas (13) or the barrel grips (13) as shown in Figs. 1A, 1H, 1J, 2A and 2B. The function of the barrel grips (13) is to improve the user’s grip. In some embodiments, the barrel grip (13) may be tapered distally and / or it may include protrusions for a better grip.

[0097]

[0085] Referring to Fig. 1H, some embodiments of the barrel (12) may include a first slit or notch (62) in the proximal portion of the barrel wall (16) and a second slit or notch (62) mirroring the first slit or notch (62) and located at 180 degrees on the circumference of the barrel wall (16) from the first slit or notch (62). In the embodiments where the barrel (12) also includes the barrel grips (13s), a position of the barrel grip (13) relative to the notch (62) on the wall (16) may be at about 90 degrees to each other. This additional slit and / or notch (62) may create some extra room for the applicator barrel (12) to bend and flex during insertion of the plunger (14), which may reduce friction force and / or interference generated during clicking.

[0098]

[0086] Referring to Fig. 1 J, the barrel (12) may have a curved contour (64) at the barrel proximal end (12P) wherein the proximal edge of the barrel (12). In some embodiments as shown in Fig. U, a pair of curved flaps (66s) may be located at the proximal end (12P), opposite to each other and parallel, perpendicular and / or askew from the wall (16). Preferably, the flares of the curved flaps (66s) may be increased to extend outward on the barrel to further improve user grip.

[0099]

[0087] The curved flap (66) may be located proximally to the barrel grip (13) and at any angle to the barrel grip (13), such as, for example, parallel, perpendicular and / or askew from the barrel grip (13).

[0100]

[0088] In some embodiments, the applicator barrel (12), apart from the plunger (14), may or may not be able to stand upright on a flat surface via an inclusion of a flatter edge at the proximal end (12P) of the barrel (12) which may or may not be incorporated into the curved flaps (66s). In other embodiments, the proximal edge (12P) of the barrel (12) may be fully curved all around. In other embodiments, there may be a pair of curved flaps (66s) on the opposite sides at the end of the barrel (12).

[0101]

[0089] Referring to Figs. 1A-1D, IF, 1H, 1J and Fig. 4A-4C, embodiments of the plunger (14) may include those wherein the plunger (14) is a tubal body having a length (LI) between a distal end (14D) and a proximal end (14P). The tubal body of the plunger (14) may be solid, hollow, or semi-solid with one or more channels through the length (LI). The plunger (14) is configured in its shape and length with the shape and the length (L) of the barrel (12) such that the plunger (14) is insertable with the distal end (14D) being inserted first into the shaft (18) of the barrel (12) and movable in the shaft of the barrel (12) along the central longitudinal axis (12D / 12P).

[0102]

[0090] The plunger (14) may or may not have a hole (52) located centrally on a distal surface (15) at the distal end (14D) of the plunger (14). The hole (52) has a diameter sufficient for allowing a pull string or pull tab (312) of the menstrual device (300) to pass through the plunger hole (52).

[0103]

[0091] Referring to Figs. 4B and 4C, the plunger hole (52) may be dimensioned to allow the pull string or pull tab (312) to pass through with some clearance such that the widest section of the menstrual device pull string (312) which is positioned at the attachment point between the pull string (312) and the rim of the device (310) may pass through the hole (52). In some embodiments, the clearance may be preferably between about 0.1 and about 2 mm per side. Having some clearance, the plunger hole (52) may ensure that the plunger / menstrual device interface allows for a seamless passage of the menstrual device pull string (312) with minimized friction and also that entanglement or obstruction may be avoided. When in use with the barrel (12), the plunger (14) may hold the device string (312) along the longitudinal axis (12D / 12P) of the barrel (12) during deployment. This prevents rotation of the menstrual device (300) within the barrel (12) as the rotation should be avoided in order to protect the menstrual device (300) from incorrect deployment.

[0104]

[0092] In some embodiments, the plunger base (54) may contain a proximal opening (not shown), allowing for the plunger (14) to be hollow such that the pull string (312) may be passed through the plunger.

[0105]

[0093] The proximal portion (54) of the plunger (14) which may be referred to as the plunger base (54), may have a greater diameter than the shaft of the plunger (14) in some embodiments. In some embodiments, the plunger base (54) may or may not be of a greater diameter than that of the proximal end (12P) of the applicator barrel (12). The plunger base (54) may or may not be flared out. In some embodiments, the offset may be in the range from about 0.1 mm to about 1.5 mm and / or the draft may be in the range from about 0.1 to about 1.5 degrees.

[0106]

[0094] In some embodiments, the plunger (14) may have a first flat surface (50) in at least a proximal portion of the hollow tubal body (14) or along the full length of the hollow tubal body (14), and a mirroring second flat surface (50) located at 180 degrees from the first flat surface (50). The flat surface (50) may be tapered in the distal direction from (14P) to (14D). The width of the flat surface (50) may vary, but preferably it may be sufficiently wide in order to accommodate a finger grasp. Flat surfaces (50) can be of variable length, including through the entirety of the length, just at the base, or just at the tip.

[0107]

[0095] Preferably, in embodiments wherein the plunger (14) has the flat surfaces (50s), the barrel (12) may also have two matching flat surfaces (13). The flat surfaces (50) may mirror the barrel surfaces (13) which may be referred in this disclosure as the barrel grip surface (13). Preferably, the surfaces (13) and (50) may be of the same or about the same width and length. Having the barrel grips (13) aligned over the flat surfaces (50) of the plunger, when the plunger is inserted in the shaft (18) of the barrel (12), helps in minimizing friction and interference between the plunger (14) and the barrel (12), especially in the areas where the barrel grip surface (13) is located.

[0108]

[0096] In embodiments where the barrel (12) and the plunger (14) are circular, the flat surfaces (50 and 13) may be placed at any location along the circumference as long as the first flat surface (50) and the second flat surface (50) are 180 degrees from each other and as long as the barrel grip surfaces (13) mirror the locations. The flat surfaces (50 and 13) also act as keying features that help a user align the plunger (14) and the barrel (12) of the applicator (10).

[0109]

[0097] In embodiments, wherein the barrel (12) and plunger (14) are elliptical, the two flat surfaces (50) and the mirroring two surfaces (13) may be placed either on the minor or major axis. The flat surfaces (50 and 13) must be on the same axis for both the barrel (12) and plunger (14) (i.e., both barrel (12) and plunger (14) may have the respective flat surfaces (13 and 50) on the minor axis). In these embodiments, the flat surfaces (50 and 13) also act as keying features that help the user align the plunger (14) and the barrel (12) of the applicator (10).

[0110]

[0098] Additional technical advantages may include the following: the flat surface (50) allows the offset between the plunger (14) and the barrel (12) to be closer and may also provide an extra grip on the plunger (14) in addition to the plunger base. The flat surfaces (50) of the plunger (14) may or may not be where small outdent / protrusions or recesses / divots (56) can be found for the clicking mechanism.

[0111] Incorporation of an antimicrobial additive in applicator and / or menstrual device

[0112]

[0099] Applicators and menstrual devices according to this disclosure can be made from various elastomeric and semi-elastomeric plastic and / or rubber materials. In embodiments, suitable materials may include, but are not limited to medical grade PP, PE, TPE and / or silicon rubber.

[0113]

[0100] One of the concerns with reusable menstrual devices and / or applicators is how to properly clean them between uses and how to prevent microbial growth. In order to address this concern, applicators and / or menstrual devices according to this disclosure may be made of a plastic material which incorporates a biocompatible antimicrobial additive. Suitable antimicrobial plastic additives include, but are not limited to, silver ions, copper ions or some other anti-microbial biocompatible chemical compounds which may be incorporated on the surfaces of or infused into the applicators and / or menstrual devices according to this disclosure. This technical solution aims to enhance the overall hygiene and safety of the applicator and / or menstrual device by protecting the polymeric material from growth of bacteria, viruses, molds, biofilm and / or fouling such that sterilization and / or boiling between uses may be omitted.

[0114] Menstrual Devices, Including Menstrual Discs

[0115]

[0101] In yet another aspect, this disclosure relates to foldable menstrual devices, including discs which may be reusable or disposable. Preferably, the foldable menstrual devices are reusable. Referring to Figs. 5A, 5B and 5C, an embodiment of the foldable menstrual device according to this disclosure, generally (300), is shown. The foldable menstrual device (300) contains a reservoir (302) having a volume for collecting menstrual discharge and preferably being capable of holding at least about 10 ml and more preferably at least about 20 ml and most preferably at least about 40 ml of fluids. In its unfolded form as shown in Fig. 5A, the foldable menstrual device (300) may be a bowl -like reservoir (302) formed by a curved wall (304) and capable of containing a volume of menstrual discharge and having a rim (310) attached to the circumference of the bowl-like reservoir (302). The foldable menstrual device (300) has a bottom surface (306) which may be at least partially flattened in some embodiments. The foldable menstrual device (300) has a height (h) between the bottom surface (306) and the free edge (308) of the rim (310). The wall (304) has a distal edge (304D) which is the closest to rim edge (308). A diameter of the reservoir (302) may be smaller than a diameter of the rim (310). If for example the rim (310) diameter is 60mm, the reservoir (302) diameter may be less than that. Suitable dimensions for the foldable menstrual device (300) may include the height (h) in the range from about 10 mm to about 40 mm, and more preferably from about 15 mm to about 35 mm and / or a rim (310) diameter measured at the edge (308) in the range from about 50 mm to about 80 mm, and more preferably from about 60 mm to about 70 mm.

[0116]

[0102] In some embodiments, the rim (310) may be injection molded together with the reservoir (302), or the rim (310) may be made separately and then attached at the distal edge (304D) of the wall (304). Made of an elastic or semi-elastic polymeric material, one of the functions of the rim (310) is to improve a fit within the body when the foldable menstrual device (300) is in use. In embodiments, the rim (310) may be circular, elliptical, or in any other suitable shape. The rim (310) may have a wall thicker than the reservoir wall (304). In preferred embodiments, the rim (310) may be selfsizing and may incorporate an expandable / contractible feature in order to produce an adjustable fit during the use. Self-sizing is characterized by the rim having the capacity to remain in its most expanded state or shrink down to a smaller size based on the user’s fornix size.

[0117]

[0103] In some embodiments, the rim (310) may have an outer diameter in the range from about 50 mm to about 80 mm, and more preferably from 60 mm to about 70 mm. The wall of the rim (310) can be made, for example, in the range from about 2 mm to about 7 mm. The rim (310) may be concave or semi-concave. The height (H) of the rim (310) may be in the range from about 3 mm to about 20 mm. Other dimensions may be also suitable.

[0104] In some embodiments, the foldable menstrual device (300) according to this disclosure may contain a pull string or pull tab (312) which may be attached to the rim (310) and / or to the wall (302). The pull string or pull tab (312) may have a texture or indents (314s) in order to improve a user’s grip. The pull string or the pull tab (312) may be made of a flexible material and of the length that when in use, a portion of the pull string or the pull tab may be extended out of the body and allowing the user to remove the foldable menstrual device by pulling the pull string or the pull tab (312). In some embodiments, the length of the pull string or the pull tab (312) may be in the range from about 45 mm to about 75 mm, and preferably from about 55 mm to about 70 mm.

[0118]

[0105] The foldable menstrual device (300) may be made of an elastic or semi-elastic polymeric material, such as for example as silicone rubber, which may be molded into a bowl-like structure. In embodiments, the foldable menstrual devices according to this disclosure can be folded and placed in the body with the applicator according to this disclosure. In order to improve folding and loading of the foldable menstrual device (300) into the applicator barrel, a portion of the curved wall (302) adjacent to the rim (310) may be made thicker than the rest of the wall (302), one embodiment of which is shown in Fig. 5C which is a cross-sectional view of a detail from Fig. 5B, showing a portion of the rim wall (310), the adjacent thickened reservoir wall portion (316) and then a portion of the reservoir wall of normal thickness (304) proximally to the thickened portion (316). In some preferred embodiments, the reservoir wall (304) thickness varies and has been thickened at and near the connection edge with the device rim (310).

[0119]

[0106] In some embodiments, the reservoir wall (304) may include the thickened portion (316) positioned proximally to the device rim (310). When the device rim (310) is being folded, the thickened portion (316) may create a tension in the reservoir (302) which pulls against the thickened portion (316) and allows the reservoir (302) to neatly and efficiently collapse into the device rim (310), promoting a compact form of the foldable menstrual device (300). In some embodiments, a thickness of the thickened portion (316) may be increased from 5% to about 300% in comparison to a thickness of the reservoir wall (304). In some embodiments, the thickened area (306) may have a width in the range from 0.3 mm to 1 mm.

[0120]

[0107] In some preferred embodiments, the reservoir wall (304) may be thickened at and near the bottom surface (306) of the reservoir (302). Thickening the bottom portion (306) of the reservoir wall (304) may help with maintaining the structural strength of the foldable menstrual device (300) and in particular with supporting vestige, while also maintaining the flexibility of the remainder of the reservoir wall (304) which may remain thinner than the bottom portion (306) and / or the area (316) at and near the connection edge with the device rim (310).

[0121]

[0108] Most preferably, the foldable menstrual devices according to this disclosure may include a thickened wall portion (316) at and near the connection edge with the device rim (310) and / or also at the bottom portion (306) of the wall (302). Some embodiments include reusable menstrual discs, while other embodiments include disposable menstrual discs.

[0122] Systems

[0123]

[0109] In another aspect, this disclosure relates to systems containing the foldable menstrual device (300) folded and positioned in the shaft (18) of the applicator (10), some of the technical advantages of which is that the systems ameliorate high deployment force by lowering friction between the menstrual device (300) and the applicator (10). The applicators (10) and menstrual devices (300) according to this disclosure may have one or more of the following features which help with achieving either a linear or exponential device (300) deployment dynamics.

[0124] [HO] The device deployment dynamic relates to a notion of how the device (300) is released out of the applicator barrel (12), while the device (300) deployment force describes the force it takes to push the plunger (14) through the barrel (12) to release the device (300).

[0125] [Hl] As for the menstrual device (300) deployment dynamic, one concern is explosive deployment dynamic. The “explosive” nature relates to how sudden the device (300) returns to its original shape after being released out of the barrel (12) due to its “squeezed” state. For example, causes for this explosive nature could be due to one or the combination of the following: 1) high deployment force, 2) how tightly the device is folded inside the barrel (12), and 3) durometer and elastomeric properties of a material used for the device (300). By mitigating high deployment force and by selecting a material with appropriate elastic properties, the explosive deployment dynamics may be avoided or minimized. Improvements for lowering deployment force by reducing friction between the device (300) and the applicator (10) are also included in this disclosure.

[0126]

[0112] In order to lower deployment force, one or more features may be included. The barrel wall (16) inner surface may or may not have a textured surface finish in some embodiments, and / or the exterior surface of the foldable menstrual device (300) may have a textured surface finish.

[0127]

[0113] The roughness of the surface texture may help with reducing the contact surface between the menstrual device (300) and the barrel wall (16) inner surface. However, if the surface texture is too rough, the deployment force could increase and thus, a good balance is required.

[0128]

[0114] In some embodiments, the menstrual disc surface finish may be uniform across the entire external surface of the menstrual device (300). In other embodiments, the rim (310) may have a textured surface finish different from that of the reservoir wall (304). The internal surface of the menstrual disc may or may not have the same textural surface as the external surface.

[0129]

[0115] In some embodiments, the menstrual device (300), the applicator barrel (12), and / or plunger (14) material may be formulated with a lubricative additive in order to reduce a friction coefficient. In some embodiments, a small amount, for example 0.25- 5 wt%, of a lubricant additive such as silicone oil or polytetrafluoroethylene (PTFE) may be added into the menstrual disc (300) material, the applicator barrel (12) material, and / or the plunger (14) material. A coating may also be applied to the inner surfaces of the barrel (12) and / or plunger (14), or on the exterior surfaces of the barrel (12) and / or plunger (14), or on the entirety of the applicator (10). Separately, it is also important to select the barrel (12) and plunger (14) materials that already include and / or are formulated with a slip agent. A slip agent is different than the addition of a lubricative additive. Lubricative additives are an addition to the barrel (12) and plunger (14) materials that need to be compounded by a compounder as described here, e.g. silicone oil. Both lubricative additives and slip agents help in reducing a friction coefficient.

[0130]

[0116] In some embodiments, the menstrual device (300) may be made of fluorosilicone and / or it may be coated with a coating which lowers friction. The coating may be applied to the entirety of the menstrual device (300) exterior surface, or it may be applied locally only to the rim (310) of the menstrual device (300). Suitable coatings may include, but are not limited to: a parylene coating, silicone conformal coating, and / or a silicone adhesive coating.

[0131]

[0117] In some embodiments, the device rim (310) may contain regions of variable thickness in order to reduce or increase the stiffness of the device rim (310). In some embodiments, a stiffening wire / rod / bead / etc may be incorporated into the device rim (310). A metal or thermoplastic stiffener may be insert molded into the device rim (310).

[0132]

[0118] In some embodiments, a reverse taper may be incorporated into the applicator barrel (12) inner diameter (ID), while maintaining a uniform taper on the barrel outer diameter (OD).

[0133]

[0119] To enhance usability and streamline an insertion process of the system according to this disclosure, the external surface of the barrel (12) and the external surface the plunger (14) may be embossed with an alignment mark or logo (70), which in some embodiments may be specifically the letter “F ” Additionally, this logo (70) may be also replicated on an internal surface of the menstrual device rim (310), preferably with a slight engraving and textured finish.

[0134]

[0120] The alignment mark or logo (70) is to guide users during the menstrual device (300) insertion process using the applicator (10) and ensure correct orientation. The location of the logo (70) on the menstrual device (300) (opposite to the pull string, at 180 degrees) signifies a folding / pinching point to fold the menstrual device (300) in half. The logo (70) on the menstrual device (300) also marks the entry point into the bottom (12P) of the barrel (12) first. The logo (70) on the barrel (12) indicates the direction where the opening of the device (300) should face, i.e., the opening (“front surface”) on the device (300) should face toward the “F” logo (70) on the barrel (12). Similarly, the logos (70) on the applicator barrel (12) and the plunger (14) allow users to align and insert the plunger (14) into the barrel (12) accurately, aligning the two logos (70s) on the same axis.

[0135]

[0121] Alternative symbols or alphabets may be also used as the logo (70). The logo (70) may be embossed or engraved (3D), but other methods can be also used, such as the logo (70) may be included in 2D such as by pad-printing and / or simply by adding a surface finish texture that would not be considered engraving or embossing. Alternatively or additionally the logo (70) may be tactile, visual, or encoded, including but not limited to a raised surface, ink, color contrast, or any method of printing elements such as logos, symbols, or markings.

[0136]

[0122] In other embodiments, each applicator part (12 and 14) may accommodate multiple logos (70), such as placing logos (70s) on both distal and proximal ends and / or on opposing sides of the plunger (14) and barrel (12) on both the major and / or minor axes. Similarly, the device (300) may have multiple logos (70s); for instance, two logos (70s) placed on opposing sides (180 degrees apart). In preferred embodiments, the two logos (70) would be positioned where the pull string (312) extends from the rim (310) and / or the reservoir (302) and to the opposite of that location.

[0123] Alignment of the logos (70s) along the same axis is vital for ensuring intuitive assembly and usability, particularly with elliptical-shaped applicators (10). For example, if a logo (70) is positioned on one end of the minor axis of an elliptical-shaped barrel (12), it should align with the same axis of the elliptical-shaped plunger (14), facilitating a smooth insertion process and improving the overall user experience.

[0137]

[0124] By providing clear visual cues and alignment markers through logos (70), the inventors mitigate user errors during insertion, allowing for consistent and intuitive orientation of the menstrual device (300), barrel (12), and plunger (14). This ensures proper insertion with the opening of the menstrual device (300) facing the cervix and optimizing usability for menstrual collection.

[0138] Manufacturing Methods and Uses

[0139]

[0125] Methods for manufacturing products according to this disclosure may include injection molding, two-shot molding, multi-shot molding, insert molding, co-molding, compression molding, over-molding, heat bonding / sealing / staking, radiofrequency sealing, ultrasonic / thermal impulse / radiofrequency welding, dip molding, thermoforming, vacuum forming and / or compression molding.

[0140]

[0126] In another aspect, this disclosure relates to uses of the menstrual devices and applicators according to this disclosure for personal care during a menstrual cycle.

Claims

1. CLAIMSWe claim:

1. An applicator for placement of a menstrual device, the applicator being composed of a barrel and plunger, the plunger being insertable into the barrel and movable inside the barrel, wherein the barrel is a hollow tubal body having a wall encircling a shaft having a diameter, the hollow tubal body having a length between a distal end and a proximal end, the hollow tubal body having a proximal end opening into the shaft and a distal end opening from the shaft, and wherein the plunger is a tubal body having a length between a distal end and a proximal end, the plunger being insertable through the proximal end opening into the shaft of the barrel and movable in the shaft along the length of the barrel, wherein the plunger has a proximal portion base having a diameter greater than the shaft of the barrel.

2. The applicator of claim 1, wherein- the barrel has two or more petal flaps, and wherein the two or more petal flaps are either directly attached to the distal end of the wall or the two or more petal flaps are sharing a common base attached to the distal end of the wall, the petal flaps located on the circumference of the wall and each of the petal flaps having a free edge suspended over the distal opening;- the applicator has a clicking mechanism between the barrel and the plunger, the clicking mechanism including one or more of the following:- one or more protrusions located on the external surface of the plunger at or near the proximal end of the plunger and mirroring recesses / divots located on the internal surface of the barrel at or near the proximal end of the barrel;- one or more recesses / divots located on the external surface of the plunger at or near the proximal end of the plunger and mirroring protrusions located on the internal surface of the barrel at or near the proximal end of the barrel;- one or more protrusions are located on or near the distal end of the outer plunger surface and one or more mirroring recesses / divots are located on or near the proximal end of the inner barrel surface, or vice versa;- the protrusions or recesses form a continuous structure around the full circumference; and / or- any combination thereof; and wherein the clicking mechanism enables one or more of the following functions: i) a clicking occurs when a plunger is fully inserted into the barrel; ii) a clicking occurs when a plunger is first inserted into the barrel; and / or iii) a combination of i) and ii).

3. The applicator of claim 1 or 2, wherein the applicator is further characterized by one or more of the following features:- the plunger comprises a hollow, semi-solid, or solid body;- the barrel is tapered toward its distal or proximal end;- the barrel wall comprises an overlap rim located at or near the distal end of the barrel;- the plunger and / or barrel includes one or more flat, raised, or recessed surfaces;- the plunger and / or the barrel having at least one area composed of a different material, preferably the material being TPE;- at least a portion of an external surface, at least a portion of an internal surface, or at least a portion or entirety of both surfaces of the barrel include a textured surface finish;- at least a portion of an external surface, at least a portion of an internal surface, or at least a portion or entirety of both surfaces of the plunger include a textured surface finish;- the barrel and / or plunger is made of plastic material formulated with a lubricant additive and / or a slip agent, preferably silicone oil or PTEE;- a coating applied to the internal surface, external surface, or both, of the barrel and / or plunger, or to the entire applicator; and / or- any combination thereof.

4. The applicator of claim 3, wherein the applicator is further characterized by one or more of the following features:- the overlap rim is recessed;- the overlap rim includes one or more protrusions extending distally from or near the overlap rim, the protrusions may have a spiral, straight, or any other suitable structure;- the overlap rim includes one or more mechanical interlocks, preferably open holes, partial depth holes, perforations, grooves, channels, or other structures formed on or near the overlap rim or on protrusions extending distally from or near the overlap rim; and / or- the overlap rim has one or more cut-outs.

5. The applicator of claim 1 or 2, wherein an external surface of the barrel and an external surface of the plunger contains one or more alignment marks located on an external or internal surface of the barrel and / or plunger, the alignment mark being configured to visually or tactilely indicate proper alignment between the two components.

6. The applicator of claim 1 or 2, wherein the barrel has the petal flaps injection molded with the barrel as a one piece, or the petal flaps are attached to a shared base that is attached to the barrel wall, by two-shot molding, multishot molding, overmolding, or the petal flaps are attached individually to the barrel wall by other molding or bonding methods including thermal bonding,ultrasonic bonding, adhesive bonding, chemical adhesion, mechanical interlock fusion or any combination thereof.

7. The applicator of claim 6, wherein the shared base of the petal flaps is attached to an optional overlap rim of the barrel, the overlap rim optionally being recessed and comprising one or more mechanical interlocks, protrusions, or surface features configured to secure the shared base.

8. The applicator of claim 7, wherein the protrusions are straight, spiral, or any other shape and / or the protrusions are perforated.

9. The applicator of claim 1 or 2, wherein the overmold and barrel wall are both made from the same or compatible polymeric or elastomeric material, or the overmold and barrel are made from material pairs selected from TPE and PP or PE, LDPE and HDPE, or TPU and PU.

10. The applicator of claim 1 or 2, wherein the petal flap includes a thickened region on or within the flap body, optionally shaped as a rib, wedge, or ridge, and configured to facilitate structural reinforcement and / or return of the petal flap to its pre-deployment position.

11. The applicator of claim 2, wherein the clicking mechanism includes one or more additional surface features selected from a second recess, divot, groove, or relief area and positioned proximally to a first clicking feature, the additional surface feature being located on either the barrel or the plunger.

12. The applicator of claim 1 or 2, wherein the plunger and / or barrel base is flared out.

13. The applicator of claim 1 or 2, wherein the barrel wall is cylindrical or elliptical and / or one or both of the barrel and plunger include one or more flat surfaces and optionally configured to mirror each other.

14. The applicator of claim 2, wherein the plunger includes one or more flatsurfaces, and the clicking mechanism comprises one or more protrusions located on or adjacent to one or more flat or curved surfaces of the plunger.

15. The applicator of claim 1 or 2, wherein the barrel includes one or more slits or notches located in the proximal portion of the barrel wall, the slits or notches optionally spaced at an angular position around the circumference.

16. The applicator of claim 1 or 2, wherein the proximal end of the barrel includes a curved contour extending around all or a portion of the circumference, optionally accompanied by one or more curved flaps with a flat or outwardly protruding grip regions located adjacent to or beneath the curved contour.

17. The applicator of claim 1 or 2, wherein one or more components of the applicator, including the barrel, plunger, overmold, petal flaps, is made of or coated with a biocompatible antimicrobial, antifungal, or biofilm-resistant additive.

18. A system comprising one or more of the applicators according to claim 1 or 2 and at least one foldable menstrual device having a bowl-like reservoir formed by a curved wall and capable of containing a volume of menstrual discharge, the foldable menstrual device having a bottom surface opposite to an opening to the reservoir, the curved wall having a rim located around the circumference of a distal edge of the curved wall.

19. The system of claim 18, wherein a portion of the curved wall adjacent to the rim is thickened relative to the rest of the wall, the thickening being internal, external, or both; and / or the menstrual device includes a pull feature selected from a pull string, pull tab, or integrally molded grip located on or near the rim or wall.

20. The system of claim 18, wherein the menstrual device comprises one or more alignment marks located on an internal and / or an external surface of the menstrual device.

21. The system of claim 18, wherein one or more components of the foldable menstrual device are made of or coated with a biocompatible antimicrobial, antifungal, or biofilm-resistant additive.

22. The system of claim 18, wherein at least a portion of an external surface, at least a portion of an internal surface, or at least a portion or entirety of both surfaces on the barrel, plunger, foldable menstrual device and / or the menstrual device rim includes a textured surface finish.

23. The system of claim 18, wherein the foldable menstrual device is made of fluorosilicone and / or comprises one or more friction lowering agents, including PTFE, silicone oil, slip agents or coatings including parylene or silicone conformal coatings, the agents being incorporated into the material and / or applied onto any portion of the menstrual device, including the rim, inner surface, outer surface, or entirety of the device.

24. A method of manufacturing the system of claim 18, wherein one or more components of the system are made by a method comprising injection molding, two-shot molding, multi-shot molding, insert molding, co-molding, compression molding, over-molding, heat bonding / sealing / staking, radiofrequency sealing, ultrasonic / thermal impulse / radiofrequency welding, dip molding, thermoforming, vacuum forming and / or compression molding.

25. The method of claim 24, wherein the method further comprises forming mechanical interlocks in the overlap rim of the barrel and applying a material of petal flaps or overmold, wherein the material contacts, surrounds, or at least partially permeates the interlocks.

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